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CatalYm Strengthens Leadership Team to Advance Visugromab Through Late-Stage Development

Monoclonal AntibodyOncologyLeadership Change
  • CatalYm appointed four experienced executives to accelerate visugromab's progression into late-stage clinical development following promising Phase 2a results.
  • The company's GDFATHER-2 trial demonstrated that visugromab combined with anti-PD-1 inhibitor produced deep and durable responses across multiple solid tumor types with favorable safety.
  • CatalYm is advancing visugromab into multiple Phase 2b studies including first-line metastatic NSCLC and cachexia indications based on Nature-published data.
  • The leadership changes position the GDF-15-targeting therapy developer for potential regulatory approval and commercial success in oncology and cachexia markets.

First-in-Human Study of the GDF-15 Neutralizing Antibody Visugromab (CTL-002) in Patients With Advanced Cancer (GDFATHER)

NCT04725474Active, Not RecruitingPhase 1
CatalYm GmbH
Posted 12/9/2020

Trial Investigating Visugromab in Combination With Immunochemotherapy in 1L Treatment of Participants With Metastatic NSCLC

NCT07098988RecruitingNot Applicable
CatalYm GmbH
Posted 8/1/2025

Visugromab in Cachexia International Trial

NCT07112196Not Yet RecruitingNot Applicable
CatalYm GmbH
Posted 2/1/2026

Phrontline Biopharma Initiates Phase 1 Trial for TJ101 Dual-Target ADC in Solid Tumors

Oncology
  • Phrontline Biopharma successfully dosed the first patient in its Phase 1 clinical trial of TJ101 on September 14, 2025, marking a significant milestone for the company's lead ADC candidate.
  • TJ101 is an innovative antibody-drug conjugate targeting both EGFR and B7-H3 using proprietary linker-drug technology, designed to treat multiple solid tumor types.
  • The Phase 1 study will evaluate safety, tolerability, pharmacokinetics, and preliminary antitumor activity through dose escalation followed by expansion cohorts.
  • The trial represents part of Phrontline's broader dual payload ADC platform strategy, which aims to overcome resistance mechanisms and improve treatment outcomes for cancer patients.

Apollo Hospitals Invests Rs 573 Crore in Advanced Proton Therapy Oncology Center in Gurugram

OncologyCAR-TPrecision Medicine
  • Apollo Hospitals announces a Rs 573 crore investment to establish a 100-bed Comprehensive Oncology Centre in Gurugram featuring the Proteus One single gantry Proton Beam Therapy system.
  • The facility will mark Apollo's third proton therapy installation in India and is expected to serve an additional 350 patients annually by FY 2029.
  • Apollo aims to double its oncology business to over Rs 5,000 crore in the next 3-4 years through advanced treatments including proton therapy, robotics, immunotherapy, and CAR-T cell therapies.
  • The company simultaneously acquired IFC's 31% stake in Apollo Health and Lifestyle Ltd for Rs 1,254 crore to consolidate its healthcare portfolio operations.

FORE Biotherapeutics Reports Durable Clinical Benefit with Plixorafenib in BRAF-Altered Thyroid Cancers

Targeted TherapyOncology
  • FORE Biotherapeutics presented Phase 1/2a data showing plixorafenib achieved a median progression-free survival of 64 months and 85.7% clinical benefit rate in MAPK inhibitor-naïve BRAF V600-mutated papillary thyroid cancer patients.
  • The novel BRAF inhibitor demonstrated durable disease control in both papillary and anaplastic thyroid cancers, with four patients remaining on treatment for over five years without requiring combination with MEK inhibitors.
  • The company is advancing the registrational FORTE Phase 2 basket trial evaluating plixorafenib across multiple BRAF-altered tumor types, including thyroid cancers where BRAF alterations occur in 45-60% of cases.

A Study to Assess the Efficacy and Safety of FORE8394 in Participants With Cancer Harboring BRAF Alterations

NCT05503797RecruitingPhase 2
Fore Biotherapeutics
Posted 2/21/2023

Oncotelic Therapeutics Reports Progress Across Six Late-Stage Drug Programs in Oncology and Rare Diseases

Rare DiseaseOncology
  • Oncotelic Therapeutics announced significant clinical and regulatory progress across its late-stage pipeline over the past two years, with multiple drug candidates achieving important milestones.
  • The company's lead program OT-101, a TGF-β inhibitor, has advanced to Phase 3 trials for pancreatic cancer and shows additional applications in ARDS and COVID-19 treatment.
  • The pipeline includes six advanced programs targeting multi-billion-dollar markets, including OXi4503 in Phase 2 for AML/MDS and AL-101 in Phase 2 for Parkinson's disease.
  • The company is leveraging the 505(b)(2) regulatory pathway for its nanomedicine pipeline, offering a faster and more cost-efficient route to market approval compared to traditional NDAs.

ALX Oncology Appoints Barbara Klencke as Interim Chief Medical Officer to Advance Cancer Pipeline

Leadership ChangeOncology
  • ALX Oncology has appointed Dr. Barbara Klencke as Interim Chief Medical Officer, replacing Dr. Alan Sandler who will return to the company's Board of Directors.
  • Dr. Klencke brings over 30 years of experience in oncology drug development, including leadership roles at Sierra Oncology, Onyx Pharmaceuticals, and Genentech.
  • The appointment aims to accelerate development of ALX Oncology's pipeline, including evorpacept, a CD47 blocker in multiple clinical trials, and ALX2004, an EGFR-targeted antibody-drug conjugate that entered Phase 1 trials in August 2025.
  • Dr. Klencke previously served on ALX Oncology's Board of Directors since January 2025 and has witnessed the progress of both clinical programs firsthand.

Actuate Therapeutics Raises $17.25 Million to Advance GSK-3β Inhibitor for Difficult-to-Treat Cancers

Oncology
  • Actuate Therapeutics completed a $17.25 million public offering to fund development of elraglusib, a novel GSK-3β inhibitor targeting high-impact, difficult-to-treat cancers.
  • The company's lead drug candidate targets molecular pathways involved in tumor growth and resistance to conventional chemotherapy through inhibition of NF-κB and DNA damage response.
  • Elraglusib may also enhance anti-tumor immunity by regulating multiple immune checkpoints and immune cell function.
  • Net proceeds of approximately $15.62 million will support working capital and general corporate purposes for the clinical-stage biopharmaceutical company.

Medicines Discovery Catapult and Crown Bioscience Form Strategic Alliance to Accelerate Radiopharmaceutical Development

OncologyPrecision MedicineDrug Discovery
  • Medicines Discovery Catapult and Crown Bioscience have established a strategic global collaboration to create an integrated translational biology platform for radiopharmaceutical development.
  • The partnership combines MDC's radiochemistry expertise and imaging technologies with Crown Bioscience's preclinical oncology capabilities to support companies across the radiopharmaceutical pipeline.
  • The collaboration aims to accelerate drug development by enabling rapid testing of radiopharmaceutical efficacy and safety while reducing clinical development risk.
  • Together, the organizations will deliver preclinical comparator studies with approved standards of care to support successful Investigational New Drug submissions.

Imaging Endpoints Files Patent for AI-Enhanced Imaging Review Charter System to Optimize Oncology Trials

AIOncology
  • Imaging Endpoints has filed a provisional patent application for its revolutionary AI enhanced Imaging Review Charter (IRC) system designed to enhance customized IRCs for oncology clinical trials.
  • The AIRC System addresses long-standing challenges in trial imaging design by providing dynamic customization, criteria optimization, enhanced regulatory compliance, and increased efficiency through AI integration.
  • The company boasts a 95% marketing approval success rate across over 200 regulatory approvals, positioning it as the global leader in oncology imaging CRO services.
  • The system integrates datasets from industry standards, published oncology criteria, and trial information to generate dynamic IRC documents while ensuring alignment with FDA, EMA, and other global regulatory requirements.

Celcuity Secures $500 Million Credit Facility Following Positive Phase 3 Data for Gedatolisib in Advanced Breast Cancer

Oncology
  • Celcuity has upsized its senior secured credit facility to $500 million with Innovatus Capital Partners and Oxford Finance, including $350 million in committed capital and up to $150 million at mutual discretion.
  • The financing follows positive topline data from the PIK3CA wild-type cohort of the pivotal VIKTORIA-1 Phase 3 clinical study evaluating gedatolisib in advanced breast cancer patients.
  • The enhanced financial structure provides funding for the rolling NDA submission to FDA via the RTOR program and commercial launch preparations for gedatolisib.
  • Additional milestone-based funding includes $100 million upon FDA approval of gedatolisib for second-line wild-type advanced breast cancer patients and $120 million upon achieving commercial revenue milestones.

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