HIGHLIGHTS Files its first IND application for a CAR-T cell therapy targeting a solid cancer. The IND application is directed at a first-in-human Phase 1/2a clinical trial in advanced colorectal cancer patientsColorectal cancer is the third most common cancer worldwide and the second deadliest cancer for all Australians with the incidence of colorectal cancer rising in people under 50 in Australia and worldwide ADELAIDE, Australia, Dec. 12, 2022 (GLOBE NEWSWIRE) — Carina Biotech Pty Ltd (Carina), a cell therapy immuno-oncology company, today announced the submission of 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.” About Carina BiotechImmuno-oncology company Carina Biotech is developing CAR-T and other adoptive cell therapies for the treatment of solid cancers. In addition to its LGR5-targeted CAR-T cell therapy CNA3103 for advanced colorectal cancer, Carina has a deep pipeline of CAR-T programs. Using its proprietary chemokine receptor platform, Carina aims to improve access to and infiltration of solid cancers by CAR-containing cells, resulting in more potent and specific cancer killing and reduced off-target effects. Carina also has a fully integrated, proprietary manufacturing process that has both reduced manufacturing time and improved CAR-T cell quality, capable of delivering robust “serial-killing” CAR-T cells to patients. About CNA3103Carina’s proprietary CNA3103 CAR-T cell targets LGR5, a cancer stem cell marker that is highly expressed on advanced colorectal cancer and some other cancers. In colorectal cancer patients, LGR5 expression has been correlated with poor prognosis. Cancer stem cells are a small sub-population of cells within a tumor with the ability to self-renew, differentiate into the many cell types of a tumor, initiate new tumors, and resist chemotherapy and radiotherapy (leading to relapses). By targeting cancer stem cells, it is hoped that this therapy will reduce the tumor’s ability to generate new cancer cells, resulting in durable tumor suppression and preventing the relapses that are very common in patients with colorectal cancer. Carina’s pre-clinical studies of CNA3103 have shown promising results with complete tumor regression and no tumor recurrence following a single administration. CNA3103 has also demonstrated impressive tumor access and prolonged survival enabling rejection of new tumors. https://www.wcrf.org/cancer-trends/colorectal-cancer-statistics/ https://www.cancer.org/cancer/colon-rectal-cancer/about/key-statistics.html https://www.canceraustralia.gov.au/cancer-types/bowel-cancer/statistics For more information please contact: Deborah Rathjen, PhD Kathy SharradCEO & Managing Director Communications ManagerCarina Biotech Carina Biotech+61 418 160 425 +61 415 922 914deborah@carinabiotech.com kathy@carinabiotech.com Stephanie Carrington ICR Westwicke +1 646 277 1282 stephanie.carrington@westwicke.com