The Antibody Society

the official website of the antibody society

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

partis is now certified as AIRR-compliant

by

The AIRR Community is excited to announce that partis has been certified as compliant with the AIRR-C v1.0 standard for AIRR-Seq software tools. partis is an HMM-based framework for B- and T-cell receptor sequence annotation, simulation, clonal family and germline inference, and affinity prediction. It is built on top of the ham HMM compiler and ig-sw set of Smith-Waterman annotation tools. partis is free software under the GPL v3.

In an effort to enable rigorous and reproducible immune repertoire research at the largest scale possible, the AIRR-C Software Working Group has established a standard to validate software tools using the AIRR-C Standards and meeting a series of interoperability and quality criteria. Developers interested in certifying their tools should complete the checklist and submit it to the AIRR-C Software Working Group for evaluation and ratification by its members.

More details can be found at the website AIRR Software WG – Guidance for AIRR Software Tools.

All compliant tools will be issued a badge and listed on the website AIRR Software WG – List of Tools Certified as Compliant. The list currently includes CompAIRR, Dandelion, Immcantation, ImmuneDB, ImmuneML, Scirpy, SONAR and TRUST4 in addition to partis.

Computational Antibody Discovery: State of the Art

by

Join us on June 22 for this free virtual Symposium – Registration is open!

Recent advances in computational and machine learning sciences have had a substantial impact on the antibody discovery process. Novel protocols that incorporate computational approaches can now be used to generate functional antibody therapeutics with good developability. In silico methods complement existing experimental strategies, and their use has become more mainstream in the biopharmaceutical industry. However, the application of computational de novo design strategies requires a thorough understanding of their capabilities, limitations, and experimental validation, as well as their place in the overall discovery pipeline and value chain.

In this Symposium, leading experts in computational antibody discovery from academia and industry will discuss their scientific strategies and progress to date. The event aims to provide a platform for better understanding of the breakthroughs and future directions in this multidisciplinary field, through talks, a panel session, and your questions and insights.

The Symposium commences at 8am PT/11am ET/4pm BST/5pm CET with speakers Drs. Pietro Sormanni, Yanay Ofran, Victor Greiff, Sandeep Kumar, and Ben Holland. The panel session, moderated by Konrad Krawczyk and including Jiye Shi, Tom Diethe and several speakers, will start at ~2pm ET. The Symposium concludes at 3pm ET following final remarks by Andrew Buchanan.

The full agenda is available here.

Biographical information for the Symposium speakers, panelists and hosts can be found here.

Register here for this free Symposium.

Announcing the AIRR Community Seminar Series!

by

Join the AIRR Community for a 90 minute “lab-style” virtual seminar.  Each month an established and an early career scientist will discuss their AIRR-seq related research. Seminar time will be 16:00 – 17:30 Central European Time (CET), typically on the 4th Thursday of the month.  Most talks will be recorded and posted on the AIRR Community YouTube channel.  In the spirit of open science collaboration we want to give credit where credit is due – this seminar series is modelled after and a follow-up to the highly successful iReceptor Plus Seminar Series: Theories and Applications of Immune Repertoires which ran from 2020-2022. Check out their website for many scientifically related talks!

Register today for the April 27th talks presented by Hashem Koohy from Oxford University and Marcos Vieria from University of Chicago.

Check out the seminar series web page for upcoming seminars and registration links.

 

First global approval for glofitamab (COLUMVI®)

by

Hoffmann-La Roche Limited (Roche Canada) announced that on March 24, 2023 Health Canada authorized COLUMVI® (glofitamab for injection) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from follicular lymphoma (trFL), or primary mediastinal B-cell lymphoma (PMBCL), who have received two or more lines of systemic therapy and are ineligible to receive or cannot receive CAR-T cell therapy or have previously received CAR-T cell therapy. COLUMVI has been issued marketing authorization with conditions, pending the results of trials to verify its clinical benefit. The authorization of COLUMVI® is the first in Canada and globally.

Glofitamab (RO7082859) is a full-length IgG1λ/ҡ bispecific T cell redirecting antibody targeting CD20 on malignant B cells and CD3 on T cells. This bispecific antibody was developed by Roche using the 2:1 CrossMab technology, characterized by 3 antigen-binding fragment (Fab) arms enabling monovalent binding to CD3ɛ and bivalent binding to CD20, with the second CD20 arm fused to the CD3ɛ-binding arms via a flexible linker. Glofitamab also features a heterodimeric Fc region engineered with PG LALA mutations to abolish binding to FcɣRs and C1q.

The Health Canada authorization is based on data from the open-label, phase I/II, multicenter, multi-cohort trial (NP30179) conducted to evaluate COLUMVI as monotherapy in patients with relapsed or refractory B-cell lymphoma. In the single-arm DLBCL cohort (n=108), 84.3% of patients were refractory to their most recent therapy and about one-third (34.3%) had received prior CAR T-cell therapy. The primary efficacy outcome measure was complete response (CR) rate as assessed by the IRC using 2014 Lugano response criteria. Results showed that 35.2% of patients (n=38/108) achieved a complete response (CR; a disappearance of all signs of cancer), and 50.0% (n=54/108) achieved an objective response (OR; the combination of CR or partial response, a decrease in the amount of cancer in their body).

An marketing authorization application containing data from the Phase 1/2 NP30179 study (NCT03075696) evaluating glofitamab for NHL was submitted to the European Medicines Agency. A biologics license application for glofitamab undergoing review by the Food and Drug Administration has a first action date of July 1, 2023.

Need data for other antibody therapeutics that have received marketing authorizations? Go to our searchable table of approved antibody therapeutics and those in regulatory review for more information.

FDA approves Zynyz™ (retifanlimab-dlwr) for Merkel cell carcinoma

by

On March 22, 2023, the US Food and Drug Administration approved Zynyz™ (retifanlimab-dlwr) for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). Retifanlimab (INCMGA00012, MGA012) is a humanized, hinge-stabilized IgG4k antibody targeting PD-1. The biologics license application for Zynyz for MCC was approved under accelerated approval based on tumor response rate and duration of response.

FDA’s approval was based on data from the Phase 2 POD1UM-201 trial (NCT03599713), an open-label, multiregional, single-arm study that evaluated Zynyz in adults with metastatic or recurrent locally advanced MCC who had not received prior systemic therapy for their advanced disease. In this study, patients received Zynyz 500 mg intravenously every four weeks until disease progression, unacceptable toxicity, for up to 24 months. The primary endpoint was objective response rate (ORR) as determined by independent central radiographic review using RECIST v1.1. Secondary endpoints included duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS). Among chemotherapy-naïve patients (n=65), Zynyz monotherapy resulted in an ORR of 52% (95% confidence interval [CI]: 40-65). Complete response was seen in 12 patients (18%), and 22 patients (34%) showed partial response. Among the responding patients, the DOR ranged from 1.1 to 24.9+ months; 76% (26/34) experienced a DOR of six months or longer and 62% (21/34) experienced a DOR of 12 months or longer by landmark analysis.

Incyte Corporation, which licensed retifanlimab from MacroGenics in 2017, is sponsoring clinical studies evaluating retifanlimab monotherapy as a treatment for other cancers, including endometrial cancer, non-small cell lung cancer, and squamous cell carcinoma of the anal canal.