Black Diamond Therapeutics Announces First Patients Dosed in Phase 1 Clinical Trial Expansion Cohorts Evaluating BDTX-1535 in Patients with Intrinsic Driver and Acquired Resistance EGFR Mutation Positive Non-Small Cell Lung Cancer
11 September 2023 - 10:00PM
Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage
precision oncology company developing therapies that target
families of oncogenic mutations in patients with genetically
defined cancers, today announced the first patients dosed in
mutation matched expansion cohorts of non-small cell lung cancer
(NSCLC) in the ongoing Phase 1 clinical study evaluating BDTX-1535.
BDTX-1535, a fourth-generation, brain-penetrant
epidermal growth factor receptor (EGFR) MasterKey tyrosine kinase
inhibitor (TKI), is under investigation for the treatment of NSCLC
harboring intrinsic driver and/or acquired resistance
(post-osimertinib) EGFR mutations and glioblastoma multiforme (GBM)
with multiple EGFR alterations. The BDTX-1535 expansion cohort
portion of the study will assess single-agent objective response
rate (ORR) in a second- or third-line setting in NSCLC patients
with EGFR intrinsic driver and/or acquired resistance mutations,
who have received prior treatment with approved EGFR TKI.
The dosing of the first patients in the
expansion cohorts follows the Company’s initial data readout from
the dose escalation portion of the BDTX-1535 Phase 1 clinical
study, which demonstrated clinical proof of activity through
radiographic responses in NSCLC patients harboring diverse types of
EGFR mutations including intrinsic driver and post-osimertinib
acquired resistance EGFR mutations.
“The Phase 1 expansion cohorts will assess
objective response rate and durability of response in NSCLC
patients whose disease has progressed after prior EGFR inhibitor
therapy, including prior osimertinib, and who have evidence of a
variety of EGFR driver or resistance mutations that are targeted by
BDTX-1535,” said Sergey Yurasov, M.D., Ph.D., Chief Medical Officer
of Black Diamond Therapeutics. “In conjunction with establishing an
optimal dose for a future pivotal study, these efficacy data will
be essential for establishing a regulatory pathway for BDTX-1535.
Despite significant recent advances in treating lung cancer, there
is a large unmet medical need for a targeted therapy for these EGFR
mutation-positive NSCLC patients, for whom chemotherapy is still
the most common treatment option.”
“Dosing of the first patients in the BDTX-1535
dose expansion cohorts represents an important step towards
offering an oral therapeutic with manageable side effects as a
potential alternative to chemotherapy-based regimens following
progression on osimertinib for patients with treatment-resistant
lung cancer,” said David Epstein, Ph.D., President and Chief
Executive Officer of Black Diamond Therapeutics. “The population of
EGFR mutation-positive NSCLC is genetically heterogeneous – which
has presented challenges in the development of effective therapies.
BDTX-1535 was designed to disrupt the limited existing treatment
paradigm by addressing real-world patterns of patient-specific EGFR
mutations, and we remain focused on the rapid advancement of this
novel MasterKey inhibitor.”
The discovery and development of BDTX-1535 was
informed by the Company’s powerful Mutation-Allostery-Pharmacology
(MAP) drug discovery engine, which leverages critical genomic
profiling to expand the addressable patient population by targeting
families of mutations with a single drug. Emergence of intrinsic
driver and acquired resistance EGFR mutations to osimertinib
represents a significant unmet need for patients with EGFR-mutant
lung cancer. Thirteen percent of patients in the U.S. with EGFR
mutation-positive NSCLC show presence of intrinsic driver
mutations, which are associated with worse clinical outcomes when
treated with currently approved EGFR TKIs. Fifteen percent of
patients in the U.S. whose disease has progressed after osimertinib
therapy show evidence of acquired resistance EGFR mutations (e.g.,
C797S) for which currently there is no approved EGFR TKI.
The Company is advancing BDTX-1535 as a
potential targeted therapy option for patients with this broad
spectrum of EGFR mutations in second-line NSCLC, and plans to
investigate safety and efficacy in a first-line setting in NSCLC
patients with intrinsic driver EGFR mutations after discussion with
the U.S. Food and Drug Administration (FDA).
BDTX-1535 Phase 1 Clinical Study
DesignThe Phase 1 first-in-human, open-label clinical
trial of BDTX-1535 (NCT05256290) consists of a dose escalation
portion that evaluated the safety, pharmacokinetics (PK), and
preliminary anti-tumor activity of BDTX-1535 followed by dose
expansion cohorts. The trial is evaluating BDTX-1535 in patients
with advanced/metastatic NSCLC harboring EGFR mutations with or
without central nervous system (CNS) disease, or with recurrent GBM
expressing EGFR alterations. The Phase 1 dose escalation portion of
the study in NSCLC and GBM patients has been completed and the
study is now progressing to evaluate BDTX-1535 as a single agent,
second-line or third-line therapy in two cohorts of EGFR
mutation-positive NSCLC patients with progressive disease after
prior therapy with EGFR TKI (e.g., osimertinib) to assess ORR, CNS
ORR, duration of response, and progression-free survival and
further evaluate safety, tolerability and PK:
- Second- or third-line NSCLC
patients with acquired EGFR resistance mutations +/- CNS
metastasis; and
- Second- or third-line NSCLC
patients with EGFR intrinsic driver mutations +/- CNS
metastasis.
About Black Diamond
TherapeuticsBlack Diamond Therapeutics is a clinical-stage
precision oncology medicine company focused on the development of
therapies that target families of oncogenic mutations in clinically
validated targets. Black Diamond leverages a deep understanding of
cancer genetics and onco-protein structure and function, to
discover and develop innovative therapies. The Company’s MasterKey
therapies are designed to overcome resistance, minimize on-target,
wild-type mediated toxicities, and be brain-penetrant to address
significant unmet medical needs of patients with genetically
defined cancers. The Company is advancing a robust pipeline with
lead clinical-stage program BDTX-1535, targeting MasterKey
mutations in both EGFR mutant-positive NSCLC and in GBM, and
BDTX-4933, a program targeting RAF MasterKey mutations 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 continuation of the BDTX-1535 dose
expansion cohorts in EGFR mutation positive NSCLC patients, the
expected timing for data updates for BDTX-1535 and presentation of
the full BDTX-1535 dose escalation data in NSCLC, and the continued
development of the MAP drug discovery engine. 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.
ContactsFor Investors:Julie Seidel, Stern
Investor Relations(212) 362-1200investors@bdtx.com
For Media:Joan Bosisio, VSCmedia@bdtx.com
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