SOUTH SAN FRANCISCO, Calif. - IDEAYA Biosciences, Inc. (NASDAQ:IDYA) announced positive interim Phase 1 expansion data for its investigational drug IDE397, targeting MTAP-deletion urothelial cancer (UC) and non-small cell lung cancer (NSCLC). The data, presented as a late breaker at the EORTC-NCI-AACR Symposium in Barcelona, Spain, showed a ~33% overall response rate (ORR) in heavily pre-treated patients.
The study evaluated 27 patients with a median of 2 to 3 prior lines of therapy. Results indicated a 40% confirmed ORR in MTAP-deletion UC and approximately 38% in squamous NSCLC. Additionally, the drug demonstrated a high disease control rate of 93% with no drug-related serious adverse events or discontinuations at the 30mg daily dose.
According to Dr. Benjamin Herzberg, M.D., Assistant Professor of Medicine at Columbia University, the clinical efficacy and manageable safety profile support the potential for combination development. Chief Medical Officer Darrin M. Beaupre, M.D., Ph.D., highlighted the high disease control rate and confirmed RECIST responses, emphasizing the drug's manageable adverse event profile.
IDEAYA plans to expand the Phase 1/2 study of IDE397 in combination with Trodelvy® in MTAP-deletion UC in the fourth quarter of 2024. A patient case study of a partial response by RECIST 1.1 and a rapid >95% ctDNA reduction of the combination will be presented at ENA 2024.
The company has activated over 35 clinical trial sites worldwide and is collaborating with Gilead (NASDAQ:GILD) for the supply of Trodelvy. The IDE397 monotherapy or in combination with Trodelvy has not been approved by any regulatory agency, and its efficacy and safety are not yet established.
This announcement comes at a critical time, as there are currently no FDA-approved therapies for patients with MTAP-deletion solid tumors, highlighting the urgent need for effective treatments. The annual incidence of MTAP-deletion in UC and NSCLC in the U.S. is estimated at approximately 48,000 patients.
The information presented is based on a press release statement and reflects interim data subject to further review and confirmation.
In other recent news, Ideaya Biosciences has been the focus of analysts' attention due to promising developments in its drug candidates. UBS initiated coverage on the company with a Buy rating, emphasizing the potential of its leading drug candidate, darovasertib, to significantly impact the treatment of uveal melanoma. The firm suggested that darovasertib could achieve peak sales of approximately $1.3 billion, surpassing the consensus estimate of around $800 million.
Cantor Fitzgerald also initiated coverage on Ideaya Biosciences with an Overweight rating, highlighting the potential of the company's leading drug candidates in targeted oncology. Goldman Sachs (NYSE:GS) reaffirmed their Buy rating on Ideaya Biosciences, estimating peak sales for darovasertib to reach $3.0 billion, an increase from the previous forecast of $2.6 billion.
Mizuho Securities maintained its Outperform rating on Ideaya Biosciences, adjusting the probability of success for darovasertib from 50% to 60% and reflecting increased confidence in the drug's prospects. RBC Capital also maintained its Outperform rating, expressing confidence in the drug's commercial potential for neoadjuvant uveal melanoma.
In addition to these analyst notes, Ideaya Biosciences presented Phase 1 expansion results of its drug candidate IDE397 at the EORTC-NCI-AACR Symposium. The company recently made significant strides in oncology drug development, with its leading drug candidates, darovasertib and IDE397, showing promising results in clinical trials. These are the recent developments in Ideaya Biosciences.
InvestingPro Insights
IDEAYA Biosciences' positive interim Phase 1 expansion data for IDE397 comes at a crucial time for the company, as reflected in recent financial metrics and analyst projections. According to InvestingPro data, IDEAYA has a market capitalization of $2.47 billion, indicating significant investor interest in its potential.
Despite the promising clinical results, InvestingPro Tips highlight some financial challenges. The company is not profitable over the last twelve months, and analysts anticipate a sales decline in the current year. This aligns with the reported revenue of $11.96 million in the last twelve months, representing a substantial revenue decline of 73.51%.
However, it's important to note that IDEAYA holds more cash than debt on its balance sheet, which could provide financial flexibility as it advances its clinical programs. This strong cash position is particularly crucial for biotechnology companies in the development stage, as it can support ongoing research and clinical trials.
The company's focus on unmet medical needs, such as MTAP-deletion solid tumors, is reflected in its high revenue valuation multiple. This suggests that investors are pricing in future growth potential based on the company's pipeline, including IDE397.
For investors seeking a more comprehensive analysis, InvestingPro offers 10 additional tips for IDEAYA Biosciences, providing a deeper understanding of the company's financial health and market position.
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