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Clinical Trial News

Akeso Reports Record Sales Growth as Ivonescimab Meets Overall Survival Endpoint in Phase III Trial

Drug Approval
  • Akeso's commercial sales surged 49.20% to RMB 1,401.6 million in the first half of 2025, driven by expanded indications and NRDL inclusion for its bispecific antibodies.
  • Ivonescimab achieved a statistically significant overall survival benefit in the final analysis of the HARMONi-A Phase III trial, marking a key milestone for the PD-1/VEGF bispecific.
  • The company is advancing its "IO 2.0 + ADC 2.0" strategy with 23 registrational/Phase III trials for ivonescimab and cadonilimab across multiple cancer types.
  • Akeso's non-oncology portfolio expanded with approvals for ebdarokimab and ebronucimab, while gumokimab and manfidokimab showed positive Phase III results.

CorrectSequence Therapeutics Achieves First Successful Sickle Cell Disease Treatment in China Using Base Editing Technology CS-101

  • CorrectSequence Therapeutics successfully treated the first sickle cell disease patient in China using its base editing therapy CS-101, marking a significant milestone in gene editing applications.
  • The 21-year-old Nigerian patient showed sustained increases in fetal hemoglobin levels and remained crisis-free for six months post-treatment with no adverse events reported.
  • CS-101 has now treated nearly 20 patients with β-hemoglobinopathies, with the first β-thalassemia patient remaining transfusion-free for over 22 months.
  • The company is advancing toward pivotal Phase II/III trials with global recruitment underway for both sickle cell disease and β-thalassemia indications.

Virax Biolabs Partners with Emory University for Long COVID Diagnostic Study Using T Cell Technology

  • Virax Biolabs has signed a Research Services Agreement with Emory University's ADJUST Center to conduct clinical studies of ViraxImmune™ technology for diagnosing long COVID and other post-viral syndromes.
  • The collaboration will generate clinical data to support regulatory submissions and commercial rollout, with Emory's laboratory handling patient recruitment, testing, and analysis.
  • Virax is preparing for an FDA pre-submission meeting in early September 2025 to discuss the regulatory pathway for ViraxImmune™ in post-acute sequelae of SARS-CoV-2.
  • ViraxImmune™ represents a proprietary T cell testing technology that evaluates immune response profiles, offering a more comprehensive assessment than conventional antibody testing.

Dr. Reddy's Launches First-in-Class Linaclotide for Chronic Constipation in India

  • Dr. Reddy's Laboratories has launched Colozo (Linaclotide), a novel guanylate cyclase-C receptor agonist for chronic constipation management in adults in India.
  • The USFDA-approved medication is indicated for chronic idiopathic constipation, irritable bowel syndrome with constipation in adults, and functional constipation in pediatric patients aged 6-17 years.
  • The company claims to be the first to launch this therapy in India, offering it in 72 mcg and 145 mcg strengths as part of its expanding gastrointestinal portfolio.
  • This launch follows Dr. Reddy's introduction of BixiBat last year and supports the company's goal to serve 1.5 billion patients by 2030.

ZYUS Life Sciences Initiates Phase 2a Trial for Novel Non-Opioid Cancer Pain Treatment

  • ZYUS Life Sciences has activated its first clinical site at Centre Hospitalier de l'Université de Montréal and enrolled the first patient in the Phase 2a UTOPIA-1 trial for Trichomylin® softgel capsules.
  • The single-arm, proof-of-concept study will investigate the safety and preliminary analgesic efficacy of the cannabinoid-based drug candidate in patients with advanced cancer and moderate to severe cancer-related pain.
  • Trichomylin® is designed to bridge the treatment gap between conventional therapies such as opioids and NSAIDs, offering a differentiated pharmaceutical approach for cancer pain management.
  • The trial represents a significant milestone for ZYUS' clinical development program as the company pursues regulatory approval for non-opioid-based pharmaceutical pain management solutions.

Unique Treatment of Oncology Pain in Advanced Cancer

NCT06533657RecruitingPhase 2
ZYUS Life Sciences Inc.
Posted 6/12/2025

Abbott Secures First Denosumab Biosimilar Approval in Thailand, Expanding Access to Bone Disease Treatment

Drug Approval
  • Abbott received regulatory approval for Thailand's first denosumab biosimilar, making advanced osteoporosis and cancer-related bone loss therapy more affordable for an estimated 3 million affected Thais.
  • The approval addresses a significant treatment gap, as fewer than 40% of hip fracture patients in Thailand currently begin anti-osteoporosis therapy due to barriers including cost and treatment availability.
  • Thailand faces a growing osteoporosis burden with 1 in 5 women and 1 in 10 men affected, and the country's aging population is projected to reach 25% aged 60 or older within the next decade.
  • This launch builds on Abbott's expanding biosimilar portfolio in the Asia-Pacific region, following recent approvals in Malaysia and India as part of the company's strategy to increase access to high-quality medicines.

Controlled Release Drug Delivery Market Expands with Major Pharma Investment in Precision Medicine Technologies

Precision Medicine
  • Major pharmaceutical companies including AbbVie, AstraZeneca, and Merck are actively developing controlled drug release systems to enhance treatment of chronic diseases, cancer, and neurological disorders.
  • The market is shifting toward personalized and targeted drug delivery mechanisms driven by biotechnology advances and precision medicine approaches.
  • Non-invasive delivery methods such as implantable systems and transdermal patches are gaining traction for improved patient convenience and compliance.
  • Clinical trials span multiple therapeutic areas from pain management and oncology to neurological diseases and metabolic disorders, validating safety and efficacy of these advanced delivery systems.

BioArctic and Novartis Partner on BrainTransporter Technology for Neurodegeneration Treatment Development

  • BioArctic has entered into a collaboration agreement with Novartis to develop new neurodegeneration treatments using BioArctic's proprietary BrainTransporter technology platform.
  • The partnership includes a $30 million upfront payment to BioArctic, with potential milestone payments of up to $772 million if Novartis exercises its licensing option.
  • BioArctic will initially combine its BrainTransporter technology with a Novartis proprietary antibody to create a new drug candidate targeting an undisclosed neurodegeneration target.
  • This represents the third collaboration for BioArctic's BrainTransporter platform, demonstrating the technology's potential to improve brain drug delivery across multiple therapeutic applications.

Zephyr AI Names Watson Pharmaceuticals Founder Dr. Allen Chao as CEO, Acquires Aster Insights to Accelerate Cancer Drug Development

AIPrecision MedicineReal World EvidenceOncology
  • Zephyr AI has appointed Dr. Allen Chao, founder of Watson Pharmaceuticals, as Chief Executive Officer, bringing over 40 years of biopharmaceutical leadership experience.
  • The company simultaneously acquired Aster Insights, gaining access to the world's largest observational cancer study dataset with over 400,000 lifetime-consented patients.
  • The combined entity creates a formidable real-world evidence platform that integrates AI-driven precision medicine with comprehensive genomic, clinical, and transcriptome data.
  • Integration efforts are already underway focusing on biomarker discovery, clinical trial optimization, and AI-enabled companion diagnostics development.

Peach Bowl Donates $2.5 Million to Advance 18 Pediatric Cancer Clinical Trials

  • Peach Bowl, Inc. donated $2.5 million to the Aflac Cancer and Blood Disorders Center, expanding support for 18 promising pediatric cancer clinical trials across seven facilities nationwide.
  • The donation builds on the original $20 million Peach Bowl LegACy Fund established in 2019, with 79 children currently enrolled in various cancer drug trials.
  • Four new trials launched in the latest funding cycle include studies of tumor-suppressing drugs, immunotherapy for osteosarcoma, brain tumor treatments, and prevention of transplant complications.
  • The fund was created in honor of Anna Charles Hollis, who died from acute myeloid leukemia in 2018, and aims to accelerate novel cancer treatments from bench to bedside.

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