Last update 22 Jun 2024
CNTY-101
Last update 22 Jun 2024
Overview
Basic Info
Drug Type CAR-NK |
Synonyms CNTY 101, CNTY-101 |
Target |
Mechanism CD19 modulators(B-lymphocyte antigen CD19 modulators), Immunologic cytotoxicity, Natural killer cell replacements |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhasePhase 1 |
First Approval Date- |
Regulation- |
Related
2
Clinical Trials associated with CNTY-101The CALiPSO-1 Study: A Study of CNTY-101, a CD19-targeted CAR iNK Cell Product, in Participants With Moderate to Severe Systemic Lupus Erythematosus
CALiPSO-1 is a Phase 1, multi-center, dose-finding study to evaluate the safety and efficacy of CNTY-101 in participants with moderate to severe systemic lupus erythematosus.
Start Date01 Aug 2024 |
Sponsor / Collaborator |
The ELiPSE-1 Study: A Phase 1, Multicenter, Open-Label Study of CNTY-101 in Subjects With Relapsed or Refractory CD19-Positive B-Cell Malignancies
ELiPSE-1 is a Phase 1, multi-center, dose-finding study to evaluate the safety, pharmacokinetics, and preliminary efficacy of CNTY-101 in participants with relapsed or refractory cluster of differentiation (CD)19-positive B-cell malignancies.
Start Date24 Jan 2023 |
Sponsor / Collaborator |
100 Clinical Results associated with CNTY-101
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100 Translational Medicine associated with CNTY-101
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100 Patents (Medical) associated with CNTY-101
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35
News (Medical) associated with CNTY-10103 Jun 2024
In ongoing dose escalation, CNTY-101 has demonstrated a manageable safety profile with no observed DLTs or GvHD and with majority of patients treated in outpatient setting Encouraging preliminary efficacy in heavily pretreated R/R NHL at initial dose levels Novel cell-free DNA method for detecting total body PK suggests CNTY-101 persists outside the bloodstream Enrollment continues in dose escalation phase of ELiPSE-1 at dose levels 3B (three weekly infusions of 1 billion cells) and 4A (single infusion of 3 billion cells) per cycle PHILADELPHIA, June 03, 2024 (GLOBE NEWSWIRE) -- Century Therapeutics (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology and autoimmune and inflammatory disease, today announced a poster presentation highlighting interim results from the ongoing Phase 1 ELiPSE-1 study evaluating CNTY-101 in relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) at the American Society of Clinical Oncology (ASCO) Annual Meeting being held May 31 – June 4, 2024 in Chicago, Illinois. CNTY-101 is an investigational CD19 targeting allogeneic, iPSC-derived natural killer (NK) cell therapy with six precision gene edits powered by Century’s Allo-Evasion™ technology enabling repeat dosing without the need for continued lymphodepletion. ELiPSE-1 (NCT05336409) is an ongoing Phase 1, multicenter, open-label clinical trial to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of CNTY-101 in patients with R/R, CD19-positive B-cell malignancies. “These interim results continue to support our belief in the potential of CNTY-101, which shows additional responses across escalating doses and different types of B-cell malignancies in heavily pretreated patients with predominantly aggressive or high-risk histologies,” said Adrienne Farid, PhD, Chief Operations Officer and Head of Early Development. “We are also encouraged by the safety profile we are seeing at higher doses, with no dose-limiting toxicities to date, after multiple treatment cycles, which we believe was achieved by leveraging our proprietary Allo-Evasion™ technology to avoid host rejection. Further, the majority of these cycles have been administered in the outpatient setting, providing additional support for CNTY-101 as a new paradigm for allogeneic cell therapies. We look forward to completing dose escalation and moving into dose expansion in the coming months.” Interim Results from the ELiPSE-1 Study: A Phase 1, Multicenter, Open-Label Study of CNTY-101 in Subjects with Relapsed or Refractory CD19-Positive B-Cell MalignanciesPoster Board Number: 6Session Title: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic LeukemiaSession Date & Time: Monday, June 3, 2024, from 9:00 am – 12:00 pm CDT CNTY-101 is Century’s lead iNK cell therapy and the first iPSC-derived NK cell therapy engineered with six precision gene edits, featuring antigen-specific killing of CD19+ B cells, homeostatic cytokine support for enhanced persistence, Allo-Evasion™ edits to prevent rejection by the patients’ immune system, and a safety switch. CNTY-101 is being assessed in heavily pre-treated relapsed or refractory NHL patients with predominantly aggressive or high-risk indolent histologies who have received two to five prior therapies, four of whom received prior CAR-T therapy. The Company previously announced initial data in December 2023, demonstrating a favorable safety profile in the initial seven patients treated with Dose Level 1 (100 million cells) and Dose Level 2 (300 million cells) on a once monthly schedule. In these low dose levels, CNTY-101 demonstrated encouraging early response signals, including two complete responses (CRs) and one partial response (PR). As of the interim data cutoff date of March 27, 2024, preliminary safety and efficacy were evaluated across Dose Level 1, Dose Level 2 and Dose Level 3 (one billion cells) and two dosing schedules (Schedule A with single infusion, and Schedule B with three weekly infusions, per cycle). CNTY-101 infusions of up to one billion cells per cycle (as a single infusion of one billion cells, or 3 weekly infusions of 300 million cells) demonstrated a favorable safety profile with no observations of graft-versus-host disease (GvHD) or dose-limiting toxicities (DLT), and 8/12 subjects received at least one cycle of CNTY-101 in an outpatient setting. Preliminary efficacy in all evaluable patients (n=10) across dose schedules and histologies demonstrated a complete response rate (CRR) of 30% and an objective response rate (ORR) of 40% in heavily pretreated patients, with a 40% CRR and 60% ORR observed in the five patients treated with the two higher Schedule A dose levels, 300 million cells and one billion cells. Pharmacokinetics (PK) evaluated by a novel cell-free DNA (cfDNA) method for detecting total body PK showed that CNTY-101 rapidly traffics out of circulation and persists outside the bloodstream, with AUC trending to increase with dose level. In patients who received additional cycles of CNTY-101 without lymphodepleting chemotherapy, three out of four patients had positive detection of CNTY-101 on Day 3 and beyond. The ELiPSE-1 study is currently ongoing in the dose escalation phase and is enrolling in Dose Level 3B (one billion cells in three weekly infusions per cycle), and Dose Level 4A (single infusion of 3 billion cells per cycle). The full poster will be available on the Scientific Resources page of Century’s website at the start of the poster presentation. About CNTY-101CNTY-101 is an investigational off-the-shelf 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 preclinically to improve functionality and persistence. Further, to address potential safety considerations, the iNK cells were engineered with an EGFR safety switch, and preclinical proof-of-concept studies have demonstrated that the cells can be quickly eliminated in vivo 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 clinical trial. The Company intends to initiate its second Phase 1 clinical trial assessing CNTY-101 in patients with moderate to severe systemic lupus erythematosus, in addition to pursuing additional regulatory filings in other prioritized autoimmune disease indications. About Allo-Evasion™ 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. About Century Therapeutics Century Therapeutics (NASDAQ: IPSC) is harnessing the power of adult stem cells to develop curative cell therapy products for cancer and autoimmune and inflammatory diseases that we believe will allow us to overcome the limitations of first-generation cell therapies. Our genetically engineered, iPSC-derived cell product candidates are designed to specifically target hematologic and solid tumor cancers, with a broadening application to autoimmune and inflammatory diseases. 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 and autoimmune and inflammatory disease care. For more information on Century Therapeutics please visit www.centurytx.com. Century Therapeutics Forward-Looking Statement This press release contains forward-looking statements within the meaning of, and made pursuant to the safe harbor provisions of, The Private Securities Litigation Reform Act of 1995. All statements contained in this press release, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding our clinical development plans and timelines and the initial safety and efficacy profiles of CNTY-101 are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “should,” “expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “forecast,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this press release are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control, including, among others: our ability to successfully advance our current and future product candidates through development activities, preclinical studies, and clinical trials; our dependence on the success of our lead product candidate, CNTY-101; the ability of CNTY-101 to be administered as part of a multi-dose strategy and to enable responses without lymphodepletion; uncertainties inherent in the results of preliminary data, pre-clinical studies and earlier-stage clinical trials, which may not be predictive of final results or the results of later-stage clinical trials; the timing of and our ability to initiate and successfully enroll the Phase 1 SLE trial; our ability to obtain FDA clearance of our future IND submissions and commence and complete clinical trials on expected timelines, or at all; our reliance on the maintenance of certain key collaborative relationships for the manufacturing and development of our product candidates; the timing, scope and likelihood of regulatory filings and approvals, including final regulatory approval of our product candidates; the impact of geopolitical issues, banking instability and inflation on our business and operations, supply chain and labor force; the performance of third parties in connection with the development of our product candidates, including third parties conducting our clinical trials as well as third-party suppliers and manufacturers; our ability to successfully commercialize our product candidates and develop sales and marketing capabilities, if our product candidates are approved; our ability to recruit and maintain key members of management and our ability to maintain and successfully enforce adequate intellectual property protection. These and other risks and uncertainties are described more fully in the “Risk Factors” section of our most recent filings with the Securities and Exchange Commission and available at www.sec.gov. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that we may face. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. For More Information: Investors/Media: Julie Seidel/ Noor Pahlavi – century@argotpartners.com
Clinical ResultImmunotherapyPhase 1ASCOCell Therapy
03 Jun 2024
Pictured: NK cells attacking a cancer cell/ selvanegra for iStock
When the first CAR T cell therapy was approved by the FDA in 2017, it was heralded as a breakthrough in cancer treatment. The approach allowed for a targeted attack on cancer cells using a patient’s own immune cells, as compared with the broad-strokes assault levied by traditional treatments such as chemotherapy and radiation.
While a total of six CAR-Ts have been approved to date, the approach works only for a subset of patients, has shown promise mainly for blood cancers and has notable side effects. To overcome these shortcomings, many researchers and biotech companies have turned their attention to natural killer (NK) cells, which are a part of the innate immune response—the body’s first line of defense against any infection.
Historically, NK cells have been notoriously difficult to culture, leading them to be overlooked, said Alicja Copik, associate professor of medicine and core scientist at the University of Central Florida.
“Better understanding of how to grow [NK cells] in the laboratory has led to an immense research interest in these cells,” she told BioSpace. “A decade ago, just one company was looking at NK cells. Now, several groups are exploring different ways to use them as cell therapies.”
Overcoming CAR-T’s Challenges
CAR-T therapies involve reengineering T cells, typically derived from the patient. Once isolated, these cells are genetically modified to express chimeric antigen receptors (CARs) on their surface, arming them to better recognize and attack cancer cells.
However, CAR-Ts have been shown to cause several side effects, including cytokine release syndrome, neurotoxicity and blood disorders such as anemia and thrombocytopenia. In terms of allogeneic CAR-Ts, where donor T cells are used, there is the risk of graft-versus-host disease, a strong immune reaction that leads to a rejection of the transplanted cells.
“T cells with CARs can go crazy and grow uncontrollably, which leads to some of the major side effects,” said Sumiti Jain, chief scientific officer of ImmuneBridge, a San Francisco–based biotech startup that raised $12 million in seed funding in 2023 to develop NK cells from the umbilical cord. NK cell–based therapies do not cause cytokine release syndrome and neurotoxicity because “they don’t grow as robustly,” Jain said.
CAR-Ts have also been associated with secondary malignancies such as leukemias, skin cancers and T cell non-Hodgkin lymphomas. Noting this potential side effect, the FDA recently announced that it will require an update to the boxed warnings of CAR T cell therapies, alerting patients and prescribers to a heightened risk of secondary T cell malignancies.
Furthermore, David Shook, chief medical officer of Nkarta, which is developing allogeneic CAR-NK cells, told BioSpace that CAR T cell therapies, despite their benefits, have remained largely inaccessible to patients due partly to a “cumbersome” manufacturing process. The process of isolating and engineering a patient’s T cells takes over two weeks before the cells can be infused back into the patient.
“There are patients who are eligible for CAR-Ts and are on the waitlist but are not able to access them because of manufacturing constraints,” Shook said.
Advantages of NK Cell Therapy
Ann Cheung, chief scientific officer and head of R&D at Dragonfly Therapeutics, which is developing NK cell–stimulating antibodies, noted that, unlike CAR-T therapies, NK cell therapies do not require patients to undergo lymphodepletion chemotherapy with toxic agents such as fludarabine and cyclophosphamide. “Not every patient is eligible for these chemotherapies,” she told BioSpace, because of other immune conditions or a susceptibility to infections. “In that sense, the safety pro NK cell therapies is much better.” Moreover, she said, NK cells work by recognizing multiple antigens, making them strong contenders to destroy cancer cells.
NK cell therapies have also shown promise for treating solid cancers, an area where CAR-Ts have largely failed to show benefits, Jain said. “CAR-Ts are amazing for blood cancers, but put them in solid tumors, and they seem to freeze.” NK cells seem to have the ability to migrate into solid tumors better than CAR-Ts, she explained.
These characteristics have inspired several biotech and research groups to explore the potential of turning NK cells into therapies. Nkarta is developing CAR-NK cells from a donor-derived pool of NK cells. But after seeing initial success with one candidate, NKX101, an interim evaluation of Phase I data in 14 acute myeloid leukemia patients showed a “meaningfully lower” response rate than in the first six reported patients, causing the company to deprioritize the program.
Other companies are moving forward with CAR NK cell therapy candidates. Fate is in Phase I trials with FT522 for B cell lymphoma, and Century has a CD19-targeting therapy, CNTY-101, in Phase I for B cell malignancies.
And while some are focused on genetically modifying NK cells to enhance their cancer-fighting abilities, others are harnessing the inherent qualities of NK cells. For example, San Diego–based Artiva Biotherapeutics, in partnership with Merck, is developing a non–genetically modified NK cell therapy that enhances antibody responses to specific cancers and autoimmune diseases. Meanwhile, NKGen Biotech just released interim Phase I data for its allogeneic non–genetically modified NK cell therapy, SNK02, showing that it was well tolerated—all patients completed the eight treatment cycles—and showed signs of clinical activity against pretreated solid tumors. And ImmuneBridge wants to harness the pool of NK cells from hematopoietic stem cells derived from umbilical cords, which Jain said are most likely to show anti-tumor activities against specific cancers.
The Road Ahead
Despite recent advancements, experts suggest the road ahead for upscaling NK cell therapies may not be straightforward.
“NK cells don’t live for very long,” Shook said, so patients may require a high dose and multiple rounds of injections.
Jain added that differentiating NK cells derived from donors can exhaust the cells and mellow their potential to be effective cancer killers. “We need durable cell NK therapies,” she said.
According to a study of clinical trial data recently published in Nature, the clinical benefits from NK cell–based therapies often lasted only a few months before relapse, likely due to resistance or low NK cell persistence. “NK cell persistence typically ranges from a few days to 4 months, with an average of 7 days,” the authors noted, adding that cryopreservation of NK cells further impacts their ability to grow.
While there are currently no FDA-approved NK cell therapies for cancer, Copik is hopeful that some of these therapies will make it to market. “More studies are showing us that the NK cell therapies are effective and have better safety profiles compared to CAR-Ts,” she said.
Jain holds a similar view. “Patients are battling every day. Having a new therapy that is readily accessible will be a huge advancement.”
Aayushi Pratap is a New York-based health and science journalist and an alum of Columbia Journalism School. Reach her on LinkedIn.
Phase 1Cell TherapyClinical ResultImmunotherapyDrug Approval
10 May 2024
In vitro data showcases CNTY-101’s ability to induce CD19-specific cytolysis of B-cells and potential to treat B-cell driven autoimmune diseases including systemic lupus erythematosus (SLE)Preclinical data demonstrates potential utility of using a synthetic ligand targeting CD300a as a universal strategy for preventing NK mediated rejection in allogeneic cell therapies PHILADELPHIA, May 10, 2024 (GLOBE NEWSWIRE) -- Century Therapeutics (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology and autoimmune and inflammatory disease, today announced two poster presentations at the ASGCT 27th Annual Meeting. The data presented highlights the potential of the Company’s lead candidate, CNTY-101, to treat B-cell driven autoimmune diseases including SLE. Additionally, the Company presented data which further demonstrates the capabilities of its Allo-Evasion™ technology through new preclinical data of a CD300a agonist which can potentially inhibit natural killer (NK) cell alloreactivity. “As demonstrated today, we remain dedicated to continuously investing in the evolution of our Allo-Evasion™ platform to further enable our iPSC candidates to have a more controlled, durable and tolerable profile than other cell therapies currently in development to treat autoimmune disease,” said Hy Levitsky, M.D., President of Research and Development at Century Therapeutics. “The data demonstrate CNTY-101, an allogeneic iPSC-derived NK cell therapy engineered using Allo-Evasion™ edits, eliminates CD19+ B-cells in vitro while enhancing persistence and durability with less inflammatory cytokine secretion after target killing. We are also excited to highlight preclinical data of a novel synthetic ligand to CD300a, a potent inhibitory receptor found in nearly all NK cells tested across a wide sampling of the population to render engineered cells resistant to NK cell mediated rejection, potentially offering greater protection for a variety of allogeneic cell therapies currently in development. Together, these capabilities have the potential to allow us not only to protect allogeneic cell therapies better than leading alternatives, but also improve outcomes and deliver a broadly beneficial treatment option across a range of indications.” Details of the posters are as follows: Characterization of CNTY-101, an Allogeneic Anti-CD19 iPSC-Derived NK Product, for the Treatment of B Cell-Driven Autoimmune DiseasesPoster Board Number: 1815Session Title: Immune Targeting and Approaches with Genetically-Modified Cells and Cell TherapiesSession Date & Time: Friday, May 10th, 2024, at 12:00 PM -7:00 PM ET B-cell targeted allogeneic iPSC-derived immune effector cells have the potential to deliver long-term remission in autoimmune diseases mediated by pathogenic B-cells, including SLE. Century’s lead candidate, CNTY-101, is currently being evaluated in patients with B-cell Non-Hodgkin Lymphoma, and studies in SLE patients will soon begin. Early clinical experience with this iPSC-derived NK cell demonstrates the potential for tight control over drug exposure, potentially enabling B-cell depletion without causing prolonged B-cell aplasia. CNTY-101 was engineered with multiple precision gene edits, incorporating a CD19-specific CAR, homeostatic cytokine support for enhanced persistence, Allo-Evasion™ edits to prevent rejection by the patients’ immune system, and a safety switch. In non-clinical studies the Company demonstrated that CNTY-101 was more potent in vitro than peripheral blood mononuclear cell (PBMC) derived CAR-T cells in inducing CD19-specific cytolysis of B-cells isolated from multiple healthy and SLE patient donors with less detectable inflammatory cytokine secretion after B-cell depletion. Beyond HLA-E: Universal Protection of Allogeneic T Cells from Natural Killer Cells Via CD300a AgonismPoster Board Number: 1816Session Title: Immune Targeting and Approaches with Genetically-Modified Cells and Cell TherapiesSession Date & Time: Friday, May 10th, 2024, at 12:00 PM -7:00 PM ET The therapeutic potential of allogeneic, off-the-shelf T cell therapies is hindered by immune-mediated rejection by the host. While ablation of human leukocyte antigen (HLA) removes most T cell and humoral alloreactivity, this renders the cells vulnerable to attack by natural killer (NK) cells. Expression of natural inhibitory ligands such as HLA-E can diminish NK mediated killing, however, the extent of this resistance varies from host to host and a solution that allows for universal protection again NK cell response has not been found. To overcome this challenge, Century is engineering a class of synthetic ligands called trans antigen signaling receptors (TASRs), which agonize CD300a, an inhibitory receptor present on the vast majority of NK cells across a broad sampling of the population. Researchers assessed expression of a CD300a TASR on T cells edited to lack HLA-I in a large human cohort study. CD300a TASR outperformed leading alternatives, including CD47 and HLA-E, both in terms of protection against NK mediated killing as well as enhanced CAR-T cell efficacy under allogeneic pressure. Notably, peripheral blood from CMV-seropositive donors (>50% of the population) expressed NK cell subsets with relative resistance to HLA-E mediated inhibition, while cells expressing CD300a TASR were protected, broadening the population with the potential to be effectively treated by next-generation allogeneic cell therapies. As such, surface expression of an engineered CD300a agonist acted as a universal ligand against NK cell alloreactivity. CD300a TASR has the potential to be a solution to a key constraint against the broad use of allogeneic cell therapies for hematologic malignancies, cancer, autoimmunity and beyond. These results further strengthen Century’s Allo-Evasion™ platform, focused on designing cells capable of evading identification and destruction by the host immune system while simultaneously allowing for repeat dosing of CAR-modified cell therapies to generate durable responses across autoimmune and inflammatory diseases as well as hematologic and solid tumors. A preprint of the data from the poster was shared in bioRix and can be viewed here. About Allo-Evasion™ 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. About Century Therapeutics Century Therapeutics (NASDAQ: IPSC) is harnessing the power of adult stem cells to develop curative cell therapy products for cancer and autoimmune and inflammatory diseases that we believe will allow us to overcome the limitations of first-generation cell therapies. Our genetically engineered, iPSC-derived cell product candidates are designed to specifically target hematologic and solid tumor cancers, with a broadening application to autoimmune and inflammatory diseases. 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 and autoimmune and inflammatory disease care. For more information on Century Therapeutics please visit www.centurytx.com. Century Therapeutics Forward-Looking Statement This press release contains forward-looking statements within the meaning of, and made pursuant to the safe harbor provisions of, The Private Securities Litigation Reform Act of 1995. All statements contained in this press release, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding our clinical development plans and timelines, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “should,” “expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “forecast,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this press release are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control, including, among others: our ability to successfully advance our current and future product candidates through development activities, preclinical studies, and clinical trials; our dependence on the success of our lead product candidate, CNTY-101; the ability of CNTY-101 to be administered as part of a multi-dose strategy and to enable responses without lymphodepletion; uncertainties inherent in the results of preliminary data, pre-clinical studies and earlier-stage clinical trials, which may not be predictive of final results or the results of later-stage clinical trials; the timing of and our ability to initiate and successfully enroll the Phase 1 SLE trial; our ability to obtain FDA clearance of our future IND submissions and commence and complete clinical trials on expected timelines, or at all; our reliance on the maintenance of certain key collaborative relationships for the manufacturing and development of our product candidates; the timing, scope and likelihood of regulatory filings and approvals, including final regulatory approval of our product candidates; the impact of geopolitical issues, banking instability and inflation on our business and operations, supply chain and labor force; the performance of third parties in connection with the development of our product candidates, including third parties conducting our clinical trials as well as third-party suppliers and manufacturers; our ability to successfully commercialize our product candidates and develop sales and marketing capabilities, if our product candidates are approved; our ability to recruit and maintain key members of management and our ability to maintain and successfully enforce adequate intellectual property protection. These and other risks and uncertainties are described more fully in the “Risk Factors” section of our most recent filings with the Securities and Exchange Commission and available at www.sec.gov. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that we may face. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. For More Information: Investors/Media: Julie Seidel/ Noor Pahlavi – century@argotpartners.com
Cell TherapyImmunotherapyAACR
100 Deals associated with CNTY-101
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R&D Status
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Systemic Lupus Erythematosus | Phase 1 | - | 01 Aug 2024 | |
| Aggressive Non-Hodgkin Lymphoma | Phase 1 | US | 24 Jan 2023 | |
| CD19 positive B-Cell Lymphoma | Phase 1 | US | 24 Jan 2023 | |
| Indolent Non-Hodgkin Lymphoma | Phase 1 | US | 24 Jan 2023 |
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Clinical Result
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Evaluation
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| Study | Phase | Population | Analyzed Enrollment | Group | Results | Evaluation | Publication Date |
|---|
Phase 1 | CD19 positive B-Cell Lymphoma CD19 Positive | 1 | ynotltfmti(dsoheswdae) = All doses of CNTY 101 with and without IL-2 or LDC demonstrated acceptable safety and clinical benefit ruwwpivavc (natarhmqyk ) | Positive | 09 Dec 2023 |
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