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FORE Biotherapeutics Secures $38 Million in Series D-2 Financing to Advance Plixorafenib Clinical Trials

Targeted TherapyOncologyPrecision Medicine
  • FORE Biotherapeutics has raised $38 million in Series D-2 financing to advance its global Phase 2 FORTE Master Protocol evaluating plixorafenib across multiple BRAF-mutated cancer indications.
  • The company anticipates interim analyses in 2025 across three monotherapy indications: BRAF V600 primary recurrent CNS tumors, rare BRAF V600 mutated solid tumors, and advanced solid tumors with BRAF fusions.
  • Plixorafenib, designed with a first-in-class mechanism to address limitations of earlier BRAF inhibitors, has previously demonstrated promising efficacy with a 67% overall response rate in BRAF V600 primary recurrent CNS tumors.

U.S. Drug Prices Double as Pharmaceutical Industry Shifts Focus to Rare Diseases

Oncology
  • The median annual list price for newly launched pharmaceuticals in the U.S. has more than doubled to $370,000 in 2024 compared to $180,000 in 2021, according to a Reuters analysis.
  • Treatments for rare diseases now account for 72% of new drug launches, up from 51% in 2019, with over 40% of these orphan drug approvals targeting oncology indications.
  • The highest-priced new therapy is Orchard Therapeutics' Lenmeldy, a gene therapy for metachromatic leukodystrophy, costing patients over $4 million per year.

Bayer Launches Centafore: New Imaging Core Lab to Enhance Clinical Trial Imaging and SaMD Development

OncologyAI
  • Bayer has launched Centafore, an Imaging Contract Research Organization (iCRO) with over 25 years of experience supporting more than 200 clinical trials globally.
  • Centafore offers comprehensive imaging services spanning from early research through Phase IV trials and Software as a Medical Device development across multiple therapeutic areas including oncology, cardiovascular, and CNS.
  • The new imaging solution provider leverages an extensive network of imaging professionals across 50+ countries, aiming to enhance trial outcomes and support informed decision-making in drug development.

Peptide Drug Conjugates Emerge as Next-Generation Cancer Therapeutics with Over 30 Candidates in Clinical Development

Targeted TherapyOncologyDrug Approval
  • Peptide drug conjugates represent a novel targeted therapy approach that combines disease-targeting peptides with small molecule drugs to deliver treatments directly to diseased tissues while minimizing systemic toxicity.
  • The global peptide drug conjugate market has experienced remarkable growth of over 300% absolute growth and 27% CAGR from 2018-2024, with market opportunities exceeding $1.4 billion.
  • Two peptide drug conjugates have received regulatory approval as of May 2025: Novartis's Lutathera for gastroenteropancreatic neuroendocrine tumors and Oncopeptides' Pepaxti for multiple myeloma.
  • More than 30 peptide drug conjugate candidates are currently advancing through various stages of clinical trials, primarily focused on oncology applications but expanding into neurodegenerative and inflammatory disorders.

ZYUS Life Sciences Prepares to Launch Phase 2A Trial of Novel Cannabinoid-Based Pain Therapy for Cancer Patients

Oncology
  • ZYUS Life Sciences is finalizing site initiation for its Phase 2A UTOPIA-1 clinical trial to evaluate Trichomylin® softgel capsules for cancer-related pain, with patient enrollment expected to begin in June 2025.
  • The trial comes amid growing scientific support for cannabinoids in cancer symptom management, backed by a recent meta-analysis of over 10,000 studies showing "strong consensus" for their therapeutic potential.
  • ZYUS aims to develop a non-opioid alternative for cancer pain management, with interim data from the UTOPIA-1 trial anticipated by mid-summer 2025 to guide the subsequent randomized, placebo-controlled UTOPIA-2 study.

Syantra Expands IP Portfolio with Novel "Tumor Education" Approach for Cancer Detection and Treatment

Precision MedicineOncology
  • Syantra has filed new patents expanding their cancer molecular diagnostics platform to include novel drug targets and therapeutics based on their "tumor education" approach.
  • The company's Onco-ID platform uses whole blood mRNA analysis to detect early-stage cancer by monitoring the body's immune response rather than cancer cells or DNA fragments.
  • Syantra's proprietary cellular discovery models have enabled researchers to investigate molecular pathways and chemical compounds in ways that could significantly impact understanding of cancer progression.

NeoGenomics Launches c-MET Companion Diagnostic for Advanced Non-Small Cell Lung Cancer Treatment

Targeted TherapyDrug ApprovalOncologyPrecision Medicine
  • NeoGenomics has commercially launched c-MET CDx for NSCLC, a companion diagnostic assay that detects c-Met protein overexpression in advanced non-small cell lung cancer patients with a 48-hour turnaround time.
  • The diagnostic test supports patient selection for newly FDA-approved targeted therapy EMRELIS™ (telisotuzumab vedotin-tllv), offering a precision medicine approach for a biomarker observed in up to 50% of advanced NSCLC patients.
  • This validated companion diagnostic complements NeoGenomics' broader PanTracer™ portfolio, enhancing comprehensive biomarker profiling capabilities for lung cancer treatment decisions.

Phase Scientific Secures $34 Million to Advance Urine-Based Cancer Diagnostics

Oncology
  • Hong Kong-based Phase Scientific has raised $34 million in Series A funding to develop non-invasive urine-based diagnostic tests for cancer detection, bringing its total funding to $57 million.
  • The company's proprietary Phasify technology can amplify biomarkers in urine, capturing 10 times more target molecules than existing gold standard tests, with their HPV test achieving 98.1% accuracy.
  • Phase Scientific aims to expand beyond HPV detection to develop urine tests for "systemic" cancers like lung and breast cancer, addressing the growing global cancer burden projected to reach 35 million new cases by 2050.

Comac Medical Group Acquires ILIFE Consulting to Strengthen Oncology and Early-Phase Trial Capabilities

Oncology
  • UK-based Comac Medical Group has acquired Paris-based ILIFE Consulting, expanding its pan-European footprint and deepening expertise in oncology and rare disease clinical trials.
  • The strategic acquisition enhances Comac's service portfolio with ILIFE's specialized capabilities in early-phase biotech trials, creating a more comprehensive offering for small and medium-sized biopharma clients.
  • ILIFE founder Marina Iché will retain her leadership role and become a significant shareholder in the Group, ensuring continuity while supporting the combined entity's growth initiatives across Europe.

Samsung Bioepis to Become Wholly-Owned Subsidiary of Samsung Biologics in Strategic Restructuring

Oncology
  • Samsung is restructuring its biopharmaceutical business governance by making Samsung Bioepis a wholly-owned subsidiary of Samsung Biologics, streamlining operations and decision-making processes.
  • The strategic reorganization aims to enhance competitiveness in the global biosimilar market, where Samsung Bioepis has already established a strong portfolio of approved products.
  • Industry analysts view this consolidation as Samsung's preparation for expanding its biopharmaceutical footprint beyond contract manufacturing into innovative drug development.

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