ADC Therapeutics (UK) Ltd.

– Companies to Leverage Lead Product Candidate from IGM’s Proprietary IgM Antibody Platform with ZYNLONTA® for Novel Combination Therapy in Relapsed/Refractory B Cell NHL – – Phase 1 Trial Expected to be Initiated in 1Q23 – MOUNTAIN VIEW, Calif. and LAUSANNE, Switzerland, Nov. 02, 2022 (GLOBE NEWSWIRE) -- IGM Biosciences, Inc., (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing IgM antibodies, and ADC Therapeutics SA (NYSE: ADCT) today announced that they have entered into a clinical trial collaboration and supply agreement to evaluate the combination of imvotamab, IGM’s novel IgM CD20 x CD3 T cell engaging bispecific antibody, and ZYNLONTA® (loncastuximab tesirine-lpyl), ADC Therapeutics’ CD19-directed antibody drug conjugate (ADC), for the treatment of patients with relapsed/refractory (R/R) B cell non-Hodgkin’s lymphoma (NHL). “Patients with B cell non-Hodgkin’s lymphoma are in need of efficacious and well-tolerated treatments,” said Chris Takimoto, M.D., Ph.D., F.A.C.P., Chief Medical Officer of IGM Biosciences. “We are excited to enter this collaboration with ADC Therapeutics that aims to provide a novel combination regimen targeting both CD19- and CD20-expressing cells for patients with relapsed/refractory B cell non-Hodgkin’s lymphoma. We look forward to working with the team at ADC Therapeutics and initiating clinical testing in the first quarter of 2023.” In data previously reported at the 2021 American Society of Hematology (ASH) Annual Meeting, imvotamab showed a 50% complete response (CR) rate at the likely optimal 100 mg dose (n=10). Of the 28 patients treated in the titration dosing cohorts at that time, cytokine release syndrome was seen in less than 20% of patients. “We are pleased to collaborate with IGM Biosciences to explore ZYNLONTA in combination with imvotamab,” said Joseph Camardo, M.D., Chief Medical Officer of ADC Therapeutics. “This collaboration extends ADC Therapeutics’ commitment to maximizing the potential of our CD19-directed ADC for patients with significant unmet medical needs, both as a single agent and in novel combinations with other anti-cancer agents. The safety pro imvotamab and the activity observed so far in Phase 1 are highly promising for future development.” Under the terms of the agreement, IGM will be responsible for conducting clinical testing to evaluate the safety and efficacy of imvotamab in combination with ZYNLONTA® for the treatment of patients with R/R NHL. ADC Therapeutics will provide clinical expertise on ZYNLONTA® as well as drug supply to support the trial. IGM expects to initiate the trial in the first quarter of 2023. The clinical collaboration is based on compelling mechanistic rationale and preclinical data showing strong activity of this approach. About IGM Biosciences, Inc. IGM Biosciences is a clinical-stage biotechnology company committed to developing and delivering a new class of medicines to treat patients with cancer, infectious diseases and autoimmune and inflammatory diseases. The Company’s pipeline of clinical and preclinical assets is based on the IgM antibody, which has 10 binding sites compared to conventional IgG antibodies with only 2 binding sites. The Company also has an exclusive worldwide collaboration agreement with Sanofi to create, develop, manufacture, and commercialize IgM antibody agonists against oncology and immunology and inflammation targets. For more information, please visit . About Imvotamab (IGM-2323) Imvotamab is a novel IgM-based CD20 x CD3 bispecific antibody T cell engager (TCE) with the therapeutic potential to be a backbone treatment in hematology. Preclinical research demonstrates that imvotamab may have advantages over IgG bispecific antibodies including greater binding power to CD20 expressing cancer cells especially when CD20 expression has been reduced due to prior treatment with anti-CD20 antibodies. It has also been shown to have good target cell killing efficacy combined with a lower cytokine release pro with the T cell directed cellular cytotoxicity (TDCC) mechanism. Data generated from Phase 1 clinical trials provide evidence that imvotamab exhibits a favorable safety and tolerability pro promising activity in refractory or relapsed NHL patients. Imvotamab is currently being studied in two Phase 2 trials to assess the safety and efficacy of two doses 100 mg and 300 mg, in patients with diffuse large B cell lymphoma (DLBCL) and follicular lymphoma (FL). About ZYNLONTA® (loncastuximab tesirine-lpyl) ZYNLONTA® is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death. The U.S. Food and Drug Administration (FDA) has approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL not otherwise specified, DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy. About ADC Therapeutics ADC Therapeutics (NYSE: ADCT) is a commercial-stage biotechnology company improving the lives of those affected by cancer with its next-generation, targeted antibody drug conjugates (ADCs). The Company is advancing its proprietary PBD-based ADC technology to transform the treatment paradigm for patients with hematologic malignancies and solid tumors. ADC Therapeutics’ CD19-directed ADC ZYNLONTA (loncastuximab tesirine-lpyl) is approved by the FDA for the treatment of relapsed or refractory diffuse large b-cell lymphoma after two or more lines of systemic therapy. ZYNLONTA is also in development in combination with other agents. Cami (camidanlumab tesirine) is being evaluated in a pivotal Phase 2 trial for relapsed or refractory Hodgkin lymphoma and in a Phase 1b clinical trial for various advanced solid tumors. In addition to ZYNLONTA and Cami, ADC Therapeutics has multiple ADCs in ongoing clinical and preclinical development. ADC Therapeutics is based in Lausanne (Biopôle), Switzerland and has operations in London, the San Francisco Bay Area and New Jersey. For more information, please visit and follow the Company on Twitter and LinkedIn. ZYNLONTA® is a registered trademark of ADC Therapeutics SA. IGM Biosciences Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements, including statements relating to IGM’s plans, expectations and forecasts and to future events. Such forward-looking statements include, but are not limited to: the potential of, and expectations regarding, IGM’s technology platform and its IgM antibodies and product candidates, including IGM-2323; expectations regarding the agreement with ADC Therapeutics; IGM’s plans and expectations regarding its clinical development efforts and activities; statements regarding the clinical development of IGM-2323, including the timing of initiation of a Phase 1 trial in combination with Zynlonta; and statements by IGM’s Chief Medical Officer. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially, including but not limited to: potential delays and disruption resulting from the COVID-19 pandemic and governmental responses to the pandemic, including any future impacts to IGM’s operations, the manufacture of its product candidates, the progression of its clinical trials, enrollment in its current and future clinical trials and progression of its collaborations and related efforts; the risk of the occurrence of any event, change or other circumstance that could give rise to the termination of collaborations with third parties, including the agreement with Sanofi; IGM’s early stages of clinical drug development; risks related to the use of engineered IgM antibodies, which is a novel and unproven therapeutic approach; IGM’s ability to demonstrate the safety and efficacy of its product candidates; IGM’s ability to successfully and timely advance its product candidates through preclinical studies and clinical trials; IGM’s ability to enroll patients in its clinical trials; the potential for the results of clinical trials to differ from preclinical, preliminary, initial or expected results; the risk of significant adverse events, toxicities or other undesirable side effects; IGM’s ability to successfully manufacture and supply its product candidates for clinical trials; the potential impact of continuing or worsening supply chain constraints; the risk that all necessary regulatory approvals cannot be obtained; the potential market for IGM’s product candidates, and the progress and success of alternative therapeutics currently available or in development; IGM’s ability to obtain additional capital to finance its operations, if needed; uncertainties related to the projections of the size of patient populations suffering from the diseases IGM is targeting; IGM’s ability to obtain, maintain and protect its intellectual property rights; developments relating to IGM’s competitors and its industry, including competing product candidates and therapies; general economic and market conditions; and other risks and uncertainties, including those more fully described in IGM’s filings with the Securities and Exchange Commission (SEC) including IGM’s most recent Quarterly Report on Form 10-Q filed with the SEC on August 8, 2022 and in IGM’s future reports to be filed with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and IGM specifically disclaims any obligation to update any forward-looking statement, except as required by law. ADC Therapeutics Forward-Looking Statements This press release contains statements that constitute forward-looking statements. All statements other than statements of historical facts contained in this press release, including statements regarding our future results of operations and financial position, cash runway, business and commercial strategy, market opportunities, products and product candidates, research pipeline, ongoing and planned preclinical studies and clinical trials, regulatory submissions and approvals, projected revenues and expenses and the timing of revenues and expenses, timing and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including those described in our filings with the U.S. Securities and Exchange Commission. No assurance can be given that such future results will be achieved. Such forward-looking statements contained in this document speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to update these forward-looking statements contained in this press release to reflect any change in our expectations or any change in events, conditions, or circumstances on which such statements are based unless required to do so by applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. IGM Biosciences Contact: Argot Partners David Pitts 212-600-1902 igmbio@argotpartners.com ADC Therapeutics Investors Contacts: Eugenia Litz ADC Therapeutics Eugenia.Litz@adctherapeutics.com +44 7879 627205 Amanda Loshbaugh ADC Therapeutics Amanda.Loshbaugh@adctherapeutics.com +1 917-288-7023 ADC Therapeutics Media Contact: Mary Ann Ondish ADC Therapeutics maryann.ondish@adctherapeutics.com +1 914-552-4625

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。ZYLONTA®（loncastuximab tesirine-lpyl）是美国食品和药物管理局（FDA）批准的目前世界上第一个也是唯一一个针对CD19的靶向抗体药物偶联物（ADC），用于治疗至少接受过2线及以上系统治疗的复发或难治性弥漫大B细胞淋巴瘤（r/r DLBCL）成年患者。2021年4月该药物通过优先审查程序获得美国FDA加速批准之后，相关企业也在积极推进在国内的进展。在国内的进展7月11日，瓴路药业（Overland Pharmaceuticals）和ADC Therapeutics SA（纽约证券交易所股票代码：ADCT）创建的合资企业瓴路爱迪思（Overland ADCT BioPharma）宣布，针对Loncastuximab tesirine与利妥昔单抗联合疗法的LOTIS-5确证性三期全球临床试验在中国完成了首例患者给药。此项临床试验将通过对比标准免疫化学疗法，评估Loncastuximab tesirine与利妥昔单抗联合疗法针对弥漫性大B细胞淋巴瘤（DLBCL）二线及以后且不符合移植条件的患者的有效性和安全性。本次研究的主要研究者中国医学科学院血液病医院淋巴瘤诊疗中心主任邱录贵教授表示：“我国复发或难治性DLBCL患者中有一半以上的患者不适合接受自体造血干细胞移植，缺乏有效的治疗选择。此次三期临床试验是我国在r/r DLBCL领域的一个重大进展。我们期待此次临床试验能获得积极结果，助力Loncastuximab tesirine惠及更多患者。”在中国台湾和新加坡的进展与此同时，7月12日瓴路爱迪思宣布，已与友華生技（Orient EuroPharma，OEP）建立战略合作伙伴关系，OEP被授予在中国台湾和新加坡分销和商业化的专有权ZYLONTA®。通过此次合作，瓴路爱迪思将与OEP联手推动ZYNLONTA的商业化，并解决中国台湾和新加坡DLBCL患者未满足的需求。OEP集团首席执行官Calvin Tsai表示：“我们非常高兴能与Overland ADCT BioPharma合作抗击癌症。OEP已经开发和销售抗癌药物20年了。我们不仅在中国台湾、中国香港、新加坡和菲律宾拥有坚实的销售和营销团队，而且还与专门从事血癌，胸癌和癌症手术的医生建立了牢固的关系。OEP一直在努力扩大其抗癌产品组合，以覆盖更多类型的癌症，并为台湾和亚洲其他地区的癌症患者带来新的希望。我们相信ZYNLONTA将成为中国台湾复发/难治性DLBCL患者的一个受欢迎的选择。”其他地区在前几天的7月8日，ADC Therapeutics SA也宣布，已与Swedish Orphan Biovitrum AB（Sobi®）签订独家许可协议，用于美国、大中华地区、新加坡和日本以外的所有血液学和实体肿瘤适应症的ZYNLONTA®开发和商业化。ZYNLONTA的上市授权申请（MAA）于2021年10月底由欧洲药品管理局（EMA）验证，ZYNLONTA的孤儿药指定用于治疗欧洲DLBCL。ADC Therapeutics和Sobi打算在2023年第一季度做出监管决定后推出ZYNLONTA。同时根据协议条款，ADC Therapeutics将获得5500万美元的预付款，并且有资格在欧盟委员会批准ZYNLONTA三线DLBCL中获得5000万美元的预付款，并在额外的监管和销售里程碑中获得高达约3.3亿美元的额外金额。ADC Therapeutics还将根据ZYNLONTA在Sobi境内的净销售额，从十几岁到二十多岁不等，获得一定比例的版税。Sobi将分担选定的全球ZYNLONTA临床试验费用的一部分。“我们很高兴与Sobi建立这一重要的合作伙伴关系，以继续扩大我们的全球影响力，将ZYNLONTA带给全球尽可能多的患者，”ADC Therapeutics首席执行官Ameet Mallik表示，“Sobi拥有强大的全球商业基础设施，在血液学和罕见疾病领域拥有成熟的能力，重要的是，分享了我们对改善患者生活的热情。”由此可见，全球相关科研人员和药企正在快速推进Loncastuximab tesirine的临床试验，如果能顺利确保最大限度地发挥Loncastuximab tesirine的潜力，将为全球淋巴瘤患者带来更多治疗选择。相关产品和企业介绍关于Loncastuximab tesirine（ZYNLONTA®）Loncastuximab tesirine是一个靶向CD19的ADC药物，单克隆IgG1 kappa抗体成分与人CD19（B谱系细胞表面表达的跨膜蛋白）结合，小分子成分是SG3199，一个PBD（吡咯并苯并二氮杂䓬，可识别和键合DNA特定序列）二聚物和烷基化剂（具有细胞毒素作用）。在与CD19结合后，Loncastuximab tesirine内在化的下一步就是SG3199小分子通过蛋白切割而被释放，释放出的SG3199与DNA小沟相结合，形成强效的细胞毒性的DNA链间交联，导致DNA复制停滞，从而破坏复制等必要的DNA代谢过程，最终使细胞周期阻滞从而导致肿瘤细胞死亡。loncastuximab tesirine分子结构美国FDA已批准Loncastuximab tesirine用于治疗经过两线或多线全身治疗后r/r DLBCL患者，包括非特定类型DLBCL、低分化淋巴瘤引起的DLBCL以及高级别B细胞淋巴瘤。在与利妥昔单抗联合疗法的LOTIS-5确证性三期全球临床试验中，纳入了广泛接受重度预治疗且难以治疗的疾病患者（中位三种先前治疗线），包括对一线治疗无反应的患者，对所有先前治疗线无效的患者，具有双重/三重打击遗传学的患者以及在用ZYNLONTA治疗之前进行干细胞移植和CAR-T治疗的患者。该适应症由FDA根据总体反应率的加速批准批准，并且该适应症的持续批准可能取决于确认性试验中临床益处的验证和描述。同时，ZYNLONTA也被评估为其他B细胞恶性肿瘤和早期治疗线的联合研究中的治疗选择。关于瓴路爱迪思（Overland ADCT BioPharma）Overland ADCT BioPharma由瓴路药业（Overland Pharmaceuticals）和ADC Therapeutics创建的合资企业，正在大中华区和新加坡开发和商业化ADC Therapeutics的四种ADC候选药物，用于难以治疗的血液学和实体瘤，包括ZYNLONTA®，ADCT-601，ADCT-602和ADCT-901。关于ADC TherapeuticsADC Therapeutics（纽约证券交易所代码：ADCT）是一家商业阶段的生物技术公司，公司正在推进其专有的基于PBD的ADC技术，以改变血液系统恶性肿瘤和实体瘤患者的治疗模式。ADC Therapeutics总部位于瑞士洛桑（Biopôle），在伦敦、旧金山湾区和新泽西州开展业务。关于友華生技（Orient EuroPharma，OEP）OEP成立于1982年，是一家具有研发，制造和营销能力的跨国制药公司，于2003年在中国台湾交易所（4120）正式上市，专注于处方药、营养保健和抗衰老领域。该公司在中国台湾和美国设有研发中心。其有两家制药厂，生产经台湾FDA批准的口服制剂和高致敏性注射剂。公司在东南亚、中国香港、中国大陆、美国设有销售团队。关于Swedish Orphan Biovitrum AB（Sobi®）Sobi是一家专业的国际生物制药公司，致力于改变罕见病患者的生活。Sobi提供血液学、免疫学和专科护理领域的创新药物的可持续获取，在欧洲、北美、中东和亚洲拥有约1600名员工。2021年，收入达155亿瑞典克朗。Sobi的股票（STO：SOBI）在斯德哥尔摩纳斯达克上市。参考信息：[1]www.oladct.com[2]https://www.oepgroup.com/en-global[3]https://ir.adctherapeutics.com/press-releases/default.aspx[4]https://www.sobi.com/[5]https://www.overlandpharma.com/overland-adct-biopharma-announces-first-patient-dosed-in-china-with-zynlonta-in-combination-with-rituximab-in-global-phase-3-clinical-trial/ —END—联系我们，体验药融云更多专业服务会议合作园区服务数据库咨询定制服务媒体合作数据库咨询 | 琳琳 18983288589（微信同号）会议合作 | 赖老师 13550291524（微信同号）园区合作 | 周老师 18725665133（微信同号）定制服务 | 陈老师 18908392210（微信同号）媒体合作 | 小薇  18908208341（微信同号）点击阅读原文，体验药融云专业服务！

7月11日，瓴路药业和ADC Therapeutics SA（纽约证券交易所股票代码：ADCT）创建的合资企业瓴路爱迪思宣布，针对旗下全球首个且唯一一个靶向CD19的ADC药物Loncastuximab tesirine与利妥昔单抗联合疗法的LOTIS-5确证性三期全球临床试验在中国完成了首例患者给药。此项临床试验将通过对比标准免疫化学疗法，评估Loncastuximab tesirine与利妥昔单抗联合疗法针对弥漫性大B细胞淋巴瘤（DLBCL）二线及以后且不符合移植条件的患者的有效性和安全性。2021年4月，Loncastuximab tesirine获得了美国食品药品监督管理局（FDA）的加速批准，成为首个也是唯一一个靶向CD19的抗体偶联药物（ADC），用于单药治疗至少接受过二线及以上系统治疗的复发/难治性弥漫大B细胞淋巴瘤（r/r DLBCL）成年患者。瓴路爱迪思现已加入Loncastuximab tesirine的LOTIS-5确证性三期全球临床试验，该试验旨在支持Loncastuximab tesirine在美国和中国针对二线且不符合移植条件的DLBCL患者的补充生物制剂许可申请（sBLA）。瓴路爱迪思首席执行官许建恩表示：“完成三期全球临床试验中的首例患者给药，对瓴路爱迪思和中国DLBCL患者来说是一项重大成就。这是我们针对Loncastuximab tesirine启动的第二项研究，我们致力于为中国DLBCL患者提供前沿的创新疗法，满足中国肿瘤患者的未尽之需。”本次研究的主要研究者，中国医学科学院血液病医院淋巴瘤诊疗中心主任邱录贵教授表示：“我国复发或难治性DLBCL患者中有一半以上的患者不适合接受自体造血干细胞移植，缺乏有效的治疗选择。此次三期临床试验是我国在r/r DLBCL领域的一个重大进展。我们期待此次临床试验能获得积极结果，助力Loncastuximab tesirine惠及更多患者。”作为瓴路爱迪思的主要候选产品，Loncastuximab tesirine是目前首个也是唯一一个靶向CD19的ADC药物。多项临床试验显示，Loncastuximab tesirine单药治疗在广泛的复发/难治性弥漫大B细胞淋巴瘤、套细胞淋巴瘤和滤泡性淋巴瘤患者人群中，均表现出显著的临床活性。ADC Therapeutics首席执行官Ameet Mallik称：“我们很高兴看到瓴路爱迪思的同事正在快速推进Loncastuximab tesirine的临床试验，我们的目标是确保最大限度地发挥Loncastuximab tesirine的潜力，为全球淋巴瘤患者带来更多治疗选择。”关于Loncastuximab tesirineLoncastuximab tesirine是一种靶向CD19的抗体偶联药物（ADC）。当ZYNLONTA与表达CD19的肿瘤细胞结合时，会被细胞内化，随后释放吡咯并苯二氮杂䓬二聚体（PBD）细胞毒素。PBD与DNA小沟结合，形成强效的细胞毒性DNA链间交联，导致DNA复制停滞，阻断细胞周期从而导致肿瘤细胞死亡。而因PBD交联引起的DNA修复机制微小且易于隐藏，因此并不会改变DNA的结构。最终，Loncastuximab tesirine能够使细胞周期阻滞从而导致肿瘤细胞死亡。美国食品药品监督管理局（FDA）已批准Loncastuximab tesirine用于治疗至少接受过2线及以上系统治疗的复发或难治性弥漫大B细胞淋巴瘤（r/r DLBCL）成年患者，包括非特定类型的DLBCL、低分化淋巴瘤转化的DLBCL和高级别B细胞淋巴瘤。该项临床试验入组了既往接受过多线治疗的复发难治性患者（既往接受的中位系统治疗的线数为3种），包括对一线治疗耐药的患者、对既往所有治疗均无效的患者、具有双/三打击的患者，以及造血干细胞移植和CAR-T治疗后复发的患者。此次加速批准基于总缓解率数据，针对该适应症的继续批准将取决于验证性试验中对临床益处的验证和描述。Loncastuximab tesirine也正在被评估为其他B细胞恶性肿瘤和早期治疗线联合研究中的一种治疗选择。关于瓴路爱迪思瓴路爱迪思是一家专注于抗体药物偶联物（Antibody-drug Conjugate, ADC）研发、生产和商业化的生物制药公司，将通过引进全球最前沿的品牌首创（first-in-class）ADC药物，建成包括研究、开发、生产、营销等环节在内的完整产业价值链，致力于为大中华区和新加坡肿瘤患者开发并提供有突破性治疗效果且可负担的创新疗法。www.oladct.com关于 ADC TherapeuticsADC Therapeutics（纽约证券交易所股票代码：ADCT）是一家处于商业阶段的生物技术公司，通过其下一代靶向抗体药物结合物（ADC）改善癌症患者的生活。公司正在推进其基于PBD的ADC专利技术，以改变血液系统恶性肿瘤和实体瘤患者的治疗模式。关于瓴路药业瓴路药业为具有全方位研发能力的生物制药公司，其使命是通过提供创新药物解决亚洲和世界各地患者未被满足的临床需求。瓴路药业将与全球战略合作伙伴在不同的治疗领域进行战略合作，将最有前途的医药创新成果惠及患者。www.overlandpharma.com