Launch of Sustained-Duration G-CSF Product G-Lasta in Japan

On November 27, 2014 Kyowa Hakko Kirin reported that sustained-duration G-CSF product G-Lasta subcutaneous injection 3.6mg (G-Lasta) [generic name: pegfilgrastim (genetical recombination)] will be launched in Japan on November 28, 2014 (Press release Kyowa Hakko Kirin, NOV 26, 2014, View Source [SID:1234501021]).

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G-Lasta is a sustained duration form of Granulocyte Colony-Stimulating Factor (G-CSF) product, which is produced by PEGylation of filgrastim, for decreasing the incidence of chemotherapy-associated febrile neutropenia. While filgrastim requires repeated daily doses over several days, G-Lasta shows comparable efficacy with a single dose per chemotherapy cycle. G-Lasta is therefore expected to reduce the burden of drug administration and to decrease frequent hospital visits of outpatients undergoing chemotherapy. Also, prophylactic administration of G-Lasta prior to febrile neutropenia is expected to reduce risks of infection, which results in clinical benefits such as improving the compliance with doses and schedules of chemotherapy.

Pegfilgrastim, originally generated by Amgen, Inc., was licensed from Kirin-Amgen Inc., to Kyowa Hakko Kirin. It has already been approved in 107 countries and regions around the world.

Kyowa Hakko Kirin is focusing on the oncology area, along with three other focused areas as our category-based strategy. Kyowa Hakko Kirin is expecting to contribute to the treatment of cancer patients through the approval of drugs in accordance with medical needs.

TCR Technology

The TCR constructs used by Juno are selected by screening healthy donors for naturally-occurring high-affinity TCRs against a MHC/peptide combination of interest (Company Pipeline Juno, NOV 25, 2014, View Source [SID:1234501011]). Depending on the binding affinity of the selected TCR construct, it is either used directly or modified by mutating a specific region, the hypervariable domain, of the TCR binding pocket to create a higher affinity construct. Due to the variability of MHC types across the human population, different TCRs will be required for various segments of the population.

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Clinical Pipeline

JCAR016 is a high-affinity TCR T cell product candidate targeting WT-1 which is under development by Juno Therapeutics for the treatment of cancer (Company Pipeline Juno, NOV 25, 2014, View Source [SID:1234501012]).

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Preclinical Pipeline

New pipeline entries: L1CAM product candidate, MUC-16/IL-12 product candidate, ROR-1 product candidate (Company Pipeline Juno, NOV 25, 2014, View Source [SID:1234501013]).

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FPA008

FPA008 is an anti-CSF1R antibody that block the ability of IL-34 and CSF1 to bind to and activate CSF1R which is under development by Five Prime for the treatment of autoimmune disorders and cancer (Company Pipeline Five Prime Therapeutics, NOV 25, 2014, View Source [SID:1234501014]).

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