Slide 1: Lacutamab in Patients with Advanced Mycosis Fungoides According to KIR3DL2 Expression
LACUTAMAB IN PATIENTS WITH ADVANCED MYCOSIS FUNGOIDES ACCORDING TO KIR3DL2 EXPRESSION STAGE 1 RESULTS FROM THE TELLOMAK PHASE 2 TRIAL Martine Bagot1, Youn H Kim2, Pablo L Ortiz-Romero3, Pier Luigi Zinzani4, Marie Beylot-Barry5, Stéphane Dalle6, Eric Jacobsen7, Andrea Combalia8, Auris Huen9, Neha Meh
Slide 2: M. Bagot Disclosures
M. BAGOT DISCLOSURES • Employment or leadership position: N/A • Consultant or advisory role: Innate Pharma, Kyowa Kirin, Takeda, Galderma, Helsinn/Recordati • Stock ownership: N/A • Honoraria: N/A • Research funding: N/A • Other remuneration: N/A
Slide 3: Lacutamab: KIR3DL2 targeted treatment in T-Cell Lymphoma
Lacutamab KIR3DL2 targeted treatment in T-Cell Lymphoma • Lacutamab • Potential first-in-class humanized anti-KIR3DL2 cytotoxicity-inducing antibody • Under development for the treatment of T-cell lymphomas i.e. CTCL (Sezary Syndrome (SS)1 and Mycosis Fungoides (MF)2) & PTCL • Phase 11 data in SS pa
Slide 4: Clinical indications informed by Target Expression
Lacutamab Clinical indications informed by Target Expression • T-cell lymphomas represent at least two thirds of all primary cutaneous lymphomas with Mycosis Fungoides (MF) and Sézary syndrome (SS) being the most frequent entities. INCIDENCE APPROVED AGENTS KIR3DL2 EXPRESSION (US, EU5, Japan), 2025
Slide 5: TELLOMAK: T-cell Lymphoma anti-KIR3DL2 therapy
TELLOMAK: T-cell Lymphoma anti-KIR3DL2 therapy Phase 2 Study in Two CTCL Subtypes - NCT03902184 Sézary Syndrome (N~60) Mycosis Fungoides (N~100) ≥ 2 prior systemic therapies ≥ 2 prior systemic therapies Cohort 1 Cohort 2 Cohort 3 All Comers All comers, SS, must include KIR3DL2 KIR3DL2+EXPRESSION KIR
Slide 6: TELLOMAK: Patient characteristics of MF cohorts 2 and 3
TELLOMAK Patient characteristics of MF cohorts 2 and 3 Cohort 2 Cohort 3 KIR3DL2 ≥ 1% KIR3DL2 < 1% (N= 21) (N=18) Age in years, Median (range) 59 (33-77) 58 (19-81) • Female, N (%) 7 (33%) 3 (17%) • Male, N (%) 14 (67%) 15 (83%) • Stage IB / II, N (%) 16 (76%) 15 (83%) • Stage III1, N (%) 5 (24%) 3
Slide 7: TELLOMAK MF Cohort 2 Global Overall Response in patients with KIR3DL2 ≥ 1%
TELLOMAK MF Cohort 2 Global Overall Response in patients with KIR3DL2 ≥ 1% (N=21) % N [95%CI] Global ORR 6 28.6% Skin 2CR; 4PR [13.8-50.0] Skin 12 57.1% 2CR; 10 PR [36.5-75.5] Blood1 5 62.5% 5CR [30.6-86.3] Lymph 1 7.7% node2 1PR [1.4-33.3] Viscera NA NA 1. 8 pts with Blood involvement: B1 2. 13 pts
Slide 8: TELLOMAK MF Cohort 2 PFS and DoR in patients with KIR3DL2 ≥ 1%
TELLOMAK MF Cohort 2 PFS and DoR in patients patients with KIR3DL2 ≥ 1% (N=21) • Median PFS = 12.0 mo (4.6–15.4) • PFS at 6 mo (95%CI): 59.6 (34.9-77.5) • PFS at 12 mo (95%CI): 53.6 (29.4-72.8) • Median DOR = 10.2 mo (4.6 – NA) N: number, DOR: Duration Of Response, PFS: Progression Free Survival Spo
Slide 9: TELLOMAK MF Cohort 3 Global Overall Response in patients with KIR3DL2 < 1%
TELLOMAK MF Cohort 3 Global Overall Response patients with KIR3DL2 < 1% (N=18) % N [95%CI] Global 2 11.1 % ORR 2PR [3.1-32.8] Skin Skin 3 16.7% 3PR [5.8-39.2] Blood1 1 25% 1CR [4.6-69.9] Lymph 0 0% node2 *patient previously treated by Mogamulizumab Viscera NA NA 1. 4 pts with Blood involvement: B1 2
Slide 10: TELLOMAK MF Cohort 3 PFS and DoR in patients with KIR3DL2 < 1%
TELLOMAK MF Cohort 3 PFS and DoR in patients with KIR3DL2 < 1% (N=18) • Median PFS = 8.5 mo (4.1 – NA) • PFS at 6 mo (95%CI): 66.8 (37.3-84.8) • PFS at 12 mo (95%CI): 39.6 (13.6-65.0) • Median DOR = NA (NA – NA) (At DCO, the two patients were still in response with a DoR of 3.6 and 10.2 months respe
Slide 11: TELLOMAK MF Cohorts 2&3: Treatment Emergent Adverse Events
TELLOMAK MF Cohorts 2&3 (N=39) Treatment Emergent related Adverse Events1 (at least 5%) Total N=39 n (%) Any treatment-emergent AEs (TEAEs) 36 (92.3) Any Lacutamab-related TEAEs 23 (59.0) Most frequent Lacutamab-related TEAEs • Asthenia 5 (12.8) • Arthralgia 4 (10.3) • Nausea 3 (7.7) Any Serious TEA
Slide 12: PK and Immunogenicity
TELLOMAK MF Cohorts 2&3 (N=39) PK and Immunogenicity • Lacutamab has low immunogenicity in MF patients, with no impact on PK profile • PK profile was consistent with Phase 1 data1, obtained is SS patients • Target concentration for skin anti-tumor efficacy and for optimal ADCC activity is reached La
Slide 13: TELLOMAK Conclusions - Preliminary data from Stage 1
TELLOMAK Conclusions - Preliminary data from Stage 1 • Within the advanced and heavily pre-treated population enrolled in TELLOMAK, Lacutamab demonstrates clinical activity with a favorable safety profile. • Lacutamab met the predefined threshold of activity in the KIR3DL2 expressing MF patients coh
Slide 14: With Thanks
With Thanks France (10) Germany (8) Spain (6) USA (16) Italy (4) Belgium (3) Austria (1) Poland (1) In total 49 active sites Thank you to all our investigators, experts, site staff, and ultimately the patients and their families Sponsor: Innate Pharma 14