La Merie
Ulrich Martin

Ulrich Martin

The next two years will give definitive clues about the prospects of this promising treatment modality for solid tumors

STUTTGART, Germany I May 23, 2018 I T-Cell Receptors (TCR) and Chimeric Antigen Receptors (CAR) are the cuttingedge of adoptive T-cell therapy. Both receptors deploy T-cells to target the tumor, but CAR T-cells (CAR-T) are limited to binding to cell surface antigens, while TCR T-cells (TCR-T) recognize peptides (derived from intracellular proteins) presented on the cell surface by the major histocompatibility complex (MHC) class I.

STUTTGART, Germany I March 12, 2017 I Global sales of branded recombinant therapeutic antibodies and proteins in the calendar year 2017 reached an all time high of more than US$ 188 bln, as reported by La Merie Publishing. The increase by 11.9% compared with the previous year was driven by the double-digit growth of cancer antibodies and new anti-inflammatory antibodies, but also by the favorable currency exchange rate. 2017 was also the year of the anti-TNF antibody Humira which posted global sales of US$ 18.9 bln. AbbVie was able to defend Humira in the first litigation by postponing US market entry of Amgen’s Humira biosimilar to 2023, but Amgen will enter the European Humira market in October 2018. The anti-TNF antibodies Enbrel and Remicadepd continued their slow decline in sales by increasingly strong biosimilar competition.

STUTTGART, Germany I March 12, 2017 I Global sales of branded recombinant therapeutic antibodies and proteins in the calendar year 2017 reached an all time high of more than US$ 188 bln, as reported by La Merie Publishing. The increase by 11.9% compared with the previous year was driven by the double-digit growth of cancer antibodies and new anti-inflammatory antibodies, but also by the favorable currency exchange rate. 2017 was also the year of the anti-TNF antibody Humira which posted global sales of US$ 18.9 bln. AbbVie was able to defend Humira in the first litigation by postponing US market entry of Amgen’s Humira biosimilar to 2023, but Amgen will enter the European Humira market in October 2018. The anti-TNF antibodies Enbrel and Remicadepd continued their slow decline in sales by increasingly strong biosimilar competition.

STUTTGART, Germany I June 23, 2017 I Overlooked for many years, RNA languished as the ugly stepchild of nucleic acid vaccine development and was thought to be a poor choice for a therapeutic agent given its short half-life in vivo and its immunogenicity. But two of the main problems of messenger RNA (mRNA) technologies, i.e. stability and manufacturing, sufficiently have been solved and optimized nanoparticlecarrer technologies enable targeted mRNA delivery in vivo.

STUTTGART, Germany I June 23, 2017 I Overlooked for many years, RNA languished as the ugly stepchild of nucleic acid vaccine development and was thought to be a poor choice for a therapeutic agent given its short half-life in vivo and its immunogenicity. But two of the main problems of messenger RNA (mRNA) technologies, i.e. stability and manufacturing, sufficiently have been solved and optimized nanoparticle carrer technologies enable targeted mRNA delivery in vivo.

STUTTGART, Germany I March 17, 2017 I Sales of branded originator biologics in 2016 continued to reach a record high of US$ 163 bln, a plus of 5.8% compared with the previous year. Growth drivers were therapeutic antibodies fortreatment of cancer and inflammatory diseases, especially the emerging immuno-oncology antibodies and novel anti-inflammatory antibodies different from anti-TNF. Interestingly, sales of all anti-inflammatory antibodies including the anti-TNF family were 63% higher than those of the cancer antibodies. Nearly two-thirds of all biologics sales are attributable to antibodies, while 2016 sales of therapeutic proteins were 10% lower than those in 2015. Nearly all classes of therapeutic proteins except enzyme replacement therapies have seen a declineof sales in 2016.

STUTTGART, Germany I March 17, 2017 I Sales of branded originator biologics in 2016 continued to reach a record high of US$ 163 bln, a plus of 5.8% compared with the previous year. Growth drivers were therapeutic antibodies fortreatment of cancer and inflammatory diseases, especially the emerging immuno-oncology antibodies and novel anti-inflammatory antibodies different from anti-TNF. Interestingly, sales of all anti-inflammatory antibodies including the anti-TNF family were 63% higher than those of the cancer antibodies. Nearly two-thirds of all biologics sales are attributable to antibodies, while 2016 sales of therapeutic proteins were 10% lower than those in 2015. Nearly all classes of therapeutic proteins except enzyme replacement therapies have seen a declineof sales in 2016.

STUTTGART, Germany I January 25, 2017 I The acquisition of oncolytic virus company BioVex by Amgen in late 2011 for up to US$ 1 bln has been a game changer for the field of oncolytic viruses, now recognized as a promising new therapeutic approach for cancer treatment. The approval of Amgen‘s herpes simplex oncolytic virus Imlygic in late 2015 further strengthened this trend as evidenced by the fact that total venture equity investment into oncolytic companies in the year 2016 was nearly 17-fold higher than that in 2010. Although the total economic value of all transactions with oncolytic viruses in the year 2016 was in excess of US$ 370 mln, it is only a marginal amount compared with the US$ 3.5 bln moved in transactions related to TCR and CAR T-cell therapies in the year 2015.

Big Pharma companies active in the immuno-oncology field and a few selected investors were among the first to realize the potential clinical and commercial value of oncolytic viruses. In the short term, combination of an oncolytic virus with an immune checkpoint inhibitor represents a quick path towards approval. Amgen and Merck are in the lead with a pivotal phase III combination trial. Early clinical data indiate synergistic efficacy without increased toxicity. Apart from direct cancer cell lysis, oncolytic viruses induce a tumor-specific systemic immunity which can be enhanced by combination with immune checkpoint inhibitors.

The next generation constructs of oncolytic viruses in development incorporate transgenes to locally express immune system co-stimulatory molecules, such as 4-1BB, CD40L, OX40 or CD80, but also the CD3 receptor to recruit T-cells, or even single chain antibodies for local anti-PD-1 action. If proven effective in clinical studies, this profile of oncolytic viruses could convert them again to stand-alone therapeutics independent from the combination with other immune checkpoint inhibitors (or stimulators).

In a new report released by La Merie Publishing, the competitive landscape of oncolytic virus stakeholders, technologies, pipelines, financing and deals is described and analyzed.

This report „The Oncolytic Virus Landscape 2017: an analysis of pipeline, stakeholders, deals, industry trends & opportunities“ as of January 2017 brings you up-to-date regarding key players, key technologies, oncolytic virus products and projects, business deals and private and public financing rounds. The report analyzes the oncolytic virus pipeline and stakeholders in the field, especially among Big Pharma/Biotech and technology companies. The report highlights the value of oncolytic viruses in terms of partnering terms and conditions, venture and private financing, (initial) public offerings and mergers & acquisitions.

About La Merie

La Merie Publishing is a Business Intelligence enterprise fully dedicated to provide high quality R&D information to the biopharmaceutical industry. La Merie offers individual consultancy services and publishes reports and periodicals. For more information visit www.lamerie.com and www.PipelineReview.com, the Biologics News Center and Online Store of La Merie Publishing.

SOURCE: La Merie Publishing

STUTTGART, Germany I January 25, 2017 I The acquisition of oncolytic virus company BioVex by Amgen in late 2011 for up to US$ 1 bln has been a game changer for the field of oncolytic viruses, now recognized as a promising new therapeutic approach for cancer treatment. The approval of Amgen‘s herpes simplex oncolytic virus Imlygic in late 2015 further strengthened this trend as evidenced by the fact that total venture equity investment into oncolytic companies in the year 2016 was nearly 17-fold higher than that in 2010. Although the total economic value of all transactions with oncolytic viruses in the year 2016 was in excess of US$ 370 mln, it is only a marginal amount compared with the US$ 3.5 bln moved in transactions related to TCR and CAR T-cell therapies in the year 2015.

Big Pharma companies active in the immuno-oncology field and a few selected investors were among the first to realize the potential clinical and commercial value of oncolytic viruses. In the short term, combination of an oncolytic virus with an immune checkpoint inhibitor represents a quick path towards approval. Amgen and Merck are in the lead with a pivotal phase III combination trial. Early clinical data indiate synergistic efficacy without increased toxicity. Apart from direct cancer cell lysis, oncolytic viruses induce a tumor-specific systemic immunity which can be enhanced by combination with immune checkpoint inhibitors.

The next generation constructs of oncolytic viruses in development incorporate transgenes to locally express immune system co-stimulatory molecules, such as 4-1BB, CD40L, OX40 or CD80, but also the CD3 receptor to recruit T-cells, or even single chain antibodies for local anti-PD-1 action. If proven effective in clinical studies, this profile of oncolytic viruses could convert them again to stand-alone therapeutics independent from the combination with other immune checkpoint inhibitors (or stimulators).

In a new report released by La Merie Publishing, the competitive landscape of oncolytic virus stakeholders, technologies, pipelines, financing and deals is described and analyzed.

This report „The Oncolytic Virus Landscape 2017: an analysis of pipeline, stakeholders, deals, industry trends & opportunities“ as of January 2017 brings you up-to-date regarding key players, key technologies, oncolytic virus products and projects, business deals and private and public financing rounds. The report analyzes the oncolytic virus pipeline and stakeholders in the field, especially among Big Pharma/Biotech and technology companies. The report highlights the value of oncolytic viruses in terms of partnering terms and conditions, venture and private financing, (initial) public offerings and mergers & acquisitions.

About La Merie

La Merie Publishing is a Business Intelligence enterprise fully dedicated to provide high quality R&D information to the biopharmaceutical industry. La Merie offers individual consultancy services and publishes reports and periodicals. For more information visit www.lamerie.com and www.PipelineReview.com, the Biologics News Center and Online Store of La Merie Publishing.

SOURCE: La Merie Publishing

STUTTGART, Germany I August 10, 2016 I Immunotherapy of B-cell malignancies with specifically targeted autologous T-cells most probably will see the first adoptive cell therapy products approved in the year 2017. Novartis, Kite Pharma and Juno Therapeutics are in a head-to-head race to be first on the market with anti-CD19 chimeric antigen receptor (CAR) T-cells. However, the success story with CD19 CAR T-cells is not as easily repeated with CAR T-cells directed against other targets in hematologic malignancies and - even more - in solid tumors. Limitations by lack of target specificity resulting in on-target, off-tumor toxicity, is one of the major hurdles associated with insufficient activity of current CAR constructs.

As a consequence, the limitations are adressed by a multitude of measures. Gene editing capabilities appears as a key technology not only to generate allogeneic CAR T-cells from donor cells or renewable, pluripotent stem cells, but also to bring CAR design and engineering to a new level of multiplex editing. Knock-out of auto-antigens or immune checkpoints, but also incorporation of on- and off switches for controlling of T-cell activity and enhance potency are some of the features enableb by genome editing of T-cells.

In a new report released by La Merie Publishing, the competitive landscape of CAR T-Cell stakeholders, technologies, pipelines, financing and deals is described and analyzed.

This report „TCR & CAR Engineered T-Cell and NK Cell Therapeutics 2016: Convergence of technologies opens business opportunities beyond CD19 CARTs“ describes and analyzes the status of the adoptive cell therapy industry as of August 2016. The report covers autologous and allogeneic engineered chimeric antigen receptor (CAR) and T-cell receptor (TCR) T-cell therapy candidates as well as natural killer (NK) cell and CAR engineered NK cells in research and development by biopharmaceutical companies. Cytotoxic lymphocytes (CTLs), donor lymphocyte infusions (TILs) and tumor infiltrating lymphocytes (TILs) complement the spectrum of the report.

About La Merie

La Merie Publishing is a Business Intelligence enterprise fully dedicated to provide high quality R&D information to the biopharmaceutical industry. La Merie offers individual consultancy services and publishes reports and periodicals. For more information visit www.lamerie.com and www.PipelineReview.com, the Biologics News Center and Online Store of La Merie Publishing.

SOURCE: La Merie Publishing

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