Dynavax Technologies Corporation (DVAX) announced that it will initiate a phase I/II clinical trial, LYM-01, to assess the safety and preliminary efficacy of its pipeline candidate, SD-101.
SD-101 is an investigational toll-like receptor (TLR) 9 agonist, which is being evaluated for untreated low-grade B-cell lymphoma. LYM-01 is an open-label dose escalation and expansion study, which will assess the safety, tolerability and initial local and distant antitumor activity of SD-101.
The initiation of this trial will further advance Dynavax's TLR-based cancer immunotherapy research and development efforts.
Immunotherapy has received a lot of attention in recent times as pharmaceutical companies began to focus their research and development efforts on the same. Dynavax expects the study to provide a range of data which will enable the company to evaluate SD-101 both independently and in combination with other immuno-oncology agents, such as checkpoint inhibitors.
We are encouraged by the recent bout of positive news on Dynavax. Last month, Dynavax completed the planned enrolment in the ongoing clinical trial, HBV-23, on its experimental hepatitis B vaccine, Heplisav-B.
HBV-23 is a large safety and immunogenicity study, which is designed to address the complete response letter (CRL) issued by the FDA in Feb 2013. The FDA has asked for additional safety data in its meeting with the company to discuss the CRL issued in 2013.
This study will provide an adequate safety database to support licensure. The phase III study will evaluate the overall safety and immunogenicity of Heplisav as compared to GlaxoSmithKline’s (GSK) Engerix-B in patients aged between 18 to 70 years.
The study will also evaluate the immunogenicity of Heplisav-B in patients who did not respond well to the currently approved Hepatitis B vaccines. Dynavax has enrolled more than 8,250 adults for the study at 40 sites in the U.S.
Dynavax carries a Zacks Rank #2 (Buy). Other well placed stocks in the health care sector include Plursistem, Inc. (PSTI) and Medivation Inc (MDVN), each carrying a Zacks Rank #1 (Strong Buy).
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