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BDTX - Black Diamond Therapeutics Inc News Story

$24.33 0.2  0.7%

Last Trade - 20/04/21

Mid Cap
Market Cap £624.4m
Enterprise Value £399.1m
Revenue £n/a
Position in Universe 2952nd / 6849

Black Diamond Therapeutics Presents Pre-Clinical Data on Lead Product Candidate BDTX-189 at the 32nd EORTC-NCI-AACR Virtual Symposium

Mon 26th October, 2020 11:45am
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CAMBRIDGE, Mass. and NEW YORK, Oct. 26, 2020 (GLOBE NEWSWIRE) -- Black Diamond
Therapeutics, Inc. (Nasdaq: BDTX), a precision oncology medicine company
pioneering the discovery and development of small molecule, tumor-agnostic
therapies, today announced the presentation of pre-clinical data on the
Company’s lead product candidate BDTX-189 at the 32(nd) EORTC-NCI-AACR
Virtual Symposium on Molecular Targets and Cancer Therapeutics (ENA 2020).

“These pre-clinical data demonstrate BDTX-189’s ability to potently and
selectively inhibit a full spectrum of allosteric EGFR and HER2 mutations
while sparing wild-type EGFR (WT-EGFR), a profile that supports our hypothesis
that BDTX-189 has the potential to achieve clinically relevant dose levels
while limiting toxicities associated with inhibition of WT-EGFR,” said
Elizabeth Buck, Ph.D., Executive Vice President, Discovery and Translational
Sciences at Black Diamond Therapeutics. “With a pre-clinical pharmacokinetic
(PK)/pharmacodynamic (PD) profile designed for rapid and sustained target
inhibition, BDTX-189 has shown dose-dependent regression of allosteric EGFR
and HER2 tumors in an in vivo setting including patient-derived xenograft
(PDX) models, to date, suggesting that BDTX-189 has the potential to offer a
differentiated clinical profile for patients with these genetically defined

In cell-based assays, BDTX-189 achieved potent inhibition of each of the 48
allosteric ErbB mutant variants tested with an average selectivity vs. WT-EGFR
of greater than 50-fold, including the family of epidermal growth factor
receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) Exon 20
insertion mutations. Additionally, the potency and selectivity profile for
BDTX-189 against a selection of allosteric EGFR and HER2 mutations was
compared to that of other currently approved ErbB tyrosine kinase inhibitors
(TKIs) (erlotinib, afatinib, dacomitinib, osimertinib, and neratinib) and with
ErbB TKIs currently in clinical development (mobocertinib, poziotinib, and
CLN-081). BDTX-189’s selectivity compared favorably with the other
inhibitors evaluated, which either lacked potency against the broad panel of
allosteric ErbB mutant oncogenes or did not achieve targeted selectivity vs.

Pre-clinical evaluation of BDTX-189’s PK profile revealed that BDTX-189
achieved the desired rapid and sustained target occupancy with rapid
clearance, which supports BDTX-189’s potential to achieve a long PD effect
while minimizing potential toxicities. Additionally, BDTX-189 demonstrated
dose-dependent tumor inhibition and regression in both engineered HER2 S310F
tumor models and in EGFR Exon 20 insertion PDX models.

“These pre-clinical results provide support for BDTX-189’s uniquely
differentiated profile as a potent and selective inhibitor of a range of
allosteric ErbB oncogenic driver mutations,” said David M. Epstein, Ph.D.,
President and Chief Executive Officer of Black Diamond Therapeutics. “We
look forward to continuing to advance BDTX-189 through Phase 1/2 clinical
development with the goal of bringing a novel targeted therapy to patients
with otherwise limited therapeutic options.”

The presentation from the ENA 2020 meeting is 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, tumor-agnostic 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, Mutation-Allostery-Pharmacology (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. Black Diamond was founded by David M. Epstein, Ph.D. and Elizabeth
Buck, Ph.D., and, beginning in 2017, together with Versant Ventures, began
building the MAP platform and chemistry discovery engine. 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 and advancement of BDTX-189. 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 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, 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. 2020
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