Entry ID | 2569 |
INN | None |
Status | Terminated |
Drug code(s) | TY027 |
Brand name | None |
mAb sequence source | mAb - source TBD |
General Molecular Category | TBD |
Format, general category | TBD |
Format details | TBD |
Isotype (Fc) | TBD |
Light chain isotype | TBD |
Linker | None |
Ave. DAR | None |
Conjugated/fused moiety | None |
Discovery method/technology | None |
Target(s) | SARS-CoV-2 (spike protein) |
Indications of clinical studies | COVID-19 |
Primary therapeutic area | Infectious diseases |
Most advanced stage of development (global) | Terminated at Phase 3 |
Status | Inactive |
Start of clinical phase (IND filing or first Phase 1) | June 09, 2020 |
Start of Phase 2 | |
Start of Phase 3 | December 04, 2021 |
Date BLA/NDA submitted to FDA | |
Year of first approval (global) | None |
Date of first US approval | |
INN, US product name | None |
US or EU approved indications | None |
Company | Tychan Pte. Ltd. |
Licensee/Partner | None |
Comments about company or candidate | NCT04649515 Phase 3 of TY027 for Early Treatment of COVID-19 started in Dec 2020 was Terminated (Low recruitment rate) as of March 2022. NCT04429529 Phase 1 First-in-Human, Time Lagged, Randomised, Placebo Controlled, Double Blind, Single Ascending Dose Study of TY027 in Healthy Adult Volunteers started on June 9, 2020. June 10, 2020. Singapore's Tychan, a biotechnology firm backed by state investor Temasek Holdings, said it will begin human clinical trials next week for a potential monoclonal antibody treatment for COVID-19. The first phase of the trial to be conducted on 23 healthy volunteers will take about six weeks to evaluate the safety and tolerability of TY027 - a monoclonal antibody that specifically targets SARS-CoV-2, the virus that causes COVID-19. TY027 is being explored for the treatment of patients with COVID-19 to slow the progression of the disease and accelerate recovery, as well as for its potential to provide temporary protection against infection with SARS-CoV-2. |
Full address of company | Singapore Asia Singapore https://sg.linkedin.com/company/tychanltd |
Tychan developed TY027 through extensive and rapid research, including the use of advanced proprietary computational platform technology, and leveraged prior experience in the successful development of therapeutics for Zika and Yellow Fever. TY027, made on 25 February 2020 was identified as the most promising amongst several mAbs that demonstrated 100% neutralisation against live SARS-CoV-2 viruses in the lab. It has also successfully completed safety studies in animals and other regulatory requirements including a 3-week drug stability test. These were all completed in less than four months before this first-in-human infusion.
Anticipated events | None |
Factor(s) contributing to discontinuation | None |