Cell therapy company Chimeric Therapeutics has moved a step closer to trialling its treatment for gastrointestinal and neuroendocrine cancers on humans following a successful meeting with powerful American regulator the Food and Drug Administration (FDA).
Chimeric management is buoyed by the success of the meeting, citing it as a significant milestone on the path to eventually making the treatment, called CHM 2101, available to cancer sufferers. It says the FDA’s advice supports both the company’s proposed trial and technical operations strategy for the treatment.
Chimeric chief executive officer and managing director Jennifer Chow said: “The positive feedback we received from the FDA was encouraging and aligns clearly with our development plan for CHM 2101.”
“We are highly appreciative of the FDA’s support and guidance as this brings us closer to potentially transforming the lives of patients with gastrointestinal and neuroendocrine tumours.”
Interestingly, the boost Chimeric has received from the FDA comes hot on the heels of the company announcing it had secured supplies of a vital component – so-called “viral vectors” – that are needed in the manufacture of “CAR T” cell therapies like CHM 2101.
Viral vectors deliver genetic material into cells and Chimeric announced earlier this month its securing supply of sufficient viral vectors meant the company had navigated one of the most critical and challenging components of manufacturing CAR T therapies and that it would help progress its CHM 2101 treatment to a clinical trial.
That ambition now appears to have moved another step closer to becoming a reality.
The FDA meeting was what is known as a pre-Investigational New Drug (pre-IND) meeting and its purpose was to facilitate regulatory communication and guidance through the IND submission process for CHM 2101. The process included specific questions regarding the company’s clinical development plan and technical operations, including manufacturing of the drug and its quality release procedure.
Chimeric says it has received positive written responses from the FDA that will provide a clear path for the company’s IND submission for CHM 2101.
The ASX-listed company believes cellular therapies have the promise to cure cancer, not just delay the disease’s progression. CHM 2101, invented at the University of Pennsylvania, is described by Chimeric as a first-in-class third-generation autologous CAR T cell therapy. It is one of a range of cancer treatments at various stages of development and trialling in Chimeric’s product pipeline.
CHM 2101is currently in preclinical development and preclinical evidence for the potential treatment was published in the journal Nature Cancer in March 2022. Chimeric says that data demonstrated strong evidence of efficacy with complete eradication of eight different types of gastrointestinal cancers with no relapse or toxicity. Neuroendocrine tumours are cancers that begin in cells called neuroendocrine cells. Though they are rare, they can occur anywhere in the body.
Any progress in combatting gastrointestinal cancers will be good news for the medical profession and most especially sufferers, whose life expectancy is lower than for other more well-known cancers with a five-year survival rate of just 51 per cent.
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