对多种类型乳腺癌的疾病控制率约90%的ADC；有望预防和治疗三阴性乳腺癌的癌症疫苗... | 一周盘点

▎药明康德内容团队编辑

本期看点

1. SystImmune公司两款抗体偶联药物（ADC）的早期临床数据亮眼，针对不同类型的乳腺癌患者，疾病控制率（DCR）均在90%左右。

2. Replimune Group公司公布了其溶瘤病毒疗法RP1的两项临床研究结果，有望为PD-1抑制剂耐药或不适合接受PD-1抑制剂治疗的皮肤癌患者提供新的治疗选择。

3. 下一代ADC疗法DAN-222的早期临床结果积极，与PARP抑制剂的作用互补，两者联用可增强疗效，且不受患者BRCA或同源修复缺陷状态的限制。

4. Anixa Bioscience公司开发的α-乳清蛋白疫苗有望预防和治疗三阴性乳腺癌。

药明康德内容团队整理

BL-M07D1、BL-B01D1：公布1期临床试验数据

SystImmune公司公布了其两款ADC候选疗法BL-M07D1和BL-B01D1的1期临床试验的积极结果。BL-M07D1以曲妥珠单抗为基础，具有两个特异性结合域，靶向人表皮生长因子受体2（HER2）。每个BL-M07D1分子携带7-8个单位的SystImmune专有的ED-04毒素。该候选疗法可与过度表达会驱动癌细胞增殖和存活的HER2结合，然后被癌细胞内化。在抗体介导的内化过程中，BL-M07D1被运送到癌细胞的溶酶体，释放出其治疗载荷，激活导致癌细胞死亡的通路。

此次公布的针对BL-M07D1开展的1期研究的数据显示，在50例HER2+转移性乳腺癌患者中，缓解率为80%，确认的缓解率超过60%，DCR达到100%。之前接受过HER2 ADC治疗并不影响BL-M07D1的疗效，18名此类患者显示出与总人群类似的总缓解率。该研究的初步结果显示，38名接受过大量先前治疗的HER2低表达转移性乳腺癌患者的总缓解率（ORR）为50%，DCR为86%。安全性方面，在接受治疗的130名患者中，只有1名患者出现了2级间质性肺病（ILD）。

BL-B01D1是一款靶向表皮生长因子受体（EGFR）和HER3的ADC，每个BL-B01D1分子携带7-8个单位的SystImmune专有的ED-04毒素。此次公布的针对BL-B01D1开展的1期研究的数据显示，先前接受过治疗的HER2-/HR+乳腺癌（n=38）、三阴性乳腺癌（n=35）和HER2+乳腺癌（n=23）患者亚组的ORR分别为44.7%、31.4%和39.1%，DCR分别为91.4%、94.7%和87%。安全性方面，在至少接受过一次BL-B01D1治疗的127例患者中，未观察到ILD。

RP1：公布两项1/2期临床试验的数据

Replimune Group公司公布了其溶瘤病毒疗法RP1联用PD-1抑制剂nivolumab治疗PD-1抑制剂治疗失败的黑色素瘤和非黑色素瘤皮肤癌（NMSC）患者的临床试验IGNYTE的数据，以及RP1作为单药治疗曾接受过实体器官或造血细胞移植的皮肤癌患者的临床试验ARTACUS的数据。

IGNYTE研究的结果显示，该联合疗法在PD-1抑制剂治疗失败的黑色素瘤患者（n=156）中的ORR为31.4%，完全缓解（CR）率为12%，临床获益率（CBR）约为50%。在获得缓解的患者中，100%的患者在6个月时缓解仍在持续，截至2023年11月6日，78%的患者的缓解仍在持续，中位缓解持续时间超过24个月。该联合疗法的耐受性良好，治疗相关不良事件主要为1-2级。

IGNYTE试验中报告的NMSC队列的数据来自首批30例患者，所有患者都接受了至少6个月的随访，包括皮肤鳞状细胞癌、Merkel细胞癌、基底细胞癌和血管肉瘤患者。数据显示，对于NMSC患者，该联合疗法的ORR为30%，CBR为60%。该联合疗法在这一患者群体中耐受性良好，其安全性与迄今为止该疗法在皮肤癌中的总体表现一致。

ARTACUS研究的结果显示，RP1单药治疗曾接受过实体器官移植或造血细胞移植的皮肤癌患者的ORR为34.8%（8/23），5名患者达到CR，3名患者达到部分缓解（PR）。这些患者一般不适合接受抗PD-1治疗，因为这种治疗可能会诱发移植排斥反应。截至2023年9月18日的数据，大多数患者仍处于持续缓解状态。RP1单药治疗的耐受性良好，没有证据表明存在异体移植排斥反应。其安全性与在非免疫功能低下的晚期皮肤癌患者中观察到的安全性相似。

DAN-222：公布1期临床试验数据

Dantari公司公布了其下一代ADC疗法DAN-222单药和与PARP抑制剂（niraparib）联用治疗转移性HER2-乳腺癌患者的1期临床试验数据。DAN-222是一种含有拓扑异构酶1抑制剂（TOPO1）有效载荷的新型高容量偶联药物。TOPO1产品的主要风险是骨髓毒性，而DAN-222在临床前模型中的骨髓暴露率低，且与PARP抑制剂的作用机制互补，因此具有广泛的应用潜力，可作为PARP抑制剂和其他药物的联合疗法提供新的效用。重要的是，这种互补性增强的疗效与患者的BRCA状态和广义的同源修复缺陷状态无关。

此次公布的结果显示，DAN-222单药和与niraparib联用的安全和耐受性良好，并显示出良好的抗肿瘤活性。38%接受DAN-222单药治疗的患者达到了疾病稳定（SD)，67%接受DAN-222联用niraparib治疗的患者达到了SD。

α-乳清蛋白疫苗：公布1期临床试验数据

Anixa Bioscience公司公布了其开发的乳腺癌疫苗用于高风险可手术的三阴性乳腺癌患者和具有三阴性乳腺癌高遗传风险的患者的1期临床试验的积极数据。该疫苗通过激活针对在生命周期中的某些时间点具有功能，但随后会“退休”的内源性蛋白的免疫反应来发挥作用。其中一种蛋白是乳腺特异性的泌乳蛋白——α-乳清蛋白，它在哺乳期后的正常和衰老组织中会消失，但存在于大多数三阴性乳腺癌中。该候选疫苗还含有一种佐剂，可激活先天性免疫反应，使免疫系统对新出现的肿瘤做出反应，防止肿瘤生长。因此，该候选疫苗可针对表达α-乳清蛋白的乳腺肿瘤提供先发制人的免疫保护。

此次公布的结果显示，该候选疫苗疫苗安全且耐受性良好，在所有剂量水平下均观察到抗原特异性T细胞反应，免疫介导的T细胞活化生物标志物IFNγ和IL-17从基线开始逐渐增加。

Vepdegestrant（ARV-471）：公布1b期临床试验数据

Arvinas公司和辉瑞（Pfizer）公布了在研PROTAC蛋白降解剂vepdegestrant（ARV-471）联用palbociclib的1b期临床试验的。该试验入组患者为局部晚期或转移性ER+/HER2-乳腺癌患者，既往接受过中位4线治疗。ARV-471是一款口服、靶向降解ER的PROTAC蛋白降解剂。ARV-471可在肿瘤细胞内降解几乎所有的ER分子，并在许多ER驱动的动物肿瘤模型中，引起肿瘤大量的缩小。

此次公布的中期结果表明，接受联合疗法乳腺癌患者的CBR（定义为确认CR、PR或SD≥24周的比率）为63%，ORR为42%，中位无进展生存期（PFS）为11.1个月，证明vepdegestrant联合palbociclib治疗乳腺癌的潜力。

Bexmarilimab：公布1/2期临床试验数据

Faron Pharmaceuticals公司公布了其靶向Clever-1的单克隆抗体bexmarilimab正在进行的1/2期研究的积极临床进展。Bexmarilimab是Faron公司全资拥有的研究性免疫疗法，旨在通过靶向髓系细胞功能和激活免疫系统，克服对现有疗法的耐药性并优化临床疗效。Bexmarilimab能与巨噬细胞上的免疫抑制受体Clever-1结合，该受体有助于肿瘤生长和转移（即帮助癌症躲避免疫系统）。通过靶向巨噬细胞上的Clever-1受体，bexmarilimab可改变肿瘤微环境，将巨噬细胞从免疫抑制（M2）状态重编程为免疫刺激（M1）状态，上调干扰素的产生，启动免疫系统攻击肿瘤，使癌细胞对标准治疗敏感。

此次公布的结果显示，bexmarilimab单药治疗可诱导巨噬细胞活化并增加IFNɣ信号传导，从而使晚期转移性实体瘤患者的疾病得到控制，生存期获得延长。在皮肤黑色素瘤、胃癌、肝细胞癌、ER+乳腺癌和胆道癌患者中观察到的DCR为25%-40%不等。在一项分析中，疾病控制与生存率的提高相关，并与治疗前肿瘤内Clever-1阳性率高和治疗中血清干扰素γ（IFNγ）水平升高相关。安全性方面，bexmarilimab安全且耐受性良好，未报告严重不良反应。

LYT-200：公布1期临床试验数据

PureTech Health公司公布了其靶向半乳糖凝集素-9（galectin-9）的候选抗体疗法LYT-200作为单一疗法以及与靶向PD-1的抗体tislelizumab联用治疗转移性实体肿瘤的效果。在临床前模型中，LYT-200作为单药的效果优于PD-1抑制剂。在活体癌症模型中，LYT-200还能与PD-1抑制剂协同激活CD4和CD8 T细胞。

此次公布的结果显示，LYT-200单药治疗的耐受性良好，没有观察到剂量限制性毒性，仅有低级别的不良反应，在接受过大量先前治疗的胰腺癌患者和1名结直肠癌患者中，LYT-200的使患者获得了长期的SD，已超过了一年。

此外，LYT-200与tislelizumab联用的安全性良好，并且具有抗肿瘤活性。迄今为止，接受联合治疗的4名头颈癌患者中有3人的病情得到控制，其中1名患者已保持CR状态9个月，1名患者已保持深度PR状态8个月，1名患者已保持SD状态4个月，这些患者的治疗仍在进行中。两名可评估的尿道癌患者的病情分别稳定了7个月和3个月，目前也仍在接受治疗。

BI-1607：公布1b期临床试验数据

BioInvent Internationa公司公布了其开发的第二款抗FcγRIIB（一种抑制性Fc受体，是抗肿瘤免疫中的T细胞检查点）抗体BI-1607联合曲妥珠单抗治疗HER2+晚期实体肿瘤患者的首个积极临床数据，这些患者此前曾接受过含有曲妥珠单抗的治疗并出现进展。BI-1607旨在提高现有癌症治疗（如曲妥珠单抗）的疗效并克服肿瘤的耐药性。床前数据表明，使用BI-1607治疗可增强当前抗HER2方案（如曲妥珠单抗）的疗效。

此次公布的结果显示，治疗剂量范围为75-900 mg时，BI-1607治疗的耐受性良好，未观察到严重不良事件。截至目前，11名可评估患者中有6名患者达到SD，疾病控制已持续21周。

XTX101：公布1期临床试验数据

Xilio Therapeutics公司公布了其靶向CTLA-4的抗体XTX101单药治疗难治性实体肿瘤患者的1期临床试验的最新数据。结果显示，XTX101单药治疗通常耐受性良好，治疗相关不良事件主要为1级或2级，没有患者因治疗相关不良事件而停止治疗。接受2期推荐剂量XTX101治疗的12名可评估患者的DCR为33%，其中1名PD-L1阴性的IV期非小细胞肺癌患者实现了PR，并维持了36周，肝转移灶完全消退。1名三阴性乳腺癌患者，1名黑色素瘤患者和1名微卫星稳定型结直肠癌患者实现了SD。

Palazestrant（OP-1250）：公布1b/2期临床试验的新数据

Olema Oncology公司公布了其候选药物palazestrant（OP-1250）联用CDK4/6抑制剂Ibrance（palbociclib）治疗晚期和/或转移性ER+/HER2-乳腺癌患者的1b/2期临床试验的初步数据。OP-1250是一种具有完全ER拮抗剂（CERAN）和选择性ER降解剂（SERD）这两种双重活性的口服小分子药物。此前，OP-1250已获得了FDA授予的快速通道资格。

此次公布的数据显示，palazestrant与palbociclib之间没有观察到药物相互作用，且在联合使用时，它们的代谢或暴露量都没有增加。无论是在ESR1突变型肿瘤还是ESR1野生型肿瘤患者中，都观察到了肿瘤的缓解和持久的SD，包括那些先前接受过CDK4/6抑制剂治疗的患者。7名患者出现PR，其中两名为确认的PR。所有患者的CBR为46%，在基线时ESR1发生突变的患者的CBR为60%，先前未接受过CDK4/6抑制剂治疗的患者的CBR为71%。53%的患者的靶病灶有缩小。

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参考资料（可上下滑动查看）

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[15] RIBOMIC Phase I and II Data Published in the Eye: Full TOFU/RAMEN/TEMPURA Trial Results Demonstrate Clinical Proof of Concept of Umedaptanib Pegol in Exudative Age-Related Macular Degeneration (nAMD). Retrieved December 5, 2023, from https://www.businesswire.com/news/home/20231204246876/en

[16] Century Therapeutics Receives FDA Clearance of IND Application for CNTY-101 in Systemic Lupus Erythematosus. Retrieved December 7, 2023, from https://www.globenewswire.com/news-release/2023/12/06/2791671/0/en/Century-Therapeutics-Receives-FDA-Clearance-of-IND-Application-for-CNTY-101-in-Systemic-Lupus-Erythematosus.html

[17] Coherus Presents Phase 1/2 Clinical Data on Casdozokitug, a First-in-Class IL-27-Targeted Antibody, at the 2023 ESMO Immuno-Oncology Congress. Retrieved December 7, 2023, from https://www.globenewswire.com/news-release/2023/12/06/2791515/33333/en/Coherus-Presents-Phase-1-2-Clinical-Data-on-Casdozokitug-a-First-in-Class-IL-27-Targeted-Antibody-at-the-2023-ESMO-Immuno-Oncology-Congress.html

[18] Delix Presents Interim Data From Phase I Trial of Novel Neuroplastogen at ACNP Annual Meeting. Retrieved December 7, 2023, from https://www.businesswire.com/news/home/20231206561331/en

[19] CDR-Life Announces First Patient Dosed in Phase 1 Study with Boehringer Ingelheim Evaluating Potential Treatment for Geographic Atrophy. Retrieved December 7, 2023, from https://www.globenewswire.com/news-release/2023/12/06/2791553/0/en/CDR-Life-Announces-First-Patient-Dosed-in-Phase-1-Study-with-Boehringer-Ingelheim-Evaluating-Potential-Treatment-for-Geographic-Atrophy.html

[20] Crescendo Biologics announces first U.S. patients dosed in expanded Phase 1b clinical trial of CB307 for patients with mCRPC. Retrieved December 7, 2023, from https://www.globenewswire.com/ca/news-release/2023/12/06/2791637/0/en/Crescendo-Biologics-announces-first-U-S-patients-dosed-in-expanded-Phase-1b-clinical-trial-of-CB307-for-patients-with-mCRPC.html

[21] Anixa Biosciences and Cleveland Clinic Present Positive New Data from Phase 1 Study of Breast Cancer Vaccine. Retrieved December 7, 2023, from https://www.prnewswire.com/news-releases/anixa-biosciences-and-cleveland-clinic-present-positive-new-data-from-phase-1-study-of-breast-cancer-vaccine-302007568.html

[22] Faron Announces Publication of Full Analysis from Phase 1/2 MATINS Trial of Bexmarilimab in Solid Tumors in Cell Reports Medicine. Retrieved December 7, 2023, from https://www.globenewswire.com/news-release/2023/12/07/2792226/0/en/Faron-Announces-Publication-of-Full-Analysis-from-Phase-1-2-MATINS-Trial-of-Bexmarilimab-in-Solid-Tumors-in-Cell-Reports-Medicine.html

[23] PureTech Presents Data from Phase 1 Trial of LYT-200 Targeting Galectin-9 in Solid Tumors at the ESMO Immuno-Oncology Congress 2023. Retrieved December 7, 2023, from https://www.businesswire.com/news/home/20231207651720/en

[24] Xilio Therapeutics Announces Initiation of Enrollment for Phase 1 Combination Trial of XTX101, a Tumor-Activated, Fc-Enhanced Anti-CTLA-4, and Updated Phase 1 Monotherapy Data. Retrieved December 7, 2023, from https://www.globenewswire.com/news-release/2023/12/07/2792409/0/en/Xilio-Therapeutics-Announces-Initiation-of-Enrollment-for-Phase-1-Combination-Trial-of-XTX101-a-Tumor-Activated-Fc-Enhanced-Anti-CTLA-4-and-Updated-Phase-1-Monotherapy-Data.html

[25] NextPoint Therapeutics Announces IND Clearance from the FDA to Advance NPX887, a Novel Therapeutic Targeting HHLA2 to Reactivate Exhausted T and NK Cells in HHLA2+ Solid Tumors. Retrieved December 7, 2023, from https://www.businesswire.com/news/home/20231207185510/en

[26] Vittoria Biotherapeutics Announces FDA Clearance of IND Application for VIPER-101 to Treat T-Cell Lymphoma. Retrieved December 7, 2023, from https://www.globenewswire.com/news-release/2023/12/07/2792443/0/en/Vittoria-Biotherapeutics-Announces-FDA-Clearance-of-IND-Application-for-VIPER-101-to-Treat-T-Cell-Lymphoma.html

[27] Aligos Therapeutics Presents Positive Clinical Data at Hep-DART 2023 from Phase 1 Studies in HBV (ALG-000184) and NASH (ALG-055009). Retrieved December 7, 2023, from https://www.globenewswire.com/news-release/2023/12/07/2792883/0/en/Aligos-Therapeutics-Presents-Positive-Clinical-Data-at-Hep-DART-2023-from-Phase-1-Studies-in-HBV-ALG-000184-and-NASH-ALG-055009.html

[28] SpyBiotech Announces First Patient Dosed in Phase I Trial of SPYVLP01. Retrieved December 8, 2023, from https://www.businesswire.com/news/home/20231207232622/en

[29] First Patient Dosed in Spago Nanomedical's Clinical Phase I/IIa Study within the Tumorad(R) Program. Retrieved December 8, 2023, from https://www.accesswire.com/814264/first-patient-dosed-in-spago-nanomedicals-clinical-phase-iiia-study-within-the-tumoradr-program

[30] Dantari's Novel High-Capacity Drug Conjugate DAN-222 Shows Promising Antitumor Activity in Patients with Metastatic HER2-Negative Breast Cancer. Retrieved December 8, 2023, from https://www.prnewswire.com/news-releases/dantaris-novel-high-capacity-drug-conjugate-dan-222-shows-promising-antitumor-activity-in-patients-with-metastatic-her2-negative-breast-cancer-302005214.html

[31] Regor Announces Promising Safety And Single Agent Efficacy Data Evaluating RGT-419B In HR+/HER2- Advanced Breast Cancer Patients Who Have Progressed On CDK4/6 Inhibitors And Endocrine Therapy. Retrieved December 8, 2023, from https://www.prnewswire.com/news-releases/regor-announces-promising-safety-and-single-agent-efficacy-data-evaluating-rgt-419b-in-hrher2--advanced-breast-cancer-patients-who-have-progressed-on-cdk46-inhibitors-and-endocrine-therapy-302009555.html

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