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Dynavax Receives Notification of PDUFA Extension for HEPLISAV-B to December 15, 2016
BERKELEY, CA -- (Marketwired) -- 04/27/16 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that the U.S. Food and Drug Administration (FDA) will require additional time to complete its review of the Biologics License Application (BLA) for HEPLISAV-B™, Dynavax's investigational vaccine for immunization of adults against hepatitis B infection. In a notice received from the FDA, the Prescription Drug User Fee Act (PDUFA) action date for HEPLISAV-B has been extended by three months to December 15, 2016.

On April 8, in response to an FDA request, Dynavax submitted individual trial data sets that had been provided as integrated data in the March 2016 BLA resubmission. FDA then determined that the addition of these large data sets represented a major amendment to the BLA and thus extended the PDUFA action date to allow for a full review.

The HEPLISAV-B BLA is based on results from clinical trials that have generated data in more than 14,000 total participants.

"We appreciate the commitment of the FDA staff to conduct a complete review of all of the data supporting our BLA and we remain committed to working closely with them over the coming months in order to achieve HEPLISAV-B approval in 2016," said Eddie Gray, chief executive officer of Dynavax.
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Source: press release, 4/27/16. http://investors.dynavax.com/releaseDetail.cfm?ReleaseID=967014

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Dynavax Announces FDA Acceptance for Review of Biologics License Application and PDUFA Action Date for HEPLISAV-B(TM)
Investigational Adult Hepatitis B Vaccine Offers Higher Rates of Protection in Two Doses Over One Month
BERKELEY, CA -- (Marketwired) -- 03/30/16 -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for HEPLISAV-B™, the company's vaccine candidate for immunization against hepatitis B infection in adults 18 years of age and older. The FDA has established September 15, 2016 as the Prescription Drug User Fee Act (PDUFA) action date.

"This filing is another important step toward our goal of bringing HEPLISAV-B to market to protect adults against hepatitis B," said Eddie Gray, chief executive officer for Dynavax. "We will continue to work closely with the FDA over the coming months in order to achieve HEPLISAV-B approval in the third quarter of 2016."

The HEPLISAV-B BLA is based on positive immunogenicity results from clinical trials that have generated safety data in more than 10,000 participants. Results of these trials showed that two doses of HEPLISAV-B given one month apart provides significantly higher rates of protection with an equivalent safety profile compared to three doses of Engerix-B, a currently marketed hepatitis B vaccine that is administered over six months. In Phase 3 studies across all participants, HEPLISAV-B achieved peak seroprotection rates of 95.7 percent compared with 79.5 percent for Engerix-B. Additionally, in more than 1,100 participants with diabetes, HEPLISAV-B provided seroprotection rates of 90 percent compared to 65.1 percent for Engerix-B.

"Adult hepatitis B infection remains an important public health concern. If approved, HEPLISAV-B will represent the first advance in hepatitis B immunization in the United States in more than 25 years and will offer rapid protection from hepatitis B after only two doses in just one month," said Robert Janssen, M.D., chief medical officer and vice president, clinical development for Dynavax. "We believe HEPLISAV-B will provide a significant real-world improvement over currently marketed hepatitis B vaccines."
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Source: press release, 3/30/16. http://investors.dynavax.com/releaseDetail.cfm?ReleaseID=962813

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Eddie Gray, CEO and Director, gave guidance for the regulatory situation for Heplisav. He stated, "I can confirm again today that we are on track to file the amendment to the BLA by the end of this quarter and then consequently the 6-month agreemet that we have with the agency for the review of that refiling means a PDUFA date at the end of September - begining of October."
Source: Cowen and Company 36th Annual Health Care Conference, 3/09/16.

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Heplisav Infectious DiseaseHepatitis B infection (prophylaxis)Hepatitis B vaccine1018 ISS and HBsAg

Mechanism of action: Heplisav is an investigational adult hepatitis B vaccine comprised of a first generation 1018 immunostimulatory sequence (1018 ISS) and hepatitis B surface antigen (HBsAg). In Phase 3 trials, HEPLISAV demonstrated earlier and higher protection with fewer doses than currently licensed vaccines.

Phase of Development: Filed

Event Type: Regulatory FDA: PDUFA DATE

Dates: 2016-12-15

Results:

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Dynavax Receives Complete Response Letter from U.S. Food and Drug Administration for Biologics License Application for HEPLISAV-B
Company to Host Conference Call Today at 8:30 a.m. Eastern Time
BERKELEY, CA -- (Marketwired) -- 11/14/16 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for HEPLISAV-B™ [Hepatitis B Vaccine, Recombinant (Adjuvanted)] for immunization of adults 18 years and older against hepatitis B infection. The FDA issues CRLs to communicate that the Agency has completed a review cycle of an application and to request additional information for review and approval. Dynavax expects a Class 2 designation for a resubmission of the BLA, which would result in a target review period of six months.

The CRL seeks information regarding several topics, including clarification regarding specific adverse events of special interest (AESIs), a numerical imbalance in a small number of cardiac events in a single study (HBV-23), new analyses of the integrated safety data base across different time periods, and post-marketing commitments. In the CRL, the FDA acknowledged that it has not yet completed its review of responses received from Dynavax in early October, including those pertaining to AESIs and the numerical imbalance in cardiac events. The responses included an extensive analysis that included independent expert consultation supporting our view that the imbalance was driven by an unexpectedly low number of events in the comparator arm. It would appear the Agency could not fully assess the responses in the current review period. In the CRL, there is no request for additional clinical trials and there are no apparent concerns with rare serious autoimmune events.

"The CRL is consistent with our opinion that HEPLISAV-B is approvable and we are seeking to meet with the FDA as soon as possible," said Eddie Gray, chief executive officer of Dynavax. "However, the time and resources that will be required to gain approval leads us to consider that we may not be able to advance this program on our own and we are moving swiftly to identify a potential pharmaceutical or financial partner. We will maintain our efforts on the oncology programs, including our lead cancer immunotherapy candidate, SD-101, for which we recently announced encouraging early clinical data in metastatic melanoma."

Conference Call Details
The Dynavax management team will host a conference call and webcast today, Monday, November 14, 2016, at 8:30 a.m. Eastern, to provide more information about the CRL. The live call can be accessed by phone by dialing (877) 479-1857 (domestic) or +1 (503) 343-6309 (international) and specifying conference call code 19882810. A link to the live webcast may be accessed by visiting the "Investors" section of the Dynavax website or directly at (www.dynavax.com). A replay of the conference call may be accessed for one week following the call by dialing (855) 859-2056 (domestic) or +1 (404) 537-3406, and the passcode is 19882810.
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Source: press release, 11/14/16. http://investors.dynavax.com/releaseDetail.cfm?ReleaseID=999142

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