Welcome to another edition of "3 Things In Biotech You Should Learn Today," a daily digest dedicated to helping you uncover the news from the biotech and pharmaceutical industries.

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Though it currently holds the first-line therapy spot in kidney cancer, Pfizer's (NYSE:PFE) multi-targeted kinase inhibitor sunitinib is in danger of losing this hegemony as effective agents like cabozantinib from Exelixis (NASDAQ:EXEL) and Bristol-Myers Squibb's (NYSE:BMY) nivolumab are explored in first-line metastatic disease.

PFE's response? Go low. As in earlier treatment stages. The company has previously announced a supplemental drug application for sunitinib in adjuvant therapy for patients with kidney cancer and high risk of recurrence. This would be the first approved targeted therapy in an earlier treatment setting.

Now, we have gotten word that PFE has a meeting with the Oncology Drug Advisory Committee (ODAC) on September 19 to discuss this application. The ODAC will be responsible for scientific grilling of the company on the risks and benefits of sunitinib in this earlier treatment line. It will also be responsible for giving the scientific thumbs up or thumbs down, a crucial step in the FDA's overall review process.

Looking forward: I'm sure PFE has its fingers crossed, as first-line metastatic therapy is beset by competition from promising agents. Moving to even earlier treatment settings could allow it to remain in the foreground of clinicians' minds when managing patients at high risk for recurrence. But it's no sure thing, either, as we'll find out once the FDA publishes the advisory brief a few days before the actual meeting. So keep your eyes peeled for that news in about a month!

Lipocine, Inc. (NASDAQ:LPCN) is a developmental pharma company engaged in the development of therapies for low testosterone, formally called hypogonadism. In particular, its late-stage candidate is an oral version of testosterone, which the company hopes will address challenges associated with injectable and topical forms of the hormone.

However, the company was hit with a complete response letter from the FDA back in June of last year, which detailed some issues with the titration scheme proposed for marketing. This led to difficulty translating how the drug would be used in the real world compared with how it was used in the phase 3 study.

The next step for LPCN was to conduct a dosing validation study to prove that the proposed algorithm will yield the expected results seen in the phase 3 study. Now, over a year later, the company has resubmitted its NDA to the FDA.

Looking forward: Because the complete response letter in June 2016 did not outline any other major issues divulged by LPCN, it would be surprising if the FDA comes back with more negative feedback. Of course, it's possible that the dosing validation study will not be sufficient, but I imagine that the company has done its homework with FDA meetings to try and nail down exactly what it needs. And that can serve as a lesson for all of us in the investment community: small issues can lead to pretty long-term delays.

You might expect that most of the big news to come out of the world of hormone receptor-positive breast cancer is related to the CDK4/6 inhibitors marketed by Lilly (NYSE:LLY), Novartis (NYSE:NVS), and Pfizer. But of course research continues along a huge number of other avenues.

One of those is the targeting of a member of the EGFR family, HER3. And this specifically is where Merrimack Pharmaceuticals (NASDAQ:MACK) finds itself. Its investigational monoclonal antibody, seribantumab, is designed to block HER3 dimer formation with other members of the EGFR family.

This is potentially important due to the known role of PI3K/Akt signaling in hormone-positive breast cancer. And HER3 is the most potent activator of this signaling pathway in the EGFR family. Seribantumab in combination with exemestane was shown to reduce the risk of death in patients with hormone receptor-positive breast cancer and progression on endocrine therapy at last year's AACR meeting.

Now, the company is moving forward with a phase 2 randomized study assessing the potential benefit of this antibody combined with fulvestrant in untreated, advanced breast cancer.

Looking forward: Seribantumab has yielded some interesting early findings in breast cancer, though its history has been a bit mixed. A prior study in ovarian cancer showed that this agent did not improve outcomes for patients when given in combination with paclitaxel. However, hormone receptor-positive breast cancer has a known association with PI3K/Akt signaling, so if the findings here are discrepant, I won't be shocked.

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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.

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3 Things In Biotech You Should Learn Today: August 12, 2017 - Seeking Alpha

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