Malin Corporation PLC Immunocore announces FDA approval of KIMMTRAK(R) (7727Z)

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

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Brian Garrahy / Daragh O'Reilly

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Bidhi Bhoma

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Eavan Gannon

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January 27, 2022 02:00 ET (07:00 GMT)