FDA has removed a 15-month clinical hold on Dynavax Technologies’ HBV vaccine, Heplisav™. The firm is still not allowed to test the candidate in healthy volunteers but has been given the go-ahead for a Phase III trial in individuals with chronic kidney disease.

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The news propelled Dynavax’ stock almost 67% to open trading today at $2.92. In the past year and a half or so, the firm’s value had depreciated over 103% and reached an all time low of $0.16 in November 2008.

The placement of the clinical hold in March of last year sent the company’s share price down 64% in the first week of trading; it went from $5.95 on March 14 to $2.12 by March 20. Then in October 2008 the FDA confirmed that Heplisav was not safe to be tested in healthy people, keeping the company’s share price below $0.50 for the next couple of months.

The agency noted in October the possibility of evaluating the vaccine in those with renal failure, but that was not enough to keep partner, Merck & Co., in tow. By December 2008, Merck had pulled out of the collaboration, sending Dynavax’ stock spiraling downward again by 28% in the first day of trading. Dynavax could have earned $105 million in milestones under the arrangement with Merck over and above the $31.5 million up-front fee.

Now Dynavax says that it will initiate a Phase III study in chronic kidney disease patients in the near-term. The aim is to test Heplisav for its ability to provide increased, rapid protection with fewer doses than current vaccines. Heplisav combines hepatitis B surface antigen with a toll-like receptor 9 agonist to enhance the immune response.

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The company is also planning another Phase III lot-to-lot consistency trial in adults over 40 years in early 2010. It says that its global strategy, which is based on discussions with FDA and EMEA, is to develop the HBV vaccine for populations that less responsive to current vaccines, including those over 40 years and others.

Source: GEN News

Popularity: 3% [?]

Pharmaceuticals giant GlaxoSmithKline (GSK; Brentford, England) has made a worldwide agreement with Enigma Diagnostics (Salisbury, England) to develop a fast, highly accurate point-of-care influenza diagnostics test based on Enigma’s real-time polymerase chain reaction (RT-PCR) platform.

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Separately, another pharmaceuticals company, Abbott (Des Plaines, IL), announced an agreement with GSK to develop an automated molecular diagnostic test, also based on RT-PCR technology, to screen non-small cell lung cancer (NSCLC) tumors for expression of the MAGE-A3 antigen. GSK’s MAGE-A3 ASCI (antigen specific cancer immunotherapy) candidate is currently being evaluated as an adjuvant treatment in resected NSCLC in the Phase III clinical study MAGRIT, the largest lung cancer treatment study ever conducted.

Fast, accurate influenza testing
The GSK-Enigma partnership aims for joint development of the Enigma ML (mini laboratory) PCR platform to deliver fully-automated results from swab samples in less than 60 minutes at the point of care–to the same accuracy standards as reference laboratories. Thus, patients can be tested for specific influenza subtypes and quickly receive appropriate treatment. Operators of the Enigma ML system will not require specialist training.

A trial involving working prototypes of the ML system with front line health care providers across Europe is planned for Q4 2009. Launch of Enigma ML is anticipated in early 2011, subject to successful clinical trials and regulatory approval.

Under the terms of the agreement, GSK will make a small equity investment in Enigma, as well as an upfront payment and research and development funding. The companies will share profits on sales. Further payments will be subject to development progress and agreed milestones.

Cancer immunotherapy

Under terms of the GSK-Abbott agreement, the partners will develop and commercialize an RT-PCR test–designed to detect MAGE A3–for use on the Abbott m2000 automated instrument system.

“This is an exciting collaboration with a leading company in cancer immunotherapy research,” said Stafford O’Kelly, head of Abbott’s molecular diagnostics business. “The agreement is indicative of our focus on personalized medicine and developing analytical molecular tools to identify patients most likely to benefit from important pharmacogenomic therapies.”

Currently, there are no nucleic acid based tests approved by the U.S. Food and Drug Administration for use in identifying patients who may derive treatment benefits from targeted non-small cell lung cancer therapies.

“Lung cancer is the biggest cancer killer globally,” said Vincent Brichard, M.D., Ph.D., vice president and head of Immunotherapeutics, GSK. “Through this partnership we aim to make MAGE-A3 testing of lung tumors available in standard pathology labs around the world. This means patients globally could be able to find out if they are eligible and can potentially benefit from targeted cancer treatment against this antigen, such as GSK’s MAGE-A3 candidate ASCI.” MAGE-A3 is a tumor-specific antigen that is expressed in non-small cell lung cancer and a wide variety of other cancers (including melanoma, head and neck cancer, and bladder cancer), but not in normal cells. To be eligible to receive GSK’s MAGE A3 ASCI, patients must have MAGE-A3 expressing NSCLC tumors.

GSK says its ASCIs represent a novel class of medicines designed to train the immune system to recognize and eliminate cancer cells in a highly specific manner. They combine tumor antigens, delivered as purified recombinant proteins, and GSK’s proprietary Adjuvant Systems, which are specific combinations of immunostimulating compounds selected to increase the anti-tumor immune response. ASCIs are being investigated in the clinic to support their use to reduce the risk of tumor recurrence following surgery, or to impact tumor growth in an early metastatic setting. The highly specific mode of action of GSK’s ASCIs allows development of diagnostic tools to aid in selecting patients eligible for the treatment, depending on the expression of the tumor antigens.

MAGE-A3 protein has been in-licensed by GSK from the Ludwig Institute for Cancer Research, the largest international academic institute dedicated to understanding and controlling cancer. MAGE-A3 ASCI is an investigational compound and it is not approved for use in any indication in any country at this time.

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The Abbott m2000 system, an automated instrument for DNA and RNA testing in molecular laboratories, consists of the m2000sp for automated sample preparation and the m2000rt for PCR detection an analysis. It is marketed in most major markets throughout the world and offers an extensive menu for infectious disease testing, including HIV viral load, hepatitis B viral load, chlamydia detection, chlamydia/gonorrhea (CT/NG) multiplexed assay, hepatitis C (HCV) viral load, HCV genotyping, cytomegalovirus, Epstein-Barr virus and human papillomavirus. With the exception of the CT/NG assay, these tests currently are not available on the m2000 in the United States.

Source: BioOptics World

Popularity: 10% [?]

Crucell reported Wednesday that the Netherlands-based vaccine maker is in discussions with Wyeth that may lead to a merger agreement between the companies. The Dutch firm, which manufactures vaccines for hepatitis B, influenza, typhoid and cholera, confirmed that it is “in friendly discussions with Wyeth,” specifying that “these discussions are at a preliminary stage and there is no certainty that they will result in a transaction. An update will be provided in due course.”

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Crucell’s statement follows reports earlier in the day, which stated that Wyeth was in talks to purchase Crucell in a deal that could value the company at more than $1.35 billion, citing people familiar with the matter. However, Crucell spokesperson, Oya Yavuz, said she “can’t confirm or deny” the price being discussed. In response to the news, a Wyeth spokesman declined to comment, saying, “I refer you to their (Crucell’s) statement.”

Earlier in the day, Wyeth CEO Bernard Poussot indicated that the company would be seeking acquisitions in 2009, adding that the proportion of revenue coming from sources other than traditional medicines, such as biotech drugs and vaccines, would be increased in the coming years. Caris & Co. analyst David Moskowitz remarked that “vaccines are probably one of Wyeth’s most important platforms of technology, so I think this is a smart move for them.”

Source: FirstWord

Popularity: 4% [?]