CD40HVac / EnnoDC - LARVOL DELTA

Randomized phase I/II trial adjuvant CD40.HVAC, an immunotherapy engaging dendritic cells (DC), in patients with HPV16+ oropharyngeal carcinoma (OPC). (ASCO 2026) - P1/2 | "In cohorts 1 (n=11) and 2 (n=11), pts were randomized (5:1) to receive subcutaneously, Hiltonol® (1mg) adjuvanted CD40.HVac, 1 and 3 mg, respectively, or placebo, at W0, 4, 24. The safety and immunogenicity of CD40.HVac support further clinical development of this strategy in pts with HPV16+ OPC."

Clinical • IO biomarker • P1/2 data • Oncology • Oropharyngeal Cancer • Solid Tumor • CD40 • CD8 • GZMB • IFNG • IL2 • LAMP1 • PD-1

HPVDCVax: Therapeutic Vaccine in Patients With Human Papillomavirus HPV-positive Oropharyngeal Cancer (clinicaltrials.gov) - P1/2 | N=24 | Completed | Sponsor: Gustave Roussy, Cancer Campus, Grand Paris | Recruiting ➔ Completed | Trial completion date: Aug 2026 ➔ Mar 2026

Trial completion • Trial completion date • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

HPVDCVax: Therapeutic Vaccine in Patients With Human Papillomavirus HPV-positive Oropharyngeal Cancer (clinicaltrials.gov) - P1/2 | N=24 | Recruiting | Sponsor: Gustave Roussy, Cancer Campus, Grand Paris | Trial primary completion date: Aug 2025 ➔ Nov 2025

Trial primary completion date • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

PRELIMINARY RESULTS OF A MULTICENTRIC RANDOMIZED PHASE I/II TRIAL HPV.DCVAX OF AN IMMUNOTHERAPY ENGAGING DENDRITIC CELLS (DC), CD40.HVAC, IN PATIENTS WITH HPV16-POSITIVE OROPHARYNGEAL CARCINOMA (OPC) (IPVC 2025) - P1/2 | "In cohorts 1 (n=11) and 2 (n=11), patients were randomized (5:1) to receive subcutaneously, Hiltonol® (1mg) adjuvanted CD40.HVac, 1 and 3 mg respectively, or placebo, at W0, 4, and 24. CD40.HVac is an innovative way to deliver oncoproteins and to engage DC to improve immunogenicity. The safety and robust immunogenicity of CD40.HVac support further clinical development of this strategy in patients with advanced OPC."

Clinical • IO biomarker • P1/2 data • Fatigue • Oncology • Oropharyngeal Cancer • Solid Tumor • CD40 • CD8 • GZMB • IFNG • IL2 • LAMP1 • PD-1

EnnoDC presents preliminary data for immunotherapy candidate CD40.HVac in HPV+ oropharyngeal cancer at ESMO IO 2024 (GlobeNewswire) - "EnnoDC...announces that new preliminary data of a Phase I/IIa clinical study evaluating its immunotherapy candidate CD40.HVac in patients with human papillomavirus (HPV16)-associated oropharyngeal carcinoma (OPC), will be presented at the ESMO Immuno-Oncology Congress 2024, 11-13 December 2024 in Geneva, Switzerland."

P1/2 data • Oropharyngeal Cancer

Preliminary results of a multicentric randomized phase I/IIa trial of an immunotherapy targeting dendritic cells (DC), CD40HVac, in patients with HPV16-positive oropharyngeal carcinoma (OPC) (ESMO-IO 2024) - P1/2 | "Twelve pts were included per dose group (1 (completed), or 3 mg (ongoing) CD40HVac subcutaneously-adjuvanted with Hiltonol®1mg), and randomized 5:1 to receive vaccine or placebo at Week (W) 0, 4 and 24 starting 16 – 22 W after end of curative treatment. AIM assay confirmed the elicitation of HPV-specific CD4+ and CD8+ T cells.Conclusions Adjuvanted CD40HVac immunotherapy is well tolerated in OPC HPV16-positive pts and induced, after two boosts at the lowest dose, specific and functional T-cell responses including CD8+ T cells exhibiting markers of cytotoxicity. W26 immunogenicity results will be presented."

Clinical • IO biomarker • P1/2 data • Oncology • Oropharyngeal Cancer • Solid Tumor • CD40 • CD8 • GZMB • IFNG • IL2 • LAMP1

EnnoDC unveils the next generation of dendritic cell-targeting immunotherapies supported by new leadership and an evolved strategy (GlobeNewswire) - "EnnoDC...unveils today its promising pipeline of preclinical and clinical-stage programs for cancer and infectious diseases...The technology has already entered clinical development in the field of infectious diseases. EnnoDC is now extending the use of its technology to expand its portfolio of immunotherapies to fight cancers...EnnoDC is planning to initiate in Q2 2025 a Phase IIb in HPV16+ oropharyngeal cancer patients and is planning a pre-IND filing for a Phase I/IIa trial in prostate cancer early 2027."

New P2b trial • Pipeline update • Regulatory • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor

LinKinVax and Gustave Roussy Announced First Patient Dosed in Phase I/IIa Clinical Study on HPV.DCVax in HPV-positive Oropharyngeal Cancer (Businesswire) - "LinKinVax...and Gustave Roussy...announced the treatment at Gustave Roussy of the first patient in a Phase I/IIa clinical study with CD40HVac, a new therapeutic vaccine candidate for HPV-positive oropharyngeal cancer....This multicentre study will test 2 doses of CD40HVac using a dose escalation regimen. Up to 24 patients will be recruited in this double-blind, randomised and placebo-controlled study."

Trial status • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor

LinKinVax and Gustave Roussy Collaborate on a Phase I/IIa HPV.DCVax Clinical Trial for the Treatment of Patients with HPV-Positive Oropharyngeal Cancer (Businesswire) - "LinKinVax...and Gustave Roussy...announced a collaboration to conduct a first-in-human Phase I/IIa clinical trial with CD40HVac, a new therapeutic vaccine candidate against head and neck cancer associated with human papillomavirus (HPV)."

Licensing / partnership • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor

HPVDCVax: Therapeutic Vaccine in Patients With Human Papillomavirus HPV-positive Oropharyngeal Cancer (clinicaltrials.gov) - P1/2 | N=24 | Recruiting | Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

IO biomarker • New P1/2 trial • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • CD69 • TNFRSF9