MedPath

Clinical Trial News

Curogen Appoints Industry Veteran Arvind Sood as Global COO to Lead US Expansion of Nanotechnology-Based Autoimmune Therapies

  • Curogen, a South Korean biotechnology company focused on nanotechnology-based autoimmune treatments, has appointed Arvind Sood as Global Chief Operating Officer to establish and grow its US operations.
  • The company expanded its board of directors with seven distinguished leaders, including rheumatology expert Dr. Allan Gibofsky and biotech investor Dr. Craig Gordon, to support its global expansion strategy.
  • Curogen's preclinical pipeline includes innovative small molecules and multi-specific TRAP proteins targeting inflammatory bowel disease, hidradenitis suppurativa, and other high unmet need autoimmune conditions.
  • The strategic appointments position Curogen to accelerate research and development efforts while expanding its footprint in US and global markets with novel oral drug approaches for autoimmune diseases.

Protara Therapeutics Appoints William Conkling as Chief Commercial Officer to Lead Commercialization Strategy

CAR-T
  • Protara Therapeutics has appointed William Conkling as Chief Commercial Officer, bringing over two decades of experience in developing and commercializing cancer and rare disease therapeutics.
  • Conkling previously led commercial organizations at Rafael Holdings, Immunomedics, and Novartis, including the successful launch of Trodelvy for triple negative breast cancer and Kymriah CAR-T therapy.
  • The appointment positions Protara for potential transition to a commercial-stage organization as it advances TARA-002 for bladder cancer and lymphatic malformations through Phase 2 trials.

Five-Year Data Show Lasting Survival Benefits from Single-Dose TIL Therapy in Advanced Melanoma

Drug Approval
  • Long-term follow-up data from the C-144-01 Phase 2 trial demonstrate that lifileucel TIL therapy achieved tumor shrinkage in 79.3% of patients with treatment-refractory advanced melanoma.
  • Nearly one in five patients (19.7%) remained alive at five years following a single infusion, with 31.4% of responders maintaining their response at the five-year mark.
  • The therapy represents the first FDA-approved cellular treatment for solid tumors and is currently under regulatory review in Europe and the UK for broader clinical use.

Pembrolizumab in Treating Patients With Desmoplastic Melanoma That Can or Cannot Be Removed by Surgery

NCT02775851Active, Not RecruitingPhase 2
National Cancer Institute (NCI)
Posted 2/6/2017

Researchers Develop High-Throughput Lectin-Based Screening Method to Optimize Sialic Acid Glycosylation in Drug Development

  • Researchers have developed a lectin-based high-throughput screening method to streamline the selection of clones with optimal sialic acid glycosylation profiles for drug development.
  • The screening technique utilizes lectins—proteins that bind specifically to sugar molecules—to rapidly assess and quantify sialic acid levels across numerous samples simultaneously.
  • This advancement addresses challenges associated with traditional techniques by offering faster and more efficient analysis critical for therapeutic development.
  • The method enhances efficiency in identifying clones that exhibit desirable glycosylation patterns, which significantly influence protein function and therapeutic effectiveness.

Frontage Laboratories Expands Manufacturing Capabilities with New 46,300 sq ft CRDMO Facility in Pennsylvania

  • Frontage Laboratories officially opened a new 46,300-square-foot Good Manufacturing Practice facility in Exton, Pennsylvania, featuring nine GMP suites including high-potent and aseptic manufacturing capabilities.
  • The state-of-the-art facility supports comprehensive pharmaceutical manufacturing including injectables, tablets, capsules, and specialized preparations, offering end-to-end clinical supply solutions.
  • This expansion significantly enhances Frontage's contract research, development and manufacturing organization footprint, positioning the company to better serve pharmaceutical and biotech clients' evolving development needs.

Rebecsinib Becomes First Space-Tested Cancer Drug to Enter Clinical Trials

  • Rebecsinib, a cancer drug targeting the ADAR1 gene, has received FDA approval to enter clinical trials under Investigational New Drug status after successful testing aboard the International Space Station.
  • The drug demonstrated superior performance compared to FDA-approved Fedratinib in arresting cancer tumor organoid growth during Axiom Missions 2 and 3.
  • Axiom Mission 4, launching June 10, will test Rebecsinib's effectiveness against triple-negative breast cancer cells in microgravity conditions.
  • Microgravity accelerates tumor growth, with mini-tumors doubling in size within 10 days, providing an enhanced environment for cancer drug testing and development.

Eisai's LENVIMA Combination Therapy Receives Chinese Approval for Unresectable Hepatocellular Carcinoma

Drug Approval
  • China's NMPA approved LENVIMA (lenvatinib) combined with pembrolizumab and TACE for treating unresectable, non-metastatic hepatocellular carcinoma based on Phase III LEAP-012 trial results.
  • The combination therapy demonstrated a 34% reduction in disease progression risk compared to TACE alone, with median progression-free survival extending from 10.0 to 14.6 months.
  • This approval addresses a critical unmet need in China, which accounts for over 40% of global liver cancer cases with approximately 367,000 new cases and 316,000 deaths in 2022.
  • The treatment represents a significant advancement for patients with unresectable HCC, where TACE has been standard care but many patients experience disease progression within one year.

Berkshire Biomedical Secures $2.9M NIH Grant for Biometric Methadone Dispensing System Clinical Study

  • Berkshire Biomedical Corporation received a two-phase Fast-Track SBIR grant worth approximately $2.9 million from NIH's National Institute of Drug Abuse to evaluate their COPA System for take-home methadone medication management.
  • The COPA System is a novel oral liquid dispensing device that uses dual biometric identification (fingerprint and dentition) to ensure only authenticated users receive precise medication doses.
  • The clinical study will assess patient retention and other benefits of the biometric system for Medication for Opioid Use Disorder treatment, addressing the challenge that daily clinic visits reduce treatment retention rates.
  • This represents Berkshire's second NIH Fast-Track SBIR grant, following a previous $2.2 million award in 2022, reflecting continued federal support for the technology's potential to expand access to opioid treatment programs.

Enterome Reports Positive Phase 2 Data for EO2463 in Indolent Non-Hodgkin Lymphoma

Oncology
  • Enterome will present positive Phase 2 data for EO2463, its lead OncoMimics immunotherapy, in treating indolent non-Hodgkin lymphoma at the International Conference on Malignant Lymphoma on June 21, 2025.
  • The SIDNEY study demonstrates EO2463's potential as a frontline therapy across multiple patient groups, including watch-and-wait, first-line, and relapsed/refractory settings.
  • Enterome recently held a positive Type-C meeting with the FDA, establishing a clear regulatory pathway to marketing approval for EO2463 in indolent non-Hodgkin lymphoma.
  • EO2463 is an innovative off-the-shelf immunotherapy combining four synthetic peptides that target multiple B-cell markers including CD20, CD22, CD37, and CD268.

Culturally Tailored Intervention Shows Promise for Latina Breast Cancer Survivors in Randomized Trial

  • A randomized controlled trial of 136 Latina breast cancer survivor-caregiver pairs demonstrated high engagement rates, with 71.4% attending at least five of eight intervention sessions and 82% retention at six months.
  • The culturally tailored group intervention showed clinically meaningful improvements in anxiety and fatigue among survivors at six months compared to usual care controls.
  • While improvements were clinically significant, statistical significance was not maintained after adjusting for confounding variables, highlighting the complexity of measuring efficacy in community-based interventions.
  • The study, conducted across Washington D.C., New York City, and San Jose, demonstrates the feasibility of implementing culturally competent psychosocial interventions in underserved populations.

MedPath

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

© 2025 MedPath, Inc. All rights reserved.