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IDEAYA Biosciences, Inc. (NASDAQ: IDYA) is an innovative biotechnology firm concentrated on oncology. Established in 2015 and headquartered in South San Francisco and La Jolla, California, the company is dedicated to the discovery and development of precision medicine therapies for genetically defined patient groups. Their focus areas include synthetic lethality and immuno-oncology, targeting DNA damage repair mechanisms and the tumor microenvironment, respectively.
IDEAYA's pioneering approach leverages molecular diagnostics to identify and develop targeted therapeutics. The company's leading product candidate, IDE196, is a potent inhibitor of protein kinase C (PKC), aimed at treating cancers with GNAQ or GNA11 mutations. In addition, IDEAYA is advancing several clinical programs, such as the darovasertib program, which is currently in Phase 2 trials for uveal melanoma (UM) and has shown promising results in tumor shrinkage and eye preservation.
In synthetic lethality, IDEAYA's IDE397 targets methionine adenosyltransferase 2 alpha (MAT2A) in solid tumors with MTAP deletion, a condition prevalent in 15% of solid tumors. The IDE397 program includes both monotherapy and combination trials with other investigational drugs.
Financially, IDEAYA is robust with cash reserves exceeding $941.4 million as of Q1 2024, ensuring operational funding through 2028. Key investors include 5AM Ventures, Canaan Partners, and Celgene. The company has formed strategic collaborations with major pharmaceutical players like Pfizer, Amgen, Gilead Sciences, GSK, and Merck to amplify its research and clinical capabilities.
IDEAYA's scientific advisory board is composed of esteemed researchers, including a Nobel laureate and members of the National Academy of Sciences, underscoring the company's commitment to groundbreaking research.
Recent developments are promising: IDEAYA reported favorable Phase 2 trial results for IDE196 in UM, with significant tumor reduction and eye preservation rates. Additionally, a collaboration with Merck for the IDE161 program aims to tackle endometrial cancer using advanced immunotherapy combinations.
For more detailed updates and financial information, visit IDEAYA's Investor Relations page.
IDEAYA Biosciences reported a strong cash position of approximately $373.1 million as of December 31, 2022, sufficient to fund operations into 2026. The company is advancing its lead program, darovasertib, targeting ocular melanoma, with regulatory updates anticipated after a Q1 2023 FDA meeting. Clinical updates for darovasertib are expected mid-year 2023, aiming for an overall response rate >20% and a median progression-free survival >5 months. IDEAYA also plans IND submissions for IDE161 and Pol Theta Helicase candidates in 2023, alongside collaborations with GSK and Amgen to expand its pipeline.
IDEAYA Biosciences (NASDAQ: IDYA) announced its participation in two key investor conferences in March 2023. The first is the Oppenheimer 33rd Annual Healthcare Conference on March 14, where CSO Michael White and CMO Darrin Beaupre will engage in a fireside chat. The second is the Guggenheim 4th Annual Healthy Altitudes Summit on March 15, featuring CEO Yujiro S. Hata. Live audio webcasts will be available on IDEAYA's website, with replays accessible for 30 days post-event. The company is committed to developing targeted therapeutics using molecular diagnostics, focusing on synthetic lethality in oncology.
IDEAYA Biosciences (NASDAQ: IDYA), a precision medicine oncology company, will participate in Citi's 2023 Virtual Oncology Leadership Summit on February 21, 2023, at 9:00 AM ET. The event features a fireside chat with President and CEO Yujiro S. Hata, hosted by Dr. Yigal D. Nochomovitz. Investors can access a live audio webcast via IDEAYA's website, with a replay available for 30 days after the event.
IDEAYA focuses on synthetic lethality and targeted therapeutics, using molecular diagnostics to identify patient populations that benefit from its innovative therapies. The company is dedicated to advancing precision medicine in oncology.
IDEAYA Biosciences, Inc. (NASDAQ: IDYA) announced its participation in the 2023 Guggenheim Oncology Conference, scheduled for February 9, 2023, at 7:45 AM PT. The event will feature a fireside chat with President and CEO Yujiro S. Hata and Chief Scientific Officer Michael White, hosted by equity research analyst Charles Zhu, Ph.D. A live audio webcast of the discussion will be available on IDEAYA's website, with a replay accessible for 30 days post-event. IDEAYA focuses on synthetic lethality and precision medicine, developing targeted therapeutics based on molecular diagnostics to enhance treatment efficacy for selected patient populations.
IDEAYA Biosciences has initiated a Phase 2 clinical trial to evaluate darovasertib as a neoadjuvant treatment for uveal melanoma (UM) before primary therapies like enucleation or radiation. The study focuses on eye preservation, reduced radiation, and functional vision. With an annual incidence of about 8,700 cases in the US and EU, UM presents a significant unmet medical need. The trial protocol allows for darovasertib treatment for up to six months, followed by primary treatment and adjuvant therapy. Clinical data updates, particularly on darovasertib combined with crizotinib for metastatic UM, are anticipated in 2023.
IDEAYA Biosciences announced FDA clearance for its IND application, enabling the Phase 1 clinical trial of IDE161, a novel PARG inhibitor for tumors with homologous recombination deficiencies (HRD), particularly in breast and ovarian cancer patients with BRCA mutations. Dosing is set to commence in Q1 2023, starting at half the estimated efficacious dose from preclinical studies. The trial focuses on ER+/Her2- breast cancer, constituting 10-14% of cases. IDEAYA will present IDE161's profile at the J.P. Morgan Healthcare Conference on January 10, 2023.
IDEAYA Biosciences (NASDAQ: IDYA) announced its participation in the 41st Annual J.P. Morgan Healthcare Conference on January 10, 2023. The event will feature a presentation by CEO Yujiro S. Hata at 4:30 pm PT (7:30 pm ET), followed by a Q&A session hosted by Anupam Rama. Investors can access a live audio webcast on IDEAYA's website, with a replay available for 30 days post-event. IDEAYA is focused on precision medicine and developing targeted therapeutics using molecular diagnostics, emphasizing synthetic lethality in oncology.
IDEAYA Biosciences (Nasdaq: IDYA) has appointed Dr. Karlene Cimprich and Dr. Kornelia Polyak to its Scientific Advisory Board. Dr. Cimprich, from Stanford University, specializes in replication stress mechanisms and DNA damage repair pathways relevant to cancer therapeutics. Dr. Polyak, from Dana-Farber Cancer Institute, focuses on breast cancer biology and clinical management. This expansion aims to enhance IDEAYA's expertise in synthetic lethality and advance its precision medicine oncology pipeline, particularly the clinical evaluation of IDE161, a potential first-in-class PARG inhibitor.
IDEAYA Biosciences has submitted an Investigational New Drug (IND) application to the FDA for IDE161, a potential first-in-class PARG inhibitor targeting homologous recombination deficiency in BRCA1/2-mutant breast and ovarian cancers. This submission marks a significant milestone in IDEAYA's approach to addressing the unmet medical need for patients resistant to current PARP inhibitors. The proposed clinical development plan will be discussed in an Investor R&D Day webcast on December 12, 2022.
IDEAYA Biosciences (NASDAQ: IDYA) has received Fast Track designation from the U.S. FDA for its combination therapy of darovasertib and crizotinib aimed at treating metastatic uveal melanoma (MUM). This designation facilitates an expedited regulatory process, enhancing the potential for accelerated approval. The company plans to initiate a Phase 2/3 trial in Q1 2023, pending FDA guidance. Darovasertib is also recognized as an Orphan Drug, offering IDEAYA various incentives such as tax credits and marketing exclusivity. An Investor R&D Day is scheduled for December 12, 2022.
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