Positive preliminary results of Proxalutamide for treatment of COVID-19.
As a novel androgen receptor (AR) antagonist, Proxalutamide was found thatit could limit the expression of ACE-2 and TMPRSS2, which play a critical rolefor SARS-CoV-2 to bind and enter host cells in the lung. In an investigatorinitiated randomised, double-blind and placebo-controlled clinical trial(NCT04446429) in Brazil conducted by Kintor and Applied Biology, thepreliminary analysis showed that, for the 319 enrolled patients, thehospitalisation rate of Proxalutamide arm is 0.8% which is significantly lowerthan the Controlled Arm (27.0%). In addition, the percentage of mechanicalventilation usage was 0% for the Proxalutamide Arm compared to 9.0% forthe Controlled Arm. The percentage of death was 0% for the ProxalutamideArm, compared to 2.0% for the Controlled Arm. Besides, in terms of the RTPCRtest between day 0 and day 30, Proxalutamide Arm had shown greaterreduction of viral load starting from day 7. All preliminary results mentionedabove indicate a promising prospect for Proxalutamide as a treatment forCOVID-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. GT90001is a fully human monoclonal antibody against ALK-1 (Activin Receptor-LikeKinase-1). Kintor obtained the global exclusive development, production andcommercialization rights from Pfizer in 2018. Kintor announces that it hascollected positive data in phase II clinical trials of combination therapy ofGT90001 and Nivolumab for the second line therapy of advancedhepatocellular carcinoma (HCC) in Taiwan.
Promising efficacy of GT90001 in combination with Nivolumab. This is asingle-arm, open-ended and two-stage phase II trial conducted in Taiwan(NCT03893695) to evaluate the safety and efficacy of GT90001 incombination therapy with Nivolumab in patients with advanced HCC who wereprogressed 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 receivedtreatment in the trial, who were treated with 7mg/kg of GT90001 biweekly and3mg/kg of Nivolumab biweekly. Among the 20 eligible patients, eight patients(40%) were observed partial remission (PR). The side effects were welltolerated and manageable. The pharmacokinetic parameters of GT90001 andNivolumab are similar to those of monotherapy. The full set of data will bepresented at the ASCO-GI meeting which will be held in Jan 2021. This combotherapy demonstrated much higher response rate and Nivolumabmonotherapy (40% combo vs 15~20% mono). We believe this is a veryencouraging efficacy signal for GT90001.
Rich pipeline progress. As for Proxalutamide: (1) Phase III clinical trial ofProxalutamide monotherapy on 2L+ mCRPC will continue to collect OS data.
(2) Patient enrollment is ongoing for the Phase III trial assessingProxalutamide in combination with abiraterone in treating 1L mCRPC in China.
We expect Kintor to file NDA for Proxalutamide for treatment of 1L mCRPC in2021E. (3) In Jul 2020, Kintor finished the patient enrollment for the Phase IItrial of Proxalutamide targeting mCRPC patients failed either Abiraterone orEnzalutamide in the US. We expect this US Phase II trial data to be releasedsoon. As for Pyrilutamide: (4) On 3 Aug, Kintor completed the phase Ib clinicaltrials of Pyrilutamide in the US. (5) Pyrilutamide’s phase II trial onandrogenetic alopecia has started in 3Q20 in China with data to be available by 1H21E. (6) On 17 Sep, Kintor obtained NMPA’s IND approval ofPyrilutamide gel formula for acne vulgaris while the trial may start in 1Q21E.
As for bispecific antibody: (7) On 20 Aug, Kintor obtained from Gensun anexclusive 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-yearDCF model (WACC: 11.8%, terminal growth rate: 2.0%). We like Kintor givenits 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.