Black Diamond Therapeutics Inc (BDTX)

[dcaf7]

What I learned from yesterday's presentation:
1. Drug demonstrated dose linear PK. It allows for greater predictability in drug response, simplifies the dosing process, reduces risk of dose-related toxicity, and makes drug development process easier.
2. Manageable EGFR TKI safety profile. In fact, at the proposed 200 mg QD dose, safety profile of BDTX-1535 is similar to Osimertinib.
3. Drug is active. ORR of 50% in patients progressed on Osimertinib, although it is true for evaluable population.
4. Clear anti-tumor activity in CNS. One comment from invited KOL was that many patients have CNS only resistance. Very high unmet medical need.
5. Robust reduction of ctDNA carrying mutant alleles. In a few cases, mutant clones were eliminated completely after 1535 treatment.
6. Activity against acquired and intrinsic mutations in this study. Preclinical studies indicate that drug is active for more than 50 different EGFR mutations.
7. Plan to initiate dose expansion cohorts in newly diagnosed patients with intrinsic driver mutations as well as in 2nd line Osimertinib R/R patients. One cohort will study patients with CNS mets.
8. First pivotal trial may be a single arm trial with ORR as a primary endpoint for accelerated approval. I expect a BTD designation.
9. Patient population in NSCLC in the US only: 4000 patients with intrinsic driver mutations and 6000 patients with acquired resistance mutations, including C797S and a number of complex mutations. It is 10,000 not even counting GBM patients.