Innate Pharma presents preliminary data from TELLOMAK trial showing
clinical response for lacutamab in mycosis fungoides
First data set from TELLOMAK
establishes
safety, clinical
responses and
skin improvement in
patients with mycosis fungoides that
express KIR3DL2
Data support
continued development
of lacutamab for
KIR3DL2-expressing
T-cell
lymphomas
Results presented at
16th International Conference on
Malignant Lymphoma; Innate to
host investor event tomorrow, June 23,
at 2:00
p.m.
CEST / 8:00
a.m.
EDT
Innate Pharma SA (Euronext Paris: IPH – ISIN:
FR0010331421; Nasdaq: IPHA) (“Innate” or the
“Company”) today announced preliminary data from
the mycosis fungoides (MF) cohort of the Phase 2 TELLOMAK clinical
trial, evaluating lacutamab, an anti-KIR3DL2 cytotoxicity-inducing
antibody, in an oral presentation at the 16th International
Conference on Malignant Lymphoma (16-ICML).
Lacutamab demonstrated clinical responses in
patients with MF that express KIR3DL2 (cohort 2), reaching the
pre-determined threshold to advance to stage 2.1
As of the May 10, 2021 data cutoff, in the
KIR3DL2-expressing cohort (n=17), complete (n=1), partial (n=3) and
unconfirmed partial (n=2) global responses were
observed. Following the data cutoff, the two
unconfirmed partial responses have been confirmed.
When evaluating responses in the skin, one
patient had a complete response, eight patients had a partial
response and two patients had an unconfirmed partial response. Out
of seven patients with blood involvement, four had a complete
response in the blood, and out of eight patients with lymph node
involvement, one had a partial response. Following the data cutoff,
the two unconfirmed partial responses in the skin have been
confirmed. All
patients (n=19) in the KIR3DL2-non-expressing cohort (Cohort 3)
have been recruited. The threshold of responses needed to advance
to stage 2 has not been reached, and follow up is ongoing.
“We are pleased by the response demonstrated to
date in patients with mycosis fungoides that express KIR3DL2, which
has enabled us to advance this cohort earlier than expected,” said
Joyson Karakunnel, M.D.,
MSc, FACP, Chief Medical Officer of Innate
Pharma. “These data confirm our initial hypothesis that
lacutamab may benefit patients with KIR3DL2-expressing T-cell
lymphomas, and support our data-driven approach in pursuit of a new
standard of care in this population. Looking ahead, we continue to
enroll patients in both the mycosis fungoides and Sézary syndrome
cohorts of our TELLOMAK study. In addition, we plan to initiate our
peripheral T-cell lymphoma program for lacutamab, with our Phase 1b
monotherapy study expected to start mid-year and an
investigator-sponsored combination study expected in the second
half of this year.”
In line with previous observations, lacutamab
demonstrated a favorable safety profile in MF. Grades 1-2
treatment-related adverse events (AE) were observed, with one
patient (out of 36) experiencing a grade 3 AE. No relevant skin
toxicities were observed.
“Mycosis fungoides, and cutaneous T-cell
lymphomas more broadly, are associated with poor clinical outcomes,
particularly at advanced stages,” said Pr. Martine
Bagot, Head of the Dermatology
Department, Saint Louis Hospital, Paris,
and a study investigator. “The clinical responses and favorable
safety profile observed in the TELLOMAK study are quite encouraging
so far. I am particularly pleased by the preliminary skin
responses, as relapsed/refractory patients are in need of new
treatment options that can improve their quality of life, and slow
disease progression. I look forward to seeing more data from
lacutamab as this trial progresses with the enrollment of
additional patients in this cohort.”
Innate will provide additional information on
these results tomorrow, June 23, 2021, in an investor event
scheduled for 2:00 p.m. CEST / 8:00 a.m. EDT. Details to access the
live event are available in the investors section of Innate’s
website, where a replay of the webcast will also be archived for 90
days following the event.
About
Lacutamab:
Lacutamab (IPH4102) 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. 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 mycosis fungoides and
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 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.
- Cohort 2: lacutamab being evaluated as
a single agent in up to approximately 50 patients with MF that
express KIR3DL2, as determined at baseline.
- Cohort 3: lacutamab being evaluated as
a single agent in up to approximately 38 patients with MF that do
not express KIR3DL2, as determined at baseline.
The MF 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
global response rate. Key secondary endpoints are progression-free
survival, duration of response, quality of life and adverse
events.
Global response in cutaneous lymphoma is
measured by the guidelines published by Olsen et. al in the Journal
of Clinical Oncology in 2011.2
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 is 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, 2020,
and subsequent filings and reports filed with the AMF or SEC, or
otherwise made public, by the Company.
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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: |
InvestorsInnate PharmaTel.: +33
(0)4 30 30 30 30investors@innate-pharma.com |
|
MediaInnate PharmaTracy Rossin
(Global/US)Tel.: +1 240 801
0076Tracy.Rossin@innate-pharma.comATCG Press Marie
Puvieux (France)Tel.: +33 (0)9 81 87 46
72innate-pharma@atcg-partners.com |
1 In this trial, KIR3DL2-expression is defined
as tumors that have KIR3DL2 staining detected in ≥1% of mononuclear
cells by immunohistochemistry using central evaluation.2 Olsen EA,
Whittaker S, Kim YH, et al. Clinical end points and response
criteria in mycosis fungoides and Sézary syndrome: a consensus
statement of the International Society for Cutaneous Lymphomas, the
United States Cutaneous Lymphoma Consortium, and the Cutaneous
Lymphoma Task Force of the European Organisation for Research and
Treatment of Cancer. J Clin Oncol. 2011;29(18):2598-2607.
doi:10.1200/JCO.2010.32.0630
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