CNTY-101

Century Therapeutics has decided it\'s time to join a burgeoning trend, discarding a cancer trial to jump on the autoimmune bandwagon.\n Century Therapeutics has joined the onslaught of cell therapy biotechs taking hits, discontinuing a phase 1 cancer study to turn its focus toward autoimmune diseases.The move isn’t shocking, as it follows Century’s acquisition of autoimmune cell therapy biotech Clade Therapeutics last year and mirrors an industrywide pattern as numerous other companies turn from cancer to autoimmune.For Century, the change means ending a study of CNTY-101, the company’s first allogeneic cell therapy candidate that was being tested among patients with late-stage relapsed-refractory non-Hodgkin lymphoma, according to an annual financial report shared after market close March 19.The program, dubbed Elipse-1, launched in the beginning of 2023 and had an estimated enrollment of 75 patients, according to ClinicalTrials.gov. While Century called the therapy’s clinical activity and tolerability profile encouraging, the data didn’t meet the company’s standard to be considered “transformational” for the patient population, according to the release.The Philadelphia-based biotech said it was “committed to providing continued treatment access in the Elipse-1 trial for patients showing benefit.”Century is pointing to the Elipse-1 data as reason to move CNTY-101 into autoimmune diseases, citing deep B-cell depletion and evidence of the therapy trafficking to lymph nodes. The company plans to share more data from the trial later this year, it said in a statement.  The cell therapy company is now launching a new trial for its sole clinical asset, this time for patients with B-cell-mediated autoimmune diseases. The early-stage study, called Calipso-1, is slated to start dosing this month at U.S. sites, with plans to expand to certain European countries later this year.“We believe CNTY-101 is well-positioned to potentially impact the standard of care meaningfully in B-cell-mediated autoimmune diseases,” Century CEO Brent Pfeiffenberger said in the release.The company also expects further insights on the CD19 CAR-iNK cell therapy candidate to come from a phase 1/2 investigator-initiated clinical trial, dubbed Caramel.The study will be sponsored by the Friedrich-Alexander University Erlangen-Nürnberg in Germany and will enroll patients with systemic lupus erythematosus, lupus nephritis, idiopathic inflammatory myopathy and diffuse cutaneous systemic sclerosis. The study is expected to launch in mid-2025.Analysts with William Blair view the discontinuation as \"as unfortunate but necessary,\" citing a competitive treatment landscape for non-Hodgkin lymphoma in a March 20 note. Leerink Partners echoed the sentiment, citing a challenging financing environment for early-stage cell therapy companies. The analyst said it supported Century\'s decision to continue development of CNTY-101 in autoimmune diseases. Meanwhile, the biotech is prioritizing its preclinical pipeline to feature four programs, led by CNTY-308, a CD19-targeted CAR-iT cell therapy. The therapy is being developed for B-cell-mediated autoimmune diseases and malignancies.Another of Century’s candidates is CNTY-341, a CD19/CD22 dual-targeted CAR-iT cell therapy. The prioritized preclinical programs all use induced-pluripotent-stem-cell-derived “tunable” CD4+/CD8+ ab T cells, according to Century.“In the case of CNTY-308 and CNTY-341 in B-cell-mediated diseases, we are aiming for comparable or better performance to approved autologous CAR-T therapies,” Century Chief Scientific Officer Chad Cowan, Ph.D., said in the release. “With our combined expertise in protein engineering, cell differentiation and manufacturing, we aim to launch allogeneic cell therapies at antibody-like scale and cost. For our solid tumor and non-immune cell programs, this brings the potential to expand access to cell therapies much more broadly.”The company will host a live webcast April 22 to discuss each of the programs in more detail. The biotech’s pipeline pivot follows Bristol Myers Squibb’s own “portfolio prioritization efforts” that eliminated a pact with Century in December.Century had entered a collaboration with BMS back in 2022 in which the partners were working to develop stem-cell-derived, engineered natural killer cell and gamma delta T-cell candidates for blood cancers. The Big Pharma paid out $150 million in cash and an equity investment and offered up more than $3 billion in biobucks.After reviewing its own portfolio, BMS axed the entire deal “without cause,” a dissolution that became effective March 12.Century still lists two preclinical cancer candidates—named CNTY-104 and CNTY-106—that were being developed with BMS on its site.As of Dec. 31, 2024, Century had $220 million in cash and marketable securities, a runway expected to bring the biotech into the final quarter of 2026.  Editor\'s note: This story was updated at 10 a.m. ET on March 20 to include analyst commentary.