IPH6501 / Innate - LARVOL DELTA

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 (EHA 2025) - P1/2 | "Yet, there remains an unmet medical need for patients ineligible, refractory to, or relapsing (R/R) from these therapies.Leveraging natural killer (NK) cells emerges as a promising strategy in hematological malignancies, as reported in a Phase 1/2 study with IPH6101/SAR'579 in R/R AML (Garciaz, EHA 2024). The ex vivo preclinical evaluation of IPH6501 using patient samples provides supportive evidence to explore IPH6501 in R/R DLBCL and FL patients. Furthermore, the strong antitumor activity of IPH6501 in a rituximab-resistant model, together with the significant improvement of its antitumor activity when combined with R-CHOP in a rituximab sensitive model suggests that IPH6501 could be employed in B-NHL patients beyond monotherapy and paves the way for the evaluation of other combinations. IPH6501 is currently under investigation in a global first-in-human Phase 1/2 study (NCT06088654)."

IO biomarker • Preclinical • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • IL2

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 (Businesswire) - "In preclinical in vitro models, IPH6501 demonstrated potent NK cell proliferation and tumor cell killing activity in DLBCL and FL patient samples, supporting its therapeutic potential in these indications. In preclinical in vivo xenografted mouse tumor models, IPH6501 showed strong activity in a rituximab-resistant model — even in the presence of rituximab highlighting their combination potential. Additionally, when combined with R-CHOP, IPH6501 showed enhanced antitumor efficacy, leading to tumor eradication that was maintained after treatment discontinuation. These findings underscore the potential of IPH6501 in improving standard-of-care R-CHOP treatment in previously untreated DLBCL and FL patients and support further evaluation of additional combination strategies in B-NHL."

Preclinical • Diffuse Large B Cell Lymphoma • Follicular Lymphoma

Innate Pharma Highlights ANKET Abstracts Selected for the EHA 2025 Congress (Businesswire) - "Innate Pharma SA...today 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....In addition, an abstract related to SAR’514/IPH6401 (developed by Sanofi) was accepted for online publication."

Preclinical • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Multiple Myeloma

Innate Pharma Reports First Quarter 2025 Business Update and Financial Results (Businesswire) - "€15 million investment by Sanofi, in addition to the ongoing partnership including the development of BCMA targeting ANKET program in autoimmune indications....The Phase 1/2 clinical trial evaluating IPH6501 in B-cell Non-Hodgkin’s lymphoma (B-NHL) is ongoing. The study is planned to enroll up to 184 patients. Clinical sites are open in the US, Australia and France and the first safety and preliminary activity data are expected in late 2025....The Phase 1 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....A Trial in Progress Poster will be shared at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting in June 2025."

Financing • P1/2 data • Trial status • Breast Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Ovarian Cancer • Urothelial Cancer

IPH6501 (proprietary) (Businesswire) - "In March 2024 the first patient was dosed in the Phase 1/2 clinical trial 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 and the first safety and preliminary activity data are expected in late 2025."

P1/2 data • Trial status • Non-Hodgkin’s Lymphoma

Preclinical Characterization of Antitumor Activity of IPH6501, a First-in-Class IL2v-Armed Tetraspecific NK Cell Engager Directed Against CD20, and Comparison with Approved CD20-Targeting Therapies (ASH 2024) - P1/2 | "Polatuzumab vedotin in combination with R-CHP was recently approved, and emerging combination treatments including T cell engagers will offer additional treatment options for untreated B-NHL patients...Here, we report data on IPH6501 mechanisms of action and comparison with approved CD20-targeting therapies in preclinical settings.MethodsThe induction of NK cell-mediated antitumor activity by IPH6501 was compared to that of rituximab and obinutuzumab in an in vitro assay against B-NHL target cells...IPH6501 is therefore a promising first-in-class NK cell engager candidate for the treatment of B-NHL. Its safety and preliminary efficacy are currently under investigation as single agent in a first-in-human Phase 1/2 study in R/R CD20+ B-NHL patients (NCT06088654)."

Preclinical • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • FCGR3A • IL2

Innate Pharma and the Institute for Follicular Lymphoma Innovation (IFLI) Announce up to $7.9M Investment From IFLI to Support IPH6501 Development in Follicular Lymphoma (Businesswire) - "Innate Pharma SA...today announced that they have entered into an agreement to clinically study the potential of IPH6501, Innate's anti-CD20 ANKET in follicular lymphoma (FL)...To support the Phase 1/2 trial and inclusion of FL patients, IFLI will initially invest 3m USD into new shares of Innate, issued through a capital increase reserved to IFLI at a price of €1.56 per share and representing 2.26% of the share capital of Innate. IFLI may also invest up to an additional 4.9m USD into new shares of Innate, depending on the completion of certain milestones, at a price to be determined at the time of the said investments."

Financing • Follicular Lymphoma

Preclinical characterization of IPH6501: a novel IL2v-armed tetraspecific NK cell engager targeting CD20 in relapsed or refractory B cell non-Hodgkin lymphoma subtypes and post-CAR-T therapy (SITC 2024) - P1/2 | "NK cell engager molecules have shown efficacy in acute myeloid lymphoma (IPH6101/SAR'579, NCT05086315)...In vitro, cytotoxicity assays reveal that IPH6501 stimulates PBMCs from post rituximab R/R B-NHL patients to kill a CD20+ lymphoma cell line...Cell collection were obtained through the CeVi_Collection Project from the CALYM Carnot Institute funded by the French National Research Council (ANR). Additional amples were collected and stored within the biobank of the CRB SUD, CRB HCL (BB-0033-00046), the CRB-Santé Rennes (BB-0033-00056), the CRB Cancer IUCTO (BB-0033-00014), the CRB CHU de Montpellier (BB-0033-00031) and CRB Gustave Roussy (2022- A00472-41) which has been declared to the Ministry of Higher Education and Research after receiving approval from the ethical committee."

IO biomarker • Preclinical • Acute Myelogenous Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • IL2RA

Innate Pharma Announces Publication in Science Immunology Highlighting Innovative Next-generation ANKET IPH6501 (Businesswire) - "Innate Pharma SA...today announced the publication in Science Immunology of preclinical data demonstrating the potential of IPH6501, Innate’s proprietary NK cell engager including an IL-2v and targeting CD20 from the ANKET platform....The data published shows that IPH6501, also called CD20-NKCE-IL2v in the publication, boosts NK cell proliferation and cytotoxicity, showing activity against a range of B-NHL cell lines, including those with low CD20 density. In vivo studies in nonhuman primates and tumor mouse models further validated its efficacy and revealed that IPH6501 induces peripheral NK cell migration at the tumor site."

Preclinical • Non-Hodgkin’s Lymphoma

A tetraspecific engager armed with a non-alpha IL-2 variant harnesses natural killer cells against B cell non-Hodgkin lymphoma. (PubMed, Sci Immunol) - "We evaluated IPH6501, a clinical-stage, tetraspecific NK cell engager (NKCE) armed with a non-alpha IL-2 variant (IL-2v), which targets CD20 and was developed for treating B cell non-Hodgkin lymphoma (B-NHL)...In vivo studies in nonhuman primates and tumor mouse models further validated its efficacy and revealed that CD20-NKCE-IL2v induces peripheral NK cell homing at the tumor site. CD20-NKCE-IL2v emerges as a potential alternative in the treatment landscape of B-NHL."

Journal • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • IL2

Innate Pharma Highlights Data From Its Innovative Oncology Portfolio Selected for the SITC Annual Meeting 2024 (Businesswire) - "Innate Pharma SA...today announced that new preclinical data supporting the clinical development of its proprietary next generation antibody-drug conjugate (ADC) and innovative tetra-specific ANKET will be presented at the SITC Annual Meeting 2024...'We are thrilled to share our latest preclinical data at the SITC Annual Meeting, highlighting the potential of IPH6501, our tetra-specific NK cell engager and IPH4502, our innovative ADC targeting Nectin-4. These findings underscore our commitment to advancing next-generation immunotherapies and reflect significant progress in the development of our drug candidates.'"

Preclinical • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

PRECLINICAL ASSESSMENT OF IPH6501, A FIRST-IN-CLASS IL2V-ARMED TETRASPECIFIC NK CELL ENGAGER DIRECTED AGAINST CD20 FOR R/R B-NHL, IN COMPARISON WITH A CD20-TARGETING T CELL ENGAGER (EHA 2024) - "Leveraging natural killer ( NK ) cells emerges as a promising strategy in hematological malignancies, as reported in a Phase 1 study with IPH6101/SAR ' 579 in R/R AML ( Stein, ASCO 2023; Bajel, ASH 2023 ) . The preclinical demonstrations of IPH6501 activities across various in vivo models and its effectiveness in ex vivo assays using cells from R/R B-NHL patients provide compelling evidence of its therapeutic potential and tolerability. IPH6501 is emerging as a promising new candidate within the treatment landscape for R/R B-NHL and is currently being investigated in a global, first-in-human phase 1/2 study ( NCT 06088654 ) ."

IO biomarker • Preclinical • Hematological Disorders • Non-Hodgkin’s Lymphoma • CD20 • FCGR3A • IL2RA • NKG2D

A PHASE 1/2 TRIAL INVESTIGATING SAFETY, TOLERABILITY, AND PRELIMINARY ANTITUMOR ACTIVITY OF IPH6501, A FIRST-IN-CLASS NK CELL ENGAGER, IN PATIENTS WITH R/R CD20-EXPRESSING NHL (EHA 2024) - P1/2 | "Leveraging natural killer (NK) cellsemerges as a promising strategy, as demonstrated in a Phase 1 study with IPH6101/SAR'579 in R/R AML (Stein,ASCO 2023; Bajel, ASH 2023), and offers a novel approach that could complement or provide an alternative toT-cell therapies. Not applicable. Trial in progress."

Clinical • IO biomarker • P1/2 data • Bone Marrow Transplantation • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation • CD20 • FCGR3A • IL2RA

Preclinical assessment of IPH6501, a first-in-class IL2v-armed tetraspecific NK cell engager directed against CD20 for R/R B-NHL, in comparison with a CD20-targeting T cell engager. (ASCO 2024) - "Leveraging natural killer (NK) cells emerges as a promising strategy in hematological malignancies, as shown in a Phase 1 study with IPH6101/SAR'579 in R/R AML (Stein, ASCO 2023; Bajel, ASH 2023). The preclinical demonstrations of IPH6501 activities across various in vivo models and its effectiveness in ex vivo assays using cells from R/R B-NHL patients provide compelling evidence of its therapeutic potential and tolerability. IPH6501 is emerging as a promising new candidate within the treatment landscape for R/R B-NHL and is currently being investigated in a global, first-in-human phase 1/2 study (NCT 06088654)."

IO biomarker • Preclinical • Hematological Disorders • Non-Hodgkin’s Lymphoma • CD20 • FCGR3A • IL2 • IL2RA • NKG2D

A phase 1/2, open-label, multicenter trial investigating the safety, tolerability, and preliminary antineoplastic activity of IPH6501, a first-in-class NK cell engager, in patients with relapsed and/or refractory CD20-expressing non-Hodgkin lymphoma. (ASCO 2024) - P1/2 | "Leveraging natural killer (NK) cells emerges as a promising strategy, as demonstrated in a Phase 1 study with IPH6101/SAR'579 in R/R AML (Stein, ASCO 2023; Bajel, ASH 2023), and offers a novel approach that could complement or provide an alternative to T-cell therapies. The Phase 2 part will enroll one or more cohorts of selected B-cell NHL subtypes to be determined at a later stage. Up to 184 subjects will be enrolled, and the study is open in the United States, Australia and Europe."

Clinical • IO biomarker • P1/2 data • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20 • FCGR3A • IL2 • IL2RA

Innate Pharma Highlights Abstracts Selected for ASCO 2024 Annual Meeting (Businesswire) - "Innate Pharma SA...announced today that five abstracts with Innate’s drug candidates have been accepted for the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting, taking place May 31-June 4, 2024 in Chicago, Illinois...Top line results of TELLOMAK Phase 2 trial in mycosis fungoides confirming promising clinical activity of lacutamab; Two posters on IPH6501...for the treatment of relapsed/refractory CD20-expressing B-cell Non-Hodgkin's Lymphoma; AstraZeneca to present poster on updated results for monalizumab from Phase 2 stage III unresectable NSCLC trial; Monalizumab SCLC Phase 2 MOZART trial poster..."

P1/2 data • P2 data • Preclinical • Cutaneous T-cell Lymphoma • Mycosis Fungoides • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Small Cell Lung Cancer

Innate Pharma Highlights Abstracts Selected for EHA 2024 Congress (Businesswire) - "Innate Pharma SA...announced today that four abstracts with Innate’s drug candidates have been accepted for the European Association of Hematology (EHA) 2024 Congress, taking place June 13-16, 2024 in Madrid, Spain. Two abstracts are related to SAR443579 (IPH6101), an investigational trifunctional anti-CD123 NKp46xCD16 NK cell engager from a joint research collaboration between Innate Pharma and Sanofi and currently being evaluated as a monotherapy in a Sanofi-sponsored Phase 1/2 clinical trial for the treatment of blood cancers with high unmet needs. Two abstracts are related to IPH6501, Innate’s second generation ANKET for the treatment of relapsed or refractory CD20-expressing B-cell Non-Hodgkin's Lymphoma, currently in Phase 1/2 clinical trial."

P1/2 data • Preclinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Myelodysplastic Syndrome • Non-Hodgkin’s Lymphoma • Oncology

Phase1/2 Study of IPH6501 in Patients With Relapsed /Refractory B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1/2 | N=184 | Recruiting | Sponsor: Innate Pharma | Not yet recruiting ➔ Recruiting | Initiation date: Oct 2023 ➔ Mar 2024

Enrollment open • Trial initiation date • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Innate Pharma: First Patient dosed in Phase 1/2 study of IPH6501 in relapsed /refractory B-Cell non-Hodgkin’s Lymphoma (Businesswire) - "Innate Pharma SA...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)....The study is planned to enroll up to 184 patients."

Trial status • Non-Hodgkin’s Lymphoma

Innate Pharma Announces Licensing of a Fourth Natural Killer Cell Engager in Oncology to Sanofi (Businesswire) - "Innate Pharma SA...and Sanofi...announced today that Sanofi has exercised its option to license a natural killer (NK) cell engager program in solid tumors from Innate’s ANKET^® (Antibody-based NK Cell Engager Therapeutics) platform pursuant to the terms of the research collaboration and license agreement signed in December 2022. Following a research collaboration period, Sanofi will be responsible for all development, manufacturing and commercialization. Sanofi still retains the option to one additional ANKET^® target as per the license agreement....Under the terms of the December 2022 agreement, Innate will receive a €15m payment for the exercise of this option."

Licensing / partnership • Oncology • Solid Tumor

Innate Pharma Reports Third Quarter 2023 Financial Results and Business Update (Businesswire) - "SAR’514/IPH6401: The Phase 1/2 clinical trial with SAR’514 / IPH6401, a trifunctional anti-BCMA Nkp46xCD16 NK cell engager, led by Sanofi, in patients with Relapsed/Refractory Multiple Myeloma (RRMM) and Relapsed/Refractory Light-chain Amyloidosis (RRLCA) is ongoing....IPH6501 (proprietary): Following approval of the IND-filing by the FDA in July 2023, IPH6501, Innate’s proprietary CD20 targeted tetra-specific ANKET® continues toward a Phase 1 clinical trial in 2023....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....The investigator-sponsored CHANCES Phase 1 trial of IPH5301 by Institut Paoli-Calmettes is ongoing."

Enrollment status • Trial status • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lung Cancer • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

Phase1/2 Study of IPH6501 in Patients With Relapsed /Refractory B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1/2 | N=184 | Not yet recruiting | Sponsor: Innate Pharma

New P1/2 trial • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

IPH6501 IS A FIRST-IN-CLASS TETRASPECIFIC ANTIBODY-BASED NATURAL KILLER CELL ENGAGER THERAPEUTIC DEVELOPED FOR THE TREATMENT OF B-CELL NON-HODGKIN'S LYMPHOMAS (EHA 2023) - "Despite several generations of CD20-targeting drugs including rituximab, ofatumumab, and obinutuzumab, and more recent approvals of new CD20-targeting agents, innovative strategies are still needed for B-NHL patients who relapse or are refractory (R/R) after multiple lines of treatment. Our preclinical data showed that IPH6501, a CD20-targeting tetraspecific antibody-based NK cell engager therapeutic, could be a powerful first-in-class new asset to harness the anti-tumor functions of NK cells in CD20 +B-cell malignancies. IPH6501 is expected to enter FIH clinical study in 2023. 1."

IO biomarker • Hematological Disorders • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • FCGR3A • IL2RA

Innate Pharma Highlights Proprietary Tetra-specific ANKET NK Cell Engager IPH6501 at the EHA 2023 Congress (Businesswire) - "IPH6501 is progressing towards a Phase 1 clinical trial in 2023...Innate Pharma SA...announced that updated preclinical data on its IPH6501 tetra-specific ANKET® (Antibody-based Natural Killer cell Engager Therapeutics) are presented at the European Hematology Association (EHA) 2023 congress. IPH6501 is a first-in-class CD20-targeting tetra-specific ANKET® that co-engages two activating receptors (NKp46 and CD16), the interleukin-2 receptor (without involvement of the IL-2Rα subunit) with a human IL-2 variant and CD20 target antigen on malignant B cells....In preclinical settings, IPH6501 was shown to induce NK cell proliferation and to trigger high NK cell cytoxicity against CD20+ target cells in in vitro assays, in ex vivo assays with relapse/refractory (R/R) B-NHL patient samples who received at least one prior treatment, as well as in in vivo studies in non-human primates."

New P1 trial • Preclinical • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

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