Innate Pharma Reports Third Quarter 2024 Business Update and Financial Results
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Jonathan Dickinson appointed Chief Executive Officer and Chairman of
the Executive Board
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Encouraging initial FDA feedback received on lacutamab regulatory
pathway
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Lacutamab health-related quality of life and translational data to be
presented at the upcoming ASH Annual Meeting
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IPH4502, a Nectin-4 ADC received FDA clearance of the IND to be
developed in solid tumors
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Preclinical data for proprietary tetra-specific NK cell engager IPH6501
and novel ADC IPH4502 presented at SITC
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Cash position of EUR96.4 million1 as of September 30, 2024, anticipated
cash runway to end of 2025
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Conference call to be held today at 2:00 p.m. CET / 8:00 a.m. ET
MARSEILLE, France--(BUSINESS WIRE)--November 13, 2024--
Regulatory News:
Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") today announced its business update and financial results for the first nine months of 2024.
"I'm honored to join Innate Pharma at such a pivotal moment in its evolution," said Jonathan Dickinson, Chief Executive Officer of Innate Pharma. "We achieved notable regulatory milestones during the quarter including encouraging initial feedback from the FDA for lacutamab's development plans and the IND approval for IPH4502, our nectin-4 ADC, which paves the way for its entry into clinical development. With presentations at ASH and SITC showcasing the depth of our translational science and patient-centered data, we are well-positioned to advance our mission of bringing transformative treatments to patients. Our cash position, with runway to the end of 2025, allows us to continue driving forward, and I am excited to lead the Company into its next phase of growth."
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/381945831 Participants may also join via
telephone using the following registration link:
https://registrations.events/direct/Q4I280043 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.
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(1) Including short term investments (EUR14.0 million) and non-current
financial instruments (EUR10.3 million).
Pipeline highlights:
Lacutamab (anti-KIR3DL2 antibody):
Cutaneous T Cell Lymphoma
TELLOMAK is a global, open-label, multi-cohort Phase 2 clinical trial evaluating lacutamab in patients with Sézary syndrome and mycosis fungoides.
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During the financial quarter ending September 30, 2024, the FDA
provided encouraging initial feedback on the Company's proposed
regulatory pathway, which could potentially include Accelerated Approval
for Sézary syndrome, and the Company continues to align with the FDA
around the confirmatory Phase 3 trial.
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Results from the study in Sézary syndrome and mycosis fungoides
were presented at the American Society of Hematology $(ASH)$ 2023 Annual
Meeting and the American Society of Clinical Oncology (ASCO) 2024 Annual
Meeting respectively.
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Quality of life data and translational analysis from the TELLOMAK trial
in patients with relapsed/refractory cutaneous T-cell lymphoma will be
presented at the ASH Annual Meeting 2024.
Peripheral T Cell lymphoma (PTCL)
The Phase 2 KILT (anti-KIR in T Cell Lymphoma) trial, an investigator-sponsored, randomized controlled trial led by the Lymphoma Study Association (LYSA) to evaluate lacutamab in combination with chemotherapy GEMOX (gemcitabine and oxaliplatin) versus GEMOX alone in patients with KIR3DL2-expressing relapsed/refractory PTCL is ongoing and continues to recruit patients.
ANKET$(R)$ (Antibody-based NK cell Engager Therapeutics):
ANKET(R) is Innate's proprietary platform for developing next-generation, multi-specific NK cell engagers to treat certain types of cancer. Innate's pipeline includes five drug candidates that have merged from the ANKET(R) platform: SAR443579/IPH6101 (SAR'579; trifunctional anti-CD123 NKp46xCD16 NKCE), SAR445514/IPH6401 (SAR'514 trifunctional anti-BCMA NKp46xCD16 NKCE), IPH62 (anti-B7-H3), IPH67 (target undisclosed, solid tumors) and tetra-specific IPH6501 (anti-CD20 with IL-2v). Several other undisclosed proprietary preclinical targets are being explored.
IPH6501 (proprietary)
IPH6501 is Innate's proprietary tetra-specific second-generation ANKET(R) targeting CD20 with an IL-2v. The Phase 1/2 clinical trial evaluating IPH6501 in B cell Non-Hodgkin's lymphoma (B-NHL) is ongoing and enrolling patients.
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Preclinical data supporting the evaluation of IPH6501 in relapsed or
refractory B-NHL subtypes and post-CAR-T therapy were presented at the
Society for Immunotherapy of Cancer $(SITC)$ 2024 Annual Meeting.
SAR'579/IPH6101, SAR'514/IPH6401, IPH62 and IPH67 (partnered with Sanofi)
SAR'579/IPH6101
The Phase 1/2 clinical trial by Sanofi is progressing well, evaluating SAR'579 / IPH6101, a trifunctional anti-CD123 NKp46xCD16 NK-cell engager and ANKET(R) platform lead asset, in patients with relapsed or refractory acute myeloid leukemia $(AML.UK)$, B-cell acute lymphoblastic leukemia (B-ALL) or high-risk myelodysplastic syndrome (HR-MDS).
SAR'514/IPH6401
The Sanofi led Phase 1/2 clinical trial with SAR'514 / IPH6401, a trifunctional anti-BCMA Nkp46xCD16 NK-cell engager, in patients with Relapsed/Refractory Multiple Myeloma and Relapsed/Refractory Light-chain Amyloidosis is ongoing.
IPH62, IPH67 and option
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IPH62 is a NK-cell engager program targeting B7-H3 under development
from Innate's ANKET(R) platform. Following a research collaboration
period and upon candidate selection, Sanofi will be responsible for all
development, manufacturing and commercialization.
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During the third quarter of 2024, Sanofi terminated the IPH67 license
during the research collaboration period. As a consequence, Innate plans
to regain the full rights to IPH67, an NK-cell engager program in solid
tumors from Innate's ANKET(R) platform. The rest of the 2022 research
collaboration and license agreement remains unchanged.
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Sanofi still retains the option of one additional ANKET(R) target under
the terms of the 2022 research collaboration and license agreement.
Antibody Drug Conjugates:
Innate is leveraging its antibody engineering capabilities and is also exploring Antibody Drug Conjugates $(ADC)$ formats.
IPH4502 (Nectin-4 ADC):
IPH4502 is Innate's novel and differentiated topoisomerase I inhibitor ADC targeting Nectin-4.
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In September, the U.S Food and Drug Administration (FDA) cleared
Innate's investigational new drug $(IND.AU)$ application to initiate a Phase 1
clinical study of IPH4502 in Nectin-4 expressing solid tumor indications.
Innate expects to initiate the Phase 1 study by Q1 2025.
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The Phase 1, open-label, multi-center study, will include a Part
1 Dose Escalation and a Part 2 Dose Optimization, and will assess
the safety, tolerability, and preliminary efficacy of IPH4502 as a
single agent in advanced solid tumors known to express Nectin-4,
including but not limited to urothelial carcinoma, non-small cell
lung, breast, ovarian, gastric and colorectal cancers.
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Preclinical data of IPH4502 in Nectin-4 expressing tumors were
presented at the SITC 2024 Annual Meeting.
Monalizumab (anti-NKG2A antibody), partnered with AstraZeneca:
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The Phase 3 PACIFIC-9 trial run by AstraZeneca 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 $(CRT)$ is ongoing. This
follows the Independent Data Monitoring Committee recommendation for the
continuation of the Phase 3 PACIFIC-9 trial based on a pre-planned
analysis.
IPH5201 (anti-CD39), partnered with AstraZeneca:
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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. Following a pre-planned interim analysis, the MATISSE Phase
2 trial continues according to plans.
IPH5301 (anti-CD73):
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The investigator-sponsored CHANCES Phase 1 trial of IPH5301 by Institut
Paoli-Calmettes is ongoing.
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