3 Things In Biotech, June 4, 2018: A Big Collaboration In The Works For Cabo?

by: Zach Hartman

Exelixis and Roche cast a much, much wider net in collab.

Advaxis divulges deeper prostate cancer data.

Circassia breathes deep and dives into the NDA process.

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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.

Exelixis and Roche cast a much, much wider net in collab

Company: Exelixis (EXEL) and Roche (OTCQX:RHHBF)(OTCQX:RHHBY)

Therapy: Cabozantinib and atezolizumab

Disease: Various

News: EXEL announced that they would be amending the protocol for their COSMIC-021 study to include 10 new expansion cohorts. This study is assessing the combination of their flagship drug cabozantinib and RHHBF's atezolizumab in various solid tumors. The ten disease areas are in EGFR-mutant non-small cell lung cancer, first-line renal cell carcinoma, triple-negative breast cancer, platinum-resistant ovarian cancer, endometrial cancer, first-line hepatocellular carcinoma, gastric cancer, metastatic colorectal cancer, head and neck cancer, and differentiated thyroid cancer.

Looking forward: Reading down that list is like a what's what of hard-to-treat tumors. This is very interesting news for the collaboration, and that brings the entire study up to 18 expansion cohorts. This is a remarkably wide net for a phase 1b trial, and it makes me wonder whether they have seen anything of particular interest so far in their study. At any rate, it would seem that the various pieces of information we're likely to get out of this study will be worth watching in the years to come.

Advaxis divulges deeper prostate cancer data

Company: Advaxis, Inc (ADXS) and Merck (MRK)

Therapy: ADXS-PSA and pembrolizumab

Disease: Metastatic castration-resistant prostate cancer

News: In a press release, ADXS divulged more data from their poster presentation at ASCO 2018 (covered here in Mining for ASCO 2018's Gold). Previously, we knew about the disease control rate, which looked encouraging for the combination of the listeria-based immunotherapy ADXS-PSA and pembrolizumab. But it seems there were also hints at a survival benefit for patients, since the median overall survival was not reached in the combination group after 13 months of follow-up.

Looking forward: These findings appear to be fairly positive for the combination of these two drugs. The press release indicated that ADXS expects to have mature results soon, and it will be important to see where they land in terms of median overall survival. Right now, there isn't much of a comparator, since these patients had been previously treated with quite a few regimens, and it's another case for the company that there aren't adequate options to compare against. I consider these data positive, and I continue to feel you should have ADXS on your radar.

Circassia breathes deep and dives into the NDA process

Company: Circassia (OTC:CSSPF) and AstraZeneca (AZN)

Therapy: Duaklir Pressair

Disease: Chronic obstructive pulmonary disorder (COPD)

News: CSSPF announced that they have submitted a new drug application to the FDA for their fixed-dose two-drug bronchodilator Duaklir Pressair for the treatment of COPD. This agent is being developed in conjunction with AstraZeneca, and last September the companies announced that Duaklir significantly preserved lung function in patients with COPD.

Looking forward: With four large clinical trials under the belt of this product, Duaklir has demonstrated compelling evidence that it is really helping patients with COPD. Combining the two bronchodilators seems to be the way to go, and I fully expect that the FDA will accept this application. Will it be with priority review? Will it get approved? These are important questions that we'll know the answers to by late 2018 or early 2019.

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