|< FAQs from the investor meetings as of October 2021 >
We (or “PharmAbcine”) prepared this FAQ (Frequently Asked Questions) to provide answers to questions frequently raised by our shareholders and investors in October 2021. We recommend viewers to refer to the previous FAQs as this issue only addresses newly raised questions.
Q1. In regards to Olinvacimab, what other combo therapies are being considered?
The Company is considering numerous combo therapies for olinvacimab. In terms of a partnering molecule, we are currently most keen on anti-Trop2 ADCs (Antibody Drug Conjugate), such as Trodelvy, Datopotamab, and Trastuzumab Derustecan. In terms of indications, we are interested in combo studies in solid tumors including gastric cancer, lung cancer, ovarian cancer, and colorectal cancer. Thanks to olivacimab’s excellent safety profile, we have been getting combo study proposals from principal investigators around the world.
Q2. Can you tell us about the progress on CDMO (Contract Development and Manufacturing Organization) services from Samsung Biologics and Thermo Fisher?
PharmAbcine currently has three CDMO contracts outstanding from two companies. We signed two CDMO agreements with Samsung Biologics in August 2020, one for PMC-402 and the other for PMC-403. We also signed a CDMO contract with Thermo Fisher in June 2020 for PMC-309. Under the contract, both companies will provide PharmAbcine with cell line development, process development, cGMP clinical manufacturing, and IND filing support for aforementioned preclinical molecules.
Samsung Biologics already completed non-GMP production of PMC-403 and PMC-402 for GLP-tox studies. We received a notice from Samsung that the GMP production for clinical studies will begin in November 2021.
Thermo Fisher just completed the GMP drug substance production of PMC-309 for the Phase I clinical trial next year and it is undergoing product quality assessment.