PharmAbcine Newsletter - 2Q 2021
2Q Updates
PharmAbcine had three major events in 2Q 2021. First, PharmAbcine signed a clinical trial agreement with MSD in April to proceed the Phase II combination trial of olinvacimab with pembrolizumab in mTNBC (metastatic triple-negative breast cancer) patients. Second, PharmAbcine announced the nonclinical data of PMC-309, its first immuno-oncology asset, at AACR (American Association for Cancer Research). Third, the Company also announced the nonclinical data of PMC-403, a vessel normalizing antibody, at ARVO (Association for Research in Vision and Ophthalmology).
PharmAbcine and MSD agreed to enter the Phase II mTNBC study in both Australia and South Korea thanks to highly encouraging results from the Phase Ib trial. The Phase Ib study showed efficacy data of 50% ORR (Overall Response Rate) and 67% DCR (Disease Control Rate) in the 16mg/kg Olinvacimab cohort. This data is highly encouraging because the pembrolizumab monotherapy in mTNBC showed only 9% ORR.
The nonclinical data of PMC-309 presented at AACR in April showed that the anti-VISTA monoclonal antibody has a unique mode of action that indirectly activates T cells. The data also showed significantly improved anti-tumor effects when used in combination with an anti-PD-1 drug. 
The data from ARVO presentation in May showed that PMC-403 normalizes pathological blood vessels with a  TIE2-activating mechanism. In ophthalmology animal models, it demonstrated retinal leakage reduction comparable to and better improvements in optic nerve responses than the leading eye drugs available in the market. 
We noted from this year’s BIO Digital two weeks ago that there were heightened interests among our business partners in our preclinical assets after the data release.
Upcoming Events
The clinical development team is taking necessary procedures to get approval for the study from HREC (Human Research Ethics Committees) in Australia. We expect an approval in July this year. PharmAbcine recently started GLP-Tox studies for all our preclinical assets, including PMC-403, PMC-309, and PMC-402, and these assets are expected to enter clinics in 2022. 

Updates on current studies and future events

 Olinvacimab (anti-VEGFR mAb, Best-in-Class)
◆ Combination studies
  • The HREC approval of the Phase II combination trial of olinvacimab with pembrolizumab in Australia for mTNBC patients is expected in July 2021.
  • Two Phase Ib combination trials of olinvacimab with pembrolizumab in mTNBC and rGBM (recurrent Glioblastoma) are still ongoing. Two patients still getting treated in the mTNBC trial and one patient in the rGBM trial. The Company plans to finalize these studies by 2022.
◆ Monotherapy
  • The Phase IIa clinical trial of olinvacimab monotherapy in Avastin-refractory rGBM (recurrent Glioblastoma Multiforme) patients, which began in November 2019, is still ongoing in Australia and the U.S. As of now, 12 patients are recruited and registered. The patient recruitment is still slow due to the COVID-19 pandemic. According to the principal investigators, the study could take as many as two more years to complete the study.

PMC-403 (TIE2 activating mAb, First-in-Class)
◆ Presentation at ARVO
  •  In May 2021, the Company presented the nonclinical data of PMC-403 at ARVO Annual Meeting. 
  • PMC-403 normalizes pathological blood vessels with a  TIE2-activating mechanism.
  • It also demonstrated retinal leakage reduction comparable to and better improvements in optic nerve responses than the leading eye drugs available in the market.
  •  Click the link for the related press release and E-poster (attached file).
◆ Development Progress
    • The company already initiated GLP-Tox studies for PMC-403 in May 2021. The safety data of PMC-403 is expected to be generated 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 therapeutic effects in SCLS (Systemic Capillary Leak Syndrome) is ongoing. We observed some positive results from in vitro studies and are preparing for in vivo studies. 
    • The Company is also conducting multiple nonclinical studies with other organizations to evaluate PMC-403’s efficacy in diverse indications such as CKD (Chronic Kidney Diseases), diabetic foot ulcer, diabetic retinopathy, etc.

      PMC-309 (anti-VISTA mAb)
      ◆ Presentation at AACR
      • In April 2021, the nonclinical data of PMC-309 was presented at AACR annual meeting. 
      •  The data showed that PMC-309 has a unique mode of action that indirectly activates T cells. 
      •  It also showed significantly improved anti-tumor effects when used in combination with an anti-PD-1 drug.
      • Click the link for the related press release and E-poster (attached file).
      ◆ Development Progress
      • The company already initiated GLP-Tox studies for PMC-309 in April 2021 to establish its safety profile before entering the clinical study. The studies are expected to be finalized in February 2022. 
      •  The Phase I clinical trial is expected to start in 2022.

      PMC-402 (Tie2 activating mAb, First-in-Class)
      • The company already initiated GLP-Tox studies for PMC-402 in January 2021. The studies are expected to be finished in early 2022. 
      •  We expect IND submission for a Phase I clinical trial in 2022. 

      Other Early-stage Assets 
      • PMC-122: a bispecific antibody targeting both PD-L1 and CD47, is under optimization process.
      • COVID-19 Therapeutics:  The company has developed a candidate that could work against the new COVID-19 mutation variants. The Company is currently conducting multiple studies to evaluate its efficacy.

      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.
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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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