Antigenics

Antigenics CEO Garo Armen

Maureen Martino — Thu, 10 Apr 2008 09:20:47 -0400

ALSO NOTED: FDA approves Orencia; Delay on Amgen clotting drug decision; Icahn files suit for Biogen Idec papers; and much more

Wed, 09 Apr 2008 06:59:50 -0400

> The FDA has approved Bristol-Myers Squibb's Orencia for juvenile arthritis. Release

> Amgen says that the FDA will delay a decision on its blood clotting drug by three months. A decision had been expected by April 23. Release

> Not satisfied with Biogen Idec's explanation of its failed effort to find a buyer, Carl Icahn has filed suit to get a hold of internal documents on the search. No way, responds Biogen Idec, which says it's just another ploy aimed at forcing a sale. Report

> Antigenics has raised $21 million in a private placement. The money will be used to market Oncophage, a cancer vaccine that just won regulatory approval in Russia. Release

> Potentia Pharmaceuticals has completed a $12 million round of financing. The funds will allow Potentia to complete Phase I and move into Phase II clinical development of Potentia's novel investigational drug candidate, POT-4. Release

> Schering-Plough has officially terminated its partnership with Novacea for its Asentar prostate cancer program. A clinical trial was halted earlier due to an imbalance of deaths between the two treatment arms. Release

> The FDA has rebuked GlaxoSmithKline for failing to regularly report post-marketing Avandia data. Report

> Scientists at Memorial Sloan-Kettering Cancer Center in New York City have identified the molecular process by which breast cancer cells spread to other tissue during metastasis. Report

> The heparin death toll is far worse than we originally thought. The FDA has tripled the number of deaths it's attributing to allergic reactions to the blood thinner since January 2007, to 62 from 19. Report

> Just why would Novartis pay $11 billion for one-fourth of eye-care Alcon company and promise another $28 billion for another big chunk? Report

> Expect the FDA to stay out of the Vytorin fray, at least for now. Report

> In the latter part of the 20th century, the conventional wisdom in the drug industry was simple: bigger is better. But now the Big-Big management model is cracking up. Report

And Finally... It turns out that hundreds of bacteria can actually 'eat' antibiotics, according to researchers at Harvard Medical School. Report

Antigenics gets world's first cancer vaccine approval

Tue, 08 Apr 2008 06:59:57 -0400

Russia has improbably emerged as a world leader in new cancer vaccines. The country's regulatory body approved the use of Antigenics' new kidney cancer vaccine, Oncophage--a world first. And shares of little Antigenics swiftly soared 23 percent on the news.

The FDA has not approved the therapy, one of the first of a wave of treatments that is intended to train the immune system to recognize and destroy cancer. Oncophage failed a clinical trial, but researchers found in a follow-up analysis of the data that patients taking the therapy lived 1.7 years longer without the cancer reoccurring. This is the first time Russia has approved a drug that was not yet OK'd in its country of origin.

- check out the release
- read the article from CNBC
- here's the AP story

Related Articles:
Big Pharma takes an interest in cancer vaccines. Report
Antigenics' cancer vax gets mixed Phase III results. Report
Antigenics reports positive data in brain cancer trial. Report
Antigenics shares punished on Oncophage failure. Report
Antigenics slashes staff in bid to conserve cash. 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

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