On January 9, 2023 Alaunos Therapeutics, Inc. ("Alaunos" or the "Company") (Nasdaq: TCRT), a clinical-stage oncology-focused cell therapy company reported its expected milestones and strategic priorities for 2023 (Press release, Alaunos Therapeutics, JAN 9, 2023, View Source [SID1234626122]).
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"Achieving the first-in-human objective clinical response in a patient with a solid tumor using a non-viral TCR-T cell therapy made for an exciting 2022. We believe we are well positioned to increase the pace of enrollment in 2023 and with the addition of two new TCRs to our library we have doubled the potential addressable market of our therapy," commented Kevin S. Boyle, Sr., Chief Executive Officer of Alaunos. "In December we treated our third patient, a pancreatic patient, with a KRAS-G12V mutation. The year ahead will focus on increasing patient enrollment with an aim towards advancing the program to Phase 2 readiness. We are excited about our progress to date and as leaders in the TCR-T cell therapy space we look forward to bringing the promise of our therapies to even more patients in need."
Anticipated 2023 Milestones and Strategic Priorities
Expand TCR library using hunTR TCR discovery platform to increases addressable market: In the fourth quarter of 2022, the Company submitted an IND amendment to the U.S. Food and Drug Administration (FDA) adding two new TCRs to its clinical trial targeting frequent mutations and HLAs, with the potential to double the addressable market of its TCR-T program. The addition of these new TCRs highlights our strategy to add both more HLAs to existing mutations (KRAS-G12V and HLA-DRB1*07:01) and new mutations within our targeted gene families (TP53-R273C and HLA-DPB1*04:02). In 2023, the Company expects to further expand its library with exclusively owned TCRs targeting recurrent hotspot mutations in KRAS, TP53 and EGFR.
Advance TCR-T library program to Phase 2 readiness: The Company continues to actively enroll patients in its TCR-T Library Phase 1/2 trial targeting KRAS, TP53, and EGFR hotspot mutations across six solid tumor indications. In September 2022, the Company announced the first objective clinical response from a TCR-T cell therapy using non-viral Sleeping Beauty targeting solid tumors. The Company successfully dosed its third patient in the trial in December 2022 and expects to enroll multiple patients in the first half of 2023. Alaunos anticipates providing an interim data update by mid-2023 as it works towards advancing the program into Phase 2.
Optimize manufacturing process towards commercial scalability: The Company continues to execute on its multi-pronged strategy to expand manufacturing capacity and efficiency. The Company doubled its manufacturing capacity in 2022 allowing for production of two products simultaneously. The Company also filed an IND amendment to move from fresh to cryopreserved product and expects to begin implementing this change in the first half of 2023. The use of cryopreserved cell products will reduce manufacturing process time from 30 days to 26 days, a 13% decrease, while increasing flexibility for patient scheduling and treatment. The Company has ongoing initiatives to optimize the process and further reduce the manufacturing time.
Explore next generation TCR-T cell therapy approaches to deepen clinical responses: The Company is advancing its mbIL-15 TCR-T cell therapy program towards an IND filing anticipated in the second half of 2023. The Company believes mbIL-15 has the potential to increase the survival of TCR-T cells in the harsh tumor microenvironment and deepen clinical responses. In addition, Alaunos continues to conduct translational assessments of treated patients to guide next generation TCR-T therapy approaches including potential combination and multiplexed TCR-T cell therapies.
Cash Position and Financial Guidance
Alaunos ended the fourth quarter of 2022 with unaudited cash and cash equivalents of approximately $39.1 million and restricted cash of approximately $13.9 million. Based on current operating plans, the Company expects its operating cash flow for 2023 to be between approximately $35 million and $40 million. The Company expects to have sufficient cash resources to fund research and development programs and operations into Q4 2023.