Institut Jean Paoli & Irene Calmettes

ReSET-02 dose escalation Phase I is completedPhase II PoC randomized segment is starting No dose-limiting toxicities, no safety or tolerability issuesThe highest dose is to be used in both hematological and solid tumors Paris, France – October 23, 2024 – Smart Immune, a clinical-stage biotechnology company pioneering ProTcell, a thymus-empowered T-cell progenitor therapy platform, today announced that the recommended dose for its lead candidate, SMART101, has been established following the completion of the ReSET-02 trial dose escalation segment. This international multicenter study is evaluating the safety and efficacy of a single infusion of SMART101 administered after a standard-of-care HLA-mismatched allogeneic stem cell transplant in adult patients with hematological malignancies such as acute leukemia or myelodysplastic syndrome. Patients were treated with three doses of SMART101 at 1.5, 4, and 9 million cells per kg of body weight. No toxicities and no primary graft failures were reported. Patients didn’t experience severe acute graft versus host disease or serious adverse events related to SMART101. This data demonstrates an excellent tolerability and safety profile of SMART101. Based on these results, Smart Immune has established the highest dose of 9 million CD7+ cells per kg of body weight to be used in adult patient proof-of-concept cancer trials evaluating SMART101 in hematology and solid tumors. The recommended dose choice was endorsed by the Chair of the Independent Data Monitoring Review Committee after examining all the data from segment 1 of the trial. In addition, the preliminary data on immune recovery is very promising in patients treated with intermediate and high doses of SMART101 and should be further confirmed by the randomized part of the trial. Dr. Raynier DEVILLIER, Team Leader, Allogeneic Immunotherapy – Paoli-Calmettes Institute, Comprehensive Cancer Center at Marseille, France, said: “As an investigator for the ReSET-02 study, I've been pleased by the tolerability and safety profile of SMART101 among our cohort, which is composed of elderly and fragile patients. As it may offer the greatest potential for efficacy, establishing the maximum dose level as the recommended regimen for adult cancer patients is very promising. I'm thrilled to continue contributing to this line of research. ” Dr. Rahim FANDI, Chief Medical Officer of Smart Immune, added: “This is an important step in the development of SMART101. Following the determination of the recommended dose, we have launched the randomized part of the ReSET-02 study, and we are preparing new proof-of-concept trials in immune-oncology, notably in solid tumor indications. This is a major milestone for Smart Immune to contribute to the fight against cancer and bring new therapeutic options to patients.” About Smart Immune Smart Immune is a clinical-stage biotechnology company developing ProTcell, a thymus-empowered T-cell progenitor platform to rapidly re-arm the immune system against cancer and infection. The company aims to radically improve outcomes for patients in hematology and immuno-oncology. SMART101 is in Phase I/II trials for patients with acute leukemia or primary immunodeficiencies (PID), in the EU and the US. Additional clinical applications are planned to be evaluated in combination with innovative cancer therapies. https://www.smart-immune.com/LinkedIn | X (formerly Twitter) About the ReSET-02 clinical trial ReSET-02 is a first-in-human, open-label, randomized, multicenter phase I/II study evaluating the safety and activity of a single infusion of SMART101 post-HSCT in adult patients with hematological malignancies eligible for an HLA-mismatched PT-Cy HSCT as standard of care. In the Phase II segment, patients will be randomized to receive SMART101 after HSCT (SMART101 arm) or the standard of care with HSCT (SoC; control arm). This will allow generating an internal control group. The trial is currently conducted at multiple sites in France and Italy and coordinated by Fabio Ciceri (San Raffaele Hospital, Milan, IT). For more information, visit www.clinicaltrials.gov, study identifier number NCT05768035. About SMART101 SMART101 is generated ex vivo in 7 days from allogeneic blood stem cells, using Smart Immune’s ProTcell T-cell therapy platform. Once injected into the patient, the SMART101 human T-cell progenitors travel to the thymus where they are educated to become fully functional and self-tolerant T-cells. Preclinical data suggest that the ProTcell platform could reconstitute the immune system in 100 days instead of the 12 to 18 months observed in physiology, thereby protecting patients from infection and relapse. Media contact: Pauline Rodrigue info@smart-immune.com

PARIS, Oct. 21, 2024 /PRNewswire/ -- Okomera announces Bpifrance funding to develop and standardize novel CRISPR screening assay to accelerate drug discovery in oncology with leading cancer research center of Marseille, CRCM. Okomera is developing desktop platform for automated organoid screening using droplet-microfluidics and AI to accelerate drug discovery. Their patented tech developed after 10 years of research at Pasteur Institute and Ecole Polytechnique, provides Multiplexing, Co-culture and High-throughput screening of drug candidates on miniaturized Patient Derived Organoids (PDOs). Continue Reading Raphael Tomasi, CTO & Co-Founder of Okomera "We are honored to receive this grant from Bpifrance," said Sidarth Radjou, CEO of Okomera. Dr. Thomas Miller, Principal Investigator at IPC and CRCM, emphasized the significance of this collaboration: "This partnership is an extraordinary opportunity to advance our understanding of cancer biology. By developing and standardizing a CRISPR screening assay that can be directly applied to PDOs, we can create more accurate disease models. This will not only improve our ability to study cancer mechanisms but also enhance our capability to identify new therapeutic targets and develop more effective treatments." "We are thrilled to embark on this collaboration, as it offers an unprecedented opportunity to leverage cutting-edge technologies in cancer research," said Dr. Geraldine Guasch, Research Director Inserm at CRCM and Scientific Director of the 3D-HUB-O organoid platform. "By integrating CRISPR technology with Okomera's advanced organoid screening platform, we are setting the stage for more precise and effective therapeutic strategies. This project represents a significant step forward in translating scientific discoveries into tangible clinical applications, ultimately bringing us closer to improving outcomes for cancer patients." Corentin Molson, representing Bpifrance, commented: "Bpifrance is proud to support Okomera in this pioneering effort. Their innovative approach to developing and standardizing CRISPR screening on PDOs reflects our commitment to fostering innovation in healthcare. This project has the potential to make significant contributions to the field of precision medicine and improve outcomes for cancer patients." We would also like to recognize the contribution and assistance provided by AstraZeneca to support the successful grant application. About Okomera, visit our website: Paoli-Calmettes Institute: Based in Marseilles, Paoli-Calmettes Institute (IPC) is the first cancer comprehensive centre in region providing global care for cancer. It is a member of the national federation Unicancer. Further information: Photo - Logo - Contact: Sidarth Radjou, CEO [email protected] SOURCE Okomera WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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