On December 14, 2022 Carina Biotech files its first IND application for a CAR-T cell therapy targeting a solid cancer (Press release, Carina Biotech, DEC 15, 2022, View Source [SID1234625251]). The IND application is directed at a first-in-human Phase 1/2a clinical trial in advanced colorectal cancer patients.
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has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for first-in-human Phase 1/2a clinical trial of CNA3103, its LGR5-targeted chimeric antigen receptor T cell (CAR-T) therapy candidate, in patients with advanced colorectal cancer.
"We are delighted to achieve the major milestone of submitting this first IND to the FDA for our lead LGR5 CAR-T cell therapy candidate as our team continues to advance Carina’s vision to create a future that defeats cancer," said Deborah Rathjen, PhD, Carina’s Chief Executive Officer.
"Colorectal cancer is a lethal cancer, and a clear need exists for more effective treatment options. CAR-T cell therapy is a revolutionary and targeted cancer treatment option that harnesses a patient’s own immune system to fight their cancer. We are targeting the recruitment of the first patients in the Phase 1/2a trial in early 2023."
"Carina’s CAR-T cell therapy candidate, CNA3103, is targeted at LGR5, a cancer stem cell marker that is highly expressed on advanced colorectal cancer and some other cancers," stated José Iglesias, MD, Carina’s Chief Medical Officer. "In colorectal cancer patients, LGR5 expression has been correlated with a particularly poor prognosis and by targeting cancer stem
cells, this therapy may potentially reduce the tumor’s ability to generate new cancer cells, resulting in enhanced tumor suppression and preventing the relapses that are very common in patients with this disease."
Dr Iglesias added, "Colorectal cancer is the third most common cancer worldwide and the third most common cancer diagnosed in the United States, excluding skin cancers. Colorectal cancer is the deadliest cancer for young Australians and the second deadliest cancer for all Australians with its incidence rising in people under 50. Many younger people, who are often
diagnosed when their cancer is in its later stages, are given a very poor prognosis with very limited treatment options."