Innate Pharma SA (the "Company" - Euronext Paris: FR0010331421 -
IPH), the innate immunity company developing first-in-class
therapeutic antibodies for cancer and inflammatory diseases, today
announced that the first Phase II trial of IPH2201, a
first-in-class NKG2A checkpoint inhibitor, was opened at the
Charité Comprehensive Cancer Center (CCCC), Berlin, Germany.
IPH2201-201 is an open label Phase II trial
testing IPH2201 as a single agent in a pre-operative setting of
squamous cell carcinoma of the oral cavity (OCSCC), a tumor type
representative of the larger group of squamous cell cancer of the
head and neck.
Dr Jan D Raguse, assistant medical director,
Clinic for Oral & Maxillofacial Surgery, Berlin Centre of
Reconstructive Surgery, CCCC, and principal investigator of the
study, said: "The rationale for this trial is based on the frequent
expression of the NKG2A receptor and its ligand, HLA-E, in patients
with OSCC". He added: "The pre-operative setting is very appealing
as the absence of prior therapy eliminates confounding effects.
This design optimizes our ability to evaluate the antitumor
activity of IPH2201. Access to the tumor is another key attractive
feature of the study as it will allow a detailed pharmacological
evaluation".
Hervé Brailly, CEO and co-founder of Innate
Pharma, said: "We are very enthusiastic to start this first Phase
II trial of IPH2201, a novel checkpoint inhibitor entering the
immuno-oncology field. IPH2201 is exciting because it has the
potential to stimulate both the innate and adaptive arms of the
immune system to kill tumor cells". He added: "The CCCC is a
reference cancer center with a large experience in the treatment of
squamous cell cancer of the head and neck. IPH2201 will be further
tested in both hematologic and solid tumors with high level of
HLA-E expression".
The rationale of this trial is based on the
expression of NKG2A by both NK and CD8+ cells infiltrating OCSCC
(Katou, Ohtani et al. 2007). Binding of IPH2201 to NGK2A blocks the
HLA-E driven inhibition of NK and CD8+ cells. HLA-E is expressed in
about 80% of patients with squamous cell carcinoma of the head and
neck (SSCHN) (Silva 2011; Nasman, Andersson et al. 2013). The
resulting stimulation of both the innate and acquired immunity
could lead to clinical and pharmacological antitumor activity. In a
Phase I dose-escalation safety trial conducted by CCCC, IPH2201
appeared to have a safe and well-tolerated profile.
About study IPH2201-201:
The primary objective of this open label Phase
Ib/II trial is to evaluate the clinical and pharmacological
activity of IPH2201 as a single-agent in treatment-naïve
pre-operative patients with resectable intermediate or high risk
(stage III-IVa) OCSCC. The secondary objectives are to assess the
safety of IPH2201, the pharmacokinetics, the immunogenicity and the
pharmacodynamics including intra-tumoral biomarkers.
43 patients are planned to be enrolled. The
first 6 patients will receive IPH2201 at a dose of 4 mg/kg q2w
x 4. Subsequent patients will be treated at a dose of 10 mg/kg q2w
x 4. Based on a previous Phase I study with IPH2201, these dosages
are expected to induce saturation of the NKG2A receptor. Standard
loco-regional treatment with surgery followed by adjuvant therapy
will be initiated after the last administration of IPH2201.
Progression-free survival and survival will be assessed at 12 and
36 months after treatment administration, offering other
opportunities to perform preliminary assessments of the antitumor
activity.
About squamous cell carcinoma of the oral
cavity (OCSCC):
Squamous carcinoma of the oral cavity (OCSCC)
represents at least 25% of squamous cell cancers of the head and
neck (HNSCC). They are often diagnosed at a locally advanced stage,
stage III to stage IV (with a large primary tumor and/or invaded
lymph nodes). For patients with locally advanced OCSCC, surgical
resection remains, whenever it is feasible, the cornerstone of the
treatment. The risk of loco-regional or distant relapse is however
high. Preoperative chemotherapy (also called "neoadjuvant
chemotherapy") has been assessed with the aim to facilitate the
surgical resection and to reduce the incidence of relapses, without
success. Current prognosis of locally advanced but resectable OCSCC
remains poor. Around 30% of the patients relapse during the first
year, and 50% during the first 2 to 3 years following the resection
of the tumor, despite the adjuvant treatment. Around 20% of the
patients die during the year after surgery. Five year disease-free
survival (DFS) and overall survival (OS) of operated patients does
not exceed 50-60% (Licitra, Grandi et al. 2003; Zhong, Zhang et al.
2013).
About IPH2201:
IPH2201 is a first-in-class immune checkpoint
inhibitor targeting NKG2A receptors expressed on tumor infiltrated
cytotoxic NK and CD8 T lymphocytes.
NKG2A is an inhibitory receptor binding HLA-E.
By expressing HLA-E, cancer cells can protect themselves from
killing by NKG2A+ immune cells. HLA-E is frequently up-regulated on
cancer cells of many solid tumors or hematological malignancies.
IPH2201, a humanized IgG4, blocks the inhibitory function of NKG2A.
Hence, IPH2201 may re-establish a broad anti-tumor response
mediated by NK and T cells. IPH2201 may also enhance the cytotoxic
potential of other therapeutic antibodies.
About Innate Pharma:
Innate Pharma S.A. is a biopharmaceutical
company discovering and developing first-in-class therapeutic
antibodies for the treatment of cancer and inflammatory
diseases.
Its innovative approach has translated into
major alliances with leaders in the biopharmaceutical industry such
as Bristol-Myers Squibb and Novo Nordisk A/S.
The Company has two clinical-stage programs in
immuno-oncology, a new therapeutic field that is changing cancer
treatment by enhancing the capability of the body's own immune
cells to recognize and kill cancer cells. Innate Pharma science
also has potential in chronic inflammatory diseases.
Listed on Euronext-Paris, Innate Pharma is based
in Marseille, France, and had 97 employees as at September 30,
2014.
Learn more about Innate Pharma at
www.innate-pharma.com.
Practical Information about Innate Pharma
shares:
ISIN
code Ticker code |
FR0010331421 IPH |
Disclaimer:
This press release contains certain
forward-looking statements. Although the company believes its
expectations are based on reasonable assumptions, these
forward-looking statements are subject to numerous risks and
uncertainties, which could cause actual results to differ
materially from those anticipated. For a discussion of risks and
uncertainties which could cause the company's actual results,
financial condition, performance or achievements to differ from
those contained in the forward-looking statements, please refer to
the Risk Factors ("Facteurs de Risque") section of the Document de
Reference prospectus filed with the AMF, which is available on the
AMF website (http://www.amf-france.org) or on Innate Pharma's
website.
This press release and the information contained
herein do not constitute an offer to sell or a solicitation of an
offer to buy or subscribe to shares in Innate Pharma in any
country.
For additional information, please
contact:
Innate Pharma |
ATCG
Press |
Laure-Hélène Mercier Director,
Investor Relations |
Judith
Aziza, Mob.:+33 (0)6 70 07 77 51 Marielle Bricman, Mob.:+33 (0)6 26
94 18 53 |
Tel.: +33 (0)4 30 30 30 87 |
|
investors@innate-pharma.com |
presse@atcg-partners.com |
First Phase II trial with IPH2201 open in head and neck cancer
http://hugin.info/155662/R/1881859/663856.pdf
HUG#1881859
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