FDA clears IDEAYA’s Phase 1 trial for new cancer drug

SOUTH SAN FRANCISCO - IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a $1.79 billion market cap company specializing in precision medicine oncology, has received U.S. Food and Drug Administration (FDA) clearance for a Phase 1 clinical trial of its investigational drug IDE849. According to InvestingPro data, the company maintains a strong financial position with more cash than debt on its balance sheet, positioning it well for clinical development activities. This trial is set to evaluate the drug’s efficacy in treating several types of solid tumors, including small cell lung cancer (SCLC) and neuroendocrine tumors (NETs).

IDE849 is described as a potential first-in-class delta-like ligand 3 (DLL3)-targeting Topoisomerase I (TOP1) payload antibody drug conjugate (ADC). DLL3 expression is typically upregulated in various solid tumor types, making it a promising target for cancer therapy. The drug’s development aims to address the significant unmet medical needs for these conditions. With a robust current ratio of 14.97x and analysts anticipating sales growth, IDEAYA appears well-positioned to advance its clinical programs. For deeper insights into IDEAYA’s financial health and growth prospects, investors can access the comprehensive Pro Research Report available on InvestingPro.

The clearance follows promising preliminary results from an ongoing multi-site open label Phase 1 clinical trial conducted by Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276), where IDE849 has shown multiple partial responses at therapeutic dose levels. Treatment-related adverse events (TRAEs) were predominantly Grade 1 or 2, with no drug-related discontinuations reported, and the maximum tolerated dose has not been reached as of the data cut-off date of December 10, 2024.

Hengrui Pharma plans to present clinical efficacy and safety data from the trial involving over 40 SCLC patients at a medical conference in Q3 2025. The presentation will cover findings from both the dose escalation phase and multiple expansion doses.

Additionally, IDEAYA aims to showcase preclinical data on the combined use of IDE849 with its Phase 1 PARG inhibitor IDE161, which has shown potential for enhanced durability and combination synergy in preclinical studies. The company will present this data at a medical conference in the third quarter of 2025.

IDEAYA is also targeting to evaluate IDE849 as a monotherapy in a global clinical trial for various DLL3 upregulated solid tumor types and in combination with IDE161 in the second half of 2025.

The company emphasizes that the forward-looking statements in the press release involve risks and uncertainties that could affect the actual results of IDEAYA’s drug development programs. These statements are not guarantees of future performance and are subject to the inherent uncertainties of the drug development process. Based on InvestingPro’s Fair Value analysis, IDEAYA’s stock is currently trading near its Fair Value, with analysts setting price targets ranging from $27 to $65 per share. The company’s next earnings report is scheduled for May 13, 2025.

The information for this report is based on a press release statement from IDEAYA Biosciences.

In other recent news, IDEAYA Biosciences has made significant advancements in its Phase 3 clinical trial for darovasertib as a neoadjuvant therapy for primary uveal melanoma. The trial, which follows a successful FDA Type D meeting, aims to evaluate the drug’s safety and efficacy, focusing on eye preservation and visual acuity maintenance. IDEAYA Biosciences is conducting the trial with approximately 520 patients divided into two cohorts, with primary endpoints including eye preservation rates and visual acuity outcomes. Additionally, the company announced a change in its Board of Directors, with Dr. Susan L. Kelley deciding not to seek re-election at the 2025 annual meeting. Dr. Kelley will transition to serve as Chair of IDEAYA’s newly formed Clinical Advisory Board. Furthermore, IDEAYA Biosciences has appointed Joshua Bleharski, Ph.D., as its new Chief Financial Officer, effective early May 2025. Dr. Bleharski brings extensive experience from his previous role at J.P. Morgan, where he served as Managing Director and Global Co-Head of Biopharma. These developments reflect IDEAYA’s ongoing efforts in research, governance, and executive leadership.

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