BDTX Black Diamond Therapeutics Inc.
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
BDTX-1535
Glioblastoma multiforme (GBM) and NSCLC.
|
Phase 1
Phase 1
|
IND due 1H 2022.
|
|
BDTX-189 (MasterKey-01)
Solid tumors
|
Phase 1/2
Phase 1/2
|
Phase 2 portion to begin 2H 2021.
|
Latest News
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CAMBRIDGE, Mass. and NEW YORK, Nov. 08, 2021 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (NASDAQ:BDTX), a precision oncology medicine company pioneering the discovery and development of MasterKey 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 following upcoming investor conferences:
- The Stifel 2021 Virtual Healthcare Conference. The corporate presentation will take place on Monday, November 15, 2021 at 4:40 PM ET.
- The 2021 Jefferies London Healthcare Conference. The presentation will be available on-demand beginning Thursday, November 18, 2021, starting at 4:00 AM ET.
A webcast of the Stifel presentation can be accessed by visiting the investor relations section of the Company's website, www.blackdiamondtherapeutics.com. A replay of each presentation will also be available and archived on the site for 30 days.
About Black Diamond Therapeutics, Inc.
Black Diamond Therapeutics is a precision oncology medicine company pioneering the discovery of 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, the 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 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 www.blackdiamondtherapeutics.com.
Contacts
For Investors:
Natalie Wildenradt
[email protected]For Media:
Kathy Vincent
(310) 403-8951
[email protected]
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- Black Diamond continues preparation for initiation of the Phase 2 portion of MasterKey-01 study of BDTX-189 this year
- Pre-clinical data from BDTX-1535, BRAF, and FGFR programs presented at AACR-NCI-EORTC (ANE) International Conference
- Strategic partnership established with OpenEye to accelerate drug discovery efforts through cloud-based molecular dynamics technology
- Cash, cash equivalents, and investments of $235.0 million as of September 30, 2021, expected to be sufficient to fund operations into the second half of 2023
CAMBRIDGE, Mass. and NEW YORK, Nov. 08, 2021 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (NASDAQ:BDTX), a precision oncology medicine company pioneering the discovery and development of MasterKey therapies, today reported financial results for the third quarter ended September 30, 2021 and provided a corporate update.
"Black Diamond's approach remains deeply rooted in our proprietary Mutation-Allostery-Pharmacology (MAP) drug discovery engine, which leverages population-level genetic sequencing that allows for the identification of novel oncogenic mutations. We are well-positioned to advance differentiated MasterKey programs across a range of oncogenic targets for patient populations with unmet need," said David Epstein, Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. "We are excited by the continuing progression of our pipeline of MasterKey inhibitor programs, including the BDTX-189 MasterKey-01 study, our BDTX-1535 program with an IND filing anticipated by the first half of 2022, and our BRAF and fibroblast growth factor receptor (FGFR) programs."
Recent Developments
BDTX-189:
- Black Diamond remains on-track with preparations for initiating the Phase 2 portion of the MasterKey-01 Phase 1/2 study of BDTX-189 by the end of 2021. The Company completed the Phase 1 dose-escalation portion of the study and has selected the recommended Phase 2 dose for BDTX-189.
BDTX-1535:
- Black Diamond continues to advance BDTX-1535 through IND-enabling studies and expects to file an IND application by the first half of 2022.
- In October 2021, Black Diamond presented pre-clinical data for BDTX-1535 at the ANE International Conference:
- In cell-based assays, BDTX-1535 achieved potent and selective inhibition of a range of EGFR mutations expressed in glioblastoma (GBM) and non-small cell lung cancer (NSCLC), including canonical, non-canonical, and drug-resistance mutations, such as EGFR-C797S that can arise following treatment with osimertinib.
- BDTX-1535 demonstrated a favorable brain-penetrant pharmacokinetic (PK) profile in mouse, rat, and dog models.
- In a range of tumor models, including intercranial GBM models and lung cancer drug resistance models expressing the targeted EGFR mutations, BDTX-1535 showed dose-dependent tumor growth inhibition and achieved complete regression without notable impact on body weight.
Early-Stage Pipeline:
- Black Diamond continues to progress its early-stage pipeline programs designed to target cancers driven by mutations in BRAF and FGFR. The Company anticipates IND filings for both programs in 2022.
- In October 2021, Black Diamond presented pre-clinical data for both the BRAF and FGFR programs at the ANE International Conference:
- BRAF:
- The presentation described pre-clinical data for a lead compound from Black Diamond's BRAF program, which is designed for potency and selectivity against a spectrum of non-canonical Class II/III mutations, in addition to Class I mutations (V600E).
- In cell-based assays, the lead compound demonstrated potent inhibition of a spectrum of Class I/II/III BRAF mutations.
- In contrast to current-generation BRAF inhibitors, such as encorafenib and vemurafenib, treatment of cells harboring wild type BRAF (WT-BRAF) with the Black Diamond compound was not observed to lead to an increase in pERK, a signal of paradoxical activation.
- In a BRAF-KIAA1549 fusion allograft tumor model, the lead compound exhibited dose-dependent inhibition of pERK and anti-tumor efficacy.
- FGFR:
- The presentation was illustrative of the Black Diamond approach, centered on a four-pronged optimization strategy with the goal of delivering an inhibitor that has broad coverage of FGFR2 and FGFR3 oncogenes, while sparing inhibition of FGFR1 and retaining activity against resistance mutations.
- In cell-based assays, FGFR program compounds demonstrated potent and selective inhibition of a spectrum of FGFR2/3 oncogenic mutations, while sparing FGFR1. Additionally, FGFR program compounds demonstrated improved potency against resistance mutations.
- In an in vivo study conducted in a UM-UC-14 (FGFR3-S249C) mouse model, FGFR program compounds demonstrated anti-tumor activity. Additionally, in mouse and rat models, FGFR program compounds did not promote hyperphosphatemia.
- BRAF:
Corporate:
- In September 2021, Black Diamond entered into a strategic partnership with OpenEye Scientific to incorporate OpenEye's Orion® molecular design platform into Black Diamond's proprietary Mutation-Allostery-Pharmacology (MAP) drug discovery engine to help advance MasterKey inhibitor cancer therapies. OpenEye's Orion Software-as-a-Service platform enables Black Diamond to perform rapid simulations and analysis of protein motion.
Financial Highlights
- Black Diamond ended the third quarter of 2021 with $235.0 million in cash, cash equivalents, and investments compared to $315.1 million as of December 31, 2020. Net cash used in operations was $26.5 million for the third quarter of 2021 compared to $11.5 million for the third quarter of 2020.
- Research and development (R&D) expenses were $27.6 million for the third quarter of 2021 compared to $12.9 million for the third quarter of 2020. The increase in R&D expenses was primarily related to an increase in headcount and increased spend across preclinical and clinical development.
- General and administrative (G&A) expenses were $7.7 million for the third quarter of 2021 compared to $5.6 million for the third quarter of 2020. The increase in G&A expenses was primarily due to an increase in personnel and other corporate-related costs.
About Black Diamond Therapeutics, Inc.
Black Diamond Therapeutics is a precision oncology medicine company pioneering the discovery of 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, the 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 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 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 of BDTX-189 and the timing for initiating 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, and the development of the BRAF and FGFR programs, including timing for filing INDs in each program, 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: the success, cost, and timing of the Company's product candidate development activities and planned IND-enabling studies 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 pre-clinical studies, supply chain, and operations, as well as those risks and uncertainties set forth in its 2020 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,
2021December 31,
2020Cash, cash equivalents, and investments $ 235,008 $ 315,067 Total assets $ 274,126 $ 329,670 Accumulated deficit $ (217,953 ) $ (118,224 ) Total stockholders' equity $ 218,948 $ 307,758 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 30,2021 2020 2021 2020 Operating expenses: Research and development $ 27,626 $ 12,929 $ 77,165 $ 30,453 General and administrative 7,738 5,551 23,627 15,934 Total operating expenses 35,364 18,480 100,792 46,387 Loss from operations (35,364 ) (18,480 ) (100,792 ) (46,387 ) Other income (expense): Interest expense — — — (1 ) Interest income 776 1,162 2,876 2,787 Other (expense) income (489 ) (594 ) (1,813 ) (1,027 ) Total other income (expense), net 287 568 1,063 1,759 Net loss $ (35,077 ) $ (17,912 ) $ (99,729 ) $ (44,628 ) Net loss per share, basic and diluted $ (0.97 ) $ (0.50 ) $ (2.76 ) $ (1.42 ) Weighted average common shares outstanding, basic and diluted 36,219,137 35,927,485 36,175,249 31,860,716 Contacts:
For Investors:
Natalie Wildenradt
[email protected]For Media:
Kathy Vincent
(310) 403-8951
[email protected]
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CAMBRIDGE, Mass. and NEW YORK, Oct. 08, 2021 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (NASDAQ:BDTX), a precision oncology medicine company pioneering the discovery and development of MasterKey therapies, today announced the presentation of preclinical data for three early-stage pipeline programs in oral and poster sessions at the AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics.
"Despite clinical advances in precision medicines for patients with non-small cell lung cancer (NSCLC) harboring an epidermal growth factor receptor (EGFR) mutation, multiple areas of unmet need persist, which include patients whose tumors have developed resistance to current-generation therapies, express non-canonical (or uncommon) mutations, and have metastasized to the brain," said Elizabeth Buck, Ph.D., Chief Scientific Officer of Black Diamond Therapeutics. "BDTX-1535 has demonstrated a breadth of coverage of oncogenic EGFR mutations expressed in NSCLC, which coupled with a brain-penetrant pharmacokinetic (PK) profile, supports the potential of BDTX-1535 as an optimal therapeutic candidate for these NSCLC patient populations."
Dr. Buck continued: "Additionally, B-Raf (BRAF) and fibroblast growth factor receptor (FGFR) are validated therapeutic targets, yet current standards of care are associated with meaningful limitations, yielding persistent unmet needs for these cancer patients. Our BRAF program compounds are designed to selectively target a full spectrum of Class II/III BRAF oncogenic mutations without inducing paradoxical activation, which can lead to secondary malignancies. Our FGFR compounds are designed to target a full spectrum of oncogenic FGFR2 and FGFR3 mutations, including known resistance mutations, while sparing FGFR1, the inhibition of which is associated with toxicities, including hyperphosphatemia."
The presentations describe the following data:
BDTX-1535 Program:
The presentation describes preclinical data for BDTX-1535, which is designed as a potent, selective, and brain-penetrant inhibitor of a spectrum of EGFR mutations expressed in glioblastoma multiforme (GBM) and NSCLC.- In cell-based assays, BDTX-1535 achieved potent and selective inhibition of EGFR mutations expressed in NSCLC, including the EGFR- C797S mutation that can arise following treatment with osimertinib.
- BDTX-1535 demonstrated a favorable brain-penetrant PK profile in mouse, rat, and dog models.
- In an EGFR Exon19+C797S mouse allograft efficacy model, BDTX-1535 showed dose-dependent tumor growth inhibition and achieved complete regression without notable impact on body weight.
- Black Diamond expects to file an Investigational New Drug (IND) application for BDTX-1535 in the first half of 2022.
BRAF Program:
The presentation describes preclinical data for a lead compound from Black Diamond's BRAF program, which is designed for potency and selectivity against a spectrum of non-canonical Class II/III (non-V600) mutations, as well as to avoid induction of paradoxical activation.- In cell-based assays, the lead compound demonstrated potent inhibition of a spectrum of Class II/III BRAF mutations.
- In contrast to current-generation BRAF inhibitors, such as encorafenib and vemurafenib, treatment of cells harboring wild type BRAF (WT-BRAF) with the Black Diamond compound was not observed to lead to an increase in protein kinase RNA-like endoplasmic reticulum kinase (pERK), a signal of paradoxical activation.
- In a BRAF-KIAA1549 fusion allograft tumor model, the lead compound exhibited dose-dependent inhibition of pERK and anti-tumor efficacy.
- Black Diamond anticipates an IND filing in 2022.
FGFR Program:
The presentation illustrates the Black Diamond approach, which centers on a four-pronged optimization strategy designed to deliver an inhibitor with broad coverage of FGFR2 and FGFR3 oncogenes, while sparing inhibition of FGFR1 and retaining activity against resistance mutations.- In cell-based assays, FGFR program compounds demonstrated potent and selective inhibition of a spectrum of FGFR2/3 oncogenic mutations, while sparing FGFR1.
- Additionally, in cell-based assays, FGFR program compounds demonstrated improved potency against resistance mutations.
- In an in vivo study conducted in a UM-UC-14 (FGFR3-S249C) mouse model, FGFR program compounds demonstrated anti-tumor activity. Additionally, in mouse and rat models, FGFR program compounds did not promote hyperphosphatemia.
- Black Diamond anticipates an IND filing in 2022.
"Our BDTX-1535, BRAF, and FGFR programs exemplify Black Diamond's MasterKey approach to drug discovery in which we are able to harness the power of our proprietary MAP drug discovery engine to design spectrum-selective candidates engineered to overcome the limitations of current therapies in each target area," said David M. Epstein, Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. "These programs underscore the productivity of our MAP engine, and we look forward to providing updates across our pipeline as we advance toward our goal of delivering product candidates that can expand the reach of precision medicine and, in turn, address areas of true unmet need."
The presentations from the AACR-NCI-EORTC meeting are available on the "Scientific Presentations and Publications" section of the Black Diamond Therapeutics website.
About Black Diamond Therapeutics, Inc.
Black Diamond Therapeutics is a precision oncology medicine company pioneering the discovery of 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, the 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 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 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, including expectations for filing an IND, and the development of the BRAF and FRGR programs, including the timing for filing INDs in each program. 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 studies 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 Annual Report on Form 10-K for the year ended December 31, 2020, filed with the United States Securities and Exchange Commission and in 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
[email protected]For Media:
Kathy Vincent
(310) 403-8951
[email protected]
-
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CAMBRIDGE, Mass. and NEW YORK, Sept. 30, 2021 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (NASDAQ:BDTX), a precision oncology medicine company pioneering the discovery and development of MasterKey therapies, today announced the presentation of pre-clinical data for three pipeline programs in oral and poster sessions at the upcoming AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics being held October 7-10, 2021.
Oral presentation information is as follows:
Title: BDTX-1535, a CNS penetrant MasterKey inhibitor of common, uncommon and resistant EGFR mutations, demonstrates in vivo efficacy and has potential to treat osimertinib-resistant NSCLC with or without brain metastases
Session Title: Plenary Session 2: New Drugs on the Horizon I
Abstract Number: 5208
Presentation Date: Friday, October 8, 11:05-11:20 AM ETPoster presentation information is as follows:
Title: Pre-clinical evaluation of next-generation inhibitor targeting a wide spectrum of oncogenic BRAF dimers
Poster Number: P229Title: Discovery and characterization of selective, FGFR1 sparing, inhibitors of FGFR2/3 oncogenic mutations for the treatment of cancers
Poster Number: P246Full abstracts will be available on the meeting platform at the start of the meeting on Thursday, October 7, 2021 at 9:00 AM ET.
About Black Diamond Therapeutics, Inc.
Black Diamond Therapeutics is a precision oncology medicine company pioneering the discovery of 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, the 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 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 www.blackdiamondtherapeutics.com.Contacts:
For Investors:
Natalie Wildenradt
[email protected]For Media:
Kathy Vincent
(310) 403-8951
[email protected]
-
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CAMBRIDGE, Mass. and NEW YORK, Sept. 21, 2021 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (NASDAQ:BDTX), a precision oncology medicine company pioneering the discovery and development of MasterKey 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 2021 Cantor Fitzgerald Virtual Global Healthcare Conference on Tuesday, September 28, 2021 at 4:40 PM 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 Therapeutics, Inc.
Black Diamond Therapeutics is a precision oncology medicine company pioneering the discovery of 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 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 www.blackdiamondtherapeutics.com.
Contacts
For Investors:
Natalie Wildenradt
[email protected]For Media:
Kathy Vincent
(310) 403-8951
[email protected]