On December 5, 2017 At the American Society of Hematology (ASH) (Free ASH Whitepaper)’s 59th Annual Meeting and Exposition in Atlanta, Georgia, researcher Gustavo Milone, MD, and his team reported that will present a study that investigates the post-marketing trends of Novex, a biosimilar rituximab that has been approved in Argentina for the same indications as the reference product (MabThera, Rituxan) (Press release, mAbxience, DEC 5, 2017, View Source [SID1234594760]).1 Since Novex’s commercial launch, the first national pharmacovigilance plan for a biosimilar monoclonal antibody has been implemented, and data from this post-marketing surveillance show that, in terms of tolerability, this biosimilar has a similar safety profile to that of the reference product.

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In order to determine deviations from expected frequencies of adverse events (AEs), a prospective treatment registry for the biosimilar was implemented from the start of its commercialization on November 26, 2014. Data in the study are reported until June 30, 2017. Physicians, 180 in total, tracked age, gender, indication, dose, dose frequency, and date of treatment initiation and finalization for each patient receiving the biosimilar.

The study comprised the records of 525 patients who had at least 1 follow-up. The majority of patients were female (52%), the mean age was 63.3 years (range, 10-90), and most patients received the biosimilar rituximab for hematological disease (91.2% of cases). The treatment duration ranged from 154 to 309 days, with the number of treatment cycles varying from 1 to 12. Individual Case Safety Reports (ICSRs) were collected from 24 patients with 29 AEs.

The most frequently reported AEs were:

Acute infusion-related reaction (14)
Arrhythmia (3)
Pneumonia (2)
Stroke (2)
The researchers noted that 41 treatments with rituximab were initiated before the launch of the product; assuming treatment began with MabThera, these 41 treatments imply switching to the biosimilar from the reference.

Researchers investigating data from the post-marketing surveillance found a similar incidence of AEs after the use of rituximab biosimilar when compared to the published data of the reference product. Thus, in terms of tolerability, the biosimilar has a similar safety profile compared with its reference.

On December 5, 2017 Delcath Systems, Inc. (OTCQB:DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, announces that results of a multi-center retrospective analysis of Delcath’s PHP Therapy have been accepted for publication in the peer-reviewed Journal of Surgical Oncology (Press release, Delcath Systems, DEC 5, 2017, View Source;p=RssLanding&cat=news&id=2321097 [SID1234522379]). The study, Percutaneous Hepatic Perfusion with Melphalan in Uveal Melanoma: A Safe and Effective Treatment Modality in an Orphan Disease, was conducted by researchers from Moffitt Cancer Center in Tampa, FL and the University Hospital Southampton in the United Kingdom. The publication of the data is expected in an upcoming edition of the Journal. An abstract of this study was presented at the 12th Annual Regional Therapies International Symposium in Snowbird, Utah in February 2017.

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Commenting on the announcement, Jennifer K. Simpson, Ph.D., President and CEO of Delcath Systems, said, "this study represents the largest data set outside of a controlled clinical trial on the use of PHP Therapy in the treatment of uveal melanoma metastatic to the liver. Preliminary results of the study presented at the Regional Therapies conference earlier this year showed data indicating tumor response and overall survival benefit with PHP Therapy beyond the 6-8 months seen with other therapies in this patient population. The most common serious side effects following treatment were anemia, thrombocytopenia and neutropenia; these were expected and the majority managed with supportive care. The preliminary data provide confidence that our Phase 3 clinical trial in ocular melanoma liver metastases can provide the evidence necessary to support an application for a labeled indication in this tumor type, and we look forward to the publication of the full study results."

PHP Therapy with Melphalan/HDS was developed by Delcath Systems as a targeted, whole organ therapy for the liver. It is commercially available as a device in Europe, where it is marketed as CHEMOSAT. The system has not been approved by the U.S. Food and Drug Administration, and is undergoing Phase 3 clinical testing in the U.S. as an investigational product.

On December 4, 2017 Abbott (NYSE: ABT) reported that it will present at the 36th Annual J.P. Morgan Healthcare Conference on Monday, Jan. 8, 2018 (Press release, Abbott, DEC 4, 2017, View Source [SID1234522346]). Brian Yoor, executive vice president of finance and Chief Financial Officer, will present at the conference at 6 p.m. Central time.

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A live audio webcast of the presentation will be accessible through Abbott’s Investor Relations website at www.abbottinvestor.com. An archived edition of the presentation will be available the next day.

On December 4, 2017 Kymab’s reported that data at the British Society for Immunology Congress demonstrates efficient identification and validation of human antibodies (Press release, Kymab, DEC 4, 2017, View Source [SID1234537007])

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Three poster presentations at the 2017 British Society for Immunology Congress describe how Kymab’s efficient human antibody platforms were able to identify an anti-PD-L1 antibody, KY1003, and show it was an effective anti-tumour antibody in in vitro and in vivo models.

In Rachael Kimber’s poster, Cell based screening cascade to select anti-human PD-L1 antibodies, the team describe a cell-based, in vitro screening cascade that enabled functional characterisation of anti-human PD-L 1 antibodies.

They identified a panel of potent fully human, antagonistic antibodies that bind human and cynomolgus PD-L1 and enhance T-cell activity, identifying a lead clone, KY1003, that has the characteristics of a clinically relevant PD-L1 antibody.

Lucy Hepburn presents Development and characterization of a human T cell:tumour cell co-culture assay for assessment of immunomodulatory antibodies, which suggests that prolonged co-culture of human T-cells with the A375 tumour cell line, designed to mimic chronic antigen stimulation, generates T-cells that appear ‘exhausted’.

By using these T-cells, the team confirm that Kymab’s anti-PD-L1 antibody, KY1003, can enhance in vitro T-cell killing of A375 cells and inhibit immunosuppressive PD-1/PD-L1 signalling to increase tumour elimination by T cells in vivo.

Morgane Lecointre’s poster, Development of a "tumour-educated" T cell killing assay for predictive in vitro assessment of anti-PD-L1 antibodies, demonstrates how KY1003 can revert T-cell exhaustion in in vitro models using A375 tumour cells.

Importantly, KY1003 shows a strong anti-tumour efficacy in an in vivo human melanoma xenograft model. The approach is biologically relevant in validation of antibodies that target T-cell immune-modulatory molecules.

Notes to Editors
PDF versions of the posters
Cell based screening cascade to select anti-human PD-L1 antibodies (0.5 MB: Kimber et al., Poster P074)
Development and characterization of a human T cell:tumour cell co-culture assay for assessment of immunomodulatory antibodies (0.7 MB: Hepburn et al., Poster P077)
Development of a "tumour-educated" T cell killing assay for predictive in vitro assessment of anti-PD-L1 antibodies (4.3 MB: Lecointre et al., Poster P075)

On December 4, 2017 NantKwest Inc. (Nasdaq:NK), a pioneering, next generation, clinical-stage immunotherapy company focused on harnessing the unique power of our immune system using natural killer (NK) cells to treat cancer, infectious diseases and inflammatory diseases, reported an oral presentations will be given at the upcoming 59th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in Atlanta, Georgia on Saturday, December 9, 2017 (Press release, NantKwest, DEC 4, 2017, http://ir.nantkwest.com/phoenix.zhtml?c=254059&p=RssLanding&cat=news&id=2320823 [SID1234522350]).

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Presentation Title

CD19-Chimeric Antigen Receptor (CAR) Engineered Natural Killer (NK) Cell Therapy: Novel "Off the Shelf" Immunotherapy in CD20 Resistant B-Cell Non-Hodgkin Lymphoma (NHL) Cell Lines, Primary NHL Cells, and a Human Lymphoma Xenograft Model Target Activated Natural Killer (CD19.taNK) Cellular Therapy: A Novel Immunotherapeutic Approach to the Treatment of Non-Hodgkin Lymphoma (NHL)

Abstract #110: View Source

Presenter: Sneha Purvey, MD, Department of Hematology and Oncology, Tufts Medical Center, Boston, MA

Date: Saturday, December 9, 2017, 9:45AM, Building C, Level 1, C101 Auditorium (Georgia World Congress Center)

Presentation Summary

This oral presentation will present preclinical data on the company’s CD19.taNK program. CD19.taNK cell therapy is based on the use of engineered NK cells expressing a human anti-CD19 CAR that target CD19 expressing cells. The study was designed to more deeply understand the mechanism of action associated with NK-based therapy in B cell NHL and determine the potential for CD19.taNK cells as an "off the shelf" therapy.

The study author’s identified high levels of NK activating ligands indicative of a conserved mechanistic response to CD19-CAR NK cell therapy. In addition, the authors determined that CD19.taNK cell therapy induced significant single-agent cytolytic activity against a wide range NHL cells, including primary DLBCL cells, and cells resistant to standard anti-CD20 antibody.

"CD20 targeted antibody therapy represent one of the most effective and widely used therapeutic interventions in blood cancers. However, resistance is common, occurring in a large percentage of patients," said Patrick Soon-Shiong, MD, Chairman and CEO of NantKwest. "For next generation therapies, such as our CD19.taNK cell therapy, circumventing resistance requires both a deeper understanding of the mechanisms of resistance and the mechanisms of action. We believe these study results provide encouraging data elucidating the significant, single-agent cytolytic activity of CD19.taNK cell therapy and takes us one step closer in our focus to transition this novel NK cell therapy to clinical cancer care."