Black Diamond Therapeutics, Inc. is focused on developing innovative cancer therapies through its MasterKey approach, which aims to address a wide range of genetically defined patient populations. This approach is particularly significant as it seeks to overcome resistance mechanisms that often limit the effectiveness of current targeted therapies, which typically focus on a narrow subset of oncogenic mutations. By creating therapies that are designed to be brain-penetrant, Black Diamond targets complex conditions such as non-small cell lung cancer (NSCLC) and glioblastoma (GBM), thereby enhancing treatment options for patients suffering from these aggressive cancers.

The company's pipeline includes several promising candidates, such as BDTX-1535, which is being developed for various stages of NSCLC and GBM, and BDTX-4933, aimed at RAF/RAS-mutant solid tumors. These candidates are currently in various stages of clinical development, with BDTX-1535 showing significant progress in Phase 1 and Phase 2 trials. Black Diamond's commitment to addressing the challenges of cancer treatment is further exemplified by its focus on minimizing wild-type mediated toxicities, thereby improving the overall safety and efficacy of its therapies for patients.

United States

Black Diamond targets undrugged mutations in patients with genetically defined cancers for whom limited treatment options currently exist. Black Diamond is built upon a deep understanding of cancer genetics, protein structure and function, and medicinal chemistry.

Cancer

Lung Diseases

Black Diamond Therapeutics, Inc.

Non-small cell lung carcinoma

BDTX-1535 is designed as an irreversible, mutant selective, brain-penetrant MasterKey inhibitor of oncogenic mutations of epidermal growth factor receptor (EGFR) expressed in glioblastoma multiforme (GBM) and intrinsic and acquired resistance EGFR mutations in non-small cell lung cancer (NSCLC). In pre-clinical studies, Black Diamond has demonstrated that oncogenic alterations of EGFR, particularly those associated with GBM, result in distinct conformations which impart unique pharmacology and drug resistance. It is estimated that approximately 50% of GBM patients harbor an oncogenic EGFR alteration that has the potential to be addressed by BDTX-1535, representing a potential patient population of greater than 60,000 patients annually across the US, EU, Japan and China. It is estimated that across the US, EU, Japan and China there are approximately 20,000 patients who are diagnosed annually with non-small cell lung cancer (NSCLC) harboring an EGFR intrinsic or acquired resistance mutation.

BDTX-1535

Glioblastoma

BDTX-4933 is designed as a brain-penetrant, small molecule MasterKey reversible oral inhibitor of oncogenic BRAF Class I, II and III active RAF dimers promoted by upstream oncogenic alterations expressed by human cancers, while also avoiding paradoxical activation.

BDTX-4933

Solid tumor/s

<ul class="font_7">
 <li>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.</li>
 <li>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.</li>
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Black Diamond Therapeutics, Inc.

Company Details