P-BCMA-ALL01

Additional new profiling of patient responses from the optimized lymphodepletion arm (Arm C) show consistent P-BCMA-ALLO1 cellular expansion and persistence across subgroups New preclinical data supports P-CD19CD20-ALLO1's strong anti-cancer profile and the ongoing Phase 1 clinical trial Case study demonstrates reactivation of an autologous Poseida CAR-T therapy with a T-cell engager in patient with relapsed multiple myeloma, highlighting potential of TSCM-based CAR-T therapies to deliver a strong anti-myeloma response with long-term remission and CAR-T cell persistence SAN DIEGO, Dec. 9, 2024 /PRNewswire/ -- Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage allogeneic cell therapy and genetic medicines company advancing differentiated non-viral treatments for patients with cancer, autoimmune and rare diseases, today will highlight interim clinical data from its Phase 1 trial of P-BCMA-ALLO1 in patients with relapsed/refractory multiple myeloma (RRMM), including new profiling of patient responses from Arm C, an optimized lymphodepletion arm. The P-BCMA-ALLO1 data are being presented, along with two additional Company poster presentations covering new preclinical data for P-CD19CD20-ALLO1 and a patient case study demonstrating the reactivation of a Poseida autologous CAR-T therapy with a T-cell engager, at the 66th ASH Annual Meeting and Exposition being held in San Diego on December 7-10, 2024. P-BCMA-ALLO1 is an investigational non-viral, stem cell memory T cell (TSCM)-rich allogeneic CAR-T cell therapy in Phase 1/1b clinical development for the treatment of patients with RRMM. P-CD19CD20-ALLO1 is an investigational, non-viral TSCM-rich allogeneic CAR-T cell therapy in Phase 1 clinical development for the treatment of patients with B-cell malignancies and is the Company's first dual CAR-T program. P-BCMA-ALLO1 and P-CD19CD20-ALLO1 are being developed in collaboration with Roche. "We continue to gain confidence in the potential for P-BCMA-ALLO1 in multiple myeloma, including from the additional sub-analysis of the Phase 1 data presented at ASH," said Kristin Yarema, Ph.D., President and Chief Executive Officer of Poseida Therapeutics. "We believe the data to-date provide strong validation for our allogeneic cell therapy platform, laying the groundwork for us to extend our non-viral, TSCM-rich approach and drive value with additional clinical programs. This includes P-CD19CD20-ALLO1, our first dual CAR-T supported by preclinical data presented at ASH, and with clinical data anticipated in 2025." P-BCMA-ALLO1 Phase 1 Data The poster presentation will highlight Phase 1 clinical data first presented at the 21st International Myeloma Society (IMS) Annual Meeting in September 2024. The data showed a 91% overall response rate (ORR) in Arm C (an optimized lymphodepletion arm), including a 100% ORR in B-cell maturation antigen (BCMA)-naïve patients, and an 86% ORR in those who had received at least one prior BCMA- and/or G protein-coupled receptor class C group 5 member D (GPRC5D)-targeting treatment modality, along with differentiated safety results with no dose-limiting toxicities, low rates of cytokine release syndrome (CRS) and immune effector cell neurotoxicity syndrome (ICANS), all Grade 2 or less, and no graft vs. host disease or Parkinsonism. No patients required anti-myeloma bridging therapy or prophylaxis with steroids or tocilizumab, and there was no invasive apheresis; an average manufacturing wait time, from treatment decision to clinical response, was only 3.5 weeks1 (with a median time to response of 16 days post initial P-BCMA-ALLO1 therapy). The patients in this study had more advanced disease than the myeloma patients studied in clinical trials of approved autologous CAR-T therapies2, and in the intent-to-treat population, 100% of patients were infused with P-BCMA-ALLO1. New profiling of patient responses from Arm C are included in the ASH poster presentation. The data from this analysis show consistent P-BCMA-ALLO1 cellular expansion and persistence across different subgroups, including patients that are typically more challenging to treat. Key highlights suggest that P-BCMA-ALLO1: Cellular kinetics were not impacted by prior BCMA/GPRC5D-targeted therapy Expands and persists in patients with extramedullary disease (EMD) P-CD19CD20-ALLO1 Preclinical Data Preclinical data has demonstrated that P-CD19CD20-ALLO1 delivers high in vitro potency and strong in vivo antitumor activity for either CD19 or CD20 single-positive target cells, as well as double-positive targets. New preclinical data included in the poster presentation show that compared to CD19-single targeting or CD20-single targeting CAR-T cells, P-CD19CD20-ALLO1: Achieved higher and more durable killing of tumor cells over three rechallenges, even in the presence of only one tumor antigen Exhibited higher cytotoxicity Produced higher and more sustained levels of effector cytokines (IL-2, IFN-γ, sFasL, Granzyme A and Granulysin) that play an important role mediating the immune system response to cancers Showed higher in vivo antitumor efficacy than the CD19-single targeting CAR-T cells The Company's P-CD19CD20-ALLO1 Phase 1 clinical trial is enrolling patients with selected B-cell malignancies, with initial clinical data anticipated in 2025. CAR-T Reactivation with T-cell Engager Case Study The case study highlights the reactivation of an autologous Poseida CAR-T therapy with a T-cell engager in a patient with relapsed multiple myeloma. The patient attained and remained in stringent complete response over 12 months after CAR-T reactivation. This case highlights the potential of Poseida's TSCM-based CAR-T therapies to deliver a strong anti-myeloma response with long-term remission and CAR-T cell persistence. The Company believes this is the first time that a T-cell engager has been seen to reactivate a CAR-T therapy. ASH 2024 Poster Presentations Title: Late Polyclonal P-BCMA-101 CAR-T Cell Re-expansion and Rapid Complete Response in a Patient with Relapsed Multiple Myeloma Treated with One Cycle of Talquetamab, More Than 3 Years After CAR-T Infusion Presenting Author: Anupama Kumar, M.D., Assistant Professor, Hematology, Blood & Marrow Transplant, and Cellular Therapy (HBC) Program, University of California, San Francisco (UCSF) Session: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster I Presentation Date/Time: Saturday, December 7, 2024, 5:30-7:30 p.m. PT (8:30-10:30 p.m. ET) Room: Halls G-H, San Diego Convention Center Abstract Number: 2083 Title: P-CD19CD20-ALLO1: Potent Fully Allogeneic CAR-T Therapy Targeting CD19 and CD20 with Superior Efficacy Over Single-Target Products Presenting Author: Samy Jambon, Ph.D., Poseida Therapeutics Session: 702. CAR-T Cell Therapies: Basic and Translational: Poster III Presentation Date/Time: Monday, December 9, 2024, 6:00-8:00 p.m. PT (9:00-11:00 p.m. ET) Room: Halls G-H, San Diego Convention Center Abstract Number: 4805 Title: A Phase 1 Study of P-BCMA-ALLO1, a Non-viral, Allogeneic BCMA Directed CAR-T in Relapsed/Refractory Multiple Myeloma (RRMM): Results from Optimized Lymphodepletion Cohort Presenting Author: Caitlin Costello, M.D., Professor of Medicine, Director of Multiple Myeloma Program, Division of Blood and Marrow Transplant, Moores Cancer Center, University of California, San Diego (UCSD) Session: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster III Presentation Date/Time: Monday, December 9, 2024, 6:00-8:00 p.m. PT (9:00-11:00 p.m. ET) Room: Halls G-H, San Diego Convention Center Abstract Number: 4828 About P-BCMA-ALLO1 P-BCMA-ALLO1 is an allogeneic CAR-T product candidate licensed to Roche targeting B-cell maturation antigen (BCMA) for the treatment of relapsed/refractory multiple myeloma. This allogeneic program includes a VH-based binder that targets BCMA, and interim clinical data presented at IMS in September 2024 support the Company's belief that T stem cell (TSCM)-rich allogeneic CAR-Ts have the potential to offer effective, safe and reliable treatment addressing unmet needs in multiple myeloma. The FDA has granted P-BCMA-ALLO1 Orphan Drug designation for multiple myeloma and Regenerative Medicine Advanced Therapy (RMAT) designation for adult patients with relapsed/refractory multiple myeloma after three or more prior lines of therapies including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody. P-BCMA-ALLO1 is currently being evaluated in a Phase 1/1b trial in patients with multiple myeloma. Additional information about the trial is available at using identifier: NCT04960579. About P-CD19CD20-ALLO1 P-CD19CD20-ALLO1 is an allogeneic CAR-T cell therapy product candidate being developed for relapsed or refractory B-cell malignancies in partnership with Roche. P-CD19CD20-ALLO1 expresses two fully functional CAR molecules to target cells that express either CD19 or CD20. The dual targeting approach employed in P-CD19CD20-ALLO1 aims to overcome the antigen escape limitations of CD19-only targeted CAR-T therapies by simultaneously targeting both CD19 and CD20. In addition to the dual targeting, P-CD19CD20-ALLO1 uses a novel CD19 binder that showed greater potency in in vivo preclinical models when compared to the canonical FMC63 Single-chain variable fragment (scFv) binder. P-CD19CD20-ALLO1 is an off-the-shelf CAR-T therapy for which patients do not have to undergo apheresis and wait for cells to be manufactured, which can potentially overcome the limitation of autologous CAR-T therapies associated with significant manufacturing times. P-CD19CD20-ALLO1 is being studied in a Phase 1 study in B-cell malignancies ( using identifier: NCT06014762). Building on the transformative potential of the CAR-T modality beyond oncology, the Company has recently submitted investigational new drug (IND) applications to the U.S. Food and Drug Administration (FDA) to investigate this program's potential for patients with multiple sclerosis and systemic lupus erythematosus. About Poseida Therapeutics, Inc. Poseida Therapeutics is a clinical-stage biopharmaceutical company advancing differentiated allogeneic cell therapies and genetic medicines with the capacity to cure. The Company's pipeline includes investigational allogeneic CAR-T cell therapies for hematologic cancers, autoimmune diseases, and solid tumors, as well as investigational in vivo genetic medicines that address patient populations with high unmet medical need. The Company's approach is based on its proprietary genetic editing platforms, including its non-viral transposon-based DNA delivery system, Cas-CLOVER™ Site-Specific Gene Editing System, Booster Molecule and nanoparticle gene delivery technologies, as well as in-house GMP cell therapy manufacturing. The Company has formed strategic collaborations with Roche and Astellas to unlock the promise of cell therapies for cancer patients. Learn more at and connect with Poseida on X and LinkedIn. Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, expected plans with respect to clinical trials, including timing of clinical data updates; anticipated timelines and milestones with respect to the Company's development programs and manufacturing activities and capabilities; the potential capabilities and benefits of the Company's technology platforms and product candidates, including the efficacy and safety profile of such product candidates; the quote from Dr. Yarema; and the Company's plans and strategy with respect to developing its technologies and product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon the Company's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the fact that interim data from the Company's clinical trials may change as more patient data become available and remain subject to audit and verification procedures that could result in material differences from the final data; the Company's reliance on third parties for various aspects of its business; risks and uncertainties associated with development and regulatory approval of novel product candidates in the biopharmaceutical industry; the Company's ability to retain key scientific or management personnel; the Company's ongoing and planned clinical trials; risks and uncertainties associated with conducting clinical trials; competition in the Company's target markets; whether any of the Company's product candidates will be shown to be effective, safe or reliable; the Company's ability to finance continued operations; the fact that the Company will have limited control over the efforts and resources that Roche devotes to advancing development programs under the collaboration agreement with Roche; the fact that the Company may not receive the potential fees, reimbursements and payments under its collaboration agreement with Roche; the ability of Roche to early terminate the collaboration, such that the Company may not fully realize the benefits of the collaboration; and the other risks and uncertainties described in the Company's filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. ### SOURCE Poseida Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

1200字17图，阅读大约需要4分钟。 数据新进展：暂无 数据新挫折：处于商业化阶段贝伐珠单抗眼科制剂ONS-5010用于治疗wAMD（湿性老年性黄斑变性），第二项3期NORSE EIGHT试验未能达到非劣终点；处于2期阶段TREM2单抗AL002用于治疗早期阿尔茨海默病（AD），INVOKE-2试验未达主要终点CDR-SB，终止长期研究，裁员17%；处于NDA阶段CNS ARI Govorestat/AT-007用于治疗经典半乳糖血症，收到FDA发出CRL，临床应用存在缺陷；处于3期阶段FLNA激活剂Simufilam用于治疗轻中度阿尔兹海默病，ReThink-ALZ研究未达主要终点，52周ADAS-COCG12和ADCS-ADL     20241125-20241129 美股龙虎榜 20241125-20241129 美股蛇猫榜 1 Poseida Therapeutics/PSTX 2024年11月26日，Poseida公司宣布处于1期阶段同种异体BCMA CAR-T细胞疗法P-BCMA-ALLO1用于治疗多发性骨髓瘤MM，被罗氏以15亿美元收购。   关于这家公司想多说4点。 第一点，从2022年与罗氏达成最高达60亿美元的合作至今，Poseida公司累计从罗氏确认收到的收入合计约为2.9美元，而且合作项目一旦过了1期之后，将由罗氏承担所有开发费用，所以看到最新P-BCMA-ALLO1的数据后，具备一定的成药可能性，罗氏为了免去支付潜在不到60亿美元的里程费付款，干脆溢价2倍多以15亿美元收购了。 第二点，前阵子科济药业也披露了早期几例同种异体BCMA CAR-T的数据，大家可以留意下这两者的差别，比如给药剂量、CAR copies数、既往有无经过BCMA双抗或细胞疗法的治疗等。 第三点，同种异体CAR-T的再次兴起，与清淋技术的优化有着莫大关系。 第四点，最新的及过去几年收集（绝版）的Poseida公司合计几十份PPT已上传知识星球。 下面摆上9月份IMS的最新数据。     2 Arrowhead Pharmaceuticals/ARWR 2024年11月26日，Arrowhead公司宣布处于1/2期阶段化学修饰的RNAi ARO-DUX4用于治疗FSHD1（1型面肩肱型肌营养不良症），与Sarepta达成潜在100亿美元的交易。 Arrowhead将立即获得8.25亿美元，包括5亿美元预付款和3.25亿美元（溢价35%）的股权投资，并将在5年内获得额外的2.5亿美元（每年5000万美元），有可能在近期获得额外的3亿美元临床试验入组相关里程碑付款，未来里程碑付款高达100亿美元。 具体每个项目的开发里程碑付款在1.1-4.1亿美元，销售里程碑付款在5-7亿美元。 临床项目包括ARO-DUX4用于治疗FSHD1、ARO-DM1用于治疗DM1、ARO-MMP7用于治疗IPF（特发性肺纤维化）、ARO-ATXN2用于治疗SCA2（脊髓小脑共济失调2型），临床前项目包括ARO-HTT用于治疗亨廷顿氏病、ARO-ATXN1用于治疗SCA1、ARO-ATXN3用于治疗SCA3，以及5年内提名最多6个新的CNS或肌肉靶点项目。 3 Century Therapeutics/IPSC 2024年11月27日，Century公司的核心品种处于1期阶段iPSC CD19同种异体iNK细胞CNTY-101用于治疗自免疾病，获Casdin Capital增持。 4 Outlook Therapeutics/OTLK 2024年11月27日，Outlook公司宣布处于商业化阶段贝伐珠单抗眼科制剂ONS-5010用于治疗wAMD（湿性老年性黄斑变性），第二项3期NORSE EIGHT试验未能达到非劣终点，第二天反弹20%。 预设95%CI下限为-3.5，-4.044已超出预设的下限。 5 Alector/ALEC 2024年11月25日，Alector公司宣布处于2期阶段TREM2单抗AL002用于治疗早期阿尔茨海默病（AD），INVOKE-2试验未达主要终点CDR-SB，终止长期研究，裁员17%。 6 Applied Therapeutics/APLT 2024年11月27日，Applied公司宣布处于NDA阶段CNS ARI Govorestat/AT-007用于治疗经典半乳糖血症，收到FDA发出CRL，临床应用存在缺陷。 7 Cassava Sciences/SAVA 2024年11月25日，Cassava公司宣布处于3期阶段FLNA激活剂Simufilam用于治疗轻中度阿尔兹海默病，ReThink-ALZ研究未达主要终点，52周ADAS-COCG12和ADCS-ADL。 同时停止第二项3期ReFocus-ALZ研究，也停止开放标签试验。 声明：以上内容仅供参考，不构成投资建议。 药渡媒体商务合作 媒体公关 | 新闻&会议发稿 张经理：18600036371（微信同号） 点击下方“药渡“，关注更多精彩内容 免责声明 “药渡”公众号所转载该篇文章来源于其他公众号平台，主要目的在于分享行业相关知识，传递当前最新资讯。图片、文章版权均属于原作者所有，如有侵权，请及时告知，我们会在24小时内删除相关信息。 微信公众号的推送规则又双叒叕改啦，如果您不点个“在看”或者没设为"星标"，我们可能就消散在茫茫文海之中~点这里，千万不要错过药渡的最新消息哦！👇👇👇