|제목|| <FAQs from the investor meetings as of December 2021 >|
|참고||F A Q|
FAQs from the investor meetings as of December 2021
We (or “PharmAbcine”) prepared this FAQ (Frequently Asked Questions) to provide answers to questions frequently raised during investor meetings in December 2021. We recommend viewers to refer to the previous FAQs as this issue only addresses newly raised questions.
Q1. Can you tell us about the patient cohorts in the ongoing Phase IIa olinvacimab mono study for Avastin-refractory rGBM (recurrent Glioblastoma)?
The study, which was initiated in both Australia and the US in 4Q19, is designed to have three cohorts with 12 patients in each group.
Under the protocol, the patients in each cohort are to receive different doses: 16mg/kg for the first cohort, 20mg/kg for the second cohort, and 24mg/kg for the last cohort. 12 patients have been recruited for the first cohort and two patients for the second thus far. Our clinical experts expect the trial to be completed by end-2023.
Q2. Where will the Phase I clinical trial of PMC-309 take place and why?
The Company plans to initiate clinical trials of PMC-309 in Australia due to the following four reasons.
First, Australia offers the best value for money. The Australian government offers tax incentives for companies which set up a local operation and conduct clinical studies in Australia. Including the tax incentives, doing a clinical study in Australia is about 20-25% cheaper than in Korea.
Second, the regulatory approval process is much shorter in Australia. Our experiences show that the time it takes to get a regulatory approval in Australia is about one half of that in the US.
Third, Australia is a favorite clinical study location for most global pharmaceutical companies because Australia has the racial diversity needed for a US FDA approval.
Lastly, it is much easier for us to oversee and manage clinical studies performed in Australia because Korea and Australia are in a similar time zone. Australia is only one hour ahead of Korea.
Q3. PMC-403, a TIE2-activating antibody that normalizes leaky blood vessel, looks promising in ophthalmology area. Are there other TIE2-activating competitors in development?
There are only two direct TIE2-activating antibodies in development. Our PMC-403 is the leading molecule, followed by an antibody from Unity Biotechnology.
Multiple global biotechs are developing molecules that activate TIE2 as well, but they are either indirect TIE2-activating antibodies or TIE2-activating peptide/small molecules.