- SynOx is developing emactuzumab - a potential best-in-class,
next-generation CSF1(R) inhibiting monoclonal antibody
- Provides flexible loan facility to support additional
clinical work and activities to drive its successful registration
and commercialisation
- Funding is additional to recent $75m Series B financing
DUBLIN and OXFORD, England, April
30, 2024 /PRNewswire/ -- SynOx Therapeutics Limited ("SynOx"
or the "Company"), the late-stage clinical biopharmaceutical
company developing emactuzumab for the treatment of Tenosynovial
Giant Cell Tumour (TGCT) and other diseases, today announces it has
entered into a $35m loan facility
with Hercules Capital, Inc. (NYSE: HTGC) ("Hercules").
The transaction strengthens the Company's balance sheet as it
executes TANGENT, a registrational Phase 3 study of emactuzumab,
SynOx's potentially best-in-class CSF-1(R) inhibiting monoclonal
antibody (mAb) for the treatment of TGCT.
This loan facility provides SynOx with flexibility to fund
additional clinical work in TGCT to augment TANGENT, activities to
support the successful registration and commercialisation of
emactuzumab in TGCT, and potentially to explore the use of
emactuzumab in other CSF-1 driven and macrophage-mediated
diseases.
The term loan facility provides up to $35m, in total, in four tranches. The initial
tranche was drawn on signing, with subsequent tranches
available over the medium term and upon achievement of certain
clinical milestones.
Ray Barlow, Chief Executive
Officer of SynOx Therapeutics, said: "This funding will
provide SynOx with additional capital to fulfil its mission of
establishing emactuzumab as a best-in-class drug, to address
significant unmet medical needs and greatly improve the quality of
life for as many patients as possible. We are grateful for the
support from Hercules, which together with the $75m we raised recently in our Series B round,
puts SynOx on a strong financial footing."
R. Bryan Jadot, Senior
Managing Director and Group Head - Life Sciences, Hercules,
said: "We have been impressed by the quality of data SynOx
has already generated on emactuzumab, which demonstrate it to be
highly differentiated from other CSF-1 inhibiting drugs in
development. Emactuzumab is showing great promise in treating TGCT,
and we believe it has the potential to treat other related
conditions as well."
TGCT is a type of tumour that affects the soft tissue lining of
joints and tendons. It is a highly debilitating disease that often
impacts large, important joints such as the knee, hip and
ankle. It seriously impacts quality of life by causing
significant pain and stiffness in affected joints and limiting
range of motion. While most patients receive surgical intervention,
more than 50% of patients with diffuse disease experience tumour
recurrence within three years of surgery[1].
Emactuzumab, a novel next-generation CSF-1R mAb with a
potentially best-in-class profile, has demonstrated substantial
clinical activity in earlier clinical work in TGCT[2], with an
objective response rate (ORR) of 71%, rapid and robust tumour
reduction, a long duration of effect, significant improvements in
functional ability, good tolerability and a manageable safety
profile. The Phase 3 TANGENT trial will assess its safety and
efficacy in patients with localized and diffuse TGCT.
About SynOx Therapeutics
SynOx Therapeutics Limited is
a Dublin and Oxford -based, late-stage clinical
biopharmaceutical company developing emactuzumab, a best-in-class
monoclonal antibody against CSF-1R, for the treatment of
Tenosynovial Giant Cell Tumour (TGCT) and other CSF-1 related and
macrophage driven disorders. SynOx is led by an experienced
team of industry professionals with a successful track record of
developing and bringing products to commercialisation. It is backed
by a strong syndicate of premier life science investors including
Forbion, HealthCap, BioQube, Hercules Capital, Inc. and
Medicxi.
About Tenosynovial Giant Cell Tumour
(TGCT)
Tenosynovial Giant Cell Tumour (TGCT), previously
termed pigmented villonodular synovitis (PVNS), is a type of tumour
that affects the soft tissue lining of joints and tendons. TGCTs
are categorised as fibrohistiocytic tumours by the WHO
classification and are subclassified based on growth patterns
(localised- and diffuse types) and location (tendon sheath, and
intra- and extra-articular forms). TGCTs are locally destructive
and can be aggressive tumours. TGCT is a chronically debilitating
disease which often impacts patients throughout their lives. It
causes loss of function of the affected joints, pain, stiffness,
limited range of motion and a significant impact on the quality of
life as a result. Most patients receive surgical intervention, with
3-year post-surgery recurrence rates in more than 50% of
patients[3]. Symptoms typically progress slowly but can be
aggressive and destructive. If left untreated complications include
moderate to severe joint deformity, degenerative articular changes,
and osteoarthritis, which if severe enough, can lead to cortical
bone destruction and occasionally the need for arthrodesis or
amputation.
About CSF-1 and Emactuzumab
CSF-1 (or macrophage
colony-stimulating factor) is a cytokine that binds to the CSF-1
receptor (CSF-1R), expressed on macrophages and certain other
cells, with effects on production, differentiation, and function of
these cells. Emactuzumab is a humanised IgG1 CSF-1R targeted
antibody that inhibits and depletes macrophages in the tumour
tissue. Emactuzumab was originally discovered and developed by
Roche and has been tested in several phase 1/b studies as a
monotherapy and in combination with other agents, including
chemotherapeutics and immunotherapies. In clinical studies as a
monotherapy in 63 patients with TGCT, emactuzumab has shown a
substantial effect on tumour response (ORR ~71%) and was well
tolerated2. Emactuzumab is a novel monoclonal antibody
inhibiting CSF-1R that offers a short course of treatment. Phase
I/II studies indicated good tolerability and a manageable safety
profile and substantial preliminary efficacy in TGCT patients with
rapid, robust tumour reduction and durable response. Emactuzumab
may also have utility in other macrophage driven diseases and the
company is actively considering potential options in these
areas.
- Lin F, et. al. JHEOR, 2022.
- Cassier et al. "Long-term clinical activity, safety and
patient-reported quality of life for emactuzumab-treated patients
with diffuse-type tenosynovial giant-cell tumour" European Journal
of Cancer 141:162-170, 2020
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