KITE-753 / Gilead - LARVOL DELTA

A Phase 1 study of KITE-753 or KITE-363 in patients with relapsed/refractory B-cell lymphoma: Initial safety and preliminary efficacy of KITE-753 and updated results of KITE-363 (ASH 2025) - "Amongall treated patients (N=37), 9 died (8 due to progression).Lymphodepletion was reduced and immune reconstitution was improved with KITE-363 compared toaxicabtagene ciloleucel (axi-cel; Locke FL, et al. KITE-363 results showed high response rates with encouraging durability in DL3 and amanageable safety profile. KITE-753's rapid manufacturing process preserving a juvenile productphenotype, in addition to its bicistronic CAR design with dual co-stimulation, was associated with lowincidence of CRS and ICANS, mostly Grade 1/2. The preliminary efficacy and safety profiles of KITE-753DL3 appeared promising; the expansion phase with DL3 in LBCL (n=17) is ongoing and will be presented."

Clinical • P1 data • B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Indolent Lymphoma • Infectious Disease • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Respiratory Diseases • Respiratory Syncytial Virus Infections

Initial Results from Kite-753, Optimized with Novel Manufacturing Process That Preserves T-Cell Fitness, Show High Complete Response Rate and Favorable Safety Trend (Gilead Press Release) - "Results for KITE-753 showed that at a median follow-up of 4.0 months overall and 2.9 months at dose level three (DL3; 0.2×106 CAR T cells/kg), 11 of 14 CAR-naïve patients (79%) receiving DL3 had a complete response, where the cancer completely disappeared....Meanwhile, results for KITE-363 revealed that at a median follow-up of 17.5 months, there was a durable benefit at the highest dose level (2×106 CAR T cells/kg) among CAR-naïve patients, with more than 70% of complete responders evaluable at 12 months remaining in remission."

P1 data • Large B Cell Lymphoma

KITE-753: An Autologous Rapid Manufactured Anti-CD19/CD20 CAR-T Product for the Treatment of B-Cell Malignancies (ASH 2024) - P1 | "Hence, a Phase 1, first-in-human, open-label, multicenter study is currently ongoing to evaluate the safety and efficacy of KITE-363, a dual-targeting anti-CD19/CD20 CAR T-cell therapy, for the treatment of patients with relapsed/refractory B-cell lymphomas (NCT04989803). In addition to the potential to prevent and rescue CD19 negative relapses, the improved product potency of the rapid manufactured KITE-753 may enable the use of lower CAR-T doses in the clinic. A Phase 1, first-in-human, open-label, multicenter study is currently ongoing to evaluate the safety and efficacy of KITE-753 in patients with relapsed/refractory B-cell lymphomas (NCT04989803)."

IO biomarker • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • B Cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Gilead and Kite Showcase Continued Progress in Transforming Blood Cancer Care With New Cell Therapy Data at ASH 2025 (Businesswire) - "Updated Results from Phase 2 Pivotal iMMagine-1 Study of Anito-cel for Relapsed/Refractory Multiple Myeloma to be Presented Orally...Kite will also share new data on its next-generation bicistronic autologous CAR T-cell therapies, KITE-363 and KITE-753...A key presentation for Yescarta (axicabtagene ciloleucel) includes a joint analysis of 4-year follow-up data from ZUMA-7, which evaluated Yescarta as a second-line therapy in patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) eligible for autologous stem-cell transplant (ASCT), alongside 2-year follow-up data from ALYCANTE that evaluated patients who were ASCT ineligible."

Clinical data • Acute Lymphocytic Leukemia • Burkitt Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Large B Cell Lymphoma • Mantle Cell Lymphoma • Multiple Myeloma

KT-US-499-0150: Study of KITE-363 or KITE-753 in Participants With Relapsed and/or Refractory B-cell Lymphoma (clinicaltrials.gov) - P1 | N=114 | Recruiting | Sponsor: Kite, A Gilead Company | Trial completion date: May 2027 ➔ Oct 2027 | Trial primary completion date: May 2027 ➔ Oct 2027

Trial completion date • Trial primary completion date • B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CSF2 • CXCL8 • IL15 • IL1R1 • IL7

KT-US-499-0150: Study of KITE-363 or KITE-753 in Participants With Relapsed and/or Refractory B-cell Lymphoma (clinicaltrials.gov) - P1 | N=114 | Recruiting | Sponsor: Kite, A Gilead Company | Trial primary completion date: Jul 2026 ➔ May 2027 | Trial completion date: Jul 2026 ➔ May 2027

Trial completion date • Trial primary completion date • B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CSF2 • CXCL8 • IL15 • IL1R1 • IL7

Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells (clinicaltrials.gov) - P=N/A | N=1000 | Enrolling by invitation | Sponsor: Kite, A Gilead Company | N=700 ➔ 1000

Enrollment change • Hematological Disorders • Hematological Malignancies • Oncology

Kite to Highlight Industry-Leading CAR T-Cell Therapy Portfolio at ASH 2024… (Businesswire) - "Advancements in Kite’s pipeline will...be highlighted, including data presented on Kite’s next generation CAR T-cell therapy KITE-753, an autologous anti-CD19/CD20 CAR T-cell therapy for the treatment of B-cell malignancies."

P1 data • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

KT-US-499-0150: Study of KITE-363 or KITE-753 in Participants With Relapsed and/or Refractory B-cell Lymphoma (clinicaltrials.gov) - P1 | N=114 | Recruiting | Sponsor: Kite, A Gilead Company | Trial completion date: Jan 2027 ➔ Jul 2026 | Trial primary completion date: Jul 2025 ➔ Jul 2026

CAR T-Cell Therapy • Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

KT-US-499-0150: Study of KITE-363 or KITE-753 in Participants With Relapsed and/or Refractory B-cell Lymphoma (clinicaltrials.gov) - P1 | N=114 | Recruiting | Sponsor: Kite, A Gilead Company | Trial completion date: Jan 2041 ➔ Jan 2027 | Trial primary completion date: Apr 2024 ➔ Jul 2025

CAR T-Cell Therapy • Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology