TENDU Vaccine / Zelluna - LARVOL DELTA

Preclinical development and clinical safety assessment of a synthetic peptide conjugate enabling endogenous antibody binding to promote innate receptor engagement. (PubMed, Mol Ther Oncol) - "Herein, we describe the generation of a prostate cancer vaccine candidate (TENDU) based on this technology...Transgenic humanized HLA-DR4 mice displayed T cell responses and increased anti-MTTE IgG levels after vaccination with a peptide construct including an HLA-DR4 epitope. The vaccine candidate was found safe, and a positive correlation between T cell responses and anti-MTTE antibodies was noted in the first-in-human study."

Journal • Preclinical • Genito-urinary Cancer • Infectious Disease • Oncology • Prostate Cancer • Solid Tumor • Tetanus • CD4 • CD8

Squamous Cell Lung Cancer Still Remains the Most Common Histological Subtype of Lung Cancer in Rural India (IASLC-WCLC 2024) - "Bidis are hand rolled, small indigenous cigarettes with tobacco rolled into tendu leaves...Conclusions : Majority of lung tumors in patients from rural India are central and of squamous histological subtype . Smoking habits of the rural population are also different from what is reported from urban areas."

Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • TP63

TENDU Vaccine in Patients With Relapse After Primary Radical Prostatectomy (clinicaltrials.gov) - P1 | N=12 | Completed | Sponsor: Ultimovacs ASA | Active, not recruiting ➔ Completed | Trial completion date: Dec 2023 ➔ Aug 2023

Trial completion • Trial completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Phase I data from TENDU101, a first-in-human trial of a novel synthetic peptide conjugate cancer vaccine platform assessed in recurrent prostate cancer patients before salvage treatment (AACR 2024) - P1 | "The administration of TTd and TENDU to the same anatomical location although spaced in time appeared to negatively influence immune responses to TTd and TENDU. In conclusion, the novel synthetic peptide conjugate vaccine conjugate was found safe with no serious AEs reported and a positive correlation between anti-MTTE and T cell responses was noted in patients when TENDU was administrated in the abdomen."

Clinical • P1 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CD4 • CD8 • CTCs

Ultimovacs to Present Poster at the American Association for Cancer Research (AACR) Annual Meeting 2024 (GlobeNewswire) - "Ultimovacs ASA...announces that the data from the TENDU-101 study in patients with relapse after primary radical prostatectomy (NCT04701021) will be presented in a poster at the 2024 American Association for Cancer Research (AACR)....Additionally, a poster with results related to the Phase I study in prostate cancer (NCT01784913) at Oslo University Hospital will be presented at AACR. The presentation focuses on the changes in transcriptome and TCR-repertoire pre- and post-treatment of hTERT vaccination in combination with androgen deprivation therapy and radiotherapy."

P1 data • Prostate Cancer

Ultimovacs Announces Completion of Exploratory Phase I TENDU Study of TET Vaccine Technology Platform Meeting the Primary Endpoint (GlobeNewswire) - P1 | N=12 | TENDU (NCT04701021) | Sponsor: Ultimovacs ASA | "Ultimovacs ASA...announced the conclusion of the exploratory Phase I TENDU study (NCT04701021) of the company’s vaccine technology platform, Tetanus-Epitope Targeting (TET), in patients with prostate cancer....The dose range investigated in the study was considered safe. No serious adverse reactions were reported, and there were no indications of systemic risks of cytokine release or complement activation. No dose-limiting toxicities were observed, indicating a potential for increasing the dose of tetanus-based vaccines in future clinical studies."

P1 data • Trial completion • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

TENDU Vaccine in Patients With Relapse After Primary Radical Prostatectomy (clinicaltrials.gov) - P1 | N=12 | Active, not recruiting | Sponsor: Ultimovacs ASA | Recruiting ➔ Active, not recruiting | N=18 ➔ 12

Enrollment change • Enrollment closed • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Ultimovacs Announces Completed Patient Recruitment in TENDU Phase I Clinical Trial in Prostate Cancer (GlobeNewswire) - "Ultimovacs ASA...announced that last patient enrollment has been completed in the Phase I TENDU trial in prostate cancer. Patients with relapse after primary radical prostatectomy received four doses of the TENDU vaccine during a 6-week treatment period. Three different dose levels have been explored (40, 400, 960 mcg) and half of the patients were treated at the highest dose level....The primary objective of TENDU is to evaluate safety and tolerability of different doses of the vaccine in patients with progressive disease after prostatectomy. No safety concerns have emerged in the on-going study. All patients are followed up for 6 months after the last treatment."

Enrollment closed • Genito-urinary Cancer • Oncology • Prostate Cancer

TENDU Vaccine in Patients With Relapse After Primary Radical Prostatectomy (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Ultimovacs ASA | Trial completion date: Dec 2022 ➔ Dec 2023 | Trial primary completion date: Jul 2022 ➔ Jul 2023

Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Ultimovacs Expands High Dose Cohort Size in TENDU Phase I Prostate Cancer Trial after Safety Review (GlobeNewswire) - "Ultimovacs...has completed treatment of three patients at the highest dose cohort in the phase I TENDU trial without any safety concerns. Based on these results, the company plans to enroll up to three additional patients at the highest dose level. The Drug Safety Monitoring Board, a group of experts set up to monitor patient safety during a clinical trial, found no safety concerns in any of the three dose cohorts. A total of nine patients have now been treated; three at each dose level (40 mcg, 400 mcg and 960 mcg). Ultimovacs plans to enroll up to three additional patients at the highest dose level (960 mcg) providing a broader base of early safety data for the TET platform."

Trial status • Genito-urinary Cancer • Oncology • Prostate Cancer

Promoting immunogenicity of synthetic long peptide vaccines based on in vivo IgG complex formation: Preclinical evaluation and clinical entry of the TET platform (AACR 2022) - "Secondary endpoints involve cellular immune responses, systemic PSA and PAP levels along with dose level selection. In conclusion, TENDU, a first-in-class vaccine candidate is under clinical development evaluating safety and tolerability for the TET vaccine platform technology."

Preclinical • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Ultimovacs to Present Preclinical Data on TET Platform at American Association for Cancer Research (AACR) 2022 Annual Meeting (GlobeNewswire) - "The presentation at AACR22 will be the first time Ultimovacs has shared data on the TET platform with the R&D community. The data is part of the package that helped inform the entry of TET into the current ongoing Phase 1 dose escalation study in prostate cancer, TENDU. The 40 mcg and 400 mcg dose cohorts have now been completed and is currently proceeding to the third and highest dose, 960 mcg."

Preclinical • Trial status • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Ultimovacs to Progress to Last Cohort in Phase I Prostate Cancer TENDU study (GlobeNewswire) - "Ultimovacs ASA...announced it has completed treatment of the second dose cohort in the Phase I TENDU trial. The study is designed to evaluate the Company's Tetanus-Epitope Targeting (TET)-platform in patients with prostate cancer....The Drug Safety Monitoring Board (DSMB), a group of experts set up to monitor patient safety during a clinical trial, found no safety concerns related to the first two dose cohorts. A total of six patients have been treated; three in each dose level (40 and 400 μg). The conclusion from the DSMB enables the dose escalation study to proceed with enrollment of patients in the third and last dose cohort (960 μg)."

DSMB • Enrollment status • Trial status • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Ultimovacs ASA: Third quarter 2021 result presentation (GlobeNewswire) - "Ultimovacs ASA....announces its third quarter 2021 results today....INITIUM trial: 91 patients enrolled to date compared to 68 patients in the previous quarterly report. NIPU trial: 45 patients enrolled to date compared to 38 patients in the previous quarterly report; FOCUS trial: The first patient was enrolled on 4 August 2021, and 5 patients have been enrolled to date. DOVACC trial: Regulatory approval is in place and the first patient is expected to be enrolled during Q4 2021. TENDU trial: The Drug Safety Monitoring Board found no safety concerns related to the first cohort of three patients at the 40 μg dose, enabling the trial to advance with enrollment of patients in the second cohort at the 400 μg dose. In total, 4 patients have been enrolled to date."

DSMB • Enrollment status • Trial status • Gynecologic Cancers • Malignant Pleural Mesothelioma • Melanoma • Mesothelioma • Oncology • Ovarian Cancer • Prostate Cancer • Skin Cancer

Ultimovacs Begins Dosing of Second Cohort in Phase I TENDU Study Investigating Prostate Cancer-Specific Therapeutic Vaccine (GlobeNewswire) - “Ultimovacs ASA…announced it has started dosing of the second cohort in the Phase I TENDU trial, evaluating the Company's Tetanus-Epitope Targeting (TET)-platform... Dosing of the 400 μg cohort has now been initiated.”

Trial status • Genito-urinary Cancer • Oncology • Prostate Cancer

TENDU Vaccine in Patients With Relapse After Primary Radical Prostatectomy (clinicaltrials.gov) - P1; N=18; Recruiting; Sponsor: Ultimovacs ASA; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Ultimovacs Starts Clinical Evaluation of Novel TET-Platform with Phase I TENDU Study Investigating Prostate Cancer-Specific Therapeutic Vaccine (Businesswire) - "Ultimovacs ASA...announced the treatment of the first patient in the Phase I TENDU trial, representing the start of clinical evaluation for the Company’s Tetanus-Epitope Targeting (TET)-platform...The Company expects to provide the first interim, preliminary safety readout from the trial by the end of this year."

P1 data • Trial status • Genito-urinary Cancer • Oncology • Prostate Cancer