Indication intelligence, analysis and sector perception

Fate Therapeutics (FATE) FDA clears an IND for FATE-NK100

March 13, 2017 12:57pm

FATE jumps $0.33 or +6.87% to $5.13 and holding; hoping a natural killer cell immunotherapy is a safe and efficacious approach to target and durably destroy leukemia cells in these patients - HOLD

FATE-NK100 is a next-generation immunotherapy that is uniquely tailored to fully realize the anti-cancer activity of natural killer cells, and we are excited to pioneer the clinical investigation of this novel NK cell therapy.

FATE expects a first-in-human clinical trial of FATE-NK100 for advanced acute myeloid leukemia (AML) to open enrollment at the Masonic Cancer Center, University of Minnesota following approval of the Center's institutional review board.

The Bottom Line: The first-in-human study will evaluate the safety and determine the maximum dose of a single intravenous infusion of FATE-NK100 in subjects with refractory or relapsed AML. Secondary and investigational endpoints will assess anti-tumor activity including rates of complete response, clearance of minimal residual disease, disease-free survival and overall survival. The clinical trial will utilize an accelerated dose escalation design, which is intended to test up to four dose levels of FATE-NK100 with one subject enrolled per dose level until a dose-limiting toxicity (:DLT) is observed. The study will convert to a 3+3 design in the event a DLT is observed, and will enroll a ten subject expansion cohort at the maximum dose level.

BIG move with 3.257 M shares trade <3 month average = 253.5 K shares>

35 companies, 1 interpreter!

Insight, foresight and recommendation

My motto … never leave an investor uninformed! I say today what others won’t, so you can do what others can’t.

My name is Henry McCusker; I endorse these opinions under my own name and with a subscription based membership.

Do you have an opinion you would like to share with us? We would like to hear from you.

Please e-mail us at hwm@regmedinvestors.com.

Editor and Publisher ... Henry McCusker enters his tenth (10th) year at RegMed Investors with past experience in sell-side analysis, buy-side management, corporate management and due diligence.

RegMed Investors (RMi) or Regmedinvestors.com content is the intellectual property of Henry McCusker. Any copying, republication or redistribution of RMI’s content, including by framing or similar means, is expressly prohibited without the prior written consent of Scimitar; who also shall not be liable for any errors or delays in content, or for any actions taken in reliance thereon. For additional information on other Scimitar media services or reposting please email hwm@regmedinvestors.com.

The information included above as well as individual companies and/or securities mentioned should be construed as guidance in RMi reviews.

The facts stated and the opinions given in this publication are based on data and information considered to be reliable and have been carefully worked into my qualitative analyses and prognoses. However, no guarantee can be given as to their fairness, accuracy or completeness.

Henry McCusker, the editor and publisher of RegMed Investors does not hold or have positions in securities referred to in this publication.