ALLO-316 / Cellectis, Allogene Overland Biopharm, Overland Therapeutics - LARVOL DELTA

ALLO-316 in advanced clear cell renal cell carcinoma (ccRCC): Updated results from the phase 1 TRAVERSE study. (ASCO 2025) - P1 | "Clinical Trial Registration Number: NCT04696731 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Metastases • P1 data • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Solid Tumor

Allogene Therapeutics to Present Updated ALLO-316 Clinical Results in Kidney Cancer in Oral Presentation and ALPHA3 Trial-in-Progress Poster for Cema-Cel at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (GlobeNewswire) - "Allogene Therapeutics...announced that it will present updated data from the completed Phase 1 TRAVERSE trial of ALLO-316 in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting....In addition, a trial-in-progress poster is also being presented to highlight the ongoing pivotal Phase 2 ALPHA3 trial, which is evaluating cemacabtagene ansegedleucel (cema-cel) as part of first-line (1L) treatment for patients with large B-cell lymphoma (LBCL)."

P1 data • Trial status • Large B Cell Lymphoma • Renal Cell Carcinoma

ALLO-316: TRAVERSE Trial in RCC (GlobeNewswire) - "Phase 1b Expansion Cohort Enrollment Completed with Data Expected Mid-2025."

P1 data • Trial status • Genito-urinary Cancer • Renal Cell Carcinoma

ALLO-316 in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC): Updated safety and efficacy from the phase 1 TRAVERSE multicenter study (SITC-SSC 2025) - No abstract available

Clinical • Metastases • P1 data • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Solid Tumor

ALLO-316 in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC): updated safety and efficacy from the phase 1 TRAVERSE multicenter study (SITC 2024) - P1 | "Escalating doses of ALLO-316 (40–240 × 106 allogeneic CAR+ T cells) were administered intravenously on Day 0 after lymphodepletion with fludarabine and cyclophosphamide +/- ALLO-647, an anti-CD52 monoclonal antibody...Immune effector cell-associated HLH-like syndrome (IEC-HS) was observed in a subset of patients and will be presented along with its management with ruxolitinib...Preliminary analyses in patients with tumors expressing CD70 provided encouraging evidence of CAR activity. These findings support further evaluation of ALLO-316 in CD70+ ccRCC and other CD70+ malignancies."

Clinical • Metastases • P1 data • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Solid Tumor • CD70

Cellectis Provides Business Updates and Financial Results for Third Quarter 2024 (GlobeNewswire) - "Allogene announced that enrollment is ongoing in the relapsed/refractory (r/r) CLL cohort of the Phase 1 ALPHA2 trial of cema-cel, and that initial data readout from the CLL cohort is projected by early 2025. Allogene announced that a Phase 1 data update of the TRAVERSE trial of ALLO-316 from approximately 20 patients with CD70 positive RCC is planned by YE 2024."

P1 data • Chronic Lymphocytic Leukemia • Renal Cell Carcinoma

TRAVERSE: Updated safety and efficacy of ALLO-316 in advanced/metastatic clear cell renal cell carcinoma (ccRCC) (IKCS 2024) - P1 | "Escalating doses of ALLO-316 (40 to 240×10^6 allogeneic CAR+ T cells) were administered intravenously after lymphodepletion (fludarabine and cyclophosphamide +/- ALLO-647, an anti-CD52 monoclonal antibody)...A subset of patients experienced immune effector cell-associated HLH-like syndrome (IEC-HS); these IEC-HS data and management with ruxolitinib will be presented...Single-dose ALLO-316 demonstrated a manageable safety profile in relapsed/ refractory advanced/metastatic ccRCC. Preliminary analyses in CD70+ tumors provided encouraging evidence of CAR activity, supporting further evaluation of ALLO-316 in CD70+ ccRCC and other"

Clinical • Metastases • Anemia • Clear Cell Renal Cell Carcinoma • Fatigue • Genito-urinary Cancer • Graft versus Host Disease • Hematological Disorders • Immunology • Leukopenia • Neutropenia • Oncology • Renal Cell Carcinoma • Solid Tumor • CD70

Allogene Therapeutics Announces Positive Phase 1 Data Demonstrating the Potential of ALLO-316 in Heavily Pretreated Patients with Advanced Renal Cell Carcinoma at SITC and IKCS (GlobeNewswire) - P1 | N=120 | TRAVERSE (NCT04696731) | Sponsor: Allogene Therapeutics | "Phase 1 TRAVERSE Trial Demonstrated a Single Infusion of ALLO-316 Can Yield an Overall Response Rate of 50% and Confirmed Response Rate of 33% in Patients with CD70 Tumor Proportion Score (TPS) of Greater than 50%; TRAVERSE Trial Highlights the Ability of CD70 Dagger Technology to Promote Robust Expansion and Persistence of ALLO-316 with Standard Lymphodepletion, Validating its Potential as the Next Generation Allogeneic Platform; ALLO-316 Demonstrated a Manageable Safety Profile; Newly Implemented Diagnostic and Management Algorithm Appears Highly Effective in Abating IEC-HS While Preserving CAR T Efficacy."

P1 data • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Allogene Therapeutics to Present New Data Demonstrating the Potential of ALLO-316 in Heavily Pretreated Adult Patients with CD70 Positive Advanced Renal Cell Carcinoma (RCC) at the International Kidney Cancer Symposium (IKCS) and Society for Immunotherapy of Cancer (SITC) Annual Meeting (GlobeNewswire) - "Allogene Therapeutics, Inc...announced that it will present new data from the ongoing Phase 1 TRAVERSE trial at the 2024 International Kidney Cancer Symposium (IKCS) and the Society for Immunotherapy of Cancer's (SITC) annual meeting....These presentations will highlight data from 26 heavily pretreated patients with CD70 positive renal cell carcinoma (RCC) and will include details on the diagnostic and treatment algorithm used to mitigate treatment-associated hyperinflammatory response seen in some patients."

P1 data • Clear Cell Renal Cell Carcinoma

Allogene Therapeutics Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for ALLO-316, an AlloCAR T Investigational Product for Adult Patients with Advanced or Metastatic Renal Cell Carcinoma (RCC) (GlobeNewswire) - "Allogene Therapeutics, Inc...announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-316 for the treatment of adult patients with CD70 positive advanced or metastatic renal cell carcinoma (RCC). The RMAT designation was based on clinical data from the TRAVERSE trial indicating the potential of ALLO-316 to address the unmet need for patients with difficult-to-treat RCC who have failed multiple standard RCC therapies, including an immune checkpoint inhibitor and a VEGF-targeting therapy....The Company will present updated Phase 1 data from the TRAVERSE trial at the Society for Immunotherapy of Cancer (SITC) annual meeting."

FDA event • P1 data • Renal Cell Carcinoma

Cellectis Reports Financial Results for First Quarter 2024 (GlobeNewswire) - "Anti-CD19 program:...Allogene further announced that enrollment is ongoing in the relapsed/refractory (r/r) CLL cohort of the Phase 1 ALPHA2 trial of cema-cel....Anti-CD70 program:...Allogene announced that a Phase 1 data update of the ongoing TRAVERSE trial with ALLO-316 in RCC from approximately 20 patients with CD70 positive RCC is planned by YE 2024."

Enrollment status • P1 data • Chronic Lymphocytic Leukemia • Clear Cell Renal Cell Carcinoma

Allogene Therapeutics Awarded Grant from the California Institute for Regenerative Medicine to Advance Development of an Allogeneic CAR T in Renal Cell Carcinoma (GlobeNewswire) - "Allogene Therapeutics, Inc...announced that it has received a $15 million grant from the California Institute for Regenerative Medicine (CIRM) to support the clinical development of ALLO-316, an AlloCAR T investigational product targeting CD70 in development for the treatment of advanced or metastatic renal cell carcinoma (RCC)....The grant will support the ongoing Phase 1 TRAVERSE trial which assesses safety, tolerability and preliminary efficacy of ALLO-316 in advanced RCC that has progressed despite standard therapy....Details on a potentially cornerstone safety algorithm discovered during the initial portion of the Phase 1 TRAVERSE trial...is planned for a publication in Q2 2024. A more comprehensive data update from the ongoing trial is planned for later in 2024."

Financing • P1 data • Genito-urinary Cancer • Renal Cell Carcinoma

Innovative perspectives in renal carcinoma therapy: exploring the therapeutic potential of Car-T cells directed to the CD70 and Allo 316. (ICUC 2024) - "Car-T immunotherapy, aiming at the CD70 in tumor cells, brings hope in the treatment of advanced renal cell carcinoma.Traversse study highlights the efficacy of Allo-316, with a high rate of disease control.However, side effects such as neurotoxicity and cytokine release syndrome require careful monitoring.These results represent advances in the search for safer and more effective treatments for patients with advanced kidney cancer."

CAR T-Cell Therapy • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Infectious Disease • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • CD20 • CD52 • CD70

Allogene Therapeutics Announces 2024 Platform Vision to Redefine the Future of CAR T Led by ALPHA3, the Industry's First Pivotal Trial for Frontline Consolidation in Large B-Cell Lymphoma (GlobeNewswire) - "During the careful advancement of the TRAVERSE trial with ALLO-316, the Company has observed remarkable allogeneic CAR T cell expansion and persistence driven by its unique CD70 CAR that allows elimination of alloreactive host lymphocytes...The Company has recently implemented a protocol amendment to further maximize the benefit-risk of ALLO-316 in patients with CD70+ RCC....The next update from this trial is planned for a medical forum in Q2 2024 and will discuss the algorithm that is believed to be a critical advance for both the TRAVERSE trial as well as the industry at large. A more robust data update from the ongoing trial with the updated protocol is planned for later in 2024."

Clinical protocol • P1 data • Trial status • Clear Cell Renal Cell Carcinoma

Allogene Therapeutics Reports Third Quarter 2023 Financial Results and Business Update (GlobeNewswire) - "The Phase 1 dose escalation TRAVERSE trial 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 is ongoing. Dose escalation in the TRAVERSE trial is expected to be completed by early 2024. The Company intends to target an academic forum in early 2024 to provide an update from this trial."

P1 data • Trial status • Renal Cell Carcinoma

Allogene Therapeutics Presents Preclinical Data on Next Generation Cloak and Dagger Technologies at the Society for Immunotherapy of Cancer Annual Meeting (GlobeNewswire) - "Cloak and Dagger Technologies Show Potential to Reduce Dependence on Standard Lymphodepletion and Enhance Performance of AlloCAR T Cells; Data from Preclinical Study of Cloak Technology Highlights Ability to Engineer Allogeneic Cells to Evade Detection by the Host Immune System; Dagger 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."

Preclinical • Oncology • Solid Tumor

TRAVERSE: Safety and Efficacy of ALLO-316 in Subjects With Advanced or Metastatic Clear Cell Renal Cell Carcinoma (clinicaltrials.gov) - P1 | N=120 | Recruiting | Sponsor: Allogene Therapeutics | Trial primary completion date: Dec 2022 ➔ Aug 2025

Metastases • Trial primary completion date • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

A Phase 1 multicenter study (TRAVERSE) evaluating the safety and efficacy of ALLO-316 following conditioning regimen in pts with advanced or metastatic clear cell renal cell carcinoma (ccRCC) (KCRS 2023) - No abstract available

Clinical • Metastases • P1 data • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

A phase 1 multicenter study (TRAVERSE) evaluating the safety and efficacy of ALLO-316 following conditioning regimen in pts with advanced or metastatic clear cell renal cell carcinoma (ccRCC) (AACR 2023) - P1 | "Due to the high incidence (~80%) of CD70 antigen expression in primary and mRCC, yet limited expression in normal tissue, ccRCC is an attractive proof-of-concept tumor for CD70 directed allogeneic CAR T. TRAVERSE (NCT04696731), a first-in-human trial, seeks to identify a maximum tolerated dose (MTD) of ALLO-316 after conditioning with fludarabine/cyclophosphamide with/without ALLO-647 in pts with advanced or metastatic ccRCC. ALLO-316, an allogeneic CAR T cell product targeting CD70 in advanced mRCC, is demonstrating encouraging antitumor activity and a manageable safety profile. A single administration of ALLO-316 could be an effective treatment for pts with CD70+ solid tumors, including RCC, and hematologic malignancies. The MTD for ALLO-316 in TRAVERSE will support Phase 2 trial design."

Clinical • IO biomarker • Metastases • P1 data • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Hematological Malignancies • Oncology • Renal Cell Carcinoma • Solid Tumor • CD70

Dr Srour on the Mechanism of Action of ALLO-316 in Metastatic Clear Cell RCC (OncLive) - P1 | N=120 | TRAVERSE (NCT04696731) | Sponsor: Allogene Therapeutics | "Preliminary data presented at the 2023 AACR Annual Meeting showed ALLO-316 demonstrated antitumor activity and a favorable safety profile. In the efficacy evaluable population (n = 18), the overall response rate (ORR) was 17%, and the disease control rate (DCR) was 89%. Among patients with CD70-positive RCC (n = 10), 3 patients (30%) achieved a partial response, the DCR was 100%, and the median progression-free survival was 5.0 months....Findings from the dose-escalation portion of the trial showed that no unexpected safety signals were reported."

P1 data • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma

""ALLO-316 indeed has very unique features in the way it was genetically engineered." #AACR23 Watch now: https://t.co/6VkwFQ5bRY" (@CGT_Live)

Oncology

Allogene Therapeutics Reports First Quarter 2023 Financial Results and Business Update (Allogene Therapeutics Press Release) - "ALLO-316: Dose escalation in the TRAVERSE trial is expected to be completed in 2023."

Trial status • Oncology • Solid Tumor

Allogene Therapeutics Presents Interim Phase 1 Data on ALLO-316 in Renal Cell Carcinoma at the American Association of Cancer Research (AACR) Annual Meeting (GlobeNewswire) - P1 | N=120 | TRAVERSE (NCT04696731) | Sponsor: Allogene Therapeutics | "Allogene Therapeutics...presented interim data from its Phase 1 TRAVERSE trial of ALLO-316, the Company’s first AlloCAR TTM investigational product candidate for solid tumors, in an oral presentation at the American Association for Cancer Research (AACR) Annual Meeting....As of the March 23, 2023 data cutoff, 19 patients were enrolled in the Phase 1 trial, 10 of whom had RCC confirmed to express CD70....Anti-tumor activity was primarily observed in patients with tumors confirmed to express CD70. Among 18 patients evaluable for efficacy, the disease control rate (DCR) was 89%. In the 10 patients whose tumors were known to express CD70, the disease control rate was 100%, which included three patients who achieved partial remission (two confirmed, one unconfirmed). The longest response lasted until month eight. There was a trend toward greater tumor shrinkage in patients with higher levels of CD70 expression."

P1 data • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Allogene Therapeutics Announces Oral Presentation of Phase 1 Data on ALLO-316 at the American Association of Cancer Research (AACR) Annual Meeting (GlobeNewswire) - "Allogene Therapeutics...announced that it will present interim data from its Phase 1 TRAVERSE trial of ALLO-316, the Company’s first AlloCAR T candidate for solid tumors, in an oral presentation at the American Association for Cancer Research (AACR) Annual Meeting taking place in April in Orlando, Florida."

P1 data • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Allogene Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update (GlobeNewswire) - "ALLO-316: Subject to ongoing results in the TRAVERSE trial, the Company intends to complete planned dose exploration and initiate expansion cohort enrollment in 2023."

Trial status • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor