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First Ascent Biomedical Partners with Fight Colorectal Cancer for $350,000 Precision Medicine Study

  • First Ascent Biomedical and Fight Colorectal Cancer have launched a $350,000 prospective feasibility study to advance precision oncology for colorectal cancer patients using xDRIVE tumor profiling technology.
  • The study will enroll 25 patients with metastatic colorectal cancer in Minnesota, integrating functional drug testing, genetic analysis, and artificial intelligence to provide personalized treatment insights.
  • Led by gastrointestinal cancer specialist Dr. Hao Xie and principal investigator Dr. Noah Berlow, the study aims to complete enrollment within nine months and deliver actionable data to oncologists.
  • The collaboration represents a strategic focus on enhancing care for patients with limited treatment options through advanced research and rapid, individualized tumor profiling.

Denovo Biopharma Forms Neuroscience Advisory Board to Advance Precision Medicine Approach for Treatment-Resistant Depression

  • Denovo Biopharma has established a neuroscience Scientific Advisory Board chaired by Dr. Charles B. Nemeroff to guide development of its Phase 3-ready biomarker-guided depression therapy DB104.
  • The company's lead asset liafensine is a first-in-class triple reuptake inhibitor that targets serotonin, norepinephrine, and dopamine transporters for treatment-resistant depression.
  • Denovo's AI-based platform identified a novel genetic biomarker at the ANK3 gene that correlates with liafensine efficacy, representing the first genetic biomarker validated in psychiatry.
  • The advisory board includes industry veterans with experience developing major CNS treatments including Cymbalta, Trintellix, and Cobenfy for schizophrenia.

GlycoMimetics Stockholders Approve Merger with Crescent Biopharma, Creating New Oncology-Focused Entity

  • GlycoMimetics stockholders approved the proposed merger with Crescent Biopharma on June 5, 2025, along with all related proposals including a 1-for-100 reverse stock split.
  • The combined company will trade on Nasdaq under the name "Crescent Biopharma, Inc." with ticker symbol "CBIO" starting June 16, 2025, with approximately 14.8 million shares outstanding.
  • Crescent Biopharma focuses on precision-engineered molecules for solid tumors, including lead program CR-001, a tetravalent PD-1 x VEGF bispecific antibody.
  • The merger combines GlycoMimetics' glycobiology platform for cancer and inflammatory diseases with Crescent's pipeline of three oncology programs targeting validated biology.

Roche's Tecentriq Cuts Colon Cancer Recurrence by 50% in Patients with DNA Repair Defects

  • Roche's immunotherapy drug Tecentriq combined with chemotherapy reduced cancer recurrence and death by 50% in colon cancer patients with deficient DNA mismatch repair tumors.
  • The phase 3 trial enrolled 712 patients with dMMR stage 3 colon cancer, representing about 15% of colon cancer cases that typically don't respond well to chemotherapy alone.
  • Study leader Dr. Frank Sinicrope called the findings a major advance that will change treatment standards for this specific type of colon cancer.
  • Benefits were observed even in the oldest patients and those at particularly high risk, with treatment involving six months of combination therapy followed by six months of Tecentriq alone.

Inka Health Launches Global AI-Oncology Consortium to Advance Predictive Cancer Research

  • Inka Health, a subsidiary of Onco-Innovations Limited, is establishing the PROmAI Consortium to bring together pharmaceutical companies, academic institutions, and data science experts for AI-driven cancer research collaboration.
  • The consortium will focus on developing next-generation AI approaches that integrate real-world and clinical trial data from molecular, imaging, clinical, and other multimodal sources to enhance predictive accuracy in oncology.
  • PROmAI aims to accelerate progress toward personalized, cost-effective cancer care while establishing standards for AI transparency and trustworthiness in clinical drug development contexts.
  • The initiative is currently in its formative phase with formal discussions underway with prospective founding members, representing a strategic milestone in AI-driven oncology innovation.

Servier India Launches First-in-Class IDH1-Targeted Therapy Ivosidenib for Rare Blood and Bile Duct Cancers

  • Servier India received CDSCO approval on May 14, 2025, to launch Ivosidenib (Tibsovo®), the first oral targeted therapy for IDH1-mutated acute myeloid leukemia and cholangiocarcinoma in India.
  • The therapy addresses a critical unmet medical need, as only 30-40% of AML patients in India receive adequate treatment and IDH1 mutations occur in approximately 7-14% of Indian AML patients.
  • Ivosidenib has already gained regulatory approval in over 42 countries, including FDA approval in 2019 and EMA approval in 2023 for specific patient populations.
  • The company is prioritizing accessibility and affordability through collaborations with healthcare providers, patient advocacy groups, and policymakers to ensure broader patient access across India.

MGI Tech Expands Partnership with Brazil's Fiocruz to Enhance Genetic Sequencing for Cancer and Infectious Disease Diagnostics

  • MGI Tech has expanded its partnership with Brazil's Fiocruz to advance genetic sequencing capabilities for diagnosing infectious diseases, genetic conditions, and major cancer types including breast, ovarian, colorectal, and prostate cancers.
  • The collaboration will enable UNADIG laboratories to process over 2,000 samples weekly using state-of-the-art MGI sequencing equipment, significantly expanding access to high-complexity diagnostic tests for the Brazilian population.
  • The partnership aims to transform healthcare delivery by accelerating diagnosis and treatment of oncological and epidemiological diseases while reducing costs and strengthening Brazil's response to disease outbreaks.

Elucidata and Sapien Biosciences Form Strategic Partnership to Transform India's Largest Biobank into AI-Ready Data Platform

  • Elucidata and Sapien Biosciences announced a strategic partnership to convert Sapien's 300,000+ patient sample biobank into AI-ready, multimodal data products for drug discovery and diagnostic development.
  • The collaboration will focus initially on building AI models that infer genomic and transcriptomic insights from digital pathology images using NGS-annotated slides from Sapien's cancer biobank.
  • Sapien operates one of the top 10 biobanks globally with over 85,000 cancer patients and represents the largest integrated resource for Asian patient data across multiple disease areas.
  • The partnership aims to address underrepresentation in global omics datasets while accelerating precision medicine through synthetic clinicogenomic data generation.

Vividion Secures Exclusive Rights to First-in-Class WRN Inhibitor VVD-214 for MSI-High Cancers

  • Vividion Therapeutics has secured exclusive worldwide rights to develop VVD-214, the only clinical-stage covalent inhibitor of Werner helicase (WRN) currently in development globally.
  • Preliminary data from a first-in-human Phase I study presented at AACR showed VVD-214 is well tolerated with promising signs of activity in solid tumors with high microsatellite instability.
  • The compound targets a synthetic lethal pathway in MSI-high cancers including colorectal, endometrial, ovarian, and gastric tumors, addressing significant unmet medical need in patients who relapse or become refractory to immune checkpoint inhibitors.

FDA Grants First-Ever Authorization for AI Platform to Predict Breast Cancer Risk from Mammograms

  • Clairity receives FDA De Novo authorization for CLAIRITY BREAST, the first AI platform to predict five-year breast cancer risk using routine screening mammograms alone.
  • The platform analyzes subtle imaging features invisible to the human eye to deliver validated risk scores through existing clinical infrastructures.
  • This breakthrough addresses limitations of traditional risk models that rely on age and family history, despite 85% of breast cancer patients having no family history.
  • The technology promises more equitable healthcare by overcoming biases in traditional models built primarily on European Caucasian women data.
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