Malin Corporation PLC Immunocore announces FDA approval of KIMMTRAK(R) (7727Z)
27 Janeiro 2022 - 4:00AM
UK Regulatory
TIDM0Y71
RNS Number : 7727Z
Malin Corporation PLC
27 January 2022
Malin Corporation plc
Immunocore announces FDA approval of KIMMTRAK(R)
(tebentafusp-tebn) for the treatment of unresectable or metastatic
uveal melanoma
-- KIMMTRAK is the first and only FDA approved therapy for the
treatment of unresectable or metastatic uveal melanoma (mUM)
-- KIMMTRAK is the world's first approved T cell receptor (TCR) therapeutic
-- Immunocore expects to make the product commercially available
in the United States within weeks.
Dublin-Ireland, 27 January 2022 : Malin Corporation plc.
(Euronext Growth Dublin:MLC) (Malin), a company investing in highly
innovative life sciences companies, is pleased to note that
Immunocore, a Malin investee company, has announced the approval
from the United States Food and Drug Administration (FDA) of
KIMMTRAK(R) (tebentafusp-tebn) for the treatment of
HLA-A*02:01-positive adult patients with unresectable or metastatic
uveal melanoma (mUM).
KIMMTRAK's approval establishes many firsts as the first TCR
therapeutic to receive regulatory approval from the FDA, the first
bispecific T cell engager to receive regulatory approval from the
FDA to treat a solid tumour, and the first and only therapy for the
treatment of unresectable or metastatic uveal melanoma to be
approved by the FDA.
The approval of KIMMTRAK is based on the results of Immunocore's
Phase 3 IMCgp100-202 clinical trial, in which KIMMTRAK demonstrated
statistically and clinically meaningful overall survival (OS)
benefit, hazard ratio of 0.51, with median OS of almost 22
months.
Immunocore is ready to commercialize KIMMTRAK and expects to
make the product commercially available in the United States within
weeks.
"The approval of KIMMTRAK in the US is a significant milestone
for Immunocore and a major development in the treating metastatic
uveal melanoma patients, w ho, until now, had no approved treatment
options," said Darragh Lyons, Malin Chief Executive Officer. "The
approval validates the strength of the Immunocore platform and the
potential of its deep clinical pipeline of oncology programs."
Malin owns approximately 6% of Immunocore.
A copy of Immunocore's press release is available to view
below:
http://www.rns-pdf.londonstockexchange.com/rns/7727Z_1-2022-1-26.pdf
ENDS
About Malin Corporation plc
Malin (Euronext Growth Dublin:MLC) is a company investing in
highly innovative life sciences companies. Its purpose is to create
shareholder value through the application of long-term capital and
operational and strategic expertise to a diverse range of global
healthcare businesses. Malin has a focus on innovative businesses
underpinned by exceptional science and works with its investee
companies, providing strategic and financial support to enable them
to reach their value potential. Malin is headquartered and
domiciled in Ireland and listed on the Euronext Growth Dublin. For
more information visit www.malinplc.com
For further information please contact:
Malin
Fiona Dunlevy, Company Secretary
Tel: +353 (0)1 901 5700
investorrelations@malinplc.com
Davy Corporate Finance (Euronext Growth Adviser & Joint
Broker)
Brian Garrahy / Daragh O'Reilly
Tel: +353 1 679 6363
Liberum (Joint Broker)
Bidhi Bhoma
Tel: +44 (0) 20 3100 2000
Powerscourt (Irish Media enquiries)
Eavan Gannon
Tel: +353 87 236 5973
malin@powerscourt-group.com
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