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Researchers Develop First Risk Prediction Model for Early-Stage Hodgkin's Lymphoma

Precision MedicineOncology
  • An international research team has developed and validated the first individualized risk prediction model for early-stage classic Hodgkin's lymphoma, called the Early-stage Hodgkin International Prognostication Index (E-HIPI).
  • The model was developed using data from over 3,000 patients in four international phase III clinical trials and validated in more than 2,300 patients from real-world registry cohorts.
  • E-HIPI uses routine clinical measures like patient sex, tumor size, hemoglobin and albumin levels to predict two-year progression-free survival and outperformed existing classification systems.
  • The research team created interactive online risk calculators to support shared decision-making between clinicians and patients, with findings published in NEJM Evidence.

dGenThera and Nusano Partner to Scale Astatine-211 Production for Next-Generation Cancer Therapy

Precision MedicineOncology
  • dGenThera and Nusano signed a letter of intent to provide reliable access to high-purity astatine-211, a best-in-class alpha-emitting isotope for targeted cancer therapy.
  • Nusano's breakthrough accelerator technology will increase global At-211 supply by 100-fold through a facility with alpha beam current 10 times greater than all comparable systems combined.
  • The partnership enables dGenThera to advance its theranostic molecular pairs platform, which uses covalently-bonded At-211 to create precision radiotherapies that can cross the blood-brain barrier.
  • At-211's unique properties include pure alpha emission with no problematic daughter isotopes and a 7.2-hour half-life ideal for systemic delivery and tumor targeting.

Simcere Zaiming Initiates US Phase 1 Trial of Trispecific Antibody SIM0500 for Relapsed/Refractory Multiple Myeloma

Oncology
  • Simcere Zaiming has dosed the first US patient in a Phase 1 trial of SIM0500, a trispecific antibody targeting GPRC5D, BCMA, and CD3 for relapsed/refractory multiple myeloma treatment.
  • The investigational therapy combines dual tumor antigen targeting with T-cell engagement and has received FDA Fast Track designation, showing promising preclinical cytotoxicity against multiple myeloma cells.
  • SIM0500 is being developed in partnership with AbbVie, which holds an option to license the compound following preliminary data suggesting good safety profile and encouraging efficacy results.

Study of SIM0500 Alone in Participants With Relapsed or Refractory Multiple Myeloma

NCT06375044RecruitingPhase 1
Jiangsu Simcere Pharmaceutical Co., Ltd.
Posted 5/24/2024

BioNTech Shuts Down Maryland Cell Therapy Manufacturing Following CAR-T Trial Failure

CAR-TOncology
  • BioNTech will lay off 63 employees and wind down cell therapy manufacturing at its Gaithersburg, Maryland facility by the end of 2025 following disappointing Phase 1 trial results.
  • The company discontinued development of its CAR-T candidate BNT211 targeting CLDN6 in testicular cancer and germ cell tumors due to insufficient efficacy data.
  • Despite the setback, BioNTech continues studying BNT211 in other CLDN6-expressing cancers including ovarian, sarcoma, endometrial, and gastric cancers.
  • The facility closure is part of broader oncology pipeline restructuring as BioNTech realigns resources and reduces global workforce by up to 1,350 jobs by 2027.

BrightSpring's Onco360 Pharmacy Selected as National Partner for Three New Cancer and Rare Disease Therapies

OncologyRare DiseaseDrug ApprovalTargeted Therapy
  • BrightSpring Health Services announced that its specialty pharmacy Onco360 has been selected as the national pharmacy partner for three newly approved therapies targeting advanced cancers and rare genetic disorders.
  • The partnership includes GOMEKLI for neurofibromatosis type 1 patients with plexiform neurofibromas, AVMAPKI FAKZYNJA CO-PACK for KRAS-mutated recurrent low-grade serous ovarian cancer, and IBTROZI for ROS1-positive non-small cell lung cancer.
  • Onco360 will provide comprehensive patient support including access, education, data management, and expert clinical guidance for these innovative treatments across all 50 states.

Respiratorius Secures FDA Pre-IND Meeting for VAL001 Cancer Treatment Following Positive Physician Survey

Oncology
  • Respiratorius has been granted a pre-IND meeting with the FDA for VAL001, an innovative oral formulation of sodium valproate designed as pre-treatment for cancer therapy, particularly Diffuse Large B-cell Lymphoma.
  • A comprehensive physician survey across the U.S., Europe, and Japan involving 135 treating physicians and key opinion leaders found that over 70% would be willing to prescribe VAL001, citing favorable clinical efficacy and established safety profile.
  • Commercial analysis projects VAL001 could achieve annual sales of USD 190 million at estimated market penetration, with cumulative revenue of USD 2.3 billion over the period of market exclusivity.
  • The company has secured patent protection for VAL001's formulation across key markets including the U.S., Europe, Japan, and Canada, with the European patent recently granted providing at least 20 years of market exclusivity.

Ashvattha Therapeutics Unveils Novel Nanomedicine Radiotracers for Neuroinflammation and Cancer Imaging at SNMMI 2025

Precision MedicineOncology
  • Ashvattha Therapeutics will present data on two breakthrough nanomedicine radiotracers at the SNMMI Annual Meeting, demonstrating selective targeting capabilities in neuroinflammation and cancer.
  • The company's flurimedrimer radiotracer selectively targets activated microglia in the human brain, supporting development of precision imaging tools for neurological conditions.
  • A second radiotracer designed to target tumor-associated macrophages shows potential for advancing precision imaging in oncology applications.
  • The data demonstrates the versatility of Ashvattha's hydroxyl dendrimer platform to achieve selective uptake in different inflammatory environments across therapeutic areas.

HanchorBio's HCB101 Checkpoint Inhibitor Shows Promising Safety and Efficacy Balance in Phase 1b Trial

Oncology
  • HanchorBio presented interim Phase 1b data for HCB101, a CD47-targeting checkpoint inhibitor, at the 2025 ASCO Annual Meeting showing favorable safety and tolerability across escalating doses.
  • The treatment demonstrated early anti-tumor activity with confirmed partial responses in head and neck cancer and non-Hodgkin's lymphoma patients, while achieving high-level CD47 receptor occupancy.
  • HCB101 achieved a 26.7% disease control rate in Phase 1a data with 100% safety across all dose levels, addressing the traditional trade-off between safety and efficacy in checkpoint inhibitor treatments.
  • The company has launched a multi-region Phase 2 trial spanning Taiwan, the United States, and China, enrolling patients with multiple cancer types including lung, head and neck, stomach, and breast cancers.

A Safety and Efficacy Study of HCB101, Fc-fusion Protein Targeting SIRPα-CD47 Pathway, in Solid or Hematological Tumors

NCT05892718RecruitingPhase 1
FBD Biologics Limited
Posted 10/2/2023

FDA Grants Orphan Drug Designation to Medicovestor's First-in-Class ADC for Pancreatic Cancer

Oncology
  • The FDA has granted Orphan Drug Designation to ADoBind MC001, Medicovestor's lead antibody-drug conjugate candidate for treating pancreatic cancer, one of the most aggressive malignancies with a five-year survival rate under 10%.
  • ADoBind MC001 represents a new class of chemoimmunotherapy ADCs that combines enhanced antibody-dependent cellular cytotoxicity with improved payload delivery and prolonged tumor engagement through proprietary platform innovations.
  • The designation provides seven years of market exclusivity upon approval, tax credits, and fee waivers, while Medicovestor progresses through IND-enabling studies with Phase 1 trials expected to begin in early 2026.

Orion and Glykos Extend ADC Partnership to Develop Six Next-Generation Cancer Therapies

OncologyMonoclonal Antibody
  • Orion Corporation and Glykos Finland have extended their research collaboration to develop up to six next-generation antibody-drug conjugates (ADCs) targeting solid tumors.
  • The expanded agreement doubles Orion's access to Glykos' proprietary hydrophilic payload and linker technology, which offers improved efficacy and tolerability compared to conventional ADCs.
  • Glykos will receive milestone payments and royalties from the development and commercialization of the ADC programs, maintaining the same financial terms as the original three-program agreement.
  • The collaboration leverages Orion's oncology expertise and clinical development capabilities with Glykos' advanced ADC technology platform to bring new cancer treatments to patients.

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