The Antibody Society

the official website of the antibody society

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

FDA approves Solensia (frunevetmab) for osteoarthritis pain in cats

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On January 13, 2022, the U.S. Food and Drug Administration (FDA) approved Solensia (frunevetmab), the first monoclonal antibody (mAb) new animal drug approved by the FDA for use in any animal species. Solensia™ is approved for the control of pain associated with osteoarthritis in cats.

Developed by Zoetis Inc., frunevetmab is a felinized immunoglobulin G mAb that targets nerve growth factor. Similar to humanization, felinization is a process in which all regions of a murine antibody are replaced with feline counterparts except for the complementarity-determining regions. Substantial evidence of effectiveness was demonstrated by the results of two field studies in cats with naturally occurring osteoarthritis. The endpoints used to evaluate the effectiveness of Solensia™ were observer-reported measures conducted by either owners (assessment of the cat’s activities before development of osteoarthritis, as well as before and after treatment) or veterinarians (orthopedic examinations before and after treatment).

Solensia™ is given by subcutaneous injection once a month and is dosed by weight range. Cats are given the full contents of 1 or 2 vials based on body weight to target a minimum dose of 1 mg/kg. Each vial contains 7 mg of frunevetmab.

At least one other mAb, lokivetmab (Cytopoint), is approved for veterinarian use in the US.  Manufactured by Zoetis, the product is used to treat atopic dermatitis in dogs, but it was approved by the US Department of Agriculture, not FDA. More information on FDA’s Center for Veterinary Medicine and the New Animal Drug Application (NADA) process can be found here.

AIRR Community Meeting VI Event Information – May 17-19, 2022

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The AIRR-C Meetings Sub-committee is pleased to share information about the upcoming AIRR-C VI Meeting which will take place in beautiful La Jolla, California, from May 17th to 19th, 2022.

Please save the date (if you haven’t already) and watch for the launch of the registration platform in early March.

This meeting will include many exciting, collaborative and mentoring activities and we are seeking your interest and participation!

We are excited to announce our keynote presenters:

Dennis Burton, Scripps Research
Gunilla Karlsson Hedestam, Karolinska Institutet
Shane Crotty, La Jolla Institute for Immunology
Atul Butte, University of California, San Francisco

Tool/Software Demos and Tutorial Sessions
These sessions will be a great opportunity for you and your team to promote your tools and software. If you are interested in either giving a brief overview demonstration or a longer tutorial, please complete this form by January 30th, 2022.

Student/Post-doc Mentoring Session and Match-ups
Are you willing to be a mentor and share your insights and exciting research with the future generation of AIRR-researchers? Please send an email indicating your interest to meetings@airrc.antibodysociety.org by February 15th, 2022. We will have a dedicated session for this activity during the meeting and are looking for volunteers.

Travel Award Grants for Student/Post-doc/Junior Faculty Members
The AIRR-C VI Meetings Sub-committee obtained an NIH grant to provide travel support for up to 10 early career faculty and student/post-doc trainees who are planning to attend the meeting. If you are interested in learning more about the criteria and applying for this opportunity contact meetings@airrc.antibodysociety.org for access to the secure application form.
Competition closes on March 31st, 2022.

Poster Sessions & Short Talks
Our fun and informative poster sessions are back. Start thinking about your poster now! Sign-up for this session will be through the meeting registration platform. Additionally, if you are interested in being considered for a short talk based on your poster abstract, be sure to indicate your interest when you register.

Industry Networking Reception and Sponsorship Opportunities
We will be hosting an industry networking reception. If you or your company are interested in participating in this event or in sponsorship opportunities please contact us at meetings@airrc.antibodysociety.org for further details.

Volunteer Opportunities
The Meetings Sub-committee is looking for volunteers to help during the Meeting with various in-person tasks. We promise lots of fun! If you are interested in getting involved please contact us at meetings@airrc.antibodysociety.org.

More detailed information on AIRR-C Meeting VI can be found on the meeting website.

If you are new to the AIRR Community (or even if you’re not) and would like to learn more about adaptive immune receptor repertoire research through in depth workshop and webinar recordings check out the AIRR Community YouTube channel. 

Follow us at #airrc6

Thank you to our sponsors!

Learn about Modeling Biologic Molecules on January 27th!

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Registration is open for our next webinar, “Modeling Biologic Molecules“, to be held Thursday January 27, 2022, 11am ET / 5pm CET.

The speakers are Dr. Monica Fernández-Quintero and Prof. Klaus R. Liedl.

Modeling in Chemistry obviously depends on a strong link to reality. Even though the mathematical description of chemistry has been possible for almost 100 years, realistic modelling has only recently become available due to the recent massive increase of computing power following Moore’s law. Still, appropriate statistics, initial conditions and boundaries pose considerable challenges. Nowadays, methodological advances and progress in hardware allows the observation of biological systems for relevant time periods. Hence, dynamic processes like reorientations, folding and binding can be seen in atomistic resolution leading to completely new insights.

Describing an antibody’s binding site using only one single static structure limits the understanding and characterization of the antibody’s function and properties, whereas various biophysical properties are governed by its dynamics, e.g., antibody-antigen binding. This limitation is even more pronounced when no experimentally determined structure is available or the crystal structure is distorted by packing effects, which can result in misleading antibody paratope structures. To improve antibody structure prediction and to take the strongly correlated CDR loop and interface movements into account, antibody paratopes should be described as interconverting states in solution with varying probabilities. These kinetically characterized paratope ensembles with their respective state probabilities allow the identification of the dominant conformation in solution, which frequently has been shown to coincide with the binding competent conformation. Therefore, the definition of kinetically and functionally relevant states, so-called paratope states, can be successfully used to improve the accuracy and enhance the predictivity of antibody-antigen docking.

Register for this webinar here!

FDA approves 10 antibody-based therapeutics in 2021

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The US Food and Drug Administration approved a total of 10 novel antibody-based therapeutics in 2021. Of the newly approved products, 4 are treatments for cancer (endometrial, non-small cell lung, and cervical cancers, as well as B-cell lymphoma) and 6 are treatments for non-cancer indications (hypercholesterolemia, Alzheimer’s disease, systemic lupus erythematousus, asthma, generalized myasthenia gravis, and atopic dermatitis).

The products are:

  • Evkeeza (evinacumab-dgnb) approved 2/11/2021 to treat homozygous familial hypercholesterolemia
  • Jemperli (dostarlimab-gxly) approved 4/22/2021 to treat endometrial cancer
  • Zynlonta (loncastuximab tesirine-lpyl) approved 4/23/2021 to treat certain types of relapsed or refractory large B-cell lymphoma
  • Rybrevant (amivantamab-vmjw) approved 5/21/2021 to treat a subset of non-small cell lung cancer
  • Aduhelm (aducanumab-avwa) approved 6/7/2021 to treat Alzheimer’s disease
  • Saphnelo (anifrolumab-fnia) approved 7/30/2021 to treat moderate-to severe systemic lupus erythematousus along with standard therapy
  • Tivdak (tisotumab vedotin-tftv) approved 9/20/2021 to treat recurrent or metastatic cervical cancer with disease progression on or after chemotherapy
  • Tezspire (tezepelumab-ekko) approved 12/17/2021 to treat severe asthma as an add-on maintenance therapy
  • Vyvgart (efgartigimod alfa-fcab) approved 12/17/2021 to treat generalized myasthenia gravis
  • Adbry (tralokinumab-ldrm), approved 12/27/2021 to treat moderate-to-severe atopic dermatitis

Links to further information for these products, including approval letters and labels, can be found here.

Wondering what might be approved in 2022? The Antibody Society maintains a table of antibody therapeutics in regulatory review in the US or European Union. The table can be found here.

FDA approves Adtralza® (tralokinumab) for atopic dermatitis

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On December 27, 2021, the US Food and Drug Administration approved Adtralza® (tralokinumab) for the treatment of moderate-to-severe atopic dermatitis in adults 18 years or older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Tralokinumab had previously been approved in the European Union, in June 2021, for the treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy.

Tralokinumab is a human IgG4 antibody that interferes with IL-13-mediated signaling by blocking its interactions with both IL-13 receptor α1 and IL-13 receptor α2. The recommended dose is 300 mg administered subcutaneously every 2 weeks, with a loading dose of 600 mg on day 1, and the dose of 300 mg every 4 weeks for patients who achieve clear or almost clear skin after 16 weeks of treatment.

The approvals were supported by data from two Phase 3 monotherapy efficacy and safety studies (ECZTRA 1 (NCT03131648) and ECZTRA 2 (NCT03160885)), as well as a Phase 3 combination therapy efficacy and safety study (ECZTRA 3 (NCT03363854)). These studies included over 1900 patients who received either an initial dose of 600 mg tralokinumab (four 150 mg injections) on day 1, followed by 300 mg every 2 weeks up to Week 16, or they received matching placebo. Patients who responded to tralokinumab were re-randomized at Week 16 and administered tralokinumab maintenance subcutaneous injection regimen every 4 weeks for 36 weeks. In the ECZTRA 3 study, patients received concomitant topical corticosteroids on active lesions as needed. Tralokinumab was administered by subcutaneous injection in the studies. The primary endpoints, the proportion of patients with eczema area and severity index-75 at Week 16 and the proportion of patients with an Investigator’s Global Assessment score of 0 or 1 at Week 16, were met in the three pivotal studies; however, the European Medicines Agency noted that the majority of patients enrolled in the two monotherapy studies did not respond to treatment.

Adtralza is the 13th antibody therapeutic to be first approved for marketing in the EU or US in 2021. Explore our searchable table of antibody therapeutics approved in the EU or US for details.