3 Things In Biotech, June 11: Acceleron's Second Punch, Advaxis's Letdown, Seattle's New Hope

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Includes: ADXS, ALPMY, CELG, GERN, SGEN, XLRN
by: Zach Hartman
Summary

Acceleron and Celgene land another big blow with their TGF blocker.

Advaxis's bad news from the EMA not offset by good news for the FDA.

Astellas and Seattle Genetics launch a key study for another antibody-drug conjugate.

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.

Acceleron and Celgene land another big blow with their TGF blocker

Company: Acceleron (XLRN) and Celgene (CELG)

Therapy: Lustpatercept

Disease: Beta-thalassemia

News: Following on recent news that lustpatercept improved survival in patients with lower-risk myelodysplastic syndrome, XLRN and CELG have announced that the BELIEVE study also met its primary study endpoint of erythroid response, defined as a reduction of transfusion dependence of at least 33% from baseline. Lustpatercept also improved the rate of 50% reduction in transfusion dependence at various time points, including from week 37 to 48, suggesting durable responses.

Looking forward: An interesting one-two punch for pivotal studies involving lustpatercept. Beta-thalassemia is another blood disorder where there isn't a ton of work being done. There was Geron's (GERN) imetelstat, but they've focused more on developing this agent for MDS and MF. So having a treatment option in this space has the potential to make a big difference for patients.

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Advaxis's bad news from the EMA not offset by good news for the FDA

Company: Advaxis (ADXS)

Therapy: Axalimogene filolisbac and ADXS-HOT

Disease: Cervical cancer

News: ADXS announced feedback from the EMA regarding their application for conditional approval for axalimogene filolisbac in the treatment of metastatic cervical cancer. The agency has signaled that the data included in the application would not be sufficient to garner a positive opinion. Rather than wait it out and try for an appeal next year, the company has decided that it would withdraw the application. In tandem, ADXS announced that it had submitted an IND for ADXS-HOT, the first such application for their non-personalized neoantigen program.

Looking forward: Well, so much for coming out of the doldrums. I had expected, based on the timing of other EMA applications, that July would be the first round of back-and-forth between the company and the agency. As I have stated before, this particular application was never a sure bet, although I felt pretty optimistic. However, the uncertainty surrounding the drug has won out, and ADXS is following through with its vision for the future, which does not prioritize internal development of axalimogene filolisbac, despite the good data we have seen so far.

Astellas and Seattle Genetics launch a key study for another antibody-drug conjugate

Company: Astellas (OTCPK:ALPMY) and Seattle Genetics (SGEN)

Therapy: Enfortumab vedotin

Disease: Bladder cancer

News: SGEN announced that it has begun dosing patients in the phase 3 EV-301 trial, which is comparing the Nectin-4 antibody-drug conjugate enfortumab vedotin with placebo in patients with metastatic urothelial cancer. This study is designed to confirm the findings from EV-201, which contributed to the Breakthrough Therapy designation for this drug in bladder cancer. Patients in this study were required to undergo prior therapy with a platinum chemotherapy and also an immune checkpoint inhibitor.

Looking forward: This news is important for SGEN, which continues to work hard to find a key move forward in cancer after their initial success with brentuximab vedotin. They have struggled in recent years to get moving, despite success on the front of brentuximab in Hodgkin lymphoma and other forms of lymphoma. Hopefully, this trial will be a success for them, since bladder cancer continues to represent a significant challenge in solid tumor oncology.

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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.

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