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Zymeworks Discontinues ZW171 Mesothelin-Targeted T Cell Engager After Phase 1 Safety Concerns

Oncology
  • Zymeworks voluntarily discontinued clinical development of ZW171, a mesothelin-directed T cell engager for gynecological, thoracic, and digestive system cancers, following completion of Phase 1 dose escalation cohorts.
  • The decision was based on dose-limiting toxicities consistent with mesothelin-related on-target off-tumor toxicity that would be unlikely to support an acceptable benefit-risk profile for monotherapy.
  • Despite the setback, Zymeworks continues advancing its broader pipeline including ongoing Phase 1 trials of ZW191, planned Phase 1 initiation of ZW251 in 2025, and IND filing preparation for ZW209 in the first half of 2026.

A Study of ZW171 in Participants With Advanced or Metastatic Mesothelin-expressing Cancers

NCT06523803Active, Not RecruitingPhase 1
Zymeworks BC Inc.
Posted 9/30/2024

Hemex Expands Global Clinical Network Alliance to Strengthen End-to-End CRO Capabilities

OncologyAI
  • Hemex AG announced the expansion of its global footprint through a Clinical Network Alliance with international partners, combining specialized expertise in oncology, regulatory operations, digital health, and site management.
  • The alliance provides comprehensive access to international trial networks across the United States, Europe, and India, supported by over 130 experienced professionals and a Quality Assurance team with successful regulatory inspections from major authorities worldwide.
  • Key partners include Kitsa USA with AI-driven platform capabilities, Shankus Hospitals with 13 oncology centers managing over 33,000 outpatients annually, and specialized CROs offering bioavailability/bioequivalence studies and regulatory compliance services.
  • The collaboration aims to deliver faster patient recruitment, stronger regulatory alignment, and efficient cross-border execution for pharmaceutical, biotech, and medtech companies conducting clinical trials.

Brenus Pharma Initiates First-in-Human Trial of STC-1010 Immunotherapy for Advanced Colorectal Cancer

Oncology
  • Brenus Pharma has successfully dosed the first patients in a Phase I/IIa trial evaluating STC-1010, a novel in vivo immunotherapy for unresectable, locally advanced or metastatic colorectal cancer.
  • The first patient completed eight weeks of treatment with no adverse events attributed to the investigational therapy, with three patients already enrolled in the study.
  • The international "BreAK CRC-001" trial will assess STC-1010 in combination with immunostimulatory agents and standard chemotherapy in over 80 patients, with first results expected in the first half of 2026.
  • The therapy targets pMMR/MSS colorectal cancer patients who have limited immunotherapy options, aiming to convert "cold" tumors into "hot" tumors responsive to immune attack.

First-in-human Trial of STC-1010, an Immunotherapy, in Patients With Unresectable Locally Advanced or Metastatic Colorectal Cancer

NCT06934538RecruitingPhase 1
Brenus Pharma
Posted 6/17/2025

Searle Secures Pakistani Regulatory Approval for Denosumab Biosimilar Injections

Monoclonal AntibodyDrug ApprovalOncology
  • The Searle Company Limited has obtained registration from Pakistan's Drug Regulatory Authority for Denosumab biosimilar injections in 60mg and 120mg doses.
  • The company holds marketing and sales rights in Pakistan under a licensing agreement with Chinese manufacturer Mabwell Pharmaceuticals.
  • The 60mg formulation targets osteoporosis management while the 120mg dose is intended for oncology care applications.
  • Searle is preparing for commercial launch, marking a significant expansion of its product portfolio in Pakistan's pharmaceutical market.

TME Pharma Secures €2.35M in Funding to Advance Cancer and Eye Disease Therapies

Orphan DrugOncology
  • TME Pharma completed its August financing round, raising €500,000 to bring total cash position to €2.35 million following earlier May funding.
  • The company's lead asset NOX-A12 has received FDA Fast Track Designation for glioblastoma treatment and is advancing through Phase 1/2 trials.
  • Strategic restructuring under new CEO Diede van den Ouden aims to create cost-efficient operations while developing novel cancer and ophthalmic therapies.
  • NOX-E36, the company's second lead compound, targets ophthalmic diseases requiring anti-fibrotic treatments with improved tolerability profiles.

Glioblastoma Treatment With Irradiation and Olaptesed Pegol (NOX-A12) in MGMT Unmethylated Patients

NCT04121455Active, Not RecruitingPhase 1
TME Pharma AG
Posted 9/12/2019

Olaptesed With Pembrolizumab and Nanoliposomal Irinotecan or Gemcitabine/Nab-Paclitaxel in MSS Pancreatic Cancer

NCT04901741Not Yet RecruitingPhase 2
TME Pharma AG
Posted 1/1/2026

Exelixis Promotes Dana Aftab to Lead Consolidated R&D Operations Amid Strategic Restructuring

Oncology
  • Exelixis has promoted Dana T. Aftab, Ph.D., to Executive Vice President of Research and Development, consolidating discovery, translational research, and late-stage development under unified leadership.
  • The leadership transition occurs alongside significant operational restructuring, including 130 layoffs and closure of the Pennsylvania site, as the company balances cost efficiency with innovation.
  • Aftab brings over 25 years of institutional knowledge and was instrumental in developing cabozantinib, which now generates over $2 billion annually for the company.
  • The restructuring aims to streamline operations for key pipeline assets including zanzalintinib, a third-generation tyrosine kinase inhibitor currently in pivotal Phase III trials.

Bicycle Toxin Conjugates Emerge as Novel Cancer Drug Class with Promising Clinical Results

Targeted TherapyOncology
  • Bicycle toxin conjugates (BTCs) represent a rapidly evolving field in targeted oncology that combines the binding affinity of bicyclic peptides with cytotoxic chemotherapy activity.
  • Zelenectide pevedotin (BT8009) demonstrated striking efficacy in Phase 1/2 trials when combined with immune checkpoint inhibitors, showcasing the potential of upfront combination regimens.
  • The technology offers advantages over conventional antibody-drug conjugates through deep tissue penetration and decreased systemic exposure while maintaining therapeutic activity.
  • Regulatory bodies including the US FDA are showing increasing confidence in BTCs through ramp-up programs, indicating growing institutional acceptance of this novel therapeutic approach.

Tetraspecific Antibodies Poised for First FDA Approval by 2029, Market Report Reveals

OncologyDrug Approval
  • The first tetraspecific antibody approval is expected by 2029, marking a significant milestone in multispecific immunotherapy development.
  • Sichuan Baili Pharmaceutical's Emfizatamab is currently in Phase II trials for hematological malignancies, representing a leading candidate in the field.
  • The bispecific antibody market has already exceeded $10 billion, with tetraspecific antibodies expected to capture even greater market share due to their enhanced targeting capabilities.
  • China and the USA are dominating the tetraspecific antibody clinical development landscape, with multiple companies advancing candidates through trials.

RNA Polymerase I Inhibitors Emerge as Promising Cancer Therapy with Pindnarulex Leading Clinical Development

Oncology
  • RNA Polymerase I inhibitors represent a novel oncology approach targeting ribosomal RNA synthesis, with tumors showing MYC overexpression, homologous recombination defects, or p53 pathway dysregulation being exceptionally sensitive to this interference.
  • Pindnarulex, the most advanced first-in-class Pol I inhibitor, has progressed to Phase I/II trials across multiple cancer types and received FDA fast-track designation for HRD-positive tumors.
  • Second-generation compounds like PMR-116 are entering clinical development with improved pharmacokinetics and enhanced specificity, while combination strategies with PARP inhibitors show promising synergistic potential.
  • Development challenges include phototoxicity concerns, off-target effects on normal proliferating cells, and the absence of qualified predictive biomarkers for optimal patient selection.

FDA Approves Foresee's CAMCEVI ETM 21mg for Advanced Prostate Cancer Treatment

Drug ApprovalOncology
  • The FDA has approved CAMCEVI ETM (leuprolide mesylate 21 mg), a ready-to-use long-acting injectable formulation administered every 3 months for advanced prostate cancer treatment.
  • The approval was based on a successful Phase 3 clinical study with 144 advanced prostate cancer patients, demonstrating 97.9% of subjects achieved the primary efficacy endpoint.
  • CAMCEVI ETM is exclusively licensed to Accord BioPharma for U.S. commercialization, with commercial launch expected after obtaining a J-code.
  • This represents Foresee Pharmaceuticals' second FDA-approved prostate cancer treatment, following CAMCEVI 42 mg which launched in April 2022.

Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate (LMIS 25 mg) in Subjects With Prostate Cancer

NCT03261999CompletedPhase 3
Foresee Pharmaceuticals Co., Ltd.
Posted 9/26/2017

A Study of Osimertinib With or Without Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer (FLAURA2)

NCT04035486Active, Not RecruitingPhase 3
AstraZeneca
Posted 7/2/2019

Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer

NCT03155997Active, Not RecruitingPhase 3
Eli Lilly and Company
Posted 7/12/2017

Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC)

NCT05280470Active, Not RecruitingPhase 2
Daiichi Sankyo
Posted 3/9/2022

Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1)

NCT05501886RecruitingPhase 3
Celcuity Inc
Posted 12/8/2022

A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)

NCT05118789RecruitingPhase 1
Nuvalent Inc.
Posted 1/4/2022

Study of RP-6306 With Gemcitabine in Advanced Solid Tumors

NCT05147272TerminatedPhase 1
Repare Therapeutics
Posted 12/16/2021

Study of PDS0101 and Pembrolizumab Combination I/O in Subjects With HPV16 + Recurrent and/or Metastatic HNSCC

NCT04260126CompletedPhase 2
PDS Biotechnology Corp.
Posted 3/29/2021

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