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

Summary

• 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.

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Comments

[rancherho]

Zach:

More on CD48:

Br J Haematol. 2012 Jan;156(2):213-24. doi: 10.1111/j.1365-2141.20... Epub 2011 Nov 21.
CD48 as a novel molecular target for antibody therapy in multiple myeloma.

http://bit.ly/2DdM1yf
and at:
http://bit.ly/2G89wf3

[Zach Hartman]

Thank you, Rancherho!