- Lacutamab demonstrated encouraging efficacy and a favorable
safety profile in heavily pretreated, post-mogamulizumab patients
with advanced Sézary syndrome
- In addition, Innate’s ANKETTM (Antibody-based NK cell
Engager Therapeutics) platform on display at ASH via oral
presentation and posters
Regulatory News:
Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate”
or the “Company”) today presented data from a preliminary analysis
of the TELLOMAK Phase 2 trial demonstrating clinical activity and a
favorable safety profile for lacutamab, a first-in-class
anti-KIR3DL2 humanized cytotoxicity-inducing antibody, in patients
with advanced Sézary syndrome, a form of T cell lymphoma. The data
were presented during the 2022 ASH (American Society Hematology)
Annual Meeting, in New Orleans (United States).
At the time of data cut off (April 29, 2022), the Intention To
Treat (ITT1) population included 37 post mogamulizumab patients
with advanced, highly refractory Sézary syndrome, and 35 patients
were Evaluable for Efficacy (EES2). The patient population was
heavily pre-treated with a median of 6 prior lines of therapy. The
median follow-up was 10.9 months.
In the ITT population, the global objective response rate (ORR)
was 21.6% (8/37). ORR in the blood was 37.8% (95% confidence
interval (CI): 24.1-53.9), with 21.6% (8/37) achieving complete
response (CR). ORR in the skin was 35.1% (95% CI: 21.8-51.2). In
the EES population, global objective response rate (ORR) was 22.9%
(8/35). ORR in the blood was 40.0% (95% CI: 25.6-56.4) and ORR in
the skin was 37.1% (95% CI: 23.2‑53.7).
Within the subgroup of patients that achieved a global response,
median duration of global response was 10.8 months (95% CI:
6.2-12.3) with median time to global response of 4 months (range:
1.0-6.5); median time to blood response was 1.0 month (range:
1.0-6.5) and median time to skin response was 2.8 months (range:
0.9-10.2).
Best Global
Response
N=37 (ITT)
N=35 (EES)
Best Response
in Skin
N=37 (ITT)
N=35 (EES)
Best Response
in Blood
N=37 (ITT)
N=35 (EES)
Best Response
in Lymph Node
N=28 (ITT)
N=26 (EES)
ORR %
[95% CI]
ITT
21.6%
[11.4-37.2]
35.1%
[21.8-51.2]
37.8%
[24.1-53.9]
10.7%
[3.7-27.2]
EES
22.9%
[12.1-39.0]
37.1%
[23.2-53.7]
40.0%
[25.6-56.4]
11.1%
[3.9-28.1]
In line with previous observations, lacutamab demonstrated a
favorable safety profile for patients with advanced Sézary syndrome
in the TELLOMAK Phase 2 preliminary analysis. Grade ≥ 3
Treatment-related (TR) Treatment-Emergent Adverse events (TEAEs)
were observed in 6/37 (16.2%) patients. Most common TR TEAEs were
general disorders and administration site conditions (N=6, 16.2%),
skin and subcutaneous tissue disorders (N=5, 13.5%), and
gastrointestinal disorders (N=3, 8.1%).
Dr. Joyson Karakunnel, MD, Chief Medical Officer of Innate
Pharma, said: “This encouraging preliminary analysis in Sézary
syndrome adds to the encouraging cutaneous T-cell lymphoma data we
previously shared within the Phase 1 study, and Phase 2 mycosis
fungoides cohort. The data continues to support our fast to market
strategy for lacutamab in the niche setting of Sézary syndrome
where lacutamab was granted U.S. Fast Track designation and EU
Prime designation. We look forward to final data in 2023 while we
continue investigate the role of lacutamab in other T-cell
lymphomas including the monotherapy and combination trials for
peripheral T-cell lymphoma.”
Dr. Pierluigi Porcu, Director, Division of Hematologic
Malignancies and Hematopoietic Stem Cell Transplantation, Sidney
Kimmel Cancer Center, Jefferson Health, Philadelphia, added:
“It is encouraging to see lacutamab achieve clinically meaningful
efficacy and favorable safety in this post-mogamulizumab, heavily
pre-treated population. The responses observed in the blood and
skin are encouraging in terms of ORR, but also the rapid time to
response and duration of response. This advanced, highly refractory
and heavily pre-treated disease, where patients typically have poor
prognosis, and poor quality of life is an area of significant unmet
need. The interim analysis adds to growing evidence supporting the
development of lacutamab in T cell lymphomas. We thank the
investigators, clinical research coordinators, patients and
caregivers involved in the ongoing TELLOMAK program.”
Other presentations to be held at ASH
2022
ANKET™ (Antibody-based NK cell Engager Therapeutics):
During the ASH annual meeting, Pr. Vivier, DVM, PhD, Chief
Scientific Officer of Innate Pharma, gave an oral presentation on
Innate’s multispecific antibodies platform, ANKETTM, which
harnesses the antitumor functions of NK cells, boosting their
capacity to proliferate, to accumulate at the tumor site and to
kill tumor cells.
“NK cells are attractive alternatives to T cell-based approach.
Our ANKETTM platform is creating an entirely new class of molecules
to induce synthetic immunity against cancer. It leverages the
advantages of harnessing NK cell effector functions against cancer
cells and also provides proliferation and activation signals
targeted to NK cells. It has shown better anti-tumor efficacy than
approved benchmark antibodies in preclinical tumor models.” Pr.
Vivier said. “Progress continues toward investigational new
drug (IND) filing in 2023 for our latest innovation, Innate’s CD20
targeted tetra-specific ANKETTM, IPH6501.”
In addition, Innate partner Sanofi will display two posters on
the NK cell engagers SAR’579/IPH6101 and SAR’514/IPH6401.
The posters and presentation will be available on the
Publications section of Innate’s website following the meeting.
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 ANKETTM
ANKETTM (Antibody-based NK cell Engager
Therapeutics) is Innate's proprietary platform for
developing next-generation, multi-specific natural killer (NK) cell
engagers to treat certain types of cancer.
This versatile, fit-for-purpose technology is creating an
entirely new class of molecules to induce synthetic immunity
against cancer. It leverages the advantages of harnessing NK cell
effector functions against cancer cells and also provides
proliferation and activation signals targeted to NK cells.
Our latest innovation, the tetra-specific ANKET molecule, is the
first NK cell engager technology to engage activating receptors
(NKp46 and CD16), a tumor antigen and an interleukin-2 receptor
(via an IL-2 variant, IL-2v) via a single molecule.
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 code
FR0010331421
Ticker code
Euronext: IPH Nasdaq: IPHA
LEI
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, 2021,
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.
_______________________ 1 ITT (Intention to Treat): entered into
the study and treated with lacutamab 2 EES (Efficacy Evaluable
Set): treated with lacutamab and have a baseline and at least one
post baseline disease assessment
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For additional information, please contact
Investors and Media
Innate Pharma Henry Wheeler Tel.: +33 (0)4 84 90 32 88
Henry.wheeler@innate-pharma.fr
NewCap Arthur Rouillé Tel.: +33 (0)1 44 71 00 15
innate@newcap.eu
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