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Clinical Trial News

Wockhardt Exits US Generics Business to Focus on Novel Antibiotic Drug Discovery

Drug Discovery
  • Wockhardt Ltd has filed for voluntary liquidation of its US subsidiaries Morton Grove Pharmaceuticals Inc. and Wockhardt USA LLC under Chapter 7 of the US Bankruptcy Code to exit its loss-making generics business.
  • The company's US generics business incurred nearly $8 million in losses in FY25 and has been unprofitable for several years, prompting the strategic exit.
  • Wockhardt is pivoting to focus on its novel antibiotic drug discovery program, with six candidates in development targeting drug-resistant bacterial infections.
  • The company's lead antibiotic candidate Zaynich has completed global phase 3 trials and has an addressable market potential of $7 billion in the US and Europe.

Onco-Innovations Appoints Dr. Islam Mohamed as Scientific Advisory Board Chair to Advance Oncology Pipeline

Oncology
  • Onco-Innovations Limited has appointed Dr. Islam Mohamed, an experienced radiation oncologist and clinical researcher, as Chair of its Scientific and Clinical Advisory Board to strengthen its clinical leadership capabilities.
  • Dr. Mohamed brings over two decades of experience in oncology innovation, having led numerous clinical trials in breast, lung, and oligometastatic cancers while serving on research ethics boards and national clinical trial committees.
  • The appointment reflects the company's commitment to advancing its oncology pipeline and translational research initiatives, with Dr. Mohamed's expertise in stereotactic radiation delivery and biotech investment expected to guide strategic R&D decisions.
  • Onco-Innovations holds an exclusive worldwide license to patented technology targeting solid tumors and aims to accelerate innovative oncology solutions through expert-led research.

Daré Bioscience Receives $6 Million Grant Installment for Smart Drug Delivery Platform Development

  • Daré Bioscience received a $6 million non-dilutive grant installment, bringing total funding to $37.8 million of up to $49 million committed for DARE-LARC1 contraceptive development.
  • The DARE-IDDS platform features a programmable, wirelessly controlled device capable of delivering hundreds of individualized doses over months or years without recharging or surgical replacement.
  • Originally developed at MIT by Dr. Robert Langer and Dr. Michael Cima, the platform has broader therapeutic potential beyond contraception, including obesity, diabetes, and neurologic diseases.
  • The company is exploring strategic partnerships to expand the platform's application beyond reproductive health into multibillion-dollar therapeutic markets.

Microsoft Launches BioEmu AI System to Accelerate Drug Discovery Through Protein Simulation

AIDrug Discovery
  • Microsoft has introduced BioEmu, an AI system that can predict protein structural changes and movements in hours rather than the years typically required for traditional computer simulations.
  • The system achieves prediction errors of less than 1 kcal/mol and correlation scores above 0.6 on large test datasets, demonstrating high accuracy in matching real-world experimental protein stability data.
  • BioEmu can generate thousands of protein structures per hour using just one GPU, offering a scalable and cost-effective alternative to traditional molecular dynamics simulations.
  • The AI system can identify cryptic binding pockets in proteins, which are hidden drug target sites that could lead to the development of new therapeutic compounds.

Brenig Therapeutics Appoints New Leadership and Expands Parkinson's Disease Pipeline with NLRP3 Inhibitor Acquisition

  • Brenig Therapeutics appointed David L. Lucchino as CEO and Tien Dam, M.D., as Chief Medical Officer to advance its neurodegenerative disease pipeline.
  • The company acquired BT-409, a brain-penetrant NLRP3 inhibitor from Mwyngil Therapeutics, targeting neuroinflammation in Parkinson's disease and other conditions.
  • Brenig's lead candidate BT-267, a selective LRRK2 inhibitor for Parkinson's disease, continues advancing through clinical development with promising brain penetration and safety profiles.
  • The new NLRP3 inhibitor program will enter pre-IND studies with plans to advance into Phase 1 safety trials.

Scalp Cooling Combined with Antioxidants Shows Promise for Preventing Chemotherapy-Induced Hair Loss

  • Researchers at Sheffield Hallam University discovered that combining scalp cooling with antioxidants like N-Acetylcysteine or Resveratrol significantly reduces chemotherapy-induced hair follicle damage.
  • The study found optimal cooling at 18°C prevents hair loss, while sub-optimal cooling at 26°C combined with antioxidants provides comparable protection.
  • This breakthrough could transform scalp cooling into a more consistent treatment for the 65% of chemotherapy patients who experience hair loss.
  • The combined approach effectively reduces reactive oxygen species production, addressing a key mechanism of chemotherapy-induced hair follicle damage.

Intuitive Receives FDA Clearance for Vessel Sealer Curved, First Advanced Energy Instrument Approved for Lymphatic Vessel Transection

  • Intuitive's Vessel Sealer Curved has received FDA clearance as the first advanced energy instrument approved for transection of lymphatic vessels in robotic surgery.
  • The fully wristed bipolar electrosurgical instrument features a slim, curved jaw design that follows natural anatomical contours to improve visibility and control in tight surgical spaces.
  • The device is cleared for sealing, cutting, grasping, and dissecting tissue, including blood vessels up to 7mm in diameter, expanding surgical capabilities for da Vinci systems.
  • This milestone comes as Intuitive marks its 30th year in robotic-assisted technology development, with nearly 17 million da Vinci procedures performed and 90,000 surgeons trained on their systems.

MiNK Therapeutics Reports Complete Remission in Metastatic Testicular Cancer Patient Using Allogeneic iNKT Cell Therapy

  • MiNK Therapeutics published a landmark case in Nature's Oncogene showing complete and durable remission in a patient with metastatic, treatment-refractory testicular cancer following treatment with agenT-797, their allogeneic iNKT cell therapy.
  • The patient achieved complete clinical, radiologic, and biochemical remission with no evidence of disease over two years after receiving a single infusion of agenT-797 alongside nivolumab, despite having failed multiple prior therapies including platinum-based chemotherapy, autologous stem cell transplant, and multiple immune checkpoint inhibitors.
  • The treatment was well-tolerated with no cytokine release syndrome or graft-versus-host disease, and donor iNKT cells remained detectable up to six months post-infusion.
  • Additional clinical evidence from MiNK's Phase 2 gastric cancer trial demonstrates immune activation, increased tumor infiltration, and extended survival beyond 12 months in several patients previously refractory to checkpoint inhibitors.

A Study of agenT-797 in Combination With Botensilimab, Balstilimab, Ramucirumab, and Paclitaxel for People With Esophageal, Gastric, or Gastro-esophageal Junction Cancer

NCT06251973RecruitingPhase 2
Memorial Sloan Kettering Cancer Center
Posted 2/1/2024

A Study Investigating agenT-797 in Participants With Relapsed/Refractory Solid Tumors

NCT05108623CompletedPhase 1
MiNK Therapeutics
Posted 1/28/2022

Cerevance Reports Positive Phase 1 Results for Novel KCNK13 Inhibitor CVN293 Targeting Neuroinflammation

  • Cerevance's Phase 1 clinical trial of CVN293, a novel KCNK13 inhibitor, demonstrated good central nervous system exposure and was generally well-tolerated in patients.
  • CVN293 targets KCNK13, a potentially novel regulator of NLRP3 inflammasome activation, aiming to reduce neuroinflammation and slow disease progression in neurodegenerative disorders.
  • The company will present Phase 1 safety and pharmacokinetic data at the Alzheimer's Association International Conference 2025, alongside research on astrocyte function in Alzheimer's disease.
  • KCNK13 was identified through Cerevance's proprietary NETSseq platform, which analyzes brain tissue from over 20,000 donors to identify disease-driving molecular changes.

I Peace and Vita Therapeutics Partner to Develop Universal iPS Cells for FSHD Treatment

Gene Editing
  • I Peace and Vita Therapeutics have announced a joint development program to create universal induced pluripotent stem cells (iPSCs) for cell transplantation therapy, with an initial focus on facioscapulohumeral muscular dystrophy (FSHD).
  • The collaboration will produce GMP-grade iPS cells modified with proprietary gene editing technology to create hypoimmune cell lines that have depleted Class I and II HLA genes to prevent transplant rejection.
  • The manufactured master cell bank will be registered in the FDA Drug Master File, with I Peace retaining rights to supply both normal and gene-edited cells for therapeutic applications globally.
  • Universal cells are designed to suppress immune rejection due to HLA incompatibility, allowing transplantation without requiring compatibility matching with the recipient's HLA type.

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