DV 601

[chanthou]

Look at this! Is there any hope for us all?

Dynavax Reports Additional Positive Phase 1B Immunogenicity Data for Hepatitis B Therapy Candidate

BERKELEY, CA -- (MARKET WIRE) -- 02/22/11 -- Dynavax Technologies Corporation (NASDAQ: DVAX) reported in a poster session Saturday, February 19 at the 21st Conference of the Asian Pacific Association for the Study of the Liver (APASL 2011) in Bangkok, Thailand new Phase 1b immunogenicity data for DV-601, its proprietary hepatitis B therapeutic vaccine. The study evaluated three doses of the candidate therapeutic vaccine escalation in 14 patients with chronic hepatitis B infection, including six patients that were HBeAg negative and eight patients who were HBeAg positive, and found:

    * The therapeutic regimen was safe and generally well tolerated at all dose levels;
    * Most common systemic reactions were fatigue and malaise. No SAEs were recorded;
    * DV601 was found to elicit immune responses at all dose levels, and anti-HBe antibodies were elicited in two of eight (2/8) patients;
    * Anti-HBs antibodies were elicited in four of 14 (4/14) patients;
    * Amongst the eight HBeAg positive patients, two had HBeAg clearance, and one of those individuals also had HBsAg clearance;
    * Three patients are still in the follow-up observation period.

According to Tyler Martin, M.D., President and Chief Medical Officer, "This trial was primarily designed to assess the safety of our vaccine. The positive immunogenicity results, in particular, the two HBeAg seroconversions, including one HBsAg serocoversion, provide a strong rationale for an expanded evaluation of our approach in collaboration with a potential partner."

Dynavax in December 2010 reported that all doses were generally safe and well tolerated and that individual immunologic and virologic responses had been observed across cohorts at all dose levels.

Dynavax's treatment approach combines both the surface and core hepatitis B virus (HBV) antigens with ISCOMATRIX® adjuvant originally entered into development by Rhein Biotech prior to its acquisition by Dynavax in 2006. The candidate vaccine, DV-601, is designed to induce an immune response against HBV-infected cells and if proven to be safe and effective, may offer an alternative therapeutic option for patients chronically infected with HBV.

About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV™, a Phase 3 investigational adult hepatitis B vaccine designed to enhance protection more rapidly with fewer doses than current licensed vaccines. For more information, visit www.dynavax.com.

ISCOMATRIX® is a registered trademark of ISCOTEC AB, a CSL Limited Company

Contact:

Michael Ostrach

Vice President and Chief Business Officer

510-665-7257

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Source: Dynavax Technologies

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[StephenCastlecrag]

Please, that will be great. It is NCT01027065.(clinicaltrials.gov) You are right, if T cells are  rejuvenated, they will go after the infected liver cells. A website in China, www.hbver.com posted a review article on Myrcludex, I re-posted it to the Chinese forum. I read from your link, the slides by Stephen Locarnini. Prof Locararnini is very big in HBV in Australia, he specializes in antiviral drugs resistance.

[stef2011]

we have the trial of il7+vaccines+etv or tnf here in bologna but actually having a baseline cirrhosis i declined because at seroconversion there is usually a alt flare that might be very dangerous in my case
i will try to get any info when the trial starts, recruiting is from april 2010, i think they have difficulties to find the patients

[StephenCastlecrag]

The discussion at the Chinese forum was a waste of time. One guy got excited because HbSab was elicited in 4 patients, causing him to conclude that 4 patients were cured. The rest of the discussion was just to point out to him that he was wrong. The Chinese are very keen on therapeutic HBV vaccines, because two of them in phase II/III and are overdue for reporting. I think therapeutic vaccines are not there yet, according to Professor Marcel (I can send you a draft of her very technical paper), it seems when to administer the vaccine may be crucial. However, a lot of excitement about IL-7 and the SOCS gene:
"IL-7 blocks SOCS-3 in  T cells, allowing them to proliferate and attack the virus-infected cells.". Very early days.

[ferrariF2010]

yeah, like stefano said, only ONE person seroconverted.

REP9AC looked WAY more promising as almost all patients in the trial seroconverted; Too bad we haven't heard anything lately

[stef2011]

too early to say, it is years from market and actually only about 1 person seroconverted

there is a good discussion on this at chinese forum

http://translate.googleusercontent.com/translate_c?hl=it&ie=UTF-8&sl=zh-CN&tl=en&u=http://www.hbvhbv.com/forum/thread-1009776-1-1.html&rurl=translate.google.com&twu=1&usg=ALkJrhjvKdKHb20uYM6Heg9raxMfZJYpGA