3 Things In Biotech, March 13, 2018: Uncertainty Abounds!

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 You Should Learn Today," a daily digest dedicated to helping you keep pace with the fast-moving world of pharmaceutical and biotechnology research.

Advaxis halts its phase 1/2 combo study.

Company: Advaxis, Inc. (NASDAQ:ADXS)

Therapy: Axalimogene filolisbac and durvalumab

Disease: Advanced, HPV-associated cancers

News: ADXS disclosed that its phase 1/2 study evaluating the combination of axalimogene filolisbac and the PD-L1 inhibitor durvalumab (branded Imfinzi) was placed on hold by the FDA after a trial site reported a grade 5 adverse event. The patient suffered respiratory failure shortly after receiving her latest round of therapy after over a year of treatment. No details of the adverse event in question were offered.

Looking forward: This seems like deja vu for ADXS, which had a ground-shaking hold a few years ago that impacted trial recruitment and ultimately came to naught. I don't think this is in the same league, though, because it's one program among many for the company, and it does not affect the development of axalimogene filolisbac. Given that this adverse event has not been reported yet in any context for ADXS, I would expect that the FDA will lift this hold sooner or later, with the caveat of providing monitoring for the adverse event in question.

Overall, the naysayers are calling for the Advaxis doom, but I'm not convinced on this news alone.

AstraZeneca guides a delay in its MYSTIC study

Company: AstraZeneca (NYSE:AZN)

Therapy: Durvalumab and tremelimumab

Disease: Advanced non-small cell lung cancer

News: AZN announced an update to its timeline on reporting of overall survival data from the phase 3 MYSTIC trial, which is assessing the combination of durvalumab and tremelimumab compared with chemotherapy as first-line therapy for advanced non-small cell lung cancer. The company now expects to report these findings in the second half of 2018 instead of the first half.

Looking forward: I'm not quite sure what to make of these developments, honestly. On one hand, a delay of any kind would be a bad look for a trial that already has a pedigree of failure (recall that MYSTIC failed to demonstrate a PFS benefit over chemotherapy). However, since the trial is event-driven, a longer-than-expected OS readout could possibly indicate favorable results. However, that is extremely speculative at this point.

Overall, this news isn't too groundshaking, but if you like to read the tea leaves... positive findings from MYSTIC would reap major rewards for AZN, for sure.

Anthera Pharmaceuticals kills a pivotal exocrine pancreatic insufficiency trial

Company: Anthera Pharmaceuticals (NASDAQ:ANTH)

Therapy: Sollpura

Disease: Exocrine pancreatic insufficiency due to cystic fibrosis

News: ANTH announced top line data from its phase 3 RESULT study, showing that this trial failed to reach its primary endpoint of non-inferiority compared with porcine pancreatic enzyme replacement therapy in terms of coefficient of fat absorption, with a proportion of patients having their condition worsen. The secondary endpoint, coefficient of nitrogen absorption, met the noninferiority goal. The company indicated that it would suspend further development of Sollpura.

Looking forward: This news proved catastrophic for ANTH, as it lost some 80% of its value on the day of this announcement, down to a sub-$10 million market cap. It would appear as though this could be a last breath for the company before succumbing to wounds inflicted by such a disastrous trial.

No way I would think about buying this company, as there is very little in the near term that could bring it out of the depths here.

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