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FDA approves Omvoh™ (mirikizumab-mrkz)

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On October 26, 2023, Eli Lilly and Company announced that the U.S. Food and Drug Administration approved Omvoh™ (mirikizumab-mrkz) infusion (300 mg/15 mL)/injection (100 mg/mL) for the treatment of moderately to severely active ulcerative colitis (UC) in adults. The approval was based on results from the LUCENT program, which included two randomized, double-blind, placebo-controlled Phase 3 clinical trials consisting of one 12-week induction study (UC-1) and one 40-week maintenance study (UC-2) for 52 weeks of continuous treatment.

Mirikizumab (LY3074828) is a humanized IgG4ҡ monoclonal antibody that blocks the activity of interleukin 23 by targeting the p19 subunit the cytokine. The antibody is engineered with the following mutations: S228P for hinge stabilization, F234A and L235A to abrogate effector function, and K447> del to reduce IgG4 C-terminal heterogeneity.

The recommended induction dosage is 300 mg administered by intravenous infusion over at least 30 minutes at Weeks 0, 4, and 8. The recommended maintenance dosage is 200 mg administered by subcutaneous injection (given as two consecutive injections of 100 mg each) at Week 12, and every 4 weeks thereafter. Lilly received approval for Omvoh in Japan and the European Union earlier in 2023.

FDA approves LOQTORZI™ (toripalimab-tpzi)

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On October 27, 2023, Coherus BioSciences, Inc. and Shanghai Junshi Biosciences Co., Ltd. announced that the U.S. Food and Drug Administration approved LOQTORZI™ (toripalimab-tpzi) in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC), and as monotherapy for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy.

Toripalimab (marketed as Tuoyi® in China) is an IgG4k anti-PD-1 monoclonal antibody developed by Shanghai Junshi Bioscience Co., Ltd. Coherus partnered with the company to co-develop toripalimab, with Coherus responsible for the development and commercialization of toripalimab in the US and Canada. In 2018, toripalimab became the first anti-PD1 approved in China, and the product is now approved there for multiple types of cancer.

Toripalimab was granted Orphan Drug designations by the FDA for the treatment of NPC, mucosal melanoma, soft tissue sarcoma, esophageal cancer, and SCLC. FDA also granted Breakthrough Therapy designation to toripalimab for the treatment of recurrent or metastatic NPC with disease progression on or after platinum-containing chemotherapy and in combination with gemcitabine and cisplatin as a first-line treatment for patients with recurrent or metastatic NPC.

FDA’s approval was based on results of the JUPITER-02 Phase 3 study and the POLARIS-02 Phase 2 study and is irrespective of a patient’s PD-L1 status. The recommended LOQTORZI dose with cisplatin and gemcitabine is 240 mg every three weeks until disease progression, unacceptable toxicity, or up to 24 months. The recommended LOQTORZI dose as a single agent for previously treated NPC is 3 mg/kg every two weeks until disease progression or unacceptable toxicity.

The Phase 3 JUPITER-02 (NCT03581786) study included patients with recurrent or metastatic NPC and no previous chemotherapy for recurrent or metastatic disease. Patients (n=289)  were randomized (1:1) to receive either toripalimab (240 mg) or placebo in combination with gemcitabine-cisplatin therapy every 3 weeks for up to six cycles, followed by monotherapy with toripalimab or placebo. The primary endpoint was PFS as assessed by a blinded independent review committee according to RECIST v.1.1. The combination of toripalimab and gemcitabine-cisplatin improved the median progression-free survival compared to the chemotherapy arm (11.7 vs 8 months, respectively), the overall response rate (77.4% vs. 66.4% (P = 0.033), respectively) and the median duration of response (10.0 vs. 5.7 months, respectively).

In the POLARIS-02 clinical study, LOQTORZI demonstrated durable antitumor activity in patients with recurrent or metastatic NPC who failed previous chemotherapy, with an objective response rate (ORR) of 20.5%, a disease control rate (DCR) of 40.0%, and a median OS of 17.4 months with an acceptable safety profile.

FDA approves Bimzelx (bimekizumab-bkzx)

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On October 18, 2023, the US Food and Drug Administration approved Bimzelx (bimekizumab-bkzx) for the treatment of moderate to severe plaque psoriasis  in adults who are candidates for systemic therapy or phototherapy. [1] Bimekizumab is a humanized IgG1 kappa antibody that selectively inhibits IL-17A and IL-17F by binding regions that are common to these pro-inflammatory cytokines, which share ~50% sequence identity and are expressed as homodimers and IL-17A/F heterodimers. Bimekizumab is approved at a recommended dose of 320 mg, administered by two subcutaneous injections of 160 mg each every four weeks to week 16 and every eight weeks thereafter.

The approval of bimekizumab is supported by data from two Phase 3 studies that compared the effects of bimekizumab to those of either ustekinumab (Stellara®; BE VIVID study; NCT03370133) or adalimumab (Humira®; BE SURE study; NCT03412747) in adults with moderate to severe plaque psoriasis. These pivotal studies met their co-primary endpoints at Week 16, demonstrating superiority of bimekizumab over the active comparator in certain defined measures (e.g., Psoriasis Area and Severity Index). Clinical responses achieved with bimekizumab at Week 16 were maintained up to one year. [2-3] Coprimary endpoints were also met in the Phase 3 BE READY study (NCT03410992), which investigated the efficacy and safety of bimekizumab in patients with moderate to severe plaque psoriasis compared to placebo. [4]

  1. UCB. BIMZELX[®] Approved by the U.S. FDA for the Treatment of Adults with Moderate to Severe Plaque Psoriasis.
  2. Reich K, Papp KA, Blauvelt A, et al. Bimekizumab versus ustekinumab for the treatment of moderate to severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo-controlled phase 3 trial. Lancet. 2021;397(10273):487-498.
  3. Warren RB, Blauvelt A, Bagel J, et al. Bimekizumab versus Adalimumab in Plaque Psoriasis. N Engl J Med. 2021;385(2):130-141.
  4. Gordon KB, Foley P, Krueger JG, et al. Bimekizumab efficacy and safety in moderate to severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal phase 3 trial. Lancet. 2021;397(10273):475-486.

2023 James S. Huston Antibody Science Talent Award recipient is announced!

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We are delighted to announce that Dr. Heather J. Bax has been selected as the 2023 James S. Huston Antibody Science Talent Award Recipient!

Dr. Heather J. Bax is a Postdoctoral Research Fellow at St John’s Institute of Dermatology, King’s College London. She trained at GlaxoSmithKline as an industrial placement and undergraduate project student supporting drug discovery for asthma and allergic inflammation. She completed her PhD in Professor Hannah Gould’s laboratory, King’s College London, focusing on the interaction between IgE antibodies and mast cells in the context of allergic diseases.

As a Postdoctoral Research Associate in Professor Sophia Karagiannis’ laboratory, King’s College London, Dr. Bax undertook multidisciplinary research on the ground-breaking preclinical development of the first-in-class IgE antibody, MOv18 IgE, for the treatment of folate receptor alpha (FRα)-expressing ovarian cancers. In this role, she established and implemented several clinical trial assays to support the now successfully completed first-in-man, Phase 1 clinical trial of MOv18 IgE (ClinicalTrials.gov Identifier: NCT02546921). She also led the preclinical studies of CSPG4 IgE, another IgE therapeutic candidate targeting melanoma.

Dr. Bax currently supports a translational research program funded by the King’s College London spinout Epsilogen Ltd (formerly IGEM Therapeutics Ltd.), the first immuno-oncology company focusing on IgE immunotherapies for cancer. Leading a team of two postdoctoral researchers and working closely with colleagues at Epsilogen Ltd., she oversees several research studies focusing on the next generation of IgE-based antibodies for the treatment of solid tumors.

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 2023.

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.

FDA approves Veopoz (pozelimab-bbfg) for CHAPLE disease

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On August 18, 2023, the US Food and Drug Administration (FDA) approved Veopoz (pozelimab-bbfg) injection for the treatment of adult and pediatric patients 1 year of age and older with CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE disease. Pozelimab (REGN3918) is a human IgG4k antibody targeting complement component 5 (C5) developed by Regeneron. Veopoz received fast track, orphan drug, and rare pediatric disease designations.

Veopoz is the first FDA-approved treatment for CHAPLE disease. An initial dose of 30 m/kg Veopoz is administered intravenously (IV), followed by weekly injections of 10 m/kg given subcutaneously by a health care provider. See the prescribing information for details

The efficacy and safety study of pozelimab in patients with CHAPLE were evaluated in an open-label, single arm Phase 2/3 study (NCT04209634). The study included 10 patients from 3 to 19 years of age with a clinical diagnosis of CD55-deficient PLE disease who received a single loading IV dose on Day 1, then fixed SC doses based on body weight every week over the treatment period. The primary outcome measure of the study was the proportion of patients with active disease at baseline achieving both normalization of serum albumin and clinical outcome improvement. All 10 patients achieved a serum albumin concentration of at least 3.5 g/dL by week 12, which was maintained through at least 72 weeks. All 10 patients also demonstrated a reduction in the number of hospitalizations and number of albumin transfusions over the first 48 weeks of treatment as compared to the 48 weeks prior to treatment.

Interested in data for other antibody therapeutics that have received marketing authorizations? Go to our searchable table of approved antibody therapeutics and those in regulatory review for more information.