GoldenBiotech Signed MOU with BNC Korea for Cooperation and Licensing of Covid-19 New Drug Antroquinonol in South Korea.

TAIPEI, Aug.27. Golden Biotechnology Corporation (TWO: 4132), a leading Taiwanese biopharmaceutical company has signed the MOU with BNC Korea Co., Ltd. for the cooperation,co-development and licensing scopes of its new drug Antroquinonol.

The Memorandum of Understanding (MOU) is made and entered into effect as of Aug. 6th, 2020 by and between Golden Biotechnology Corporation (GoldenBiotech,GBC) and BNC Korea Co., Ltd. (BNC). GBC and BNC has agreed to the articles in the MOU and confirmed the friendly and collaborative relations between both parties, recognizing each party’s role arising out of such collaboration based on mutual trust, and remaining confident that the interaction and collaboration in the development of Antroquinonol will contribute to the promotion of public health, in particular for relief in COVID-19, viral- or bacteria-induced pneumonia.

The purpose of this MOU is for both parties to interact and collaborate in the development of Antroquinonol, where significant development is expected in the future. The scopes of collaborative works under this MOU are including investment, licensing , co-development, manufacturing and strategic alliance.Under the MOU, GBC out-licenses rights of Antroquinonol to BNC in the territory of South Korea. BNC shall be responsible for clinical trial execution in part and further registration and commercial activities in the territory of South Korea.

GBC and BNC may expand Antroquinonol production by utilizing BNC’s manufacturing facility, and/or explore new dosage form of Antroquinonol.

In the interest of forming strategic alliance, the parties will discuss the scope of profit-sharing, and the possibilities of development, manufacturing and commercialization of other product candidates.

This MOU shall be effective upon the date first set for the above, and shall remain in force and effect through the earlier of Dec. 31st, 2020 or the signing of the Definitive Agreement unless earlier terminated. The term of the MOU may be extended by mutual written agreement between the parties.

In June 2020, Golden Biotechnology Corporation received approval from US FDA for its investigational new drug (IND) application for a Phase II clinical trial of  Antroquinonol (Hocena®) on COVID-19 hospitalized patients in USA.

The Phase II trial will be a randomized, double-blinded, placebo-controlled study of Antroquinonol as a potential treatment option for mild-to-moderate pneumonia in COVID-19 patients, as measured by the proportion of patients alive and free of respiratory failure (i.e., need for invasive mechanical ventilation, non-invasive ventilation, high-flow oxygen, or extracorporeal membrane oxygenation [ECMO]) on Day 14.

At present, physician can only provide supportive care such as oxygen supplementation, mechanical ventilation, and/or extracorporeal membrane oxygenator (ECMO) based on the clinical symptoms of the patients or enroll them in available clinical trials. Clearly, new and more effective drugs are still in need to fight the pandemic. Thus, it is imperative to provide immediate and ample supply to the world should our study improve the efficacy of any newly authorized treatments recommended as standard of care (SoC) for COVID-19.”

Currently there is no drug in development for treating Covid-19 that can effectively improve the severe inflammatory response induced by the virus nor the overall survival rate. We can see that by far there is no single drug that can simultaneously fight against the COVID-19 virus (SARS-CoV2) and the symptoms induced. Combination therapies adopted by other clinical trials may solve the shortcomings of single-drug therapies with slightly better efficacy, but the higher risk of adverse effects is inevitable. 

Antroquinonol was found to reduce viral nucleic acid replication and viral protein synthesis in both cell and animal experiments. Prevention of organ and tissue damage was also observed with Antroquinonol when treating mice with excessive inflammation. The characteristic of multiple effects makes Antroquinonol more advantageous than other antiviral and/or anti-inflammatory drugs. GoldenBiotech is now actively promoting the Phase II study for COVID-19 in the hopes that Antroquinonol will not only improve the symptoms of COVID-19, but also minimize the possible side effects that may be induced during the treatment process.

Evidence has revealed that severely ill COVID-19 patients exhibited elevated levels of cytokines and inflammatory indices,suggesting the involvement of a cytokine storm which represents an overreacted immune response characterized by overproduction of pro-inflammatory cytokines and chemokines. Serological tests indicate that inflammatory cytokine storm response is associated with COVID-19 severity and mortality. Current developing Covid-19 antiviral drugs are not sufficient to prevent or treat the inflammatory complications especially in severely ill COVID-19 patients.

Antroquinonol were also granted Orphan Drug Designation(ODD) by US FDA in treating pancreatic cancer, AML(acute myeloid leukemia) and HCC(Liver cancer) in 2015 as well as orphan drug for pancreatic cancer by European EMA in 2017.