Université d'Aix-Marseille

ImCheck Receives FDA Fast Track Designation for ICT01in Combination with Azacitidine and Venetoclaxin First-Line Acute Myeloid Leukemiafor Patients Unfit for Induction Chemotherapy Treatment ICT01, a humanized anti-butyrophilin 3A monoclonal antibodydesigned to selectively activate Vγ9Vδ2 T cells, has shown encouraging clinical datain AML in its ongoing Phase 1/2a EVICTION study Marseille, France, September 18, 2024, 11 am CET – ImCheck Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ICT01 in combination with azacitidine and venetoclax for the treatment of acute myeloid leukemia (AML) patients 75 years or older, or who have comorbidities that preclude use of standard intensive induction chemotherapy. Based on encouraging results from the Phase 1 dose-escalation portion of the EVICTION study evaluating ICT01 monotherapy in relapsed/refractory hematological malignancies (European Society for Medical Oncology Congress 2023), ImCheck initiated in October 2023 a randomized dose-optimization cohort (NCT04243499), evaluating two doses of ICT01 in combination with azacitidine and venetoclax, the current standard of care for newly diagnosed patients with AML who are deemed unfit for induction chemotherapy. “The growing body of data on ICT01 together with the FDA’s Fast Track designation further validates our development of ICT01 in first-line AML patients and highlights the critical need for therapies that generate higher response rates and improve overall survival for these patients,” said Stephan Braun, MD, PhD, Chief Medical Officer of ImCheck Therapeutics. “We are highly encouraged by ICT01’s potentially broad applicability in solid tumor and hematological cancer indications and look forward to sharing updates from the EVICTION study at upcoming scientific conferences.” The FDA designed Fast Track status to facilitate the development and expedite the review of therapeutic candidates that have the potential to treat serious conditions and address an unmet medical need. A therapeutic candidate that receives Fast Track designation may be eligible for more frequent interactions with the FDA to discuss the candidate’s development plan. Candidates with Fast Track designation may also be eligible for Priority Review and Accelerated Approval if supported by clinical data, with the goal of bringing approved therapies to patients earlier. EVICTION is an open-label multicohort Phase 1/2a trial studying ICT01, a humanized anti-butyrophilin 3A monoclonal antibody that selectively activates γ9δ2 T cells; the study comprises cohorts investigating ICT01 as a monotherapy and combination therapy in solid and hematological tumors. As reported at ESMO 2023, the Phase 1 dose-escalation cohort in relapsed/refractory hematological cancers included 26 patients who failed all available treatment options, 24 of which had AML, one with diffuse large B-cell lymphoma and one with follicular lymphoma. No dose-limiting toxicities were revealed for ICT01 administered at doses ranging from 200 μg to 75 mg every 21 days. Based on encouraging safety, pharmacokinetic and pharmacodynamic data, a dose-optimizing and efficacy-estimating part was initiated for patients with newly diagnosed AML who are older or deemed unfit for standard chemotherapy, which has enrolled 29 patients to date. Emerging pharmacodynamic and pharmacokinetic data for ICT01 in combination with azacitidine-venetoclax showed reproducible activation and migration of γ9δ2 T cells from the blood within hours of dosing, suggesting effective target engagement as the basis for the observed efficacy. *** About IMCHECK THERAPEUTICS ImCheck Therapeutics is designing and developing a new generation of immunotherapeutic antibodies targeting butyrophilins, a novel super-family of immunomodulators. As demonstrated by its lead clinical-stage program ICT01, which has a mechanism of action to simultaneously modulate innate and adaptive immunity, ImCheck's “first-in-class” activating antibodies may be able to produce superior clinical results as compared to the first-generation of immune checkpoint inhibitors and, when used in combination, to overcome resistance to this group of agents. In addition, ImCheck’s antagonist antibodies are being evaluated as potential treatments for a range of autoimmune and infectious diseases. ImCheck benefits from support from Prof. Daniel Olive (INSERM, CNRS, Institut Paoli Calmettes, Aix-Marseille University), a worldwide leader in γ9δ2 T cells and butyrophilins research, as well as from the experience of an expert management team and from the commitment of leading US and European investors. For further information: https://www.imchecktherapeutics.com/ Press contacts: US and EU Trophic CommunicationsGretchen Schweitzer +49 (0) 172 861 8540imcheck@trophic.eu FranceATCG PARTNERSCéline Voisin+33 (0)9 81 87 46 72 / +33 (0)6 62 12 53 39imcheck@atcg-partners.com Attachment PR in English

The PIONeeR Project to Present Late-Breaking Results from its Phase Ib/IIa umbrella study at the ESMO Congress 2024 The Presidential Symposium "Eyes to the future" will feature the first-ever presentation of the clinical trial portion of the PIONeeR Project (Precision Immuno-Oncology for advanced Non-Small Cell Lung Cancer Patients with PD-(L)1 ICI Resistance).PIONeeR is a major international hospital-university research (RHU) project addressing the critical challenge of resistance to PD-1(L1) immune checkpoint inhibitors (ICIs) in patients with advanced non-small cell lung cancer (NSCLC), including a biomarker program (> 400 biomarkers) and an umbrella clinical trial (4 ICI combinations).The PIONeeR trial used an innovative and adaptive design for trial reporting and decision making, to identify signals of efficacy for novel ICI combinations in advanced NSCLC patients progressing after PD-(L)1 inhibitors. Marseille, France, Sept 12, 2024 – The PIONeeR Project consortium today announced that Pr Pascale Tomasini, Principal investigator of the PIONeeR early phase randomized umbrella trial, will present the first data from the PIONeeR Project’s clinical trial at the upcoming ESMO Congress 2024, to be held September 13-17 in Barcelona, Spain, and virtually, during the Presidential Symposium III: Eyes to the future. " The PIONeeR trial is a collaborative success, fighting on multiple fronts at once, with all the artillery at our disposal, to explore how to overcome resistance to sequential or concurrent PD-(L)1 inhibitors in advanced NSCLC. The clinical trial is now complete, and we are conducting extensive biomarker analyses that we hope will shed light on the path on how to address this major challenge," said Prof. Fabrice BARLESI, coordinator of the PIONeeR Project, General Director at Gustave Roussy and Professor at Paris-Saclay University. "I would like to highlight this incredible act of selflessness by our more than 450 patients enrolled in our biomarker part of the PIONeeR Project, and our more than 150 patients being screened for inclusion in the clinical trial portion of the study. We are grateful for the dedication of our patients, which has taken us a giant step forward in advancing this study.” Details on the abstract accepted for presentation at ESMO Congress 2024 include: Presidential Symposium III: Eyes to the future Title: Precision Immuno-Oncology for advanced Non-small cell lung cancer (NSCLC) patients with PD-(L)1 inhibitors Resistance (PIONeeR): a phase Ib/IIa clinical trial targeting identified resistance pathways Presentation Number: LBA8.Presenter: Pr Pascale Tomasini, Aix Marseille Université, AP-HM, Early Phase Clinical Trials in Oncology Unit, Principal investigator of the PIONeeR early phase randomized clinical trialPresentation Time: Monday September 16, 2024, 4:30 - 6:15 pm CEST Abstract will be available on the ESMO website: ESMO Congress 2024 - Conference Calendar. All accepted abstracts will be published in the ESMO Congress 2024 Abstract Book, a supplement to the official ESMO journal, Annals of Oncology. ***About the PIONeeR Project Winner of the 3rd University-Hospital Research in Health call for projects in the “Investments for the Future program”, the PIONeeR Project gathers over 100 scientists across 3 different countries, 8 research labs, and 16 hospitals, all committed to the scientific, medical and human adventure that it represents. The project has recruited 450+ patients to its biomarker program and 114 patients to the PIONeeR Phase Ib/IIa clinical trial. The clinical trial is now complete and extensive biomarker analyses are ongoing. The partners of the PIONeeR Project are Marseille Immunopôle (MI), Aix Marseille Université (amU), Inserm, CNRS, 4 research & technology centers (CIML, CRCM, CIPHE, MImAbs), Assistance Publique-Hôpitaux de Marseille (AP-HM), the Paoli-Calmettes Institute, the Léon-Bérard Center, Gustave Roussy Institute, and industrial partners AstraZeneca, ImCheck Therapeutics, Innate Pharma and Veracyte. This 7-year project1 has been granted a French public funding (ANR-17-RHUS-0007). Press contact: Marie Puvieux, ATCG Partners, +33 6 10 54 36 72 communication@the-pioneer-project.org 1 Initially a 5-year project. Extension period granted, notably linked to the Covid crisis. Attachment PR in English

WASHINGTON, Aug. 22, 2024 /PRNewswire/ -- The American Pharmacists Association (APhA) Foundation today announced the recipients of the 2024 Pinnacle Awards. Established in 1998, the Pinnacle Awards celebrate significant contributions to the medication use process leading to enhancements such as increasing patient adherence, reducing adverse drug events, promoting the use of national treatment guidelines, improving patient outcomes, and enhancing communication among the members of the health care team. "The APhA Foundation has the great pleasure of recognizing this year's Pinnacle award recipients," said Benjamin Bluml, RPh, APhA Foundation Executive Director and Senior Vice President, Research & Innovation. "These individuals and organizations are community champions of continued medication use improvement and quality care." 2024 Pinnacle Award Recipients and Categories Michael E. Klepser, PharmD, FCCP, FIDP Category I: Individual Award for Career Achievement presented to an individual who has demonstrated exceptional leadership in enhancing health care quality and medication use. Klepser has been in practice for more than 30 years. He has been a professor at the Ferris State University College of Pharmacy since 2001 and is an adjunct faculty at the University of Nebraska College of Pharmacy. Klepser is the founder and Director of The Collaboration of Advance Pharmacy Enterprises (CAPE). Under CAPE, Klepser works with numerous enterprises to improve quality of and patient access to care. Dispensary of Hope Category III: Award presented to Voluntary Health Agencies, Nonprofit Organizations, Associations, Government Agencies or Public/Private Partnerships that demonstrated approaches to assist patients and their caregivers in achieving better outcomes from their medications. Nashville-based nonprofit, Dispensary of Hope, has been actively operating and building a national model of medication access for the most vulnerable for over a decade. Dispensary of Hope is comprised of a network of dispensing sites, focused on a shared mission to provide vital medication access to low-income and uninsured individuals across the United States. This innovative model unifies pharmaceutical manufacturing and safety net health care delivery with a common goal of saving and transforming lives. The Innovations in Pharmacy Practice Lecture will be delivered by both Michael E. Klepser, PharmD, FCCP, FIDP, and Hillary Blackburn, PharmD, MBA, the Chief Pharmacy Officer of Dispensary of Hope. Support for the APhA Foundation Pinnacle Awards Program is provided by an educational grant from Merck. SOURCE American Pharmacists Association Foundation