A First-in-Human (FIH) Phase 1/2 Study to Assess Safety, Tolerability, and Preliminary Anti-Tumor Activity of REGN7945, an Anti-CD38 x Anti-CD28 Costimulatory Bispecific Monoclonal Antibody, in Combination With Linvoseltamab, an Anti-BCMA x Anti-CD3 Bispecific Monoclonal Antibody, in Participants With Relapsed/Refractory Multiple Myeloma

This study is researching an experimental drug called REGN7945 in combination with another experimental drug called linvoseltamab, (also known as REGN5458) (each individually called a "study drug" or "study drugs" when combined).
This study is the first time REGN7945 will be tested in humans. Linvoseltamab has previously been studied by itself (without other cancer drugs) in participants who had advanced multiple myeloma that returned and needed to be treated again after several other therapies had failed.
The aim of the study is to see how safe, tolerable, and effective REGN7945 is when given in combination with linvoseltamab, compared with linvoseltamab alone.
The study is looking at several other research questions, including:
* What side effects may happen from taking the study drug(s)
* How many people treated with REGN7945 and linvoseltamab compared to linvoseltamab alone have improvement of their multiple myeloma and by how much
* How long people benefit from receiving REGN7945 in combination with linvoseltamab compared with linvoseltamab alone
* How much study drug(s) is in the blood at different times
* Whether the body makes antibodies against the study drugs(s) (which could make the study drug(s) less effective or could lead to side effects)
* If there is any change in pain and cancer-related symptoms, how well people are able to function, and their quality of life when taking the study drug(s)

开始日期2024-12-20

申办/合作机构

Regeneron Pharmaceuticals, Inc.

NCT06140524 / Recruiting临床2期

Phase 2 Dose-Ranging and Interception Study of Linvoseltamab in Patients With High-Risk Monoclonal Gammopathy of Undetermined Significance or Non-High-Risk Smoldering Multiple Myeloma

The primary purpose of the study is to understand how well the study drug can eliminate abnormal plasma cells and laboratory signs of high-risk monoclonal gammopathy of undetermined significance (HR-MGUS) and non high-risk smoldering multiple myeloma (NHR-SMM). This requires understanding the safety and tolerability of the study drug (how the body reacts to linvoseltamab) as well as the effectiveness of the study drug (how well linvoseltamab eliminates plasma cells). All participants will start treatment with gradually increasing doses of linvoseltamab (step-up doses) before they start receiving the assigned full dose.
The study is split into 2 parts:
* In Part 1, separate groups of 3-6 patients will receive different full doses of linvoseltamab to evaluate the short-term side effects (safety) and tolerability of the study drug within the first 5 weeks after starting treatment. The data collected will help to make a decision about the dosing regimens chosen for Part 2.
* In Part 2, a larger number of participants will be randomized to different dosing regimens to further assess the side effects of linvoseltamab, and to evaluate the ability of linvoseltamab to eliminate abnormal plasma cells in HR-MGUS and NHR-SMM.
The study is looking at several other research questions, including:
* How many participants treated with linvoseltamab have improvement of their HR-MGUS or NHR-SMM?
* What side effects may happen from taking the study drug?
* How much study drug is in the blood at different times?
* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects).

开始日期2024-09-16

申办/合作机构

Regeneron Pharmaceuticals, Inc.

NCT06376526 / Recruiting临床2期IIT

Immuno-consolidation for Newly Diagnosed Multiple Myeloma Using Lack of MRD Negativity After Initial COmbination Therapy to Pursue Deeper Responses with Linvoseltamab and Delay Transplant

The purpose of this study is to determine whether Linvoseltamab therapy in patients with newly diagnosed multiple myeloma will convert the disease status from minimal residual disease (MRD)-positive to MRD-negative, and increase the length of time that the disease is controlled. The researchers also want to find out the effects (good and bad) that Linvoseltamab has on participants and the condition.

开始日期2024-08-21

申办/合作机构

University of Miami

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项与 Linvoseltamab 相关的文献（医药）

2024-12-31·mAbs

Antibodies to watch in 2024

Article

作者: Crescioli, Silvia ; Kaplon, Hélène ; Wang, Lin ; Reichert, Janice M. ; Visweswaraiah, Jyothsna ; Chenoweth, Alicia

The 'Antibodies to Watch' article series provides an annual summary of commercially sponsored monoclonal antibody therapeutics currently in late-stage clinical development, regulatory review, and those recently granted a first approval in any country. In this installment, we discuss key details for 16 antibody therapeutics granted a first approval in 2023, as of November 17 (lecanemab (Leqembi), rozanolixizumab (RYSTIGGO), pozelimab (VEOPOZ), mirikizumab (Omvoh), talquetamab (Talvey), elranatamab (Elrexfio), epcoritamab (EPKINLY), glofitamab (COLUMVI), retifanlimab (Zynyz), concizumab (Alhemo), lebrikizumab (EBGLYSS), tafolecimab (SINTBILO), narlumosbart (Jinlitai), zuberitamab (Enrexib), adebrelimab (Arelili), and divozilimab (Ivlizi)). We briefly review 26 product candidates for which marketing applications are under consideration in at least one country or region, and 23 investigational antibody therapeutics that are forecast to enter regulatory review by the end of 2024 based on company disclosures. These nearly 50 product candidates include numerous innovative bispecific antibodies, such as odronextamab, ivonescimab, linvoseltamab, zenocutuzumab, and erfonrilimab, and antibody-drug conjugates, such as trastuzumab botidotin, patritumab deruxtecan, datopotamab deruxtecan, and MRG002, as well as a mixture of two immunocytokines (bifikafusp alfa and onfekafusp alfa). We also discuss clinical phase transition and overall approval success rates for antibody therapeutics, which are crucial to the biopharmaceutical industry because these rates inform decisions about resource allocation. Our analyses indicate that these molecules have approval success rates in the range of 14-32%, with higher rates associated with antibodies developed for non-cancer indications. Overall, our data suggest that antibody therapeutic development efforts by the biopharmaceutical industry are robust and increasingly successful.

2024-08-01·JOURNAL OF CLINICAL ONCOLOGY

Linvoseltamab for Treatment of Relapsed/Refractory Multiple Myeloma

Article

作者: Boyapati, Anita ; Suvannasankha, Attaya ; Munder, Markus ; Dhodapkar, Madhav V. ; Shah, Mansi R. ; Wu, Ka Lung ; Chokshi, Dhruti ; Ye, Jing Christine ; Hoffman, James E. ; Houvras, Yariv ; Maly, Joseph J. ; Yancopoulos, George D. ; Martínez-Lopez, Joaquín ; Jagannath, Sundar ; Namburi, Swathi ; Baz, Rachid ; Bumma, Naresh ; Rodriguez Lorenc, Karen ; Pianko, Matthew J. ; Lee, Hans C. ; Min, Chang-Ki ; Silbermann, Rebecca ; Kroog, Glenn S. ; Byun, Ja Min ; DeVeaux, Michelle ; Vekemans, Marie-Christiane ; Lentzsch, Suzanne ; Cassady, Kaniel ; Richter, Joshua ; Hazra, Anasuya ; Sirulnik, L. Andres ; Zonder, Jeffrey A.

PURPOSE:

We present a phase I/II first-in-human trial evaluating the safety and efficacy of 50 mg and 200 mg doses of linvoseltamab, a B-cell maturation antigen × CD3 bispecific antibody in relapsed/refractory multiple myeloma (RRMM).

METHODS:

Phase II eligible patients had RRMM that either progressed on/after ≥three lines of therapy including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 antibody or was triple-class (PI/IMiD/anti-CD38) refractory. Phase II treatment was once a week through week 14 and then once every 2 weeks. Phase II 200 mg patients who achieved a ≥very good partial response by week 24 received linvoseltamab once every 4 weeks. The primary end point in phase II was overall response rate (ORR).

RESULTS:

Among the 117 patients treated with 200 mg, the median age was 70 years, 39% had high-risk cytogenetics, and 28% had penta-refractory disease. At a median follow-up of 14.3 months, the ORR was 71%, with 50% achieving ≥complete response (CR). In 104 patients treated with 50 mg at a median follow-up of 7.4 months, the ORR was 48%, with 21% achieving ≥CR. The median duration of response (DOR) for 200 mg patients (n = 83) was 29.4 months (95% CI, 19.2 to not evaluable). Among 200 mg patients, the most common adverse events included cytokine release syndrome (35.0% Gr1, 10.3% Gr2, 0.9% Gr3), neutropenia (0.9% Gr2, 18.8% Gr3, 23.1% Gr4), and anemia (3.4% Gr1, 4.3% Gr2, 30.8% Gr3). Immune effector cell-associated neurotoxicity syndrome occurred in 7.7% of patients (2.6% each Gr1, Gr2, Gr3). Infections were reported in 74.4% of patients (33.3% Gr3, 2.6% Gr4); infection frequency and severity declined over time.

CONCLUSION:

Linvoseltamab 200 mg induced deep and durable responses, with a median DOR of 29.4 months, in patients with RRMM with an acceptable safety profile.

2023-12-02·Expert opinion on biological therapy

Bispecific antibodies as monotherapy or in combinations for hematological malignancies: latest updates from the EHA 2023 annual meeting

Article

作者: Zhang, Peng ; Jiang, Zhongxing ; Han, Lijie ; Sun, Hao ; Yu, Jifeng ; Li, Xingchen

According to recent research, bispecific antibodies (BsAbs) are a promising new immunotherapy method. Various BsAb forms are constantly being developed. In the year 2022 alone, four BsAbs (tebentafusp, faricimab, mosunetuzumab, and teclistamab) were approved for clinical applications. BsAbs including odronextamab, talquetamab, linvoseltamab, and elranatamab are being actively evaluated in different clinical studies. Preliminary results show promising response rates in relapsed/refractory follicular lymphoma (RRFL), relapsed/refractory diffuse large B-cell lymphoma (RRDLBCL), and relapsed/refractory multiple myeloma (RRMM), especially in heavily pretreated patients, including those who have progressed after proteasome inhibitors, immunomodulatory drugs, anti-CD38 antibodies, and CAR-T therapies. We summarized data published at the 28th European Hematology Association (EHA) annual meeting, which was held in Frankfurt between 8 June 2023 and 11 June 2023 on BsAbs monotherapy or combination therapy for RRFL, RRDLBCL, and RRMM.

111

项与 Linvoseltamab 相关的新闻（医药）

2024-12-04

·PRNewswire

Rutgers Cancer Institute and RWJBarnabas Health to Unveil Pioneering Blood Cancer Research at the 66th American Society of Hematology Annual Meeting and Exposition

The institution will highlight its latest advancements in hematology and oncology through 66 oral and poster presentations NEW BRUNSWICK, N.J., Dec. 4, 2024 /PRNewswire/ -- Physician-scientists from Rutgers Cancer Institute and RWJBarnabas Health will showcase a diverse range of hematology/oncology data from their clinical research program at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition, being held in San Diego, California (and online) from December 7-10, 2024. A total of 66 abstracts have been accepted (including 21 oral presentations, 39 poster presentations, 1 special-interest session, 1 oral symposium, 2 satellite symposia and 2 scientific workshops), comprising of clinical data and analyses that advance the understanding, treatment, and prognosis of blood cancers and disorders such as sickle cell disease, lymphoma, leukemia, and myeloma. Rutgers Cancer Institute, together with RWJBarnabas Health, is New Jersey's only National Cancer Institute-designated Comprehensive Cancer Center. Continue Reading Rutgers Cancer Institute and RWJBarnabas Health (PRNewsfoto/Rutgers Cancer Institute and RWJBarnabas Health) "At the heart of our research efforts is a commitment to improving patients' lives and serving our community. This promise is shared by our nationally recognized team of cancer specialists, who work tirelessly to translate groundbreaking discoveries into the best options for our patients," said Matthew Matasar, MD, Chief, Division of Blood Disorders, Rutgers Cancer Institute, and Professor of Medicine, Rutgers Robert Wood Johnson Medical School. "The impressive contributions of our faculty, showcased at this year's ASH Annual Meeting, underscore the clinical excellence, innovation, and discovery that define Rutgers Cancer Institute and RWJBarnabas Health. We're proud to lead cutting-edge research that has the potential to improve the lives of every patient and family we serve. We remain singularly focused on my, and our, goal to end blood cancers and disorders entirely." Highlights of the high-impact science from Rutgers Cancer Institute at ASH 2024: Data from a study that leverages big data to improve prognostication in advanced stage classic Hodgkin Lymphoma (cHL). This study, which analyzed 1,240 patients, used multistate modeling (MSM) and individual patient data from the HoLISTIC Consortium to refine prognostication across the cHL disease course, through specifically assessing the relationships between Advanced Stage Hodgkin Lymphoma International Prognostication Index (A-HIPI), interim PET (iPET) and end of treatment (EOT) response, and whether the A-HIPI and iPET provide independent prognostic information. Researchers examined the bispecific antibody linvoseltamab in patients with relapsed/refractory multiple myeloma (RRMM), assessing longer follow-up and a select high-risk subgroup analysis of the Linker-MM1 study. Additional analyses were conducted to evaluate the effectiveness of linvoseltamab, focusing on how long patients responded to treatment (duration of response), how long they remained free from disease progression (progression-free survival), and their overall survival. These results, based on a safety follow-up period of over 14 months, were specifically looked at in high-risk patient groups. A primary analysis from the ELM-1 expansion cohort, evaluated the efficacy and safety of the bispecific antibody odronextamab monotherapy in patients with diffuse large b-cell lymphoma (DLBCL) who had disease progression after CAR T-cell therapy. The primary endpoint was objective response rate, as assessed by independent central review according to the Lugano classification. The key secondary endpoints included duration of response, progression-free survival, and overall survival. Exploratory endpoints included immune biomarker assessment. A study leveraging real-world evidence compared the overall survival associated with different treatment sequences in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) in the United States. The study used an electronic health record database from Flatiron Health to identify adult patients with CLL or SLL who started treatment in 2016 or later and had received at least two lines of therapy. An evaluation of CAR-HEMATOTOX scoring as a predictor of infection risk following treatment with odronextamab in relapsed/refractory (R/R) diffuse large b-cell lymphoma (DLBCL) and in follicular lymphoma (FL). These retrospective analysis of the ELM-1 and ELM-2 studies evaluated infections in 219 patients receiving odronextamab monotherapy for R/R DLBCL and FL, respectively. The full list of presentations at this year's American Society of Hematology (ASH) Annual Meeting and Exposition can be found here. About Rutgers Cancer Institute As New Jersey's only National Cancer Institute-designated Comprehensive Cancer Center, Rutgers Cancer Institute, together with RWJBarnabas Health, offers the most advanced cancer treatment options, including bone marrow transplantation, proton therapy, CAR T-cell therapy and complex surgical procedures. Along with clinical trials and novel therapeutics such as precision medicine and immunotherapy – many of which are not widely available – patients have access to these cutting-edge therapies at Rutgers Cancer Institute in New Brunswick, Rutgers Cancer Institute at University Hospital in Newark, as well as through RWJBarnabas Health facilities. For journalists – contact: Krista Didzbalis Corporate Communications Specialist, Strategic Communications, RWJBarnabas Health 732.507.8307 [email protected] For patient appointments/inquiries – contact: 844-CANCERNJ (844-226-2376) SOURCE Rutgers Cancer Institute and RWJBarnabas Health WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果ASH会议细胞疗法免疫疗法

2024-11-26

·Endpoints

Food allergy biotech Alladapt closes after Phase 3 talks with FDA

Alladapt Immunotherapeutics, a well-financed biotech working in the food allergy field, shut down following talks with the FDA, according to a source familiar with the company. After claiming success in a Phase 1/2 trial in June 2023, Alladapt prepared for a Phase 3 of its experimental food allergy drug. Codenamed ADP101, the oral candidate had received the FDA fast track tag for mono- and multi-food allergies. But a late-stage trial proved too financially daunting. The “FDA guidance for the Phase 3 trial made it economically unviable,” according to the source, who confirmed the company closure to Endpoints News on the condition of anonymity. Investors got a “partial recovery on their investment,” the source added. The Menlo Park, CA-based startup was co-founded in 2018 by CEO Ashley Dombkowski and Kari Nadeau, a former Stanford allergist and now chair of the Department of Environmental Health at Harvard School of Public Health. Dombkowski didn’t respond to an Endpoints inquiry. Alladapt disclosed a $119 million funding round in June 2022 and a $50 million loan with Hercules Capital two months later. The biotech disclosed construction of a manufacturing facility on the outskirts of Philadelphia the year prior. The facility was expected to be completed in “late 2024,” according to architecture and engineering firm Genesis. The company’s investors included Patient Square Capital’s Enavate Sciences, Gurnet Point Capital, AllerFund, Red Tree Venture Capital, Novartis and others. Its equipment was listed for auction in July. Rock Creek Advisors, a firm that works on liquidations and restructurings, lists Alladapt as a client on its website. Some of its top executives left this year for posts at Eccogene and Navigator Medicines . The food allergy space has been through a series of ups and downs in recent years. Nestlé’s attempt to market a peanut allergy drug — known as Palforzia, from its $2.6 billion Aimmune acquisition — had failed commercially. There was a major win in February with the FDA approval of Novartis and Genentech’s Xolair for children and adults with one or more food allergies. Novartis had also axed a peanut allergy Phase 3 trial earlier this year, but said it expected to start a new study of the anti-inflammatory, dubbed ligelizumab, later in 2024. With its ADP101 candidate, Alladapt aimed to deliver small bits of protein from the “big nine” food allergies — milk, eggs, wheat, fish, shellfish, peanuts, tree nuts, soy and sesame — so that patients wouldn’t be as sensitized to the allergens. The startup also terminated an open-label extension study this year. Also in the food allergy space are Leaps by Bayer-backed Ukko and Regeneron, which is testing Dupixent combined with its hematology drug linvoseltamab in Phase 1 .

临床3期并购快速通道临床1期

2024-11-19

·氨基观察

再生元的中年危机

氨基观察-创新药组原创出品作者 | 黄凯再生元是biotech届眼中的吾辈楷模，没有一家biotech不想成为再生元。“成为中国的再生元”，更是是诸多国内biotech的slogan。但是，这样的再生元也躲不过自己的中年危机。对手的进击、Eylea仿制药的胜利、双抗接二连三的打击，让再生元处在一个极其微妙的阶段。一方面，凭借两款爆款药物，再生元完成了从biotech到big pharma的蜕变，上半年股价不断上涨，成功突破千亿美元门槛，市值最高达1332亿美元。另一方面，市场虽相信再生元研发和平台技术能力的，但新的百亿重磅药物，哪有那么容易？而再生元被寄予厚望的肿瘤业务，并不像自免、眼科那样光鲜，进展也乏善可陈。所以我们看到，当市值冲上千亿美元后，市场对再生元的未来走向，已经有了分歧。而当岌岌可危的增长，碰上专利诉讼失败，不及预期的三季报，进一步放大焦虑，造就了短时间的连续下跌，500亿美元市值随之蒸发。一直以来，当我们谈及大药企的危机，总离不开一个老生常谈的问题：专利悬崖。再生元今日之危机，也与专利悬崖脱不开关系。但如果换个角度，就会发现，big pharma经营之道也是非常重要。对于再生元来说，现有的产品（Eylea、Dupilumab）能够保底一个很高的基础价值，但后续价值如何演绎，还是要看后续研发。而在“弱肉强食”的商业环境中，big pharma的生存之道，要么是通过收购他人来做大自己的规模，要么是一直保留业内最高的研发效率，将对手远远甩开。再生元需要保持自己的研发梦想，同时，也要考虑现实。 / 01 / 跌落千亿过去几年里，再生元持续进击。旧王牌Eylea的稳定输出，新王牌Dupixent迅速成长为百亿级别的重磅药物，带动再生元业绩的持续增长。其中，Eylea在专利悬崖以及罗氏的眼科双抗Vabysmo抢占市场份额的双重冲击下，销售额经历了连续的下滑，而随后凭借高剂量版本的推出（Eylea HD），在今年二季度重回增长。与赛诺菲合作的Dupilumab更是一路高歌猛进。从销售额来看，Dupilumab在2024年上半年的销售额为61.38亿欧元（约66.63亿美元），已经成功超越修美乐，成为了自免新药王。并且，Dupilumab同样在不断拓展适应症，近期COPD适应症已于欧盟获批，大疱性类天疱疮、慢性自发性荨麻疹等适应症的关键临床3期数据也将在下半年读出，Dupilumab正在迎来密集收获期。这也意味着，Dupixent将是一个比Eylea还成功的重磅炸弹，销售峰值预测已经来到200亿美元。于是，我们看到，今年上半年再生元成为美股医药板块，礼来、诺和诺德之外少有的亮点，股价不断上涨，成功突破千亿美元门槛，市值最高达1332亿美元。凭借两款爆款药物，再生元完成了从biotech到big pharma的蜕变，市值一度超越了百时美施贵宝等巨头，紧跟在辉瑞后面。然而，自8月27日股价摸到1211.2美元/股历史高点后，再生元至今跌幅接近40%。短短2个半月时间，几乎腰斩。如今，再生元市值为837亿美元，较高点蒸发500亿美元。翻看再生元的历史K线图，这样连续且陡峭的跌法，在过去几乎是没有过的事情。专利悬崖，是每一家大药企都必须要面对的，从罗氏、赛诺菲、艾伯维到默沙东，莫不如是。市场对于Eylea的专利悬崖也早有预期。那么，为什么在8月高点之后，再生元转头，一路向下？ / 02 / 转型之槛市场都在期待再生元奇迹。然而，接二连三的打击、对手的进击、仿制药的胜利，让再生元处在一个极其微妙的阶段。目前看，未来短时间内Eylea、Dupilumab仍是拉动再生元业绩增长的两个绝对重磅品种。但随着罗氏Vabysmo的强势冲击，以及生物类似药的不断获批，Eylea的市场份额不断被压缩，即使Eylea HD保持高增长，但也被Eylea的下滑大幅冲减。三季报显示，Eylea系列总销售额在第三季度仅增长3%，达到15.4亿美元。进一步加剧市场担忧的是，安进的Eylea生物类似药Pavblu即将进入市场。此前，在诉讼中获胜的安进表示，计划尽快在美国推出Pavblu。这被视作今年美国制药行业最大的排他性损失。尽管再生元似乎对Eylea的表现并不太担忧，CEO在财报电话会议上强调公司的“强劲季度”，三季度收入为37.2亿美元，同比增长11%。包括PD-1单抗Libtayo在内的其他产品增速较快。但是，市场并不买单，这份财报发布当天，其股价大跌9.2%。至于Dupilumab，预期一再拔高，再生元获得的分成也不断增长，但考虑到总增速会被Eylea拖累，且其与赛诺菲“三七”分，目前能为公司贡献业绩的部分还需打个折扣。因此，要想坐稳千亿市值，仅靠这两个产品远无法达到预期。转型迫在眉睫。然而，再生元被寄予厚望的抗肿瘤业务，并不像自免、眼科那样光鲜。目前仅有一款抗肿瘤药物能排上号——Libtayo，但在一众PD-1单抗竞对，双抗也逐渐面世的市场中，也很难撑起再生元的门面。上半年，Libtayo销售额5.61亿美元，第三季度2.89亿美元，在距离首个适应症获批上市的第六年，终于有望突破10亿美元大关。十亿美元分子来之不易。这也是再生元抗肿瘤药物研发的缩影。 Libtayo之后，在抗肿瘤药物的研发布局上，再生元将很大一部分精力投入到双抗研发。2024年对于再生元来说，是非常关键的一年——两款双抗药物距离商业化只差临门一脚。但流年不利，Odronextamab、Linvoseltamab均被FDA拒之门外。尽管这并非是因为疗效和安全性问题，Odronextamab被拒的原因可以归结为FDA重新审视快速审批通道后的结果，Linvoseltamab则是因为不靠谱的第三方制造商。 FDA接连两次的拒绝，对再生元的双抗事业还是造成了一定的打击，也使得其在双抗领域中落后于强生、罗氏和艾伯维。直到8月底，Odronextamab成功在欧盟获批上市，才算迎来一个好消息。某种程度上，当市值冲上千亿美元后，市场对于再生元的未来走向，已经有了分歧。而当岌岌可危的增长，碰上专利诉讼失败，不及预期的三季报，进一步放大焦虑，造就了500亿美元的“惨案”。 / 03 / Big pharma之道这样的极速暴跌之下，有什么变化了吗？没有，一定程度上再生元仍是最优秀的生物科技企业之一。营收还在增长，研发并未懈怠，创始、研发灵魂人物也还在。只是，当大家把预期抬得过高，眼前的繁华会让大家忽视背后的风险，哪怕概率很低。创新药研发，自始至终都是一项风险高、不确定性高的事业。即使有着最优抗体技术的再生元，也不能保证自己的爆品成功率。更何况，在再生元的价值观中，“商业”是次之的，或者说商业是科学价值的附庸。而面对专利悬崖，几乎所有大药企都在不断买买买，希望为自己的未来增加筹码，并试图让投资者相信，下一个营收断层到来时，不会像看起来那么糟糕。再生元依旧保持着自己的节奏。“历史上有很多时候，人们做一些事情是因为他们有很大的商业机会，或是基于一种模棱两可的科学……很多以商业思维驱动业务的人只能看到这个行业已经走到了哪里，却很难看出这个行业应该走向何方……如果我们开发出了一款重要的药物，那么商业方面的问题也就迎刃而解了。这就是为什么永远要以科学为先（science should always lead）。”这是美国再生元的首席科学家George Yancopoulos博士，去年接受媒体采访时所说。这很再生元。在这一信条下，再生元研发出了Eylea、Dupilumab两大爆款。拥有平台技术优势的再生元也不止于此，自2015年之后，再生元几乎每年至少有一款药物（新适应症）获得FDA批准，至今已经上市（获得授权）的产品达11种，临床三期、二期的管线超20个。只是，这尚不能弥补市场对于专利悬崖和增长的焦虑。毕竟，新的重磅炸弹可遇不可求。再生元的经历也告诉我们，从biotech成为big pharma，只需要两款爆款。然而，要想坐稳这个位子，这还远远不够。正如任正非所说，要敢于打破自己的优势形成新的优势，最好的防御就是进攻。其实从艾伯维走出修美乐专利悬崖也能看出，药企保持积极的进攻态势，何其重要。这种进攻，既包括研发、并购，更涉及商业、专利方方面面。当然，再生元近两年也在不断进攻。尽管肿瘤进展乏善可陈，但其也在积极布局其他领域，比如减重、基因疗法等。减重是过去一年的研究热点，再生元则重点关注减重的质量，选择性减少脂肪含量，而减少肌肉含量的流失。目前已经启动了Trevogrumab联合Semaglutide±Garetosmab治疗肥胖症的临床2期研究。此外再生元还差异化布局了GPR75靶点，正在开发siRNA、小分子、抗体等多种靶向GPR75的药物。甚至在研发之外，再生元还做起了风投。4月，其宣布成立风险投资基金Regeneron Ventures，专注于有前景的生物制药、医疗保健和技术公司，其表示将在五年内每年投入1亿美元建立该基金。再生元正在变得更加开放，更加多元。只是，这还有待时间的验证。永远增长，永远焦虑。再生元或许正在试着重新理解big pharma之道。 PS：欢迎扫描下方二维码，添加氨基君微信号交流。

并购临床3期临床成功

100 项与 Linvoseltamab 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
多发性骨髓瘤	申请上市	美国	Regeneron Pharmaceuticals, Inc.	2023-12-01
意义不明的单克隆丙种球蛋白病	临床2期	美国	Regeneron Pharmaceuticals, Inc.	2024-09-16
意义不明的单克隆丙种球蛋白病	临床2期	西班牙	Regeneron Pharmaceuticals, Inc.	2024-09-16
免疫球蛋白轻链淀粉样变性	临床2期	美国	Regeneron Pharmaceuticals, Inc.	2024-08-07
免疫球蛋白轻链淀粉样变性	临床2期	西班牙	Regeneron Pharmaceuticals, Inc.	2024-08-07
免疫球蛋白轻链淀粉样变性	临床2期	英国	Regeneron Pharmaceuticals, Inc.	2024-08-07
阴燃多发性骨髓瘤	临床2期	西班牙	Regeneron Pharmaceuticals, Inc.	2024-01-30
难治性多发性骨髓瘤	临床2期	美国	Regeneron Pharmaceuticals, Inc.	2019-01-23
难治性多发性骨髓瘤	临床2期	日本	Regeneron Pharmaceuticals, Inc.	2019-01-23
难治性多发性骨髓瘤	临床2期	比利时	Regeneron Pharmaceuticals, Inc.	2019-01-23

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临床结果

适应症

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


LINKER-MM1 (GlobeNewswire) 人工标引	临床1/2期	多发性骨髓瘤	117	linvoseltamab 200 mg	範餘衊簾觸鹹繭糧齋蓋(鹽簾膚積願鑰餘廠鏇鹽) = 衊鏇範構膚鬱艱鏇鬱範願餘衊餘選鹽齋艱窪襯 (築鑰範獵夢製糧蓋願齋 ) 更多	积极	2023-12-07
IMS2023	N/A	复发性多发性骨髓瘤 soluble BCMA	302	Linvoseltamab 200 mg	糧鏇構願鹽繭憲構齋壓(蓋醖壓觸蓋鬱夢積廠糧) = 鏇衊鏇憲窪遞製簾淵蓋齋膚餘網襯願醖廠膚憲 (窪鬱遞觸築簾壓壓艱選 )	-	2023-09-26