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BDTX - Black Diamond Therapeutics Inc News Story

$25.5 -0.1  -0.2%

Last Trade - 07/05/21

Mid Cap
Market Cap £660.0m
Enterprise Value £434.5m
Revenue £n/a
Position in Universe 2925th / 6858

Black Diamond Therapeutics Announces Preclinical Data Presentations on BDTX-189 and BDTX-1535 at American Association for Cancer Research Annual Meeting

Sat 10th April, 2021 1:30pm
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CAMBRIDGE, Mass. and NEW YORK, April 10, 2021 (GLOBE NEWSWIRE) -- Black
Diamond Therapeutics, Inc. (Nasdaq: BDTX), a precision oncology medicine
company pioneering the discovery and development of small molecule, MasterKey
therapies, today announced the presentation of preclinical data on BDTX-189
and BDTX-1535 at the American Association for Cancer Research Annual Meeting
(AACR), taking place April 9-14, 2021.

“These preclinical data demonstrate achievement of a key goal of our
pharmacokinetic (PK)/pharmacodynamic (PD) strategy for BDTX-189 with a
preclinical PK/PD profile designed for rapid and sustained target inhibition
with rapid clearance,” said Elizabeth Buck, Ph.D., Executive Vice President,
Discovery and Translational Sciences at Black Diamond Therapeutics. “We look
forward to presenting preliminary clinical data, including detailed PK data,
from the Phase 1 dose-escalation portion of the MasterKey-01 study in the
first half of this year.”

Dr. Buck continued: “Additionally, these data illustrate the MasterKey
profile of BDTX-1535 as a brain-penetrant, epidermal growth factor receptor
(EGFR) mutant selective inhibitor. BDTX-1535 has been shown to potently and
selectively inhibit the family of EGFR variants implicated in glioblastoma
multiforme (GBM), as well as Exon 18 mutations and the C797S mutations evident
in non-small cell lung cancer (NSCLC). This breadth of coverage, coupled with
a brain-penetrant PK profile, supports the potential to develop a novel and
differentiated candidate for GBM and solid tumors expressing un-drugged EGFR
mutations, including NSCLC.”

The presentations describe the following data:

Preclinical PK BDTX-189 Data:
* Black Diamond employed a novel physiologically based pharmacokinetic (PBPK)
modeling strategy, accounting for compound-specific determinants of BDTX-189
metabolism and disposition, to prospectively predict the clinical PK profile
and active dose range of BDTX-189.
* Preclinical PBPK modeling indicated that BDTX-189 would be readily orally
absorbed with a short elimination half-life (approximately two hours) while
maintaining suppression of ErbB pathway biomarkers over the dosing interval,
consistent with the irreversible mechanism of action and the desired PK/PD
* Active dose levels in humans were projected to be in the 400–800 mg QD
range based on the exposure-tumor growth inhibition relationship in multiple
mouse patient-derived xenograft (PDX) models harboring ErbB allosteric
* Enrollment and dosing of patients in the Phase 1/2 MasterKey-01 study of
BDTX-189 is ongoing, and the Company is on track to complete the
dose-escalation portion of the Phase 1 clinical trial in the first half of
Preclinical BDTX-1535 Data:
* GBM tumors express a family of allosteric oncogenic EGFR variants that often
appear together in GBM and, as shown by the Company’s preclinical work, must
all be effectively inhibited to secure a meaningful anti-tumor response. In
cell-based assays, BDTX-1535 achieved potent and selective inhibition of all
members of the family of oncogenic EGFR variants expressed in GBM.
* BDTX-1535 demonstrated a favorable brain-penetrant PK profile in mouse, rat,
and dog models.
* Tumor growth inhibition in mouse models bearing intracranial GBM6
patient-derived tumors expressing allosteric EGFR mutants was achieved.
* BDTX-1535 demonstrated potent and selective inhibition of rare Exon 18
mutations and the C797S mutation, supporting the potential for utility beyond
GBM, such as in NSCLC.
* Black Diamond expects to file an Investigational New Drug (IND) application
for BDTX-1535 in the first half of 2022.
“Collectively, these data support the differentiated profiles of both
BDTX-189 and BDTX-1535, the foundation of our ErbB franchise, and our ability
to develop novel therapies for patients with genetically defined cancers,”
said David M. Epstein, Ph.D., President and Chief Executive Officer of Black
Diamond Therapeutics.

The presentations from the AACR meeting are available on the “Scientific
Presentations and Publications” section of the Black Diamond Therapeutics

About BDTX-189
BDTX-189 is an orally available, irreversible small molecule inhibitor that is
designed to block the function of family of oncogenic proteins defined by
driver mutations across a range of tumor types, and which affect both of the
epidermal growth factor receptor (EGFR) and the tyrosine-protein kinase,
ErbB-2, or human epidermal growth factor receptor 2 (HER2). BDTX-189 is
designed as a MasterKey inhibitor targeting a family of previously undrugged
and functionally similar mutations in a tumor-agnostic manner. These mutations
include extracellular domain allosteric mutations of HER2, as well as EGFR and
HER2 kinase domain Exon 20 insertions, and additional activating oncogenic
drivers of ErbB. The ErbB receptors are a group of receptor tyrosine kinases
involved in key cellular functions, including cell growth and survival.
BDTX-189 is also designed to spare normal, or wild-type, EGFR, which we
believe has the potential to improve upon the toxicity profiles of current
ErbB kinase inhibitors. Currently, there are no medicines approved by the U.S.
Food and Drug Administration (FDA) to target all of these oncogenic mutations
with a single therapy.

BDTX-189 is currently being evaluated in a Phase 1/2 clinical trial
(MasterKey-01) in adult patients with advanced solid tumors with at least one
MasterKey mutation who have no standard therapy available or for whom standard
therapy is considered unsuitable or intolerable. In July 2020, the FDA granted
Fast Track designation to BDTX-189 for the treatment of adult patients with
solid tumors harboring an allosteric HER2 mutation or an EGFR or HER2 Exon 20
insertion mutation who have progressed following prior treatment and who have
no satisfactory treatment options.

About Black Diamond Therapeutics
Black Diamond Therapeutics is a precision oncology medicine company pioneering
the discovery of small molecule, MasterKey therapies. Black Diamond targets
undrugged mutations in patients with genetically defined cancers. Black
Diamond is built upon a deep understanding of cancer genetics, protein
structure and function, and medicinal chemistry. The Company’s proprietary
technology platform and drug discovery engine,
Mutation-Allostery-Pharmacology, or MAP, platform, is designed to allow Black
Diamond to analyze population-level genetic sequencing data to identify
oncogenic mutations that promote cancer across tumor types, group these
mutations into families, and develop a single small molecule therapy in a
tumor-agnostic manner that targets a specific family of mutations, termed a
MasterKey therapy. Black Diamond was founded by David M. Epstein, Ph.D., and
Elizabeth Buck, Ph.D. For more information, please visit

Forward-Looking Statements
Statements 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 of BDTX-189 and the timing for completing the dose escalation
portion, initiating the safety expansion cohort, or starting the Phase 2
portion of the ongoing clinical trial of BDTX-189, the continued development
and advancement of BDTX-1535 in IND-enabling studies, including expectations
for filing an IND. 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: the success, cost, and timing of the
Company’s product candidate development activities and planned IND-enabling
and clinical trials, the Company’s ability to execute on its strategy,
regulatory developments in the United States, the Company’s ability to fund
operations, and the impact that the current COVID-19 pandemic will have on the
Company’s clinical trials and preclinical studies, supply chain, and
operations, as well as those risks and uncertainties set forth in its 2019
annual report on Form 10-K filed with the United States Securities and
Exchange Commission and its other 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.


For Investors:
Natalie Wildenradt

For Media:
Kathy Vincent
(310) 403-8951


GlobeNewswire, Inc. 2021
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