The Antibody Society

the official website of the antibody society

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

FDA approves HYMPAVZI™ (marstacimab-hncq)

by

On October 11, 2024, Pfizer Inc. announced that the U.S. Food and Drug Administration approved HYMPAVZI™ (marstacimab-hncq) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients 12 years of age and older with hemophilia A (congenital factor VIII deficiency) without factor VIII (FVIII) inhibitors, or hemophilia B (congenital factor IX deficiency) without factor IX (FIX) inhibitors. Marstacimab is an IgG1l monoclonal antibody targeting tissue factor pathway inhibitor, a single-chain polypeptide that can reversibly inhibit Factor Xa. The antibody’s Fc mutations (L234A, L235A, G237A) impair Fc effector functions.

HYMPAVZI  is the first hemophilia medicine approved in the U.S. to be administered via a pre-filled, auto-injector pen. The approval was based on results of the Phase 3 BASIS study (NCT03938792), which evaluated the efficacy and safety marstacimab in adult and teenage participants with severe hemophilia A or moderately severe to severe hemophilia B.  In the study, HYMPAVZI reduced the annualized bleeding rate (ABR) for treated bleeds by 35% and 92% after a 12-month active treatment period compared to routine prophylaxis and on-demand treatment, respectively, in patients with hemophilia A or B without inhibitors. The safety profile for HYMPAVZI was consistent with Phase 1/2 results.

In September 2024, the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion for marstacimab for the routine prophylaxis of bleeding episodes in adults and adolescents 12 years and older with severe hemophilia A without FVIII inhibitors, or severe hemophilia B without FIX inhibitors. A decision by the European Commission is expected by the end of 2024.

Curious about what other antibody therapeutics are approved or in regulatory review? Our online table contains details for over 200 such antibodies! 

 

New episode of our Antibody News podcast is now available!

by

Antibody News is the 10-minute news podcast of The Antibody Society.

In this episode, we cover new business news, advancements in the clinical pipeline, and important regulatory updates, including new marketing applications and marketing approvals from September 15 – October 1, 2024.

Listen for FREE on:

PodBean –> https://lnkd.in/eqchSdT7
Spotify –> https://lnkd.in/e_5BeucT
Apple Podcasts –> https://lnkd.in/ec9S6HJp
Amazon Music –> https://lnkd.in/es5Dz3hW
Audible –> https://lnkd.in/einBGchf

Register now for the Sept 26th AIRR Community Seminar

by

Registration for the September 26th (4:00 PM – 5:30 PM CET) AIRR-C Seminar Series session is open. Following the usual format of the series, an established and an early career scientist will discuss their AIRR-seq related research. Sol Efroni, of Bar Ilan University, Israel, will present “The T cell receptor core qualities, as seen by a language model.” Next, Giulio Isacchini, of Imprint, USA, will present “Generative Modeling of AIRRs with SoNNia.”

Register now!

Visit the AIRR Community Seminar Series website to learn more about this monthly series and access the recordings of past sessions.

Results of the Imaging Calendar Competition announced!

by

The Society’s Communication and Membership Committee is glad to announce that:
Eva Smorodina (University of Oslo and Oslo University Hospital, Norway) is the winner of our Imaging Calendar Competition! 
Congratulations!

The Imaging Calendar Competition ran from April 1st to July 15th 2024 and was open to all members. Participants submitted a high-resolution image with a brief explanation of the research behind it and the scientific method. This year we accepted both wet-lab and in-silico originated images.

Based on the results of our online poll, the winning image is “Getting closer to binding with every step” by Eva Smorodina (University of Oslo and Oslo University Hospital, Norway)

Image description: The image represents different levels of complexity surrounding antibody-antigen binding. We start from a more general understanding of the interaction kinetics with SPR, then identify the global binding site with cryo-EM, refine the region with HDX-MS to achieve peptide-level resolution, and move forward towards residue- and atom-wise resolution with computational techniques like docking and molecular dynamics. All these steps give us a better understanding of the structural rules behind antibody-antigen binding.

Antibodies used: Trastuzumab in complex with HER2

Instrument used: PyMOL, FoldX, IgFold

The winner will receive:

The winning image will be featured as the cover image for the 2025 volume of mAbs, and also as the cover image of the calendar. The calendar will be distributed at the 2024 Antibody Engineering & Therapeutics, in San Diego, in December.

 

We are also glad to reveal the scientists behind the other short-listed images. These images will be included as well in The Antibody Society 2025 calendar, one every month.

Stefania Vilbois (University of Lausanne, Switzerland): Intravital mouse melanoma.

Jessica Anania (University of Southampton, UK): Follicular Dendritic Cell Organization in Germinal Centers for Immune Memory.

Andrew O’Connor (University of Southampton, UK): Inflammation in the mouse cochlea.

Rodrigo García Valiente (Amsterdam UMC, The Netherlands): Clonal fireworks.

Danielle Fails (Fortis Life Sciences, USA): Cells in Focus.

Shaoli Lin (National Cancer Institute, NIH, USA): Therapeutic antibody targeting GPC3 in liver cancer.

Suzanne Buss (University of Southampton, UK): Astrocytes – helping protect our brain.

Anthony Cheung (King’s College London, UK): Antibody-drug conjugates trigger microvesicle release ahead of endosomal internalization.

Alicia Chenoweth (King’s College London, UK): Heterogeneity of melanoma.

Ordspono™ (odronextamab) approved in the European Union

by

On August 26, 2024, Regeneron announced that the European Commission approved Ordspono™ (odronextamab) to treat adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy. This marks the first regulatory approval of Ordspono in the world for these patients.

Odronextamab (REGN1979) is a hinge-stabilized, bispecific human IgG4k antibody targeting CD20 and CD3 with an Fc that was modified to reduce Fc receptor binding. The antibody was derived from Regeneron’s VelocImmune® technology and Veloci-Bi® platform and is being developed for the treatment of RR B-cell NHL. In 2020, Regeneron granted Zai Lab rights to develop and exclusively commercialize odronextamab in oncology in mainland China, Hong Kong, Taiwan, and Macau. Odronextamab received Fast Track designation from FDA and Orphan Drug designations by the FDA and EMA for the treatment of patients with FL and DLBCL, which are subtypes of NHL.

The approval in the European Union is based on results from the Phase 1 ELM-1 (NCT02290951)  and pivotal Phase 2 ELM-2 (NCT03888105) trials, which demonstrated robust, durable response rates in adults with R/R FL or R/R DLBCL

  • Results from ELM-1 (N=60) in R/R DLBCL patients who had progressed after CAR-T therapy, as assessed by an independent review committee (IRC) showed 48% objective response rate (ORR), with 32% achieving a complete response (CR). Among responders (n=29), the median duration of response (DoR) was 15 months (95% CI: 3 months to not estimable (NE)).
  • Results from ELM-2 (N=127) in R/R DLBCL patients who were CAR-T therapy naive, as assessed by an IRC showed 52% ORR, with 31% achieving a CR. Among complete responders the median DoR was 18 months (95% CI: 10 months to NE).
  • In R/R FL, results from ELM-2 (N=128) as assessed by an IRC showed an objective response rate (ORR) of 80%, with 73% achieving a CR. Among complete responders, the median DoR was 25 months (95% confidence interval [CI]: 20 months to NE).

Regeneron submitted biologics license applications (BLAs) for odronextamab for RR FL and DLBCL to FDA. In March 2024, Regeneron announced that the FDA issued complete response letters for the Biologics License Applications for odronextamab. The company noted that FDA’s only approvability issue is related to the enrollment status of the confirmatory trials.