On November 13, 2024 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported its business update and financial results for the first nine months of 2024 (Press release, Innate Pharma, NOV 13, 2024, View Source
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"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 (Free ASH Whitepaper) and SITC (Free SITC Whitepaper) 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:
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Participants may also join via telephone using the following registration link:
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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 (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.
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.
Results from the study in Sézary syndrome and mycosis fungoides were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2023 Annual Meeting and the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2024 Annual Meeting respectively.
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 (Free ASH Whitepaper) 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 (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 five drug candidates that have merged from the ANKET 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 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.
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) (Free SITC Whitepaper) 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 platform lead asset, in patients with relapsed or refractory acute myeloid leukemia (AML), 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
IPH62 is a NK-cell engager program targeting B7-H3 under development from Innate’s ANKET platform. Following a research collaboration period and upon candidate selection, Sanofi will be responsible for all development, manufacturing and commercialization.
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 platform. The rest of the 2022 research collaboration and license agreement remains unchanged.
Sanofi still retains the option of one additional ANKET 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.
In September, the U.S Food and Drug Administration (FDA) cleared Innate’s investigational new drug (IND) 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.
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.
Preclinical data of IPH4502 in Nectin-4 expressing tumors were presented at the SITC (Free SITC Whitepaper) 2024 Annual Meeting.
Monalizumab (anti-NKG2A antibody), partnered with AstraZeneca:
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:
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):
The investigator-sponsored CHANCES Phase 1 trial of IPH5301 by Institut Paoli-Calmettes is ongoing.
Corporate update
The Supervisory Board appointed Jonathan Dickinson as the Company’s new Chief Executive Officer (CEO) and Chairman of the Executive Board, effective November 1, 2024. Jonathan Dickinson succeeds Hervé Brailly, co-founder of the Company, who was interim CEO, during the search process.
Jonathan Dickinson most recently served as Executive Vice President and General Manager, Europe at Incyte, a role he held since 2016. Prior to Incyte, he gained significant leadership experience through several senior positions at ARIAD Pharmaceuticals, a US oncology focused biotechnology company and Bristol-Myers Squibb. This followed a distinguished 13-year tenure at Hoffmann-La Roche, where he was instrumental in driving the success of several of the company’s flagship oncology therapies. Mr. Dickinson began his career at Novartis, holding roles of increasing responsibility within the oncology and endocrinology divisions. He holds a Bachelor of Science degree in Genetics and a Master of Business Administration from the University of Nottingham.
The 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 of American Depositary Shares ("ADS") is still in place. As of September 30, 2024, no sales have been made under the program.
Financial Results
Cash, cash equivalents and financial assets of the Company amounted to €96.4 million as of September 30, 2024. At the same date, financial liabilities amounted to €33.2 million.
Revenues for the first nine months of 2024 amounted to €10.2 million (€36.5 million for the same period in 2023). For the nine-month period, ended September 30, 2024, revenue from collaboration and licensing agreements mainly resulted from the partial or entire recognition of the proceeds received pursuant to the agreements with AstraZeneca and Sanofi.