Blackdiamond Therapeutics (NASDAQ: BDTX) - 2024 AACR 발표

 

2024.02.26 - [개별 스터디] - Black Diamond Therapeutics (NASDAQ: BDTX) 정리 분석

 

4세대 EGFR 저해제들이 마땅히 없는 상황에서 가장 앞서 나가 있는..

과거 BPMC가 앞서 있긴 했었는데 ctDNA 감소는 확실히 보였지만 tumour regression이 없었음.

그러다 결국 drop.

 

사실상 4th Generation에서는 BDTX-1535만 남아 있는 상황.

BDTX-1535도 C797S 반응보다는 uncommon mutation에서 잘 나오는 듯한 그림.

 

2024 AACR에서 아래와 같이 발표가 있었음.

AACR 2024 _BDTX-1535_FINAL Presentation 20240405.pdf

3.91MB

Abstract Number: 1229
Title: BDTX-1535 – A MasterKey EGFR Inhibitor Targeting Classical, Non-Classical and the C797S Resistance Mutation to Address the Evolved Landscape of EGFR Mutant NSCLC
Session Title: Minisymposia
Session Date and Time: Sunday, April 7, 2024, 3:00-5:00pm PDT
Location: San Diego Convention Center

 

https://investors.blackdiamondtherapeutics.com/news-releases/news-release-details/black-diamond-therapeutics-announces-topline-results-phase-1

Black Diamond Therapeutics Announces Topline Results from Phase 1 Dose Escalation Trial of BDTX-1535 in Patients with Recurrent

과거 GBM 대상으로 결과를 절반 정도만 해서 AACR이나 ASCO 나와서 그러려나 했는데

이번 AACR에서 임상데이터는 없었음.

확실히 selectivity는 상당히 좋아보임.

 

NSCLC 환자 대상 waterfall plot만 예전에 공개했던 그 범주로 포함

(2024 ASCO에서 GBM 세부 데이터가 나오지 않을까 싶음)

 

2024년 1월에 업데이트했던 예상 마일스톤:
https://investors.blackdiamondtherapeutics.com/news-releases/news-release-details/black-diamond-therapeutics-announces-corporate-update-and

• FDA feedback on BDTX-1535 enables initiation of Phase 2 cohort in first-line treatment of non-classical EGFR mutant NSCLC
• Fast Track Designation granted for BDTX-1535 as second-line treatment for EGFR mutant/C797S NSCLC
• BDTX-1535 Phase 2 results for 2L/3L patients with EGFR mutant NSCLC expected Q3 2024
• BDTX-1535 Phase 1 clinical trial results and “window of opportunity” data in patients with EGFR mutant GBM expected to be presented at a medical meeting in Q2 2024
• BDTX-4933 Phase 1 results in patients with KRAS mutant NSCLC expected Q4 2024