Black Diamond Therapeutics Announces Corporate Update and Expected 2024 Milestones
January 04 2024 - 7:00AM
Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage
oncology company developing MasterKey therapies that target
families of oncogenic mutations in patients with genetically
defined cancers, today provided a corporate update outlining
clinical development plans and anticipated corporate milestones for
2024.
“We made significant progress in 2023 and
sharpened our focus on our clinical programs: BDTX-1535 in both
EGFR mutant NSCLC and GBM, and BDTX-4933 in KRAS mutant NSCLC,”
said Mark Velleca, M.D., Ph.D., Chief Executive Officer of Black
Diamond Therapeutics. “In 2024, we anticipate key readouts from
each of these programs, including Phase 2 data from BDTX-1535 in
NSCLC. Moreover, recent FDA feedback enables the enrollment of
first-line NSCLC patients into the Phase 2 trial, reflecting the
potential of BDTX-1535 to benefit patients in earlier lines of
therapy. Due to disciplined spend, we expect our cash to be
sufficient for this year’s milestones and to extend into the second
quarter of 2025.”
Clinical Program Updates/Anticipated 2024
Milestones
BDTX-1535 in patients with Epidermal Growth Factor
Receptor (EGFR) mutant Non-Small Cell Lung Cancer
(NSCLC)
- Dose escalation
results were presented at the AACR-NCI-EORTC International
Conference on Molecular Targets and Cancer Therapeutics in October
2023. Phase 2 data in second/third-line patients with
EGFR mutant NSCLC are expected in the third quarter of 2024.
The Company intends to discuss Phase 2 results with the U.S. Food
and Drug Administration (FDA) to finalize a pivotal clinical trial
design.
- BDTX-1535
received Fast Track Designation for the treatment of patients with
EGFR mutant C797S-positive NSCLC whose disease has progressed
on/after a third-generation EGFR tyrosine kinase inhibitor
(TKI).
- Following End of
Phase 1 feedback received from the FDA in the fourth quarter of
2023, a Phase 2 cohort in first-line patients with non-classical
EGFR mutant NSCLC is being initiated.
- The Company is
also exploring the potential development of BDTX-1535 in first-line
patients who are post-osimertinib adjuvant treatment.
BDTX-1535 in patients with EGFR mutant Glioblastoma
(GBM)
- Following
release of top-line Phase 1 data in December 2023, presentation of
Phase 1 trial results is anticipated at a medical meeting in the
second quarter of 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.
- The Company
expects that results from the dose escalation and “window of
opportunity” trials will inform the next steps in the GBM
development program, including a potential randomized trial in the
first-line setting.
BDTX-4933 in patients with KRAS mutant NSCLC
- BDTX-4933 was
designed as a “RAF/RAS clamp” to target the activated RAF
conformation in the context of either RAF or RAS mutations, a
mechanism distinct from earlier generation RAF inhibitors.
- Enrollment in a
Phase 1 trial began in September 2023 in patients with KRAS mutant
NSCLC. Results from this trial are anticipated in the fourth
quarter of 2024.
About BDTX-1535BDTX-1535 is an
oral, brain-penetrant MasterKey inhibitor of oncogenic epidermal
growth factor receptor (EGFR) mutations in non-small cell lung
cancer (NSCLC), including classical driver mutations, families of
non-classical driver mutations (e.g., L747P, L718Q), acquired
resistance C797S mutation, and complex mutations. BDTX-1535 is a
fourth-generation tyrosine kinase inhibitor (TKI) that potently
inhibits, based on preclinical data, more than 50 oncogenic EGFR
mutations expressed across a diverse group of patients with NSCLC
in multiple lines of therapy. Based on preclinical data, BDTX-1535
also inhibits EGFR extracellular domain mutations and alterations
commonly expressed in glioblastoma (GBM) and avoids paradoxical
activation observed with earlier generation reversible TKIs. A
“window of opportunity” trial of BDTX-1535 in patients with GBM is
ongoing (NCT06072586) and a Phase 2 trial is currently ongoing in
patients with NSCLC (NCT05256290).
About BDTX-4933BDTX-4933 is an
oral, brain-penetrant RAF MasterKey inhibitor designed to target
oncogenic alterations in KRAS, NRAS and BRAF, while also avoiding
paradoxical activation. In preclinical studies, BDTX-4933 has
demonstrated a potential best-in-class profile, showing potent
target engagement, inhibition of MAPK signaling and strong
anti-tumor activity/tumor regression across tumor models driven by
either KRAS, NRAS or BRAF mutations. BDTX-4933 also exhibits high
central nervous system (CNS) exposure leading to dose-dependent
tumor growth inhibition and a survival benefit in an intracranial
tumor model harboring oncogenic BRAF mutation. The ongoing
BDTX-4933 Phase 1 clinical trial is currently in dose escalation
with emphasis on KRAS mutant NSCLC patients (NCT05786924).
About Black Diamond
TherapeuticsBlack Diamond Therapeutics is a clinical-stage
oncology company focused on the development of MasterKey therapies
that address families of oncogenic mutations in clinically
validated targets. The Company’s MasterKey therapies are designed
to address broad genetically defined patient populations, overcome
resistance, minimize wild-type mediated toxicities, and be brain
penetrant to treat CNS disease. The Company is advancing two
clinical-stage programs: BDTX-1535, a brain-penetrant
fourth-generation EGFR MasterKey inhibitor targeting EGFR mutant
NSCLC and GBM, and BDTX-4933, a brain-penetrant RAF MasterKey
inhibitor targeting KRAS, NRAS and BRAF alterations in solid
tumors. For more information, please visit
www.blackdiamondtherapeutics.com.
Forward-Looking
StatementsStatements contained in this press release
regarding matters that are not historical facts are
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995. Because such statements
are subject to risks and uncertainties, actual results may differ
materially from those expressed or implied by such forward-looking
statements. Such statements include, but are not limited to,
statements regarding: the continued development and advancement of
BDTX-1535 and BDTX-4933, including the ongoing clinical trials and
the timing of clinical updates for BDTX-1535 in patients with NSCLC
and in patients with recurrent GBM, and for Phase 1 clinical trial
results for BDTX-4933, the potential of BDTX-1535 to benefit
patients with NSCLC in earlier lines of therapy, potential future
development plans for BDTX-1535 in NSCLC and GBM, including in
first-line settings, and the Company’s expected cash runway. Any
forward-looking statements in this statement are based on
management’s current expectations of future events and are subject
to a number of risks and uncertainties that could cause actual
results to differ materially and adversely from those set forth in
or implied by such forward-looking statements. Risks that
contribute to the uncertain nature of the forward-looking
statements include those risks and uncertainties set forth in its
Annual Report on Form 10-K for the year ended December 31, 2022,
filed with the United States Securities and Exchange Commission and
in its subsequent filings filed with the United States Securities
and Exchange Commission. All forward-looking statements contained
in this press release speak only as of the date on which they were
made. The Company undertakes no obligation to update such
statements to reflect events that occur or circumstances that exist
after the date on which they were made.
Contacts
For Investors:Mario Corso, Head of Investor Relations, Black
Diamond Therapeuticsmcorso@bdtx.com
For Media:media@bdtx.com
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