The Antibody Society

the official website of the antibody society

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

You are here: Home / Archives for Janice Reichert

Anti-SARS-CoV-2 antibody therapeutics Ronapreve and Regkirona approved in the EU

by

On November 11, 2021, the European Medicines Agency’s human medicines committee recommended authorizing anti-SARS-CoV-2 antibody therapeutics Ronapreve (casirivimab/imdevimab) and Regkirona (regdanvimab) for COVID-19.

  • The Committee recommended authorizing Ronapreve for treating COVID-19 in adults and adolescents (from 12 years of age and weighing at least 40 kilograms) who do not require supplemental oxygen and who are at increased risk of their disease becoming severe. Ronapreve can also be used for preventing COVID-19 in people aged 12 years and older weighing at least 40 kilograms. The company that applied for authorization of Ronapreve was Roche Registration GmbH.
  • The Committee recommended authorizing Regkirona for treating adults with COVID-19 who do not require supplemental oxygen and who are also at increased risk of their disease becoming severe. The applicant for Regkirona was Celltrion Healthcare Hungary Kft.

On November 12, 2021, the European Commission approved both products.

Join us for ‘Developing a portfolio of first-in-class immune-oncology antibodies’

by

Tuesday November 23, 2021 at 11am ET

What does it take to develop a portfolio of immune-oncology candidates? In this fireside chat, Dr. Tom Burt, Sofinnova Partners SAS, will discuss the strategies needed and the path to building a world-class immuno-oncology biotech, along with Dr. Martin Welschof and experts Drs. Christine Power and Björn Cochlovius. During the session, Dr. Welschof, CEO of BioInvent, a clinical-stage company based in Sweden that is developing immuno-modulatory antibodies for the treatment of cancer, and the panel will detail their experiences of the many facets that contribute to building an innovative clinical stage antibody enterprise, including antibody discovery, clinical development, partnership, manufacturing and finance.

Registration is open, and free of course!

2021 James S. Huston Antibody Science Talent Award winner is announced!

by

We are delighted to announce that Dr. Laura M. Walker has been selected as the 2021 James S. Huston Antibody Science Talent Award Recipient!

Dr. Walker is the Senior Director of Antibody Sciences at Adimab and the Chief Scientific Officer and a co-founder of Adagio Therapeutics. Her team at Adimab is focused on understanding human B cell responses to viral infection and discovering broadly neutralizing antibodies to a wide variety of emerging viral pathogens, including Ebola, Zika, yellow fever, and SARS-CoV-2. At Adagio, Laura oversees a broad portfolio of research in the area of viral immunology, including the identification of potent and broadly neutralizing antibodies to advance into clinical development. Prior to joining Adimab in 2012, Dr. Walker earned her Ph.D. in Immunology and Microbiology in Prof. Dennis Burton’s laboratory at The Scripps Research Institute and completed a post-doctoral research fellowship in Immunology at The University of California-San Francisco. Dr. Walker has received multiple fellowships and awards, including the Endpoints News “The 20 under 40 in biopharma” award in 2020.

The James S. Huston Antibody Science Talent Award is sponsored by The Antibody Society to recognize and encourage upcoming scientists in the field of Antibody Engineering and Therapeutics. Early career research scientists who have received an advanced degree (Ph.D., M.D., or equivalent) within the past ten (10) years are eligible for the Award. The scientist is recognized for making important contributions to the antibody field and/or the dissemination of antibody knowledge. The recipient will be invited to give a lecture on their work, which will be made available on-line on The Antibody Society’s website, and to give a lecture at the Antibody Engineering & Therapeutics conference in December 2021.

The award includes: international recognition of the scientist’s accomplishments, a $1500 USD prize, and travel costs and registration fees to attend the annual Antibody Engineering & Therapeutics conference in San Diego, California.
 

Tisotumab vedotin approved by FDA for cervical cancer

by

On September 20, 2021, FDA granted accelerated approval to TIVDAK (tisotumab vedotin-tftv) for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. The BLA for TIVDAK for this indication was given a Priority review. TIVDAK’s approval was based on tumor response and the durability of the response; verification and description of clinical benefit in confirmatory trials may be necessary for continued approval for this indication.

TIVDAK is an ADC comprising Genmab’s human tissue factor IgG1k antibody targeting tissue factor conjugated to MMAE via a protease-cleavable linker using Seagen’s ADC technology. The companies are co-developing the product. The recommended dose of TIVDAK is 2 mg/kg (up to a maximum of 200 mg) given as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity.

FDA’s approval was based on results of the pivotal single-arm Phase 2 innovaTV 204 study (NCT03438396), which included 101 patients with recurrent or metastatic cervical cancer who had received no more than two prior systemic regimens in the recurrent or metastatic setting, including at least one prior platinum-based chemotherapy regimen. Patients received tisotumab vedotin 2.0 mg/kg IV every 3 weeks  until progression or toxicity. The major efficacy outcome measures were confirmed objective response rate as assessed by an independent review committee using RECIST v1.1 criteria and duration of response (DOR). The objective response rate was 24% [95% CI: 15.9%-33.3%], including 7 patients (7%) with a complete response and 17 patients (17%) with a partial response, and the median DOR was 8.3 months (95% CI: 4.2, not reached).

TIVDAK is the 9th 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 US or EU for details.

FDA issues Complete Response Letter for oportuzumab monatox BLA

by

Oportuzumab monatox (Vysyneum™, Vicineum®, VB4-845) is a humanized single-chain variable fragment (scFv) targeting epithelial cell adhesion molecule fused to Pseudomonas aeruginosa exotoxin A (ETA(252-608). Sesen Bio is developing the drug, administered intravesically or intratumorally, as a treatment of high-risk non-muscle invasive bladder cancer (NMIBC) that is unresponsive to treatment with bacillus Calmette-Guérin (BCG). Oportuzumab monatox was granted FDA’s Fast Track designation for the treatment of NMIBC.

Sesen Bio’s rolling BLA submission for oportuzumab monatox for the treatment of BCG-unresponsive NMIBC was completed in December 2020, and accepted by FDA and granted Priority Review in February 2021. On August 13, 2021, the company announced that it received a Complete Response letter from the FDA in which the agency provided recommendations specific to additional clinical and statistical data and analyses, as well as Chemistry, Manufacturing and Controls (CMC) issues. Sesen Bio plans to work with FDA to address the concerns expressed in the letter. If another clinical trial is required, the company projects resubmitting the BLA in 2023. [1]

Sesen Bio submitted an MAA to the EMA for oportuzumab monatox for the treatment of high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) in March 2021, but withdrew the application in August 2021. [2]