更新于：2024-12-12
Vilastobart
更新于：2024-12-12
概要
基本信息
最高研发阶段临床1/2期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评- |
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序列信息
Sequence Code 523914763H
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Sequence Code 565455358L
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关联
1
项与 Vilastobart 相关的临床试验A First-in-Human, Multicenter, Phase 1/2, Open-Label Study of Vilastobart (XTX101) Monotherapy and Vilastobart (XTX101) and Atezolizumab Combination Therapy in Patients with Advanced Solid Tumors
This is a first-in-human, Phase 1/2, multicenter, open-label study designed to evaluate the safety and tolerability of vilastobart (XTX101) as monotherapy and vilastobart (XTX101) and atezolizumab combination therapy in patients with advanced solid tumors.
开始日期2021-09-13 |
申办/合作机构 |
100 项与 Vilastobart 相关的临床结果
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100 项与 Vilastobart 相关的转化医学
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100 项与 Vilastobart 相关的专利（医药）
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46
项与 Vilastobart 相关的新闻（医药）2024-11-13
Combination of vilastobart and atezolizumab demonstrated encouraging early evidence of anti-tumor activity, including unconfirmed partial responses observed in two patients with difficult-to-treat, immunologically “cold” tumors
Complete resolution of a metastatic liver lesion observed in a patient with microsatellite stable colorectal cancer (MSS CRC)
Safety data indicated combination of vilastobart and atezolizumab was generally well-tolerated and support the potential of vilastobart to be a differentiated next-generation anti-CTLA-4 in combination with PD-(L)1 inhibitors
Continue to anticipate initial data from Phase 2 trial for combination of vilastobart and atezolizumab in metastatic MSS CRC patients with and without liver metastases in fourth quarter of 2024
Xilio Therapeutics to host investor conference call and webcast today at 4:30 pm EST
Nov. 07, 2024 -- Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies for people living with cancer, today announced initial clinical data from its ongoing Phase 1C clinical trial evaluating vilastobart (XTX101), a tumor-activated, Fc-enhanced, high affinity binding anti-CTLA-4, in combination with atezolizumab (Tecentriq®) in patients with advanced solid tumors. The data will be presented in a late-breaker poster presentation (abstract #1455) on November 8, 2024, at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting taking place in Houston, Texas.
“These Phase 1 combination data for vilastobart and atezolizumab provide promising initial clinical evidence of the potential for the combination in patients with traditionally immunotherapy-resistant tumors, or “cold” tumors, including MSS colorectal cancer,” said René Russo, Pharm.D., president and chief executive officer of Xilio. “In particular, we are encouraged by the potentially differentiated safety profile and two unconfirmed partial responses, including complete resolution of a metastatic liver lesion observed in a patient with MSS colorectal cancer. The majority of metastatic MSS colorectal cancer patients have liver metastases, which have proven to be resistant to existing immuno-oncology treatments, including combination treatments, and represent a significant unmet need. We look forward to sharing initial Phase 2 data for the combination of vilastobart and atezolizumab in patients with metastatic MSS colorectal cancer with and without liver metastases later this year.”
“With the increasing incidence of MSS colorectal cancer, particularly in younger adults, the lack of effective treatment options for these patients represents one of the most significant challenges in oncology today,” said Diwakar Davar, M.D., Associate Professor of Medicine, Clinical Director of the Melanoma Program and Medical Oncologist/Hematologist at the UPMC Hillman Cancer Center and the lead author of the study. “These initial combination data for vilastobart are encouraging as they show early evidence of meaningful anti-tumor activity in patients with traditionally immunotherapy-resistant tumors and highlight the potential for vilastobart to be a differentiated, next-generation anti-CTLA-4 in combination with PD-(L)1 inhibitors in MSS colorectal cancer and other tumors.”
As of a data cutoff date of October 7, 2024, 17 patients had been treated with the combination of vilastobart at doses ranging from 75 mg to 150 mg once every six weeks (Q6W) and atezolizumab at 1200 mg once every three weeks (Q3W). Across all patients treated:
Tumor types included MSS CRC (n=12) and microsatellite instability high (MSI-H) CRC, non-small cell lung cancer (NSCLC), esophageal cancer, ampullary carcinoma and cancer of the abdomen (n=1 each).
The median age was 69 years (ranging from 39 to 77 years), and patients were generally heavily pre-treated.
83% of patients previously received three or more prior lines of anti-cancer therapy.
As of the data cutoff date, seven patients were continuing on treatment with the combination of vilastobart and atezolizumab, and 10 patients had discontinued treatment.
Safety data support the potential for vilastobart to be a differentiated next-generation anti-CTLA-4 in combination with PD-(L)1 inhibitors—combination was generally well-tolerated with patients experiencing minimal immune-related adverse events
Across all dose levels, no Grade 4 or Grade 5 treatment-related adverse events (AEs) were reported by investigators. In addition, no endocrine immune-related AEs (irAEs) and limited skin irAEs were reported by investigators. Only one patient (6%) experienced a dose reduction due to a treatment-related AE, and only one patient (6%) discontinued treatment of both vilastobart and atezolizumab due to a treatment-related AE.
Across all dose levels, investigators reported Grade 3 treatment-related AEs in only three patients: alanine aminotransferase (ALT) increase (12%); diarrhea, colitis and blood alkaline phosphatase (ALP) increase (6% each). Of these Grade 3 treatment-related AEs, two patients at the 150 mg dose level for vilastobart had dose-limiting toxicities: one patient with Grade 3 colitis and diarrhea and one patient with Grade 3 ALT increase and blood ALP increase.
Across all dose levels, the most common treatment-related AEs (≥10% incidence) of any grade reported by investigators were the following: infusion-related reactions (59%); aspartate aminotransferase (AST) increase, ALT increase and lipase increase (18% each); diarrhea, fatigue and blood ALP increase (12% each). Of the 10 patients with infusion-related reactions, four patients experienced reactions related to vilastobart, three patients experienced reactions related to atezolizumab and three patients experienced reactions related to the combination.
Patient with MSS CRC and a metastatic liver lesion: A patient with MSS CRC and a metastatic liver lesion achieved a partial response (pending confirmation) per Response Evaluation Criteria in Solid Tumors (RECIST) (33% reduction in the sum of diameters of target lesions), including full resolution of the liver lesion. The patient previously progressed on five prior lines of therapy and was administered the combination of vilastobart at the 150 mg Q6W dose level and atezolizumab (1200 mg Q3W).
Patient with ampullary carcinoma: A patient with ampullary carcinoma achieved a partial response (unconfirmed) per RECIST (32% reduction in the sum of diameters of target lesions) accompanied by a substantial decrease in the serum tumor marker CA 19-9 (from 700.2 at baseline to 40.8 after 6 weeks of treatment). CA 19-9 associated antigen levels are often significantly elevated in patients with pancreatic cancer. The patient previously progressed on two prior lines of therapy and was administered the combination of vilastobart at the 150 mg Q6W dose level and atezolizumab (1200 mg Q3W). The patient withdrew consent prior to undergoing a confirmatory scan.
The initial Phase 1C data supported the selection of an initial recommended Phase 2 dose (RP2D) for vilastobart at 100 mg Q6W in combination with atezolizumab at 1200 mg Q3W. In addition, Xilio continues to enroll patients in Phase 1C dose escalation for the combination of vilastobart at the 150 mg Q6W dose level and atezolizumab at 1200 mg Q3W.
Xilio is currently enrolling patients in its ongoing Phase 2 clinical trial evaluating the combination of vilastobart and atezolizumab at the initial combination RP2D in patients with metastatic MSS CRC, including patients with and without liver metastases.
Xilio expects to report initial Phase 2 data for the combination in approximately 20 patients with metastatic MSS CRC in the fourth quarter of 2024 and additional Phase 2 data for the combination in a total of approximately 40 patients with metastatic MSS CRC in the first quarter of 2025.
Vilastobart is an investigational tumor-activated, Fc-enhanced, high affinity binding anti-CTLA-4 monoclonal antibody designed to block CTLA-4 and deplete regulatory T cells when activated in the tumor microenvironment (TME). In 2023, Xilio entered into a co-funded clinical trial collaboration with Roche to evaluate vilastobart in combination with atezolizumab (Tecentriq®) in a multi-center, open-label Phase 1/2 clinical trial. Xilio is currently evaluating the safety of the combination in Phase 1C dose escalation in patients with advanced solid tumors and the safety and efficacy of the combination in Phase 2 in patients with metastatic microsatellite stable colorectal cancer with and without liver metastases. Please refer to NCT04896697 on www.clinicaltrials.gov for additional details.
Xilio Therapeutics is a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology (I-O) therapies with the goal of significantly improving outcomes for people living with cancer without the systemic side effects of current I-O treatments. The company is using its proprietary platform to advance a pipeline of novel, tumor-activated clinical and preclinical I-O molecules that are designed to optimize the therapeutic index by localizing anti-tumor activity within the tumor microenvironment, including tumor-activated cytokines, antibodies, bispecifics and immune cell engagers. Learn more by visiting www.xiliotx.com and follow us on LinkedIn (Xilio Therapeutics, Inc.).
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临床结果免疫疗法引进/卖出
2024-11-10
·药明康德
▎药明康德内容团队编辑
本期看点
1. 阿斯利康（AstraZeneca）双特异性T细胞接合器AZD0486治疗复发/难治性滤泡性淋巴瘤（R/R FL）患者的1期临床试验结果亮眼，接受2.4 mg及以上剂量患者的总缓解率（ORR）高达96%，完全缓解（CR）率达85%。
2. 潜在“first-in-class”的menin抑制剂revumenib联用venetoclax和去甲基化剂（HMA）ASTX727治疗携带特定基因变异的急性白血病患者，在一项1/2期研究中的ORR达88%。
3. 潜在“best-in-class”合成致死疗法TNG462的早期临床结果积极，多种癌症类型患者的肿瘤有缩小。
药明康德内容团队整理
AZD0486：公布1期临床试验数据
阿斯利康宣布将在今年的美国血液学会（ASH）年会上公布旗下多款血液学管线的临床结果，其中包括该公司的CD19 x CD3靶向双特异性T细胞接合器AZD0486用于复发/难治性滤泡性淋巴瘤患者的1期临床试验结果。
结果显示，R/R FL患者对2.4 mg及以上剂量的AZD0486高度应答，患者的ORR高达96%，CR达85%，且患者的最小残留病灶（MRD）阴性比率很高。此外，1期试验中期结果也显示，接受过大量治疗的弥漫大B细胞淋巴瘤（DLBCL）患者也对AZD0486高度应答，患者的CR率高。最新数据还显示AZD0486具有良好的安全性，双倍递增给药方案可有效缓解患者发生细胞因子释放综合征（CRS）和免疫效应细胞相关神经毒性综合征（ICANS）事件。
Revumenib：公布1/2期临床试验数据
Syndax Pharmaceuticals公司宣布将在ASH年会上公布其在研疗法revumenib联用venetoclax和去甲基化剂ASTX727（decitabine/cedazuridine）治疗携带KMT2A重排、NUP98重排或NPM1突变的复发/难治性急性髓系白血病（r/r AML）或混合谱系急性白血病（MPAL）儿童和成人患者的1/2期临床试验结果。Revumenib是一种针对menin-KMT2A相互作用的强效、选择性小分子抑制剂。
截至2024年7月的数据，共有26名患者入组该试验，ORR为88%（23/26），CR或带部分血液学恢复的完全缓解（CRh）率为58%（15/26）。15名达到CR/CRh的患者中有14名的MRD状态可评估，其中93%（13/14）为MRD阴性。中位随访时间为6.6个月时，患者6个月时的无复发生存率为59%，总生存率为74%。CR/CRh患者的中位缓解持续时间尚未达到。该组合疗法总体上耐受性良好。
TNG462：公布1/2期临床试验数据
Tango Therapeutics公司宣布，基于在研疗法TNG462在1/2期临床试验剂量递增和早期剂量扩展队列中获得的积极数据，该公司已选择TNG462进入全面开发。新闻稿指出，TNG462是一种潜在“best-in-class”的甲硫腺苷（MTA）协同的蛋白精氨酸甲基转移酶5（PRMT5）抑制剂。PRMT5是甲硫腺苷磷酸化酶（MTAP）突变的合成致死靶点。MTAP基因缺失发生在大约10%的癌症中，包括胰腺癌、肺癌和膀胱癌，这些患者体内存在异常升高的MTA水平，从而抑制PRMT5的活性。PRMT5是一种参与基本细胞功能的酶，MTA的升高使得肿瘤细胞对额外PRMT5的抑制变得更为敏感。TNG462是一款基于合成致死理念设计的精准抗癌疗法，它可在抑制MTAP缺失细胞中PRMT5功能的同时，保留健康细胞中的PRMT5功能，从而选择性地杀死肿瘤细胞。
截至2024年10月20日，共有59名患者入组，其中39名患者可评估，涵盖13种癌症类型。数据显示，TNG462在多种肿瘤类型中展现了抗癌活性且耐受性良好，包括非小细胞肺癌（NSCLC）和胰腺癌。多种肿瘤类型的肿瘤体积随着持续治疗而缩小，约60%最初被评估为疾病稳定（SD）的患者在之后出现部分缓解（PR）。尽管目前大多数癌症类型的患者数和随访时间不足以准确估算客观缓解率，但在已入组的7名胆管癌患者中，观察到其中3名（43%）患者获得确认的客观缓解。此外，TNG462在活性剂量下具有良好的安全性和耐受性，剂量限制性毒性（DLT）为血小板减少。该药物的其他不良事件（如恶心、呕吐、腹泻和疲劳）发生率低于20%，且主要为1级。
▲TNG462治疗胆管癌患者的临床试验结果（图片来源：参考资料[4]）
ISB 2001：公布1期临床试验的新数据
Ichnos Glenmark Innovation公司宣布将在ASH年会上进行口头报告，展示其三特异性抗体ISB 2001用于复发/难治性多发性骨髓瘤（r/r MM）的1期研究的数据。ISB 2001同时靶向MM细胞上的BCMA和CD38，以及T细胞上的CD3，旨在增加对MM细胞的特异性结合，同时最大限度地减少脱靶效应。
截至2024年7月的数据，12名可评估疗效患者的ORR为75%（9/12），其中包括1例MRD阴性的严格CR。安全性方面，ISB 2001具有良好的安全性和耐受性，未观察到DLT，仅有一例高于2级的特殊关注不良事件，且没有因治疗而停药的情况。
Vilastobart（XTX101）：公布1c期临床试验数据
Xilio Therapeutics公司公布了其正在进行的1c期临床试验的初步临床数据，该试验评估了vilastobart（XTX101）联用PD-L1抑制剂atezolizumab治疗晚期实体瘤患者的效果。Vilastobart是一种肿瘤激活、Fc增强、高亲和力结合的抗CTLA-4抗体。
截至2024年10月7日，17名患者接受了vilastobart联用atezolizumab的治疗。观察到两名患有难以治疗的、免疫学上为“冷肿瘤”的患者达到了未确认的PR。在1名微卫星稳定型结直肠癌（MSS CRC）患者中观察到转移性肝脏病灶的完全消退。安全性数据显示，该联合治疗总体上耐受良好，vilastobart有潜力成为与PD-1/PD-L1抑制剂联合使用的差异化下一代抗CTLA-4抗体。
VK2735：公布早期临床试验的新数据
Viking Therapeutics在肥胖协会年会肥胖周（ObesityWeek）上公布了其在研减重疗法胰高血糖素样肽1（GLP-1）/葡萄糖依赖性胰岛素促泌肽（GIP）受体联合激动剂VK2735的最新临床试验数据。分析显示，接受每日VK2735口服片剂28天的受试者，其安慰剂调整后平均体重较基线减轻达6.8%。而接受每周VK2735皮下注射治疗13周的肥胖患者的平均体重则较基线减轻达14.7%。值得一提的是，在试验第一周时便观察到接受皮下剂型患者显著的体重减轻效果，近100%患者在停药4周后其体重减轻的大部分效果仍然维持。目前该公司正在规划VK2735注射剂型的3期研究，以及口服剂型的2期研究，详细信息将在接近试验启动时间时公布。
▲接受口服VK2735治疗28天受试者的体重减轻效果（图片来源：参考资料[1]）
▲接受VK2735皮下注射13周受试者的体重减轻效果（图片来源：参考资料[1]）
▲接受VK2735皮下注射受试者在停药后体重减轻效果持续维持（图片来源：参考资料[1]）
AZD5004：公布1期临床试验数据
阿斯利康公司公布了在研口服GLP-1疗法AZD5004，在患有2型糖尿病的肥胖患者中进行的1期临床试验的最新结果。AZD5004是一款每日一次、低剂量的小分子GLP-1受体激动剂，该药物在临床前研究中证明具有理想的疗效和安全性。去年11月，阿斯利康与诚益生物（Eccogene）达成独家协议，以潜在18.25亿美元的总额获得小分子GLP-1受体激动剂ECC5004（即AZD5004），用于治疗包括肥胖症、2型糖尿病和其他合并症在内的适应症。
此次公布的数据显示，接受剂量为50 mg的AZD5004治疗的患者中，4周后患者体重与基线相比降低5.8%，约为9.4斤。同时，患者的空腹血糖等指标也有所下降。
▲AZD5004降低患者体重和血糖指标（图片来源：阿斯利康官网）
CIN-109、CIN-110：公布1期临床试验数据
CinFina Pharma公司公布了其CIN-110的单剂量递增（SAD）研究的初步中期数据以及CIN-109的多剂量递增（MAD）研究的最终数据。CIN-110是一种强效、高选择性的肽YY（PYY3-36）类似物，具有延长的半衰期，旨在显著减少其他PYY分子观察到的恶心和呕吐，同时促进有效的长期体重减轻。CIN-109是一种新型长效生长分化因子15（GDF-15）类似物，有可能减少食欲、维持能量消耗和促进体重减轻，同时保持瘦体重。
两项研究均显示这些候选疗法具有良好的耐受性，并能导致显著的体重减轻。CIN-110的1期研究共纳入24名平均BMI为34 kg/m²的肥胖受试者，在给药一周内，他们的食物摄入量减少了28%，体重最多下降了1.8%。总共报告了3例轻度恶心，通常在给药后12-48小时内出现，并在一天内缓解。在CIN-109的1期研究中，平均BMI为35 kg/m²的肥胖受试者的食物摄入量呈剂量依赖性的减少，最高达50%，患者在1-2个月内体重减轻了多达3.7%。此外，每两周给药一次CIN-109的耐受性更好，大部分减轻的体重来自于脂肪，且未观察到与治疗相关的严重副作用。
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参考资料（可上下滑动查看）
[1] Viking Therapeutics Reports New Data from VK2735 Obesity Program at ObesityWeek® 2024. Retrieved November 4, 2024 from https://www.prnewswire.com/news-releases/viking-therapeutics-reports-new-data-from-vk2735-obesity-program-at-obesityweek-2024-302294915.html
[2] AZN Meet the Management: Weight Management Virtual Event. Retrieved November 4, 2024, from https://www.astrazeneca.com/content/dam/az/Investor_Relations/events/Weight-Management-Virtual-Event-IR-presentation.pdf
[3] Tango Therapeutics Reports Positive TNG462 Clinical Data and Provides Update on PRMT5 Development Program. Retrieved November 6, 2024, from https://ir.tangotx.com/news-releases/news-release-details/tango-therapeutics-reports-positive-tng462-clinical-data-and
[4] Tango Therapeutics Corporate Presentation. Retrieved November 6, 2024, from https://ir.tangotx.com/static-files/c49a558d-602e-4fed-9d53-dcbc004ffdf5
[5] AstraZeneca showcases strength of haematology portfolio and pipeline at ASH 2024. Retrieved November 7, 2024 from https://www.astrazeneca.com/media-centre/press-releases/2024/astrazeneca-showcases-strength-of-haematology-portfolio-and-pipeline-at-ash-2024.html
[6] Xilio Therapeutics Announces Initial Clinical Trial Data from Phase 1C Dose Escalation for Vilastobart (XTX101), a Tumor-Activated Anti-CTLA-4, in Combination with Atezolizumab in Patients with Advanced Solid Tumors. Retrieved November 7, 2024 from https://www.globenewswire.com/news-release/2024/11/07/2976781/0/en/Xilio-Therapeutics-Announces-Initial-Clinical-Trial-Data-from-Phase-1C-Dose-Escalation-for-Vilastobart-XTX101-a-Tumor-Activated-Anti-CTLA-4-in-Combination-with-Atezolizumab-in-Pati.html
[7] CinFina Pharma Presents Positive Phase 1 Study Results in Poster Session for CIN-109 and in Late-Breaking Poster for CIN-110, Demonstrating the Potential of Next-Generation Mechanisms at ObesityWeek® 2024. Retrieved November 7, 2024 from https://cinrx.com/cinfina-pharma-phase-1-study-results-poster-session-cin-109-late-breaking-poster-cin-110-demonstrating-potential-next-generation-mechanisms-obesityweek-2024
[8] Ichnos Glenmark Innovation (IGI) Announces First Presentation of Data from Phase 1 Study of the Trispecific ISB 2001 in Relapsed/Refractory Multiple Myeloma (r/rMM) at Upcoming ASH Annual Meeting. Retrieved November 7, 2024 from https://www.globenewswire.com/news-release/2024/11/05/2974962/0/en/Ichnos-Glenmark-Innovation-IGI-Announces-First-Presentation-of-Data-from-Phase-1-Study-of-the-Trispecific-ISB-2001-in-Relapsed-Refractory-Multiple-Myeloma-r-rMM-at-Upcoming-ASH-Ann.html
[9] Syndax Announces Revumenib Abstracts to Be Presented at the 66th ASH Annual Meeting. Retrieved November 7, 2024 from https://www.prnewswire.com/news-releases/syndax-announces-revumenib-abstracts-to-be-presented-at-the-66th-ash-annual-meeting-302296077.html
[10] Oncoinvent Announces Publication of 18-Month Safety and Efficacy Data from the Phase 1/2a Study of Radspherin® in Colorectal Cancer. Retrieved November 5, 2024 from https://www.businesswire.com/news/home/20241101923447/en/Oncoinvent-Announces-Publication-of-18-Month-Safety-and-Efficacy-Data-from-the-Phase-12a-Study-of-Radspherin%C2%AE-in-Colorectal-Cancer/
[11] Arcellx to Present Clinical Data for Its Phase 1 and iMMagine-1 Studies in Patients with Relapsed or Refractory Multiple Myeloma at the 66th ASH Annual Meeting and Exposition and Announces Progress in iMMagine-3 Study. Retrieved November 5, 2024 from https://ir.arcellx.com/news/news-details/2024/Arcellx-to-Present-Clinical-Data-for-Its-Phase-1-and-iMMagine-1-Studies-in-Patients-with-Relapsed-or-Refractory-Multiple-Myeloma-at-the-66th-ASH-Annual-Meeting-and-Exposition-and-Announces-Progress-in-iMMagine-3-Study/default.aspx
[12] Beam Therapeutics to Present Data Across Hematology Franchise, Including First Clinical Data for BEAM-101 in Sickle Cell Disease and ESCAPE Non-human Primate Data, at American Society of Hematology (ASH) Annual Meeting. Retrieved November 5, 2024 from https://www.globenewswire.com/news-release/2024/11/05/2974971/0/en/Beam-Therapeutics-to-Present-Data-Across-Hematology-Franchise-Including-First-Clinical-Data-for-BEAM-101-in-Sickle-Cell-Disease-and-ESCAPE-Non-human-Primate-Data-at-American-Societ.html
[13] TScan Therapeutics Announces Upcoming Oral Presentation of Data from the ALLOHA™ Phase 1 Heme Trial at the 66th American Society of Hematology Annual Meeting and Exposition. Retrieved November 5, 2024 from https://www.globenewswire.com/news-release/2024/11/05/2975010/0/en/TScan-Therapeutics-Announces-Upcoming-Oral-Presentation-of-Data-from-the-ALLOHA-Phase-1-Heme-Trial-at-the-66th-American-Society-of-Hematology-Annual-Meeting-and-Exposition.html
[14] C4 Therapeutics Announces First Patient Dosed in CFT8919 Clinical Trial. Retrieved November 8, 2024 from https://www.globenewswire.com/news-release/2024/11/06/2975566/0/en/C4-Therapeutics-Announces-First-Patient-Dosed-in-CFT8919-Clinical-Trial.html
[15] Nouscom’s Off-the-Shelf Neoantigen Immunotherapy, NOUS-209, Continues to Elicit Potent and Durable Immune Responses in Lynch Syndrome Carriers Highlighting its Potential to ‘Intercept’ Cancer. Retrieved November 8, 2024 from https://www.morningstar.com/news/globe-newswire/1001011427/nouscoms-off-the-shelf-neoantigen-immunotherapy-nous-209-continues-to-elicit-potent-and-durable-immune-responses-in-lynch-syndrome-carriers-highlighting-its-potential-to-intercept-cancer
[16] Korro Announces Regulatory Filing for Initiation of KRRO-110 First-In-Human Study and Formation of Clinical Advisory Board. Retrieved November 8, 2024 from https://ir.korrobio.com/news-releases/news-release-details/korro-announces-regulatory-filing-initiation-krro-110-first
[17] Zymeworks Announces First Patient Dosed in Phase 1 Clinical Trial Evaluating ZW191 in Folate Receptor-⍺ Expressing Advanced Solid Tumors. Retrieved November 8, 2024 from https://ir.zymeworks.com/news-releases/news-release-details/zymeworks-announces-first-patient-dosed-phase-1-clinical-trial-0
[18] Ankyra Therapeutics Announces First Visceral Tumor Patient Dosed in Phase 1 ANCHOR Clinical Trial of ANK-101, an Anchored Interleukin-12 (IL-12). Retrieved November 8, 2024 from https://ankyratx.com/press-releases/ankyra-therapeutics-announces-first-visceral-tumor-patient-dosed-in-phase-1-anchor-clinical-trial-of-ank-101-an-anchored-interleukin-12-il-12/
[19] HiFiBiO Therapeutics Receives FDA Clearance of IND Application for HFB200604, a Best-in-Class BTLA Agonist Antibody for the Treatment of Inflammatory and Immunology Diseases. Retrieved November 8, 2024 from https://hifibio.com/hifibio-therapeutics-receives-fda-clearance-of-ind-application-for-hfb200604-a-best-in-class-btla-agonist-antibody-for-the-treatment-of-inflammatory-and-immunology-diseases/
[20] Xencor Doses First Subject in Phase 1/2 Study of XmAb®942 in Development for Patients with Inflammatory Bowel Disease. Retrieved November 8, 2024 from https://investors.xencor.com/news-releases/news-release-details/xencor-doses-first-subject-phase-12-study-xmabr942-development
[21] Elicio Therapeutics Presents Updated Translational Data from ELI-002 Phase 1 AMPLIFY-7P Study at the Society for Immunotherapy of Cancer (“SITC”) 2024 Annual Meeting. Retrieved November 8, 2024 from https://www.globenewswire.com/news-release/2024/11/07/2977121/0/en/Elicio-Therapeutics-Presents-Updated-Translational-Data-from-ELI-002-Phase-1-AMPLIFY-7P-Study-at-the-Society-for-Immunotherapy-of-Cancer-SITC-2024-Annual-Meeting.html
[22] HotSpot Therapeutics Presents Additional Phase 1 Biomarker Data on Novel CBL-B Inhibitor HST-1011 at 2024 Society for Immunotherapy of Cancer Annual Meeting. Retrieved November 8, 2024 from https://www.prnewswire.com/news-releases/hotspot-therapeutics-presents-additional-phase-1-biomarker-data-on-novel-cbl-b-inhibitor-hst-1011-at-2024-society-for-immunotherapy-of-cancer-annual-meeting-302298481.html
[23] OncoResponse Announces Phase 1 Results of the Clinical Trial of OR502, anti-LILRB2 Antibody, in Subjects with Advanced Cancer. Retrieved November 8, 2024 from https://www.prnewswire.com/news-releases/oncoresponse-announces-phase-1-results-of-the-clinical-trial-of-or502-anti-lilrb2-antibody-in-subjects-with-advanced-cancer-302298422.html
[24] Allogene Therapeutics Announces Positive Phase 1 Data Demonstrating the Potential of ALLO-316 in Heavily Pretreated Patients with Advanced Renal Cell Carcinoma at SITC and IKCS. Retrieved November 8, 2024 from https://www.globenewswire.com/news-release/2024/11/07/2976851/0/en/Allogene-Therapeutics-Announces-Positive-Phase-1-Data-Demonstrating-the-Potential-of-ALLO-316-in-Heavily-Pretreated-Patients-with-Advanced-Renal-Cell-Carcinoma-at-SITC-and-IKCS.html
[25] Bolt Biotherapeutics Presents Updated Preclinical Data for BDC-4182 and Key Learnings from Phase 1 Dose-Escalation Trial of BDC-1001 at SITC 39th Annual Meeting. Retrieved November 8, 2024 from https://www.globenewswire.com/news-release/2024/11/07/2976848/0/en/Bolt-Biotherapeutics-Presents-Updated-Preclinical-Data-for-BDC-4182-and-Key-Learnings-from-Phase-1-Dose-Escalation-Trial-of-BDC-1001-at-SITC-39th-Annual-Meeting.html
[26] Aummune Announces Results from Phase 1 Trial of its Novel AM003 Immunotherapy for the Treatment of Solid Tumors. Retrieved November 8, 2024 from https://www.globenewswire.com/news-release/2024/11/07/2976844/0/en/Aummune-Announces-Results-from-Phase-1-Trial-of-its-Novel-AM003-Immunotherapy-for-the-Treatment-of-Solid-Tumors.html
[27] Cellenkos Announces Oral Presentation at ASH Annual Meeting 2024 Highlighting Phase 1b Clinical Data of CK0804 in Myelofibrosis. Retrieved November 8, 2024 from https://www.prnewswire.com/news-releases/cellenkos-announces-oral-presentation-at-ash-annual-meeting-2024-highlighting-phase-1b-clinical-data-of-ck0804-in-myelofibrosis-302298808.html
[28] Indaptus Therapeutics Presents Encouraging Interim Safety Data from Phase 1 Clinical Trial of Decoy20 at the Society for Immunotherapy of Cancer (SITC) 2024 Annual Meeting. Retrieved November 8, 2024 from https://www.globenewswire.com/news-release/2024/11/07/2976598/0/en/Indaptus-Therapeutics-Presents-Encouraging-Interim-Safety-Data-from-Phase-1-Clinical-Trial-of-Decoy20-at-the-Society-for-Immunotherapy-of-Cancer-SITC-2024-Annual-Meeting.html
[29] Nimbus Therapeutics Presents Positive Updated Data from Phase 1/2 Clinical Trial of HPK1 Inhibitor for Advanced Solid Tumors at SITC 39th Annual Meeting. Retrieved November 8, 2024 from https://www.businesswire.com/news/home/20241107226079/en/Nimbus-Therapeutics-Presents-Positive-Updated-Data-from-Phase-12-Clinical-Trial-of-HPK1-Inhibitor-for-Advanced-Solid-Tumors-at-SITC-39th-Annual-Meeting
[30] Indapta Therapeutics Presents Clinical and Preclinical Data of Allogenic Natural Killer Cell Therapy at Society for Immunotherapy of Cancer Meeting. Retrieved November 8, 2024 from https://www.businesswire.com/news/home/20241107081017/en/Indapta-Therapeutics-Presents-Clinical-and-Preclinical-Data-of-Allogenic-Natural-Killer-Cell-Therapy-at-Society-for-Immunotherapy-of-Cancer-Meeting
[31] Radella Pharmaceuticals Announces Topline Data from the Phase 1a Study of MD-18, a First-In-Class Peptide Targeting PTP1B for Obesity. Retrieved November 8, 2024 from https://www.businesswire.com/news/home/20241107046414/en/Radella-Pharmaceuticals-Announces-Topline-Data-from-the-Phase-1a-Study-of-MD-18-a-First-In-Class-Peptide-Targeting-PTP1B-for-Obesity#:~:text=Radella%20Pharmaceuticals%20Announces%20Topline%20Data%20from%20the%20Phase,its%20platform%20targeting%20cardiometabolic%20disease%20and%20its%20adjacencies
[32] Palisade Bio Announces First Subject Dosed in Phase 1 Clinical Study of PALI-2108 for the Treatment of Moderate-to-Severe Ulcerative Colitis (UC). Retrieved November 8, 2024 from https://palisadebio.com/palisade-bio-announces-first-subject-dosed-in-phase-1-clinical-study-of-pali-2108-for-the-treatment-of-moderate-to-severe-ulcerative-colitis-uc/
[33] SystImmune, Inc. Announces FDA Clearance of IND Application for BL-M17D1 in Advanced Solid Tumors. Retrieved November 8, 2024 from https://www.prnewswire.com/news-releases/systimmune-inc-announces-fda-clearance-of-ind-application-for-bl-m17d1-in-advanced-solid-tumors-302298993.html
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2024-11-07
Studies Selected for Presentation at Global Gathering
FORT MYERS, Fla., Nov. 7, 2024 /PRNewswire/ -- Clinical research conducted with participation from Florida Cancer Specialists & Research Institute, LLC (FCS) continues to advance science and breakthroughs in cancer immunotherapy, which uses the body's immune system to find, target and fight many forms of the disease. FCS physician investigators are co-authors of research results being presented this week at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in Houston, the largest cancer immunotherapy conference of international leaders in the field.
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FCS physician investigators are co-authoring research being presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in Houston, the world’s largest gathering of leaders in immunotherapy research.
FCS President & Managing Physician Lucio N. Gordan, MD said, "Our shared aim is to make immunotherapy a standard of care to improve outcomes for cancer patients. Each discovery achieved through our robust clinical trials research program is bringing us closer to that reality."
The following FCS physician investigators are co-authors of research results being presented during oral and/or poster abstract presentations:
FCS Director of Drug Development Manish Patel, MD:
Phase 1B/2, multicenter dose escalation and expansion of muzstotug (ADG126, a masked anti-CTLA-4 SAFEbody®) in combination with Pembrolizumab in advanced/metastatic MSS CRC (abstract #744); Noted as a "Top 100"
Evaluation of immunomodulatory effects of ifinatamab deruxtecan (I-DXd) in the IDeate-Pantumor01 phase 1/2 study in patients with advanced solid tumors (abstract #629)
A phase 1/2 clinical trial of anti-VISTA KVA12123 alone and in combination with Pembrolizumab in patients with advanced solid tumors (abstract #625)
Triple blockade of DNAM-1 axis with COM701 (anti-PVRIG) + COM902 (anti-TIGIT) + pembrolizumab shows preliminary antitumor activity in patients with platinum resistant ovarian cancer, interim results of a phase I trial (abstract #985)
Peripheral Blood and Tumor Gene Expression as Biomarkers and Potential Predictors of Clinical Outcome with HST-1011, an Oral CBL-B inhibitor (abstract #1310)
Director of Drug Development, Lake Nona DDU Cesar Perez, MD – the late-breaking abstract: Phase 1 study of XTX101, a tumor-activated, Fc-enhanced anti-CTLA-4 monoclonal antibody, in combination with atezolizumab in patients with advanced solid tumors (abstract #1455)
Alexander Philipovskiy, MD, PhD – Abequolixron (RGX-104), a first-in-class oral immunotherapy targeting the liver-X receptor (LXR), in combination with docetaxel in recurrent advanced/metastatic non-small cell lung cancer (NSCLC) (abstract #657).
FCS Associate Director of Drug Development Judy Wang, MD:
CONSORTIUM-IO: A phase 1 study evaluating a combination of an 11-strain bacterial consortium (VE800) and Nivolumab in treatment of select refractory or metastatic cancers (abstract #607); Noted as a "Top 100"
Pharmacodynamic activities of the anti-MICA/B monoclonal antibody CLN-619, evaluated as a monotherapy, support the proposed mechanisms of action and correlate with response (abstract #195)
"Immunotherapy clinical trials continue to play a large role in oncology drug development," notes Dr. Manish Patel. "In ongoing studies conducted at our three drug development units, we continue to uncover critical new information about the body's response to immunotherapy, which is improving effectiveness and offering new hope for cancer patients worldwide."
As one of the largest clinical research programs in the country, FCS provides access to more than 300 clinical trials at any given time within its 32 late-phase designated FCS clinics and three Drug Development Units, where research is conducted on new treatments when they are first developed, prior to FDA approval. In fact, the majority of new cancer drugs approved for use in the U.S. have been studied in clinical trials with FCS participation.
Learn more about clinical trials and advance research conducted a FCS here: .
About Florida Cancer Specialists & Research Institute, LLC: (FLCancer.com)
Florida Cancer Specialists & Research Institute (FCS) offers patients access to more clinical trials than any private oncology practice in Florida. The majority of new cancer drugs recently approved for use in the U.S. were studied in clinical trials with FCS participation.* Recognized for our research, FCS is a recipient of the national Clinical Trials Participation Award presented by the American Society of Clinical Oncology (ASCO). FCS physicians, trained in prestigious medical schools and research institutes, are consistently ranked nationally as Top Doctors by U.S. News & World Report.
Celebrating its 40th year in 2024, FCS has built a national reputation for excellence that is reflected in exceptional and compassionate patient care, driven by innovative clinical research, cutting-edge technologies and advanced treatments, including targeted therapies genomic-based treatment and immunotherapy. Our highest values are embodied by our outstanding team of highly trained and dedicated physicians, clinicians and staff.
*Prior to approval
SOURCE Florida Cancer Specialists & Research Institute
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
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| 晚期恶性实体瘤 | 临床2期 | 美国 | 2021-09-13 | |
| 实体瘤 | 临床2期 | 美国 | 2021-09-13 | |
| 实体瘤 | 临床2期 | 美国 | 2021-09-13 |
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| 研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
|---|
临床1期 | 15 | (Part 1C) | 遞艱顧鹽蓋構積鏇壓網(簾築獵顧觸鹹顧艱構製) = infusion reactions (n=4), fatigue and diarrhea (n=2 each), and no G4 or G5 TRAEs were reported. 蓋廠廠衊簾鹽糧積鬱網 (襯繭積願廠齋襯顧願鹹 ) 更多 | 积极 | 2024-11-05 | ||
临床1期 | 18 | XTX101 150mg | 齋築窪醖鹹夢蓋網淵餘(廠積襯廠構廠顧鹹築鬱) = 醖襯壓夢鏇簾積網壓簾 繭網鹽憲鬱衊獵簾鬱蓋 (繭築網遞夢齋壓簾鹽願 ) 更多 | 积极 | 2023-12-07 | ||
临床1/2期 | 22 | 觸糧網鑰醖遞構繭構鹹(遞壓願襯獵鹽淵窪積淵) = 1 dose limiting toxicity (DLT) of colitis among 8 patients treated at 60 mg Q3W, while 2 DLTs of colitis were reported among 6 pts at 180 mg Q3W. 齋廠觸餘壓夢窪願廠繭 (鑰齋範壓齋選鑰遞願鬱 ) 更多 | 积极 | 2023-05-26 | |||
临床1/2期 | 12 | 膚壓簾糧餘鬱遞糧鹽襯(夢鹽襯鑰觸顧範齋鏇積) = A maximum tolerated dose (MTD) has not yet been determined, and enrollment in the dose-escalation cohort is ongoing. 廠鏇夢窪願積繭鏇餘鑰 (窪選蓋窪齋襯壓積襯構 ) 更多 | 积极 | 2022-08-09 |
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