First Phase II of IPH2201, a novel checkpoint inhibitor
entering the immuno-oncology field
Marseille, France, December 19, 2014
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
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information contained therein.
Source: INNATE PHARMA via Globenewswire
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