PharmAbcine Newsletter - 4Q22 |
|
|
4Q22 Updates
PharmAbcine accomplished significant milestones in the fourth quarter of 2022.
In December 2022, we announced a clinical trial collaboration with MSD (Merck Sharp & Dohme), under which MSD will supply pembrolizumab (Keytruda®), MSD’s anti-PD-1 drug, for a Phase 1 clinical trial in combination with PMC-309, PharmAbcine’s novel anti-VISTA antagonizing antibody. We are looking forward to initiating this study because we believe that PMC-309, with a novel mechanism that indirectly activates T cells, can help to treat patients who do not respond well to the existing immuno-oncology therapies. The Phase I clinical trial is under preparation and will have its clinical trial application submitted to the Australian Human Research Ethics Committee (HREC) in the first quarter of 2023.
PharmAbcine also submitted an Investigational New Drug (IND) application of PMC-403, the Company’s novel TIE2 agonistic antibody, to the Korean Ministry of Food and Drug Safety (MFDS) for a Phase I clinical trial in neovascular age-related macular degeneration (nAMD). Unlike the existing drugs and candidates that block angiogenesis through VEGF-A signal inhibition, PMC-403 has a unique mode of action that normalizes pathologically leaky blood vessels and can be used for patients who do not respond to the marketed drugs. PharmAbcine plans to start the clinical trial at multiple sites in South Korea, including Seoul National University Bundang Hospital.
Other clinical trial programs are progressing well. The Phase II olinvacimab-pembrolizumab combination trial in metastatic Triple-Negative Breast Cancer (mTNBC) is currently ongoing. The study was initiated based on the encouraging clinical data from the previous Phase Ib olinvacimab-pembrolizumab combination study in mTNBC. The Phase Ib interim data showed a 50% overall response rate (ORR) in the high-dose cohort and an excellent safety profile. The Phase II study is currently taking place in Australia and recruiting patients to enroll 36 in total.
Upcoming Events
PharmAbcine will participate in the upcoming 41th Annual J.P. Morgan Healthcare Conference and Biotech Showcase 2023. The Company will meet with global investors and executives from biotech and pharmaceutical companies to explore potential investment and/or licensing deal opportunities for its key pipeline assets. The events will occur in San Francisco during JPM week (January 9-12, 2023).
|
|
|
Updates on current studies and future events |
|
|
Olinvacimab (anti-VEGFR2 mAb, Best-in-Class) |
|
|
- The Phase II combination trial of olinvacimab with pembrolizumab in mTNBC is ongoing actively, recruiting patients at three hospital sites in Australia (36 patients planned).
|
|
|
PMC-403 (TIE2 activating mAb, First-in-Class)
|
|
|
- The IND for the Phase I clinical trial in neovascular age-related macular degeneration (nAMD) was submitted to the Korean Ministry of Food and Drug Safety (MFDS) in December 2022.
- The Phase I trial will evaluate the safety, tolerability, maximum tolerated dose (MTD), and recommended phase 2 dose (RP2D) in nAMD patients (36 patients planned).
- The research collaboration with NIH to evaluate PMC-403’s preclinical efficacy in SCLS (Systemic Capillary Leak Syndrome) animal model is ongoing.
|
|
|
- The updated preclinical data of PMC-309 was presented at Society for Immunotherapy of Cancer (SITC) 2022 in November 2022. The presentation includes the GLP-Toxicology and PK data needed to determine the clinical dosage and interval.
- PharmAbcine announced a clinical trial collaboration with MSD to initiate a Phase I clinical trial in combination with pembrolizumab for patients with advanced solid tumors in December 2022.
- The Company expects to submit a clinical trial application to the Australian Human Research Ethics Committee (HREC) in the 1st quarter of 2023.
|
|
|
Early-Stage Development Project (Bispecific Antibody)
|
|
|
- The Company is actively developing the next-generation bispecific antibody which was selected to receive government research grant from KDDF (Korea Drug Development Fund), a government drug development project.
- Utilizing the government grant, PharmAbcine is developing a bispecific antibody targeting both PD-L1 and SIRPα. SIRPα is an inhibitory receptor on macrophages that binds to CD47 and inhibits phagocytic actions of macrophages.
|
|
|
Events and Accomplishments |
|
|
SITC 2022 (November 8-12, 2022, in Boston) |
|
|
- Secured PK data needed for establishing dosing intervals in a clinical trial.
- Data in both safety and dosage groups needed for a clinical trial were generated through GLP-Toxicology studies.
|
|
|
Disclaimer
This document has been prepared by PharmAbcine Co., Ltd. (hereafter, the “Company”) to provide information on presentations to institutional investors regarding the proposed. “Forecast information” in this document is information that has not been subject to an individual verification. The forecast is related to future events, not the past, which means the Company’s future management status and financial performance. In terms of expression, it includes words such as “forecast,” “prospect,” “plan,” “expectation,” and “(E).”The above “forecast information” is influenced by future changes in management environment and inherently subject to uncertainties that may result in significant discrepancies between actual future performance and what is stated or implied in “forecast information. “Furthermore, the prospect is based on the presentation date, considering the present market conditions and the direction of the Company's management. Please be aware that changes may occur without notice due to changes in the market environment and strategies. Please note that the Company and its employees are not liable for any loss or damage incurred in connection with the use of this document, including negligence or otherwise. This document does not constitute any solicitation for offers, sales, trading, or subscription of stock, and any part of this document cannot be the basis for the relevant contracts, arrangements, or investment decisions. Please note that this material may be used for Preprofit purposes without content modification(however, source representation is required), and unauthorized distribution and reproduction of materials with modified content without prior approval of the Company may result in legal sanctions. |
|
|
Contact Info
IR/PR: Sookyoung Shin, Head T: +82.42.863.2017
E: sookyoung.shin@pharmabcine.com |
IR/PR: Sungjun Park, Associate T: +82.42.863.2017 E: sungjun.park@pharmabcine.com |
|
|
PharmAbcine
2F, Research Building 2, 70, Yuseong-daero 1689 beon-gil, Yuseong-gu, Daejeon, Republic of Korea
|
|
|
|
|
