- Phase 2 TELLOMAK trial fully recruited, final data expected
Q4 2023
- Phase 1b PTCL trial awaiting futility interim analysis,
preliminary data expected Q4 2023
- US FDA places lacutamab IND on partial clinical hold for new
patient enrollment following one unexpected severe adverse
reaction
Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA)
(“Innate” or the “Company”) today announced that the
U.S. Food and Drug Administration (FDA) has placed a partial
clinical hold on the lacutamab IND leading to a pause in new
patient enrollment to the Company’s ongoing lacutamab trials
IPH4102-201 (Phase 2 TELLOMAK) and 102 (Phase 1b PTCL). The partial
clinical hold follows one fatal case of hemophagocytic
lymphohistiocytosis (HLH), a rare hematologic disorder. Patients
already on study treatment who are deriving clinical benefit may
continue treatment after being reconsented.
TELLOMAK, Innate Pharma’s ongoing Phase 2 trial of lacutamab in
cutaneous T-cell lymphoma (CTCL), completed enrollment in Q2 2023
(n=170 patients). Enrollment is also completed to the initial
cohort (n=20 patients) of the Phase 1b PTCL trial and is awaiting a
futility interim analysis to progress to the next stage. Innate
Pharma is on track for final data from the Phase 2 TELLOMAK trial
and preliminary data on PTCL in Q4 2023.
“Patient safety is of paramount importance to us, and we are
currently undertaking efforts to address the FDA requests, which
include incorporation of risk mitigation and management strategies
for hemophagocytic lymphohistiocytosis in ongoing lacutamab
studies.” said Mondher Mahjoubi, Chief Executive Officer of
Innate Pharma. “Additionally, with all patients recruited into
the Phase 2 TELLOMAK study, we do not currently anticipate any
delay for the TELLOMAK Phase 2 final data due shortly.”
About Lacutamab
Lacutamab is a first-in-class anti-KIR3DL2 humanized
cytotoxicity-inducing antibody that is currently in clinical trials
for treatment of cutaneous T-cell lymphoma (CTCL), an orphan
disease, and peripheral T cell lymphoma (PTCL). Rare cutaneous
lymphomas of T lymphocytes have a poor prognosis with few
efficacious and safe therapeutic options at advanced stages.
KIR3DL2 is an inhibitory receptor of the KIR family, expressed
by approximately 65% of patients across all CTCL subtypes and
expressed by up 90% of patients with certain aggressive CTCL
subtypes, in particular, Sézary syndrome. It is expressed by up to
50% of patients with mycosis fungoides and peripheral T-cell
lymphoma (PTCL). It has a restricted expression on normal
tissues.
Lacutamab is granted European Medicines Agency (EMA) PRIME
designation and US Food and Drug Administration (FDA) granted Fast
Track designation for the treatment of patients with relapsed or
refractory Sézary syndrome who have received at least two prior
systemic therapies. Lacutamab is granted orphan drug status in the
European Union and in the United States for the treatment of
CTCL.
About TELLOMAK:
TELLOMAK (NCT03902184) is a global, open-label, multi-cohort
Phase 2 clinical trial recruiting patients with Sézary syndrome and
mycosis fungoides (MF) in the United States and Europe.
Specifically:
- Cohort 1: lacutamab being evaluated as a single agent in
approximately 60 patients with Sézary syndrome who have received at
least two prior systemic therapies, including mogamulizumab. The
Sézary syndrome cohort of the study could enable the registration
of lacutamab in this indication.
- Cohort 2: lacutamab being evaluated as a single agent in
patients with MF that express KIR3DL2, as determined at baseline
with a Simon 2-stage design.
- Cohort 3: lacutamab being evaluated as a single agent in
patients with MF that do not express KIR3DL2, as determined at
baseline, with a Simon-2 stage design.
- All comers: lacutamab being evaluated as a single agent in
patients with both KIR3DL2 expressing and non-expressing MF to
explore the correlation between the level of KIR3DL2 expression and
treatment outcomes utilizing a formalin-fixed paraffin embedded
(FFPE) assay under development as a companion diagnostic.
The trial is now fully enrolled. The primary endpoint of the
trial is objective global response rate. Key secondary endpoints
are progression-free survival, duration of response, overall
survival, quality of life, pharmacokinetics and immunogenicity and
adverse events.
About the Phase 1b in PTCL:
The Phase 1b clinical trial (NCT05321147) is investigating
lacutamab monotherapy in KIR3DL2-expressing patients with
relapsed/refractory PTCL who have received at least one prior
systemic therapy (N=20, with futility interim ungating N=20
expansion). The trial is designed to evaluate safety, as well as
characterize clinical outcomes, pharmacokinetics and immunogenicity
of lacutamab alone in PTCL. Further expansion will be determined
based on preliminary efficacy signals.
About Innate Pharma
Innate Pharma S.A. is a global, clinical-stage biotechnology
company developing immunotherapies for cancer patients. Its
innovative approach aims to harness the innate immune system
through therapeutic antibodies and its ANKET®
(Antibody-based NK cell Engager
Therapeutics) proprietary platform.
Innate’s portfolio includes lead proprietary program lacutamab,
developed in advanced form of cutaneous T cell lymphomas and
peripheral T cell lymphomas, monalizumab developed with AstraZeneca
in non-small cell lung cancer, as well as ANKET® multi-specific NK
cell engagers to address multiple tumor types.
Innate Pharma is a trusted partner to biopharmaceutical
companies such as Sanofi and AstraZeneca, as well as leading
research institutions, to accelerate innovation, research and
development for the benefit of patients.
Headquartered in Marseille, France with a US office in
Rockville, MD, Innate Pharma is listed on Euronext Paris and Nasdaq
in the US.
Learn more about Innate Pharma at www.innate-pharma.com and
follow us on Twitter and LinkedIn.
Information about Innate Pharma shares
ISIN code Ticker code
LEI
FR0010331421
Euronext: IPH Nasdaq: IPHA
9695002Y8420ZB8HJE29
Disclaimer on forward-looking information and risk
factors
This press release contains certain forward-looking statements,
including those within the meaning of the Private Securities
Litigation Reform Act of 1995. The use of certain words, including
“believe,” “potential,” “expect” and “will” and similar
expressions, is intended to identify forward-looking statements.
Forward-looking statements in this press release include, but are
not limited to, the Company’s expectations regarding the timing of
data for TELLOMAK Phase 2 clinical trial and Phase 1b PTCL clinical
trial and statements concerning the Company’s efforts to address
the FDA requests relating to the partial clinical hold. 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. These risks and
uncertainties include, among other things, Innate Pharma’s ability
to address the FDA requests including the incorporation of risk
mitigation and management strategies for hemophagocytic
lymphohistiocytosis in ongoing lacutamab studies and the
effectiveness of such strategies, the timing of release of the
TELLOMAK Phase 2 trial final data, the timing of release of the
Phase 1b PTCL trial preliminary data, the uncertainties inherent in
research and development, including related to safety, progression
of and results from its ongoing and planned clinical trials and
preclinical studies, review and approvals by regulatory authorities
of its product candidates, the Company’s commercialization efforts
and the Company’s continued ability to raise capital to fund its
development. For an additional 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 Universal
Registration Document filed with the French Financial Markets
Authority (“AMF”), which is available on the AMF website
http://www.amf-france.org or on Innate Pharma’s website, and public
filings and reports filed with the U.S. Securities and Exchange
Commission (“SEC”), including the Company’s Annual Report on Form
20-F for the year ended December 31, 2022, and subsequent filings
and reports filed with the AMF or SEC, or otherwise made public, by
the Company.
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20231004595765/en/
Investors Innate
Pharma Henry Wheeler Tel.: +33 (0)4 84 90 32 88
Henry.wheeler@innate-pharma.fr
Media Relations
NewCap Arthur Rouillé Tel.: +33 (0)1 44 71 00 15
innate@newcap.eu
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