Das könnte durchaus im 1Q 2022 passieren... Gem. Roadmap soll im 1. - 2. Q/22 das Ergebnis von einigen Studien kommen. U.a. OSU - pan sarbecovirus Studie
BVX-0918A Phase I Study of a Bihaptenized Autologous Ovarian Tumor Cell Vaccine in Ovarian Cancer Patients After Relapse - Non-GMP vaccine bioproduction "dry-run" (1/2022) - GMP bioproduction, facility & process validation (1Q/2022) - CRO selection, PI on-boarding, patient recruitment (1Q-2Q2022) - CTA (1Q/2022) - Vaccination of first Phase I subjects (summer 2022) - US IND submission 4Q2022 (utilize EU data)
SARS-CoV-2 Platform Development - In vivo preclinical to meet FDA CBER guidance (complete) - CHO cell line / expression system and GLP s-protein bioproduction (complete) - ACE2 protein/protein assay (12/2021) - OSU+BIOV collaboration on pan-sarbecovirus (β Cov B) vaccine (12/2021-1Q2022) - GLP SARS-CoV-1 haptenization for OSU program (1Q2022) - GMP s-protein haptenization and clinical yield bioproduction (3Q2020) - Regulatory submissions (i) BVX-0320 and/or (ii) haptentized SARS-CoV-1 + BVX-0320 (3Q/2022) - Phase I Study (4Q2022)
CoviDT Development Plan Completed Milestones - EUA request filed (2/2021) and FDA CBER Assignment (3/2021) - Submission of Pre-IND Meeting Request and Briefing Document (4/2021) - Wuxi Biologicals CHO cell expression system for recombinant SARS-CoV-2 s-protein (Complete) - Non GMP human data (Available) - FDA Pre-IND Written Response (Complete) - Clinical Protocol Summary (Complete) - Rabbit model acute toxicity study (Complete)
Upcoming Milestones US/CAN/EU - Bioproduction of clinical supply SARS-CoV-2 protein (12/2021-2Q2022) - Submission of IND (2Q2022) - Phase I/II Combination Study (3Q2022) - CTA Submission for EU (3Q-4Q2022)
Upcoming Milestones (Non-Regulated Markets) - Import and commercial licensure for non- regulated markets (2Q-4Q2022) |