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The Antibody Society

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

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“Antibodies to Watch in 2020” is now online!

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This 2020 installment of the annual ‘Antibodies to Watch’ series documents the antibody therapeutics approved in 2019 and in regulatory review in the United States or European Union, as well as those in late-stage clinical studies, as of November 2019*.  At this time, a total of 5 novel antibody therapeutics (romosozumab, risankizumab, polatuzumab vedotin, brolucizumab, and crizanlizumab) had been granted a first approval in either the US or EU, and marketing applications for 13 novel antibody therapeutics (eptinezumab, teprotumumab, enfortumab vedotin, isatuximab, [fam-]trastuzumab deruxtecan, inebilizumab, leronlimab, sacituzumab govitecan, satralizumab, narsoplimab, tafasitamab, REGNEB3 and naxituximab) were undergoing review in these regions, which represent the major markets for antibody therapeutics. Also as of November 2019, 79 novel antibodies were undergoing evaluation in late-stage clinical studies. Of the 79 antibodies, 39 were undergoing evaluation in late-stage studies for non-cancer indications, with 2 of these (ublituximab, pamrevlumab) also in late-stage studies for cancer indications. Companies developing 7 (tanezumab, aducanumab, evinacumab, etrolizumab, sutimlimab, anifrolumab, and teplizumab) of the 39 drugs have indicated that they may submit a marketing application in either the US or EU in 2020. Of the 79 antibodies in late-stage studies, 40 were undergoing evaluation as treatments for cancer, and potentially 9 of these (belantamab mafodotin, oportuzumab monatox, margetuximab, dostarlimab, spartalizumab, 131I-omburtamab, loncastuximab tesirine, balstilimab, and zalifrelimab) may enter regulatory review in late 2019 or in 2020. Overall, the biopharmaceutical industry’s clinical pipeline of antibody therapeutics is robust, and should provide a continuous supply of innovative products for patients in the future.

*Note on key updates through December 20, 2019: 1) the US Food and Drug Administration granted accelerated approval to [fam-]trastuzumab deruxtecan (Enhertu) on December 20, 2019; 2) the US Food and Drug Administration granted accelerated approval to enfortumab vedotin-ejfv (Padcev) on December 18, 2019, bringing the total number of novel antibody therapeutics granted a first approval in either the US or EU during 2019 to 7; 3) the European Commission approved romosozumab on December 9, 2019; 4) the European Medicines Agency issued a positive opinion for brolucizumab; 5) Sesen Bio initiated a rolling biologics license application (BLA) on December 6, 2019; 6) GlaxoSmithKline submitted a BLA for belantamab mafodotin; 7) Macrogenics submitted a BLA for margetuximab; and 8) the status of the Phase 3 study (NCT04128696) of GSK3359609 in patients with head and neck squamous cell carcinoma was updated to recruiting from not yet recruiting.

“Antibodies to Watch in 2020” at PEGS Europe

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Over the past decade, the ‘Antibodies to Watch’ article series has documented the results of the global biopharmaceutical industry’s efforts to bring innovative antibody therapeutics to patients in need. Dr. Janice Reichert, Executive Director of The Antibody Society, offered a preview of the 2020 version on Wednesday November 20, 2019 during the ‘Developing Successful Antibody Products’ session at PEGS Europe.

‘Antibodies to watch in 2020’ includes updates on recent and anticipated events relevant to antibody therapeutics in clinical development. Data for antibody therapeutics that were first approved in either the US or EU during 2019, as well as several products first approved in Russia or India, were provided. Antibody therapeutics undergoing regulatory review by the Food and Drug Administration or the European Medicines Agency as of November 2019 were also discussed. Brief summaries of antibody therapeutics in late-stage clinical study that may progress to regulatory review in late 2019 or 2020, based on public disclosures by the sponsoring companies, were included. In concluding, Dr. Reichert noted that the late-stage clinical pipeline is robust, and she anticipated that more antibody therapeutics will be in late-stage studies in 2020 than any year previously documented. Remarkably, compared to 2010, the number of antibody therapeutics currently in late-stage studies has nearly tripled (to 75 antibody therapeutics).

The ‘Antibodies to watch in 2020′ presentation can be downloaded here.

The Antibody Society was very pleased to see so many of our corporate sponsors in attendance at PEGS Europe!

FDA approves brolucizumab-dbll (BEOVU®)

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On October 7, 2019, the US Food and Drug Administration (FDA) approved brolucizumab-dbll (BEOVU®) for the treatment of neovascular age-related macular degeneration (nAMD). Brolucizumab is a humanized antibody single-chain variable fragment that binds to the 3 major isoforms of human vascular endothelial growth factor (VEGF), thereby interfering with their interaction with receptors VEGFR-1 and VEGFR-2 and suppressing endothelial cell proliferation, neovascularization and vascular permeability. BEOVU is administered by intravitreal injection, and the recommended dose is 6 mg monthly for the first three doses, followed by one dose of 6 mg every 8-12 weeks. A marketing application for brolucizumab is undergoing review by EMA.

FDA’s approval was based on data from two Phase 3 studies, HAWK (NCT02307682) and HARRIER (NCT02434328), comparing the efficacy and safety of intravitreal injections of brolucizumab versus aflibercept in nAMD. Brolucizumab met the primary efficacy endpoint of non-inferiority to aflibercept (EYLEA®) in mean change in best-corrected visual acuity (BCVA) at week 48 in both trials, with a mean change in BCVA of 6.6 letters for brolucizumab 6 mg versus 6.8 letters for aflibercept in HAWK trial and 6.9 letters versus 7.6 letters, respectively, in the HARRIER study. Additionally, at week 48, brolucizumab was superior to aflibercept in secondary endpoints considered key parameters of the disease, such as central subfield retinal thickness and retinal fluid (intraretinal fluid and/or subretinal fluid). Results at 96 weeks reaffirmed the superiority of brolucizumab 6 mg in reduction of retinal fluid, and patients who received this dose continued to demonstrate reductions in central subfield thickness.

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The Antibody Society maintains a comprehensive table of approved monoclonal antibody therapeutics and those in regulatory review in the EU or US. Located in the ‘Web Resources’ section of our website, the list is updated regularly and can be downloaded in Excel format.

New antibody-drug conjugate approved in the US

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On June 10, 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Polivy (polatuzumab vedotin-piiq), in combination with the chemotherapy bendamustine and a rituximab product (BR), to treat adult patients with diffuse large B-cell lymphoma (DLBCL) that has progressed or returned after at least two prior therapies. Polivy is composed of a humanized anti-CD79b IgG1 antibody conjugated to the antimitotic agent monomethyl auristatin E (MMAE). The antibody’s target is highly expressed on B cells of patients with lymphoma. The biologics license application for Polivy was granted FDA’s Breakthrough Therapy and priority review designations. The drug also has European Medicines Agency (EMA)’s PRIME designation, and US and EU Orphan Drug designations for DLBCL. EMA is reviewing a marketing authorization application for Polivy.

The drug’s efficacy was evaluated in a study of 80 patients with relapsed or refractory DLBCL who were randomized to receive Polivy with BR or BR alone. Efficacy was based on complete response rate and duration of response (DOR), defined as the time the disease stays in remission. At the end of treatment, the complete response rate was 40% with Polivy plus BR compared to 18% with BR alone. Of the 25 patients who achieved a partial or complete response to Polivy plus BR, 16 (64%) had a DOR of at least six months and 12 (48%) had a DOR of at least 12 months.

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The Antibody Society maintains a comprehensive table of approved mAb therapeutics and those in regulatory review in the EU or US. Located in the ‘Web Resources’ section of our website, the list is updated regularly and can be downloaded in Excel format. Information about other antibody therapeutics that may enter regulatory review in 2019 can be found in ‘Antibodies to watch in 2019’.

 

Anti-IL17 netakimab registered in Russia

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On May 7, 2019, BIOCAD announced the registration of netakimab (Efleira®, BCD-085) in Russia for the treatment of moderate to severe plaque psoriasis. Netakimab is a humanized IgG1 monoclonal antibody (mAb) in which the VH domain is replaced by a Lama glama VHH domain possessing a long complementarity-determining region (CDR-H3).  The mAb targets interleukin (IL)-17, a pro-inflammatory cytokine that plays a critical role in the pathogenesis of psoriasis. The registration is the first for an innovative mAb developed in Russia.

The efficacy and safety of Efleira® in psoriasis patients was confirmed in the Phase 3 BCD-085-7/PLANETA study (NCT03390101), which was conducted in 22 certified study sites in Russia and 2 study sites in the Republic of Belarus. After 12 weeks of the treatment, 83.3% of patients who received netakimab once a month after induction for the first 3 weeks achieved a 75% improvement in Psoriasis Area and Severity Index. The total duration of therapy and follow-up in this study is 3 years.

BIOCAD, which is based in Moscow, is planning to start a pivotal clinical trial of netakimab in psoriasis in Europe later in 2019.

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