- First patient dosed in monalizumab Phase 3 lung cancer
trial, PACIFIC-9 sponsored by AstraZeneca, which triggered a $50
million milestone payment extending Company cash runway into
2024
- Monalizumab data presented by AstraZeneca at AACR and in
Journal of Clinical of Oncology
- Cash position to €131.7 million1 as of March 31, 2022 (not
including the $50 million payment from AstraZeneca)
- Conference call to be held today at 2:00 p.m. CEST / 8:00
a.m. EDT
Regulatory News:
Innate Pharma SA (Euronext Paris:
IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today
reported its consolidated financial results for the quarter ending
March 31, 2022.
“Again this quarter we made
significant progress in our pipeline in particular with the
presentation of positive data and clinical progress with our
anti-NKG2A, monalizumab. We also saw a $50 million milestone from
AstraZeneca triggered due to the first patient dosed in April in
the Phase 3 lung cancer trial. This means our cash position is
considerably strengthened to fund our pipeline ambitions into
2024,” said Mondher Mahjoubi, Chief Executive Officer of Innate
Pharma. “We look forward to additional clinical milestones this
year from our broad antibody pipeline, specifically readouts for
lacutamab in the second half and further progress on ANKETTM, as we
leverage scientific expertise and strong partnerships to deliver
innovative treatments for people with cancer.”
Webcast and
conference call will be held today at 2:00pm CEST (8:00am
EDT)
The live webcast
will be available at the following link: https://event.on24.com/wcc/r/3759098/7B02319F4F19D3C195707D21AF02B664
Participants may
also join via telephone using the dial-in details below: France:
0805 620 704 United States: 1 844 200 6205 / 1 646 904 5544 United
Kingdom: 44 208 0682 558 All other locations: +1 929 526 1599
Access code: 051477
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.
Pipeline highlights:
Lacutamab
(IPH4102, anti-KIR3DL2 antibody):
- The Phase 2 TELLOMAK study in Sézary syndrome and mycosis
fungoides (MF) continues to progress and the Company expects to
report preliminary data from both cohorts in the second half of
2022. In March 2022, Innate announced the opening of a new MF
all-comers cohort in the TELLOMAK study. The all-comers cohort will
be recruiting both KIR3DL2 expressors and non-expressors to explore
the correlation between the level of KIR3DL2 expression and
treatment outcomes utilizing a formalin-fixed paraffin embedded
(FFPE) assay as a potential companion diagnostic.
- Two clinical trials are underway evaluating lacutamab in
patients with KIR3DL2-expressing, relapsed/refractory peripheral
T-cell lymphoma (PTCL):
- Phase 1b trial: a Company-sponsored Phase 1b clinical trial to
evaluate lacutamab as a monotherapy in patients with
KIR3DL2-expressing relapsed PTCL.
- Phase 2 KILT (anti-KIR in T Cell Lymphoma) trial: The Lymphoma
Study Association (LYSA) investigator-sponsored, randomized trial
to evaluate lacutamab in combination with chemotherapy GEMOX
(gemcitabine in combination with oxaliplatin) versus GEMOX alone in
patients with KIR3DL2-expressing relapsed/refractory PTCL.
ANKETTM (Antibody-based NK cell Engager
Therapeutics):
- Recruitment continues in the Phase 1/2 clinical trial by Sanofi
evaluating IPH6101/SAR443579, the first NKp46/CD16-based NK cell
engager, 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).
- IPH64, the second ANKETTM drug candidate of the research
collaboration with Sanofi, is progressing and the Company looks
forward to updates on this asset.
- Innate will provide updates on IPH65, the tetra-specific
ANKETTM, throughout the year as progress is made toward an
IND-enabling study in 2023.
Monalizumab (anti-NKG2A antibody),
partnered with AstraZeneca:
- On April 29, 2022, Innate announced a $50 million milestone
payment from AstraZeneca was triggered for dosing the first patient
in the Phase 3 clinical trial, PACIFIC-9, evaluating durvalumab
(anti-PD-L1) in combination with monalizumab or AstraZeneca’s
oleclumab (anti-CD73) in patients with unresectable, Stage III
non-small cell lung cancer (NSCLC) who have not progressed
following definitive platinum-based concurrent chemoradiation
therapy (CRT). This is a post-period event.
- Detailed results from the randomized AstraZeneca-sponsored
Phase 2 COAST clinical trial, including monalizumab data in
combination with durvalumab, were published in the Journal of
Clinical Oncology on April 22, 2022. The results were initially
presented during the European Society for Medical Oncology (ESMO)
Congress 2021. The results of the interim analysis showed
monalizumab in combination with durvalumab improved
progression-free survival (PFS) and objective response rate (ORR)
compared to durvalumab alone in patients with unresectable, Stage
III non-small cell lung cancer (NSCLC) who had not progressed after
concurrent chemoradiation therapy (CRT). The Journal of Clinical
Oncology publication now includes exploratory subgroup
analysis.
- An oral presentation on April 11, 2022 at the American
Association for Cancer Research (AACR) Annual Meeting from the
AstraZeneca-sponsored Phase 2 NeoCOAST randomized trial in
resectable, early-stage NSCLC highlighted improved disease
responses with durvalumab in combination withmonalizumab, oleclumab
or danvatirsen, when compared to durvalumab alone. The follow-up
randomized clinical trial, NeoCOAST-2, is enrolling patients with
resectable, stage IIA-IIIA NSCLC to receive neoadjuvant durvalumab
combined with chemotherapy and either oleclumab or monalizumab,
followed by surgery and adjuvant durvalumab plus oleclumab or
monalizumab.
- The AstraZeneca-sponsored Phase 3 INTERLINK-1 trial of
monalizumab plus cetuximab in immuno-oncology-pretreated head and
neck cancer is ongoing with final data expected in 2024.
IPH5201 (anti-CD39), partnered with
AstraZeneca:
- Data for the Phase 1 trial in solid tumors with IPH5201 alone
or in combination with durvalumab (PD-L1) are expected to be
presented in 2023.
IPH5301 (anti-CD73):
- In March 2022, The Institut Paoli-Calmettes announced that the
first patient had been dosed in the investigator-sponsored Phase 1
trial of IPH5301 (CHANCES). The trial will be conducted in two
parts, Part 1, the dose escalation, followed by a Part 2 safety
expansion study cohort. Part 2 will evaluate IPH5301 in combination
with chemotherapy and trastuzumab in HER2+ cancer patients.
ATM program:
- On May 05, 2022, Innate announced the commencement 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.
Financial
Results:
Cash, cash equivalents and financial assets
of the Company amounted to €131.7 million as of March 31, 2022. At
the same date, financial liabilities amounted to €43.8 million.
Cash, cash equivalents and financial assets as of March 31, 2022 do
not include the $50.0 million payment to be received from
AstraZeneca.
Revenues for the first three months of 2022
amounted to €2.6 million (€4.5 million for the same period in
2021). For the three-month period, ended March 31, 2022, revenue
from collaboration and licensing agreements mainly results from the
spreading of the payments received under our agreements with
AstraZeneca.
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,
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, 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 Including short term investments
(€16.3 million) and non-current financial instruments (€38.8
million). Not including PACIFIC-9 milestone payment to be received
by the Company.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220509005822/en/
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 ATCG Press Marie
Puvieux (France) Tel.: +33 981 87 46 72
innate-pharma@atcg-partners.com
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