IDEAYA Biosciences (NASDAQ:IDYA), Inc., a clinical-stage biopharmaceutical company, announced today a significant update on the clinical progress of its investigational drug, IDE397. The drug is currently in a Phase 2 trial for patients with MTAP-deletion urothelial cancer and non-small cell lung cancer (NSCLC).
The interim data from the Phase 2 study showed that IDE397, a potent and selective inhibitor targeting the enzyme MAT2A, demonstrated preliminary clinical efficacy and a favorable safety profile.
Out of 18 patients treated with a once-a-day 30 mg dose, the overall response rate was approximately 39%, including one complete response and six partial responses as evaluated by RECIST 1.1 criteria. Furthermore, a disease control rate of 94% was observed, which encompasses stable disease in addition to the responses.
The patients in the study had been heavily pre-treated, with a median of two prior lines of therapy. Eleven patients are still on treatment, and the median duration of treatment, response, and progression-free survival have not yet been reached.
The safety profile of IDE397 was also encouraging, with only 5.6% of patients experiencing Grade 3 or higher drug-related adverse events, and no serious adverse events were reported. Importantly, no drug-related adverse events led to treatment discontinuation.
Additionally, IDEAYA reported a circulating tumor DNA (ctDNA) molecular response rate of 81%, indicating a significant reduction in tumor DNA for the majority of patients evaluated.
The company highlighted the unmet medical need for FDA-approved therapies for patients with MTAP-deletion solid tumors. MTAP-deletion is prevalent in over 15% of NSCLC and over 25% of urothelial cancer cases. IDEAYA estimates that approximately 48,000 patients are affected annually by MTAP-deletion in the U.S. alone.
IDEAYA has over 35 clinical trial sites activated globally and is also collaborating with Amgen (NASDAQ:AMGN) on a Phase 1/2 trial combining IDE397 with AMG 193 for MTAP-Deletion NSCLC. The companies plan to develop a joint publication strategy in 2024.
The company is also initiating a Phase 1 trial to evaluate IDE397 in combination with Trodelvy and is advancing preclinical programs to enable further combinations with IDE397, targeting a development candidate nomination in the second half of 2024.
This update is based on a press release statement and reflects the company's commitment to addressing the needs of patients with limited treatment options. The information presented here is derived directly from the company's SEC filing.
In other recent news, IDEAYA Biosciences announced the voluntary resignation of its Chief Legal Officer and Secretary, Jason Throne, effective July 11, 2024. The pharmaceutical company has not yet named a successor, but assures that Throne's departure will not impact its operations or strategic direction.
In the realm of clinical development, IDEAYA advanced its drug, IDE397, into Phase 2 for treating MTAP-deletion cancers, activating over 35 clinical trial sites globally. Stifel raised IDEAYA's target to $63 in response to promising results from darovasertib monotherapy trials, which showed potential in preserving eyesight in patients.
The company reported a first-quarter earnings per share of $1.49 and revenue of $1.16 billion, exceeding analyst estimates. Daniel A. Simon, a veteran in life sciences and strategy consulting, was appointed as the new Chief Business Officer.
Finally, IDEAYA was selected for an oral presentation at the American Society of Clinical Oncology Annual Meeting, where interim results for darovasertib will be shared. These are among the recent developments at IDEAYA Biosciences.
InvestingPro Insights
As IDEAYA Biosciences continues to advance its clinical trials, investors and stakeholders may find the financial health and market sentiment around the company to be of particular interest. According to InvestingPro data, IDEAYA Biosciences holds a market capitalization of $2.59 billion, reflecting the market's valuation of the company. Despite challenging market conditions, the company has demonstrated a strong return over the last year, with a price total return of 50.26%. This suggests a positive investor outlook on the company's potential, even as analysts have revised earnings downwards and anticipate a sales decline in the current year.
Two key InvestingPro Tips highlight that IDEAYA holds more cash than debt on its balance sheet and that liquid assets exceed short-term obligations, providing the company with a solid financial footing to support its ongoing clinical trials. However, with a negative gross profit margin over the last twelve months and an expected drop in net income, the financial performance of IDEAYA Biosciences will be critical to watch in the upcoming periods. For investors seeking deeper insights, there are 6 additional tips available on InvestingPro that could inform investment decisions. To access these insights, consider subscribing with the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription.
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