Black Diamond Therapeutics Inc (BDTX)

[FACT-MASTER]

That is also good information. Thank you.

As a point of interest, i'll also add to this the fact, that osimertinib received Fast Track / Breakthrough Therapy/ and Orphan Drug designation from the FDA.

https://www.fda.gov/drugs/resources-information-approved-drugs/osimertinib-tagrisso

This definitely looks like an interesting scenario with BDTX-1535 in light of the above, regarding osimertinib

January 2023 Presentation:

https://investors.blackdiamondtherapeutics.com/static-files/4cb29b59-4501-4be8-9abf-2efc7c3b337f

[dcaf7]

They said results in 2H2023. As of Jan 2023, 28 patients were enrolled and they are in the midst of dose-escalation part of the trial.

[FACT-MASTER]

Thanks for posting that informative review.

That sounds highly positive in many ways for BDTX-1535, that is of course if clinical results come in positive.

Was there any mention of when clinical data might be forthcoming? It appears that the primary completion date is April/23.

https://clinicaltrials.gov/ct2/show/NCT05256290

[dcaf7]

Interesting presentation by David Epstein at Cowen today. He said that Osimertinib currently is not used in 2nd line setting, only in 1st line. What does it mean for 2nd line post Osimertinib therapy? It means simply a loss of T790M mutation. And they don’t see T790M patients in BDTX-1535 Ph1 trial. What they do see is Osi-resistance mutations, like C797S. They also see a whole family of mutations in EGFR that occur on a backbone of a primary driver mutations. Therefore, high unmet medical need in 2nd line setting. This observation has been overlooked by virtually every company developing 4th generation EGFR inhibitors.