IN8bio, formerly Incysus Therapeutics, has instituted cash-saving measures to funnel resources into advancing its acute myeloid leukaemia (AML) allogenic cell therapy, INB-100, to a registrational trial.
As part of the strategic restructuring, the US-based company will reduce its headcount by about 49% and suspend enrolment in the glioblastoma development programme.
IN8bio plans to adopt a wait-and-monitor approach for the two studies, the Phase II trial of INB-400 (NCT05664243) and the Phase I trial (NCT04165941) of INB-200, in glioblastoma indications. The company added that it plans to “explore partnership opportunities” for INB-400, an autologous gamma-delta T cell therapy.
In addition to job cuts, IN8bio’s board and management team will also reduce its cash compensation by 11%, per an SEC filing. The workforce reduction is expected to cost the company $0.3m, mostly in cash severance payments.
The news comes a month after IN8bio announced that it had received guidance on the registrational pathway for INB-100 from the US Food and Drug Administration (FDA). To that end, the company plans to add a control cohort to its ongoing Phase I trial (NCT03533816). The prospective control cohort is expected to enrol ten patients and will receive standard haplotransplantation.
The company also plans to expand the cohort receiving the recommended Phase II dose to enroll approximately 25 patients. The funds freed from the company’s reorganisation are expected to fund the cohort expansion. The enrolment in the additional cohorts is expected to be completed by H1 2025, with long-term follow-up data expected in late 2025-2026.
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In June, IN8bio revealed a 100% relapse-free status at a one-year follow-up for all ten patients with AML enrolled in the Phase I trial, adding that “two of the patients treated with INB-100 remain alive and relapse-free for over three and a half years, and a third patient is now nearing three years”.
The company noted that as of 30 August, 100% of AML patients remain relapse-free after receiving their dose of INB-100 after a median follow-up of 18.7 months.
The Phase I trial also enrolled patients with other leukaemic diagnoses, including acute lymphoblastic leukaemia (ALL), but these patients have since relapsed. In the proposed registrational Phase II trial, IN8bio only plans to enrol patients with AML.
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
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