Blackdiamond Therapeutics (NASDAQ: BDTX) - 2024 ASCO?

NOVEMBER 7, 2023
Abstract Submission Opens

 

FEBRUARY 6, 2024 at 11:59 PM ET
Abstract Submission Deadline

 

MARCH 11, 2024 at 12:00 PM ET
Late-breaking Submission Deadline (Abstract placeholder is required by the February 6 deadline)

 

MARCH 29, 2024
Abstract Notifications Sent to First Authors

 

APRIL 7, 2024 at 11:59 PM ET
Abstract Withdrawal Deadline

 

APRIL 24, 2024 at 10:00 AM ET
Abstract Titles, including LBAs, Posted on meetings.asco.org

 

2024 ASCO 초록 공개 관련 일정

 

BDTX는 지금 2Q medical meeting에서 BDTX-1535 임상 1상 GBM 데이터 및 "Window of Opportunity" IIT 임상 결과를 발표 계획.

(아마도 2024 ASCO라고 추측되는건데..)

BDTX-1535 Dose Escalation in GBM은 press release로 되게 건조하게 발표했었음. (2023-12-13)
https://investors.blackdiamondtherapeutics.com/news-releases/news-release-details/black-diamond-therapeutics-announces-topline-results-phase-1

내용을 보면 24년 4분기 medical meeting에서 발표한다고 하려고 아마 건조하게 발표했던거라 추측

 

갑자기 기대되는건 "Window of Opportunity" 임상

https://classic.clinicaltrials.gov/ct2/show/NCT06072586

Study of BDTX-1535 in Recurrent High-Grade Glioma (HGG) Participants With EGFR Alterations or Fusions - Full Text View - Clinica

Recurrent GBM (2L+ 대상) 

22명 시험대상자 대상으로 2023년 10월 18일 시작했던 임상이

24년 2분기에 학회 발표를 한다고 함

(등록할 시험대상자를 죄다 모아놓고 23년 10월에 시작한건가?)

(아니면 등록이 그냥 빨리 되었을까?)

(24년 2분기라면 PFS라기 보다는 그냥 반응율 / 뇌투과율 정도 보일것 같은데)

 

 

BDTX의 발표들을 정리 해봄.

2024-01-04:

• 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
• Enrollment is ongoing in a “window of opportunity” trial sponsored by the Ivy Brain Tumor Center in patients with recurrent glioma who are undergoing a planned resection. Results from this trial are expected to be presented at a medical meeting in the second quarter of 2024.
  (Regular Submission으로 제출한건가?)

2024-03-12 (23년 4분기 실적발표):

• Additional planned data releases for 2024 include GBM results for BDTX-1535 in Q2, and initial results for BDTX-4933 in non-G12C KRASm NSCLC in Q4
• Phase 0/1 “window of opportunity” clinical trial of BDTX-1535 began enrollment in October 2023 to evaluate the pharmacokinetic, pharmacodynamic, and clinical response in patients with recurrent high-grade glioma (HGG) with EGFR alterations and/or fusions who are undergoing a planned surgical resection. The trial is sponsored by the Ivy Brain Tumor Center in Phoenix, Arizona. (NCT06072586)
• Black Diamond anticipates the following upcoming key milestones for BDTX-1535:
  • Oral presentation describing real world data of the evolving EGFR mutation landscape in patients with NSCLC, and the MasterKey profile of BDTX-1535 addressing a broad spectrum of mutations at the American Association for Cancer Research (AACR) annual meeting on April 7, 2024.
  • Phase 2 clinical data in patients with NSCLC and non-classical driver or acquired resistance EGFR mutations in the third quarter of 2024.
  • Phase 1 dose escalation data in patients with relapsed/recurrent GBM, and initial results from the investigator sponsored “window of opportunity” trial in patients with recurrent HGG are expected to be presented at a medical meeting in the second quarter of 2024.

(3월 11일이 Late-Breaker 제출 마감이였는데 우선 같은 문장)

3월 29일이 Notification이 나갔었을것 같음.

 

4월 10일에 진행한 23rd Annual Needham Virtual Healthcare Conference에서

GBM 임상 1상 Dose Escalation 및 "Window of Opportunity" 임상이 같은 학회에서 발표한다고 언급.

BDTX Needham 10April2024.pdf

2.20MB

 

ASCO Title 공개는 우리나라 시간으로 24년 4월 24일 오후 11시