InflaRx Reports Progress in Ongoing Phase II Clinical Trial with Vilobelimab in Cutaneous Squamous Cell Carcinoma
February 16 2022 - 7:30AM
InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical
company developing anti-inflammatory therapeutics by targeting the
complement system, today announced the start of the second dosing
cohort of the vilobelimab and PD-1 checkpoint inhibitor,
pembrolizumab, combination arm of the Phase II clinical trial in
cutaneous squamous cell carcinoma (cSCC).
The open label, non-comparative, two-stage,
Phase II trial (NCT04812535) is ongoing at sites in Europe, the
U.S. and elsewhere. The study is investigating two independent
arms: vilobelimab alone (Arm A) and vilobelimab in combination with
pembrolizumab (Arm B). 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. The trial is
expected to enroll a total of approximately 70 patients.
“We are pleased to see the progress in our first
oncology study with vilobelimab and that there are to date no
safety concerns in either arm,” said Dr. Korinna Pilz, Global Head
of Clinical Research and Development at InflaRx. “Scientific data
suggest C5a involvement in tumor formation and progression, as well
as in immunosuppression, and there is pre-clinical evidence of
synergies between PD-1 and C5a/C5aR inhibitors in inducing
anti-tumor responses. While there are PD-1 checkpoint inhibitors
approved for the treatment of advanced cSCC, there currently are no
treatment options for patients who are PD-1 checkpoint inhibitor
resistant or refractory. We look forward to continuing to advance
the development of vilobelimab with the hope of bringing a new
therapy to treat the advanced stages of this potentially deadly
skin cancer.” In the combination Arm B, three patients have
been treated for at least 36 days in the first dosing cohort of the
study, receiving intravenous infusions of 400 mg of vilobelimab on
Days 1, 4, 8, and 15 and from Day 22 onwards, 800 mg every two
weeks. Patients are also receiving 400 mg of pembrolizumab starting
on Day 8 of the first cycle and every six weeks thereafter. The
data from the first 36 days of treatment have been reviewed by the
Steering Committee and no safety concerns were raised. The Steering
Committee recommended to continue the study as planned and to open
enrollment for the second dosing cohort with 1200 mg vilobelimab
every two weeks after administration of 600 mg vilobelimab on Days
1,4, 8 and 15. The interim analysis in Arm B required
to move to the second stage of the Phase II trial is expected after
ten patients have been treated and are evaluable for response
assessment at the recommended Phase II dose level, which will be
selected based on data from the safety run-in phase of the study.
These data are expected to be available in the first quarter of
2023.
In parallel, enrollment continues in the
monotherapy Arm A. In this arm, patients are receiving a dose of
800 mg vilobelimab on Days 1, 4, 8, and 15 of the first cycle,
followed by a dose of 1600 mg vilobelimab every two weeks starting
on Day 22. Six patients are now enrolled in this arm. The interim
analysis in Arm A required to proceed to the second stage is
expected to be available after ten patients are evaluable for
response assessment. These data are expected to be available in the
third quarter of 2022.
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% in the past three decades. Approximately 5% of patients with
cSCC develop locally advanced or metastatic disease. These forms of
cSCC have a poor prognosis with low survival rates. Over 15,000
people in the U.S. die each year from this disease.
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 in pre-clinical studies to control the
inflammatory response driven tissue and organ damage by
specifically blocking C5a as a key “amplifier” of this response.
Vilobelimab is believed to be the first monoclonal anti-C5a
antibody introduced into clinical development. Over 300 people have
been treated with vilobelimab in completed 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 and pyoderma
gangraenosum, as well as other areas, such as critical COVID-19 and
cutaneous squamous cell carcinoma (cSCC).
About InflaRx N.V.InflaRx
(Nasdaq: IFRX) is a clinical-stage biopharmaceutical company
focused on applying its proprietary technology to discover and
develop first-in-class or best-in-class, potent and specific
inhibitors of C5a and C5aR. Complement C5a and C5aR are powerful
inflammatory mediators 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 OfficerJason Stewart –
Strategy & Investor RelationsEmail: IR@inflarx.deTel: +1
917-338-6523
MC Services AGKatja Arnold,
Laurie Doyle, Andreas JungferEmail: inflarx@mc-services.euEurope:
+49 89-210 2280US: +1-339-832-0752FORWARD-LOOKING STATEMENTSThis
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