June 21, 2012

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BioTech Primer

Editor's Corner:
Therapeutic cancer vaccines: Optimism for the future at BIO 2012

Today's Top Stories:
1. FDA green-lights GSK's MenHibrix
2. HPV DNA vax should enter the clinic in 2013
3. Genocea's HSV-2 vax to hit the clinic
4. CSL flu shot fits linked to viral components
5. Anthrax vax to move into new Phase II trials
6. Controversy halts HPV vax trial in India

Spotlight:
Grass pollen allergy vaccine not to be sneezed at

Also Noted:
Single shot could kick the cocaine habit; Sanofi has recalled its TB vaccine in Canada; Much more...

News From The Fierce Network:
1. BIO 2012 International Convention Slideshow
2. Celgene's hopes for Revlimid stymied
3. House votes to extend med device user fees

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Editor's Corner

Therapeutic cancer vaccines: Optimism for the future at BIO 2012

By Suzanne Elvidge

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There has been a lot of talk about vaccines for cancer, and the move to market has seemed a little slow, with only one on the market so far--Dendreon's Provenge, for prostate cancer. However, the field is still very active, and Glenn Dranoff of the Cancer Vaccine Center at Dana-Farber Cancer Institute, opened "Therapeutic Cancer Vaccines: Renewed Optimism for the Product Pipeline" at BIO2012 with a positive note: "It's an exciting time for immunotherapy."

One of the issues facing developers of cancer vaccines, according to Dranoff, is that tumors send mixed messages. They can trigger the innate arm of the immune system, but they can also defeat the immune system because they can "hide," as they retain features of "self," and they can also have immunosuppressive effects. This means that the key objectives of a cancer vaccine are two-fold--not only to trigger an immune reaction, but also to block the tumor's tendency to immunosuppression.

One approach to this is to block CTLA4, a protein that regulates the immune system, and Dranoff showed some examples of the combination of BioSante Pharmaceuticals' ($BPAX) GVAX vaccines and Bristol-Myers Squibb's ($BMY) Yervoy (ipilimumab), an anti-CTLA4 monoclonal antibody improving survival, with patients still alive even at 8 or 9 years after treatment.

John Bell, CSO at Jennerex, introduced the concept of oncolytic viruses--viruses that selectively attack tumors. A genetically-engineered version of the smallpox (vaccinia) vaccine, these are administered intravenously or straight into the tumor and replicate and spread beyond their original site of administration. As well as acting as a vaccine and triggering an immune response, they also attack the tumor and its blood vessels, making the most of the fact that the processes that the tumor uses to hide from the immune system make it more vulnerable to infection. In Phase I trials in metastatic melanoma, injecting JX-594 into some of the cancer sites also reduced cancer in non-injected sites, and in liver cancer, there were signs of improvements in survival. As a smallpox vaccine, the vaccinia virus has been used safely throughout the world for many years, and the virus is stable in the bloodstream and is large enough to carry a genetic message for a "payload" (JX-594 codes for GM-CSF, which improves its immune response). This ability differentiates it from other virus-based vaccines in development--reoviruses can be given intravenously but can't carry a payload, and herpes viruses, such as OncoVex (picked up from BioVex by Amgen in January 2011 and now known as talimogene laherparepvec; in phase III for melanoma) can only be given directly into the tumor.

James Trager, senior director of researcher at Dendreon, reviewed data for Provenge (sipleucel-T, its autologous cancer vaccine for prostate cancer, and looked to the future. The immune responses to Provenge seem to correlate with better outcomes for survival, which could lead to the development of markers that could guide physicians to select which patients should be the best responders and which should get other therapies. He noted that the pattern of cytokine responses differed between patients, stating: "If we can learn what successful patients look like, this will help us to develop new vaccines."

With a different approach, Marc Mansour, CSO, Immunovaccine, looked at vaccines as maintenance therapy, based on the idea of a life with well-controlled cancer, rather than cure. Vaccines have a lot to do to have an impact on an established tumor, so Immunovaccine's approach is to use the vaccine as maintenance therapy in patients with minimal residual disease after chemotherapy and radiotherapy. The company's target of choice is survivin, a target that is expressed on many cancer cells.

Immunovaccine's DPX-Survivac uses the DepoVax depot formulation for slow release, providing a controlled and prolonged exposure to the vaccine, and the company combines this with low-dose cyclophosphamide, which supports the vaccine's anticancer effect. The vaccine is currently in Phase I/II trials in Canada in advanced ovarian cancer.

Mansour's conclusion was that, to beat cancer, we need to target multiple pathways with a range of approaches. This includes triggering an immune response to the cancer along with attacking the tumor's blood supply and returning the lymphatic system to normal, by combining vaccines, chemotherapy, radiotherapy and surgery. -- Suzanne Elvidge (email)

Read more about: Yervoy, undefined

Today's Top Stories

1. FDA green-lights GSK's MenHibrix

By Suzanne Elvidge

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After asking for more information back in June 2010, two years later the FDA has green-lighted MenHibrix, GlaxoSmithKline's ($GSK) combination meningitis vaccine for the U.S. market. This targets infections with Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type B, and is given as four doses between 6 weeks and 18 months of age. Both of these infections can cause meningitis.

This vaccine has a couple of advantages over its competitors--it is the only meningitis vaccine that can be given to children as young as 6 weeks old, Leonard Friedland, vice president of clinical and medical affairs in North America for GSK Vaccines, told FierceBiotech. It also doesn't add to the vaccination burden for these young children. "MenHibrix gives healthcare providers the option of combining Hib immunization with meningococcal C and Y immunization without increasing the number of shots for infants and toddlers," Freidland said.

- read the press release from the FDA
- see GSK's release
- check out the FierceBiotech article

Related Articles:
GSK grabs FDA nod for combo meningitis vax
GSK's Nimenrix gets green light in Europe

Read more about: FDA
back to top

2. HPV DNA vax should enter the clinic in 2013

By Suzanne Elvidge

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Vaccibody's lead therapeutic DNA vaccine, developed for the treatment of precancerous changes in the cervix caused by human papillomavirus (HPV) infection, is expected to move into the clinic in late 2013 once funding is in place, the company CEO Ole Henrik Brekke told FierceVaccines  at BIO 2012. The trial will recruit women who are infected with HPV-16 and have cervical intraepithelial neoplasia (CIN) at grade 1 or 2.

The Norwegian vaccine company has designed the vaccine to trigger a T cell response in a single shot by targeting the dendritic cells (also known as antigen-presenting cells). The HPV vaccine is administered just under the skin or into the muscle using electroporation technology, where a small charge allows the plasmid (a small circle of coding DNA) into the cell. The genetic information then harnesses the cell's manufacturing capabilities to create the three-component protein vaccine.

"We see a higher immune response than other DNA vaccines in animal studies, and it doesn't need an adjuvant," says Brekke. "We think that this is because the vaccine molecules adhere to the dendritic cells."

Future formulations of the vaccine could use needle-free administration techniques. The technology also has potential for infectious disease and in veterinary use, as a prophylactic vaccine, and the company is in discussion with a number of potential partners, according to Brekke.

- read the company overview at BIO 2012

Related Articles:
GeoVax: Meeting the HIV vaccine challenge
DNA vaccine swats TB and HIV
Army uses ducks and DNA vax to make antivirals
Scancell's DNA melanoma vaccine poised for Phase II
DNA vaccine for prostate cancer moves into Phase III

Read more about: prophylactic vaccines, needle-free
back to top

3. Genocea's HSV-2 vax to hit the clinic

By Suzanne Elvidge

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Herpes simplex virus (HSV-2) infections cause recurring and painful genital sores, with the disease being most severe in people with suppressed immune systems. There is no preventive vaccine or cure, but Genocea Biosciences has a prophylactic HSV-2 vaccine moving into a first in-human clinical trial in third quarter 2012, Chip Clark, president and CEO told FierceVaccines at BIO2012. Seth Hetherington, CMO, was also at the meeting, presenting in the session "Therapeutic Vaccines Against Chronic Infectious Diseases: Vaccines versus Microbes Part 2."

The planned trial is a Phase I/IIa study, which will involve 150 otherwise healthy people with HSV-2 infection, explained Hetherington in the presentation. The trial will measure safety and immune response, and will also look at viral shedding and the frequency of and severity of recurrent genital sores. Data should be available in the third quarter of 2013, according to Hetherington.

Five years ago, Genocea Biosciences set out to create a new class of vaccines, Clark explained, which were designed to trigger a T cell response, in contrast with the traditional focus on the B cell (antibody) response. To create the HSV-2 vaccine, Genocea Biosciences screened the blood from hundreds of people who had been exposed to the virus, including people with frequent disease, infrequent disease or asymptomatic disease, using the company's high-throughput T cell antigen discovery technology: AnTigen Lead Acquisition System (ATLAS). This technology was created at The University of California at Berkeley and Harvard Medical School.

For the HSV-2 project, the ATLAS technology identified a number of proteins that are associated with protection against HSV-2 infection. The vaccine includes two of these, a T cell antigen and a B cell antigen, as well as a T cell adjuvant to increase the immune response.

The company now has five T cell-based vaccines in preclinical development, with one poised to enter the clinic, and is interested in speaking with potential collaborators.

"There is no other discovery platform for T cell vaccines," said Clark. "We are interested in speaking with potential collaborators, as we now have five vaccines in the pipeline, and that is a lot for a small company. We created these to show the versatility of the platform, and we have two vaccines against HSV-2, and vaccines against bacteria (Chlamydia trachomatis and Streptococcus pneumoniae) and protozoa (Plasmodium falciparum; malaria). These are all large targets, with lots of proteins, and we feel that ATLAS gives us a comparative advantage."

The next step will be to move the company's pneumococcal vaccine into the clinic, likely to be around the end of 2013. Because Genocea's vaccines target T cells rather than B cells, this could be used in combination with existing vaccines.

- check out the session abstract

Related Articles:
Chlamydia vaccine protects in animal studies
Clark named CEO of Genocea
Genocea applies tech to therapeutic vaccines

Read more about: Chip Clark, Seth Hetherington
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4. CSL flu shot fits linked to viral components

By Suzanne Elvidge

Comment | Forward | Twitter | Facebook | LinkedIn

In 2010, CSL's Fluvax seasonal flu vaccine was linked with cases of febrile convulsions (fits related to high fever) in the under-5s, and the company has presented the results of its investigations at the Public Health Association of Australia's 13th National Immunisation Conference. This follows warning letters from the FDA in 2010 and 2011, when the company was told that it needed to investigate the issues adequately. According to Bloomberg, CSL's shares fell by 1.2% on the news.

The study showed that Fluvax caused more fits in this group than at least one other licensed vaccine, but that the vaccine had not been linked with increased levels of convulsions in the past. The final conclusion from the company was that this was linked to the levels of virus components in the end product, rather than it being a problem with manufacturing, and that the increased levels of fits must be related to characteristics of the virus unique to the 2010 strain.

Dr Darryl Maher, vice president of medical and research at CSL Biotherapies said: "While influenza vaccines must contain virus components to stimulate sufficient protection against influenza, it appears that components of the inactivated virus retained in Fluva in 2010 overstimulated the developing immune systems of some young children compared to previous seasons."

The company is continuing studies, and in the meantime the vaccine will remain restricted to children over 5 years. Maher added: "Influenza is a serious disease and as Australia's only on-shore manufacturer of influenza vaccine, we are committed to ensuring Fluvax is safe and effective for all age groups."

- read the press release
- see the article in Bloomberg

Related Articles:
CSL confirms convulsions appear tied to Fluvax manufacturing
CSL confirms Fluvax manufacturing tied to convulsions in children
CSL recalling product tainted with ethylene glycol

Read more about: CSL, Fluvax
back to top

5. Anthrax vax to move into new Phase II trials

By Suzanne Elvidge

Comment | Forward | Twitter | Facebook | LinkedIn

Anthrax is a lethal disease caused by infection with the bacterium Bacillus anthracis. Its spores can lay dormant for centuries, and infection can occur through swallowing or breathing the spores, or even through the skin. These deadly characteristics make it a perfect bioterrorism weapon worthy of a spy thriller. PharmaThene, supported with federal funding, is developing an anthrax vaccine, SparVax, and is planning further Phase II trials for the second half of 2012.

In previous clinical and preclinical trials, SparVax's protection was between 90% and 100% when given on a 6- or 12-month booster dose regime. Thomas Fuerst, executive vice president and CSO commented: "SparVax has previously been evaluated in two separate Phase II clinical trials involving approximately 770 subjects. This latest Phase II trial, which we expect will commence in the second half of this year, will be a dose-ranging and schedule study designed to evaluate the safety and immunogenicity of SparVax in approximately 300 healthy subjects."

The second-generation recombinant vaccine has been manufactured to full cGMP standards using the company's E. coli-based rPA technology platform, and the trial will use the final drug product in pre-filled syringes. According to the company, this is a major step forward, with a much improved yield and more robust process, compared with the first-generation anthrax vaccine. The vaccine's development is funded by the National Institute of Allergy and Infectious Diseases, National Institutes of Health and the Biomedical Advanced Research and Development Authority.

The vaccine currently used in the U.S., BioThrax from Emergent Solutions, requires 5 doses over 18 months, with annual boosters. It not clear yet what SparVax's dosing schedule could be, but the company could have an advantage if it is a shorter schedule, or requires fewer doses.

- read the press release

Related Articles:
U.S. considers anthrax vaccine trials--for kids
Emergent BioSolutions gets gov't order for BioThrax
BARDA continues support of pre- and post-exposure anthrax vax
U.S. increases Emergent BioSolutions' anthrax vax contract
Combo anthrax/smallpox vax beats anthrax vax alone

Read more about: PharmAthene
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6. Controversy halts HPV vax trial in India

By Suzanne Elvidge

Comment | Forward | Twitter | Facebook | LinkedIn

Human papillomavirus infection is the cause of nearly all cases of cervical cancer, and so immunizing young women before they are exposed to the virus could save a great many lives. So, the idea of a large scale clinical trial of an HPV vaccine in India seems like a valid idea, based on the country's supposed huge cervical cancer healthcare burden. Not so--according to a paper published in the Journal of the Royal Society of Medicine, the epidemiology behind the study is flawed and the trial is currently the subject of an investigation by the Indian government.

The trial was under the auspices of PATH, an international health charity, and included over 23,000 girls in the Indian states of Gujarat and Andhra Pradesh. The charity had claimed that "in raw numbers, India has the largest burden of cancer of the cervix of any country worldwide." However, according to the study, led by Allyson Pollock of Barts and The London Medical School, the cancer surveillance, registration and monitoring in India in general, particularly in the Gujarat and Andhra Pradesh regions, were incomplete, so that it would be impossible to tell whether the vaccine would be successful in preventing the disease.

The figures that do exist for India show that there were only 22 cases of cervical cancer per 100,000 in 2004/2005 in india, falling from 43 cases per 100,000 in 1982/1983--this is around half the rate in countries like Brazil and Zimbabwe.

"This trial has clearly raised serious concerns for the people and government of India," says Pollock. "We found that current data on cervical cancer incidence do not support PATH's claim that India has a large burden of cervical cancer or its decision to roll out the vaccine program."

India does have major health burdens, for example in malaria and other infectious diseases, maternal anemia and malnutrition, and so the use of an expensive HPV vaccine, which is one of the more expensive vaccines on the market, for a health issue with a lower impact would seem to be a flawed use of limited financial resources.

- read the press release
- see the paper

Related Articles:
GAVI Alliance could be closer to HPV vax deal
Gardasil could cut cancer in women already infected with HPV
Study: Most girls who get HPV vax say they see need to practice safe sex

Read more about: cervical cancer, India
back to top

Also Noted

TODAY'S SPOTLIGHT... Grass pollen allergy vaccine not to be sneezed at

Hay fever makes the summer miserable for so many people, and the possibilities for treatment are daily antihistamines, or allergy shots, low doses of an extract of pollen under the skin for as long as 5 years. Biomay is developing a recombinant grass pollen allergy vaccine, known as BM32, that could cut symptoms after just three doses. The vaccine has just started a Phase II trial in Vienna, where 60 patients will get three doses, and the researchers are looking for a fall in symptoms, as well as indications for the dose for larger clinical trials. This is the first of Biomay's peptide-carrier vaccines, made up of an antigen fused to a carrier peptide, and if the results are positive, the company will use the technology to develop vaccines against other allergies. Article

> Cocaine addiction can be treated with behavioral modification and support but this is a long and slow process--what if it could be treated with just a single shot? Researchers in the U.S. have developed a virus-based therapeutic that delivers genes coding for a cocaine antibody, which captures the drug and prevents it from crossing the blood-brain barrier. Press release | Paper

> Sanofi has voluntarily recalled its tuberculosis (BCG) vaccine in Canada because of manufacturing issues that could affect the vaccine's quality. Article

> The world's first hepatitis E vaccine, Hecolin, is likely to be launched in China this year, through Xiamen University's Xiamen Innovax Biotech. Article

> Biovest has submitted formal notification to the European Medicines Agency (EMA) of its intent to file a Marketing Authorization Application (MAA) for approval in Europe of BiovaxID, its personalized follicular non-Hodgkin's lymphoma therapeutic vaccine; this could make it the first lymphoma vaccine available in Europe. Press release

> Militants have banned polio vaccination teams in North Waziristan, a region of Pakistan, as a protest against U.S. drone strikes. Article

> Anergis has reached preclinical milestones for its ragweed pollen allergy vaccine, AllerR. Article

> U.S. courts have ruled that Apotex is not infringing Merck's patent with its generic form of NASONEX. Press release

> NovaRx has completed enrollment in its Phase III clinical trial of Lucanix (belagenpumatucel-L), its whole tumor cell vaccine for the treatment of non-small cell lung cancer. Press release

> The CDC has voted to recommend the expanded use of Pfizer's Prevnar 13 vaccine in adults of 19 and older who have compromised immune systems. Article

> Hepatitis B vaccine appears to protect for 25 years, making boosters unnecessary. Article

> Texas A&M has won a federal contract that could be worth $1.5-2 billion over 25 years, to become a national hub of vaccine production and bioterror preparedness. Article

And Finally… Bharat Biotech and the University of Maryland Center's for Vaccine Development (CVD) have received a $4 million Strategic Translation Award from the Wellcome Trust for the clinical development of a vaccine against non-typhoidal Salmonella. Article

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