Clinical Trials and Efficacy - CNTY-101 is currently in Phase 1 trials targeting CD19 for B-cell malignancies and autoimmune disorders, with a focus on repeat dosing enabled by Allo-Evasion™ technology[22]. - The ELiPSE-1 study shows a median overall response rate (ORR) of 83% with a median follow-up of 2.9 months, indicating promising efficacy for CNTY-101[32]. - CNTY-101 demonstrated increased exposure and dose-responsive efficacy, with higher doses correlating with improved outcomes[29][33]. - The study enrolled heavily pre-treated patients, with a median of 4 prior therapies and 60% classified as refractory[28]. - CNTY-101 demonstrated an 83% overall response rate (ORR) at dose level 3B in a heavily pretreated patient population[43]. - The Phase 1 study ELiPSE-1 showed increased CNTY-101 exposure with multiple infusions, indicating extended persistence in circulation beyond day 15[36]. - CNTY-101 treatment resulted in rapid B-cell depletion observed in the first cycle, with a naive non-class switched profile of re-emergent B-cells[39]. - The Phase 1 ELiPSE-1 trial of CNTY-101 is ongoing, with updated clinical data expected for multiple malignancies[78]. - The CALiPSO-1 trial has been initiated for participants with systemic lupus erythematosus (SLE), lupus nephritis (LN), idiopathic inflammatory myopathies (IIM), and diffuse cutaneous systemic sclerosis (dcSSc)[80]. Safety Profile - CNTY-101's safety profile includes no instances of Graft vs Host Disease (GvHD) and manageable adverse events, such as Grade 1 and 2 cytokine release syndrome (CRS)[32]. - The study included 11 patients in Schedule A and 8 patients in Schedule B, with favorable initial safety profiles allowing outpatient delivery[43]. - CNTY-101's pharmacokinetics and pharmacodynamics are characterized by short-lived, predictable profiles, contributing to manageable safety[48]. Product Development and Pipeline - CNTY-101 incorporates six precision gene edits, including CD19-targeted CAR and safety switches, enhancing its therapeutic profile[22]. - The product pipeline includes multiple candidates, with CNTY-308 and CNTY-361 also targeting autoimmune diseases and B-cell malignancies, respectively[15]. - CNTY-308, another product in development, is an iPSC-derived CD19-targeted CAR-iT cell therapy showing comparable preclinical activity to autologous CAR-T cells[59]. - Century Therapeutics is focusing on expanding its pipeline into additional autoimmune indications, leveraging its Allo-Evasion™ technology[77]. - The differentiated pipeline includes multiple opportunities in autoimmune diseases, supported by promising preclinical data[80]. Manufacturing and Technology - The company is advancing its iPSC-derived cell types, focusing on scalable and reproducible manufacturing processes to reduce costs[5]. - The company has established in-house manufacturing capabilities, including a 53,000 ft² cGMP facility, to ensure efficient and scalable production[76]. - The iPSC Precision Engineering platform allows for precise CRISPR-mediated gene editing, reducing off-target integration and enhancing product quality[75]. - The platform enables lower cost of goods sold (COGs) compared to donor-derived or autologous therapies, enhancing batch-to-batch consistency[48]. - The company aims to manufacture at antibody-like scale, optimizing processes to maximize yield and reduce costs[76]. Financials and Future Plans - The company ended FY24 with cash and investments of approximately $2 million, noting that this estimate is unaudited and preliminary[79]. - Future development plans include progressing CNTY-101 through clinical trials and obtaining FDA clearance for IND submissions[3]. - The company is expanding clinical trial sites to the EU in 2025, following the initial enrollment in the USA[53]. - Century Therapeutics is advancing next-generation iPSC-derived NK and T cell therapy candidates for cancer treatment, with encouraging preliminary clinical data from Phase 1 trial of CNTY-101 in R/R B-cell lymphomas[77].
Century Therapeutics(IPSC) - 2024 Q4 - Annual Results