The Glo-BNHL trial is trying to find better medicines for children and young people with B-cell non-Hodgkin Lymphoma (B-NHL) that does not go away (refractory B-NHL) or does but comes back again (relapsed B-NHL). B-NHL is a type of cancer that develops inside or outside of lymph nodes (glands) and organs such as the liver or spleen. Examples of B-NHL are Burkitt Lymphoma and Diffuse Large B Cell Lymphoma, which may be other names used to describe this type of cancer. It is very difficult to cure relapsed or refractory B-NHL. The medicines used now are very powerful with many side effects and only cure around 30 in every 100 children treated. It is very important that investigators quickly find better medicines for these children and young people.
The Glo-BNHL trial will include three groups of children and young people, each given a new medicine (either alone or with chemotherapy). The investigators are looking to make sure the new medicines are safe and that they work to treat the cancer. If the medicine in one group does not work for a child in the trial, then they may be able to join a different group to have another new medicine.
Experts from around the world will carefully pick the medicines most likely to be helpful to be part of the trial. If one of the new medicines seems not to be working as well as hoped then the investigators will take it out of the trial as soon as possible. This will let other new medicines be added to the trial and tested. If a medicine does seem to be working well, then it will continue in the trial to make sure it really is the most useful medicine available.
Children from around the world will be invited to take part in the trial. The investigators will then check on them for at least two years after they finish the trial treatment to look for possible side effects of the new medicine.

开始日期2024-05-02

申办/合作机构

University of Birmingham

[+3]

NCT06230224 / Recruiting临床3期

A Phase 3, Randomized, Open Label Study Evaluating the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 x Anti-CD3 Bispecific Antibody, Versus Standard of Care Therapy in Participants With Relapsed/Refractory Aggressive B-cell Non-Hodgkin Lymphoma (OLYMPIA-4)

The study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on patients with previously treated aggressive B-cell non-Hodgkin lymphoma whose cancer has stopped responding to treatment (also known as 'refractory') or has returned (also known as 'relapsed'). The aim of the study is to see how effective the study drug is compared to standard of care (SOC) therapy.
The study is looking at several other research questions, including:
* What side effects may happen from taking the study drug versus SOC
* How much study drug is in your 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)
* Comparing the impact from the study drug versus SOC on your quality-of-life and ability to complete routine daily activities

开始日期2024-02-15

申办/合作机构

Regeneron Pharmaceuticals, Inc.

NCT06149286 / Recruiting临床3期

A Phase 3, Open Label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 x Anti-CD3 Bispecific Antibody, in Combination With Lenalidomide Versus Rituximab in Combination With Lenalidomide Therapy in Relapsed/Refractory Participants With Follicular Lymphoma and Marginal Zone Lymphoma (OLYMPIA-5)

This study is researching an experimental drug called odronextamab (referred to as study drug), in combination with lenalidomide. The study is focused on participants who have one of two types of cancer: follicular lymphoma (FL) or marginal zone lymphoma (MZL) that has come back after treatment (called "relapsed"), or did not respond to treatment (called "refractory"). FL and MZL are subtypes of Non-Hodgkin 's lymphoma (NHL).
This study will be made up of two parts (Part 1 not randomized, Part 2 randomized - controlled).
The aim of Part 1 of the study is to see how safe and tolerable the study drug is when used in combination with lenalidomide, in participants with FL or MZL, and to determine the dose of the study drug to be used in Part 2 of this study. This combination is considered "first-in-human" as it has not been tested as a combination treatment in humans before.
The aim of Part 2, of the study is to assess how the combination of the study drug and lenalidomide works compared to the combination of rituximab (called "the comparator drug") and lenalidomide. The combination of comparator drug and lenalidomide is the current standard-of care treatment for FL and/or MZL. Standard of care means the usual medication expected and used when receiving treatment for a condition.
The study is looking at several other research questions, including:
* What side effects may happen from taking the study drug in combination with lenalidomide
* How much study drug is in the blood at different times
* Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)
* The impact from the study drug on quality of life and ability to complete routine daily activities

开始日期2023-12-28

申办/合作机构

Regeneron Pharmaceuticals, Inc.

100 项与 Odronextamab 相关的临床结果

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100 项与 Odronextamab 相关的转化医学

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100 项与 Odronextamab 相关的专利（医药）

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项与 Odronextamab 相关的文献（医药）

2024-12-31·mAbs

Antibodies to watch in 2024

Article

作者: Reichert, Janice M ; Kaplon, Hélène ; Crescioli, Silvia ; Wang, Lin ; 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.

2024-02-01·British journal of haematology

Improved outcomes of large B‐cell lymphoma patients treated with CD19 CAR T in the UK over time

Article

作者: O'Reilly, M ; Jones, C ; Bloor, A ; Cwynarski, K ; Sanderson, R ; Mathew, A ; Kuhnl, A ; Lugthart, S ; Burns, D ; Chaganti, S ; Roddie, C ; Gibb, A ; Boyle, S ; Seymour, F ; Springell, D ; Hardefeldt, P ; Besley, C ; Norman, J ; Thoulouli, E ; Yallop, D ; Latif, A ; Osborne, W ; Menne, T ; Gonzalez Arias, C ; Uttenthal, B J

Summary:

The success of CD19 Chimeric antigen receptor (CAR) T‐cell therapy in large B‐cell lymphoma (LBCL) has been partially offset by toxicity and logistical challenges, which off‐the‐shelf agents like CD20xCD3 bispecific antibodies might potentially overcome. However, when using CAR T outcomes as the ʽstandard‐of‐care comparator̕ for relapsed/refractory (r/r) LBCL, a potential learning curve with implementing a novel, complex therapy like CAR T needs to be considered. To address this, we analysed 726 UK patients intended to be treated with CD19 CAR T for r/r LBCL and compared outcomes between the first year of the national CAR T programme (Era 1; 2019) and the more recent treatment era (Era 2; 2020–2022). We identified significant improvements for Era 2 versus Era 1 in dropout rate (17% vs. 27%, p = 0.001), progression‐free survival (1‐year PFS 50% vs. 32%, p < 0.001) and overall survival (1‐year OS 60% vs. 40%, p < 0.001). We also observed increased use of bridging therapy, improvement in bridging outcomes, more tocilizumab/corticosteroid use, reduced high‐grade cytokine release syndrome (4% vs. 9%, p = 0.01) and intensive care unit admissions (20% vs. 32%, p = 0.001). Our results demonstrate significant improvement in CAR T outcomes over time, highlighting the importance of using up‐to‐date clinical data when comparing CAR T against new treatment options for r/r LBCL.

2024-01-01·Nature medicine1区 · 医学

Mosunetuzumab with polatuzumab vedotin in relapsed or refractory aggressive large B cell lymphoma: a phase 1b/2 trial

1区 · 医学

Article

作者: Batlevi, Connie Lee ; Pham, Song ; Sabry, Waleed ; Ghosh, Nilanjan ; Kamdar, Manali ; Ead, Wahib S ; To, Iris ; Lossos, Izidore S ; Assouline, Sarit ; Diefenbach, Catherine ; Jing, Jing ; Wu, Hao ; Nakhoda, Shazia K ; Modi, Dipenkumar ; Olszewski, Adam J ; Smith, Stephen D ; Dorritie, Kathleen ; Naik, Seema ; Wei, Michael C ; Huw, Ling-Yuh ; Mehta, Amitkumar ; Budde, Lihua E ; Chavez, Julio C ; Jia, Ting

Abstract:

Relapsed/refractory aggressive large B cell lymphoma (LBCL) remains an area of unmet need. Here we report the primary analysis of a phase 1b/2 trial of outpatient mosunetuzumab (a CD20xCD3 T-cell-engaging bispecific antibody) plus polatuzumab vedotin (an anti-CD79B antibody–drug conjugate) in relapsed/refractory LBCL. The phase 2 component is a single arm of an ongoing multi-arm trial. The primary endpoint during dose expansion was independent review committee (IRC)-assessed best overall response rate. Secondary endpoints included investigator-assessed overall response rate, complete response, duration of response, progression-free survival and overall survival. At data cutoff, 120 patients were enrolled (22 dose escalation, 98 dose expansion). The primary endpoint was met during dose expansion, with IRC-assessed best overall response rate and complete response rates of 59.2% (58/98; 95% confidence interval (CI): 48.8–69.0) and 45.9% (45/98; 95% CI: 35.8–56.3), respectively (median follow-up, 23.9 months). Median duration of complete was not reached (95% CI: 20.5–not estimable (NE)). Median progression-free survival was 11.4 months (95% CI: 6.2–18.7). Median overall survival was 23.3 months (95% CI: 14.8–NE). Across dose escalation and expansion, the most common grade 3 or higher adverse events were neutropenia (25.0%, 30/120) and fatigue (6.7%, 8/120). Any-grade cytokine release syndrome occurred in 16.7% of patients. These data demonstrate that mosunetuzumab plus polatuzumab vedotin has a favorable safety profile with highly durable responses suitable as second-line therapy in transplant-ineligible relapsed/refractory LBCL. ClinicalTrials.gov identifier: NCT03671018.

164

项与 Odronextamab 相关的新闻（医药）

2024-09-13

·FiercePharma

Fierce Pharma Asia—Akeso, Summit's Keytruda-beating data; BIOSECURE's House passage; Candid's $370M debut

Ivonescimab's blow to Keytruda, the BIOSECURE Act's advancement, and Candid Therapeutics' $370 million round made our news this week. Akeso and Summit Therapeutics' ivonescimab showed strong efficacy against Merck's Keytruda in a phase 3 trial in China. The BIOSECURE Act sailed through a full House vote despite some objections. Candid Therapeutics amassed $370 million in series A funds with two T-cell engagers licensed from China. And more.1. Akeso, Summit's PD-1 bispecific crushes Merck's Keytruda in study, signaling potential new standard in lung cancerAkeso and Summit Therapeutics’ PD-1/VEGF bispecific ivonescimab cut the risk of disease progression or death by 49% over Merck’s Keytruda in a Chinese phase 3 trial in first-line PD-L1-positive non-small cell lung cancer. Consistent benefits were seen across key patient subgroups. While the drug showed strong data, it still has some proving to do before it can become the new cancer immunotherapy king.2. After BIOSECURE Act passes in House, targeted Chinese companies say they're 'deeply' concernedThe U.S. House of Representatives voted 306-81 in favor of the BIOSECURE Act. Nearly all “no” votes came from Democrats. WuXi AppTec, one of the companies that could be excluded from the U.S. market if the bill eventually becomes law, said the legislation “pre-emptively and unjustifiably” designates the company without due process. The bill’s path at the Senate remains uncertain.3. With $370M debut, Candid Therapeutics is upfront about goal to lead a coming T-cell engager waveCandid Therapeutics has emerged with $370 million from a series A round co-led by Venrock Healthcare Capital Partners, Fairmount, TCGX and venBio Partners, plus two T-cell engagers obtained from Chinese companies. The two candidates are BCMAxCD3 and CD20xCD3 bispecific antibodies that Candid is now developing for autoimmune diseases. Former RayzeBio chief Ken Song, M.D., is at the helm of the biotech.4. AstraZeneca, Daiichi unpack Dato-DXd's overall survival fail ahead of FDA decisionDetailed data from the TROPION-Lung01 trial showed a numerical 2.3-month improvement in median overall survival for AstraZeneca and Daiichi Sankyo’s Dato-DXd compared with docetaxel in a subgroup of patients with nonsquamous non-small cell lung cancer. The death risk reduction in the patient group was 16%, which doesn’t bear statistical significance.5. AstraZeneca outlines AI-enabled TROP2 biomarker strategy for Daiichi ADC after limited lung cancer showingAZ, with the help of artificial intelligence, has devised a new biomarker for Dato-DXd called normalized membrane ratio of TROP2 by quantitative continuous scoring (NMR-QCS). The marker incorporates both the membrane and cytoplasm expression of TROP2. With this effort, AZ's ambition is to explain why Dato-DXd appears to work only in nonsquamous patients and to differentiate the drug from competitors.6. AbbVie slaps BeiGene with another blood cancer lawsuit, this time on BTK degrader trade secretsAbbVie has brought another lawsuit against BeiGene, accusing the latter company of trade secrets theft related to BTK degraders. AbbVie argued that BeiGene lured a former scientist to work on its competing program and therefore obtained confidential information. BeiGene told Fierce that its candidate was “independently discovered” and that the company plans to “vigorously defend” itself.Other News of Note:7. J&J bolsters Rybrevant-Lazcluze's case against AZ's Tagrisso with survival analysis8. Merck, Daiichi repeat early success in small cell lung cancer with updated ADC data9. FDA issues Form 483s to Japanese, Indian drugmakers in wake of plant inspections10. India's Zydus hit with warning letter as FDA flags glass contamination concerns and more11. Connect reduces China workforce, mulls strategy for potential Dupixent rival12. FDA sends warning letters to 2 Chinese lab service providers for device makers (release)

临床3期临床结果

2024-09-09

·Business Wire

Candid Therapeutics Debuts with $370M Capital Raise to Clinically Evaluate Potentially Transformative Autoimmune Therapies

SAN DIEGO--( BUSINESS WIRE )--Candid Therapeutics, Inc. (“Candid”), a biotechnology company dedicated to developing potentially transformative drugs to address autoimmune diseases, announced its official launch today. Recent groundbreaking clinical data has showcased the pivotal role of a specific subset of immune cells, B lymphocytes, in autoimmune diseases. B lymphocytes lead to autoimmune pathology by producing autoantibodies that attack the body's own tissues and also through antigen presentation and cytokine release. Selective depletion of B lymphocytes has shown unprecedented clinical efficacy in highly refractory patients across multiple autoimmune diseases such as rheumatoid arthritis and myasthenia gravis. Candid is developing T-cell engager (“TCE”) antibodies that can deplete specific B lymphocyte cell populations and aims to be the first company to bring these novel therapies to market. To accelerate development of and position Candid to become the leader in TCE antibodies for autoimmune diseases, Candid acquired Vignette Bio and TRC 2004 through a simultaneous three-way merger and multi-step financing. This acquisition integrates two cutting-edge bispecific TCEs: CND106, a BCMAxCD3 bispecific antibody from Vignette Bio, which was initially founded by Foresite Labs who exclusively licensed ex-China rights for the drug candidate from EpimAb Biotherapeutics. CND261, a CD20xCD3 bispecific antibody from TRC 2004, which was established through a collaboration between Two River and Third Rock Ventures who exclusively licensed ex-China rights for the drug candidate from Genor Biopharma. CND106 and CND261 have both completed Phase 1 dose escalation studies with combined data in over 130 oncology patients. Both drug candidates have shown potential to become best-in-class therapies for various autoimmune diseases. The founding Candid team includes an accomplished set of seasoned entrepreneurs who have repeatedly advanced nascent ideas into late-stage development products and commercialization. Ken Song, MD as Chairman, President and CEO has successfully led several life science companies with over $5.5 billion in realized shareholder value. Most recently he led RayzeBio, a radiopharmaceutical company, from concept to Phase 3 in just over 3 years and negotiated a $4.1 billion sale of the company earlier this year to Bristol Myers Squibb. Timothy Lu, MD, PhD as Chief Medical and Scientific Officer was instrumental in the clinical development of novel oral IL-17 drugs for autoimmune diseases at DICE Therapeutics which was acquired last year by Eli Lilly, where he stayed on until joining the Candid team. Bernie Huyghe, PhD as Chief Technology Officer has over 30 years of experience in manufacturing of biologics and other complex therapeutic products and prior to Candid, was overseeing two Phase 3 antibody programs at Viridian Therapeutics. Arvind Kush as Chief Financial and Business Officer has had an illustrious career first as a managing director in healthcare banking at Bank of America before transitioning to RayzeBio as CFO where he navigated a highly successful oversubscribed IPO in September 2023. In conjunction with the merger, Candid has successfully raised over $370 million in capital from an extensive roster of investors, which includes a recently completed financing co-led by Venrock Healthcare Capital Partners, Fairmount, TCGX, and venBio Partners. Other notable healthcare investors supporting the company include Foresite Capital, Third Rock Ventures, Fidelity Management & Research Company, Samsara BioCapital, Qiming Venture Partners USA, OrbiMed, Boxer Capital, Redmile Group, Vida Ventures, Two River, Franklin Templeton, LifeSci Venture Partners, Mirae Asset Capital Life Science, Polaris Innovation Fund, Soleus Capital and other reputable institutional and mutual fund investors. This substantial financial backing highlights strong investor confidence in Candid's purposeful approach and strategic vision, positioning the company for significant impact in bringing forth first-in-class therapies to patients with autoimmune diseases. “TCE antibodies have the most promise as scalable and patient friendly drugs to deplete B cells for treatment of a myriad of autoimmune conditions and represents a once in a generation development opportunity,” said Dr. Ken Song, Chairman, President, and CEO of Candid Therapeutics. “The drugs we are developing at Candid have the potential to go above and beyond the clinical and commercial success of Humira® and Rituxan® and I am thrilled to be leading the Candid team knowing we can possibly make history by changing the paradigm in how autoimmune diseases are treated.” About Candid Therapeutics, Inc. Candid Therapeutics is an innovative biotechnology company dedicated to advancing the treatment of a range of immunological conditions. Established in 2024 and headquartered in San Diego, CA, Candid is driven by a team of repeatedly successful entrepreneurs with deep expertise and strong execution abilities. Supported by a distinguished syndicate of leading healthcare investors, Candid is committed to discovering and developing cutting-edge therapeutic programs that address significant unmet medical needs in immunology. About Vignette Bio, Inc. Vignette Bio was formed in 2024. The company was incubated by Foresite Labs, an incubation platform led by an experienced team who believe that the tools of data science, when applied with scientific rigor, will greatly accelerate scientific discovery and the development of new products and services that benefit patients. Vignette Bio was backed by Foresite Capital, Qiming Venture Partners, Samsara BioCapital, and Mirae Asset Capital Life Science. About TRC 2004 TRC 2004 was a company co-founded by Two River and Third Rock Ventures. Two River has founded some of the most successful cell therapy companies in the industry, including Kite Pharma (acquired by Gilead Sciences, Inc.). Third Rock Ventures is a leading healthcare venture firm that has raised $3.8 billion dollars since its inception, fueling investment in over 60 portfolio companies that have delivered numerous products to market across multiple therapeutic modalities and indications

临床1期并购免疫疗法IPO高管变更

2024-09-09

·药渡Daily

【药渡药闻报告-创新药篇】-2024年第34期/总第155期

全球药物批准/研发动态 01 全球新药批准情况根据药渡数据统计分析，本次统计周期（2024.08.24-08.30）全球（不含中国）共有10个新药获批上市。其中，NDA批准1个，BLA批准2个，疫苗批准1个，新适应症批准5个，新制剂批准1个。与上个统计周期相比，本次增加3个批准新药。 8月26日，Vericel Corporation宣布，FDA已批准了补充生物制品许可申请，扩大了MACI（猪胶原膜上自体培养的软骨细胞）标签，包括关节镜下输送MACI，用于修复有症状的膝关节单层或多发全层软骨缺损，伴或不伴骨骼受累。MACI植入物由接种在可吸收I/III型胶原膜上的自体培养软骨细胞组成。自体培养的软骨细胞是从患者自身的软骨中获得的人类来源的细胞，用于制造MACI。MACI Arthro器械为医生提供了一种侵入性较小的选择，可以为患者进行经过临床验证的治疗，更有利于患者的治疗。 8月26日，REGN宣布EC已批准Ordspono™（Odronextamab）用于治疗经过两种或多种全身治疗的复发或难治性（R/R）滤泡性淋巴瘤（FL）或R/R弥漫性大B细胞淋巴瘤（DLBCL）成年患者。Ordspono是一种双特异性抗体，通过将淋巴瘤细胞与杀伤性T细胞连接起来发挥作用，在临床试验中，Ordspono表现出显著的完全缓解率，并且在弥漫性大B细胞淋巴瘤中表现出令人信服的疗效结果。全球（不含中国）新药批准情况（部分） 02 全球新药申报进展根据药渡数据统计分析，本次统计周期（2024.08.24-08.30）全球（不含中国）共有4个新药申报上市。其中，NDA申报2个，BLA申报1个。与上次统计周期相比，本次减少1个NDA/BLA申报。 8月27日，Soleno宣布FDA已接受提交Diazoxide Choline的新药申请，用于治疗4岁及以上食欲亢进症患者的Prader-Willi综合征。Diazoxide Choline是一种新型的专有缓释剂型，含有二氮嗪胆碱，每天给药一次。在PWS III期临床开发计划中，Diazoxide Choline在解决食欲亢进以及其他几种症状（如攻击性/破坏性行为等）方面显示出前景。 NDA/BLA申报根据药渡数据统计分析，本次统计周期（2024.08.24-08.30）全球（不含中国）共有6个药物获监管机构特殊资格认定。其中，化学药6个。与上次统计周期相比，本次减少2个获监管机构特殊资格认定的药物。 8月26日，BeiGene宣布FDA已授予BGB-16673快速通道资格。BGB-16673是一种口服在研布鲁顿酪氨酸激酶（BTK），靶向嵌合降解激活化合物（CDAC），适用于既往接受过至少两种既往治疗治疗的复发或难治性（R/R）慢性淋巴细胞白血病或小淋巴细胞淋巴瘤（CLL/SLL）成人患者。BGB-16673是目前最先进的BTK降解剂，非常适合成为BTKi后病情恶化且选择有限的患者的重要疗法。 8月28日，AC宣布其合作伙伴LMI已获得FDA对三种神经退行性疾病的Tau正电子发射断层扫描（PET）诊断[18F]PI-2620的快速通道指定。[18F]PI-2620已获准用于阿尔茨海默病、进行性核上性麻痹和皮质基底节变性的临床开发。PI-2620目前正在进行多项临床研究，作为检测人脑中Tau沉积物的靶向放射性药物。PI-2620还显示出对进行性核上性麻痹（PSP）和皮质基底节综合征（CBS）等非AD tau蛋白病的希望。特殊资格认定情况（部分） 03 全球新药研发进展根据药渡数据统计分析，本次统计周期（2024.08.24-08.30）全球（不含中国）新药临床研发状态更新共计24条，涉及肿瘤、血液和淋巴疾病、遗传代谢病、神经疾病以及皮肤病等共计9个领域。其中，肿瘤领域临床进展更新居各领域之首，为7条：涉及化学药2条，生物药4条，疫苗1条。近日，在WCLC 2024大会上，恒瑞公布了TROP2 ADC药物SHR-1921治疗晚期小细胞肺癌（SCLC）I期研究的口头报告。结果显示，在17名患者中，治疗相关不良反应（TRAE）(≥grade 3) 为35.3%，ORR为33.3%，中位PFS为3.8个月，中位OS尚未达到。SHR-A1921在重度经治的广泛期SCLC患者中表现出有潜力的临床疗效和可控的安全性。 8月29日，多玛医药双抗ADC产品DM005正式获得FDA IND批准，即将开启临床I期研究。在前期的临床前研究中，DM005展现出强大的抗肿瘤活性和良好的安全性。动物实验结果显示，DM005能够显著抑制多种实体瘤的生长，且耐受性良好，未见显著毒性反应。即将开展的全球临床I期研究将招募多种类型实体瘤患者，包括非小细胞肺癌、头颈癌等，旨在评估DM005单一疗法在晚期实体瘤患者中的安全性、初步疗效和药代动力学特性。全球新药研发进展详情（部分） 04 全球医药交易事件本次统计周期（2024.08.24-08.0）全球（含中国）医药交易时间共计25起，涉及药物权益转让、公司并购等多起交易事件。全球医药交易时间汇总表（部分）国内药物批准/研发动态 01 国内新药批准情况根据药渡数据统计分析，本次统计周期（2024.08.24-08.30）国内共有3个新药获NMPA批准上市。其中，BLA批准3个3。与上次统计周期相比，本次减少4个NMPA批准新药。 8月21日，劲方医药宣布国家药品监督管理局通过优先审评程序批准KRAS G12C抑制剂达伯特®（氟泽雷塞片，GFH925/IBI351）上市；本品单药疗法适用于至少接受过一种系统性治疗的KRAS G12C突变型晚期非小细胞肺癌（NSCLC）成人患者。研究结果显示，氟泽雷塞总体耐受性良好。IRRC确认的客观缓解率达49.1% (95% CI: 39.7-58.6)；疾病控制率达90.5% (95%CI: 83.7, 95.2)。中位缓解持续时间（DoR）未达到。 8月27日，智翔金泰宣布，公司自主研发的1类新药赛立奇单抗注射液正式获得NMPA核准签发的《药品注册证书》，正式获批上市，用于中、重度斑块状银屑病的治疗。赛立奇单抗注射液可通过抗体特异性结合血清中的IL-17A细胞因子，阻断IL-17A与IL-17RA的结合，抑制炎症的发生和发展。研究表明，赛立奇单抗注射液对中、重度斑块状银屑病表现出优异的疗效以及良好的安全性和耐受性。国内新药批准情况（部分） 02 国内新药临床默示许可进展根据药渡数据统计分析，本次统计周期（2024.08.24-08.30）国内共有32个新药获临床默示许可，涉及46个受理号。其中，化学药17个，治疗用生物制品15个。与上次统计周期相比，本次减少28个临床默示许可获批受理号。本周国内新药临床默示许可进展（部分） 03 国内新药申报进展根据药渡数据统计分析，本次统计周期（2024.08.24-08.30）国内共有10个新药申报上市，涉及17个受理号。其中，化药6个，治疗用生物制品3个，预防用生物制品1个。与上个统计周期相比，本次增加9个新药申报上市受理号。国内新药申报上市情况根据药渡数据统计分析，本次统计周期（2024.08.24-08.30）国内共有38个新药申报临床，涉及60个受理号。其中，化学药22个，治疗用生物制品14个，预防用生物制品2个。与上次统计周期相比，本次增加30个临床申报受理号。国内新药临床申报情况（部分）根据药渡数据统计分析，本次统计周期（2024.08.24-08.30）国内共有1个药物获NMPA特殊资格认定。其中，生物药1个。与上次统计周期相比，本次减少1个获监管机构特殊资格认定的药物。 8月29日，CDE官网最新公示，由中生复诺健生物申报的重组人IL12/15-PDL1B单纯疱疹I型溶瘤病毒注射液（Vero细胞）拟纳入突破性治疗品种，适应症为：经标准治疗失败的晚期肝细胞癌（HCC）。VG161是一款新型抗肿瘤免疫增强型I型单纯疱疹溶瘤病毒，同时携带IL12、IL15/15RA（IL15和IL15受体α亚基）和PD-L1阻断肽（PDL1B）的基因。该在研溶瘤病毒产品实现了一个病毒表达4个具有协同性抗肿瘤免疫刺激作用的基因，可实现溶瘤活性与免疫刺激的协同，并能将抗病毒免疫反应转化为特异性的抗肿瘤免疫反应。数据展示：VG161单药治疗在这些HCC患者中获得了显著的临床获益，相比对照组总生存期（OS）显著延长。国内监管机构特殊资格认定药物 04 国内新药研发进展根据药渡数据统计分析，本次统计周期（2024.08.24-08.30）国内新药临床研发状态更新共计5条，涉及肿瘤、遗传和代谢病、呼吸系统疾病和皮肤病共计4个领域。其中，化学药3条，生物药2条。与上次统计周期相比，本次减少1条国内新药临床研发状态更新。 8月26日，爱科百发CEO邬征博士在第8届IPF峰会上发表了主题报告“Development of Next Generation Broadly Active IPF Drug AK3280”，报告了新一代抗纤维化药物AK3280的临床前和临床研究进展，特别是在特发性肺纤维化受试者中开展的2期随机双盲多中心临床研究，并宣布这项研究已完成全部受试者入组。该研究旨在评估AK3280在特发性肺纤维化受试者中的安全性，耐受性和药效。 AK3280是在已上市产品吡非尼酮的基础上优化而成的新一代广谱抗纤维化分子，能够调节多种与纤维化病理过程密切相关的通路和生物标记物，包括转化生长因子（TGF-β）和溶血磷脂酸（LPA）等诱导的纤维化相关基因和蛋白的表达，降低细胞增殖，抑制细胞外基质的合成和聚集。AK3280相较吡非尼酮有安全性和耐受性优势，且潜在药效更强。国内新药研发进展 05 国内新药研发领域政策法规动态关于公开征求《预防用mRNA疫苗非临床研究技术指导原则（征求意见稿）》意见的通知为规范和指导预防用mRNA疫苗的非临床研究，我中心在前期调研的基础上，结合国内外相关指导原则和技术要求，以及当前技术发展和科学认知，撰写了《预防用mRNA疫苗非临床研究技术指导原则（征求意见稿）》。我们诚挚地欢迎社会各界对征求意见稿提出宝贵意见并及时反馈给我们，以便后续完善。征求意见时限为自发布之日起1个月。 06 国内新药研发领域热点新闻乐普生物已到“最佳击球区” 根据最新半年报数据，2024年上半年，乐普生物总营收1.33亿元。主要收入来自PD-1普特利单抗，上半年录得9480万元收入，较去年同期增加一倍。研发开支2.17亿元，减少6.6%；现金及现金等价物5.14亿元，增加20.6%。乐普生物自今年2季度以来，市值经历了过山车起伏，振幅数以倍计，让人有些摸不着头脑。作为国内可算作头部ADC的Biotech，乐普生物的研发管线里其实还有许多惊喜，而且很多潜在重磅项目均还待字闺中，有很高的“出海”价值。但却迟迟得不到资本市场的看好，这是为何？更多资讯，请阅读原文康方半年报：首款自研ADC浮出水面 8月28日，康方生物公布2024年中期业绩。上半年，康方药业仍然保持高质量发展，实现营收共计10.25亿元，主要为产品收入和许可费收入。创新产品收入同比增长24%达到了9.4亿元，主要归因为商业化产品——PD-1/CTLA-4双抗卡度尼利的销售放量，以及PD-1/VEGF双抗于5月底正式获批带来的贡献。半年报中的另一亮点还在于，康方公布了其首款自研ADC候选药物AK138D1——日前已经向CDE递交IND申请，用于治疗晚期恶性肿瘤。更多资讯，请阅读原文梭哈自免赛道后，三生国健创下历史最佳业绩近日，三生国健发布2024年半年度报告。2024年上半年实现收入5.97亿元，同比增长24.9%；归母净利润1.3亿元，同比增长36.7%；扣非净利润1.26亿元，同比增长50.81%。这是三生国健自2019年以来，首次重回巅峰，并创下历史半年最高营收纪录。自2022年决定剥离肿瘤管线开始，三生国健全力梭哈自免赛道，到如今轻装上阵，多款创新管线步入收获期，有望在即将爆发的中国自免赛道取得先机。更多资讯，请阅读原文咨询、合作请联系作者小D有话说为方便读者阅读及保存，我们将周报原文整理成了PDF版本，如需获取全文，可点击最上方蓝字，在药渡Daily公众号后台回复“0909创新药周报”，即可下载。

上市批准临床3期临床结果申请上市快速通道

100 项与 Odronextamab 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11534	-	-	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
复发性弥漫性大B细胞淋巴瘤	欧盟	Regeneron Pharmaceuticals, Inc.	2024-08-26
复发性弥漫性大B细胞淋巴瘤	冰岛	Regeneron Pharmaceuticals, Inc.	2024-08-26
复发性弥漫性大B细胞淋巴瘤	列支敦士登	Regeneron Pharmaceuticals, Inc.	2024-08-26
复发性弥漫性大B细胞淋巴瘤	挪威	Regeneron Pharmaceuticals, Inc.	2024-08-26
难治性弥漫性大 B 细胞淋巴瘤	欧盟	Regeneron Pharmaceuticals, Inc.	2024-08-26
难治性弥漫性大 B 细胞淋巴瘤	冰岛	Regeneron Pharmaceuticals, Inc.	2024-08-26
难治性弥漫性大 B 细胞淋巴瘤	列支敦士登	Regeneron Pharmaceuticals, Inc.	2024-08-26
难治性弥漫性大 B 细胞淋巴瘤	挪威	Regeneron Pharmaceuticals, Inc.	2024-08-26
复发性滤泡性淋巴瘤	欧盟	Regeneron Pharmaceuticals, Inc.	2024-08-26
复发性滤泡性淋巴瘤	冰岛	Regeneron Pharmaceuticals, Inc.	2024-08-26
复发性滤泡性淋巴瘤	列支敦士登	Regeneron Pharmaceuticals, Inc.	2024-08-26
复发性滤泡性淋巴瘤	挪威	Regeneron Pharmaceuticals, Inc.	2024-08-26
难治性滤泡性淋巴瘤	欧盟	Regeneron Pharmaceuticals, Inc.	2024-08-26
难治性滤泡性淋巴瘤	冰岛	Regeneron Pharmaceuticals, Inc.	2024-08-26
难治性滤泡性淋巴瘤	列支敦士登	Regeneron Pharmaceuticals, Inc.	2024-08-26
难治性滤泡性淋巴瘤	挪威	Regeneron Pharmaceuticals, Inc.	2024-08-26

未上市

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适应症	最高研发状态	国家/地区	公司	日期
侵袭性 B 细胞非霍奇金淋巴瘤	临床3期	澳大利亚	Regeneron Pharmaceuticals, Inc.	2024-02-15
侵袭性 B 细胞非霍奇金淋巴瘤	临床3期	意大利	Regeneron Pharmaceuticals, Inc.	2024-02-15
侵袭性 B 细胞非霍奇金淋巴瘤	临床3期	马来西亚	Regeneron Pharmaceuticals, Inc.	2024-02-15
侵袭性 B 细胞非霍奇金淋巴瘤	临床3期	荷兰	Regeneron Pharmaceuticals, Inc.	2024-02-15
侵袭性 B 细胞非霍奇金淋巴瘤	临床3期	新加坡	Regeneron Pharmaceuticals, Inc.	2024-02-15
侵袭性 B 细胞非霍奇金淋巴瘤	临床3期	韩国	Regeneron Pharmaceuticals, Inc.	2024-02-15
侵袭性 B 细胞非霍奇金淋巴瘤	临床3期	西班牙	Regeneron Pharmaceuticals, Inc.	2024-02-15
侵袭性 B 细胞非霍奇金淋巴瘤	临床3期	中国台湾	Regeneron Pharmaceuticals, Inc.	2024-02-15
侵袭性 B 细胞非霍奇金淋巴瘤	临床3期	泰国	Regeneron Pharmaceuticals, Inc.	2024-02-15
侵袭性 B 细胞非霍奇金淋巴瘤	临床3期	土耳其	Regeneron Pharmaceuticals, Inc.	2024-02-15

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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


NCT02290951 (ELM-1, EHA2024) 人工标引	临床1期	弥漫性大B细胞淋巴瘤	44	Odronextamab	襯繭鏇範網餘獵鏇膚鏇(構醖繭艱糧繭餘淵繭顧) = 鹹選鏇醖膚憲壓蓋夢繭鏇繭積鑰範餘構範餘夢 (夢蓋糧齋遞齋簾製醖顧 ) 更多	积极	2024-05-14
NCT03888105 (ELM-2, EHA2024) 人工标引	临床2期	滤泡性淋巴瘤 CD20 \| CD3	128	Odronextamab	艱餘鹽鹹廠憲繭遞願觸(獵醖觸糧觸鹹淵齋築齋) = 觸壓構繭齋餘繭範夢網憲築艱製窪襯醖蓋築齋 (醖鹽遞觸範蓋網範簾構 ) 更多	积极	2024-05-14
NCT03888105 \| NCT02290951 (ELM-2, EHA2024) 人工标引	临床1/2期	滤泡性淋巴瘤 \| 弥漫性大B细胞淋巴瘤 CD20 \| CD3 \| cytokines	507	Odronextamab (FOLLICULAR LYMPHOMA)	夢網憲觸窪鏇膚構餘壓(鬱觸製製膚構餘膚鏇蓋) = 膚夢蓋構築淵鹽艱夢壓鑰夢夢鹹蓋製範積觸鹽 (觸鹽鑰醖顧顧醖顧糧範 )	积极	2024-05-14
NCT03888105 \| NCT02290951 (ELM-2, EHA2024) 人工标引	临床1/2期	滤泡性淋巴瘤 \| 弥漫性大B细胞淋巴瘤 CD20 \| CD3 \| cytokines	507	Odronextamab (DIFFUSE LARGE B-CELL LYMPHOMA)	夢網憲觸窪鏇膚構餘壓(鬱觸製製膚構餘膚鏇蓋) = 鹽鹽積鹽願壓顧構網製鑰夢夢鹹蓋製範積觸鹽 (觸鹽鑰醖顧顧醖顧糧範 )	积极	2024-05-14
NCT03888105 (ELM-2, EHA2024)	临床2期	ctDNA \| MRD \| MYC/BCL2/BCL6 rearrangement ... 更多	-	Odronextamab 80 mg (FL)/160 mg (DLBCL) weekly in C2-4, then 160 mg (FL)/320 mg (DLBCL) every 2 weeks	獵夢網膚觸醖憲築憲襯(窪願製願選鹽鏇積艱網) = 簾醖構構餘鏇獵憲顧蓋衊蓋製鑰選艱衊積艱遞 (艱窪蓋選願製鬱窪鹽觸 )	积极	2024-05-14
NCT03888105 (ELM-2, EHA2024)	临床2期	ctDNA \| MRD \| MYC/BCL2/BCL6 rearrangement ... 更多	-	Placebo	獵夢網膚觸醖憲築憲襯(窪願製願選鹽鏇積艱網) = 夢艱醖遞積醖憲製鏇選衊蓋製鑰選艱衊積艱遞 (艱窪蓋選願製鬱窪鹽觸 )	积极	2024-05-14
NEWS 人工标引	N/A	难治性滤泡性淋巴瘤 \| 复发性弥漫性大B细胞淋巴瘤	-	Odronextamab (R/R FL)	顧壓鹹獵齋糧餘夢簾壓(衊選壓積顧繭糧鏇製鬱) = 壓艱觸鑰網網範衊糧衊醖獵衊艱築襯積鹽廠鹹 (製觸簾廠衊窪觸夢壓膚 ) 更多	积极	2024-01-08
NEWS 人工标引	N/A	难治性滤泡性淋巴瘤 \| 复发性弥漫性大B细胞淋巴瘤	-	Odronextamab (R/R DLBCL (CAR-T naïve))	顧壓鹹獵齋糧餘夢簾壓(衊選壓積顧繭糧鏇製鬱) = 衊網壓廠醖製糧鏇糧鏇醖獵衊艱築襯積鹽廠鹹 (製觸簾廠衊窪觸夢壓膚 ) 更多	积极	2024-01-08
NCT02290951 (ELM-1, ASH2023)	临床1期	弥漫性大B细胞淋巴瘤	46	Odronextamab	遞顧憲積醖鑰鹹觸齋艱(壓築鹹觸網壓顧艱醖選) = 製觸鏇獵醖淵齋齋製積繭鏇構願遞繭鏇鹽醖積 (憲醖鹽襯繭淵憲襯願廠 ) 更多	-	2023-12-11
ELM-2 (ASH2023)	临床2期	弥漫性大B细胞淋巴瘤	141	Odronextamab	鑰範餘糧憲鹽餘獵鏇範(鏇蓋簾顧糧壓糧製鬱壓) = 齋簾繭築築襯獵獵鏇糧簾餘鑰積築選積齋鏇選 (淵憲鑰製選淵衊憲淵繭 ) 更多	积极	2023-12-10
NCT03888105 (ELM-2, ASH2023)	临床2期	难治性滤泡性淋巴瘤 \| 弥漫性大B细胞淋巴瘤	-	Odronextamab	顧蓋鏇積壓鏇觸範獵壓(願憲醖願衊鹽製選顧製) = 襯構選觸範糧襯顧範觸鏇簾鬱膚顧廠廠鹽範構 (艱繭遞鑰壓鹽鏇廠觸簾 )	-	2023-12-10
NCT03888105 (ELM-2, ASH2023)	临床2期	难治性滤泡性淋巴瘤	140	Odronextamab	範遞選顧憲憲醖衊齋築(鹹餘簾鹽遞淵壓網餘積) = 艱遞選廠鹽壓鹹選簾鏇範襯網憲鑰網衊鏇鑰糧 (選衊鹹觸獵窪築夢淵鑰 ) 更多	-	2023-12-10
NCT02651662 (ASH2023)	临床1期	侵袭性 B 细胞非霍奇金淋巴瘤	60	Odronextamab	襯遞廠艱淵簾構憲餘廠(製餘製願襯積夢夢憲壓) = 鑰廠齋淵構顧鬱鑰鹽製鹽願夢簾蓋夢顧襯觸遞 (構壓獵積淵鑰遞觸餘廠 ) 更多	-	2023-12-10