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You are here: Home / Archives for antibody therapeutics

Emergency Use Authorization requested for leronlimab

August 15, 2020 by Janice Reichert

On August 12, 2020, Cytodyn requested that the Food and Drug Administration grant an Emergency Use Authorization for leronlimab for mild to moderate COVID-19 based on data from the Phase 2 CD10 study (NCT04343651). In this study, patients were randomized to receive weekly doses of 700 mg leronlimab or placebo, both of which were administered via subcutaneous injection. Top-level results of the study showed that, in patients with Total Clinical Symptom Scores of ≥ 4 at baseline (higher scores equate to poorer health state), at Day 3, more subjects treated with leronlimab reported improvement in total clinical symptom score compared to the placebo group (90% on leronlimab arm vs. 71% on placebo). The EUA request was disclosed in an investment community conference call that will be available until September 12, 2020.

  • Leronlimab is a humanized IgG4 antibody targeting C-C chemokine receptor type 5.

Filed Under: COVID-19 Tagged With: antibody therapeutics, clinical, COVID-19, Emergency Use Authorization, Food and Drug Administration, leronlimab

Antibody Engineering & Therapeutics Europe Poster Competition Winners Announced!

August 7, 2020 by Janice Reichert

Congratulations to our winners!

To recognize the research activities of promising student and postdoctoral attendees of Antibody Engineering & Therapeutics Europe, The Antibody Society sponsors a competition for members who submit posters for display at the meeting. Our judges select the best work based on originality, relevance and perceived impact on the field of antibody research and development.

This year, our judges selected one student and one postdoc winners who receive: 1) complimentary registration to all conference sessions; 2) an opportunity to give a short oral presentation of their work in one of the conference sessions; and 3) a lovely crystal award.

The winners of the contest are:

Ms. Monica Fernandez-Quintero (University of Innsbruck)
Poster title: Antibodies exhibit multiple paratope states that can differ in VH-VL domain orientations

Dr. Christian Fercher (University of Queensland)
Poster title: Development of Reagentless Fluorescence Immunosensors for Continuous Analyte Monitoring

Please join us for the virtual Antibody Engineering & Therapeutics Europe conference on August 24-27, 2020.

Society members receive a 15% discount on the registration fee. Contact us at membership@antibodysociety.org for the code.

Filed Under: Antibody discovery, Antibody therapeutic, Award for Excellence Tagged With: antibody therapeutics

FDA grants first approval to tafasitamab-cxix

August 4, 2020 by Janice Reichert

On July 31, 2020, the FDA approved Monjuvi® (tafasitamab-cxix) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant. FDA had granted Monjuvi® an orphan drug designation for this indication, as well as Fast Track and Breakthrough Therapy designations, and the biologics license application was given a Priority Review. Monjuvi® was approved under FDA’s accelerated approval regulations, which require that further adequate and well-controlled studies/clinical trials be done to verify and describe clinical benefit. A marketing application for tafasitamab is undergoing evaluation by the European Medicines Agency.

Tafasitamab-cxix is a humanized cytolytic CD19-targeting monoclonal antibody that contains a IgG1/2 hybrid Fc-domain with 2 amino acid substitutions to modify the Fc-mediated functions of the antibody. Upon binding to CD19, tafasitamab-cxix mediates B-cell lysis through apoptosis and immune effector mechanisms, including antibody-dependent cell-mediated cytotoxicity and antibody-dependent cellular phagocytosis.

FDA’s approval was based on the efficacy of Monjuvi® in combination with lenalidomide followed by Monjuvi® as monotherapy demonstrated in L-MIND (NCT02399085), an open label, multicenter single arm trial. Results from the study showed an overall response rate of 55% (primary endpoint), including a complete response rate of 37% and a partial response rate of 18%. The median duration of response was 21.7 months. The approval was granted to MorphoSys US Inc. MorphoSys and Incyte will co-commercialize the product in the United States. Incyte has exclusive commercialization rights outside the United States.

Antibodies to watch

Tafasitamab-cxix is the 6th antibody therapeutic to be granted a first approval in the US in 2020. Marketing applications for a substantial number of investigational antibody therapeutics are currently undergoing either FDA or EMA review, including:

  • Ansuvimab, a human IgG1 targeting Ebola virus glycoprotein for Ebola virus infection
  • Inolimomab, a mouse IgG1 targeting CD25 for host vs. graft disease
  • Bimekizumab, a humanized IgG1 targeting IL-17A, F for psoriasis
  • Omburtamab, a murine IgG1 targeting B7-H3 for CNS/leptomeningeal metastases from neuroblastoma
  • Tralokinumab, a human IgG4 targeting IL-13 for atopic dermatitis
  • Evinacumab, a human IgG4 targeting angiopoietin-like 3 for homozygous familial hypercholesterolemia
  • Sutimlimab, a humanized IgG4 targeting C1s for cold agglutinin disease
  • Aducanumab, a human IgG1 targeting amyloid beta for Alzheimer’s disease
  • Teplizumab, a humanized IgG1 targeting CD3 for Type 1 diabetes
  • Dostarlimab, a humanized IgG4 targeting PD-1 for endometrial cancer
  • Tanezumab, a humanized IgG2 targeting nerve growth factor for osteoarthritis pain
  • Margetuximab, a chimeric IgG1 targeting HER2 for HER2+ breast cancer
  • Naxitamab, a humanized IgG1 targeting GD2 for high-risk neuroblastoma and refractory osteomedullary disease
  • Belantamab mafodotin, a humanized IgG1 antibody-drug conjugate targeting BCMA for multiple myeloma
  • Oportuzumab monatox, a humanized scFv immunotoxin targeting EpCAM for bladder cancer
  • REGNEB3 (odesivimab, maftivimab, atoltivimab), a mixture of 3 human IgG1 targeting Ebola virus for Ebola virus infection
  • Narsoplimab, a human IgG4 targeting MASP-2 for hematopoietic stem cell transplant-associated thrombotic microangiopathies
  • Satralizumab, a humanized IgG2 targeting IL-6R  for neuromyelitis optica and neuromyelitis optica spectrum disorders

The Antibody Society maintains a comprehensive table of approved monoclonal antibody therapeutics and those in regulatory review in the EU or US. The table, which is located in the Web Resources section of the Society’s website, can be downloaded in Excel format. Information about other antibody therapeutics that may enter regulatory review in 2020 can be found in ‘Antibodies to watch in 2020’.

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Filed Under: Antibody therapeutic, Approvals, Food and Drug Administration Tagged With: antibody therapeutics, approved antibodies, Food and Drug Administration

FDA approves Uplizna (inebilizumab-cdon) for NMOSD

June 12, 2020 by Janice Reichert

On June 11, 2020, the U.S. Food and Drug Administration approved Uplizna (inebilizumab-cdon) for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4)-antibody positive. This rare disease primarily affects the optic nerves and spinal cord. Uplizna is a humanized anti-CD19 monoclonal antibody developed by Viela Bio. By targeting CD19, Uplizna depletes CD19+ B cells and plasmablasts responsible for the production of autoantibodies directed against AQP4, thereby ameliorating symptoms of the disease.

The effectiveness of inebilizumab was demonstrated in the Phase 2/3 N-MOmentum trial (NCT02200770). This study enrolled 230 patients with and without the AQP4-IgG antibody who were randomized 3:1 to receive either 2 doses of 300 mg of inebilizumab as a monotherapy or placebo at Day 1 and Day 15, and then followed for a total of 28 weeks. The primary endpoint (time to first attack) and a majority of the secondary endpoints of the study were met. Of patients in the anti-AQP4 antibody positive group, 89% remained relapse-free during the post-treatment period, compared to 58% of the patients taking placebo. There was no evidence of a benefit in patients who were anti-AQP4 antibody negative. Inebilizumab demonstrated a favorable safety and tolerability profile, with an adverse event rate similar to placebo.

Uplizna is the second antibody therapeutic to be approved in the US for NMOSD. FDA approved Soliris (eculizumab) injection for intravenous use for the treatment of NMOSD in adult patients who are anti-aquaporin-4 (AQP4) antibody positive in June 2019. Soliris, which targets C5 was first approved by FDA in 2007 for paroxysmal nocturnal hemoglobinuria. A biologics license application for anti-IL6R satralizumab as a possible treatment for NMOSD is currently under review at FDA. More information about antibody therapeutics approved in the US and EU, and those in regulatory review, can be found here.

Filed Under: Food and Drug Administration, Immune-medited disorders, Orphan drug Tagged With: antibody therapeutics, Food and Drug Administration, inebilizumab

Anti-SARS-CoV-2 REGN-COV2 enters clinical study

June 11, 2020 by Janice Reichert

On June 11, 2020, Regeneron Pharmaceuticals, Inc. announced the start of the first clinical trial of REGN-COV2 for the prevention and treatment of COVID-19. REGN-COV2 is a cocktail of the human antibodies REGN10933 and REGN10987, which were derived from Regeneron’s parallel efforts using both humanized VelocImmune® mice and blood samples from recovered COVID-19 patients to generate a large and diverse collection of antibodies targeting multiple different regions of the receptor-binding domain of the SARS-CoV-2 spike protein. Two papers describing the creation of REGN-COV2 and its anti-viral activity have been accepted for publication in Science.

The REGN-COV2 clinical program will consist of four separate study populations: hospitalized COVID-19 patients, non-hospitalized symptomatic COVID-19 patients, uninfected people in groups that are at high-risk of exposure and uninfected people with close exposure to a COVID-19 patient. The placebo-controlled trials will be conducted at multiple sites. The first two adaptive Phase 1/2/3 studies are evaluating REGN-COV2 as a treatment for hospitalized and non-hospitalized patients with COVID-19. The Phase 1 portion will focus on virologic and safety endpoints, and the Phase 2 portion will focus on virologic and clinical endpoints. Data from the Phase 1 and Phase 2 studies will be used to refine the endpoints and determine size for the Phase 3 studies.

REGN-COV2 is the 3rd anti-SARS-CoV-2 antibody-based drug to enter clinical study in the past 2 weeks. On June 1, 2020, Eli Lilly and Company announced LY-CoV555 had entered clinical study, and on June 7. 2020, Junshi Biosciences announced JS016 had entered clinical study.

Filed Under: Antibody therapeutic, Coronavirus, COVID-19 Tagged With: antibody therapeutics, COVID-19, SARS-CoV-2

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