CD58

- First landmark, peer-reviewed publication of successful in vivo CAR T-cell data in an immune competent NHP model -- Data validate the VivoVec™ platform in a translationally relevant model and support its transition into human clinical testing, offering a potential paradigm shift in the field of CAR T-cell therapies - SEATTLE, June 13, 2024 (GLOBE NEWSWIRE) -- Umoja Biopharma, Inc. (Umoja), a transformative immunotherapy company creating off-the-shelf treatments that aim to extend the reach and effectiveness of CAR T-cell therapies in oncology and autoimmunity, today announced that pre-clinical non-human primate (NHP) data on its VivoVec in vivo CAR T delivery system was published in Blood, the flagship journal of the American Society of Hematology. Results showed that in the absence of lymphodepleting chemotherapy, VivoVec lentiviral particles successfully generated CAR positive T (CAR+ T) cells targeting CD20 in vivo leading to the complete and durable depletion of B cells in excess of 10 weeks. Key Study Findings VivoVec particles (VVPs) incorporating CD80 and CD58 costimulation proteins exhibit enhanced capacity for in vivo CAR T-cell generation and produce CAR T-cells with increased antitumor functionality compared to those produced from VVPs displaying anti-CD3 scFvs alone.Combining the anti-CD3 scFv together with the ligand binding domains of CD80 and CD58 into a single multi-domain fusion (MDF) protein markedly augments the particles’ ability to bind, activate, and transduce T-cells.VVPs incorporating MDF compatible with NHP T-cell activation and costimulation potently generate anti-CD20 CAR T-cells in vivo, comprising up to 65% of circulating T-cells, and results in complete B-cell depletion for up to 76 days. “Currently approved ex vivo CAR T-cell therapies have significantly improved treatment outcomes in cancers like non-Hodgkin's lymphoma and multiple myeloma. However, their adoption and patient access are limited by the need for extensive infrastructure such as apheresis facilities, and the lengthy process of manufacturing patient-by-patient lots of CAR T-cells,” said Byoung Ryu, Ph.D., Executive Vice President of Vector Biology and In Vivo Sciences at Umoja Biopharma added, “We are excited to move several VivoVec drug candidates into initial human trials later this year, aiming to address these challenges.” “We are encouraged by these data that show continued validation of our VivoVec platform demonstrating the successful generation of CAR+ T-cells directly in vivo, eliminating the need for external cell collection, genetic modification, and extensive testing,” said Christopher Nicolai, Ph.D., lead author of the publication. The VivoVec platform utilizes advanced lentiviral particles that are surface engineered with a multidomain fusion protein to drive particle binding to T-cells, and subsequent activation and transduction, resulting in CAR expression. The CAR transgene is delivered to reprogram the T-cells to target specific cancer cells. The data published in Blood were collected in collaboration with the Washington National Primate Research Center. Umoja plans to initiate first-in-human trials of VivoVec-generated candidates in the second half of 2024. About VivoVec Umoja’s VivoVec gene delivery platform combines third generation lentiviral vector gene delivery with a novel T-cell targeting and activation surface complex. VivoVec is designed to enable T-cells in the body to manufacture their own cancer-fighting CAR T-cells in vivo. This has the potential to eliminate many challenges associated with traditional CAR T approaches, including reliance on gathering a patient’s own or donor cells which are modified externally before being delivered back to the patient, the associated time lag and manufacturing challenges of ex vivo cell modification, and the need for patient’s lymphodepletion. About Umoja Biopharma Umoja Biopharma, Inc. is a clinical-stage biotechnology company aiming to develop off-the-shelf therapeutics that improve the reach, effectiveness, and access of CAR T-cell therapies in both oncology and autoimmunity. Umoja’s VivoVec in vivo gene delivery technology is intended to empower a patient’s own immune system to fight disease. Enabling its core technology is the Company’s state-of-the-art lentiviral vector development and manufacturing facility in Louisville, Colorado. Umoja believes its approach can provide broader access and improved effectiveness of the most advanced immunotherapies, enabling more patients to live better, fuller lives. To learn more, connect with Umoja on LinkedIn and visit http://umoja-biopharma.com/. Umoja Forward-Looking Statements: This press release contains forward-looking statements about Umoja Biopharma, Inc. (the “Company,” “we,” “us,” or “our”). The Company has based these forward-looking statements largely on its current expectations, estimates, forecasts and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. These statements are subject to risks and uncertainties that could cause the actual results to vary materially, including, among others, the risks inherent in drug development such as those associated with the initiation, cost, timing, progress and results of the Company’s current and future research and development programs, preclinical and clinical trials, as well as any economic, market and social disruptions. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason. InvestorsStephen JasperGilmartin Group, LLCstephen@gilmartinir.com Media Matt WrightReal Chemistrymwright@realchemistry.com

Cloak™ and Dagger™ Technologies Show Potential to Reduce Dependence on Standard Lymphodepletion and Enhance Performance of AlloCAR T™ CellsData from Preclinical Study of Cloak™ Technology Highlights Ability to Engineer Allogeneic Cells to Evade Detection by the Host Immune SystemDagger™ Technology, a Feature of ALLO-316 Currently Being Investigated in a Phase 1 Study for Solid Tumors, Enables Dual AlloCAR T™ Cells to Selectively Eliminate CD70 Positive, Alloreactive Host Immune Cells While Simultaneously Killing CD19-Positive Tumor Cells SOUTH SAN FRANCISCO, Calif., Nov. 03, 2023 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products for cancer, today presented data highlighting the Company’s next generation Cloak™ and Dagger™ technologies designed to help enhance engraftment, expansion and the persistence of AlloCAR T cell candidates, at the Society for Immunotherapy of Cancer (SITC) Annual Meeting November 1-5, 2023, in San Diego, CA. The development of “off-the-shelf” CAR T products that utilize cells from healthy donors has the potential to make CAR T therapies scalable and accessible to more patients. However, the effectiveness of allogeneic CAR T cells requires controlling rejection of the allogeneic CAR T cells by the patient’s immune system. Allogene’s proprietary Cloak and Dagger technologies are two novel strategies the Company is investigating to help control immune rejection and enhance expansion, persistence, and performance of AlloCAR T cells with the use of standard lymphodepletion regimens. “These promising data show that both our Cloak and Dagger technology platforms can engineer AlloCAR T cells to minimize the potential of rejection by host immune cells, without impacting performance and in some cases, enhancing efficacy,” said Zachary Roberts, M.D., Ph.D., Executive Vice President, Research & Development and Chief Medical Officer of Allogene. “These innovative approaches are intended to simplify the lymphodepletion requirement for allogeneic CAR T products, and may provide a path to further expand the potential of off-the-shelf CAR T products beyond current targets and indications.” The Cloak platform technology is designed to prevent AlloCAR T cells from being recognized by host T cells without triggering substantial natural killer (NK) cell rejection while preserving CAR T cell function. Data shown previously demonstrated that knockout of RFX5, a transcriptional regulator that controls expression of HLA molecules, enhanced survival of allogeneic CAR T cells in the presence of host T cells and elicited only minor NK cell reactivity, thereby effectively mitigating rejection. This preclinical study evaluated an additional anti-rejection approach to immune evasion by inactivating CD58 and ICAM-1, key components of the immune synapse required for effective recognition and lysis by alloreactive T/NK cells. In the study, the survival of “cloaked” cells was assessed in mixed lymphocyte reaction assays with T cells and NK cells. The knockout of CD58 and ICAM-1 effectively reduced T cell rejection of allogeneic CAR T cells without triggering NK cell rejection or impacting effector function and worked additively with the knockout of RFX5. The Dagger platform technology arms AlloCAR T cells with a CD70 CAR designed to recognize and deplete CD70-positive host immune cells while enabling tumor-targeting anti-CD19 AlloCAR T cells to resist rejection from the host immune cells. This endows the CAR-expressing T cells with dual specificity against tumors that co-express CD19 and CD70, which includes approximately 70% of patients with large B-cell lymphoma (LBCL). As a result, this potential advance provides both a prolonged window of persistence during which AlloCAR T cells can expand and actively target and destroy cancer cells as well as insure against CD19 loss-mediated tumor escape, a known mechanism of resistance to CD19 CAR T therapy. The Dagger technology, a feature of our ALLO-316 candidate, has clinically demonstrated its unique immunomodulatory effect, contributing to robust AlloCAR T cell expansion and persistence even with relatively lower doses of CAR T cells and lymphodepletion than in other AlloCAR T programs. The ongoing Phase 1 dose escalation TRAVERSE study using investigational ALLO-316 in patients with advanced or metastatic renal cell carcinoma (RCC) who have progressed on standard therapies including an immune checkpoint inhibitor and a VEGF-targeting therapy. About Allogene TherapeuticsAllogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on X (formerly Twitter) and LinkedIn. Cautionary Note on Forward-Looking Statements for AllogeneThis press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release may, in some cases, use terms such as “advance,” "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things Allogene’s ability to develop and deliver readily available allogeneic CAR T products for cancer treatment on-demand, more reliably, and at greater scale to more patients. Various factors may cause material differences between Allogene’s expectations and actual results, including risks and uncertainties related to: our product candidates are based on novel technologies, which makes it difficult to predict the time and cost of product candidate development and the likelihood of obtaining regulatory approval; the extent to which the FDA disagrees with our clinical or regulatory plans, which could cause future delays to our clinical trials or require additional clinical trials; and we may not be able to demonstrate the safety and efficacy of our product candidates in our clinical trials, which could prevent or delay regulatory approval and commercialization. These and other risks are discussed in greater detail in Allogene’s filings with the SEC, including without limitation under the “Risk Factor” Heading in its Form 10-Q filed for the quarter ended September 30, 2023. Any forward-looking statements that are made in this press release speak only as of the date of this press release. Allogene assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. AlloCAR T™, Cloak™ and Dagger™ are trademarks of Allogene Therapeutics, Inc. Allogene’s AlloCAR T™ programs utilize Cellectis technologies. The anti-CD70 AlloCAR T programs are licensed exclusively from Cellectis by Allogene and Allogene holds global development and commercial rights to these AlloCAR T programs. Allogene Media/Investor Contact:Christine CassianoChief Corporate Affairs & Brand Strategy OfficerChristine.Cassiano@allogene.com Additional Allogene Media Contacts:Leslie BryantLeslie.Bryant@allogene.com Madeleine GoldsteinMadeleine.Goldstein@allogene.com

Launch of Pin-pointTM base editing reagents improves access to new-generation editing technology Access to the Pin-point system now bridges discovery, preclinical and clinical with the same technology platform Reagent launch puts clinically relevant base editing in the hands of preclinical laboratories seeking to accelerate genomic insights and cell therapy research WALTHAM, Mass.--(BUSINESS WIRE)-- Revvity, Inc., (NYSE: RVTY) today unveils its groundbreaking Pin-point™ base editing platform reagents, providing researchers with unparalleled access to implement the advanced gene editing technique in their preclinical laboratories. Base editing represents a pivotal advancement in CRISPR gene editing, providing the capability for complex and safe multi-gene editing, which can result in enhanced functional genomics insights for optimizing drug development, as well as streamlining cell line and cell therapy development and manufacturing. The Pin-point platform is one of the few established base editing technologies currently being employed in clinical settings, positioning it as both a discovery and therapeutic tool. Michelle Fraser, head of cell and gene therapy at Revvity, underscores the importance of providing broad access to this technology: "Base editing has been extensively demonstrated in numerous studies to safely and precisely control the correction of single base changes at multiple target sites, simultaneously. This streamlined approach simplifies complex multi-gene editing, holding great promise for the development of new cell therapies targeting rare inherited genetic diseases, cancer, and in the creation of universal donor cells as the foundation of allogeneic cell therapies." The initial reagents launch includes mRNAs for nCas9 and rat APOBEC, as well as three guide RNAs designed to knockout the TRAC, CD58 and PDCD1 loci. These reagents have undergone extensive validation and have demonstrated their performance in T-cells and induced pluripotent stem cells (iPSCs). Furthermore, Revvity offers the flexibility of ordering custom guides for other targets through its Dharmacon™ custom gRNA ordering tool for the Pin-point base editing platform, supporting diverse research applications. Increasing Access to Accelerate Discovery to Cure The introduction of Pin-point base editing reagents signifies a momentous stride toward democratizing access to base editing. Until now, base editing reagents were either custom-ordered by end-users or obtained by non-profit laboratories as individual components. However, with the newly launched reagents, scientists now have the ability to fully evaluate the Pin-point base editing platform in-house. Alan Fletcher, senior vice president of life sciences at Revvity, emphasizes the importance of bridging the gap between discovery, diagnosis and cure: "In an era where the lines between precision and personalized medicine are increasingly blurred, translating genomic insights into clinically relevant actions is pivotal for us to expedite tomorrow's groundbreaking therapies and drive innovation from target identification to cure. Revvity is uniquely poised to drive these translational breakthroughs by offering accessible technologies like the Pin-point platform that seamlessly span the journey from discovery to therapy." Furthering that aim, Revvity announced earlier this year it entered into a non-exclusive license agreement with AstraZeneca, granting access to its Pin-point base editing technology to help advance the biopharma company’s work in cell therapy for the treatment of cancer and immune-mediated diseases. About Revvity At Revvity, “impossible” is inspiration, and “can’t be done” is a call to action. Revvity provides health science solutions, technologies, expertise and services that deliver complete workflows from discovery to development, and diagnosis to cure. Revvity is revolutionizing what’s possible in healthcare, with specialized focus areas in translational multi-omics technologies, biomarker identification, imaging, prediction, screening, detection and diagnosis, informatics and more. With 2022 revenue of more than $3 billion and over 11,000 employees, Revvity serves customers across pharmaceutical and biotech, diagnostic labs, academia and governments. It is part of the S&P 500 index and has customers in more than 190 countries. Stay updated by following our Newsroom, LinkedIn, X, YouTube, Facebook and Instagram. View source version on businesswire.com: Contacts Investor Relations: Steve Willoughby (781) 663-5677 steve.willoughby@revvity.com Media Relations: Mary Karpa (215) 896-4022 mary.karpa@revvity.com Source: Revvity View this news release online at: