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Clinical Trial News

Adocia's Ultra-Rapid Insulin BioChaperone Lispro Meets Primary Endpoint in Phase 3 Trial for Type 2 Diabetes

  • BioChaperone Lispro (THDB0206) demonstrated non-inferior HbA1c reduction compared to Humalog in a Phase 3 trial of 1,040 Chinese adults with Type 2 diabetes.
  • The ultra-rapid insulin formulation showed statistically significant reduction in post-meal blood glucose rise and improved daily glucose control versus standard care.
  • The trial results support Adocia's partnership with Tonghua Dongbao and advance the innovative insulin toward potential regulatory approval in China.

Efficacy and Safety of THDB0206 Compared to Insulin Lispro Injection in Participants With Type 2 Diabetes

NCT05834868RecruitingPhase 3
Tonghua Dongbao Pharmaceutical Co.,Ltd
Posted 5/6/2022

Fermented Stevia Extract Shows Selective Cytotoxicity Against Pancreatic Cancer Cells in Laboratory Study

  • Researchers at Hiroshima University discovered that fermented stevia extract demonstrates significantly greater cytotoxicity against pancreatic cancer cells compared to non-fermented stevia extract.
  • The fermentation process with Lactobacillus plantarum SN13T creates chlorogenic acid methyl ester (CAME), which selectively kills cancer cells while sparing healthy kidney cells.
  • Laboratory tests showed fermented stevia extract blocks cancer cells at specific life cycle phases and triggers apoptosis, offering potential for targeted cancer therapy development.
  • The findings represent early-stage research requiring animal and human studies before clinical applications can be considered.

EU Regulatory Approval Advances Pfizer-BioNTech LP.8.1-Adapted COVID-19 Vaccine for 2025-2026 Season

Drug Approval
  • The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval for Pfizer and BioNTech's LP.8.1-adapted COMIRNATY vaccine targeting XFG and NB.1.8.1 variants.
  • The updated vaccine demonstrates improved immune responses against emerging SARS-CoV-2 sublineages and maintains a safety profile consistent with prior formulations.
  • European Commission authorization is expected to enable vaccine deployment as early as fall 2025 for the 2025-2026 season, with manufacturing already underway at risk.
  • The global mRNA vaccines and therapeutics market is projected to grow at 13.3% CAGR, expanding from $53.14 billion in 2025 to $144.31 billion by 2033.

Everest Medicines Raises HK$1.57 Billion to Accelerate AI+mRNA Platform and Pipeline Development

CAR-TOncology
  • Everest Medicines completed a significantly oversubscribed share placement raising approximately HK$1.57 billion to fund global R&D and commercialization efforts.
  • The company will allocate 50% of proceeds to advance its AI+mRNA platform, including EVM14 and EVM16 cancer vaccines that have achieved regulatory milestones.
  • EVM14 became Everest's first mRNA therapeutic vaccine to receive dual IND acceptance from both China's NMPA and the U.S. FDA.
  • The funding will also support commercialization of existing products including NEFECON for IgA nephropathy and the anticipated approval of VELSIPITY for ulcerative colitis.

Rocket Pharmaceuticals Cuts 30% of Workforce, Refocuses on Cardiovascular Gene Therapies

  • Rocket Pharmaceuticals is laying off 80 employees, representing 30% of its workforce, to reduce cash burn by almost 25% and extend its runway into 2027.
  • The company is narrowing its pipeline focus to prioritize late-stage cardiovascular gene therapies for Danon disease and cardiomyopathy conditions following regulatory setbacks.
  • The strategic realignment comes after an FDA clinical hold on its pivotal Danon disease trial following a patient death and previous rejection of its Kresladi gene therapy.
  • Rocket's hematology programs, including RP-L102 for Fanconi anemia previously targeted for 2025 approval, face significant delays as resources shift to cardiovascular assets.

Leads Biolabs Raises $189 Million in Hong Kong IPO, Advances First-in-Class 4-1BB Immunotherapy

  • Leads Biolabs successfully listed on the Hong Kong Stock Exchange, raising $189 million to fund clinical trials and expand its immuno-oncology pipeline.
  • The company's lead candidate LBL-024 became the world's first 4-1BB-targeted molecule to reach registrational trials, showing 75% response rates in neuroendocrine carcinoma.
  • The biotech operates proprietary platforms including LeadsBody™ for T-cell engagers and X-body™ for 4-1BB agonists, with 14 drug candidates across oncology and autoimmune diseases.
  • LBL-024 received breakthrough therapy designation from China's NMPA and orphan drug status from the FDA for neuroendocrine neoplasms.

Absci Raises $50 Million to Advance AI-Driven Drug Discovery Platform and Internal Pipeline

AIDrug Discovery
  • Absci Corporation completed a $50 million public offering of 16.67 million shares at $3.00 per share to fund its AI-powered drug discovery programs and internal pipeline development.
  • The company's cash reserves increased to $134 million as of March 2025, extending its operational runway through 2027 while advancing preclinical candidates ABS-101 and ABS-201.
  • Absci's Integrated Drug Creation platform combines generative AI with synthetic biology and has secured partnerships with pharmaceutical giants including Merck and Moderna.
  • The AI-driven biologics market is projected to grow from $13.9 billion in 2024 to over $30 billion by 2030, positioning Absci in a rapidly expanding sector.

PROCEPT BioRobotics Expands Prostate Cancer Trial to Outpatient Setting with First ASC Procedures

  • East Valley Urology completed the first three prostate cancer procedures in PROCEPT BioRobotics' FDA-approved WATER IV trial using Aquablation therapy in an ambulatory surgery center setting.
  • The outpatient procedures were performed without complications and achieved same-day discharge, demonstrating potential for more scalable and cost-effective prostate cancer treatment.
  • The WATER IV trial compares Aquablation therapy to radical prostatectomy in men with localized prostate cancer (grade group 1 to 3).
  • Aquablation therapy uses robotically controlled waterjet technology to remove prostate tissue while potentially preserving erectile, ejaculatory, and continence functions.

Magnetically Steerable Drug Delivery Vesicles Show Promise for Precision Cancer Treatment

Precision MedicineTargeted Therapy
  • Researchers at the University of Illinois Urbana-Champaign have developed microscopic lipid vesicles containing magnetic particles that can be precisely steered to target locations using magnetic fields.
  • The system combines magnetic steering with light-triggered drug release, creating a comprehensive prototype for precision drug delivery that could significantly advance cancer treatment.
  • The lipid vesicles are designed to interact only with specific cell types, offering advantages for targeted cancer therapy while utilizing existing MRI technology for navigation.
  • The team is now preparing for in vitro studies using real drugs in microfluidic systems that simulate biological environments.

Janux Therapeutics Advances Multi-Platform Pipeline with Novel ARM Technology for Autoimmune Diseases

Oncology
  • Janux Therapeutics showcased its expanded immunotherapy pipeline at R&D Day, highlighting three proprietary platforms: TRACTr, TRACIr, and the novel ARM platform targeting autoimmune diseases.
  • The company's CD19-ARM demonstrated rapid, deep B-cell depletion with prolonged memory B cell reset in non-human primates while maintaining a large safety window, positioning it for first-in-human trials in H1 2026.
  • Clinical programs JANX007 and JANX008 continue enrollment with data updates expected in H2 2025, while new TROP2-TRACTr and PSMA-TRACIr programs advance toward clinical development.
  • The company reported $996.0 million in cash and investments as of Q2 2025, providing substantial runway for its expanding development programs.

Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)

NCT05519449RecruitingPhase 1
Janux Therapeutics
Posted 9/15/2022

Study of JANX008 in Subjects With Advanced or Metastatic Solid Tumor Malignancies

NCT05783622RecruitingPhase 1
Janux Therapeutics
Posted 4/19/2023

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