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

A phase 1/2, open-label study of oral S241656 (BDTX-4933) as monotherapy and in combination with other anti-cancer therapies in patients with KRAS, BRAF and other selected RAS/MAPK mutation positive malignancies. (ASCO-GI 2026) - P1/2 | "Funded by Servier Clinical Trial Registration Number: NCT05786924 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Clinical • Combination therapy • Monotherapy • P1/2 data • Gastrointestinal Cancer • Oncology • BRAF • KRAS

BDTX-4933-101: Phase 1/2 Trial of S241656 in Selected RAS/MAPK Mutation- Positive Malignancies (clinicaltrials.gov) - P1/2 | N=554 | Recruiting | Sponsor: Institut de Recherches Internationales Servier | Phase classification: P1 ➔ P1/2 | N=100 ➔ 554 | Trial completion date: Dec 2026 ➔ Jun 2028 | Trial primary completion date: Jun 2026 ➔ Jun 2028

Enrollment change • Monotherapy • Phase classification • Trial completion date • Trial primary completion date • Brain Cancer • Colorectal Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Thyroid Gland Carcinoma • BRAF • KRAS • NRAS

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 | Recruiting | Sponsor: Institut de Recherches Internationales Servier | Active, not recruiting ➔ Recruiting

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

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