Partner Therapeutics, Inc.

Today, a brief rundown of news involving Daiichi Sankyo, Agenus and Amgen, as well as updates from the U.S. PTO, Bluebird bio and Merus that you may have missed.AstraZeneca and Daiichi Sankyo on Friday revealed new study results supporting their revised approval plans for the closely watched cancer drug datopotamab deruxtecan, or dato-dxd. A pooled analysis from two clinical trials showed dato-dxd kept tumors in check for a median of about six months in people whose non-small cell lung tumors were driven to growth by mutations in the EGFR gene. Among 117 people, median survival was 15.6 months, according to a statement. The findings underpin an accelerated approval filing the partners submitted last month in EGFR-mutated lung cancer a much narrower request than theyd originally anticipated. Ben FidlerAgenus will cut yearly spending by 60% to focus resources around a cancer immunotherapy combination thats approaching late-stage testing in colorectal cancer, the company said Thursday. The company will implement significant cost-cutting measures, including layoffs and other unspecified adjustments, to lower its cash burn to $100 million for the 2025 fiscal year. Agenus has been streamlining costs since last year, when it laid off 25% of its workforce, and has said its restructuring initiatives are a bridge to a forthcoming strategic transaction designed to deliver substantial resources. Ben FidlerAmgen said Thursday it will invest another $1 billion to expand its manufacturing footprint in Holly Springs, North Carolina. The new investment builds on a previously announced $550 million commitment and will add a second drug substance manufacturing facility that will employ about 370 people. Amgen has already boosted its drug production capabilities this year, having opened a production plant in Ohio in February. It didnt say when the new Holly Springs facility will begin operating. Delilah AlvaradoThe U.S. Patent and Trademark Office is withdrawing a controversial proposed rule that aimed to prevent so-called patent thickets around pharmaceutical products that can deter price competition from generic and biosimilar drugs. A notice published Wednesday cited resource constraints as a reason for pulling the rule after it received 349 comments. In the proposed rule, the PTO sought to reduce the legal burden on companies challenging intellectual property by narrowing the case to just the original inventions and not obvious variations on which the patent owner may have also claimed legal exclusivity. Jonathan GardnerNext Thursday, every 20 shares of Bluebird biowill be merged into one single share as the gene therapy developer moves ahead with a reverse stock split to regain compliance with Nasdaq listing rules. Shares in Bluebird have steadily declined this year and, since August, traded below $1 apiece. The company had to work to secure sufficient investor support for the move, which will give it more financing options. While Bluebird sells three approved gene therapies, its still struggling to break even on cash flows. Ned PagliaruloThe Food and Drug Administration granted an accelerated approval to Merus drug zenocutuzumabin adults with either non-small cell lung or pancreatic cancers that harbor a certain alteration to a gene called NRG1. The clearance is the FDAs first of a systemic therapy for these specific tumors. Merusrecently agreed to license U.S. rights to the drug, which will be sold as Bizengri, to Partner Therapeutics for an undisclosed sum. Bizengri is Merus first approved product. Ned Pagliarulo '

The Dutch biotech Merus received the first-ever FDA accelerated approval for a systemic treatment targeting a specific genetic fusion in patients with either non-small cell lung cancer or pancreatic cancer. The approval, disclosed Wednesday evening , is Merus’ first, and the drug will be sold as Bizengri. It’s a bispecific antibody targeting HER2 and HER3, and is approved for patients with advanced, unresectable, or metastatic non-small cell lung cancer or pancreatic adenocarcinoma who have an NRG1 gene fusion. Bizengri, also known as zenocutuzumab, was tested in an open label trial among 64 patients with NSCLC and 30 with pancreatic cancer. The overall response rate in the lung cancer cohort was 33%, and 40% in the pancreatic cancer group. The label includes a black box warning for pregnant women. Merus won’t actually spearhead commercialization of the drug in the US, after selling off rights earlier this week to Partner Therapeutics in exchange for an undisclosed upfront fee and $130 million in potential milestone payments. Merus’ development efforts have centered on another late-stage bispecific, petosemtamab, with new data giving the company optimism that it could be the standard-of-care in second-line head and neck cancer. Phase 2 results for petosemtamab released Sunday found that among 12 evaluable patients receiving the 1,500 mg dose of petosemtamab, one had a complete response, three had a partial response and another had an unconfirmed partial response. The data came from a dose comparison cohort that has so far randomized 42 patients to receive the 1,500 mg dose or the 1,100 mg dose.

▎Armstrong 2024年12月4日，Merus宣布FDA批准其HER2/HER3双抗Zenocutuzumab上市，用于治疗NRG1+ 胰腺癌和非小细胞肺癌，商品名为Bizengri。 此次批准是基于eNRGy临床数据，30例NRG1+胰腺癌患者ORR为40%，DoR从3.7到16.6个月。64例NRG1+NSCLC，ORR为33%，mDoR为7.4个月。 Zenocutuzumab为全球首款HER2/HER3双抗。 最新的临床数据如下，疗效有所深化。 安全性数据如下。 Zenocutuzumab同时靶向HER2和HER3。 总结 两天前，Merus刚刚宣布将Zenocutuzumab的美国商业权益授权给Partner Therapeutics，目前内部核心管线为EGFR/LGR5双抗，处于三期临床阶段，已经在头颈癌中取得优异疗效。 Armstrong技术全梳理系列 GPRC5D靶点全梳理； CD40靶点全梳理； CD47靶点全梳理； 补体靶向药物技术全梳理； 补体药物：眼科治疗的重要方向； Claudin 6靶点全梳理； Claudin 18.2靶点全梳理； 靶点冷暖，行业自知； 中国大分子新药研发格局； 被炮轰的“me too”； 佐剂百年史； 胰岛素百年传奇； CUSBEA：风雨四十载； 中国新药研发的焦虑； 中国生物医药企业的研发竞争； 中国双抗竞争格局； 中国ADC竞争格局； 中国双抗技术全梳理； 中国ADC技术全梳理； Ambrx技术全梳理； Vir Biotech技术全梳理； Immune-Onc技术全梳理； 亘喜生物技术全梳理； 康哲药业技术全梳理； 科济药业技术全梳理； 恺佧生物技术全梳理； 同宜医药技术全梳理； 百奥赛图技术全梳理； 腾盛博药技术全梳理； 创胜集团技术全梳理； 永泰生物技术全梳理； 中国抗体技术全梳理； 德琪医药技术全梳理； 德琪医药技术全梳理2.0； 和铂医药技术全梳理； 荣昌生物技术全梳理； 再鼎医药技术全梳理； 药明生物技术全梳理； 恒瑞医药技术全梳理； 豪森药业技术全梳理； 正大天晴技术全梳理； 吉凯基因技术全梳理； 基石药业技术全梳理； 百济神州技术全梳理； 百济神州技术全梳理第2版； 信达生物技术全梳理； 信达生物技术全梳理第2版； 中山康方技术全梳理； 复宏汉霖技术全梳理； 先声药业技术全梳理； 君实生物技术全梳理； 嘉和生物技术全梳理； 志道生物技术全梳理； 道尔生物技术全梳理； 尚健生物技术全梳理； 康宁杰瑞技术全梳理； 科望医药技术全梳理； 科望医药技术全梳理2.0； 岸迈生物技术全梳理； 礼进生物技术全梳理； 康桥资本技术全梳理； 余国良的抗体药布局； 荃信生物技术全梳理； 安源医药技术全梳理； 三生国健技术全梳理； 仁会生物技术全梳理； 乐普生物技术全梳理； 同润生物技术全梳理； 宜明昂科技术全梳理； 派格生物技术全梳理； 迈威生物技术全梳理； Momenta技术全梳理； NGM技术全梳理； 普米斯生物技术全梳理； 普米斯生物技术全梳理2.0； 三叶草生物技术全梳理； 贝达药业抗体药全梳理； 泽璟制药抗体药全梳理； 恒瑞医药抗体药全梳理； 齐鲁制药抗体药全梳理； 石药集团抗体药全梳理； 豪森药业抗体药全梳理； 华海药业抗体药全梳理； 科伦药业抗体药全梳理； 百奥泰技术全梳理； 凡恩世技术全梳理。