BDTX Black Diamond Therapeutics Inc.

33.96
+0.42  (+1%)
Previous Close 33.54
Open 34.92
52 Week Low 17.63
52 Week High 46.25
Market Cap $1,222,412,614
Shares 35,995,660
Float 24,043,312
Enterprise Value $875,709,304
Volume 512,085
Av. Daily Volume 234,507
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Latest News

  1. CAMBRIDGE, Mass. and NEW YORK, Nov. 24, 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 that its President and Chief Executive Officer, David M. Epstein, Ph.D., will present an update about the Company's progress at the Piper Sandler 32nd Annual Virtual Healthcare Conference, taking place December 1-3, 2020.

    A webcast of the presentation will be made available at the start of the conference on the investor relations section of the Company's website, www.blackdiamondtherapeutics.com. A replay of the presentation will also be available and archived on the site for three weeks…

    CAMBRIDGE, Mass. and NEW YORK, Nov. 24, 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 that its President and Chief Executive Officer, David M. Epstein, Ph.D., will present an update about the Company's progress at the Piper Sandler 32nd Annual Virtual Healthcare Conference, taking place December 1-3, 2020.

    A webcast of the presentation will be made available at the start of the conference on the investor relations section of the Company's website, www.blackdiamondtherapeutics.com. A replay of the presentation will also be available and archived on the site for three weeks.  

    About Black Diamond

    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 www.blackdiamondtherapeutics.com.

    Contacts:

    For Investors:

    Natalie Wildenradt

    For Media:

    Kathy Vincent

    (310) 403-8951



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    • BDTX-1535 nominated as development candidate with IND-enabling studies underway
    • Pre-clinical data support novel and differentiated approach in GBM

    CAMBRIDGE, Mass. and NEW YORK, Nov. 20, 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 nomination of BDTX-1535 as the Company's development candidate for the treatment of glioblastoma multiforme (GBM), as well as the commencement of Investigational New Drug (IND)-enabling studies.

    Additionally, Black Diamond Therapeutics today announced a presentation at the 2020 Society for Neuro-Oncology Annual Meeting (SNO) of the pre-clinical…

    • BDTX-1535 nominated as development candidate with IND-enabling studies underway

    • Pre-clinical data support novel and differentiated approach in GBM

    CAMBRIDGE, Mass. and NEW YORK, Nov. 20, 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 nomination of BDTX-1535 as the Company's development candidate for the treatment of glioblastoma multiforme (GBM), as well as the commencement of Investigational New Drug (IND)-enabling studies.

    Additionally, Black Diamond Therapeutics today announced a presentation at the 2020 Society for Neuro-Oncology Annual Meeting (SNO) of the pre-clinical data for BDTX-1535 and the biological rationale for a MasterKey approach to treating GBM patients whose tumors harbor allosteric oncogenic mutations in epidermal growth factor receptor (EGFR).

    "These pre-clinical data demonstrate the achievement of our program's key design principles, including potent and selective inhibition of the family of EGFR variants implicated in GBM and penetration of the blood-brain barrier, and further support our ability to develop a novel and differentiated candidate for the treatment of this disease," said Elizabeth Buck, Ph.D., Executive Vice President, Discovery and Translational Sciences at Black Diamond Therapeutics. "This profile, coupled with the in vivo data that showed tumor growth inhibition in intracranial patient-derived xenograft (PDX) tumor models expressing allosteric EGFR mutants, supports the potential for BDTX-1535 to meaningfully transform the treatment paradigm for patients with GBM."

    GBM tumors express a family of allosteric oncogenic EGFR variants that often appear together in GBM and, as shown by the Company's pre-clinical work, must all be effectively inhibited to secure a meaningful anti-tumor response. In cell-based assays, BDTX-1535 achieved potent MasterKey inhibition of all members of the family of oncogenic EGFR variants expressed in GBM with selectivity v. wild-type-EGFR (WT-EGFR). Additionally, in mouse models, BDTX-1535 demonstrated a pharmacokinetic profile that supports its ability to penetrate the blood-brain barrier. BDTX-1535 achieved complete and sustained inhibition of the phosphorylated state of EGFR in mouse models bearing Ba/F3 allosteric EGFR mutants, as well as tumor growth inhibition in mouse models bearing intracranial PDX tumors expressing allosteric EGFR mutants.

    "Glioblastoma places an enormous burden on patients and their families, and we're encouraged by these pre-clinical data that support BDTX-1535's potential to improve treatment options for those impacted by GBM. The advancement of BDTX-1535 into early development is a critical step in our pursuit of a truly innovative approach for the treatment of this devastating disease," said David M. Epstein, Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. "We remain committed to the broad deployment of our proprietary MAP platform to produce novel MasterKey inhibitor therapies for a range of genetically defined diseases."

    The presentation from the SNO 2020 meeting is available on the "Scientific Presentations and Publications" section of the Black Diamond Therapeutics website.

    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 www.blackdiamondtherapeutics.com.

    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-1535 in IND-enabling studies. 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, 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.

    Contacts:

    For Investors:

    Natalie Wildenradt

    For Media:

    Kathy Vincent

    (310) 403-8951



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  2. CAMBRIDGE, Mass. and NEW YORK, Nov. 11, 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 that its President and Chief Executive Officer, David M. Epstein, Ph.D., will present an update about the Company's progress at the Jefferies 2020 Virtual London Healthcare Conference on Wednesday, November 18, 2020, at 2:40 PM GMT/9:40 AM ET.

    A live webcast of the presentation can be accessed by visiting the investor relations section of the Company's website, www.blackdiamondtherapeutics.com. A replay of the presentation will also be available and archived on the site for three weeks.

    About

    CAMBRIDGE, Mass. and NEW YORK, Nov. 11, 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 that its President and Chief Executive Officer, David M. Epstein, Ph.D., will present an update about the Company's progress at the Jefferies 2020 Virtual London Healthcare Conference on Wednesday, November 18, 2020, at 2:40 PM GMT/9:40 AM ET.

    A live webcast of the presentation can be accessed by visiting the investor relations section of the Company's website, www.blackdiamondtherapeutics.com. A replay of the presentation will also be available and archived on the site for three weeks.

    About Black Diamond

    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 www.blackdiamondtherapeutics.com.

    Contacts:

    For Investors:

    Natalie Wildenradt

    For Media:

    Kathy Vincent

    (310) 403-8951

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    • Continued to enroll and dose patients in Phase 1/2 clinical trial of BDTX-189, with Phase 1 portion on track to complete by first half of 2021
    • Strengthened Board of Directors with appointment of Robert A. Ingram as Chairman
    • Bolstered executive team with appointment of Rachel Humphrey, M.D., as Chief Medical Officer
    • Cash, cash equivalents, and investments of $333.1 million as of September 30, 2020, expected to be sufficient to fund operations into 2023

    CAMBRIDGE, Mass. and NEW YORK, Nov. 10, 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 reported financial results for the third quarter ended…

    • Continued to enroll and dose patients in Phase 1/2 clinical trial of BDTX-189, with Phase 1 portion on track to complete by first half of 2021
    • Strengthened Board of Directors with appointment of Robert A. Ingram as Chairman
    • Bolstered executive team with appointment of Rachel Humphrey, M.D., as Chief Medical Officer
    • Cash, cash equivalents, and investments of $333.1 million as of September 30, 2020, expected to be sufficient to fund operations into 2023

    CAMBRIDGE, Mass. and NEW YORK, Nov. 10, 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 reported financial results for the third quarter ended September 30, 2020 and provided a corporate update.

    "At Black Diamond, we are leveraging our proprietary MAP platform to pioneer a differentiated approach to drug development, in which we aggregate novel oncogenic driver mutations into druggable families enabling the design of potent and selective MasterKey inhibitor product candidates," said David M. Epstein, Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. "This MasterKey profile extends not only to our lead product candidate BDTX-189, which is currently progressing through Phase 1/2 clinical development, but also throughout our early-stage pipeline. We believe the addition of Rachel Humphrey to our executive team to shepherd these programs through the clinic, as well as the appointment of Bob Ingram as Chairman of our Board to lend his leadership and industry expertise, will enable us to realize the potential of our science and to deliver precision medicines to patients who currently lack targeted treatment options."

    Recent Developments

    • Black Diamond continued to enroll and dose patients in the MasterKey-01 study, a Phase 1/2 clinical trial of BTDX-189. The Company remains on track to complete the Phase 1 portion of the trial in the first half of 2021.
    • In October 2020, Black Diamond presented pre-clinical data on BDTX-189 at the 32nd Annual EORTC-NCI-AACR Virtual Symposium:
      • In cell-based assays, BDTX-189 achieved potent inhibition of 48 ErbB mutant variants, including the family of epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) Exon 20 insertion mutations, while maintaining selectivity vs. wild-type EGFR (WT-EGFR).
      • 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) and with ErbB TKIs currently in clinical development. 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. WT-EGFR.
      • Pre-clinical evaluation of BDTX-189's pharmacokinetic (PK) profile revealed that BDTX-189 achieved the desired rapid and sustained target occupancy with rapid clearance.
      • BDTX-189 demonstrated dose-dependent tumor inhibition and regression in both engineered HER2 S310F tumor models and in EGFR Exon 20 insertion patient-derived xenograft models.
    • Black Diamond continued to advance its program in glioblastoma multiforme (GBM) toward nomination of a development candidate, as well as its early-stage pipeline programs derived from the Company's Mutation-Allostery-Pharmacology (MAP) platform.
    • In September 2020, Black Diamond appointed biopharmaceutical veteran Robert A. Ingram as Chairman of its Board of Directors.
    • In September 2020, Black Diamond strengthened its executive team with the appointment of Rachel Humphrey, M.D., as Chief Medical Officer.

    Financial Highlights

    • Black Diamond ended the third quarter of 2020 with $333.1 million in cash, cash equivalents, and investments, compared to $78.7 million for the third quarter of 2019. Net cash used in operations was $11.5 million for the third quarter of 2020 compared to $5.3 million for the third quarter of 2019.
    • Research and development (R&D) expenses were $12.9 million for the third quarter of 2020 compared to $5.6 million for the third quarter of 2019. The increase in R&D expenses was primarily related to an increase in headcount and external fees related to the development of our MAP platform and our product candidates, including BDTX-189.
    • General and administrative (G&A) expenses were $5.6 million for the third quarter of 2020 compared to $2.5 million for the third quarter of 2019. The increase in G&A expenses was primarily due to increased headcount and higher legal and other professional fees due to operating as a public company.

    Upcoming Events

    • The Company will present pre-clinical data on Black Diamond's GBM program at the Society of Neuro-Oncology 2020 Annual Meeting, taking place November 19-21, 2020:
      • Abstract Title: Potent, selective, and brain penetrant inhibitors of extracellular domain EGFR oncogenic mutants expressed in GBM demonstrate efficacy in an intracranial patient derived xenograft model
      • Abstract ID: EXTH-59
      • Session: Experimental and Translation Sciences Session III
    • David M. Epstein, Ph.D., President and CEO of Black Diamond, will present at the Jefferies Virtual London Healthcare Conference on Wednesday, November 18, 2020, at 2:40 PM GMT/9:40 AM ET.

    About MasterKey-01

    MasterKey-01 (NCT04209465) is a combined Phase 1/2 open-label, two-part, multicenter study to assess the safety, tolerability, pharmacokinetics, and anti-tumor activity of BDTX-189, in adult patients with advanced solid tumors who have no standard therapy available or for whom standard therapy is considered unsuitable or intolerable. Part A is a Phase 1, first-in-human, open-label dose escalation study, comprised of initial single-patient, accelerated titration cohorts followed by multiple-patient cohorts utilizing a Bayesian design. Part A is designed to determine the recommended Phase 2 dose and schedule in up to 100 patients with allosteric human epidermal growth factor receptor 2 (HER2) or HER3 mutation; epidermal growth factor receptor (EGFR) or HER2 exon 20 insertion mutation; HER2 amplified or overexpressing tumor; or, EGFR exon 19 deletion or L858R mutation. Part B is a Phase 2, open-label, multicenter basket study designed to determine antitumor activity and safety in adult patients with solid tumors that have an allosteric HER2 mutation or EGFR or HER2 exon 20 insertion mutations using next-generation sequencing. This part will utilize a Simon 2-stage design and enroll up to 100 patients in four cohorts: 1) non-small cell lung cancer with EGFR or HER2 exon 20 insertion mutations; 2) breast cancer with an allosteric ErbB mutation; 3) solid tumors (except breast) with S310F/Y mutation; and, 4) other tumors harboring allosteric ErbB mutations not included in cohorts 1-3.

    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 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 U.S. Food and Drug Administration (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

    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 www.blackdiamondtherapeutics.com.

    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 future plans or expectations for the Mutation-Allostery-Pharmacology platform, including the potential of the Company's strategy and product candidates, and the continued development and advancement of the Company's pipeline, including BDTX-189, the GBM program and other early-stage pipeline programs. 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.

    Black Diamond Therapeutics, Inc.

    Condensed Consolidated Balance Sheet Data (Unaudited)

    (in thousands)

     September 30,

    2020
     December 31,

    2019
    Cash, cash equivalents, and investments$333,072  $154,666 
    Total assets$346,435  $158,295 
    Derivative liabilities$  $16 
    Convertible preferred stock$  $200,573 
    Accumulated deficit$(95,598) $(50,970)
    Total stockholders' equity (deficit)$327,345  $(47,157)





    Black Diamond Therapeutics, Inc.

    Condensed Consolidated Statements of Operations (Unaudited)

    (in thousands, except share and per share data)

     Three Months Ended

    September 30,
     Nine Months Ended

    September 30,
     2020 2019 2020 2019
    Operating expenses:       
    Research and development (inclusive of $190, $3,480, $2,293 and $8,497 respectively, with a related party)$12,929  $5,634  $30,453  $14,293 
    General and administrative (inclusive of $0, $176, $0 and $357 respectively, with a related party)5,551  2,514  15,934  4,695 
    Total operating expenses18,480  8,148  46,387  18,988 
    Loss from operations(18,480) (8,148) (46,387) (18,988)
    Other income (expense):       
    Interest expense    (1)  
    Interest income1,162  1  2,787  21 
    Change in fair value of derivative liabilities  (1,116)   (6,416)
    Other (expense) income(594) (5) (1,027)  
    Total other income (expense), net568  (1,120) 1,759  (6,395)
    Net loss$(17,912) $(9,268) $(44,628) $(25,383)
    Net loss per share, basic and diluted$(0.50) $(4.50) $(1.42) $(12.36)
    Weighted average common shares outstanding, basic and diluted35,927,485  2,065,676  31,860,716  2,054,115 
                

    Contacts:

    For Investors:

    Natalie Wildenradt

    For Media:

    Kathy Vincent

    (310) 403-8951

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  3. 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 32nd 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…

    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 32nd 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 cancers."

    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. WT-EGFR.

    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 website.

    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 www.blackdiamondtherapeutics.com.

    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.

    Contacts:

    For Investors:

    Natalie Wildenradt

    For Media:

    Kathy Vincent

    (310) 403-8951

    Primary Logo

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