MedPath

Clinical Trial News

Sana Biotechnology Reports Breakthrough in Type 1 Diabetes Cell Therapy with 6-Month Clinical Data

CAR-T
  • Sana Biotechnology presented positive 6-month clinical results showing hypoimmune-modified pancreatic islet cells survived and functioned without immunosuppression in type 1 diabetes patients.
  • The New England Journal of Medicine published the company's 12-week clinical results, demonstrating stable C-peptide production and successful immune evasion.
  • The company raised $105 million in new capital and expects to file investigational new drug applications for SC451 and SG299 as early as 2026.
  • Clinical data from ongoing GLEAM and VIVID trials evaluating allogeneic CAR T cell therapies are expected to be reported in 2025.

Garden Launches BLOOM AI Engine to Accelerate IP-Aware Drug Discovery

AIDrug Discovery
  • Garden has launched BLOOM, a Markush structure search engine that provides AI drug-design teams with near-instant verification of small-molecule intellectual property landscapes during the discovery process.
  • The system delivers a 32.44× speed improvement over standard search methods, reducing verification time from 1.491 ms to 0.047 ms per comparison while eliminating false positives that plague legacy approaches.
  • BLOOM integrates graph-based reasoning with patent databases to enable real-time go/no-go decisions during ideation, addressing the bottleneck between AI molecule generation and IP diligence verification.

Tahoe Therapeutics Secures $30M to Create World's Largest Single-Cell Dataset for AI-Driven Drug Discovery

AIPrecision MedicineDrug Discovery
  • Tahoe Therapeutics raised $30 million in Series A funding led by Amplify Partners to build a one billion single-cell datapoint dataset for training Virtual Cell Models.
  • The company's previous Tahoe-100M dataset has been downloaded nearly 100,000 times and already led to discovery of promising therapeutic candidates for major cancer subtypes.
  • The new dataset will map one million drug-patient interactions and aims to reduce clinical trial failure rates while accelerating precision medicine development.
  • Tahoe plans to select a single strategic partner to access the dataset and collaborate on developing the first medicines powered by virtual cell models.

Veru Selects Novel Modified-Release Enobosarm Formulation for Weight Loss Management Using Advanced 3D Printing Technology

  • Veru Inc. has selected a novel modified-release oral formulation of enobosarm, a selective androgen receptor modulator, for chronic weight loss management following successful pharmacokinetic clinical study results.
  • The new formulation, developed using Laxxon Medical's proprietary SPID®-Technology, demonstrated improved drug release profile with reduced maximum plasma concentration and delayed time to peak levels compared to immediate release capsules.
  • The formulation is protected by robust patent estate through 2037 and beyond, with new patent applications filed for the modified-release version potentially extending protection to 2046.
  • This advanced formulation will be available for Phase 3 clinical studies and commercialization of enobosarm as a next-generation drug to enhance GLP-1 receptor agonist therapy for obesity treatment.

IO Biotech Phase 3 Trial Fails to Meet Primary Endpoints

  • IO Biotech's Phase 3 clinical trial has failed to deliver on its primary objectives, marking a significant setback for the company's development program.
  • The trial failure represents a major disappointment for investors and stakeholders who had anticipated positive results from the late-stage study.
  • This development highlights the inherent risks in pharmaceutical development, where even promising therapies can fail in advanced clinical testing phases.

Intermittent Fasting Enhances Anti-Androgen Therapy Efficacy in Prostate Cancer, Preclinical Study Shows

  • Researchers demonstrated for the first time that alternate-day fasting increases the efficacy of anti-androgen therapy in prostate cancer through preclinical mouse models.
  • The study found that intermittent fasting reduces androgen receptor expression and signaling, enhancing the antitumor activity of enzalutamide by reducing amino acid levels and protein synthesis.
  • Clinical trials are now underway to evaluate restricted eating patterns in prostate cancer patients receiving hormone therapy and plant-based diets for cancer patients on chemotherapy.

INOVIO's INO-3107 DNA Medicine Shows Sustained Long-Term Benefits in Recurrent Respiratory Papillomatosis Treatment

Orphan DrugRare Disease
  • INOVIO's DNA medicine INO-3107 demonstrated improved long-term efficacy in treating Recurrent Respiratory Papillomatosis, with overall response rates increasing from 72% in Year 1 to 86% in Year 2.
  • Complete response rates nearly doubled from 28% to 50% between Year 1 and Year 2, while mean annual surgeries dropped 78% from 4.1 pre-treatment to 0.9 in Year 2.
  • The retrospective study published in The Laryngoscope followed 28 patients for a median of 2.8 years, showing sustained clinical benefits without serious adverse events.
  • INO-3107 has received FDA Orphan Drug and Breakthrough Therapy designations and is eligible for accelerated approval pathway submission.

IO Biotech's Cylembio Plus Pembrolizumab Demonstrates Clinical Improvement in Advanced Melanoma Phase 3 Trial

  • IO Biotech's therapeutic cancer vaccine Cylembio combined with pembrolizumab achieved a median progression-free survival of 19.4 months versus 11.0 months with pembrolizumab alone in advanced melanoma patients.
  • The combination showed particularly pronounced benefits in PD-L1-negative patients, with median PFS of 16.6 months compared to 3.0 months for pembrolizumab monotherapy.
  • Despite narrowly missing statistical significance (p=0.056), the company plans to meet with FDA this fall to discuss potential regulatory pathways for approval.
  • The treatment was well-tolerated with no new safety signals, with injection site reactions being the most common adverse event in 56% of patients.

IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma (IOB-013 / KN-D18)

NCT05155254Active, Not RecruitingPhase 3
IO Biotech
Posted 5/17/2022

Combination Therapy With Nivolumab and PD-L1/IDO Peptide Vaccine to Patients With Metastatic Melanoma

NCT03047928CompletedPhase 1
Inge Marie Svane
Posted 2/22/2018

IO102-IO103 in Combination With Pembrolizumab as First-line Treatment for Patients With Metastatic NSCLC, SCCHN, or mUBC

NCT05077709Active, Not RecruitingPhase 2
IO Biotech
Posted 2/14/2022

Phase II Trial of Neoadjuvant and Adjuvant IO102-IO103 and Pembrolizumab KEYTRUDA® in Patients With Resectable Tumors

NCT05280314RecruitingPhase 2
IO Biotech
Posted 12/21/2023

Subcutaneous EEG Device Demonstrates Superior Seizure Detection in Treatment-Resistant Epilepsy Study

AI
  • A landmark study published in Epilepsia shows that a subcutaneous EEG device accurately detected seizures in patients with treatment-resistant epilepsy over 15 months of home monitoring.
  • The AI-powered implantable device captured 754 seizures across nearly 72,000 hours of real-world data, revealing that patients only correctly recorded 48% of their episodes in traditional seizure diaries.
  • The coin-sized device, placed under the scalp behind the ear, was well-tolerated by participants and could transform epilepsy treatment by providing objective seizure data to clinicians.
  • Results demonstrate the potential for this technology to replace unreliable patient-reported seizure tracking, particularly benefiting the one-third of epilepsy patients who have treatment-resistant disease.

IO Biotech's Melanoma Vaccine Narrowly Misses Primary Endpoint in Phase 3 Trial Despite Promising Subgroup Results

  • IO Biotech's cancer vaccine Cylembio combined with Keytruda showed a 23% relative risk reduction in disease progression or death compared to Keytruda alone, but narrowly missed statistical significance with a p-value of 0.056.
  • The combination therapy demonstrated a median progression-free survival of 19.4 months versus 11.0 months for Keytruda monotherapy, with particularly strong results in PD-L1-negative patients showing 16.6 months versus 3.0 months.
  • Despite the primary endpoint miss, IO Biotech plans to meet with the FDA in Q3 to discuss potential approval based on subgroup analyses, including a 46% risk reduction in patients testing negative for immunotherapy response proteins.
  • The company's stock fell over 20% following the announcement, reflecting investor skepticism about regulatory approval prospects despite the narrow statistical miss.

IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma (IOB-013 / KN-D18)

NCT05155254Active, Not RecruitingPhase 3
IO Biotech
Posted 5/17/2022

MedPath

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

© 2025 MedPath, Inc. All rights reserved.