-- IPH4502 Nectin-4 ADC Phase 1 enrollment progressing well: Preclinical update and Trial In Progress presented at AACR Annual Meeting 2025 and ASCO 2025 Annual Meeting. -- Lacutamab BTD and Phase 3 preparation: FDA Breakthrough Therapy Designation (BTD) in February 2025 based on long-term follow-up data from the TELLOMAK clinical study presented at ASCO Annual Meeting 2025. Preparation of the confirmatory Phase 3 trial protocol is close to completion, following discussions with the FDA and EMA. -- Monalizumab: AstraZeneca Phase 3 PACIFIC-9 enrollment is completed and high level read-out is expected in H2 2026. -- Strategic focus: Innate Pharma plans to prioritize its investment in what it believes are its highest-value clinical assets, IPH4502, lacutamab, and monalizumab (partnered with AstraZeneca); its preclinical research and development (R&D) efforts will focus on advancing the next ADCs toward development, leveraging its pipeline of innovative targets. In line with such strategic focus and its objectives, the Company intends to streamline its organization. Staffing levels are expected to decrease overall by about 30%. -- Corporate update: Eric Vivier has decided to return to academic research full-time, and he will continue to support the Company's innovation as an advisor to the R&D Committee of the Board of Directors. As Chief Operating Officer $(COO)$, Yannis Morel will continue to be responsible for preclinical research and development, and will assume Chief Scientific Officer (CSO) responsibilities. -- EUR15m equity investment by Sanofi in April 2025, in addition to the ongoing partnership with Sanofi, which includes the development of the BCMA targeting ANKET$(R)$ program in autoimmune indications. -- Cash position of EUR70.4 million1 as of June 30, 2025, anticipated cash runway until end Q3-2026. -- Conference call to be held today at 2:00 p.m. CEST / 8:00 a.m. EDT. MARSEILLE, France--(BUSINESS WIRE)--September 17, 2025--
Regulatory News:
Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") today reported its consolidated financial results for the six months ended June 30, 2025. The consolidated financial statements are attached to this press release.
"With key milestones anticipated over the next 12 months, our primary focus will be on progressing what we believe are our most promising and highest-value clinical assets and advancing our next ADCs toward development. In line with this strategic focus and in a challenging funding environment, we are taking necessary action to focus our resources on what we believe are the programs with the highest potential to deliver value for both patients and shareholders, and we therefore plan to streamline the size of the organization," said Jonathan Dickinson, Chief Executive Officer of Innate Pharma. "We made meaningful progress during the first half of the year in our pipeline and are determined to build on this momentum. At ASCO, we presented a Trial In Progress for our Nectin-4 ADC, IPH4502, which is progressing rapidly through Phase 1 enrollment; and we shared long-term follow-up data for lacutamab, for which preparation of the confirmatory Phase 3 trial protocol is close to completion, following discussions with the FDA and EMA. Looking ahead, we have a number of important catalysts, including first patient data for IPH4502 in H1 2026, and high level read-out of AstraZeneca's PACIFIC-9 Phase 3 trial with monalizumab in H2 2026."
____________________ (1) Including short term investments (EUR6.3 million) and non-current financial instruments (EUR10.4 million) Webcast and conference call will be held today at 2:00 p.m. CEST (8:00 a.m. ET) Access to live webcast: https://events.q4inc.com/attendee/642492835 Participants may also join via telephone using the registration link below: https://registrations.events/direct/Q4I970472 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:
Strategic focus
Innate Pharma plans to prioritize its investment on what it believes are its highest-value clinical assets, IPH4502, lacutamab, and monalizumab (partnered with AstraZeneca); its preclinical research and development (R&D) efforts will focus on advancing the next Antibody Drug Conjugates (ADCs) toward development, leveraging its pipeline of innovative targets.
IPH4502 (Nectin-4 ADC, proprietary):
IPH4502 is Innate's novel and differentiated topoisomerase I inhibitor ADC targeting Nectin-4.
-- The first patient was dosed in a Phase 1 study in January 2025. The Phase 1 study will assess the safety, tolerability, and preliminary efficacy of IPH4502 in advanced solid tumors known to express Nectin-4, including but not limited to urothelial carcinoma, non-small cell lung, breast, ovarian, gastric, esophageal, and colorectal cancers. The study plans to enroll approximately 105 patients. A Trial in Progress Poster was shared at the ASCO Annual Meeting in June 2025. Enrollment is in progress and expected to be completed at the end of 2025 or in the first quarter of 2026. -- New preclinical data were presented at the American Association for Cancer Research (AACR) Annual Meeting 2025. IPH4502 demonstrated superior preclinical anti-tumor activity compared to enfortumab vedotin (EV) in urothelial carcinoma (UC) models with low or heterogeneous Nectin-4 expression, as well as in models resistant to EV. Beyond UC, IPH4502 also exhibited anti-tumor activity in preclinical models of triple-negative breast cancer, head and neck squamous cell carcinoma, and esophageal cancer, suggesting broader potential clinical applicability.
Lacutamab (anti-KIR3DL2 antibody, proprietary):
Cutaneous T Cell Lymphoma
-- In February 2025, the FDA granted Breakthrough Therapy Designation to lacutamab for relapsed or refractory Sézary syndrome (SS) based on TELLOMAK Phase 2 results demonstrating efficacy and a favorable safety profile in patients with advanced SS, heavily pretreated, post-mogamulizumab. Breakthrough Therapy Designation is intended to accelerate the development and regulatory review in the U.S. of drugs that are intended to treat a serious condition. -- At the 2025 ASCO Annual Meeting, updated long-term data from the Phase 2 TELLOMAK trial reinforced the clinical activity and durability of lacutamab in relapsed/refractory SS and mycosis fungoides (MF). In SS, lacutamab achieved a 42.9% ORR with a median duration of response of 25.6 months, while in MF, responses were observed regardless of KIR3DL2 expression, with a median PFS of 10.2 months. Across both cohorts, lacutamab was well tolerated, with no safety concerns and sustained improvements in quality of life. -- Preparation of the confirmatory Phase 3 trial protocol is close to completion, following discussions with the FDA and EMA. Innate is evaluating potential paths forward to advance lacutamab toward Phase 3 initiation, including discussions with partners and investors.
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, to evaluate lacutamab in combination with GEMOX (gemcitabine and oxaliplatin) chemotherapy versus GEMOX alone, in patients with KIR3DL2-expressing relapsed/refractory PTCL, is ongoing and continues to recruit patients.
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. Enrollment in the trial is completed, and high level read-out is expected in H2 2026. -- At the ASCO Annual Meeting in June 2025, AstraZeneca presented updated results from the Phase 2 NeoCOAST-2 trial evaluating neoadjuvant and adjuvant durvalumab-based combinations in resectable NSCLC. The regimen including durvalumab, monalizumab, and chemotherapy (Arm 2, n=70) showed 25.7% pathological complete response (pCR) and 50.0% major pathologic response (mPR).
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.
IPH6501 (ANKET(R) anti-CD20 with IL-2V, proprietary)
-- The Phase 1/2 clinical trial is evaluating IPH6501 in B-cell Non-Hodgkin's lymphoma (B-NHL). The study is planned to enroll up to 184 patients. Clinical sites are open in the US, Australia, and France. The dose escalation phase in the trial has been completed. Limited signals of activity were observed during the escalation phase, and maximum tolerated dose $(MTD)$ is currently being explored to further assess clinical relevance. Clinical data are expected in late 2025 or beginning of 2026.
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