Black Diamond Therapeutics to Host Webcast Presentation of Data From Phase 1 Dose-Escalation Portion of MasterKey-01 Clinical Trial

Rhea-AI Summary

Black Diamond Therapeutics (Nasdaq: BDTX) announced a webcast presentation on May 19, 2021, to discuss pharmacokinetic, safety, and preliminary efficacy data from the Phase 1 dose-escalation portion of the MasterKey-01 trial for BDTX-189, targeting advanced solid tumors. Key data will also be presented at the ASCO Annual Meeting on June 4, 2021. BDTX-189 is designed to inhibit oncogenic mutations of EGFR and HER2, with Fast Track designation from the FDA, highlighting its potential significance for patients with limited treatment options.

Positive

• Successful Phase 1 dose-escalation of BDTX-189 for advanced solid tumors.
• Fast Track designation from FDA emphasizes potential market impact.
• Presentation at ASCO Annual Meeting indicates strong scientific interest.

Negative

• None.

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: 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, 2021 at 9:00 AM ET
Abstract ID: 3097

Full 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
investors@bdtx.com

For Media:
Kathy Vincent
(310) 403-8951
media@bdtx.com

FAQ

What is the MasterKey-01 trial for BDTX?

The MasterKey-01 trial is a Phase 1/2 clinical study evaluating BDTX-189, targeting oncogenic mutations in advanced solid tumors.

When will the pharmacokinetic data for BDTX-189 be presented?

The pharmacokinetic data will be discussed during a webcast on May 19, 2021, and at the ASCO Annual Meeting on June 4, 2021.

What are the implications of BDTX-189's Fast Track designation?

Fast Track designation indicates that BDTX-189 could expedite its development and review process due to the unmet medical need it addresses.

What is the focus of BDTX-189 in cancer treatment?

BDTX-189 aims to inhibit specific mutations in the EGFR and HER2 proteins across various tumor types, enhancing treatment options.