3 Things In Biotech, May 29: Can't Get Enough Liver Cancer Drugs These Days

|
Includes: CYYNF, ESALY, MRK, ONCY
by: Zach Hartman
Summary

Eisai has to wait a little longer to hear about their liver cancer opportunity.

Cynata gets moving on its mesenchymal stem cell program.

Oncolytics spreads further into myeloma.

Note: Subscribers to Avisol Capital Partners Total Pharma Tracker got an early look at this publication. Try for free today and see what we're talking about! Here is some more information if you're curious.

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

Company: Eisai (OTCPK:ESALY) and Merck (MRK)

Therapy: Lenvatinib

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)

Therapy: CYP-001

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)

Therapy: Reolysin

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.

Author's note: Thank you for taking some time out of your day to read some commentary on recent biotech happenings. I hope you'll consider leaving a comment or a question in the section below! This is one way in which Seeking Alpha is able to gauge the effectiveness of its writers and the platform. So if you want to keep seeing more editions of "3 Things," go ahead and participate!

As I mentioned above, I am now collaborating with Avisol Capital Partners on their Marketplace service known as the Total Pharma Tracker (TPT). Some of my work will be available to TPT subscribers either exclusively, or in advance. I will also collaborate in developing watchlists and other investment essentials. Please subscribe to TPT by clicking on this link - Total Pharma Tracker.

Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Editor's Note: This article covers one or more microcap stocks. Please be aware of the risks associated with these stocks.