This section highlights FDA-related milestones and regulatory updates for drugs developed by Innate Pharma (IPHA).
Over the past two years, Innate Pharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
IPH45, IPH4502, IPH6101/SAR443579, IPH6501, and Lacutamab. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
IPH45 - FDA Regulatory Timeline and Events
IPH45 is a drug developed by Innate Pharma for the following indication: a Novel Nectin-4 Antibody Drug Conjugate.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- IPH45
- Announced Date:
- April 10, 2024
- Indication:
- a Novel Nectin-4 Antibody Drug Conjugate
Announcement
Innate Pharma SA 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.
AI Summary
Innate Pharma SA recently presented the first preclinical data for its asset IPH45 at the AACR Annual Meeting 2024. IPH45 is a novel exatecan-antibody drug conjugate targeting Nectin-4, a protein found at high levels on several solid tumors. In preclinical studies, the data showed that IPH45 effectively stops tumor growth both in laboratory and animal tests, including models that do not respond to the approved treatment Enfortumab Vedotin (EV). The studies revealed that IPH45 has stronger activity than EV, even in tumors with both high and low Nectin-4 expression. Additionally, when combined with anti-PD1 treatment, IPH45 showed an extra anti-tumor effect. The encouraging preclinical efficacy and favorable toxicology results support further development, and the company plans to file an IND in 2024, moving the asset closer to clinical trials.
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IPH4502 - FDA Regulatory Timeline and Events
IPH4502 is a drug developed by Innate Pharma for the following indication: Topoisomerase I inhibitor Antibody Drug Conjugate (ADC) conjugated to exatecan targeting Nectin-4.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- IPH4502
- Announced Date:
- May 19, 2025
- Indication:
- Topoisomerase I inhibitor Antibody Drug Conjugate (ADC) conjugated to exatecan targeting Nectin-4.
Announcement
Innate Pharma SA Highlights Abstracts Selected for ASCO 2025 Annual Meeting
AI Summary
Innate Pharma SA has announced that four abstracts featuring its innovative drug candidates in clinical development have been selected for presentation at the ASCO Annual Meeting 2025 in Chicago, scheduled for May 30 to June 3, 2025. Among these, the company will highlight long-term follow-up results from the TELLOMAK Phase 2 trial, which evaluated lacutamab in patients with relapsed and refractory Sézary syndrome and mycosis fungoides. The abstracts will be featured in sessions focused on both immunotherapy and molecularly targeted agents, underscoring Innate Pharma’s commitment to advancing new cancer therapies. By sharing these pivotal data, Innate Pharma aims to demonstrate the potential of its treatment strategies, including Antibody Drug Conjugates and NK cell engager platforms, to improve patient outcomes and further innovate within the field of immuno-oncology.
Read Announcement- Drug:
- IPH4502
- Announced Date:
- April 29, 2025
- Indication:
- Topoisomerase I inhibitor Antibody Drug Conjugate (ADC) conjugated to exatecan targeting Nectin-4.
Announcement
Innate Pharma SA today shared new preclinical data for IPH4502, its novel and differentiated topoisomerase I inhibitor Antibody Drug Conjugate (ADC) targeting Nectin-4.
AI Summary
Innate Pharma SA recently presented new preclinical data for its innovative ADC, IPH4502, at the AACR Annual Meeting 2025. IPH4502 is a novel topoisomerase I inhibitor Antibody Drug Conjugate that targets Nectin-4—a molecule found in various solid tumors such as urothelial carcinoma, triple-negative breast cancer, head and neck, and esophageal cancers. Preclinical studies revealed that IPH4502 not only demonstrated potent anti-tumor activity but also outperformed an existing Nectin-4 ADC, enfortumab vedotin (EV), particularly in tumor models with low or mixed Nectin-4 expression and in models resistant to EV. The enhanced internalization, cytotoxicity, and bystander killing effects of IPH4502 suggest improved efficacy and potential for overcoming current resistance mechanisms, supporting its ongoing evaluation in a Phase 1 trial for advanced solid tumors.
Read Announcement- Drug:
- IPH4502
- Announced Date:
- January 27, 2025
- Indication:
- Topoisomerase I inhibitor Antibody Drug Conjugate (ADC) conjugated to exatecan targeting Nectin-4.
Announcement
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.
AI Summary
Innate Pharma SA announced that the first patient has been dosed in its Phase 1 study of IPH4502. This early trial is testing the safety and tolerability of the new treatment in patients with advanced solid tumors that express the Nectin-4 protein. IPH4502 is an antibody-drug conjugate designed to deliver a targeted therapy directly to tumor cells, aiming to provide a more precise treatment option for cancers such as breast, lung, and gastrointestinal cancers.
The Phase 1 trial will start by exploring different dosage levels to find the ideal balance between safety and effectiveness. The study, which plans to enroll roughly 105 patients, marks an important first step toward developing a new targeted treatment for tumors with limited treatment options and may offer hope of improved outcomes in the future.
Read Announcement- Drug:
- IPH4502
- Announced Date:
- January 21, 2025
- Estimated Event Date Range:
- February 5, 2025 - February 5, 2025
- Target Action Date:
- February 05, 2025
- Indication:
- Topoisomerase I inhibitor Antibody Drug Conjugate (ADC) conjugated to exatecan targeting Nectin-4.
Announcement
Innate Pharma SA announced that it 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.
AI Summary
Innate Pharma SA announced an event for institutional investors and analysts focused on its Antibody-Drug Conjugate (ADC) strategy, with a special emphasis on Nectin-4, the target of its lead candidate program, IPH4502. The company will host this event in a hybrid format in New York on Wednesday, February 5, 2025, from 10:00 a.m. to 12:00 p.m. EDT. During the session, CEO Jonathan Dickinson will share the latest scientific and clinical advancements related to Nectin-4 and discuss the potential of this target in the treatment of various cancers. The event will offer a clear view into the company’s updated strategic focus on its ANKET® platform and ADC programs. Interested participants can register online or attend via a live webcast available on Innate Pharma’s website.
Read Announcement- Drug:
- IPH4502
- Announced Date:
- September 23, 2024
- Indication:
- Topoisomerase I inhibitor Antibody Drug Conjugate (ADC) conjugated to exatecan targeting Nectin-4.
Announcement
Innate Pharma SA 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.
AI Summary
Innate Pharma SA recently received clearance from the U.S. Food and Drug Administration (FDA) to begin a Phase 1 clinical study of its novel drug, IPH4502. This innovative treatment is a topoisomerase I inhibitor antibody drug conjugate (ADC) targeting Nectin-4, a cell adhesion protein found in various solid tumors.
The open-label, multi-center study is designed to evaluate the safety, tolerability, and early signs of effectiveness of IPH4502 in patients with advanced solid cancers, such as urothelial carcinoma, non-small cell lung, breast, ovarian, gastric, and colorectal cancers. Innate expects to start the study in the coming months, marking an important milestone as this is the company’s first ADC program to enter clinical trials.
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IPH6101/SAR443579 - FDA Regulatory Timeline and Events
IPH6101/SAR443579 is a drug developed by Innate Pharma for the following indication: Solid Tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- IPH6101/SAR443579
- Announced Date:
- September 12, 2024
- Indication:
- Solid Tumors
Announcement
Innate Pharma SA reported its consolidated financial results for the six months ended June 30, 2024. The consolidated financial statements are attached to this press release.
AI Summary
Innate Pharma SA has released its consolidated financial results for the six months ended June 30, 2024. According to the press release, the company disclosed its full set of consolidated financial statements in the attached documents. The financial report highlights key metrics and details the firm's financial position during the period. Notably, the results show a strong cash position with a total of €102.1 million in cash, cash equivalents, short-term investments, and financial assets as of June 30, 2024. The report includes comprehensive information on operating results, research and development expenses, and general administrative costs as part of its overall strategy. With a focus on advancing its growth strategy and innovative pipeline, the CEO Hervé Brailly emphasized the importance of these results in guiding the company's next steps. The detailed financial statements provide investors and stakeholders with insight into the company’s current financial health and strategy moving forward.
Read Announcement- Drug:
- IPH6101/SAR443579
- Announced Date:
- June 17, 2024
- Indication:
- Solid Tumors
Announcement
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.
AI Summary
Innate Pharma SA recently announced updated results from the dose-escalation part of its Phase 1/2 study with SAR443579/IPH6101, an investigational NK cell engager that targets CD123. This molecule, part of the ANKET® platform and developed in collaboration with Sanofi, was designed to treat challenging blood cancers such as relapsed/refractory acute myeloid leukemia (R/R AML), B‑cell acute lymphoblastic leukemia (B-ALL), and high‑risk myelodysplasia (HR‑MDS).
During an oral presentation at the European Hematology Association 2024 Congress held in Madrid, Spain on Sunday, June 16 at 11:45 CEST, the updated efficacy and safety findings were detailed. The study demonstrated promising and durable clinical benefits, including several complete remissions, with a favorable safety profile. These results are expected to guide the selection of optimal dosing as the trial advances into Phase 2.
Read Announcement- Drug:
- IPH6101/SAR443579
- Announced Date:
- May 21, 2024
- Indication:
- Solid Tumors
Announcement
Innate Pharma SA announced that in an abstract published on 14 May 2024 for the European Hematology Association 2024 Congress on SAR443579/IPH6101, submitted by Sanofi, it was mentioned that the molecule received breakthrough designation
AI Summary
Innate Pharma SA recently clarified an error regarding the regulatory designation of its molecule SAR443579/IPH6101. An abstract submitted by Sanofi for the European Hematology Association 2024 Congress on May 14, 2024, mistakenly mentioned that the molecule received breakthrough designation. According to the company, this is incorrect. In fact, the molecule has been granted the US FDA Fast Track Designation, a status communicated previously in June 2023.
This correction is significant because it emphasizes the specific regulatory recognition that the molecule holds. The Fast Track Designation is intended to speed up the development and review process for new treatments that address unmet medical needs. By drawing attention to this clarification, Innate Pharma aims to ensure that stakeholders have an accurate understanding of the regulatory status and the progress of its innovative cancer treatment platform.
Read Announcement- Drug:
- IPH6101/SAR443579
- Announced Date:
- May 15, 2024
- Indication:
- Solid Tumors
Announcement
Innate Pharma SA announced 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.
AI Summary
Innate Pharma SA announced that four abstracts featuring its innovative drug candidates have been accepted for presentation at the European Association of Hematology (EHA) 2024 Congress. The event will be held from June 13-16, 2024 in Madrid, Spain. The abstracts include two focused on SAR443579 (IPH6101), a trifunctional NK cell engager developed in collaboration with Sanofi, which is being studied as a monotherapy for treating blood cancers with high unmet needs. The remaining two abstracts detail IPH6501, Innate’s second-generation ANKET® designed for relapsed or refractory CD20-expressing B-cell Non-Hodgkin’s Lymphoma, currently under evaluation in a Phase 1/2 clinical trial. This inclusion in the EHA Congress underscores the continued momentum and potential impact of Innate Pharma’s novel NK cell engager therapies in addressing severe blood cancers.
Read Announcement- Drug:
- IPH6101/SAR443579
- Announced Date:
- April 15, 2024
- Indication:
- Solid Tumors
Announcement
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.
AI Summary
Innate Pharma SA announced exciting progress in its clinical research as the first patient was dosed in the Phase 2 dose expansion phase of a Sanofi-sponsored trial. The trial is testing SAR443579 / IPH6101, an innovative NK cell engager, as a monotherapy in patients with blood cancers that have high unmet treatment needs. Specifically, the study evaluates its use for relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia, and high-risk myelodysplasia. This advancement marks an important step forward in the program’s development and demonstrates the potential of SAR443579 to provide a critical new treatment option for patients facing these challenging blood cancers. The shared progress underlines continued collaboration between Innate Pharma and Sanofi in addressing significant clinical gaps in cancer therapy.
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IPH6501 - FDA Regulatory Timeline and Events
IPH6501 is a drug developed by Innate Pharma for the following indication: In B-cell non-Hodgkin lymphoma (B-NHL).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- IPH6501
- Announced Date:
- June 13, 2025
- Indication:
- In B-cell non-Hodgkin lymphoma (B-NHL)
Announcement
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.
AI Summary
Innate Pharma SA announced that it will present new preclinical data for its drug candidate, IPH6501, at the European Hematology Association Congress 2025 in Milan, Italy (June 12–15). IPH6501 is part of the company’s proprietary ANKET® platform and is currently being evaluated in a Phase 1/2 study for relapsed and/or refractory B-cell non‐Hodgkin lymphoma.
The preclinical results showed that IPH6501 has strong antitumor effects. It demonstrated potent activity by boosting natural killer cell proliferation and killing tumor cells derived from patients with diffuse large B-cell lymphoma and follicular lymphoma. In animal models, the combination of IPH6501 with R-CHOP improved efficacy, even in cases resistant to rituximab. These data support further clinical evaluation of IPH6501 as a promising new treatment strategy for B-cell non‐Hodgkin lymphoma.
Read Announcement- Drug:
- IPH6501
- Announced Date:
- December 6, 2024
- Indication:
- In B-cell non-Hodgkin lymphoma (B-NHL)
Announcement
Innate Pharma SA announced that they have entered into an agreement to clinically study the potential of IPH6501, Innate's anti-CD20 ANKET® in follicular lymphoma (FL).
AI Summary
Innate Pharma has announced a new agreement with the Institute for Follicular Lymphoma Innovation (IFLI) to study the potential of its anti-CD20 ANKET® therapy, IPH6501, for follicular lymphoma. The clinical investigation will include patients with relapsed or refractory follicular lymphoma as part of an ongoing Phase 1/2 trial, which focuses on evaluating the safety, tolerability, and early effectiveness of the treatment in patients with CD20+ Non-Hodgkin Lymphoma.
To support this study, IFLI will invest an initial 3 million USD by purchasing new shares in Innate Pharma, with the option to invest up to an additional 4.9 million USD based on milestone achievements. This collaboration aims to expand treatment options for follicular lymphoma patients and advance the development of IPH6501 as a promising therapeutic option.
Read Announcement- Drug:
- IPH6501
- Announced Date:
- November 19, 2024
- Indication:
- In B-cell non-Hodgkin lymphoma (B-NHL)
Announcement
Innate Pharma SA 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.
AI Summary
Innate Pharma SA recently announced the publication in Science Immunology of preclinical data highlighting the potential of IPH6501, its proprietary NK cell engager. IPH6501 is a first-in-class tetra-specific molecule that includes an IL-2 variant and targets CD20, using the company’s ANKET® platform. The published research shows that IPH6501 can boost natural killer (NK) cell proliferation and enhance their cytotoxicity against B-cell non-Hodgkin lymphoma. Data from in vitro, in vivo, and ex vivo studies demonstrated that IPH6501 not only effectively inhibits tumor cells even in cases of low CD20 expression but also promotes NK cell migration and infiltration into tumors. These promising findings support the further clinical development of IPH6501, currently under investigation in a Phase 1/2 trial for relapsed and refractory B-NHL, and may offer a safer, targeted alternative to traditional therapies.
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Lacutamab - FDA Regulatory Timeline and Events
Lacutamab is a drug developed by Innate Pharma for the following indication: Treatment of patients with relapsed or refractory Sézary syndrome.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Lacutamab
- Announced Date:
- May 23, 2025
- Indication:
- Treatment of patients with relapsed or refractory Sézary syndrome
Announcement
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 Sézary syndrome (SS) and mycosis fungoides (MF), two rare and aggressive forms of cutaneous T-cell lymphoma (CTCL).
AI Summary
Innate Pharma SA announced that it will present long-term follow-up data from the Phase 2 TELLOMAK trial at the ASCO Annual Meeting in 2025. The trial is evaluating lacutamab, an anti-KIR3DL2 monoclonal antibody, in patients with Sézary syndrome (SS) and mycosis fungoides (MF), two rare and aggressive forms of cutaneous T-cell lymphoma (CTCL).
The data from this study showed promising results, with heavily pretreated SS patients achieving a global overall response rate of 42.9% and a median duration of response of 25.6 months. MF patients also benefited, with a global overall response rate of 19.6%. These findings suggest that lacutamab has the potential to provide meaningful clinical benefits and durable responses in patients facing limited treatment options, reinforcing its promise as a new therapeutic option for these challenging CTCL conditions.
Read Announcement- Drug:
- Lacutamab
- Announced Date:
- March 27, 2025
- Indication:
- Treatment of patients with relapsed or refractory Sézary syndrome
Announcement
Innate Pharma SA provided Business Update
AI Summary
Innate Pharma SA provided a robust business update in its consolidated financial results for 2024, highlighting a clear strategy to drive innovation through its proprietary ANKET® NK-cell engager platform and ADC programs. The company’s CEO emphasized significant clinical progress with key drug candidates, including IPH6501 and the Phase 1 study for the Nectin-4 ADC, while advancing lacutamab, which recently received the FDA Breakthrough Therapy Designation for relapsed or refractory Sézary syndrome. This designation underlines lacutamab’s potential as a transformative treatment option for advanced cutaneous T cell lymphomas. Additionally, the update noted a strong cash position of €91.1 million, extending the runway to mid-2026, and strategic investments—such as up to $7.9 million from the Institute for Follicular Lymphoma Innovation—to further support clinical trials and development programs. The company remains focused on delivering innovative therapies for patients worldwide.
Read Announcement- Drug:
- Lacutamab
- Announced Date:
- February 17, 2025
- Indication:
- Treatment of patients with relapsed or refractory Sézary syndrome
Announcement
Innate Pharma Announces 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.
AI Summary
Innate Pharma announced that the FDA has granted Breakthrough Therapy Designation (BTD) to lacutamab, a first-in-class anti-KIR3DL2 antibody, for adult patients with relapsed or refractory Sézary Syndrome. This designation applies to patients who have already received at least two prior systemic therapies, including mogamulizumab. The decision by the FDA was supported by promising results from early clinical studies, including the Phase 2 TELLOMAK trial, which showed lacutamab’s encouraging efficacy and favorable safety profile in heavily pretreated patients. The BTD is designed to help speed up the development and review process for drugs treating serious conditions, and this milestone highlights lacutamab’s potential as a significant new treatment option for patients suffering from this aggressive form of cutaneous T-cell lymphoma.
Read Announcement- Drug:
- Lacutamab
- Announced Date:
- December 9, 2024
- Indication:
- Treatment of patients with relapsed or refractory Sézary syndrome
Announcement
Innate Pharma SA announced new data highlighting the quality-of-life improvements observed in patients with cutaneous T-cell lymphoma (CTCL) treated with lacutamab in the TELLOMAK Phase 2 clinical study
AI Summary
Innate Pharma SA has released new data from the TELLOMAK Phase 2 study showing that lacutamab improves quality of life for patients with cutaneous T-cell lymphoma (CTCL). The findings reveal that patients suffering from severe symptoms, like constant itching and skin issues, experienced noticeable relief within just a few weeks of starting treatment.
Key results from the study indicate that both Sézary syndrome and mycosis fungoides patients saw early improvements, with a significant reduction in itch intensity and better skin condition scores beginning at Week 5 and continuing over time. These promising outcomes suggest lacutamab may offer a new treatment option for CTCL patients who have few alternatives, potentially easing distressing symptoms and enhancing their daily lives.
Read Announcement- Drug:
- Lacutamab
- Announced Date:
- June 4, 2024
- Indication:
- Treatment of patients with relapsed or refractory Sézary syndrome
Announcement
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.
AI Summary
At the ASCO 2024 Annual Meeting in Chicago, Innate Pharma SA presented positive results from its Phase 2 TELLOMAK study of lacutamab in patients with mycosis fungoides (MF). The study involved heavily pretreated MF patients who had received a median of four prior systemic therapies. Notably, lacutamab demonstrated meaningful anti-tumor activity regardless of the patients’ baseline KIR3DL2 expression levels. The global objective response rate ranged from 16.8% to 22.4%, and responses were seen as early as one month into treatment. Additionally, the safety profile of lacutamab was consistent with previous studies, showing that the treatment was well tolerated. These promising findings suggest that lacutamab may offer a valuable therapeutic option for patients with MF, an area with limited treatment alternatives, and support its continued development in addressing this challenging disease.
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