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Clinical Trial News

Nuvalent to Present Pivotal Data for ROS1-Selective Inhibitor Zidesamtinib in Advanced Lung Cancer

Orphan Drug
  • Nuvalent will host a webcast on June 24, 2025, to discuss pivotal data for zidesamtinib in TKI pre-treated patients with advanced ROS1-positive non-small cell lung cancer from the ARROS-1 Phase 1/2 trial.
  • Zidesamtinib is a novel brain-penetrant ROS1-selective inhibitor designed to overcome resistance to current ROS1 inhibitors and address brain metastases in cancer patients.
  • The drug has received breakthrough therapy designation for ROS1-positive metastatic NSCLC patients previously treated with 2 or more ROS1 tyrosine kinase inhibitors.
  • The ARROS-1 trial's Phase 2 portion is designed with registrational intent for both TKI-naïve and TKI pre-treated patients with ROS1-positive NSCLC.

A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)

NCT05384626RecruitingPhase 1
Nuvalent Inc.
Posted 6/9/2022

A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)

NCT05118789RecruitingPhase 1
Nuvalent Inc.
Posted 1/4/2022

Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC

NCT06765109RecruitingPhase 3
Nuvalent Inc.
Posted 7/17/2025

iBio Advances AI-Driven Obesity Pipeline with Myostatin and Activin E Antibody Therapies

Monoclonal AntibodyPrecision Medicine
  • iBio will present promising preclinical data on its long-acting Myostatin antibody IBIO-600 and Activin E targeting therapies for obesity and cardiometabolic diseases.
  • The company will announce a third target in its AstralBio Collaboration during a June 24 conference call, expanding its precision antibody therapy pipeline.
  • iBio's AI-driven approach combines proprietary 3D modeling with computational biology to develop next-generation antibody medicines with potentially better tolerability and sustainable efficacy.
  • The biotech company is positioning itself to address significant unmet medical needs in obesity treatment through targeted, longer-lasting therapeutic approaches.

PathAI Receives FDA Clearance for AISight Dx Digital Pathology Platform for Primary Diagnosis

AI
  • PathAI announced FDA 510(k) clearance for its AISight Dx digital pathology platform for primary diagnosis in clinical settings, building on initial clearance received in 2022.
  • The FDA decision includes a Predetermined Change Control Plan (PCCP) that allows PathAI to implement major changes like additional displays, scanners, and file formats without requiring new 510(k) submissions.
  • AISight Dx is a cloud-native platform designed to modernize anatomic pathology workflows through intelligent case management, high-performance slide review, and seamless collaboration capabilities.
  • The platform is FDA-cleared for use with Hamamatsu NanoZoomer S360MD and Leica Aperio GT 450 DX slide scanners, offering interoperability for organizations of any size.

Sanofi Invests $25 Million in Adagene's SAFEbody Platform for Next-Generation Cancer Immunotherapy

  • Sanofi has committed up to $25 million in strategic investment to Adagene, extending the biotech's cash runway into 2027 and supporting clinical development of its lead SAFEbody candidate muzastotug.
  • The partnership includes Sanofi exercising its option on a third SAFEbody discovery program and sponsoring a combination clinical trial with muzastotug in over 100 patients with advanced solid tumors.
  • Adagene's SAFEbody technology uses precision masking to enable tumor-specific targeting while minimizing toxicity in healthy tissues, addressing key safety challenges in cancer immunotherapy.
  • The collaboration reinforces Sanofi's aggressive R&D expansion strategy, following recent major deals including a $5.2 billion alliance with Exscientia and acquisitions totaling over $6 billion in immuno-oncology assets.

TAM Global Appoints Leading Cancer Immunologist Dr. Francesco Marincola as Chief Scientific Officer

  • TAM Global has appointed Dr. Francesco Marincola, one of the world's most prolific tumor immunologists with over 700 peer-reviewed publications, as Chief Scientific Officer across its expanding healthcare platform.
  • Dr. Marincola will oversee scientific strategy for all TAM Global subsidiaries including cellular therapy, diagnostics, AI, and biologic therapeutics divisions.
  • The appointment signals TAM Global's aggressive expansion into integrative cancer care, stem cell therapy, molecular diagnostics, and personalized medicine under a unified platform.
  • TAM Global's model combines hospital infrastructure in Mexico with full in-house laboratory capabilities to accelerate translation from discovery to patient benefit.

FDA's Acting Drug Chief Jacqueline Corrigan-Curay to Retire Amid Leadership Exodus

Drug Approval
  • Jacqueline Corrigan-Curay, the FDA's acting director of the Center for Drug Evaluation and Research, announced her retirement in July after more than eight years at the agency.
  • Her departure adds to a significant leadership exodus at the FDA, with the agency losing approximately 20% of its workforce through layoffs and departures since the Trump administration took office.
  • The turnover occurs as FDA Commissioner Martin Makary implements major regulatory changes, including stricter COVID-19 vaccine standards and new AI adoption initiatives.
  • Despite leadership assurances that drug review timelines remain unaffected, some companies have reported unexpected delays attributed to "resource constraints."

Australian Government Invests $12 Million in Cardiovascular and Diabetes Medical Technology Innovation

  • The Australian Government has allocated $12 million through MTPConnect's Targeted Translation Research Accelerator program to support 14 domestic biotech and medtech companies developing treatments for cardiovascular disease and diabetes.
  • The funding targets critical health conditions affecting over 2.6 million Australians, with cardiovascular disease being the second leading cause of death and diabetes ranking among the top 10 causes of death in Australia.
  • Selected companies are developing innovative medical devices and pharmaceuticals across multiple therapeutic areas, including atrial fibrillation, stroke, diabetic complications, and coronary artery disease.
  • The investment has attracted over $17 million in additional industry contributions, creating nearly $30 million in total support for Australian life science innovation, with 50% of funded companies led by women.

Sichuan Biokin's First-in-Class EGFR/HER3 ADC Advances to Phase 3 Trials Across Multiple Cancer Types

Oncology
  • Sichuan Biokin's izalontamab brengitecan (SI-B001/BL-B01D1) represents a first-in-class bispecific antibody-drug conjugate targeting both EGFR and HER3 receptors, showing promising early efficacy data across multiple solid tumor types.
  • The company is advancing multiple Phase 2/3 trials with key data readouts expected in 2025-2026, including studies in triple-negative breast cancer, ER+/HER2- breast cancer, and small cell lung cancer.
  • Bristol-Myers Squibb licensed ex-China rights to the drug for $800 million upfront with potential milestones exceeding $1.5 billion, validating the therapeutic potential in a multibillion-dollar oncology market.
  • Early Phase 1 data demonstrated encouraging response rates including 100% disease control rates in nasopharyngeal carcinoma and 75% confirmed objective response rates in small cell lung cancer.

A Study Comparing BL-B01D1 With Topotecan in Patients With Recurrent Small Cell Lung Cancer

NCT06500026RecruitingPhase 3
Sichuan Baili Pharmaceutical Co., Ltd.
Posted 8/7/2024

Illumina Acquires SomaLogic for $425 Million to Accelerate Proteomics and Multiomics Strategy

  • Illumina announced a definitive agreement to acquire SomaLogic, a leader in data-driven proteomics technology, for $350 million in cash plus up to $75 million in performance-based milestones and royalties.
  • The acquisition builds on a three-year partnership between the companies and will integrate SomaLogic's aptamer-based proteomics platform with Illumina's NGS ecosystem to advance biomarker discovery and disease profiling.
  • The transaction is expected to close in the first half of 2026, with the combined business projected to become profitable in 2027 and achieve operating margins in line with Illumina by 2028.
  • SomaLogic's proteomics technology demonstrates strength in plexity, scalability, and technical reproducibility, enabling researchers to analyze thousands of protein markers in a single high-throughput experiment.

Dr Ashleys Limited Acquires Impact BioMedical in Strategic Reverse Merger to Accelerate Global Drug Development

  • Dr Ashleys Limited, a Hong Kong-based pharmaceutical company, announced a strategic reverse merger with Impact BioMedical Inc. (NYSE American: IBO) on June 21, 2025, creating a combined entity to be traded on NYSE American.
  • The merger combines Dr Ashleys' global manufacturing capabilities and over 300 million annual medical doses with Impact BioMedical's robust portfolio of 90+ patents across critical health areas.
  • Both companies focus on addressing infectious diseases including malaria, COVID-19, tuberculosis, and dengue fever, as well as cancer and gastrointestinal disorders.
  • The transaction requires regulatory approvals and Impact BioMedical shareholder approval, with the combined entity to be operated by Dr Ashleys' management team.

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