immune system

IRX Therapeutics raises $25M Series A

Tue, 03 Jun 2008 06:59:55 -0400

New York-based IRX Therapeutics announced that it has raised $25 million in a Series A. The new money will be used to further develop IRX's cancer and viral disease product platform, including IRX-2 (citoplurikin), its lead candidate for cancer treatment. IRX researchers are developing a therapy that stimulates a coordinated cellular immune response that can enable a patient's own immune system to fight disease. IRX has reported positive mid-stage data and say they plan to launch a late-stage trial.

- check out IRX's release

ALSO: Canada's Inimex Pharmaceuticals has rounded up $22 million in venture funds to conduct the first clinical trials of its IDR drugs. 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

Pharming shares sink after Rhucin gets thumbs down

Thu, 20 Mar 2008 07:59:57 -0400

There's new trouble for Pharming's Rhucin, an experimental treatment for hereditary angioedema. Pharming shares plunged after the company announced that the EMEA's Committee for Medicinal Products for Human Use is expected to refuse to approve Rhucin, saying that there is insufficient evidence of clinical benefits after repeated use and a possibility of immune system reactions. Pharming's shares were down about 27 percent after initially dropping by almost half.

Rhucin has been a major headache for Pharming since the EMEA first denied approval last December, sending its stock into a downward spiral. The drug is manufactured in the milk of transgenic animals and has long been held up as a leading example of the potential of transgenic therapies. But Pharming isn't giving up. "European denial for the drug is not the end for Rhucin nor for Pharming," Chief Commercial Officer Rein Strijker told reporters. The company insists that additional data will convincingly make their case for Rhucin and win eventual approval.

- see Pharming's release
- check out the ABN story

Related Articles:
Pharming says it's closing in on Rhucin approval. Report
Pharming steps up marketing plans on Phase III data. Report
Regulators focusing on transgenic animals. Report
Pharming gets orphan status for transgenic therapy. Report

Breakthrough reported in flu vaccine research

Mon, 10 Mar 2008 07:59:57 -0400

A Japanese chemical company saw its stock shoot up 20 percent this morning, the maximum allowed on the Japanese market, after researchers for NOF and Japan's National Institute of Infectious Diseases announced that they had found a way to create a new vaccine that could protect people from all types of bird flu viruses. One of the researchers said that the new approach targets the inside of the virus, preventing it from replicating. Current vaccines rely on alerting the immune system to attack the virus and become ineffective when the virus mutates.

"We are continuing the joint study in the hope that it will have universal effect on human influenza as well as a variety of other influenza viruses," said NOF. Any vaccine for human use is still far off, though. Researchers plan to start testing the vaccine in biotech mice in April.

- read the AFP report

Related Articles:
Breakthrough in understanding mechanism of bird flu. Report
Antibodies used to protect against bird flu. Report
Bird flu scientist says annual mutations likely. Report
Experimental vaccines show efficacy against H5N1 viruses. Report

Wyeth takes another look at antibody pact

Thu, 06 Dec 2007 06:59:54 -0500

In yet another sign of monoclonal antibodies' popularity among big drug developers, Wyeth has extend its evaluation of selected Raven Biotechnologies MAb antibodies. Raven, which signed a pact with Wyeth earlier this year, will receive an undisclosed milestone payment.

2007 hasn't been a pretty year for Wyeth. A string of woeful developments has left the company stripped of three of its leading drug candidates, and the drug developer could certainly use MAb technology to revive its pipeline. A new Datamonitor report projects 14 percent annual growth in the market for the antibody drugs, which mimic the body's own immune system. Raven was a 2003 Fierce 15 company.

- see this release for more

ALSO: Take a look at Wyeth's pipeline. Report

Related Articles:
MAbs are hottest segment of biotech industry. Report
New venture round boosts Raven's cancer work. Report

Pfizer buys Coley for $164M

Fri, 16 Nov 2007 06:59:58 -0500

In what is sure to be one of many acquisitions to come, Pfizer has agreed to purchase Wellesley, MA-based Coley Pharmaceuticals for $8 per share, bringing the total deal to $164 million. Pfizer will gain access to Coley's vaccine adjuvant technology. Coley also has a new class of immunomodulatory drug candidates--TLR Therapeutics--which work by stimulating or blocking important immune system receptors.

"This acquisition is an important component of Pfizer's vaccine strategy and reflects our commitment to research new and more effective vaccines to prevent infectious diseases and to treat cancers and other debilitating conditions. Coley's innovative product candidate portfolio and technology have the potential to significantly enhance future vaccine and immunotherapeutic approaches to a broad range of diseases..." said Jeffrey B. Kindler, chairman and CEO of Pfizer.

- see Pfizer's release for more

Related Articles:
Who should Pfizer buy? Report
Pfizer hires new R&D chief, launches biotech center. Report

SPOTLIGHT: Argos, J&J make a deal

Fri, 16 Nov 2007 06:59:53 -0500

Therakos, a Johnson & Johnson company, has struck a licensing deal with Argos Therapeutics. Therakos gains Arros' technology related to part of the immune system known as regulatory T cells. Financial details were not disclosed. Release

Momenta shares tumble after FDA rejection

Tue, 06 Nov 2007 06:59:58 -0500

It's Momenta Pharmaceuticals' turn at the Wall Street whipping post as investors respond to the news that the FDA has rejected its generic version of the anti-clotting drug Lovenox, which is made by Sanofi. The company said the FDA's non-approvable letter cited an inadequate look at the drug's possible effects on the immune system. The agency's response is a heavy blow to Momenta, which had been looking for an approval to help gin new revenue for its research work. Its stock crashed in pre-market trading, losing almost half of its value. Momenta's partner, Sandoz, received the rejection letter.

- check out Momenta's release on the rejection
- read the AFX report for more info

Related Articles:
Momenta sees delay in generic Lovenox development. Report
Sanofi loses Lovenox patent protection. Report
Lovenox reduces cardio risks but can cause bleeding. Report
Sandoz takes big stake in Momenta. Report
Lovenox reduces cardio risks but can cause bleeding. 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

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

Genmab regains HuMax-CD4 rights

Fri, 29 Jun 2007 00:01:35 -0400

Denmark's Genmab has regained the rights to the antibody Humax-CD4 from Merck Serono. Genmab granted Merck Serono worldwide rights to develop and market Humax-CD4, which is used for treatment of T-cell lymphomas, an immune system related cancer form, two years ago. The company says it will continue the development of the antibody and will further work targeting the CD4 receptor as a mechanism to prevent or slow HIV infection.

"We are very enthusiastic about having HuMax-CD4 back in the hands of Genmab's experienced clinical development team," said Genmab chief executive Lisa N. Drakeman.

- check out Genmab's release
- here's the report from Hemscott

Related Articles:
Glaxo forges $2.1B deal for HuMax-CD20. Report
Genmab touts positive trial data. Report

Accentia shares soar on cancer trial results

Thu, 19 Oct 2006 20:01:37 -0400

Shares of Accentia Biopharmaceuticals soared 54 percent Thursday after the drug developer announced positive results from a small clinical trial of its BiovaxId cancer therapy for relapsed Follicular Non-Hodgkins Lymphoma. In the trial, 20 patients, or 80 percent, who took BiovaxId following chemotherapy saw their cancer go into remission for 20 to 51 months. The drug relied on the patient's cells to create a therapy that is designed to get the immune system to recognize the cancer and attack it.

- here's the AP report on Accentia

Related Article
In May the FDA granted fast track status to Accentia's drug. Report

Genmab shares up on new antibody tech

Tue, 17 Oct 2006 20:01:38 -0400

Shares of Denmark's Genmab surged on the news that it had unveiled a new technology for developing smaller antibodies. Genmab CEO Lisa Drakeman said that its new UniBody technology will help advance the antibody field. Smaller antibodies would be able to reach new drug targets and could be delivered orally rather than by injection. Drakeman also said that she's in discussions with several potential partners for HuMax-CD20.

"We believe that UniBody constitutes the next generation in antibody development," said Jan G. J. van de Winkel, Ph.D., chief scientific officer at Genmab. "It does not activate the immune system, so it may be useful to treat autoimmune disease where the goal is to regulate and preserve the target cells. It may also be effective against certain cancer targets where it is not expected to cause unwanted cell growth."

- see the release on Genmab

New research focuses on PD-1's role

Mon, 21 Aug 2006 20:01:36 -0400

The Wall Street Journal takes an in-depth look at new research into what causes the immune system to shut down and how scientists hope to switch it back on. Much of this new research focuses on the role of the PD-1 molecule that lies on the surface of T-cells. PD-1 is a natural regulator of the immune system and may be key to getting the body to rid itself of HIV, hepatitis C and cancer cells. But researchers are proceeding cautiously, with an eye on the disastrous drug trial in London that sent six volunteers to the hospital with organ failure.

- here's the report on PD-1 research from The Wall Street Journal (sub. req.)

Congress launches probe of NIH conflicts policies

Wed, 09 Aug 2006 20:01:38 -0400

A group of congressional leaders in Washington has launched a probe into the financial ties of a senior NIH scientist, Dr. Thomas J. Walsh, to several drug companies. They will determine if the NIH has a sufficiently effective policy in place to unveil potential conflicts on its staff. Dr. Walsh has conducted trials of the companies' therapies designed to treat fungal infections among patients with a compromised immune system. The lawmakers decided to launch their probe after The Los Angeles Times unveiled his financial ties to Pfizer and Merck and his appearances with company representatives before the FDA.

- here's the article on the NIH from The Los Angeles Times

Transplant drugs may offer Type 1 help

Tue, 07 Mar 2006 19:01:37 -0500

The Wall Street Journal examines some of the new clinical research work being done on immunosuppressants to treat Type 1 diabetes. Researchers haven't come up with a significant new therapy for Type 1 since the 1920s, but drugs like Roche's Daclizumab may offer some major improvements for patients. Just as immunosuppressants work to help patients' bodies avoid rejecting new organs, this method may help stop the immune system from attacking insulin-producing beta cells in the pancreas.

- here's The Wall Street Journal article (sub. req.)

Researchers tout ricin vaccine data

Mon, 30 Jan 2006 19:01:39 -0500

Researchers at the University of Texas Southwestern Medical Center have published data indicating that a new vaccine for the lethal toxin ricin is safe and effective. The vaccine, RiVax from DOR Biopharma, includes a genetically modified toxin which alerts the body's immune system to attack ricin once it is detected. Fifteen people were divided into three groups and received various doses of the vaccine. All five in the highest dose level group produced antibodies that neutralize ricin. Scientists said that their main concern was safety. They will now manipulate dose levels of the vaccine. The U.S. government has been pouring billions of dollars into drug research aimed at protecting the country from a bioterror attack.

- read this BBC report for more

SPOTLIGHT: CellCept wins orphan status

Tue, 03 Jan 2006 19:01:33 -0500

The FDA has granted orphan drug status to the immunosuppressant CellCept, being developed by Roche and Aspreva. CellCept is currently in a late-stage trial for Myasthenia Gravis, a rare immune system ailment. Report

SPOTLIGHT: Osiris granted orphan status

Tue, 20 Dec 2005 19:01:33 -0500

The FDA has given orphan drug status to Osiris Therapeutics' Prochymal adult stem cell product, which is being investigated as a treatment for acute Graft vs. Host Disease. Prochymal is intended to modulate the body's immune system. The FDA put Prochymal on a fast track back in January. Release

Cyclacel to go public in reverse merger with Xcyte

Thu, 15 Dec 2005 19:01:36 -0500

In a reverse merger, Seattle-based Xcyte Therapies is taking over Scotland's Cyclacel Pharmaceuticals in a deal that will allow Cyclacel to emerge as a public company in the US. Xcyte shareholders will wind up with 20 percent of the new company, which will be based in Short Hills, NJ. Xcyte was reduced to a mere shell company earlier this year after the FDA raised objections to its design of a major clinical trial of technology designed to arouse the immune system to ward off disease. Facing a major delay, Xcyte reduced its workforce from 100 to 5 and began to look for someone to come in and take over. The remaining employees will be dismissed and Xcyte's Seattle operations will be closed. Cyclacel will focus on two trials for experimental oncology therapies.

- read this article from The Seattle Times for more information

ALSO: Xcyte sold its T-cell expansion technology to Invitrogen for $5 million. Report