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3 Things In Biotech, March 6: Amgen Prepares, Sorrento Shows Promise, G1 Surprises

Mar. 07, 2018 8:00 AM ETAMGN, GTHX, SRNEQ8 Comments
Zach Hartman profile picture
Zach Hartman


  • Amgen preps for another advisory board.
  • Sorrento announces promising findings in solid tumor CAR-T cell therapy.
  • G1 Therapeutics's CDK inhibitor could be a big deal.

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 preps for another advisory board

Company: Amgen (AMGN)

Therapy: Blinatumomab

Disease: Acute lymphoblastic leukemia

News: AMGN received the briefing documents from the FDA regarding their upcoming FDA ODAC meeting on March 7 to discuss their application for the treatment of minimal residual disease-positive acute lymphoblastic leukemia. This board will discuss the strength of the data supporting the application, in addition to laying out potential concerns regarding efficacy and safety in this treatment setting. In particular, the briefing documents saw concerns in the 2% rate of treatment-related fatalities, as well as flaws in the propensity analysis used to compare blinatumomab to historical controls.

Looking forward: While the ODAC concerns are important, I think they will ultimately not sink this particular application. There were some issues relating to heterogeneity of the population in the study and the outcomes therein, but blinatumomab appeared to establish a fairly clear benefit as far as non-randomized studies can, and the risk of sepsis was reduced compared with other patients with relapsed/refractory ALL.

Overall, be cautiously optimistic about AMGN's chances here, and note that an approval would make a big difference in the blinatumomab franchise.

Sorrento announces promising findings in solid tumor CAR-T cell therapy

Company: Sorrento Therapeutics (SRNE)

Therapy: Anti-CEA CAR-T cells

Disease: Liver metastases

News: SRNE announced initial results from their phase 1b HITM-SURE study, investigating their CAR-T cell therapy directed against carcinoembryonic antigen (CEA) in patients with relapsed CEA-positive liver metastases. The three patients who have completed the protocol achieved an average reduction of 19 ng/mL of the antigen, providing an

This article was written by

Zach Hartman profile picture
I am a former PhD scientist-turned-writer focused on cancer education. My writings in Seeking Alpha have been devoted to helping people identify promising investment opportunities in cancer research through commentary of recent events. Readers can learn more about other aspects of cancer research by visiting my site Invest Against Cancer.I also collaborate 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. If you are interested, please click the link above!

Analyst’s 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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Comments (8)

qwefnui profile picture
Hi Zach, I always read your daily updates. do you have any thoughts on RETA?
Even understandable to a veritable lay person. Thanks!!
Zach Hartman profile picture
Thank you, xdentist!
tcheatham profile picture
johnson papiya profile picture
tcheatham profile picture
Both JNp and Pgnx are reporting q4 tomorrow
johnson papiya profile picture
Hi Zach. Interesting as usual, keep up the good work! QQ: can you confirm PGNX are reporting their Q4 numbers tomorrow? Cheers from Milan.
Zach Hartman profile picture
Hi Johnson, I'm afraid I cannot, as I do not know for sure!
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SymbolLast Price% Chg
Amgen Inc.
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Sorrento Therapeutics, Inc.

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