【Company Research】Kintor Pharmaceutical (9939 HK) – Promising clinical data from Proxalutamide on COVID-19 and GT90001 (ALK-1) on 2L HCC
- Positive preliminary results of Proxalutamide for treatment of COVID-19. As a novel androgen receptor (AR) antagonist, Proxalutamide was found that it could limit the expression of ACE-2 and TMPRSS2, which play a critical role for SARS-CoV-2 to bind and enter host cells in the lung. In an investigator initiated randomised, double-blind and placebo-controlled clinical trial (NCT04446429) in Brazil conducted by Kintor and Applied Biology, the preliminary analysis showed that, for the 319 enrolled patients, the hospitalisation rate of Proxalutamide arm is 0.8% which is significantly lower than the Controlled Arm (27.0%). In addition, the percentage of mechanical ventilation usage was 0% for the Proxalutamide Arm compared to 9.0% for the Controlled Arm. The percentage of death was 0% for the Proxalutamide Arm, compared to 2.0% for the Controlled Arm. Besides, in terms of the RT-PCR test between day 0 and day 30, Proxalutamide Arm had shown greater reduction of viral load starting from day 7. All preliminary results mentioned above indicate a promising prospect for Proxalutamide as a treatment for COVID-19.
- Data of phase II clinical trial of GT90001 (ALK-1) antibody and Nivolumab (Opdivo) for 2L HCC to be presented at 2021 ASCO-GI meeting. GT90001 is a fully human monoclonal antibody against ALK-1 (Activin Receptor-Like Kinase-1). Kintor obtained the global exclusive development, production and commercialization rights from Pfizer in 2018. Kintor announces that it has collected positive data in phase II clinical trials of combination therapy of GT90001 and Nivolumab for the second line therapy of advanced hepatocellular carcinoma (HCC) in Taiwan.
- Promising efficacy of GT90001 in combination with Nivolumab. This is a single-arm, open-ended and two-stage phase II trial conducted in Taiwan (NCT03893695) to evaluate the safety and efficacy of GT90001 in combination therapy with Nivolumab in patients with advanced HCC who were progressed on or intolerant to first line therapy with Sorafenib or Lenvatinib. From 9 Jul 2019 to 30 Sep 2020, a total of 20 eligible patients received treatment in the trial, who were treated with 7mg/kg of GT90001 biweekly and 3mg/kg of Nivolumab biweekly. Among the 20 eligible patients, eight patients (40%) were observed partial remission (PR). The side effects were well tolerated and manageable. The pharmacokinetic parameters of GT90001 and Nivolumab are similar to those of monotherapy. The full set of data will be presented at the ASCO-GI meeting which will be held in Jan 2021. This combo therapy demonstrated much higher response rate and Nivolumab monotherapy (40% combo vs 15~20% mono). We believe this is a very encouraging efficacy signal for GT90001.
- Rich pipeline progress. As for Proxalutamide: (1) Phase III clinical trial of Proxalutamide monotherapy on 2L+ mCRPC will continue to collect OS data. (2) Patient enrollment is ongoing for the Phase III trial assessing Proxalutamide in combination with abiraterone in treating 1L mCRPC in China. We expect Kintor to file NDA for Proxalutamide for treatment of 1L mCRPC in 2021E. (3) In Jul 2020, Kintor finished the patient enrollment for the Phase II trial of Proxalutamide targeting mCRPC patients failed either Abiraterone or Enzalutamide in the US. We expect this US Phase II trial data to be released soon. As for Pyrilutamide: (4) On 3 Aug, Kintor completed the phase Ib clinical trials of Pyrilutamide in the US. (5) Pyrilutamide’s phase II trial on androgenetic alopecia has started in 3Q20 in China with data to be available by 1H21E. (6) On 17 Sep, Kintor obtained NMPA’s IND approval of Pyrilutamide gel formula for acne vulgaris while the trial may start in 1Q21E. As for bispecific antibody: (7) On 20 Aug, Kintor obtained from Gensun an exclusive license of a pre-clinical stage PD-L1/ TGF-β bispecific antibody (GS19 PLB-1C) and aimed to file IND in 2021E.
- Maintain BUY. Maintain our TP of HK$19.38 unchanged based on a 10-year DCF model (WACC: 11.8%, terminal growth rate: 2.0%). We like Kintor given its robust pipelines including Proxalutamide, Pyrilutamide, ALK-1 antibody, PD-L1/TGF-β bispecific antibody, AR degrader (PROTAC), etc.
- Risks: Delay in pipeline progress; Competition from peers.
