3 Things In Biotech, August 10: Is Incyte Really Done In The IDO Space?

by: Zach Hartman

BeiGene strikes for Merck's turf in China.

Pluristem allowed to move forward with key phase 3 trials.

Epacadostat shows some glimmers of movement.

Welcome to another edition of "3 Things In Biotech," a daily digest dedicated to helping you keep pace with the fast-moving world of pharmaceutical and biotechnology research.

BeiGene strikes for Merck's turf in China

Company: BeiGene (BGNE)

Therapy: Tislelizumab

Disease: Non-small cell lung cancer (NSCLC)

News: BGNE announced that it has dosed the first patient in a phase 3 trial investigating tislelizumab added to chemotherapy for patients with squamous cell NSCLC. This adds to a growing repertoire of tumor areas being explored for this developmental PD-1 antibody, mostly centered in China.

Looking forward: News like this is building on an important body of work for BGNE, which wants to break into the PD-1 space in a nearly completely untapped market: China. Obviously, this could be a huge difference maker for a company positioning itself to be one of as many as 7 competitors in the immune checkpoint inhibitor space as early as next year. Having near-exclusivity in China would go a long way toward making that a reality.

Buy, sell, or hold? BGNE has been moving downward recently on a somewhat underwhelming Hong Kong public trading debut, "only" netting some $900 million. With negative sentiment coming out, I continue to think this company has potential for some serious legs. When others are scared, I'm tempted to buy, but I wouldn't try to catch the falling knife here. Wait for the price to stabilize again before considering a position in this one.

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Pluristem allowed to move forward with key phase 3 trials

Company: Pluristem (PSTI)

Therapy: PLX-PAD

Disease: Critical limb ischemia and muscle injury

News: PSTI announced that the Israeli Ministry of Health has cleared a pair of phase 3 trials to move forward with enrollment, one in the treatment of patients with critical limb ischemia, and another in the treatment of patients with muscle injury following hip fracture surgery. The company hopes for these studies to be the culmination of several regulatory designations, including Fast Track from the FDA. The study for critical limb ischemia has already been recruiting in several countries, including the US, UK, and Germany, among others.

Looking forward: Opening as many recruitment sites as possible is critical for quick accrual into these studies, so I view this as a positive development. We should be careful not to overanalyze, of course, as there is still a ways to go yet before a possible approval for PLX-PAD. As I wrote in my June article, there are still some ongoing cash concerns for PSTI that one would want to consider before investing.

Buy, sell, or hold? Truth be told, I think the risks outweigh the benefit for PSTI at this time, and this news does not sway that distinction very much at all. Only new data or some way of addressing the cash concern would move me on it right now, so I'd take a pass.

Epacadostat shows some glimmers of movement

Company: Incyte (INCY) and IMV (IMV)

Therapy: DPX-Survivac and epacadostat

Disease: Advanced ovarian cancer

News: IMV announced that it has completed enrollment of its phase 1b trial combining its therapeutic vaccine DPX-Survivac with cyclophosphamide, with or without INCY's epacadostat. At the same time, the company announced that the first patient was enrolled in a phase 2 study of this combination. This builds on an encouraging presentation of the results from said phase 1b study in ovarian cancer, presented at ASCO this year.

Looking forward: From the catastrophic failure of IDO inhibitors and the jettisoning of studies from various big players' pipelines, it's surprising to see any movement on drugs like epacadostat at all. It makes me seriously wonder whether we've really seen the end of this line of therapy, or whether we're still just waiting until the right tumor setting pops up. Ovarian cancer, a particular recurrent disease, remains a huge unmet need, so hopefully this study will bear fruit.

Buy, sell, or hold? I would hold on to Incyte with respect to the epacadostat news. It's still too risky and nebulous at this time, and it could announce any day that it's dropping all development of this agent, as well as all collaborations. So for now it's a huge caveat emptor with respect to IDO inhibitors. Similarly, IMV is operating in a very risky space, with very few therapeutic vaccines demonstrating much efficacy. This news does not make me feel strongly about a buy signal here.

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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.