MedPath

Tagged News

Intermountain Health Pioneers First Remote CAR-T Cell Collection Site in Southern Utah

  • Intermountain Health has established the nation's first remote CAR-T cell collection site at St. George Regional Hospital, bringing advanced cancer treatment closer to patients in Southern Utah and Nevada.
  • The innovative satellite clinic eliminates the need for patients to travel hundreds of miles to Salt Lake City for initial collection procedures, significantly improving accessibility to this cutting-edge immunotherapy.
  • CAR-T cell therapy, which reprograms patients' immune cells to target and destroy cancer cells, has shown remarkable success in treating various hematologic cancers including leukemia, lymphoma, and multiple myeloma.

STEERLife Unveils Solvent-Free Melt Fusion Technology for Potent Drug Development

  • STEERLife has introduced a groundbreaking solvent-free melt fusion technology that eliminates harmful organic solvents in pharmaceutical manufacturing, enhancing safety and efficiency.
  • The company has initiated development of generic versions of several high-potency drugs including Apalutamide, Enzalutamide, Venetoclax, and Olaparib, with market releases planned from 2026.
  • Through strategic partnerships, STEERLife aims to serve pharmaceutical markets across multiple regions including the United States, Europe, Latin America, and Asia.

Elucent Medical's EnVisio X1 Surgical Navigation System Receives FDA Breakthrough Device Designation

  • Elucent Medical's EnVisio X1 In-Body Spatial Intelligence System has received FDA Breakthrough Device Designation, potentially accelerating its path to market for soft tissue surgical navigation.
  • The system features permanently implantable SmartClip markers and real-time 3D guidance technology that wirelessly tracks surgical instruments, enhancing precision during thoracic and abdominal soft tissue excisions.
  • This innovative technology aims to improve surgical outcomes by enabling more precise excisions, reducing positive margins, and minimizing the need for repeat procedures in cancer surgeries.

Narmafotinib Combination Shows Superior Response in Pancreatic Cancer ACCENT Trial

  • Amplia Therapeutics' Phase 1b/2a ACCENT trial has recorded 15 confirmed partial responses in pancreatic cancer patients receiving narmafotinib combined with standard chemotherapy.
  • The trial results demonstrate that adding narmafotinib, a highly selective FAK inhibitor, to gemcitabine and Abraxane chemotherapy is superior to chemotherapy alone in advanced pancreatic cancer.
  • With 21 of 55 enrolled patients still on study, researchers anticipate additional partial responses may be observed before final data readout expected in mid-Q3 2025.

Telisotuzumab Vedotin Plus Osimertinib Shows Promise in TKI-Resistant NSCLC with c-MET Overexpression

  • The combination of telisotuzumab vedotin and osimertinib demonstrated a 50% objective response rate in patients with EGFR-mutant NSCLC who had progressed after prior osimertinib treatment.
  • All patients experienced at least one treatment-emergent adverse event, with peripheral sensory neuropathy (50%) and peripheral edema (32%) being most common, though no dose-limiting toxicities were reported.
  • The promising efficacy data, including a median progression-free survival of 7.4 months, suggests this combination could address an unmet medical need in patients with c-MET protein overexpression-mediated resistance to EGFR TKIs.

Heidelberg Pharma Initiates Phase I Trial of HDP-102 for Non-Hodgkin Lymphoma as Second Amanitin-Based ADC Enters Clinic

  • Heidelberg Pharma has dosed the first patient with HDP-102, an amanitin-based antibody-drug conjugate targeting CD37, in a Phase I study for relapsed or refractory non-Hodgkin lymphoma.
  • The multicenter trial will evaluate safety, tolerability, and pharmacokinetics across Moldova, Israel, and selected EU countries, with plans for dose escalation followed by expansion phases.
  • HDP-102 represents the company's second ATAC technology candidate to reach clinical development, following encouraging safety and efficacy data from HDP-101 in multiple myeloma.
  • Non-Hodgkin lymphoma affects over 550,000 new patients annually, with conventional chemotherapy achieving response rates above 50% but frequent relapses highlighting the need for more durable treatments.

Ibrutinib/Nivolumab Combination Shows Promising 77.8% Response Rate in Relapsed CNS Lymphoma Trial

  • A phase 2 trial of ibrutinib plus nivolumab demonstrated a high objective response rate of 77.8% in patients with relapsed/refractory central nervous system lymphoma, with 50% achieving complete responses.
  • At a median follow-up of 31 months, the median overall survival was 21 months, with 17% of patients experiencing durable remissions lasting more than two years without additional treatment.
  • The combination therapy was well-tolerated with manageable side effects, though 50% of patients experienced at least one grade 3-4 treatment-related adverse event, most commonly neutropenia and oral mucositis.

Merck KGaA Joins Peregrine Ventures' Incentive Incubator as Strategic Partner

  • Merck KGaA has become a strategic partner in Peregrine Ventures' Incentive Incubator, gaining early access to startups in bioconvergence, pharma, and biotechnology fields.
  • The collaboration will focus on ventures with significant market potential aligned with Merck's three global divisions: Healthcare, Life Science, and Electronics, with priority given to bioconvergence ventures.
  • Through this partnership, eligible startups will receive support including investments, regulatory guidance, business development assistance, and potentially early-phase trial planning.

Exelixis Initiates Phase 1 Trial of XB628, a Novel Bispecific NK Cell Engager for Advanced Solid Tumors

  • Exelixis has begun dose-escalation in a first-in-human Phase 1 trial of XB628, a first-in-class bispecific antibody targeting both NKG2A and PD-L1 in patients with recurrent advanced or metastatic solid tumors.
  • XB628 represents a novel immunotherapy approach by engaging natural killer cells through dual targeting of an inhibitory receptor (NKG2A) and the immune checkpoint protein PD-L1.
  • The investigational therapy was developed through a collaboration between Exelixis and Invenra, leveraging Invenra's proprietary B-Body® platform for creating multispecific antibodies with superior biophysical properties.

NHIA and Roche Expand Partnership to Reduce Cancer Treatment Costs in Nigeria

  • The National Health Insurance Authority and Roche have signed an expanded Memorandum of Understanding to enhance access to affordable cancer care and treatment for Nigerian patients.
  • The partnership introduces a cost-sharing model where Roche covers 50% of monoclonal medicine costs while NHIA manages patient access and coordinates financing mechanisms.
  • Since the initial 2021 partnership, the number of cancer Centers of Excellence has nearly tripled from seven to 20 facilities across Nigeria.
  • The initiative specifically targets breast cancer, which caused over 30,000 new cases in Nigeria in 2022 and remains the leading cause of death among Nigerian women.

MedPath

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

© 2025 MedPath, Inc. All rights reserved.