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Wondering which Antibodies to Watch in 2023?

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Join us for our next webinar to learn which late-stage antibodies you should watch next year!

Registration is open!

Antibodies to Watch in 2023

 

Thursday January 12, 2023, 11am ET / 4pm CET

Speakers: Drs. Janice Reichert, Silvia Crescioli, Alicia Chenoweth & Jyothsna Visweswaraiah

“Antibodies to Watch in 2023” highlights key events in commercial monoclonal antibody therapeutics development that occurred in 2022 and forecasts events that might occur in 2023. In this presentation, we will discuss the antibody therapeutics granted first approvals in either the United States or European Union in 2022, which include 4 bispecific antibodies ((tebentafusp, faricimab, mosunetuzumab and teclistamab) and 1 ADC (mirvetuximab soravtansine). We will also discuss approvals for antibody therapeutics that were first granted in China or Japan in 2022, which include 2 bispecific antibodies (cadonilimab and ozoralizumab). Globally, at least 24 investigational antibody therapeutics are undergoing review by regulatory agencies. Our data show that, with antibodies for COVID-19 excluded, the late-stage commercial clinical pipeline grew by ~20% in the past year to include nearly 140 investigational antibody therapeutics that were designed using a wide variety of formats and engineering techniques. Of those in late-stage development, marketing application submissions for at least 23 may occur by the end of 2023, of which 5 are bispecific (odronextamab, erfonrilimab, linvoseltamab, zanidatamab, and talquetamab) and 2 are ADCs (datopotamab deruxtecan, and tusamitamab ravtansine).

Everyone who registers will receive 3 reminders before the event, as well as the link to the On Demand version when it is available.

Registration is open!

FDA approves TZIELD™ (teplizumab-mzwv) to delay the onset of Stage 3 type 1 diabetes

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On November 17, 2022, the US Food and Drug Administration (FDA) approved TZIELD™ (teplizumab-mzwv) to delay the onset of Stage 3 type 1 diabetes (T1D) in adult and pediatric patients aged 8 years and older with Stage 2 T1D. The approval was based in part on a clinical trial in Stage 2 T1D patients in which TZIELD delayed the median onset of Stage 3 T1D by 25 months, or approximately 2 years, compared to placebo.

Teplizumab is a humanized, anti-CD3e IgG1k antibody originally developed at Tolerance Therapeutics, Inc. and the University of California. The antibody Fc region was mutated (L234A; L235A) to reduce effector functions. Teplizumab binds CD3 expressed on mature T cells and may induce expansion and/or regulatory function in T cell subsets. In 2005, teplizumab was licensed to MacroGenics. In 2018, Provention Bio acquired all rights to teplizumab and subsequently continued its development for the prevention and treatment on T1D. The FDA granted teplizumab Orphan Drug designation for the treatment of recent-onset T1D. Teplizumab was also granted FDA’s Breakthrough Therapy designation for the prevention or delay of clinical T1D in at-risk individuals and EMA’s PRIority MEdicines (PRIME) designation for the same indication. As of October 2022, Provention Bio and Sanofi had entered into a co-promotion agreement for teplizumab.

Provention Bio is currently evaluating teplizumab in patients with newly diagnosed insulin-dependent T1D in the global PROTECT (PROvention T1D trial Evaluating C-peptide with Teplizumab) Phase 3 study (NCT03875729). This randomized, double-blind, placebo-controlled, multicenter trial will enroll 300 patients with recent onset T1D who will be randomized 2:1 to either two 12-day cycles of teplizumab (IV) or placebo. The primary efficacy endpoint is C-peptide change. Secondary endpoints include insulin use, HbA1c, hypoglycemic episodes, and safety. The company expects top line data from PROTECT Phase 3 study in 2H 2023.

Interested in more information about approved antibody therapeutics? Explore our searchable table of antibody therapeutic products for details.

 

Call for Papers: Collection on Bispecific and Multispecific Antibodies

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Antibodies and antibody-derived bispecifics are one of the most successful therapeutic classes due to their excellent target specificity and tunable drug-like properties. The ability to tailor antibody functions using modern engineering approaches has ushered in a new wave of bi- and multi-specific antibody therapeutics that unlock novel target classes, biology, and mechanisms of action for the treatment of human diseases. In this collection of reviews, we invite The Antibody Society members, mAbs readers, and the broader scientific community to contribute review articles focused on bispecific and multispecific antibody-based molecules. The reviews should narrate the current state of the art in bi- and multi-specific antibody therapeutics, challenges and opportunities, and speculate on new vistas for the field.

mAbs will waive publication charges for up to 8 of the best review articles selected from pre-submission inquiries, which should include the authors, title, abstract, and general outline of the intended review article.

The deadline for pre-submission enquiries is January 31, 2023.

We are particularly interested in reviews in the following topics:

•         Overview of bispecific and multispecific antibody platforms (includes but not limited to Fc engineering, heavy and light chain pairing methodologies, high throughput production methods, geometrical and valency considerations etc.).

•         Reviews on multispecific antibodies (beyond bispecifics i.e., more than two binding epitopes) and their applications.

•         Reviews on bispecifics and multispecific antibodies beyond oncology (i.e., neurology, infectious disease, ophthalmology, rare diseases etc.).

•         Reviews on various cell engagers (T cells, NK cells, macrophages etc.), overview of their design strategies, formats, applications and considerations for safety and tolerability in multiple disease areas.

•         Bispecific/Biparatopic and multispecific/multiparatopic targeting beyond antibodies (Antibody drug conjugates, antibody cytokine fusions, CAR-T/NK/M therapies, ProTACs etc) in various therapeutic areas.

•         Clinical development experience with bispecific and multispecific molecules with a focus on any or all of these areas: safety and tolerability, immunogenicity, biomarkers and/or bioanalytical assay development.

•         Reviews on tissue targeting via bispecific and multispecific antibodies, important considerations for safety, tolerability and preclinical and clinical development.

•         Focused review on developability of bispecific and multispecific molecules, CMC and manufacturing considerations. Bispecifics design and challenges in cell line development, upstream and downstream process development, analytical method development, product quality control strategy, process design and scale up, material demand and commercial manufacturing, regulatory guidance, etc.

Although these topics are especially of interest, we welcome well-written reviews in related areas as well. We intend to waive publication charges for up to 8 of the best review articles selected from pre-submission inquiries, which should consist of the title, abstract and general outline of the intended review article.

The deadline for submission of the completed review articles is August 15, 2023.

Please send pre-submission inquiries to Editor-in-Chief Dr. Janice Reichert (reichert.biotechconsulting@gmail.com), and Assistant Editors Drs. Nimish Gera (ngera@mythictx.com), Li Zhou (li.zhou@abbvie.com) and Jonathan Sockolosky (jonathan@curie.bio). Please feel free to contact us if you have any questions.

For examples of other mAbs Collections, please visit the journal website.

Tremelimumab combination with Imfinzi (durvalumab) approved by FDA for liver cancer

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On October 24, 2022, AstraZeneca announced that Imjudo (tremelimumab) in combination with Imfinzi (durvalumab) has been approved in the US for the treatment of adult patients with unresectable hepatocellular carcinoma (HCC), the most common type of liver cancer. Tremelimumab (CP-675,206), originally developed by Pfizer using Abgenix’s XenoMouseÔ technology, is a human IgG2ҡ antibody targeting CTLA-4. In 2011, MedImmune (now AstraZeneca) gained tremelimumab’s global development rights, while Pfizer retained the rights for use in certain combination therapies. Tremelimumab blocks the activity of the immune checkpoint CTLA-4, contributing to T-cell activation, fostering antitumor immune responses and cancer cell death. Tremelimumab and anti-PD-L1 durvalumab (Imfinzi) were granted Orphan Drug designation in the US for the treatment of hepatocellular carcinoma (HCC), and tremelimumab was also granted Orphan Drug designation for HCC in the EU. On October 24, 2022[JR1] , FDA approved the combination of tremelimumab with Imfinzi for unresectable advanced liver cancer based on the results of the Phase 3 HIMALAYA trial. Marketing applications for this combination for liver cancer is under review by regulatory authorities in other countries and regions. Moreover, based on the results of the POSEIDON trial, marketing applications for the combination of tremelimumab with Imfinzi and chemotherapy for first-line metastatic NSCLC are also under review.

HIMALAYA (NCT03298451) is a randomized, open-label, global Phase 3 trial evaluating the safety and efficacy of durvalumab monotherapy and the combination of durvalumab and tremelimumab versus sorafenib, a standard-of-care multi-kinase inhibitor, as first-line treatment in patients with unresectable HCC who had not received prior systemic therapy and were not eligible for localized treatment. The combination of durvalumab and tremelimumab, called the STRIDE regimen (Single Tremelimumab Regular Interval Durvalumab), comprises a single priming dose of 300 mg of tremelimumab added to 1500 mg of durvalumab followed by durvalumab every four weeks.[1] Patients were randomized to STRIDE (n=393), durvalumab (n=389), or sorafenib (n=389). The primary outcome measure was overall survival. Results of the HIMALAYA trial were presented at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium held January 20-22, 2022 in San Francisco. At data cutoff, the primary objective was met: OS was significantly improved for STRIDE vs sorafenib (hazard ratio [HR], 0.78; 96% confidence interval [CI], 0.65–0.92; p=0.0035. 3). In addition, the ORRs were higher for STRIDE and durvalumab (20.1% and 17.0%, respectively) than for sorafenib (5.1%).

Interested in more information about approved antibody therapeutics? Explore our searchable table of antibody therapeutic products for details.

Vabysmo™ (faricimab) approved in the European Union for ophthalmic disorders

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On September 15, 2022, the European Commission approved Vabysmo ™ (faricimab) for the treatment of wet, or neovascular, age-related macular degeneration (AMD) and visual impairment due to 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 in the European Union was based in part on results from four Phase 3 studies in wet AMD and DME. The 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 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. Results of the TENAYA and LUCERNE and YOSEMITE and RHINE studies were published in The Lancet.

Interested in more information? Explore our searchable table of antibody therapeutics approved in the EU or US for details.