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Clinical Trial News

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.

Henlius Presents Comprehensive Serplulimab Data at ASCO 2025, Demonstrating Broad Efficacy Across Multiple Cancer Types

Monoclonal Antibody
  • Shanghai Henlius Biotech presented results from over ten studies of serplulimab (HANSIZHUANG) at the 2025 ASCO Annual Meeting, covering lung and gastrointestinal cancers with promising efficacy data.
  • The phase 3 ASTRUM-005 trial showed serplulimab plus chemotherapy achieved a median overall survival of 15.8 months versus 11.1 months for placebo in extensive-stage small cell lung cancer patients.
  • Multiple combination studies demonstrated high objective response rates, including 92% ORR in HER2-positive gastric cancer and 74.47% ORR in metastatic pancreatic cancer when combined with targeted therapies.
  • Real-world studies across various cancer types confirmed the safety profile and clinical effectiveness of serplulimab-based treatments in diverse patient populations.

Efficacy and Safety of Anti-PD-1, Thymalfasin, and SOX in Neoadjuvant Treatment of cStage III Gastric/Gastroesophageal Junction Adenocarcinoma

NCT06461910RecruitingPhase 2
Zekuan Xu
Posted 6/14/2024

SBRT Addition to Nivolumab-Ipilimumab Fails to Improve Outcomes in Metastatic Castration-Resistant Prostate Cancer

  • The phase 2 CheckPRO trial demonstrated that nivolumab plus ipilimumab showed clinical activity in metastatic castration-resistant prostate cancer patients with PSA response rates of approximately 21%.
  • Adding stereotactic body radiation therapy (SBRT) to the immunotherapy combination was well tolerated but did not enhance treatment efficacy across key endpoints.
  • Both treatment arms showed similar progression-free survival of approximately 2.5 months and overall survival of around 9-10 months in heavily pretreated patients.
  • The study highlights the need for further research to identify which mCRPC patients are most likely to respond to immune checkpoint inhibitor therapy.

Checkpoint Inhibitors and SBRT for MCRPC

NCT05655715CompletedPhase 2
Herlev and Gentofte Hospital
Posted 11/25/2019

Arrowhead Pharmaceuticals Launches First-in-Human Trial of ARO-ALK7 for Obesity Treatment

  • Arrowhead Pharmaceuticals has dosed the first subjects in a Phase 1/2a clinical trial of ARO-ALK7, marking the first investigational RNAi therapeutic to target a gene expressed in adipose tissue for obesity treatment.
  • ARO-ALK7 is designed to silence the ACVR1C gene to reduce production of Activin receptor-like kinase 7 (ALK7), which regulates energy homeostasis in adipose tissue and signals the body to store fat.
  • The study will evaluate single and multiple ascending doses of ARO-ALK7 as monotherapy in healthy obese volunteers, followed by combination therapy with tirzepatide in obese patients with and without type 2 diabetes.
  • Preclinical animal studies demonstrated that ALK7 silencing in adipose tissue led to reduced body weight and fat mass while preserving lean muscle mass.

Study of ARO-ALK7 in Adult Volunteers With Obesity With and Without Type 2 Diabetes Mellitus

NCT06937203RecruitingPhase 1
Arrowhead Pharmaceuticals
Posted 5/7/2025

Regeneron's Trevogrumab Shows Promise in Preserving Muscle Mass When Combined with Wegovy in Weight-Loss Study

  • Regeneron's experimental drug trevogrumab, when combined with Novo Nordisk's Wegovy (semaglutide), helped preserve up to 80% of lean muscle mass compared to semaglutide alone in a mid-stage clinical study.
  • The combination therapy demonstrated enhanced fat loss while maintaining muscle mass, addressing a key concern in obesity treatment where muscle preservation is critical for metabolic health.
  • A triple combination including garetosmab showed substantially higher discontinuation rates due to tolerability issues, highlighting the importance of balancing efficacy with safety in combination therapies.
  • Full study results are expected later this year, which could provide crucial data for advancing this muscle-preserving approach to obesity treatment.

OnCusp's CDH6-Directed ADC CUSP06 Shows 36% Response Rate in Platinum-Resistant Ovarian Cancer

  • OnCusp Therapeutics reported initial Phase 1a results for CUSP06, a CDH6-directed antibody-drug conjugate, showing a 36% overall response rate in heavily pretreated platinum-resistant high-grade serous ovarian cancer patients.
  • The study enrolled 37 patients who received CUSP06 at doses ranging from 1.6 to 5.6 mg/kg every three weeks, with patients having a median of 4 prior lines of therapy.
  • CUSP06 demonstrated a manageable safety profile with hematologic toxicities as the most common treatment-related adverse events, and achieved a 92% clinical benefit rate in ovarian cancer patients.
  • The FDA recently granted Fast Track designation to CUSP06 for platinum-resistant ovarian cancer treatment, supporting its potential as a best-in-class therapy.

A Study of CUSP06 in Patients With Platinum-Refractory/Resistant Ovarian Cancer and Other Advanced Solid Tumors

2024-519862-33-00WithdrawnPhase 1
Oncusp Therapeutics Inc.

Kivu Bioscience Partners with Sterling Pharma for Phase 1 Manufacturing of Next-Generation ADC KIVU-107

Oncology
  • Kivu Bioscience has selected Sterling Pharma Solutions to manufacture cGMP clinical material for its lead oncology ADC candidate KIVU-107 ahead of Phase 1 trials.
  • KIVU-107 is described as a potential first-in-class antibody-drug conjugate featuring site-specific conjugation technology that positions the linker-payload in a natural antibody cavity.
  • The partnership leverages Sterling's dedicated bioconjugation facility in Deeside, UK, which recently received a £10 million investment to double its GMP manufacturing capacity.
  • The collaboration includes comprehensive development activities from process familiarization through analytical development and scale-up preparation for clinical manufacturing.

Newcastle University Researchers Identify Novel CD30-Targeting Combination Therapy to Overcome Immune Checkpoint Blockade Resistance in Melanoma

  • Newcastle University scientists led by Dr. Shoba Amarnath have discovered why over 60% of cancer patients fail to respond to immune checkpoint blockade therapy, identifying regulatory T cells as key drivers of resistance.
  • The research reveals that blocking PD-1 paradoxically enhances CD30 expression on regulatory T cells, promoting tumor growth and immune suppression in resistant patients.
  • A Phase II trial combining anti-PD1 therapy with Brentuximab Vedotin (anti-CD30) demonstrated 24% median survival benefit in patients with refractory metastatic cutaneous melanoma.
  • The findings, published in Nature Immunology, suggest this combination approach could benefit patients with lung, bowel, pancreatic and other solid cancers currently resistant to ICB monotherapy.

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