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Compass Therapeutics has shared promising results from a phase 2/3 study of its investigational bispecific antibody in biliary tract cancer (BTC). The ongoing COMPANION-002 trial has been evaluating the candidate, tovecimig (formerly CTX-009), alongside paclitaxel in adults with unresectable advanced, metastatic or recurrent BTC who have received one prior systemic chemotherapy regimen. The study met its primary endpoint, with tovecimig plus paclitaxel achieving a 17.1% overall response rate (ORR), including one complete response, compared to an ORR of 5.3% for paclitaxel alone. The tovecimig combination was also associated with progressive disease rates of 16.2% compared to 42.1% in patients on paclitaxel alone, and the safety profile of Compass’ drug was found to be consistent with prior studies. The pre-specified number of events required to inform the analyses of the study’s secondary endpoints, including progression free survival, overall survival and duration of response, have not yet been met and the company said it is expecting to report results for these endpoints in the fourth quarter of 2025. Thomas Schuetz, chief executive officer of Compass and vice chairman of the board of directors, said: “We believe these findings highlight the potential of tovecimig to provide a much-needed treatment option for the majority of patients with BTC who have limited alternatives after first-line therapy. We look forward to discussing this data with regulatory authorities.” Around 23,000 cases of BTC, a rare and aggressive cancer of the bile ducts, are diagnosed in the US every year. Nearly all patients develop progressive disease following first-line treatment with chemotherapy, Compass outlined, underscoring the need for safe and effective therapies in patients with advanced BTC. Tovecimig is designed to block both the Delta-like ligand 4 and vascular endothelial growth factor A signalling pathways, providing anti-tumour activity. “Patients currently have very limited treatment options, with the vast majority in the second-line setting having no approved therapeutic alternative whatsoever,” said Juan Valle, chief medical officer of the Cholangiocarcinoma Foundation. “Each investigative trial helps in this fight to advance new treatment options, and I look forward to following tovecimig’s continued progress.”

South Korean biotech ABL Bio has lined up another platform license agreement with a European pharma giant in the area of neurodegenerative diseases. ABL Bio has now garnered the interest of GSK, which will hand over £38.5 million ($49.5 million) in an immediate upfront payment, three years after it signed on Sanofi as a partner. GSK has also promised up to £2.075 billion ($2.67 billion) in R&D, regulatory and commercialization biobucks, according to a Sunday evening press release . The move gives the UK drugmaker access to ABL’s so-called Grabody-B platform, which helps medicines make it across the blood-brain barrier, a key hurdle for many brain health treatments. GSK could develop antibody medicines, siRNA treatments, antisense oligonucleotides or other types of drugs using the platform, ABL said. “Many of the most promising new therapies are antibodies, which cannot efficiently reach the brain without a shuttle to get them across the BBB,” GSK’s SVP of research technologies Christopher Austin said in a statement. GSK’s neuroscience pipeline includes a Phase 3 frontotemporal dementia treatment prospect, a Phase 2 Alzheimer’s disease experimental medicine and earlier-stage work. GSK has been active on the neuroscience dealmaking front. The company forged an Alzheimer’s partnership with Muna Therapeutics for €33.5 million upfront in December. It bought a small molecule treatment candidate for Parkinson’s disease from Flagship’s Vesalius Therapeutics in November. While ABL was responsible for leading Phase 1 development in its Sanofi tie-up, GSK wants more direct involvement in its pact. GSK will drive preclinical and clinical work, according to the announcement. “Given the increasing number of patients suffering from neurodegenerative diseases such as Alzheimer’s and Parkinson’s diseases, we hope this partnership will accelerate the development of innovative treatments and bring renewed hope to patients worldwide,” ABL CEO Sang Hoon Lee said in a statement. The Seongnam-based biotech’s shares traded up nearly 30% on the Kosdaq stock exchange in reaction to the news. ABL also counts I-Mab, Compass and others as partners.

4月1日，Compass therapeutics公司公布其VEGF/DLL-4双抗Tovecimig （CTX-009）在二线胆管癌中的2/3期临床数据。数据显示，比单独使用紫杉醇5.3%的客观响应率，Tovecimig （CTX-009）的客观响应率达到了17.1%，达到了该项临床额首要终点。受此消息推动，公司股价大涨17.89%。CTX-009是一种双特异性抗体，可同时阻断Delta样配体4（DLL4）和血管内皮生长因子A（VEGF-A）信号通路，这两种通路对血管生成和肿瘤血管化至关重要。CTX-009的临床前和早期临床数据表明，阻断这两种通路可在结直肠癌、胃癌、胆管癌、胰腺癌和非小细胞肺癌（NSCLC）等多种实体瘤中发挥强大的抗肿瘤活性。在对已获批准的抗血管内皮生长因子疗法耐药、且已接受过多重治疗的癌症患者中，已观察到CTX-009单药治疗所引发的部分缓解（PR）。COMPANION-002 是该公司正在进行的Tovecimig (以前称为 CTX-009) 联合紫杉醇治疗晚期胆道癌 (BTC)患者的 2/3 期临床试验。该研究招募了 168 名成年患者。所有患者均在每个 28 天周期的第 1、8 和 15 天接受 80 mg/m2 紫杉醇治疗。Tovecimig组患者还在每个 28 天周期的第 1 和 15 天接受 10 mg/kg 托维西米治疗。主要结果显示：在二线治疗的 BTC 患者中，Tovecimig 联合紫杉醇治疗（111 名患者中的 19 名）的总体反应率 (ORR) 为 17.1%，其中包括 1 名完全反应，而单独使用紫杉醇治疗的ORR为 5.3%（57 名患者中的 3 名）。对于接受联合治疗的患者来说，ORR 相对改善了11.8%，具有统计学意义（p=0.031）。该研究还显示了其他疗效指标在不同治疗组之间的差异，包括接受Tovecimig联合紫杉醇治疗的患者的疾病进展 (PD) 率为 16.2%，而单用紫杉醇治疗的患者的疾病进展 (PD) 率为 42.1%。Tovecimig 的安全性与先前的研究一致。COMPANION-002 研究还在进行中，目前用于次要结果测量（包括 PFS、OS 和 DoR）分析的数据尚未成熟。触发该次要终点分析所需的预定事件数量尚未达到。该公司预计将在 2025 年第四季度报告包含次要终点分析的详细安全数据。据估计，美国每年约有 23,000 名患者患有胆道癌。对于约 85% 的 BTC 患者，其肿瘤不含有经批准的靶向疗法可操作的突变，目前尚无 FDA 批准的二线治疗方法。在这种情况下使用的未标明用于此适应症的治疗组合通常具有 ~5% 或更低的 ORR，患者的中位总生存期约为六个月。End声明：本公众号所有发文章(包括原创及转载文章)系出于传递更多信息之目的，且注明来源和作者。本公众号欢迎分享朋友圈或大群，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/商务/投稿 | 联系微信15618157102（sum_Gmi）商务合作稿件征集点击了解详情往期回顾1关张、破产、裁员 | 2024年生物药企的阴影2全球第一款司美格鲁肽咀嚼软糖上市！3中国首个男性HPV疫苗获批上市!