3 Things In Biotech, March 8: A Tale Of 3 New Trials

by: Zach Hartman


Seattle Genetics steps into multiple myeloma with a phase 1 study.

Daiichi Sankyo gets rolling in phase 2 for HER2-positive colorectal cancer.

Allena Pharmaceuticals heads for the phase 3 goal in hyperoxaluria.

Note: Subscribers to Avisol Capital Partners Total Pharma Tracker got an early look at this publication.

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.

Seattle Genetics steps into multiple myeloma with a phase 1 study

Company: Seattle Genetics (SGEN)

Therapy: SGN-CD48A

Disease: Relapsed/refractory multiple myeloma

News: SGEN announced that it initiated a phase 1 clinical study to assess the safety and tolerability of its CD48-directed antibody-drug conjugate SGN-CD48A in patients with relapsed/refractory multiple myeloma. The study will enroll 75 patients, and in addition to looking for a maximally tolerated dose, the company will evaluate antitumor activity.

Looking forward: Interesting approach getting underway from a proven leader in antibody-drug conjugate development. Hopefully, SGEN's efforts will pay off better than its other programs in recent years, as it still needs to find a new treatment option if it's to build on the success it has realized from marketing of brentuximab vedotin. For now, I don't personally know much about targeting CD48 in myeloma, so that approach is news to me, and I wouldn't want to offer too in-depth a comment on the prospect of this study.

However, this is still an interesting development, and I always welcome more ADC developments from SGEN.

Daiichi Sankyo gets rolling in phase 2 for HER2-positive colorectal cancer

Company: Daiichi Sankyo (OTCPK:DSKYF)

Therapy: DS-8201

Disease: HER2-positive advanced colorectal cancer

News: DSKYF has initiated a global phase 2 investigating the anti-HER2 antibody-drug conjugate DS-8201 in patients with HER2-positive colorectal cancer. This study will enroll patients who have received at least two prior lines of standard therapy, with a primary endpoint of overall response rate. Unsurprisingly, given the relatively heavily pretreated patient population, there is no placebo control.

Looking forward: HER2-positive colorectal cancer is fairly rare in the grand scheme of this common tumor type, occurring in only around 3% of cases. Still, HER2 is an important driver of tumor growth wherever it shows up, be it in breast cancer or gastric cancer (where Herceptin and other treatment options are approved) or other tumor types like lung cancer (where there is currently no approved HER2-directed therapy). So DSKYF is taking an interesting trek here to get its foot in the door, and this may be a good way to build on the breakthrough therapy designation it received in breast cancer for this agent.

Overall, this is favorable news for an underserved area of oncology, and DSKYF stands to gain significant credibility in the HER2-directed therapy space if it's successful here.

Allena Pharmaceuticals heads for the phase 3 goal in hyperoxaluria

Company: Allena Pharmaceuticals (ALNA)

Therapy: ALLN-177

Disease: Enteric hyperoxaluria

News: ALNA initiated the first of two phase 3 trials involving the use of ALLN-177 to treat the severe kidney disorder enteric hyperoxaluria. Patients with this disease have a propensity to absorb increased amounts of oxalate from the digestive system, leading to a risk of kidney stones and damage. ALLN-177 is an orally administered enzyme that is intended to help break down oxalate and prevent its accumulation.

Looking forward: ALNA guided that it anticipates top-line data to come out from this study in 2H 2019, and it hopes to be the first company to have a drug approved in this disease area. While it is a rather rare condition (1 case per 120,000 live births, at least in Europe), this may facilitate a speedier regulatory pathway, especially since there are no other approved therapies.

For ALNA, this is important news, although I would hold off until closer to the primary analysis before considering a buy-in based on this study.

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 discusses one or more securities that do not trade on a major U.S. exchange. Please be aware of the risks associated with these stocks.