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Business Wire
01-05-2025
- Business
- Business Wire
Crown Bioscience and NEXT Oncology Cement Partnership Extension
SAN DIEGO--(BUSINESS WIRE)--Crown Bioscience, a global contract research organization (CRO) headquartered in the United States and part of JSR Life Sciences and Japan-based JSR Corporation, is pleased to announce the extension of its partnership with NEXT Oncology, one of the world's largest Phase I Oncology Clinical Trial networks. This strategic partnership will continue to leverage Crown Bioscience's extensive experience in developing clinically relevant cancer organoid and patient-derived xenograft (PDX) models, together with NEXT Oncology's global clinical network and Phase I clinical trials expertise. Crown Bioscience and NEXT Oncology Cement Partnership Extension Share Through this extended agreement, Crown Bioscience reaffirms its exclusive rights to provide services based on patient samples sourced from NEXT Oncology's industry-leading global clinical trial network. This collaboration underscores Crown Bioscience's commitment to providing the most clinically relevant PDX and organoid models and solutions for translational oncology research. "We are thrilled to continue our exclusive partnership with NEXT Oncology," said John Gu, CEO of Crown Bioscience. "NEXT Oncology is globally recognized for its pioneering work in Phase I clinical oncology trials. Extending this partnership allows us to broaden our portfolio and strengthen our position as a leader in translational oncology platforms and integrated solutions. Our combined expertise and global reach will ensure rapid and scalable access to groundbreaking cancer models for our biopharma partners." 'NEXT Oncology is excited to continue our strong partnership with Crown Bioscience,' said Dr. Anthony Tolcher, CEO of NEXT Oncology. 'Together, we will continue to develop new and highly relevant patient models that Crown's biopharma partners can utilize to advance their translational oncology programs. Our combined efforts continue to support both companies' missions to help cancer patients receive the most advanced medicines possible.' About Crown Bioscience Crown Bioscience, a JSR Life Sciences company, is a global contract research organization (CRO) dedicated to accelerating drug discovery and development in oncology and immuno-oncology. We partner with biotech and pharmaceutical companies to provide innovative, tailored solutions spanning preclinical research, translational platforms, and clinical trial support. With the world's largest commercially available patient-derived xenograft (PDX) collection and approximately 1,000 tumor organoid models powered by Hubrecht Organoid Technology, we offer unparalleled insights across 35 cancer indications. Our expertise spans in vivo, in vitro, ex vivo, and in silico methods, complemented by advanced laboratory services that span the entire drug development continuum. Additionally, our extensive biobank of liquid and human biospecimens, complete with clinical histories, enhances oncology research capabilities. Operating from 11 state-of-the-art facilities across the US, Europe, and APAC, our laboratories meet the highest industry standards, including accreditation by the College of American Pathologists (CAP) and the International Organization for Standardization (ISO). To learn more, visit About NEXT Oncology NEXT Oncology is dedicated to the development of new anticancer agents for patients whose current cancer therapy is no longer working to benefit them and are looking for their next option. NEXT Oncology is partnered with Texas Oncology, the largest private oncology practice in the United States with more than 400 referring medical oncologists. Texas Oncology is a practice within The US Oncology Network, a network of independent, community-based oncologists in the U.S. This formidable size and reach provide NEXT Oncology unprecedented opportunities to transform what has come to be expected from clinical trials of new agents.
Yahoo
10-03-2025
- Business
- Yahoo
Alterome Doses First Patient in Phase 1 Study of ALTA3263, a Novel Pan-KRAS Dual ON/OFF Inhibitor, in Advanced Solid Tumors
ALTA3263 is a potential best-in-class KRAS-selective small molecule inhibitor that potently targets >90% of KRAS mutations ALTA3263 is designed for complete KRAS target coverage, which will be required to achieve breakthrough efficacy and safety for patients with KRAS-driven cancers SAN DIEGO, March 10, 2025--(BUSINESS WIRE)--Alterome Therapeutics, Inc., a clinical-stage biopharmaceutical company pioneering the development of next-generation, small molecule targeted therapies for the treatment of cancer, today announced that the first patient has been dosed in the Phase 1/1b trial of ALTA3263 in adults with KRAS mutant solid tumors. ALTA3263 is an oral KRAS-selective inhibitor specifically designed to potently inhibit the KRAS "ON" (active) state of greater than 90% of all KRAS mutations and to provide complete target coverage in tumors. These properties have the potential to translate into best-in-class safety and efficacy. KRAS driver mutations are found in greater than 20% of all patients with metastatic cancer, with the majority in non-small cell lung cancer (NSCLC), pancreatic ductal carcinoma (PDAC), and colorectal cancer (CRC). "With this trial, we hope to bring a breakthrough therapy to the many patients with KRAS-driven cancers who are still underserved," said Andrew Chi, M.D., Ph.D., Chief Medical Officer of Alterome. "We have shown in preclinical studies that ALTA3263 has the attributes to potentially address this significant unmet need and transform patient outcomes." "While progress has been made in KRAS mutant cancers, we still regularly see patients who have exhausted all available effective treatment options and also suffer from toxic side effects of current therapies," said Anthony Tolcher, M.D., FRCPC, Founder of NEXT Oncology and primary investigator on the ALTA3263 Phase 1/1b trial. "We are excited to participate in this trial, and hope that ALTA3263 will usher in the next generation of KRAS targeted therapies that promise greater efficacy and improved tolerability and safety for patients." The Phase 1/1b, open-label, dose-escalation and multiple cohort study is evaluating the safety, tolerability, pharmacokinetics, and preliminary clinical activity of ALTA3263 in adults with advanced unresectable or metastatic solid tumors with KRAS mutations (NCT06835569). About ALTA3263 ALTA3263 is a non-covalent, orally bioavailable, highly potent KRAS isoform-selective dual ON/OFF state inhibitor designed to target >90% of all KRAS driver mutations in cancer. While mutation-specific KRAS inhibitors that target the KRAS OFF-state have demonstrated clinical benefit, highly prevalent KRAS mutations such as G12D and G12V exist predominantly in the ON-state and remain a substantial unmet medical need. ALTA3263 inhibits KRAS with picomolar to low single-digit nanomolar potency and targets both the ON and OFF states while exhibiting high selectivity for KRAS over HRAS and NRAS to allow for a favorable therapeutic index. These properties, together with excellent pharmacokinetic and tolerability profiles enable complete and continuous target coverage to inhibit KRAS-driven cancers. ALTA3263 led to deep regressions in multiple KRAS mutant preclinical models while being well-tolerated during prolonged oral dosing. These data were presented in an oral presentation at the 2024 EORTC-NCI-AACR (ENA) Symposium. For more information on ALTA3263, visit About Alterome Therapeutics, Inc. Alterome Therapeutics, Inc. is a clinical-stage precision oncology biotechnology company developing alteration-specific therapeutics to address high-value and validated oncogenic drivers. Our pipeline includes two Phase 1 therapies in development for solid tumors: ALTA2618, a first-in-class, oral mutation-selective inhibitor for AKT1 E17K-driven cancers, and ALTA3263, a potential best-in-class, KRAS-selective (ON/OFF) inhibitor for KRAS-driven cancers. Alterome has raised more than $231 million in venture capital to date and is led by a team of precision oncology R&D leaders with a history of developing marketed oncology small molecule drugs. For more information, visit and follow us on LinkedIn and Bluesky. View source version on Contacts Investors:Scott MoorefieldAlterome Therapeuticsinvestors@ Media:Michael GalfettiTen Bridge Communicationsalterome@ Sign in to access your portfolio


Associated Press
10-03-2025
- Business
- Associated Press
Alterome Doses First Patient in Phase 1 Study of ALTA3263, a Novel Pan-KRAS Dual ON/OFF Inhibitor, in Advanced Solid Tumors
Alterome Therapeutics, Inc., a clinical-stage biopharmaceutical company pioneering the development of next-generation, small molecule targeted therapies for the treatment of cancer, today announced that the first patient has been dosed in the Phase 1/1b trial of ALTA3263 in adults with KRAS mutant solid tumors. ALTA3263 is an oral KRAS-selective inhibitor specifically designed to potently inhibit the KRAS 'ON' (active) state of greater than 90% of all KRAS mutations and to provide complete target coverage in tumors. These properties have the potential to translate into best-in-class safety and efficacy. KRAS driver mutations are found in greater than 20% of all patients with metastatic cancer, with the majority in non-small cell lung cancer (NSCLC), pancreatic ductal carcinoma (PDAC), and colorectal cancer (CRC). 'With this trial, we hope to bring a breakthrough therapy to the many patients with KRAS-driven cancers who are still underserved,' said Andrew Chi, M.D., Ph.D., Chief Medical Officer of Alterome. 'We have shown in preclinical studies that ALTA3263 has the attributes to potentially address this significant unmet need and transform patient outcomes.' 'While progress has been made in KRAS mutant cancers, we still regularly see patients who have exhausted all available effective treatment options and also suffer from toxic side effects of current therapies,' said Anthony Tolcher, M.D., FRCPC, Founder of NEXT Oncology and primary investigator on the ALTA3263 Phase 1/1b trial. 'We are excited to participate in this trial, and hope that ALTA3263 will usher in the next generation of KRAS targeted therapies that promise greater efficacy and improved tolerability and safety for patients.' The Phase 1/1b, open-label, dose-escalation and multiple cohort study is evaluating the safety, tolerability, pharmacokinetics, and preliminary clinical activity of ALTA3263 in adults with advanced unresectable or metastatic solid tumors with KRAS mutations (NCT06835569). About ALTA3263 ALTA3263 is a non-covalent, orally bioavailable, highly potent KRAS isoform-selective dual ON/OFF state inhibitor designed to target >90% of all KRAS driver mutations in cancer. While mutation-specific KRAS inhibitors that target the KRAS OFF-state have demonstrated clinical benefit, highly prevalent KRAS mutations such as G12D and G12V exist predominantly in the ON-state and remain a substantial unmet medical need. ALTA3263 inhibits KRAS with picomolar to low single-digit nanomolar potency and targets both the ON and OFF states while exhibiting high selectivity for KRAS over HRAS and NRAS to allow for a favorable therapeutic index. These properties, together with excellent pharmacokinetic and tolerability profiles enable complete and continuous target coverage to inhibit KRAS-driven cancers. ALTA3263 led to deep regressions in multiple KRAS mutant preclinical models while being well-tolerated during prolonged oral dosing. These data were presented in an oral presentation at the 2024 EORTC-NCI-AACR (ENA) Symposium. For more information on ALTA3263, visit Alterome Therapeutics, Inc. is a clinical-stage precision oncology biotechnology company developing alteration-specific therapeutics to address high-value and validated oncogenic drivers. Our pipeline includes two Phase 1 therapies in development for solid tumors: ALTA2618, a first-in-class, oral mutation-selective inhibitor for AKT1 E17K-driven cancers, and ALTA3263, a potential best-in-class, KRAS-selective (ON/OFF) inhibitor for KRAS-driven cancers. Alterome has raised more than $231 million in venture capital to date and is led by a team of precision oncology R&D leaders with a history of developing marketed oncology small molecule drugs. Scott Moorefield Alterome Therapeutics [email protected]: Michael Galfetti SOURCE: Alterome Therapeutics, Inc. Copyright Business Wire 2025. PUB: 03/10/2025 07:30 AM/DISC: 03/10/2025 07:30 AM