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! What else do you get from me with a subscription?
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.
Merck KGaA give a good hint of efficacy in a special form of liver cancer
Company: Merck KGaA (OTCPK:MKGAY)
Disease: MET-mutated hepatocellular carcinoma (HCC)
News: MKGAY announced findings from two phase 2 trials involving their MET inhibitor tepotinib in patients with advanced HCC. These studies are assessing the drug in first-line and second-line treatment of tumor that harbor mutations in the gene encoding the MET protein, with primary endpoints for the two studies, including time to progress and progression-free survival. Both of these studies met their primary endpoints, according to MKGAY. No new safety signals have been observed.
Looking forward: This is more interesting than it may seem at first glance. You might think "MET inhibitor" and immediately imagine Exelixis's (EXEL) cabozantinib. But by targeting MET-positive HCC only, MKGAY stands to set itself apart from cabozantinib. In addition, if this drug's activity is confirmed, then it gives MKGAY an inroad to target other tumor types that are associated with the development of mutations in the MET gene. This includes non-small cell lung cancer as a notable possibility. Patients with MET-mutant non-small cell lung cancer have a poor prognosis, and there are no targeted therapies available to tackle that target yet. You'll want to keep an eye on this one!
Advaxis launches into personal immunotherapy trial
Disease: Non-small cell lung cancer
News: ADXS announced that the first patient in their phase 1 trial for the neoantigen-based immunotherapy ADXS-NEO has been injected, marking the official beginning of this study well over a year after the study's IND was allowed by the FDA. This study is being conducted in partnership with AMGN, who licensed the ADXS-NEO technology back in 2016.
Looking forward: This is a long-anticipated announcement on the part of ADXS. We've been waiting for the trial to start since last year. It marks one piece of progress I expected in my recent article on ADXS. Now, the big question on everyone's minds: is there a milestone payment associated with starting this trial? If so, how much? ADXS has ongoing cash concerns, and their partnership with AMGN is one of the key possibilities for resolving these cash issues for the foreseeable future, so now we wait.
Vical falters in antiviral study... scratch one more
Company: Vical (VICL)
Disease: Herpes simplex virus type 2 (HSV-2) infection
News: VICL announced negative top-line data from their randomized, phase 2 clinical trial of its bivalent anti-HSV-2 vaccine. The primary endpoint, annualized lesion (genital wart) recurrence rate, was not improved significantly with the vaccine compared with placebo. VICL has decided to terminate development of this vaccine on the basis of these results.
Looking forward: This is a shame, but it's better to cut the line loose once you have a decent idea that it won't work. Better to find out in phase 2 rather than phase 3, when things tend to get a lot more expensive. For its sake, the company indicated that they would be continuing development of their other antimicrobial platforms, particularly their antifungal drugs like VL-2397. So, hopefully, they'll be able to bounce back soon from this news.
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 am/we are long ADXS. 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.