CD82

COPENHAGEN, Denmark--( BUSINESS WIRE )--Genmab A/S (Nasdaq: GMAB): More than 20 abstracts, including four oral presentations, with new clinical data across lines of therapy and subgroups of non-Hodgkin’s lymphoma (NHL) patients New and updated data from EPCORE ® clinical trial program reinforce the potential of epcoritamab as a monotherapy and in combination to treat multiple B-cell malignancies across lines of therapy Genmab A/S (Nasdaq: GMAB) announced today more than 20 abstracts evaluating epcoritamab-bysp (EPKINLY ® ), a T-cell engaging bispecific antibody administered subcutaneously, across lines of therapy and B-cell non-Hodgkin’s lymphoma (NHL) subtypes, will be presented at the 66th Annual Meeting and Exposition of the American Society of Hematology (ASH), being held at the San Diego Convention Center in San Diego, California, and online, December 7-10. The breadth of the epcoritamab development program will be featured at this year's ASH in four oral presentations. Three of the oral presentations will highlight data evaluating fixed-duration subcutaneous epcoritamab in patients with previously untreated diffuse large B-cell lymphoma (DLBCL), large B-cell lymphoma (LBCL), and relapsed/refractory (R/R) follicular lymphoma (FL). The fourth oral presentation will feature the results of a study evaluating epcoritamab monotherapy in patients with R/R chronic lymphocytic leukemia (CLL). Additionally, three-year efficacy and safety data for subcutaneous epcoritamab in patients with R/R DLBCL from the EPCORE ® NHL-1 trial will be presented. “The data evaluating epcoritamab being presented at this year’s ASH highlight the encouraging clinical results we have seen across epcoritamab clinical trials and demonstrate its potential as a core therapy for B-cell malignancies,” said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. “This has been a pivotal year for epcoritamab, and alongside our partner AbbVie, we are committed to progressing the comprehensive epcoritamab development program with the goal of potentially providing additional therapeutic options to patients in need of treatments.” All abstracts accepted for presentation have been published on the ASH Website . 2024 R&D Update and ASH Data Review On Wednesday, December 11, at 11:00 AM EST (5:00 PM CET/4:00 PM GMT), Genmab will host its 2024 R&D Update and ASH Data Review. The event will be virtual and webcast live. Details, including the webcast link and registration will be available on www.genmab.com . This meeting is not an official program of the ASH Annual Meeting. Abstracts accepted for presentation at ASH include: Oral Presentations Abstract Number Abstract Title Type of Presentation Date/Time of Presentation 342 Fixed-Duration Epcoritamab + R2 Drives Deep and Durable Responses in Patients with Relapsed or Refractory Follicular Lymphoma: 2-Year Follow-Up from Arm 2 of the EPCORE NHL-2 Trial Oral Saturday, December 7, 4:00 - 5:30 PM PT 581 Fixed-Duration Epcoritamab + R-CHOP Induces High Complete Response Rates in Patients with Previously Untreated Diffuse Large B-Cell Lymphoma with High-Risk Features: Long-Term Results from the EPCORE NHL-2 Trial Oral Sunday, December 8, 12:00 - 1:30 PM PT 867 EPCORE DLBCL-3 First Disclosure: Fixed-Duration Epcoritamab Monotherapy in Older (≥75 y), Anthracycline-Ineligible Patients with Previously Untreated Large B-Cell Lymphoma Oral Monday, December 9, 2:45 - 4:15 PM PT 883 Epcoritamab Monotherapy in Patients (Pts) with Relapsed or Refractory (R/R) Chronic Lymphocytic Leukemia (CLL): Results from CLL Expansion and Optimization Cohorts of EPCORE CLL-1 Oral Monday, December 9, 2:45 - 4:15 PM PT Poster Presentations Abstract Number Abstract Title Type of Presentation Date/Time of Presentation 1414 Exposure-Response Analyses Supporting Optimal Epcoritamab 48 mg Full Dose and Dosing Schedule in Relapsed or Refractory Follicular Lymphoma Poster Saturday, December 7, 5:30 - 7:30 PM PT 1622 Epcoritamab with R-CHOP Overcomes Poor Risk Features of High Metabolic Tumor Volume in High-Risk Large B-Cell Lymphoma Poster Saturday, December 7, 5:30 - 7:30 PM PT 1627 Fixed-Duration Epcoritamab in Combination with Bendamustine + Rituximab for First-Line Treatment of Follicular Lymphoma: Initial Results from EPCORE NHL-2 Arm 3 Poster Saturday, December 7, 5:30 - 7:30 PM PT 1703 Trends in All-Cause Mortality Rates in Patients with Follicular Lymphoma in the US before and during the COVID-19 Pandemic: A Retrospective Observational Study Poster Saturday, December 7, 5:30 - 7:30 PM PT 1734 Immune Biomarkers of Mechanism of Action of Epcoritamab (Epcor) Plus Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (pola-R-CHP) in Frontline DLBCL Poster Saturday, December 7, 5:30 - 7:30 PM PT 1737 Efficacy and Safety of Epcoritamab Monotherapy in Patients with Relapsed or Refractory LBCL Not Previously Exposed to CAR T: Subanalysis of the EPCORE NHL-1 Trial Poster Saturday December 7, 5:30 - 7:30 PM PT 2349 Indirect Comparisons of the Efficacy of Epcoritamab Vs Glofitamab in Patients (Pts) with Relapsed or Refractory (R/R) Large B-Cell Lymphoma (LBCL) Poster Saturday, December 7, 5:30 - 7:30 PM PT 2998 Epcoritamab Induces in vitro-derived Terminally Differentiated Exhausted T Cells to Kill B Cells Poster Saturday, December 7, 5:30 - 7:30 PM PT 3106 Fixed-Duration Epcoritamab + R-Mini-CHOP in Patients with Previously Untreated Diffuse Large B-Cell Lymphoma Ineligible for Full-Dose R-CHOP: Updated Results from Arm 8 of the EPCORE NHL-2 Trial Poster Sunday, December 8, 6:00 - 8:00 PM PT 3110 Fixed-Duration Epcoritamab Plus Lenalidomide in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL): Updated Results from Arm 1 of the Epcore NHL-5 Trial Poster Sunday, December 8, 6:00 - 8:00 PM PT 3115 Prior Bendamustine (Benda) Exposure Did Not Impact Clinical Outcomes and Decreased CD4+ but Not CD8+ T-Cells in Patients with Diffuse Large B-Cell Lymphoma (DLBCL) Treated with the Bispecific Antibody Epcoritamab (Epcor) Poster Sunday, December 8, 6:00 - 8:00 PM PT 3231 T cells from CLL patients on venetoclax mount potent cytotoxic responses in combination with epcoritamab, a CD20/CD3 bispecific antibody. Poster Sunday, December 8, 6:00 - 8:00 PM PT 3723 Patient Characteristics and Treatment Patterns for Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) By CAR T Eligibility and Treatment Status in France, Germany, Italy, Spain, the UK, and Japan Poster Sunday, December 8, 6:00 - 8:00 PM PT 4480 3-Year Update from the EPCORE NHL-1 Trial: Epcoritamab Leads to Deep and Durable Responses in Relapsed or Refractory Large B-Cell Lymphoma Poster Monday, December 9, 6:00 - 8:00 PM PT 4491 Three-Factor Prediction Model for Grade 2+Cytokine Release Syndrome in Large B-Cell Lymphoma Patients Receiving Epcoritamab Monotherapy Poster Monday, December 9, 6:00 - 8:00 PM PT 5124 Epcoritamab for Relapsed/ Refractory B cell Lymphoma – the Israeli Real-World Experience Poster Monday, December 9, 6:00 - 8:00 PM PT E-publications Abstract Number Abstract Title Type of Presentation Date/Time of Presentation 7614 Cost-Effectiveness of Epcoritamab Versus Glofitamab in Relapsed or Refractory Large B-Cell Lymphoma after at Least Two Lines of Therapy in the United States E-publication N/A 7617 A Canadian Cost-Utility Analysis of Epcoritamab Versus Current Therapies in Third-Line or Later Large B-Cell Lymphoma E-publication N/A 7757 Epcoritamab plus Gemcitabine and Oxaliplatin versus Glofitamab or Rituximab plus Gemcitabine and Oxaliplatin in Transplant-Ineligible Relapsed/Refractory Diffuse Large B-Cell Lymphoma Patients: A Match-Adjusted Comparative Analysis E-publication N/A 7760 Epcoritamab plus Gemcitabine and Oxaliplatin versus Rituximab, Gemcitabine, and Oxaliplatin in Transplant-Ineligible Relapsed/Refractory Diffuse Large B-Cell Lymphoma Patients: A Match-Adjusted Comparative Analysis E-publication N/A 7802 Matching-Adjusted Indirect Treatment Comparison of Epcoritamab versus Zanubrutinib Plus Obinutuzumab in Relapsed or Refractory Follicular Lymphoma E-publication N/A The safety and efficacy of epcoritamab has not been established for these investigational uses. About Epcoritamab Epcoritamab is an IgG1-bispecific antibody created using Genmab's proprietary DuoBody ® technology and administered subcutaneously. Genmab's DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells. i Epcoritamab (approved under the brand name EPKINLY ® in the U.S. and Japan, and TEPKINLY ® in the EU) has received regulatory approval in certain lymphoma indications in several territories. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Both companies will pursue additional international regulatory approvals for the investigational R/R FL indication and additional approvals for the R/R DLBCL indication. Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes four ongoing Phase 3, open-label, randomized trials including a trial evaluating epcoritamab as a monotherapy in patients with R/R DLBCL compared to investigators choice chemotherapy ( NCT04628494 ), a trial evaluating epcoritamab in combination with R-CHOP in adult participants with newly diagnosed DLBCL ( NCT05578976 ), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) in patients with R/R FL ( NCT05409066 ), and a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) compared to chemoimmunotherapy in patients with previously untreated FL ( NCT06191744 ). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit www.clinicaltrials.gov for more information. EPKINLY ® (epcoritamab-bysp) U.S. IMPORTANT SAFETY INFORMATION Important Warnings—EPKINLY can cause serious side effects, including: Cytokine release syndrome (CRS) , which is common during treatment with EPKINLY and can be serious or life-threatening. To help reduce your risk of CRS, you will receive EPKINLY on a step-up dosing schedule (when you receive 2 or 3 smaller step-up doses of EPKINLY before your first full dose during your first cycle of treatment), and you may also receive other medicines before and for 3 days after receiving EPKINLY. If your dose of EPKINLY is delayed for any reason, you may need to repeat the step-up dosing schedule. Neurologic problems that can be life-threatening and lead to death. Neurologic problems may happen days or weeks after you receive EPKINLY. People with DLBCL or high-grade B-cell lymphoma should be hospitalized for 24 hours after receiving their first full dose of EPKINLY on day 15 of cycle 1 due to the risk of CRS and neurologic problems. Tell your healthcare provider or get medical help right away if you develop a fever of 100.4°F (38°C) or higher; dizziness or lightheadedness; trouble breathing; chills; fast heartbeat; feeling anxious; headache; confusion; shaking (tremors); problems with balance and movement, such as trouble walking; trouble speaking or writing; confusion and disorientation; drowsiness, tiredness or lack of energy; muscle weakness; seizures; or memory loss. These may be symptoms of CRS or neurologic problems. If you have any symptoms that impair consciousness, do not drive or use heavy machinery or do other dangerous activities until your symptoms go away. EPKINLY can cause other serious side effects, including: Infections that may lead to death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment and treat you as needed if you develop an infection. You should receive medicines from your healthcare provider before you start treatment to help prevent infection. Tell your healthcare provider right away if you develop any symptoms of infection during treatment, including fever of 100.4°F (38°C) or higher, cough, chest pain, tiredness, shortness of breath, painful rash, sore throat, pain during urination, or feeling weak or generally unwell. Low blood cell counts, which can be serious or severe. Your healthcare provider will check your blood cell counts during treatment. EPKINLY may cause low blood cell counts, including low white blood cells (neutropenia), which can increase your risk for infection; low red blood cells (anemia), which can cause tiredness and shortness of breath; and low platelets (thrombocytopenia), which can cause bruising or bleeding problems. Your healthcare provider will monitor you for symptoms of CRS, neurologic problems, infections, and low blood cell counts during treatment with EPKINLY. Your healthcare provider may temporarily stop or completely stop treatment with EPKINLY if you develop certain side effects. Before you receive EPKINLY, tell your healthcare provider about all your medical conditions, including if you have an infection, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. If you receive EPKINLY while pregnant, it may harm your unborn baby. If you are a female who can become pregnant , your healthcare provider should do a pregnancy test before you start treatment with EPKINLY and you should use effective birth control (contraception) during treatment and for 4 months after your last dose of EPKINLY. Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment with EPKINLY. Do not breastfeed during treatment with EPKINLY and for 4 months after your last dose of EPKINLY. In DLBCL or high-grade B-cell lymphoma, the most common side effects of EPKINLY include CRS, tiredness, muscle and bone pain, injection site reactions, fever, stomach-area (abdominal) pain, nausea, and diarrhea. The most common severe abnormal laboratory test results include decreased white blood cells, decreased red blood cells, and decreased platelets. In follicular lymphoma the most common side effects of EPKINLY include injection site reactions, CRS, COVID-19, tiredness, upper respiratory tract infections, muscle and bone pain, rash, diarrhea, fever, cough, and headache. The most common severe abnormal laboratory test results include decreased white blood cells and decreased red blood cells. These are not all of the possible side effects of EPKINLY. Call your doctor for medical advice about side effects. You are encouraged to report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch or to Genmab US, Inc. at 1-855-4GENMAB (1-855-443-6622). Please see Medication Guide , including Important Warnings. About Genmab Genmab is an international biotechnology company with a core purpose of guiding its unstoppable team to strive toward improving the lives of patients with innovative and differentiated antibody therapeutics. For 25 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with knock-your-socks-off (KYSO ® ) antibody medicines. Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X . This Media Release contains forward looking statements. The words “believe,” “expect,” “anticipate,” “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov . Genmab does not undertake any obligation to update or revise forward looking statements in this Media Release nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law. Genmab A/S and/or its subsidiaries own the following trademarks: Genmab ® ; the Y-shaped Genmab logo ® ; Genmab in combination with the Y-shaped Genmab logo ® ; HuMax ® ; DuoBody ® ; HexaBody ® ; DuoHexaBody ® , HexElect ® and KYSO™. _______________________________ i Engelberts PJ, Hiemstra IH, de Jong B, et al. DuoBody-CD3xCD20 induces potent T-cell-mediated killing of malignant B cells in preclinical models and provides opportunities for subcutaneous dosing. EBioMedicine . 2020;52:102625. DOI: 10.1016/j.ebiom.2019.102625.

ROCKVILLE, Md., Dec. 13, 2023 /PRNewswire/ -- On February 8, 2024, The Speak Foundation, a patient-led 501(c)(3) organization for Limb-Girdle Muscular Dystrophy (LGMD), will be convening a multi-stakeholder LGMD Scientific Drug Development Workshop in Rockville, Maryland. The workshop will continue to drive the momentum for the sense of urgency needed by the patient community to accelerate LGMD drug development. Continue Reading LGMD Scientific Drug Development Workshop The Speak Foundation logo Academic medical experts, senior leaders from the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER), highly experienced drug developers, and other specialists will come together to discuss LGMD pathophysiology, clinical outcomes and patient-focused drug development, surrogate endpoints and the accelerated approval pathway. The meeting will focus on six LGMD subtypes: LGMD2A/R1, LGMD2B/R2, LGMD2C/R3, LGMD2D/R4, LGMD2E/R5, and LGMD2I/R9. "In September 2022, at the LGMD community's first Externally-Led Patient Focused Drug Development Meeting (EL-PFDD), the FDA heard perspectives of patients and caregivers on the health effects, daily impacts, treatment goals, and decision factors that would be considered when seeking out or selecting a treatment," explains Kathryn Bryant, founder of the Speak Foundation. "This workshop is a continuing step to work with the FDA and LGMD scientific leaders on pushing critical drug development forward. The time is now." LGMD Scientific Workshop session presenters will include CBER Director Dr. Peter Marks, and CDER's Office of New Drugs (OND) Director, Dr. Peter Stein. Other confirmed speakers include Dr. Jerry R. Mendell, retired attending neurologist of Nationwide Children's Hospital, Dr. Nicholas Johnson of Virginia Commonwealth University, Dr. Louise Rodino-Klapac of Sarepta Therapeutics, Dr. Douglas Sproule of ML Bio Solutions, a BridgeBio affiliate, Dr. Katherine Mathews of University of Iowa Health Care, Dr. Matthew Wicklund of University of Texas San Antonio, Dr. Peter Kang of University of Minnesota Medical School and Dr. Lindsay Alfano of Nationwide Children's Hospital. "As a translational clinician scientist, devoting a lifetime of work toward improving the lives of patients with muscular dystrophy, workshops like the LGMD Scientific meeting are important venues for discussing the current scientific understanding of LGMD and the implications for drug development." said Dr. Jerry R. Mendell. "Bringing key LGMD stakeholders together to share ideas and research findings in a public forum is the most productive way to find solutions and advance therapies that will improve the lives of LGMD patients." The LGMD Scientific Workshop will be a focused discussion with clinicians, scientific researchers, drug developers, regulators, patients and patient advocates on the characteristics of LGMD that drive drug development programs. The meeting will be held virtually and by invitation for in-person attendance. Proceedings will be recorded and shared with the broader patient and scientific communities through The Speak Foundation. More details will be added soon to: The Speak Foundation - Limb Girdle Muscular Dystrophy. About The Speak Foundation: The Speak Foundation is a 501(c)(3) nonprofit charity, which is focused on supporting patients living with all forms of LGMD and on facilitating development of treatments for these diseases. About Limb Girdle Muscular Dystrophy: Limb-Girdle Muscular Dystrophy (LGMD) is a group of muscular dystrophies caused by mutations in one of over 30 genes. The age of onset, symptoms, progression, and inheritance pattern varies among genetic subtypes, but generally result in severe disability and are often life-threatening due to cardiac and respiratory complications. There are estimated to be some 20,000+ people living with a form LGMD in the United States. Media Contact: Rachel DeConti [email protected] 860-209-0492 SOURCE The Speak Foundation

Clinical Presentations to Include Initial Clinical Data of FT576 BCMA-targeted CAR NK Cell Product Candidate for Multiple Myeloma and FT819 CD19-targeted CAR T-cell Product Candidate for B-cell Lymphoma Preclinical Data of FT555 GPRC5D-targeted CAR NK Cell Collaboration Candidate for Multiple Myeloma to be Jointly Presented with Janssen Novel Approaches to Eliminate Patient Conditioning and Promote Functional Persistence of Off-the-shelf, iPSC-derived Cell Therapies to be Highlighted SAN DIEGO, Nov. 03, 2022 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for patients with cancer, today announced that fourteen presentations for the Company’s induced pluripotent stem cell (iPSC) product platform were accepted for presentation at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition being held in New Orleans, Louisiana, or virtually, December 10-13, 2022. The presentations include initial Phase 1 clinical data for FT576, the Company’s multiplexed-engineered, iPSC-derived CAR NK cell product candidate targeting BCMA for multiple myeloma, and for FT819, the Company’s iPSC-derived CAR T-cell product candidate targeting CD19 for B-cell lymphoma. In addition, the Company will jointly present with its collaboration partner Janssen preclinical data for FT555, a multiplexed-engineered, iPSC-derived CAR NK cell product candidate targeting GPRC5D, a tumor-associated orphan G-protein-coupled receptor found to be highly expressed on myeloma cells. In May, Janssen exercised its commercial option to FT555, and the companies are conducting IND-enabling activities to support first-in-human clinical investigation of FT555 for the treatment of multiple myeloma as monotherapy and in combination with the CD38-targeted monoclonal antibody daratumumab. The Company will also highlight multiple novel strategies to eliminate the need for patient conditioning for off-the-shelf cell therapy. These strategies include arming iPSC-derived effector cells with an alloimmune defense receptor (ADR), which targets 41BB-expressing alloreactive host immune cells to promote expansion, persistence, and anti-tumor activity; the combined genetic ablation of the adhesion molecules CD54 and CD58, which reduces immune synapse formation resulting in host immune cell evasion; and the genetic ablation of CD38 in combination with CD38-targeted monoclonal antibody therapy, which uniquely targets and depletes CD38-expressing activated host immune cells. Details of the ASH presentations are as follows: Clinical Programs Interim Phase I Clinical Data of FT819-101, a Study of the First-Ever, Off-the-Shelf, iPSC-Derived TCR-Less CD19 CAR T-Cell Therapy for Patients with Relapsed / Refractory B-Cell MalignanciesPublication Number: 2000Session Name: 704. Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster IPresentation Date / Time: Saturday, December 10, 2022; 5:30 PM Room: Ernest N. Morial Convention Center, Hall DInterim Phase I Clinical Data of FT576 As Monotherapy and in Combination with Daratumumab in Subjects with Relapsed / Refractory Multiple MyelomaPublication Number: 2004Session Name: 704. Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster IPresentation Date / Time: Saturday, December 10, 2022; 5:30 PM Room: Ernest N. Morial Convention Center, Hall DA Phase I Study of FT538, an Off-the-Shelf, Multiplexed-Engineered, iPSC-Derived NK Cell Therapy in Combination with Daratumumab in Relapsed / Refractory Multiple MyelomaPublication Number: 4639Session Name: 704. Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster IIIPresentation Date / Time: Monday, December 12, 2022, 6:00 PMRoom: Ernest N. Morial Convention Center, Hall D Preclinical Programs FT555: Off-the-Shelf CAR-NK Cell Therapy Co-Targeting GPRC5D and CD38 for the Treatment of Multiple MyelomaPublication Number: 1992Session Name: 703. Cellular Immunotherapies: Basic and Translational: Poster IPresentation Date / Time: Saturday, December 10, 2022; 5:30 PM Room: Ernest N. Morial Convention Center, Hall DA Novel Dual-Antigen Targeting Approach Enables Off-the-Shelf CAR NK Cells to Effectively Recognize and Eliminate the Heterogenous Population Associated with AMLPublication Number: 4623Session Name: 703. Cellular Immunotherapies: Basic and Translational: Poster IIIPresentation Date / Time: Monday, December 12, 2022; 6:00 PM Room: Ernest N. Morial Convention Center, Hall D iPSC Product Platform Alloimmune Defense Receptor Harnesses Host Immune Cell Activation to Potentiate Functional Persistence and Anti-Tumor Activity of Off-the-Shelf, Cell-Based Cancer TherapyPublication Number: 1986Session Name: 703. Cellular Immunotherapies: Basic and Translational: Poster IPresentation Date / Time: Saturday, December 10, 2022; 5:30 PM Room: Ernest N. Morial Convention Center, Hall DCombined Genetic Ablation of CD54 and CD58 in CAR Engineered Cytotoxic Lymphocytes Effectively Averts Allogeneic Immune Cell RejectionPublication Number: 481Session Name: 703. Cellular Immunotherapies: Basic and Translational IVPresentation Date / Time: Sunday, December 11, 2022; 9:30 AM Room: Ernest N. Morial Convention Center, 388-390iPSC-Derived CD38-Null NK Cells in Combination with CD38-Targeted Antibody: A Dual Therapeutic Strategy to Enable ADCC and Eliminate Host Immune Cells in Multiple MyelomaPublication Number: 3288Session Name: 703. Cellular Immunotherapies: Basic and Translational: Poster II Presentation Date / Time: Sunday, December 11, 2022; 6:00 PM Room: Ernest N. Morial Convention Center, Hall DA CD3 Fusion Receptor (CD3-FR) Uniquely Enables Compatibility of Allogeneic CAR-T and -NK Cells with T Cell Engagers to Enhance Antitumor Function and Limit Antigen EscapePublication Number: 3308Session Name: 703. Cellular Immunotherapies: Basic and Translational: Poster IIPresentation Date / Time: Sunday, December 11, 2022; 6:00 PM Room: Ernest N. Morial Convention Center, Hall DMulti-Antigen Targeting By Novel Combination of CAR-T Cells and hnCD16 Transgene, Yields in Complete Tumor Clearance Via Antibody Dependent Cellular CytotoxicityPublication Number: 4605Session Name: 703. Cellular Immunotherapies: Basic and Translational: Poster IIIPresentation Date / Time: Monday, December 12, 2022; 6:00 PM Room: Ernest N. Morial Convention Center, Hall DThe Development of Allogeneic Tips-Derived TCR- CAR+ CD8αβ T CellsPublication Number: 4624Session Name: 703. Cellular Immunotherapies: Basic and Translational: Poster IIIPresentation Date / Time: Monday, December 12, 2022; 6:00 PM Room: Ernest N. Morial Convention Center, Hall DCharacterization of Engineered Macrophages and Other Myeloid Cells Differentiated from CD34+ Hematopoietic Progenitor Cells Derived from Pluripotent Stem CellsPublication Number: 1218Session Name: 501. Hematopoietic Stem and Progenitor Cells and Hematopoiesis: Basic and Translational: Poster IPresentation Date / Time: Saturday, December 10, 2022; 5:30 PM Room: Ernest N. Morial Convention Center, Hall DHigh-Density Cryopreservation of Off-the-Shelf CAR-NK Cells Facilitates On-demand Treatment AccessPublication Number: 2045Session Name: 711. Cell Collection and Processing: Poster IPresentation Date / Time: Saturday, December 10, 2022; 5:30 PM Room: Ernest N. Morial Convention Center, Hall DCD82 Is Sufficient to Uniquely Identify Pluripotent Stem Cell-Derived Hemogenic Endothelium with the Hematopoietic Lineage Potency to Give Rise to Bona Fide LymphocytesPublication Number: 2532Session Name: 501. Hematopoietic Stem and Progenitor Cells and Hematopoiesis: Basic and Translational: Poster IIPresentation Date / Time: Sunday, December 11, 2022; 6:00 PM Room: Ernest N. Morial Convention Center, Hall D About Fate Therapeutics’ iPSC Product PlatformThe Company’s proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that are designed to be administered with multiple doses to deliver more effective pharmacologic activity, including in combination with other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single engineered iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf for patient treatment. As a result, the Company’s platform is uniquely designed to overcome numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is subject to batch-to-batch and cell-to-cell variability that can affect clinical safety and efficacy. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 350 issued patents and 150 pending patent applications. About Fate Therapeutics, Inc.Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Company’s immuno-oncology pipeline includes off-the-shelf, iPSC-derived natural killer (NK) cell and T-cell product candidates, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens using chimeric antigen receptors (CARs). Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com. Forward-Looking StatementsThis release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the Company's product candidates, clinical studies and preclinical research and development programs, its ongoing and planned clinical studies, the safety and therapeutic potential of the Company’s product candidates, and expectations regarding the Company’s collaborations, including the objectives, plans and goals of its collaboration with Janssen. These and any other forward-looking statements in this release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that the Company’s product candidates may not demonstrate the requisite safety or efficacy to warrant further development or to achieve regulatory approval, the risk that results observed in prior studies of the Company’s product candidates, including preclinical studies and clinical trials, will not be observed in ongoing or future studies involving these product candidates, the risk of a delay or difficulties in the manufacturing of the Company’s product candidates or in the initiation and conduct of, or enrollment of patients in, any clinical trials, the risk that the Company may cease or delay preclinical or clinical development of any of its product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities on the initiation or conduct of clinical trials, changes in the therapeutic, regulatory, or competitive landscape for which the Company’s product candidates are being developed, the amount and type of data to be generated or otherwise to support regulatory approval, difficulties or delays in patient enrollment and continuation in the Company’s ongoing and planned clinical trials, difficulties in manufacturing or supplying the Company’s product candidates for clinical testing, and any adverse events or other negative results that may be observed during preclinical or clinical development), and the risk that the Company’s product candidates may not produce therapeutic benefits or may cause other unanticipated adverse effects. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Company’s periodic filings with the Securities and Exchange Commission, including but not limited to the Company’s most recently filed periodic report, and from time to time in the Company’s press releases and other investor communications. Fate Therapeutics is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise. Contact:Christina TartagliaStern Investor Relations, Inc.212.362.1200christina@sternir.com