Genitope

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

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Big Pharma takes an interest in cancer vaccines. Report

ALSO NOTED: Genitope's MyVax misses Phase III endpoint; Report: Pfizer looks at Danish biotechs; and much more...

Fri, 21 Dec 2007 06:59:50 -0500

> Genitope's MyVax, a treatment for follicular B-cell non-Hodgkin's lymphoma, has flunked a Phase III trial. There was no difference in progression-free survival between patients taking the drug and the control substance. On the bright side, however, the company noted that the MyVax arm of the trial "showed a highly statistically significant difference in PFS between patients who mounted a positive immune response to the tumor-specific target and those who did not." Genitope's shares took a beating on the news, dropping 50 percent. The company said that it would work with the FDA to determine the best path for MyVax. Release

> Report: According to the site Copenhagen Capacity, Pfizer is taking a close look at several Denmark-based drug developers. A number of Danish biotechs are working on therapies for obesity, diabetes and cancer, all of which may be of interest to Pfizer. Report

> Bavarian Nordic has gained a $25 million milestone payment as part of its deal with the Department of Health and Human Services to provide 20 million doses the smallpox vaccine Imvamune. Release

> The FDA has extended its review of Genta's advanced melanoma treatment Genasense by 60 days. Release

> Daiichi Sankyo will be marching three of its subsidiaries--Sankyo Chemica., Sankyo Organic Chemicals, and Daiichi Sankyo Chemical Pharma--in order to "management resources on the pharmaceutical businesses." Release

> Valeant Pharmaceuticals is selling the U.S. and Canadian rights to Infergen, a hepatitis C treatment. Three Rivers Pharmaceuticals will acquire the drug for $91 million. Valeant says it's selling Infergen in order to simplify its operations. Release

> Redwood City, CA-based A.P. Pharma is on the hunt for a new CEO. Report

And Finally... A group of scientists have derived four embryonic stem cell lines that could lead to the creation of cells that will not cause immune rejection. Report

Big Pharma takes an interest in cancer vaccines

Maureen Martino — Wed, 19 Sep 2007 10:49:50 -0400

For two decades, biotech companies have struggled to develop therapeutic cancer vaccines designed to treat the disease by stimulating the immune system to attack cancer cells without harming normal cells. This approach would be a major step forward for cancer treatment, as current therapies attack both diseased and healthy cells and can result in hair loss, vomiting and infection.

So far, the FDA has yet to approve a single therapeutic cancer vaccine. The issue is that the vaccines must do more than slow tumor growth – they must actually improve patient survival, which can take years to measure, requiring long Phase III trails. But a crop of late-stage cancer vaccines are showing a lot of promise and attracting the attention of large pharma and biotech companies. “There are possibilities here, and now the big companies are starting to be interested, but they haven't had the courage before because it has been too risky for them," noted Haakan Mellstedt, a professor in oncological biotherapy at Karolinska Institutet in Stockholm. Cancer treatment is a $50 billion annual market, and research firm Arrowhead Publishers says that if approved, cancer vaccines could grab $6 billion in annual sales by 2010. Analysts expect the cancer vaccine market will soar to $8 billion by 2012. Here’s a look at some of the late-stage drug candidates that could revolutionize the cancer treatment field:

Earlier this year, Sanovi-aventis bought the rights to TroVax from Oxford BioMedica for $720 million (in fact, it was one of the top 5 deals of the first half of 2007). TroVax is currently in Phase III for renal cancer, but the company is exploring its utility in a range of cancers including colorectal, lung, breast and prostate cancer.
Glaxo said it will be recruiting 2,000 patients for a Phase III trial of its lung-cancer vaccine MAGE-A3, making it the largest cancer vaccine study ever.
Also competing in the lung cancer market, Merck KGaA is recruiting patients for a Phase III study of Stimuvax, bought from Canada's Biomira in January. In the Phase II trial, patients taking Stimuvax lived an average of 30.6 months compared to an average of 13.3 months for patients receiving supportive care alone.
Genitope is developing MyVax for an incurable form of non-Hodgkin's lymphoma. The company plans to wrap up a trial of the vaccine by the end of this year. The developer hoped to end the trial sooner, but last month an independent board recommended that the clinical trial continue.
Antigenics has reported positive data for Oncophage, a brain cancer treatment. Previously, Antigenics took a beating when Oncophage failed late-stage trials for skin and kidney cancer.

For more:
- read the Wall Street Journal article

Related Article:
Vaccine "renaissance" attracts huge new venture investments. Report