BDTX-4933 / Black Diamond Therap, Servier - LARVOL DELTA

Servier and Black Diamond Therapeutics Announce Global Licensing Agreement for BDTX-4933, A Targeted Oncology Therapy (GlobeNewswire) - "Servier...and Black Diamond Therapeutics...announced a strategic worldwide licensing agreement for BDTX-4933, a potential best-in-class targeted therapy for solid tumors. Under this global agreement, Servier will develop and commercialize BDTX-4933, a small molecule designed by Black Diamond Therapeutics to address unmet medical needs in RAF/RAS-mutant solid tumors....Black Diamond will receive an upfront payment of $70 million and up to $710 million in development and commercial sales milestone payments plus royalties."

Licensing / partnership • Solid Tumor

BDTX-4933-101: A Study of BDTX-4933 in Patients With KRAS, BRAF and Select RAS/MAPK Mutation-Positive Cancers (clinicaltrials.gov) - P1 | N=100 | Active, not recruiting | Sponsor: Black Diamond Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Brain Cancer • Colorectal Cancer • Endocrine Cancer • Gastrointestinal Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Thyroid Gland Carcinoma • BRAF • KRAS • NRAS

Black Diamond Therapeutics Announces Restructuring Plan to Focus Resources on BDTX-1535 and Extend Cash Runway (GlobeNewswire) - "Black Diamond Therapeutics...announced today a corporate restructuring to focus resources on advancing lead program BDTX-1535 into pivotal development, and to extend the Company’s expected cash runway into Q2 2026....In Q1 2025, Black Diamond anticipates sharing initial Phase 2 data for BDTX-1535 in the frontline setting for patients with EGFRm NSCLC. Also in Q1 2025, the Company plans to present updated Phase 2 results for BDTX-1535 in patients with recurrent EGFRm NSCLC and a potential registration path in the recurrent setting based on feedback from the FDA. Black Diamond is actively seeking partnerships as it deprioritizes its BDTX-4933 program in RAF/RAS-mutant solid tumors."

P2 data • Pipeline update • Non Small Cell Lung Cancer

Black Diamond Therapeutics Reports Second Quarter 2024 Financial Results and Provides Corporate Update (GlobeNewswire) - "BDTX-4933: Enrollment of patients with BRAF and select RAS/MAPK mutation-positive cancers, with an emphasis on patients with KRAS mutant NSCLC, is progressing through escalating doses in a Phase 1 trial...An update from this trial is on track for Q4 2024."

Enrollment status • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Black Diamond Therapeutics Reports First Quarter 2024 Financial Results and Provides Corporate Update (GlobeNewswire) - "Enrollment of patients with BRAF and select RAS/MAPK mutation-positive cancers, with an emphasis on patients with KRAS mutant NSCLC is ongoing in a Phase 1 dose escalation trial of BDTX-4933, a brain-penetrant oral inhibitor of oncogenic alterations in KRAS, NRAS and BRAF...An update from this trial is anticipated in Q4 2024."

P1 data • Trial status • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Black Diamond Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update (GlobeNewswire) - "BDTX-4933: A Phase 1 clinical trial for BDTX-4933 was initiated in the second quarter of 2023 in patients with BRAF and select RAS/MAPK mutation-positive cancers, with an emphasis on patients with KRAS mutant NSCLC. The trial is currently in dose escalation with an update anticipated in the fourth quarter of 2024."

P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Black Diamond Therapeutics Announces Corporate Update and Expected 2024 Milestones (GlobeNewswire) - "BDTX-1535 in patients with Epidermal Growth Factor Receptor (EGFR) mutant Non-Small Cell Lung Cancer (NSCLC)...Phase 2 data in second/third-line patients with EGFR mutant NSCLC are expected in the third quarter of 2024. The Company intends to discuss Phase 2 results with the U.S. Food and Drug Administration (FDA) to finalize a pivotal clinical trial design....BDTX-4933 in patients with KRAS mutant NSCLC: Enrollment in a Phase 1 trial began in September 2023 in patients with KRAS mutant NSCLC. Results from this trial are anticipated in the fourth quarter of 2024."

P1 data • P2 data • Non Small Cell Lung Cancer

Black Diamond Therapeutics Reports Third Quarter 2023 Financial Results and Provides Corporate Update (GlobeNewswire) - "Black Diamond anticipates the following upcoming key milestones for BDTX-1535...Initial results from an investigator sponsored 'window of opportunity' trial in patients with GBM in the second quarter of 2024...A Phase 1 clinical trial for BDTX-4933 was initiated in the second quarter of 2023 in patients with BRAF and select RAS/MAPK mutation-positive cancers, with an emphasis on patients with KRAS mutant NSCLC. The trial is currently in dose escalation (NCT05786924)....Research and Development Expenses: Research and development (R&D) expenses were $16.2 million for the third quarter of 2023, compared to $15.8 million for the same period in 2022. The increase in R&D expenses was primarily due to the advancement of the Company’s pipeline programs, BDTX-1535 and BDTX-4933."

Commercial • P1 data • Trial status • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Black Diamond Therapeutics Presents Dose Escalation Data Demonstrating Durable Responses in Patients with NSCLC from Phase 1 Trial of BDTX-1535 (GlobeNewswire) - "Black Diamond also presented...additional posters outlining the...preclinical data for BDTX-4933, a brain-penetrant MasterKey RAF inhibitor targeting KRAS, NRAS and BRAF alterations in solid tumors....BDTX-4933 demonstrated strong anti-tumor activity and regression across cell line and patient-derived xenograft models expressing several MAPK pathway mutations, including KRAS G12D, KRAS G12V, and KRAS G13C mutant NSCLC models. BDTX-4933 exhibited high central nervous system (CNS) exposure leading to dose-dependent tumor growth inhibition and survival benefit in mice implanted intracranially with xenograft BRAF mutant tumors."

Preclinical • Non Small Cell Lung Cancer

Black Diamond Therapeutics to Present Preclinical and Clinical Data at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics (GlobeNewswire) - "Black Diamond Therapeutics...announced forthcoming presentations during the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston, October 11-15, 2023. The three poster presentations include initial dose escalation data from the Company’s Phase 1 clinical trial of BDTX-1535 in non-small cell lung cancer (NSCLC), the study design of this ongoing Phase 1 clinical trial, and preclinical data for BDTX-4933."

Clinical protocol • P1 data • Preclinical • Glioblastoma • Non Small Cell Lung Cancer

Preclinical efficacy of BDTX-4933, a brain-penetrant, orthosteric RAF inhibitor, targeting oncogenic RAF conformation shared by groups of BRAF and upstream driver mutations. (AACR-NCI-EORTC 2023) - No abstract available

Preclinical • Oncology • BRAF

Black Diamond Therapeutics Reports Second Quarter 2023 Financial Results and Provides Corporate Update (GlobeNewswire) - "Black Diamond continues to leverage its Mutation-Allostery-Pharmacology (MAP) drug discovery engine to advance its discovery-stage pipeline to bring therapies to underserved patients and expects to progress another undisclosed program in solid tumors to development candidate nomination in 2023....Research and Development Expenses: Research and development (R&D) expenses were $13.2 million for the second quarter of 2023, compared to $16.2 million for the same period in 2022. The decrease in R&D expenses was primarily due to reduced clinical trial activities stemming from the discontinuation of the development of BDTX-189 to focus on advancement of the Company’s pipeline programs, BDTX-1535 and BDTX-4933."

Commercial • New molecule • Oncology • Solid Tumor

Black Diamond Therapeutics to Present at the Jefferies Healthcare Conference (GlobeNewswire) - "Black Diamond Therapeutics, Inc...announced that its President and Chief Executive Officer, David M. Epstein, Ph.D., will present an overview of the Company’s MasterKey programs, including BDTX-1535 and BDTX-4933, at the Jefferies Healthcare Conference on Friday, June 9, 2023, at 12:45 p.m. ET in New York, NY."

Clinical data • Oncology

A Study of BDTX-4933 in Patients With BRAF and Select RAS/MAPK Mutation-Positive Cancers (clinicaltrials.gov) - P1 | N=140 | Recruiting | Sponsor: Black Diamond Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Brain Cancer • Colorectal Cancer • Endocrine Cancer • Gastrointestinal Cancer • Glioma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Thyroid Gland Carcinoma • BRAF • KRAS • NRAS

Preclinical characterization of a brain penetrant RAF inhibitor, BDTX-4933, targeting oncogenic BRAF Class I/II/III and RAS mutations (AACR 2023) - "BDTX-4933 has a best-in-class profile to treat cancer patients harboring BRAF mutations or RAF dimer-promoting upstream genetic alterations. IND-enabling studies for BDTX-4933 are on-going."

Preclinical • Oncology • BRAF • KRAS • NRAS

Black Diamond Therapeutics Presents Trial in Progress Poster for BDTX-1535 and Preclinical Data on BDTX-1535 and BDTX-4933 at the 2023 American Association of Cancer Research Annual Meeting (GlobeNewswire) - "In a poster...Black Diamond outlined its approach to characterizing BRAF, RAS and MAPK pathway in addition to the design and preclinical development of BDTX-4933....In a panel of cancer cell lines that endogenously express BRAF or RAS mutations, BDTX-4933 demonstrated inhibition of the MAPK pathway signaling without paradoxical activation, resulting in potent inhibition of cellular proliferation. In tumor models in vivo, BDTX-4933 showed target engagement, inhibiting ERK phosphorylation, achieving strong anti-tumor activity and tumor regression across tumor models driven by either BRAF or RAS mutations....Black Diamond expects to initiate a Phase 1 clinical trial of BDTX-4933 in patients with tumors harboring all-class BRAF or RAS mutations in the second quarter of 2023."

Preclinical • Trial status • Oncology • Solid Tumor • BRAF • RAS

A Study of BDTX-4933 in Patients With BRAF and Select RAS/MAPK Mutation-Positive Cancers (clinicaltrials.gov) - P1 | N=140 | Not yet recruiting | Sponsor: Black Diamond Therapeutics, Inc.

New P1 trial • Brain Cancer • Colorectal Cancer • Endocrine Cancer • Gastrointestinal Cancer • Glioma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Thyroid Gland Carcinoma • BRAF • KRAS • NRAS

Black Diamond Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Update (GlobeNewswire) - "In April 2022, Black Diamond dosed the first patient in its Phase 1 global clinical trial of BDTX-1535 for the treatment of NSCLC, including in patients with brain metastases, and GBM. The dose-escalation portion of the Phase 1 clinical trial is actively recruiting and enrolling patients, and the Company remains on track to provide a clinical update on BDTX-1535 in the second half of 2023....The Company expects to initiate a Phase 1 clinical trial of BDTX-4933 in patients with tumors harboring all-class BRAF or RAS mutations in the first half of 2023."

New P1 trial • P1 data • Brain Cancer • CNS Tumor • Glioblastoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Black Diamond Therapeutics Announces Spinout of Launchpad Therapeutics, Inc., an Antibody-Focused Precision Oncology Company (GlobeNewswire) - "Black Diamond Therapeutics, Inc...today announced the formation of Launchpad Therapeutics, Inc. (Launchpad), an antibody-focused precision oncology company, together with a $30 million Series A investment by founding investors, Versant Ventures and New Enterprise Associates (NEA)....The spinout allows Black Diamond to continue our focus on BDTX-1535, BDTX-4933 and small molecule pipeline..."

Financing • Pipeline update • Oncology

Black Diamond Therapeutics Reports Third Quarter 2022 Financial Results and Provides Corporate Update (GlobeNewswire) - "BDTX-1535: The Company remains on track to provide a clinical update on BDTX-1535 in 2023; BDTX-4933: Black Diamond expects to submit an IND application for BDTX-4933 with the U.S. Food and Drug Administration (FDA) in the first half of 2023."

Clinical • IND • Brain Cancer • CNS Tumor • Glioblastoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Preclinical efficacy of BDTX-4933, a brain penetrant MasterKey inhibitor targeting oncogenic BRAF Class I/II/III mutations (AACR-NCI-EORTC 2022) - "BDTX-4933 achieves on-target inhibition of the RAF-MEK-ERK signaling pathway and anti-tumor activity in multiple preclinical tumor models, including intracranial models. IND-enabling studies for BDTX-4933 are underway."

Preclinical • Brain Cancer • CNS Tumor • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • BRAF

Black Diamond Therapeutics Presents Preclinical Data on BDTX-1535 and BDTX-4933 at the 34th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics (GlobeNewswire) - "Black Diamond Therapeutics...announced the presentation of three posters reporting new preclinical data on BDTX-1535 and BDTX-4933 at the 34th European Organisation for Research and Treatment of Cancer-National Cancer Institute-American Association for Cancer Research (EORTC-NCI-AACR) Symposium on Molecular Targets and Cancer Therapeutics....BDTX-1535 demonstrated potent systemic and CNS anti-tumor activity and survival benefit in multiple PDX models of GBM and NSCLC tumors driven by a family of EGFR alterations, including resistance mutations and EGFR amplification. BDTX-4933 is a MasterKey inhibitor of oncogenic isoforms of the RAF family, which demonstrated on-target cell growth inhibition in vitro and tumor growth regression in in vivo tumor models driven by oncogenic Class I, II and III BRAF alterations and NRAS mutations."

Preclinical • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • BRAF • EGFR • NRAS

Black Diamond Therapeutics Announces Pipeline Prioritization and Workforce Realignment (GlobeNewswire) - "Black Diamond Therapeutics...announced that it is realigning its resources to focus on key near-term value drivers and to extend its cash runway into the third quarter of 2024, supporting the execution of important clinical and preclinical milestones....Black Diamond has discontinued the development of BDTX-189 and realigned its workforce to focus on progressing its pipeline through important upcoming milestones for BDTX-1535, BDTX-4933 and discovery efforts....Black Diamond initiated investigational new drug (IND)-enabling studies in the first quarter of 2022 and expects to submit an IND for BDTX-4933 in the first half of 2023....Black Diamond anticipates announcing a development candidate for its FGFR program in 2022 in addition to disclosing a new small molecule development candidate in 2023."

Discontinued • IND • Pipeline update • Oncology

Black Diamond Therapeutics Presents Preclinical Data on BDTX-1535, BRAF, and FGFR Programs at the 33rd AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics (GlobeNewswire) - "BRAF Program: In cell-based assays, the lead compound demonstrated potent inhibition of a spectrum of Class II/III BRAF mutations....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."

IND • Preclinical • Oncology