The Antibody Society

the official website of the antibody society

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

The 2022 Science Writing Competition is open!

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Attention Student & Post-doc members:
The 2022 Science Writing Competition is open!

Clear, concise communication is essential to make your science accessible. The Antibody Society is offering you a chance to grow this skill through a Science Writing Competition. For examples, view winning essays from the 2021 Science Writing Competition.

We invite you to submit an essay of 1200 – 1500 words on a topic related to antibody research. Feel free to use an eye-catching self-generated high-resolution graphic (jpg format) to help make your main point. Relevant topics include, but are not limited to:

Antibody engineering
Antibody therapeutics
Fc effector function and neutralization
Bispecific antibodies
Antibody-drug conjugates
Adaptive immune receptor repertoires

The winning essays are featured on The Antibody Society’s website and winners receive a $400 cash prize.

Two winners (1 student, 1 post-doc) will be selected by our panel of judges based on the originality, creativity, clarity, and structure of their essays.

Send your essay to membership@antibodysociety.org as a Word document. The first 30 submissions will be considered for the competition. Please include your contact details and whether you are a student or post-doc in your email.

Submission deadline: May 1, 2022
Essays should be written for a general reader. Guidance on effective scientific writing can be found here and here.

Entry is limited to The Antibody Society student and post-doc members. Additional information can be found here.

Not a member? Membership is free for students and post-docs – register here!

Rare Disease Day, February 28, 2022

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Rare Disease Day is held to raise awareness of the more than 7,000 diseases that each affect a small number of people. In the US, any disease affecting fewer than 200,000 people (1 per ~1,650 people) is considered rare, while in Europe rare diseases ae defined as those that affect fewer than 1 in 2,000 people.

Regulatory agencies in the US, Europe, Japan, as well as other countries, have ‘orphan drug’ programs, which incentivize the development of drugs to treat rare diseases. Numerous monoclonal antibody (mAb) therapeutics have been granted Orphan Drug designations, as illustrated by the examples below.

Recently approved by FDA

Tebentafusp (KIMMTRAK®) for uveal melanoma

Approved by FDA in January 2022, tebentafusp-tebn is a bispecific fusion protein composed of: 1) a T cell receptor (TCR) recognizing a human leukocyte antigen (HLA)-A*02:01 complexed with a peptide derived from gp100 antigen expressed by melanoma cells, and 2) an antibody single-chain variable fragment that binds CD3 present on T cells. Developed by Immunocore, this molecule creates a bridge between tumor cells and immune cells, and thus facilitates tumor-cell killing by T cells. As the TCR domain recognizes a peptide presented on HLA-A*02:01, tebentafusp can only be used to treated patients expressing this HLA type. Tebentafusp was granted Breakthrough Therapy, Fast Track, and Orphan Drug designations by the FDA. Tebentafusp is marketed by Immunocore Holdings plc.

Sutimlimab (Enjaymo) for cold agglutinin disease

Sutimlimab-jome, a hinge-stabilized, humanized IgG4k antibody that targets and inhibits complement component 1s (C1s), was approved by FDA in February 2022 as a treatment of hemolysis in adult patients with cold agglutinin disease (CAD). A mutation in the Fc region (L235E) reduces the effector functions of the antibody. This rare autoimmune disorder is characterized by hemolysis caused by activation of the classic complement pathway. Sutimlimab received FDA’s Breakthrough Therapy and Orphan Drug designations for CAD, and Orphan Drug designation in the European Union for this indication. Sutimlimab is marketed by Sanofi.

Biological license applications in FDA review

Spesolimab (Boehringer Ingelheim) for generalized pustular psoriasis

Spesolimab is a humanized IgG1k antibody that blocks activation of the IL-36 receptor, which is involved in the pathogeneses of neutrophilic skin diseases such as generalized pustular psoriasis (GPP), palmoplantar pustulosis and hidradenitis suppurativa. FDA granted spesolimab Orphan Drug designation for the treatment of GPP. Marketing applications are undergoing evaluation by the FDA, as well as the European Medicines Agency (EMA).

Teclistamab (Janssen Research & Development, LLC) for multiple myeloma

Teclistamab (JNJ-64007957) is an IgG4l T-cell redirecting antibody derived from Ligand’s transgenic mouse (OmniAb) and Genmab’s DuoBody technology. The antibody selectively targets BCMA and CD3. Teclistamab was granted Breakthrough Therapy designation for the treatment of relapsed or refractory multiple myeloma (MM) by the FDA, and EMA’s PRIME designation for treatment of adult patients with relapsed or refractory MM who previously received ≥3 prior lines of therapy in 2021. Teclistamab had previously been granted Orphan Drug designations for MM in both the US and EU. Marketing applications are undergoing evaluation by the FDA and EMA.

BLA submission anticipated in Q1 2022

Mirvetuximab soravtansine (ImmunoGen, Inc.) for ovarian cancer   

Mirvetuximab soravtansine (IMGN853), comprising a humanized folate receptor alpha (FRα) IgG1k antibody conjugated to the maytansinoid drug DM4 via a cleavable disulfide linker, is being developed by ImmunoGen as a treatment for epithelial malignancies, including ovarian cancer adenocarcinoma. The drug has been granted US and EU Orphan Drug designations for ovarian cancer, as well as FDA’s Fast Track designation for a specific subset of patients with medium to high FRα-positive platinum-resistant ovarian cancer who received at least one, but no more than three prior systemic treatment regimens, and for whom single-agent chemotherapy is appropriate as the next line of therapy. ImmunoGen anticipates submission of a biologics license application in the first quarter of 2022, with potential accelerated approval in 2022.

Keep up to date on the late-stage pipeline and antibody therapeutic approvals all year by visiting our website!

More information about approved antibody therapeutics, including target, format and year of approval, can be found here.

More information about antibody therapeutics in late-stage studies can be found in ‘Antibodies to Watch in 2022‘ and in our searchable online table found here.

FDA issues emergency use authorization for bebtelovimab

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On February 11, 2022, the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for bebtelovimab (LY-CoV1404), an anti-SARS-CoV-2 monoclonal antibody that demonstrates neutralization against the Omicron variant. Bebtelovimab targets the SARS-CoV-2 spike glycoprotein receptor binding domain. The EUA was issued to Eli Lilly and Co.

The EUA for bebtelovimab is supported by clinical and nonclinical data. The clinical data are from a Phase 2, randomized, single-dose clinical trial (NCT04634409) evaluating the efficacy of bebtelovimab alone and bebtelovimab combined with other monoclonal antibodies for treating mild to moderate COVID-19.

Bebtelovimab is authorized for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. The authorized dose of bebtelovimab is 175 mg given as an intravenous injection over at least 30 seconds. A fact sheet for health care providers with additional information about bebtelovimab can be found here.

As previously announced, Lilly signed an agreement with the U.S. government to supply up to 600,000 doses of investigational drug bebtelovimab for at least $720 million.

FDA approves Enjaymo (sutimlimab-jome) for cold agglutinin disease

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On February 4, 2022, the US Food and Drug Administration (FDA) approved Enjaymo (sutimlimab-jome) infusion to decrease the need for red blood cell transfusion due to hemolysis in adults with cold agglutinin disease (CAD). This rare autoimmune disorder is characterized by hemolysis caused by activation of the classic complement pathway. Sponsored by Sanofi, sutimlimab is a hinge-stabilized, humanized IgG4k antibody that targets and inhibits complement component 1s (C1s). A mutation in the Fc region (L235E) reduces the effector functions of the antibody. Sutimlimab received FDA’s Breakthrough Therapy and Orphan Drug designations for CAD, and Orphan Drug designation in the EU for this indication.

The BLA was based on data from the CARDINAL open-label, single-arm study (NCT03347396), which enrolled 24 adult patients with CAD who received a recent blood transfusion. All participants received Enjaymo for up to six months and could choose to continue therapy in a second part of the trial. Based on body weight, participants received either a 6.5 g or 7.5 g infusion of Enjaymo on day 0, day 7, and every 14 days through week 25. In total, 54% of participants responded to Enjaymo. In this study, sutimlimab administration rapidly halted hemolysis, increased hemoglobin levels, and reduced fatigue.

The European Medicines Agency has accepted the submission of a Marketing Authorisation Application for sutimlimab.

Enjaymo is the 3rd antibody-based therapeutic granted a first approval for marketing in the EU or US in 2022. Explore our searchable table of antibody therapeutics approved in the EU or US for details.

FDA approves Vabysmo™ (faricimab-svoa) for ophthalmic disorders

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On January 28, 2022, Genentech announced that the U.S. Food and Drug Administration has approved Vabysmo ™ (faricimab-svoa) for the treatment of wet, or neovascular, age-related macular degeneration (AMD) and diabetic macular edema (DME). Faricimab (RO6867461, RG7716) is an anti-vascular endothelial growth factor-A (VEGF-A) and anti-angiopoietin-2 (Ang-2) bispecific antibody derived from Roche’s CrossMab technology.

The approval was based in part on results from four Phase 3 studies in wet AMD and DME. The randomized, double-masked, and active comparator-controlled TENAYA (NCT03823287) and LUCERNE (NCT03823300) studies evaluated the effects of faricimab (6.0 mg administered at fixed intervals of every two, three, or four months) and aflibercept (Eylea®) (2.0 mg administered at fixed two-month intervals) in wet AMD patients. The primary endpoint of the studies, average change in best-corrected visual acuity (BCVA) from baseline through week 48, was met in both studies. The average vision gains from baseline in the faricimab arms were +5.8 and +6.6 letters, compared to +5.1 and +6.6 letters in the aflibercept arms, in the TENAYA and LUCERNE studies, respectively, demonstrating the non-inferiority of faricimab compared to aflibercept. The study also showed that faricimab’s treatment interval could be longer than that of aflibercept – nearly 80% of patients treated with faricimab were able to go three months or longer between treatments during the first year.

The 3-arm, randomized, double-masked, active comparator-controlled YOSEMITE (NCT03622580) and RHINE studies (NCT03622593) compared the effects of faricimab (6.0 mg administered at personalized treatment intervals (PTI) of up to four months or 6.0 mg administered at fixed two-month intervals) to those of aflibercept (2.0 mg administered at fixed two-month intervals) in DME patients. The primary endpoint, average change in BCVA score from baseline at one year, was met, with faricimab again showing non-inferiority in visual acuity gains compared to aflibercept. In the YOSEMITE study, the average vision gains from baseline were +11.6, +10.7, and +10.9 letters eye chart letters in the faricimab PTI, faricimab two-month, and aflibercept arms, respectively. The average vision gains from baseline were +10.8, +11.8, and +10.3 letters in the faricimab PTI, faricimab two-month, and aflibercept arms, respectively, in the RHINE study.

Further details for the TENAYA and LUCERNE and YOSEMITE and RHINE studies were published in The Lancet.

The European Medicines Agency has accepted the submission of a Marketing Authorisation Application for faricimab.

Vabysmo ™ is the 2nd antibody-based therapeutic granted a first approval for marketing in the EU or US in 2022. Explore our searchable table of antibody therapeutics approved in the EU or US for details.