Innate Pharma Third Quarter 2021 Report
16 Novembre 2021 - 7:00AM
Business Wire
- Monalizumab in combination with durvalumab significantly
delayed disease progression in AstraZeneca’s randomized Phase 2
COAST study in unresectable, Stage III NSCLC, advancing to Phase
3
- Pre-clinical data presented at SITC with Sanofi from the
lead next-generation NK cell engager platform, ANKET™ targeting
CD123 in acute myeloid leukemia
- Cash position of €141.8million1 as of September 30,
2021
- Conference call to be held today at 2:00 p.m. CET / 8:00
a.m. ET
Regulatory News:
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 2021.
“In the period, we continued to execute against our strategic
priorities as we reported readouts from two of our partnered
portfolio programs. This included randomized Phase 2 data for
monalizumab in combination with durvalumab in unresectable, Stage
III NSCLC as well as pre-clinical data from our lead ANKET molecule
targeting CD123 in acute myeloid leukemia. These readouts continue
to set the stage for delivering both near and long-term value,
while also highlighting the strength and depth of our core R&D
efforts,” said Mondher Mahjoubi, Chief Executive Officer of
Innate Pharma. “Looking ahead, we will continue to advance our
lacutamab development program and move our early-stage R&D
activities towards the clinic with our next generation ANKET
platform. We also look forward to seeing AstraZeneca’s upcoming
plans for monalizumab’s registrational study in unresectable, Stage
III NSCLC, which further reinforces our strategy of building a
sustainable business with a robust R&D engine.”
Webcast and conference call
will be held today at 2:00 p.m. CET (8:00 a.m. ET) The live
webcast will be available at the following link:
https://event.on24.com/wcc/r/3492971/A9D12AE41D08D16F4096ACD3C27EC089
Participants may also join via telephone using the following dial
in numbers: France dial-in number: +33 8056 20 704 United States:
+1 646 904 5544 All other locations: +1 929 526 1599 Access code:
043615 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 following the
event.
Pipeline highlights:
Monalizumab (anti-NKG2A antibody),
partnered with AstraZeneca:
- In September, AstraZeneca presented a late-breaker abstract on
the randomized COAST Phase 2 trial in patients with unresectable,
Stage III non-small cell lung cancer (NSCLC) at the European
Society for Medical Oncology (ESMO) Congress. The presentation
highlighted progression-free survival (PFS) and overall response
rate (ORR) results for durvalumab in combination with monalizumab,
Innate’s lead partnered asset, and oleclumab, AstraZeneca’s
anti-CD73 monoclonal antibody. After a median follow-up of 11.5
months, the results of an interim analysis showed a 10-month PFS
rate of 72.7% for durvalumab plus monalizumab, versus 39.2% with
durvalumab alone in unresectable, Stage III NSCLC patients
following chemoradiation therapy. The results also showed an
increase in the primary endpoint of confirmed ORR for durvalumab
plus monalizumab over durvalumab alone (36% vs. 18%).
- Based on the data, AstraZeneca announced plans to initiate a
Phase 3 trial for both combinations of monalizumab or oleclumab
plus durvalumab in the unresectable, Stage III NSCLC setting for
patients who had not progressed after concurrent chemoradiation
therapy.
- Separately, AstraZeneca also announced that it is starting a
Phase 2 clinical trial, NeoCOAST-2, that includes a treatment arm
with durvalumab in combination with chemotherapy and monalizumab in
resectable, early-stage NSCLC.
- Innate will present data from the Phase 2 expansion cohort
(‘cohort 3’), exploring the combination of monalizumab, cetuximab
and durvalumab in first-line IO naïve patients with
recurrent/metastatic squamous cell carcinoma of the head and neck,
which was accepted as a mini oral presentation at the ESMO
Immuno-Oncology (ESMO-IO) conference in December 2021.
Lacutamab (anti-KIR3DL2
antibody):
- Two parallel clinical trials to study lacutamab in patients
with KIR3DL2-expressing, relapsed/refractory peripheral T-cell
lymphoma (PTCL) are initiating:
- 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) plans to initiate an
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.
ANKET™ (Antibody-based NK cell Engager
Therapeutics):
IPH6101/SAR443579
- In November Innate and Sanofi shared new data on
IPH6101/SAR443579 at the Society for Immunotherapy of Cancer (SITC)
conference. IPH6101/SAR443579 is the first NKp46/CD16-based NK cell
engager using Innate’s proprietary ANKET™ multispecific antibody
format that targets CD123 on acute myeloid leukemia (AML) cells and
co-engages NKp46 and CD16a on NK cells. IPH6101/SAR443579
demonstrated potent antitumor activity against AML cell lines and
primary AML blasts, including those resistant to ADCC by a
comparator anti-CD123 antibody. IPH6101/SAR443579 also promoted
strong and specific NK-cell activation and induced cytokine
secretion only in the presence of AML target cells. In addition,
IPH6101/SAR443579 had sustained pharmacodynamic effects in
non-human primates, combining efficient depletion of
CD123-expressing cells with minor cytokine release and a favorable
safety profile in comparison to T-cell engagers.
Tetra-specific ANKET
- In September and November 2021, Innate also presented at the
ESMO 2021 and SITC conferences respectively. Innate shared data
from its tetra-specific ANKET molecule, which is the first NK cell
engager technology to engage two NK cell activating receptors
(NKp46 and CD16), a cytokine receptor (IL-2Rb) and a tumor antigen
via a single molecule. In preclinical studies, the tetra-specific
ANKET demonstrated in vitro the ability to induce human NK cell
proliferation, cytokine production and cytolytic activity against
cancer cells expressing the targeted antigen. The tetra-specific
ANKET also demonstrated in vivo anti-tumor efficacy in several
tumor models, allowing regression of established tumors as well as
control of metastasis, associated with increased NK cell
infiltration, cytokine and chemokine production at the tumor site.
ANKET also showed a pharmacodynamic effect, low systemic cytokine
release and a manageable safety profile in non-human primates.
IPH5201 (anti-CD39):
- AstraZeneca is conducting a Phase 1 trial in solid tumors with
IPH5201 alone or in combination with durvalumab. The data is
expected to be presented in 2022.
IPH5301 (anti-CD73):
- The Company is initiating an investigator-sponsored Phase 1
trial of IPH5301 in collaboration with the Institut
Paoli-Calmettes.
Financial Results:
Cash, cash equivalents and
financial assets of the Company amounted to €141.8 million as of
September 30, 2021. At the same date, financial liabilities
amounted to €16.1 million.
Revenues for the first nine
months of 2021 amounted to €10.3 million (€33.6 million for the
same period in 2020). For the nine-month period, ended September
30, 2021, revenue from collaboration and licensing agreements
mainly results from the spreading of the payments received under
our agreements with AstraZeneca and Sanofi.
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, 2020, 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 (€15.8
million) and non-current financial instruments (€39.9 million)
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version on businesswire.com: https://www.businesswire.com/news/home/20211115006329/en/
Investors Henry Wheeler +33
761 88 38 74 Henry.Wheeler@innate-pharma.fr
Media Tracy Rossin
(Global/US) +1 240 801 0076 Tracy.Rossin@innate-pharma.com
ATCG Press Marie Puvieux (France) +33 (0)9 81 87 46 72
innate-pharma@atcg-partners.com
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