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Clinical Trial News

Solvonis Therapeutics Raises £1M to Accelerate AI-Driven CNS Drug Discovery for Depression and Stimulant Addiction

  • Solvonis Therapeutics secured £1.0 million from three major shareholders to accelerate its AI-supported central nervous system drug discovery programme targeting depression and stimulant use disorders.
  • The funding will enable lead identification and early-stage candidate validation in therapeutic areas with significant unmet needs, including stimulant addiction which currently has no FDA-approved medications.
  • The company's AI-enabled R&D platform integrates proprietary compound libraries and predictive modelling to drive innovation in neuropsychiatric conditions traditionally marked by low investment and slow progress.
  • The global antidepressant market was valued at approximately £15 billion in 2024 and is projected to grow at 7.5% annually through 2034, highlighting the commercial potential of the programme.

mRNA Victoria Funds Breakthrough Alzheimer's Research Projects Targeting Prevention and Treatment

  • mRNA Victoria has funded two innovative Alzheimer's disease research projects at the Florey Institute that could position Victoria as a leader in mRNA-based neurological therapies.
  • Dr. Abdel Belaidi is developing the first mRNA-based system designed to cross the blood-brain barrier and deliver beneficial protein variants to protect neurons and slow disease progression.
  • Dr. Rebecca Nisbet is creating an mRNA vaccine targeting amyloid-beta clearance to prevent Alzheimer's disease from developing in later life.
  • Both projects leverage recent breakthroughs in mRNA technology to address the lack of effective treatments for Alzheimer's disease, which is the leading cause of dementia in Australia.

Targeted Protein Degradation Emerges as Multi-Billion Dollar Therapeutic Frontier with First PROTAC Approval Expected in 2026

Drug ApprovalOncology
  • Targeted protein degradation (TPD) has evolved from niche science to mainstream drug development, with over 40 PROTAC candidates in clinical testing and the first potential market approval expected for Arvinas/Pfizer's ARV-471 by June 2026.
  • Major pharmaceutical companies have committed over $10 billion in partnerships since 2024, with deals including AbbVie's $1.64 billion agreement with Neomorph and LEO Pharma's $1.7 billion alliance with Gilead Sciences.
  • The Asia-Pacific region, particularly China and South Korea, has emerged as a leading hub for TPD research, with multiple companies advancing candidates through late-stage clinical trials.
  • The global TPD market is projected to surge from $1 billion currently to $6.94 billion by 2035, driven by advances in computational tools and AI-enabled drug design.

BrECADD Chemotherapy Preserves Fertility Better Than Standard Treatment in Advanced Hodgkin's Lymphoma

Oncology
  • The new BrECADD chemotherapy regimen preserves fertility significantly better than the previous standard eBEACOPP treatment in advanced Hodgkin's lymphoma patients without compromising cure rates.
  • Three years post-treatment, 95% of women and 86% of men in the BrECADD group had normal hormone levels compared to 73% and 40% respectively in the eBEACOPP group.
  • The HD21 phase III trial involving over 1,500 participants across 233 centers in nine countries demonstrates BrECADD's superior fertility preservation, particularly benefiting male patients' chances of biological paternity.
  • BrECADD has become the new standard first-line treatment for patients wishing to have children at University Hospital Cologne and in current Onkopedia guidelines.

Hydrogels Emerge as Next-Generation Platform for Precision Cancer Drug Delivery

Precision Medicine
  • A comprehensive bibliometric analysis of 4,108 publications reveals hydrogels as a rapidly growing field in cancer drug delivery, with annual publications exceeding 613 in 2024.
  • Injectable hydrogels offer minimally invasive chemotherapy delivery that reduces systemic side effects while improving therapeutic efficacy through localized drug release and enhanced tumor penetration.
  • Emerging research trends focus on immunotherapy applications, immunogenic cell death mechanisms, and multifunctional antimicrobial hydrogels that combine cancer treatment with infection prevention.
  • Current hotspots include carboxymethyl cellulose-based systems, chitosan nanocomposites, and stimulus-responsive hydrogels that enable precise spatiotemporal drug release control.

BBOT Completes $382 Million SPAC Merger to Advance Next-Generation RAS-Targeted Cancer Therapeutics

Oncology
  • BridgeBio Oncology Therapeutics (BBOT) completed its business combination with Helix Acquisition Corp. II on August 11, 2025, raising approximately $382 million in gross proceeds to advance RAS-pathway cancer therapeutics.
  • The company secured $261 million through a PIPE investment led by Cormorant Asset Management, with only 39% shareholder redemption rate marking the second lowest for biotech de-SPAC transactions since 2022.
  • BBOT's pipeline includes three clinical-stage programs targeting KRAS mutations and PI3Kα malignancies, including BBO-8520 for KRASG12C tumors, BBO-10203 as a novel RAS-PI3Kα interaction blocker, and BBO-11818 as a panKRAS inhibitor.
  • The combined company expects to have approximately $490 million in cash and equivalents to accelerate development of therapeutics targeting the two most prevalent oncogenes in human tumors.

Dose Escalation and Dose Expansion Study of BBO-10203 in Subjects with Advanced Solid Tumors

2024-519445-29-00RecruitingPhase 1
Theras Inc.
Posted 10/29/2024

Open-label Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer

NCT06343402RecruitingPhase 1
TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
Posted 5/22/2024

BBO-11818 in Adult Subjects With KRAS Mutant Cancer

NCT06917079RecruitingPhase 1
TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
Posted 3/31/2025

OneTouch-PAT Breast Imaging System Demonstrates Promise in Early Clinical Tests with AI-Enhanced Detection

AI
  • University at Buffalo researchers developed OneTouch-PAT, a pain-free breast imaging system that combines photoacoustic and ultrasound imaging to complete scans in under one minute without painful compression.
  • The system tested on 61 breast cancer patients and 4 healthy individuals produced clear AI-powered 3D images showing unique vascular patterns for different cancer subtypes including Luminal A, Luminal B, and Triple-Negative Breast Cancer.
  • OneTouch-PAT eliminates operator error through automated scanning and shows particular promise for women with dense breast tissue, where traditional mammography is less accurate.
  • The technology uses deep learning networks to process imaging data and provides more detailed tumor visualization compared to operator-dependent photoacoustic and ultrasound systems.

Biogen and Acumen Advance Alzheimer's Research with Long-Term Data and Novel Targeting Approaches at AAIC 2025

Monoclonal Antibody
  • Biogen presents 48-month data from LEQEMBI's Clarity AD open-label extension study and introduces subcutaneous formulation for maintenance dosing at AAIC 2025.
  • The company shares baseline characteristics from CELIA Phase 2 trial evaluating BIIB080, an investigational antisense oligonucleotide therapy targeting tau protein.
  • Acumen Pharmaceuticals demonstrates cost savings from pTau217 screening in its ALTITUDE-AD Phase 2 trial and presents selectivity data for sabirnetug targeting toxic amyloid beta oligomers.

A Study to Evaluate Efficacy and Safety of Intravenous Sabirnetug in Participants With Early Alzheimer's Disease (ALTITUDE-AD)

NCT06335173Active, Not RecruitingPhase 2
Acumen Pharmaceuticals
Posted 2/29/2024

A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease

NCT03887455Active, Not RecruitingPhase 3
Eisai Inc.
Posted 3/27/2019

A Study to Learn About the Safety of BIIB080 Injections and Whether They Can Improve Symptoms of Participants With Mild Cognitive Impairment Due to Alzheimer's Disease (AD) or Mild AD Dementia Between 50 to 80 Years of Age

NCT05399888Active, Not RecruitingPhase 2
Biogen
Posted 8/24/2022

Compass Therapeutics Receives FDA Fast Track Designation for CTX-009 Bispecific Antibody

Oncology
  • Compass Therapeutics received FDA Fast Track Designation for CTX-009, its bispecific DLL4/VEGF-A antibody, when used in combination with other treatments.
  • The designation indicates FDA recognition of CTX-009's potential to address unmet medical needs and commitment to supporting its development.
  • CMPX shares surged 4.01% on the news, marking the third consecutive day of gains with a cumulative increase of 7.95% over three days.
  • The Fast Track Designation is expected to expedite the development and approval process while potentially attracting increased investor attention and collaboration opportunities.

CDSCO Mandates Online Submission for Cell and Gene Therapy Clinical Trial Applications

  • India's Central Drugs Standard Control Organization (CDSCO) has mandated that all clinical trial applications for cell and gene therapeutic products must be submitted exclusively through its online SUGAM portal system, effective July 10, 2025.
  • The regulatory change affects Phase I, II, and III clinical trial applications for cell and gene therapeutics, with offline submissions no longer being accepted after the implementation date.
  • CDSCO has provided comprehensive support materials including user manuals and video tutorials to assist stakeholders in transitioning to the digital submission process.
  • This digitization initiative is part of CDSCO's broader effort to streamline regulatory processes and improve the quality of submissions through enhanced user experience features.

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