3 Things In Biotech, March 30: Amgen Hunts, Exelixis Moves On Europe, Cynata Enters The Fray

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.

Amgen is going to hunt down the last remnants of ALL

Company: Amgen (AMGN)

Therapy: Blinatumomab

Disease: Acute lymphoblastic leukemia

News: AMGN announced that the FDA has approved its supplemental application for blinatumomab for use in patients with acute lymphoblastic leukemia who have so-called “minimal residual disease,” which is a strong risk factor for relapse. By treating with blinatumomab, patients may be able to achieve eradication of these last remaining bits of disease, potentially increasing the likelihood of long-term disease control.

Looking forward: Use of minimal residual disease as a tool for treatment adaptation has been in the works for a while in ALL. While there have been studies showing that you can choose which patients should receive a stem cell transplant based on minimal residual disease, blinatumomab is now the first therapy specifically approved for patients with this feature. It is also not as rough a treatment as stem cell transplantation.

This should make a big difference in AMGN’s bottom line and in the outcomes of patients.

Ipsen and Exelixis make cabo’s move in Europe for liver cancer

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

Therapy: Cabozantinib

Disease: Hepatocellular carcinoma, the most common form of liver cancer

News: IPSEY announced that the EMA has accepted an application for cabozantinib use in patients with previously treated hepatocellular carcinoma. This application was based on the recently presented findings from the CELESTIAL trial, which demonstrated a significant improvement in overall survival for cabozantinib over placebo in this setting.

Looking forward: I had heard that some shareholders were not terribly impressed with the CELESTIAL data, but it seems likely to me that they’re going to be favorable enough for approval, which will put cabozantinib in the liver cancer continuum. This means that it will almost certainly be used, even if it is unclear which order patients should receive the various available therapies. It could be a situation analogous to kidney cancer, where there are quite a few similar options, so they all get used in sequence.

So this should be pretty big news for EXEL as we await a decision in Europe.

Cynata’s GVHD treatment is now an orphan

Company: Cynata Therapeutics (OTC:CYYNF)

Therapy: CYP-001

Disease: Acute graft-versus-host disease (GVHD)

News: CYYNF announced that the US FDA has granted its mesenchymal stem cell product CYP-001 Orphan Drug designation for the treatment of acute GVHD. The designation was granted in part because of recent findings showing high response rates and a 100-day overall survival rate of 87.5%. This would appear to be a substantial improvement compared with current treatment, which yields 100-day rates not exceeding 60%.

Looking forward: GVHD in general remains one of the grim specters of transplant biology, as it is often a rapidly fatal complication occurring in the most desperate of circumstances. Thus, every innovation is welcome in the biotech realm, although I understand that mesenchymal stem cell-based treatments have been around for a while, including Prochymal. So there is definitely room for another challenger for the space of acute GVHD.

Definitely very early, but this is encouraging news for CYYNF.

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