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RYSTIGGO® (rozanolixizumab-noli) approved by FDA

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On June 27, 2023, the US Food and Drug Administration approved RYSTIGGO® (rozanolixizumab-noli) for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibody positive. Rozanolixizumab-noli is a humanized IgG4 monoclonal antibody that binds to the neonatal Fc receptor, resulting in the reduction of circulating IgG. The drug is administered by subcutaneous infusion. UCB has indicated that rozanolixizumab-noli will be commercially available in the US during the 3rd quarter of 2023.

FDA’s approval is supported by safety and efficacy data from the pivotal Phase 3 MycarinG study (NCT03971422), published in The Lancet Neurology in May 2023. The primary efficacy endpoint was the comparison of the change from baseline between treatment groups in the MG-ADL total score at day 43. MG-ADL is a measurement tool which assesses the impact of gMG on daily functions of 8 signs or symptoms that are typically affected in gMG, such as breathing, talking, swallowing, and being able to rise from a chair. Each item is assessed on a 4-point scale where a score of 0 represents normal function and a score of 3 represents loss of ability to perform that function. A total score ranges from 0 to 24, with the higher scores indicating more impairment. A statistically significant difference favoring rozanolixizumab-noli was observed in the MG-ADL total score change from baseline [-3.4 points in rozanolixizumab-noli-treated group at either dose vs -0.8 points in the placebo-treated group (p<0.001)].

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.

Columvi® (glofitamab-gxbm) approved by FDA

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On June 15, 2023, the U.S. Food and Drug Administration (FDA) approved Columvi® (glofitamab-gxbm) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response in the Phase 1/2 NP30179 study. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Glofitamab (RO7082859, CD20-TCB, RG6026) is a full-length IgG1λ/ҡ bispecific T cell-redirecting antibody targeting CD20 on malignant B cells and CD3 on T cells. This bispecific antibody was developed by Roche using the 2:1 CrossMab technology, characterized by 3 antigen-binding fragment (Fab) arms enabling monovalent binding to CD3ɛ and bivalent binding to CD20, with the second CD20 arm fused to the CD3ɛ-binding arms via a flexible linker. Glofitamab also features a heterodimeric Fc region engineered with PG LALA mutations to abolish binding to FcɣRs and C1q.

The FDA accelerated approval is based on positive results from the Phase 1/2 NP30179 study of Columvi given as a fixed course for 8.5 months in 132 patients with DLBCL who had relapsed or were refractory to prior therapies, including 30% who had received prior CAR T-cell therapy. Additionally, 83% were refractory to their most recent therapy. Results showed patients treated with fixed-duration Columvi achieved durable remission, with 56% of patients achieving an overall response (OR; 74/132 [95% confidence interval (CI): 47-65]) and 43% of patients achieving a complete response (CR; 57/132 [95% CI: 35-52]). Over two-thirds of those who responded continued to respond for at least nine months (68.5% [95% CI: 56.7-80.3]). The median duration of response was 1.5 years (18.4 months [95% CI: 11.4-not estimable]). Data from the NP30179 study were recently published in the New England Journal of Medicine.

Columvi received its first worldwide approval in Canada in March 2023, and the European Medicines Agency’s Committee for Medicinal Products for Human Use recently granted a positive opinion recommending its approval in the European Union.

Glofitamab is under investigation in a randomized, open-label, multicenter Phase 3 study (STARGLO, NCT04408638) where patients with relapsed or refractory DLBCL receive glofitamab or rituximab in combination with gemcitabine + oxaliplatin (GemOx). Patients will receive up to 8 cycles of glofitamab IV or rituximab IV in combination with GemOx IV followed by up to 4 cycles of glofitamab monotherapy. The primary outcome measure is overall survival. The estimated study primary completion date is in April 2025.

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.

Enter soon – the James S. Huston Antibody Science Talent Award Competition deadline is Sep 15th!

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The Huston Award is given 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 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 live webinar on their work, which will also be made available on demand on The Antibody Society’s Learning Center and YouTube channel, and to give a lecture at the Antibody Engineering & Therapeutics conference.

The application submission deadline is September 15, 2023.

The Award includes:

  • International recognition of the scientist’s accomplishments,
  • $1500 USD, and
  • Travel expenses and registration fee to attend the Antibody Engineering & Therapeutics conference, to be held December 14-16, 2023 in San Diego, California.

The award criteria and application details are here. Please note: Applicants must be nominated by a Member of the The Antibody Society.

What is it like to win? Our 2022 Huston Award recipient, Prof. Brandon DeKosky, describes his experience in this 2-min video.

FDA approves bispecific antibody EPKINLY™ (epcoritamab-bysp)

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On May 19, 2023, the US Food and Drug Administration approved EPKINLY™ (epcoritamab-bysp) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B‑cell lymphoma, after two or more lines of systemic therapy. Created using Genmab’s DuoBody® technology, epcoritamab (GEN3013, DuoBody®-CD3xCD20) is a T cell-engaging bispecific IgG1k/l antibody targeting CD20 and CD3 that is jointly owned by Genmab and AbbVie. EPKINLY was approved under FDA’s accelerated approval program based on response rate and durability of response. Continued approval for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial(s).

FDA’s approval was supported by data from the pivotal Phase 1/2 EPCORE NHL-1 trial (NCT03625037) studying epcoritamab in 157 patients with relapsed or refractory large B-cell lymphoma who had received at least two prior systemic therapies, including some who had received prior treatments with CAR-T cell therapy. The dose escalation findings from the Phase 1 part identified a dose of 48 mg as the recommended Phase 2 dose. In the Phase 2 part, patients received 48 mg of epcoritamab as 1 ml subcutaneous injections in 28-day cycles, with weekly dosing in Cycles 1-2, dosing every second week in Cycles 3-6, and dosing every 4 weeks from Cycle 7 onward. An overall response (complete or partial response) was seen in 61% (90/148 [95 percent confidence interval (CI): 52.5-68.7]) of patients and 38% (56/148 [95 percent CI: 30.0-46.2]) achieved complete remission. The median duration of response was 15.6 months (95 percent CI: 9.7-Not reached).

Epcoritamab is being investigated in multiple ongoing clinical studies across different settings and histologies. The most advanced of these is the randomized, open-label Phase 3 EPCORE™DLBCL-1 trial (NCT04628494) of epcoritamab vs investigator’s choice chemotherapy in patients with R/R DLBCL. The study is recruiting an estimated 552 patients and has an estimated primary completion date in June 2024.

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.

Computational Antibody Discovery: State of the Art

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Join us on June 22 for this free virtual Symposium – Registration is open!

Recent advances in computational and machine learning sciences have had a substantial impact on the antibody discovery process. Novel protocols that incorporate computational approaches can now be used to generate functional antibody therapeutics with good developability. In silico methods complement existing experimental strategies, and their use has become more mainstream in the biopharmaceutical industry. However, the application of computational de novo design strategies requires a thorough understanding of their capabilities, limitations, and experimental validation, as well as their place in the overall discovery pipeline and value chain.

In this Symposium, leading experts in computational antibody discovery from academia and industry will discuss their scientific strategies and progress to date. The event aims to provide a platform for better understanding of the breakthroughs and future directions in this multidisciplinary field, through talks, a panel session, and your questions and insights.

The Symposium commences at 8am PT/11am ET/4pm BST/5pm CET with speakers Drs. Pietro Sormanni, Yanay Ofran, Victor Greiff, Sandeep Kumar, and Ben Holland. The panel session, moderated by Konrad Krawczyk and including Jiye Shi, Tom Diethe and several speakers, will start at ~2pm ET. The Symposium concludes at 3pm ET following final remarks by Andrew Buchanan.

The full agenda is available here.

Biographical information for the Symposium speakers, panelists and hosts can be found here.

Register here for this free Symposium.