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Clinical Trial News

Solid Tumor Market Sees Innovation with Aethlon Medical's Hemopurifier Trial and New Immunotherapy Approvals

  • Aethlon Medical activates a clinical trial site in Australia for its Hemopurifier device in patients with solid tumors resistant to anti-PD-1 therapies.
  • The solid tumors market is projected to reach $375.4 billion by 2034, driven by advancements in targeted and immunotherapies.
  • Immuneering reports promising initial data for IMM-1-104 in pancreatic cancer, showing a 40% objective response rate in early trials.
  • FDA approves new immunotherapy combinations from AstraZeneca, Merck, and GlaxoSmithKline for advanced endometrial cancer, expanding treatment options.

Rocket Pharma Completes Enrollment in Phase 2 Trial of RP-A501 for Danon Disease

  • Rocket Pharmaceuticals has completed enrollment in its Phase 2 pivotal trial of RP-A501 for male patients with Danon disease.
  • The trial enrolled 12 patients across the U.S. and EU, evaluating RP-A501's efficacy and safety with a dose of 6.7 x 10^13 GC/kg.
  • RP-A501 targets LAMP2 protein expression and left ventricular mass, with potential for accelerated approval based on biomarker endpoints.
  • Rocket plans to pursue simultaneous regulatory filings in the U.S. and other regions, addressing the unmet need for Danon disease treatment.

A Gene Therapy Study of RP-A501 in Male Patients With Danon Disease

NCT06092034RecruitingPhase 2
Rocket Pharmaceuticals Inc.
Posted 9/5/2023

TransCode Therapeutics Advances Metastatic Cancer Therapy with TTX-MC138 Phase 1 Trial

  • TransCode Therapeutics has dosed the first two patients in a Phase 1 clinical trial of TTX-MC138, a novel therapy for metastatic cancers.
  • The trial is designed to evaluate the safety and tolerability of TTX-MC138 in patients with various metastatic solid tumors.
  • TTX-MC138 targets microRNA-10b, a key driver of metastasis, and showed evidence of delivery to metastatic lesions in a Phase 0 trial.
  • Initial dosing of the first cohort in the Phase 1a trial has been completed with no significant safety or dose-limiting toxicities reported.

Study of TTX-MC138 in Subjects With Advanced Solid Tumors

NCT06260774RecruitingPhase 1
TransCode Therapeutics
Posted 9/5/2024

Guard Therapeutics' RMC-035 Shows Kidney-Protective Effect in Phase 2 Trial

  • Guard Therapeutics' Phase 2 AKITA study results, published in eClinicalMedicine, demonstrate a statistically significant kidney-protective effect of RMC-035 in patients undergoing open-heart surgery.
  • RMC-035 improved kidney function, measured by estimated glomerular filtration rate (eGFR), at 90 days post-surgery compared to placebo, indicating a clinically relevant benefit.
  • The study also showed a reduction in Major Adverse Kidney Events (MAKE) at 90 days, aligning with the expected primary efficacy endpoint for a future Phase 3 trial.
  • A Phase 2b study (POINTER) has been initiated to optimize the dose and identify the target patient population for RMC-035 before a pivotal Phase 3 study.

Poseida's Allogeneic CAR-T Therapy P-BCMA-ALLO1 Shows High Response in Myeloma

  • Poseida Therapeutics reported a 91% overall response rate with P-BCMA-ALLO1 in relapsed/refractory multiple myeloma patients in an optimized lymphodepletion arm.
  • The allogeneic CAR-T therapy demonstrated a favorable safety profile, with low rates of cytokine release syndrome and no graft-versus-host disease.
  • P-BCMA-ALLO1 has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA, expediting its development for multiple myeloma.
  • The Phase 1 trial results highlight the potential of P-BCMA-ALLO1 as an off-the-shelf treatment option, eliminating the need for apheresis or bridging therapy.

P-BCMA-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Multiple Myeloma

NCT04960579RecruitingPhase 1
Poseida Therapeutics, Inc.
Posted 5/5/2022

BeiGene's Tevimbra Approved in Israel for Advanced Esophageal Cancer

  • The Israeli Ministry of Health has approved Tevimbra (tislelizumab) as a monotherapy for unresectable or metastatic esophageal squamous cell carcinoma (OSCC).
  • This approval provides a new treatment option for adult patients who have previously undergone systemic chemotherapy, addressing a critical need in cancer care.
  • BeiGene is expanding Tevimbra's availability in Israel, with submissions for first- and second-line treatments for non-small cell lung cancer (NSCLC) underway.
  • Over 900,000 patients have been prescribed Tevimbra globally, demonstrating its potential to improve survival and quality of life across various tumor types.

Cullinan Therapeutics Advances CLN-978 for SLE Treatment with Phase 1 Trial Approval

  • Cullinan Therapeutics has received approval to initiate a global Phase 1 clinical trial of CLN-978 for systemic lupus erythematosus (SLE).
  • The Phase 1 trial will assess the safety, pharmacokinetics, and initial clinical activity of CLN-978 in SLE patients across multiple sites, including Australia.
  • CLN-978 is a novel CD19xCD3 bispecific T cell engager designed for convenient dosing and potential treatment-free remission in SLE patients.
  • The FDA has also approved Cullinan to expand its global trial to include U.S. patients with moderate to severe SLE.

Boston Scientific's INGEVITY+ Pacing Leads Receive FDA Expanded Indication for LBBA Pacing

  • Boston Scientific has gained FDA approval for an expanded indication of its INGEVITY+ Pacing Leads.
  • The expanded indication includes conduction system pacing (CSP) and sensing of the left bundle branch area (LBBA).
  • LBBA pacing offers an alternative to traditional right ventricular pacing for symptomatic bradycardia, potentially reducing heart failure risk.
  • The approval was supported by data from the INSIGHT-LBBA study, involving approximately 400 patients.

Synbiotic Supplementation to Prevent Preterm Birth: A Multi-Center Trial

  • A multi-center, randomized, placebo-controlled trial is underway to investigate the efficacy of synbiotic supplementation in preventing spontaneous preterm birth (sPTB).
  • Pregnant women at risk for sPTB between 80/7 and 106/7 weeks of gestation will receive either a synbiotic containing eight Lactobacillus strains or a placebo daily until delivery.
  • The primary outcome is gestational age at delivery, with secondary outcomes including PTB rates, PPROM rates, vaginal microbiome analysis, and neonatal outcomes.
  • The trial aims to recruit 402 participants across seven Belgian teaching hospitals over approximately 36 months to determine if synbiotics can prolong pregnancy and improve neonatal health.

Ascletis' ASC30 Enters Phase I Trials as Novel Oral and Injectable Obesity Treatment

  • Ascletis has initiated two Phase I clinical trials in the U.S. for ASC30, a small molecule GLP-1R agonist, offering both once-monthly subcutaneous injection and once-daily oral tablet options for obesity treatment.
  • Preclinical data indicates ASC30 is two- to threefold more potent than orforglipron in vitro and demonstrates superior insulin secretion in non-human primates.
  • Animal studies show that ASC30 sustains weight loss with both monthly injections and daily oral doses, supporting its potential for convenient administration in humans.
  • Topline data from the Phase I trials are expected in the first quarter of 2025, potentially positioning ASC30 as a first-in-class and best-in-class GLP-1R agonist.

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