- Positive final results of lacutamab TELLOMAK Phase 2 trial
in Sézary syndrome selected for oral presentation and preliminary
data in Peripheral T Cell lymphoma to be displayed in a poster at
ASH Annual Meeting 2023
- ASH presentation on SAR443579/IPH6101, a potential
first-in-class NKp46/CD16-based NK cell engager targeting CD123;
the ANKET® platform lead asset and under development by
partner Sanofi, which demonstrated clinical remissions
- IPH6501, Innate’s proprietary tetra-specific ANKET®,
progressing towards Phase 1 clinical trial in 2023
- Cash position of €121.9 million1 as of 30 September 2023,
anticipated cash runway into H2 2025
- Conference call to be held today at 2:00 p.m. CET / 8:00
a.m. ET
Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA)
(“Innate” or the “Company”) today announced its
revenues and cash position for the first nine months of 2023.
“With our strong cash position, we continue to execute against
our strategy to develop innovative proprietary and partnered assets
with key players. We look forward to this year’s ASH Annual Meeting
where we will present the final results of the lacutamab TELLOMAK
Phase 2 study in patients with Sézary syndrome. We are also very
pleased that at the same meeting, our partner Sanofi will share
updated data from the Phase 1/2 study using SAR443579 / IPH6101 in
patients with hematologic malignancies, a product using Innate’s
innovative ANKET® NK cell engager platform,” said Mondher
Mahjoubi, Chief Executive Officer of Innate Pharma. “As
monalizumab continues to progress in Phase 2 and 3 lung cancer
trials with AstraZeneca, we look forward to sharing further updates
on our proprietary portfolio as we progress our lead proprietary
ANKET® NK cell engager, IPH6501 and our Nectin-4 targeted ADC,
IPH45 towards the clinic.”
Webcast and conference call
will be held today at 2:00pm CET (8:00am ET)
The live webcast will be
available at the following link:
https://events.q4inc.com/attendee/172996087
Webcast participants can use the
chat tool to ask written questions during the conference.
Participants may also join via
telephone to ask oral questions during the conference using the
following registration link:
https://registrations.events/direct/Q4E61217
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.
___________________________
1 Including short term investments (€22.0
million) and non-current financial instruments (€32.2 million).
Pipeline highlights:
Lacutamab (anti-KIR3DL2
antibody):
- TELLOMAK, the ongoing Phase 2 trial of lacutamab in cutaneous
T-cell lymphoma (CTCL), completed enrollment in Q2 2023 (n=170
patients). Final data in Sézary syndrome will be presented in an
oral presentation at the ASH (American Society of Hematology)
Annual Meeting 2023. The Company plans to share the results with
the regulatory authorities. The Company still expects final data
from the mycosis fungoides (MF) cohort in H2 2023.
- The Company announced that it will report positive final data
from the Phase 2 TELLOMAK study in Sézary syndrome at the ASH 2023
Annual Congress on 9 December. The ASH abstract states that the
data demonstrate that lacutamab showed promising clinical activity
and an overall favorable safety profile. In the heavily pre-treated
post-mogamulizumab patient population with an average of six prior
lines of therapy, in the Intention to treat population (ITT), the
global confirmed objective response rate (ORR) was 37.5% (21/56).
Confirmed ORR in the skin was 46.4% (26/56) and confirmed ORR in
the blood was 48.2% (27/56). Median progression-free survival was
8.0 months (95% CI 4.7-21.2). Additional data will be presented at
the ASH 2023 Annual Congress.
- Two parallel clinical trials to study lacutamab in patients
with KIR3DL2-expressing, relapsed/refractory (R/R) peripheral
T-cell lymphoma (PTCL) are ongoing. The Phase 1b trial is a
Company-sponsored clinical trial to evaluate lacutamab as a
monotherapy in patients with KIR3DL2-expressing relapsed PTCL. The
Phase 2 KILT (anti-KIR in T Cell Lymphoma) trial is an
investigator-sponsored, randomized trial by The Lymphoma Study
Association (LYSA) to evaluate lacutamab in combination with
chemotherapy GEMOX (gemcitabine in combination with oxaliplatin)
versus GEMOX alone in patients with KIR3DL2-expressing
relapsed/refractory PTCL.
- Initial data from the Phase 1b trial will be presented in a
poster session at the ASH Annual Meeting 2023. The ASH 2023
abstract states that preliminary Phase 1b data in patients with R/R
PTCL confirm the acceptable safety profile of lacutamab
monotherapy.
- The Phase 2 KILT study is ongoing.
- In October 2023, the US Food and Drug Administration (FDA)
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. The Company is
currently undertaking efforts to address the US FDA requests, which
include incorporation of risk mitigation and management strategies
for hemophagocytic lymphohistiocytosis in ongoing lacutamab
studies.
ANKET® (Antibody-based NK cell Engager
Therapeutics):
ANKET® is Innate’s proprietary platform for developing
next-generation, multi-specific NK cell engagers to treat certain
types of cancer. Innate’s pipeline includes four public drug
candidates born from the ANKET® platform: SAR443579/IPH6101
(CD123-targeted), SAR’514/IPH6401 (BCMA-targeted), IPH62
(B7-H3-targeted) and tetra-specific IPH6501 (CD20-targeted).
Several other undisclosed proprietary preclinical targets are being
explored.
SAR443579/IPH6101, SAR’514/IPH6401 and IPH62 (partnered with
Sanofi)
SAR443579/IPH6101
- The Phase 1/2 clinical trial by Sanofi is progressing well,
evaluating SAR443579 / IPH6101, a trifunctional anti-CD123
NKp46×CD16 NK cell engager and ANKET® platform lead asset, in
patients with relapsed or refractory acute myeloid leukemia (R/R
AML), B-cell acute lymphoblastic leukemia (B-ALL) or high-risk
myelodysplastic syndrome (HR-MDS).
- At ASH 2023, a presentation from the Sanofi oncology pipeline
will report updated efficacy and safety results and show data
across all dose levels tested, including observed clinical
remissions. Abstract details include:
- As of July 5, 2023, 43 patients (42 R/R AML and 1 HR-MDS)
across 8 Dose Levels (DLs) at 10 – 6000 μg/kg/dose were included.
Patients had received a median of 2.0 (1.0 – 10.0) prior lines of
treatment with 13 patients (30.2%) reporting prior hematopoiectic
stem cell transplantation and 36 patients (83.7%) with prior
exposure to venetoclax. In DLs with a highest dose of 1000 μg/kg
QW, 5/15 AML (33.3%) patients achieved a CR (4 CR / 1 CRi) as of
the cut-off date. Data from PK/PD and in vitro mechanistic analyses
studying dose-response relations will also be presented. SAR443579
was well tolerated up to doses of 6000 μg/kg QW with observed
clinical benefit in patients with R/R AML. The results are
consistent with the predicted favorable safety profile.
- Preliminary Pharmacokinetics (PK) and Pharmacodynamic (PD)
Analysis of the CD123 NK Cell Engager SAR’579/IPH6101 in patients
with relapsed or refractory AML, B-ALL or HR-MDS were presented
during the ESMO (European Society for Medical Oncology) Congress
2023. As of the data cut-off on August 7, 2023, two responders
remained in remission after 8.8 and 12.2 months of treatment.
SAR’514/IPH6401
- The Phase 1/2 clinical trial with SAR’514 / IPH6401, a
trifunctional anti-BCMA Nkp46xCD16 NK cell engager, led by Sanofi,
in patients with Relapsed/Refractory Multiple Myeloma (RRMM) and
Relapsed/Refractory Light-chain Amyloidosis (RRLCA) is
ongoing.
IPH62
- As announced on December 19, 2022, Sanofi licensed IPH62, a NK
cell engager program targeting B7-H3 from Innate’s ANKET® platform,
and the company has the option to add up to two additional ANKET®
targets. Upon candidate selection, Sanofi will be responsible for
all development, manufacturing and commercialization. Under the
terms of the agreement, Innate received a €25m upfront payment and
is eligible for up to €1.35bn total in preclinical, clinical,
regulatory and commercial milestones plus royalties on potential
net sales.
IPH6501 (proprietary)
- Following approval of the IND-filing by the FDA in July 2023,
IPH6501, Innate’s proprietary CD20 targeted tetra-specific ANKET®
continues toward a Phase 1 clinical trial in 2023.
Monalizumab (anti-NKG2A antibody),
partnered with AstraZeneca:
- Innate continues to see progress for monalizumab in the early
non-small cell lung cancer (NSCLC) setting, with the ongoing Phase
3 PACIFIC-9 trial run by AstraZeneca. The trial is evaluating
durvalumab (anti-PD-L1) in combination with monalizumab or
AstraZeneca’s oleclumab (anti-CD73) in patients with unresectable,
Stage III NSCLC who have not progressed following definitive
platinum-based concurrent chemoradiation therapy (CRT).
IPH5201 (anti-CD39), partnered with
AstraZeneca:
- The MATISSE Phase 2 clinical trial conducted by Innate in
neoadjuvant lung cancer for IPH5201, an anti-CD39 blocking
monoclonal antibody developed in collaboration with AstraZeneca, is
ongoing and recruitment is on track.
IPH5301 (anti-CD73):
- The investigator-sponsored CHANCES Phase 1 trial of IPH5301 by
Institut Paoli-Calmettes is ongoing.
Antibody Drug
Conjugates:
Fueling its R&D engine, the Company continues to develop
different approaches for the treatment of cancer utilizing its
antibody engineering capabilities to deliver novel assets, with its
innovative ANKET® platform and continuing to explore Antibody Drug
Conjugates (ADC) formats. Beyond its proprietary programs, the
Company has an ongoing agreement with Takeda on ADCs.
IPH45 (Nectin-4 ADC):
- IPH45 is Innate’s proprietary Nectin-4 targeting antibody drug
conjugate including a Topoisomerase I inhibitor payload. IPH45
continues toward a Phase 1 clinical trial.
Corporate update
- Dr. Sonia Quaratino, MD, PhD, has been appointed as Executive
Vice President and Chief Medical Officer of Innate Pharma,
effective October 2023. Dr. Quaratino brings over 25 years of
experience in basic research, clinical development, and
translational medicine, having worked in academia, global large
pharmaceuticals, and biotechs. Recently, Dr. Quaratino was Chief
Medical Officer at Georgiamune INC.(USA) and prior to that she was
Chief Medical Officer at Kymab (UK), a clinical-stage
biopharmaceutical company with a focus on immune-mediated diseases
and immuno-oncology, acquired by Sanofi in 2021. Previously, she
held roles at Novartis (Switzerland) and Merck Serono (Germany) and
was Professor of Immunology in UK at the University of Southampton.
Her research has been published in high impact scientific
journals.
- On April 26, 2023, Innate announced the establishment of an
At-The-Market (ATM) program, pursuant to which it may, from time to
time, offer and sell to eligible investors a total gross amount of
up to $75 million American Depositary Shares (“ADS”). Each ADS
representing one ordinary share of Innate. As of September 30,
2023, the balance available under our April 2023 sales agreement
remains at $75 million.
Financial Results:
Cash, cash equivalents and financial assets of the Company
amounted to €121.9 million as of September 30, 2023. At the same
date, financial liabilities amounted to €40.3 million.
Revenues for the first nine months of 2023 amounted to €36.5
million (€44.3 million for the same period in 2022). For the
nine-month period, ended September 30, 2023, revenue from
collaboration and licensing agreements mainly results from the
partial or entire recognition of the proceeds received pursuant to
the agreements with AstraZeneca, Sanofi and Takeda.
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231113498888/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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