B-cell lymphoma recurrent

C-CAR039 study at median follow up of 30.0 months demonstrated a 91.5% overall response rate and an 85.1% complete response rate among evaluable patients with r/r NHL C-CAR066 study at median follow up of 27.7 months demonstrated a 92.9% overall response rate and a 57.1% complete response rate among evaluable patients with LBCL who failed prior CD19 CAR-T therapy ROCKVILLE, Md., Dec. 12, 2023 /PRNewswire/ -- AbelZeta Pharma, Inc. ("AbelZeta" or the "Company"), a global clinical-stage biopharmaceutical company focused on discovery and development of innovative and proprietary cell-based therapeutic products, presented clinical data for both C-CAR039 for the treatment of patients with relapsed or refractory (r/r) B-cell non-Hodgkin lymphoma (B-NHL), and C-CAR066, for the treatment of patients with r/r large B-cell lymphoma (LBCL) who failed prior CD19 CAR-T therapy at the 65th American Society of Hematology (ASH) Annual Meeting. Continue Reading "We are thrilled to share the long-term follow-up results from our clinical studies of C-CAR039 and C-CAR066 at the Annual Meeting of ASH, said Tony (Bizuo) Liu, Chairman and CEO of the Company. "The positive outcomes underscore the potential of these novel therapies in advancing the treatment landscape for patients with r/r B-NHL. The observed response rates, durability, and manageable safety profile demonstrated in both studies reinforce our commitment to pioneering innovative and effective solutions in immuno-oncology for patients suffering from serious hematological malignancies." "The positive outcomes underscore the potential of these novel therapies in advancing treatment for patients with B-NHL" Post this "We are proud of our collaboration and license agreement with Janssen to facilitate the global development and accessibility of C-CAR039 and C-CAR066. This strategic partnership aligns with our mission to bring innovative and life-changing therapies to patients worldwide." In May 2023, AbelZeta Pharma (formerly CBMG) entered into a global collaboration and license agreement with Janssen Biotech, Inc. (Janssen), a Johnson & Johnson company, for C-CAR039, an anti-CD19 & CD20 bi-specific CAR-T therapy, and C-CAR066, an anti-CD20 CAR-T. Study Conclusions At a longer median follow-up of 30.0 months, C-CAR039 demonstrated a favorable safety profile with deep and durable response in patients with r/r B-NHL, especially in LBCL patients. Longer term follow-up demonstrated that C-CAR066 can produce a deep and durable response with a favorable safety profile in patients with r/r LBCL who failed prior CD19 CAR-T therapy. About the C-CAR039 Study C-CAR039 has been developed as a novel 2nd generation 4-1BB bi-specific CAR-T targeting both CD19 and CD20 antigens with an optimized bi-specific antigen binding domain. C-CAR039 has consistently shown ability to eradicate CD19/CD20 single or double positive tumor cells in vitro and in vivo. GMP manufacturing of C-CAR039 was carried out in a serum free and fully closed semi-automatic system. In the Phase I clinical trials in China (NCT04317885, NCT04655677, NCT04696432, NCT04693676), dose escalation and expansion studies were conducted to evaluate the safety and efficacy of C-CAR039 in r/r B-NHL patients. C-CAR039 was administered as a single intravenous dose after a 3-day cyclophosphamide (300mg/m2x3d) plus fludarabine (30mg/m2x3d) conditioning regimen. Key Results of C-CAR039 Between November 5, 2019, and January 11, 2022, 48 patients received C-CAR039 at the dose ranges of 1.0 x 106 to 5.0x106 CAR-T cells/kg. Of the 48 patients, 44 (91.7%) patients had large B-cell lymphoma (LBCL) (DLBCL, n=37; PMBCL, n=3; tFL, n=4), 3 patients had FL and 1 patient had MCL. The median age was 55 (range, 25-71) years, and 11 (22.9%) patients were ≥ 65 years. Thirty-six (75%) patients were in Ann Arbor Stage III/IV with 3 median prior lines of therapy, 32 (66.7%) patients were refractory to their last treatment, and 22 (45.8%) patients never achieved CR to their prior therapies. As of September 25, 2023, 45 patients (93.8%) experienced CRS, only 1 (2.1%) were grade 3. Three patients had grade 1 or 2 ICANS at a dose of 5.0x106 CAR-T cells/kg. Grade 3 or higher cytopenia not resolved by Day 30 following C-CAR039 infusion included neutropenia (54.2%), thrombocytopenia (20.8%), and anemia (20.8%). At cutoff date, 66.7% patients had infections with 25% grade 3 or higher. Second primary malignancy after C-CAR039 infusion was observed in 3 patients and none were related to C-CAR039. Fifteen deaths occurred, 11 due to disease progression. Of the 48 patients, 47 patients were evaluable for efficacy. The median follow-up time was 30.0 months. The ORR and CR rate among evaluable patients were 91.5% and 85.1% respectively. Of the 43 LBCL patients, the ORR was 90.7%, with 86.0% CR. Median duration of response (DOR) was not reached. 23/47 (48.9%) patients remain in CR, 10 of them for more than 36 months. Median PFS has not been reached. KM estimates of 24-m PFS rate were 62.6% (all patients) and 64.1% (LBCL). Median OS has not been reached. KM estimates of 24-m OS rate were 76.5% (all patients) and 79.0% (LBCL). The complete text of the abstract can be found About the C-CAR066 Study C-CAR066 is a novel second generation CAR-T therapy targeting the CD20 antigen. Preclinical studies suggest that C-CAR066 has superior anti-tumor activity compared to anti-CD20 CAR-Ts derived from scFVs of Leu16, Rituximab and Obinutuzumab, and to anti-CD19 CAR-Ts derived from scFV FMC63. The Phase I clinical trials (NCT04036019, NCT04316624) were conducted in Shanghai Tongji Hospital and Institute of Hematology & Blood Diseases Hospital in Tianjin, China, to evaluate the safety and efficacy of C-CAR066 in subjects with r/r B-NHL who were previously treated with and failed after an anti-CD19 CAR-T therapy. C-CAR066 was administered as a single intravenous dose after a 3-day cyclophosphamide (300mg/m2x3d) plus fludarabine (30mg/m2x3d) conditioning regimen. Key Results of C-CAR066 Between October 16, 2019, and August 17, 2021, a total of 14 patients received C-CAR066 at doses of 2.0x106 CAR-T cells/kg and 3.0x106 CAR-T cells/kg. Eleven patients (78.6%) were DLBCL, 3 patients (21.4%) were tFL. The median age was 54.5 years (range, 37-67). Twelve patients (85.7%) were in Ann Arbor Stage III/IV. The median number of prior lines of therapy was 5 (range, 2-7). All patients had prior CD19 CAR-T therapy. As of October 10, 2023, 12/14 patients (85.7%) experienced CRS, all were grade 1/2, except for 1 patient who experienced a grade 4 CRS. No patients experienced ICANS. Grade 3 or higher cytopenia not resolved by Day 30 following C-CAR066 infusion occurred in 28.6% patients and included neutropenia (21.4%), thrombocytopenia (14.3%), and anemia (14.3%). At cutoff date, 8 patients experienced infections, only 2 were grade 3. Seven deaths occurred and all due to disease progression. No SPM and new safety signals were observed with longer follow-up. The investigator assessed ORR was 92.9%, with 57.1% CR. With the median follow-up of 27.7 months, median PFS and DOR were 9.4 months and 8.3 months, respectively. Four patients had remained in CR for more than 30 months. The Kaplan-Meier estimate of median OS was 34.8 months (11.4 - NA). The complete text of the abstract can be found About AbelZeta Pharma, Inc. AbelZeta is a global clinical-stage biopharmaceutical company with centers of excellence in Rockville, Maryland and Shanghai, China. AbelZeta is focusing on developing innovative and proprietary cell-based therapeutic products and is committed to ushering in bespoke treatments that harness the body's own immune system to fight against hematological malignancies and solid tumors, as well as inflammatory and immunological diseases. AbelZeta advances research and development in its own GMP facilities at its centers of excellence for early-stage clinical studies, with a pipeline comprised of CAR-T and TIL therapies. Forward-Looking Statements Statements in this communication relating to plans, strategies, specific activities, and other statements that are not descriptions of historical facts are forward-looking statements. Forward-looking information is inherently subject to risks and uncertainties, and actual results could differ materially from those currently anticipated due to a number of factors, which include any risks detailed from time to time in the Company's reports. Such statements are based on the management's current beliefs and expectations and are subject to significant risks and uncertainties outside of management and the Company's control. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as otherwise required by law, the Company does not undertake any obligation, and expressly disclaims any obligation, to update, alter or otherwise revise any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future events or otherwise. Company Contact: Sarah Kelly Director of Communications AbelZeta Pharma, Inc. Phone: +1 (240) 552 5870 Email: [email protected] SOURCE AbelZeta Pharma, Inc.

SHANGHAI, Dec. 12, 2023 /PRNewswire/ -- Dizal presented compelling data from its robust portfolio of hematological oncology at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition held in San Diego, California from December 9-12. The data showcased updated results of Dizal's two leading assets: golidocitinib, the first and only JAK1 selective inhibitor for the treatment of peripheral T-cell lymphoma (PTCL), and DZD8586, a first-in-class LYN and BTK dual inhibitor for the treatment of relapsed or refractory (r/r) B-cell non-Hodgkin lymphoma (B-NHL). This underscores Dizal's dedication to developing and delivering innovative, life-changing medicines in the field of hematological oncology. Golidocitinib The first and only JAK1 selective inhibitor for the treatment of PTCL Golidocitinib, a novel JAK1-only inhibitor developed by Dizal, is currently in the NDA stage for the treatment of r/r PTCL. The China National Medical Products Administration (NMPA) recognized its potential and granted it Priority Review in September 2023. Notably, golidocitinib stands as the world's first and only highly selective JAK1 inhibitor specifically developed for PTCL. Furthermore, it has obtained Fast Track Designation from the U.S. Food and Drug Administration (FDA), positioning it as the first Chinese innovative PTCL drug to receive this designation. The efficacy of golidocitinib in PTCL was highlighted at 2023 ASH, with two studies being selected for presentation. Particularly noteworthy is the multinational, pivotal study of golidocitinib for the treatment of r/r PTCL (JACKPOT8 PART B), which was selected for oral presentation and simultaneously published in the peer-reviewed journal The Lancet Oncology (Impact Factor: 54.4). The potential best-in-class treatment option for r/r PTCL There is no consensus on the standard treatment for r/r PTCL and the 5-year survival rate is below 30%. The results of JACKPOT8 PART B study revealed that golidocitinib demonstrated superior and durable clinical benefits in the treatment of r/r PTCL with a favorable safety profile that outperformed existing treatment options. Per independent review committee (IRC) assessment, golidocitinib achieved an overall response rate (ORR) of 44.3% and a complete response rate (CRR) of 23.9%. Both were more than double that of existing treatment options. Tumor responses were observed across various PTCL subtypes. The responses were durable, with the median duration of response (mDoR) of 20.7 months. This is higher than the DoR observed with existing therapies, which is typically below 12 months. The median progression-free survival (mPFS) was 5.6 months, and the median overall survival (mOS) was 19.4 months and still ongoing. Promising and durable efficacy in PTCL after first-line systemic therapy Approximately 40% of patients with complete response (CR) and 80% of patients with partial response (PR) have disease relapse within 2 years after initial tumor response. These patients currently lack a standard maintenance therapy. JACKPOT 26 is a phase 2, single-arm, multicenter study to evaluate the safety and efficacy of golidocitinib for maintenance treatment after first-line therapy. At the data cut-off date of October 12, 2023, in the cohort of patients achieving CR post first-line therapy, median disease-free survival (DFS) has not been reached, with 76.7% patients still event free. In the cohort of patients achieving PR post first-line therapy, median DoR has not been reached, with 33% of patients achieving a CR and 85.7% of patients still responding to the treatment. The median PFS was 16.7 months. The treatment-related adverse events (TRAEs) observed in this study were similar to those previously reported for golidocitinib and were clinically manageable and reversible. DZD8586 A first-in-class non-covalent LYN and BTK dual inhibitor with excellent blood-brain barrier (BBB) penetration DZD8586 is a rationally designed, oral, non-covalent, LYN/BTK dual inhibitor with excellent BBB penetration as a potential treatment option for B-NHL. While Bruton's Tyrosine Kinase (BTK) inhibitors have been approved for the treatment of B-NHL, resistance can emerge due to various mechanisms. This includes acquired mutations at residue C481X of BTK which disrupts covalent BTKi binding, as well as non BTK-driven mutations that seems more common in patients who have failed non-covalent BTKi such as pirtobrutinib. Currently, there is no targeted therapy available to address both resistance mechanisms, highlighting an urgent need for a safe and effective treatment option for patients with r/r B-NHL. Potential to overcome resistance to both covalent and non-covalent BTK inhibitors Preclinical studies have shown that DZD8586 can overcome resistance mutations observed with approved covalent and non-covalent BTK inhibitors. DZD8586 has exhibited potent inhibition of cell growth by blocking both BTK-dependent and BTK-independent signaling pathways. No BTK inhibitor has been approved for treating diffuse large B-cell lymphoma (DLBCL). It is hypothesized that blockage of BTK pathway alone is not sufficient to bring meaningful clinical benefit in DLBCL. DZD8586 shows strong inhibition of LYN and BTK phosphorylation and achieves superior anti-tumor efficacy in DLBCL and chronic lymphocytic leukemia (CLL) models than selective BTK inhibitors. Due to limited BBB penetration of the current therapies, treatment of central nervous system lymphoma (CNSL) remains a clinical challenge. DZD8586 indicated CNS penetration with the potential to treat CNSL. A novel treatment option for r/r B-NHL DZD8586 is currently being evaluated in two phase 1/2 clinical trials for patients with r/r B-NHL worldwide. At 2023 ASH, the pooled analysis from the two studies were debuted. The results revealed that DZD8586 showed encouraging anti-tumor activity with manageable safety and favorable PK profile in heavily pre-treated B-NHL patients. Highlights of the study findings include: ORR of 64.7% across all dose levels, 71.4% at 50 mg Tumor response in different subtypes, including DLBCL (ORR 83.3%), CNSL, and CLL ORR of 50% in patients resistant to BTKi treatment "Our research findings presented at ASH demonstrate Dizal's distinctive competitiveness in the field of hematological oncology. We are fully committed to pushing the boundaries of innovation and developing transformative drugs to improve the lives of patients globally." said Xiaolin Zhang, PhD, Chairman and CEO of Dizal. - End - About golidocitinib (DZD4205) Golidocitinib is currently the first and only Janus kinase 1 (JAK1) selective inhibitor being evaluated for the treatment of r/r PTCL. At the data cut-off date of August 31, 2023, golidocitinib has demonstrated robust and durable anti-tumor efficacy, with an ORR of 44.3%. More than 50% of the patients with tumor remission achieved a complete response with a CRR of 23.9%. Per IRC assessment, mDoR reached 20.7 months. Golidocitinib was granted Fast Track Designation by the U.S. FDA for the treatment of r/r PTCL in February 2022. In September 2023, the CDE accepted its NDA and granted Priority Review for the treatment of r/r PTCL. The Phase I clinical data of golidocitinib (JACKPOT8 PART A) was published in Annals of Oncology (Impact Factor: 51.8), and global pivotal trial data of golidocitinib for the treatment of r/r PTCL (JACKPOT PART B) was published in The Lancet Oncology (Impact Factor: 54.4). About DZD8586 DZD8586 is an orally available, highly selective small molecule inhibitor to target both BTK-dependent and BTK-independent B-cell receptor (BCR) signaling pathways, with full blood-brain barrier penetration. Pre-clinical research revealed that DZD8586 demonstrated good safety profile and could effectively inhibit the growth of B-NHL cells. A healthy volunteer study of DZD8586 has been completed to investigate the clinical safety and PK/PD correlation. Additionally, a global phase I/II study is ongoing to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy of DZD8586 in patients with r/r B-NHL. Preliminary results from the clinical trial suggest that DZD8586 exhibits favorable PK properties, good safety profile, and preliminary anti-tumor efficacy in patients with B-NHL. About Dizal Dizal is a biopharmaceutical company, dedicated to the discovery, development and commercialization of differentiated therapeutics for the treatment of cancer and immunological diseases. The company aims to develop first-in-class and groundbreaking new medicines, and further address unmet medical needs around the world. Deep-rooted in translational science and molecular design, it has established an internationally competitive portfolio of five clinical-stage assets with two leading assets in global pivotal studies and one already launched. To learn more about Dizal, please visit , or follow us at Linkedin or Twitter. Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", and "intend" and similar expressions, as they relate to Dizal, are intended to identify certain forward-looking statements. Dizal does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections, and understandings of the management of Dizal with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties, and other factors, some of which are beyond Dizal's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Dizal's competitive environment, and political, economic, legal, and social conditions. Dizal, the Directors, and the employees of Dizal assume (a) no obligation to correct or update the forward-looking statements contained on this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turnout to be incorrect. Contacts Investor Relations: [email protected] Business Development: [email protected] SOURCE Dizal Pharmaceutical

AlloNK plus rituximab is intended to treat systemic lupus erythematosus in patients with active lupus nephritis. Credit: mi_viri / Shutterstock.com. The US Food and Drug Administration (FDA) has approved Artiva Biotherapeutics’ investigational new drug (IND) application for the combination of AlloNK (AB-101) and rituximab to treat systemic lupus erythematosus (SLE) in active lupus nephritis (LN) patients. Designed to improve antibody-dependent cellular cytotoxicity (ADCC), AlloNK is a non-genetically modified, allogeneic, cord blood-derived, cryopreserved NK cell therapy candidate. Recommended Reports Reports LOA and PTSR Model - (Cannabidiol + Dronabinol) in Sedation GlobalData Reports LOA and PTSR Model - Siremadlin Succinate in Well Differentiated Liposarcoma GlobalData View all Companies Intelligence Artiva Biotherapeutics Inc View all AlloNK is currently under assessment in two cancer trials, where it is being studied alongside antibody or NK-engager biologics. In May 2022 the company revealed preliminary results from the dose-escalation stage of its Phase I/II clinical trial involving AB-101. The trial, which focused on patients with relapsed/refractory B-cell non-Hodgkin’s lymphoma (B-NHL), showed AlloNK’s therapeutic potential and favourable safety profile when used in conjunction with rituximab. Artiva CEO Fred Aslan stated: “AlloNK given in combination with rituximab, an anti-CD20 antibody that targets B-cells, is already driving complete responses in late line B-NHL patients in an ongoing Phase I study by enhancing the activity of rituximab. “Our hypothesis is that AlloNK plus rituximab also has the potential to drive deep B-cell depletion in LN patients with an off-the-shelf therapy that could be administered and managed in an outpatient setting.” SLE is a severe autoimmune condition characterised by faulty B-cell activity and production of autoantibodies. Its clinical symptoms include end-organ damage and increased risk of death. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content. Free Whitepaper Cell and gene therapies: Pipe dream to pipeline The cell and gene industry is gaining momentum, with a new wave of therapies promising to transform the way doctors treat, and even cure, disease. In this report, Cytiva and GlobalData have collaborated to explore the rise of the cell and gene therapy industries, the current state of the market, present and future opportunities for advancement, and the challenges that lie ahead. By Cytiva Thematic By downloading this case study, you acknowledge that GlobalData may share your information with Cytiva Thematic and that your personal data will be used as described in their Privacy Policy