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Massalia Therapeutics Launches with Seed Funding to Target Fibrosis-Neoplasm-Neovascularization Interface

Oncology
  • Massalia Therapeutics has launched as a biotechnology spin-off from Aix-Marseille University's C2VN Institute, backed by seed financing to develop its novel SANF factor therapeutic platform.
  • The company's proprietary SANF (Soluble Angiogenic Neoplastic and Fibrotic) factor targets the critical intersection of fibrosis, neoplasm, and neovascularization, representing a potential paradigm shift in treatment approaches.
  • With preclinical testing complete, Massalia plans to begin first-in-human trials within six months and advance toward IND-enabling studies, leveraging 20 years of research by co-founders Dr. Marcel Blot-Chabaud and Professor Nathalie Bardin.

FDA Approves 18 New Personalized Medicines in 2024, Marking Significant Shift in Treatment Paradigm

Drug ApprovalOncologyRare DiseaseAIReal World EvidencePrecision Medicine
  • The FDA approved 18 new personalized medicines in 2024, representing 38% of all newly approved therapeutic molecular entities across multiple treatment areas including cancer and Alzheimer's disease.
  • Six new gene and cell-based therapies for rare genetic diseases and cancers were authorized, alongside expanded indications for 11 diagnostic testing systems and the first-ever expanded indication for an approved gene therapy.
  • Personalized medicines now constitute at least 25% of drug approvals for the past decade, a substantial increase from less than 10% ten years ago, demonstrating the healthcare system's shift away from one-size-fits-all approaches.

Merck and Daiichi Sankyo Launch Phase 3 Trial of Novel B7-H3 Targeted ADC for Advanced Esophageal Cancer

Oncology
  • The IDeate-Esophageal01 Phase 3 trial has begun evaluating ifinatamab deruxtecan, a potential first-in-class B7-H3 directed antibody-drug conjugate, against standard chemotherapy in advanced esophageal squamous cell carcinoma.
  • Esophageal squamous cell carcinoma accounts for 90% of global esophageal cancers with dismal survival rates of 15-20%, highlighting the urgent need for new treatment approaches after first-line therapy failure.
  • The trial follows promising early-phase results and will enroll approximately 510 patients across Asia, Europe, and North America, with overall survival as the primary endpoint.

A Phase 3 Study of I-DXd in Subjects with Relapsed SCLC

2023-509628-16-00RecruitingPhase 3
Daiichi Sankyo Inc.

A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)

NCT06925737RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 5/13/2025

A Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXd) In Subjects With Recurrent Or Metastatic Solid Tumors (IDeate-PanTumor02)

NCT06330064RecruitingPhase 2
Daiichi Sankyo
Posted 4/10/2024

A Study of Ifinatamab Deruxtecan in Subjects With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC) (IDeate-Esophageal01)

NCT06644781RecruitingPhase 3
Daiichi Sankyo
Posted 3/27/2025

Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Participants With Advanced Solid Malignant Tumors

NCT04145622RecruitingPhase 1
Daiichi Sankyo
Posted 11/3/2019

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

New Mainland Chinese Cancer Drug Shows Promising Results in Phase 1 Trial

OncologyTargeted Therapy
  • A multinational study led by Chinese University of Hong Kong researchers found that D3S-001, a mainland-developed cancer drug, effectively treats tumors driven by KRAS-G12C gene mutations.
  • The phase 1 trial demonstrated remarkable efficacy with over 70% of the 42 participating patients experiencing significant tumor shrinkage or complete disappearance after treatment.
  • Researchers noted that D3S-001 inhibits the KRAS-G12C mutation more quickly and potentially for longer durations than existing first-generation inhibitors, showing promise for non-small-cell lung, colorectal, and pancreatic cancers.

FDA Rejects ImmunityBio's Expanded Anktiva Application While Lifting Hold on Atara's Ebvallo Trials

Oncology
  • ImmunityBio received an FDA "refusal to file" letter for its application to expand Anktiva's use in bladder cancer patients, causing a 25% stock plunge and prompting calls for agency clarification.
  • The rejection comes despite Anktiva's approval last year for a related subset of bladder cancer patients, with ImmunityBio's founder Patrick Soon-Shiong citing "confounding inconsistency" in the FDA's decision-making process.
  • In contrast, Atara Biotherapeutics received positive news as the FDA lifted its clinical hold on blood cancer drug Ebvallo and scheduled discussions for resubmission, driving a 6% stock increase.

€13.6M EU-Funded PREDI-LYNCH Project Aims to Transform Cancer Screening for Lynch Syndrome Patients

AIOncology
  • The PREDI-LYNCH project has received €13.6 million in EU funding to develop non-invasive liquid biopsy tests for early cancer detection in Lynch Syndrome carriers, addressing a critical unmet medical need.
  • Swedish diagnostics company Elypta joins 27 partners across 16 European countries in this six-year initiative (2025-2031), contributing its proprietary glycosaminoglycan-based biomarker technology.
  • With only 5% of Europe's estimated 2 million Lynch Syndrome carriers under cancer surveillance, the project aims to create affordable, accessible screening methods for colorectal, endometrial, and urothelial cancers.

Azvudine Shows Comparable Effectiveness to Nirmatrelvir/Ritonavir for COVID-19 Patients with Chronic Liver Disease

Oncology
  • A multicenter retrospective study found that azvudine demonstrated effectiveness comparable to nirmatrelvir/ritonavir in reducing all-cause death and disease progression in COVID-19 patients with pre-existing chronic liver diseases.
  • Azvudine showed superior effectiveness specifically for COVID-19 patients with comorbid primary malignant tumors, potentially offering an alternative treatment option for this vulnerable population.
  • Both antiviral medications demonstrated acceptable safety profiles, with azvudine showing slightly better liver function outcomes in patients with chronic liver disease, providing important clinical guidance for treatment selection.

The Real-world Clinical Study of Azvudine Tablets in the Treatment of COVID-19

NCT06349655Completed
The First Affiliated Hospital of Zhengzhou University
Posted 12/5/2023

Weight Gain Combined with Delayed Motherhood Nearly Triples Breast Cancer Risk, Study Finds

Oncology
  • New research reveals women who gain significant weight after age 20 and delay childbirth until after 30 (or remain childless) face a 2.7 times higher risk of developing breast cancer.
  • The study, presented at the European Congress on Obesity, is the first to establish how weight gain and age of first birth interact to affect breast cancer risk in women.
  • Researchers analyzed data from nearly 48,500 women with an average age of 57, identifying over 1,700 breast cancer cases during the six-year follow-up period.

Former President Biden Diagnosed with Metastatic Prostate Cancer

Oncology
  • Former President Joe Biden, 82, has been diagnosed with aggressive prostate cancer that has metastasized to his bones, with a Gleason score of 9 indicating high-grade disease.
  • The cancer was discovered after Biden reported urinary symptoms, and while it represents an advanced stage with a 37% five-year survival rate for metastatic disease, it appears to be hormone-sensitive.
  • Biden's medical team is reviewing treatment options including androgen deprivation therapy and androgen receptor-targeted therapy, which have significantly improved outcomes for metastatic prostate cancer in recent years.
  • The diagnosis highlights the importance of symptom-based screening in older adults, as routine prostate cancer screening is typically discontinued at age 70.

CDSCO Approves AstraZeneca's Protocol Amendments for Durvalumab-Tremelimumab Combination in Advanced Liver Cancer

Monoclonal AntibodyOncology
  • India's CDSCO expert committee has approved AstraZeneca's protocol amendment for a Phase III trial evaluating durvalumab and tremelimumab combination as first-line treatment for advanced hepatocellular carcinoma.
  • The approval follows AstraZeneca's presentation of protocol amendment version 8.0 dated June 17, 2024, allowing the company to proceed with modifications to their ongoing clinical investigation.
  • This development comes alongside CDSCO's separate approval of AstraZeneca's protocol amendment for AZD0901, an antibody-drug conjugate being studied in advanced gastric cancer expressing claudin18.2.

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