MedPath

Clinical Trial News

Anbogen Receives FDA Clearance for Phase 1/2 Trial of ABT-301 Triplet Therapy in Metastatic Colorectal Cancer

FDA Approval
  • Anbogen Therapeutics received FDA approval for its Investigational New Drug application to initiate a Phase 1/2 clinical trial of ABT-301 combined with tislelizumab and bevacizumab for metastatic colorectal cancer patients.
  • The open-label, multi-center international study will enroll 66 patients with proficient mismatch repair or non-microsatellite instability-high metastatic colorectal cancer in Taiwan and Australia.
  • ABT-301 is an oral HDAC1/2/3 inhibitor that converts "cold tumors" into "hot tumors" by promoting CD8+ T cell infiltration and enhancing immune checkpoint inhibitor efficacy.
  • The therapy targets approximately 95% of metastatic colorectal cancer patients who respond poorly to current immunotherapies, representing a potential $9 billion market opportunity.

Dose-Seeking Study of MPT0E028 in Subjects With Advanced Solid Malignancies Without Standard Treatment

NCT02350868CompletedPhase 1
Taipei Medical University
Posted 4/24/2015

Alveolus Bio Secures Strategic Investment from Shilpa Medicare to Advance Respiratory Therapeutics Platform

  • Alveolus Bio announced a strategic financing round led by Shilpa Medicare Limited, positioning the company for Phase 2 clinical trials and first-in-human studies of its respiratory therapeutics platform.
  • The partnership establishes Shilpa Biologics as Alveolus Bio's exclusive global development and manufacturing partner, accelerating clinical advancement of the company's resMIT platform for targeted lung therapy delivery.
  • Alveolus Bio's proprietary resMIT platform enables targeted delivery of inhaled therapies to deep lung regions, addressing unmet medical needs in COPD, Bronchopulmonary Dysplasia, and Pulmonary Fibrosis.
  • The collaboration combines Alveolus Bio's live biotherapeutics and small molecule platform with Shilpa Medicare's extensive experience in drug discovery, development, manufacturing, and regulatory capabilities.

Alphamab Oncology Receives IND Approval for First-in-Class Bispecific ADC JSKN022 Targeting PD-L1 and Integrin αvβ6

  • Alphamab Oncology's IND application for JSKN022, a novel bispecific antibody-drug conjugate targeting both PD-L1 and integrin αvβ6, has been officially accepted by China's NMPA.
  • JSKN022 represents the first ADC worldwide to target either integrin αvβ6 or PD-L1, with all related investigational candidates currently remaining in clinical development stages.
  • The innovative therapy utilizes a glycan-specific conjugation platform and topoisomerase I inhibitor to potentially overcome resistance to PD-1/PD-L1 inhibitors in multiple cancer types.
  • A Phase I first-in-human clinical study will evaluate safety, tolerability, and antitumor activity in patients with advanced malignant solid tumors who have failed standard therapies.

University of Michigan Develops At-Home Melanoma Detection Patch Using Microneedle Technology

  • Researchers at the University of Michigan have developed the ExoPatch, a silicone patch with star-shaped microneedles that can detect melanoma by capturing disease-specific exosomes from skin tissue.
  • The device successfully distinguished melanoma from healthy tissue in mouse studies, collecting 11.5 times more exosomal protein from melanoma samples and producing test strips 3.5 times darker for positive results.
  • The patch works similarly to at-home COVID tests, requiring only 15 minutes of application and providing immediate results without blood draws or biopsies.
  • Human pilot studies and clinical trials are planned next, with potential applications extending to other cancers including lung, breast, colon, prostate and brain cancer.

DEP-SN38 Dendrimer Nanoparticle Shows Promise in Advanced Solid Tumors with Reduced Toxicity Profile

  • DEP-SN38, a dendrimer nanoparticle formulation of topoisomerase I inhibitor SN38, demonstrated encouraging anticancer activity in 114 heavily pretreated patients with advanced solid tumors including ovarian, colorectal, pancreatic, and breast cancers.
  • The study established a recommended phase 2 dose of 12.5mg/m2 with significantly lower rates of severe gastrointestinal toxicity and no cholinergic toxicity compared to irinotecan.
  • Patients showed signals of prolonged benefit despite having received a median of 4 prior therapy lines, with many able to return to work and everyday activities during treatment.
  • The dendrimer nanotechnology platform leverages enhanced permeability and retention effects in tumor microenvironments, potentially offering broader applications for oncology drug development.

Australia Develops World-First mRNA Vaccine for Foot-and-Mouth Disease in Livestock

  • Australian researchers have successfully developed the world's first biodegradable mRNA vaccine to protect livestock from foot-and-mouth disease through a $20 million partnership between Meat & Livestock Australia, Tiba Biotech, and the NSW Government.
  • Preliminary trials in Germany demonstrated complete protection, with all nine vaccinated cattle remaining disease-free and not shedding the virus when exposed to foot-and-mouth disease.
  • The vaccine offers critical advantages including room temperature storage for one month, rapid deployment within weeks of an outbreak, and DIVA capacity to differentiate infected from vaccinated animals.
  • An FMD outbreak could cost the Australian economy up to $80 billion according to ABARES modeling, making this preventive measure crucial for biosecurity preparedness.

Luye Pharma Initiates Phase 1 Trial for Novel Triple-Target Antidepressant LY03021

  • Luye Pharma has enrolled the first subject in a Phase 1 clinical trial for LY03021, a potential first-in-class antidepressant targeting NET, DAT, and GABAAR for Major Depressive Disorder treatment.
  • The investigational drug demonstrated rapid onset of action within 24 hours in preclinical studies, addressing the 2-4 week delay typical of current antidepressants.
  • LY03021's novel mechanism aims to improve efficacy while reducing sedation side effects through balanced targeting of synaptic and extrasynaptic GABAA receptors.
  • The Phase 1 study is a randomized, double-blind, placebo-controlled dose-escalation trial evaluating safety, tolerability, and pharmacokinetics in healthy subjects.

CDSCO Panel Recommends Approval for Vorasidenib with Phase-III Waiver for IDH-Mutant Gliomas in India

Drug ApprovalOrphan DrugTargeted Therapy
  • India's CDSCO panel has recommended approval for vorasidenib tablets (10 mg and 40 mg) with a waiver from local Phase-III clinical trials for treating IDH-mutant gliomas.
  • The dual IDH1/IDH2 inhibitor is indicated for adult and pediatric patients aged 12 years and older with Grade 2 astrocytoma or oligodendroglioma harboring IDH mutations.
  • The committee acknowledged the unmet medical need for these indications in India and noted the drug's orphan status in other countries.
  • A Phase-IV clinical trial in Indian patients will be mandatory, with the protocol to be submitted within 3 months of approval.

LG Group Invests in Strand Therapeutics' mRNA Cancer Platform Through Series B Funding

  • LG Group has invested in Strand Therapeutics, a Cambridge-based biotech developing messenger RNA-based cancer therapies, through its venture capital arm LG Technology Ventures.
  • Strand Therapeutics specializes in programming cells to produce precise amounts of antigens at optimal timing to treat cancer, autoimmune conditions, and rare diseases.
  • This investment brings LG Technology Ventures' cumulative biotech funding to over $50 million, aligning with the conglomerate's strategic focus on AI, biotechnology, and clean technology sectors.
  • The move supports LG's broader biohealth strategy, which includes recent investments in ADARx Pharmaceuticals and the development of AI diagnostic tools like Exaone Pass 2.0.

New Peritoneal Surface Malignancy Guidelines Address Critical Care Gaps for 70,000 US Patients Annually

  • New clinical guidelines for peritoneal surface malignancies have been published for the first time since 2018, addressing care disparities for approximately 70,000-80,000 US patients affected annually.
  • The updated guidelines feature enhanced representation including patient advocates, international stakeholders, and endorsement from the Society of Surgical Oncology, with adoption into NCCN guidelines.
  • The guidelines aim to address critical challenges including difficult imaging detection, exclusion from clinical trials, and advanced disease presentation that often leads to bowel obstructions and poor outcomes.
  • A methodologically rigorous Delphian process was used to create seven comprehensive papers covering different treatment pathways, published jointly in Cancer and Annals of Surgical Oncology.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.