ASX Health Stocks: Chimeric surges 70pc after FDA approval, takes its CAR T cell drug to the clinic

Chimeric surged by as high as 73pc this morning after a big FDA announcement
CHM says its CAR T program, CHM 2101, was approved by the FDA
Algorae participates in CSIRO artificial intelligence program

Chimeric’s CHM 2101 approved IND status by US FDA

Chimeric Therapeutics (ASX:CHM) skyrocketed by as high as 73% this morning after a big announcement related to its lead asset CHM 2101, a novel 3rd generation CDH17 CAR T cell therapy for gastrointestinal cancers.

Chimeric says the US Food and Drug Administration (FDA) has given the all-clear for the Investigational New Drug (IND) application of CHM 2101.

The approval means that CHM 2101 is expected to be the first ever CDH17 CAR T cell therapy to enter the clinic.

With the FDA IND clearance, Chimeric will now begin the initiation of a Phase 1/2 multi-site clinical trial in patients with advanced colorectal cancer, gastric cancer and neuroendocrine tumours.

The study is planned to begin patient enrolment in 2024.

This clinical program builds upon the preclinical studies published in the preeminent scientific journal, Nature Cancer in March 2022 by leading immunotherapy scientist Xianxin Hua and his team at the Abramson Family Cancer Research Institute at the University of Pennsylvania.

Hua’s experiments demonstrated that CHM 2101 was able to eradicate established tumours in seven cancer models, with no toxicity to normal tissues.

“This is a critical step forward in developing an entirely new CAR T therapy for GI-cancers and neuroendocrine tumors, providing new hopes for the cancer patients who are refractory to the existing therapies,” Hua said.

CHM 2101 is a third generation, novel CDH17 CAR T cell therapy that targets CDH17, a cancer target associated with poor prognosis and metastasis in the most common gastrointestinal and neuroendocrine tumours.

Algorae to participate in CSIRO’s AI program

Algorae Pharmaceuticals (ASX:1AI) has entered into a multi-party agreement including the University of NSW (UNSW) for Algorae to become an industry participant to the Next Generation Artificial Intelligence Graduate Program (NGAIGP).

The program was established and operated by Australia’s national science agency, CSIRO.

Under the agreement, UNSW will recruit three PhD candidates for the purpose of advancing the development of Algorae Operating System (AlgoraeOS).

AlgoraeOS is an AI platform designed for the biopharma industry to predict new drug candidates, and to improve development outcomes.

These candidates will be supervised and managed by AlgoraeOS lead investigator and AI expert, Associate Professor Fatemeh Vafaee, and another post-doctoral operating officer.

The hand-selected PhD candidates will form part of the research and development team for the AlgoraeOS project and will be co-funded by CSIRO and Algorae.

CSIRO will provide approximately two-thirds of the funding required for the candidates, with Algorae providing approximately the rest of the funding over the three-year term of the scholarships.

The aim of NGAIGP is to grow a pipeline of home-grown, job-ready graduates to unlock the immense economic opportunity offered by artificial intelligence and emerging technologies, such as robotics, cyber security, quantum computing and blockchain.