cancer vaccine

GVAX questions depress Dendreon shares

John Carroll — Thu, 28 Aug 2008 11:43:55 -0400

After halting one GVAX study so it could further investigate a disturbing number of deaths, Cell Genesys' hopes for the vaccine are now focused on a separate Phase III trial that has not raised the same safety concerns. And analysts note that a success in that trial--which provides GVAX alone--could still warrant an approval. In the meantime, shares of Dendreon also traded lower as investors considered the possible implications for all the developers advancing cancer vaccines. Report

Deaths force halt to Cell Genesys cancer vaccine trial

John Carroll — Wed, 27 Aug 2008 10:07:55 -0400

A closely watched trial for Cell Genesys' prostate cancer vaccine GVAX was brought to a sudden halt after an independent monitoring committee noted a significantly higher death rate in the group taking a combination of the vaccine and Taxotere compared to the control arm of the study. In a statement, Cell Genesys said that 67 patients taking the combo therapy had died compared to 47 who were taking Taxotere alone. The company said it doesn't know why the vaccine group would experience a higher rate of death.

Investors weren't waiting for details. The news quickly wiped out 70 percent of the company's share price, leaving it at 85 cents this morning and pointed downward. The committee will now examine the death rate in a separate trial of GVAX called VITAL-1. In January, the committee gave researchers a green light to continue with that trial.

- check out the Cell Genesys release
- read the AP report

Kennedy's surgery may be followed by experimental therapy

Mon, 02 Jun 2008 06:59:58 -0400

Legendary Duke neurosurgeon Dr. Allan Friedman is scheduled to remove Senator Ted Kennedy's brain tumor this morning, and there's already significant speculation that the lawmaker will undergo experimental therapy in a follow-up treatment. According to a statement, the Duke neurosurgeon will surgically remove the tumor and the senator will undergo radiation and chemotherapy to combat the glioblastoma. About half of all glioblastoma patients die within a year of surgery. Median survival time is 12 to 15 months.

Kennedy, though, is in the hands of the countries best neuro-oncologists. In addition to the chemo drug Temodar, Kennedy may be treated with Avastin. While approved for other cancers, using Avastin to starve the tumor of blood is still only in the experimental stage for brain tumors.

- read the AP report

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

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

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

Antigenics' cancer vax gets mixed Phase III results

Wed, 20 Feb 2008 06:59:54 -0500

Antigenics' cancer vaccine Oncophage failed to meet its primary endpoint of overall survival in a late-stage clinical trial for metastatic melanoma, but patients receiving a minimum of 10 injections did see an improved median survival of 3.7 months. The results of the Phase III study were previously announced at the American Society of Clinical Onocology in June 2006 and showed that patients with less advanced disease who received at least 10 doses of Oncophage had improved median survival of approximately 18.4 months versus patients who received physician's choice of treatment.

"Patients with stage IV melanoma are particularly difficult to treat. These patients generally have a very poor prognosis and there is currently no consensus regarding standard of care," said Alessandro Testori, MD, Istituto Europeo di Oncologia, Milan, Italy. "The results demonstrate that Oncophage may provide certain melanoma patients additional survival time. Given that currently approved therapies for metastatic melanoma are extremely limited, further investigation is warranted evaluating a predetermined number of Oncophage doses in patients with less advanced metastatic disease."

- read the release

Related Articles:
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
Big Pharma takes an interest in cancer vaccines. Report

Is Sanofi preparing a bid for Oxford BioMedica?

Tue, 12 Feb 2008 06:59:57 -0500

Investors have focused their attention on Oxford BioMedica, a struggling UK developer that is the hotly rumored takeover target of Sanofi Aventis. Speculation about a possible buyout drove up Oxford BioMedica stock by 27 percent on Monday as analysts did the math on a possible deal. The company right now would probably fetch around $547 million, analysts tell the Financial Times. But a successful development program for the cancer vaccine TroVax would cost Sanofi--which partnered on the therapy--$753 million. Phase III data on TroVax is due next year while with Phase I/II data this year for a gene therapy aimed at Parkinson's.

"Sanofi Aventis has committed about £350 million and if everything is successful they are never going to pay this when the company is so cheap at the moment," says Navid Malik, an analyst at Collins Stewart. The companies, though, aren't saying anything for now.

- check out the article from the Financial Times

Related Articles:
Rumor Mill: Sanofi to buy 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

Rumor Mill: Sanofi to buy Oxford BioMedica

Mon, 11 Feb 2008 06:59:56 -0500

Rumors are swirling that Sanofi-Aventis may be making a bid for Oxford BioMedica, a U.K.-based developer of gene-based medicines. Oxford's shares have surged in response to a report published in The Mail claiming that a Sanofi bid for the company is imminent. Neither side is sharing details, however; spokespeople for both Sanofi and Oxford declined to comment.

A takeover by Sanofi isn't out of the question, as the drug developer has indicated in recent months that it's looking to acquire a biotech. Additionally, last year Sanofi hopped on the cancer vaccine bandwagon when it inked a $690 million licensing deal for Oxford BioMedica's TroVax. However, another news source reported that the rumors are false and that Sanofi doesn't have plans to change its relationship with the company.

- read this CNN report

Related Articles:
Sanofi: We're looking for biotech deals. 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

SPOTLIGHT: Geron gains milestone from Merck

Wed, 12 Dec 2007 06:59:53 -0500

Merck has filed an IND for a cancer vaccine candidate that targets telomerase, triggering a $4 million milestone payment to licensing partner Geron. Release

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

SPOTLIGHT: Big Pharma takes an interest in cancer vaccines

Wed, 19 Sep 2007 06:59:53 -0400

For two decades, companies have struggled to develop therapeutic vaccines designed to treat cancer by stimulating the immune system to attack cancer cells without harming normal cells. So far, the FDA has yet to approve a single therapeutic cancer vaccine. But a crop of late-stage cancer vaccines are showing a lot of promise and attracting the attention of pharma and biotech companies. Check out this report for a look at some of the late-stage drug candidates that could revolutionize the cancer treatment field. Article

4. Sanofi-Aventis and Oxford BioMedica

Maureen Martino — Tue, 11 Sep 2007 09:04:14 -0400

Who: Sanofi-Aventis
With: Oxford BioMedica
What: $690 million licensing deal

Summary: Sanofi-Aventis hopped on the cancer vaccine bandwagon when it inked a $690 million licensing deal for Oxford BioMedica's TroVax. Oxford BioMedica is slated to get $39 million up front and $25 million payments as targets are hit. The deal includes additional payments if TroVax goes on to win approval for multiple indications--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. The Sanofi/Oxford BioMedica pact is an example of big pharma's interest in cancer vaccines. Release

Related Articles:
Sanofi inks $690M pact for cancer vaccine. Report
Cancer vaccine market to soar. Report
Oxford BioMedica says licensing talks heating up. Report
Oxford BioMedica touts mid-stage TroVax trial data. Report

Press Release: Introgen Therapeutics's INGN 225 Molecular Cancer Vaccine Demonstrates Promising Results In Phase 2 Trial

Maureen Martino — Mon, 29 Jan 2007 11:11:02 -0500

Introgen Therapeutics's INGN 225 Molecular Cancer Vaccine Demonstrates Promising Results In Phase 2 Trial

AUSTIN, Texas -- Approximately half of patients with advanced small cell lung cancer responded to Introgen Therapeutics, Inc.'s INGN 225 molecular cancer vaccine in combination with subsequent chemotherapy. The encouraging Phase 2 clinical data were presented over the weekend by Introgen's collaborator Dr. Scott Antonia of the H. Lee Moffitt Cancer Center & Research Institute. Patients in the study achieved a 52 percent objective tumor response rate and 41 percent of patients were still alive one year after receiving the immunotherapy. Historically, tumor responses to second-line chemotherapy are between 6 and 30 percent and most patients survive for less than 6 months. The data imply that INGN 225 immunotherapy can sensitize cancer cells to the effects of chemotherapy restoring its effectiveness. INGN 225 is a cancer vaccine containing the p53 gene. p53 is called the "Guardian of the Genome," and is known to help restore normal cellular function and to promote apoptosis, or programmed cell death in abnormal cells such as cancer cells, allowing tumors to die when treated with chemotherapy.

Dr. Antonia, associate professor in the Department of Interdisciplinary Oncology and Molecular Medicine, reported the data during the Fourth Biennial Meeting of Molecular Targets in Cancer Therapy in Clearwater Beach, Florida. An interim analysis of the phase 2 clinical trial was previously published in the medical journal Clinical Cancer Research.

"Data from Introgen's study in lung cancer patients, as well as other published studies, supports the novel approach of using a combination of immunotherapy and chemotherapy to treat cancer patients," said Dr. Dmitry Gabrilovich, also of H. Lee Moffitt Cancer Center & Research Institute, organizer of the conference and co-principal investigator of the clinical trial. "INGN 225 sensitized tumors to the effects of platinum and taxane chemotherapies. Of particular interest, some patients who previously failed platinum chemotherapy responded to platinum re-treatment. These findings have important implications for improving the efficacy of these widely utilized cancer chemotherapies."

INGN 225 is an immunotherapy (vaccine) that utilizes an adenovector to deliver the p53 gene to a patient's immune cells, stimulating an anti-tumor immune response. Induction of p53-specific immune responses were observed following INGN 225 therapy and were found to correlate with increased tumor responses to the administered chemotherapy.

Introgen Therapeutics, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of targeted molecular therapies for the treatment of cancer and other diseases. Introgen is developing molecular therapeutics, immunotherapies, vaccines and nano-particle therapies to treat a wide range of cancers using tumor suppressors and cytokines. Introgen maintains integrated research, development, manufacturing, clinical and regulatory departments and operates multiple manufacturing facilities including a commercial scale cGMP manufacturing facility.

Statements in this release that are not strictly historical may be "forward-looking" statements, including those relating to Introgen's future success with its INGN 225 clinical development program for treatment of lung and other cancers. The actual results may differ from those described in this release due to risks and uncertainties that exist in Introgen's operations and business environment, including Introgen's stage of product development and the limited experience in the development of gene-based drugs in general, dependence upon proprietary technology and the current competitive environment, history of operating losses and accumulated deficits, reliance on collaborative relationships, and uncertainties related to clinical trials, the safety and efficacy of Introgen's product candidates, the ability to obtain the appropriate regulatory approvals, Introgen's patent protection and market acceptance, as well as other risks detailed from time to time in Introgen's filings with the Securities and Exchange Commission including its filings on Form 10-K and Form 10-Q. Introgen undertakes no obligation to publicly release the results of any revisions to any forward-looking statements that reflect events or circumstances arising after the date hereof.

EDITOR'S NOTE: For more information on Introgen Therapeutics, or for a menu of archived press releases, please visit Introgen's Website at: www.introgen.com.

Contact: Introgen Therapeutics, Inc. Naomi Puhl, 512-708-9310, ext. 341 n.puhl@introgen.com

ALSO NOTED: Cancer vaccine market to soar; Point Therapeutics cuts staff; and much more...

Thu, 09 Nov 2006 19:01:30 -0500

> Analysts say that the cancer vaccine market will soar to $8 billion by 2012. Report

> Fledgling Point Therapeutics has cut its workforce by 15 percent, with most of the cuts focused on its preclinical development group. "In our ongoing efforts to further talabostat's clinical development, particularly our Phase III program, it became necessary for Point to undertake measures to reduce our costs," said CEO Don Kiepert. The company announced positive preclinical data on talabostat at the end of October. Release

> Australia's pSivida has inked a deal with an investment fund for $33.7 million in funds to advance its macular edema therapy. Report

> Dendreon is touting positive preliminary data from a new trial of Provenge that demonstrated its effect in boosting the immune response to fight prostate cancer. Almost half of the patients in the study benefited from the drug. Report

> The wrinkle treatment company Thermage raised $42 million in its IPO, significantly under its original expectations. Report

> Cambridge, MA-based Immunogen says its Phase I trial of its anticancer therapy huN901-DM1 shows it was well tolerated and produced evidence of efficacy that included a complete remission for one of the patients enrolled. Release

> Boehringer Ingelheim has received the FDA's approval to market Mirapex for restless leg syndrome. Mirapex has long been on the market as a therapy for Parkinson's symptoms. Release

> Alnylam has filed a shelf registration with the SEC to periodically sell up to $150 million in stock. Alnylam is focused on RNAi, a hot prospect in the biotech world. Report

And Finally… A new class of sirtuin activators are being pursued by biotechs who see big potential in the anti-aging therapies. Article

Biomira expands its portfolio with ProlX buyout

Mon, 30 Oct 2006 19:01:36 -0500

Canada's Biomira has expanded its oncology portfolio with a deal to buy ProlX Pharmaceuticals for cash and stock worth a collective $23.9 million. Up to $15 million in additional Biomira stock will be paid for achieving certain milestones. The acquisition will give Biomira control of Stimuvax, a synthetic MUC1 peptide vaccine now in Phase III, and PX-12, a thioredoxin inhibitor which is headed into Phase II. Two more drugs and headed into the clinic in the next year and ProlX also held a number of preclinical drugs.

"The acquisition of ProlX is a transformative event for Biomira, expanding and diversifying our pipeline of cancer therapies in development," said Robert L. Kirkman, M.D., President and CEO. "The combined programs will give us products in several phases of clinical development directed against multiple targets, diversifying risk while retaining our focus on the treatment of solid tumors. This is a major step toward our goal of building a leading oncology franchise."

- see the release on the deal

Related Article:
Biomira shares jump on cancer vaccine data. Report

Receptor BioLogix acquires Aphton assets

Sun, 30 Jul 2006 20:01:35 -0400

Receptor BioLogix has acquired the cancer vaccine Insegia and other assets of Aphton Corp. in a Chapter 11 bankruptcy sale. Insegia, also known as G17DT, is a therapeutic cancer vaccine that has been extensively studied for its effects on cancers of gastrointestinal origin. The immunotherapeutic stimulates the body to produce antibodies that neutralize the peptide hormone, gastrin. No financial details were disclosed.

"Insegia has been clinically studied in very difficult forms of cancer," said Thomas A. Glaze, CEO of Receptor BioLogix. "In view of the promising clinical trial results to date, we believe there is a strong likelihood Insegia has a beneficial effect on these cancers and warrants further clinical development. In addition, the available mechanisms for expedited regulatory approval in the United States and Europe will be pursued."

- take a look at the release on the buyout

Biomira shares jump on cancer vaccine data

Thu, 27 Apr 2006 20:01:37 -0400

Shares of Canada's Biomira jumped 17 percent after the biotech announced positive survival data from a mid-stage trial of its cancer vaccine. Patients taking Stimuvax lived an average of 30.6 months compared to an average of 13.3 months for patients receiving supportive care alone. The study followed 171 patients with advanced lung cancer whose disease had been stabilized by chemotherapy. Biomira's collaborator on Stimuvax, Merck KGaA, plans to begin a pivotal trial in the summer.

- read the AP report on the trial data