PharmAbcine Newsletter - 3Q21
3Q21 Updates
The single most important event that took place in 3Q21 was the receipt of HREC (Human Research Ethics Committee) clearance in September to commence the Phase II combination trial of olinvacimab and pembrolizumab for mTNBC (metastatic Triple-Negative Breast Cancer) in Australia.
The Phase II clinical trial is designed to enroll 36 immuno-oncology drug naïve patients with mTNBC, a hard-to-treat disease that has very few FDA approved treatment options available. The goal of the study is to evaluate the clinical efficacy, safety, and pharmacodynamics of the combination therapy after the administration of 16mg/kg of olinvacimab and 200mg of pembrolizumab. PharmAbcine (“the Company” or “we”) will be the main sponsor of the study, and MSD will supply pembrolizumab. The Company expects the first-patient-in to take place in 4Q21.
Back in June, we received good news from the NIH (National Institutes of Health) in the US that it will proceed with in vivo studies to evaluate PMC-403’s therapeutic effects in SCLS (Systemic Capillary Leak Syndrome) based on highly encouraging data from in vitro studies. The NIH appears to have finished designing of the animal model and is taking the next step of preparing test animals. We currently expect the in vivo study to take less than a year. (*SCLS is a fatal orphan vascular disease in which blood vessels leak fluids from the bloodstream into surrounding tissues, and there is no approved drug in this indication.)
In September, the Company announced the additional nonclinical data of PMC-309, its first immuno-oncology asset, at KSMO (Korean Society of Medical Oncology) 2021. The new nonclinical data showed that the anti-VISTA antibody not only inhibits immunosuppressive MDSC (Myeloid-Derived Suppressor Cell), but also inhibits the proliferation of Treg (regulatory T cell), another key immunosuppressing cell.

Upcoming Events
PharmAbcine will participate in the upcoming partnering events, such as BIO Europe in October 2021 and J.P. Morgan Healthcare Conference in January 2022. These partnering events are like a big market place where potential business partners like global pharmaceutical companies come looking for new drug candidates presented by biotech companies. At these events, we will present our assets to the potential partners to look for the partnering opportunities.
Updates on current studies and future events
Olinvacimab (anti-VEGFR mAb, Best-in-Class)
◆ Development Progress
      ■  Combination studies
  • In September 2021, the Company received HREC approval in Australia for the Phase II combination trial of olinvacimab with pembrolizumab for mTNBC patients. The first-patient-in is expected in 4Q21. 
  • Two Phase Ib combination trials of olinvacimab with pembrolizumab in mTNBC and rGBM (recurrent Glioblastoma) are still ongoing. Two patients are still treated in the mTNBC trial and one patient in the rGBM trial. The Company plans to finalize these two studies by end-2022.
                ■  Combination studies
          • Currently 14 patients have enrolled for the Phase IIa clinical trial of olinvacimab monotherapy for Avastin-refractory rGBM (recurrent Glioblastoma Multiforme) patients. This mono study has initiated in 4Q19 in Australia and the U.S. Our clinical team expects the clinical trial to take up to two more years to the full completion. 
          PMC-403 (TIE2 activating mAb, First-in-Class)
          ◆ Development Progress
          • The GLP-Tox studies for PMC-403, which began in May 2021, is currently ongoing. We expect the safety data by mid-2022. 
          • PharmAbcine will submit IND filings for a Phase I clinical trial for an ophthalmological indication in late-2022. 
          • The research collaboration with U.S NIH (National Institutes of Health) to evaluate PMC- 403’s preclinical efficacy in SCLS (Systemic Capillary Leak Syndrome) is preparing test animals for in vivo studies.  
                  PMC-309 (anti-VISTA mAb)
                  ◆ Presentation at KSMO
                  • In September 2021, a new nonclinical data of PMC-309 was presented at KMSO. The data showed that PMC-309 inhibits both MDSC and Treg. Treg is a key immunosuppressing cell which suppresses T cell activations and inhibits anti-tumor effects in tumor microenvironment. Also, when used in combination with an anti-PD-1 drug, PMC-309 showed significantly improved tumor growth inhibition. Click the link for the related E-poster and summary (attached file).
                          ◆ Development Progress
                            • The GLP-Tox studies for PMC-309, which began in April 2021, is currently ongoing. The safety data is expected to be generated by 1Q22. 
                            •  The Company expects the IND submission of the Phase I clinical trial in 2Q22.
                                        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 2Q22.
                                                            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
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