|제목||< FAQs from the investor meetings as of August 2021 >|
We (or “PharmAbcine”) prepared this FAQ (Frequently Asked Questions) to provide answers to questions raised during the Q&A session of the investor meeting in August, 2021. We recommend viewers to refer to the previous FAQs as this issue only addresses newly raised questions.
Q1. How many PharmAbcine shares does Orbimed hold as of now?
Orbimed no longer holds any stake in PharmAbcine at end-Aug. Orbimed, a global venture capital firm specializing in the bio sector, held an 8.27% stake at the beginning of the year.
The firm initially invested in PharmAbcine via Series A funding in 2009, nine years before the PharmAbcine’s initial public offering in 2018.
Orbimed did not indicate the reasons for liquidating its position. But considering the fact that the firm held a relatively small position for an unusually long time of 12 years, its investment decision is not a surprising one.
Q2. What is the current progress on the ongoing Phase II olinvacimab mono study for Avastin-refractory rGBM (recurrent Glioblastoma)?
So far, 14 out of 36 patients have been enrolled in the study. PharmAbcine initiated the study in both Australia and the US in 4Q19. The study is designed to have three cohorts with 12 patients in each group.
In June 2021, we completed the recruitment of 12 patients in the first cohort who are receiving 16mg/kg bi-weekly. After evaluating the safety of the therapy by DSMB (Drug Safety Monitoring Board) in July, we started the second cohort study with an escalated dose of 20mg/kg and have two patients enrolled.
The patient recruitment is still ongoing, and our clinical team expects the clinical trial to take up to two more years before the full completion.
Q3. What is the development status of PMC-309?
PMC-309, one of the Company’s first immuno-oncology drug candidates, is undergoing GLP-Tox studies ahead of human trials. PharmAbcine expects the safety data to be available in early 2022. Once there are no serious safety issues, the Company will enter a global clinical trial in late 2022.
PMC-309 antagonizes VISTA (V-domain Ig suppressor of T cell activation), commonly found on immunosuppressive cells such as MDSCs (Myeloid-Derived Suppressor Cells). Unlike existing PD-1/PD-L1 drugs that directly activate T cells, PMC-309 inhibits MDSCs and indirectly enhances T cells’ anti-tumor responses.
Q4. What is the status of manpower in PharmAbcine?
There are currently 57 employees in Korea, of which 43 employees work for the R&D team. The size of our R&D team has doubled from 20 in May 2019. Over 70% of R&D team employees hold master’s degree or above. We also have a team of R&D experts at Wincal Biopharm, a 100%-owned US subsidiary. The team is headed by Dr. Tae-Weon Lee, Chief Scientific Officer and a founding member of Wincal.