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Clinical Trial News

Evogene Completes First-in-Class AI Foundation Model for Small Molecule Design with 90% Precision

AIDrug Discovery
  • Evogene Ltd. has completed its generative AI foundation model version 1.0 for small molecule design, developed in collaboration with Google Cloud, achieving approximately 90% precision compared to 29% in traditional GPT AI models.
  • The model addresses the core challenge of identifying novel small molecules that simultaneously meet multiple complex product criteria while being patentable, essential for both pharmaceutical and agriculture applications.
  • Built on a dataset of approximately 38 billion molecular structures and trained using Google Cloud's advanced AI infrastructure, the model expands ChemPass AI capabilities to generate truly novel molecular structures.
  • Development is already underway on version 2.0 with enhanced flexibility for multi-parameter optimization, incorporating customized parameters tailored to therapeutic contexts and specific agriculture requirements.

Silicogenix Partners with BioDuro to Accelerate AI-Driven Drug Discovery for Complex Diseases

AIDrug DiscoveryOncology
  • Silicogenix, a pioneer in AI-powered small molecule design technology, has formed a strategic partnership with global CRDMO BioDuro to streamline drug discovery for complex and rare diseases.
  • The collaboration combines SGX's proprietary polypharmacology frameworks with BioDuro's integrated drug discovery platform to reduce development costs and timelines from concept to preclinical stages.
  • SGX's technology enables access to the majority of the human proteome and supports novel therapeutic approaches including combination therapies with standard-of-care treatments.
  • The partnership aims to accelerate development of first-in-class oncology and immunology therapeutics that address significant unmet medical needs in complex disease areas.

ImmVira Initiates Phase II Trial for Novel Oncolytic Immunotherapy in BCG-Unresponsive Bladder Cancer

  • ImmVira has dosed the first patient in a multi-regional Phase II clinical trial evaluating MVR-T3011, a novel oncolytic immunotherapy for BCG-unresponsive non-muscle invasive bladder cancer.
  • Phase I data demonstrated an encouraging complete response rate of over 80% at the 2×10⁹ PFU dose cohort, with sustained 3-month recurrence-free survival exceeding 80% in 16 evaluable patients.
  • The FDA-approved Phase II study will enroll patients at 15-20 cancer centers across the United States and China to confirm the recommended dose and assess anti-tumor efficacy.
  • MVR-T3011 combines a replication-competent oncolytic virus with PD-1 antibody and IL-12 expression to enhance immune responses in the tumor microenvironment.

A Study of T3011 in Patients With BCG-Unresponsive NMIBC or BCG-Exposed, Chemotherapy-Unresponsive NMIBC

NCT06971614RecruitingPhase 2
ImmVira Pharma Co. Ltd
Posted 6/9/2025

FDA Approves XIFYRM Injectable Meloxicam for Moderate-to-Severe Pain Management

Drug Approval
  • The FDA has approved XIFYRM (meloxicam injection), a once-daily intravenous NSAID formulation for managing moderate-to-severe pain in adults.
  • The 30mg/mL injection is administered via IV bolus over 15 seconds and can be used alone or combined with non-NSAID analgesics.
  • XIFYRM addresses clinical needs for non-opioid alternatives in multimodal analgesia strategies, particularly amid ongoing efforts to reduce opioid dependence.
  • The drug is not recommended when rapid onset of analgesia is required due to its delayed onset profile.

FDA Places Clinical Hold on Gilead's Weekly HIV Combination Therapy Following Safety Signal

  • The FDA has placed a clinical hold on five Gilead HIV trials involving weekly combination therapy GS-1720 and GS-4182 after safety signals showed decreased CD4+ T-cell and lymphocyte counts in some patients.
  • The hold affects two Phase II/III WONDERS trials comparing the weekly combo to Biktarvy in both treatment-naive and virologically suppressed HIV patients, plus three Phase I studies.
  • Analysts expect no impact on the pending June 19 FDA decision for lenacapavir's HIV prevention indication, as GS-4182 is a different pro-drug formulation than the approved Sunleca version.
  • Gilead maintains confidence in resolving the hold and continues developing multiple other long-acting HIV treatment combinations with weekly, monthly, quarterly, and twice-yearly dosing schedules.

Study of Oral Weekly GS-1720 and GS-4182 Compared With Biktarvy in People With HIV-1 Who Have Not Been Treated

NCT06613685Active, Not RecruitingPhase 2
Gilead Sciences
Posted 10/21/2024

Study of Oral Weekly GS-1720 and GS-4182 Versus Biktarvy in People With HIV-1 Who Are Virologically Suppressed

NCT06544733Active, Not RecruitingPhase 2
Gilead Sciences
Posted 8/20/2024

hellocare.ai Partners with Mayo Clinic to Develop Ambient Clinical Intelligence Technology

AI
  • hellocare.ai has entered into a collaboration with Mayo Clinic to develop ambient clinical intelligence technology that could enable more proactive healthcare approaches and potentially reduce hospitalizations.
  • Mayo Clinic has joined hellocare.ai's $47 million growth round as an investor, expanding the funding for the AI-assisted virtual care platform company.
  • The partnership aims to create next-generation capabilities for early disease detection, reduced clinician workload, and safer inpatient care through AI technology.
  • hellocare.ai's platform is currently deployed across more than 70 health systems, offering services including ambient documentation, digital whiteboards, and hospital-at-home programs.

Antares Therapeutics Launches with $177 Million Series A to Advance First-in-Class Cancer Precision Medicines

Precision MedicineOncology
  • Antares Therapeutics launched with $177 million in Series A financing co-led by five major healthcare investment firms to develop first-in-class precision medicines for cancer and other serious diseases.
  • The company is a spin-out of Scorpion Therapeutics, which recently sold its PI3Kα inhibitor program STX-478 to Eli Lilly for up to $2.5 billion in March 2025.
  • Led by Scorpion's former executive team, Antares plans to advance its first new product candidate into clinical trials in 2026, focusing on previously undruggable targets including transcription factors.
  • Pierre Fabre Laboratories acquired global rights to two clinical-stage mutant EGFR inhibitor programs for non-small cell lung cancer treatment from the company's pipeline.

Centauri Therapeutics Demonstrates Novel Immunotherapy Approach Against Multi-Drug Resistant Gram-Negative Infections

  • Centauri Therapeutics published proof-of-concept data in The Journal of Immunology showing their CTX-09 molecule achieved >99.9% bacterial clearance against multi-drug resistant Gram-negative strains.
  • The bifunctional molecule leverages the company's Alphamer platform to recruit naturally occurring anti-αGal antibodies, demonstrating dual mechanism of action with both direct antibacterial activity and immune-mediated clearance.
  • CTX-09 showed broad-spectrum activity against Gram-negative bacteria at sub-therapeutic doses, potentially addressing the urgent need for new treatments against increasingly prevalent multi-drug resistant infections.
  • The positive results provide foundational validation for Centauri's platform technology as their lead candidate ABX-01 advances toward Phase I clinical trials.

NHS Becomes First European Health System to Trial Revolutionary Histotripsy Cancer Treatment

  • The NHS will be the first health system in Europe to trial histotripsy, a non-invasive ultrasound technology that destroys liver tumors using sound waves to create "bubble clouds" that pulverize cancer cells.
  • The treatment takes just 30 minutes with limited pain and quick recovery, offering an alternative to surgery for patients with primary and secondary liver cancers at Addenbrooke's Hospital in Cambridge.
  • Clinical trial data shows 73.3% one-year survival rates for primary liver cancer patients and 48.6% for secondary tumors, with over 1,500 patients worldwide already treated using this FDA-approved technology.
  • Health Secretary Wes Streeting fast-tracked approval through the new Innovative Devices Access Pathway, potentially expanding treatment to pancreatic and kidney cancers in the future.

Tagomics Secures £860k Grant to Develop Novel Multiomics Test for Early Colorectal Cancer Detection

  • Tagomics received £860k from Innovate UK's Biomedical Catalyst programme as part of a £1.2 million project to customize their Interlace multiomics platform for early colorectal cancer detection.
  • The company will collaborate with Salford Royal NHS Foundation Trust to conduct a pilot study profiling 250 patients suspected of having colorectal cancer to validate biomarkers.
  • The Interlace platform uses a unique epigenetic profiling approach that enriches unmethylated DNA for analysis without modifying the underlying DNA sequence.
  • Following project completion, Tagomics plans to expand the platform's capabilities with support from partner Agilent Technologies.

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