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Welcome to another edition of "3 Things In Biotech You Should Learn Today," a daily digest dedicated to helping you keep pace with the fast-moving world of pharmaceutical and biotechnology research.
Eisai has to wait a little longer to hear about their liver cancer opportunity
Disease: Hepatocellular carcinoma
News: ESALY and MRK announced that the FDA has delayed the action date for a decision on the supplemental new drug application for lenvatinib, a kinase inhibitor, for the treatment of hepatocellular carcinoma. This indication would place lenvatinib as only the second such inhibitor for use in first-line therapy. The application was based on findings from the phase 3 REFLECT trial, which showed improved progression-free survival compared with sorafenib. The action date was bumped from May 24 to August 24.
Looking forward: I'm surprised by this, personally. First, REFLECT showed better efficacy, with no major toxicity signals that I can recall. Furthermore, the Japanese regulators already approved lenvatinib in this indication. And it isn't exactly a new drug, having been approved for thyroid cancer for quite a few years now. So it seems unlikely that manufacturing concerns are slowing down the proceedings. Color me baffled! But I think the FDA will ultimately approve this one.
Cynata gets moving on its mesenchymal stem cell program
Company: Cynata Therapeutics (OTC:CYYNF)
Disease: Acute graft-versus-host disease (GVHD)
News: CYYNF announced that they have finished treating cohort B of their phase 1 trial evaluating their mesenchymal stem cell therapy for patients with acute, steroid-refractory GVHD. This rounds out a cohort of 8 patients who received up to 200 million cells, which was double the maximum dose allowed in cohort A.
Looking forward: Obviously, safety will be the primary concern here with this therapy and an increased dose. But it's important to recall CYYNF saw some very interesting signals of efficacy in cohort A, as well, with an 87.5% survival rate at day 100. Will cohort B do better? I wouldn't count on that, since dose-response won't follow quite as cleanly as with small molecule inhibitors. Why? Cells could be nonviable as they increase in number, or the body might suppress them as they are increased. No, I'd be happy just to see them repeat the interesting results from cohort A.
Oncolytics spreads further into myeloma
Company: Oncolytics Biotech (ONCYF)
Disease: Multiple myeloma
News: ONCYF announced that they will be collaborating with the Keck School of Medicine at USC to deliver combination therapy consisting of Reolysin, bortezomib, pembrolizumab, and dexamethasone. Basically, they're taking the REO 019 study protocol and adding pembrolizumab to it. This was based on observation that bortezomib and Reolysin treatment increased PD-L1 expression in myeloma, potentially increasing the ability to target it using pembrolizumab.
Looking forward: This is interesting news from ONCYF, but I wonder if it's a bit of fishing for anything that will work. The REO 019 study didn't blow anybody away in terms of efficacy, and just seeing the result that PD-L1 was increased does not mean that pembrolizumab will be effective. Moreover, pembrolizumab in myeloma now has a bit of a black cloud cast over it, due to trial suspensions in this disease setting. It seems likely to me that this was the fault of combining pembrolizumab with the immunomodulatory drugs, but it still spells potentially higher levels of scrutiny. I am rooting for ONCYF here, and I look forward to hearing about the first patients being dosed.
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