Biosyngen announces FDA IND approval of its second product for EBV-positive lymphoma

GUANGZHOU,China,April 18,2023 -- April 15,2023,Biosyngen Pte Ltd (hereinafter as "Biosyngen") announced that the Company received IND approval for its second product in the pipeline,a T-cell redirection therapy for the treatment of EBV-positive lymphoma. A week prior to this,the IND application of the same therapy has just been approved by China NMPA.

A few months earlier,the Company's first product (BRG01) targeting relapsed/metastatic nasopharyngeal cancer has been granted IND approval by both the US FDA and China NMPA. Following this IND approval to initiate the phase I/II clinical trials,Biosyngen makes a significant first-step towards the goal to gaining marketing authorization in the US and China. Biosyngen,an innovative biopharmaceutical company,is now the first in the CGT industry to possess dual IND approval from above regulatory bodies for its two products.

At present,Biosyngen's IND application filing to Health Sciences Authority (HSA) is under review. Within 2023,the Company made plans for other IND applications to carry out phase I/II clinical trials for other therapies such as lung cancer,liver cancer and digestive track cancers across key regions – Singapore,the US and China.

Biosyngen broad director & COO,Michelle Chen,"Currently,cell therapy is a key strategy in healthcare development in many countries,including Singapore,China and the US. It is commonly acknowledged that cell therapy will accelerate human's efforts to better address unconquered diseases to fulfill unmet medical needs and therefore benefit patients around the world".

About EBV-positive Lymphoma

EBV,the first oncovirus identified,is a human herpesvirus and has infected ~95% of global population. It has been listed as Group 1 carcinogen ("Carcinogenic to humans") by World Health Organization (WHO) and proved to be associated with a range of diseases including nasopharyngeal cancer,EBV-positive gastric cancers,lymphoma and lymphoproliferative diseases. EBV is so markedly lymphotropic that,for those who suffer from impaired immune system,especially T cell function,EBV may even induce lymphoblastic malignancies. EBV reactivation was also observed in patients who received bone marrow transplantation and CD7 CAR-T cell therapy,who may even develop EBV positive lymphoma.

The therapy developed by Biosyngen is an engineered T cell therapy,also known as a type of adoptive immune cell therapy indicated for nasopharyngeal cancer and EBV-positive lymphoma. Patients' T cells are isolated and genetically modified in a GMP-compliant facility to enhance their ability to recognize and attack specific antigens on cancer cells. The modified T cells are expanded ex vivo and infused back into the patient. The infused T cells would bind to specific antigen on the cancer cells to mediate tumor killing. The preliminary safety and efficacy of BRG01 Therapy have been demonstrated in data from exploratory clinical trials.

The scientific direction of Biosyngen is focused on targeting multiple solid tumors and hematological tumors. The company has independently developed a number of exclusive technical platforms specifically for cancer immunotherapy,including IDENTIFIER,SUPER-T and MSE-T. These platforms are designed for improved safety and efficacy,equipping the company with capabilities to overcome challenges in antigen identification,antibody TCR screening and identification of immune cell function.

AboutBiosyngen

Biosyngen is a cell and gene therapy biotechnology company,focusing on R&D in immunotherapy and drug development; to achieve the best outcome for cancer patients.

The company's R&D team consists of multinationals from Singapore,Germany,Australia,France and the US,many of whom received their Phd. from renowned universities. Biosyngen's strategy of dual R&D centres and dual GMP facilities in Singapore and China,firmly anchors it as an Asian company towards a global ambition. The company's product pipeline potentially addresses an estimated value of 50 billion USD in the global oncology market.

Biosyngen possesses exclusive licenses and patented therapies targeting multiple solid tumors and hematological malignancies including nasopharyngeal cancer,gastric cancer,gastrointestinal cancer and EBV-positive hematological malignancies. The company's first-in-class product BRG01 was granted IND approval by US FDA and CN NMPA for Phase I/II clinical trial. Biosyngen is also one of a few biopharmaceutical companies that possess a portfolio consisting of CAR-T,TCR-T,TIL and multi-specific antibodies.

Based in Singapore and Guangzhou,Biosyngen collaborate closely with the world's leading biomedical research and clinical institutes including A*STAR,Helmholtz Zentrum München,Hannover Medical School,Sun Yat-Sen University Cancer Center and a network of hospitals to advance R&D,develop products and conduct clinical trials in Singapore,Australia and China.

Through our R&D capability and translational medicine platform,Biosyngen have been able to engage the end-to-end cycle in drug development from lead identification,preclinical studies,cell production,quality control,regulatory filing,to clinical studies - integrating the entire chain of R&D,clinical trial,GMP manufacturing and commercialization.