F-Star Biotechnology Ltd.. (5/21/18). "Press Release: F-Star Announces First Patient Dosed in Phase I Clinical Trial of FS118, a First-in-class Immuno-oncology Bispecific Antibody". Cambridge.

	Organisation	F-Star Biotechnology Ltd. (F-Star Therapeutics)
	Organisation 2	Merck KGaA
	Group	Merck (DE) (Group)
	Product	FS118 (F-Star)
	Product 2	clinical research
	Index term	Merck (DE)–F-Star: antibody cancer drug, 201706– strategic collab €115m upfront + €1b milestones develop 5 bispecific ABs incl lead asset FS118
	Person	Haurum, John (F-Star 201205–201810 CEO before ImClone System + Symphogen LEFT 10/18)
	Person 2	Brewis, Neil (F-Star 201611 CSO)

> Lead programme FS118 to be investigated in cancer patients relapsing after PD-1/PD-L1 therapy

> Clinical validation of F-star’s proprietary Modular Antibody Technology™ platform and bispecific format, mAb²™

F-star, a clinical-stage biopharmaceutical company developing novel bispecific antibodies, today announced successful dosing of the first patient with FS118 in a Phase I clinical trial.

FS118 is a first-in-class bispecific antagonist simultaneously targeting LAG-3 (Lymphocyte-Activation Gene 3) and PD-L1 (Programmed Death-Ligand 1), two immune checkpoint molecules involved in tumour growth through attenuation of immune surveillance. In preclinical models, FS118 has demonstrated potent anti-cancer activity, as recently presented by F-star at the 2018 AACR meeting.

“The initiation of a Phase I clinical study of FS118 is a pivotal milestone for F-star and validation of our unique bispecific technology and approach to improving cancer care” said John Haurum, CEO of F-star. ”FS118 leverages novel biology that cannot be attained through combination approaches, we believe this is an important step forward in providing improved therapies for patients with advanced cancer.”

The first-in-human study is designed to assess the safety, tolerability and pharmacokinetic profile of FS118 in patients with advanced malignancies that have progressed while on PD-1/PD-L1 therapy. The trial is being conducted at clinical centres in the US.

“FS118 is positioned to address a clear unmet medical need as only approximately one in five patients treated with checkpoint inhibition monotherapy reach durable and clinically meaningful responses” according to F-star’s CSO, Neil Brewis. “FS118 has the potential to increase this response rate by overcoming tumour resistance and restoring anti-cancer immunity and responsiveness.”

FS118 was generated using F-star’s proprietary Modular Antibody Technology™ by incorporating an anti-LAG-3 Fcab (Fc-region with antigen binding) into a PD-L1-specific antibody. The mAb² is under option to Merck KGaA, Darmstadt, Germany as part of a collaboration announced in June 2017.

Further information about the trial is available on clinicaltrials.gov NCT03440437.

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For further information, please contact:

At F-star For media enquiries

Pierre Peotta
Communications Manager
+44 (0)1223 948 094
+44 (0)7392 080 279
pierre.peotta@f-star.com

Instinctif Partners (UK and RoW)
Sue Charles/Ashley Tapp
+44 (0)20 7866 7923
F-star@instinctif.com

Lazar Partners (USA)
Glenn Silver
+1 212 867 1762
Gsilver@lazarpartners.com

About F-star

F-star is a clinical-stage biopharmaceutical company committed to delivering life-changing treatments to cancer patients. Through our highly efficient Modular Antibody Technology™ platform, we are building and progressing an extensive immuno-oncology pipeline of mAb²™, a novel class of disruptive bispecific antibodies designed to unlock new biology which cannot be achieved by combining monospecific drugs. F-star’s technological expertise and scientific approach have been validated through strategic partnerships with leaders in the pharma and biotech industries.

Find out more at www.f-star.com. Connect with us via LinkedIn and Twitter.

Record changed: 2023-06-05