3 Things In Biotech You Should Learn Today: May 31, 2017

by: Zach Hartman, PhD


Advaxis springs a new combo trap for cervical cancer.

Bristol-Myers not stopping there with the collaboration announcements.

INDIVIOR files for marketing approval to stop opioid addiction.

Welcome to another edition of "3 Things in Biotech You Should Learn Today," a daily digest dedicated to helping you identify actionable events in companies you may or may not be paying attention to.

So let's get to the news!

Advaxis springs a new combo trap for cervical cancer

Advaxis (NASDAQ:ADXS) is one of two companies looking to advance live, attenuated Listeria as a vector for cancer immunotherapy. So far in 2017, they've demonstrated some favorable findings for their flagship product, axalimogene filolisbac, in previously treated, advanced cervical cancer, and they started the phase 3 AIM2CERV study, to assess this agent's ability to prevent recurrence following chemotherapy and radiotherapy.

On May 30, ADXS announced that they have initiated a collaboration with Bristol-Myers Squibb (NYSE:BMY) to study a second version of anti-HPV Listeria in combination with Opdivo in patients with metastatic cervical cancer. Both companies will provide the reagents, and ADXS will foot the administrative costs for the study.

Looking forward: It's interesting to see ADXS advancing a parallel clinical program that is similar in principle to axalimogene filolisbac, this one covering more than one type of HPV. On one hand, it's highly promising that the likes of BMY continue to show interest in collaborating with ADXS. However, it does betray a tiny lack of focus on the company's part, as they have intimated that they will seek regulatory approval for axalimogene filolisbac in Europe in 2017. Shareholders are very interested in finding out answers, which they hope to receive at the investor's day on June 12.

Bristol-Myers not stopping there with the collaboration announcements

The combination of Yervoy and Opdivo have made inroads in certain high-risk forms of cancer, especially metastatic melanoma. However, outside some areas of unmet need, this combination hasn't yet gained substantial traction, due in part to the enhanced toxicity of such an approach.

However, BMY has shown interest in combining their immune checkpoint inhibitors with other therapies, a strategy that has exploded due to the interest of combining the time to response of targeted therapy and chemotherapy with the durable remissions observed with immunotherapy.

Now, BMY and Array BioPharma (NASDAQ:ARRY) have announced the initiation of a phase 1/2 study evaluating the safety and efficacy of Opdivo in combination with Yervoy and binimetinib, a MEK inhibitor, for patients with colorectal cancer and microsatellite stable disease.

Looking forward: This is an interesting development to me. Though the mechanisms of action between the two checkpoint inhibitors and binimetinib differ substantially, I would have expected that combining all three would present a deterring risk to BMY and ARRY. This goes to show what I know. It's also interesting to see "MSI-stable" beginning to show up in the oncology lexicon, which just goes to show you the impact that the Merck (NYSE:MRK) approval has already had on the immune checkpoint inhibitor space.

INDIVIOR files for marketing approval to stop opioid addiction

INDIVIOR PLC (OTCPK:INVVY) has been working on a once-monthly injection to help combat substance abuse disorders called RBP-6000 for nearly a decade, showing some promising findings compared with placebo last August.

The study results showed that over the course of 6 months, RBP-6000 led to a significant decrease in both the user-reported rates of opioid use as well as urine levels of opioids compared with placebo.

Now, INVVY has announced that they have filed a new drug application with the FDA, representing one of the final steps needed to seek approval of RBP-6000 in the United States.

Looking forward: RBP-6000 builds on available agents for substance abuse disorder, as the active agent is not novel. However, the ability to achieve significant disease control with a once-monthly injection (as opposed to an implanted pump or daily oral formulations) could prove to be a good point for INVVY's entry. Time will tell if they receive approval, but the results look favorable.


Thank you for checking out another edition of this digest! It is clear that BMY continues to tear through as many combination studies with Opdivo as possible, and hopefully they'll find a good combo that helps control these various forms of cancer.

If you found this digest helpful, I hope you'll consider becoming a follower of mine on Seeking Alpha. This will allow you to receive real-time email updates when new editions go live. Regardless, I thank you for your time!

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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