An Open-Label Multicenter 3-Arm Randomized Phase 2 Study to Assess the Efficacy and Safety of TTX-030 and Chemotherapy With or Without Budigalimab, Compared to Chemotherapy Alone, for the Treatment of Patients Not Previously Treated for Metastatic Pancreatic Adenocarcinoma

This is a Phase 2, multicenter, open-label, 3-arm, randomized, parallel group study to evaluate the efficacy and safety of TTX-030 with or without budigalimab in combination with chemotherapy (gemcitabine + nab-paclitaxel) in subjects with metastatic PDAC who did not have prior treatment for metastatic disease and are eligible to receive gemcitabine and nab-paclitaxel chemotherapy as SOC.

开始日期2024-03-25

申办/合作机构

Trishula Therapeutics, Inc.初创企业

[+1]

NCT04306900 / Completed临床1期

Phase 1/1b Study to Evaluate the Safety and Activity of TTX-030 (Anti-CD39) in Combination With Pembrolizumab or Budigalimab and/or Chemotherapy in Subjects With Advanced Solid Tumors

This is a phase 1/1b study of TTX-030 in combination therapy, an antibody that inhibits CD39 enzymatic activity, leading to accumulation of pro-inflammatory adenosine triphosphate (ATP) and reduction of immunosuppressive adenosine, which may change the tumor microenvironment and promote anti-tumor immune response.
This trial will study the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of TTX-030 in combination with immunotherapy and/or standard chemotherapies.

开始日期2020-03-30

申办/合作机构

Trishula Therapeutics, Inc.初创企业

[+1]

NCT03884556 / Completed临床1期

Phase 1/1b Study of the Safety of TTX-030 as a Single Agent and in Combination With Pembrolizumab or Chemotherapy in Patients With Lymphoma or Solid Tumor Malignancies

This is a phase 1/1b study of TTX-030, an antibody that inhibits CD39 enzymatic activity, leading to accumulation of pro-inflammatory adenosine triphosphate (ATP) and reduction of immunosuppressive adenosine, which may change the tumor microenvironment and promote anti-tumor immune response.
This trial will study the safety, tolerability, pharmacokinetics, and anti-tumor activity of TTX-030 as a single agent and in combination with an approved anti-PD-1 immunotherapy and standard chemotherapies.

开始日期2019-04-10

申办/合作机构

Trishula Therapeutics, Inc.初创企业

100 项与 Eltivutabart 相关的临床结果

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100 项与 Eltivutabart 相关的转化医学

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100 项与 Eltivutabart 相关的专利（医药）

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项与 Eltivutabart 相关的文献（医药）

2020-01-01·mAbs2区 · 医学

Fully human anti-CD39 antibody potently inhibits ATPase activity in cancer cells via uncompetitive allosteric mechanism

2区 · 医学

Article

作者: Spatola, Bradley N. ; dela Cruz, Tracy ; Losenkova, Karolina ; Lerner, Alana G. ; Kovalenko, Maria ; Fung, Wanchi ; Beers, Courtney ; Corbin, John ; Wong, Clifford ; Welch, Megan ; Soros, Vanessa B. ; Yegutkin, Gennady G.

The extracellular ATP/adenosine axis in the tumor microenvironment (TME) has emerged as an important immune-regulatory pathway. Nucleoside triphosphate diphosphohydrolase-1 (NTPDase1), otherwise known as CD39, is highly expressed in the TME, both on infiltrating immune cells and tumor cells across a broad set of cancer indications. CD39 processes pro-inflammatory extracellular ATP to ADP and AMP, which is then processed by Ecto-5'-nucleotidase/CD73 to immunosuppressive adenosine. Directly inhibiting the enzymatic function of CD39 via an antibody has the potential to unleash an immune-mediated anti-tumor response via two mechanisms: 1) increasing the availability of immunostimulatory extracellular ATP released by damaged and/or dying cells, and 2) reducing the generation and accumulation of suppressive adenosine within the TME. Tizona Therapeutics has engineered a novel first-in-class fully human anti-CD39 antibody, TTX-030, that directly inhibits CD39 ATPase enzymatic function with sub-nanomolar potency. Further characterization of the mechanism of inhibition by TTX-030 using CD39⁺ human melanoma cell line SK-MEL-28 revealed an uncompetitive allosteric mechanism (α < 1). The uncompetitive mechanism of action enables TTX-030 to inhibit CD39 at the elevated ATP concentrations reported in the TME. Maximal inhibition of cellular CD39 ATPase velocity was 85%, which compares favorably to results reported for antibody inhibitors to other enzyme targets. The allosteric mechanism of TTX-030 was confirmed via mapping the epitope to a region of CD39 distant from its active site, which suggests possible models for how potent inhibition is achieved. In summary, TTX-030 is a potent allosteric inhibitor of CD39 ATPase activity that is currently being evaluated in clinical trials for cancer therapy.

项与 Eltivutabart 相关的新闻（医药）

2024-09-22

·药明康德

使88%患者前列腺特异性抗原减少超90%的联合疗法；疾病控制率近90%的ADC疗法…… | 一周盘点

▎药明康德内容团队编辑本期看点 1. 抗体偶联药物（ADC）rinatabart sesutecan（Rina-S）用于治疗表达叶酸受体α（FRα）的晚期卵巢癌患者，在一项早期临床试验中的疾病控制率（DCR）近90%。 2. 第二代抗雄激素药物masofaniten联用恩杂鲁胺（enzalutamide）治疗转移性去势抵抗性前列腺癌（mCRPC）患者的1/2期临床试验结果积极，88%患者的前列腺特异性抗原（PSA）减少≥90%（PSA90）。 3. 抗CD39抗体TTX-030的联合疗法一线治疗转移性胰腺癌，在一项早期临床试验中使3名患者获得完全缓解（CR）。药明康德内容团队整理 Rinatabart Sesutecan（Rina-S）：公布1/2期临床试验数据 Genmab公司公布了其靶向FRα的抗体偶联药物Rina-S的1/2期临床试验数据。Rina-S旨在治疗比第一代FRα靶向ADC更广泛的患者群体。2024年1月，美国FDA授予Rina-S快速通道资格，用于治疗表达FRα的高级别浆液性或子宫内膜样铂耐药卵巢癌患者。该研究的B部分将42名既往接受过治疗的经组织学或细胞学确诊的晚期卵巢癌（上皮性卵巢癌、原发性腹膜癌或输卵管癌）的患者随机分配接受100 mg/m2 Rina-S（n=22）或120 mg/m2 Rina-S（n=20）治疗。接受100 mg/m2 Rina-S治疗患者的确认的客观缓解率（ORR）为18.2%，4名患者获得了部分缓解（PR），15例患者实现疾病稳定（SD），DCR为86.4%。120 mg/m2组患者的ORR为50.0%，1名患者获得CR，4名患者获得了PR，8名患者为SD，DCR为88.9%。基于这些结果，Rina-S 120 mg/m2剂量已被选定在2024年开始的针对晚期卵巢癌患者的3期临床试验中进行进一步评估。安全性方面，该研究中常见的治疗伴发不良事件（TEAE）包括贫血、中性粒细胞减少、恶心、血小板减少、白细胞减少、疲劳、呕吐、脱发和腹泻。剂量减少和治疗中止的情况较少，未观察到眼部毒性、神经病变或间质性肺病（ILD）的信号。 Masofaniten（EPI-7386）：公布1/2期联合治疗临床试验的新数据 ESSA Pharma公司公布了其第二代抗雄激素药物masofaniten与恩杂鲁胺联合治疗转移性去势抵抗性前列腺癌患者的1/2期临床试验的新数据。Masofaniten是一种高选择性的雄激素受体N-末端结构域的口服小分子抑制剂。此次公布的研究结果显示，该组合疗法32个给药周期测试的剂量水平下耐受性良好。无论患者先前的化疗状态如何，包括接受低于全剂量（120 mg）恩杂鲁胺的患者在内，mCRPC患者的PSA都有快速、深度且持久的降低。在所有队列中，88%（14/16）的患者达到了PSA90，69%（11/16）的患者在90天内达到PSA90，63%（10/16）患者达到PSA<0.2 mg/mL的水平。中位随访时间为15.2个月时，PSA进展的中位时间以及影像学无进展生存期尚未达到。 TTX-030：公布1期临床试验数据 Trishula Therapeutics公司公布了其与艾伯维（AbbVie）合作开发的抗CD39抗体TTX-030一线治疗转移性胰腺癌患者的1期临床试验结果。CD39是一种将三磷酸腺苷（ATP）转化为单磷酸腺苷（AMP）的酶，是在肿瘤微环境中生成腺苷的初始步骤。TTX-030能够阻止免疫抑制性胞外腺苷的生成，并维持高水平的免疫激活性胞外ATP，进而刺激树突状细胞和骨髓衍生细胞，促进先天性和适应性抗肿瘤免疫反应。该1期临床试验评估了TTX-030＋吉西他滨/白蛋白结合型紫杉醇联合使用±budigalimab（一种在研PD-1抗体）作为胰腺癌一线治疗的效果。在可评估疗效的人群（n=57）中，92%为一线转移性胰腺癌患者，8%为局部晚期不可切除患者，ORR为30%，其中3名患者获得了CR。中位无进展生存期（PFS）为7.5个月，中位总生存期（OS）为19.1个月。在28名高表达免疫相关生物标志物HLA-DQ的患者中，ORR为46%，中位PFS为9.6个月，中位OS为21.9个月。安全性方面，两种治疗方案的耐受性良好，只有5名患者（8%）因不良事件（AE）中止治疗。最常见的不良事件为标准化疗方案中预期出现的不良反应，未见发生频率或严重程度的增加。 CFT1946：公布1期临床试验数据 C4 Therapeutics公司公布了其小分子降解剂CFT1946治疗携带BRAF V600突变的实体瘤患者的1期临床试验数据。CFT1946可以直接降解突变BRAF蛋白，消除其蛋白支架的功能，从而彻底规避RAF信号的异常激活。在临床前研究中，CFT1946导致BRAF-V600E突变体的降解，显著抑制MAPK信号传导，并且在降低BRAF-V600E细胞生存能力的同时并未影响野生型BRAF细胞。在BRAF V600E小鼠肿瘤模型中，CFT1946也导致肿瘤显著缩小。截至2024年7月19日的数据，27名可评估患者中有16名的靶转移灶缩小，2名患者获得了CR。此外，CFT1946在迄今为止探索的5个剂量水平中表现出剂量依赖性的生物利用度。在迄今为止收集的所有可用的治疗后活检样本中，均观察到BRAF V600E蛋白的降解。安全性方面，CFT1946具有良好的耐受性和安全性，支持其作为单一疗法以及与MEK和EGFR抑制剂联用进行进一步的临床开发。 Brenetafusp（IMC-F106C）：公布1期临床试验数据 Immunocore公司公布了brenetafusp在铂耐药卵巢癌患者中的1期数据。IMC-F106C是一种通过ImmTAX平台开发，靶向PRAME抗原的双特异性蛋白。该研究中，37例既往接受过大量治疗（中位线数为5线）的浆液性卵巢癌患者接受了 brenetafusp单药治疗，大多数患者既往接受过贝伐珠单抗（81%）和PARP抑制剂（59%）。31例可评估患者的DCR为58%，2例患者获得确认的PR。在所有37例患者中，中位PFS为3.3个月，6个月时的总生存率为73%。在可评估循环肿瘤DNA（ctDNA）的29例患者中，31%获得了分子学缓解。 16例既往接受过大量治疗（中位线数为4线）的铂类耐药卵巢癌患者接受了brenetafusp联用化疗的治疗，大多数患者既往接受过贝伐珠单抗（75%）和PARP抑制剂（75%）。Brenetafusp联合化疗的安全性与每种单独药物的预期特征一致。13例可评估患者的DCR为69%，3例患者获得PR。在可评估ctDNA的11例患者中，82%获得了分子学缓解。 IMA401：公布1期临床试验数据 Immatics公司公布了其下一代半衰期延长的T细胞受体（TCR）双特异性抗体平台的首个候选药物IMA401的概念验证临床数据。IMA401靶向HLA-A*02呈递的肽，该肽来源于两种不同的癌症相关蛋白，即黑色素瘤相关抗原4和/或8（MAGEA4/8）。来自首次人体1期剂量递增试验的数据表明，IMA401单药治疗具有初始抗肿瘤活性和可控的耐受性。患者群体包括35名既往接受过大量治疗的患者，共涉及16种不同的实体瘤类型。在MAGEA4/8水平高且接受相关IMA401剂量的患者人群中，ORR为29%，DCR为53%。此外，在头颈部鳞状细胞癌、神经内分泌肿瘤、皮肤和粘膜黑色素瘤患者中观察到客观缓解，包括长达超过13个月的持久PR和深度缓解（肿瘤缩小≥50%）。药代动力学数据表明，IMA401的中位半衰期为16.9天，支持当前的每两周一次的给药方案和未来延长至四周一次的给药方案。 ▲IMA401的概念验证研究数据（图片来源：参考资料[6]） CY-101（CyPep-1）：公布1/2a期临床试验数据 Cytovation公司公布了其双功能免疫疗法CY-101联用抗PD-1疗法帕博利珠单抗治疗晚期实体瘤的1/2a期临床试验结果。CyPep-1是一种独特的、高度差异化的合成肽疗法，它具有独特的双重作用机制，既能通过激活Axin2抑制Wnt/β-catenin致癌通路，还能通过释放新抗原激活全身性肿瘤特异性免疫反应。此次公布的结果显示，在推荐的2期剂量（RP2D）下，CY-101具有良好的耐受性。配对肿瘤活检分析表明，患有不同癌种的患者接受RP2D治疗，癌细胞的死亡率>70%，并转化为临床获益。值得注意的是，在接受CY-101单药治疗的6例肾上腺皮质癌患者中，观察到DCR为50%，2例患者缓解超过6个月。这两名患者均表达β-catenin，且Wnt/β-catenin通路中发生了体细胞突变。 Luveltamab tazevibulin（luvelta）：公布1b期联合治疗临床试验的新数据 Sutro Biopharma公司公布了正在进行的luveltamab tazevibulin（luvelta）联合贝伐珠单抗治疗上皮性卵巢癌患者的1b期研究的最新数据。Luvelta是一种FRα靶向ADC，每个抗体含有4个hemiasterlin细胞毒素，能够精确定位并有效递送至肿瘤，同时确保给药后的全身稳定性。在这项研究中，luvelta联合贝伐珠单抗在晚期卵巢癌患者中显示出令人鼓舞的抗肿瘤活性，无论FRα表达如何（包括没有FRα表达的患者），以及既往接受过贝伐珠单抗治疗的患者，总缓解率为35%，中位缓解持续时间为9.3个月。RP2D组患者的ORR为56%。这些早期数据提示luvelta有望作为一种非生物标志物驱动的方法来治疗上皮性卵巢癌患者。 APV-527：公布1期临床试验数据 Alligator Bioscience公司和Aptevo Therapeutics公司公布了APV-527用于治疗可能表达肿瘤抗原5T4的实体瘤患者的1期临床试验数据。APV-527是一种靶向4-1BB和肿瘤抗原5T4的双特异性抗体，仅在与4-1BB和5T4同时结合时才有活性。此次公布的结果显示，15名疗效可评估的患者中有9名（60%）实现了SD，1名乳腺癌患者已保持SD超过11个月，1名结肠癌患已保持SD超过4个月。安全性方面，APV-527在所有队列中均表现出积极的安全性和耐受性，尚未确定最大耐受剂量。 GV20-0251：公布1期临床试验数据 GV20 Therapeutics公司公布了其靶向新型免疫检查点IGSF8的抗体疗法GV20-0251治疗实体瘤患者的1/2期研究结果。结果显示，29例疗效可评估的患者中有14例获得了SD，包括4例肿瘤缩小。在12例疗效可评估的转移性皮肤黑色素瘤患者中观察到2例确认的PR。安全性方面，GV20-0251在所有剂量水平下均具有良好的耐受性，未观察到剂量限制性毒性。大多数治疗相关不良事件为1/2级，仅报道1例3级肺炎。 ▲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] Investigational Rinatabart Sesutecan (Rina-S) Shows Promising Anti-Tumor Activity as Single Agent in Heavily Pretreated Patients with Ovarian and Endometrial Cancers in Phase 1/2 Clinical Trial. Retrieved September 20, 2024, from https://ir.genmab.com/news-releases/news-release-details/investigational-rinatabart-sesutecan-rina-s-shows-promising-anti [2] ESSA Pharma Presents Updated Phase 1/2 Masofaniten (EPI-7386) Clinical Data at the 2024 ESMO Congress. Retrieved September 20, 2024, from https://www.prnewswire.com/news-releases/essa-pharma-presents-updated-phase-12-masofaniten-epi-7386-clinical-data-at-the-2024-esmo-congress-302248122.html [3] Trishula Therapeutics Presents Positive Results from Phase 1 Trial of TTX-030 in First-Line Metastatic Pancreatic Cancer Patients. Retrieved September 20, 2024, from https://www.prnewswire.com/news-releases/trishula-therapeutics-presents-positive-results-from-phase-1-trial-of-ttx-030-in-first-line-metastatic-pancreatic-cancer-patients-302247474.html [4] C4 Therapeutics Presents Monotherapy Data Demonstrating Proof of Mechanism and Early Evidence of Proof of Concept From Ongoing CFT1946 Phase 1 Trial in BRAF V600 Mutant Solid Tumors at the European Society for Medical Oncology (ESMO) Congress 2024. Retrieved September 20, 2024, from https://www.globenewswire.com/news-release/2024/09/13/2946010/0/en/C4-Therapeutics-Presents-Monotherapy-Data-Demonstrating-Proof-of-Mechanism-and-Early-Evidence-of-Proof-of-Concept-From-Ongoing-CFT1946-Phase-1-Trial-in-BRAF-V600-Mutant-Solid-Tumor.html [5] Immunocore presents Phase 1 data of brenetafusp, an ImmTAC bispecific targeting PRAME, in patients with ovarian cancer. Retrieved September 20, 2024, from https://www.globenewswire.com/news-release/2024/09/14/2946230/0/en/Immunocore-presents-Phase-1-data-of-brenetafusp-an-ImmTAC-bispecific-targeting-PRAME-in-patients-with-ovarian-cancer.html [6] Immatics Presents Clinical Proof-of-Concept Data from Ongoing Phase 1 Dose Escalation Trial with TCR Bispecific Molecule TCER® IMA401 Targeting MAGEA4/8 at ESMO 2024 and Provides Development Update. Retrieved September 20, 2024, from https://investors.immatics.com/news-releases/news-release-details/immatics-presents-clinical-proof-concept-data-ongoing-phase-1-0/ [7] Cytovation to present full safety and efficacy data from the CICILIA Phase I/IIa trial evaluating CY-101 in solid tumors at ESMO 2024. Retrieved September 20, 2024, from https://www.globenewswire.com/news-release/2024/09/13/2945717/0/en/Cytovation-to-present-full-safety-and-efficacy-data-from-the-CICILIA-Phase-I-IIa-trial-evaluating-CY-101-in-solid-tumors-at-ESMO-2024.html#:~:text=Cytovation%20to%20present%20full%20safety%20and%20efficacy%20data,activity%2C%20especially%20in%20tumors%20with%20dysregulated%20Wnt%2F%CE%B2-catenin%20signalling [8] Alligator Bioscience and Aptevo Therapeutics Announce Data from Phase 1 ALG.APV-527 Monotherapy Trial Showing 60% of Evaluable Patients Achieved Stable Disease in Solid Tumor Study. Retrieved September 20, 2024, from https://alligatorbioscience.se/en/mfn_news/alligator-bioscience-and-aptevo-therapeutics-announce-data-from-phase-1-alg-apv-527-monotherapy-trial-showing-60-of-evaluable-patients-achieved-stable-disease-in-solid-tumor-study/ [9] Sutro Biopharma Announces Updated Data from Phase 1b Study of Luvelta in Combination with Bevacizumab at ESMO 2024. Retrieved September 20, 2024, from https://www.globenewswire.com/news-release/2024/09/14/2946228/0/en/Sutro-Biopharma-Announces-Updated-Data-from-Phase-1b-Study-of-Luvelta-in-Combination-with-Bevacizumab-at-ESMO-2024.html [10] GV20 Therapeutics Presents Promising Phase 1 Monotherapy Data on Novel Checkpoint Inhibitor GV20-0251 at ESMO Congress 2024. Retrieved September 20, 2024, from https://www.prnewswire.com/news-releases/gv20-therapeutics-presents-promising-phase-1-monotherapy-data-on-novel-checkpoint-inhibitor-gv20-0251-at-esmo-congress-2024-302247149.html [11] AAVantgarde announces first patient dosed in First-In-Human Phase 1/2 LUCE-1 study, evaluating AAVB-081 (Dual-AAV) in retinitis pigmentosa related to Usher Syndrome type 1B. Retrieved September 20, 2024, from https://www.globenewswire.com/news-release/2024/09/16/2946331/0/en/AAVantgarde-announces-first-patient-dosed-in-First-In-Human-Phase-1-2-LUCE-1-study-evaluating-AAVB-081-Dual-AAV-in-retinitis-pigmentosa-related-to-Usher-Syndrome-type-1B.html [12] Biosyngen's first-in-class CAR-T asset targeting solid tumors has entered pivotal phase II trial, Phase I trial data debut at ESMO 2024 Annual Congress. Retrieved September 20, 2024, from https://www.prnewswire.com/news-releases/biosyngens-first-in-class-car-t-asset-targeting-solid-tumors-has-entered-pivotal-phase-ii-trial-phase-i-trial-data-debut-at-esmo-2024-annual-congress-302251709.html [13] Vico Therapeutics Announces Positive Interim Phase 1/2a Clinical Data of VO659 in Treatment of Huntington's Disease. Retrieved September 20, 2024, from https://www.prnewswire.com/news-releases/vico-therapeutics-announces-positive-interim-phase-12a-clinical-data-of-vo659-in-treatment-of-huntingtons-disease-302247239.html [14] Cybrexa Therapeutics Announces Positive Final Data at ESMO 2024 from Phase 1 Study of Peptide Drug Conjugate CBX-12 in Advanced Solid Tumors. Retrieved September 20, 2024, from https://www.globenewswire.com/news-release/2024/09/16/2946456/0/en/Cybrexa-Therapeutics-Announces-Positive-Final-Data-at-ESMO-2024-from-Phase-1-Study-of-Peptide-Drug-Conjugate-CBX-12-in-Advanced-Solid-Tumors.html [15] Cullinan Therapeutics Announces Submission of Investigational New Drug Application to U.S. Food and Drug Administration for CLN-978 to Treat Systemic Lupus Erythematosus. Retrieved September 20, 2024, from https://www.globenewswire.com/news-release/2024/09/16/2946504/0/en/Cullinan-Therapeutics-Announces-Submission-of-Investigational-New-Drug-Application-to-U-S-Food-and-Drug-Administration-for-CLN-978-to-Treat-Systemic-Lupus-Erythematosus.html [16] TORL BioTherapeutics Presents Updated Phase 1 Results of Novel Claudin 6 Targeted Antibody-Drug Conjugate TORL-1-23 at the 2024 European Society of Medical Oncology Congress. Retrieved September 20, 2024, from https://www.prnewswire.com/news-releases/torl-biotherapeutics-presents-updated-phase-1-results-of-novel-claudin-6-targeted-antibody-drug-conjugate-torl-1-23-at-the-2024-european-society-of-medical-oncology-congress-302248489.html [17] NextCure Presented Results of the Phase 1b Study of NC410 in Combination with Pembrolizumab at ESMO 2024. Retrieved September 20, 2024, from https://www.globenewswire.com/news-release/2024/09/16/2946611/0/en/NextCure-Presented-Results-of-the-Phase-1b-Study-of-NC410-in-Combination-with-Pembrolizumab-at-ESMO-2024.html [18] Sonnet BioTherapeutics Completes Enrollment in Phase 1 Study of SON-1010 (IL12-FHAB) as a Monotherapy (SB101) for the Treatment of Solid Tumors. Retrieved September 20, 2024, from https://www.sonnetbio.com/news-media/press-releases/detail/97/sonnet-biotherapeutics-completes-enrollment-in-phase-1 [19] Engrail Therapeutics Initiates ENX-104 Clinical Program for the Treatment of Major Depressive Disorder Characterized by Anhedonia. Retrieved September 20, 2024, from https://www.globenewswire.com/news-release/2024/09/18/2948077/0/en/Engrail-Therapeutics-Initiates-ENX-104-Clinical-Program-for-the-Treatment-of-Major-Depressive-Disorder-Characterized-by-Anhedonia.html [20] Antennova Releases Latest Data of CD73 Inhibitor ATN-037, including a DCR of 89.5%, in a Mini Oral at ESMO Congress 2024. Retrieved September 20, 2024, from https://www.prnewswire.com/news-releases/antennova-releases-latest-data-of-cd73-inhibitor-atn-037--including-a-dcr-of-89-5-in-a-mini-oral-at-esmo-congress-2024--302247371.html [21] Incyte’s CDK2 Inhibitor INCB123667 Shows Promising Evidence of Clinical Activity in Patients with Advanced Solid Tumors, Notably Ovarian Cancer. Retrieved September 20, 2024, from https://investor.incyte.com/news-releases/news-release-details/incytes-cdk2-inhibitor-incb123667-shows-promising-evidence [22] Eisbach Bio Announces First Patient Dosed in Phase 1/2 Trial for EIS-12656, a First-In-Class Allosteric Inhibitor of ALC1 in Refractory Advanced Solid Tumors. Retrieved September 20, 2024, from https://www.globenewswire.com/news-release/2024/09/16/2946482/0/en/Eisbach-Bio-Announces-First-Patient-Dosed-in-Phase-1-2-Trial-for-EIS-12656-a-First-In-Class-Allosteric-Inhibitor-of-ALC1-in-Refractory-Advanced-Solid-Tumors.html [23] Nxera’s Partner Cancer Research UK to Present on Phase 1/2a Clinical Trial with Cancer Immunotherapy Drug HTL0039732 at ESMO. Retrieved September 20, 2024, from https://www.globenewswire.com/news-release/2024/09/13/2945711/0/en/Nxera-s-Partner-Cancer-Research-UK-to-Present-on-Phase-1-2a-Clinical-Trial-with-Cancer-Immunotherapy-Drug-HTL0039732-at-ESMO.html [24] Scorpion Therapeutics Presents Initial Clinical Data from Its Phase 1/2 Trial of STX-478 Demonstrating Potentially Best-in-Class Mutant-Selective PI3Kα Inhibition for the Treatment of Advanced Solid Tumors at ESMO Congress 2024. Retrieved September 20, 2024, from https://www.scorpiontx.com/press-release/scorpion-therapeutics-presents-initial-clinical-data-from-its-phase-1-2-trial-of-stx-478-demonstrating-potentially-best-in-class-mutant-selective-pi3k%ce%b1-inhibition-for-the-treatment-of-advanced-so/ [25] Satellos Announces Dosing of First Participant in Phase 1 Clinical Study of SAT-3247. Retrieved September 20, 2024, from https://www.businesswire.com/news/home/20240918008946/en/Satellos-Announces-Dosing-of-First-Participant-in-Phase-1-Clinical-Study-of-SAT-3247 [26] Anokion Announces New Data from the Phase 1 MoveS-it Study Supporting ANK-700 as a Novel, Potential Disease Modifying Treatment for Relapsing-Remitting Multiple Sclerosis. Retrieved September 20, 2024, from https://www.businesswire.com/news/home/20240917374019/en/Anokion-Announces-New-Data-from-the-Phase-1-MoveS-it-Study-Supporting-ANK-700-as-a-Novel-Potential-Disease-Modifying-Treatment-for-Relapsing-Remitting-Multiple-Sclerosis [27] Tectonic Therapeutic Announces Favorable Phase 1a Safety, Tolerability and PK/PD Results for Lead Program TX45. Retrieved September 20, 2024, from https://www.globenewswire.com/news-release/2024/09/19/2949404/0/en/Tectonic-Therapeutic-Announces-Favorable-Phase-1a-Safety-Tolerability-and-PK-PD-Results-for-Lead-Program-TX45.html [28] Beacon Therapeutics Presents 36-Month Interim Results from Phase I/2 HORIZON Trial of AGTC-501 in Patients with XLRP. Retrieved September 20, 2024, from https://www.prnewswire.com/news-releases/beacon-therapeutics-presents-36-month-interim-results-from-phase-i2-horizon-trial-of-agtc-501-in-patients-with-xlrp-302252375.html [29] Edgewise Therapeutics Announces Positive Top-Line Data from Phase 1 Trial in Healthy Subjects and Phase 2 CIRRUS-HCM Trial in Patients with Obstructive Hypertrophic Cardiomyopathy (HCM). Retrieved September 20, 2024, from https://www.businesswire.com/news/home/20240919115598/en/Edgewise-Therapeutics-Announces-Positive-Top-Line-Data-from-Phase-1-Trial-in-Healthy-Subjects-and-Phase-2-CIRRUS-HCM-Trial-in-Patients-with-Obstructive-Hypertrophic-Cardiomyopathy-HCM [30] TransCode Therapeutics Announces First Patients Treated in Phase 1 Clinical Trial with First-in-Class Lead Therapeutic Candidate. Retrieved September 20, 2024, from https://www.globenewswire.com/news-release/2024/09/17/2947285/0/en/TransCode-Therapeutics-Announces-First-Patients-Treated-in-Phase-1-Clinical-Trial-with-First-in-Class-Lead-Therapeutic-Candidate.html [31] Prelude Therapeutics’ SMARCA2 Degrader PRT3789 Demonstrated Promising Initial Clinical Activity and Safety Profile in Phase 1 Trial. Retrieved September 20, 2024, from https://investors.preludetx.com/news-releases/news-release-details/prelude-therapeutics-smarca2-degrader-prt3789-demonstrated [32] Botensilimab/Balstilimab Clinical Responses in Refractory Sarcomas Presented at ESMO 2024. Retrieved September 20, 2024, from https://investor.agenusbio.com/news/news-details/2024/BotensilimabBalstilimab-Clinical-Responses-in-Refractory-Sarcomas-Presented-at-ESMO-2024/default.aspx [33] CureVac’s CVGBM Cancer Vaccine Induces Promising Immune Responses in Phase 1 Study in Glioblastoma Presented at the ESMO 2024 Congress. Retrieved September 20, 2024, from https://www.curevac.com/en/curevacs-cvgbm-cancer-vaccine-induces-promising-immune-responses-in-phase-1-study-in-glioblastoma-presented-at-the-esmo-2024-congress/ 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床结果快速通道临床2期抗体药物偶联物

2024-09-16

·PRNewswire

Trishula Therapeutics Presents Positive Results from Phase 1 Trial of TTX-030 in First-Line Metastatic Pancreatic Cancer Patients

Results presented at ESMO Congress 2024 SOUTH SAN FRANCISCO, Calif., Sept. 16, 2024 /PRNewswire/ -- Trishula Therapeutics, Inc., a clinical stage, privately held biotechnology company, today reported final results from a Phase 1 trial of TTX-030, a potential first-in-class, anti-CD39 antibody, in patients with first-line metastatic pancreatic cancer. Results were presented at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain. "The Phase 1 results demonstrated a strong median overall survival in patients with metastatic pancreatic cancer following treatment with TTX-030 combinations as well as marked benefit in those with high levels of tumor HLA-DQ biomarker expression," said Anil Singhal, Chief Executive Officer of Trishula Therapeutics. "These findings have led to our currently enrolling global, randomized Phase 2 ELTIVATE study with results expected in 2026." The Phase 1 trial evaluated TTX-030 in combination with gemcitabine/nab-paclitaxel, with or without budigalimab (an investigational anti-PD-1 antibody), as first-line treatment for pancreatic adenocarcinoma. In the efficacy-evaluable population (n=57) consisting of 92% first-line metastatic and 8% locally advanced nonresecetable patients, the objective response rate (ORR) was 30%, with 3 complete responses; the median progression free survival (mPFS) was 7.5 months (95%CI 5.2, 9.4); and median overall survival was 19.1 months (9.8, NR). Analysis of pre-treatment tumor biopsies identified a subset of patients with a high expression of an immune-associated biomarker, HLA-DQ (HLA-DQhigh) and favorable clinical outcomes with TTX-030 combinations. Of the 28 HLA-DQhigh patients, the ORR was 46%, mPFS was 9.6 months (95% CI 3.9, 11.8), and mOS of 21.9 months (9.8, NR). Both treatment combinations were well-tolerated, with only five patients (8%) discontinuing treatment due to adverse events (AEs). The most frequent AEs were those expected from the standard of care chemotherapy backbone without an increase in frequency or severity. "Prior evaluation of immune checkpoint treatment has demonstrated limited benefit in this patient population and new approaches are needed. These results are very encouraging, especially in the biomarker high patients and warrant further investigation of TTX-030 for patients with advanced pancreatic cancer," said Zev Wainberg, MD, Professor of Medicine, UCLA. TTX-030 is currently being evaluated as first-line treatment for metastatic pancreatic adenocarcinoma in the global Phase 2 ELTIVATE trial (NCT06119217) that is randomizing approximately 180 patients into three study arms: TTX-030 and chemotherapy (gemcitabine and nab-paclitaxel); TTX-030 plus budigalimab and chemotherapy; or chemotherapy alone. The primary endpoint of the trial is progression-free survival (PFS) in a biomarker-enriched (HLA-DQhigh) population. Secondary endpoints include PFS in the overall population, safety, objective response rate, duration of response and overall survival. Further information on the study can be found at (clinicaltrials.gov link). About TTX-030 TTX-030 is a potential first-in-class, anti-CD39 antibody designed to inhibit the activity of CD39, an enzyme that converts adenosine triphosphate (ATP) to adenosine monophosphate (AMP), the initial step in the generation of adenosine in the tumor microenvironment. TTX-030 prevents the formation of immune-suppressive extracellular adenosine and maintains high levels of immune-activating extracellular ATP, stimulating dendritic and myeloid-derived cells promoting both innate and adaptive anti-tumor immunity. Trishula is continuing to develop TTX-030 in collaboration with AbbVie Inc. About Trishula Trishula is a privately held biotechnology company dedicated to the development of TTX-030. For more information, please visit . Media Contact: Julie Rathbun Rathbun Communications [email protected] 206-769-9219 SOURCE Trishula Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果临床2期临床1期免疫疗法

2024-02-07

·FierceBiotech

Gilead will not buy Tizona after paying $300M for the right to do so

Gilead's agreement with Tizona centered on a novel checkpoint inhibitor targeting HLA-G. Gilead will not buy immunotherapy biotech Tizona Therapeutics, backing out of an option that the company paid $300 million for in 2020. The pharma's opt-in oncology program with the biotech was absent from the company’s pipeline as of the end of 2023. Now, Gilead has confirmed in an email to Fierce Biotech that it will not opt into the deal. Gilead invested $300 million in Tizona back in July 2020 for nearly 50% of the company and exclusive rights to buy out the remainder for up to an additional $1.25 billion. At the center of the deal was TTX-080, a novel checkpoint inhibitor targeting HLA-G, that was on the precipice of a phase 1 trial at the time the deal was announced. The trial has been ongoing for more than three years, testing TTX-080 as both a monotherapy and as a combo treatment with either Keytruda or Erbitux. An update to the clinical trial record posted a month ago deleted text in the description that said the study was enrolling in the dose expansion arms. When announced, then-Tizona CEO Scott Clarke said that the deal would help fund further TTX-080 development but also advance “our rich, first-in-class preclinical portfolio and target validation efforts.” But no new programs are listed beyond TTX-080, and the “undisclosed programs” in the pipeline remain in the discovery stage. As part of the Gilead deal, Tizona spun off its AbbVie-partnered antibody, TTX-030, into a separate entity. Large equity deals have become a staple of Gilead’s business development efforts, with at least two announced in the last year. The Foster City pharma now owns a third of Arcus after a $320 million equity investment last month. And in October 2023, Gilead bought $15.2 million in equity of Assembly Bio, representing 19.9% of outstanding shares. Subject to certain conditions, GIlead agreed to buy up to 29.9% of outstanding shares at a premium. The deal with Assembly, which included $84.8 million upfront, gives Gilead first dibs to all of Assembly’s current and future programs throughout the 12-year deal.

临床1期并购引进/卖出免疫疗法

100 项与 Eltivutabart 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
转移性胰腺导管腺癌	临床2期	美国	Trishula Therapeutics, Inc.初创企业	2024-03-25
转移性胰腺导管腺癌	临床2期	澳大利亚	Trishula Therapeutics, Inc.初创企业	2024-03-25
转移性胰腺导管腺癌	临床2期	法国	Trishula Therapeutics, Inc.初创企业	2024-03-25
转移性胰腺导管腺癌	临床2期	意大利	Trishula Therapeutics, Inc.初创企业	2024-03-25
转移性胰腺导管腺癌	临床2期	韩国	Trishula Therapeutics, Inc.初创企业	2024-03-25
转移性胰腺导管腺癌	临床2期	西班牙	Trishula Therapeutics, Inc.初创企业	2024-03-25
转移性胰腺导管腺癌	临床2期	中国台湾	Trishula Therapeutics, Inc.初创企业	2024-03-25
胃食管交界处癌	临床1期	-	Tizona Therapeutics, Inc.初创企业	2022-04-13
晚期恶性实体瘤	临床1期	美国	Trishula Therapeutics, Inc.初创企业	2020-03-30
晚期恶性实体瘤	临床1期	韩国	Trishula Therapeutics, Inc.初创企业	2020-03-30

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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


NCT04306900 (ESMO2024) 人工标引	临床2期	晚期胰腺腺癌一线 HLA-DQ	59	TTX-030 40mg/kg budigalimab 20mg/kg every two weeks	襯簾鏇鹽壓築遞鹹鏇繭(選遞鑰觸廠鹹襯膚鏇網) = neutrophil count decreased (41%), neutropenia (22%), anaemia (20%), fatigue (12%) and ALT increased (10%). 獵獵遞膚糧廠襯積廠淵 (蓋膚範遞選鏇襯簾壓願 )	积极	2024-09-14
NCT04306900 (ESMO2024) 人工标引	临床2期	晚期胰腺腺癌一线 HLA-DQ	59	TTX-030/TTX-030TTX-030+budigalimab (HLA-DQ high)		积极	2024-09-14
TTX-030-002 (AACR2022)	N/A	胃食管交界处癌	-	TTX-030	蓋蓋鑰鬱繭窪憲淵蓋簾(鹹壓夢觸繭顧鬱夢獵鹹) = 餘蓋構製鹹衊顧網蓋襯蓋鬱齋網餘製簾顧鏇壓 (蓋範糧鹽簾蓋憲淵觸範 )	-	2022-06-15
NCT03884556 \| NCT04306900 (Biospace) 人工标引	临床1期	胃食管交界处癌 \| 胃癌一线	44	TTX-030	願觸膚鹽醖窪願築鬱餘(齋鬱糧顧遞獵顧願餘夢) = 獵餘鏇鏇遞糧製齋壓遞壓淵願獵範網願蓋鹹積 (淵製夢窪製齋範願糧餘 ) 更多	积极	2022-04-12