TerSera Therapeutics LLC

Insight 数据库「医药交易」模块显示，本周全球范围内共发生 24 项医药交易（截至 10 月 25 日）。其中 MNC 活动尤为频繁，高达 42% 的交易有 MNC 参与，涉及默沙东、罗氏、拜耳、葛兰素史克、百时美施贵宝、艾伯维等。 其中： 大额交易中，有默沙东超 13 亿美元收购抗癌新锐获得临床前化合物，罗氏超 10 亿美元与 Dyno 二次合作开发下一代腺相关病毒（AAV）载体用于神经疾病的基因治疗； 与此同时，也有部分合作进展并不顺利，比如 BMS 退还礼新医药 CLDN18.2 ADC 权益，优时比终止与罗氏的阿尔茨海默病药物合作等； 另外还有其他公司达成新合作，如艾伯维、BMS、GSK、海和药物、三生制药等，涉及分子胶降解剂、体内基因编辑药物、抗 HER2 单抗等多种创新产品。 下面，Insight 数据库将节选部分备受关注的交易案例做介绍，仅供读者参阅。 默沙东、罗氏、拜耳等跨国药企布局新疗法   默沙东超 13 亿美元收购抗癌新锐 Modifi Biosciences 与默沙东达成协议，默沙东将通过子公司收购前者，从而囊获通过利用 DNA 修复缺陷治疗难治性癌症的临床前化合物。根据协议，Modifi 公司将获得 3000 万美元的预付款，其股东还有资格获得总额高达 13 亿美元的潜在里程碑付款。 Modifi 公司创立于 2021 年，基于耶鲁大学科学家的突破性研究而成立。该公司开发了一种新型小分子，用于靶向缺乏关键 DNA 修复蛋白 O6-甲基鸟嘌呤甲基转移酶 (MGMT) 表达的癌细胞。Modifi 表示，其设计的小分子能够以独特的方式克服数十年来已知但至今无法解决的临床耐药机制。   罗氏超 10 亿美元与 Dyno 二次合作 Dyno Therapeutics 宣布与罗氏进行第二次研究合作，开发下一代 AAV 载体用于针对神经疾病的基因治疗。Dyno 公司与罗氏此前于 2020 年 10 月宣布了神经系统疾病和肝脏定向疗法的研究合作和许可协议。 根据新协议的条款，Dyno 公司将负责设计和发现具有改进功能特性的新型 AAV 衣壳，罗氏则负责进行衣壳验证研究，并为利用新型衣壳的多种神经基因治疗候选产品开展进一步的临床前、临床和商业化活动。为此，罗氏将预付 5000 万美元，以及总计超过 10 亿美元的潜在里程碑付款等。   拜耳 4.24 亿美元引进心肌病疗法 拜耳与 Dewpoint Therapeutics 签订一项独家许可协议，获得一款针对特定扩张型心肌病（DCM）研发项目的全球开发和商业化权益。根据协议，Dewpoint 公司将获得 4.24 亿美元的预付款及其他开发和商业里程碑付款。 此次授权的项目是一款调节凝聚体的小分子药物，它在临床前研究中表现出逆转疾病进程的潜力。这也是自 2019 年 11 月拜耳与 Dewpoint 公司开始研究合作以来，拜耳首次行使选择权。   GSK 投资 5000 万英镑与剑桥大学合作 GSK 宣布，将投资 5000 万英镑与剑桥大学和剑桥大学医院进行为期五年的重大合作，以加快免疫相关疾病的研究和开发，合作将集中在两个疾病领域：呼吸系统和肾脏。 这项合作将被称为剑桥-葛兰素史克转化免疫学合作（CG-TIC），它将 GSK 在免疫系统、人工智能和临床开发方面的专业知识与剑桥大学的互补专业知识结合在一起，以进一步加快肾脏和呼吸道疾病的疗法研发。   Evotec 与 MBS 扩大合作并获得 5000 万美元 Evotec 公司宣布与 BMS 在建立分子胶管线方面的战略合作伙伴关系取得了进展，关键的科学成就推动了分子胶降解剂在肿瘤学以外领域的管线扩张，引发了 BMS 向 Evotec 公司支付 5000 万美元。 Evotec 公司和 BMS 于 2018 年建立了蛋白质降解战略合作伙伴关系，并于 2022 年 5 月扩大合作范围，因为双方最初的合作产生了一条有前景的管线。自扩大合作以来，Evotec 公司从 BMS 的 cereblon E3 连接酶调节剂库（CELMoDs）中开发出极具前景的化合物。   艾伯维和 Gedeon Richter 宣布新的合作 艾伯维和 Gedeon Richter 宣布达成一项新的发现、共同开发和许可协议，以推进神经/精神疾病治疗的潜在新靶点。根据协议，合作包括临床前和临床研发活动，双方共享资金。Richter 公司将获得 2500 万美元的预付现金，以及未来潜在的开发、监管和商业化里程碑付款和基于销售的分级特许权使用费等。 此次新的合作建立在艾伯维和 Richter 近二十年来在中枢神经系统（CNS）领域的合作基础上，包括在全球推出治疗精神分裂症和抑郁症的 Cariprazine，以及发现用于治疗双相抑郁症和广泛性焦虑症的候选药 ABBV-932。 BMS、罗氏等终止合作，联拓倒闭后产品被收购   BMS 退还礼新医药 CLDN18.2 ADC 权益 据外媒 ApexOnco 报道，百时美施贵宝（BMS）已终止与礼新医药关于 Claudin 18.2 靶向 ADC LM-302/TPX-4589 的协议，ApexOnco 从 BMS 处证实该项目的权益已于去年退回给礼新医药。 早在 2022 年 5 月，Turning Point 以 2500 万美元预付款从礼新医药获得 LM-302 的许可，随后 Turning Point 被 BMS 收购。目前，LM-302 正在开展胃肠道肿瘤的 3 期临床试验，它还曾获得 FDA 授予孤儿药资格。   优时比终止与罗氏的阿尔茨海默病药物合作 优时比宣布，在与罗氏及旗下基因泰克终止合作协议后，该公司已重新获得 Bepranemab 所有全球权利。Bepranemab 是一种针对 tau 蛋白中部的研究性抗 tau 抗体，正在 2 期临床研究中评估其延缓阿尔茨海默病进展的潜力。 2020 年 7 月，优时比与罗氏及旗下基因泰克签订了一项全球独家许可协议，后者可在全球范围内开发、制造和商业化治疗阿尔茨海默病的 Bepranemab。该合作预付款达到 1.2 亿美元，潜在交易总额接近 20 亿美元。   联拓生物倒闭，NImune 收购自免新药 Omilancor NImune Biopharma 宣布收购自免新药 Omilancor 在亚洲的开发和商业化权，涵盖的市场包括中国(含港澳台）、泰国、新加坡、韩国、柬埔寨、印度尼西亚、缅甸、菲律宾、泰国和越南。交易完成后，NImmune 公司将完全拥有Omilancor 和整个 LANCL2 免疫调节治疗组合的全球权利。 Omilancor 是一种 LANCL2 刺激剂药物，目前正在开展治疗溃疡性结肠炎（UC）的 Ⅲ 期临床临床和克罗恩病的 Ⅱ 期临床。据 NImmune 公司创始人兼 CEO 表示，2024 年 2 月 13 日联拓生物宣布倒闭，为该公司巩固 Omilancor 的全球权利提供了机会。此前，联拓生物曾从 Landos Biopharma 引进该产品在大中华区和亚洲特定市场开发和商业化的独家权利。 其它授权合作   海和药物与三生制药达成合作 海和药物和三生制药宣布，三生制药子公司沈阳三生获得海和药物子公司诺迈西旗下产品紫杉醇口服溶液在中国大陆及香港地区的独家商业化权利。根据协议，沈阳三生将支付首付款及研发及销售里程碑付款，诺迈西将继续负责已开展的 Ⅲ 期临床及后续的开发、临床及注册等工作。 紫杉醇口服溶液由韩国大化制药基于脂质自乳化药物递送技术开发而成，海和药物获得了其在中国及泰国的研发、生产及销售权利。该产品已于今年 9 月在中国获批用于一线含氟尿嘧啶类方案治疗期间或治疗后出现疾病进展的晚期胃癌患者。   Editas 与 Genevant 达成 2.38 亿美元合作 Editas Medicine 与 Genevant Sciences 宣布已达成一项合作和非排他性许可协议，将前者的 CRISPR Cas12a 基因组编辑系统与后者专有的 LNP 技术结合起来，开发针对 Editas 两个未公开靶点的体内基因编辑药物。 根据协议条款，Genevant 公司已授予 Editas 公司在某些 LNP 技术下的非独家全球许可，以开发针对特定领域两个未公开靶点的 mRNA CRISPR Cas12a LNP 产品。Genevant 公司有资格获得高达 2.38 亿美元的预付款和里程碑付款，以及未来产品销售的分级特许权使用费。   MacroGenics 向 TerSera 出售抗 HER2 单抗 MacroGenics 公司和 TerSera therapeutics 宣布已达成协议，后者将收购前者 Margenza（margetoximab-cmkb）的全球权利。根据协议，该交易预计将于 2024 年第四季度完成，TerSera 公司将在交易结束时支付 4000 万美元，MacroGenics 公司还可能会收到总额高达 3500 万美元的额外销售里程碑付款。 Margenza 是一款靶向人表皮生长因子受体 2(HER2) 的单克隆抗体药物，已于 2020 年 12 月被美国 FDA 批准与化疗联合用于治疗成年转移性 HER2 阳性乳腺癌患者。 除了上述案例，本周还有一些其它公司也达成了不同类型的合作，限于篇幅，此处不再一一介绍。欲了解本周更多授权合作信息，可点击阅读原文前往 Insight 数据库「医药交易」模块查看。 封面来源：站酷海洛 Plus 免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。 编辑：馨药 PR 稿对接：微信 insightxb 投稿：微信 insightxb；邮箱 insight@dxy.cn 多样化功能、可溯源数据…… Insight 数据库网页版等你体验 点击阅读原文，立刻解锁！

ROCKVILLE, MD & DEERFIELD, IL, USA I October 22, 2024 I MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative antibody-based therapeutics for the treatment of cancer, and TerSera Therapeutics LLC, a privately-held biopharmaceutical company with a focus in oncology and non-opioid pain management, announced today that they have entered into an agreement in which TerSera will acquire global rights to MARGENZA® (margetuximab-cmkb). MARGENZA was approved by the U.S. Food and Drug Administration (FDA) in December 2020 in combination with chemotherapy for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. The approval was based on results from the pivotal Phase 3 head-to-head clinical trial (SOPHIA) evaluating the safety and efficacy of MARGENZA vs. Herceptin® (trastuzumab), both combined with chemotherapy. Pursuant to the terms of the agreement, TerSera will pay MacroGenics $40 million at closing. MacroGenics may receive additional sales milestone payments of up to an aggregate of $35 million. The transaction is expected to close in the fourth quarter of 2024, subject to customary closing conditions. “This transaction will enable us to focus our efforts on advancing our pipeline of novel and differentiated oncology product candidates,” said Scott Koenig, M.D., Ph.D., President and Chief Executive Officer of MacroGenics. “We believe TerSera’s established and complementary U.S. commercial infrastructure has the potential to broaden patient access to MARGENZA.” “MARGENZA is an important treatment option for patients with metastatic HER2+ breast cancer,” said Edward Donovan, Chief Executive Officer of TerSera. “We are very excited to add MARGENZA to our existing oncology portfolio, deepening our commitment to the treatment of patients with breast cancer.” IMPORTANT SAFETY INFORMATION BOXED WARNING: LEFT VENTRICULAR DYSFUNCTION AND EMBRYO-FETAL TOXICITY WARNINGS & PRECAUTIONS: Left Ventricular Dysfunction Embryo-Fetal Toxicity Infusion-Related Reactions (IRRs) MOST COMMON ADVERSE REACTIONS: The most common adverse drug reactions (>10%) with MARGENZA in combination with chemotherapy are fatigue/asthenia (57%), nausea (33%), diarrhea (25%), vomiting (21%), constipation (19%), headache (19%), pyrexia (19%), alopecia (18%), abdominal pain (17%), peripheral neuropathy (16%), arthralgia/myalgia (14%), cough (14%), decreased appetite (14%), dyspnea (13%), infusion-related reactions (13%), palmar-plantar erythrodysesthesia (13%), and extremity pain (11%). You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch or to MacroGenics at (844)-MED-MGNX (844-633-6469). INDICATION MARGENZA is a HER2/neu receptor antagonist indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. Please see full Prescribing Information , including Boxed Warning. About HER2-positive Breast Cancer Human epidermal growth factor receptor 2 (HER2) is a protein found on the surface of some cancer cells that promotes growth and is associated with aggressive disease and poor prognosis. Approximately 15-20% of breast cancer cases are HER2-positive. Monoclonal antibodies targeting HER2 have greatly improved outcomes; however, a significant number of patients progress to later lines of therapy. Effective treatments for metastatic HER2-positive breast cancer continue to remain an unmet need. About MARGENZA MARGENZA (margetuximab-cmkb) is an Fc-engineered, monoclonal antibody that targets the HER2 oncoprotein. HER2 is expressed by tumor cells in breast, gastroesophageal and other solid tumors. Similar to trastuzumab, margetuximab-cmkb inhibits tumor cell proliferation, reduces shedding of the HER2 extracellular domain and mediates antibody-dependent cellular cytotoxicity (ADCC). However, through MacroGenics’ Fc Optimization technology, margetuximab-cmkb has been engineered to enhance the engagement of the immune system. In vitro, the modified Fc region of margetuximab-cmkb increases binding to the activating Fc receptor FCGR3A (CD16A) and decreases binding to inhibitor Fc receptor FCGR2B (CD32B). These changes lead to greater in vitro ADCC and NK cell activation. The clinical significance of in vitro data is unknown. About MacroGenics, Inc. MacroGenics is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics’ technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company’s website at www.macrogenics.com . About TerSera Therapeutics TerSera Therapeutics is a biopharmaceutical company with a focus in oncology and non-opioid pain management. Founded in 2016, TerSera is building new cornerstones of care through its portfolio of unique therapeutics, amplifying their ability to deliver meaningful outcomes for patients. TerSera has been recognized as a 2024 Healthcare Top Workplace. For additional information, please visit tersera .com and follow us on LinkedIn . SOURCE: MacroGenics

Plus, news about Annexon, Passkey Therapeutics, XOMA Royalty and Twist Bioscience: MacroGenics sells breast cancer drug rights for up to $75 million: The company is handing over Margenza’s rights to TerSera Therapeutics in exchange for $40 million when the deal closes and up to $35 million in sales milestones. The treatment, which is administered with chemotherapy for some patients with metastatic HER2-positive breast cancer, was approved by the FDA in 2020. — Jaimy Lee Rice University launches biotech accelerator: RBL LLC is looking to speed up the journey of biotech startups with medical tech developed out of the Rice Biotech Launch Pad, the university’s innovation accelerator. RBL will use patents from university faculty and bring together executives and scientists to launch “multiple” companies, according to RBL . — Katherine Lewin Annexon reports more data from Phase 2 eye drug trial: The company is back with positive secondary endpoint data from a mid-stage trial. Last year, it said its complement inhibitor didn’t prove statistically significant in the primary endpoint of reducing lesion eye growth. On Tuesday, it said the drug, ANX007, showed “enhanced protection of vision and greater preservation of central photoreceptor cells” in a subpopulation of patients in the trial that had less advanced geographic atrophy. It expects to share data from a pivotal Phase 3 trial in the second half of 2026. — Katherine Lewin Passkey emerges from stealth with $20M in seed funding: The raise will go toward developing a new class of single-drug therapies that the company is calling synergistic multifunctional therapeutics, which will be designed to “modulate rare combinations of proteins that work together.” Breakout Ventures, Innovation Endeavors and Bison Ventures led the funding round. — Katherine Lewin XOMA’s new royalty deal with Twist: The company will get $15 million upfront in cash in exchange for one-half of milestones and royalties from agreements that Twist is already engaged in. — Jaimy Lee