MedPath

Tagged News

Inotrem's Precision Medicine Strategy Shows Breakthrough Results for Septic Shock Treatment with Nangibotide

  • Inotrem published breakthrough precision medicine strategy for nangibotide in Intensive Care Medicine, demonstrating significant clinical improvements in septic shock patients with elevated sTREM-1 biomarker levels.
  • The study showed statistically significant organ function improvement (p=0.007) and increased shock reversal rates (+22.2%, p=0.006) in biomarker-positive patients who received nangibotide versus placebo.
  • This mechanism-based approach has regulatory approval from FDA, EMA, and PMDA, representing a new paradigm for drug development in intensive care medicine.
  • The precision medicine strategy addresses a critical unmet need in septic shock, which affects over 1.1 million people annually in the US and five main EU countries with mortality rates up to 40%.

HMNC Brain Health and Spruce Biosciences Launch Phase 2 Trial for Precision Depression Treatment

  • HMNC Brain Health and Spruce Biosciences have dosed the first patient in the Phase 2 TAMARIND trial, evaluating tildacerfont as a precision treatment for major depressive disorder.
  • The trial targets a biologically distinct subtype of MDD patients with HPA axis dysregulation, using HMNC's proprietary genetic marker-based patient selection tool.
  • Tildacerfont, a CRF1 receptor antagonist, has the potential to address up to 50% of MDD patients worldwide through personalized medicine approaches.
  • The randomized, double-blind, placebo-controlled study will enroll 88 adults across eight UK sites, with topline results expected in the first half of 2026.

SurgiVance Secures $2.2M NIH Grant to Advance Direct-to-Digital Pathology Platform

  • SurgiVance Inc. received a $2,245,000 National Cancer Institute Small Business Innovation Research Direct-to-Phase II grant to commercialize its "pathology lab-in-a-box" technology.
  • The platform enables direct-to-digital, in-office pathology using advanced imaging hardware and AI processing on whole tissue without traditional glass microscope slides.
  • Clinical studies will be conducted at NYU Langone Health, The Rockefeller University, Northwell Health, and Oregon Health & Science University targeting cancer at cellular and molecular levels.
  • The technology promises to deliver histopathologic diagnosis in minutes, potentially transforming cancer management and precision medicine through 3D molecular imaging biomarkers.

ProMIS Neurosciences Receives FDA Fast Track Designation for Alzheimer's Drug PMN310

  • ProMIS Neurosciences received FDA Fast Track designation for PMN310, a therapeutic candidate targeting Alzheimer's disease, driving stock prices up 177% in pre-market trading.
  • The company's PMN310 is currently in Phase 1b trials evaluating safety, tolerability, and pharmacokinetics in early Alzheimer's patients, with interim results expected in Q2 2026.
  • Wall Street analysts maintain a Moderate Buy rating with an average price target of $3.50, representing potential 695% upside from current levels.
  • Trading volume surged to over 79 million shares compared to the three-month daily average of 3.5 million shares following the FDA announcement.

MedGenome Secures $47.5 Million Series E Funding to Expand Genomic Diagnostics Access Across India

  • Bengaluru-based MedGenome raised $47.5 million in Series E funding co-led by Maj Invest and existing investor Novo Holdings to expand genomic diagnostics access.
  • The funding will enable broader access to genomics and integrated diagnostics solutions across India and other emerging markets.
  • MedGenome aims to reduce India's disease burden through early detection and targeted disease management using affordable genetic diagnostics tools.
  • The investment reflects growing adoption of genomics in personalized and preventive healthcare across emerging economies.

MVP Health Care Partners with Renalytix to Expand Access to AI-Powered Kidney Disease Testing

  • MVP Health Care and Renalytix announced a partnership to expand access to the FDA-approved kidneyintelX.dkd test for patients with type 2 diabetes and chronic kidney disease.
  • The collaboration aims to identify patients at higher risk for progressive kidney function decline earlier, enabling more targeted therapeutic interventions and personalized care plans.
  • The test will be available to all MVP customers in New York, including Medicare and Medicaid beneficiaries, and is recommended by KDIGO clinical guidelines.
  • Renalytix reports measurable improvements in patient outcomes and quality metrics, including HEDIS measures for blood pressure and HbA1c control in high-risk populations where the test is implemented.

Omega Funds Closes Oversubscribed $647M Fund VIII to Accelerate Life Sciences Innovation

  • Omega Funds successfully closed its eighth fund with $647 million in capital commitments, exceeding its $600 million target despite challenging fundraising conditions.
  • The firm has achieved significant commercial success with 52 products brought to market, 50 M&A exits, and 47 public listings since 2004.
  • Fund VIII will continue supporting innovative life sciences companies in the US and Europe targeting severe unmet medical needs across oncology, rare diseases, and precision medicine.
  • Recent notable exits include Scorpion Therapeutics acquired by Eli Lilly for potentially $2.5 billion and EyeBio purchased by Merck for $1.3 billion.

NIHR Pilots 'Just in Time' Clinical Trial Initiative for Pancreatic Cancer Using Pembrolizumab-Olaparib Combination

  • The National Institute for Health and Care Research is piloting a 'Just in Time' scheme that could reduce clinical trial setup time from months to days, potentially improving patient access to trials closer to home.
  • The initiative is being tested in the PemOla trial, which explores combination immunotherapy using pembrolizumab and olaparib for pancreatic cancers with high genetic mutation burden.
  • Pancreatic cancer remains one of the most challenging cancers to treat, with only 5% of patients surviving more than 10 years and limited progress in outcomes over the past 50 years.
  • The scheme enables hospitals to join trials when eligible patients are identified, potentially accelerating recruitment and speeding development of precision medicines for rare patient groups.

MOMA Therapeutics Initiates First-in-Human Trial of Werner Helicase Inhibitor MOMA-341 for MSI-H Solid Tumors

  • MOMA Therapeutics has dosed the first patient in a Phase 1 clinical trial of MOMA-341, a novel oral Werner helicase inhibitor targeting advanced or metastatic solid tumors with high microsatellite instability.
  • The drug represents a potentially best-in-class therapeutic with a novel chemical scaffold discovered through MOMA's proprietary KNOMATIC platform, designed to exploit Werner helicase dependency in MSI-H/dMMR tumor cells.
  • The global multi-center trial will evaluate MOMA-341 as monotherapy and in combination with chemotherapy or immunotherapy, with initial monotherapy data expected in mid-2026.
  • This marks MOMA's second clinical entry within a year, following their Pol θ helicase inhibitor MOMA-313, demonstrating the company's rapid pipeline advancement in precision oncology.

10x Genomics Partners with Singapore Institute to Launch AI-Driven Cancer Drug Discovery Study

  • 10x Genomics and A*STAR Genome Institute of Singapore announced the TISHUMAP project, an ambitious collaboration to analyze up to 2,500 clinical tissue samples using AI and spatial biology technology.
  • The study will focus on gastric, liver, and colorectal cancers, utilizing 10x Genomics' Xenium platform to visualize gene activity within individual cells in intact tissues.
  • The collaboration aims to accelerate drug target discovery and enable precision medicine by identifying novel biomarkers and therapeutic targets for cancer and inflammatory diseases.
  • Advanced AI will be combined with spatial omics data to detect critical patterns across large datasets, potentially leading to new diagnostics and personalized treatment plans.

MedPath

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

© 2025 MedPath, Inc. All rights reserved.