HONG KONG - South Korean biopharmaceutical company Quratis Inc. and Indonesia’s state-run company, Bio Farma PT, have entered a term sheet agreement to develop and commercialize Quratis’ tuberculosis (TB) vaccine, QTP-101, for adults and adolescents. The total amount of the deal is around ₩1.2 trillion (US$1.1 billion), according to the Seoul-based company.

The two firms have agreed on the main conditions for the contract and details on the future sales. Quratis will be in charge of the global clinical trials, while Bio Farma will pay milestone amounts for each phase of the clinical trials. The agreement also includes exclusive local supply rights in Indonesia after regulatory approval.

Bio Farma plans to list Quratis’ TB vaccine in the National Immunization Program (NIP) to administer the drug to Indonesians who need the vaccine.

“We will accelerate the TB vaccine’s global marketing throughout approximately 40 countries, including Korea and Indonesia,” Quratis’ managing director, Yuhwa Choi, told BioWorld Asia. “Currently, we are discussing licensing and exclusive marketing rights with some vaccine companies in Russia and Thailand and hope to announce good news in the near future.”

Founded in 2016, Quratis is focused on developing vaccines, cell therapy platforms and peptide nucleic acids. QTP-101 is the lead candidate vaccine, and it is designed to boost the immune response induced by Bacillus Calmette-Guerin (BCG), preventing TB after three inoculations. The company has completed its phase I trial in the U.S. and phase Ib and IIa trials in South Africa. Currently, a phase IIa trial for adults and a phase I trial for adolescents are underway in South Korea. 

Another compound in Quratis’ pipeline is fusion protein ID93, a multistage antigen comprising virulent antigens (Rv2608, Rv3619, Rv3620) and a latent antigen (Rv1813). Quratis has fused selected proteins through bioinformatics analysis while maintaining merits of subunit vaccines such as safety and purity.

The company is also developing glucopyranosyl lipid adjuvant (GLA), which is an improved substance derived from the main ingredient monophosphoryl lipid (MPL). Quratis plans to use glucopyranosyl lipid adjuvant-stable emulsion (GLA-SE) to carry vaccines for various diseases, including TB. The adjuvant is currently in in vitro testing.

Additionally, the company develops cell therapies based on dendritic cells (DCs). Those are currently at a nonclinical safety study stage. The main function of DCs is to process antigen material and present it on the cell surface to the T cells of the immune system. They act as messengers between the innate and the adaptive immune systems.

Using DCs, the company develops therapeutics to treat TB and cancer. It also develops autoimmune disease cell therapies for patients with rheumatoid arthritis using plasmacytoid dendritic cells.   

“Quratis will secure a drug manufacturing facility that meets cGMP standard in Osong Bio Valley, Korea,” Namchun Cho, senior managing director at Aju IB Investment Co. Ltd., told BioWorld Asia. “The facility will produce ID93, GLA-SE and vaccines that will spur the company’s growth.”

Bio Farma was founded in 1890 as Parc-vaccinogène (State Vaccine Development Agency) during the Dutch colonial period. The Bandung-based pharmaceutical company is specialized in developing and producing vaccines.

The Indonesian company has 17 types of vaccine products for various diseases, including measles, flubio influenza HA, recombinant hepatitis B, tetanus and tetanus neonatal (tetanus in newborns), pentabio (DTP-HB-Hib), diphtheria, tetanus and pertussis, and poliomyelitis types I and III. The state-owned company’s vaccine products have received prequalification recognition from the World Health Organization.     

The state-owned company also provides health care services such as vaccinations, examinations and treatment. Its Clinical and Immunization Unit aims to meet the large need for Indonesian patients’ through vaccinations for both adults and children.    

Drug-resistant TB on the rise

According to a report from TBVI (Tuberculosis Vaccine Initiative) in 2018, a $1.25 billion investment is needed to fund the development of the most efficient strategy to combat the spread of TB, namely a TB vaccine.

The TVBI report states that TB is the leading cause of death globally from a single infectious agent, killing approximately 1.67 million people in 2016. In comparison, 1 million people died of HIV/AIDS-related diseases and 445,000 died of malaria in 2016. At least one-quarter of people worldwide, approximately 1.7 billion, are infected with Mycobacterium tuberculosis (Mtb), the bacterium that causes TB disease. Among those infected individuals, about 10%, or 170 million globally, will be expected to develop TB during their lifetimes.

While cases of drug-sensitive TB demonstrate a slow, worldwide decline, the incidence of Mtb strains resistant to more than one drug, including multidrug-resistant TB (MDR-TB) and extensively drug-resistant TB (XDR-TB), has been increasing, and represents a significant threat to public health.

Current treatment regimens for MDR-TB require a combination of five or more drugs to be administered over nine months or longer and, in some cases, there is an overtly dangerous toxicity of the drugs included in the regimen.

Initial drug treatment cures only about 50% of MDR-TB patients, who often require repeat regimens with more and different TB drugs for a longer period. Treating XDR-TB is harder than treating MDR-TB, requiring that five or more drugs be administered for up to three years. Treatment success for XDR-TB is poor, however, with an estimated cure rate of 26%.

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