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Clinical Trial News

Lisata Therapeutics Reports Promising 60% Response Rate in Pancreatic Cancer Trial with Certepetide

Orphan Drug
  • Lisata Therapeutics and WARPNINE completed enrollment in the Phase 1b/2a iLSTA trial evaluating certepetide in combination with standard-of-care therapy for locally advanced pancreatic ductal adenocarcinoma.
  • Updated preliminary data presented at ESMO-GI demonstrated a 60% overall response rate and 100% disease control rate, with 13 of 20 participants showing partial response and one complete response.
  • The study represents the first evaluation of certepetide in locally advanced non-resectable pancreatic cancer, an earlier disease stage where immunotherapy has been largely ineffective.
  • Certepetide is designed to enhance tumor penetration of co-administered anti-cancer drugs and has received multiple regulatory designations including Fast Track and Orphan Drug status.

Harrow Secures Exclusive US Rights to Samsung Bioepis Ophthalmology Biosimilars Portfolio

Drug Approval
  • Harrow has entered into a partnership with Samsung Bioepis to gain exclusive US commercial rights to two FDA-approved ophthalmology biosimilars, BYOOVIZ and OPUVIZ, following Biogen's termination of its commercialization agreement.
  • The biosimilars target the $9 billion retinal disease treatment market, offering 30-40% wholesale acquisition cost reduction compared to reference drugs LUCENTIS and EYLEA.
  • BYOOVIZ became the first ophthalmology biosimilar approved in the US in September 2021, while OPUVIZ received FDA approval in May 2024 for broader indications including diabetic retinopathy.
  • The transition is expected to drive Harrow's revenue past $280 million in 2025, with analysts projecting the company could capture 15-20% of the US retinal disease market within three years.

I-Mab Acquires Bridge Health Biotech to Strengthen Givastomig Bispecific Antibody Development

  • I-Mab announced the acquisition of Bridge Health Biotech for $1.8 million upfront plus milestone payments to secure upstream rights to the CLDN18.2 parental antibody used in givastomig.
  • The acquisition eliminates royalty obligations and reduces future milestone payments for givastomig, which recently demonstrated an 83% objective response rate in Phase 1b dose escalation studies.
  • Givastomig is a bispecific antibody targeting CLDN18.2-positive gastric cancers that conditionally activates T cells through the 4-1BB signaling pathway in the tumor microenvironment.
  • The company expects to present topline results from Phase 1b dose expansion studies in Q1 2026, with enrollment proceeding ahead of schedule.

Regen BioPharma Prepares Phase I Trial for HemaXellerate Stem Cell Therapy Targeting Severe Aplastic Anemia

  • Regen BioPharma has received FDA clearance for an IND to begin Phase I clinical trials of HemaXellerate, an innovative stem cell-derived therapy for severe aplastic anemia in chemotherapy patients.
  • The therapy addresses a $1 billion market opportunity where the only current treatment is costly stem cell transplants requiring matched donors and carrying risk of graft-versus-host disease.
  • The company is transitioning from preclinical to clinical stage development and may pursue Orphan Drug Designation for HemaXellerate, which could significantly enhance its market position.
  • Regen BioPharma maintains a robust intellectual property portfolio with 11 awarded patents and 17 pending applications, plus two additional filed INDs in its development pipeline.

DiaMedica's DM199 Shows Promising Blood Pressure Reduction in Phase 2 Preeclampsia Trial

  • DiaMedica Therapeutics reported positive interim Phase 2 results for DM199 (rinvecalinase alfa) in treating preeclampsia, showing statistically significant reductions in both systolic and diastolic blood pressure.
  • The highest dose cohort achieved substantial mean reductions of 35 mmHg in systolic blood pressure and 15 mmHg in diastolic blood pressure at 5 minutes post-infusion.
  • DM199 demonstrated no placental transfer and was generally well-tolerated with only mild adverse events, addressing a key safety concern in preeclampsia treatment development.
  • The drug also produced a 13.2% reduction in uterine artery pulsatility index, indicating improved placental perfusion that could support fetal growth and disease modification.

UroMems Receives FDA and ANSM Clearance for Pivotal Trial of Smart Artificial Urinary Sphincter

FDA Approval
  • UroMems received investigational device exemption approval from the FDA and French ANSM to begin the SOPHIA2 pivotal trial of its UroActive smart implant for treating male stress urinary incontinence.
  • The UroActive system represents the first automated artificial urinary sphincter with smart technology, utilizing a MyoElectroMechanical System that adapts treatment based on patient activity without complex manipulation.
  • The multicenter trial follows strong feasibility study results in France showing over one year with no need for revision or explant, with the study serving as the basis for regulatory submissions to commercialize in US and European markets.

A Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter (AUS)

NCT06968741RecruitingNot Applicable
UroMems SAS
Posted 5/19/2025

Clinical Investigation to Assess a New Artificial Urinary Sphincter to Treat Urinary Incontinence in Women

NCT05828979Active, Not RecruitingNot Applicable
UroMems SAS
Posted 5/2/2023

Clinical Investigation to Assess a New Artificial Urinary Sphincter to Treat Urinary Incontinence in Men

NCT05547672Active, Not RecruitingNot Applicable
UroMems SAS
Posted 8/31/2022

Fifty1 Labs Partners with BioSpark AI to Accelerate Drug Repurposing Through Advanced Literature Mining

AI
  • Fifty1 AI Labs announces strategic partnership with intent to acquire BioSpark AI Technologies, combining AI-powered literature mining with predictive modeling for drug repurposing applications.
  • The collaboration has successfully structured over 2,000 real-world treatment pathways from medical literature using BioSpark's patented AI system for clinical data extraction.
  • The partnership aims to transform functional medicine by automating the analysis of patient journeys and treatment outcomes from vast volumes of unstructured clinical data.
  • Next phase involves AI-guided hypothesis generation using proprietary models to identify dose-response trends and synergistic drug combinations for clinical validation.

Moleculin Appoints Roche Veteran Adriano Treve as Strategic Advisor Ahead of Phase 3 AML Trial Data

Oncology
  • Moleculin Biotech has appointed Adriano Treve, a 40-year Roche veteran, as Strategic Advisor for partnerships as the company approaches key milestones in its Phase 3 MIRACLE trial.
  • The appointment comes ahead of the first unblinding of data for 45 patients in the Phase 2B/3 MIRACLE trial evaluating Annamycin in combination with cytarabine for relapsed or refractory acute myeloid leukemia.
  • Treve's extensive international experience and market access expertise are expected to enhance Moleculin's strategic positioning as interest from potential partners has significantly increased.
  • The company expects to reach the first unblinding in the second half of 2025, with the second unblinding anticipated in the first half of 2026.

Vor Bio Appoints Telitacicept Development Expert Dr. Qing Zuraw as Chief Development Officer

Drug Approval
  • Vor Bio has appointed Dr. Qing Zuraw as Chief Development Officer, bringing over 25 years of experience in autoimmune disease clinical development.
  • Dr. Zuraw previously led telitacicept development at RemeGen across four indications, achieving regulatory approvals in China for SLE, generalized myasthenia gravis, and rheumatoid arthritis.
  • The appointment positions Vor Bio to advance telitacicept through Phase 3 clinical development and global commercialization for autoantibody-driven conditions.
  • Dr. Zuraw secured multiple FDA designations for telitacicept including Fast Track, Breakthrough Therapy, and Orphan Drug status across various indications.

Congressional Lawmakers Push for Fast-Track Approval of Antiparasitic Treatments as New World Screwworm Threat Approaches U.S. Border

  • Congressional lawmakers led by Rep. Tony Gonzales and Rep. Kat Cammack are urging federal agencies to expedite approval of antiparasitic treatments for livestock to combat the approaching New World screwworm threat.
  • The lawmakers are pressing HHS to fast-track approvals for proven treatments including ivermectin, doramectin, permethrin and coumaphos that are effective abroad but lack proper U.S. labeling.
  • USDA estimates that a New World screwworm outbreak in Texas alone could cost producers $732 million annually and result in total economic losses of $1.8 billion for the state.
  • The initiative calls for coordinated action between HHS, USDA, EPA and pharmaceutical manufacturers to address regulatory barriers before the parasite crosses the southern border.

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