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F-star Announces First Patient Dosed in Phase I Clinical Trial of FS118, a First-in-class Immuno-oncology Bispecific Antibody

F-star Announces First Patient Dosed in Phase I Clinical Trial of FS118, a First-in-class Immuno-oncology Bispecific Antibody

  • 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™

Cambridge, UK – 21 May 2018 – 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.

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.

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Issued for and on behalf of F-star by Instinctif Partners.
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Sue CharlesManaging Partner

Ashley TappAssociate Partner