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Vaccine Development Aided by New Techniques
November 1, 2008
Field Revitalized by In-Depth Understanding of Infectious Diseases and Immunology
Angelo DePalma, Ph.D.
The cyclical fortunes that have characterized the vaccines business for decades have swung decidedly positive, with no indication that they will slip again any time soon.
Today, vaccine development and manufacturing, more than perhaps any other area of biotechnology, are characterized by innovation, even daring. Developers tackle not just the easy targets like seasonal influenza but the most intractable communicable and noncommunicable diseases as well.
The industry has received several shots in the arm from the emergence of potentially pandemic viral infections, the threat of bioterrorism, and the promise of vaccination against noninfectious diseases such as cancer and heart disease.
“For years vaccines were considered a competitive, high-risk business characterized by low prices and high-liability exposure,” says Mike Kowolenko, Ph.D., svp for biotechnology at Wyeth. “Advances in our understanding of infectious diseases and immunology have revitalized vaccine development. Today’s vaccines are, therefore, more cost-effective and scientifically driven.”
Vaccine manufacturing has tracked development and manufacturing trends in biotech but has lagged by several years. Today’s developers increasingly seek to upgrade their production and expression systems, in favor of new cell culture technologies. Vaccine makers are beginning to adopt newer analytic techniques as well as more formal quality practices and methodologies like process analytic technology (PAT) and quality by design.
“Biotech was a black box back in the seventies,” notes Dr. Kowolenko. “It only became less so once we gained knowledge and understanding of those tools that influence process outcomes. Vaccine makers are now beginning to apply lessons learned from biotech.”
Vaccine makers must continuously innovate through manufacturing efficiencies, by concentrating on difficult targets, or by adding significant value to existing products.
For example Wyeth is looking to improve on its Prevnar pneumococcus vaccine, which is heptavalent, by developing a 13-valent product. “To do so requires the ability to control polysaccharide expression in bacteria, and to purify and conjugate those antigens,” Dr. Kowolenko reports.
In vaccines, the entry of even two or three competitors quickly relegates products to commodity status. This is what has happened, cyclically, to manufacturers of seasonal flu vaccine.
“The low-hanging fruit in vaccinology has already been harvested,” says Vijay Samant, CEO of Vical, which focuses exclusively on DNA vaccines. “If you’re going to be a player, pick a target nobody is working on and either get a head start, come up with a high-efficiency process, or figure out a way to provide long-term immunity.”
Vical has a Phase II DNA-based cytomegalovirus vaccine for treating bone marrow transplant patients and is working on products to combat SARS, Ebola, West Nile, herpes, and human immunodeficiency viruses, in addition to programs on dengue, angiogenesis, and melanoma. It is also developing a vaccine to prevent hematopoietic necrosis virus, a pathogen that spreads from wild salmon, in which it is harmless, to farm-raised salmon, which it kills.
“Vaccines made outside the human body are limited to generating antibody-mediated responses,” Samant notes. “The same is true for vaccines produced in cell culture. The only thing that comes close to generating the response from DNA vaccines are live attenuated vaccines.”
Vical manufactures its vaccines through fermentation of E. coli in 1,000 to 2,000 liter bioreactors. Fermentation is more productive and easier to standardize, validate, and scale, and presents fewer matrix impurities than cell culture. Also, with DNA vaccines, processes tend to be of the platform variety, suitable for almost any vaccine product.
Manufacturing DNA vaccines in weeks rather than months may provide a significant advantage when dealing with emerging infectious diseases such as pandemic influenza. “The speed at which we can make the vaccine is, in part, due to the fact that we do not need to handle the pathogen itself,” explains Samant.
Vical recently announced preliminary clinical trial data suggesting that its DNA vaccines safely induce significant human immune responses against H5N1 pandemic influenza.
The 100-person Phase I study demonstrated that the company’s Vaxfectin® adjuvant-formulated vaccine produced potentially protective antibodies, as measured by hemagglutination inhibition titers, similar to those of conventional vaccines. The data also suggests that the vaccine induces immunity to strains of H5N1 influenza not matching that of the vaccine. Cross-strain protection is key for utilizing vaccine stockpiled against rapidly-mutating viruses.
Alternative Delivery Mechanisms
DNA vaccines lend themselves to several novel gene-delivery systems including nonpathogenic viral carriers. In July, GeoVax announced it had engaged the services of Vivalis, to adapt the French company’s EBx® cell lines to produce modified vaccinia Ankara (MVA), a smallpox virus component of GeoVax’ DNA HIV vaccine.
MVA is an attenuated virus created by passaging 500 times in chicken cells. The result is a virus that grows easily in chicken cells, but cannot replicate within mammalian cells. MVA is programmed with genes coding for HIV proteins, which are then expressed in the cytoplasms of infected cells. Like other DNA-based vaccines, GeoVax’s early-stage clinical product induces both antibody and T-cell immunity.
Previously, GeoVax expressed MVA in cultured, attachment-dependent chicken cells in small, multiple vessels. Vivalis’ avian stem cell-derived EBx lines produce suspension cultures, allowing the GeoVax MVA component to be grown and scaled to appropriate volumes in bioreactors.
In addition to carrying genes for expressing three of the major antigenic HIV proteins—GAG (an internal structural protein), POL (polymerase), and env (envelope)—MVA serves as a kind of adjuvant and immunizes against smallpox in the bargain. According to Harriet Robinson, Ph.D., svp of R&D at GeoVax, the vaccine can be used as a therapeutic as well as a preventive measure.
“Aside from protective immunity, the vaccine might also serve to control viral load in HIV without the need to take antiviral drugs. Administered early enough, it might even prevent immune system damage.”
The success of Merck’s Gardasil HPV can only be viewed as encouraging for developers of vaccines based on virus-like particles (VLPs). VLPs are recombinant structures that mimic the size and shape of a virus, but lack genetic material and, therefore, the ability to replicate. Their ability to present antigens in the same configuration as viruses is believed to be the source of the immune response VLPs induce.
In August, Novavax reported favorable results from a Phase I/IIa trial of its pandemic influenza VLP vaccine candidate. The unadjuvanted vaccine targets an Indonesian strain of avian flu with fatality rates above 80%. In this study, the vaccine induced dose-dependent levels of strong neutralizing antibodies.
Disposable Processing to the Rescue
While Merck produces Gardasil in yeast, Novavax relies on baculovirus-transfected insect cell cultures. Novavax has teamed with GE Healthcare to develop an entirely disposable process for its VLP vaccine, claiming yields that are seven to ten times higher than for traditional egg-based or mammalian cell culture manufacturing.
Because baculovirus does not infect humans, manufacturing need not occur under strict biocontainment conditions. Plus, the flexibility of disposables permits rapid commissioning of manufacturing space, at a fraction of the cost for egg- or cell culture-based processes.
The Novavax manufacturing facility was constructed for less than $20 million. Compare that to the cost of a typical vaccine plant using multiple-use equipment, which is in the $200 million to $400 million range. According to Novavax, its VLP vaccines can reach clinics within three months of identifying a pandemic strain. Egg-based products take about six months.
Novavax operates a prototype facility in Rockville, which when fully operational, will feature a 1,000 L process capable of producing one million doses per week. This facility was built for less than $6 million, including facility renovation and equipment.
“The use of disposables allows us to shift 70% of costs to variable cost,” says Rahul Singhvi, Ph.D., president and CEO. Low costs allow Novavax to build manufacturing plants across the globe. Rather than stockpiling vaccines, these sites would create it on demand, in response to an outbreak of pandemic flu and unimpeded by travel restrictions likely to be imposed in the event of a pandemic. Such facilities could also produce seasonal flu vaccines. “And because our lead time is several weeks rather than half a year, we’d be able to release a vaccine before the first wave of infection hits the local population,” Dr. Singhvi points out.
Novavax is also working on a vaccine against seasonal flu. While current seasonal flu vaccines consist almost entirely of the hemagglutin antigen, Novavax’ development-stage product includes neuraminidase and matrix protein as well, and is, therefore, potentially more effective, according to the company.
Boosting the Immune Response
Vaccine developers have long believed that the right adjuvant can make a huge difference in the immune response to a vaccine. To date, only one adjuvant—alum—has been approved in the U.S., but several are under development.
FDA has been guarded about approving new adjuvants due to safety concerns, says Marc Mansour, Ph.D., vp for R&D at Immunovaccine Technologies (IVT). “Regulators recognize that alum is inadequate in many cases, and that we need better adjuvants,” he says. “But FDA is approaching the issue cautiously.”
IVT announced late in 2007 that it had successfully scaled up the manufacturing process for Vaccimax®, its vaccine platform that includes antigens, adjuvants, and liposomes. This work validates the suitability of the platform for commercial applications in therapeutic cancer and infectious disease indications. IVT expects to get its cancer formulation into Phase I by the end of 2009.
The manufacturing development was performed at Dalton Pharma Services, a cGMP contract manufacturer and development company. IVT hopes to out-license the platform for vaccines to treat cancer and infectious diseases.
Currently, IVT’s development-stage vaccines, which use short, synthetic peptide antigens, are targeted to cancer of the prostate, ovary, and breast. IVT is also researching vaccines against pandemic flu based on the usual HA antigens.
Like many small companies, particularly vaccine firms, IVT’s business strategy involves developing vaccines through mid-late clinical stages, then finding a business or licensing partner. “This type of deal is common in the vaccine business,” notes Dr. Mansour.
Related Link: http://www.genengnews.com/articles/chitem.aspx?aid=2651
Source: Copyright © Genetic Engineering & Biotechnology News, November 1, 2008
On The Move - ImmunoVaccine Technologis Inc. has been selected as one of Canada's Top 10 Life Sciences Companies
October 7, 2008
ImmunoVaccine Technologies, a vaccine development company, has been selected as one of Canada’s Top 10 life sciences companies. Winners are chosen by an independent expert panel of Canadian and U.S. venture capitalists. The award gives the firm the opportunity to present at the 12th Annual Ottawa Venture and Technology Summit this week.
Related Link: http://thechronicleherald.ca/Search/1083309.html
Source: Copyright © The Chronicle Herald, On The Move, October 7, 2008
Vaccine breakthrough heralds new cancer treatment
October 7, 2008
Some of the world's biggest pharmaceutical players have got their eye on a young Canadian firm with a vaccine technology that could soon be good news for cancer victims. Halifax-based ImmunoVaccine Technologies Inc. (IVT) has developed a vaccine platform called VacciMax® that could soon become a breakthrough treatment for cervical, breast, ovarian, prostate, colon and lung cancers. The NRC Industrial Research Assistance Program (NRC-IRAP) is pleased to have given the company a boost at an important stage of its vaccine development work.
Dr. Marc Mansour, Vice-President of R&D at IVT, says its vaccine technology was first developed for animal contraception. "Our core vaccine platform came to life in the 1990s when the researchers who founded IVT were helping the government humanely reduce the local seal population," he recalls. Using a unique formulation, that team created a single-dose contraceptive vaccine that kept seals from reproducing for the full ten years they were monitored.
IVT then turned its attention to protecting livestock from a variety of infectious diseases. Soon, Pfizer Animal Health saw that IVT's single-dose vaccine formulation would dramatically simplify the management of animal health. "We have signed agreements with Pfizer Animal Health to license our technology for use in livestock vaccines," adds Dr. Mansour.
Evidence is mounting that VacciMax® can be used with any antigen. "Whenever we present our results to venture capital firms, they are really excited about its potential," says Dr. Mansour. "But before investing, they want to see success in human clinical trials. So we are focusing on bringing our technology into the clinic as quickly as possible." The technology has broad applicability, so IVT has been exploring its use in hepatitis B, whooping cough and influenza vaccines.
NRC-IRAP recognized a winner when IVT approached it for support in 2003. "NRC-IRAP helped us demonstrate the efficacy of our platform with the seasonal flu vaccine, which was an important step in our current effort to develop an effective vaccine for pandemic influenza," says Dr. Mansour. "Thanks to this support, we were able to demonstrate an immune response that was four times stronger than with conventional influenza vaccines." The results from a single dose for hepatitis and whooping cough were equally impressive.
IVT is now exploring the technology's cancer fighting potential. "Immunotherapy for cancer follows the same principle as prophylactic vaccination, but with cancer you try to raise a different type of immune response," says Dr. Mansour. "The idea is that, if you can teach the immune system to respond strongly to a specific target, you can train it to recognize a cancer and kill it. But we needed to find out if we could do this with VacciMax®."
In 2004, the company launched a division to work on cancer immunology. "The Eureka moment came in our first experiment when we saw that, with a single dose, cervical cancer tumours disappeared in 100 percent of vaccinated mice," he says. "We also tried the formulation with a melanoma model, with the same astonishing results."
The company's next big breakthrough will be to demonstrate the efficacy of VacciMax® in treating cancer in humans. "This is a huge challenge because cancer has immune-regulating mechanisms that shut down the immune system enough to let the cancer grow, undetected," says Dr. Mansour. "We need a really potent vaccine to help the immune system recognize and attack the cancer despite its camouflaging capacity." With no other product in development reporting such pre-clinical success, VacciMax® looks like a very promising candidate. If everything goes according to plan, IVT will conduct its first phase of clinical testing in 2009.
NRC-IRAP is now developing another project with the company, which would bring IVT into a close working relationship with the Halifax facility of the NRC Institute for Biodiagnostics. Perhaps this collaboration will be a stepping stone to the cancer therapy the world has been waiting for.
Related Link: http://www.nrc-cnrc.gc.ca/highlights/2008/0810ivt_e.html
Source: Copyright © National Research Council Canada, October 7, 2008
ImmunoVaccine Wins Japenese Patent for Vaccine Technology
August 6, 2008
ImmunoVaccine Technologies, a vaccine development company, has received patent approval from the Japanese Patent Office for its vaccine platform.
The specific patent, vaccines with enhanced immune response and methods for their preparation, claims broad exclusivity that an effective, long-term immune response to treat a disease can be produced using a vaccine comprising of an antigen, an adjuvant, vesicles known as liposomes, and a hydrophobic carrier.
Securing broad patent coverage is said to be part of ImmunoVaccine Technologies's (IVT) strategy to maximize the market potential of its VacciMax platform in the pharmaceutical markets in the world; including the US, Europe, Canada, Australia and Japan.
The company's VacciMax technology is based on a novel approach to the use of liposomes in an oil emulsion. IVT has discovered that liposomes, stabilized in the VacciMax technology, significantly enhance antibody production, creating a more rapid immune response, following a single vaccination.
Randal Chase, president and CEO of IVT, said: "The issuance of the patent in Japan complements the US and European patents for our vaccine platform technology. We are watching the growth of the Asian market, and patent coverage in Japan is an important step in contributing to the wide reach of our vaccine products."
Related Link: http://www.redorbit.com/news/health/1513125/immunovaccine_wins_japanese_patent_for_vaccine_technology/
Source: Copyright © The Red Orbit, August 6, 2008
Biotech startup wins startling support from local investors
June 23, 2008
By BILL POWER Staff Reporter
Private investors, most of them in the greater Halifax area, ponied up $11 million to back ImmunoVaccine Technologies Inc. as the biotech startup heads toward human testing of its needle-free vaccine platform.
"This is private investment from high net-worth individuals in Atlantic Canada at a time when it’s getting harder to interest investors in biotech in North America," vice-president Brian Lowe said.
He said the "overwhelming response" of local investors speaks to the power of the technology and the credibility of the management team, which is reviewing a number of options for institutional investors to raise at least another $8 million. The firm is ramping up for human testing of the needle-free platform for cancer vaccines sometime in 2009.
Private investment in the Halifax biotech operation cleared the $11-million mark in May after ImmunoVaccine Technologies orchestrated an interim round of financing for $1.5 million from private equity investors.
"I’ve certainly never heard of this much money being raised through private individuals in Atlantic Canada," said Mr. Lowe.
ImmunoVaccine is one of the few companies to emerge from Dalhousie University’s research laboratories and has received significant buzz in the industry for its needle-free technology that can be used to treat cancer and infectious diseases in a single dose.
The company, which operates on the Halifax waterfront, has received about $3.8 million from the Atlantic Canada Opportunities Agency and is currently negotiating an additional $3 million from the government agency, said the vice-president.
The company has also received support from the National Research Council’s Industrial Research Assistance Program, said the vice-president.
Officials with ImmunoVaccine participated in the BIO International Convention in San Diego last week, which attracted more than 20,000 scientists and entrepreneurs.
Mr. Lowe said the company has already exceeded Health Canada and U.S. Food and Drug Administration requirements toward a 2009 start of clinical trials with humans.
( bpower@herald.ca )
Related Link: http://www.thechronicleherald.ca/Search/1063708.html
Source: Copyright © The Chronicle Herald, June 23, 2008
VacciMax maker set to start clinical trial
January 24, 2008
By Bruce Erksine Business Reporter
ImmunoVaccine Technologies Inc. of Halifax is moving forward with a Phase 1 human clinical trial application for its VacciMax vaccine enhancement platform.
"We are seeing impressive pre-clinical results with the VacciMax platform," Dr. Randal Chase, president and CEO of ImmunoVaccine, said in a release Wednesday announcing that the bioscience firm has met with Health Canada regulators to discuss application requirements for the trial, which will combine new antigens with the VacciMax platform.
The platform stimulates earlier, more powerful and longer lasting immune responses that could provide new ways to treat cancer and infectious diseases.
ImmunoVaccine vice-president Brian Lowe said in an interview Wednesday that the firm, which plans to meet with U.S. Food and Drug Administration officials in June, hopes to begin the Phase 1 clinical trial in January 2009 and complete it by June 2009.
ImmunoVaccine, which is getting $3 million in funding from ACOA’s Atlantic Innovation Fund to develop new vaccines for enhancing human immune systems, is also conducting a Phase 1 clinical trial in the United States through Immunotope, a Pennsylvania bioscience firm it acquired last year.
That trial, which is not based on the VacciMax platform, will evaluate the safety of candidate antigens for a therapeutic vaccine in ovarian and breast cancer patients.
Earlier this month, ImmunoVaccine licensed its technology to Pfizer Animal Health, a division of Pfizer Inc., the world’s largest drug maker, for the potential development of livestock vaccines.
( berskine@herald.ca)
Related Link: http://www.thechronicleherald.ca/Search/1033675.html
Source: Copyright © The Chronicle Herald, January 24, 2008
Atlantic projects get $63m
January 22, 2008
Bioscience firm among 8 N.S. companies receiving ACOA help
By BRUCE ERSKINE Business Reporter
ImmunoVaccine Technologies Inc., a Halifax bioscience company, is getting $3 million from the Atlantic Canada Opportunities Agency’s Atlantic Innovation Fund for a $6-million project to develop new vaccines for enhancing human immune systems.
"Having ACOA recognize the market potential of our innovative vaccine platform is a tremendous boost," company vice-president Brian Lowe said in a release Monday. "This funding will enable us, over the next three years, to create novel vaccines for the treatment of cancer and infectious diseases."
The funding is the maximum granted to a private company under Round 5 of the federally funded innovation find, which is designed to increase leading-edge research and development in Atlantic Canadian research facilities.
ImmunoVaccine says its VacciMax platform can stimulate an earlier, more powerful and long-lasting immune response that could provide new ways to treat a wide range of diseases.
The company, which last year purchased Immunotope Inc., a Pennsylvania biotechnology firm that develops products to treat and prevent cancer and infectious diseases, said VacciMax has broad potential medical applications, including prostate, breast, cervical, ovarian, colon and lung cancer treatments, as well as vaccines for pandemic influenza and other infectious diseases.
"We’re moving into our own human clinical trials with therapeutic cancer vaccines in early 2009," Mr. Lowe said. "If they successfully treat cancer, it opens up a lot of opportunities to hook up with big pharmaceuticals."
ImmunoVaccine employs 19 people, and Mr. Lowe said the funding will allow the company, which grew out of research done at Dalhousie University, to hire five more scientists over three years.
The ImmunoVaccine funding was part of $63 million in Atlantic Innovation Fund investments announced Monday for 29 regional research and development projects, including eight in Nova Scotia that will receive up to $17.4 million in funding.
Other Nova Scotia projects receiving funding include Dalhousie, which will receive up to $2 million to develop a lung function monitor; St. Francis Xavier University, which will get up to $1.8 million to study the long-term development capac-ity for geothermal and wind energy in Atlantic Canada; and Halifax’s Capital district health authority, which will get up to $2.7 million to develop a diagnostic tool for orthopedic implants.
The Nova Scotia Agricultural College in Bible Hill will receive up to $1.9 million to lead a research project to revitalize the rural fruit industry in the Atlantic region.
METOCEAN Data Systems Ltd. of Dartmouth will get up to $1.3 million to develop an ocean subsurface profiling instrument that can be launched from planes or helicopters and used in a variety of fields from oceanography to weather forecasting.
The Nova Scotia Community College campus in Middleton will receive up to $3 million to develop a suite of tools for the environmental assessment and management of watershed quality.
Acadian Seaplants Ltd. of Dartmouth will get $1.7 million to commercialize two new seaweed food products for the Japanese export market and develop rapid screening methods for potential species suitable for its land-based cultivation operation in Shelburne County.
( berskine@herald.ca)
Source: Copyright © The Chronicle Herald, January 22, 2008
Pfizer licenses local pharmaceutical
January 15, 2008
Health Drug giant to give global reach to vaccine booster
BY ANDREA MACDONALD
The Daily News
Pharmaceutical giant Pfizer, the maker of Viagra, has chosen a Halifax company's product to treat infectious diseases in livestock.
ImmunoVaccine Technologies is licensing its technology for VacciMax to Pfizer Animal Health Inc. The product enhances current vaccines by boosting antibodies and thus allowing a greater immune response.
Terms of the agreement have not been released, but IVT will receive upfront signing fees as well as milestone and royalty payments.
It's a dream come true for IVT, which never intended to take VacciMax to market on its own, because to do so would cost hundreds of millions of dollars.
The deal has been in the works since 1993, when someone from Pfizer noticed the IVT website and the company began working with IVT on its technology - running trials in livestock, conducting an evaluation and entering into an option-to-license agreement.
IVT vice-president Brian Lowe said yesterday that it took some time to agree on terms, but the end result is "very exciting."
"They're the world's largest animal-health-care company when it comes to vaccines and for us to have them license our technology says a lot, no question."
Pfizer has been granted worldwide exclusive licensing rights for the technology, which represents a major step for IVT.
"To date, we've been solely reliant on investor equity as working capital and now this is monumental in that it's showing that our technology can get out of the gates and generate revenue," Lowe said.
This is just the beginning, Lowe added. He hopes Pfizer will extend VacciMax to more vaccines. IVT recently proved its technology can be scaled up to human applications and is looking at starting its own human clinical trials in early 2009 for ovarian and breast cancer.
How long VacciMax may take to get to market with Pfizer depends on each country's regulatory-approval process.
Pfizer Animal Health Inc. spokesman Rick Goulart said yesterday that IVT's technology is "very attractive," but refused to be more specific.
amacdonald@hfxnews.ca
Related Link: http://www.hfxnews.ca/index.cfm?sid=98137&sc=96
Source: Copyright © The Daily News, January 15, 2008
ImmunoVaccine Signs Pfizer Animal Health As First Customer
January 15, 2008
By Johnathan Matsey
DowJones VentureWire
A month after agreeing to acquire cancer vaccine company Immunotope Inc., Canadian vaccine enhancement company ImmunoVaccine Technologies Inc. has signed Pfizer Inc.'s animal health division as its first customer.
Financial terms of the Pfizer deal were not disclosed, but Brian Lowe, vice president at IVT, said it will provide multi-year revenue in the firms of an upfront fee, royalties and milestone payments.
Based in Halifax, Nova Scotia, IVT was founded in March 2000 as a spin-out of Dalhousie University, which has a stake on the company. The company has developed a non-viral platform, called VacciMax, which uses liposomes to create an immune response against select cancers. "We've developed a novel vaccine-enhancement platform," Lowe said. "[ Pfizer] wanted to see if it would give an advantage to their vaccines in the marketplace."
Lowe said IVT and Pfizer Animal Health have been in discussions since 2003, a time period which included a two-year internal trial of VacciMax by the drug giant.
While the Pfizer deal covers livestock vaccines, Lowe said the company's main therapeutic area remains people - a strategy sometimes employed by start-ups to generate quick cash from the veterinary and agricultural markets to bankroll more expensive human trials. "Our focus is entirely in human health," he said. "This deal presents us with some early revenue."
The deal comes a month after IVT signed a deal to purchase Immunotope, a clinical-stage company backed by Ben Franklin Technology Partners of Southeastern Pennsylvania, which will give IVT U.S. operations. Lowe said Pfizer is the first customer for either of the companies. "Not unlike Immunotope, IVT has been more of a research-and-development company," he said.
To date, IVT, with 19 employees, has raised C$10 million in angel funding and C$5 million in government grants, Lowe said. The company, working in conjunction with Immunotope, is actively fund-raising for a possible $30 million round.
Source: Copyright © Dow Jones & Company, Inc. January 15, 2008
MaxiMum impact
December 23, 2007
ImmunoVaccine Technologies poised to become a major international player in the race to find a cure for cancer
By Bill Power, Staff Reporter
JUST ABOUT EVERYBODY knows and loves somebody who is fighting for life against the devastation of cancer.
Perhaps this is why there are so many hopeful eyes on ImmunoVaccine Technologies Inc. of Halifax, which plans several moves in 2008 to place its VacciMax immunization platform front and centre in the international race to find a cure.
Investors are also watching the small biotechnology company with big ambitions that got its start five years ago and now has a laboratory on the Halifax waterfront and corporate offices on Granville Street.
"Our technology is very broad-based; it appears to apply to every instance that we’ve looked at, both animal and human," Randal Chase, CEO and president, said in an interview.
"ImmunoVaccine Technologies is about delivering vaccines," Mr. Chase said.
"What was developed originally at Dalhousie University and was spun off as a separate company . . . was an ability to make a vaccine work better than, frankly, had every been observed before."
There has been a big buzz in the Atlantic regional life-sciences sector about the ability of this locally researched and developed technology to trigger the immune system to fight cancer cells and a range of infectious
diseases.
The ability of the VacciMax platform to deliver a single-shot immunity vaccine, as in the event of a flu pandemic, has dramatic implications for the field of public health, as most immunization vaccines require two shots over 30 days.
"When you’ve got a disease that is killing millions, you do not want to wait a month," Mr. Chase said.
In laboratory tests conducted on models for melanoma and cervical cancer, the VacciMax platform was proven effective in eliminating 100 per cent of tumours.
The results created a stir among international cancer researchers.
"It creates a stronger response and a longer-lasting response," said Mr. Chase, a biochemist with a list of achievements in the biotechnology and pharmaceutical sectors who joined the company after company founder Warwick Kimmins died of cancer in August.
Soon after bringing the VacciMax platform to market, the Halifax company moved to acquire Immunotope Inc., a Pennsylvania biotechnology company developing immunotherapy products for the treatment and prevention of cancer and infectious diseases.
This move gave ImmunoVaccine the opportunity to create a line of proprietary therapeutic vaccines aimed at cancer and infectious diseases.
"This also gives us a U.S. address, which is very important when attracting investors," said Mr. Chase.
In the fall, the company also attracted some major biotechnology and cancer researchers to serve on its scientific advisory board.
ImmunoVaccine has completed scale-ups of VacciMax to show the product can be produced in volume and retain its effectiveness, and the company is also preparing to begin clinical trials of its own anti-cancer
vaccine.
"There is a huge amount of work going on worldwide in this field and a lot of progress is being made, but nobody has been successful yet," Mr. Chase said.
"The reason is that the body responds, but not quite strongly enough. And our technology would appear to maybe be the opportunity to give it the boost it needs, to give it that extra response that has been lacking.
"The idea that you can have a product that works wonderfully well after a single dose is an idea that meets some profound needs."
Related Link: http://thechronicleherald.ca/Business/999823
Source: Copyright © The Chronicle Herald, December 23, 2007
ImmunoVaccine Buys Immunotope
December 11, 2007
Byline: Trista Morrison, Staff Writer
ImmunoVaccine Nabs Immunotope
ImmunoVaccine Technologies Inc. agreed to acquire Immunotope Inc., combining the two companies efforts in vaccine development.
Both companies are privately held, and terms of the deal were not disclosed.
Halifax, Nova Scotia-based ImmunoVaccine is best known for its VacciMax® vaccine platform, which uses liposomes to enhance humoral and cell-mediated immune responses. The approach has been tested in various cancer and infectious disease models, and ImmunoVaccine is in the process of optimizing and validating the manufacturing process to prepare for clinical trials.
Doylestown, Pa.-based Immunotope is conducting a Phase I trial with IMT-1012, a multivalent therapeutic cancer vaccine that combines 12 antigens each targeting different pathways in ovarian and breast tumors. The product arose from Immunotope’s panels of tumor signature antigens, which also can be used to develop biomarker-based diagnostics. The company is using grant funding to pursue identification of autoantibody signatures associated with ovarian and prostate cancers for use in diagnostics; it is also collaborating with partners to apply its platform to infectious diseases.
ImmunoVaccine said it would continue to support Immunotope’s ongoing Phase I trial. The deal is expected to close in June 2008.
Source: Copyright © BioWorld Today, The Daily Biotechnology Newspaper
On The Move - 2007 Discovery Awards for Science and Technology
December 5, 2007
The 2007 Discovery Awards for Science and Technology were handed out recently in Halifax. Recipients included David Lane of Saint Mary’s University — science; ImmunoVaccine Technologies, developers of the VacciMax® vaccination for HPV and cervical cancer —innovation; Michael Quilliam, principal research officer with Halifax’s Institute for Marine Biosciences — professional of distinction; Christine Chambers, associate professor of pediatrics and psychology, Dalhousie University and department of pediatrics, IWK Health Centre — emerging professional; and Oliver Hatheway and Darren Rhodenizer of Park View Education Centre, Bridgewater — youth award. Three people were also inducted into the Nova Scotia Hall of Fame for Science and Technology — Frederic Sexton, founder of technical education in Nova Scotia; Ransom Myers, a world leader in large marine animal analysis; and Robert Ackman, co-founder of the Canadian Institute of Fisheries Technology. Awards were also presented to Graham North, a journalism student from University of King’s College; and Kelly Maguire of Mount Saint Vincent University’s bachelor of public relations program for their achievements in BioNova’s Life Sciences Scrum.
Source: Copyright © The Chronicle Herald, On The Move, December 5, 2007
Vaccine Ready for Market
December 5, 2007
A Halifax company’s vaccine delivery system will soon be produced on a commercial scale.
By successfully producing VacciMax® at a commercially relevant batch size, ImmunoVaccine Technologies Inc. plans to license its vaccine technology worldwide for the therapy and prevention of cancer and infectious diseases.
Source: Copyright © The Daily News, December 5, 2007
Playing the Game to Win
November 28, 2007
The Making of a Block Buster
By Peter Moreira
A novel product that prevents and eradicates cancer? That's what the test data shows. As ImmunoVaccine Technologies moves into clinical trials, the region gets a shot in the arm.
When scientist Warwick Kimmins set out to control seal populations on Sable Island in the 1990s, he had no idea that a decade later he would be overseeing a start-up biotech company with the potential to be the manufacturer of a blockbuster product that can help cure cancer. He also wouldn’t have predicted that his company’s efforts to raise seed financing would give birth to the region’s first organized angel financing network.
The company is Halifax–based ImmunoVaccine Technologies (IVT), and its signature product is called VacciMax®, a patented vaccine platform that destroys cancer cells. Kimmins, the company’s founder, passed away in August after a year-long battle with colon and liver cancer. His legacy lies in the development of a therapeutic treatment for cancer through the use of vaccines. When a therapeutic cancer vaccine is formulated into VacciMax® and then injected, VacciMax® safely and effectively delivers the vaccine, which enhances the body’s antibody production.
Therapeutic cancer vaccines are a new trend, with huge potential in cancer research as an alternative to traditional and painful treatments such as chemotherapy or radiation. Today Kimmins’ company is on the verge of entering a long expensive process of getting its vaccine platform approved for human use by regulators in Canada, the United States, and the European Union. If successful, the IVT team hopes to partner with a major pharmaceutical company with the resources to develop and market the product internationally.
The team is also talking openly about the possibility that this vaccine platform—which was discovered, developed, and largely financed in Atlantic Canada—could become a blockbuster, one whose sales could be in the billions. So far only 84 of these platforms have been developed worldwide. “This is exciting, and it may have global importance,” says Randal Chase, a veteran of the biotech industry who became the company’s CEO in late 2006. “People are thrilled by the fact that this was developed at Dalhousie University.”
To recognize the importance of VacciMax®, you first must understand what it is. It’s not a vaccine in and of itself; rather, it’s a liquid mixture of oils and substances called liposomes and adjuvants that form a “vaccine-enhancement platform,” or a delivery system for vaccines. In other words, if a patient needs a vaccine that will cure a disease such as cancer, VacciMax® intensifies the effects of the therapeutic vaccine; it efficiently activates the immune system to ensure a robust response.
To date, VacciMax® has been tested in proof of principle tests in mice with cancer, and the results have been astonishing. “It’s some of the strongest data I’ve seen in my career,” says Chase. So far the platform has been used with vaccines to treat lab mice with cervical cancer and skin cancer. The tests show that even a single vaccination applied with VacciMax® not only prevents the growth of tumours but also can destroy cancer cells and tumours.
STARTING WITH SEALS
In the 1990s, when Kimmins was the dean of science at Dalhousie University, officials at National Sea Products Ltd. (now High Liner Foods Inc.) asked him to help them come up with a humane way to control the overabundant North Atlantic seal population, which was devouring tons of fish annually. Kimmins and a team of Dalhousie scientists devised a birth control medication for female seals, but there was a major problem: the drug had to be administered several times throughout the year, and the seals came ashore to give birth only once a year. How, then, could they administer and track the medication? The team developed an immunocontraceptive vaccine called SpayVac, a combination of adjuvants and oils that would release the drug slowly over a set period of time. Kimmins’ team made annual outings to Sable Island when the seals came ashore to give birth and found that over the years, the 300 seals they had inoculated were not reproducing. Then Kimmins discovered that other scientists around the world were using the same birth control medicines to inoculate seals, but without any luck. The team realized that the reason for their success must be the platform, or the delivery method, being used to administer the vaccine.
Kimmins also knew the market value lay in producing a platform that could administer drugs to humans, so in 2000 he and three Dalhousie scientists formed ImmunoVaccine Technologies, with the intention of developing and commercializing a platform for cancer vaccines that would eradicate tumours more effectively and with a single inoculation. As the inaugural CEO, Kimmins spent most of the first year successfully negotiating with Dalhousie for the intellectual property to SpayVac, which had been developed with $4.3 million in donations from National Sea Products and the Department of Fisheries and Oceans.
The team also had to transform its band of scientists into a company. A major move occurred in 2000 with the appointment of COO Brian Lowe, who, from the early 1980s to 1994, had started and sold three environmental companies based in Dartmouth. Using his network of local contacts, Lowe went to work raising money for the fledgling enterprise. Since then the company’s funding has included $450,000 in donations from charitable organizations and $4.2 million in grants and interest-free loans from such public sector organizations as the Atlantic Canada Opportunities Agency.
The most important fundraising factor is the $8.9 million from 107 private investors, about half of whom hail from Nova Scotia. IVT’s most recent round of fundraising took place earlier this year, when it raised $2.4 million, 20% more than its goal. The latest round values the company at about $30 million. “We’ve had amazing support over the years from our original angel investors,” says Lowe, “but now we’ve got investors spanning the globe, in the U.K. and South Africa.”
What Lowe and Chase stress about the shareholder base is that it’s almost exclusively composed of wealthy individuals. One exception is Dalhousie University, which owns 2% of the company. The fact that there is no institutional investment in the company means that IVT has complete flexibility in its financing options as it enters the capital-intensive phase of its development. There are no strings attached to its equity holdings or its loans, so it could raise money through more individual contributions, by bringing in venture capital investors or through an IPO.
Why is the next phase going to require so much capital? Because the company must establish that it has the following components: a product that can be reproduced economically in commercial quantities; a product safe for use in humans; and a product that helps prevent or cure diseases in humans.
"This is where medicine is headed and this is where business is headed. All the big pharmas are getting into vaccines”
Randal Chase, CEO, ImmunoVaccine Technologies
Since VacciMax® is a platform for vaccines that treat various diseases, it will have to gain regulatory approval for each disease, all of which is going to take money.
The founders of IVT knew they would one day be facing this phase of their development, and in preparation they arranged to bring in a drug-development veteran to marshal them through the approval process. Last December Kimmins stepped aside as CEO to become chair, and Chase became CEO. Chase, who commutes weekly between his home in Aurora, Ont., and IVT’s Halifax office, has more than 30 years of experience in the biotech and pharmaceutical industries, including heading startups (he was president of Shire, a global biopharmaceutical
company) and sitting on boards of corporate giants such as Bristol Myer and BIOTECanada.
In particular, Chase has experience developing vaccines, which he describes as the most exciting area of medicine, because only vaccines can eradicate a disease. As evidence, he points to smallpox, which has been eradicated by vaccine, and polio, which has almost been wiped out. “This is where medicine is headed and this is where business is
headed,” says Chase. “All the big pharmas are getting into vaccines.”
FINDING THE FUNDS
Chase and his team spent this past summer working with Toronto’s Dalton Chemical Laboratories establishing a method to produce marketable quantities of VacciMax®. By November, IVT expects to produce the vaccine platform in 10-litre to 50-litre batches, big enough to establish the large-scale manufacturability of the platform and prove its commercial viability.
IVT has retained PricewaterhouseCoopers to secure $40 million in the global finance market. The capital is required to see the company through its Phase 1 approvals, which assess the vaccine platform’s safety, for the treatment of cervical cancer, which it predicts will cost roughly $6 million. IVT plans to file its application in the fourth quarter of 2008 with the hope of achieving approval in 2009. After that it will spend at least 18 months to two years, and about $25 million to $30 million, going through Phase 2 approvals, which assess the platform’s effectiveness in humans.
Of all of the various scientific and business variables that will be at play throughout the process, perhaps the biggest is who will actually own the company when it’s all said and done. Chase and Lowe know that they need the assistance of a pharmaceutical giant to market the vaccine platform, if it is to be successful. However, the company’s prospectus says that it could either exist as an independent public company, making its money through licensing agreements with pharma giants, or it could simply sell out to a big corporation.
The beauty of its position is that the backing of its shareholders allows it to put off that decision for some time, which should mean a bigger payday at the end for Dalhousie and the other 50 or so Nova Scotian investors. “Developing a drug is not a fast process,” says Chase. “Beginning to end, you’re probably looking at seven years. But if you’re successful, the market is enormous.”
Source: Copyright © Progress Magazine November 2007
Vaccine company on verge of breakthrough
October 13, 2007
By Andrea MacDonald – The Daily News
Brian Lowe is asking shareholders to have a little patience.
He believes his company is on the verge of a major breakthrough: a vaccine that eradicates cancerous tumours in mice that could eventually be used in humans.
But it’s early days yet in a race fraught with hurdles.
Lowe is chief operating officer of ImmunoVaccine Technologies Inc., a Halifax company whose single-dose VacciMax proves long-term protection with no significant side effects and requires no booster shot.
Incorporated in March 2000, IVT started off in animal infectious diseases. In 2004, it branched out to human health. Today, the company focuses largely on therapeutic vaccines for cancers such as cervical and melanoma, not to mention flu and whopping cough.
Results have been extremely promising in clinical trials involving mice genetically cloned to replicate humans.
Scientists initially injected the mice with cancer cells, which formed huge tumours and made them very ill. Within 14 days of receiving the vaccine, each one became tumour-free and perfectly healthy. The mice were re-injected and no new tumours formed. The trials were repeated three times with the same results.
In October 2006, IVT held a cancer workshop in Halifax to show off its findings.
“The experts who attended said it was just striking data, and the sooner we can move into humans, the better,” Lowe said yesterday at Atlantic Canada Opportunities Agency’s Atlantic Art of Success conference. IVT was one of 20 successful entrepreneurs recognized byt ACOA as part of its 20th anniversary celebrations.
Several years ago, IVT received $3.8 million through ACOA’s Atlantic Innovation Fund. It was the largest such awards for any privately held company in Nova Scotia and gave the company credibility and the chance to leverage other private-equity capital.
Wealthy individuals have kicking in about $10 million to help finance the first phase of the human clinical trials. IVT hopes to start injecting people in the last quarter of 2008.
The company has no intention of taking its vaccine all the way to market, which would cost hundreds of millions. Instead, it plans to license the technology to a large pharmaceutical company.
“Some of these companies came to us when they only had an embryonic idea on a piece of paper,” ACOA spokesman Richard Gauthier said of the 20 companies recognized this week.
“And we and other partners had a role to help them along, build their business case and in many instances, they-re one of the leading companies in their sector in Atlantic Canada.”
amacdonald@hfxnews.ca
Source: Copyright © The Daily News
Biotech needs cash injection
September 28, 2007
By Bill Power Business Reporter
There is nothing wrong with the life sciences industry in Nova Scotia that some big handfuls of cash could not cure.
This appeared to be the consensus at the BioPort Atlantic conference in Halifax on Thursday, as scientists and business people from around Atlantic Canada gathered to discuss ways to take their products to international market.
There was a similar message from Michael Dennis of science development at the Chezzetcook headquarters of Bluebio Sustainable Biotechnology Inc., which is beginning to marker a line of microbe-infused, environmentally friendly cleansers that munch on petroleum byproducts.
"It's a product that allows for solvent-free cleansing of oily machine parts that has applications in the automotive, aerospace, marine and rail industries," said Mr. Dennis.
The company is about to begin some local distribution of its SmartWasher product line, but with some serious financial backing could ramp up production, new product development and profits, he said.
Some people working in the biotech and life-science industries had a chance to pitch their products during the two-day conference.
"This year, we're focusing on exports and the impact the life science sector is having on the region’s economy," said Marli MacNeil, CEO of BioNova, the industry organization that hosted the event.
She said more than 3,400 people work for Nova Scotia's life sciences companies and research institutions, which have sales of about $200 million annually.
Accomplishments in research and development in the province include the patent for the VacciMax long-duration vaccination platform, held by ImmunoVaccine Technologies Inc. of Halifax.
"We're growing by leaps and bounds," said Ella Korets-Smith, the research company's associate director of business development.
"We have 20 employees and plan to expand in the near future."
(bpower@herald.ca)
Source: Copyright © The Halifax Herald Limited
Prescription for Success
July 5, 2007
Atlantic Business Magazine
By Beste Alpargun
Some scientists in Halifax are excited – for good reason.
They are moving nearer to the commercialization of a novel vaccine technology that helps ensure a long period of immunity with a single dose without significant side effects. The VacciMax® platform, which can improve existing vaccines or help in the development of new vaccines for humans and animals, has the potential for both preventative and therapeutic use. This includes vaccines in the pipeline for infectious diseases and cancer.
Let us put this into perspective. According to a report from Kalorama Information, the global vaccine market is expected to top US$10 billion in 2007 and US$23.8 billion in 2012. The most dramatic growth is predicted to occur with vaccines for influenza (estimated US$ 4 billion) and hepatitis (estimated US$ 1.5 billion in 2012). Another high-growth segment will be cancer vaccines, which currently sit at US$ 135 million but are forecast to hit US$8 billion in 2012.
This is a huge market for a small, early-stage company like ImmunoVaccine Technologies Inc. and its technology, VacciMax®. So what is the company’s strategy?
The starting point is science. ImmunoVaccine Technologies (IVT), a spin-off from Dalhousie University, has been evaluating its platform in a number of different applications in the pre-clinical setting. An early demonstration came with the development of SpayVac®, an immunocontraceptive animal fertility control vaccine. A single SpayVac® immunization results in multi-year contraceptive immune response in a variety of animals. Also VacciMax® has been examined in cancer and infectious diseases applications using a number of animal models. Researchers discovered that VacciMax® can eliminate 100% of HPV-induced tumors and melanoma tumors in mice and humanized mice.
These are a few success stories among the series of studies conducted by IVT. The company also maintains a close relationship with Dalhousie University, a significant source of research and researchers.
The second phase of the strategy is management and governance. The chair of the board, Dr. Warwick Kimmins, is a co-founder of the company. In 2004, Denis Ryan (investment banker and businessman) and Wade Dawe (businessman, President and CEO of Linear Gold) joined the board and brought with them significant networking capabilities especially in terms of financing. Brian Lowe, a board member and COO, has been instrumental in the company’s initial funding as well as for its start-up in 2000. Last year, Dr. Randal Chase joined IVT as President and CEO. He is well known in the biotechnology and pharmaceutical sectors and has three decades of experience on which to draw. Dr. Chase is expected to open many doors for IVT with his vision and his expertise.
Which brings us to phase three: funding. In order for early-stage companies to succeed, they need sufficient and sustainable funding (not to mention patient investors). Since its incorporation, IVT has been successfully funded through a number of sources. To date, the company has raised approximately $8.9 million in private equity and $5.6 million from governmental and charitable sources which includes an award of $3.8 million from the Atlantic Innovation Fund. For the current fiscal year, the company has roughly $4.1 million of working capital.
For Atlantic Canadians and for investors the bottom line is promising. There is an emerging industry growing in our backyard. Biotech companies like IVT are attracted to this region because of the steady supply of scientists we have to offer. Once such companies take root, as many have, they can and will draw the attention of larger firms.
In IVT’s case, the company is poised for take off. Yes, the human trials will take time, but there will be many options in front of a successful biotech company like this.
One of those options is to complete the commercialization stage with strategic and/or financial partners and generate revenues through licensing fees, milestone payments, and royalties. This may be en route to going public when the time is right. Another option is to be taken over by a larger pharmaceutical company with greater resources and market reach.
Either way, ImmunoVaccine Technologies should be on investors’ radar.
Source: Copyright © Atlantic Business Magazine July/August 2007
Halifax Biotech Company Developing Cancer Vaccine
September 28, 2006
The Chronicle Herald
By Clare Mellor, Business Reporter
Early-stage firm seeks partners
Researchers at a Halifax-based biotech company have destroyed huge cancer tumours in mice with their new vaccine technology. ImmunoVaccine Technologies hopes to soon be able to start Phase 1 clinical trials of its technology on humans.
"We truly do, as we see it, have a breakthrough in cancer," Brian Lowe, ImmunoVaccine’s chief operating officer said Wednesday. "We were successful on repeated trials, three times, totally eradicating the tumours and rendering the mice perfectly healthy, which is quite exciting," he said. "Now we have to move to the next level to prove that it can" help people.
ImmunoVaccine was just one of seven Atlantic Canadian biotech companies showcasing their stuff at BioPort Atlantic, an annual life sciences industry conference held in Halifax on Wednesday.
Peformance Genomics Inc., Origin BioMed Inc., NovaBioMed Inc., DeNovaMed Inc., EastMed and Atlantic Canada Network on Bioactive Compounds all got a chance during a morning session to pitch their companies to the audience of over 200 people.
The early-stage companies, which have products ranging from technologies that kill cancer cells to ones that halt deadly bacterial infections, believe they could one day have markets worth millions or billions of dollars. But right now, they are all looking for partners, investors or distributors to help take their companies to the next level.
"We are looking to broaden our base with partnerships," Mr. Lowe said following Wednesday’s session.
So far, ImmunoVaccine has received financial support from agencies such as the Atlantic Canada Opportunities Agency, the National Research Council and through equity from wealthy people.
"The object is to raise money before you need to raise money," Mr. Lowe said.
ImmunoVaccine, which was spun off from research originally conducted at Dalhousie University, was named the most promising early-stage biotech company in Canada in 2005 by the Canadian National Biotechnology Association. The company’s vaccine technology triggers a rapid immune response that enhances the effects of existing vaccines or newly developed vaccines, Mr. Lowe said.
The technology can be also used to fight infectious diseases and is currently being used commercially in veterinary medicine.
ImmunoVaccine’s cancer research, which focuses on melanoma and cervical cancer, is being carried out on mice that have been given human genes.
"These mice, within 14 days, became totally healthy — all tumours removed. We kept the mice for a year. We re-injected them with cancer antigens and no new cancers formed, and these mice had huge tumours and were really sick."
In October, the company will spend about $80,000 to bring several leading cancer researchers from around the globe to Halifax to review its data during a two-day workshop.
"We never thought we would take our own vaccine into human clinical trials. Well, that’s where we are embarking now," Mr. Lowe said.
"We are going to assess what we have to date in the area of cancer research (and) get their feedback as to maybe what more we should do before selecting our course for human clinical trials," he said.
(cmellor@herald.ca)
Source: Copyright © 2006 The Chronicle Herald
Eradication of established HPV 16-expressing tumors by a single administration of VacciMax®
April 18, 2006
“Vaccine”, April 18, 2006, Epub ahead of publication. Title: “Eradication of established HPV 16-expressing tumors by a single administration of a vaccine composed of a liposome-encapsulated CTL-T helper fusion peptide in a water-in-oil emulsion”. Authors: Pirouz Daftariana, Marc Mansoura, Anita C. Benoita, Bill Pohajdaka, David W. Hoskinb, Robert G. Browna, W. Martin Kastc,
a ImmunoVaccine Technologies, 1819 Granville St., Suite 303, Halifax, NS, Canada B3J 3R1 b Department of Pathology and Microbiology and Immunology, Dalhousie University, Halifax, NS, Canada B3H 1X5 c Department of Molecular Microbiology and Immunology and Norris Comprehensive Cancer Center, University of Southern California, 1501 San Pablo Street, Los Angeles, CA 90033, USA Received 7 December 2005; received in revised form 26 February 2006; accepted 24 March 2006
Abstract
Human papillomavirus (HPV)-induced cervical cancer is the second most common cancer among women worldwide with half a million new cases per year. Despite the encouraging development of a preventative vaccine for HPV, a therapeutic vaccine for cervical cancer or pre-cancerous lesions remains a high priority. The preclinical study reported here used VacciMax® (VM) to deliver a peptide-based vaccine composed of an HPV 16 E7-derived cytotoxic T lymphocyte (CTL) epitope fused to the T helper epitope PADRE (FP) and combined with CpG or lipopeptide adjuvant. In the study, C57BL/6 mice received 0.5 million HPV 16-expressing C3 tumor cells. Mice were inoculated post-tumor challenge with a single s.c. injection of FP-CpG-VM on either day 4, 5, 6, 9 and 14. All mice that received the FP-CpG-VM vaccine were tumor-free to day 130 when the experiment was terminated. In contrast, only a minority of mice that received a control vaccine were tumor-free on day 60. Cytotoxicity assays, ELISPOT and intracellular staining for interferon (IFN)-gamma showed the immune response was specific for the selected CTL epitope. All mice that received the FP-CpG-VM vaccine remained tumor-free when re-challenged with 6 million C3 cells. Cytotoxicity assays 4 months post-challenge showed that only splenocytes from mice inoculated with the FP-CpG-VM vaccine had high lysis activity. These results indicate that VacciMax® causes a rapid, robust, durable and therapeutic CTL response to HPV 16 E7 protein expressing tumors.
Source: Copyright © Vaccine, April 18, 2006. p.5235-5244
VacciMax® Therapeutic Treatment of Cervical Cancer
November 17, 2005
Journal of Immunotherapy, November/December 2005, Volume 28(6)
Eradication of Large Palpable HPV 16 Expressing C3 Tumors by Single Dose Vaccination With A CTL-T Helper Fusion Peptide and CpG in VacciMax® [Abstracts: Abstracts for the 20th Annual Scientific Meeting of the International Society for Biological Therapy of Cancer (Primary Authors are Italicized): TURNING IMMUNIZATION INTO TUMOR REGRESSION: OBSTACLES AND STRATEGIES] Daftarian, Pirouz1; Pohajdak, Bill1; Benoit, Anita1; Mansour, Marc1; Hoskin, David2; Brown, Robert1; Kast, W Martin3 1Division of Tumor Biology, ImmunoVaccine Technologies (IVT), Halifax, NS, Canada; 2Microbiology and Immunology, Dalhousie University, Halifax, NS, Canada; 3Norris Comprehensive Cancer Center, University of Southern California, Los Angeles, CA
Human Papillomavirus (HPV)-induced cervical cancer, is the second most common cancer among women worldwide with half a million new cases per year. Despite the encouraging developments reported for a preventive vaccine for HPV, a therapeutic vaccine for cervical cancer or pre-cancerous lesions remains a high priority. The preclinical study reported here used a peptide based vaccine composed of an HPV 16 E7 derived cytotoxic T lymphocyte (CTL) epitope fused to the T helper epitope PADRE (FP) in VacciMax® with CpG adjuvant (FP-CpG-VM). VacciMax® hereafter abbreviated VM is a vaccine delivery platform proprietary to ImmunoVaccine Technologies (IVT).
In the study, C57BL/6 mice received 0.5 million HPV 16 expressing C3 tumor cells. Mice were inoculated post-tumor challenge with a single s.c. injection of FP-CpG-VM on either day 4, 5, 6, 9, or 14. All mice that received the FP-CpG-VM vaccine were tumor-free to day 60 when the trial was terminated. In contrast, only a minority of mice that received a placebo vaccine were tumor-free on day 60. Cytotoxicity assays and intracellular staining for IFN-[gamma] showed the immune response was specific for the selected CTL epitope. All mice that received the FP-CpG-VM vaccine remained tumor-free when re-challenged with 6 million C3 cells. Cytotoxicity assays 4 months post-challenge showed that only splenocytes from mice inoculated with the FP-CpG-VM vaccine had high lysis activity. These results indicate that the VacciMax® platform significantly elevates the robustness and durability of CTL responses when used to deliver FP derived from the HPV 16 E7 protein. These results indicate that VacciMax® with FP and CpG is a promising human cancer vaccine for phase I/II human trails.
Source: Copyright © 2005 Lippincott Williams & Wilkins, Inc. Volume 28(6), November/December 2005, p 655
Vaccine company gets shot in arm
September 26, 2005
Monday, September 26, 2005 The Daily News
Halifax firm gets European patent for vaccine platform
A Halifax-based company known for its vaccine platform received an important validation by getting a European patent, it announced yesterday.
ImmunoVaccine Technologies Inc., a vaccine development company, had already received American approval. The additional patent takes the company a step ahead.
“To have all of our claims accepted by, both by the American and European patent offices, is very good for two reasons. One, there’s tremendous diligence done by the patent offices, so it’s significant validation of our claims. Second, in terms of commercialization and seeking partnerships with big pharma, it gives them a big deal of comfort,” said Warwick Kimmins, IVT president and CEO.
Partnership with Pfizer
The company, which was formed in 2000 after research work at Dalhousie, already has a partnership with Pfizer.
With the new patent, it becomes easier to go worldwide – they already have patents in Australia and Japan as well.
Its product, VacciMax®, is a vaccine enhancement platform.
“We’re able to take antigens for infectious diseases and formulate them in our vaccine platform. The platform has the advantages over existing platforms in that it gives you efficacy with a single shot, no boosters,” Warwick said yesterday.
More pharmaceutical companies, he said, will be able to come to them with their products and work together to create more efficient vaccines.
The companies send them antigens for particular infectious diseases. IVT formulates it to the platform and sends it back to the company for trials.
Most companies are multi-nationals and knowing the product is patented in more areas is important to them.
The patent process is a lengthy one, and Kimmins said all the claims they made were accepted. In both the U.S. and Europe, the offices are overwhelmed with work and the process can take two years.
Selling Points
The advantages of VacciMax®, according to IVT’s website:
• Quick immune response after immunization.
• More “antibody titers,” which provides more complete immune protection.
• Higher proportion of antibodies to the target.
• Longer duration of immune response.
• Safety.
Source: Copyright © 2005 The Daily News
Halifax's IVT signs deal Down Under
January 27, 2003
By Our Staff
A Halifax company developing a device that helps improve the efficiency of vaccines has signed four major agreements with the largest life-sciences company in the southern hemisphere.
Robert Cervelli, director of business development for ImmunoVaccine Technologies of Halifax, said Monday the deal with CSL Ltd. of Australia [CSL Animal Health now part of Pfizer]could mean the firm's home-grown technology will be marketed globally within two years.
"In terms of significance, it's like a local IT firm landing a deal with Microsoft," he said. "It's not quite the same, but it's close."
The agreements call for both the development of two specific value-added products and collaborative research using IVT's VacciMax vaccine enhancement technology on vaccines for cattle, sheep and dogs.
Financial terms of the agreements, the diseases that will be treated and the potential end products were not disclosed.
The deal "with one of the most innovative vaccine companies in the world" is a validation of the technology, IVT president Warwick Kimmins said.
"We look forward to having CSL's commercialization expertise fast-track VacciMax-enabled veterinary vaccines to the marketplace."
Research will seek to improve CSL's existing vaccines by providing single-dose capability and greater effectiveness through the use of VacciMax, Mr. Cervelli said. All of the vaccines will utilize CSL's proprietary products.
CSL manufactures a broad range of plasma, pharmaceutical, vaccine, diagnostic and reagent products for human and veterinary markets.
Arrangements to get the initial vaccine components shipped to Australia for testing were underway Monday.
In addition to its veterinary projects, Mr. Cervelli said the company is looking for partners to develop human vaccines.
The company's vaccine enhancement technology was developed at Dalhousie University. Source: CHRONICLE HERALD
