CAMBRIDGE, Mass. - Black Diamond Therapeutics, Inc. (NASDAQ:BDTX), a clinical-stage oncology company, has reported initial Phase 2 data for its drug candidate BDTX-1535, showing promising clinical responses in patients with relapsed/refractory EGFR-mutant non-small cell lung cancer (NSCLC). The study found a favorable tolerability profile and preliminary objective response rate (ORR) of 42% in patients treated with a 200 mg daily dose.
The trial, which began in August 2023, included patients with non-classical EGFR mutations and those with C797S resistance mutations. The dose selection for pivotal clinical development was based on safety, tolerability, and pharmacokinetics data from 40 patients who received either 100 mg or 200 mg doses. The majority of adverse events were mild or moderate, with the most common being rash and diarrhea.
The preliminary ORR of 42% was observed in 19 patients at the 200 mg dose level, with eight achieving a response: five with a confirmed partial response and three with an unconfirmed partial response. Additionally, nine patients experienced stable disease. For the first three patients with a partial response, the duration of response was approximately eight months or more, and 14 of the 19 patients remain on treatment.
Black Diamond's Chief Medical Officer, Sergey Yurasov, M.D., highlighted the potential of BDTX-1535 to deliver durable responses for patients resistant to the current standard of care, osimertinib. Danny Nguyen, M.D., from the City of Hope, emphasized the significant unmet medical need for an effective oral therapy for this patient population.
The company anticipates regulatory feedback on the registration path for BDTX-1535 in the first quarter of 2025. Initial results for first-line NSCLC patients with non-classical EGFR mutations are also expected in the same timeframe.
BDTX-1535 is described as a brain-penetrant MasterKey inhibitor of oncogenic EGFR mutations, including those resistant to previous treatments. Black Diamond continues to enroll patients in various trial cohorts and is advancing another clinical-stage program, BDTX-4933, targeting solid tumors.
The information in this article is based on a press release statement from Black Diamond Therapeutics.
In other recent news, Black Diamond Therapeutics continues to make strides in the oncology therapeutics space. The company recently presented data on treatment outcomes for patients with non-small cell lung cancer (NSCLC) at the European Society for Medical Oncology conference. Analyst firms H.C. Wainwright and Piper Sandler have maintained their Buy and Overweight ratings on Black Diamond Therapeutics, respectively, despite some adjustments in their price targets due to operating expenses.
Black Diamond Therapeutics' drug candidate, BDTX-1535, is gaining significant attention for its potential in treating non-classical EGFR mutations. Both H.C. Wainwright and Piper Sandler have expressed confidence in the drug's potential, with the latter firm highlighting an expected objective response rate (ORR) of 30-40% for the upcoming third-quarter 2024 readout.
These recent developments further underscore Black Diamond Therapeutics' dedication to addressing unmet needs in oncology. The company has also announced the appointment of Shannon Campbell and Prakash Raman, Ph.D., to its Board of Directors, signaling its continuous efforts to advance clinical trials. As the company progresses, all eyes are on the upcoming Phase II data for BDTX-1535, which is expected to provide further insights into the drug's efficacy.
InvestingPro Insights
As Black Diamond Therapeutics (NASDAQ:BDTX) makes headway with its clinical trials for BDTX-1535, the market is watching closely. The company's financial health and stock performance provide additional context for investors considering the potential of its oncology pipeline. With a market capitalization of approximately $268.96 million, Black Diamond is navigating the biotech landscape with strategic focus.
From the perspective of financial metrics, the company's balance sheet reflects a cautious optimism. Black Diamond holds more cash than debt, which is a positive sign for its ability to fund ongoing research and development without the immediate need for external financing. However, the company is not without its challenges. It's quickly burning through cash, and analysts do not expect the company to be profitable this year. These factors underscore the high-risk, high-reward nature of biotech investing.
Investors should note that the stock has experienced significant volatility, with a 1-month price total return showing a decrease of 26.32%. Despite this, the year-to-date price total return paints a brighter picture with a substantial increase of 69.4%. This volatility is a reminder of the inherent uncertainties in the biotech sector, especially for clinical-stage companies like Black Diamond.
For those seeking a deeper dive into Black Diamond's financials and stock performance, InvestingPro offers additional insights. Currently, there are 11 more InvestingPro Tips available for BDTX, including analyst earnings revisions and assessments of the company's profitability. These tips can provide valuable guidance for investors looking to make informed decisions about Black Diamond's prospects.
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