NVG-111

▎药明康德内容团队编辑本期看点1. 用于治疗复发性或难治性多发性骨髓瘤（MM）患者的CAR-T细胞疗法CART-ddBCMA的1期临床研究结果积极，所有受试者的总缓解率（ORR）达100%，估计的无进展生存期（PFS）为28个月。2. 在自体CAR-T细胞疗法MB-106针对复发或难治性惰性B细胞非霍奇金淋巴瘤（NHL）患者的1/2期临床试验中，滤泡性淋巴瘤（FL）和华氏巨球蛋白血症（WM）患者的ORR为100%，100%的FL患者（n=5）实现了完全缓解（CR）。3. 在自体CAR-T细胞疗法NXC-201用于治疗复发/难治性轻链（AL）淀粉样变性的1b/2a期临床试验中，患者的ORR为100%，CR率为70%。4. 在同种异体γ-δ T细胞疗法INB-100用于治疗接受异体造血干细胞移植的高危白血病患者的1期试验中，100%接受治疗的患者实现了持久的CR，包括高危和复发性急性髓系白血病（AML）患者以及既往多线治疗（包括CAR-T）失败的患者。5. 可在护理点制造的CAR-T细胞疗法GLPG5201和GLPG5101的1期临床试验结果积极，且从制备到回输到患者体内的中位时间仅需7天。药明康德内容团队整理CART-ddBCMA（anito-cel）：公布1期扩展试验数据 Arcellx公司公布了旗下细胞治疗产品CART-ddBCMA（现名为anitocabtagene autoleucel，anito-cel）的1期扩展研究的最新临床数据。Anito-cel是一款BCMA特异性CAR修饰T细胞疗法，旨在治疗复发性或难治性MM患者。此前，该疗法已被美国FDA授予快速通道资格、孤儿药资格和再生医学先进疗法认定。截至2023年10月15日的数据，中位随访时间为26.5个月，共有38名患者可进行疗效和安全性分析评估。根据国际骨髓瘤工作组（IMWG）标准，所有受试者的ORR达100%，并且带有预后不良因素的患者出现了深入而持久的缓解。中位PFS和OS尚未达到，Kaplan-Meier模型估计的PFS为28个月。▲根据Kaplan-Meier法估算的PFS率（图片来源：参考资料[6]）MB-106：公布1/2期临床试验数据Mustang Bio公司公布了其靶向CD20的自体CAR-T细胞疗法MB-106在针对复发或难治性惰性B细胞NHL患者的1/2期临床试验的数据。结果显示，MB-106在此类患者中的安全性良好，尽管未使用预防性药物，也没有发生1级以上的细胞因子释放综合征（CRS）和任何级别的免疫效应细胞相关神经毒性综合征（ICANS），且门诊给药是可行的。所有9名患者在接受MB-106治疗后均有缓解。FL和WM患者的ORR为100%。100%的FL患者（n=5）实现了CR。在WM患者中观察到1例非常好的部分缓解（PR）和2例PR。1名毛细胞白血病变异型患者此前一直严重依赖输血，治疗后病情持续稳定，不再需要输血。NXC-201（HBI0101）：公布1b/2a期临床试验的新数据Nexcella公司公布了其靶向BCMA的自体CAR-T细胞疗法NXC-201的1b/2a期临床试验的新数据。该研究旨在评估NXC-201用于治疗复发/难治性AL淀粉样变性的安全性和有效性。此前，NXC-201已被FDA授予孤儿药资格，用于治疗AL淀粉样变性和MM。截至2023年12月10日的数据，既往接受过大量治疗（中位治疗线数为6线）的患者的ORR为100%（10/10），CR率为70%（7/10）。患者的最佳缓解持续时间为23.7个月，并且缓解仍在持续。Nexcella公司计划在40名患者接受NXC-201治疗后，向FDA递交NXC-201的生物制品许可申请（BLA），用于治疗AL淀粉样变性。INB-100：公布1期临床试验的新数据 IN8bio公司公布了其同种异体γ-δ T细胞疗法INB-100在接受异体造血干细胞移植的高危白血病患者中的1期试验的新数据。结果显示，INB-100在这类患者中具有提供持久无复发治疗的潜力。截至2023年11月3日的数据，100%接受治疗的患者（n=10）实现了持久的CR，包括高危和复发性AML患者以及既往多线治疗（包括CAR-T）失败的患者。截至上次评估，所有受试者均存活，且没有复发，6名患者已经一年多没有复发。此外，在单次施用INB-100后365天，同种异体γ-δ T细胞依然保持着长期的体内扩增和持久性。该研究目前正在扩大患者招募，以进一步评估2期推荐剂量的疗效。GLPG5201、GLPG5101：公布1期临床试验数据Galapagos公司公布了其可在护理点制造的CAR-T细胞疗法GLPG5201和GLPG5101的1期临床试验结果。GLPG5201旨在治疗复发/难治性慢性淋巴细胞白血病（CLL）患者或小淋巴细胞淋巴瘤（SLL）患者，这些患者伴或不伴Richter转化（RT）。GLPG5101旨在治疗复发/难治性NHL患者。截至2023年9月6日的数据，接受GLPG5201治疗的14名疗效可评估的CLL患者的ORR为93%（13/14），CR率为57%（8/14）。9名RT患者的ORR为89%（8/9），CR率为67%（6/9）。接受较高剂量水平（DL2）的患者的ORR为100%（8/8），CR率为63%（6/8），6名RT患者的ORR为100%。在最初获得缓解后进展的3名患者中有2名已证实为CD19阴性疾病。截至2023年9月1日的数据，在研究的第一部分，接受GLPG5101治疗的14例可评估的NHL患者的ORR为86%（12/14），CR率为79%（11/14）。接受较高剂量水平（DL2）治疗的患者的ORR为86%（6/7），CR率也为86%。中位随访时间为8.6个月时，12名有缓解的患者中有8例（67%）保持持续缓解，持续时间长达15个月。在最初获得缓解后进展的4名患者中，有2例为CD19阳性复发，1例已证实为CD19阴性疾病。在研究的第二部分，7例可评估患者的ORR为86%（6/7），CR率为57%（4/7）。中位随访时间为3.2个月时，所有6名有缓解的患者均保持缓解。安全性方面，GLPG5201和GLPG5101均显示出令人鼓舞的安全性，大多数治疗伴发不良事件为1级或2级。此外，数据表明，这两种疗法从制备到回输到患者体内的中位时间仅需7天。P-BCMA-ALLO1：公布1期临床试验数据Poseida Therapeutics公司公布了其与罗氏（Roche）共同开发的在研BCMA靶向同种异体CAR-T疗法P-BCMA-ALLO1的1期临床试验的早期疗效和安全性积极结果，该疗法用于治疗复发/难治性MM患者。在该试验中，可评估患者（n=33）的随访时间至少4周，且皆接受了大量预治疗，中位既往治疗线数为7线。分析显示，在接受充分淋巴细胞耗竭的强化预治疗患者中，接受CAR-T疗法P-BCMA-ALLO1治疗患者的ORR为82%（9/11），并具有深度临床缓解。在既往未接受过BCMA靶向双特异性T细胞衔接抗体治疗的患者中，其ORR为100%。该疗法展现良好的安全性和可靠性特征，所有意向治疗（ITT）患者均未观察到移植物抗宿主病（GvHD）或剂量限制性毒性，且观察到的CRS和神经毒性发生率较低（均≤2级）。Revumenib：公布1/2期临床试验数据Syndax Pharmaceuticals公司公布了其选择性小分子menin抑制剂revumenib联合氟达拉滨及阿糖胞苷用于携带NPM1突变或KMT2A重排的复发/难治性AML患者的积极结果。截至2023年11月1日的数据，所有9名患者均获得了形态学缓解，ORR为100%，其中78%的患者获得了复合完全缓解（CRc），其中44%的患者获得CR或是完全缓解伴部分血液学恢复（CRh）。试验中67%（6/9）的患者达到最小残留病（MRD）阴性状态。5名患者在获得缓解后接受了造血干细胞移植。两名患者开始接受revumenib的移植后维持治疗，并已持续缓解超过11个月。该组合疗法在复发和难治性患者人群中的耐受性良好，没有观察到新的安全信号。Acimtamig（AFM13）：公布1/2期临床试验数据Affimed公司公布了其潜在“first-in-class"的先天细胞衔接蛋白（ICE）acimtamig与同种异体自然杀伤（NK）细胞联用治疗复发/难治性霍奇金淋巴瘤（HL）的1/2期临床试验的最新数据。此次公布的数据显示，在所有剂量水平中，治疗方案的ORR为93%，CR率为67%；在接受推荐的2期剂量（RP2D）治疗的32例HL患者中，治疗方案的ORR为97%，CR率为78%。在所有剂量水平，中位无事件生存期（EFS）为8.8个月，中位总生存期尚未达到。对于接受RP2D治疗的HL患者，中位EFS为9.8个月，84%的患者在12个月时存活。接受RP2D治疗的HL患者的中位缓解持续时间为8.8个月。此外，治疗方案显示了良好的安全性和耐受性特征，无任何级别的CRS、ICANS或GvHD。WU-CART-007：公布1/2期临床试验数据Wugen公司公布了其同种异体现货型CAR-T细胞疗法WU-CART-007用于治疗复发/难治性T细胞急性淋巴细胞白血病（T-ALL）或淋巴细胞淋巴瘤（LBL）的全球1/2期临床试验数据。WU-CART-007靶向CD7，并能够防止CAR-T细胞自相残杀，降低发生GvHD的风险。此次公布的结果显示，WU-CART-007表现出可控的安全性，未观察到GvHD。在剂量水平≥2的18例疗效可评估的患者中，CRc为67%，接受RP2D治疗的患者的CRc为73%。没有患者产生针对供体的新型抗HLA抗体，在接受检测的18名患者中，未检测到针对CAR的抗药抗体。大家都在看作为药明康德旗下专注于细胞和基因疗法的CTDMO，药明生基致力于加速和变革基因和细胞治疗及其他高端治疗的开发、测试、生产和商业化。药明生基能够助力全球客户将更多创新疗法早日推向市场，造福病患。如您有相关业务需求，欢迎点击下方图片填写具体信息。▲如您有任何业务需求，请长按扫描上方二维码，或点击文末“阅读原文/Read more”，即可访问业务对接平台，填写业务需求信息▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料（可上下滑动查看）[1] Molecular Partners Presents Positive Initial Data from First Four Dosing Cohorts of Ongoing Phase 1/2a Trial of MP0533 for Patients with Relapsed/Refractory AML and AML/MDS at ASH Annual Meeting. Retrieved December 11, 2023, from https://www.globenewswire.com/news-release/2023/12/10/2793463/0/en/Molecular-Partners-Presents-Positive-Initial-Data-from-First-Four-Dosing-Cohorts-of-Ongoing-Phase-1-2a-Trial-of-MP0533-for-Patients-with-Relapsed-Refractory-AML-and-AML-MDS-at-ASH-.html[2] Century Therapeutics Presents Initial Data from CNTY-101 Phase 1 ELiPSE-1 Trial Supporting the Potential for a Multi-Dosing Strategy for CAR iNK Enabled by Allo-Evasion™ Edits. Retrieved December 11, 2023, from https://www.globenewswire.com/news-release/2023/12/09/2793435/0/en/Century-Therapeutics-Presents-Initial-Data-from-CNTY-101-Phase-1-ELiPSE-1-Trial-Supporting-the-Potential-for-a-Multi-Dosing-Strategy-for-CAR-iNK-Enabled-by-Allo-Evasion-Edits.html[3] Corvus Pharmaceuticals Presents New Interim Soquelitinib Data from its Phase 1/1b T Cell Lymphoma Trial. Retrieved December 11, 2023, from https://www.globenewswire.com/news-release/2023/12/09/2793436/0/en/Corvus-Pharmaceuticals-Presents-New-Interim-Soquelitinib-Data-from-its-Phase-1-1b-T-Cell-Lymphoma-Trial.html[4] Kymera Therapeutics Presents Interim Results from STAT3 Degrader Phase 1 Clinical Trial at American Society of Hematology Annual Meeting. Retrieved December 11, 2023, from https://www.globenewswire.com/news-release/2023/12/11/2793490/0/en/Kymera-Therapeutics-Presents-Interim-Results-from-STAT3-Degrader-Phase-1-Clinical-Trial-at-American-Society-of-Hematology-Annual-Meeting.html[5] Innate Pharma Shares Efficacy and Safety Phase 1 /2 Results of NK Cell Engager SAR443579 / IPH6101 Developed by Sanofi at ASH 2023. Retrieved December 11, 2023, from https://www.businesswire.com/news/home/20231210199351/en[6] Arcellx Announces Continued Robust Long-Term Responses from Its CART-ddBCMA (anito-cel) Phase 1 Expansion Trial in Patients with Relapsed or Refractory Multiple Myeloma at ASH. Retrieved December 11, 2023, from https://www.prnewswire.com/news-releases/arcellx-announces-continued-robust-long-term-responses-from-its-cart-ddbcma-anito-cel-phase-1-expansion-trial-in-patients-with-relapsed-or-refractory-multiple-myeloma-at-ash-302010481.html[7] TILT Biotherapeutics Announces Positive Clinical Data in Checkpoint Resistant Metastatic Melanoma Phase I Trial at ESMO Immuno-Oncology 2023. Retrieved December 11, 2023, from https://www.globenewswire.com/news-release/2023/12/08/2793021/0/en/TILT-Biotherapeutics-Announces-Positive-Clinical-Data-in-Checkpoint-Resistant-Metastatic-Melanoma-Phase-I-Trial-at-ESMO-Immuno-Oncology-2023.html[8] TScan Therapeutics Presents Initial Phase 1 Clinical Results on TSC-100 and TSC-101 at the 65th American Society of Hematology Annual Meeting and Exposition. Retrieved December 11, 2023, from https://ir.tscan.com/news-releases/news-release-details/tscan-therapeutics-presents-initial-phase-1-clinical-results-tsc[9] Poseida Therapeutics Presents Positive Early Results from its Phase 1 Trial of Allogeneic CAR-T P-BCMA-ALLO1 in Relapsed-Refractory Multiple Myeloma at the 65th American Society of Hematology (ASH) Annual Meeting. Retrieved December 11, 2023, from https://www.prnewswire.com/news-releases/poseida-therapeutics-presents-positive-early-results-from-its-phase-1-trial-of-allogeneic-car-t-p-bcma-allo1-in-relapsed-refractory-multiple-myeloma-at-the-65th-american-society-of-hematology-ash-annual-meeting-302010725.html[10] Affimed Announces Updated Phase 1/2 Data from Acimtamig in Combination with Allogeneic NK in Hodgkin Lymphoma Patients Who Failed Prior Chemotherapy and Are Double-Refractory to Brentuximab Vedotin (BV) and Checkpoint Inhibitors (CPIs). Retrieved December 11, 2023, from https://www.globenewswire.com/news-release/2023/12/11/2793672/0/en/Affimed-Announces-Updated-Phase-1-2-Data-from-Acimtamig-in-Combination-with-Allogeneic-NK-in-Hodgkin-Lymphoma-Patients-Who-Failed-Prior-Chemotherapy-and-Are-Double-Refractory-to-Br.html[11] Electra Therapeutics presents first clinical data from ongoing Phase 1b study of ELA026 for treatment of secondary hemophagocytic lymphohistiocytosis (sHLH). Retrieved December 11, 2023, from https://www.businesswire.com/news/home/20231211552878/en[12] Syndax Announces Positive Data for Revumenib in Patients with Acute Leukemias from the BEAT AML, SAVE AML and AUGMENT-102 Phase 1 Combination Trials. Retrieved December 11, 2023, from https://www.prnewswire.com/news-releases/syndax-announces-positive-data-for-revumenib-in-patients-with-acute-leukemias-from-the-beat-aml-save-aml-and-augment-102-phase-1-combination-trials-302011153.html[13] Mustang Bio Presents Updated Phase 1/2 Multicenter Clinical Data for MB-106 at the 2023 American Society of Hematology (ASH) Annual Meeting. Retrieved December 11, 2023, from https://www.globenewswire.com/news-release/2023/12/11/2793874/0/en/Mustang-Bio-Presents-Updated-Phase-1-2-Multicenter-Clinical-Data-for-MB-106-at-the-2023-American-Society-of-Hematology-ASH-Annual-Meeting.html[14] Initial Phase 1 Dose Escalation Data for ORIC-533 in Relapsed/Refractory Multiple Myeloma Demonstrates Clinical Activity and Strong Safety Profile Supporting Potential for Combination Development. Retrieved December 12, 2023, from https://www.globenewswire.com/news-release/2023/12/11/2794106/0/en/Initial-Phase-1-Dose-Escalation-Data-for-ORIC-533-in-Relapsed-Refractory-Multiple-Myeloma-Demonstrates-Clinical-Activity-and-Strong-Safety-Profile-Supporting-Potential-for-Combinat.html[15] Disc Presents Initial Positive Data from Ongoing Phase 1b/2 Trial of DISC-0974 in Patients with Myelofibrosis (MF) and Anemia at the 65th American Society of Hematology (ASH) Annual Meeting. Retrieved December 12, 2023, from https://www.globenewswire.com/news-release/2023/12/11/2794107/0/en/Disc-Presents-Initial-Positive-Data-from-Ongoing-Phase-1b-2-Trial-of-DISC-0974-in-Patients-with-Myelofibrosis-MF-and-Anemia-at-the-65th-American-Society-of-Hematology-ASH-Annual-Me.html[16] Wugen Presents Latest Data from First-In-Human Phase 1/2 Trial of WU-CART-007 in Patients with Difficult-to-Treat Blood Cancers at American Society of Hematology Annual Meeting. Retrieved December 12, 2023, from https://www.globenewswire.com/news-release/2023/12/11/2794234/0/en/Wugen-Presents-Latest-Data-from-First-In-Human-Phase-1-2-Trial-of-WU-CART-007-in-Patients-with-Difficult-to-Treat-Blood-Cancers-at-American-Society-of-Hematology-Annual-Meeting.html[17] MEI Pharma Reports Clinical Data on Oral CDK9 Inhibitor Voruciclib at ASH2023. Retrieved December 12, 2023, from https://www.businesswire.com/news/home/20231211089962/en[18] Biomea Fusion Presents Achievement of Minimal Residual Disease Negativity (MRD-neg) in First Complete Responder from Ongoing Phase I Study (COVALENT-101) of BMF-219 in Patients with Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) at the 2023 ASH. Retrieved December 12, 2023, from https://investors.biomeafusion.com/news-releases/news-release-details/biomea-fusion-presents-achievement-minimal-residual-disease[19] Sumitomo Pharma Presents Encouraging New Data on DSP-5336 Clinical Activity at the American Society of Hematology Annual Meeting. Retrieved December 12, 2023, from https://www.prnewswire.com/news-releases/sumitomo-pharma-presents-encouraging-new-data-on-dsp-5336-clinical-activity-at-the-american-society-of-hematology-annual-meeting-302011396.html[20] IN8bio Announces Positive Clinical Update Demonstrating Continued Durable Complete Remission in 100% of Evaluable Patients in Phase 1 Trial of INB-100 in Leukemia. Retrieved December 12, 2023, from https://investors.in8bio.com/news-releases/news-release-details/in8bio-announces-positive-clinical-update-demonstrating[21] Nurix Therapeutics Presents Positive Clinical Data from Its Novel Bruton’s Tyrosine Kinase (BTK) Degrader Programs, NX-5948 and NX-2127, at the 65th American Society of Hematology (ASH) Annual Meeting. Retrieved December 12, 2023, from https://ir.nurixtx.com/news-releases/news-release-details/nurix-therapeutics-presents-positive-clinical-data-its-novel[22] NovalGen presents NVG-111 clinical data in hematological malignancies in an oral session and preclinical data for next-generation AR T cell engager NVG-222 at the 65th American Society of Hematology Annual Meeting. Retrieved December 12, 2023, from https://www.globenewswire.com/news-release/2023/12/11/2793495/0/en/NovalGen-presents-NVG-111-clinical-data-in-hematological-malignancies-in-an-oral-session-and-preclinical-data-for-next-generation-AR-T-cell-engager-NVG-222-at-the-65th-American-Soc.html[23] Immix Biopharma Announces 100% Overall Response Rate (n=10); 23.7 months Best Response Duration (ongoing) for CAR-T NXC-201 in Relapsed/Refractory AL Amyloidosis Patients at ASH 2023. Retrieved December 12, 2023, from https://www.globenewswire.com/news-release/2023/12/11/2793969/0/en/Immix-Biopharma-Announces-100-Overall-Response-Rate-n-10-23-7-months-Best-Response-Duration-ongoing-for-CAR-T-NXC-201-in-Relapsed-Refractory-AL-Amyloidosis-Patients-at-ASH-2023.html[24] NKARTA PRESENTS NKX101 CLINICAL DATA AT THE 2023 AMERICAN SOCIETY OF HEMATOLOGY ANNUAL MEETING & EXPOSITION. Retrieved December 12, 2023, from https://ir.nkartatx.com/news-releases/news-release-details/nkarta-presents-nkx101-clinical-data-2023-american-society[25] Adicet Bio Highlights ADI-001 Expansion, Persistence and Pharmacodynamic Profile from Ongoing Phase 1 Study at the 65th American Society of Hematology (ASH) Annual Meeting. Retrieved December 12, 2023, from https://www.businesswire.com/news/home/20231210950496/en[26] ImmunoGen Presents Findings from Newly Diagnosed Acute Myeloid Leukemia Cohorts in Phase 1b/2 Study of Pivekimab Sunirine in Combination with Azacitidine and Venetoclax at ASH. Retrieved December 12, 2023, from https://www.businesswire.com/news/home/20231210537316/en[27] Aptose Tuspetinib Clinical Data Featured in Oral Presentation at the 2023 ASH Annual Meeting. 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- Patients with R/R CLL and MCL show good objective responses to ROR1-targeting T cell engager NVG-111 in combination and monotherapy settings - - Autoregulation (AR) platform displays significant protective effects from T cell engager toxicity and will enter the clinic with NVG-222 in 2024 - LONDON, Dec. 10, 2023 (GLOBE NEWSWIRE) -- NovalGen Ltd (“NovalGen”), a pioneering clinical stage immunology company, shared promising findings from the NVG-111-101, a First in Human, Phase I clinical study (NCT04763083), in an oral presentation at the 65th American Society of Hematology Annual meeting, in San Diego, USA. The study showcased positive responses in 58% of evaluable patients with relapsed refractory chronic lymphocytic leukaemia (CLL) and mantle cell lymphoma (MCL) across both combination and monotherapy regimens, durable to 24 months. Noteworthy outcomes include a remarkable achievement of MRD4 negativity in peripheral blood, determined by flow cytometry, in 30% of CLL participants. Furthermore, a complete metabolic response (CMR) by Lugano criteria was observed in one of two mantle cell lymphoma participants. Such outcomes are particularly significant in diseases characterized by poor T cell function and are associated with improved progression free survival and overall survival. Professor Amit Nathwani, Founder and CEO of NovalGen, expressed his enthusiasm for the results, stating, “The manageable safety profile together with encouraging clinical activity provide a strong foundation for ROR1 targeting T cells engagers and paves the way for their use in other hard to treat malignancies. including solid tumors.” Dr Jasani the Chief Investigator for this study stated: “Our pilot study shows the potential of ROR1 targeting T cell engagers in participants with CLL and MCL who have failed multiple lines of therapy including stem cell transplantation.” In addition to presenting these encouraging clinical outcomes, NovalGen is also introducing their proprietary Autoregulation (AR) technology platform. This innovative platform is showcased in the development of NVG-222, a next-generation T cell engager targeting ROR1 but can be applied to a range of immunotherapies including CAR-T cells to improve the therapeutic index. NVG-222 stands out with its extended half-life, enabling dosing once every two weeks. The enhanced safety profile of this novel molecule allows for higher, more efficacious dosing, potentially leading to improved patient outcomes. Professor Nathwani remarked, “By maintaining the potency of NVG-111 while extending half-life and significantly reducing mode-of-action-related toxicity, NVG-222 has the potential to extend the therapeutic window and set a new standard for patient care for ROR1 positive hematologic malignancies as well as solid tumors.” NovalGen believes that Autoregulation (AR) technology represents a transformative step in immunotherapy development, aiming to eliminate or reduce mode-of-action toxicities that limit the full potential of these new class of therapeutics leading to enhanced outcomes for patients. The company remains committed to advancing innovative solutions that address unmet medical needs and improve the lives of those affected by challenging diseases. Abstracts presented: Abstract Title: Time Limited Exposure to a ROR1 Targeting Bispecific T cell Engager (NVG-111) Leads to Durable Response in Subjects with Relapsed Refractory Chronic Lymphocytic Leukemia (CLL) and Mantle Cell Lymphoma (MCL)Link to AbstractSession Title: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: New Inhibitors and Cellular Therapies for Treatment of Relapsed CLLSession Date: Saturday, December 9, 2023Presentation Time: 4:00 PM - 5:30 PM PTLocation: Manchester Grand Hyatt San Diego, Grand Hall DPublication Number: 329Presenting Author: Dr Parag JasaniAbstract Title: NVG-222: A First-in-Class Autoregulating Half-Life Extended ROR1xCD3 T Cell Engager Heralding a New Class of Safer DrugsLink to AbstractSession Title: 605. Molecular Pharmacology and Drug Resistance: Lymphoid Neoplasms: Poster IISession Date: Sunday, December 10, 2023Presentation Time: 6:00 PM - 8:00 PM PTLocation: San Diego Convention Center, Halls G-HPublication Number: 2820Presenting Author: Dr Vincent Muczynski About NovalGen NovalGen is a privately held clinical stage immunology company developing breakthrough immunotherapies, with the aim of creating life-saving novel treatments for people with immunologically driven diseases. Our Autoregulation (AR) platform can be applied to multiple drug modalities for a wide range of indications in oncology, hematology, inflammation and other areas in the immunology space. Our dedicated team of experienced scientists, physicians and professionals are passionate about building a pipeline of disruptive and differentiated products tailored to the needs of the patient. The company’s lead program, NVG-111, is an ROR1-targeting bispecific antibody T-cell engager for the treatment of both hematological malignancies and solid tumors using our breakthrough bispecific antibody technology. Our lead AR programme, NVG-222, builds on the success of NVG-111 and is primed for entry into the clinic in 2024. About Autoregulation (AR) AR is NovalGen’s proprietary platform for next-generation therapeutics that has the potential to transform the treatment paradigm across multiple indications. AR therapies harness a response-mediated negative-feedback loop that detects when there is the risk of severe toxicities arising from the drug’s mechanism of action. When this occurs, the drug is deactivated at the site of action to prevent serious side effects. As the risk of toxicity reduces the drug is replenished from circulating active drug and treatment continues. AR enables the potential for therapies to be safely given at higher doses and for longer, widening the therapeutic index and resulting in better outcomes for patients. About Chronic Lymphocytic Leukemia (CLL) CLL is the most common form of leukemia in the Western world and is a type of cancer that affects a specific type of white blood cell called B-lymphocytes. These abnormal lymphocytes accumulate in the blood, bone marrow, lymph nodes, spleen and other tissues. Common symptoms of CLL can include fatigue, enlarged lymph nodes, and susceptibility to infections. However, not everyone with CLL will experience these symptoms. Treatment options for CLL can vary and may include watchful waiting, chemotherapy, immunotherapy, targeted therapy, or stem cell transplantation, depending on the individual's specific situation and stage of the disease. About Mantle Cell Lymphoma (MCL) MCL is an aggressive but rare cancer that affects white blood cell called B-lymphocytes located in the mantle zone the body's lymphatic system. Typical symptoms include swollen lymph nodes, fatigue, and digestive problems. It can be treated with different therapies, including chemotherapy, targeted drugs, and stem cell transplantation depending on the stage of disease and individual factors. Further informationJW CommunicationsJulia WilsonTel. +44 (0) 7818 430877Email: juliawilsonuk@gmail.com