Anbalcabtagene autoleucel

First data to be presented as a late-breaker abstract from global pivotal APPLY-PNH trial of investigational oral monotherapy iptacopan in paroxysmal nocturnal hemoglobinaria (PNH), a rare and serious complement-mediated blood disorder New data evaluating the superiority of first-line (1L) Kisqali® plus endocrine therapy vs. combination chemotherapy in pre-menopausal patients with HR+/HER2- metastatic breast cancer with aggressive disease, including patients with visceral disease New analysis from Scemblix® ASCEMBL trial on factors of response in pre-treated patients with Ph+ CML-CP and trial-in-progress update from ASC4FIRST, investigating Scemblix in newly diagnosed patients New follow-up data from the ongoing Phase I trial with our next generation CAR-T cell therapy rapcabtagene autoleucel (YTB323) in r/r DLBCL using the Novartis-developed T-ChargeTM platform Basel, November 22, 2022 — Novartis will present data on the latest advancements in breast cancer and hematology at the 2022 San Antonio Breast Cancer Symposium (SABCS), December 6-10, and the American Society of Hematology (ASH) Annual Meeting, December 10-13. More than 130 abstracts, from both Novartis-sponsored trials and investigator-initiated trials using Novartis compounds, were accepted at the meetings, reinforcing Novartis leadership and innovation in priority oncology therapeutic areas. “Novartis continues to pioneer critical medicines that redefine treatment goals in cancer and non-malignant hematology,” said Jeff Legos, Executive Vice President, Global Head of Oncology & Hematology Development, Novartis. “At SABCS and ASH this year, we’ll share new clinically-relevant and patient-focused data for Kisqali in aggressive metastatic breast cancer, and for Scemblix and YTB323 in life-threatening blood cancers, and potentially practice-changing data for iptacopan in PNH, underscoring the strength of our promising pipeline.” Key highlights of data accepted by SABCS: Medicine Abstract Title Abstract Number/ Presentation Details Kisqali® (ribociclib)* Primary results from the randomized Phase II RIGHT Choice trial of premenopausal patients with aggressive HR+/HER2− advanced breast cancer treated with ribociclib + endocrine therapy vs physician’s choice combination chemotherapy Abstract #GS1-10 Oral Presentation Tuesday, December 6 5:15 PM ET Kisqali® (ribociclib)* Pooled analysis of post-progression treatments after first-line ribociclib + endocrine therapy in patients with HR+/HER2- advanced breast cancer in the MONALEESA-2, -3, and -7 studies Abstract #P4-01-42 Poster Presentation Thursday, December 8 8:00 AM ET Kisqali® (ribociclib)* Pooled gene expression analysis and association with treatment response in patients with HR+/HER2− advanced breast cancer in the MONALEESA-2, -3, and -7 trials Abstract #PD17-08 Poster Discussion Friday, December 9 8:00 AM ET Piqray® (alpelisib) Long-term and very-long-term disease control in patients from BYLieve study cohort A with PIK3CA-Mutant, hormone receptor-positive, human epidermal growth factor receptor 2-negative, advanced breast cancer Abstract #PD13-06 Poster Discussion Thursday, December 8 6:00 PM ET Piqray® (alpelisib) Metformin (MET) for the prevention of alpelisib (ALP)-related hyperglycemia (HG) in PIK3CA-mutated, hormone receptor-positive (HR[+]) HER2-negative (HER2[-]) advanced breast cancer (ABC): The METALLICA study† Abstract #PD8-02 Poster Discussion Wednesday, December 7 6:00 PM ET Key highlights of data accepted by ASH: Medicine Abstract Title Abstract Number/ Presentation Details Iptacopan (LNP023) Oral monotherapy with iptacopan, a proximal complement inhibitor of factor B, has superior efficacy to intravenous terminal complement inhibition with standard of care Eculizumab or Ravulizumab and favorable safety in patients with paroxysmal nocturnal hemoglobinuria and residual anemia: Results from the randomized, active-comparator-controlled, open-label, multicenter, Phase III APPLY-PNH study Abstract #LBA-2 Oral Presentation Tuesday, December 13 9:15 AM ET Iptacopan (LNP023) Dose–exposure–response relationships of biomarkers and efficacy measures with iptacopan, a complement factor B inhibitor, in patients (pts) with paroxysmal nocturnal hemoglobinuria (PNH) with or without concomitant anti-C5 therapy Abstract #2571 Poster Presentation Sunday, December 11 6:00 – 8:00 PM ET Scemblix® (asciminib) Efficacy and safety results from ASC4MORE, a randomized study of asciminib (ASC) add-on to imatinib (IMA), continued IMA, or switch to nilotinib (NIL) in patients (pts) with chronic-phase chronic myeloid leukemia (CML-CP) not achieving deep molecular responses (DMRs) with ≥1 year of IMA Abstract #80 Oral Presentation Saturday, December 10 9:45 AM ET Scemblix® (asciminib) Dynamics of response and response factors in patients (pts) with chronic myeloid leukemia in chronic phase (CML-CP) after ≥2 prior tyrosine kinase inhibitors (TKIs) in the phase 3 ascembl study Abstract #3008 Poster Presentation Sunday, December 11 6:00 PM - 8:00 PM ET Scemblix® (asciminib) ASC4FIRST: A Phase III study of asciminib vs investigator-selected tyrosine kinase inhibitor in patients with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP) Abstract #3012 Poster Presentation Sunday, December 11 6:00 PM - 8:00 PM ET Scemblix® (asciminib) ASC4START: A Phase IIIb, open-label, randomized study of tolerability and efficacy of asciminib versus nilotinib in patients with newly diagnosed Philadelphia chromosome-positive chronic myelogenous leukemia in chronic phase Abstract #3021 Poster Presentation Sunday, December 11 6:00 PM – 8:00 PM ET Kymriah®  (tisagenlecleucel) Long-term clinical outcomes and correlative efficacy analyses in patients (pts) with relapsed/refractory follicular lymphoma (r/r FL) treated with tisagenlecleucel in the ELARA trial Abstract #608 Oral Presentation Sunday, December 11 4:45 PM ET Kymriah®  (tisagenlecleucel) Real-world outcomes for patients with relapsed or refractory (r/r) aggressive B-cell non-Hodgkin's lymphoma (aBNHL) treated with commercial tisagenlecleucel: subgroup analyses from the Center for International Blood and Marrow Transplant Research (CIBMTR) Registry Abstract #656 Oral Presentation Sunday, December 11 4:45 PM ET YTB323 (rapcabtagene autoleucel) YTB323 (rapcabtagene autoleucel) demonstrates durable efficacy and a manageable safety profile in patients with relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL): Phase I study update Abstract #439 Oral Presentation Sunday, December 11 9:30 AM ET Jakavi® (ruxolitinib) Ruxolitinib in pediatric patients with treatment-naive or steroid refractory acute graft versus host disease: Primary findings from the Phase I/II REACH4 study Abstract #572 Oral Presentation Sunday, December 11 12:15 PM ET Sabatolimab (MBG453) Primary results of STIMULUS-MDS1: A randomized, double-blind, placebo-controlled Phase II study of TIM-3 inhibition with sabatolimab added to hypomethylating agents (hmas) in adult patients with higher-risk myelodysplastic syndromes (MDS) Abstract #853 Oral Presentation Monday, December 12 2:45 PM ET Sabatolimab (MBG453) Disease characteristics and International Prognostic Scoring Systems (IPSS, IPSS-R, IPSS-M) in adult patients with higher-risk myelodysplastic syndromes (MDS) participating in two randomized, double-blind, placebo-controlled studies with intravenous sabatolimab added to hypomethylating agents (HMA) (STIMULUS-MDS1 and MDS2) Abstract #559 Oral Presentation Sunday, December 11 12:00 PM ET Product Information Approved indications for products vary by country and not all indications are available in every country. 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- 82% ORR (9 of 11 patients) and 82% (9 of 11 patients) CR rate documented after anbal-cel treatment to the patients in relapsed/refractory large B-cell lymphoma - 2 out of 3 patients dosed with 2x105 cells/kg of anbal-cel lasting the complete response for more than 12 months - Well tolerated up to 2X106 cells/kg dose level without DLT and not reached to MTD in Phase 1 dose escalation study DAEJEON, South Korea, June 13, 2022 /PRNewswire/ -- Curocell, Inc., a leading CAR-T company based in South Korea, announced the phase 1 dose-escalation study results documenting an 82% complete remission (CR) rate after a single dose of anbalcabtagene autoleucel (anbal-cel) to relapsed/refractory large B-cell lymphoma patients. Three (3) among 4 patients dosed at 2x105 cells/kg of anbal-cel documented complete remission, and 2 responding patients are maintaining the complete remission for more than a year. Strikingly, all patients dosed with 2x106 cells/kg reported complete remission after a single dose of anbal-cel. The complete phase 1 study results were presented at EHA at EHA (European Hematology Association) congress, Vienna, Austria, Jun 09-17, 2022. The anbal-cel is the CD19 CAR-T integrated with the OVISTM (Overcome Immune Suppression) platform. OVISTM technology consists of a dual knockdown system for two crucial immune checkpoint receptors, PD-1 and TIGIT, in CAR-T cells. "Although CD19 directed CAR-T therapy changed the treatment paradigm for Large B-cell lymphoma, which is one of the most aggressive hematologic malignant cancer, more than 50% of LBCL patients didn't experience the clinical benefit of CD19 CAR-T treatment, and there are still huge unmet medical needs. Anbal-cel's phase 1 study result demonstrates the OVISTM platform's potential to maximize CAR-T's functionality to eradicate tumors. We are very excited about this promising clinical result even though the patient number treated with anbal-cel is limited with a total of 11 and looking forward to the ongoing phase 2 clinical trial to confirm the efficacy and safety of anbal-cel. Furthermore, we believe these data represent the excellence of our next-generation CAR-T technology." said Gunsoo Kim, Curocell's chief executive officer. This phase 1 study was to evaluate the safety and preliminary efficacy in patients with r/rLBCL. Patient was infused as a single intravenous dose with 2x105 cells/kg (Dose Level 1), 7x105 cells/kg (DL2) or 2x106 cells/kg (DL3). Lymphodepletion with cyclophosphamide (500mg/m2) and fludarabine (30mg/m2) was performed for 3 days prior to anbal-cel infusion. Eleven (11) patients with r/r DLBCL were infused with anbal-cel. All patients received two or more prior lines of therapy, and 36% (4/11) received ≥4 prior lines of treatment before the study. No patient experienced DLT during the study. Of the 11 patients, 5 (46%) patients experienced CRS; 3 (27%) were grade 1 or 2 and 2 (18%) experienced grade 3 CRS. The median time to onset of CRS was 7 days (range, 1-16) with a median duration of 5 days (range, 1-19). One patient dosed with 2x106 cells/kg experienced grade 2 ICANS; the time to onset of ICANS was 7 days and lasted for 13 days. This patient had prior CNS involvement history before the study. The frequently reported grade 3/4 treatment related AEs were anemia (2/11, 18%), neutropenia (2/11, 18%), thrombocytopenia (2/11, 18%), CRS (2/11, 18%). Dose-dependent CRC01 expansion was observed; median Tmax was 15.4, 15.8 and 14.5 days at DL1, DL2 & DL3 each; Cmax, AUC0-28 day was dose proportionally increased. Based on promising safety and efficacy data from Phase 1 study, Phase 2 trial has been commenced, and patient enrollment is ongoing. Details of the oral presentation at EHA are as follows: Submission ID: EHA-3438 Title: PHASE 1/2 STUDY OF ANBAL-CEL, NOVEL ANTI-CD19 CAR-T THERAPY WITH DUAL SILENCING OF PD-1 AND TIGIT IN RELAPSED OR REFRACTORY LARGE B CELL LYMPHOMA Session Title: Aggressive Lymphoma - CART Session date and time: Saturday, June 11 11:30 - 12:45 Session room: Hall A7 Final Abstract Code: S214 About anbalcabtagene autoleucel (anbal-cel) Anbal-cel, recognized CD19 and is based on OVISTM, a first-in-class CAR-T platform. OVISTM technology downregulates PD1 and TIGIT expression in CAR-T cells. Through overcoming the immune suppression by PD-L1 and TIGIT ligands, OVISTM CAR-T has superior cytotoxicity to tumor cells in the tumor microenvironment. The Phase 2 clinical trial of anbal-cel has initiated in South Korea in the first half of 2022. About Curocell, Inc. Curocell, based in Daejeon, South Korea, is clinical-stage biotech innovating CAR-T therapies. Curocell is developing OVISTM technology intending to improve the clinical efficacy of CAR-T therapies. For more information, visit . SOURCE Curocell, Inc.