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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.

Organisations Organisation F-Star Biotechnology Ltd. (F-Star Therapeutics)
  Group F-Star (Group)
  Organisation 2 Merck KGaA
  Group Merck (DE) (Group)
Products Product FS118 (F-Star)
  Product 2 clinical research
Index term Index term Merck (DE)–F-Star: antibody cancer drug, 201706– strategic collab €115m upfront + €1b milestones develop 5 bispecific ABs incl lead asset FS118
Persons 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 NCT03440437.

- ENDS -

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

Instinctif Partners (UK and RoW)
Sue Charles/Ashley Tapp
+44 (0)20 7866 7923

Lazar Partners (USA)
Glenn Silver
+1 212 867 1762

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 Connect with us via LinkedIn and Twitter.

Record changed: 2018-05-31


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