PharmAbcine Newsletter - 4Q21
4Q21 Updates

PharmAbcine has established meaningful milestones in 4Q21. One of them was the first patient recruitment and dosing for the Phase II combination trial of olinvacimab and pembrolizumab for mTNBC (metastatic Triple-Negative Breast Cancer) in Australia.

PharmAbcine received an HREC (Human Research Ethics Committee) clearance in September to commence the Phase II combination trial in mTNBC. Recently, we received a notification from one of three clinical sites that one patient met the inclusion criteria and started receiving the treatment.

In November, PMC-309, one of the Company’s first immune-oncology assets, was selected by KDDF (Korea Drug Development Fund), a government drug development project, to receive a research grant for the preclinical studies of PMC-309. With the IND submission for the Phase I clinical trial expected in 2Q22, this grant will most likely provide a strong momentum for the development of PMC-309.

In December, PharmAbcine was awarded another research grant for the Company’s next-generation bispecific antibody development project. The Company plans to utilize the grant to develop an antibody that targets both PD-L1 and SIRPα, an inhibitory receptor on macrophages that binds to CD47. The project is expected to reinforce the Company’s bispecific programs.

Upcoming Events
PharmAbcine will virtually participate in J.P. Morgan Healthcare Conference and Biotech Showcase in January 2022. These partnering events will allow us to meet with potential business partners including global pharmaceutical companies to seek out-licensing and co-development opportunities.
Updates on current studies and future events
Olinvacimab (anti-VEGFR2 mAb, Best-in-Class)
◆ Development Progress
      ■  Combination studies
  • The first patient enrollment and dosing for the Phase II combination trial of olinvacimab with pembrolizumab in mTNBC took place in late December. 
  • The Phase Ib combination trial of olinvacimab with pembrolizumab in mTNBC is still ongoing. Among two remaining patients in the mTNBC study, one patient is still receiving the full treatment while the other patient is receiving olinvacimab-only mono treatment under compassionate use. 
  • The Phase Ib combination trial of olinvacimab with pembrolizumab in rGBM (recurrent Glioblastoma). The last patient in this trial is also receiving olinvacimab-only mono treatment under compassionate use. 
  • The Company plans to finalize two phase Ib combination studies by mid-2022.
                ■  Monotherapy
          • Currently, 14 patients have enrolled for the Phase IIa clinical trial of olinvacimab monotherapy for Avastin-refractory rGBM patients. This mono study began in 4Q19 in Australia and the U.S. Our clinical team expects the clinical trial to be completed by end-2023.
          PMC-403 (TIE2 activating mAb, First-in-Class)
          ◆ Development Progress
          • The GLP-Tox studies for PMC-403 has been ongoing since May 2021. The Company expects the safety data by 2Q22.
          • PharmAbcine will submit IND filings for the Phase I clinical trial for ophthalmological indications in 4Q22.
          • The research collaboration with NIH (National Institutes of Health) to evaluate PMC-403’s preclinical efficacy in SCLS (Systemic Capillary Leak Syndrome) is ongoing. The test animals are being prepared for in vivo studies. 
                  PMC-309 (anti-VISTA mAb)
                  ◆ Development Progress
                    • The GLP-Tox studies for PMC-309 has been ongoing since April 2021. The safety data is expected to be generated by 1Q22. 
                    • The Company expects the IND submission of the Phase I clinical trial for solid cancer in 2Q22.
                    • In November, PMC-309 was selected by KDDF to receive a research grant for the PMC-309’s preclinical studies. Visit the link for the press release.
                                PMC-402 (TIE2 activating mAb, First-in-Class)
                                ◆ Development Progress
                                      • The GLP-Tox studies for PMC-402 began in January 2021. We expect the safety data by end-2021. 
                                      • The Company expects the IND submission of the Phase I clinical trial in 4Q22.
                                                    Early-Stage Development Project (Bispecific Antibody)
                                                    ◆ Development Progress
                                                          ■  KDDF Research Grant
                                                          • In December, the Company’s next-generation bispecific antibody development project was selected by KDDF to receive a research grant. 
                                                          • The Company plans to use the grant to develop a bispecific antibody that targets both PD-L1, an immune checkpoint molecule present on tumor cells, and SIRPα, an inhibitory receptor on macrophages that binds to CD47 and inhibits phagocytic actions of macrophages.
                                                          • Visit the link for the press release.
                                                                        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