Innate Pharma(US:IPHA)2025-10-28 13:00Summary of Innate Pharma Update / Briefing (October 28, 2025) Company Overview - Innate Pharma is a biotechnology company with 26 years of experience, specializing in monoclonal antibody engineering and developing a clinical pipeline to address high unmet medical needs [3][4] Key Assets and Strategy - The company has refocused its strategy on three priority assets: 1. Lacutamab: An anti-KIR3DL2 antibody targeting cutaneous T cell lymphoma (CTCL) with breakthrough therapy designation from the FDA [6][7] 2. Monalizumab: In collaboration with AstraZeneca, currently in a Phase III study (PACIFIC-nine) with expected data in 2026 [8][9] 3. IPH4502: A novel antibody-drug conjugate (ADC) targeting NETIN4, with ongoing Phase I study and early clinical activity [10][12] Clinical Development and Regulatory Path - Lacutamab: - Targets CTCL, specifically mycosis fungoides and Sézary syndrome, with an accelerated path to approval agreed with the FDA [7][13] - A confirmatory Phase III study is planned to validate the indications and is expected to initiate in 2026 [17][73] - Anticipated regulatory milestones include: - Accelerated approval for Sézary syndrome in 2027 - Full approval for mycosis fungoides and Sézary syndrome in 2029 [81] - Monalizumab: - The PACIFIC-nine study has completed enrollment and passed a futility analysis, with significant potential financial milestones [9] - IPH4502: - Expected to provide early efficacy and safety data by the end of 2023 or early 2024 [12] Market Opportunity and Commercial Insights - The company has identified a significant commercial opportunity for lacutamab based on new claims data, indicating a larger market than previously estimated [17] - The CTCL market analysis conducted by ZS Associates highlights the prevalence and treatment patterns, emphasizing the need for effective therapies [85] Unmet Medical Needs in CTCL - CTCL, particularly Sézary syndrome and mycosis fungoides, presents significant unmet medical needs due to poor prognosis and limited effective therapies [21][46] - Current therapies often lack durable responses, leading to a need for continuous treatment and management of symptoms [47][49] - Lacutamab is positioned to address these needs with a favorable safety profile and potential for profound responses [71][72] Clinical Data Highlights - TELEMAC Study: Demonstrated rapid response rates and significant improvements in quality of life for patients with Sézary syndrome and mycosis fungoides [61][63] - Lacutamab showed a median time to global response of 2.8 months and a median duration of response of nearly 14 months in mycosis fungoides [63] Conclusion - Innate Pharma is strategically positioned to advance lacutamab through clinical trials and regulatory pathways, addressing significant unmet needs in the CTCL market while leveraging its expertise in monoclonal antibody development [4][73]