Bekanntmachung • Apr 18
Innate Pharma SA to Present MATISSE Phase 2 Interim Results of IPH5201 in Clinical Trials Plenary Session at AACR 2026 Innate Pharma SA announced that interim results from the MATISSE Phase 2 study evaluating IPH5201 in combination with durvalumab and platinum-based chemotherapy in resectable non-small cell lung cancer (NSCLC) will be presented in one of the Clinical Trials Plenary Sessions at the American Association for Cancer Research (AACR) Annual Meeting 2026, taking place April 17–22, 2026 in San Diego, California. The MATISSE study (NCT05742607) is a single arm Phase 2 clinical trial evaluating perioperative IPH5201, an anti-CD39 blocking antibody, in combination with perioperative durvalumab (anti-PD-L1) in addition to neoadjuvant platinum-based chemotherapy in previously untreated patients with resectable NSCLC. The trial is designed to assess whether dual inhibition of the CD39 and PD-L1 pathways, together with chemotherapy, can enhance anti-tumor immune responses and improve clinical outcomes in early-stage lung cancer. These results follow a pre-planned interim analysis on 40 patients. The combination of IPH5201 with durvalumab and chemotherapy demonstrated higher pathological complete response (pCR) rates compared with the benchmark set by durvalumab plus chemotherapy alone. Notably, pCR was 35.7% and 50% in patients with tumors expressing PD-L1 =1% and PD-L1 =50%, respectively. Based on these results, the study continues to recruit patients with tumors expressing PD-L1=1%. The presentation will be available in the publication section of Innate Pharma’s website. Abstract details: Dual CD39 and PD-L1 inhibition: Interim results from the Phase 2 MATISSE trial of IPH5201 plus durvalumab and platinum-based chemotherapy in patients with resectable NSCLC. Abstract Code: CT231. Session: CTPL04 – Advances in Immunotherapy. Session Date/Time: Tuesday, April 21, 2026, 10:45 – 11:00 AM PDT. IPH5201 is a first-in-class monoclonal antibody targeting CD39, a key immunosuppressive enzyme in the adenosine pathway. CD39 is expressed on tumor-infiltrating immune and stromal cells and contributes to immunosuppression by degrading extracellular adenosine triphosphate (ATP) into adenosine monophosphate (AMP), which is then further degraded into adenosine by CD73. By blocking CD39, IPH5201 promotes the accumulation of immunostimulatory ATP and reduces the production of immunosuppressive adenosine, thereby enhancing anti-tumor immune responses. IPH5201 is being co-developed in collaboration with AstraZeneca and is currently being evaluated in the Phase 2 MATISSE trial (NCT05742607), a multicenter study investigating perioperative treatment with IPH5201 in combination with durvalumab (anti-PD-L1) and platinum-based chemotherapy in patients with resectable non-small cell lung cancer (NSCLC). The MATISSE trial is designed to assess anti-tumor activity, including pathological complete response, and safety, with the goal of determining whether dual inhibition of the CD39 and PD-L1 pathways, in combination with chemotherapy, can enhance anti-tumor immunity and improve clinical outcomes in early-stage NSCLC. Bekanntmachung • Apr 14
Innate Pharma S.A., Annual General Meeting, May 21, 2026 Innate Pharma S.A., Annual General Meeting, May 21, 2026. Location: 117 avenue de luminy, marseille France Bekanntmachung • Nov 10
Innate Pharma Announces FDA Clearance to Proceed with TELLOMAK 3, a Confirmatory Phase 3 Trial of Lacutamab in CCL Innate Pharma SA announced that the U.S. Food and Drug Administration (FDA) has completed its review of the confirmatory Phase 3 protocol for lacutamab in cutaneous T-cell lymphomas (CTCL), with no further comments, clearing the trial to proceed. The planned confirmatory Phase 3 trial, TELLOMAK 3, is an open-label, randomized study designed to demonstrate the efficacy of lacutamab in patients with Sezary syndrome and Mycosis fungoides, who failed at least one prior line of systemic therapy. The trial will include two independent cohorts: one enrolling patients with Sezary syndrome post-mogamulizumab treatment randomized 1:1 to receive lacutamab or romidepsin, and one enrolling patients with Mycosis fungoides randomized 1:1 to receive Lacutamab or mogamulizumab. Data from the Phase 2 TELLOMAK trial in CTCL demonstrated durable activity, a favorable safety profile, and improvements in patients' quality of life. With this feedback from FDA, the Company is progressing towards the initiation of the confirmatory Phase 3 TELLOMAK 3 trial in H1 2026. FDA provided encouraging initial feedback on Innate Pharma's proposed regulatory pathway, which could potentially include Accelerated Approval for Sezary syndrome, once the Phase 3 trial is underway. Data from the Phase 2TELLOMAK trial in C TCL demonstrated durable activity, a favourable safety profile, and improvements in patient' quality of life. FDA provided encouraging initial feedback On Innate Pharma's proposed regulatory pathways, which could potentially include Acceleration Approval for Sezary Syndrome, once the Phase 3 trial are underway. Data from the Phase 3 TELLOMAK trial in cTCL demonstrated durable activity, an favorable safety profile, and improvement in patients' quality of life; With this feedback from FDA, PRIME designation from the EMA for SS, and Orphan Drug designation in both the US and EU for CTCL. More recently it has received Breakthrough Therapy Designation for SS. A Phase 3 in CTCL is under preparation. Bekanntmachung • Sep 17
Innate Pharma S.A. Appoints Yannis Morel as Chief Scientific Officer Innate Pharma S.A. announced that 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. Bekanntmachung • Jun 13
Innate Pharma Highlights Preclinical Antitumor Activity of IPH6501 in Diffuse Large B-Cell Lymphoma and Follicular Lymphoma at the 2025 European Hematology Association (EHA) Congress Innate Pharma SA announced the presentation of preclinical data for IPH6501, its proprietary ANKET®? targeting CD20 currently under investigation in a Phase 1/2 study in relapsed and/or refractory (R/R) B-cell non-Hodgkin lymphoma (B-NHL) (NCT06088654), at the European Hematology Association (EHA) Congress 2025, taking place June 12-15 in Milan, Italy. R-CHOP is an established standard of care for treatment-naive patients with diffuse large B cell lymphoma (DLBCL) and follicular lymphoma (FL), two subtypes of B-NHL. Bekanntmachung • May 23
Innate Pharma Highlights Durable Responses to Lacutamab in Sezary Syndrome and Mycosis Fungoides Innate Pharma SA announced the presentation of long-term follow-up data from the Phase 2 TELLOMAK clinical trial evaluating Lacutamab, an anti-KIR3DL2 monoclonal antibody, in patients with Sezary syndrome (SS) and mycosis fungoides (MF), two rare and aggressive forms of cutaneous T-cell lymphoma (CTCL). Lacutamab was recently granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of Sezary syndrome, underscoring its potential to address critical needs in advanced CTCL. Lacutamab is a first-in-class anti-KIR3DL 2 humanized cytotoxicity-inducing antibody that is currently in clinical trials for treatment of cutaneous T-cell leukemia (CTCL), an orphan disease, and peripheral T cell lymphoma (PTCL). Lacutamab has been granted European Medicines Agency (EMA) PRIME designation, and the US Food and Drug Drug Administration (FDA). Bekanntmachung • May 15
Innate Pharma Highlights Anket® Abstracts for the Eha 2025 Congress Innate Pharma SA announced that an abstract regarding IPH6501, its ANKET® targeting CD20 B cells currently developed in relapsed and/or refractory Non-Hodgkin Lymphoma, has been selected for the European Hematology Association (EHA) Congress 2025, taking place June 12-15 in Milan, Italy. Antitumor characterization of IPH6501, a novel il2v-armed tetraspecific NK cell engager targeting CD20 B cells, in DLBCL and FL patient samples, and in preclinical combination with R-CHOP. In addition, an abstract related to SAR'514/IPH6401 (developed by Sanofi) was accepted for online publication. The BCMA NK Cell Engager SAR'514 Induces Macrophage-Mediated Phagocytosis which is improved by combination with Evorpacept, a CD47 Blocker, in Multiple Myeloma. ANKET®? (Antibody-based NK cell Engager Therapeutics) is Innate's proprietary platform for developing next-generation, multi-specific natural killer (NK) cell engagers to treat certain types of cancer. This versatile, fit-for-purpose technology is creating an entirely new class of molecules to induce synthetic immune against cancer. IPH6501 is the first Antibody-based NK cellEngager Therapeutic to co-engage activating receptors on NK cells (NKp46 and CD16), IL-2R (but not the alpha subunit) through a variant of human IL-2, and a tumor antigen (CD20) via a single molecule, hence providing proliferation and activation signals targeted to NK cells and promoting their cytotoxic activity against CD20 expressing malignant cells. IPH6501 has shown better anti-tumor efficacy than approved benchmark antibodies in preclinical tumor models (Demaria, EHA 2023, Carrette, SITC 2024, Demaria et al, Science Immunology 2024). IPH6501 is currently being evaluated in a Phase 1/2 multicenter trial (NCT06088654), investigating the safety and tolerability of IPH6501 in patients with relapsed and/or ref refractory CD20-expressing B-cell Non-Hodgkin's Lymphoma. Bekanntmachung • Apr 30
Innate Pharma SA Highlights Preclinical Anti-Tumor Efficacy Data of its Antibody Drug Conjugate IPH4502 at AACR Annual Meeting Innate Pharma SA shared new preclinical data for IPH4502, its novel and differentiated topoisomerase I inhibitor Antibody Drug Conjugate (ADC) targeting Nectin-4. The data were presented at the American Association for Cancer Research (AACR) Annual Meeting 2025. Nectin-4 targeting is validated by enfortumab vedotin (EV), an ADC with a monomethyl auristatin E (MMAE) payload, approved for urothelial carcinoma (UC), an indication with high Nectin-4 expression. However, EV discontinuation due to toxicity, disease relapse, or treatment ineligibility, along with its limited efficacy in tumors with lower Nectin-4 expression, underscores the need for a differentiated Nectin-4 ADC with improved therapeutic window and improved mechanisms of action. IPH4502 is currently investigated in a Phase 1 trial in advanced solid tumors. The Phase 1 trial will assess the safety, tolerability, and preliminary efficacy of IPH4502 in different 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. In preclinical models, IPH4502 demonstrates strong bystander killing effect, and efficient internalization, enabling a potent anti-tumor activity in models with various Nectin-4 expression levels. Additionally, IPH4502 shows efficacy in models resistant to MMAE-ADC. These results support its potential for development beyond UC and in cancer patients treated with MMAE-based ADCs. Bekanntmachung • Apr 24
Innate Pharma S.A. has completed a Follow-on Equity Offering in the amount of €14.999999 million. Innate Pharma S.A. has completed a Follow-on Equity Offering in the amount of €14.999999 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 8,345,387
Price\Range: €1.7974
Transaction Features: Subsequent Direct Listing Bekanntmachung • Feb 17
Innate Pharma S.A. Announces U.S. FDA Granted Breakthrough Therapy Designation to Lacutamab for Relapsed or Refractory Sézary Syndrome Innate Pharma SA announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to lacutamab, an anti-KIR3DL2 cytotoxicity-inducing antibody, for the treatment of adult patients with relapsed or refractory (r/r) Sézary Syndrome (SS) after at least 2 prior systemic therapies including mogamulizumab. The BTD is granted based on Phase 1 study results as well as results from the Phase 2 TELLOMAK study, where lacutamab demonstrated encouraging efficacy and a favorable safety profile in heavily pretreated, post-mogamulizumab patients with advanced Sézary syndrome. A Breakthrough Therapy Designation by the FDA is intended to accelerate the development and regulatory review in the U.S. of drugs that are intended to treat a serious condition and that have shown encouraging early clinical results, which may demonstrate substantial improvement on a clinically significant endpoint over available medicines. Lacutamab previously received a Fast Track designation by the FDA in 2019 for the treatment of adult patients with relapsed or refractory Sézary syndrome who have received at least two prior systemic therapies as well as a PRIME designation by European Medicines Agency in 2020. Innate continues to align with the regulatory agencies around the confirmatory Phase 3 trial in CTCL and is actively seeking for a partner. Bekanntmachung • Jan 27
Innate Pharma Announces First Patient Dosed in Phase 1 Study of Its Nectin-4 Targeting Antibody Drug Conjugate IPH4502 in Selected Advanced Solid Tumors Innate Pharma SA announced the first patient was dosed in its Phase 1 study (NCT06781983), investigating the safety and tolerability of IPH4502, an innovative Antibody-Drug Conjugate (ADC), in patients with advanced solid tumors known to express Nectin-4. IPH4502 is a novel and differentiated topoisomerase I inhibitor ADC designed to precisely target Nectin-4, a cell adhesion molecule that is overexpressed in several types of solid tumors, including urothelial carcinoma (UC), breast cancer, non-small cell lung cancer or gastro-intestinal cancer. IPH4502 targets tumors with a wide range of Nectin-4 expression, supporting its development beyond UC. IPH4502 differentiated topoisomerase I inhibitor payload supports its potential in patients with tumors resistant to MMAE-ADC. The Phase 1, open-label, multi-center study, includes 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, esophageal, and colorectal cancers. The study plans to enroll approximately 105 patients. The initiation of this Phase 1 trial represents a significant milestone for Innate Pharma as clinical stage pipeline now includes targeted ADCs. Bekanntmachung • Nov 21
Innate Pharma S.A., Annual General Meeting, May 22, 2025 Innate Pharma S.A., Annual General Meeting, May 22, 2025. Bekanntmachung • Sep 26
Araris Biotech AG entered into an agreement to acquire ADC Transglutaminase Conjugation Technology Patents Portfolio from Innate Pharma S.A. (ENXTPA:IPH). Araris Biotech AG entered into an agreement to acquire ADC Transglutaminase Conjugation Technology Patents Portfolio from Innate Pharma S.A. (ENXTPA:IPH) on September 24, 2024. Bekanntmachung • Jun 18
Innate Pharma and Sanofi Shares Updated Results from the Sanofi Developed Blood Cancer Phase 1/2 1/2 SAR443579/IPH6101 Trial Innate Pharma SA announced that updated efficacy and safety results from the dose-escalation part of the Phase 1/2 study with SAR443579/IPH6101 (SAR'579), an investigational CD123 targeting NKp46/CD16-based Natural Killer Cell Engager (NKCE), from a joint research collaboration between Innate Pharma and Sanofi and ANKET® platform lead asset, were shared in an oral presentation at the European Hematology Association 2024 Congress in Madrid, Spain on Sunday, June 16 at 11:45 CEST. The study, led by Sanofi, tests SAR’579 as a monotherapy for the treatment of blood cancers with high unmet needs, including relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia (B-ALL) and high-risk myelodysplasia (HR-MDS). SAR’579 has FDA Fast Track Designation for the treatment of acute myeloid leukemia. Fifty-nine patients (58 R/R AML and 1 HR-MDS) across 11 dose levels (0.01 – 6mg/kg) were treated. Patients had received a median of 2 (1 – 10) prior lines of treatment. A maximum response rate was observed at a final target dose of 1 mg/kg every week with 5 AML patients achieving a CR (4 CR/1 CRi)1. The median treatment duration was 7.9 weeks, with durable CR (>10 months) observed in 3 patients with 2 remaining on maintenance therapy as of the data cutoff. SAR’579 was well tolerated up to doses of 6 mg/kg every week. These data will form the basis for selection of recommended doses for development in the Phase 2 portion of the trial. Bekanntmachung • Jun 05
Innate Pharma SA Presents Positive Results from TELLOMAK Phase 2 Study with Lacutamab in Mycosis Fungoides Innate Pharma SA announced favorable results from the Phase 2 TELLOMAK study with lacutamab in mycosis fungoides (MF). The results were presented at the ASCO 2024 Annual Meeting, in Chicago, Illinois. As of October 13, 2023, data cutoff, MF patients (n=107) received a median of 4 prior systemic therapies and had a median follow-up of 11.8 months. The data demonstrate that treatment with lacutamab resulted in meaningful antitumor activity, regardless of the KIR3DL2 baseline expression, and an overall favorable safety profile. The global objective response rate (ORR) was 16.8% (Olsen 2011) and 22.4% (Olsen 2022), including 2 complete responses (CR) and 16 partial responses (PR). In patients expressing a baseline KIR3DL2 = 1%, the ORR was 20.8% (Olsen 2011) and 29.2% (Olsen 2022). Median progression-free survival was 10.2 months (95% CI 6.5, 16.8) for all MF patients and 12.0 months (95% CI 5.6, 20.0) in the KIR3DL2 = 1% group. Time to response was 1.0 month (95% CI 1, 5). Lacutamab is a first-in-class anti-KIR3DL2 humanized cytotoxicity-inducing antibody that is currently in clinical trials for treatment of cutaneous T-cell lymphoma (CTCL), an orphan disease, and peripheral T cell lymphoma (PTCL). Rare cutaneous lymphomas of T lymphocytes have a poor prognosis with few efficacious and safe therapeutic options at advanced stages. KIR3DL2 is an inhibitory receptor of the KIR family, expressed by approximately 65% of patients across all CTCL subtypes and expressed by up 90% of patients with certain aggressive CTCL subtypes, in particular, Sézary syndrome. It is expressed by up to 50% of patients with mycosis fungoides and peripheral T-cell lymphoma (PTCL). It has a restricted expression on normal tissues. Lacutamab is granted European Medicines Agency (EMA) PRIME designation and US Food and Drug Administration (FDA) granted Fast Track designation for the treatment of patients with relapsed or refractory Sézary syndrome who have received at least two prior systemic therapies.Lacutamab is granted orphan drug status in the European Union and in the United States for the treatment of CTCL. Bekanntmachung • Apr 16
Innate Pharma Announces Advancement of Sanofi-Developed NK Cell Engager SAR443579 / IPH6101 Progressing to Phase 2 for Blood Cancer Patients Innate Pharma SA announced that the first patient was dosed in the Phase 2 dose expansion part of the Sanofi-sponsored clinical trial of SAR443579 /IPH6101 (NCT05086315), evaluating SAR443579 as a monotherapy for the treatment of blood cancers with high unmet needs, including relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia and high-risk myelodysplasia. SAR443579 is an investigational trifunctional anti-CD123 NKp46xCD16 NK cell engager from a joint research collaboration between Innate Pharma and Sanofi. SAR443579received FDA Fast Track Designation for the treatment of acute myeloid leukemia. Efficacy and safety results from the dose-escalation part of the trial were shared in a poster presentation at the American Society of Hematology 2023 Annual Meeting in San Diego, California. Under the terms of the 2016 research collaboration with Sanofi, the progression to the dose expansion part of the trial has triggered a milestone payment from Sanofi to Innate of €4 million. Bekanntmachung • Apr 10
Innate Pharma S.A. Presents at AACR 2024 Preclinical Efficacy of Its Pre-IND Drug Candidate IPH45, a Novel Nectin-4 Antibody Drug Conjugate Innate Pharma S.A. announced that first preclinical data for its asset IPH45, a novel and differentiated exatecan-Antibody Drug Conjugate (ADC) targeting Nectin-4, were presented in an oral presentation at the American Association for Cancer Research (AACR) Annual Meeting 2024. In preclinical studies, data demonstrated that IPH45 effectively inhibits Nectin-4 expressing tumorgrowth both in vitro and in vivo, including in Enfortumab Vedotin (EV) refractory models. Importantly, IPH45 shows stronger activity than EV, in multiple urothelial carcinoma PDX (patient-derived xenografted) mice models, across Nectin-4high and Nectin-4low expression levels. In addition, IPH45 has an additive anti-tumor effect to anti-PD1 treatment in vivo and has a favorable safety profile in relevant animal toxicology models. Bekanntmachung • Mar 06
Innate Pharma S.A. Announces First Patient Dosed in Phase 1/2 Study of IPH6501 in Relapsed /Refractory B-Cell Non-Hodgkin’s Lymphoma Innate Pharma S.A. announced the first patient was dosed in its Phase 1/2 multicenter trial (NCT06088654), investigating the safety and tolerability of IPH6501 in patients with Relapsed and/or Refractory CD20-expressing B-cell Non-Hodgkin’s Lymphoma (NHL). IPH6501 is Innate’s first-in-class CD20-targeting tetraspecific ANKET® (Antibody-based NK cell Engager Therapeutics) that co-engages CD20 as a target antigen on malignant B cells and three receptors on NK cells: two activating receptors (NKp46 and CD16) and the interleukin-2 receptor (but not its alpha subunit), with a human IL-2 variant, hence providing proliferation and activation signals targeted to NK cells and promoting their cytotoxic activity against CD20 expressing malignant cells. The study is planned to enroll up to 184 patients. Bekanntmachung • Feb 07
Innate Pharma S.A. has filed a Follow-on Equity Offering in the amount of $75 million. Innate Pharma S.A. has filed a Follow-on Equity Offering in the amount of $75 million.
Security Name: American Depositary Shares
Security Type: Depositary Receipt (Common Stock)
Transaction Features: At the Market Offering Bekanntmachung • Dec 11
Innate Pharma Presents Positive Results From TELLOMAK Phase 2 Study With Lacutamab in Patients With Sézary Syndrome at ASH 2023 Innate Pharma SA announced positive final results from the Phase 2 TELLOMAK study in Sézary Syndrome (SS). The results were presented at the ASH 2023 Annual Meeting, in San Diego, California. As of May 1, 2023, data cutoff, patients in the Sézary Syndrome cohort (cohort 1, n=56) received a median of 5 prior systemic therapies, including mogamulizumab, and had a median follow-up of 14.4 months. The data demonstrated that lacutamab showed robust clinical activity and an overall favorable safety profile. The global confirmed objective response rate (ORR) was 37.5% (21/56), including 2 complete responses (CR) and 19 partial responses (PR). Overall response rate (ORR) in the skin was 46.4% (26/56), including 5 CR and 21 PR and ORR in the blood was 48.2% (27/56) with 15 CR and 12 PR. Median progression-free survival was 8.0 months (95% CI 4.7-21.2). In patients who achieved a global response, the median duration of response is 12.3 months (95% CI 5.2-NE). Lacutamab is a first-in-class anti-KIR3DL2 humanized cytotoxicity-inducing antibody that is currently in clinical trials for treatment of cutaneous T-cell lymphoma (CTCL), an orphan disease, and peripheral T cell lymphoma (PTCL). Rare cutaneous lymphomas of T lymphocytes have a poor prognosis with few efficacious and safe therapeutic options at advanced stages. KIR3DL2 is an inhibitory receptor of the KIR family, expressed by approximately 65% of patients across all CTCL subtypes and expressed by up 90% of patients with certain aggressive CTCL subtypes, in particular, Sézary syndrome. It is expressed by up to 50% of patients with mycosis fungoides and peripheral T-cell lymphoma (PTCL). It has a restricted expression on normal tissues. Lacutamab is granted European Medicines Agency (EMA) PRIME designation and US Food and Drug Administration (FDA) granted Fast Track designation for the treatment of patients with relapsed or refractory Sézary syndrome who have received at least two prior systemic therapies.Lacutamab is granted orphan drug status in the European Union and in the United States for the treatment of CTCL. Bekanntmachung • Nov 03
Innate Pharma S.A. Announces New Clinical Data for Lacutamab and SAR443579/ IPH6101 at ASH 2023 Innate Pharma SA announced that several abstracts, including one oral presentation, have been selected for the 65th ASH (American Society of Hematology) Annual Meeting and Exposition, taking place December 9-12, 2023 in San Diego, California. The oral presentation will highlight the results from Cohort 1, designed to evaluate safety and efficacy of single agent lacutamab in 56 patients with relapsed/refractory Sézary syndrome after at least two prior systemic therapies including mogamulizumab. At the data cut-off of May 1, 2023, with a global confirmed Objective Response Rate (ORR) of 37.5% (n=21; 95% CI 26.0-50.6) including 2 Complete Responses (CRs), confirmed ORR in skin of 46.4% (n=26; 95% CI 34.0-59.3) including 5 CRs and confirmed ORR in blood of 48.2% (n=27; 95% CI 35.7-61.0) including 15 CRs, data confirm that lacutamab monotherapy shows promising clinical activity in a heavily pre-treated relapsed/refractory population previously treated with a median of 6 prior lines (range 2-15), including mogamulizumab, and an overall favorable safety profile. Clinical Benefit Rate (CBR, defined as CR+PR+SD) was 87.5 % (n=49; 95% CI 76.4-93.8). Median PFS was 8.0 months (95% CI 4.7, 21.2). Continued evaluation of this promising new targeted treatment option for patients with Sezary Syndrome is warranted. Preliminary Monotherapy Clinical Data and Pre-Clinical Combinability Data in Patients with Peripheral T-Cell Lymphoma (PTCL): The poster will display preclinical combination data supporting anti-tumor activity and rationale for the exploration of lacutamab in combination with approved and novel therapies in patients with PTCL. Preliminary monotherapy data from an ongoing Phase 1b study in PTCL is also presented. SAR443579/IPH6101 in patients with relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia (B-ALL) or high-risk myelodysplasia (HR-MDS) (from a Joint Research Collaboration with Sanofi). A presentation from the Sanofi oncology pipeline at ASH includes updated efficacy and safety results from an open-label, first-in-human, dose-escalation study of an investigational CD123 targeting Natural Killer Cell Engager (NKCE). Results investigating SAR443579 as a monotherapy for the treatment of blood cancers with high unmet needs, including relapsed or refractory acute myeloid leukemia, B-cell acute lymphoblastic leukemia and high-risk myelodysplasia show data across all dose levels tested. Observed clinical remissions will also be presented. Abstract details include: As of July 5, 2023, 43 patients (42 R/R AML and 1 HR-MDS) across 8 Dose Levels (DLs) at 10 – 6000 µg/kg/dose were included. Patients had received a median of 2.0 (1.0 – 10.0) prior lines of treatment with 13 patients (30.2%) reporting prior hematopoiectic stell cell transplantation and 36 patients (83.7%) with prior exposure to venetoclax. In DLs with a highest dose of 1000 µg/kg QW, 5/15 (33.3%) patients achieved a CR (4 CR /1 CRi) as of the cut-off date. Data from PK/PD and in vitro mechanistic analyses studying dose-response relations will also be presented. SAR443579 was well tolerated up to doses of 6000 µg/kg QW with observed clinical benefit in patients with R/R AML. The results are consistent with the predicted favorable safety profile. Bekanntmachung • Oct 05
Innate Pharma S.A. Provides Update on Lacutamab Clinical Program Innate Pharma SA announced that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on the lacutamab IND leading to a pause in new patient enrollment to the Company’s ongoing lacutamab trials IPH4102-201 (Phase 2 TELLOMAK) and 102 (Phase 1b PTCL). The partial clinical hold follows one fatal case of hemophagocytic lymphohistiocytosis (HLH), a rare hematologic disorder. Patients already on study treatment who are deriving clinical benefit may continue treatment after being reconsented. TELLOMAK, Innate Pharma’s ongoing Phase 2 trial of lacutamab in cutaneous T-cell lymphoma (CTCL), completed enrollment in second quarter 2023 (n=170 patients). Enrollment is also completed to the initial cohort (n=20 patients) of the Phase 1b PTCL trial and is awaiting a futility interim analysis to progress to the next stage. Innate Pharma is on track for final data from the Phase 2 TELLOMAK trial and preliminary data on PTCL in fourth quarter 2023. Lacutamab is a first-in-class anti-KIR3DL2 humanized cytotoxicity-inducing antibody that is currently in clinical trials for treatment of cutaneous T-cell lymphoma (CTCL), an orphan disease, and peripheral T cell lymphoma (PTCL). Rare cutaneous lymphomas of T lymphocytes have a poor prognosis with few efficacious and safe therapeutic options at advanced stages. KIR3DL2 is an inhibitory receptor of the KIR family, expressed by approximately 65% of patients across all CTCL subtypes and expressed by up 90% of patients with certain aggressive CTCL subtypes, in particular, Sézary syndrome. It is expressed by up to 50% of patients with mycosis fungoides and peripheral T-cell lymphoma (PTCL). It has a restricted expression on normal tissues. Lacutamab is granted European Medicines Agency (EMA) PRIME designation and US Food and Drug Administration (FDA) granted Fast Track designation for the treatment of patients with relapsed or refractory Sézary syndrome who have received at least two prior systemic therapies. Lacutamab is granted orphan drug status in the European Union and in the United States for the treatment of CTCL. Bekanntmachung • Sep 22
Innate Pharma Announces Encore Presentation of Interim Results of Phase 2 TELLOMAK Study With Lacutamab With Updated Olsen 2022 Criteria at the EORTC Cutaneous Lymphoma Tumour Group Annual Meeting 2023 Innate Pharma SA announced an encore presentation of interim efficacy results from the TELLOMAK Phase 2 study in advanced Mycosis Fungoides (MF) according to updated guidelines (Olsen 2022) at the EORTC Cutaneous Lymphoma Tumour Group Annual Meeting 2023, being held September 21-23, 2023 in Leiden, the Netherlands. The data confirms clinical activity and favorable safety profile of lacutamab, an anti-KIR3DL2 antibody. As of March 4, 2022, data cutoff, patients in the KIR3DL2-expressing MF cohort (cohort 2, n=21) received a median of 4 prior systemic therapies, and had a median follow-up of 12.2 months. In the KIR3DL2 non-expressing cohort (cohort 3, n=18), patients received a median of 4.5 prior systemic therapies and had a median follow-up of 13.8 months. Lymph Node assessment is an important component of staging and response assessment in CTCL (cutaneous T cell lymphomas). In a recent update to the Olsen 2011 guidelines, it was clarified that the pathological assessment of lymph nodes be limited to those that satisfy nodal lymphoma i.e. N3 designation. Based on these criteria, results showed that lacutamab produced an increased global objective response rate (ORR) of 42.9% (95% confidence interval [CI], 24.5-63.5) in patients with KIR3DL2 = 1% MF (cohort 2, n=21), including 2 complete responses and 7 partial responses. Clinical Benefit Rate remained unchanged at 85.7% [95% CI tbc]. In Cohort 3, comprising 18 patients with KIR3DL2 < 1% MF, findings remain unchanged. Lacutamab is a first-in-class anti-KIR3DL2 humanized cytotoxicity-inducing antibody that is currently in clinical trials for treatment of cutaneous T-cell lymphoma (CTCL), an orphan disease, and peripheral T cell lymphoma (PTCL). Rare cutaneous lymphomas of T lymphocytes have a poor prognosis with few efficacious and safe therapeutic options at advanced stages. KIR3DL2 is an inhibitory receptor of the KIR family, expressed by approximately 65% of patients across all CTCL subtypes and expressed by up 90% of patients with certain aggressive CTCL subtypes, in particular, Sézary syndrome. It is expressed by up to 50% of patients with mycosis fungoides and peripheral T-cell lymphoma (PTCL). It has a restricted expression on normal tissues. Lacutamab is granted European Medicines Agency (EMA) PRIME designation and US Food and Drug Administration (FDA) granted Fast Track designation for the treatment of patients with relapsed or refractory Sézary syndrome who have received at least two prior systemic therapies. Lacutamab is granted orphan drug status in the European Union and in the United States for the treatment of CTCL. Bekanntmachung • Jul 12
Innate Pharma SA Announces First Patient Dosed in SAR'514 / IPH6401 Phase 1/2 Clinical Trial in Relapsed/Refractory Multiple Myeloma Innate Pharma SA announced that the first patient was dosed in a Sanofi-sponsored Phase 1/2 clinical trial (NCT05839626), evaluating SAR'514 /IPH6401 in relapsed/refractory Multiple Myeloma (RRMM) and Relapsed/Refractory Light-chain Amyloidosis (RRLCA). SAR'514 is a trifunctional anti-BCMA NKp46xCD16 NK cell engager, using Sanofi's proprietary CROSSODILE® multi-functional platform, which comprises the Cross-Over-Dual-Variable-Domain (CODV) format. It induces a dual targeting of the NK activating receptors, NKp46 and CD16, for an optimized NK cell activation, based on Innate's ANKET®? (Antibody-based NK cell Engager Therapeutics) proprietary platform. The purpose of the dose escalation and dose expansion study is to evaluate the safety, pharmacokinetics and preliminary efficacy of SAR'514 in monotherapy in patients with RRMM and RRLCA. The start of the trial has triggered a milestone payment from Sanofi to Innate, which is part of a previously announced research collaboration with Sanofi. More information about the Phase 1/2 trial can be found on clinicaltrials.gov. About ANKET® (Antibody-based NK cell engager Therapeutics) is Innate's proprietary platform for developing next-generation, multi-specific natural killer (NK) cell engager to treat certain types of cancer. This versatile, fit-for-purpose technology is creating an entirely new class of molecules to induce synthetic immunity against cancer. About the Innate-Sanofi agreements: The Company has a research collaboration and license agreement with Sanofi to apply Innate's proprietary technology to the development of innovative multi-specific antibody formats engaging NK cells through the activating receptors NKp46 and CD16 to kill tumor cells. Under the terms of the 2016 research collaboration and license agreement, Sanofi is responsible for the development, manufacturing and commercialization of products resulting from the research collaboration, which includes IPH6101/SAR'579 (Trifunctional anti-CD123 NKp46xCD16 NK cell engager) and IPH6401/SAR’514 (Trifunctional anti-BCMA NKp46xCD16 NK cell engager). As part of the 2016 agreement, Innate Pharma will be eligible to up to €400m in development and commercial milestone payments as well as royalties on net sales. Bekanntmachung • Jun 27
Innate Pharma S.A. Announces First Patient Dosed in Matisse Trial of IPH5201 in Early Stage Lung Cancer Innate Pharma SA announced the first patient was dosed in MATISSE, a Phase 2 multicenter single-arm study (NCT05742607), sponsored by Innate Pharma, evaluating neoadjuvant and adjuvant treatment with IPH5201, an anti-CD39 blocking monoclonal antibody, in combination with durvalumab (anti-PD-L1) and chemotherapy, in treatment-na ve patients with resectable early stage non-small cell lung cancer (NSCLC). The primary objectives of the study are to assess antitumor activity of neoadjuvant treatment based on pathological complete response (pCR) and safety. Innate is responsible for conducting the study and shares study costs with AstraZeneca. AstraZeneca supplies clinical trial drugs. Bekanntmachung • Jun 17
Innate Pharma Sa Highlights Increased Lacutamab Clinical Activity from Interim Results of Phase 2 Tellomak Study with Updated Olsen Criteria Innate Pharma SA announced that interim efficacy results from the TELLOMAK Phase 2 study in advanced Mycosis Fungoides (MF) according to updated lymph node classification confirms clinical activity and favorable safety profile of lacutamab, an anti-KIR3DL2 antibody. The data were presented at the 17thInternational Conference on Malignant Lymphoma, in Lugano, Switzerland. As of March 4, 2022, data cutoff, patients in the KIR3DL2-expressing MF cochort (cohort 2, n=21) received a median of 4 prior systemic therapies, and had a median follow-up of 12.2 months. In the KIR3DL2 non-expressing cohort (cohort 3, n=18), patients received a median of 4.5 prior systemic therapies and had a median follow-up of 13.8 months. Lymph Node assessment is an important component of staging and response assessment in CTCL (cutaneous T cell lymphomas). In a recent update to the Olsen 2011. Lacutamab is a first-in-class anti-KIR3DL2 humanized cytotoxicity-inducing antibody that is currently in clinical trials for treatment of cutaneous T-cell lymphoma (CTCL), an orphan disease, and peripheral T cell lymphoma (PTCL). Rare cutaneous lymphomas of T lymphocytes have a poor prognosis with few efficacious and safe therapeutic options at advanced stages. KIR3DL2 is an inhibitory receptor of the KIR family, expressed by approximately 65% of patients across all CTCL subtypes and expressed by up 90% of patients with certain aggressive CTCL subtypes, in particular, Sézary syndrome. It is expressed by up to 50% of patients with mycosis fungoides and peripheral T-cell lymphoma (PTCL). It has a restricted expression on normal tissues. Lacutamab is granted European Medicines Agency (EMA) PRIME designation and US Food and Drug Administration (FDA) granted Fast Track designation for the treatment of patients with relapsed or refractory Sézary syndrome who have received at least two prior systemic therapies.Lacutamab is granted orphan drug status in the European Union and in the United States for the treatment of CTCL. TELLOMAK is a global, open-label, multi-cohort Phase 2 clinical trial recruiting patients with Sézary syndrome and mycosis fungoides (MF) in the United States and Europe. Specifically: Cohort 1: lacutamab being evaluated as a single agent in approximately 60 patients with Sézary syndrome who have received at least two prior systemic therapies, including mogamulizumab. The Sézary syndrome cohort of the study could enable the registration of lacutamab in this indication. Cohort 2: lacutamab being evaluated as a single agent in patients with MF that express KIR3DL2, as determined at baseline with a Simon 2-stage design. Cohort 3: lacutamab being evaluated as a single agent in patients with MF that do not express KIR3DL2, as determined at baseline, with a Simon-2 stage design. All comers: lacutamab being evaluated as a single agent in patients with both KIR3DL2 expressing and non-expressing MF to explore the correlation between the level of KIR3DL2 expression and treatment outcomes utilizing a formalin-fixed paraffin embedded (FFPE) assay under development as a companion diagnostic. Overall, MF cohorts (cohort 2, cohort 3 and all comers) will enroll approximately 100 patients. The primary endpoint of the trial is objective global response rate. Key secondary endpoints are progression-free survival, duration of response, overall survival, quality of life, pharmacokinetics and immunogenicity and adverse events. Bekanntmachung • Jun 09
Innate Pharma S.A. Announces SAR’579 / IPH6101 Receives FDA Fast Track Designation in the US for the Treatment of Hematological Malignancies Innate Pharma S.A. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for SAR’579 /IPH6101 for the treatment of hematological malignancies. Fast Track Designation is an FDA process designed to facilitate the development, and expedite the review of, medicines to treat serious conditions and fill unmet medical need. The FDA created this process to help deliver important new drugs to patients earlier, and it covers a broad range of serious illnesses. SAR’579, ANKET® platform lead asset, is a trifunctional anti-CD123 NKp46×CD16 NK cell engager from a joint research collaboration between Innate Pharma and Sanofi, now under development by partner Sanofi. Bekanntmachung • May 27
Innate Pharma Highlights Phase 1/2 Dose Escalation Safety and Preliminary Efficacy of Sanofi Developed First NK Cell Engager SAR'579 / IPH6101 in R/R AML Innate Pharma SA announced that the abstract entitled "A first-in-human study of CD123 NK Cell Engager SAR443579 in relapsed or refractory acute myeloid leukemia, B-cell acute lymphoblastic leukemia or high risk-myelodysplasia" was published on the ASCO 2023 Annual Meeting website. The abstract concludes that SAR'579, in development by Sanofi, was well tolerated up to doses of 3 mg/kg QW with observed clinical benefit in patients with relapsed/refractory acute myeloid leukaemia (R/R AML). Bekanntmachung • Jan 16
Innate Pharma SA Announces Publication of Preclinical Data with a Trifunctional NK Cell Engager in Acute Myeloid Leukemia in Nature Biotechnology Innate Pharma SA announced the publication in Nature Biotechnology of preclinical data showing the control of acute myeloid leukemia (AML) cells by a trifunctional NKp46-CD16a-NK cell engager (NKCE) targeting CD123. The studies were conducted by Innate and Sanofi and published in Nature Biotechnology on January 12, 2023. The study shows that expression of CD64 on AML blasts confers resistance to anti-CD123 antibody-dependent cell cytotoxicity (ADCC) and redirecting NK cells against cancer targets through binding to CD16a and NKp46 circumvents this resistance. Moreover, through their binding to NKp46, CD123-NKCE specifically target NK cells and has potent antitumor activity against primary AML blasts; it induces NK cell activation and cytokine secretion only in the presence of AML cells. In vivo, its antitumor activity in a mouse tumor model exceeds that of the comparator anti-CD123 antibody. The efficacy of CD123-NKCE in vitro in human peripheral blood mononuclear cells and in vivo in nonhuman primates was associated with the induction of low pro-inflammatory cytokine release and no signs of toxicity. These results support clinical development of CD123-NKCE. A Phase 1/2 clinical trial by Sanofi is ongoing, evaluating IPH6101/SAR’579 (SAR443579), the first NKp46/CD16-based CD123-targeted ANKET NK cell engager, in patients with relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia (B-ALL) or high-risk myelodysplastic syndrome (HR-MDS).