Carina Biotech Receives FDA “Safe to Proceed” Letter for IND Application for Candidate Phase 1/2a Clinical Trial of CAR-T Cell Therapy Targeting LGR5 for the Treatment of Advanced Colorectal Cancer

CARINA BIOTECH PTY LTD

ADELAIDE, Australia, January 23, 2023 (GLOBE NEWSWIRE) — Carina Biotech Pty Ltd (“Carina”, “the Company”), a cell therapy immuno-oncology company that develops CAR-T and other adoptive cell therapies for the treatment of solid cancers, announced today that it has received the US FDA’s “safe to proceed” letter for its Investigational New Drug application (NDA) to conduct a first Phase 1/2a human clinical trial of CNA3103, its targeted LGR5 Candidate chimeric antigen receptor (CAR-T) T-cell therapy in patients with advanced colorectal cancer (CRC).

The Phase 1/2a clinical trial will include a total of 44 patients with metastatic disease who have failed previous lines of chemotherapy and who express LGR5 in their cancer cells. Twenty-four patients in the Phase 1 segment will be enrolled at selected Australian centres. Following a BOIN (Bayesian Optimal Interval) design, ascending doses of CAR-T cells will be administered to cohorts of three patients each, to evaluate the safety and tolerability of CNA3103 and to determine its optimal dose. The subsequent Phase 2 segment will include 20 patients at the optimal dose in both Australia and the US to characterize CNA3103 activity in terms of anti-tumor response, duration of response and time to disease progression.

“Our positive engagement with the FDA marks a major step forward for Carina and our continued efforts to develop CNA3103 as a potential treatment for the third most common cancer in the US and worldwide, colorectal cancer,” said Deborah Rathjen, Director Carina’s executive. “The FDA letter provides the pathway for this clinical trial and further validates that there is a significant unmet need for more effective treatment options for colorectal cancer. Preparations, including site selection, are ongoing as we aim to begin enrolling patients during the first half of 2023.”

“This interaction with the FDA supports our ability to gain agency support for our proposed study of CNA3103 in patients with metastatic colorectal cancer,” said José Iglesias, MD, chief medical officer at Carina. “Our approach is doubly innovative in that it is one of the emerging CAR-T treatment protocols in solid tumors and that it utilizes a new and, to our knowledge, unique CAR-T construct against LGR5 – an important cancer stem cell-associated antigen. linked to the pathogenesis, spread, and resistance to treatment of colorectal cancer.”

About CNA3103

Carina’s proprietary CNA3103 CAR-T cell targets LGR5, a cancer stem cell marker that is highly expressed in advanced colorectal cancer and some other cancers. In patients with colorectal cancer, LGR5 expression has been correlated with poor prognosis. Cancer stem cells are a small subpopulation of cells within a tumor with the ability to self-renew, differentiate into the various cell types in a tumor, start new tumors, and resist chemotherapy and radiation therapy (leading to relapses). By targeting cancer stem cells, this therapy is expected to reduce the tumor’s ability to generate new cancer cells, resulting in durable tumor suppression and preventing the relapses that are so common in patients with colorectal cancer. Carina’s preclinical studies of CNA3103 showed promising results with complete tumor regression and no tumor recurrence after a single administration. CNA3103 also demonstrated impressive tumor access and prolonged survival, allowing rejection of new tumors.

About Carina Biotech

Immuno-oncology company Carina Biotech is developing CAR-T and other adoptive cell therapies for the treatment of solid cancers. In addition to its LGR5 CNA3103-targeted CAR-T cell therapy for advanced colorectal cancer, Carina has a deep pipeline of CAR-T programs. Using its proprietary chemokine receptor platform, Carina aims to improve CAR-containing cells’ access and infiltration of solid cancers, resulting in more potent and specific cancer killing and reduced off-target effects. Carina also has a fully integrated and proprietary CAR-T cell manufacturing process that has reduced manufacturing time and improved the quality of CAR-T cells, capable of delivering robust “serial death” CAR-T cells to patients.

Forecast Statements

Investment in Carina Biotech is subject to investment risk, including possible loss of income and invested capital. Carina does not guarantee any particular rate of return or performance, nor does it guarantee repayment of principal. This press release does not take into account the investment objectives, financial situation and particular needs of the investor. Before making any investment in Carina, the investor or prospective investor should consider whether such an investment is appropriate for his or her specific investment needs, objectives and financial circumstances, and consult an investment adviser as necessary.

This press release contains forward-looking statements about the potential of Carina’s projects and interests and the development and therapeutic potential of the company’s investigational CAR-T therapies. Any statement that describes a Company objective, expectation, intent or belief is a forward-looking statement and should be considered a risk statement. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing safe and effective therapies for use as human therapy and the funding of such activities.

There is no guarantee that Carina’s research and development projects and interests (where applicable) will receive regulatory approvals or prove to be technically and/or commercially successful in the future. Actual results from additional research may differ from those projected or detailed in this press release. As a result, prospective investors are cautioned not to rely on forward-looking statements. Consideration should be given to these and other risks relating to research and development programs, including but not limited to those specifically mentioned in this press release.

Contact Investor Consultations

Deborah Rathjen, PhD ICR Westwicke
CEO and Managing Director Stephanie Carrington
Carina Biotech 646-277-1282
+61 418 160 425 [email protected]
[email protected]

Carina Biotech Receives FDA “Safe to Proceed” Letter for IND Application for Candidate Phase 1/2a Clinical Trial of CAR-T Cell Therapy Targeting LGR5 for the Treatment of Advanced Colorectal Cancer

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