Indore (Madhya Pradesh): Indian Institute of Technology Indore has developed a new asparaginase drug (M-ASPAR) using protein engineering approach to treat Acute Lymphoblastic Leukemia (ALL), a type of blood cancer representing nearly a quarter of cancer cases diagnosed among children.
This drug will be manufactured with collaborative efforts of EPYGEN Biotech PVT LTD, a Biopharmaceutical company based in Navi Mumbai, at its cGMP Biologics facility. Despite being in World Health Organisation’s list of essential medicines, access to good quality asparaginase in India and Asian, African and South American countries has been a problem.
Approximately, 25,000 new cases of ALL are diagnosed in India each year. The repeated administration of asparaginase currently in use for the treatment of ALL patients causes serious side effects such as allergic reactions, neurotoxicity, immunogenicity, hypersensitivity and toxicity to pancreas, liver and spleen among other organs.
Moreover, due to immunogenic nature of current asparaginase formulations, the treatment of relapse ALL is significantly compromised. For these reasons, there is a global search for asparaginase variants with better safety profile.
Prof Avinash Sonawane, principal investigator of research, working at the Department of Biosciences and Biomedical Engineering, IIT Indore, said, “Since last 12 years, with the financial support from DBT, SERB, DST and BRNS, Government of India, we were working to develop a novel asparaginase drug that can reduce serious side effects as well as improve the treatment of primary and relapse ALL treatment.”
He further said, “M-ASPAR asparaginase is significantly less immunogenic, could kill leukemic cells, is more stable, and causes fewer toxicities including neurotoxicity in non clinical studies. Thus, it can be expected to reduce the cost of treatment, alleviate side effects and also improve outcome of relapsed ALL.” The research team lead by Prof Sonawane includes Dr Ranjit Mehta, Soumika Sengupta and Mainak Biswas.
Presently, IIT Indore, in collaboration with Advanced Centre for Treatment, Research & Education in Cancer, Tata Memorial Centre (ACTREC, TMC), Mumbai, and a Mumbai based Epygen Biotech, are going to start phase I and II clinical trials of M-ASPAR.
For this, Prof Sonawane and his team has received funding from BIRAC, DBT with Yenepoya Technology Incubator, Mangalore, under Early Translation Accelerator scheme. Dr Vikram Gota, collaborator and an expert in clinical trials from ACTREC, said, “In phase 1 clinical trial, the safety, tolerability and pharmacokinetics of the drug will be studied in 25-30 ALL patients and the number of patients for subsequent phase 2 and 3 trials will be determined during planning stage of these trials.
This collaboration with IIT Indore has provided a great opportunity for ACTREC to participate in development of an indigenous product that promises access to an improved version of asparaginase at affordable cost to patients.”
Prof Neelesh Kumar Jain, director (officiating) said, “Research has always been forte of institutes like IITs. Such development in the field of human health is very vital as it would lead to significant reduction in the side effects and most importantly reduce the cost of treatment. The Institute will strongly support the phase I and II trials till we reach to a logical conclusion.”
