IPH4502 / Innate - LARVOL DELTA

A phase 1, open-label, multi-center study of the safety, tolerability, and efficacy of IPH4502 as a single agent in advanced solid tumors. (ASCO 2025) - P1 | "Targeting Nectin-4 with enfortumab vedotin (EV), an antibody-drug conjugate (ADC) with a monomethyl auristatin E (MMAE) payload, demonstrated clinical benefit in UC, which exhibits the highest Nectin-4 expression among all solid tumor types...Participants will be randomized at a 1:1 ratio to 2 dose levels, to determine the RP2D. A maximum of 105 participants will receive treatment with IPH4502 in France and the US."

Clinical • Metastases • P1 data • Breast Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • Urothelial Cancer

Innate Pharma Reports First Quarter 2025 Business Update and Financial Results (Businesswire) - "IPH4502: The study plans to enroll approximately 105 patients. A Trial in Progress Poster will be shared at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting in June 2025....TELLOMAK is a global, open-label, multi-cohort Phase 2 clinical trial evaluating lacutamab in patients with Sézary syndrome and mycosis fungoides....Long-term follow-up for Sezary syndrome and mycosis fungoides will be presented at the ASCO Annual Meeting in June 2025....AstraZeneca will present an update on the outcomes of the Phase 2 study NeoCOAST-2 at the upcoming ASCO Annual Meeting in June 2025."

P2 data • Trial status • Breast Cancer • Colorectal Cancer • Cutaneous T-cell Lymphoma • Esophageal Cancer • Gastric Cancer • Mycosis Fungoides • Non Small Cell Lung Cancer • Ovarian Cancer • Sezary Syndrome • Urothelial Cancer

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

Innate Pharma Highlights Preclinical Anti-Tumor Efficacy Data of Its Antibody Drug Conjugate IPH4502 at the AACR 2025 Annual Meeting (Businesswire) - "IPH4502 demonstrated anti-tumor activity in EV-resistant patient-derived xenograft (PDX) model with upregulation of multi-drug resistance protein 1 (MDR1), supporting its potential to overcome resistance mechanisms in EV-refractory disease...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...In addition, in preclinical tumor models with low Nectin-4 expression, IPH4502 showed superior anti-tumor activity compared to a clinical-stage Nectin-4-exatecan ADC supported by higher internalization, cytotoxicity, and bystander killing effect....'ongoing Phase 1 trial. We look forward to sharing initial clinical data in 2026.'"

P1 data • Preclinical • Esophageal Cancer • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

IPH4502, a differentiated Nectin-4 exatecan antibody-drug conjugate (AACR 2025) - "Enfortumab vedotin (EV, PADCEV®), an antibody-drug conjugate (ADC) targeting Nectin-4 with a monomethyl auristatin E (MMAE) payload, is approved for the treatment of urothelial cancer (UC), which exhibits the highest Nectin-4 expression among all solid tumor types. The strong internalization and bystander effect of IPH4502 enable an efficient anti-tumor activity in Nectin-4 positive tumor models independent of Nectin-4 expression levels. In addition, IPH4502 shows efficacy in models resistant to EV, indicating that IPH4502 has potential for UC patients relapsing or refractory to EV treatment, as well as for cancer patients treated with MMAE-based ADCs. Finally, IPH4502 shows anti-tumor activity in various preclinical cancer models, including PDX models from different indications, supporting its development beyond UC."

Breast Cancer • Esophageal Cancer • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Solid Tumor • Triple Negative Breast Cancer • Urothelial Cancer • ABCB1

IPH4502 (Nectin-4 ADC): (Businesswire) - "New preclinical data will be presented at the AACR Annual Meeting 2025."

Preclinical • Solid Tumor

Innate Pharma Announces First Patient Dosed in Phase 1 Study of Its Nectin-4 Targeting Antibody Drug Conjugate IPH4502 in Selected Advanced Solid Tumors (Businesswire) - "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....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."

Trial status • Breast Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Non Small Cell Lung Cancer • Ovarian Cancer • Urothelial Cancer

Safety and Tolerability of IPH4502 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=105 | Recruiting | Sponsor: Innate Pharma

New P1 trial • Oncology • Solid Tumor

Innate Pharma Announces Nectin-4 Antibody Drug Conjugate Investor and Analyst Event in New York (Businesswire) - "Innate Pharma SA...will host an event for institutional investors and analysts dedicated to its Antibody-Drug Conjugate (ADC) strategy, and particularly Nectin-4, the target of its lead antibody-drug candidate program, IPH4502."

Clinical • Solid Tumor

IPH45, a next-generation antibody-drug conjugate (ADC) targeting nectin-4 (SITC 2024) - "Enfortumab vedotin (EV), a Nectin-4-targeting antibody-drug conjugate (ADC) with a monomethyl auristatin E (MMAE) payload, has been approved for the treatment of UC, which exhibits the highest Nectin-4 expression. The activity of IPH45 in various indications and its enhanced anti-tumor activity in combination with anti-PD-1 therapies in preclinical models support its development beyond UC. IPH45 is progressing towards the clinic with IND planned in 2024."

IO biomarker • Breast Cancer • Esophageal Cancer • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Solid Tumor • Triple Negative Breast Cancer • Urothelial Cancer • NECTIN4

Innate Pharma Reports Third Quarter 2024 Business Update and Financial Results (Businesswire) - "In September, the U.S Food and Drug Administration (FDA) cleared Innate’s investigational new drug (IND) application to initiate a Phase 1 clinical study of IPH4502 in Nectin-4 expressing solid tumor indications. Innate expects to initiate the Phase 1 study by Q1 2025."

New P1 trial • Oncology • Solid Tumor

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

Innate Pharma Announces FDA Clearance of the IND for IPH4502, a Nectin-4 ADC to Be Developed in Solid Tumors (Businesswire) - "Innate Pharma SA...today announced that the U.S Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to initiate a Phase 1 clinical study of IPH4502, its novel and differentiated topoisomerase I inhibitor antibody drug conjugate (ADC) targeting Nectin-4 in solid tumors. Innate expects to initiate the Phase 1 study in the coming months. The Phase 1, open-label, multi-center study...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 and colorectal cancers."

IND • New P1 trial • Breast Cancer • Colorectal Cancer • Gastric Cancer • Non Small Cell Lung Cancer • Ovarian Cancer • Urothelial Cancer

Innate Pharma Reports First Half 2024 Business Update and Financial Results (Businesswire) - "In July 2024, Sanofi initiated a new Phase 1 / Phase 2, randomized, open label, multi-cohort, multi-center study (NCT06508489) assessing the safety, tolerability and preliminary efficacy of SAR’579 / IPH6101 administered in combination with azacitidine and venetoclax in patients with CD123 expressing hematological malignancies in newly diagnosed AML...IPH45 continues towards a Phase 1 trial in 2024...The investigator-sponsored CHANCES Phase 1 trial of IPH5301 with Institut Paoli-Calmettes is ongoing. Preliminary results will be presented at the upcoming (European Society of Medical Oncology) ESMO Annual Meeting 2024."

New P1 trial • P1 data • Trial status • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • Solid Tumor

Preclinical characterization of IPH45, a novel topoisomerase I inhibitor ADC targeting Nectin-4 for the treatment of Nectin-4 expressing tumors (AACR 2024) - "Enfortumab Vedotin (EV, PADCEV®) is an ADC targeting Nectin-4 with a monomethyl auristatin E (MMAE) payload approved for the treatment of patients with urothelial carcinoma (UC), but with limited clinical activity reported beyond UC. IPH45 is a topoisomerase I ADC targeting Nectin-4 with the potential for larger therapeutic index than EV, improved safety and dosing regimen, and ability to overcome primary and secondary resistance to EV or other Nectin-4 ADC in development. IPH45 is progressing to the clinic where the translatability of this unique profile into improved patient outcomes will be assessed across indications."

Preclinical • Breast Cancer • Gastrointestinal Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • Triple Negative Breast Cancer • Urothelial Cancer

Innate Pharma Presents at AACR 2024 Preclinical Efficacy of Its Pre-IND Drug Candidate IPH45, a Novel Nectin-4 Antibody Drug Conjugate (Businesswire) - "Innate Pharma SA...announced that first preclinical data for its asset IPH45...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 tumor growth 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-4^high and Nectin-4^low expression levels....Preclinical efficacy and toxicology data support further development of IPH45 which is progressing towards the clinic with IND planned in 2024."

IND • Preclinical • Oncology

Innate Pharma Reports Full Year 2023 Financial Results and Business Update (Businesswire) - "IPH45 is Innate’s proprietary Nectin-4 targeting antibody drug conjugate including a Topoisomerase I inhibitor payload. IPH45 continues towards IND filing this year. Innate will share first preclinical data with IPH45 in an oral presentation at the American Association for Cancer Research (AACR) 2024."

IND • Preclinical • Oncology

Innate Pharma to Present Nectin-4 Antibody Drug Conjugate IPH45 Preclinical Data at AACR 2024 (Businesswire) - "Innate Pharma SA...announced that an abstract regarding its preclinical asset IPH45, a novel and differentiated topoisomerase I inhibitor Antibody Drug Conjugate (ADC) targeting Nectin-4, has been selected for oral presentation at the American Association for Cancer Research (AACR) Annual Meeting 2024....'Our studies demonstrate that IPH45 effectively inhibits tumor growth both in vitro and in vivo, and it exhibits a favorable safety profile in preclinical studies'..."

Preclinical • Oncology