Innate Pharma advances lacutamab clinical development program
TELLOMAK trial progresses as cohort 2 of KIR3DL2-expressing
mycosis fungoides patients advances to Stage 2 earlier than
anticipated
Company to initiate two new clinical
trials to investigate lacutamab in peripheral T-cell lymphoma,
including Phase 2 combination study with leading global lymphoma
research network, LYSA
Webcast featuring key opinion leaders
today at 2:00 p.m. CET / 8:00 a.m. ET
Innate Pharma SA
(Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA)
(“Innate” or the “Company”) today
announced new clinical developments for its first-in-class,
proprietary investigational asset, lacutamab, an anti-KIR3DL2
cytotoxicity-inducing antibody in development for T-cell lymphomas.
This includes advancement of the KIR3DL2-expressing mycosis
fungoides (MF) cohort (cohort 2) to Stage 2 in the TELLOMAK study,
as well as the initiation of the peripheral T-cell lymphoma (PTCL)
clinical program.
Mycosis Fungoides: Advancing TELLOMAK
Cohort 2 to Stage 2 In TELLOMAK, an open-label,
multi-cohort, Phase 2 trial, lacutamab demonstrated a positive
early signal in cohort 2. This cohort reached the pre-determined
number of responses needed to advance to stage 2, allowing the
Company to recruit additional patients. The Company plans to
present this preliminary data at a scientific meeting in 2021.
Recruitment is ongoing in cohort 3, evaluating
lacutamab as a monotherapy in KIR3DL2 non-expressing MF
patients.
Peripheral T-Cell Lymphoma: Introducing
a Data-Driven Clinical StrategyThe Company today announced
plans to initiate two parallel clinical trials to study lacutamab
in KIR3DL2-expressing patients with relapsed/refractory PTCL.
Together these trials offer a data-driven strategy to identify
potential opportunities for lacutamab in the relapsed setting, and
potential expansion into earlier lines of therapy for PTCL in the
future.
- Phase 1b trial: a Company-sponsored Phase 1b
clinical trial to evaluate lacutamab as a monotherapy in
KIR3DL2-expressing patients with relapsed PTCL.
- Phase 2 KILT (anti-KIR in T Cell Lymphoma)
trial: The Lymphoma Study Association (LYSA) will launch
an investigator-sponsored, randomized trial to evaluate lacutamab
in combination with chemotherapy GEMOX (gemcitabine in combination
with oxaliplatin) versus GEMOX alone in KIR3DL2-expressing
relapsed/refractory patients.
“Lacutamab is our priority clinical asset, and
we are pleased to share important progress of this program. The
early signal seen in the KIR3DL2-expressing mycosis fungoides
patient population is encouraging and moves us past the
pre-determined threshold for the cohort earlier than anticipated,”
said Joyson Karakunnel, M.D., MSc, FACP, Chief Medical
Officer Innate Pharma. “In addition, our PTCL trials
announced today demonstrate our strategy to first explore
lacutamab’s potential in the relapsed/refractory setting, then
potentially in earlier lines of treatment. Partnering with LYSA
will provide invaluable expertise given their track record in
advancing therapeutics for the lymphoma community.”
“Relapsed PTCL patients are in need of
alternative, effective options and we are pleased to partner with
Innate Pharma on this important study,” said Franck
Morschhauser, Professor of Hematology in Lille (France) and
President of LYSA. “KIR3DL2 represents a
meaningful target, as it is expressed in up to 50% of PTCL across
subtypes. Through our global network and deep expertise in
lymphoma, we believe this study will help us better understand the
potential for lacutamab to help these patients.”
To learn more about these updates, join Innate’s
executive leadership team, as well as Pierluigi Porcu, M.D.,
Professor of Medical Oncology, Dermatology and Cutaneous Biology
and Director, Division of Hematologic Malignancies and
Hematopoietic Stem Cell Transplantation at Jefferson University
Hospital and principal investigator of Innate’s Phase 2 TELLOMAK
study, and Olivier Hermine, M.D., Professor of Hematology at the
University of Paris Descartes, Director, Division of Adult
Hematology at Hôpital Universitaire Necker Enfants Malades and
principal investigator of the LYSA Phase 2 KILT study for a virtual
presentation today.
Webcast and
conference call will be held today at 2:00
p.m. CET / 8:00 a.m.
ET
Access to live webcast:
https://edge.media-server.com/mmc/p/yztsebvs
Participants may also
join via telephone by registering in advance of the event at
http://emea.directeventreg.com/registration/2284358. Upon
registration, participants will be provided with dial-in numbers, a
direct event passcode and a unique registrant id that they may use
10 minutes prior to the event start to access the call.
This information can
also be found on the Investors section of the Innate Pharma
website, www.innate-pharma.com. A replay of the webcast will be
available on the Company website for 90 days following the
event.
About Lacutamab:
Lacutamab (IPH4102) is a first-in-class
anti-KIR3DL2 humanized cytotoxicity-inducing antibody, which is
currently in clinical trials for treatment of cutaneous T-cell
lymphoma (CTCL), an orphan disease. This group of rare cutaneous
lymphomas of T lymphocytes has 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 peripheral t-cell lymphoma
(PTCL). It has a restricted expression on normal tissues.
About TELLOMAK:
TELLOMAK is a global, open-label, multi-cohort
Phase 2 clinical trial recruiting patients with advanced T-cell
lymphomas (TCL) in the United States and Europe. TELLOMAK is
expected to recruit up to 150 patients, with lacutamab
evaluated:
-
As a single agent in approximately 60 patients with Sézary syndrome
who have received at least two prior systemic therapies, including
mogamulizumab.
-
As a single agent in approximately 90 patients with mycosis
fungoides (MF) who have received at least two systemic
therapies.
In patients with MF, the study is designed to
evaluate the benefit of lacutamab according to KIR3DL2 expression.
The study comprises two cohorts in MF, testing lacutamab in KIR3DL2
expressing and non-expressing patients determined at baseline.
These cohorts follow a Simon 2-stage design that will terminate
early if treatment is considered futile. The Sézary syndrome cohort
of the study could enable the registration of lacutamab in this
indication.
The primary endpoint of the trial is objective
response rate. Key secondary endpoints are progression-free
survival, duration of response, quality of life and adverse
events.
About Lacutamab in PTCL:
Two clinical trials will investigate lacutamab
in KIR3DL2-expressing PTCL patients who have received at least one
prior systemic therapy. Lacutamab is being evaluated:
- In a multi-center, Phase 1b clinical trial as a single agent in
approximately 20 relapsed patients expressing KIR3DL2. 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.
- In a multi-center, randomized Phase 2 trial in combination with
GEMOX in relapsed/refractory patients expressing KIR3DL2. This
study will include approximately 60 patients. The combination
trial, KILT (anti-KIR in T-Cell Lymphoma), is being conducted by
the Lymphoma Study Association (LYSA) and its operational
organization Lymphoma Academic Research Organisation (LYSARC); it
will evaluate the efficacy and safety of lacutamab in combination
with chemotherapy GEMOX in prescreened patients, with
progression-free survival as the primary endpoint.
About Innate Pharma:
Innate Pharma S.A. is a global, clinical-stage
oncology-focused biotech company dedicated to improving treatment
and clinical outcomes for patients through therapeutic antibodies
that harness the immune system to fight cancer.
Innate Pharma’s broad pipeline of antibodies
includes several potentially first-in-class clinical and
preclinical candidates in cancers with high unmet medical need.
Innate has been a pioneer in the understanding
of natural killer cell biology and has expanded its expertise in
the tumor microenvironment and tumor-antigens, as well as antibody
engineering. This innovative approach has resulted in a diversified
proprietary portfolio and major alliances with leaders in the
biopharmaceutical industry including Bristol-Myers Squibb, Novo
Nordisk A/S, Sanofi, and a multi-products collaboration with
AstraZeneca.
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
Information about Innate Pharma
shares:
ISIN codeTicker
codeLEI |
FR0010331421Euronext: IPH Nasdaq: IPHA9695002Y8420ZB8HJE29
|
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,
the Company’s continued ability to raise capital to fund its
development and the overall impact of the COVID-19 outbreak on the
global healthcare system as well as the Company’s business,
financial condition and results of operations. 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, 2019,
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.
For additional information, please
contact:
Investors Innate
Pharma
Tel.: +33 (0)4 30 30 30 30 investors@innate-pharma.com
|
Media Innate
Pharma Tracy Rossin (Global/US) Tel.: +1 240 801
0076 Tracy.Rossin@innate-pharma.com
ATCG Press Marie Puvieux (France) Tel.: +33 (0)9
81 87 46 72 innate-pharma@atcg-partners.com |
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