About Us | ScientistBDTX Black Diamond Therapeutics Inc.
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
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BDTX-189 (MasterKey-01)
Solid tumors
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Phase 1/2
Phase 1/2
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Dose-escalation portion on track to complete in 1H 2021. Phase 2 portion to begin 2H 2021.
|
Latest News
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CAMBRIDGE, Mass. and NEW YORK, Aug. 04, 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 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 2021 Wedbush PacGrow Healthcare Conference. Dr. Epstein will be featured in a Targeted Oncology panel on Wednesday, August 11, 2021 at 10:20 AM ET. The session will be available via live webcast to conference attendees.
- The Canaccord Genuity 41st Annual Growth Conference. The presentation will take place on Thursday, August 12, 2021 at 1:00 PM ET.
A live webcast of the Canaccord Genuity 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, 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]
-
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Once-daily (QD) dose escalation completed; pharmacokinetic (PK) profile consistent with design principles and preclinical predictions
Generally well-tolerated with medically manageable toxicities observed; safety profile compares favorably in the context of other agents in the class; preliminary recommended Phase 2 dose (RP2D) selected for the QD regimen
Preliminary anti-cancer activity observed in heavily pre-treated patients (prior EGFR/HER2-directed and/or I/O agents) in a variety of tumor types and genomic alterations in EGFR or HER2, including confirmed partial responses
Conference call and webcast to be held today at 6:00 PM ET
CAMBRIDGE, Mass. and NEW YORK, May 19, 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 initial data from the Phase 1 dose-escalation portion of the MasterKey-01 trial of BDTX-189 in patients with advanced solid tumors harboring any one of more than 48 oncogenic alterations in the epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) oncogenes. These data provide early proof-of-concept for BDTX-189, including evidence of anti-cancer activity and a safety profile that is in-line with the Company's preclinical expectations. The data announced today will be presented in poster presentations at the upcoming 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place June 4-8, 2021.
"These encouraging Phase 1 safety and anti-cancer activity data provide early proof-of-concept for BDTX-189 as a differentiated MasterKey inhibitor of undrugged oncogenic mutants of EGFR, including EGFR Exon 20 insertion mutations and oncogenic mutants of HER2," said Rachel Humphrey, M.D., Chief Medical Officer of Black Diamond Therapeutics. "We look forward to the continued advancement of BDTX-189 through clinical development and remain on track to initiate the potentially pivotal Phase 2 portion of the MasterKey-01 trial in the second half of 2021."
"These initial data suggest BDTX-189 may provide meaningful clinical benefit to patients with advanced solid tumors, including those with allosteric EGFR and HER2 mutations," said Alison Schram, M.D., Medical Oncologist, Memorial Sloan Kettering Cancer Center. "The favorable tolerability profile demonstrated thus far supports the potential of BDTX-189 to address the unmet need in this patient population, for which there are no currently approved targeted therapies and where other in-clinic agents are limited by toxicity."
MasterKey-01 Part A Dose-Escalation Study Design
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 Optimal Interval (BOIN) design. Part A is designed to determine the recommended Phase 2 dose and schedule for the QD and twice-daily (BID) regimens in patients with solid tumors with an allosteric HER2 or HER3 mutation; EGFR or HER2 Exon 20 insertion mutation; HER2 amplified or overexpressing tumor; or EGFR Exon 19 deletion or L858R mutation.
Initial Study Results
As of the data cut-off date of April 2, 2021, 55 patients from the QD regimen were dosed across the dosing range, 25-400 mg QD fasting (n = 12), 800 mg QD fasting (n = 21), 800 mg QD non-fasting (n = 9), 1000 mg QD fasting (n = 7), and 1200 mg QD fasting (n = 6). The dose-escalation portion successfully enrolled patients with a broad range of tumor types and genomic alterations. Tumor types enrolled included non-small cell lung cancer (NSCLC), breast, colorectal (CRC), ovary, biliary, pancreas, cervical, cancer of unknown primary, kidney, salivary, prostate, signet ring cell, liver, and bladder. Genomic alterations enrolled included HER2 amplification and the following mutations: allosteric HER2, EGFR Exon 20 insertion, HER2 Exon 20 insertion, EGFR Exon 19 del./L858R, and HER3.
PK
The PK data for the BDTX-189 QD regimen demonstrated dose-dependent increases in exposure up to 800 mg QD, achieving the predicted efficacious exposure at 800 mg QD. BDTX-189 was rapidly absorbed, with a short elimination half-life of 1.3-4.4 hours, consistent with preclinical predictions. No apparent accumulation or change in exposure at steady state was observed.
Safety
BDTX-189 demonstrated a favorable tolerability profile, with no dose-limiting toxicities at doses of ≤800 mg QD fasting and non-fasting in the dose-escalation cohorts. 800 mg non-fasting was selected as the preliminary RP2D for the QD regimen.
The most common drug-related adverse events were gastrointestinal in nature, the majority of which were low grade and generally medically manageable. At 800 mg QD fasted or non-fasted (n = 30), the most common drug-related adverse events were diarrhea (50%, 7% Gr3), nausea (50%, 7% Gr3), vomiting (30%, 3% Gr3), ALT increased (20%, 10% Gr3), AST increased (13%, 3% Gr3), fatigue (20%, 0% Gr3), skin disorders (13%, 0% Gr3), and decreased appetite (10%, 0% Gr3).
Efficacy
In a heavily pre-treated patient population, including patients who had received prior EGFR/HER2 tyrosine kinase inhibitors (TKI), evidence of anti-cancer activity was observed. Among all cancer type/genomic alteration pairs, two had ≥ three RECIST-evaluable patients dosed at ≥800 mg QD: NSCLC harboring either EGFR Exon 20 mutations (n = 3) or HER2 Exon 20 mutations (n = 3). In the separate group of patients with solid tumors harboring HER2-amplification, six patients dosed at ≥800 mg QD were evaluable by RECIST.
- Three patients with NSCLC EGFR Exon 20 dosed at ≥800 mg QD (all at 800 mg QD) were evaluable by RECIST at the time of data cut-off, all of whom had received prior EGFR/HER2-targeted therapy. One confirmed partial response was observed in a patient who had previously responded and then progressed on poziotinib (at the data cut-off, 53% tumor regression observed and treatment with BDTX-189 ongoing 13+ weeks). One patient with stable disease and one patient with progressive disease were observed.
- Three patients with NSCLC HER2 Exon 20 dosed at ≥800 mg QD (all at 800 mg QD) were evaluable by RECIST at the time of data cut-off, two of whom had received prior EGFR/HER2-targeted therapy. All three patients demonstrated stable disease.
- Six patients with HER2-amplification across a range of tumor types dosed at ≥800 mg QD were evaluable by RECIST at the time of data cut-off, two-thirds of whom had received prior EGFR/HER2-targeted therapy. One confirmed partial response (cancer of unknown primary; at data cut-off, 90% tumor reduction and treatment with BDTX-189 ongoing 24+ weeks), one unconfirmed partial response (NSCLC), two patients with stable disease (ovarian and pancreatic), and two patients with progressive disease were observed.
"We're incredibly encouraged by the rapid progress of the MasterKey-01 study and promising proof-of-concept data for BDTX-189. These preliminary data support the differentiated profile of BDTX-189 as a MasterKey inhibitor of diverse oncogenic alterations in EGFR and HER2, as well as initial validation of Black Diamond's proprietary MAP drug discovery engine and MasterKey approach to drug development," said David M. Epstein, President and Chief Executive Officer of Black Diamond Therapeutics. "We'd like to thank all the patients, their families, and their caregivers for participating in this study."
Black Diamond is continuing to dose patients in the ongoing QD dose-escalation portion and the food effect cohort, as well as enrolling and dosing patients in the BID dose-escalation portion. The Company will initiate the safety expansion cohort ahead of the Phase 2 portion of the MasterKey-01 study, which remains on track for initiation in the second half of 2021.
Part B is a Phase 2, open-label, multi-center study designed to determine anti-cancer activity and safety in adult patients with solid tumors harboring an allosteric HER2 mutation or EGFR or HER2 Exon 20 insertion mutation. This portion of the trial will enroll patients in focused tumor/mutation cohorts and is designed to be potentially pivotal. Additionally, based on early proof-of-concept data, Black Diamond is exploring the potential for further clinical development in the HER2-amplified setting.
The data announced today will be presented in poster presentations at the upcoming ASCO meeting:
Title: Safety and Preliminary Efficacy from the Phase 1 Portion of MasterKey-01: A First-in-Human Dose-Escalation Study to Determine the Recommended Phase 2 Dose (RP2D), Pharmacokinetics (PK), and Preliminary Antitumor Activity of BDTX-189, an Inhibitor of Allosteric ErbB mutations, in Patients with Advanced Solid Malignancies
Session Type: Poster Session
Session: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Date and Time: Friday, June 4, 9:00 AM ET
Abstract ID: 3086Title: Clinical pharmacokinetics of BDTX-189, an inhibitor of allosteric ErbB mutations, in patients with advanced solid malignancies in MasterKey-01 study
Session Type: Poster Session
Session: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Date and Time: Friday, June 4, 9:00 AM ET
Abstract ID: 3097Conference Call and Webcast:
In connection with today's announcement, Black Diamond's management team will host a conference call and live audio webcast at 6:00 PM ET today, Wednesday, May 19, 2021.
The live audio webcast and accompanying slides may be accessed through the Events page in the Investors section of the Company's website at www.blackdiamondtherapeutics.com. Alternatively, the conference call may be accessed as follows:
Conference ID: 1979666
Domestic Dial-in Number: 1-833-730-3983
International Dial-in Number: 1-720-405-2158For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Investors section of the Company's website.
About BDTX-189
BDTX-189 is an orally available, irreversible, and ATP competitive small molecule inhibitor that is designed to block the function of a family of oncogenic epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) proteins across a range of tumor types. BDTX-189 is designed as a MasterKey inhibitor targeting a family of previously undrugged and functionally similar oncogenic 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 EGFR and HER2. 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 EGFR/HER2 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 expressing a range of alterations of EGFR and HER2 receptors, including oncogenic MasterKey mutations, HER2-WT amplification, HER3 mutation, EGFR Exon 19 deletion, and L858R 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 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 and completing the safety expansion cohort or starting the Phase 2 portion of the ongoing clinical trial 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 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 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.
Contacts:
For Investors:
Natalie Wildenradt
[email protected]For Media:
Kathy Vincent
(310) 403-8951
[email protected] -
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Company to host conference call on Wednesday, May 19, 2021 at 6:00 PM ET
CAMBRIDGE, Mass. and NEW YORK, May 17, 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 that it will host a webcast presentation on Wednesday, May 19, 2021 at 6:00 PM ET to discuss pharmacokinetic, safety, and preliminary efficacy data from the Phase 1 dose-escalation portion of the MasterKey-01 trial of BDTX-189 in patients with advanced solid tumors, which will also be presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place June 4-8, 2021.
Conference Call and Webcast Event
A live webcast presentation will be available on the News & Events section of the Black Diamond website at www.blackdiamondtherapeutics.com. To access the presentation, please dial 833-730-3983 (United States) or 720-405-2158 (international) and reference the conference ID 1979666. A replay of the webcast will be available on the Black Diamond website following the presentation.
Abstract Details:
Title: Safety and Preliminary Efficacy from the Phase 1 Portion of MasterKey-01: A First-in-Human Dose-Escalation Study to Determine the Recommended Phase 2 Dose (RP2D), Pharmacokinetics (PK), and Preliminary Antitumor Activity of BDTX-189, an Inhibitor of Allosteric ErbB mutations, in Patients with Advanced Solid Malignancies
Session Type: Poster Session
Session: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Date and Time: Friday, June 4, 2021 at 9:00 AM ET
Abstract ID: 3086Title: Clinical pharmacokinetics of BDTX-189, an inhibitor of allosteric ErbB mutations, in patients with advanced solid malignancies in MasterKey-01 study
Session Type: Poster Session
Session: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Date and Time: Friday, June 4, 2021 at 9:00 AM ET
Abstract ID: 3097Full abstracts will be published online at 5:00 PM ET on May 19, 2021 on the ASCO website at www.asco.org.
About BDTX-189
BDTX-189 is an orally available, irreversible, and ATP competitive small molecule inhibitor that is designed to block the function of a family of oncogenic epidermal growth factor receptor (EGFR) and ErbB-2 (epidermal growth factor receptor 2 [HER2]) proteins across a range of tumor types. BDTX-189 is designed as a MasterKey inhibitor targeting a family of previously undrugged and functionally similar oncogenic 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 expressing a range of alterations of ErbB receptors, including oncogenic MasterKey mutations, HER2-WT amplification, HER3 mutation, EGFR exon 19 deletion, and L858R 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
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 www.blackdiamondtherapeutics.com.Contacts:
For Investors:
Natalie Wildenradt
[email protected]For Media:
Kathy Vincent
(310) 403-8951
[email protected] -
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- Patient enrollment and dosing in the Phase 1/2 clinical trial of BDTX-189 continue to track in line with projections at initiation of the study, with dose-escalation portion on track to complete in first half of 2021; initial Phase 1 clinical pharmacokinetic (PK), safety, and preliminary efficacy data to be presented at American Society of Clinical Oncology (ASCO) Annual Meeting
- Pre-clinical data for BDTX-1535, a brain-penetrant MasterKey inhibitor of epidermal growth factor receptor (EGFR) mutations for glioblastoma multiforme (GBM) and solid tumors, including those that metastasize to the brain, presented at American Association for Cancer Research (AACR) Annual Meeting; program on track to enter the clinic in 2022
- Cash, cash equivalents, and investments of $290.1 million as of March 31, 2021, expected to be sufficient to fund operations into 2023
CAMBRIDGE, Mass. and NEW YORK, May 07, 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 reported financial results for the first quarter ended March 31, 2021 and provided a corporate update.
"The first quarter of 2021 has been marked by meaningful progress across Black Diamond's pipeline of MasterKey inhibitor therapies, each of which is designed by leveraging our proprietary MAP platform to address an unmet need for patients with a range of genetically defined cancers," said David M. Epstein, Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. "We look forward to presenting initial clinical data for our lead program, BDTX-189, at the ASCO Annual Meeting later this quarter, as well as to continuing to report on progress across the pipeline throughout the year."
Recent Developments
BDTX-189:
- Black Diamond continued to enroll and dose patients in the MasterKey-01 study, a Phase 1/2 clinical trial of BDTX-189. More than 50 patients have been dosed with BDTX-189 to date. Eligibility included all solid tumors harboring any of the more than 50 pre-defined genomic alterations in EGFR and human epidermal growth factor receptor 2 (HER2). The Company is on track to complete the dose-escalation portion of the Phase 1 clinical trial in the first half of 2021.
- Initial Phase 1 clinical PK, safety, and preliminary efficacy data will be presented at the ASCO Annual Meeting.
- The Company is working toward selection of the recommended Phase 2 dose for BDTX-189 and plans to initiate the safety expansion cohort in the second quarter of 2021. The Phase 2 portion of the MasterKey-01 study is on track to begin in the second half of 2021.
- In April 2021, the Company presented pre-clinical data on BDTX-189 at the AACR Annual Meeting:
- 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/pharmacodynamic (PD) profile.
- 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 mutations.
BDTX-1535:
- In April 2021, the Company presented pre-clinical data on BDTX-1535 at the AACR Annual Meeting:
- 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 non-small cell lung cancer (NSCLC).
- Black Diamond expects to file an Investigational New Drug (IND) application for BDTX-1535 in the first half of 2022.
Early-Stage Pipeline:
- In March 2021, Black Diamond presented pre-clinical data for its B-Raf Proto-Oncogene (BRAF) and fibroblast growth factor receptor (FGFR) programs at European Society for Medical Oncology Targeted Anticancer Therapies Congress:
- Black Diamond's BRAF program candidates have been designed for potency against a spectrum of non-canonical Class II/III (non-V600), as well as to avoid induction of paradoxical activation. Tumor regression in mouse models has been observed.
- Black Diamond's FGFR program candidates are inhibitors with broad coverage of FGFR2 and FGFR3 oncogenes, while sparing inhibition of FGFR1 and retaining activity against gatekeeper mutations. Tumor regression in mouse models has been observed.
- The Company anticipates IND filings for both programs in 2022.
Corporate:
- In January 2021, Black Diamond appointed oncology clinical development veteran Kapil Dhingra, M.B.B.S., to its Board of Directors.
Financial Highlights
- Black Diamond ended the first quarter of 2021 with $290.1 million in cash, cash equivalents, and investments compared to $357.2 million as of March 31, 2020. Net cash used in operations was $24.5 million for the first quarter of 2021 compared to $11.3 million for the first quarter of 2020.
- Research and development (R&D) expenses were $22.8 million for the first quarter of 2021 compared to $7.4 million for the first 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 $7.9 million for the first quarter of 2021 compared to $5.5 million for the first quarter of 2020. The increase in G&A expenses was primarily due to an increase in personnel and other corporate-related costs.
Upcoming Events
- Initial PK, safety, and preliminary efficacy data from the Phase 1 dose-escalation portion of the MasterKey-01 clinical trial of BDTX-189 in advanced solid tumors will be presented as poster presentations at the ASCO Annual Meeting. Presentation details are as follows:
- Title: Safety and Preliminary Efficacy from the Phase 1 Portion of MasterKey-01: A First-in-Human Dose-Escalation Study to Determine the Recommended Phase 2 Dose (RP2D), Pharmacokinetics (PK), and Preliminary Antitumor Activity of BDTX-189, an Inhibitor of Allosteric ErbB mutations, in Patients with Advanced Solid Malignancies
- Session Type: Poster Session
- Session: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
- Date and Time: Friday, June 4, 9:00 AM ET
- Abstract ID: 3086
- Title: Clinical pharmacokinetics of BDTX-189, an inhibitor of allosteric ErbB mutations, in patients with advanced solid malignancies in MasterKey-01 study
- Session Type: Poster Session
- Session: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
- Date and Time: Friday, June 4, 9:00 AM ET
- Abstract ID: 3097
- Title: Safety and Preliminary Efficacy from the Phase 1 Portion of MasterKey-01: A First-in-Human Dose-Escalation Study to Determine the Recommended Phase 2 Dose (RP2D), Pharmacokinetics (PK), and Preliminary Antitumor Activity of BDTX-189, an Inhibitor of Allosteric ErbB mutations, in Patients with Advanced Solid Malignancies
About BDTX-189
BDTX-189 is an orally available, irreversible, and ATP competitive small molecule inhibitor that is designed to block the function of a family of oncogenic epidermal growth factor receptor (EGFR) and ErbB-2 (epidermal growth factor receptor 2 [HER2]) proteins across a range of tumor types. BDTX-189 is designed as a MasterKey inhibitor targeting a family of previously undrugged and functionally similar oncogenic 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 expressing a range of alterations of ErbB receptors, including oncogenic MasterKey mutations, HER2-WT amplification, HER3 mutation, EGFR exon 19 deletion, and L858R 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. 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 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 and the expected announcement of initial Phase 1 clinical pharmacokinetic, safety, and preliminary efficacy data, the continued development and advancement of BDTX-1535 in IND-enabling studies, including expectations for filing an IND and entering the clinic, and the development of the BRAF and FGFR programs, including timing for filing Initial New Drug applications 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 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)March 31,
2021December 31,
2020Cash, cash equivalents, and investments $ 290,055 $ 315,067 Total assets $ 313,259 $ 329,670 Accumulated deficit $ (148,525 ) $ (118,224 ) Total stockholders' equity $ 280,753 $ 307,758 Black Diamond Therapeutics, Inc.
Condensed Consolidated Statements of Operations (Unaudited)
(in thousands, except share and per share data)Three Months Ended
March 31,2021 2020 Operating expenses: Research and development $ 22,820 $ 7,354 General and administrative 7,893 5,525 Total operating expenses 30,713 12,879 Loss from operations (30,713 ) (12,879 ) Other income (expense): Interest income 1,152 744 Other (expense) income (740 ) (10 ) Total other income (expense), net 412 734 Net loss $ (30,301 ) $ (12,145 ) Net loss per share, basic and diluted $ (0.84 ) $ (0.51 ) Weighted average common shares outstanding, basic and diluted 36,123,083 23,699,255 Contacts:
For Investors:
Natalie Wildenradt
[email protected]For Media:
Kathy Vincent
(310) 403-8951
[email protected] - Patient enrollment and dosing in the Phase 1/2 clinical trial of BDTX-189 continue to track in line with projections at initiation of the study, with dose-escalation portion on track to complete in first half of 2021; initial Phase 1 clinical pharmacokinetic (PK), safety, and preliminary efficacy data to be presented at American Society of Clinical Oncology (ASCO) Annual Meeting
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Initial pharmacokinetic (PK), safety, and preliminary efficacy data from Phase 1 dose-escalation portion of MasterKey-01 clinical trial to be presented
CAMBRIDGE, Mass. and NEW YORK, April 28, 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 that initial PK, safety, and preliminary efficacy data from the Phase 1 dose-escalation portion of the MasterKey-01 trial of BDTX-189 in patients with advanced solid tumors will be presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place June 4-8, 2021.
Presentation details are as follows:
Title: Safety and Preliminary Efficacy from the Phase 1 Portion of MasterKey-01: A First-in-Human Dose-Escalation Study to Determine the Recommended Phase 2 Dose (RP2D), Pharmacokinetics (PK), and Preliminary Antitumor Activity of BDTX-189, an Inhibitor of Allosteric ErbB mutations, in Patients with Advanced Solid Malignancies
Session Type: Poster Session
Session: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Date and Time: Friday, June 4, 9:00 AM ET
Abstract ID: 3086Title: Clinical pharmacokinetics of BDTX-189, an inhibitor of allosteric ErbB mutations, in patients with advanced solid malignancies in MasterKey-01 study
Session Type: Poster Session
Session: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Date and Time: Friday, June 4, 9:00 AM ET
Abstract ID: 3097Full abstracts will be published online at 5:00 PM ET on May 19, 2021 on the ASCO website at www.asco.org.
About BDTX-189
BDTX-189 is an orally available, irreversible, and ATP competitive small molecule inhibitor that is designed to block the function of a family of oncogenic epidermal growth factor receptor (EGFR) and ErbB-2 (epidermal growth factor receptor 2 [HER2]) proteins across a range of tumor types. BDTX-189 is designed as a MasterKey inhibitor targeting a family of previously undrugged and functionally similar oncogenic 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 expressing a range of alterations of ErbB receptors, including oncogenic MasterKey mutations, HER2-WT amplification, HER3 mutation, EGFR exon 19 deletion, and L858R 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
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 www.blackdiamondtherapeutics.com.Contacts:
For Investors:
Natalie Wildenradt
[email protected]For Media:
Kathy Vincent
(310) 403-8951
[email protected]