KKite Pharma develops cancer immunotherapies by engineering a patient’s own T cells to attack tumors. Its core product strategy centers on cell therapy where T cells are genetically modified to recognize cancer cells, expanded outside the body, and then infused back into the patient to destroy cancer. This approach differs from traditional drugs by using the immune system itself to fight cancer and by tailoring therapies to individual patients. Kite focuses on clinical trials and commercialization of approved therapies, often through partnerships and licensing with other pharmaceutical companies to reach patients worldwide. The company’s goal is to provide potentially lifesaving, durable cancer treatments and move toward a cure for cancer.
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Gilead and Kite advance leadership with new data across pipeline and portfolio at ASH 2026. Benzinga Edge Rankings not available for Gilead Sciences Inc - iMMagine-1 Data Provide 18 Months Minimum Follow-Up on Anito-cel's Durability and Safety in Relapsed or Refractory Multiple Myeloma - - Five-Year ZUMA-12 Follow-Up Data to Provide Long-Term Evidence for Yescarta(R) in First-Line High-Risk Large B-cell Lymphoma - Gilead Sciences, Inc. (NASDAQ:GILD) and Kite, a Gilead Company, today announced 23 presentations, including 7 oral presentations, will be presented at the 68th American Society of Hematology (ASH) Annual Meeting and Exposition (December 12-15, 2026). These latest clinical milestones demonstrate transformative progress across Gilead and Kite's pipeline and portfolio, from new data for the investigational anitocabtagene autoleucel (anito-cel) in relapsed or refractory (RR) multiple myeloma (MM), to early clinical results from our next-generation approaches in lymphoma and autoimmune blood disorders, and long-term follow-up data supporting standard-of-care therapies. "People living with blood cancers deserve treatments that offer more than a response; they deserve the possibility of lasting freedom from disease," said Gallia Levy, MD, PhD, Senior Vice President, Global Head of Development at Kite. "The data we are presenting reflect the breadth of our leadership and our commitment to advancing next-generation cell therapy, so more patients can benefit across multiple cancers and throughout their treatment journey." Key presentations at ASH 2026 Deepening and Expanding Clinical Evidence for Anito-cel in MM: Anito-cel is an investigational CAR T-cell therapy for the treatment of RRMM. At ASH, Kite will present 18-month minimum follow-up results from the pivotal Phase 2 iMMagine-1 open-label, single-arm, multicenter study of anito-cel in people who received three or more prior lines of therapy, including treatments from all three major drug classes for MM, alongside new comparative and collaborative research in the disease. * iMMagine-1 (4L+ RRMM): Maturing efficacy data, including progression-free survival (PFS) and overall survival (OS) analyses, alongside updated safety outcomes, from the pivotal Phase 2 open-label, single-arm study of anito-cel in RRMM. Data from the iMMagine-1 trial are the basis of the U.S. Food and Drug Administration (FDA) Biologics License Application (BLA) submission, which is under review with a Prescription Drug User Fee Act (PDUFA) target date of December 23, 2026. * Comparative Analyses (RRMM): New matching-adjusted indirect comparison (MAIC) analyses examining the efficacy and safety of anito-cel versus bispecific antibodies and other CAR T-cell therapies. * GEM-AnitoFIRST (Newly Diagnosed MM): Data from the open-label, non-randomized Phase 2 study being conducted in collaboration with the PETHEMA Foundation (Programa Español de Tratamiento en Hematología) evaluating anito-cel in newly diagnosed MM. Expanding Real-World Use and Long-Term Evidence Underscore the Track Record for Yescarta(R): * ZUMA-12 (1L High-Risk LBCL): Five-year follow-up from the first prospective Phase 2, single-arm, open-label study evaluating Yescarta(R)(axicabtagene ciloleucel) as a first-line treatment for high-risk large B-cell lymphoma (LBCL) patients who remain positron emission tomography (PET)-positive after two cycles of chemoimmunotherapy. * Real-World Evidence: Expanding real-world data, including outcomes from the French collaborative group The Lymphoma Study Association/Lymphoma Academic Research Organization (LYSA/LYSARC) (DESCAR-T) registry across established and newly authorized treatment centers, and Canadian data assessing the feasibility and safety of outpatient CAR T administration. * GELTAMO LATE-R: Second interim analysis of the Phase 2, single-arm, open-label study of axicabtagene ciloleucel in patients with late-relapsing LBCL after completing first-line chemoimmunotherapy (CIT). Initial Global Clinical Experience with Investigational Gamgertamig (CM336/OM336) in Relapsed/Refractory Autoimmune Cytopenias (AICs): Gilead and Lakefront Biotherapeutics (Lakefront) are collaborating to advance programs in inflammation, including the development of gamgertamig (CM336/OM336), an investigational BCMAxCD3 bispecific T cell engager for the treatment of autoantibody-driven, immune-mediated disease. New data from two ongoing Phase 1b studies will provide initial clinical experience with short-course subcutaneous gamgertamig, administered over a maximum of three weeks in people with relapsed or refractory AICs. * Immune Thrombocytopenia (ITP): Response, time-to-response and durability data across three dose cohorts in people with relapsed or refractory ITP, a rare autoantibody-driven disease that causes platelet destruction and increased bleeding risk. * Autoimmune Hemolytic Anemia (AIHA): Response, time-to-response and durability data across three dose cohorts in people with relapsed or refractory AIHA, a rare autoantibody-driven disease that causes destruction of red blood cells leading to anemia. Dates and times are listed in CT for the following accepted abstracts and presentations: | Abstract Details | Titles | | Oral Presentations | | Anitocabtagene Autoleucel | | Abstract #273 Saturday, December 12 2:30 - 2:45 PM MCCNO - La Nouvelle C | Updated Analysis of iMMagine-1, a Phase 2 Registrational Study of Anitocabtagene Autoleucel (Anito-cel) for the Treatment of Patients (Pts) with Relapsed and/or Refractory Multiple Myeloma (RRMM) | | Abstract #6579 Saturday, December 12 9:30 - 9:45 AM MCCNO - Hall E | Anitocabtagene Autoleucel Following Induction Therapy in Newly Diagnosed Multiple Myeloma: Early Safety, Response, and MRD Results from the Phase 2 GEM-AnitoFIRST Study* Collaboration with PETHEMA Foundation | | Axicabtagene Ciloleucel | | Abstract #1031 Monday, December 14 5:30 - 5:45 PM MCCNO - New Orleans Theatre A | Axicabtagene Ciloleucel as Second-line Treatment for Late-relapsed Aggressive Large B-cell Lymphoma: Second Interim Analysis of the GELTAMO LATE-R Phase II Trial* Collaboration with GELTAMO | | Abstract #614 Saturday, December 12 12:15 - 12:30 PM MCCNO - New Orleans Theatre C | Real-world Outcomes After Axicabtagene Ciloleucel as 2nd- vs 3rd-line Therapy in Large B-cell Lymphoma: A Propensity Score-matched Analysis from the French DESCAR-T Registry* Collaboration with LYSA/LYSARC | | Abstract #613 Sunday, December 13 12:00 - 12:15 PM MCCNO - New Orleans Theatre C | A Prospective Clinical Trial of Comprehensive Ablative Bridging Irradiation (CABI) Prior to Axicabtagene Ciloleucel for Relapsed or Refractory Large B Cell Lymphoma | | Abstract #703 Sunday, December 13 4:30 - 4:45 PM MCCNO - New Orleans Theatre B | Double-dose Axicabtagene Ciloleucel (Axi-Cel-2) as Second-line Therapy for High-risk Relapsed or Refractory Large B-cell Lymphoma: Results from the Phase 1b ENCORE-1 Trial | | Additional CAR T-Cell Therapy | | Abstract #1056 Monday, December 14 5:45 - 6:00 PM MCCNO - 388-390 | Armored TmCD19-IL18 CAR T cells in patients with CD19+ lymphomas | | Poster Presentations | | Anitocabtagene Autoleucel | | Abstract #4042 Sunday, December 13 6:00 - 8:00 PM MCCNO - Hall F | Matching-Adjusted Indirect Comparisons (MAICs) of Anitocabtagene Autoleucel (anito-cel) vs Teclistamab and Talquetamab for the Treatment of 4L+ Relapsed and/or Refractory Multiple Myeloma (RRMM): Analysis with Extended iMMagine-1 Follow-up | | Abstract #4043 Sunday, December 13 6:00 - 8:00 PM MCCNO - Hall F | Matching-Adjusted Indirect Comparisons (MAICs) of Efficacy and Safety Outcomes for Anitocabtagene Autoleucel Versus Ciltacabtagene Autoleucel in 4L+ Relapsed and/or Refractory Multiple Myeloma (RRMM): Analysis with Extended iMMagine-1 Follow-up | | KITE-753 | | Abstract #5944 Monday, December 14 6:00 - 8:00 PM MCCNO - Hall F | Response Durability and Early Immune Cell Recovery: Updated Results from the Phase 1 Multicenter PALISADES-1 Study of KITE-753 in Relapsed/Refractory B-cell Lymphoma | | Axicabtagene Ciloleucel | | Abstract #1912 Saturday, December 12 5:30 - 7:30 PM MCCNO - Hall F | 5-year Follow-up of the Phase 2 ZUMA-12 Study of Axicabtagene Ciloleucel (Axi-cel) as First-line Therapy in Patients (Pts) with High-risk Large B-cell Lymphoma (LBCL) | | Abstract #2632 Saturday, December 12 5:30 - 7:30 PM MCCNO - Hall F | Feasibility of Outpatient Axicabtagene Ciloleucel (Axi-cel) for Relapsed/Refractory Large B-Cell Lymphoma: A Single-Centre Analysis in Canada | | Abstract #2728 Saturday, December 12 5:30 - 7:30 PM MCCNO - Hall F | Audit of the Uptake of Second Line Axicabtagene Ciloleucel for Relapsed/Refractory Large B-cell Lymphoma in the Welsh Population with Assessment of the Impact of Deprivation on Access to and Response Following First Line Chemoimmunotherapy | | / | Impact of Fludarabine Exposure Levels During Lymphodepletion on the Efficacy and Toxicity of Axicabtagene Ciloleucel in Large B-cell Lymphoma: A Multicenter Retrospective Study | | Brexucabtagene Autoleucel | | Abstract #5081 Monday, December 14 6:00 - 8:00 PM MCCNO - Hall F | Brexucabtagene Autoleucel as Consolidation Therapy in Adult Patients with High-risk Philadelphia (Ph)-negative B-cell Acute Lymphoblastic Leukemia | | / | Real-world outcomes after second CD19-directed CAR T cell treatment for relapsed/refractory B cell acute lymphoblastic leukemia | | / | CD19-directed CAR T-cell therapy with brexucabtagene autoleucel or obecabtagene autoleucel produces durable remission for CML patients in lymphoid blast phase: A Rocca consortium multicenter analysis | | / | High Efficacy of Obe-cel and Brexu-cel in Patients with Extramedullary B-ALL | | Additional CAR T-Cell Therapy | | Abstract #4107 Sunday, December 13 6:00 - 8:00 PM MCCNO - Hall F | Depth of Lymphodepletion, Measured by IL-15 Serum Levels, as a Modifiable Risk Factor for Neurotoxicity and Non-relapse Mortality: Results from Large-scale Protein Screening Across 710 Patients Treated with Anti-CD19 CAR T Cell Therapy | | / | Access to CAR T cell therapy for adults with multiple myeloma or large B-cell lymphoma: Patient, caregiver, and clinician perspectives | | Gamgertamig | | Abstract #3008 Sunday, December 13 6:00 - 8:00 PM MCCNO - Hall F | Initial global clinical experience with gamgertamig (CM336/OM336), a BCMAxCD3 T-cell engager, in relapsed/refractory autoimmune cytopenias (AICs) in two parallel ongoing studies (NCT07083960, NCT07175493)* Collaboration with Lakefront | | Publication Only | | Abstract #7562 | Real-world (RW) Outcomes of Patients (Pts) with Relapsed or Refractory (R/R) Large B-cell Lymphoma (LBCL) Treated with Axicabtagene Ciloleucel (Axi-cel) in Non-Joint Accreditation Committee ISCT-Europe & EBMT (JACIE) Accredited Centers in France from the DESCAR-T Registry | *Kite collaborative or investigator-initiated studies For remaining presentation information, please visit: https://www.hematology.org/Meetings/Annual-Meeting About Yescarta & Tecartus YESCARTA (axicabtagene ciloleucel) and TECARTUS (brexucabtagene autoleucel) are genetically modified autologous T-cell immunotherapies that use a patient's own T cells, which are modified ex vivo to express a chimeric antigen receptor (CAR) designed to recognize CD19. The anti-CD19 CAR T cells are expanded and infused back into the patient, where they recognize and kill CD19-expressing target cells. U.S. Indications for YESCARTA and TECARTUS YESCARTA is indicated for the treatment of adult patients with large B-cell lymphoma (LBCL) that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy; adult patients with relapsed or refractory (R/R) LBCL after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma; and adult patients with R/R follicular lymphoma (FL) after two or more lines of systemic therapy. The FL indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory trial. TECARTUS is indicated for the treatment of adult patients with R/R mantle cell lymphoma (MCL) and adult patients with R/R B-cell precursor acute lymphoblastic leukemia (ALL). U.S. Important Safety Information for YESCARTA and TECARTUS BOXED WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES and SECONDARY HEMATOLOGICAL MALIGNANCIES * Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving YESCARTA or TECARTUS. Do not administer YESCARTA or TECARTUS to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids. * Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving YESCARTA or TECARTUS, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with YESCARTA or TECARTUS. Provide supportive care and/or corticosteroids as needed. * T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including YESCARTA. YESCARTA Warnings and precautions * Serious hypersensitivity reactions may occur during YESCARTA infusion. Monitor patients for hypersensitivity reactions during infusion. * Severe or life-threatening infections occurred in patients after YESCARTA infusion. Infections (all grades) occurred in 45% of patients with NHL. Grade 3 or higher infections occurred in 17% of patients, including Grade 3 or higher infections with an unspecified pathogen in 12%, bacterial infections in 5%, viral infections in 3%, and fungal infections in 1%. YESCARTA should not be administered to patients with clinically significant active systemic infections. Monitor patients for signs and symptoms of infection before and after YESCARTA infusion and treat appropriately. Administer prophylactic antimicrobials according to local guidelines. Febrile neutropenia was observed in 36% of patients with NHL after YESCARTA infusion and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care as medically indicated. In immunosuppressed patients, including those who have received YESCARTA, life-threatening and fatal opportunistic infections including disseminated fungal infections have been reported. The possibility of HHV-6 encephalitis and PML should be considered in immunosuppressed patients with neurologic events and appropriate diagnostic evaluations should be performed. Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, has occurred in patients treated with drugs directed against B cells, including YESCARTA. Perform screening for HBV, hepatitis C virus (HCV), and human immunodeficiency virus (HIV) in accordance with clinical guidelines before collection of cells for manufacturing. * Prolonged Cytopenias: Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and YESCARTA infusion. Grade 3 or higher cytopenias not resolved by Day 30 following YESCARTA infusion occurred in 39% of all patients with NHL and included neutropenia (33%), thrombocytopenia (13%), and anemia (8%). Monitor blood counts after YESCARTA infusion. * Hypogammaglobulinemia: B-cell aplasia and hypogammaglobulinemia can occur in patients receiving treatment with YESCARTA. Hypogammaglobulinemia was reported as an adverse reaction in 14% of all patients with NHL. Monitor immunoglobulin levels after treatment with YESCARTA and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement. * Secondary Malignancies: Patients treated with YESCARTA may develop secondary malignancies. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including YESCARTA. Monitor life-long for secondary malignancies. In the event that a secondary malignancy occurs, contact Kite at 1-844-454-KITE (5483). YESCARTA Adverse reactions * The most common adverse reactions (incidence >= 30%), excluding laboratory abnormalities, in patients with non-Hodgkin lymphoma are CRS, fever, hypotension, encephalopathy, fatigue, tachycardia, headache, nausea, febrile neutropenia, diarrhea, musculoskeletal pain, infections with pathogen unspecified, chills and decreased appetite. The most common Grade 3-4 laboratory abnormalities (>= 30%) are leukopenia, lymphopenia, neutropenia, anemia, thrombocytopenia, and hypophosphatemia. YESCARTA Dosage and administration For autologous use only. For intravenous use only. * Dosing of YESCARTA is based on the number of chimeric antigen receptor (CAR)-positive viable T cells. The target YESCARTA dose is 2 x 10[6] CAR-positive viable T cells per kg body weight, with a maximum of 2 x 10[8] CAR-positive viable T cells. * Pretreatment: Administer a lymphodepleting chemotherapy regimen of cyclophosphamide 500 mg/m[2] intravenously and fludarabine 30 mg/m[2] intravenously on the fifth, fourth, and third day before infusion of YESCARTA. * Premedication: Premedicate with acetaminophen and an H1-antihistamine. * Confirm availability of tocilizumab and verify the patient's identity prior to infusion. * Do NOT use a leukodepleting filter. * Infuse the entire contents of the YESCARTA bag within 30 minutes of thawing by either gravity or a peristaltic pump. YESCARTA is stable at room temperature for up to 3 hours after thaw. TECARTUS Warnings and precautions * Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS), including life-threatening reactions, occurred following treatment with TECARTUS. HLH/MAS occurred in 4% (3/78) of patients with ALL. Two patients experienced Grade 3 events, and 1 patient experienced a Grade 4 event. All 3 patients with HLH/MAS had concurrent CRS symptoms and neurologic events after TECARTUS infusion. Treatment of HLH/MAS should be administered per institutional standards. * Serious hypersensitivity reactions, including anaphylaxis, may occur due to dimethyl sulfoxide or residual gentamicin in TECARTUS. * Severe or life-threatening infections occurred in patients after TECARTUS infusion. Infections (all grades) occurred in 63% (105/168) of patients with MCL and 44% (34/78) of patients with ALL. Grade 3 or higher infections, including bacterial, viral, and fungal infections, occurred in 33% of patients with MCL and 29% of patients with ALL. TECARTUS should not be administered to patients with clinically significant active systemic infections. Monitor patients for signs and symptoms of infection before and after TECARTUS infusion and treat appropriately. Administer prophylactic antimicrobials according to local guidelines. Febrile neutropenia was observed in 4% of patients with MCL and 35% of patients with ALL after TECARTUS infusion and may be concurrent with CRS. The febrile neutropenia in 27 (35%) patients with ALL includes events of "febrile neutropenia" (11 (14%)) plus the concurrent events of "fever" and "neutropenia" (16 (21%)). In the event of febrile neutropenia, evaluate for infection and manage with broad spectrum antibiotics, fluids, and other supportive care as medically indicated. In immunosuppressed patients, life-threatening and fatal opportunistic infections have been reported. The possibility of rare infectious etiologies should be considered in patients with neurologic events and appropriate diagnostic evaluations should be performed. Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells. Perform screening for HBV, hepatitis C virus (HCV), and human immunodeficiency virus (HIV) in accordance with clinical guidelines before collection of cells for manufacturing. * Prolonged Cytopenias: Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and TECARTUS infusion. In patients with MCL, Grade 3 or higher cytopenias not resolved by Day 30 following TECARTUS infusion occurred in 55% (92/168) of patients and included thrombocytopenia (32%), neutropenia (42%), and anemia (14%). In patients with ALL who were responders to TECARTUS treatment, Grade 3 or higher cytopenias not resolved by Day 30 following TECARTUS infusion occurred in 20% (7/35) of the patients and included neutropenia (12%) and thrombocytopenia (12%); Grade 3 or higher cytopenias not resolved by Day 60 following TECARTUS infusion occurred in 11% (4/35) of the patients and included neutropenia (9%) and thrombocytopenia (6%). Monitor blood counts after TECARTUS infusion. * Hypogammaglobulinemia: B cell aplasia and hypogammaglobulinemia can occur in patients receiving treatment with TECARTUS. Hypogammaglobulinemia was reported in 14% (23/168) of patients with MCL and 9% (7/78) of patients with ALL. Monitor immunoglobulin levels after treatment with TECARTUS and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement. * Secondary Malignancies: Patients treated with TECARTUS may develop secondary malignancies. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies. Monitor life-long for secondary malignancies. In the event that a secondary malignancy occurs, contact Kite at 1-844-454-KITE (5483). TECARTUS Adverse reactions * The most common non-laboratory adverse reactions (incidence >= 20%) are: * MCL: CRS, fever, encephalopathy, hypotension, infection with pathogen unspecified, viral infections, fatigue, tachycardias, chills, hypoxia, tremor, cough, musculoskeletal pain, nausea, edema, headache, constipation, diarrhea, decreased appetite, dyspnea, rash, insomnia, pleural effusion, aphasia, motor dysfunction. * ALL: fever, CRS, hypotension, encephalopathy, tachycardia, nausea, chills, headache, fatigue, febrile neutropenia, diarrhea, musculoskeletal pain, hypoxia, rash, edema, tremor, infection with pathogen unspecified, constipation, decreased appetite, and vomiting. TECARTUS Dosage and administration For autologous use only. For intravenous use only. * Dosing of TECARTUS is based on the number of chimeric antigen receptor (CAR)-positive viable T cells. * MCL: The target TECARTUS dose is 2 x 10[6] CAR-positive viable T cells per kg body weight, with a maximum of 2 x 10[8] CAR-positive viable T cells. * Pretreatment: Administer a lymphodepleting chemotherapy regimen of cyclophosphamide 500 mg/m[2] intravenously and fludarabine 30 mg/m[2] intravenously on the fifth, fourth, and third day before infusion of TECARTUS. * ALL: The target TECARTUS dose is 1 x 10[6] CAR-positive viable T cells per kg body weight, with a maximum of 1 x 10[8] CAR-positive viable T cells. * Pretreatment: Administer a lymphodepleting chemotherapy regimen of fludarabine 25 mg/m[2] intravenously over 30 minutes on the fourth, third, and second day and administer cyclophosphamide 900 mg/m[2] over 60 minutes on the second day before infusion of TECARTUS. * Premedication: Premedicate with acetaminophen and an H1-antihistamine. * Confirm availability of tocilizumab and verify the patient's identity prior to infusion. * Do NOT use a leukodepleting filter. * Infuse the entire contents of the TECARTUS bag within 30 minutes of thawing by either gravity or a peristaltic pump. TECARTUS is stable at room temperature for up to 3 hours after thaw. U.S. Full Prescribing Information for YESCARTA and TECARTUS, including BOXED WARNINGS, are available at www.kitepharma.com. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. About Gilead and Kite Oncology Gilead and Kite Oncology are working to transform how cancer is treated. We are innovating with next-generation therapies, combinations and technologies to deliver improved outcomes for people with cancer. We are purposefully building our oncology portfolio and pipeline to address the greatest gaps in care. From antibody-drug conjugate technologies and small molecules to cell therapy-based approaches, we are creating new possibilities for people with cancer. About Anitocabtagene autoleucel (anito-cel) Anitocabtagene autoleucel (anito-cel, previously ddBCMA) is the first BCMA-directed CAR T-cell therapy to be investigated in multiple myeloma that utilizes a novel and compact binder known as the D-Domain. The small, stable D-Domain binder enables high CAR expression without tonic signaling and is designed to quickly release from the BCMA target. This combination may allow for the effective elimination of multiple myeloma cells without severe immunotoxicity. Anito-cel has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy Designations by the U.S. Food and Drug Administration. About KITE-753 KITE-753 is an investigational, autologous bicistronic CAR T-cell therapy being evaluated for the treatment of adult patients with relapsed or refractory B-cell lymphoma. Designed to engage two established B-cell targets simultaneously (CD19 and CD20), KITE-753 also combines dual co-stimulatory signaling (CD28 and 4-1BB) to help T-cells respond quickly and stay active over time. Its T-cell optimized manufacturing process is intended to preserve T-cell fitness and enhance durability of complete responses. About Gamgertamig (CM336/OM336) Gamgertamig (CM336/OM336) is an investigational BCMAxCD3 bispecific T cell engager for the treatment of autoantibody-driven immune-mediated disease. It has been granted Orphan Drug Designation and Fast Track Designation by the U.S. Food and Drug Administration for certain autoimmune diseases. Gamgertamig is under an open Investigational New Drug (IND) in the U.S. and is expected to enter registrational studies in 2027. Gamgertamig is being developed in collaboration with Lakefront Biotherapeutics. Forward-Looking Statements This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the ability of Gilead and Kite to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical studies, including those involving Tecartus (brexucabtagene autoleucel), Yescarta (axicabtagene ciloleucel), anito-cel, gamgertamig, and KITE-753 (such as iMMagine-1, GEM-AnitoFIRST, LATE-R, and ZUMA-12); uncertainties relating to regulatory applications and related filing and approval timelines, including pending or potential applications for indications currently under evaluation, such as the BLA for anito-cel in RRMM; the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the possibility that Gilead and Kite may make a strategic decision to discontinue development of these programs and, as a result, these programs may never be successfully commercialized for the indications currently under evaluation; and any assumptions underlying any of the foregoing. These and other risks are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended September 30, 2026, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead and Kite, and Gilead and Kite assume no obligation and disclaim any intent to update any such forward-looking statements. Yescarta, Tecartus, Gilead, the Gilead logo, Kite, and the Kite logo are trademarks of Gilead Sciences, Inc., or its related companies. U.S. Prescribing Information for Yescarta and Tecartus, including BOXED WARNINGS, is available at www.kitepharma.com.
Novel CAR-T therapy shows promising safety and durable responses in hard-to-treat multiple myeloma. Published September 23, 2026 In a phase 1 clinical trial, participants had a high response rate to anito-cel, an investigational CAR-T therapy A phase 1 clinical trial led by investigators at Mass General Brigham Cancer Institute and the University of Chicago Medicine Comprehensive Cancer Center has found that an investigational CAR-T therapy can lead to deep and durable responses in people with relapsed/refractory multiple myeloma. Results are published in The New England Journal of Medicine. Patients with relapsed or refractory multiple myeloma often run out of effective treatment options after multiple rounds of therapy. Contributing to this challenge is the fact that some existing CAR-T cell therapies targeting BCMA, a protein expressed on the surface of myeloma cells, have been linked to rare but serious neurological side effects. The research team reported the results from a Phase 1 clinical trial of anitocabtagene autoleucel (anito-cel), an investigational BCMA-targeted CAR-T cell therapy that is being developed by Kite, a Gilead company. All 38 treated participants responded to the therapy, and nearly 80% achieved a complete response. Many experienced long-lasting benefits, with more than half remaining progression-free two years later and 65% still alive after three years. Serious immune-related and neurological side effects were uncommon, and no delayed neurological complications were reported. "These were great results for a Phase 1 trial," said senior author Michael R. Bishop, MD, Professor of Medicine and Director of the David and Etta Jonas Center for Cellular Therapy at UChicago Medicine. "Even at a low dose of anito-cel, we were seeing complete responses in the majority of patients right off the bat, and not a single patient developed severe toxicities, so we wanted to investigate further why that might be." Based on their laboratory analyses, the researchers hypothesized that anito-cel's engineered BCMA-binding domain maintained cancer-killing activity while limiting excessive immune activation and other features that can impair CAR-T cell function or contribute to toxicity. "The absence of neurotoxic and inflammatory side effects in this phase 1 study is particularly encouraging, given the serious and potentially lasting impact of these complications," said lead author Matthew Frigault, MD, vice chair of Clinical Research in Hematology/Oncology and deputy program director of the Cellular Immunotherapy Program at the Mass General Brigham Cancer Institute. "The novel D-domain binder may contribute to this finding, and the combination of compelling efficacy and encouraging safety data lay important groundwork for continuing to investigate this new treatment option for patients." Anito-cel is currently being evaluated in Phase 2 and Phase 3 clinical trials to confirm these findings in larger populations of patients with multiple myeloma. Authorship: In addition to Frigault and Bishop, authors include Binod Dhakal, Andrzej J. Jakubowiak, Noopur Raje, Kamalika Banerjee, C. Jenny Mu, Kevin C. Hart, Sigal Shachar, Lawrence P. Andrews, Laurene S. Cheung, Faith M. Griffin, Alexandra R. Witter, Michael Hyde, Chester Pham, Nikitha Gandra, Tenzin Shakya, Bhargavi Rajan, Christa Cortesio, Samuel T. Haile, Heba Nowyhed, Priyanka Nair-Gupta, Priyam Mitra, Rebecca J. Chan, Ana Kostic, Christopher R. Heery, and Jacalyn Rosenblatt. Disclosures: A full list of author disclosures can be found in the published paper. Funding: Frigault is supported by the John and Ashley Ranelli Endowed Scholar in Innovation. The phase 1 clinical study design and protocol were jointly developed by Arcellx, Inc., and the academic authors, with additional funding and support by Kite, a Gilead Company. Paper cited: Frigault MJ et al. "Anito-cel, a D-Domain BCMA CAR-T: Phase 1 Results and Binder Characterization" NEJM DOI: 10.1056/NEJMoa2603527 Contributors Media contact. About Mass General Brigham. Mass General Brigham is an integrated academic health care system, uniting great minds to solve the hardest problems in medicine for its communities and the world. Mass General Brigham connects a full continuum of care across a system of academic medical centers, community and specialty hospitals, a health insurance plan, physician networks, community health centers, home care, and long-term care services. Mass General Brigham is a nonprofit organization committed to patient care, research, teaching, and service to the community. In addition, Mass General Brigham is one of the nation's leading biomedical research organizations with several Harvard Medical School teaching hospitals. For more information, please visit massgeneralbrigham.org.
Case study: REDI's partnership with Kite Pharma (formerly known as Arcellx). Guiding a Maryland life sciences success story to Rockville. Company overview. Kite Pharma (formerly known as Arcellx) was founded by David Hilbert, a serial entrepreneur and former Vice President at Human Genome Sciences. The company developed next-generation CAR-T cell therapies to treat multiple myeloma with greater efficacy and durability than current treatments. Early clinical success led to a co-development partnership with Kite Pharma in Frederick, Maryland, and ultimately to Kite Pharma's $7.8 billion acquisition by Gilead Sciences, a deal that bolstered Gilead's CAR-T cell therapy pipeline. Kite Pharma's growth trajectory reflects the broader arc of Maryland's biotech corridor: the company started at the Germantown Innovation Center, scaled into space at West Watkins Mill, and identified its headquarters at 800 King Farm in Rockville, anchoring itself in the heart of the Biotech Corridor before catching the attention of one of the world's largest biopharmaceutical companies. The challenge. As Kite Pharma moved from incubator space to a purpose-built facility, it needed more than an available building; it needed a conventional office asset transformed into a functional wet lab and R&D space. The company required a resource partner who could navigate City planning and zoning processes for a complex lab conversion project, coordinate directly with its outside project management team, and help the company build visibility and relationships within Rockville's life sciences ecosystem as a newcomer to the City. REDI's approach. Site Identification. REDI worked alongside Scheer Partners, Kite Pharma's broker, to identify the company's headquarters location at 800 King Farm in Rockville, matching the company's growth-stage needs with a building suited for repositioning into lab and R&D use. City Services Connections. REDI connected Kite Pharma with key City services, including direct lines to the Planning Department, helping the company and building owner navigate Rockville's processes as it prepared to reposition an office building for lab and operational use. Project Coordination. REDI organized and facilitated meetings between the City of Rockville and Facility Logix, the project management firm supporting Kite Pharma's build-out, ensuring alignment between the company's project team and City stakeholders throughout the repositioning process. Zoning & Code Compliance Support. REDI provided support around zoning and code compliance considerations tied to the repositioning project, helping smooth the path for a life sciences use in a previously conventional office building. Building Repositioning. 800 King Farm underwent a substantial transformation to support Kite Pharma's wet lab needs. Upgrades included new HVAC systems suited for lab operations, a full reskinning of the building's interior and common spaces, and an owner-built incubator lab space, repositioning the building from a conventional office asset into a true R&D facility with wet lab capabilities. Elected Official Engagement. REDI organized site tours for elected officials at the state, county, and City of Rockville levels, giving Kite Pharma's visibility with the policymakers who shape the region's life sciences investment climate and creating opportunities for the company to showcase its work directly to decision-makers. Marketing & Ecosystem Integration. REDI promoted Kite Pharma through its marketing channels and local industry events, helping integrate the company into Rockville's broader life sciences ecosystem and raising its profile among peer companies, partners, and prospective talent in the corridor. The Gilead acquisition: A Rockville company on the national stage. Kite Pharma's establishment at 800 King Farm positioned the company for its next major milestone: a $7.8 billion acquisition by Gilead Sciences to strengthen Gilead's CAR-T cell therapy pipeline. The deal is part of a broader wave of consolidation sweeping the global life sciences industry, as large, well-capitalized pharmaceutical companies pursue high-impact acquisitions of differentiated platforms to replace revenue at risk from expiring drug patents. That a Rockville-headquartered company was the target of one of this cycle's most notable CAR-T deals is a direct signal of the caliber of science being built locally and of the role REDI's site selection and repositioning support played in giving Kite Pharma a real, functioning R&D home base from which to reach that milestone. Why it matters. Kite Pharma's path from the Germantown Innovation Center, to West Watkins Mill, to a fully repositioned wet lab headquarters at 800 King Farm, to a $7.8 billion acquisition by Gilead Sciences mirrors the trajectory REDI aims to support: helping high-potential Maryland life sciences companies scale in place and build enough value to compete on the national stage. Rockville is considered the epicenter of life science activity within Montgomery County and the broader DC-MD-VA region, a market nationally ranked #3 as a top life science hub. Throughout the project, REDI worked alongside external partners including Scheer Partners and Banyan Street Capital, owners of 800 King Farm, to advocate for repositioning existing office space into wet lab space at a time when new lab inventory is badly needed across the region. As the life sciences industry continues to see a wave of mergers and acquisitions worldwide, Kite Pharma's acquisition underscores what's at stake for Rockville: the City has proven it can attract, house, and grow the kind of company that draws acquisition interest from major global biopharma players. That reputation strengthens Rockville's hand in recruiting the next generation of life sciences companies, even as consolidation reshapes ownership and employment within the sector. The 800 King Farm project itself remains a template for the City and proof that Rockville can convert underutilized office stock into competitive wet lab and R&D space, a capability that matters as the City competes for lab-dependent tenants across the Biotech Corridor and works to keep the value created by companies like Kite Pharma rooted in the local market.
BBG Advanced Therapies, a subsidiary of San Antonio-based nonprofit BioBridge Global, has launched a collaboration with Kite, a Gilead Company, to deploy a Mobile Leukapheresis Center across Texas. The first-of-its-kind platform enables patients to access CAR T-cell cancer therapies closer to home by bringing the initial T-cell collection step directly to communities. Kite has treated more than 34,500 patients with CAR T-cell therapy, yet only about 2 in 10 eligible patients in the US receive these treatments. The mobile unit aims to reduce travel and caregiver burdens whilst shortening logistical pathways. After collection, T-cells are sent to a Kite facility where a Chimeric Antigen Receptor gene is added before being returned to an authorised treatment centre for patient infusion.
BBG Advanced Therapies launches Mobile Leukapheresis Center, in collaboration with Kite to bring CAR T-cell therapies closer to patients. BBG Advanced Therapies, a subsidiary of San Antonio-based nonprofit BioBridge Global, today announced a collaboration with Kite, a Gilead Company and global leader in cell therapy, to deploy BBG Advanced Therapies' Mobile Leukapheresis Center (MLC) across Texas - marking an important milestone in how patients can access Kite's CAR T-cell therapies which are individualized cancer treatments made from a patient's own cells. San Antonio, Texas, July 07, 2026 (GLOBE NEWSWIRE) - BBG Advanced Therapies, a subsidiary of nonprofit BioBridge Global (BBG), today announced a collaboration with Kite, a Gilead Company and global leader in cell therapy, to deploy BBG Advanced Therapies' Mobile Leukapheresis Center (MLC) across Texas - marking an important milestone in how patients can access Kite's CAR T-cell therapies which are individualized cancer treatments made from a patient's own cells. Kite has helped pioneer CAR T-cell therapies, changing the outlook for patients with certain blood cancers. Operating across Texas, the MLC is a first-of-its-kind platform that brings the initial T-cell collection step directly to patients in their communities, aligning with Kite's strategy to scale access to cell therapy and reach more eligible people closer to home. By meeting patients where they are, this model reduces travel and caregiver burdens, shortens logistical pathways, and helps clear a major hurdle to broader adoption of advanced therapies. "Kite has treated more than 34,500 patients with CAR T-cell therapy - more than any other company - yet only about 2 in 10 eligible patients in the U.S. receive these treatments today," said Adrienne B. Mendoza, MHA, Chief Operating Officer of BBG Advanced Therapies. "That gap underscores the need for new access models. Kite's experience building one of the world's most advanced cell therapy ecosystems makes it an ideal collaborator as we expand the infrastructure needed to bring these potentially curative therapies closer to more eligible patients in Texas." Once the initial T-cell collection or leukapheresis is complete, the T-cells are then sent to a Kite facility where a Chimeric Antigen Receptor (CAR) gene is added and where the cells proliferate. After a short period, the patient's cells are sent back to an Authorized Treatment Center where the patient will receive a one-time infusion. Because these treatments are comprised of a patient's own cells, precision, consistency, and chain-of-identity are non-negotiable. BBG Advanced Therapies ensures that every collection meets rigorous quality standards and is fully integrated into Kite's GMP manufacturing workflow, reinforcing the strength and reliability of the end-to-end supply chain. For Texans today - and for regions around the world watching this model - this collaboration demonstrates how innovative infrastructure can unlock access to cutting-edge medicine. It shows how mobile, decentralized collection can help enable more patients to access cell therapy over time, so that transformative therapies are not limited by geography. The Texas deployment will serve as an important proof-of-concept model for additional markets, signaling how mobile collection infrastructure can support the continued growth of cell and gene therapies while maintaining the quality and consistency required for these complex, personalized medicines. About BBG Advanced Therapies: The newest subsidiary of San Antonio-based nonprofit BioBridge Global, BBG Advanced Therapies provides innovative and custom solutions to accelerate the development of cell and gene therapies. BBG Advanced Therapies features a fully integrated and custom portfolio of innovative solutions, including collection and processing of starting materials, testing, clinical trials support, and biomanufacturing services. Learn more at BBGAdvancedTherapies.org. About BioBridge Global: BioBridge Global (BBG) is a San Antonio-based 501(c)(3) nonprofit healthcare services enterprise that offers diverse services through its nonprofit subsidiaries - South Texas Blood & Tissue, QualTex Laboratories, BBG Advanced Therapies and The Blood & Tissue Center Foundation. BioBridge Global provides products and services in blood resource management, cellular therapy, donated umbilical cord blood and human tissue, as well as testing of blood, plasma and tissue products for clients in the United States and worldwide. The enterprise enables advances in the field of regenerative medicine and advanced therapies by providing access to starting materials, testing services and biomanufacturing and clinical trials support. BioBridge Global is committed to saving and enhancing lives through the healing power of human cells and tissue. Learn more at BioBridgeGlobal.org. management, cellular therapy, donated umbilical cord blood and human tissue, as well as testing of blood, plasma and tissue products for clients in the United States and worldwide. The enterprise enables advances in the field of regenerative medicine and advanced therapies by providing access to starting materials, testing services as well as biomanufacturing and clinical trials support. BioBridge Global is committed to saving and enhancing lives through the healing power of human cells and tissue. Learn more at BioBridgeGlobal.org. Attachments
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Industries
Company Size
1,001-5,000
Company Stage
IPO
Headquarters
Santa Monica, CA
Founded
2009
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