ICMR to advance 1st in-human trials for Zika, flu, blood cancer therapies

In a bid to attain self-sufficiency in clinical development and advance indigenous pharmaceutical agents, the Indian Council of Medical Research (ICMR) on Saturday announced formalisation of memorandum of agreements (MoAs) with multiple sponsors to advance first-in-human Phase 1 trials for four promising molecules.

First-in-human trial is a type of clinical trial in which a new drug, procedure or treatment is tested in humans for the first time. First-in-human studies take place after the new treatment has been tested in laboratory and animal studies and are usually done as Phase 1 clinical trials.

Under its network of Phase 1 clinical trials, the ICMR will partner with Hyderabad-based Indian Immunologicals for development of a vaccine against Zika, a mosquito-borne viral infection. It will also coordinate with Mynvax, based in Bengaluru for a trial of vaccine against seasonal influenza. 

 

The apex clinical research body will undertake collaborative research over a small molecule for multiple myeloma (a type of blood cancer which affects plasma cells) with Bengaluru-based Aurigene Oncology. 

The ICMR has also signed a pact with Navi Mumbai-based ImmunoACT to conduct a CAR-T cell therapy advancement study for a new indication of chronic lymphocytic leukaemia (a type of cancer that affects bone marrow and blood). 

The ICMR’s network for Phase 1 clinical trials comprises four strategically located institutions across India. These are Mumbai’s King Edward Memorial Hospital and Seth Gordhandas Sunderdas Medical College (KEMH & SGSMC), the Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) in Navi Mumbai, SRM Medical College Hospital and Research Centre in Kattankulathur, Tamil Nadu and Chandigarh’s Postgraduate Institute of Medical Education and Research (PGIMER).

“These institutes will be supported by a Central Coordinating Unit at ICMR Headquarters, New Delhi,” the body said.   

Officials at the ICMR added that this network is designed to build and enhance India’s capacity to conduct early-phase clinical trials, supported by robust infrastructure and dedicated manpower at each trial site, ensuring smooth and effective operations.

According to the sources, the ICMR will fund the Phase 1 clinical trial costs, including the costs relating to the conduct, investigations and monitoring of clinical trials.

Speaking on the transformative potential of the project, Dr Rajiv Bahl, Secretary, Department of Health Research (DHR) and Director General, ICMR said that the collaboration reflects our commitment to advancing clinical research in India through strategic public-private partnerships. 

“Establishing Phase 1 clinical trial infrastructure is a key component in fostering the development of indigenous molecules and cutting-edge treatments. Our vision is to expand this network further, ensuring that India continues to lead in the development of innovative and affordable healthcare solutions,” he added.