治疗肺癌、胰腺癌，泛RAS分子胶公布积极临床进展；多肽癌症疫苗达主要和次要终点…… | 一周盘点

本期看点：

1. 泛RAS分子胶E RAS-0015取得了积极的初步1期剂 量递增数据，单药治疗在KRAS G12X突变的非小细胞肺癌（NSCLC）和 胰腺导管腺癌（PDAC） 患者中展现出抗肿瘤活性。
2. 治疗性多肽癌症疫苗OVM-200在一项1期临床试验中达到了主要和次要终点，该试验还报告了早期的临床活性迹象。

ERAS-0015：公布1期临床试验的初步数据

Erasca公司宣布，其潜在“best-in-class”的泛RAS分子胶ERAS-0015在RAS突变实体瘤患者中取得了积极的初步1期剂量递增数据。ERAS-0015是一款在研的口服强效泛RAS分子胶，旨在抑制RAS信号传导。该药物不仅能抑制突变型RAS，还设计用于抑制野生型RAS变体，从而防止肿瘤对突变选择性抑制剂产生耐药性。此外，ERAS-0015在多种动物模型中已展现出良好的药代动力学（PK）及吸收、分布、代谢和排泄（ADME）特性。

此次公布的结果显示，ERAS-0015单药疗法在KRAS G12X突变的NSCLC患者中展现出抗肿瘤活性：在16-32 mg每日一次（QD）的药效活性剂量（PAD）下，接受二线及以上（2L+）治疗患者的未经确认总缓解率（uORR）达到62%，而在免疫检查点抑制剂/铂类经治后的二线/三线患者中，uORR达75%。在二线KRAS G12X突变的PDAC患者中，16-32 mg QD剂量下的uORR为40%，在32 mg QD剂量下，uORR达50%。安全性方面，该药整体耐受性良好，不良事件多为低级别，截至数据截止日未出现剂量限制性毒性（DLT），且未发生因治疗相关不良事件导致的停药。药代动力学表现良好，药物暴露量呈剂量依赖性增加（最大剂量为40 mg QD），未观察到暴露平台期。初步数据还显示，ERAS-0015与标准剂量的panitumumab联用安全性良好，并在结直肠癌患者中观察到1例未经确认的部分缓解（uPR）。

OVM-200：公布1期临床试验数据

Oxford Vacmedix公司的癌症疫苗OVM-200在一项1期临床试验中达到了主要和次要终点。OVM-200是一款治疗性癌症疫苗，采用该公司专有的重组重叠肽（ROP）平台技术，靶向肿瘤相关抗原survivin，目前主要面向非小细胞肺癌、卵巢癌和前列腺癌等多种实体瘤进行开发。

该1期试验是一项多中心、开放标签研究，共招募了36名晚期实体瘤患者。试验达到了安全性这一主要终点，以及免疫原性和剂量优化等次要终点。OVM-200展现出良好的安全性特征，未观察到严重的药物不良反应或DLT，不良事件仅限于1级注射部位反应。在免疫原性上，疫苗成功诱导了强烈的抗体和T细胞反应。此外，试验还报告了早期的临床活性迹象，包括在NSCLC患者中观察到的疾病稳定，以及在前列腺癌患者中观察到的前列腺特异性抗原（PSA）应答。

Telomir-Zn：IND申请获得FDA许可

Telomir Pharmaceuticals公司宣布，其候选药物Telomir-Zn获得了美国FDA的IND许可，将用于治疗晚期或转移性三阴性乳腺癌（TNBC）患者。Telomir-Zn是一款在研的小分子药物，是一种潜在的“first-in-class”疗法，其作用机制不同于传统的细胞毒性化疗、免疫检查点抑制剂、抗体偶联药物或经典表观遗传药物，而是通过调节细胞内的金属稳态（如铁和锌的平衡）以及下游的表观遗传调控，来靶向那些可能促进肿瘤进展、治疗耐药性及遗传信息不稳定的金属依赖性表观遗传脆弱性。临床前研究表明，该药物能够调节依赖铁的染色质调节酶，并影响与肿瘤生物学及细胞衰老相关的表达通路。

参考资料：

[1] Erasca Announces Positive Preliminary Phase 1 Dose Escalation Data for Potentially Best-in-Class Pan-RAS Molecular Glue ERAS-0015 in KRAS-Mutant Solid Tumors. Retrieved April 30, 2026, from https://www.globenewswire.com/news-release/2026/04/27/3281996/0/en/erasca-announces-positive-preliminary-phase-1-dose-escalation-data-for-potentially-best-in-class-pan-ras-molecular-glue-eras-0015-in-kras-mutant-solid-tumors.html

[2] Aclaris Therapeutics Announces Positive Full Top Line First-in-Human Results from Phase 1a Healthy Volunteer Clinical Trial of ATI-052, a Novel Potential First-in-Class Anti-TSLP/IL-4Rα Bispecific Antibody, and Announces Lichen Planus as Lead Indication for ATI-2138, an Oral ITK/JAK3 Inhibitor. Retrieved April 30, 2026, from https://www.globenewswire.com/news-release/2026/04/28/3282383/37216/en/aclaris-therapeutics-announces-positive-full-top-line-first-in-human-results-from-phase-1a-healthy-volunteer-clinical-trial-of-ati-052-a-novel-potential-first-in-class-anti-tslp-il.html

[3] Kestrel Therapeutics Announces First Patient Dosed in the Phase 1 Clinical Trial of KST-6051, a Potential Best-in-Class Pan-KRAS Inhibitor, in Patients with KRAS-driven Malignancies. Retrieved April 30, 2026, from https://www.globenewswire.com/news-release/2026/04/28/3282578/0/en/kestrel-therapeutics-announces-first-patient-dosed-in-the-phase-1-clinical-trial-of-kst-6051-a-potential-best-in-class-pan-kras-inhibitor-in-patients-with-kras-driven-malignancies.html

[4] BRC Therapeutics Announces Investigational New Drug Application for BRC-002 Cleared by FDA. Retrieved April 30, 2026, from https://www.prnewswire.com/news-releases/brc-therapeutics-announces-investigational-new-drug-application-for-brc-002-cleared-by-fda-302755879.html

[5] VectorY Therapeutics Receives U.K. MHRA Authorization and EMA Approval to Initiate Phase 1/2 PIONEER-ALS Clinical Trial of VTx-002 in People Living with Amyotrophic Lateral Sclerosis (ALS). Retrieved April 30, 2026, from https://secure.businesswire.com/news/home/20260428401156/en/VectorY-Therapeutics-Receives-U.K.-MHRA-Authorization-and-EMA-Approval-to-Initiate-Phase-12-PIONEER-ALS-Clinical-Trial-of-VTx-002-in-People-Living-with-Amyotrophic-Lateral-Sclerosis-ALS

[6] Diakonos Oncology Reports Positive Clinical Data from Phase 1 Pancreatic Cancer Study and Expanded Access Program in Glioblastoma at AACR and AAN 2026. Retrieved May, 1, 2026, from https://www.prnewswire.com/news-releases/diakonos-oncology-reports-positive-clinical-data-from-phase-1-pancreatic-cancer-study-and-expanded-access-program-in-glioblastoma-at-aacr-and-aan-2026-302759930.html

[7] Telomir Pharmaceuticals Announces FDA Clearance of IND for Telomir-Zn in Triple-Negative Breast Cancer. Retrieved May, 1, 2026, from https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/telomir-pharmaceuticals-announces-fda-clearance-of-ind-for-telomir-zn-1162409

[8] Laguna Announces FDA Clearance of IND Application for LGNA-100, a Novel γδ T Cell Activator for High-Risk Pediatric Leukemias. Retrieved May, 1, 2026, from https://www.globenewswire.com/news-release/2026/04/29/3283747/0/en/laguna-announces-fda-clearance-of-ind-application-for-lgna-100-a-novel-%ce%b3%ce%b4-t-cell-activator-for-high-risk-pediatric-leukemias.html

[9] Precision BioSciences Activates First Clinical Trial Site and Begins Patient Enrollment in Phase 1/2 FUNCTION-DMD Study. Retrieved May, 1, 2026, from https://secure.businesswire.com/news/home/20260429519173/en/Precision-BioSciences-Activates-First-Clinical-Trial-Site-and-Begins-Patient-Enrollment-in-Phase-12-FUNCTION-DMD-Study

[10] Theolytics Announces First Patient Dosed in the OCTOPOD-IP Trial, a US Phase 1 Trial with THEO-260, a Novel Oncolytic Immunotherapy Targeting Ovarian Cancer. Retrieved May, 1, 2026, from https://www.globenewswire.com/news-release/2026/04/28/3282264/0/en/theolytics-announces-first-patient-dosed-in-the-octopod-ip-trial-a-us-phase-1-trial-with-theo-260-a-novel-oncolytic-immunotherapy-targeting-ovarian-cancer.html

[11] Taiho Oncology, Taiho Pharmaceutical and Araris Biotech AG Advance ADC ARC-02 into Phase 1 Clinical Development. Retrieved May, 1, 2026, from https://secure.businesswire.com/news/home/20260427127507/en/Taiho-Oncology-Taiho-Pharmaceutical-and-Araris-Biotech-AG-Advance-ADC-ARC-02-into-Phase-1-Clinical-Development

[12] Dx&Vx affiliate Oxford Vacmedix reports phase 1 success for cancer vaccine OVM-200. Retrieved May, 1, 2026, from https://www.koreabiomed.com/news/articleView.html?idxno=31419

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