- FDA lifts partial clinical hold on lacutamab clinical
program
- Fatal case related to disease progression and unrelated to
the treatment
Regulatory News:
Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA)
(“Innate” or the “Company”) today announced that the
U.S. Food and Drug Administration (FDA) has lifted the partial
clinical hold placed on the lacutamab IND. On October 5, Innate
announced that the lacutamab IND has been placed on partial
clinical hold by FDA following a recent patient death in the
TELLOMAK study. The death of a patient affected by Sézary syndrome
was initially considered due to hemophagocytic lymphohistiocytosis
(HLH), a rare hematologic disorder.
The FDA decision to lift the partial clinical hold is based on
the FDA review of the fatal case which Innate, together with a
steering committee of independent experts, determined to be related
to aggressive disease progression and lacutamab unrelated.
“We have worked closely with the FDA to diligently resolve the
partial clinical hold on the lacutamab IND, which included an
in-depth analysis of the fatal case which was due to progression of
an aggressive form of the disease,” said Dr Quaratino, Chief
Medical Officer of Innate Pharma. “The lacutamab program
continues to plan following the publication of the positive Sézary
syndrome results at the recent ASH Annual Meeting 2023. We now look
forward to sharing final data in Mycosis Fungoides.”
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. The trial is designed to evaluate safety, as well
as characterize clinical outcomes, pharmacokinetics and
immunogenicity of lacutamab alone in PTCL.
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.
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, 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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For additional information, please contact:
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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