Tychan Pte Ltd.

The emergence & rapid spread of the coronavirus disease 2019 (COVID-19) since December 2019 across 188 countries globally has become a major public health crisis. COVID-19 was declared a pandemic by the World Health Organisation on 11 March 2020. To date, tens of millions of cases have been reported and over 3% of these cases have died. COVID-19 is an acute respiratory disease caused by the novel SARS-CoV-2 virus from the Betacoronavirus genus, just like SARS-CoV and MERS-CoV. SARS-CoV-2 is primarily transmitted person-to-person through respiratory droplets/close contact. Fomite transmission has also been shown as a transmission route. Common respiratory symptoms such as fever, sore throat, cough & shortness of breath, may appear 2 - 14 days after exposure. About 20% of infected cases progress to severe disease resulting in an estimated 2 - 5% mortality rate. With the unrelenting increase in cases being reported worldwide, there is thus an urgent need for therapeutics to be developed to treat disease & reduce further transmission in order to disrupt the ongoing pandemic.
To date, there are no specific proven antiviral treatment to prevent disease progression from mild to severe respiratory dysfunction among COVID-19 patients. Supportive care is recommended for symptom relief & for severe cases. Numerous vaccine candidates against SARS-CoV-2 are under development. Tychan's TY027, a fully engineered human IgG, is one of the first few biologics in the world, specifically targeting SARS-CoV-2, to enter human clinical trials. Preliminary data from our phase 1 healthy volunteer trial (SCT-001; ClinicalTrials.gov Identifier NCT04429529) reveals that TY027 is safe & well-tolerated up to 20 mg/kg tested. A total of 10 adverse events (AEs) were observed, all were of mild in intensity with none resulting in subject withdrawal from the study. There were no serious adverse events & no clinically relevant trends in mean clinical laboratory, physical examinations, vital signs or ECG results were observed. Pharmacokinetic profile of subjects across dose cohorts 1 - 4, up to Day 14, were comparable to those typical of human IgG1 antibody with serum concentrations declining in a biphasic manner. Exposure of TY027, based on Cmax, increased in a linear & generally dose proportional manner. It is anticipated that TY027, when administered to acutely infected COVID-19 patients, could reduce disease severity. It may potentially also be used as a prophylaxis against COVID-19 amongst high risk contacts.

The emergence and rapid spread of the coronavirus disease 2019 (COVID-19) since December 2019 across 188 countries globally has become a major public health crisis. COVID-19 was declared a pandemic by the World Health Organisation (WHO) on the 11th March 2020. To date, more than 14,000,000 cases and 600,000 deaths have been reported. COVID-19 is an acute respiratory disease caused by the novel SARS-CoV-2 virus from the Betacoronavirus genus, just like SARS-CoV and MERS-CoV. SARS-CoV-2 is primarily transmitted person-to-person through respiratory droplets or close contact. Fomite transmission has also been implicated as a transmission route. Common respiratory symptoms such as fever, sore throat, cough and shortness of breath, may appear 2 - 14 days after exposure. About 20% of infected cases progress to severe disease resulting in an estimated 2 - 5% mortality reported. With the unrelenting increase in cases being reported worldwide, there is thus an urgent need for therapeutics to be developed and used to disrupt the ongoing pandemic.
To date, there is no specific proven antiviral treatment for COVID-19. Supportive care is recommended for symptom relief and for severe cases, organ support is critical for optimal outcome. Numerous vaccine candidates against SARS-CoV-2 are under development and a couple have entered Phase 1 clinical trials. Remdesivir, a nucleotide analog, developed by Gilead Sciences as a treatment for Ebola virus disease is currently being repurposed and undergoing multiple clinical trials to evaluate safety and efficacy in COVID-19 patients. In a preliminary study, convalescent plasma containing neutralizing antibodies against SARS-CoV-2 has also been experimentally administered in critically ill COVID-19 patients with promising results. Donor plasma used was rich in virus specific IgG and IgM antibodies as determined by ELISA. Within days of convalescent plasma treatment, patients showed decrease in viral load (via qRT-PCR), as well as improved clinical status being observed. Tychan's TY027 will be the first biologics in the world, specifically targeting SARS-CoV-2, to enter human clinical trials. It is anticipated that a SARS-COV-2 specific monoclonal antibody therapeutic administered to acutely infected patients could reduce disease severity as well as prevent transmission by reducing viral load and viral shedding. It could also be used as prophylaxis against COVID-19 amongst high risk contacts.

Zika virus (ZIKV) infection is a new emerging arbovirus disease, caused by the same vector that transmits Dengue virus, Aedes aegypti. ZIKV is a growing public health problem, rapidly spreading throughout the continents since the first epidemic was reported in the French Polynesian islands.
Currently, there are several ZIKV vaccine candidates in clinical trials. However, no ZIKV therapy (biologic or small molecule) has advanced to clinical trials. Tyzivumab will be the first therapeutic in the world, specifically targeting ZIKV, to enter clinical trials.
This is a Phase 1, time-lagged, parallel-group, randomized, placebo-controlled, single-blind, single ascending dose, Tyzivumab, ZIKV monoclonal antibody (mAb), study to be conducted in ZIKV polymerase chain reaction (PCR) positive patients.
Tyzivumab will be administered once through single IV infusion over 30 minutes. Total duration of study participation is estimated at approximately 85 days from the date of screening. Post-trial monitoring through weekly telephone calls will continue from Day 85 post-dose onwards for another three (3) more months.
The main objective of this study is to evaluate the safety of Tyzivumab in acutely infected adult patients. Assessment of time taken to achieve negative ZIKV isolation from acute ZIKV infected subjects' blood will be the study's secondary objectives.