治療肺癌、胰腺癌，泛RAS分子膠公布積極臨床進展；多肽癌癥疫苗達主要和次要終點…… | 一周盤點

本期看點：

1. 泛RAS分子膠E RAS-0015取得了積極的初步1期劑 量遞增數據，單藥治療在KRAS G12X突變的非小細胞肺癌（NSCLC）和 胰腺導管腺癌（PDAC） 患者中展現出抗腫瘤活性。
2. 治療性多肽癌癥疫苗OVM-200在一項1期臨床試驗中達到了主要和次要終點，該試驗還報告了早期的臨床活性跡象。

ERAS-0015：公布1期臨床試驗的初步數據

Erasca公司宣布，其潛在“best-in-class”的泛RAS分子膠ERAS-0015在RAS突變實體瘤患者中取得了積極的初步1期劑量遞增數據。ERAS-0015是一款在研的口服強效泛RAS分子膠，旨在抑制RAS信號傳導。該藥物不僅能抑制突變型RAS，還設計用于抑制野生型RAS變體，從而防止腫瘤對突變選擇性抑制劑產生耐藥性。此外，ERAS-0015在多種動物模型中已展現出良好的藥代動力學（PK）及吸收、分布、代謝和排泄（ADME）特性。

此次公布的結果顯示，ERAS-0015單藥療法在KRAS G12X突變的NSCLC患者中展現出抗腫瘤活性：在16-32 mg每日一次（QD）的藥效活性劑量（PAD）下，接受二線及以上（2L+）治療患者的未經確認總緩解率（uORR）達到62%，而在免疫檢查點抑制劑/鉑類經治后的二線/三線患者中，uORR達75%。在二線KRAS G12X突變的PDAC患者中，16-32 mg QD劑量下的uORR為40%，在32 mg QD劑量下，uORR達50%。安全性方面，該藥整體耐受性良好，不良事件多為低級別，截至數據截止日未出現劑量限制性毒性（DLT），且未發生因治療相關不良事件導致的停藥。藥代動力學表現良好，藥物暴露量呈劑量依賴性增加（最大劑量為40 mg QD），未觀察到暴露平臺期。初步數據還顯示，ERAS-0015與標準劑量的panitumumab聯用安全性良好，并在結直腸癌患者中觀察到1例未經確認的部分緩解（uPR）。

OVM-200：公布1期臨床試驗數據

Oxford Vacmedix公司的癌癥疫苗OVM-200在一項1期臨床試驗中達到了主要和次要終點。OVM-200是一款治療性癌癥疫苗，采用該公司專有的重組重疊肽（ROP）平臺技術，靶向腫瘤相關抗原survivin，目前主要面向非小細胞肺癌、卵巢癌和前列腺癌等多種實體瘤進行開發。

該1期試驗是一項多中心、開放標簽研究，共招募了36名晚期實體瘤患者。試驗達到了安全性這一主要終點，以及免疫原性和劑量優化等次要終點。OVM-200展現出良好的安全性特征，未觀察到嚴重的藥物不良反應或DLT，不良事件僅限于1級注射部位反應。在免疫原性上，疫苗成功誘導了強烈的抗體和T細胞反應。此外，試驗還報告了早期的臨床活性跡象，包括在NSCLC患者中觀察到的疾病穩定，以及在前列腺癌患者中觀察到的前列腺特異性抗原（PSA）應答。

Telomir-Zn：IND申請獲得FDA許可

Telomir Pharmaceuticals公司宣布，其候選藥物Telomir-Zn獲得了美國FDA的IND許可，將用于治療晚期或轉移性三陰性乳腺癌（TNBC）患者。Telomir-Zn是一款在研的小分子藥物，是一種潛在的“first-in-class”療法，其作用機制不同于傳統的細胞毒性化療、免疫檢查點抑制劑、抗體偶聯藥物或經典表觀遺傳藥物，而是通過調節細胞內的金屬穩態（如鐵和鋅的平衡）以及下游的表觀遺傳調控，來靶向那些可能促進腫瘤進展、治療耐藥性及遺傳信息不穩定的金屬依賴性表觀遺傳脆弱性。臨床前研究表明，該藥物能夠調節依賴鐵的染色質調節酶，并影響與腫瘤生物學及細胞衰老相關的表達通路。

參考資料：

[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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