CD5

PHILADELPHIA, Feb. 27, 2024 (GLOBE NEWSWIRE) -- Vittoria Biotherapeutics, a clinical-stage cell therapy company, has announced today that accomplished life sciences leader, Rosemary Mazanet, M.D., Ph.D., has joined the Company as Chief Medical Officer. Dr. Mazanet brings over 20 years of C-suite leadership experience across all stages of drug development, backed by an exceptional track record in evaluating, conceiving, articulating, and executing clinical development and strategic visions across both public and private companies. In her role, Dr. Mazanet will serve on the Company’s executive team and will be responsible for providing leadership and direction to guide Vittoria's clinical development strategy and execution, including the advancement of Vittoria’s lead candidate, VIPER-101, into the clinic for patients with T-cell lymphoma. “Drawing on her extensive expertise in the oncology and hematology drug development ecosystem, Dr. Mazanet will be an invaluable asset to Vittoria’s executive team as we enter first-in-human studies for our lead program,” said Nicholas Siciliano, Ph.D., Vittoria’s Chief Executive Officer. “Her commitment to advancing the development of novel therapeutics in oncology demonstrates her passion for improving patient outcomes, and we’re honored to have her join in our mission to deliver groundbreaking cell therapies to patients in need.” Dr. Mazanet added, “I’m thrilled to be joining the talented Vittoria team and look forward to working with our leadership and Board to progress VIPER-101 through the clinic. Vittoria’s innovative approach to CAR-T development could change the treatment paradigm for T-cell lymphoma patients struggling with this debilitating disease. I am both inspired and excited to participate in Vittoria’s mission to turn the Senza5 CD5 knockout strategy into meaningful therapies across many disease states.” Prior to joining Vittoria, Dr. Mazanet served as interim C-suite management and as a Strategic Advisor to many companies and funds through her consultancy business, R Mazanet LLC, which was established in 2004. Dr. Mazanet has experience in public equity markets having served as Managing Partner at Apelles Investment, LLC from 2007 to 2014, and as the head of Research at Oracle Partners LP beginning in 1998. Before her public equity work, Dr. Mazanet worked at Amgen, Inc., where she led Clinical Development teams that conducted successful oncology and infectious disease programs resulting in multiple product approvals. Dr. Mazanet is an Emeritus Trustee at the University of Pennsylvania Health System and has served as the Chair of the Executive Advisory Board for the Wharton Leonard Davis Institute since December 2020. Dr. Mazanet holds a B.A. in biology from the University of Virginia, and an M.D. and Ph.D. from the University of Pennsylvania. Dr. Mazanet received her clinical training in internal medicine and oncology at Harvard Hospitals. About Senza5 Senza5 is a proprietary cell therapy engineering and manufacturing platform that combines the power of genetic engineering and a proprietary five-day manufacturing process to maximize stemness, durability, and efficacy of its produced cell therapies by disabling the CD5 signaling pathway on engineered CAR-T cells, and bypassing CD5's immunosuppressive effects to amplify the therapy’s antitumor activity. Stemness is further enhanced by the expedited five-day manufacturing process which promotes greater in vivo expansion and durability, and the potential for longer-lasting responses. By acting on the fundamental biology of T cells, Senza5 can be widely utilized to improve the efficacy of engineered T-cell therapies. About VIPER-101 VIPER-101 is a gene-edited, autologous, CAR-T cell therapy for the treatment of patients with relapsed or refractory T-cell lymphoma. Viper-101 is uniquely engineered by Vittoria’s proprietary Senza5 technology, to both avoid fratricide and unlock the benefit of circumventing the inhibitory CD5 signaling pathway. Vittoria is currently enrolling in its Phase 1 study of VIPER-101 and anticipates announcing data from this trial in the first half of 2025. About Vittoria Biotherapeutics Vittoria Biotherapeutics, Inc., is developing novel CAR-T cell therapies that transcend the limitations of current cell therapies. Based on technology exclusively licensed from the University of Pennsylvania, the Company’s proprietary Senza5 platform unlocks the antitumor potential of engineered T cells and utilizes a five-day manufacturing process to maximize stemness, durability, and target cell cytotoxicity. By acting on the fundamental biology of T cells, Senza5 can be used to improve the efficacy of engineered T cell therapies with pipeline applications in oncology and autoimmune diseases. To learn more, visit vittoriabio.com and follow us on LinkedIn. Investor Contact Vittoria Biotherapeutics Nicholas A. Siciliano, Ph.D. Chief Executive Officer +1 215-600-1380 Media Contact LifeSci Communications Jason Braco, Ph.D. jbraco@lifescicomms.com +1 646-876-4932

WALTHAM, Mass.--( BUSINESS WIRE )-- BostonGene , a leading provider of AI-driven molecular and immune profiling solutions, today announced the selection of four abstracts for oral presentation, four abstracts as poster presentations, and two abstracts for online publication at the 65 th American Society of Hematology (ASH) Annual Meeting and Exposition being held December 9-12, 2023, in San Diego, California and virtually. BostonGene will exhibit in booth #2350. “ We look forward to showcasing compelling data at ASH, which will underscore the pivotal role of molecular and immune profiling alongside advanced analytics in propelling precision medicine for individuals battling cancer,” said Nathan Fowler, MD, Chief Medical Officer at BostonGene. Details of the presentations are below: Oral presentations: Abstract: 601 Title: Clinical Outcomes of Patients with Relapsed/Refractory Follicular Lymphoma Treated with Tisagenlecleucel: Phase 2 Elara 3-Year Follow-up Date & time: Sunday, December 10, 2023 | 4:30 PM Location: Room 6CF - San Diego Convention Center Presenter: Stephen J Schuster, MD , Abramson Cancer Center, University of Pennsylvania This presentation highlights results from the Phase 2 ELARA trial that show efficacy, safety, pharmacokinetic, and exploratory biomarker analyses in relapsed/refractory follicular lymphoma patients treated with tisagenlecleucel after a median follow-up of more than 3 years. Higher baseline levels of CD8+ naive T cells are associated with improved long-term clinical outcomes. Research conducted in collaboration with The University of Texas MD Anderson Cancer Center, Abramson Cancer Center, University of Pennsylvania, The University of Melbourne, Hospital Universitario, Oslo University Hospital, Royal Brisbane Hospital, University of Michigan, City of Hope National Medical Center, Moffitt Cancer Center, Hospices Civils de Lyon and Claude Bernard Lyon 1 University, Kyushu University Hospital, Tohoku University Graduate School of Medicine, University of Amsterdam, University of California San Francisco, University of Chicago, Royal Prince Alfred Hospital, Universidad de Sevilla, Oregon Health and Science University, University of Cologne, West German Cancer Center, University of Duisburg-Essen, IRCCS San Raffaele Scientific Institute, Hokkaido University, King’s College London, University of Kansas Medical Center, Ordensklinikum Linz Barmherzige Schwestern-Elisabethinen, Universitair Ziekenhuis Gent, University Hospital of Ulm, University of Bologna, Cambridge University, Novartis Pharmaceuticals Corporation, Novartis Pharma AG, Hôpital Saint-Louis, Ludwig-Maximilians-University Hospital Abstract: 851 Title: A CD5 Gene Signature Identifies Diffuse Large B-Cell Lymphomas Sensitive to Bruton's Tyrosine Kinase Inhibition Date & time: Monday, December 11, 2023: 3:45 PM Location: Room 6DE - San Diego Convention Center Presenter: Alan Cooper, University of Chicago This study highlights the discovery of a novel transcriptomic-based biomarker of BTK inhibitors (BTK-i) response in DLBCL patients. The biomarker, a CD5 gene signature, expands upon existing genetic DLBCL classifications by identifying DLBCL patients that can benefit from BTK-i, warranting further prospective validation in BTK-i clinical trials. Research conducted in collaboration with the University of Chicago, City of Hope National Medical Center, The University of British Colombia, Janssen Research & Development, Centre for Lymphoid Cancer Abstract: 905 Title: Machine Learning (ML)-Enabled Automation for High-Throughput Data Processing in Flow Cytometry Date & time: Monday, December 11, 2023 | 3:45 PM Location: Room 6CF - San Diego Convention Center Presenter: Anna Kamysheva, MSc, BostonGene This presentation describes BostonGene’s development of an ML-based algorithm for automated cell-type labeling that enables the detection of rare and/or new cell populations with high speed and accuracy. This algorithm is applicable in clinical settings, particularly for detecting hematological abnormalities and cancers. Abstract: 983 Title: Addition of Acalabrutinib to Lenalidomide and Rituximab Induces High Complete Response Rates in Patients with Previously Untreated Follicular Lymphoma: Results of a Phase II Study Date & time: Monday, December 11, 2023 | 5:30 PM Location: Grand Hall C - Manchester Grand Hyatt San Diego Presenter: Paolo Strati, MD, MD Anderson The study demonstrates the safety and efficacy of lenalidomide and rituximab treatment in combination with acalabrutinib in previously untreated FL patients and highlights the use of bulk RNA sequencing with deconvolution to analyze the biological effects of this treatment combination on peripheral blood immune cells. Research conducted in collaboration with The University of Texas MD Anderson Cancer Center Poster presentations: Abstract: 1676 Title: Preliminary Analysis of an Ongoing Phase II Study of Response-Adapted Therapy with Copanlisib and Rituximab for Untreated Follicular Lymphoma Date & time: Saturday, December 9, 2023 | 5:30 PM - 7:30 PM Location: Halls G-H - San Diego Convention Center Presenter: Rahul Lakhotia, MBBS, National Cancer Institute, National Institutes of Health This study describes the preliminary analysis (including safety and efficacy) of an ongoing “window of opportunity” study of copanlisib, followed by response-adapted copanlisib and rituximab in treatment-naïve patients with follicular lymphoma (FL). Gene expression profiling was used to identify high-risk patients and find a predictive signature of response to PI3K inhibitor. Research conducted in collaboration with the National Cancer Institute, National Institutes of Health and Mayo Clinic Abstract : 3644 Title: A Novel Comprehensive Tumor-Informed Plasma cfDNA Assay to Monitor Minimal Residual Disease for Hematological and Solid Malignancies Date & time: Sunday, December 10, 2023 |6:00 PM - 8:00 PM Location: Halls G-H - San Diego Convention Center Presenter: Anastasiya Yudina, MSc, BostonGene This presentation describes our cell-free DNA (cfDNA) testing platform for minimal residual disease (MRD) monitoring. It encompasses all major clinically reliable genetic hotspots events and can detect clinically relevant mutations in plasma samples before clinical manifestation. Abstract: 3001 Title: Genomic and Transcriptomic Profiles of Blastoid and Pleomorphic Mantle Cell Lymphoma Are Distinct from Classic Histology Mantle Cell Lymphoma Date & time: Sunday, December 10, 2023 |6:00 PM - 8:00 PM Location: Halls G-H - San Diego Convention Center Presenter: Preetesh Jain, MD, MBBS, PhD, DM, MD Anderson This presentation highlights the use of BostonGene’s integrated genomic and transcriptomic analysis platform to provide a comprehensive portrait of the molecular differences between blastoid and pleomorphic mantle cell lymphoma (MCL), revealing mechanistic insights that can be used for the development of more effective therapeutic strategies. Research conducted in collaboration with The University of Texas MD Anderson Cancer Center Abstract: 4872 Title: Long-Term Durable Responses in Relapsed/Refractory (r/r) ALL, DLBCL, and FL Patients Treated with Tisagenlecleucel and Its Association with Persistence of CAR T-Cells Date & time: Monday, December 11, 2023: 6:00 PM - 8:00 PM Location: Halls G-H - San Diego Convention Center Presenter: Rakesh Awasthi, PhD , Novartis Institutes for BioMedical Research This study highlights a positive association between chimeric antigen receptor (CAR) persistence in peripheral blood post tisagenlecleucel (tisa-cel) infusion and durable clinical responses across three indications. Research conducted in collaboration with Novartis Institutes for BioMedical Research, Novartis Pharmaceuticals Corporation, Children's Hospital of Philadelphia, Perelman School of Medicine, University of Pennsylvania, Intermountain Primary Children’s Hospital, Huntsman Cancer Institute, Spencer Fox Eccles School of Medicine at the University of Utah, Goethe University Frankfurt, University Hospital, Knight Cancer Institute, Oregon Health & Science University, Emory University School of Medicine, Medical University of Vienna, Université de Paris, Klinikum der Universität, LMU München, MD Anderson Cancer Center Online publications: Title: Test-the-Test: Clinical Utility of Comprehensive Whole Exome Sequencing and RNA-Seq for Patients with Lymphoma This study shows an acceptable turn-around-time (TAT) of 8 days for the delivery of clinical reports that include clinically relevant findings and matched clinical trials, demonstrating the feasibility of using comprehensive WES and RNA-seq molecular profiling for lymphoma patients. Research conducted in collaboration with The University of Texas MD Anderson Cancer Center Title: Molecular Findings on Plasma Cell-Free DNA Analysis Among Adults with Histiocytic Neoplasms This study describes the use of cell-free DNA (cfDNA) analysis to evaluate the molecular findings in adults with histiocytic neoplasms, highlighting cfDNA as a potential viable tool for discovering driver mutations in multiple cancers. Research conducted in collaboration with The University of Alabama, Mayo Clinic In addition to the poster presentations, the abstracts have been published online in the November supplemental issue of “ Blood .” For more information, please visit the 65th ASH Annual Meeting and Exposition website at https://www.hematology.org/meetings/annual-meeting/abstracts . About BostonGene Corporation BostonGene has a mission to provide transformative, AI-integrated molecular analytics and biomarker discovery for precision matching of therapies to improve the lives of patients living with cancer and other immune-related diseases. BostonGene’s concierge-service model provides customized client solutions using a multi-omic approach prioritized for real-world impact to optimize standard-of-care therapies, accelerate research and provide cost-effective, measurable data-driven results. BostonGene’s tests reveal key drivers of each patient’s unique disease profile, including an in-depth profile of the immune microenvironment, actionable mutations, biomarkers of response to diverse therapies, and recommended therapies. Through these comprehensive analyses, BostonGene’s tests generate a personalized roadmap for therapeutic decision-making for each patient. For more information, visit BostonGene at http://www.BostonGene.com.

VIPER-101 is an autologous, CD5 knock-out CAR-T therapy for the treatment of T-cell lymphoma Initiating first-in-human Phase 1 trial in H1 of 2024 PHILADELPHIA, Dec. 07, 2023 (GLOBE NEWSWIRE) -- Vittoria Biotherapeutics has announced the clearance of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a first-in-human Phase 1 clinical trial to evaluate the Company’s lead candidate, VIPER-101, a gene-edited, autologous, CAR-T cell therapy for treatment of patients with relapsed or refractory T-cell lymphoma. “The FDA clearance of our investigational new drug application for VIPER-101 marks a pivotal milestone for Vittoria Biotherapeutics and our mission to transform therapeutic outcomes for patients battling difficult to treat diseases,” said Dr. Nicholas Siciliano, Ph.D., chief executive officer of Vittoria. “With limited advancements in T-cell lymphoma treatment over the last decade, this signifies a crucial step toward bringing an innovative treatment option to T-cell lymphoma patients with the potential to transform patient outcomes - an opportunity enabled by our proprietary Senza5 platform technology, designed to both enhance efficacy and improve safety.” Marco Ruella, MD, scientific co-founder of Vittoria and an assistant professor of Medicine in the Perelman School of Medicine at the University of Pennsylvania commented, “As a physician-scientist, I have seen first-hand the need for new therapies when treating T-cell lymphoma patients and as such, it is deeply gratifying to advance the first cell therapy candidate from our novel Senza5 technology into first-in-human studies. VIPER-101 is the first autologous CD5-targeting therapy designed to circumvent fratricide, improve anti-tumor efficacy, and mitigate inherent safety challenges associated with targeting T-cell malignancies with CAR-T therapies, thus creating the opportunity to deliver a potentially ground-breaking treatment for patients with T-cell lymphoma.” VIPER-101 is an autologous, CD5 deleted CAR-T therapy for the treatment of T-cell lymphoma produced using Vittoria’s proprietary cell therapy engineering and manufacturing platform, Senza5TM. CD5 is a pan-T cell marker that also regulates an immunosuppressive signaling pathway, however, conventional CAR-T cell therapies targeting CD5 for T cell malignancies can elicit fratricidal T-cell responses, diminishing treatment efficacy. VIPER-101 is uniquely engineered to both avoid fratricide and unlock the benefit of circumventing the inhibitory CD5 signaling pathway. Engineered using a proprietary five-day process to preserve cell stemness, the features of VIPER-101 synergize to maximize potency, safety, and manufacturing efficiency. At the upcoming 2023 American Society of Hematology (ASH) Annual Meeting, multiple abstracts will be presented that highlight the compelling preclinical data generated with the VIPER-101 cell therapy candidate, and that showcase the broad utility and enhanced anti-tumor efficacy of the Senza5 platform across distinct tumor models. Dr. Siciliano added: “We will continue to draw upon the same vigorous dedication of our team that enabled our rapid and cost-efficient evolution from a preclinical to clinical stage Company, as we advance VIPER-101 through clinical trials with phase 1 initiation expected in early 2024.” The Company anticipates announcing data from its Phase 1 trial in early 2025. About Senza5 Senza5 is a proprietary cell therapy engineering and manufacturing platform that combines the power of genetic engineering and a proprietary five-day manufacturing process to maximize stemness, durability, and efficacy of its produced cell therapies by disabling the CD5 signaling pathway on engineered CAR-T cells, and bypassing CD5's immunosuppressive effects to amplify the therapy’s antitumor activity. Stemness is further enhanced by the expedited five-day manufacturing process which promotes greater in vivo expansion and durability, and the potential for longer-lasting responses. By acting on the fundamental biology of T cells, Senza5 can be widely utilized to improve the efficacy of engineered T-cell therapies. About Vittoria Biotherapeutics Vittoria Biotherapeutics, Inc., is developing novel CAR-T cell therapies that transcend the limitations of current cell therapies. Based on technology exclusively licensed from the University of Pennsylvania, the Company’s proprietary Senza5 platform unlocks the antitumor potential of engineered T cells and utilizes a five-day manufacturing process to maximize stemness, durability, and target cell cytotoxicity. By acting on the fundamental biology of T cells, Senza5 can be used to improve the efficacy of engineered T cell therapies with pipeline applications in oncology and autoimmune diseases. To learn more, visit vittoriabio.com and follow us on LinkedIn. Editor’s Note Dr. Ruella is the scientific founder of, and an equity holder in, Vittoria Biotherapeutics. The University of Pennsylvania holds equity in Vittoria Biotherapeutics, has received sponsored research funding from Vittoria, has licensed certain intellectual property to Vittoria and may receive future funding and financial consideration based on development and commercialization of certain products by Vittoria. Dr. Ruella is also a paid consultant for Vittoria Biotherapeutics. Investor Contact Vittoria BiotherapeuticsNicholas A. Siciliano, Ph.D.Chief Executive Officer+1 215-600-1380 Media Contact LifeSci CommunicationsJason Braco, Ph.D.jbraco@lifescicomms.com+1 646-876-4932