Becotatug vedotin

– A potential best- and first-in-class antibody-drug conjugate (ADC) for the treatment of EGFR-expressing solid tumors, ALX2004 is uniquely designed with every component optimized to maximize the therapeutic window -First-in-human trial of ALX2004 builds upon body of positive preclinical data demonstrating dose dependent anti-tumor activity and favorable safety profile -Initial safety data anticipated in first half 2026 SOUTH SAN FRANCISCO, CA, USA I August 19, 2025 I ALX Oncology Holdings Inc., (“ALX Oncology” or the”Company”) (Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, today announced that the first patient has been dosed in the Company’s Phase 1 clinical trial for ALX2004, a potential best- and first-in-class, epidermal growth factor receptor (EGFR) ADC that is being studied for the treatment of EGFR-expressing solid tumors. “Dosing of the first patient in the Phase 1 trial is an important milestone in ALX Oncology’s mission to develop a pipeline of best-in-class drugs; ALX2004 is our first ADC and treating our first patient with this drug is a significant step forward in fulfilling the potential of EGFR-targeted ADCs,” said Jason Lettmann, Chief Executive Officer at ALX Oncology. “Our preclinical data supports our conviction that ALX2004, with its optimized antibody, linker and payload, has the potential to overcome the toxicity challenges that have limited earlier generation EGFR-targeted ADCs. We look forward to enrolling this trial and expect to report initial safety data in the first half of 2026.” The Phase 1 clinical trial ( NCT07085091 ) is a first-in-human, open-label multicenter study evaluating ALX2004 in participants with advanced or metastatic select EGFR-expressing solid tumors. The study consists of a Phase 1a dose escalation portion followed by dose exploration, and a Phase 1b dose expansion. The dose escalation portion of the trial will enroll patients with previously treated advanced or metastatic non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), esophageal squamous cell carcinoma (ESCC) and colorectal cancer (CRC). All or a subset of these tumor types may be included in the dose exploration and expansion portions of the trial. ALX2004: Optimized for Success Based on Rigorous Drug Design Process Developed by ALX Oncology’s protein engineers utilizing the Company’s proprietary topoisomerase I inhibitor (Top1i) payload and linker payload platform, ALX2004 is a uniquely designed EGFR-targeted ADC where every component is optimized to maximize the therapeutic window by reducing toxicity. This includes an affinity-tuned EGFR antibody with a binding epitope distinct from approved EGFR antibodies. ALX2004 also has a proprietary Top1i payload engineered to offer enhanced bystander effect with improved linker stability for on-target delivery of payload. Robust Preclinical Data: Supporting Differentiation in EGFR-ADC Class Preclinical data supports ALX2004’s differentiated linker-payload construct, which has demonstrated superior stability versus other ADCs in its class, with dose-dependent activity and a favorable safety profile. In addition, ALX2004 has shown dose-dependent activity across a range of tumors, EGFR expression levels and mutations. Potent activity in tumor models supports its potential for treating patients with EGFR-expressing tumors. Preclinical model findings did not demonstrate EGFR-related skin toxicity at clinically relevant doses or payload-related interstitial lung disease, supportive of a potentially differentiated safety profile. About ALX Oncology ALX Oncology (Nasdaq: ALXO) is a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives. ALX Oncology’s lead therapeutic candidate, evorpacept, has demonstrated potential to serve as a cornerstone therapy upon which the future of immuno-oncology can be built. Evorpacept is currently being evaluated across multiple ongoing clinical trials in a wide range of cancer indications. ALX Oncology’s second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate with a differentiated mechanism of action and entered the clinic in a Phase 1 trial in August 2025. More information is available at www.alxoncology.com and on LinkedIn @ ALX Oncology . SOURCE: ALX Oncology

近日，乐普生物发布了2025年上半年业绩预告，公司预计上半年将取得利润不少于2400万元，实现同比扭亏为盈。 这是公司成立以来首次实现盈利。据乐普表示，能实现转亏为盈，主要得益于公司收入的大幅成长，其中主要包括与ArriVent BioPharma就MRG007开展的许可合作收入，以及普佑恒®（普特利单抗注射液）的销售收入增长。 PD-1销售增长强势 普特利单抗（普佑恒）仍是乐普唯一的的商业化产品，于2022年7月获药监局批准上市，已获批黑色素瘤、高微卫星不稳定性或错配修复缺陷(MSI-H/dMMR)实体瘤两项适应症。 虽然普佑恒在销售收入上难以与百济、信达、君实、恒瑞等相比，但其销售增势上一众PD-1十分突出。 上市后，普佑恒的首个完整销售年度（2023年）销售额便破亿，同比增长551%，2024年进一步跃升至3亿元，同比增长约200%。 目前，乐普开展了普佑恒与其ADC管线MRG003、MRG002等的联用临床开发，以进一步拓展其他适应症。 将迎来首款上市ADC 虽然乐普在抗体、双特异性抗体、溶瘤病毒等多种形式的药物上都有涉足，但是ADC还是乐普生物最核心、进展最快的领域。 目前，乐普有7条ADC管线在研，最快的ADC管线已经到上市申报阶段，还有三款ADC管线也推到了Ⅲ期。 其中，CMG901和MRG007相继实现了对外授权，其中与ArriVent达成的授权合作（MRG007）也是公司这次能实现转亏为盈的重要原因之一。 最受期待的管线无疑是MRG003，目前全球进展最快的一款EGFR ADC，已在国内提交用于治疗复发性/转移性鼻咽癌(R/MNPC)的新药上市申请，并被纳入优先审评，有望成为国内首个批准上市的EGFR-ADC。 目前MRG003针对局部晚期头颈鳞癌（HNSCC）的III期临床正在进行中。 MRG003所处的EGFR ADC赛道竞争格局相对较好，全球范围内目前仅有一款EGFR ADC获批上市—为日本厚生省批准的光敏ADC药物Akalux，用于二线头颈鳞癌治疗。 CMG901、MRG002以及MRG004也都已经进入临床III期阶段。 双抗领域，目前还处于早期开发阶段，最新的消息是与Excalipoint达成的授权合作，两款TCE管线CTM012和CTM013被授权给了该公司，其中CTM012已申报IND。 溶瘤病毒方面，目前主要推进为引进管线CG0070，此前，其原研公司CG Oncology公布的其III期最新临床积极数据也间接利好了乐普，带动了其股价上涨。 CG0070在国内进展稍慢，目前尚处于临床Ⅰ期阶段。今年1月，CG0070还被CDE授予了突破性疗法认定，用于治疗对卡介苗（BCG）无应答的高危非肌层浸润性膀胱癌（NMIBC）患者。 总结 乐普这次实现盈利，其中合作收入做出了重要贡献，如果未来普佑恒持续保持其销售增势，加上后续有望获批的ADC产品，相信很快乐普通过产品收入实现年度盈亏平衡，迎来真正盈利。