3 Things In Biotech You Should Learn Today: January 18, 2018

by: Zach Hartman

Exelixis and Ipsen will show up big in liver at ASCO GI.

More at ASCO GI: Bristol-Myers makes its case for being "practice changing" in colon cancer.

Shire scores approval in hemophilia A.

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.

Exelixis and Ipsen will show up big in liver at ASCO GI

Company: Exelixis (EXEL) and Ipsen (OTCPK:IPSEY)

Therapy: Cabozantinib

Disease: Hepatocellular carcinoma (HCC, aka liver cancer)

News: EXEL announced that it will be presenting a late-breaking abstract detailing results from the phase 3 CELESTIAL trial on January 19 at the ASCO GI symposium in San Francisco. This study demonstrated a significant improvement for the multitargeted kinase inhibitor cabozantinib compared with placebo in patients with previously treated disease.

Looking forward: This is going to be a very interesting presentation, in my opinion, given the gravity of potential expansion of the indications for cabozantinib. EXEL is currently becoming a key player in the kidney cancer space, and this could represent an early victory in a tumor space that has only recently begun to make significant headway in terms of therapy.

I wouldn't buy today, but I would keep an eye out for these results to get a sense of the strength of its efficacy proposition in HCC.

More at ASCO GI: Bristol-Myers makes its case for being "practice changing" in colon cancer

Company: Bristol-Myers Squibb (BMY)

Therapy: Nivolumab and ipilimumab

Disease: Metastatic colorectal cancer (CRC)

News: BMY will present findings from the second cohort of patients enrolled in the CheckMate-142 study at ASCO GI. This cohort of patients had microsatellite instability-high CRC with prior exposure to chemotherapy and other treatment options. According to the abstract, the objective response rate was 55% for the combination, with 80% of patients achieving some measure of disease control. Median progression-free survival and overall survival have not yet been reached.

Looking forward: These are indeed important trial results in a space where pembrolizumab took the early shot by getting approval for any patient testing positive for mismatch repair deficiency. Apparently, the combo was also tolerated well enough, which has been a nagging issue for the nivo/ipi combination in other tumor areas.

While positive, this is definitely only one piece to BMY's ongoing assault on cancer. It could definitely be a growth driver in 2018, however, it can become the standard of care in MSI-high colorectal cancer with this combo.

Shire scores approval in hemophilia A

Company: Shire Group (SHPG)

Therapy: Adynovi, an extended half-life formulation of Factor VIII

Disease: Hemophilia A

News: SHPG announced European approval of its PEGylated Factor VIII for the treatment of hemophilia A. The intended use of this new agent is to provide preventive control of bleeding with fewer injections than "native" Factor VIII. Hopefully, through introducing fewer boluses of therapy, the formation of neutralizing antibodies will also be prevented.

Looking forward: If you ask me, this is good timing for SHPG, as the market opportunity for new versions of old coagulation factors is waning quickly, with the introduction of effective gene therapies and advanced biologics. I have no doubt that SHPG will be able to capitalize, but in a few years, news of this kind of approval might not get me very excited.

As it stands, however, this approval ensures that SHPG will maintain a foothold in the hemophilia market for several years to come, at least.

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