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Clinical Trial News

Riboscience's First-in-Class ENPP1 Inhibitor RBS2418 Shows Promising Safety and Efficacy in Phase 1a Cancer Trial

  • Riboscience completed Phase 1a dose escalation of RBS2418, the first ENPP1 inhibitor in clinical development, demonstrating excellent safety with no dose-limiting toxicities or treatment-related serious adverse events.
  • The study enrolled 24 patients with advanced solid tumors across 13 cancer types, with 83% having failed three or more prior treatment lines, showing target-dependent clinical benefit.
  • Progression-free survival was significantly increased in patients with ENPP1 and cGAS protein expression (EG+ phenotype) compared to EG- patients (p=0.001).
  • The company has initiated Phase 2 enrollment for advanced metastatic colorectal cancer based on these encouraging results.

Evaluation of RBS2418 in Subjects With Advanced, Metastatic Solid Tumors

NCT05270213RecruitingPhase 1
Riboscience, LLC.
Posted 7/11/2022

Evaluation of RBS2418 in Patients with Advanced, Metastatic, and Progressive Colorectal Cancer

NCT06824064RecruitingPhase 2
Riboscience, LLC.
Posted 1/17/2025

Femasys Raises $4.5 Million to Advance Women's Health Technologies Including FemBloc Birth Control

  • Femasys Inc. completed a $4.5 million financing through public offering and private placement to fund expansion of its women's health product portfolio.
  • The biomedical company is developing FemBloc permanent birth control and FemaSeed infertility treatment as lead product candidates for minimally invasive reproductive health.
  • Proceeds will support commercial expansion, product development, and clinical trials for the company's in-office therapeutic and diagnostic technologies.

Prospective Multi-Center Trial for FemBloc Permanent Birth Control

NCT05977751RecruitingNot Applicable
Femasys Inc.
Posted 10/31/2023

Real-World Study Shows Safe Rechallenge with Trastuzumab Deruxtecan After Grade 1 Interstitial Lung Disease

Real World Evidence
  • A multi-institutional study of 1,476 patients found that 75% of those with grade 1 interstitial lung disease (ILD) were successfully rechallenged with trastuzumab deruxtecan, remaining on therapy for a median of 215 days.
  • Patients treated with steroids for grade 1 ILD showed significantly faster radiographic improvement (29 days vs 82 days without steroids), supporting early steroid intervention.
  • Only 27% of rechallenged patients developed recurrent ILD, mostly grade 1, with no deaths from ILD after rechallenge, demonstrating the safety of this approach.
  • The study provides real-world evidence supporting rechallenge protocols for grade 1 ILD, potentially maximizing clinical benefit from this pivotal HER2-targeted therapy.

MRPL Secures US Patent for Pharmaceutical Intermediate Production Technology

  • Mangalore Refinery and Petrochemicals Limited (MRPL) has been granted a US patent for its innovative method of producing iso-Butyl Benzene (i-BB), a critical intermediate used in pharmaceutical manufacturing.
  • The patented technology utilizes a side-chain alkylation process with a specially engineered catalyst to convert low-value streams into i-BB, which is essential for synthesizing ibuprofen (Brufen).
  • MRPL is currently establishing a pilot plant for i-BB production to transition from laboratory development to commercial-scale manufacturing, reducing dependence on imported pharmaceutical intermediates.
  • This breakthrough represents a significant advancement in India's pharmaceutical ingredient self-reliance and strengthens MRPL's global footprint in pharmaceutical technology innovation.

Investor Lawsuit Challenges Novartis' $1.7 Billion Acquisition of Regulus Therapeutics Over Kidney Disease Drug

Drug Approval
  • A shareholder lawsuit seeks to block Novartis' acquisition of Regulus Therapeutics, alleging the deal primarily benefits company insiders rather than public stockholders.
  • The $1.7 billion transaction includes Regulus' lead candidate farabursen for treating the most common inherited kidney disease, with regulatory approval triggering additional payments.
  • The complaint claims Regulus violated securities laws by omitting critical information about the sales process, conflicts of interest, and financial projections in its recommendation statement.
  • The acquisition is structured as $7 per share upfront plus contingent value rights of up to $7 per share upon farabursen's regulatory approval.

Mabwell's Novel Long-Acting G-CSF Drug MAILISHENG Receives NMPA Approval for Chemotherapy-Induced Neutropenia

Drug ApprovalOncology
  • Mabwell received NMPA approval for Albipagrastim alfa (MAILISHENG), marking China's first novel G-CSF drug developed with albumin long-acting fusion technology.
  • Phase III trial data in 496 breast cancer patients demonstrated superior efficacy with 42% relative risk reduction in febrile neutropenia compared to control.
  • The drug addresses a significant unmet need, as 65.5% of patients receiving certain chemotherapy regimens experience grade 3 or 4 neutropenia.
  • MAILISHENG represents Mabwell's first commercialized innovative drug, utilizing human serum albumin fusion to extend half-life and reduce dosing frequency.

Patritumab Deruxtecan Demonstrates Promising Efficacy in First Prospective Trial for Leptomeningeal Metastases

  • The HER3-directed antibody-drug conjugate patritumab deruxtecan achieved a 65% three-month overall survival rate in patients with leptomeningeal metastatic disease from solid tumors, meeting the primary endpoint of the TUXEDO-3 trial's cohort 3.
  • This represents the first prospective clinical trial investigating an antibody-drug conjugate specifically in patients with leptomeningeal metastases, a condition with historically poor prognosis and limited treatment options.
  • The treatment demonstrated manageable safety profile with no new neurological adverse events, while maintaining or improving patients' neurological symptoms and quality of life measures throughout the treatment period.

DS-8201a for trEatment of aBc, BRain Mets, And Her2[+] Disease

NCT04420598CompletedPhase 2
MedSIR
Posted 5/25/2020

A Study of T-DXd in Participants With or Without Brain Metastasis Who Have Previously Treated Advanced or Metastatic HER2 Positive Breast Cancer

NCT04739761Active, Not RecruitingPhase 3
AstraZeneca
Posted 6/22/2021

Phase II Study of T-DX in HER2-positive Breast Cancer Brain Metastases

NCT04752059CompletedPhase 2
Medical University of Vienna
Posted 7/28/2020

HER3-DXd in Breast Cancer and NSCLC Brain Metastases and Solid Tumor Leptomeningeal Disease

NCT05865990RecruitingPhase 2
MedSIR
Posted 11/24/2023

HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer

NCT04619004Active, Not RecruitingPhase 2
Daiichi Sankyo
Posted 2/2/2021

Teddy Laboratory and LabConnect Form Strategic Partnership to Enhance Global Clinical Trial Services

  • Teddy Laboratory, a subsidiary of Tigermed, has signed a strategic cooperation agreement with LabConnect to build a full-chain laboratory service system covering China and international markets.
  • The partnership establishes Teddy Laboratory as LabConnect's preferred laboratory partner in China, while LabConnect becomes Teddy's preferred central lab partner for overseas operations.
  • The collaboration creates a complementary "China-based capabilities + global service network" model to accelerate innovative drug development and commercialization worldwide.
  • Both companies will leverage their respective strengths to enhance global clinical trial service standards and support multinational pharmaceutical companies in expanding their operations.

HER3-Targeted ADC DB-1310 Shows Promising Results in Advanced Solid Tumors, Particularly EGFR-Mutant NSCLC

  • DB-1310, a novel HER3-targeted antibody-drug conjugate, demonstrated a 44% objective response rate in patients with EGFR-mutant non-small cell lung cancer who had exhausted standard treatments.
  • The international Phase 1/2a trial showed DB-1310 achieved a median progression-free survival of seven months and overall survival of 18.9 months in EGFR-mutant NSCLC patients.
  • Across all 172 patients with advanced solid tumors, 31% responded to treatment with manageable side effects primarily consisting of low blood counts and nausea.
  • The antibody-drug conjugate delivers chemotherapy directly to HER3-expressing cancer cells, potentially offering a new treatment option for heavily pretreated patients with limited alternatives.

Carlyle and SK Capital Complete $3-5 Per Share Acquisition of Gene Therapy Pioneer bluebird bio

Rare Disease
  • Carlyle and SK Capital Partners successfully acquired 59.8% of bluebird bio shares through a tender offer that expired May 29, 2025, meeting all conditions for the acquisition.
  • Shareholders received either $3.00 per share plus contingent value rights worth up to $6.84, or a flat $5.00 per share in cash.
  • The acquisition of the gene therapy company, which has secured FDA approvals for three therapies in under two years, is expected to close on June 2, 2025.
  • bluebird bio specializes in severe genetic diseases including sickle cell disease, β-thalassemia, and cerebral adrenoleukodystrophy with the largest ex-vivo gene therapy dataset in the field.

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