MedPath

Tagged News

AstraZeneca and Revna Biosciences Launch Targeted EGFR Therapy for Lung Cancer Patients in Ghana

Targeted TherapyPrecision MedicineOncology
  • AstraZeneca has launched a targeted therapy for EGFR-mutated lung cancer patients in Ghana through its strategic partnership with Revna Biosciences, marking a significant milestone in expanding access to precision oncology in sub-Saharan Africa.
  • The collaboration has operationalized EGFR biomarker testing within diagnostic workflows at leading cancer centers, enabling targeted therapy selection at the point of care and accelerating time-to-therapy for patients.
  • The partnership has established a comprehensive infrastructure that integrates advanced molecular diagnostics with personalized treatment pathways, while building real-time data integration capabilities for enhanced clinical decision-making.
  • This initiative represents a new standard of care for historically underserved patients in the region, combining cutting-edge diagnostics with access to targeted anti-cancer therapies to ensure patients receive appropriate treatment timing.

Nuoyuan Medical's Pemefolacianine Completes Phase I Trial, Advances Precision Tumor Surgery

Targeted Therapy
  • Nuoyuan Medical's Pemefolacianine, a folate receptor alpha-targeted fluorescent imaging agent, successfully completed Phase I clinical trials in China with no drug-related adverse events reported among 32 healthy participants.
  • The novel contrast agent demonstrated favorable pharmacokinetics with dose-dependent increases in plasma concentration and fluorescence intensity, positioning it as the first FR-α targeted agent from China to receive FDA IND approval.
  • Pemefolacianine offers enhanced targeting specificity with eight times higher affinity for FR-α compared to FR-β, potentially reducing false-positive rates in intraoperative tumor imaging.
  • The company has initiated Phase II trials in China and is preparing U.S. clinical trials as part of its dual-track global development strategy, with patents secured across major markets.

Artbio Raises $132 Million Series B to Advance Lead-212 Radiopharmaceutical for Prostate Cancer

Targeted TherapyOncology
  • Artbio secured $132 million in Series B funding to advance AB001, a lead-212 based radiopharmaceutical targeting metastatic castration-resistant prostate cancer.
  • The company's AB001 drug uses Pb-212 isotope technology designed to deliver radiation more quickly to tumors compared to existing treatments like Novartis' Pluvicto.
  • Funding will support mid-stage clinical trials and manufacturing network expansion, with a Phase 1 trial beginning imminently this year.
  • The Cambridge and Oslo-based startup, led by former Novartis executive Emanuele Ostuni, aims to compete in the rapidly growing radiopharmaceutical oncology market.

Phase 0/1 Study of 212Pb-NG001 in mCRPC

NCT05725070CompletedEarly Phase 1
ARTBIO Inc.
Posted 3/6/2023

IsoBio Secures $5 Million Series Seed Funding to Advance Antibody-Isotope Conjugates for Cancer Treatment

Monoclonal AntibodyOncologyTargeted Therapy
  • IsoBio, Inc. has closed a $5 million Series Seed financing round led by ASP Isotopes Inc. to develop antibody-isotope conjugates (AICs) targeting both validated and novel tumor antigens for cancer treatment.
  • The strategic partnership with ASP Isotopes and its subsidiary PET Labs aims to address critical isotope supply chain challenges that have historically constrained radiotherapy development and commercialization.
  • IsoBio is developing radiotherapeutics containing Lutetium-177, Actinium-225, Terbium-161, and other novel radioisotopes using proprietary linker and conjugation technology.
  • The company is led by radiation oncologist Bruce Turner, M.D., Ph.D., who previously co-led the merger creating Immunome and has extensive experience in targeted oncology therapeutics.

RenovoRx Launches Multi-Center PanTheR Registry Study to Evaluate Real-World Safety of RenovoCath Device

Targeted TherapyOncology
  • RenovoRx has launched the PanTheR Post-Marketing Registry Study, a multi-center observational study designed to evaluate the long-term safety and real-world effectiveness of the FDA-cleared RenovoCath drug-delivery device in patients with solid tumors.
  • The University of Vermont Cancer Center will be the first site to initiate patient enrollment, with additional cancer centers expected to commence enrollment before the end of September 2025.
  • The registry study will capture real-world data across diverse cancer types and clinical environments, potentially informing future clinical trial designs and evidence-based treatment strategies.
  • Participating cancer centers will purchase RenovoCath devices from RenovoRx for use in the study, representing a revenue-generating opportunity for the company.

PanTheR Registry Trial

NCT06805461Recruiting
RenovoRx
Posted 8/1/2025

Comprehensive Pipeline Analysis Reveals 200+ Investigational Drugs for Metastatic Hormone Refractory Prostate Cancer

OncologyTargeted Therapy
  • A new comprehensive report analyzes over 200 pipeline drugs from 180+ companies targeting metastatic hormone refractory prostate cancer, highlighting the extensive research efforts in this challenging therapeutic area.
  • Key late-stage candidates include PNT2002 by Lantheus targeting PSMA in Phase III trials, and Opevesostat by Merck, an oral CYP11A1 inhibitor also in Phase III development.
  • The pipeline spans multiple development stages from discovery to Phase III, with promising mid-stage candidates like XL092 by Exelixis exploring receptor tyrosine kinase inhibition in Phase II trials.
  • Current treatment approaches involve next-generation androgen receptor inhibitors and chemotherapy agents, but significant unmet needs remain for patients experiencing disease progression despite anti-androgen treatments.

Multiple Cancer Clinical Trials Advance with Remote Study Models and Novel Therapeutics

Targeted Therapy
  • The SUCCEED study launches as a landmark remote clinical trial allowing small cell lung cancer patients to participate from home, addressing location barriers that have historically limited research in this aggressive disease.
  • Several phase 1b and phase 2 trials have initiated patient dosing across multiple cancer types, including urothelial cancer treatment with FX-909 and advanced solid tumors with AI-081 bispecific antibody.
  • Completed early-phase studies show promising results, with elraglusib demonstrating activity in treatment-resistant Ewing sarcoma and the phase 3 ALKAZAR trial beginning enrollment for ALK-positive lung cancer patients.

A Study of FX-909 in Patients With Advanced Solid Malignancies, Including Advanced Urothelial Carcinoma

NCT05929235RecruitingPhase 1
Flare Therapeutics Inc.
Posted 8/24/2023

Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC

NCT06765109RecruitingPhase 3
Nuvalent Inc.
Posted 7/17/2025

9-ING-41 in Pediatric Patients With Refractory Malignancies.

NCT04239092TerminatedPhase 1
Actuate Therapeutics Inc.
Posted 6/5/2020

Safety, Pharmacokinetics, and Efficacy of AI-081, a Bispecific Antibody for PD-1 And VEGF in Advanced Solid Tumors

NCT06635785RecruitingPhase 1
OncoC4, Inc.
Posted 3/26/2025

European Regulators Recommend Approval of Vorasidenib for IDH-Mutant Grade 2 Glioma

Drug ApprovalTargeted TherapyOncology
  • The European Medicines Agency's CHMP has issued a positive opinion recommending approval of vorasidenib (Voranigo) for treating grade 2 IDH-mutant glioma in patients aged 12 years and older following surgical resection.
  • The recommendation is based on the phase 3 INDIGO trial showing vorasidenib significantly improved progression-free survival to 27.7 months versus 11.1 months with placebo.
  • If approved by the European Commission, vorasidenib would become the first targeted therapy for grade 2 IDH-mutant diffuse glioma in the European Union.
  • The drug is already approved in the United States, Canada, Australia, Israel, UAE, Saudi Arabia, and Switzerland for this indication.

Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)

NCT04164901Active, Not RecruitingPhase 3
Institut de Recherches Internationales Servier
Posted 1/5/2020

Magnetically Steerable Drug Delivery Vesicles Show Promise for Precision Cancer Treatment

Precision MedicineTargeted Therapy
  • Researchers at the University of Illinois Urbana-Champaign have developed microscopic lipid vesicles containing magnetic particles that can be precisely steered to target locations using magnetic fields.
  • The system combines magnetic steering with light-triggered drug release, creating a comprehensive prototype for precision drug delivery that could significantly advance cancer treatment.
  • The lipid vesicles are designed to interact only with specific cell types, offering advantages for targeted cancer therapy while utilizing existing MRI technology for navigation.
  • The team is now preparing for in vitro studies using real drugs in microfluidic systems that simulate biological environments.

Eli Lilly Advances LOXO-435 in Phase 1 FORAGER-1 Study for FGFR3-Altered Advanced Cancers

Targeted TherapyOncology
  • Eli Lilly's FORAGER-1 Phase 1 study is evaluating LOXO-435 (LY3866288) as both monotherapy and combination treatment for locally advanced or metastatic solid tumors with FGFR3 gene alterations.
  • The open-label, multicenter trial tests the oral drug alone and in combination with pembrolizumab and enfortumab vedotin to determine optimal dosage and assess safety and efficacy.
  • The study began January 12, 2023, with primary completion date yet to be announced, representing a potential advancement in targeted cancer therapy for FGFR3-altered tumors.
  • Success in this study could enhance Eli Lilly's competitive position in the oncology market and potentially impact the company's stock performance positively.

MedPath

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

© 2025 MedPath, Inc. All rights reserved.