CUE-102 / Cue Biopharma, LG Chem - LARVOL DELTA

A novel 'Seed-and-Boost' immunotherapy drives potent TCR-T cell expansion, tumor infiltration, and durable tumor control (AACR 2026) - "Our data demonstrate that boosting with CUE-102 triggers robust in vivo expansion and activation of engineered TCR-T cells seed, resulting in effective anti-tumor responses, T cell persistence, and prolonged survival without additional cell engineering. This approach offers a potentially transformative solution for long-term benefits in solid tumor patients and can address cell therapy manufacturing and clinical management challenges by enabling the infusion of fewer seed TCR-T cells, eliminating the need for systemic IL-2 administration, and potentially avoiding toxic conditioning regimens."

Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • HLA-A • IL2 • WT1

CUE-102 in Recurrent Glioblastoma (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: David Reardon, MD | Trial completion date: Jan 2027 ➔ Jan 2028 | Trial primary completion date: Jan 2026 ➔ Jan 2027

Trial completion date • Trial primary completion date • Brain Cancer • Glioblastoma • Glioma • High Grade Glioma • Oncology • Solid Tumor

A phase 1, open-label, dose escalation and expansion study of CUE-102 monotherapy in HLA-A*0201 positive patients with WT1-positive recurrent/metastatic cancers (SITC 2022) - "Patients with colorectal and cisplatin-sensitive ovarian cancer must have documented disease progression to 2 prior systemic treatment regimens (CUE-102 will be ≥ 3rd line therapy); patients with Gastric/GEJ, pancreatic and cisplatin-resistant ovarian cancer must have documented disease progression to 1 prior systemic treatment regimens (CUE-102 will be ≥ 2nd line therapy). Results Trial is currently open and enrolling as of June 14, 2022."

Clinical • Monotherapy • P1 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • Wilms Tumor • CD8 • IL2 • WT1

A phase 1, open-label, dose escalation, and expansion study of CUE-102, a novel WT1-pHLA-IL2-Fc fusion protein, in patients with HLA-A*0201-positive disease and WT1-positive recurrent/metastatic cancers. (ASCO 2024) - P1 | "CUE-102 is a novel T cell engager that demonstrates acceptable tolerability, favorable PK, and supportive preliminary PD readouts. No DLTs or drug-related SAEs have been observed in doses up to 8 mg/kg as of the data cut-off. Adverse events have been manageable and consistent with the CUE-102 mechanism of action and underlying disease."

Clinical • Metastases • P1 data • Fatigue • Nephrology • Oncology • Ovarian Cancer • Pancreatic Cancer • Refractory Ovarian Cancer • Solid Tumor • Wilms Tumor • CD8 • HLA-A • IL2 • WT1

Cue Biopharma Announces Initiation of Investigator Sponsored Trial of CUE-102 in Recurrent Glioblastoma Multiforme (GlobeNewswire) - "The trial (NCT06917885) is a Phase 1b, open-label study of adjuvant CUE-102, the Company’s drug product candidate targeting Wilms’ Tumor 1 protein (WT1) expressing cancers....First patient dosed...at Dana-Farber Cancer Institute (DFCI)."

Trial status • Glioblastoma

CUE-102 in Recurrent Glioblastoma (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: David Reardon, MD | Not yet recruiting ➔ Recruiting | Initiation date: Sep 2025 ➔ Jun 2025

Enrollment open • Trial initiation date • Brain Cancer • Glioblastoma • Glioma • High Grade Glioma • Oncology • Solid Tumor

Cue Biopharma Reports First Quarter 2025 Financial Results and Recent Business Highlights (GlobeNewswire) - "Upcoming Event: Novel Biologics Portfolio Virtual Event planned for May 15, 2025 at 11 AM ET: Cue Biopharma’s virtual event will feature two key opinion leaders (KOLs): Richard DiPaolo, PhD (Saint Louis University) and Andrew Cope, MD, PhD (Centre for Rheumatic Diseases, King's College London). The event will highlight new preclinical data for CUE-401...and include key updates on the CUE-100 series clinical oncology programs."

Clinical • Preclinical • Immunology • Inflammation • Oncology

CUE-102 in Recurrent Glioblastoma (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: David Reardon, MD

New P1 trial • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Malignant Glioma • Oncology • Solid Tumor

CUE-102-01: A Phase 1 in Patients with HLA-A*0201+ and WT1+ Recurrent/Metastatic Cancers (clinicaltrials.gov) - P1 | N=42 | Completed | Sponsor: Cue Biopharma | Active, not recruiting ➔ Completed | Trial completion date: Dec 2026 ➔ Mar 2025 | Trial primary completion date: Dec 2024 ➔ Mar 2025

Monotherapy • Trial completion • Trial completion date • Trial primary completion date • Colon Adenocarcinoma • Colon Cancer • Colorectal Cancer • Gastric Cancer • Hepatology • Oncology • Ovarian Cancer • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • CTLA4 • WT1

A phase 1 trial of CUE-102, a novel WT1-pHLA-IL2-Fc T cell engager in HLA-A*0201 positive patients with WT1-positive recurrent/metastatic cancers (SITC 2024) - P1 | "Ethics Approval This study was approved by Ethics and Institutional Review Boards (IRBs) at all study sites. IRB reference numbers: WCG1340057 (Carolina BioOncology, Gabrail Cancer Center, University of Wisconsin Carbone Cancer Center, Samuel Oschin Cancer Center/Cedars-Sinai Medical Center, Winship Cancer Institute/Emory University, Northwest Medical Specialties/Tacoma Medical Oncology), Advarra MCC# 22112 (Moffitt Cancer Center), BRANY 22-06-326-01 (Albert Einstein Cancer Center), IRB00349569 (Johns Hopkins University School of Medicine), 2022-0761 (The University of Texas MD Anderson Cancer Center), UHIRB STUDY20221273 (UH Cleveland Medical center, Seidman Cancer Center)."

Clinical • Metastases • P1 data • Oncology • Ovarian Cancer • Pancreatic Cancer • Refractory Ovarian Cancer • Solid Tumor • Wilms Tumor • CD8 • HLA-A • IL2 • WT1

A phase 1 trial of CUE-102, a novel WT1-pHLA-IL2-Fc T cell engager in HLA-A*0201 positive patients with WT1-positive recurrent/metastatic cancers (SITC 2024) - P1 | "Ethics Approval This study was approved by Ethics and Institutional Review Boards (IRBs) at all study sites. IRB reference numbers: WCG1340057 (Carolina BioOncology, Gabrail Cancer Center, University of Wisconsin Carbone Cancer Center, Samuel Oschin Cancer Center/Cedars-Sinai Medical Center, Winship Cancer Institute/Emory University, Northwest Medical Specialties/Tacoma Medical Oncology), Advarra MCC# 22112 (Moffitt Cancer Center), BRANY 22-06-326-01 (Albert Einstein Cancer Center), IRB00349569 (Johns Hopkins University School of Medicine), 2022-0761 (The University of Texas MD Anderson Cancer Center), UHIRB STUDY20221273 (UH Cleveland Medical center, Seidman Cancer Center)."

Clinical • Metastases • P1 data • Oncology • Ovarian Cancer • Pancreatic Cancer • Refractory Ovarian Cancer • Solid Tumor • Wilms Tumor • CD8 • HLA-A • IL2 • WT1

Cue Biopharma Presents Positive Updated Data from its Phase 1 Trial of…CUE-102 in….WT1 Positive Cancers at the SITC 39th Annual Meeting (GlobeNewswire) - P1 | N=52 | NCT05360680 | Sponsor: Cue Biopharma | "Key data highlights from the completed CUE-102 dose escalation and ongoing dose expansion parts of the Phase 1 clinical trial (data cutoff of October 29, 2024) include: 67% overall DCR in late-stage pancreatic cancer patients treated with CUE-102 at 2 and 4mg/kg, including an unconfirmed PR with a 40% decrease in tumor burden. Evidence of selective stimulation and expansion of WT1-specific CD8 T cells, with no apparent increase in total numbers of non-specific CD8 T cells. No dose-limiting toxicities occurred in patients treated during the dose escalation phase at doses ranging between 1-8mg/kg of CUE-102."

P1 data • Pancreatic Cancer

Cue Biopharma Announces Upcoming Scientific Presentations at the Society for Immunotherapy of Cancer’s (SITC) 39th Annual Meeting (GlobeNewswire) - "Cue Biopharma...announced it will deliver an oral and a poster presentation on the company’s Immuno-STAT clinical assets CUE-101 and CUE-102, representative of the CUE-100 series, at the Society for Immunotherapy of Cancer’s 39th Annual Meeting (SITC 2024). The conference will be held in Houston, Texas, on November 6-10, 2024."

P1 data • Squamous Cell Carcinoma of Head and Neck

Cue Biopharma to Present at The Promise of Interleukin-2 Therapy Conference (GlobeNewswire) - "Cue Biopharma, Inc...today announced that members of its management team will deliver two presentations at The Promise of Interleukin-2 Therapy Conference, taking place September 4-7, 2024 in Paris, France....Dr. Levisetti will discuss how the company’s lead oncology programs CUE-101 and CUE-102, representative of the CUE-100 series of Immuno-STAT™ biologics, enable selective targeting of the cytokine IL-2 to tumor specific T cells for enhanced efficacy and safety profiles."

Clinical data • Oncology • Solid Tumor

Cue Biopharma to Host Business Update Call and Webcast (GlobeNewswire) - "Cue Biopharma, Inc...announced today that it will host a conference call and webcast to provide a business update on Monday, August 19, 2024 at 4:30 p.m. EDT. The company will provide a business overview of its recent restructuring and near-term strategic prioritization objectives. The discussion will focus on the...enabling data from its ongoing oncology trials for CUE-101 and CUE-102 to continue to mature. Additional clinical and business updates, as well as market opportunities and anticipated near-term milestones, will also be addressed."

Clinical data • Oncology

CUE-102-01: A Phase 1 in Patients With HLA-A*0201+ and WT1+ Recurrent/Metastatic Cancers (clinicaltrials.gov) - P1 | N=52 | Active, not recruiting | Sponsor: Cue Biopharma | Recruiting ➔ Active, not recruiting

Enrollment closed • Metastases • Monotherapy • Colon Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Ovarian Cancer • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • CTLA4 • WT1

Cue Biopharma Presents Updated Data from Phase 1 Trial of CUE-101 in Recurrent/Metastatic HPV+ Head and Neck Cancer at the 2024 ASCO Annual Meeting (GlobeNewswire) - P1 | N=52 | NCT05360680 | Sponsor: Cue Biopharma | "Key data highlights to date from the fully enrolled CUE-102 dose escalation part of the Phase 1 clinical trial (data cutoff of May 1, 2024) include: DCR of 43.5%; Two patients at the 2mg/kg dose, one with gastric cancer and one with ovarian cancer have demonstrated reductions in tumor burden. Selective expansion of WT1-specific T cells in multiple patients. No dose-limiting toxicities or drug-related serious adverse events have been reported to date in patients treated during the dose escalation phase at doses ranging between 1-8mg/kg of CUE-102."

P1 data • Gastric Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

Cue Biopharma to Present at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (GlobeNewswire) - "The presentations will highlight the Company’s Phase 1 trials of its lead interleukin 2 (IL-2)-based biologics, CUE-101 in recurrent/metastatic head and neck cancer and CUE-102 in Wilms’ Tumor 1 positive recurrent/metastatic cancers."

P1 data • Oncology • Squamous Cell Carcinoma of Head and Neck

Cue Biopharma Reports Fourth Quarter and Full Year 2023 Financial Results and Updated Business Highlights (GlobeNewswire) - P1 | N=52 | NCT05360680 | Sponsor: Cue Biopharma | "Presented notable updates from the ongoing Phase 1 clinical trials of...CUE-102 at the 2024 Oppenheimer Annual Healthcare Life Sciences Conference in February:...CUE-102 monotherapy in late-stage refractory metastatic cancers demonstrated tumor reductions and stable disease in multiple patients in the dose escalation Phase 1 trial."

P1 data • Colorectal Cancer • Gastric Cancer • Ovarian Cancer • Pancreatic Cancer

Cue Biopharma to Host Business Update Call and Webcast (GlobeNewswire) - "Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively modulate disease-specific T cells, announced today that it will host a conference call and webcast to provide a business update on Monday, April 8, 2024 at 4:30 p.m. EDT...The Company will provide a corporate update highlighting measurable progress advancing its lead clinical oncology programs, CUE-101 and CUE-102..."

Clinical • Oncology

Cue Biopharma to Present Corporate Update at the Oppenheimer 34th Annual Healthcare Life Sciences Conference - "During the presentation, Cue Biopharma’s chief executive officer, Dan Passeri, will provide a corporate update highlighting the latest developments from its lead clinical programs, CUE-101 and CUE-102, its lead preclinical autoimmune program partnered with Ono Pharmaceutical, as well as market opportunities, competitive positioning and key forecasted value-driving 2024 milestones."

Clinical • Preclinical • Oncology

Cue Biopharma to Present at the JMP Securities Hematology and Oncology Summit (GlobeNewswire) - "During the fireside chat, Cue Biopharma will discuss recent data highlights from its lead clinical programs, CUE-101 and CUE-102, representative of the IL-2-based CUE-100 series of selective T cell engagers, as well as market opportunities, competitive positioning and anticipated milestones for 2024."

Clinical data • Oncology

Cue Biopharma to Present at Three Upcoming Investor Healthcare Conferences in November (GlobeNewswire) - "During the presentations and fireside discussions, Cue Biopharma will provide a corporate overview including recent data highlights from its lead clinical programs, CUE-101 and CUE-102, representative of the IL-2-based CUE-100 series of selective T cell engagers."

Clinical data • Oncology

A phase 1 trial of CUE-102, a novel WT1-pHLA-IL2-Fc fusion protein in HLA-A*0201 positive patients with WT1-positive recurrent/metastatic cancers (SITC 2023) - "Adverse events have been manageable and consistent with the CUE-102 mechanism of action and underlying disease. Early signs of anti-tumor activity are encouraging."

Clinical • Metastases • P1 data • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • Wilms Tumor • CD8 • HLA-A • IL2 • WT1

Cue Biopharma Presents New Positive Data from Phase 1 Trials of CUE-101 in Head and Neck Cancer and CUE-102 in Wilms’ Tumor 1 Positive Cancers at SITC 2023 (GlobeNewswire) - P1 | N=52 | NCT05360680 | Sponsor: Cue Biopharma | "Key data highlights from the CUE-102 Phase 1 clinical trial to date include: No DLTs reported to date in patients treated during the dose escalation phase at doses ranging between 1–8mg/kg of CUE-102 intravenously every 3 weeks; a MTD has not been reached. Two patients at the 2mg/kg dose, one with gastric cancer and one with ovarian cancer have demonstrated reduction in tumor burden."

P1 data • Gastric Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor