|제목||<FAQs from the investor meetings as of April 2022 >|
|참고||F A Q|
F A Q
We (or “PharmAbcine”) prepared this FAQ (Frequently Asked Questions) to provide answers to questions frequently raised during investor meetings in April 2022. We recommend viewers to refer to the previous FAQs as this issue only addresses newly raised questions.
Q1. What are the development schedules for the preclinical molecules (PMC-403, PMC-309, and PMC-402)?
All three preclinical molecules are being readied for Phase I IND submission in 3Q22. We nearly completed the GLP-Tox studies for all three molecules. As for PMC-403, we recently announced the positive data in animal toxicology studies, proving that it is ready for human trial. PharmAbcine plans to initiate clinical trials globally. PMC-309, the Company’s first immuno-oncology candidate, is planned to have its Phase I trial in Australia, and the studies for both vessel-normalizing antibodies, PMC-403 and PMC-402, will take place in South Korea.
Q2. What are the Company’s licensing strategies for all its antibodies?
PharmAbcine has different licensing strategies based on their development stage.
As for olinvacimab, our clinical-stage molecule, we believe that we will get an opportunity to propose a licensing deal once we generate interim result from the ongoing Phase II trial in combination with pembrolizumab for mTNBC patients. The patient recruitment is still ongoing, and we will keep posting updates on clinical developments in the future.
Like mentioned earlier, our preclinical molecules (PMC-403, PMC-309, and PMC-402) are scheduled to enter clinical stage very soon. There are some biotech and pharmaceutical companies that are highly interested in these antibodies. Once we generate the safety profile and efficacy data through Phase I studies, we should be able to discuss the terms of licensing deals.
The early-stage pipeline candidates, such as bispecific and tumor-targeting antibodies, also look promising. Many cell therapeutic companies are looking closely at PMC-005BL, which specifically targets EGFRviii exclusively found on certain tumors. The unique targeting-property allows it to be engineered into CAR-T and CAR-NK.
We will do our best to continue the discussion with global pharmas for successful licensing deals and will generate meaningful events in the future.
Q3. There were some other small molecule drugs that show similar ORR (Overall Response Rate) to the interim data of Phase Ib olinvacimab-pembrolizumab combo trial in mTNBC (metastatic Triple-Negative Breast Cancer). What quality does olinvacimab have that makes it distinct from the existing drugs?
The excellent safety profile is what makes olinvacimab very distinct from the existing drugs. While demonstrating highly encouraging efficacy data, olinvacimab only showed mild capillary hemangioma which disappears once the treatment stops. On the other hand, the existing drugs show very severe adverse events, including organ perforation, hemorrhage, hypertension, proteinuria, etc., that can lead to other life-threatening events. Olinvacimab’s excellent safety profile can help improve overall survival rates and patients’ quality of life.