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You are here: Home / Archives for Janice Reichert

Crizanlizumab-tmca (Adakveo) approved by FDA

November 17, 2019 by Janice Reichert

On November 15, 2019, the U.S. Food and Drug Administration approved crizanlizumab-tmca (Adakveo) as a treatment to reduce the frequency of vaso-occlusive crisis (VOC), which occurs when blood circulation is obstructed by sickled red blood cells, for patients age 16 years and older. Crizanlizumab is a humanized antibody directed against P-selectin, which contributes to the pathogenesis of sickle cell disease, including vaso-occlusive events and hemolytic anemia. Crizanlizumab was granted Orphan Drug designation in the US and European Union for the treatment of VOC in patients with sickle cell disease, as well as FDA’s Breakthrough Therapy designation for prevention of VOCs in patients of all genotypes with sickle cell disease. A marketing application for crizanlizumab is undergoing review by the European Medicines Agency.

FDA’s approval was based on Phase 2 results from the SUSTAIN study (NCT01895361), which demonstrated that crizanlizumab provided significant benefit over placebo, such as:  1) the percentage of crizanlizumab-treated patients (5 mg/kg) who did not experience any vaso-occlusive crisis (VOC) was higher compared to those treated with placebo (36% vs 17%, P=0.010); 2) 45% reduction in the median annual rate of VOCs leading to health care visits in patients with or without hydroxyurea therapy compared to placebo (1.63 vs 2.98, P=0.010); 3) 42% reduction in median annual rate of days hospitalized versus placebo (4.00 vs 6.87 P=0.45), and 4) A three-fold longer median time to first VOC vs placebo (4.07 vs 1.38 months, P< 0.001). [1, 2]

1. Novartis. FDA accepts file and accelerates review of Novartis sickle cell disease medicine crizanlizumab (SEG101). July 16, 2019 press release.

2. Kutlar A, Kanter J, Liles DK, Alvarez OA, Cançado RD, Friedrisch JR, Knight-Madden JM, Bruederle A, Shi M, Zhu Z, et al. Effect of crizanlizumab on pain crises in subgroups of patients with sickle cell disease: A SUSTAIN study analysis. Am J Hematol. Am J Hematol. 2019 Jan;94(1):55-61. doi: 10.1002/ajh.25308.

Interested in more information about US- or EU- approved antibody therapeutics? The Antibody Society maintains a comprehensive table of approved mAb therapeutics and those in regulatory review in the EU or US in the Web Resources section of our website. 

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

Most read from mAbs, Nov/Dec 2019

October 28, 2019 by Janice Reichert

Most read from mAbs, Nov/Dec 2019

The Antibody Society is pleased to be affiliated with mAbs, a multi-disciplinary journal dedicated to advancing the art and science of antibody research and development. We hope you enjoy these summaries based on the abstracts of the most read papers published in a recent issue.

All the articles are open access; PDFs can be freely downloaded by following the links below.

Issue 11.8 (Nov/Dec 2019)

Insights into the IgG heavy chain engineering patent landscape as applied to IgG4 antibody development

In this new Perspective, Dumet et al., present the results from their study of the patent landscape of IgG4 Fc engineering, i.e., patents claiming modifications in the heavy chain. Thirty-seven relevant patent families were identified, comprising hundreds of IgG4 Fc variants focusing on removal of residual effector functions (since IgG4s bind to FcγRI and weakly to other FcγRs), half-life enhancement and IgG4 stability. Given the number of expired or soon to expire major patents in those 3 areas, companies developing blocking antibodies now have, or will in the near future, access to free tools to design silenced, half-life extended and stable IgG4 antibodies.

Antibody discovery and engineering by enhanced CRISPR-Cas9 integration of variable gene cassette libraries in mammalian cells

Parola et al. describe an antibody engineering and screening approach where complete variable light (VL) and heavy (VH) chain cassette libraries are stably integrated into the genome of hybridoma cells by enhanced Cas9-driven homology-directed repair (HDR), resulting in their surface display and secretion. By developing an improved HDR donor format that utilizes in situ linearization, they were able to achieve >15-fold improvement of genomic integration, resulting in a screening workflow that only requires a simple plasmid electroporation. This proved suitable for different applications in antibody discovery and engineering. By integrating and screening an immune library obtained from the variable gene repertoire of an immunized mouse, they isolated a diverse panel of >40 unique antigen-binding variants. They also successfully performed affinity maturation by directed evolution screening of an antibody library based on random mutagenesis, leading to the isolation of several clones with affinities in the picomolar range.

DuoMab: a novel CrossMab-based IgG-derived antibody format for enhanced antibody-dependent cell-mediated cytotoxicity

In this new Report,  Sustmann et al. present a generic approach to generate two novel IgG-derived antibody formats that are based on a modification of the CrossMab technology. MoAbs harbor two heavy chains (HCs) resulting in one binding entity and one Fc, whereas DuoMabs are composed of four HCs harboring two binding entities and two Fc regions linked at a disulfide-bridged hinge. The latter bivalent format is characterized by avidity-enhanced target cell binding while simultaneously increasing the ‘Fc-load’ on the surface. DuoMabs were shown to be producible in high yield and purity and bind to surface cells with affinities comparable to IgGs. The increased Fc load directed at the surface of target cells by DuoMabs modulates their ADCC competency toward target cells, making them attractive for applications that require or are modulated by FcR interactions.

Single-step Protein A and Protein G avidity purification methods to support bispecific antibody discovery and development

Heavy chain (Hc) heterodimers represent a majority of bispecific antibodies (bsAbs) under clinical development. Although recent technologies achieve high levels of Hc heterodimerization (HD), traces of homodimer contaminants are often present, and as a consequence robust purification techniques for generating highly pure heterodimers in a single step are needed. Ollier et al. describe two different purification methods that exploit differences in Protein A (PA) or Protein G (PG) avidity between homo- and heterodimers. Differential elution between species was enabled by removing PA or PG binding in one of the Hcs of the bsAb. The PA method allowed the avidity purification of heterodimers based on the VH3 subclass, which naturally binds PA and interferes with separation, by using a combination of IgG3 Fc and a single amino acid change in VH3, N82aS. The PG method relied on a combination of three mutations that completely disrupts PG binding, M428G/N434A in IgG1 Fc and K213V in IgG1 CH1. Both methods achieved a high level of heterodimer purity as single-step techniques without Hc HD (93–98%). Since PA and PG have overlapping binding sites with the neonatal Fc receptor (FcRn), they investigated the effects of the engineering both in vitro and in vivo. Mild to moderate differences in FcRn binding and Fc thermal stability were observed, but these did not significantly change the serum half-lives of engineered control antibodies and heterodimers. The methods are conceptually compatible with various Hc HD platforms such as BEAT® (Bispecific Engagement by Antibodies based on the T cell receptor), in which the PA method has already been successfully implemented.

Filed Under: Antibody discovery, Antibody therapeutic, Bispecific antibodies, Publication Tagged With: antibody engineering, antibody therapeutics, bispecific

Student/Post-doc Poster Competition Winners Announced!

October 24, 2019 by Janice Reichert

Congratulations to our winners!

To recognize the research activities of promising student and postdoctoral attendees of Antibody Engineering & Therapeutics, The Antibody Society sponsors a competition for our student/postdoc 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 R&D.

This year, our judges selected one student and one postdoc winners who receive: 1) a complimentary registration to attend the conference and pre-conference sessions; 2) an opportunity to give a short oral presentation of their work in one of the conference sessions; and 3) support for travel expenses.

The winners of the contest are:

Timothy Czajka, University of New York at Albany (graduate student winner)
Poster title: RIP-Off: An Intrabody-based Strategy to Neutralize Ricin and other Ribosome-Inactivating Protein (RIP) Toxins

Kamal Joshi, Genentech (Postdoctoral research fellow winner)
Poster title: Toward Deeper Understanding of Bispecific Antibodies

Antibody Engineering & Therapeutics, the annual meeting of The Antibody Society, managed by KNect365, will be held December 10-13, 2019 in San Diego, CA.

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

Like this post but not a member? Please join!

Filed Under: Meetings, The Antibody Society, Travel award, Uncategorized Tagged With: antibody engineering

World ADC Award Winners Announced

October 11, 2019 by Janice Reichert

The Antibody Society congratulates the winners of World ADC Awards!

World ADC Awards showcases the innovation, leadership and devotion shown by the best companies, teams and individuals in the industry. Across 9 categories, the Awards recognized the extraordinary endeavours, teamwork and commercial acumen that has propelled the antibody-drug conjugate field to the forefront of cancer research today. The 6th Annual World ADC Awards Ceremony took place on the evening of Thursday October 10, 2019 at the Manchester Grand Hyatt, San Diego. The finalists and winners were shortlisted from over 1,147 votes cast, and scientific proposals from each submission were evaluated by the Judging panel.

The 2019 winners are:

Best ADC Platform Technology

Zymeworks (ZymeLink) – Winner
LegoChem Bio (Scaffold Based Approach) – Runner Up

Best New Drug Developer

ADC Therapeutics – Winner
Zymeworks – Runner Up

Most Promising Clinical Candidate

Trastuzumab Deruxtecan (DS-8201a) – Winner
Enfortumab Vedotin (Seattle Genetics/Astella) – Runner Up

Best Contract Manufacturing Provider

BSP Pharmaceuticals – Winner
Millipore Sigma – Runner Up

Best Contract Research Provider

PPD – Winner
Abzena – Runner Up

Best Pre-Clinical Publication

Winner: Chemically triggered drug release from an antibody-drug conjugate leads to potent antitumour activity in mice. Rossin R, Versteegen RM, Wu J, Khasanov A, Wessels HJ, Steenbergen EJ, Ten Hoeve W, Janssen HM, van Onzen AHAM, Hudson PJ, Robillard MS. Nat Commun. 2018 May 4;9(1):1484.

Runner Up: Chemically Defined Antibody- and Small Molecule-Drug Conjugates for in Vivo Tumor Targeting Applications: A Comparative Analysis. Cazzamalli S, Dal Corso A, Widmayer F, Neri D. J Am Chem Soc. 2018 Feb 7;140(5):1617-1621.

Best Clinical Publication

Winner: Brentuximab Vedotin with Chemotherapy for Stage III or IV Hodgkin’s Lymphoma. Connors JM, Jurczak W, Straus DJ, Ansell SM, Kim WS, Gallamini A, Younes A, Alekseev S, Illés Á, Picardi M, Lech-Maranda E, Oki Y, Feldman T, Smolewski P, Savage KJ, Bartlett NL, Walewski J, Chen R, Ramchandren R, Zinzani PL, Cunningham D, Rosta A, Josephson NC, Song E, Sachs J, Liu R, Jolin HA, Huebner D, Radford J; ECHELON-1 Study Group. N Engl J Med. 2018 Jan 25;378(4):331-344. doi: 10.1056/NEJMoa1708984.

Individual Input to the Field 2018

Prof. Dario Neri  (ETH Zurich)

Long-Standing Contribution to the Field

Dr. Alain Beck (Pierre Fabre)

For more information about the World ADC Awards, visit http://worldadc-awards.com/

For more information about the World ADC San Diego conference, visit https://worldadc-usa.com/

Filed Under: ADC, Award for Excellence, Meetings Tagged With: ADC, Antibody drug conjugates

FDA approves brolucizumab-dbll (BEOVU®)

October 11, 2019 by Janice Reichert

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.

Like this post but not a member? Please join!

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.

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

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Recent Posts

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  • Crizanlizumab-tmca (Adakveo) approved by FDA November 17, 2019

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