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▎藥明康德內(nèi)容團(tuán)隊(duì)編輯

本期看點(diǎn)

1. Solu Therapeutics公司創(chuàng)新細(xì)胞毒性靶向嵌合體（CyTAC）藥物STX-0712的1期臨床試驗(yàn)已完成首例患者給藥。該類療法能夠靶向傳統(tǒng)療法難以作用的細(xì)胞表面蛋白。

2. 用于治療復(fù)發(fā)性生殖器皰疹的長(zhǎng)效解旋酶-引物酶抑制劑ABI-5366的1a期臨床試驗(yàn)數(shù)據(jù)積極，約20天的半衰期有望實(shí)現(xiàn)每周一次或每月一次的口服給藥方案。

藥明康德內(nèi)容團(tuán)隊(duì)整理

STX-0712：1期臨床試驗(yàn)完成首例患者給藥

Solu Therapeutics公司宣布完成4100萬美元的A輪融資，所得資金將用于推進(jìn)其核心項(xiàng)目STX-0712的臨床評(píng)估、拓展其他管線，以及探索其細(xì)胞毒性靶向嵌合體和治療指數(shù)控制靶向嵌合體（TicTAC）平臺(tái)的新應(yīng)用。該公司還宣布啟動(dòng)了STX-0712用于治療耐藥/難治性慢性粒單核細(xì)胞白血病（CMML）和其他血液系統(tǒng)惡性腫瘤的1期臨床試驗(yàn)，首位患者已開始給藥。

Solu Therapeutics公司通過以獨(dú)特的方式將強(qiáng)效、選擇性小分子與效應(yīng)抗體連接起來，能夠靶向傳統(tǒng)療法難以作用的細(xì)胞表面蛋白（如G蛋白偶聯(lián)受體和離子通道）。其雙功能小分子的一只臂可特異性進(jìn)入細(xì)胞表面蛋白中的深結(jié)合口袋，另一臂通過專有連接子技術(shù)與其專有的抗體連接，可增強(qiáng)效應(yīng)抗體的療效。

STX-0712是一種CyTAC藥物，通過靶向G蛋白偶聯(lián)受體CCR2（在惡性單核細(xì)胞中高表達(dá)），能夠清除CCR2陽性細(xì)胞，同時(shí)減少對(duì)正常細(xì)胞的影響，有望為耐藥/難治性血液腫瘤提供更精準(zhǔn)、有效的治療選擇。臨床前數(shù)據(jù)顯示，STX-0712對(duì)CMML患者樣本中的CCR2陽性單核細(xì)胞具有強(qiáng)大的離體活性。

ABI-5366：公布1a期臨床試驗(yàn)的中期數(shù)據(jù)

Assembly Biosciences公司公布了一種用于復(fù)發(fā)性生殖器皰疹的長(zhǎng)效解旋酶-引物酶抑制劑ABI-5366的1a期臨床試驗(yàn)數(shù)據(jù)。該候選療法通過靶向病毒解旋酶-引物酶復(fù)合體發(fā)揮作用。這是一種在HSV-1和HSV-2中都保守的重要病毒酶復(fù)合體，并且宿主細(xì)胞中沒有類似的酶復(fù)合體。在短期臨床研究中，HSV解旋酶-引物酶抑制劑顯示出比核苷類似物更佳的療效潛力。

此次公布的結(jié)果顯示，ABI-5366在口服劑量高達(dá)350毫克時(shí)耐受性良好，未報(bào)告3級(jí)或4級(jí)治療相關(guān)實(shí)驗(yàn)室異?；驀?yán)重不良事件。此外，在所有劑量組中觀察到ABI-5366的半衰期約為20天，有望實(shí)現(xiàn)每周一次或每月一次的口服給藥方案。

CVN293：公布1期臨床試驗(yàn)數(shù)據(jù)

Cerevance公司公布了其鉀雙孔結(jié)構(gòu)域通道亞家族K成員13（KCNK13）抑制劑CVN293的積極1期臨床試驗(yàn)結(jié)果。CVN293是一種高選擇性口服KCNK13抑制劑，旨在通過抑制神經(jīng)炎癥減緩神經(jīng)退行性疾病進(jìn)展。KCNK13是一種潛在的NLRP3炎性小體激活的新型調(diào)節(jié)因子，該靶點(diǎn)由Cerevance公司專有的NETSseq平臺(tái)發(fā)現(xiàn)。

此次公布的研究結(jié)果顯示，接受CVN293單次和14天內(nèi)多次給藥的健康成人對(duì)該藥物的耐受性良好，100%的受試者完成了試驗(yàn)，未出現(xiàn)劑量限制性毒性、治療相關(guān)停藥或具臨床意義的生命體征異常，所有不良事件均為輕度。CVN293還顯示出強(qiáng)大的腦滲透性，支持KCNK13抑制劑對(duì)以神經(jīng)炎癥為特征的神經(jīng)退行性疾病的效用。

PALI-2108：1a期臨床試驗(yàn)完成受試者給藥

Palisade Bio公司宣布，其用于治療潰瘍性結(jié)腸炎（UC）的在研藥物PALI-2108已完成1a期臨床試驗(yàn)，預(yù)計(jì)將于2025年5月底公布頂線數(shù)據(jù)。在UC和纖維狹窄型克羅恩?。‵SCD）中，較高的PDE4B表達(dá)與局部炎癥活動(dòng)有關(guān)。PALI-2108是一種PDE4抑制劑前藥，能在UC和FSCD等疾病部位局部活化，顯著提升病變組織內(nèi)PDE4抑制劑濃度，同時(shí)減少全身暴露，從而降低腹瀉等傳統(tǒng)PDE4抑制劑的副作用。

初步結(jié)果顯示，迄今為止未觀察到與實(shí)驗(yàn)室檢查或心電圖相關(guān)的嚴(yán)重不良事件或治療伴發(fā)不良事件。在臨床前研究中，與其他PDE4抑制劑相比，PALI-2108對(duì)PDE4 B和D有很強(qiáng)的抑制作用。這些結(jié)果表明，在劑量相當(dāng)?shù)那闆r下，PALI-2108具有極佳的耐受性。

ALX2004：IND申請(qǐng)獲得FDA許可

ALX Oncology公司宣布，其針對(duì)EGFR表達(dá)實(shí)體瘤的潛在“best-in-class”及“first-in-class”抗體偶聯(lián)藥物（ADC）ALX2004的IND申請(qǐng)已獲FDA批準(zhǔn)，計(jì)劃于2025年中期啟動(dòng)單劑量遞增及擴(kuò)展的1期臨床試驗(yàn)。ALX2004是通過該公司專有的拓?fù)洚悩?gòu)酶I抑制劑有效載荷平臺(tái)設(shè)計(jì)的，由三部分組成，分別是經(jīng)優(yōu)化的抗EGFR抗體骨架、穩(wěn)定性增強(qiáng)的連接子，以及能產(chǎn)生強(qiáng)旁觀者效應(yīng)的專有拓?fù)洚悩?gòu)酶I載荷，旨在克服早期EGFR靶向ADC因藥物設(shè)計(jì)、脫靶毒性及傳統(tǒng)載荷局限性導(dǎo)致的臨床瓶頸。

CVHNLC：IND申請(qǐng)獲得FDA許可

CureVac公司宣布，美國(guó)FDA已批準(zhǔn)其基于mRNA的精準(zhǔn)免疫療法CVHNLC的IND申請(qǐng)，可啟動(dòng)針對(duì)鱗狀非小細(xì)胞肺癌（sqNSCLC）患者的1期研究。CVHNLC由兩種編碼8種在sqNSCLC中常見的腫瘤相關(guān)抗原（TAA）的mRNA構(gòu)建體組成，其中4種為已知的實(shí)體瘤相關(guān)抗原，另4種為CureVac專有發(fā)現(xiàn)平臺(tái)鑒定的新TAA。該療法采用第二代mRNA骨架，使用未修飾的mRNA封裝于脂質(zhì)納米顆粒（LNP）中。該公司計(jì)劃將CVHNLC與免疫檢查點(diǎn)抑制劑pembrolizumab聯(lián)用進(jìn)行臨床試驗(yàn)，旨在放大靶向抗腫瘤免疫反應(yīng)。

參考資料（可上下滑動(dòng)查看）

[1] IDEAYA Biosciences Announces Phase 1/2 Expansion for IDE397 and Trodelvy? Combination in MTAP-Deletion Urothelial Cancer. Retrieved April 12, 2025, from https://www.prnewswire.com/news-releases/ideaya-biosciences-announces-phase-12-expansion-for-ide397-and-trodelvy-combination-in-mtap-deletion-urothelial-cancer-302425193.html

[2] ALX Oncology Receives IND Clearance from U.S. FDA for ALX2004, a Novel EGFR-targeted Antibody-drug Conjugate. Retrieved April 12, 2025, from https://ir.alxoncology.com/news-releases/news-release-details/alx-oncology-receives-ind-clearance-us-fda-alx2004-novel-egfr

[3] CureVac Receives U.S. FDA IND Clearance to Initiate Phase 1 Clinical Trial for Novel mRNA-Based Precision Immunotherapy in Squamous Non-Small Cell Lung Cancer. Retrieved April 12, 2025, from https://www.curevac.com/en/curevac-receives-u-s-fda-ind-clearance-to-initiate-phase-1-clinical-trial-for-novel-mrna-based-precision-immunotherapy-in-squamous-non-small-cell-lung-cancer/

[4] NKGen Biotech Presents Data from Phase 1/2a Clinical Trial of Troculeucel in Moderate Alzheimer’s Disease at the International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD? 2025). Retrieved April 12, 2025, from https://nkgenbiotech.com/nkgen-biotech-presents-data-from-phase-1-2a-clinical-trial-of-troculeucel-in-moderate-alzheimers-disease-at-the-international-conference-on-alzheimers-and-parkinsons-disease/

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[6] Palisade Bio Completes Dosing in Phase 1a Portion of Ongoing Phase 1a/b Study of PALI-2108. Retrieved April 12, 2025, from https://palisadebio.com/palisade-bio-completes-dosing-in-phase-1a-portion-of-ongoing-phase-1a-b-study-of-pali-2108/

[7] SciTech Development Announces 2nd FDA Approval of a Phase 1 a/b IND For ST-001. New IND Targets the Treatment of Relapsed/Refractory Small Cell Lung Cancer Following Its Previous Approval in the Treatment of T-Cell NHL. Retrieved April 12, 2025, from https://www.prnewswire.com/news-releases/scitech-development-announces-2nd-fda-approval-of-a-phase-1-ab-ind-for-st-001-new-ind-targets-the-treatment-of-relapsedrefractory-small-cell-lung-cancer-following-its-previous-approval-in-the-treatment-of-t-cell-nhl-302421487.html

[8] Cerevance Presents Positive Results from Phase 1 Study of CVN293 at American Academy of Neurology 2025 Annual Meeting. Retrieved April 12, 2025, from https://www.cerevance.com/media/cerevance-presents-positive-results-from-phase-1-study-of-cvn293-at-american-academy-of-neurology-2025-annual-meeting

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[12] Cytora Reports Successful Results of Phase 1/2a Trial of Stem Cell Treatment for Diabetic Foot Ulcers. Retrieved April 12, 2025, from https://www.prnewswire.com/news-releases/cytora-reports-successful-results-of-phase-12a-trial-of-stem-cell-treatment-for-diabetic-foot-ulcers-302424359.html

[13] KSQ Therapeutics Announces First Patient Dosed in Phase 1/2 Study for KSQ-004EX, a CRISPR/Cas9-Engineered Tumor Infiltrating Lymphocyte (eTIL?) Therapy. Retrieved April 12, 2025, from https://www.globenewswire.com/news-release/2025/04/09/3058270/0/en/KSQ-Therapeutics-Announces-First-Patient-Dosed-in-Phase-1-2-Study-for-KSQ-004EX-a-CRISPR-Cas9-Engineered-Tumor-Infiltrating-Lymphocyte-eTIL-Therapy.html

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[15] Solu Therapeutics Closes $41M Series A Financing and Announces First Patient Dosed in Phase 1 Clinical Trial of STX-0712 in Patients with CMML and Other Advanced Hematologic Malignancies. Retrieved April 12, 2025, from https://cdn.prod.website-files.com/669551ccc7908830b842dc2b/67f55ddc890a926ab1f047c9_Final%20Solu%20press%20release_4.9.pdf

[16] Context Therapeutics Doses First Patient in Phase 1 Clinical Trial of CT-95. Retrieved April 12, 2025, from https://www.globenewswire.com/news-release/2025/04/09/3058314/0/en/index.html

[17] Amylyx Pharmaceuticals Announces First Participant Dosed in Phase 1, Multiple Ascending Dose LUMINA Trial of AMX0114 in People Living with Amyotrophic Lateral Sclerosis. Retrieved April 12, 2025, from https://www.amylyx.com/news/amylyx-pharmaceuticals-announces-first-participant-dosed-in-phase-1-multiple-ascending-dose-lumina-trial-of-amx0114-in-people-living-with-amyotrophic-lateral-sclerosis

[18] Assembly Biosciences Presents New Data Highlighting Long-Acting Herpes Simplex Virus Candidate ABI-5366 and Genital Herpes Prevalence and Treatment Patterns at the 2025 ESCMID Congress. Retrieved April 12, 2025, from https://investor.assemblybio.com/news-releases/news-release-details/assembly-biosciences-presents-new-data-highlighting-long-acting

[19] Seismic Therapeutic Doses First Cohort in Phase 1 Clinical Trial of S-4321, a Novel Bifunctional Antibody that Agonizes PD-1 and FcγRIIb Inhibitory Receptors for the Treatment of Autoimmune Disease. Retrieved April 12, 2025, from https://seismictx.com/seismic-therapeutic-doses-first-cohort-in-phase-1-clinical-trial-of-s-4321-a-novel-bifunctional-antibody-that-agonizes-pd-1-and-fc%ce%b3riib-inhibitory-receptors-for-the-treatment-of-autoimmune-disea/

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