A Phase I Open-Label, Dose-escalation Trial of Tumor Necrosis Factor Alpha and Interleukin-2 Coding Oncolytic Adenovirus (TILT-123) in Combination With Pembrolizumab in Patients With Immune Checkpoint Inhibitor Refractory Non-Small Cell Lung Cancer

This is an open label, Phase 1, dose escalation trial evaluating the safety of oncolytic adenovirus TILT-123 in combination with Pembrolizumab in patients with immune checkpoint inhibitor refractory non-small cell lung cancer.

开始日期2024-03-20

申办/合作机构

TILT Biotherapeutics Oy

[+1]

NCT05222932 / Recruiting临床1期

A Phase I Open-Label, Dose-escalation Clinical Trial of Tumor Necrosis Factor Alpha and IL-2 Coding Oncolytic Adenovirus TILT-123 and Avelumab in Solid Tumor Patients (Melanoma and SCCHN) Refractory to or Progressing After Anti-PD(L)1

This is a phase 1, dose-escalation trial evaluating the safety of oncolytic adenovirus TILT-123 in combination with avelumab in patients with advanced solid tumors refractory to or progressing after anti-PD(L)1.

开始日期2023-03-08

申办/合作机构

TILT Biotherapeutics Oy

NCT05271318 / Recruiting临床1期

A Two-part, Phase I/Ib, Open-Label, Dose-escalation Trial of Tumor Necrosis Factor Alpha and Interleukin-2 Coding Oncolytic Adenovirus (TILT-123) in Combination With Pembrolizumab (Phase I Part) and Pembrolizumab and Pegylated Liposomal Doxorubicin (Phase Ib Part) in Patients With Platinum Resistant or Refractory Ovarian Cancer.

This is an open-label, phase 1, dose-escalation, multicenter and multinational trial evaluating the safety of oncolytic adenovirus TILT-123 in combination with Pembrolizumab, or Pembrolizumab and Pegylated Liposomal Doxorubicin in patients with platinum resistant or refractory ovarian cancer.

开始日期2022-05-17

申办/合作机构

TILT Biotherapeutics Oy

[+1]

100 项与 Igrelimogene litadenorepvec 相关的临床结果

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100 项与 Igrelimogene litadenorepvec 相关的转化医学

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100 项与 Igrelimogene litadenorepvec 相关的专利（医药）

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项与 Igrelimogene litadenorepvec 相关的文献（医药）

2023-12-31·Oncoimmunology

Effective intravenous delivery of adenovirus armed with TNFα and IL-2 improves anti-PD-1 checkpoint blockade in non-small cell lung cancer

Article

作者: Räsänen, Jari ; Aaltonen, Eero ; Hemminki, Otto ; Quixabeira, Dafne C A ; Havunen, Riikka ; Borenius, Kristian ; Lähdeniemi, Iris A K ; Mäyränpää, Mikko I ; Sutinen, Eva ; Santos, Joao M ; Pakola, Santeri ; Arias, Victor ; Clubb, James H A ; Cervera-Carrascon, Victor ; Verschuren, Emmy W ; Hemminki, Akseli ; Kudling, Tatiana V ; Kanerva, Anna ; Sorsa, Suvi ; Ilonen, Ilkka ; Heiniö, Camilla

Lung cancer remains among the most difficult-to-treat malignancies and is the leading cause of cancer-related deaths worldwide. The introduction of targeted therapies and checkpoint inhibitors has improved treatment outcomes; however, most patients with advanced-stage non-small cell lung cancer (NSCLC) eventually fail these therapies. Therefore, there is a major unmet clinical need for checkpoint refractory/resistant NSCLC. Here, we tested the combination of aPD-1 and adenovirus armed with TNFα and IL-2 (Ad5-CMV-mTNFα/mIL-2) in an immunocompetent murine NSCLC model. Moreover, although local delivery has been standard for virotherapy, treatment was administered intravenously to facilitate clinical translation and putative routine use. We showed that treatment of tumor-bearing animals with aPD-1 in combination with intravenously injected armed adenovirus significantly decreased cancer growth, even in the presence of neutralizing antibodies. We observed an increased frequency of cytotoxic tumor-infiltrating lymphocytes, including tumor-specific cells. Combination treatment led to a decreased percentage of immunosuppressive tumor-associated macrophages and an improvement in dendritic cell maturation. Moreover, we observed expansion of the tumor-specific memory T cell compartment in secondary lymphoid organs in the group that received aPD-1 with the virus. However, although the non-replicative Ad5-CMV-mTNFα/mIL-2 virus allows high transgene expression in the murine model, it does not fully reflect the clinical outcome in humans. Thus, we complemented our findings using NSCLC ex vivo models fully permissive for the TNFα and IL-2- armed oncolytic adenovirus TILT-123. Overall, our data demonstrate the ability of systemically administered adenovirus armed with TNFα and IL-2 to potentiate the anti-tumor efficacy of aPD-1 and warrant further investigation in clinical trials.

2020-06-01·Molecular therapy oncolytics2区 · 医学

Comparison of Clinically Relevant Oncolytic Virus Platforms for Enhancing T Cell Therapy of Solid Tumors

2区 · 医学

ArticleOA

作者: Zafar, Sadia ; Santos, Joao M ; Quixabeira, Dafne C A ; Havunen, Riikka ; Koivula, Teija ; Lumen, Dave ; Hemminki, Akseli ; Anttila, Marjukka ; Kanerva, Anna ; Garcia-Horsman, Arturo ; Sorsa, Suvi ; Heiniö, Camilla ; Vaha, Marjo ; Airaksinen, Anu J ; Cervera-Carrascon, Victor ; Clubb, James H A ; Kutvonen, Emma ; Hukkanen, Veijo ; Siurala, Mikko

Despite some promising results, the majority of patients do not benefit from T cell therapies, as tumors prevent T cells from entering the tumor, shut down their activity, or downregulate key antigens. Due to their nature and mechanism of action, oncolytic viruses have features that can help overcome many of the barriers currently facing T cell therapies of solid tumors. This study aims to understand how four different oncolytic viruses (adenovirus, vaccinia virus, herpes simplex virus, and reovirus) perform in that task. For that purpose, an immunocompetent in vivo tumor model featuring adoptive tumor-infiltrating lymphocyte (TIL) therapy was used. Tumor growth control (p < 0.001) and survival analyses suggest that adenovirus was most effective in enabling T cell therapy. The complete response rate was 62% for TILs + adenovirus versus 17.5% for TILs + PBS. Of note, TIL biodistribution did not explain efficacy differences between viruses. Instead, immunostimulatory shifts in the tumor microenvironment mirrored efficacy results. Overall, the use of oncolytic viruses can improve the utility of T cell therapies, and additional virus engineering by arming with transgenes can provide further antitumor effects. This phenomenon was seen when an unarmed oncolytic adenovirus was compared to Ad5/3-E2F-d24-hTNFa-IRES-hIL2 (TILT-123). A clinical trial is ongoing, where patients receiving TIL treatment also receive TILT-123 (ClinicalTrials.gov: NCT04217473).

2020-01-01·Oncoimmunology2区 · 医学

Tumor microenvironment remodeling by an engineered oncolytic adenovirus results in improved outcome from PD-L1 inhibition

2区 · 医学

ArticleOA

作者: Havunen, Riikka ; Santos, Joao Manuel ; Zafar, Sadia ; Sorsa, Suvi ; Mildh, Markus ; Munaro, Eleonora ; Hemminki, Akseli ; Rannikko, Antti ; Järvinen, Petrus ; Quixabeira, Dafne C.A. ; Hemminki, Otto ; Anttila, Marjukka ; Mirtti, Tuomas ; Kanerva, Anna ; Siurala, Mikko ; Cervera-Carrascon, Victor ; Heiniö, Camilla ; Nisen, Harry

Checkpoint inhibitors have revolutionized cancer therapy and validated immunotherapy as an approach. Unfortunately, responses are seen in a minority of patients. Our objective is to use engineered adenoviruses designed to increase lymphocyte trafficking and cytokine production at the tumor, to assess if they increase the response rate to checkpoint inhibition, as these features have been regarded as predictive for the responses. When Ad5/3-E2F-d24-hTNFa-IRES-hIL2 (an oncolytic adenovirus coding for TNFa and IL-2, also known as TILT-123) and checkpoint inhibitors were used together in fresh urological tumor histocultures, a significant shift toward immune activity (not only tumor necrosis alpha and interleukin-2 but also interferon gamma and granzyme B) and increased T-cell trafficking signals (CXCL10) was observed. In vivo, our viruses enabled an anti-PD-L1 (a checkpoint inhibitor) delivering complete responses in all the treated animals (hazard ratios versus anti-PD-L1 alone 0.057 [0.007; 0.451] or virotherapy alone 0.067 [0.011; 0.415]). To conclude, when an engineered oncolytic adenovirus was utilized to modify the tumor microenvironment towards what meta-analyses have pointed as predictive markers for checkpoint inhibitory therapy, the response to them increased synergistically. Of note, key findings were confirmed in fresh patient-derived tumor explants.

项与 Igrelimogene litadenorepvec 相关的新闻（医药）

2024-05-28

·BioSpace

TILT Biotherapeutics Presents Clinical Data on TILT-123 in Ovarian Cancer at ASCO 2024

Results reinforce potential to develop TILT-123 as a systemic therapy HELSINKI, Finland, May 28, 2024 (GLOBE NEWSWIRE) -- TILT Biotherapeutics (TILT), a clinical-stage biotechnology company developing cancer immunotherapies, announces that it will present two abstracts at the American Society of Clinical Oncology (ASCO) Annual Meeting 2024. Abstract (5562) demonstrates promising safety and efficacy data of TILT-123 in ovarian cancer patients, whilst abstract (2658) demonstrates the potential for TILT-123 as an intravenous therapy. Abstract (5562)* covers the results of a Phase I clinical trial of TILT-123 in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab), for the treatment of platinum-resistant or -refractory ovarian cancer, demonstrating the combination is safe and appears to induce disease control in a difficult-to-treat patient population. 14 patients (out of 15 enrolled) were evaluable for treatment response, with disease control achieved in 64.3%. Analysis of biological samples indicated the presence of TILT-123 and induction of T cells in injected and non-injected lesions. Long term survival was seen in some patients: Median progression free survival (PFS) and overall survival (OS) in all patients were 105 and 280 days. In patients with stable disease (SD) on day 92 by RECIST 1.1, median PFS was 174 days and median OS was 293 days. Abstract (2658) introduces the development of oncolytic adenovirus TILT-123 as an intravenous (IV) therapy. Results across three Phase I trials showed that IV delivery results in systemic tumor transduction and accumulation of lymphocytes at tumors. This means TILT-123 reached tumors, despite not being directly injected into them, and successfully triggered an immune system toward the cancer. The IV injection of TILT-123 results in persistence of the virus in peripheral blood for up to 7 days. Tumor transduction was observed in 75% of patients in three Phase I trials on day 8 post TILT-123 systemic administration. TILT Biotherapeutics’ founder and CEO, Akseli Hemminki, a cancer clinician who has personally treated hundreds of cancer patients with oncolytic viruses, said “This data presented at ASCO 2024 provides additional validation as we move forward in our clinical trials for patients with resistant or refractory ovarian cancer that have few other treatment options.” TILT-123, an oncolytic adenovirus armed with tumor necrosis factor alpha (TNFα) and interleukin-2 (IL-2), is designed to enhance the efficacy of T-cell therapies, including immune checkpoint blockade or adoptive cell transfer. TILT’s approach uses oncolytic viruses to selectively replicate in and lyse cancer cells, while simultaneously stimulating immune responses towards the tumor. References: Abstract (5562): Poster #433 presented 3 June at 09:00-12:00 Abstract (2658): Poster #137 presented 1 June at 09:00-12:00 *The work was supported by the Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense, in the amount of $2,098,194.00, through the Ovarian Cancer Research Program under Award No. HT9425-23-1-0988. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Assistant Secretary of Defense for Health Affairs or the Department of Defense. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Notes to Editors About TILT Biotherapeutics TILT Biotherapeutics is a clinical-stage biotechnology company developing cancer therapeutics based on its proprietary oncolytic adenoviruses armed with molecules including cytokines that can activate T cells and destroy cancer cells. The company’s patented TILT® technology can be delivered intravenously, locoregionally, or intratumorally. It modifies the tumor microenvironment and has a broader systemic effect. By making cold tumors hot, it eliminates cancer’s ability to evade immune responses, thereby enhancing T-cell therapies such as immune checkpoint inhibitors, tumor infiltrating lymphocyte (TIL) therapy, and CAR T therapies. TILT’s lead asset, TILT-123 also known as Igrelimogene litadenorepvec, is a 5/3 chimeric serotype adenovirus armed with two human cytokines: TNF alpha and IL-2. About fifty patients have been treated in four international trials sponsored by the company with promising initial efficacy responses observed in some of the patients. The company’s pioneering approach has been recognized by industry leaders. It has two collaborations with MSD (Merck & Co., Inc., Rahway, NJ, USA) investigating TILT-123 in combination with KEYTRUDA® (pembrolizumab) in ovarian cancer (NCT05271318) and in refractory non-small cell lung cancer (NCT06125197). The company is also collaborating with Merck KGaA, Darmstadt, Germany, and investigating TILT-123 in combination with avelumab. Based in Helsinki, Finland, and with an office in Boston, the company was established over a decade ago as a spin-out from the University of Helsinki. It has funding from Lifeline Ventures, Finnish Industry Investment (TESI), angel investors, Business Finland, the European Innovation Council, and the U.S. Department of Defense. Media contacts TILT Biotherapeutics COO Aino Kalervo aino@tiltbio.com Scius Communications Katja Stout +447789435990 katja@sciuscommunications.com Daniel Gooch +447747875479 daniel@sciuscommunications.com

临床结果临床1期免疫疗法ASCO会议

2024-04-14

·药明康德

完全缓解率达83%的联合疗法；疾病控制率近95%的肺癌免疫联合疗法 | 一周盘点

▎药明康德内容团队编辑本期看点1. 个体化治疗性癌症疫苗GNOS-PV02联用PD-1抑制剂与PD-1抑制剂单药相比，在一项早期临床试验中使晚期肝癌患者的总缓解率（ORR）近翻倍，患者的中位总生存期（mOS）获大幅延长。2. 癌症疫苗PDC*lung01联用PD-1抑制剂一线治疗转移性非小细胞肺癌（NSCLC），在一项1/2期临床试验中的疾病控制率（DCR）高达94.7%。3. CD47抑制剂evorpacept联用利妥昔单抗和来那度胺治疗惰性和侵袭性复发/难治性B细胞非霍奇金淋巴瘤（B-NHL），在一项1/2期临床试验中的ORR为94%，完全缓解（CR）率为83%。4. 长效IL-2超级激动剂MDNA11治疗晚期实体肿瘤，使1例转移性胰腺导管腺癌（PDAC）患者在基线时存在的所有病变完全消退。药明康德内容团队整理GNOS-PV02：公布1/2期临床试验数据Geneos Therapeutics公司公布其个体化治疗性癌症疫苗GNOS-PV02的1/2期临床试验全部入组患者的安全性、免疫原性和疗效数据。这项试验中使用的癌症疫苗是一款DNA质粒递送的新抗原疫苗。该公司通过对每例患者的肿瘤进行测序，发现基于每个患者独特的肿瘤突变产生的新抗原，然后将表达这些新抗原的DNA序列导入到DNA质粒中。这种基于DNA的个体化治疗性癌症疫苗可能包含多达40种新抗原。此次公布的结果显示，该试验达到了安全性和免疫原性的主要终点，以及基于缓解率的疗效次要终点。在36名晚期肝癌患者中，有11名（30.6%）对该疫苗与PD-1抑制剂Keytruda联合疗法产生缓解，这大约是过去对照药物缓解率的两倍。其中3例患者达到了CR，8例患者达到了部分缓解（PR）。数据截止时，患者的mOS为19.9个月，而先前报道的Keytruda和其他PD-1抑制剂单药用于二线治疗时的mOS范围为12.9-15.1个月。▲GNOS-PV02治疗晚期肝癌患者的临床结果（图片来源：参考资料[28]）此外，免疫学分析证实，在14名可评估的患者中，100%的患者出现了对疫苗编码的新抗原的新T细胞反应。单细胞测序分析显示，这些T细胞克隆中的绝大多数是CD8 T效应记忆细胞，这是诱导抗肿瘤细胞毒性的关键细胞。PDC*lung01：公布1/2期临床试验的新数据 PDC*line Pharma公司公布了其用于NSCLC患者的现货型治疗性癌症疫苗候选药物PDC*lung01单药或与抗PD-1治疗联用的1/2期临床试验中最后一批患者的中期数据。浆细胞样树突状细胞（PDC）系是一种有效的专业抗原呈递细胞系，能够激发和增强患者的抗肿瘤细胞毒性CD8+ T细胞，并能与抗PD-1治疗协同作用。PDC*lung01是由7种活性组分组成的细胞悬液，装载着多种肿瘤抗原。此次公布的数据显示，中位随访时间为12.5个月时，在19例可评估的患者中，高剂量PDC*lung01与pembrolizumab联用一线治疗IV期（转移性）NSCLC患者的DCR为94.7%，ORR为63.2%，获得缓解的患者均为PR。患者的中位无进展生存期（mPFS）为10.9个月，中位缓解持续时间为9.49个月。Evorpacept（ALX148）：公布1/2期临床试验数据ALX Oncology公布了其CD47抑制剂evorpacept（ALX148）联用利妥昔单抗和来那度胺治疗惰性和侵袭性复发/难治性B细胞非霍奇金淋巴瘤的1/2期临床试验数据。Evorpacept是一种下一代CD47阻断疗法，它将高亲和性CD47结合结构域与经特殊处理的Fc结构域相结合，因此无法激活Fc受体，有望降低CD47靶向抗体因激活Fc受体可能产生的毒副作用。此外，与其它抗CD47抗体相比，evorpacept的分子量更小，更容易渗透到实体瘤中，从而提高疗效。截至目前，evorpacept已在500多名受试者中使用，并在与各种抗癌抗体联用时，在一系列血液和实体恶性肿瘤中显示出良好的活性和耐受性。该研究中，20名惰性和2名侵袭性复发/难治性B-NHL患者接受了evorpacept联用利妥昔单抗和来那度胺的治疗，该组合疗法的耐受性良好，安全性与利妥昔单抗联用来那度胺相似，未报告剂量限制性毒性。接受evorpacept联用利妥昔单抗和来那度胺的患者的最佳ORR为94%，83%的患者实现了CR。与之相比，在先前的一项3期基准试验中，接受利妥昔单抗联用来那度胺的此类患者的ORR为78%，CR率为34%。MDNA11：公布1/2期临床试验的新数据 Medicenna Therapeutics公司公布了其下一代长效IL-2超级激动剂MDNA11治疗晚期实体瘤的新临床结果。MDNA11具有优秀的CD122（IL-2受体β）结合作用，而没有CD25（IL-2受体α）亲和力，从而能优先刺激癌症杀伤效应T细胞和NK细胞。此次公布的结果显示，MDNA11的耐受性良好，没有报告剂量限制毒性和血管渗漏综合征。截至2024年3月22日的数据，14例患者中有4例达到了PR，3例达到了疾病稳定（SD），ORR为29%，DCR为50%。MDNA11已使3名转移性黑色素瘤患者获得了6个月至18个月的持久SD，并且这些患者的肿瘤有缩小。第66周时，1例转移性胰腺导管腺癌患者在基线时存在的所有病变均完全消退。一例双检查点抑制剂治疗后进展的黑色素瘤患者的靶病灶在第28周时完全消退，非靶病灶在第36周持续缩小。Autogene cevumeran（BNT122，RO7198457）：公布1期临床试验的新数据 BioNTech公司在2024年美国癌症研究协会（AACR）年会上，公布了其针对胰腺导管腺癌的个体化癌症疫苗autogene cevumeran的临床试验随访成果。Autogene cevumeran是基于BioNTech的iNeST癌症疫苗技术平台生成的个体化新抗原疫苗，它可以编码数十种新抗原，旨在激发人体针对肿瘤细胞产生更为全面的免疫反应，防止肿瘤细胞逃避免疫系统的攻击。此前公布的结果显示，16名接受过手术治疗的患者在atezolizumab治疗后接受了autogene cevumeran治疗。在这16人中，8人（50%）产生了T细胞免疫反应，由疫苗诱导产生了大量新抗原特异性的T细胞——其中一半的T细胞可以靶向一种以上的新抗原。▲去年5月所公布autogene cevumeran与抗PD-L1抗体atezolizumab和化疗联用，治疗PDAC患者的疗效结果（图片来源：参考资料[27]）此次公布的分析表明，患者在接种PDAC癌症疫苗3年后，体内的T细胞免疫应答持续激活，并且患者的无复发生存期（RFS）得到了持续的延长。这一结果印证了该癌症疫苗的免疫持久性。DOC1021：公布1期临床试验的中期数据Diakonos Oncology公司公布了其树突状细胞疫苗DOC1021用于治疗多形性胶质母细胞瘤（GBM）患者的1期开放标签试验的中期分析结果。该公司的树突状细胞疫苗由患者自身的免疫细胞与从肿瘤样本中提取的RNA和蛋白质结合制成。这种独特的方法可以靶向完整的癌症抗原谱，而无需进行任何基因修饰。通过利用天然的免疫信号通路，这种策略使免疫系统能将癌细胞视同病毒感染的细胞一样进行识别和清除。此次公布结果时，GBM患者的mOS期尚未达到，但有望大幅超过接受标准治疗（SOC）患者12.7个月的预期mOS。平均随访时间为12.9个月时，16名新确诊的GBM患者中有12名仍然存活，且未发生可归因的严重不良事件。2021年10月入组的首例GBM患者已存活了两年多。尽管接受的治疗剂量不到预计治疗剂量的25%，接下来入组的4名患者中的每一位都存活了15个月以上，其中两名在20.3个月和17.5个月时仍然存活。MGMT未甲基化GBM患者目前的12个月生存率为88%，而接受SOC的MGMT未甲基化GBM患者的12个月生存率仅为53%。OBX-115：公布1期临床试验的新数据 Obsidian Therapeutics公司公布了其肿瘤浸润淋巴细胞（TIL）疗法OBX-115用于晚期或转移性黑色素瘤患者的1期临床试验的最新进展，包括25周的中期研究随访安全性数据和最新的详细疗效数据。OBX-115是一种新型工程化的TIL疗法，该TIL具有表达于细胞膜上受调节的白介素-15（IL-15）蛋白，因此患者在接受OBX-115治疗时不需要同时接受传统TIL治疗方案中要求的高剂量IL-2。临床前数据显示，与未经改造的TIL疗法相比，OBX-115具有增强的持久性与效力，动物模型的肿瘤控制得到改善，因此具潜力改善不同类型实体瘤患者的临床结果。此次公布的结果显示，OBX-115的耐受性良好，与使用高剂量IL-2的非工程化TIL疗法具有差异化的安全性，未报告剂量限制性毒性和≥4级的非血液学事件。OBX-115诱导了深入且持久的缓解，ORR为50%，其中CR率为33%，mPFS尚未达到，6个月无进展生存率为67%。此外，所有患者在接受治疗后肿瘤负荷有所减轻，疾病控制时间≥12周。TILT-123：公布1期临床试验的初步数据 TILT Biotherapeutics公司公布了其溶瘤病毒疗法TILT-123联合Keytruda治疗铂类耐药或难治性卵巢癌的1期临床试验的安全性和有效性数据。TILT-123是一种溶瘤腺病毒，不但能够在肿瘤内部复制、裂解肿瘤并且释放肿瘤相关抗原，还可以产生免疫刺激细胞因子TNFα和IL-2。该病毒的另一个优势是它不会在正常细胞中繁殖，而且可以使用肿瘤内注射或者静脉注射给药。TILT-123在临床前癌症模型中表现出100%的缓解率。这项研究中，患者接受了瘤内或腹膜内注射TILT-123联合静脉注射Keytruda的治疗。结果显示，71%可评估患者的疾病得到了控制，其中一名粘液腺癌患者获得了长期PR。注射和未注射的肿瘤都出现了肿瘤体积缩小和显著的免疫调节，这表明该疗法有可能导致全身性的缓解。ELVN-001：公布1期临床试验数据 Enliven Therapeutics公司公布了其小分子激酶抑制剂ELVN-001治疗复发/难治性或对现有酪氨酸激酶抑制剂（TKI）不耐受的慢性髓系白血病（CML）患者的1期临床试验的积极数据。ELVN-001是一种强效、高选择性、潜在“best-in-class”的小分子激酶抑制剂，专门针对CML患者的致癌驱动因子BCR-ABL融合蛋白。ELVN-001还具有针对耐药性最强的BCR-ABL1耐药突变体T315I和其他已知耐药突变体的活性。截至2024年3月18日的数据，ELVN-001的耐受性良好，未报告≥3级治疗相关的非血液学毒性反应。治疗12周时，既往接受过asciminib和/或对TKI耐药的患者的初始累积主要分子缓解（MMR）率为44%（7/16），与已获批的BCR-ABL1酪氨酸激酶抑制剂在1期临床试验中的数据相比具有优势。在可评估的患者中，所有患者在12周时BCR-ABL1融合蛋白的转录水平都有改善或保持稳定。大家都在看药明康德为全球生物医药行业提供一体化、端到端的新药研发和生产服务，服务范围涵盖化学药研发和生产、生物学研究、临床前测试和临床试验研发、细胞及基因疗法研发、测试和生产等领域。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] Inozyme Pharma Announces Positive Topline Data from Ongoing Phase 1/2 Trials of INZ-701 in Adults with ABCC6 Deficiency (PXE) and ENPP1 Deficiency. 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Retrieved April 9, 2024, from https://www.globenewswire.com/news-release/2024/04/09/2860391/0/en/Medicenna-Presents-Updated-Results-of-Single-Agent-MDNA11-Anti-tumor-Activity-from-Dose-Escalation-and-Ongoing-Dose-Expansion-of-the-Phase-1-2-ABILITY-1-Study-at-the-2024-Annual-Me.html[15] Corvus Pharmaceuticals Announces Initiation of Placebo-Controlled Phase 1 Clinical Trial of Soquelitinib for Atopic Dermatitis. Retrieved April 9, 2024, from https://www.globenewswire.com/news-release/2024/04/09/2860339/0/en/Corvus-Pharmaceuticals-Announces-Initiation-of-Placebo-Controlled-Phase-1-Clinical-Trial-of-Soquelitinib-for-Atopic-Dermatitis.html[16] Diakonos Oncology’s Unique Dendritic Cell Vaccine (DOC1021) Improves Survival Compared to Standard of Care in Phase 1 Trial for Glioblastoma. Retrieved April 9, 2024, from https://www.diakonosoncology.com/blog/diakonos-oncologys-unique-dendritic-cell-vaccine-doc1021-improves-survival-compared-to-standard-of-care-in-phase-1-trial-for-glioblastoma/[17] Vanqua Bio Announces First Patient Dosed in Phase 1 Clinical Trial Evaluating VQ-101, its Small Molecule GCase Activator for GBA-Parkinson’s Disease and Related Disorders. Retrieved April 9, 2024, from https://www.globenewswire.com/news-release/2024/04/09/2859875/0/en/Vanqua-Bio-Announces-First-Patient-Dosed-in-Phase-1-Clinical-Trial-Evaluating-VQ-101-its-Small-Molecule-GCase-Activator-for-GBA-Parkinson-s-Disease-and-Related-Disorders.html[18] Obsidian Therapeutics Presents Positive 25-Week Median Study Follow-Up Safety and Efficacy Data from First-in-Human Study of OBX-115 in Advanced Melanoma at the American Association for Cancer Research Annual Meeting. Retrieved April 9, 2024, from https://www.businesswire.com/news/home/20240409687216/en/[20] Tr1X Announces FDA Clearance of First Investigational New Drug Application for TRX103, an Allogeneic Regulatory T-Cell Therapy to Treat Autoimmune Diseases. Retrieved April 11, 2024, from https://www.prnewswire.com/news-releases/tr1x-announces-fda-clearance-of-first-investigational-new-drug-application-for-trx103-an-allogeneic-regulatory-t-cell-therapy-to-treat-autoimmune-diseases-302112587.html[21] ViGeneron Announces First Patient Dosed in Phase 1b Clinical Trial of VG901 For the Intravitreal Treatment of Retinitis Pigmentosa. Retrieved April 11, 2024, from https://vigeneron.com/press/vigeneron-announces-first-patient-dosed-in-phase-1b-clinical-trial-of-vg901-for-the-intravitreal-treatment-of-retinitis-pigmentosa/[22] TILT Biotherapeutics Presents Clinical Data on TILT-123 in Combination with KEYTRUDA® (pembrolizumab) for Ovarian Cancer at AACR 2024. Retrieved April 11, 2024, from https://www.globenewswire.com/news-release/2024/04/10/2860497/0/en/TILT-Biotherapeutics-Presents-Clinical-Data-on-TILT-123-in-Combination-with-KEYTRUDA-pembrolizumab-for-Ovarian-Cancer-at-AACR-2024.html[23] Enliven Therapeutics Announces Positive Proof of Concept Data from Phase 1 Clinical Trial of ELVN-001 in Chronic Myeloid Leukemia. Retrieved April 11, 2024, from https://ir.enliventherapeutics.com/news-releases/news-release-details/enliven-therapeutics-announces-positive-proof-concept-data-phase[24] Possible New Hope for Metastatic Cancer Patients: Food and Drug Administration Grants Approval for Clinical Trials For Lamassu's Groundbreaking Cancer Treatment Protocol. Retrieved April 11, 2024, from https://www.prnewswire.com/news-releases/possible-new-hope-for-metastatic-cancer-patients-food-and-drug-administration-grants-approval-for-clinical-trials-for-lamassus-groundbreaking-cancer-treatment-protocol-302114390.html[25] MEI Pharma Reports Initial Data from Clinical Study Evaluating ME-344 in Combination with Bevacizumab (Avastin®) in Relapsed Metastatic Colorectal Cancer Patients. Retrieved April 11, 2024, from https://www.businesswire.com/news/home/20240411126658/en[26] Boundless Bio Announces First Patient Dosed in First-in-Human Phase 1/2 Clinical Trial of BBI-825 in Cancer Patients with Resistance Gene Amplifications. Retrieved April 11, 2024, from https://www.businesswire.com/news/home/20240410633469/en[27] Rojas et al., (2023). Personalized RNA neoantigen vaccines stimulate T cells in pancreatic cancer. Nature, https://doi-org.libproxy1.nus.edu.sg/10.1038/s41586-023-06063-y[28] Yarchoan M, Gane EJ, Marron TU, Perales-Linares R, Yan J, Cooch N, Shu DH, Fertig EJ, Kagohara LT, Bartha G, Northcott J, Lyle J, Rochestie S, Peters J, Connor JT, Jaffee EM, Csiki I, Weiner DB, Perales-Puchalt A, Sardesai NY. Personalized neoantigen vaccine and pembrolizumab in advanced hepatocellular carcinoma: a phase 1/2 trial. Nat Med. 2024 Apr 7. doi: 10.1038/s41591-024-02894-y. Epub ahead of print. PMID: 38584166.[29] Silence Therapeutics Announces JAMA Publication of Additional Phase 1 Data for Zerlasiran in Subjects with Elevated Lipoprotein(a). Retrieved April 11, 2024, from https://www.businesswire.com/news/home/20240408451903/en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

疫苗免疫疗法临床结果

2024-04-13

·药明康德

基因编辑先驱联手打造创新递送平台，ViGeneron公司基因疗法迎来新里程碑…… | CGT周报

▎药明康德内容团队编辑近期，全球细胞和基因疗法（CGT）领域迎来系列进展。基因编辑先驱刘如谦和Keith Joung博士联合创建的Nvelop Therapeutics宣布正式启动，该公司基于病毒样蛋白颗粒（VLP）的递送平台有望克服目前递送载体的多重挑战，高效和细胞特异性递送广泛的治疗性载荷。ViGeneron公司宣布，在研基因疗法VG901在治疗视网膜色素变性（RP）的1b期临床试验中完成首例患者给药。新闻稿指出，VG901是首个将完整CNGA1基因递送到视网膜色素变性患者的视网膜感光细胞的临床期基因疗法。本文将节选其中部分重要进展做简单介绍，仅供读者参阅。图片来源：123RF———✦研发进展✦———◇Obsidian Therapeutics公司日前宣布其肿瘤浸润淋巴细胞（TIL）疗法OBX-115在首个人体临床试验中的25周安全性和疗效数据。在这项治疗黑色素瘤患者的临床试验中，OBX-115达到50%的客观缓解率（ORR）和33%的完全缓解率。所有患者在接受治疗12周后肿瘤负担减轻并获得有意义的疾病控制。中位无进展生存期尚未达到，6个月时的无进展生存率为67%。OBX-115是一款自体TIL细胞疗法，通过基因工程改造表达与细胞膜结合的IL-15，有助于提高TIL细胞疗法的持久性、抗癌活性和临床安全性。◇Tr1X公司宣布，为其现货型调节性T细胞疗法TRX103递交的IND申请已经获得美国FDA的许可，用于预防接受造血干细胞移植的患者发生移植物抗宿主病。该公司计划在2024年第二季度启动预防移植物抗宿主病的1期临床试验。TRX103是一款基于健康供体捐献的CD4阳性细胞的现货型T细胞疗法。这些CD4阳性T细胞经过改造，能生成模拟Tr1调节性T细胞功能的细胞疗法。在多项临床前疾病模型中，TRX103表现出良好的耐受性和疗效，具有恢复免疫系统到健康状态的潜力。Tr1X公司正在开发TRX103治疗多种免疫和炎症性疾病。◇Ocugen公司宣布，为其在研基因疗法OCU400递交的3期临床试验IND补件已经获得美国FDA的许可，用于治疗视网膜色素变性。新闻稿指出，这是首款进入3期临床开发阶段，无需考虑RP患者携带的基因突变类型，有潜力治疗广泛患者群体的基因疗法。OCU400是一款基于视网膜核激素受体基因NR2E3的基因疗法。NR2E3基因能够调节视网膜内的多种生理功能，例如感光细胞的发育和维持、新陈代谢、光转导、炎症和细胞生存网络。OCU400通过NR2E3的驱动功能，能够重置被改变的细胞基因网络并建立体内平衡，有望改善遗传性视网膜疾病患者的视网膜健康和功能。◇Poseida Therapeutics宣布了同种异体B细胞成熟抗原（BCMA）靶向CAR-T疗法P-BCMA-ALLO1的最新1期临床试验结果。在治疗经治复发/难治性多发性骨髓瘤患者的临床试验中，P-BCMA-ALLO1达到60%的总缓解率，所有获得临床缓解的患者达到非常好的部分缓解（VGPR）水平。其中一名患者此前曾接受过BCMA靶向双特异性抗体和自体CAR-T疗法的治疗，该患者已经维持缓解超过4个月。◇ViGeneron公司宣布，在研基因疗法VG901在治疗视网膜色素变性的1b期临床试验中完成首例患者给药。新闻稿指出，VG901是首个将完整CNGA1基因递送到视网膜色素变性患者的视网膜感光细胞的临床期基因疗法。VG901是一种基因替代疗法，采用ViGeneron新一代基于AAV2的基因疗法平台vgAAV，通过玻璃体内注射（IVT）递送CNGA1基因，从而降低视网膜损伤风险。与视网膜下注射相比，这种改良后的载体提供了更方便的给药方式和更广泛的载体分布。通过与对照血清型AAV的头对头体内实验比较，显示出了更高的转导效率。此外，玻璃体内注射避免了视网膜下给药带来的视网膜损伤风险，也比脉络膜上注射的侵入性更小。相关阅读：AAV也能高效递送大型基因，ViGeneron创新基因递送技术登上《自然》子刊◇TILT Biotherapeutics公司日前公布了其在研溶瘤病毒疗法TILT-123，与重磅PD-1抑制剂Keytruda联用，治疗对含铂化疗耐药或难治性卵巢癌患者的1期临床试验最新结果。数据显示，在可评估疗效患者中，71%的患者疾病得到控制，其中一名患者获得持久的部分缓解。在接受溶瘤病毒注射和未接受溶瘤病毒注射的肿瘤中均观察到了肿瘤体积的缩小和显著免疫调节，显示局部溶瘤病毒注射可能有激发全身性免疫反应的潜力。TILT-123是一款溶瘤腺病毒，它同时表达TNF-α和IL-2，旨在改变肿瘤微环境，增强T细胞疗法的效力，包括免疫检查点抑制剂和过继性细胞疗法。———✦融资、合作、M&A✦———◇Nvelop Therapeutics宣布走出隐匿模式，旨在开发针对广泛疾病的下一代基因药物。该公司的独有递送平台有潜力高效和细胞特异性地递送广泛的治疗性载荷。Nvelop的模块化平台基于两种已经经过体内验证的递送方法。这些方法是基于基因编辑先驱刘如谦博士和Keith Joung博士实验室的研究，有望解决目前递送平台的局限性，实现基因药物的潜力，具体改善包括：递送效率：使强效疗法能够高效递送到疾病影响的多个组织，并在其中达到提供临床获益的高度活性；组织特异性：驱动针对历史上难以触达的细胞和组织的靶向体内递送；载荷多样性：允许递送类型和大小广泛的载荷，包括暂时表达的蛋白（例如，碱基编辑系统和先导编辑系统）；安全优势：载体有潜力通过优化达到完全人源化，增加其安全性，并扩大可用基因药物治疗的疾病数量。Nvelop的一种平台技术已在包括《细胞》和Nature Biotechnology在内的著名学术期刊上发表。这一技术源于刘如谦博士的实验室，在今年1月发表的论文中，其团队对病毒样蛋白颗粒进行了优化，进一步提高了VLPs的递送效率。实验结果显示，基于工程化VLPs的递送系统能够在动物体内有效递送先导编辑器，成功对小鼠视网膜细胞中的基因进行编辑。◇Century Therapeutics宣布将收购Clade Therapeutics来增强其在癌症和自身免疫性疾病领域中，基于诱导多能干细胞（iPSC）细胞疗法的管线和平台。该公司同时宣布完成6000万美元的融资，所获资金将用以支持该公司在自身免疫性疾病方面的研发活动。Century的主打项目CNTY-101是一种靶向CD19的同种异体诱导自然杀伤细胞（iNK）疗法，采用Century的Allo-Evasion平台进行6次精确基因编辑，可重复给药而无需持续进行淋巴细胞清除。CNTY-101目前正在B细胞恶性肿瘤临床试验（ELiPSE-1）中接受评估，而其用以治疗系统性红斑狼疮（SLE）的相关临床试验（CALiPSO-1）则有望于2024年上半年启动。Century计划在2024年就多个自身免疫性疾病适应症递交CNTY-101项目的监管申请。收购Clade增强了Century在同种异体iPSC衍生细胞治疗领域的布局，增强了其下一代细胞疗法平台（包括Allo-Evasion）并扩展管线。Century将获得Clade公司通过其αβiT平台所开发的三项临床前阶段项目，涵盖癌症和自身免疫性疾病。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：[1] ViGeneron Announces First Patient Dosed in Phase 1b Clinical Trial of VG901 for the Intravitreal Treatment of Retinitis Pigmentosa. Retrieved April 12, 2024, from https://www.globenewswire.com/news-release/2024/04/10/2860550/0/en/ViGeneron-Announces-First-Patient-Dosed-in-Phase-1b-Clinical-Trial-of-VG901-for-the-Intravitreal-Treatment-of-Retinitis-Pigmentosa.html[2] Nvelop Therapeutics Launches with Dual Platforms for In Vivo Delivery of the Next Generation of Genetic Medicines. Retrieved April 12, 2024, from https://www.businesswire.com/news/home/20240409667451/en[3] Poseida Therapeutics Presents New Phase 1 Data at AACR 2024 Supporting Potential of P-BCMA-ALLO1 Allogeneic CAR-T Therapy to Benefit Broad Range of Patients with Multiple Myeloma. Retrieved April 12, 2024, from https://www.prnewswire.com/news-releases/poseida-therapeutics-presents-new-phase-1-data-at-aacr-2024-supporting-potential-of-p-bcma-allo1-allogeneic-car-t-therapy-to-benefit-broad-range-of-patients-with-multiple-myeloma-302110563.html[4] Three-Year Follow-up Data in BCG-Unresponsive NMIBC Show Durable Response to Treatment with ADSTILADRIN® (nadofaragene firadenovec-vncg) in Two Patient Cohorts. Retrieved April 12, 2024, from https://www.businesswire.com/news/home/20240408479348/en[5] Ocugen, Inc. Announces U.S. FDA Clearance of IND Amendment to Initiate OCU400 Phase 3 Clinical Trial — First Gene Therapy to Enter Phase 3 with a Broad Retinitis Pigmentosa Indication. Retrieved April 12, 2024, from https://www.globenewswire.com/news-release/2024/04/08/2859013/0/en/Ocugen-Inc-Announces-U-S-FDA-Clearance-of-IND-Amendment-to-Initiate-OCU400-Phase-3-Clinical-Trial-First-Gene-Therapy-to-Enter-Phase-3-with-a-Broad-Retinitis-Pigmentosa-Indication.html[6] Century Therapeutics Strengthens Position in Autoimmune Disease with Strategic Pipeline Expansion Supported by $60 Million Private Placement and Acquisition of Clade Therapeutics. Retrieved April 12, 2024, from https://www.globenewswire.com/news-release/2024/04/11/2861378/0/en/Century-Therapeutics-Strengthens-Position-in-Autoimmune-Disease-with-Strategic-Pipeline-Expansion-Supported-by-60-Million-Private-Placement-and-Acquisition-of-Clade-Therapeutics.html[7] Tr1X Announces FDA Clearance of First Investigational New Drug Application for TRX103, an Allogeneic Regulatory T-Cell Therapy to Treat Autoimmune Diseases. Retrieved April 12, 2024, from https://www.prnewswire.com/news-releases/tr1x-announces-fda-clearance-of-first-investigational-new-drug-application-for-trx103-an-allogeneic-regulatory-t-cell-therapy-to-treat-autoimmune-diseases-302112587.html[8] Obsidian Therapeutics Presents Positive 25-Week Median Study Follow-Up Safety and Efficacy Data from First-in-Human Study of OBX-115 in Advanced Melanoma at the American Association for Cancer Research Annual Meeting. Retrieved April 12, 2024, from https://www.businesswire.com/news/home/20240409687216/en[9] Imugene's oncolytic virotherapy VAXINIA and B cell immunotherapy HER-Vaxx featured at the AACR Annual Meeting 2024. Retrieved April 12, 2024, from https://www.globenewswire.com/news-release/2024/04/09/2860250/0/en/Imugene-s-oncolytic-virotherapy-VAXINIA-and-B-cell-immunotherapy-HER-Vaxx-featured-at-the-AACR-Annual-Meeting-2024.html[10] TILT Biotherapeutics Presents Clinical Data on TILT-123 in Combination with KEYTRUDA® (pembrolizumab) for Ovarian Cancer at AACR 2024. Retrieved April 12, 2024, from https://www.globenewswire.com/news-release/2024/04/10/2860497/0/en/TILT-Biotherapeutics-Presents-Clinical-Data-on-TILT-123-in-Combination-with-KEYTRUDA-pembrolizumab-for-Ovarian-Cancer-at-AACR-2024.html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

基因疗法临床申请细胞疗法临床1期临床3期

100 项与 Igrelimogene litadenorepvec 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
非小细胞肺癌	临床1期	美国	TILT Biotherapeutics Oy	2022-09-26
黑色素瘤	临床1期	芬兰	TILT Biotherapeutics Oy	2022-07-01
头颈部鳞状细胞癌	临床1期	芬兰	TILT Biotherapeutics Oy	2022-07-01
卵巢癌	临床1期	美国	TILT Biotherapeutics Oy	2022-05-17
卵巢癌	临床1期	芬兰	TILT Biotherapeutics Oy	2022-05-17
转移性黑色素瘤	临床1期	丹麦	TILT Biotherapeutics Oy	2020-02-26
转移性黑色素瘤	临床1期	法国	TILT Biotherapeutics Oy	2020-02-26
肺癌	临床1期	-	TILT Biotherapeutics Oy	-

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临床结果

适应症

分期

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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


NCT04695327 \| NCT05271318 \| NCT04217473 (TILT-123, ASCO2024)	临床1期	-	52	TILT-123	艱遞膚簾夢願糧餘鬱獵(廠築齋範窪憲鑰鬱範糧) = increased in the patients´ serum 齋鏇衊願獵壓製壓繭簾 (簾淵鹹簾鏇窪構夢鏇醖 )	积极	2024-05-24
NCT05271318 (AACR2024) 人工标引	临床1期	卵巢癌	15	TILT-123+pembrolizumab	膚餘窪顧衊糧遞齋鬱艱(鑰膚觸夢壓顧獵願鬱願) = not observed 膚壓鹹獵範壓壓願膚獵 (糧遞衊醖齋膚顧艱鹽獵 ) 更多	积极	2024-04-05
NCT04695327 (TUNIMO, Pubmed)	临床1期	实体瘤	20	TILT-123	蓋簾願淵鑰衊壓鏇襯鑰(遞夢齋襯壓襯鹽願網憲) = 壓壓製遞淵鹽廠鹹鏇襯顧膚淵襯淵蓋鑰齋蓋網 (鬱廠廠繭齋繭憲憲獵襯 )	积极	2024-03-28
NCT04217473 (ESMO_IO 12023 \| ESMO_IO 22023) 人工标引	临床1期	黑色素瘤	16	TILT-123	憲糧齋衊製顧獵夢餘廠(夢築衊獵顧願壓廠蓋選) = The most frequently reported adverse events (AEs) related to TILT-123 were fever (63%) and pain at the injection site (44%) while most frequent AEs related to TIL therapy were fever (50%) and chills (24%). 襯構鏇遞蓋齋製選淵範 (遞衊築鏇簾餘築鑰築鬱 )	积极	2023-12-06
NCT04695327 (TUNIMO , SITC2023) 人工标引	临床1期	实体瘤	20	TILT-123	遞簾繭選選餘憲鹹淵繭(製願鏇醖選積鹽觸夢艱) = not observed 醖窪簾獵顧顧鑰艱觸選 (齋鹹齋繭積壓獵範觸顧 ) 更多	积极	2023-10-31
NCT04695327 \| NCT05222932 \| NCT05271318 \| NCT04217473 (SITC2022) 人工标引	临床1期	实体瘤	18	TILT-123	範獵醖齋膚衊製膚蓋餘(顧獵積製遞膚觸壓遞壓) = 壓鏇壓襯鏇憲遞簾淵醖窪蓋糧獵醖構壓觸鹽襯 (觸艱鬱鬱餘築遞鏇繭窪 )	积极	2022-11-01