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Clinical Trial News

Elahere Demonstrates Promising Results in Platinum-Sensitive Ovarian Cancer

  • AbbVie's Elahere achieved a 51.9% objective response rate (ORR) in heavily pre-treated patients with FRα-positive platinum-sensitive ovarian cancer (PSOC).
  • The phase II PICCOLO study's safety profile of Elahere was consistent with previous findings, with no new safety concerns identified.
  • Elahere, a first-in-class antibody-drug conjugate (ADC), is being evaluated in multiple studies for ovarian cancer, both as monotherapy and in combination with other drugs.
  • AbbVie acquired Elahere through the ImmunoGen acquisition for $10.1 billion, diversifying its oncology pipeline and entering the ADC space.

FDA Halts Biomea Fusion's Diabetes Drug Trials Due to Hepatotoxicity Concerns

  • The FDA has placed a full clinical hold on Biomea Fusion's Phase I/II trials for BMF-219, a drug being developed for type 1 and type 2 diabetes, due to potential liver toxicity.
  • The decision was prompted by elevated liver enzyme levels observed during the dose escalation phase of the COVALENT-111 and COVALENT-112 trials, though most adverse events were mild to moderate.
  • Biomea Fusion's stock price plummeted by over 60% following the announcement, reflecting investor concerns about the future of BMF-219 and the company's clinical development program.
  • Biomea Fusion is collaborating with the FDA to address the concerns and resume the trials, emphasizing its commitment to patient safety and the potential of BMF-219 to improve glycemic control.

Abu Dhabi Health Department and Novartis Partner to Advance Genomics Research and Radioligand Therapy

  • The Department of Health - Abu Dhabi and Novartis signed an MoU at BIO 2024 to advance clinical genomics research for real-world evidence and promote understanding of radioligand therapy for cancer patients.
  • The partnership will leverage Abu Dhabi's genomics expertise and regulatory framework to explore innovative solutions in oncology, cardiovascular disease, and neuroscience, supporting the Emirati Genome Programme.
  • This collaboration aims to establish Abu Dhabi as a global life science hub while enhancing Health Technology Assessment capabilities through shared best practices and facilitated partnerships.

Sequana Medical to Present alfapump® Safety and Quality of Life Data at EASL Congress 2024

Sequana Medical announces significant findings from its North American pivotal POSEIDON study on the alfapump® system, highlighting improved quality of life for patients with recurrent or refractory ascites due to liver cirrhosis. The data, to be presented at the EASL Congress 2024, shows the alfapump's safety profile is comparable to standard care, with a strong preference among US patients for the device over traditional paracentesis procedures.

MAIA Biotechnology's THIO Shows Promising Results in NSCLC Trial

  • MAIA Biotechnology's THIO, a telomere-targeting agent, demonstrates encouraging clinical activity in advanced non-small cell lung cancer (NSCLC).
  • In the Phase 2 THIO-101 trial, THIO combined with cemiplimab showed a 38% overall response rate in third-line NSCLC patients.
  • The trial also reported a disease control rate of 85% and a median progression-free survival of 5.5 months with the THIO 180mg regimen.
  • MAIA Biotechnology has secured significant funding to advance the clinical development of THIO and its portfolio of immuno-oncology therapies.

THIO Sequenced With Cemiplimab in Advanced NSCLC

NCT05208944RecruitingPhase 2
Maia Biotechnology
Posted 6/8/2022

Cilcare and Shionogi Form €400 Million Partnership to Develop Novel Hearing Loss Treatments

  • Cilcare has granted Shionogi an exclusive option to license global rights to two promising drug candidates (CIL001 and CIL003) for hearing disorders, receiving an upfront payment of €15 million with potential milestone payments reaching €400 million.
  • CIL001, a disease-modifying molecule targeting cochlear synaptopathy, is scheduled to enter Phase 2a clinical trials in 2025, while CIL003 remains in preclinical development, both addressing significant unmet needs in hearing loss treatment.
  • The partnership aims to combat the global health crisis of hearing disorders affecting approximately 1.5 billion people worldwide, with particular focus on hidden hearing loss (cochlear synaptopathy) that impacts about 15% of the population.

FDA Advisory Panel Unanimously Recommends JN.1-Targeted COVID-19 Vaccines for Fall 2024

• The FDA's independent vaccine advisory committee unanimously voted to recommend updating COVID-19 vaccines to target the JN.1 variant lineage for the 2024-2025 season. • Current vaccines targeting KP.2 strain show reduced effectiveness against circulating variants, with JN.1 descendants KP.2 and KP.3 now dominating U.S. infections. • Vaccine manufacturers Pfizer/BioNTech, Moderna, and Novavax presented data showing their JN.1-targeted shots produce strong protection against current virus strains. • The recommendation aligns with WHO guidance and comes as COVID-19 continues evolving into new omicron subvariants rather than dramatically different strains.

Bilateral Gene Therapy Restores Hearing in Both Ears for Children with Inherited Deafness

  • Five children with DFNB9 inherited deafness gained hearing in both ears after receiving bilateral gene therapy targeting OTOF gene mutations in a world-first clinical trial.
  • The children demonstrated dramatic improvements in speech perception, sound localization, and ability to appreciate music within weeks of treatment.
  • This bilateral approach represents a significant advancement over previous single-ear treatments, enabling three-dimensional hearing crucial for communication and daily activities.
  • The therapy uses adeno-associated virus to deliver functional OTOF gene copies to restore otoferlin protein production in the inner ear.

Inhibikase Therapeutics Completes Enrollment in Phase 2 Trial for Parkinson's Disease Treatment

  • Inhibikase Therapeutics has completed enrollment of 120 participants across 32 U.S. sites in its Phase 2 '201' trial evaluating risvodetinib for untreated Parkinson's disease, with results expected in Q4 2024.
  • The company is expanding its therapeutic pipeline, including redirecting IkT-001Pro development toward Pulmonary Arterial Hypertension (PAH), with an IND application planned for early Q3 2024.
  • Inhibikase anticipates advancing multiple late-stage ready assets across its therapeutic pipeline in 2025, including pursuing an End of Phase 2 discussion with the FDA for risvodetinib by the end of 2024.

A Randomized, Double-Blind, Placebo-Controlled Trial of IkT-148009 in Untreated Parkinson's Disease

NCT05424276Active, Not RecruitingPhase 2
ABLi Therapeutics, Inc.
Posted 5/15/2023

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