Boston and Bengaluru-based biopharmaceutical company, Zumutor Biologics has received an approval from the US Food and Drug Administration (FDA) to initiate phase 1 human trials for its experimental drug ZM008 that targets multiple solid cancers.
“The FDA’s approval of IND application is an important milestone for Zumutor and a clear recognition of the intriguing preclinical data supporting novel/non overlapping mode of actions, generated thus far,” says Dr Maloy Ghosh, PhD, chief scientific officer, Zumutor Biologics in a statement.
IND (Investigational New Drug Application) is an approval from the FDA to administer an experimental drug to humans to test its safety and efficacy.
The biotech startup that has labs in Bengaluru, India, have built their novel antibody platform consisting of multiple high diversity human antibody libraries. Using this platform, they were able to discover their current molecule ZM008.
This molecule is a checkpoint antibody that helps immune cells fight against tumours by disrupting their interaction with natural killer cells (NK). The ZM008 molecule does this by blocking the LLT-1 protein found on a tumour’s surface that binds to the CD-161 receptor on NK cells.
Normally in cancer, this interaction between the tumour and NK cells causes immune evasion allowing the tumour to evade a host’s immune system, explains Dr Kavitha Iyer Rodrigues, founder and CEO of Zumutor Biologics. “Our target is called LLT-1, which is overexpressed on multiple solid tumors,” she told Happiest Health.
Currently with immunotherapy, many studies, and therapies are targeting the B and T-cells. Researchers are now going after other branches of immuno-oncology by focusing on NK cells.
“We have a lot of data on bladder cancer, triple negative breast cancer, prostate, and lung cancer” says Rodrigues.
This data comes in the form of pre-clinical research done on mice, rats, and monkeys over the last six years. The studies indicated efficacy and tolerability, meaning there is no toxicity of the product, she adds.
“We found a significant reduction in tumour size and these findings also translated very well in patient tumour tissues, showing good efficacy in lung and bladder tumours,” says Rodrigues.
Additionally, the company was able to do a head-to-head comparison with pembrolizumab which is an immunotherapy—the current standard of care for cancers of the skin, head, neck, and lung.
Preliminary data indicates that both therapies work well together, prompting the FDA to also approve the study of ZM008 in combination with pembrolizumab that could boost an individual’s immune response.
“First, we will be doing the clinical trial in the US. Once we get all the necessary approvals, we will look next at recruiting patients in India,” said Rodrigues. “Once we have finished all phases of the clinical trial followed by obtaining market approvals, it will take another five to six years for the medication to be available to everyone,” she adds.
