The Antibody Society

the official website of the antibody society

An international non-profit supporting antibody-related research and development.

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Crovalimab approved in China

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On February 8, 2024, Chugai Pharmaceutical Co., Ltd. announced that crovalimab (Chinese product name : 派圣凯®) was approved in the People’s Republic of China for treatment of adults and adolescents with paroxysmal nocturnal hemoglobinuria (PNH) not been previously treated with complement inhibitors. The regulatory application was filed by a China affiliate of F. Hoffmann-La Roche Ltd. because Roche is responsible for the development of crovalimab outside Japan and Taiwan. China is the first country in the world to approve crovalimab. Marketing applications for crovalimab have been submitted to regulatory agencies in the US, EU, and Japan.

Crovalimab (SKY59, RG6107, RO7112689) is a complement C5 inhibiting, humanized IgG1k antibody without effector functions that was engineered (M428L/N434A) to have enhanced affinity to FcRn at an acidic pH to extend its plasma half-life. Based on Chugai’s Recycling Antibody® technology, crovalimab is engineered to bind its antigen repeatedly, enabling sustained complement inhibition at a low dose administered subcutaneously (SC) every 4 weeks. Moreover, crovalimab binds a different epitope of C5 compared to existing antibody drugs, suggesting that it represents an alternative option for patients with PNH with a specific C5 gene mutation.

Crovalimab was granted Breakthrough Therapy for PNH by NMPA and the marketing application for crovalimab, which included data from the China-specific Phase 3 COMMODORE 3 study (NCT04654468), was accepted by NMPA under Priority Review.

COMMODORE 3 was a multicenter single-arm trial studying crovalimab in C5 inhibitor-naive patients with PNH in China. Patients (n=51) received crovalimab according to a weight-based dosing schedule, including loading (intravenous (IV) dose on Days 1 and 4, weekly SC doses starting from Day 2) and SC maintenance doses (every 4 weeks starting from Week 5); treatment continued after 24 weeks in patients with clinical benefit. The co-primary efficacy endpoints of hemolysis control and transfusion avoidance (TA) were met. The mean proportion of participants with hemolysis control from Week 5 through to Week 25 was 78.7% (95% CI: 67.8%, 86.6%).1 The difference between the proportion of participants with TA within 24 weeks prior to screening (0.0%) and the proportion of participants with TA from baseline through to Week 25 (51.0%) was statistically significant (p<0.0001). [1]

The global Phase 3 COMMODORE 1 (NCT04432584) and 2 (NCT04434092) studies assessed the efficacy and safety of crovalimab versus eculizumab in participants with PNH that are C5 inhibitor-experienced patients or not previously treated with complement inhibitors, respectively. COMMODORE 1 assessed safety, pharmacokinetics, pharmacodynamics, and exploratory efficacy of crovalimab. Data from the study support the favorable benefit–risk profile of crovalimab, including allowing for SC administration with the option to self-administer. [2] Data from the COMMODORE 2 study presented at European Hematology Association meeting in June 2023 in Frankfurt, Germany demonstrated that SC crovalimab Q4W was non-inferior in disease control to IV eculizumab Q2W with comparable safety for patients who have not been treated with C5 inhibitors. [3]

  1. Liu H, Xia L, Weng J, Zhang F, He C, Gao S, Jia J, Chang AC, Lundberg P, Camelia S. Sima CS, et al. Results from the first Phase 3 crovalimab (c5-inhibitor) study (commodore 3): efficacy and safety in complement inhibitor-naive patients with paroxysmal nocturnal hemoglobinuria (PNH). Presentation at: ASH Annual Meeting and Exposition; New Orleans, 2022 Dec 10-13; Abstract #293. doi.org/10.1182/blood-2022-162452.
  2. Scheinberg P, Cle D, Edwards J, Giai V, Hus M, Kim JS, Barrenetxea Lekue C, Nagy Z, Nur E, Panse J, et al. Phase III randomized, multicenter, open-label COMMODORE 1 trial: comparison of crovalimab vs eculizumab in complement inhibitor-experienced patients with paroxysmal nocturnal hemoglobinuria (PNH). Hemasphere. 2023; 7(Suppl ): e45540d8. 2023 Aug 8. doi: 10.1097/01.HS9.0000967644.45540.d8
  3. Röth A, He G, Brodsky A, Chai-Adisaksopha CC, Dumagay T, Demichelis R, Höglund M, Kelly R, Lee J-H, Nishimura J-I, et al. The PHASE III, randomized COMMODORE 2 trial: results from a multicenter study of crovalimab vs eculizumab in paroxysmal nocturnal hemoglobinuria (PNH) patients naive to complement inhibitors. Hemasphere. 2023; 7(Suppl ): e72750f1.

The Antibody Society is hiring!

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Come join The Antibody Society in our mission to help people involved or interested in antibody research and development. We seek a Marketing and Events Manager to provide expertise in promoting our brand by managing all marketing activities, including managing and promoting events and creating marketing campaigns. This is an opportunity to be a leader in an organization that aids researchers in their development of antibody therapeutics, which improve the quality of life for many. As the Marketing and Events Managers you will take charge of:

  • Marketing for 2 major events annually, coordinating exhibit hall booth and in-person networking events
  • TAbS brand management on social media and website
  • Managing virtual events, including Symposia and webinars
  • Creating targeted marketing campaigns to attract new members and sponsors
  • Coordinating promotional activities with our partners

We seek a highly engaged individual! You are an ideal candidate if:

  •  You are passionate about the purpose and mission of The Antibody Society
  •  You are pro-active, propose new ideas, and have fun at work
  • You enjoy learning new tasks, adapting to new situations, and engaging in collaborations
  •  You value the opinions and viewpoints of others and you express your own opinions

This is a full-time, fully remote position with typical working hours 9-5 PM ET zone with the ability to flex as needed to complete required tasks. The salary range for this role is $75,000 – $85,000 annually. We offer 15 days of paid time off, a total of 12 paid holidays, and a flexible and generous health reimbursement plan.

We ask that applicants have a degree in a related field and at least 3 years of related experience, including managing online webinars, virtual symposia, and marketing at in-person trade shows.

Qualified applicants interested in the position may submit a resume with references to info@antibodysociety.org.

The Antibody Society announces the election of new Directors and Officers

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The Antibody Society, Inc., an international non-profit trade association focused on the advancement of antibody research and development, is pleased to announce the election of Drs. Katherine Harris and Eric Smith to the Board of Directors. Dr. Harris was also elected Vice President (VP) of the Society, and Dr. Janine Schuurman, who served as VP during 2022-2023, was elected President. These Directors and Officers bring enormous experience and expertise through their new roles, which they kindly accepted effective January 1, 2024.

Prof. Paul Parren, Chair of the Society’s Board of Directors remarked: “I could not be more excited by such talented and motivated individuals joining our Board. With Janine Schuurman and Katherine Harris taking charge of Society’s Senior Management and Eric Smith further broadening the Board’s expertise, I am convinced the Society can make an even stronger mark in its mission to advance the therapeutic antibody field”.

Katherine Harris, Ph.D., Chief Development Officer, Rondo Therapeutics

Dr. Katherine Harris leads all IND-enabling activities at Rondo Therapeutics and is responsible for the design and execution of preclinical drug development from candidate nomination through IND submission. Previously, she was Vice President of Discovery at Amgen where she was instrumental in providing strategic and scientific direction for antibody therapeutics in Amgen’s Oncology portfolio. While at Amgen, she led integration of the acquired TeneoBio preclinical portfolio and sequence-based antibody discovery platform while serving as site head of the Amgen Newark Research Facility. As Vice President of Discovery at TeneoBio, Katherine built and led a highly successfully Oncology Research team, making key scientific and strategic contributions to clinical candidates that resulted in 4 IND approvals in less than 6 years of company operations. Dr. Harris holds a Ph.D. in Molecular and Cell Biology from the University of California, Berkeley. She has presented in numerous national and international forums and has multiple peer-reviewed publications and issued patents.

Eric Smith, Ph.D., Executive Director of Bispecifics, Regeneron

Dr. Eric Smith is a leading figure in the field of bispecific antibodies with over 20 years of experience in the pharmaceutical industry. He received his Ph.D. in Microbiology and Immunology from Duke University in 1997, and followed that with a postdoctoral fellowship at NYU. He then joined Regeneron in 2002, initially focusing on the development of cytokine traps and related molecules. His expertise in protein engineering and immunology soon drew him towards the field of bispecific antibodies, molecules that can simultaneously bind to two distinct targets and offer unique therapeutic possibilities. Dr. Smith was a founding member of the bispecific antibody group at Regeneron in 2007 and he played a key role in establishing Regeneron’s bispecific platform, which is focused on engineering fully human bispecific antibodies with optimal efficacy and safety profiles. His work has resulted in numerous patents and peer-reviewed publications, as well as the generation of more than 10 therapeutic candidate molecules currently in clinical or late-stage pre-clinical development. Currently Dr. Smith is the Executive Director of Bispecifics at Regeneron with responsibility for the discovery and development of bispecific and other antibody-based therapeutics for a variety of important areas of unmet medical need. He is also active in the protein engineering community, presenting at and helping to organize national and international conferences on antibody engineering and bispecific antibodies.

Janine Schuurman, Ph.D., Independent consultant, Lust for Life Science B.V.

Dr. Janine Schuurman’s career centers around the antibody molecule as a biological source of inspiration and as a therapeutic modality. She holds a PhD in molecular immunology from the University of Amsterdam (1997). After a few post-doctoral positions she joined Genmab in the year 2000 to develop antibody therapeutics, as one of the first ten employees on the R&D team. Throughout her Genmab years, she significantly helped propel the discovery and development of investigational therapies to help people with cancer and other diseases. She is a co-inventor of many therapeutic antibodies, including FDA-approved amivantamab (RYBREVANT® Janssen), epcoritamab (EPKINLY® Genmab/Abbvie), and others in clinical and pre-clinical stages of development. She is also a co-inventor of the successful clinically translated bispecific antibody platform DuoBody® and effector function-enhanced HexaBody® platform and the pre-clinical stage HexElect® technology. In addition, she championed many successful academic and industry partnerships in the field of antibody therapeutics and complementary fields of research. Now an independent biotech consultant (Lust for Life Science B.V.) and thought leader, Dr. Schuurman is as passionate and active as ever, collaborating with many organizations and speaking at scientific conferences around the world. She is increasingly focused on the impact of leadership and organizational culture on innovation, and it is her strong belief that being curious and valuing different expertise and capabilities is key to driving innovative research and new technologies.

About The Antibody Society

The Antibody Society, Inc. is an international non-profit trade association representing individuals and organizations involved in antibody research and development. The Society is an authoritative source of information about antibody therapeutics development, which we disseminate via our website, presentations, and publications. In addition, the Society organizes conferences and webinars on antibody research and development and related topics. The Society also serves as the home for the Adaptive Immune Receptor Repertoire Community, which focuses on developing standards and protocols for curating, analyzing and sharing antibody B and T cell receptors. As a business association, the Society can engage with government and international agencies such as the World Health Organization to discuss topics that are important to the antibody community, such as international naming conventions.

“Antibodies to Watch in 2024” is now online!

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In this 15th installment of the annual ‘Antibodies to Watch’ article series, we review commercially sponsored monoclonal antibody therapeutics currently in late-stage clinical development, regulatory review, and those granted a first approval in any country in 2023. 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.

Download or read the full paper here.

The complete abstract is here: 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.