Usha Menon

BioVaxys Confirms First Clinical Site and Principal Investigators for Ovarian Cancer Vaccine Trial and Enters into Second Tumor Cell Supply Agreement

Retrieved on: 
Wednesday, May 18, 2022

HCL is a public hospital and France's second University Hospital Center, and a premier site for clinical studies in the EU.

Key Points: 
  • HCL is a public hospital and France's second University Hospital Center, and a premier site for clinical studies in the EU.
  • Benot You, MD, PhD, of HCL who are planned Clinical Investigators for the Phase I study of BVX-0918.
  • BioVaxys is preparing to file a Clinical Trial Application ("CTA") with the European Medicines Agency ("EMA") later in 2022.
  • Access to surgically removed ovarian cancer tumor cells is a critical step enabling BioVaxys to validate the manufacturing process for BVX-0918.

BioVaxys Confirms First Clinical Site and Principal Investigators for Ovarian Cancer Vaccine Trial and Enters into Second Tumor Cell Supply Agreement

Retrieved on: 
Wednesday, May 18, 2022

HCL is a public hospital and France's second University Hospital Center, and a premier site for clinical studies in the EU.

Key Points: 
  • HCL is a public hospital and France's second University Hospital Center, and a premier site for clinical studies in the EU.
  • Benot You, MD, PhD, of HCL who are planned Clinical Investigators for the Phase I study of BVX-0918.
  • BioVaxys is preparing to file a Clinical Trial Application ("CTA") with the European Medicines Agency ("EMA") later in 2022.
  • Access to surgically removed ovarian cancer tumor cells is a critical step enabling BioVaxys to validate the manufacturing process for BVX-0918.

First Patient Enrolled in Phase II DOVACC trial of UV1 in Advanced Ovarian Cancer

Retrieved on: 
Wednesday, December 15, 2021

Innovation Norway has granted Ultimovacs NOK 10 million (approximately $1.2 million) to support the execution of the Phase II DOVACC study.

Key Points: 
  • Innovation Norway has granted Ultimovacs NOK 10 million (approximately $1.2 million) to support the execution of the Phase II DOVACC study.
  • DOVACC is one of five randomized Phase II clinical trials of Ultimovacs' telomerase vaccine UV1 in combination with other immunotherapies.
  • UV1 is being investigated in combination with checkpoint inhibitors in Phase II trials covering advanced malignant melanoma, ovarian cancer, head and neck squamous cell carcinoma, malignant pleural mesothelioma, and non-small cell lung cancer (NSCLC).
  • The trial is designed to evaluate Ultimovacs proprietary UV1 cancer vaccine in combination with AstraZenecas durvalumab, a PD-L1 checkpoint inhibitor and its PARP inhibitor, olaparib, the maintenance therapy for advanced ovarian cancer.

OncXerna Therapeutics Announces New Biomarker Data from Retrospective Analysis of Results from Phase 1b Ovarian Cancer Trial of Navicixizumab Plus Paclitaxel at the ESGO 2021 Congress

Retrieved on: 
Saturday, October 23, 2021

WALTHAM, Mass., Oct. 23, 2021 (GLOBE NEWSWIRE) -- OncXerna Therapeutics, Inc. (“OncXerna”), a precision medicine company using an innovative RNA-expression based biomarker platform to predict patient responses to its targeted oncology therapeutic candidates, today announced new biomarker data from a retrospective analysis of results from its Phase 1b clinical trial of navicixizumab in an electronic poster at the European Society of Gynaecological Oncology (ESGO) Congress 2021.

Key Points: 
  • Data presented in the poster are from a retrospective analysis of results from an open-label Phase 1b trial evaluating navicixizumab, a potentially first-in-class anti-DLL4/VEGF bispecific antibody targeting tumor vasculature, in combination with paclitaxel in patients with platinum-resistant ovarian cancer (PROC).
  • I believe the data presented at ESGO demonstrated the potential of navicixizumab together with the Xerna TME Panel to help address this need.
  • We have been searching for a predictive biomarker for anti-angiogenic therapies and the Xerna TME panel results presented at ESGO are very promising.
  • The Phase 1b trial was an open-label, non-randomized, dose-escalation and expansion study of the safety, tolerability, and efficacy of navicixizumab plus paclitaxel in patients with platinum-resistant ovarian cancer.