PharmAbcine Newsletter - 1Q22
1Q22 Updates

PharmAbcine achieved several meaningful milestones in 1Q22. First, there was a LPLV (Last Patient Last Visit) in the Phase Ib combination clinical trial of olinvacimab and pembrolizumab for mTNBC (metastatic Triple-Negative Breast Cancer) patients in Australia. Second, the GLP-Tox studies for three preclinical candidates of PMC-403, PMC-309, and PMC-402 have finished. Third, the Company signed two Research Collaboration Agreements with NuclixBio and RNAGENE, both of which specialize in the development of mRNA-based therapeutics.


The mTNBC study, which had 11 patients divided into 12mg/kg and 16mg/kg/weekly olinvacimab cohorts while equally receiving a 200mg flat dose of pembrolizumab, began in December 2018. In December 2020, the Company presented a very encouraging interim data at SABCS (San Antonio Breast Cancer Symposium). The result showed 50% ORR (Overall Response Rate) in the high-dose cohort as well as excellent safety profile. The last patient, who received the last 35th cycle of the combination treatment, is in stable condition and currently receiving olinvacimab in monotherapy as compassionate use. The clinical study result reports will be finalized in 3Q22.

The Company initiated the GLP-Tox studies for three first-in-class preclinical candidates in the first half of 2021. All studies are completed and the final reports should be ready in 2Q22 for the IND submissions. The Company will release the headline data in the near future.

In March 2022, the Company signed Research Collaboration Agreements with NuclixBio and RNAGENE for developing novel mRNA therapeutics. mRNA therapies involve the administration of mRNA in patients so that patients' own cells can produce the encoded therapeutic antibody, thus it may have some advantages over antibody drug at some point. The research collaboration could be a new turning point for PharmAbcine with the development mRNA therapeutics beyond antibody therapeutics.

Upcoming Events
PharmAbcine will participate in upcoming AACR (American Association for Cancer Research) 2022 between April 8 and 13 virtually. At the conference, the Company will present the preclinical data of PMC-309, anti-VISTA mAb for immuno-oncology, and PMC-403, a TIE2-activating antibody that normalizes pathologically leaky blood vessels.

The Company expects the ongoing GLP-Tox study results of three preclinical assets (PMC-403, PMC-309, and PMC-402) to be available in 2Q22. The IND submissions of those preclinical candidates are expected in 2Q or 3Q this year.
Updates on current studies and future events
Olinvacimab (anti-VEGFR2 mAb, Best-in-Class)
◆ Development Progress
      ■  Combination studies
  • The Phase II combination trial of olinvacimab with pembrolizumab in mTNBC is ongoing actively, recruiting patients in Australia. One patient enrolled as of late-March 2022.
  • The Company has submitted an IND filing to MFDS in South Korea to proceed the Phase II combination trial of olinvacimab with pembrolizumab in mTNBC as per agreement with MSD.
  • The LPLV (Last Patient Last Visit) for the Phase Ib combination trial of olinvacimab with pembrolizumab in mTNBC took place in February 2022. There are two patients (the last patient included) receiving olinvacimab monotherapy treatment under compassionate use per request from the patients, families, care-givers and the principal investigators.
  • In the Phase Ib combination trial of olinvacimab with pembrolizumab in rGBM, the patient who has been receiving olinvacimab monotherapy treatment under compassionate use since October 2021 has completed receiving the treatment in March 2022.
  • The final clinical study reports of the two phase 1b combination trials will be finalized in 3Q22.

      ■  Monotherapy
  • As of Apr 2022, 18 patients are enrolled for the Phase IIa clinical trial of olinvacimab monotherapy for Avastin-refractory rGBM patients. The study began in 4Q19 in Australia and the U.S and is expected to be completed by end-2023.
PMC-403 (TIE2 activating mAb, First-in-Class)
◆ Development Progress
  • The GLP-Tox studies are finalized, and the study result report is expected in 2Q22.
  • PharmAbcine will submit IND filings for the Phase I clinical trial in 3Q22 for ophthalmology indication.
  • The research collaboration with NIH to evaluate PMC-403’s preclinical efficacy in SCLS (Systemic Capillary Leak Syndrome) is ongoing.
  • The updated preclinical data of PMC-403 will be presented at AACR 2022.


  
PMC-309 (anti-VISTA mAb)
◆ Development Progress
    • The GLP-Tox studies are finalized, and the study result report is expected in 2Q22.
    • The Company expects the IND submission of the Phase I clinical trial in 3Q22 for solid tumor indication.
    • The updated preclinical data of PMC-309 will be presented at AACR 2022.





    PMC-402 (TIE2 activating mAb, First-in-Class)
    ◆ Development Progress
          • The GLP-Tox studies are finalized, and the study result report is expected in 2Q22.
          • The Company expects the IND submission of the Phase I clinical trial in 3Q22.






          Early-Stage Development Project (Bispecific Antibody)
          ◆ Development Progress
                ■  KDDF Research Grant
                • 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.







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                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.
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                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

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