BDTX - Black Diamond Therapeutics jumps 79% after data for lung cancer therapy

2023-06-27 10:40:21 ET

Black Diamond Therapeutics ( NASDAQ: BDTX ) gained ~79% in the morning hours Tuesday after the company announced early-stage data for its lead asset, BDTX-1535, from a Phase 1 trial for patients with lung cancer.

Citing dose-escalation data from the trial, Black Diamond ( BDTX ) of Cambridge, Massachusetts, said that BDTX-1535 indicated its proof of activity in patients with non-small cell lung cancer whose tumors harbor EGFR gene mutations.

As of May 20, the trial involved 51 patients with EGFR-positive NSCLC and brain cancer glioblastoma multiforme (GBM) who had received BDTX-1535, an epidermal growth factor receptor (EGFR) inhibitor, across seven dose levels.

While there were no dose-limiting toxicities at 15-200 mg QD doses, one out of 15 treated at the 300 mg QD dose and five out of 12 treated at the 400 mg QD dose experienced dose-limiting toxicities.

Citing a June readout focused on NSCLC patients who had undergone a median of two prior therapies, Black Diamond ( BDTX ) said that five out of 12 indicated a radiographically confirmed partial response (PR). One patient had an unconfirmed PR, while the remaining six had stable disease.

The company plans to start enrollments to evaluate 200 mg QD of BDTX-1535 in two expansion cohorts of NSCLC as a late-line option and intends to meet the FDA in late 2023 before starting further studies on additional doses. Phase 1 dose escalation data from recurrent GBM patients are expected in Q4 2023.

More on Black Diamond

• Black Diamond rises 8% on spinout of Launchpad Therapeutics
• Black Diamond Therapeutics: Selling For Large Discount To Cash

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