InflaRx Doses First Patient in Multicenter Phase II Clinical Trial in Cutaneous Squamous Cell Carcinoma with Vilobelimab
June 08 2021 - 7:30AM
InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical
company developing anti-inflammatory therapeutics by targeting the
complement system, today announced the enrollment of the first
patient in an open-label, multicenter Phase II clinical study
evaluating vilobelimab alone and in combination with pembrolizumab
in patients with PD-1 or PD-L1 inhibitor resistant/refractory
locally advanced or metastatic cutaneous squamous cell carcinoma
(cSCC).
The Phase II clinical trial is expected to
enroll approximately 70 patients at sites in Europe, the U.S. and
elsewhere. The study will investigate two independent arms:
vilobelimab alone and vilobelimab in combination with
pembrolizumab. The main objectives of the trial are to assess the
safety and antitumor activity of vilobelimab monotherapy and to
determine the maximum tolerated or recommended dose, safety and
antitumor activity in the combination arm.
Dr. Korinna Pilz, Global Head of Clinical
Research and Development at InflaRx, said: “We are pleased to
initiate the first clinical trial to evaluate vilobelimab in
cancer. Scientific data suggest C5a involvement in tumor formation
and progression, as well as in immunosuppression. Additionally,
there is pre-clinical evidence of synergies between PD-1 and
C5a/C5aR inhibitors in inducing anti-tumor responses. Based on
this, we believe that vilobelimab has the potential alone and in
combination with the PD-1 checkpoint inhibitor pembrolizumab to
treat the advanced stages of this potentially deadly skin
cancer.”
The C5a/C5aR pathway has been implied as a
potential driver for tumorigenesis, metastases and avoidance of
immune cell destruction, particularly in the context of cSCC.
Several independent pre-clinical studies showed
that the combination of a C5a or C5aR pathway inhibitor with
inhibition of the PD-1/PD-L1 axis leads to an antitumoral effect,
which was stronger than inhibition of one of the axes alone. This
provides a pre-clinical rationale for the combined blockade of PD-1
and C5a to restore antitumor immune responses and to inhibit tumor
cell growth.
About cutaneous squamous cell carcinoma
(cSCC)
cSCC is the second most common form of skin
cancer and, if caught early, it is generally curable. In the U.S.
alone, according to the Skin Cancer Foundation, an estimated 1.8
million cases are diagnosed each year, which translates to about
205 cases diagnosed every hour. The incidence of cSCC has increased
up to 200 percent in the past three decades. Over 15,000 people in
the U.S. die each year from this disease. Approximately 5% of
patients with cSCC develop locally advanced or metastatic disease.
These forms of cSCC have a poor prognosis with low survival
rates.
About vilobelimab (IFX-1):
Vilobelimab is a first-in-class monoclonal
anti-human complement factor C5a antibody, which highly and
effectively blocks the biological activity of C5a and demonstrates
high selectivity towards its target in human blood. Thus,
vilobelimab leaves the formation of the membrane attack complex
(C5b-9) intact as an important defense mechanism, which is not the
case for molecules blocking the cleavage of C5. Vilobelimab has
been demonstrated to control the inflammatory response driven
tissue and organ damage by specifically blocking C5a as a key
“amplifier” of this response in pre-clinical studies. Vilobelimab
is believed to be the first monoclonal anti-C5a antibody introduced
into clinical development. Approximately 300 people have been
treated with vilobelimab in clinical trials, and the antibody has
been shown to be well tolerated. Vilobelimab is currently being
developed for various indications, including Hidradenitis
Suppurativa, ANCA-associated vasculitis, Pyoderma Gangraenosum and
COVID-19 pneumonia.
About InflaRx N.V.:
InflaRx (Nasdaq: IFRX) is a clinical-stage
biopharmaceutical company focused on applying its proprietary
anti-C5a technology to discover and develop first-in-class, potent
and specific inhibitors of C5a. Complement C5a is a powerful
inflammatory mediator involved in the progression of a wide variety
of autoimmune and other inflammatory diseases. InflaRx was founded
in 2007, and the group has offices and subsidiaries in Jena and
Munich, Germany, as well as Ann Arbor, MI, USA. For further
information, please visit www.inflarx.com.
Contacts:
InflaRx N.V.Jordan Zwick –
Chief Strategy OfficerEmail: IR@inflarx.deTel: +1 917-338-6523
MC Services AGKatja Arnold,
Laurie Doyle, Andreas Jungfer Email: inflarx@mc-services.eu Europe:
+49 89-210 2280US: +1-339-832-0752
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