-
Dose escalation phase of the study completed up to the maximum
planned dose of
20 mg/kg without dose-limiting toxicities
(DLT) to date -
Preliminary patient pharmacodynamic (PD) data support continued
clinical development - Phase 1 study design featured at ASCO 2019
CAMBRIDGE, England–(BUSINESS WIRE)–F-star, a clinical-stage biopharmaceutical company delivering
tetravalent bispecific antibodies for a paradigm-shift in cancer
therapy, today provides a Phase 1 clinical update on its wholly-owned
lead programme FS118 and announces a presentation at the ASCO Annual
Meeting (Chicago, 01 June 2019). The abstract is currently available on
the meeting
library webpage.
FS118 is a LAG-3/PD-L1-targeting tetravalent bispecific antibody, in a
Phase 1 study in patients with late stage solid tumours who have
relapsed following prior PD-(L)1 therapy. The objectives of the study
are to evaluate the safety and pharmacokinetics of FS118, as well as
clinical activity and immunogenicity. Exploratory assessment of
pharmacodynamic response markers are also included.
As a supplement to the ASCO presentation, F-star provides an update on
the Phase 1 study, showing:
-
FS118 weekly treatment is well tolerated at all dose levels tested to
date and has reached the planned highest dose level without occurrence
of DLT in the treatment of 29 subjects recruited to date -
Modulation of soluble LAG-3 in patients’ serum as a PD marker of
target engagement
“We are very encouraged by the FS118 emerging safety profile and by
the early pharmacodynamic observations in advanced cancer patients who
have relapsed following PD-(L)1 containing treatments” said
Neil Brewis, Chief Scientific Officer of F-star. “LAG-3 is
an exciting target in clinical immuno-oncology as it is involved in the
development of PD-(L)1-resistance in many indications. We believe FS118
is an important part of the exciting next wave of checkpoint therapies
and we are looking forward to generating additional data to validate our
approach.”
The study is advancing as expected and is currently recruiting in the
expansion cohorts of the two highest dose levels. First study data,
including six-month data on clinical response, are expected to be
released in Q1 2020.
Details of the poster are below:
A first-in-human phase I study of FS118, an anti-LAG-3/PD-L1
bispecific antibody in patients with solid tumors that have progressed
on prior PD-1/PD-L1 therapy.
Category: Developmental Immunotherapy and Tumor Immunobiology
Date and Time: 01 June from 08:00 – 11:00
Poster Session: Board #292a
Location: McCormick Place – Chicago, IL
Abstract Number: TPS2652
The poster will be available on F-star’s website at the end of the
conference.
– ENDS –
About F-star
F-star is a leading clinical-stage biopharmaceutical company delivering
tetravalent bispecific antibodies for a paradigm-shift in cancer
therapy. By developing medicines that seek to block tumour immune
evasion, the Company’s goal is to offer patients greater and more
durable benefits than current immuno-oncology treatments. Through its
proprietary tetravalent, bispecific antibody (mAb²™) format, F-star is
generating first- and best-in-class drug candidates with monoclonal
antibody-like manufacturability. Building on the combined expertise of
its world-class management team and scientific leadership, F-star is
poised to deliver the next breakthrough immunotherapies for cancer
patients.
Find out more at www.f-star.com.
Connect with us via LinkedIn
and Twitter
About FS118
Currently in a Phase 1 trial at four clinical sites in the United
States, FS118 is a potentially first-in-class medicine for the treatment
of resistant and refractory cancer. This tetravalent, bispecific
antibody is developed to overcome tumour evasion mechanisms promoted by
two highly immuno-suppressive molecules: LAG-3 (Lymphocyte-Activation
Gene 3) and PD-L1 (Programmed Death-Ligand 1). By simultaneously
blocking both inhibitory pathways, FS118 has preclinically demonstrated
a potent anti-tumour growth activity(1) as well as a highly
differentiated mechanism of action(2) when compared to
checkpoint monotherapies alone or in combinations.
In April 2018, a Phase 1 clinical study started in patients who have
relapsed following a prior
PD-(L)1-containing therapy. Information about the trial is available on
clinicaltrials.gov NCT03440437.
FS118 is manufactured at 2000L scale using standard mAb manufacturing
processes.
Contacts
For investor enquiries
Lindsey Trickett
VP
Investor Relations
& Communications
+1 240 543 7970
lindsey.trickett@f-star.com
For
media enquiries
Pierre Peotta
Communications Manager
+44
(0)1223 948 094
+44 (0)7392 080 279
pierre.peotta@f-star.com
Consilium
Strategic Communications
Chris Gardner, Sue Stuart, David Daley
Tel:
+44 (0)20 3709 5700
E-mail: F-star@consilium-comms.com
US
Catherine
London, US President
Tel: +1 917-763-2709
E-mail: F-star@consilium-comms.com