IPH5301 / Innate - LARVOL DELTA

CHANCES: A Phase 1 First-In-Human Study of the Anti-CD73 IPH5301 Alone or in Combination With Chemotherapy and Trastuzumab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=27 | Active, not recruiting | Sponsor: Institut Paoli-Calmettes | Recruiting ➔ Active, not recruiting

Enrollment closed • First-in-human • Breast Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • Triple Negative Breast Cancer • BRCA • ER • PD-L1 • PGR

IPH5301 (anti-CD73, proprietary): (Innate Pharma Press Release) - "The investigator-sponsored CHANCES Phase 1 trial of IPH5301 with Institut Paoli-Calmettes is ongoing."

Trial status • Solid Tumor

CHANCES: A Phase 1 First-In-Human Study of the Anti-CD73 IPH5301 Alone or in Combination With Chemotherapy and Trastuzumab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=27 | Recruiting | Sponsor: Institut Paoli-Calmettes | Trial completion date: Feb 2026 ➔ Mar 2027 | Trial primary completion date: Mar 2025 ➔ Mar 2027

First-in-human • Trial completion date • Trial primary completion date • Breast Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • Triple Negative Breast Cancer • BRCA • ER • PD-L1 • PGR

Design, engineering, and functional evaluation of nanobody-based anti-CD73 for immunogenic cell death induction in chemoresistant colorectal Cancer cell line. (PubMed, Int Immunopharmacol) - "HeLiNa-73 combines CD73 inhibition with ICD induction, thereby overcoming adenosine-mediated immune suppression while enhancing tumor immunogenicity. These in vitro findings highlight HeLiNa-73 as a next-generation nanobody-based candidate for in vivo chemoresistant CRC studies and to synergize with checkpoint blockade."

Journal • Preclinical • Colorectal Cancer • Oncology • Solid Tumor • CALR • CD80 • CD86 • HMGB1

DEVELOPMENT AND FUNCTIONAL EVALUATION OF NOVEL ENGINEERED ANTI-CD73 NANOBODY FOR COLORECTAL CANCER TARGETING [WITHDRAWN] (UEGW 2025) - "The construct was developed by grafting the complementarity-determining regions (CDRs) from the humanized monoclonal antibody IPH5301 onto a camelid nanobody scaffold to retain high binding affinity for CD73 while benefiting from the nanobody's small size and tissue penetration... These results demonstrate successful design and functional characterization of a small, high-affinity anti-CD73 nanobody that holds promise to disrupt adenosine-driven immunosuppression for targeted immunotherapy in CRC. Also, it is offering a promising alternative to conventional monoclonal antibodies and merits further preclinical investigation for therapeutic development."

IO biomarker • Colorectal Cancer • Oncology • Solid Tumor

A first-in-human (FIH) phase I study of IPH5301, an anti-CD73 monoclonal antibody (mAb), in patients with advanced solid tumors (AST) (CHANCES, NCT05143970) (ESMO 2024) - P1 | "IPH5301, up to the highest tested dose, was safe and well-tolerated with preliminary signals of monotherapy antitumor activity. Combination of IPH5301 with paclitaxel-trastuzumab is currently explored in HER2-positive advanced breast and gastric cancer patients."

Clinical • Metastases • P1 data • Gastric Cancer • Gastrointestinal Cancer • HER2 Positive Breast Cancer • Oncology • Ovarian Cancer • Solid Tumor • CD73 • HER-2

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

CHANCES: A Phase 1 First-In-Human Study of the Anti-CD73 IPH5301 Alone or in Combination With Chemotherapy and Trastuzumab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=27 | Recruiting | Sponsor: Institut Paoli-Calmettes | Trial completion date: Feb 2025 ➔ Feb 2026 | Trial primary completion date: Mar 2024 ➔ Mar 2025

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Hepatology • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • 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

Innate Pharma Reports First Quarter 2023 Financial Results and Business Update (Businesswire) - "IPH6501 continues toward a Phase 1 clinical trial in 2023 for the proprietary CD20 targeted tetra-specific ANKET®; Innate continues to see progress for monalizumab in the early non-small cell lung cancer (NSCLC) setting, with the ongoing Phase 3 PACIFIC-9 study run by AstraZeneca; Two monalizumab abstracts have been accepted for 'Trial in progress' posters at the American Society for Clinical Oncology (ASCO) 2023 Annual Meeting, taking place June 2-6, 2023 in Chicago, IL; The MATISSE Phase 2 clinical trial conducted by Innate in neoadjuvant lung cancer for IPH5201...has started and is awaiting first patient dosed; The investigator-sponsored CHANCES Phase 1 trial of IPH5301, in collaboration with Institut Paoli-Calmettes is ongoing."

New P1 trial • Trial status • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

CHANCES: A Phase 1 First-In-Human Study of the Anti-CD73 IPH5301 Alone or in Combination With Chemotherapy and Trastuzumab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=27 | Recruiting | Sponsor: Institut Paoli-Calmettes | Trial completion date: Jul 2024 ➔ Feb 2025 | Trial primary completion date: Jul 2023 ➔ Mar 2024

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Hepatology • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor

A first-in-human phase I study of IPH5301, an anti-CD73 monoclonal antibody, alone or in combination with chemotherapy and trastuzumab, in patients with advanced solid tumors (CHANCES) (ESMO-IO 2022) - P1 | "In the expansion cohort, IPH5301 will be administered at the recommended dose (RP2D) and the next lower dose (RP2D-1) in combination with trastuzumab and paclitaxel in 12 patients with advanced/metastatic HER2-positive breast and gastric/esogastric cancer. The secondary objectives are to evaluate pharmacokinetic, immunogenicity and to assess preliminary clinical activity. Finally, exploratory objectives include pharmacodynamics such as CD73 expression, occupancy and enzymatic activity."

Clinical • Combination therapy • P1 data • Gastric Cancer • Gastrointestinal Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • NT5E

Innate Pharma to present adenosine franchise, IPH5201 and IPH5301 at ESMO IO 2022 (Businesswire) - "Innate Pharma SA...announced that three posters showcasing IPH5201 and IPH5301 will be presented on December 8 at the 2022 European Society for Medical Oncology I-O (ESMO Immuno-Oncology) Annual Congress in Geneva, Switzerland....A Phase 2 clinical trial conducted by Innate in lung cancer is in planning."

P1 data • Preclinical • Trial status • Breast Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor

"$IPHA Innate Pharma to present adenosine franchise, IPH5201 and IPH5301 at ESMO IO 2022 https://t.co/WOSFWBcn5I" (,@stock_titan)

"IPH5301 ( CD73 ) Cancer (solid tumors) Phase 1 started for $IPH $IPHA @sanofi @SanofiUS @pfizer Best in Class" (,@bencherki)

P1 data • Oncology • Solid Tumor

CHANCES: A Phase 1 First-In-Human Study of the Anti-CD73 IPH5301 Alone or in Combination With Chemotherapy and Trastuzumab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=27 | Recruiting | Sponsor: Institut Paoli-Calmettes | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Breast Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Hepatology • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor

"IPH5301 ( CD73 ) Cancer (solid tumors) Phase 1 started for $IPH $IPHA Best in Class" (,@bencherki)

P1 data • Oncology • Solid Tumor • CD73

CHANCES: A Phase 1 First-In-Human Study of the Anti-CD73 IPH5301 Alone or in Combination With Chemotherapy and Trastuzumab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=27; Not yet recruiting; Sponsor: Institut Paoli-Calmettes

Clinical • Combination therapy • New P1 trial • Breast Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Hepatology • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor

"IPH5301 anti-CD73 doit également faire partie des enjeux je pense. Plusieurs biotech et pharma ciblent la voie adénosine dans le traitement des cancers actuellement $IPH" (,@Tkilla65693376)

Oncology

Blocking Antibodies Targeting the CD39/CD73 Immunosuppressive Pathway Unleash Immune Responses in Combination Cancer Therapies. (PubMed, Cell Rep) - "In order to disrupt the adenosine pathway, we generated two antibodies, IPH5201 and IPH5301, targeting human membrane-associated and soluble forms of CD39 and CD73, respectively, and efficiently blocking the hydrolysis of immunogenic ATP into immunosuppressive adenosine. In a human CD39 knockin mouse preclinical model, IPH5201 increased the anti-tumor activity of the ATP-inducing chemotherapeutic drug oxaliplatin. These results support the use of anti-CD39 and anti-CD73 monoclonal antibodies and their combination with immune checkpoint inhibitors and chemotherapies in cancer."

Journal • Immune Modulation • Inflammation • Oncology

Preclinical development of humanized CD39 and CD73 blocking antibodies targeting the ATP/adenosine immune checkpoint pathway for cancer immunotherapy (AACR 2018) - "Finally, in vivo blockade of ATP/Ado pathway in CD39ko mice resulted in improved anti-tumor efficacy of immunogenic cell death inducer chemotherapy and of immune checkpoint therapies, including PD1 and CTLA4.Taken together, these data support the clinical development of anti-CD39 and anti-CD73 neutralizing Abs for cancer immunotherapy, potentially in combination with chemotherapy or Immune Checkpoint therapy. The humanized anti-huCD39 and anti-huCD73 monoclonal antibodies are currently in preclinical development.The research leading to CD73 results were obtained within the TumAdoR collaborative consortium that received funding from the European Community's Seventh Framework Program (FP7/2007-2013) under grant agreement n602200."

IO Biomarker • PD(L)-1 Biomarker • Preclinical • Oncology

IPH5301, a CD73 blocking antibody targeting the adenosine immunosuppressive pathway for cancer immunotherapy. (SITC 2019) - "These results indicate that IPH5301 blocks CD73 with a differentiated mechanism of action compared to benchmarked anti-CD73 clinical candidates and support the clinical development of IPH5301 for cancer immunotherapy, potentially in combination with chemotherapy or immune checkpoint inhibitors."

IO Biomarker • PD(L)-1 Biomarker

Innate Pharma announces preclinical data presentations at SITC 2019 (GlobeNewswire, INNATE PHARMA) - "Preclinical results of anti-CD73 IPH5301 targeting the adenosine immunosuppressive pathway. Innate will also present in vitro data on IPH5401, demonstrating that the molecule has the potential to block activation and migration of human neutrophils, a major mechanism to allow for the reactivation of effector cells. The Company believes this data supports its ongoing multi-center, open label, dose-escalation and dose expansion Phase I clinical trial (STELLAR-001), evaluating the safety and efficacy of IPH5401 in combination with durvalumab (anti-PD-L1) in patients with advanced solid tumors."

Pipeline update • Preclinical • Tumor microenvironment