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Clinical Trial News

Samsung Acquires Providence Digital Health Spinoff Xealth to Bridge Consumer Wellness and Clinical Care

  • Samsung Electronics signed an agreement to acquire Xealth, a digital health platform spun out of Providence in 2017 that serves over 500 hospitals and partners with 70+ digital health companies.
  • The acquisition aims to bridge consumer wellness data from Samsung's wearables with clinical decision-making through Xealth's centralized digital health platform.
  • Xealth enables healthcare providers to digitally order and monitor remote patient monitoring, digital therapeutics, and mHealth apps while streamlining vendor integration and data analytics.
  • The deal is expected to close later this year following regulatory approval and represents Samsung's strategic move to advance connected care in healthcare systems.

Ciloa Secures €6.5 Million French Government Funding to Advance Novel Adiponectin-Based Therapy for Obesity and Type 2 Diabetes

  • French biotech Ciloa has secured €6.5 million in government funding through France 2030 to advance its novel drug candidate APN-sEV, the world's first stable and functional form of adiponectin combined with extracellular vesicles.
  • Preclinical trials demonstrate that APN-sEV effectively reduces excess weight, clears fat storage, increases insulin sensitivity, and preserves muscle mass while targeting metabolic pathways distinct from current anti-diabetic medications.
  • The funding will enable Ciloa to implement GMP manufacturing and conduct regulatory preclinical trials, with Phase I clinical trials planned for 2027 and Phase IIa trials scheduled for 2028.
  • The therapy addresses a significant unmet medical need, targeting type 2 diabetes and obesity which affect approximately two billion patients worldwide.

ViiV Healthcare Presents Real-World Data on Long-Acting HIV Treatments at IAS 2025

Real World Evidence
  • ViiV Healthcare presented extensive real-world data at IAS 2025 demonstrating the effectiveness, safety, and tolerability of its long-acting injectable HIV treatments, including cabotegravir + rilpivirine LA for treatment and cabotegravir LA for prevention.
  • The phase IIIb VOLITION study revealed strong patient preference for switching to long-acting injectables after achieving rapid viral suppression with daily oral therapy, highlighting the appeal of reduced dosing frequency.
  • Multiple real-world studies including COMBINE-2, CARLOS, BEYOND, and OPERA cohort provided 24-month outcomes data showing sustained effectiveness and high patient satisfaction with the long-acting regimen across diverse populations.
  • Implementation studies PILLAR and EBONI demonstrated positive experiences with cabotegravir long-acting for PrEP among men who have sex with men, transgender men, and Black women, supporting broader adoption of injectable prevention strategies.

A Study to Evaluate the Efficacy, Safety, Participant Choice and Preference of an Oral Once-daily Regimen or a Long-acting Injectable Regimen Every Two Months for Treatment of Human Immunodeficiency Virus (HIV-1) in Adults Who Have Not Previously Taken Antiretroviral Therapy

NCT05917509Active, Not RecruitingPhase 3
ViiV Healthcare
Posted 7/28/2023

First Nanobody Treatment Shows Promise Against Deadly Nipah and Hendra Viruses

  • University of Queensland researchers have identified DS90, the first nanobody capable of neutralizing both Nipah and Hendra viruses, for which no approved vaccines or cures currently exist.
  • The nanobody, derived from alpaca immune cells, can access deep viral pockets that traditional antibodies cannot reach and successfully blocks viral entry into cells.
  • Combining DS90 with existing m102.4 antibody therapy prevents Nipah virus from mutating and evolving, offering a powerful strategy to prevent deadly variants from emerging.
  • The discovery represents a crucial step toward developing clinical treatments for these fatal respiratory and neurological diseases that cause regular outbreaks in Asia and Australia.

Nobel Peace Prize Laureate James Orbinski Joins AI Drug Repurposing Startup Fifty 1 Labs

AI
  • Dr. James Orbinski, who received the 1999 Nobel Peace Prize on behalf of Médecins Sans Frontières, has joined Fifty 1 Labs as Senior Scientist to advance AI-driven drug repurposing initiatives.
  • The Nevada-based biotech company unveiled a strategic plan targeting the $320.6 billion functional medicine market through its AI platform that integrates clinical trial data and patent analytics.
  • Company leadership invested $350,000 of personal capital and deferred salaries until reaching a $50 million valuation, with plans for OTCQB uplisting by Q1 2026.
  • Fifty1 AI Labs LLC, the company's subsidiary, will receive $1 million in R&D funding to develop AI-driven drug repurposing technology aimed at delivering first discovery by May 2026.

NeOnc Technologies Secures $50 Million Investment to Expand Brain Cancer Clinical Trials in MENA Region

Oncology
  • NeOnc Technologies signed a non-binding term sheet with Quazar Investment for a $50 million equity investment to establish a UAE-based clinical platform focused on the Middle East and North Africa region.
  • The partnership will create NuroCure, an Abu Dhabi operating subsidiary, to conduct clinical trials for NeOnc's brain cancer therapies NEO100 and NEO212 targeting aggressive cancers like DIPG and glioblastoma multiforme.
  • The investment will allocate 70% of funds to acquire NeOnc stock at $25 per share and 30% toward launching clinical trials and infrastructure development across the UAE and MENA region.
  • This marks NeOnc's first international expansion, leveraging Cleveland Clinic Abu Dhabi's FDA-protocol infrastructure and the company's portfolio of over 177 patents worldwide.

BostonGene Partners with SWOG Cancer Research Network for AI-Driven Small Cell Lung Cancer Precision Medicine Trial

Precision MedicineAI
  • BostonGene and SWOG Cancer Research Network launched the PRISM study, a randomized Phase II trial evaluating biomarker-directed therapy for extensive stage small cell lung cancer patients.
  • The NCI-supported trial will enroll up to 900 patients and use BostonGene's AI-powered multiomics platform to identify molecular subtypes and assign personalized treatments.
  • Current standard treatment extends overall survival by only 2-3 months, with most patients experiencing disease progression despite combination chemotherapy and immunotherapy.
  • The study builds on previous SWOG S1929 trial findings that demonstrated promising improvements in progression-free survival using targeted approaches based on four distinct SCLC molecular subtypes.

Amarna Therapeutics and NorthX Biologics Advance Gene Therapy for Type 1 Diabetes Toward Clinical Trials

  • Amarna Therapeutics and NorthX Biologics have formalized an agreement to accelerate development of Nimvec™ AM510, a gene therapy targeting Type 1 Diabetes by restoring immune tolerance to insulin-producing beta cells.
  • The collaboration enables process and analytical development activities required to advance the therapy toward cGMP manufacturing and first-in-human clinical trials planned for 2027.
  • Nimvec™ AM510 works by targeting proinsulin, the primary antigen that triggers autoimmune attacks on beta cells, potentially offering a cure for Type 1 Diabetes.
  • The Nimvec™ platform demonstrates unique advantages over other gene therapies by not triggering strong immune responses, allowing for potential repeat dosing and enhanced efficacy.

Concentra Biosciences Acquires Cargo Therapeutics for $202M Following CAR-T Trial Failure

CAR-TOncology
  • Cargo Therapeutics agreed to be acquired by Concentra Biosciences for approximately $202 million upfront after halting development of its lead CAR-T therapy firicabtagene autoleucel due to poor durability results.
  • The company's Phase II trial showed firi-cel achieved a 77% response rate but only 18% durability at three months, leading to rapid patient relapse and termination of the mid-stage study in January.
  • Concentra, backed by Tang Capital Partners, continues its acquisition strategy targeting distressed biotechs, having completed five buyouts in 2024 including Elevation Oncology and Kronos Bio.
  • The deal provides Cargo shareholders with 100% of net cash above $217.5 million at closing plus 80% of proceeds from asset sales within two years, effectively winding down the company that raised $200 million in 2023.

Champions Oncology Launches Comprehensive Radiopharmaceutical Services Platform with Expanded Isotope Capabilities

  • Champions Oncology has launched a fully integrated radiopharmaceutical services platform combining advanced radiochemistry infrastructure with their extensive patient-derived xenograft tumor model bank.
  • The company expanded its radioactive materials license to support ten key isotopes including Lu-177, Ac-225, and Y-90, enabling radioligand therapy, antibody radionuclide conjugates, and theranostic approaches.
  • More than thirty PDX models have been successfully screened in collaboration with pharmaceutical and biotech partners, providing clinically relevant systems for evaluating radiolabeled agents.
  • The platform offers integrated workflows combining in vitro, ex-vivo biodistribution, and therapeutic efficacy studies to accelerate oncology drug development decision-making.

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