immune response

Transgene to partner after cancer vax passes trial

Mon, 02 Jun 2008 06:59:56 -0400

France's Transgene is taking the wraps off of positive Phase IIb data for its experimental cancer vaccine, TG4010. The European trial of 148 patients saw progression-free survival of 44 percent of patients for six months compared to 35 percent in the control arm. The cancer vaccine uses the Modified Vaccinia Anakara virus vector to spur an immune response.

"These results clearly warrant pursuing development into a Phase III program and we will be seeking to establish a partnership in order to complete the last stages of clinical development and bring TG4010 to the market," said CEO Philippe Archinard.

- check out the press release
- read the AFX report

Related Article:
Big Pharma takes an interest in cancer vaccines

Novartis reports strong meningitis vaccine response

Tue, 06 May 2008 06:59:54 -0400

In a head-to-head trial, researchers for Novartis say that the experimental meningitis vaccine Menveo produced a more potent immune response than the standard therapy in use. And other data has underscored that the vaccine is effective in infants not covered by the current vaccine--Menactra. Bacterial meningitis kills about one in ten of its victims and leaves many of the rest deaf or suffering from seizures. In the new study, the Menveo group of 11 to 18-year-olds developed higher levels of antibodies against three of the five subtypes of meningitis and an equal amount of antibodies to a fourth.

"The number of adolescents that achieved protective antibody levels was also higher with the new vaccine," says Colin Marchant, a Boston University pediatrician.

- see this release on the data
- read the report from USA Today

ALSO NOTED: Antisoma gets $25M milestone; Takeda pays out retention bonuses; and much more...

Fri, 11 Apr 2008 06:59:50 -0400

> Novartis has kicked off a late-stage trial of ASA404 combined with first-line chemotherapy in non-small cell lung cancer, triggering a $25 million milestone payment to Antisoma. Release

> Following the $8.8 billion acquisition of Millennium, Takeda will fork over retention bonuses to Millennium employees to prevent them from jumping ship. Report

> Health experts say that an outbreak of mumps two years ago among college students occurred even though most of them had received a recommended vaccine. Report

> Shares of Crucell jumped after the developer announced that an early-stage trial of an experimental tuberculosis vaccine demonstrated a promising immune response in volunteers. Report

> An outbreak of dengue fever in and around Rio de Janeiro has afflicted more than 75,000 people since the beginning of the year, with 12 people dying in just the past week. Report

> The transplant drug probe is widening. FDA says it's identified 16 cases of an often-fatal neurological disease among patients taking Roche's CellCept drug, used to prevent organ rejection. Report

> Pharma knows that self-regulation is the best kind. That's why 12 drug and device makers have promised Sen. Chuck Grassley that they are working on plans to disclose CME grants. Report

> When Jean-Pierre Garnier makes his exit from GlaxoSmithKline next month, he'll walk away with the promise of a $4.9 billion options bonus that will pay off sometime in 2010. Report

And Finally... If you want to market your drug to patients, a new study shows the Web is not the place to do it. Report

ALSO NOTED: Crucell shares up on TB data; Celera, Merck ink cancer deal; and much more...

Thu, 10 Apr 2008 06:59:50 -0400

> A federal patent office may appeal a court ruling that threw out a new cap limiting the number of times a company can resubmit patent applications. That change was aggressively contested by the biopharma industry. Story

> Shares of Crucell jumped after the developer announced that an early-stage trial of an experimental tuberculosis vaccine demonstrated a promising immune response in volunteers. Report

> Celera has granted Merck a two-year license covering access to up to 10 cancer therapies. Release

> Bausch & Lomb has forged a deal to license select Galapagos compounds as development candidates for therapeutic uses in ophthalmic diseases. Release

> Rep. Henry Waxman and 26 of his Congressional counterparts are wading into the compulsory licensing fray. Report

> Roche is appealing to a higher power on Mircera. Report

> What does Exubera's possible cancer link teach us about drug safety? Report

And Finally... Fuzzy-headed today? Then pop a pill. Professionals of all kinds are doing it these days, according to a survey taken by Nature. Report

Oxford BioMedica benefits from TroVax results

Wed, 26 Mar 2008 07:59:55 -0400

Oxford BioMedica shares were boosted by the news that its first mid-stage trial of TroVax produced encouraging results for prostate cancer. Disease stabilization in patients currently ranges from two to 10 months. And anti-tumor immune response correlated with the clinical benefit, researchers say. TroVax is Oxford BioMedica's lead cancer immunotherapy product, which is being developed in collaboration with Sanofi-Aventis. The Phase II data were presented by the clinical investigators from the Methodist Hospital in Houston, Texas.

- and check out the press release
- read the report from Hemscott

Related Articles:
Is Sanofi preparing a bid for Oxford BioMedica? Report
Sanofi inks $690M pact for cancer vaccine. Report
Oxford BioMedica says licensing talks heating up. Report
Oxford BioMedica touts mid-stage TroVax trial data. Report

Genitope suspends cancer work, looks to alternatives

Tue, 11 Mar 2008 07:59:54 -0400

After reviewing a failed late-stage trial of MyVax for Hodgkins lymphoma, Genitope has decided to suspend development work and focus on alternatives like its antibody program. MyVax had already failed to hit a primary endpoint with no significant difference in progression-free survival of patients. But researchers had been enthusiastic about finding a positive response among patients who mounted a positive immune response to the tumor-specific target and those who did not.

"We are disappointed that we will not be able to make MyVax personalized immunotherapy available to patients with follicular non-Hodgkin's lymphoma," said CEO Dan Denney. "We firmly believe that MyVax personalized immunotherapy has the potential to safely induce long-term remissions, possibly including life-long remissions... However, we recognize that the costs and time required for further clinical development of MyVax personalized immunotherapy are prohibitive at this time, and we thus intend to focus our efforts on the development of our monoclonal antibody program."

- check out Genitope's release
- read the report from the East Bay Business Journal

Related Articles:
Genitope's MyVax misses Phase III endpoint. Report
Genitope shares slip after committee review. Report
Big Pharma takes an interest in cancer vaccines. Report

SPOTLIGHT: Cold feet at FDA over Cervarix?

Thu, 07 Feb 2008 06:59:53 -0500

The prospect of approving Cervarix for a broad audience in the U.S. may be leading to a bad case of cold feet at the FDA. The agency's Office of Vaccine Research & Review deputy director Florence Houn has expressed her own concerns that the agency doesn't fully understand the mechanism of adjuvants in immune response. Report

Sanaria takes new approach for malaria vaccine

Tue, 11 Dec 2007 06:59:55 -0500

The New York Times profiles Sanaria, a Maryland vaccines company that is taking a cue from Louis Pasteur in developing a new way to combat malaria. Instead of relying on fragments of the parasite's protein to trigger an immune response--the common approach for vaccine development--Sanaria takes the whole parasite and weakens it with gamma rays so it can't multiply, an advance on Pasteur's method of weakening rabies bacilli by air drying them. This vaccine program is one of dozens being tested around the world. The Malaria Vaccine Initiative, funded by the Bill and Melinda Gates Foundation, is bankrolling eight development projects. At Sanaria, researchers have demonstrated their new vaccine can protect lab mice and a small number of humans. But the big challenge they face is manufacturing the vaccine in bulk. The company has already won the endorsement of Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

- see the profile on Sanaria from The New York Times

Related Articles:
New malaria vaccine offers better protection. Report
Gates Foundation readies $258M for new malaria programs. Report
New tech drives huge growth in vaccine business. Report
Genome map completed on malaria parasite. Report

Merck, Dynavax ink $136M deal on hep B therapy

Thu, 01 Nov 2007 07:59:58 -0400

Merck has agreed to put up $31.5 million as a down payment for the worldwide rights to Dynavax Technologies' late-stage hepatitis B therapy. Merck will also cover the remaining development cost on the drug, pay royalties and fork out up to $105 million in milestones. On Tuesday Dynavax reported that Hepislav hit its Phase III endpoint; protecting older adults as well as healthcare workers.

Merck already markets a hep B therapy, but appeared to be attracted by an easier dosing schedule for Hepislav and its ability to work on the weakened immune systems of older people. Hepislav combines a segment of the hepatitis B virus and a DNA sequence that activates a toll-like receptor, triggering an early immune response. A spokesperson for Dynavax told The New York Times that the potential market for the drug--which could hit the market in 2010--at around $500 million. Berkeley, CA-based Dynavax also has partnerships with AstraZeneca and the NIH.

- see this release
- check out the report from Hemscott

Related Articles:
Dynavax pockets $30M to fund new development. Report
Dynavax, AstraZeneca ink $136M deal. Report
Dynavax stock jumps on hep B data. Report
Dynavax Hep B vaccine successful in Phase II. Report

New malaria vaccine offers better protection

Mon, 29 Oct 2007 07:59:55 -0400

Sanaria is grabbing headlines with its approach to fighting malaria. Researchers for the company have developed a process to create weakened parasites that create an immune response sufficient to protect 90 percent of patients for a 10-month period. The company's founder, Steven Hoffman, says that the vaccine could be a huge life saver in Africa. Malaria kills about two million people each year, and most of the victims are children.

- read the report from AHN

Related Articles:
Herbal drug used to model new malaria drug. Report
Genome map completed on malaria parasite. Report
WHO: Infectious disease a growing threat. Report

ALSO NOTED: Antigenics releases positive cancer results; NovaBay raises $24M; Bionovo wraps stock offering; and much more...

Fri, 26 Oct 2007 06:59:50 -0400

> Antigenics says that a Phase I/II trial of cancer vaccine Oncophage delivered positive results, with 11 out of 12 patients exceeding median benchmarks on survival from time of recurrence. Researchers also said that all patients demonstrated an immune response. The company launched a Phase II trial of Oncophage earlier this month to evaluate overall survival in glioma patients. Report

> San Francisco-based Exelixis has announced positive Phase II data for XL647 for non-small cell lung cancer. The company also revealed interim Phase II data for XL880, a renal cell cancer drug. Release | Release

> NovaBay Pharmaceuticals raised $24 million in their IPO, which priced at $4 a share, the bottom of their range. Report

> Bionovo raised about $24 million in a new stock offering. Report

> Isis Pharmaceuticals will receive $9.9 million from the non-profit CHDI to develop a therapy for Huntington's disease. Report

And Finally...Are you hearing messages in white noise? That could be an early sign of schizophrenia. Release

GSK prepares to go head-to-head with Merck

Wed, 17 Jan 2007 19:01:36 -0500

With a huge market at stake, GlaxoSmithKline says it will mount a head-to-head study of its cervical cancer vaccine Cervarix against Merck's Gardasil. The Phase III trial involves 1,042 volunteers in two arms, each taking one of the two vaccines. The trial will compare the immune response of 18 to 24-year-old women to two types of human papillomavirus. Secondary objectives are laid out for immune responses among older women.

- check out GSK's press release
- read the AFX report on the trial

PLUS: The Guardian covers the development of a new generation of virus-vectored vaccines that promise to take on a number of diseases like malaria. Report

Related Articles:
Merck's Gardasil OK'd for pricey rollout. Report
Cervarix more effective in girls aged 10-14. Report
Merck's McGlynn has key role developing vaccines. Report

Press Release: GSK Awarded $63 Million HHS Contract for Pandemic Vaccine Research and Development

Maureen Martino — Wed, 17 Jan 2007 12:38:17 -0500

GlaxoSmithKline Awarded $63 Million HHS Contract for Pandemic Vaccine Research and Development

Company Begins Government and Retail Shipments of its Antiviral Relenza(R)
PHILADELPHIA, Jan. 17 -- GlaxoSmithKline, one of the world's largest vaccine manufacturers, has been awarded a contract from the U.S. Department of Health and Human Services (HHS) for the development of pre-pandemic and pandemic flu vaccines. With a value of at least $63.3 million, the contract supports GSK's ongoing pandemic vaccine research in using the company's innovative adjuvant technology in combination with antigens to induce a strong immune response.
Under the terms of the contract, GSK will engage in research and development leading towards licensure of antigen-sparing pre-pandemic and pandemic vaccines with adjuvant that will help the U.S. Government extend the limited North American supply of pandemic flu vaccines to protect larger populations in the event of a flu pandemic. The 5-year contract also gives the U.S. Government the option to fund an additional $44 million of future clinical development programs related to antigen-sparing pandemic vaccines.
"A limited global supply capacity of flu antigen makes it critical that we use innovative adjuvant system technology to produce a new generation of flu pandemic vaccines," said David Stout, President of Pharmaceuticals at GlaxoSmithKline. "GSK's research in adjuvant technology over the past two decades uniquely positions our company to develop adjuvants designed to boost immune response and give broader protection while using smaller amounts of antigen. This award leverages our adjuvant expertise, and supports GSK's short and long-term vision of helping governments around the world in their pandemic preparedness efforts."
In a separate action related to pandemic preparedness GSK also announced that the company has begun shipping up to 15.5 million treatment courses of its antiviral Relenza® (zanamivir for inhalation). The Relenza shipments are part of GSK's agreement with the Federal Government announced last year to provide the U.S. Government and the states with Relenza for building their flu pandemic stockpiles. GSK also has started to ship Relenza to retail pharmacies to fulfill patient prescriptions for seasonal flu treatment and prevention.
About GlaxoSmithKline
GlaxoSmithKline is one of the world's leading research-based pharmaceutical and health care companies, and is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information visit: http://www.gsk.com.
About GSK Biologicals
GSK Biologicals, based in Rixensart, Belgium, is the vaccine division of GlaxoSmithKline. As one of the world's leading vaccine manufacturers, GSK Biologicals employs more than 1,500 scientists devoted to discovering new vaccines and developing more cost-effective and convenient combination products to prevent infections that cause serious medical problems.
GSK's 2005-2007 Milestones in Pandemic Preparedness
January 2007: GSK begins supplying its antiviral Relenza® zanamivir for inhalation), to the U.S. Government and begins working with private-sector businesses and other organizations to provide Relenza as part of their business continuity planning.

December 2006: GSK received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use CHMP) for its candidate alum-adjuvanted pandemic vaccine. GSK plans to submit a file to the European regulatory authorities in the coming weeks for the licensing of both a pandemic and a pre-pandemic vaccine with our proprietary adjuvant system technology.

November 2006: GSK received a $40 million initial order for bulk H5N1 antigen from HHS.

2006: GSK signs contracts with several countries for pre-pandemic vaccines.

September 2006: GSK reached an agreement with the Simcere Pharmaceutical Group of Nanjing, China, granting the right to manufacture and sell the antiviral influenza treatment zanamivir in China, Indonesia, Thailand, Vietnam and all Least Developed Countries.

July 2006: Clinical studies announced by GSK showed promising preliminary results on the potential immunogenicity of a vaccine for pandemic flu using a GSK novel proprietary adjuvant system.

May 2006: GSK received an award of $274 million to develop cell-culture technology to speed the development of new cell-culture-based seasonal and pandemic influenza vaccines scale-up cell-culture manufacturing capability at GSK's Marietta, PA site.

2005: GSK made three important acquisitions in North America: a vaccine manufacturing site in Marietta for cell-culture-based flu vaccines and secondary operations; Corixa Corporation, for its work in developing innovative adjuvants designed to stimulate immunity; and ID Biomedical, which offered a significant increase in flu vaccine manufacturing capacity to help address both seasonal and pandemic influenza threats.

Idera inks $455M pact for Merck vaccines

Sun, 10 Dec 2006 19:01:36 -0500

Merck has struck a deal to put Idera's toll-like receptor agonists to work in its new vaccine programs for oncology, Alzheimer's and infectious diseases. Idera gains $20 million up front for the development pact along with another $10 million equity investment at $5.50 a share. The big payoff would come if Merck can develop vaccines in all three fields, with $165 million in scheduled milestones. Another $260 million in milestones will be paid for successful development of follow-on therapies. Toll-like receptors recognize different microbial products present in pathogens such as bacteria, viruses and parasites, and mount an appropriate immune response against the foreign invaders.

"We believe that vaccines combined with TLR-targeted compounds offer great promise in treating and preventing serious diseases, and look forward to integrating Idera's TLR agonists into our vaccine development programs," said Peter S. Kim, president of Merck Research Laboratories.

- read the AFX report on the deal

Press Release: GSK to supply and store H5N1 vaccine products for US flu pandemic stockpiling

Maureen Martino — Mon, 20 Nov 2006 15:26:31 -0500

GSK to supply and store H5N1 vaccine products for US flu pandemic stockpiling

GlaxoSmithKline awarded HHS contract

Philadelphia, PA, November 20, 2006–– GlaxoSmithKline (NYSE:GSK), one of the world’s largest vaccine manufacturers, today announced it has been awarded a contract to supply pre-pandemic vaccines to the US strategic national stockpile. The company has received an initial $40 million order under the contract from the U.S. Department of Health and Human Services (HHS) for bulk H5N1 antigen - the substance in the vaccines that will help produce an immune response.

Under the terms of the contract, GSK will manufacture and store bulk H5N1 antigen using its recently acquired production facilities in North America. Terms of the contract also state that GSK may be directed by HHS to formulate this bulk antigen at some point in the future. Additionally, HHS also has the option to purchase pre-pandemic vaccines together with one of GSK’s proprietary adjuvant systems, which could mean that less antigen would be needed per dose to achieve a protective immune response. Funding for this contract is provided through the HHS Office of Public Health Emergency Preparedness and the Office of Public Health Emergency Medical Countermeasures.

“We applaud the US government’s proactive steps in protecting American citizens against this potential public health threat,” said David Stout, President, Pharmaceutical Operations, GlaxoSmithKline. “We are committed to helping governments and public health officials around the world effectively respond to the global threat of a flu pandemic and we are pleased to be working with the US government in its preparedness efforts.”

GSK remains in active discussions with other governments to supply their public health programs and has been steadily increasing its support to flu pandemic preparedness efforts globally, leveraging the company’s vaccine and anti-viral expertise.

About GlaxoSmithKline

GlaxoSmithKline is one of the world’s leading research-based pharmaceutical and health care companies, and is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information visit: www.gsk.com.

About GSK Biologicals

GSK Biologicals, based in Rixensart, Belgium, is the vaccine division of GlaxoSmithKline. As one of the world’s leading vaccine manufacturers, GSK Biologicals employs more than 1,500 scientists devoted to discovering new vaccines and developing more cost-effective and convenient combination products to prevent infections that cause serious medical problems.

Editor’s note

In 2005, GSK made three important acquisitions in North America: a vaccine manufacturing site in Marietta, Pennsylvania, for cell-culture-based flu vaccines and secondary operations; Corixa Corporation, for its work in developing innovative adjuvants designed to stimulate immunity; and ID Biomedical, which offered a significant increase in flu vaccine manufacturing capacity to help address both seasonal and pandemic influenza threats.

GSK was the first company to submit a “mock-up” dossier for an egg-based pandemic vaccine with traditional alum adjuvant to European regulators.

In May 2006, GSK announced, along with HHS, that it had received an award of $274 million to develop cell-culture technology to speed the development of new cell culture-based seasonal and pandemic influenza vaccines, and to scale-up cell culture manufacturing capability at GSK’s Mariettasite.

Clinical studies announced by GSK in July of this year showed promising preliminary results on the potential immunogenicity of a vaccine for pandemic flu using a GSK novel proprietary adjuvant system.

GSK has supplied its anti-viral, Relenza ® (zanamivir for inhalation), to the U.S. government and is now working with private-sector businesses and other organizations to provide Relenza ® as part of their business continuity planning.

A new agreement with the Simcere Pharmaceutical Group of Nanjing, China, granting Simcere the right to manufacture and sell the anti-viral influenza treatment zanamivir in China, Indonesia, Thailand, Vietnamand all Least Developed Countries.

The US is one of several countries to sign a contract with GSK for a pre-pandemic vaccine.

Avecia anthrax vaccine shows promise

Wed, 27 Sep 2006 20:01:35 -0400

A Phase I trial of Avecia's anthrax vaccine produced data that demonstrates its safety and delivers early signs of efficacy. The U.S. government sees Avecia's development program as a key back-up to the $877 million contract that was signed with VaxGen. VaxGen's program, though, has been afflicted by a series of setbacks that has become the chief example of problems with the country's biodefense program. The UK-based Avecia is working with a $71 million contract. Their new data suggests that the vaccine is generating an immune response but the response is not as strong as the one delivered by the current vaccine.

- here's the AP report on the vaccine data

Low-dose bird flu vaccine effective in trial

Wed, 06 Sep 2006 20:01:37 -0400

China's Sinovac Biotech says that its low-dose bird flu vaccine proved effective in generating an immune response from 80 percent of the 120 volunteers taking part in the trial. The vaccine was developed by using a part of the whole H5N1 virus and combining it with an adjuvant that increases the potency of the therapy. Researchers have been scrambling to find a low-dose vaccine that might work against bird flu. A low-dose vaccine would make it possible to produce enough vaccines to vaccinate large numbers of people.

- read the article on the vaccine from The International Herald Tribune

ALSO: An Indonesia teenager has died from bird flu, bringing the country's death toll to 47. Report

PowderMed touts data for new flu vaccine

Wed, 31 May 2006 20:01:37 -0400

The UK's PowderMed has reported positive results for its Phase I trial of a new flu vaccine that bombards the skin with tiny particles of the flu virus to stimulate an immune response. Researchers say it was effective in triggering an immune response in all 36 volunteers who participated in the study. Their results are prompting the launch of a mid-stage study soon for both annual and avian flu viruses.

"Recent years have seen a number of new influenza vaccine approaches tested in animal model systems and in the clinic. However, this study is the first successful demonstration of immunogenicity of an influenza DNA vaccine in humans," said Dr. Hansi Dean, now with the International AIDS Vaccine Initiative. "The relative immunogenicity of PowderMed's DNA vaccine compared to intramuscular DNA vaccination is likely attributable to the efficiency of intracellular DNA delivery by PMED."

- here's the release for more information

ALSO: With a new death from avian flu reported every two and a half days, Indonesia is on track to quickly become the hardest hit nation in the world. Report

Sanofi's avian flu drug gets mixed results

Wed, 29 Mar 2006 19:01:38 -0500

A study published in The New England Journal of Medicine reports that Sanofi's bird flu vaccine provoked an immune response in only half of the trial subjects. Additionally, very high doses of the drug were needed for a response, though this did not cause any serious side effects. This was the first major test of the drug known as 1203, which the U.S. has stockpiled in the event of a pandemic. Results of the study drew mixed responses from researchers. "We have a vaccine we know can spur an immune response, albeit at very high doses. We're going in the right direction. The sobering news is we have a long way to go. So it's muted good news," said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, which funded the study. The focus of the study will now shift to creating a more effective, lower dose drug.

- read the AP report for more

Nabi vows to push ahead with vaccine work

Tue, 21 Mar 2006 19:01:38 -0500

Nabi Biopharmaceuticals says it has decided to push ahead with studies into a potential vaccine for staph bacteria after a late-stage trial failed a primary endpoint. Nabi formed an advisory panel to investigate the trial failure of StaphVAX. The panel concluded that the antibodies generated for the late-stage trial were inferior to the antibodies generated by vaccine lots in earlier studies.

"Today's announcement marks a new beginning for our Gram-positive program, which is much enhanced by the knowledge we've gained about the bacteria and immune response," said Nabi CEO Thomas H. McLain. "Moving forward, we have a clear development pathway on which to readily advance our vaccine and antibody products toward commercialization."

- here's the AP report for more