Century Therapeutics Announces First Patient Dosed in First-In-Human Phase 1 ELiPSE-1 Trial Evaluating CNTY-101 in Relapsed or Refractory CD19 Positive B-cell Lymphomas
– CNTY-101 is the first cell therapy product candidate engineered with six precision gene edits including a CD19-CAR, Allo-Evasion™ technology, IL-15 cytokine support and a safety switch –
– ELiPSE-1 trial to test multi-dosing strategy for CAR iNK enabled by Allo-Evasion™ edits designed to resist 3 major pathways of rejection –
PHILADELPHIA, Feb. 08, 2023 (GLOBE NEWSWIRE) -- Century Therapeutics, Inc., (NASDAQ: IPSC), an innovative clinical-stage biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology, announced today that the first patient has been dosed in the first-in-human Phase 1 ELiPSE-1 trial evaluating CNTY-101 in patients with relapsed or refractory CD19 positive B-cell lymphomas. CNTY-101 is the Company’s first allogeneic cell therapy product candidate engineered with multiple complementary functionalities to enhance its product profile. These features include a CD19 CAR for tumor targeting, IL-15 support for enhanced persistence, Allo-Evasion™ technology to prevent host rejection and enhance persistence, and a safety switch to provide the option to eliminate the drug product if ever necessary.
As a leading next-generation allogeneic cell therapy candidate, CNTY-101 is the first to test the potential of a finite, repeat dosing regimen and the ability to deliver more durable responses enabled by Allo-Evasion™ gene edits. CNTY-101 is manufactured from a clonal iPSC master cell bank that yields homogeneous product, in which all infused cells have the intended modifications.
“Today’s achievement marks our transition to a clinical-stage company and represents an important milestone for both Century and for patients with relapsed or refractory CD19 positive B-cell lymphomas who are lacking efficacious therapeutic options,” said Lalo Flores, Ph.D., Chief Executive Officer, Century Therapeutics. “With our vision of a finite multi-dosing regimen combined with core Allo-Evasion™ edits, we are attempting to pave the way for our future product candidates and a new paradigm for allogeneic cell therapies.”
The Phase 1 trial, ELiPSE-1 (NCT05336409), is intended to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of CNTY-101 in patients with relapsed or refractory CD19-positive B-cell lymphomas. All patients will receive an initial standard dose of conditioning chemotherapy consisting of cyclophosphamide (300 mg/m2) and fludarabine (30mg/m2) for 3 days. Schedule A of the trial includes a single-dose escalation of CNTY-101 and subcutaneous IL-2. Schedule B will evaluate a three-dose schedule per cycle of CNTY-101. Patients who demonstrate a clinical benefit are eligible for additional cycles of treatment with or without additional lymphodepletion pending U.S. Food and Drug Administration consent.
Century’s proprietary Allo-Evasion™ technology is used to engineer cell therapy product candidates with the potential to evade identification by the host immune system so they can be dosed multiple times without rejection, enabling increased persistence of the cells during the treatment period and potentially leading to deeper and more durable responses. More specifically, Allo-Evasion™ 1.0 technology incorporates three gene edits designed to avoid recognition by patient/host CD8+ T cells, CD4+ T cells and NK cells. Knockout of beta-2-microglobulin or β2m, designed to prevent CD8+ T cell recognition, knock-out of the Class II Major Histocompatibility Complex Transactivator, or CIITA, designed to prevent CD4+ T cell recognition, and knock-in of the HLA-E gene, designed to enable higher expression of the HLA-E protein to prevent killing of CNTY-101 cells by host NK cells. Allo-Evasion™ technology may allow the implementation of more flexible and effective repeat dosing protocols for off-the-shelf product candidates.
CNTY-101 is an investigational off-the-shelf cancer immunotherapy product candidate that utilizes iPSC-derived natural killer (NK) cells with a CD19-directed chimeric antigen receptor (CAR) and includes Century’s core Allo-Evasion™ edits designed to overcome the three major pathways of host versus graft rejection - CD8+ T cells, CD4+ T cells and NK cells. In addition, the product candidate is engineered to express IL-15 to provide homeostatic cytokine support, which has been shown pre-clinically to improve functionality and persistence. Further, to potentially improve safety, the iNK cells were engineered with an EGFR safety switch, and proof-of-concept studies have demonstrated that the cells can be quickly eliminated by the administration of cetuximab, an antibody against EGFR approved by the U.S. Food and Drug Administration for certain cancers. Century is currently assessing CNTY-101 in patients with relapsed or refractory CD19-positive B-cell lymphomas in its Phase 1 ELiPSE-1 trial.
About Century Therapeutics
Century Therapeutics, Inc. (NASDAQ: IPSC) is a clinical-stage biotechnology company harnessing the power of adult stem cells to develop curative cell therapy products for cancer that we believe will allow us to overcome the limitations of first-generation cell therapies. Our genetically engineered, iPSC-derived iNK and iT cell product candidates are designed to specifically target hematologic and solid tumor cancers. We are leveraging our expertise in cellular reprogramming, genetic engineering, and manufacturing to develop therapies with the potential to overcome many of the challenges inherent to cell therapy and provide a significant advantage over existing cell therapy technologies. We believe our commitment to developing off-the-shelf cell therapies will expand patient access and provide an unparalleled opportunity to advance the course of cancer care. For more information on Century Therapeutics please visit https://www.centurytx.com/.
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