DuoBody-EpCAMx4-1BB

PART 01核心提要管线调整：丹麦生物技术巨头 Genmab 宣布停止其 III 期肺癌药物 Acasunlimab 的临床开发。合作伙伴：该药物曾是 Genmab 与 BioNTech 的合作项目，但 BioNTech 已于去年退出了该资产的开发。决策突变：这一决定颇为突然，就在本月初，Genmab 高管还曾公开表示该项目“进展顺利”且拥有“10 亿美元潜力”。战略聚焦：在近期斥资 80 亿美元 收购 Merus 后，Genmab 正重新评估竞争格局，集中资源于更具价值的管线。在生物制药领域，果断“砍管线”往往比坚持到底更考验决策者的勇气。本周一， Genmab 正式宣布，将终止其双特异性抗体 Acasunlimab （PD-L1 x 4-1BB）的临床开发工作，该药物此前正处于针对肺癌的 III 期临床阶段。这一决定是在 Genmab 完成对 Merus 的 80 亿美元巨额收购后做出的。公司表示，经过对“不断演变的竞争格局”进行彻底评估后，决定将资源集中在晚期产品组合中“最具价值创造机会”的项目上。PART 02BioNTech早已退出，CFO言论遭“打脸”？Acasunlimab 的开发之路可谓坎坷。早在去年，Genmab 的合作伙伴 BioNTech 就已决定放弃该资产。当时，Genmab CEO Jan van de Winkel 曾信心满满地表示，Genmab 处于“非常有利的位置”，有信心将 Acasunlimab 推向后期开发阶段。更令人意外的是，这一终止决定与公司管理层近期的表态形成了鲜明反差。就在本月初的花旗全球医疗健康大会上，Genmab 首席财务官 Anthony Pagano 还告诉与会者，Acasunlimab 的 III 期临床“进展顺利”，并代表着一个“约 10 亿美元 的机会”。根据美国联邦试验数据库的信息，该试验原计划还需要三年时间才能完成。PART 03止损是正确的决定随着随访时间的延长，该药物在 II 期试验中的 总生存期（OS）曲线出现了恶化 。 这或许是导致 Genmab 最终放弃该药的关键科学原因。PART 04管线大清洗与未来展望今年以来，Genmab 在消化收购（包括此前收购 ADC 制造商 ProfoundBio）的同时，进行了一系列管线清理。在过去 13 个月中，Genmab 已先后终止了 GEN1047、GEN1056、GEN3017、GEN1107、GEN1160 和 GEN1055/BNT315 的开发，并未将 GEN1042 推进至针对实体瘤的 II 期临床。Genmab 与 BioNTech 的长期合作中目前仅剩一个活跃资产——GEN1059/BNT314 （EpCAM x 4-1BB 双抗），目前正处于针对实体瘤的 I 期临床阶段。随着 Merus 的融入，Genmab 的晚期管线重心将转移至 Rina-S 和 Epkinly 等更具潜力的项目上。 .cls-1{fill:#001e36;}.cls-2{fill:#31a8ff;} .cls-1{fill:#001e36;}.cls-2{fill:#31a8ff;}

Genmab is ending clinical development of acasunlimab, a bispecific antibody that the biotech had worked on with BioNTech until that partner walked away from the asset last year. The Danish drug developer said Monday it axed the Phase 3 lung cancer asset to focus on “the most value-creating opportunities” in its late-stage portfolio and after a “thorough assessment of the evolving competitive landscape.” Genmab recently expanded its late-stage pipeline via its $8 billion acquisition of Merus, and it also has Phase 3 programs for Rina-S and Epkinly. Acasunlimab is a PD-L1x4-1BB bispecific antibody. NovaBridge Biosciences and partner ABL Bio are also in the space. The pullback is an abrupt change from earlier this month, when CFO Anthony Pagano told attendees at the Citi Global Healthcare Conference that the Phase 3 of acasunlimab was “progressing well” and presented an “around $1 billion opportunity,” according to an AlphaSense transcript. The trial was expected to take another three years, according to the entry on the US federal trials database. At the time BioNTech gave up work on the asset last year, Genmab CEO Jan van de Winkel said his company was “exceptionally well-positioned to maximize the potential of acasunlimab, and we are confident about the prospect of taking acasunlimab into late-stage development.” William Blair analyst Matt Phipps told clients in a note Monday that “acasunlimab rightfully hits the chopping block.” “We believe this is the right decision, given recent deterioration of the overall survival curve from the Phase II trial with longer follow-up,” Phipps wrote. Genmab, which will have to integrate Merus after completing a tender offer earlier this month, already made a series of pipeline culls this year as it digested its acquisition of antibody-drug conjugates maker ProfoundBio. Over the past 13 months, it has ended development of GEN1047 , GEN1056, GEN3017, GEN1107 , GEN1160 and GEN1055/ BNT315 . It also didn’t advance GEN1042 into Phase 2 for solid tumors. Genmab has no plans for a workforce reduction following the acasunlimab pullback, a Genmab spokesperson told Endpoints News. The biotech still has one active asset in its years-long collaboration with BioNTech, the spokesperson said. GEN1059/BNT314, an EpCAMx4-1BB bispecific antibody, is in Phase 1 for solid tumors.