3 Things In Biotech, April 20: AstraZeneca Re-Enters The Big Leagues, Aduro Looks Ahead, Lilly Looks Close

|
Includes: ADRO, AZN, LLY
by: Zach Hartman
Summary

AstraZeneca starts the big fight in EGFR-positive lung cancer.

Aduro teed up a new antibody therapy at AACR.

Lilly gets its materials for a big meeting with the AAC.

Note: Subscribers to Avisol Capital Partners Total Pharma Tracker got an early look at this publication. Try for free today and see what we're talking about! Here is some more information if you're curious.

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.

AstraZeneca starts the big fight in EGFR-positive lung cancer

Company: AstraZeneca (AZN)

Therapy: Osimertinib

Disease: EGFR-mutant non-small cell lung cancer

News: AZN announced approval for osimertinib in the treatment of previously untreated EGFR-positive non-small cell lung cancer. This came as little surprise, given the findings from the phase 3 FLAURA study, which demonstrated superior progression-free survival for osimertinib over erlotinib/gefitinib in the first-line setting.

Looking forward: Now the big fight begins, with osimertinib out in the lead. A few days ago, I prepared an article describing the coming fight for first-line dominance between osimertinib and dacomitinib (read that here). This is definitely going to give AZN a huge boost in the fight, being the first to market. That and for all intents and purposes, it appears as though osimertinib is the better drug. But it still remains unclear at this time whether clinicians should hold the "best" drug for later lines of therapy so they can extend their options. And for that we'll need longer-term follow-up from the FLAURA study.

Excellent news for AZN, and I expect the company to translate it into gained ground in this space.

Aduro teed up a new antibody therapy at AACR

Company: Aduro Biotech (ADRO)

Therapy: BION-1301

Disease: Multiple myeloma

News: At AACR, ADRO presented findings from an emerging treatment targeting a cell surface antigen called APRIL, which might have efficacy in multiple myeloma. This antibody, BION-1301, is the subject of an ongoing phase 1/2 trial, and these preclinical findings show that the antibody is capable of reducing the immunoglobulin burden characteristic of myeloma in mice. This suggests that this could be a viable treatment strategy for patients.

Looking forward: Count on ADRO to attack another 5-letter acronym. First STING, now APRIL. We don't know much about this just yet, other than ADRO has a track record of bringing interesting antibody therapies to clinic, and this anti-APRIL antibody is already being tested in humans. Thus, it gets my attention.

This may be another stone added to the foundation of ADRO.

Lilly gets its materials for a big meeting with the AAC

Company: Eli Lilly (LLY)

Therapy: Baricitinib

Disease: Rheumatoid arthritis

News: The FDA announced an upcoming committee meeting between LLY and the Arthritis Advisory Committee, wherein the two entities will discuss the new drug application for baricitinib in the treatment of moderately to severely active rheumatoid arthritis. This meeting will take place on April 23, 2018. Key questions that the committee will vote on pertain to the efficacy of baricitinib, both at the 2 mg and 4 mg doses. Furthermore, it remains to be seen whether the safety profile allows for a favorable-enough risk/benefit ratio to allow for approval.

Looking forward: The meeting, first announced back in March, continues as planned. The briefing documents seem to indicate overall that the committee generally regards the application favorably, in spite of the initial rejection last August. Lingering safety issues may yet sink the ship, but the resubmission's alternative dosing proposal should help.

It seems likely at this point that at least one dose of baricitinib will be approved.

Author's note: Thank you for taking some time out of your day to read some commentary on recent biotech happenings. I hope you'll consider leaving a comment or a question in the section below! This is one way in which Seeking Alpha is able to gauge the effectiveness of its writers and the platform. So if you want to keep seeing more editions of "3 Things," go ahead and participate!

As I mentioned above, I am now collaborating with Avisol Capital Partners on their Marketplace service known as the Total Pharma Tracker (TPT). Some of my work will be available to TPT subscribers either exclusively, or in advance. I will also collaborate in developing watchlists and other investment essentials. Please subscribe to TPT by clicking on this link - Total Pharma Tracker.

Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. 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.