June 2, 2017
By Mark Terry, BioSpace.com Breaking News Staff
Investors have been keeping a close eye on what’s to be presented at the American Society of Clinical Oncology (ASCO) meeting that starts today and runs through June 6 in Chicago. Often the meeting is used to present interim or even final data on ongoing clinical trials, which can have a big effect on company stock prices. Bret Jensen, writing for Seeking Alpha, takes a look at two small biotech companies that should get a shot in the arm from their releases.
Headquartered in New York, NY, TG Therapeutics focuses on acquiring, developing and commercialization of treatments for B-cell malignancies and autoimmune diseases. It has two therapies it is developing that target hematological malignancies and autoimmune diseases. TG-1101 (ublituximab) is a monoclonal antibody targeting a specific epitope on the CD20 antigen found on mature B-lymphocytes. TGR-1202 is an orally available P13K delta inhibitor also being developed for hematological malignancies. TG-1101 is also being evaluated for autoimmune disorders.
TG is giving one presentation and two poster presentations at ASCO. The oral presentation looks at the results of its GENUINE Phase III trial of ublituximab and ibrutinib in high-risk chronic lymphocytic leukemia. One poster looks at the tolerability and activity of a triplet combination of TGR-1202 ublituximab, and ibrutinib in CLL and non-Hodgkin’s lymphoma (NHL). The second poster releases data from a Phase II trial of TGR-1202 in CLL patients who were intolerant to prior BTK or PI3K-delta inhibitor therapy.
TG Therapeutics is currently trading for $12.35.
Jensen writes, “The March results brought a rash of analyst upgrades and upward price target revisions. The median analyst price target on TG Therapeutics has jumped to north of $24 a share in the past couple of months.”
Based in Berkeley, Calif., Dynavax Technologies focuses on toll-like receptor biology for immuno-oncology approaches and immunological conditions and vaccines. The company is presenting a poster regarding updated data from its ongoing Phase Ib/II clinical trial of SD-101, it’s intratumoral TLR9 agonist. It is being evaluated in combination with Merck ’s Keytruda (pembrolizumab).
Although SD-101 is of interest, it’s a little further down the line than its hepatitis B vaccine. Jensen writes, “Dynavax is better known for its multi-year saga with the FDA to get its hepatitis B vaccine Heplisav-B approved. Despite clearly superior protection (~95% versus ~81%) to the standard of care as well as better compliance traits (it can be delivered in two doses over a month rather than three doses over six months), the company is still trying to get this vaccine candidate over the finish line.”
Heplisav-B’s PDUFA date is August 10.
Jensen notes that if Heplisav-B is approved, the company will need to raise money. It has a couple alternatives. One is a straight secondary offering. He points out that if that is their approach, it could do well because of Heplisav-B and the potential of SD-101. “It could also do a large collaboration deal to market and distribute Heplisav-B through an established larger player in the market. This would provide upfront funds to continue to develop SD-101 and provide for a quicker rollout of Heplisav-B than Dynavax could do on its own.”
Dynavax is currently trading for $5.60.
