- Study protocol enables readout of the INITIUM trial after all patients have been followed for a minimum of 18 months, or after 70 patients have progressed or died.
- As of today, the 70 events have not yet occurred, but the 18-month follow-up for the last patient has now been reached. The Company expects to announce topline results from the INITIUM trial in March 2024.
- The randomized Phase II clinical trial results will provide comparative data on efficacy and safety for UV1 vaccination added to standard-of-care immunotherapy, ipilimumab and nivolumab, in patients with unresectable or metastatic malignant melanoma.
Oslo, January 16, 2024: Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical-stage biotechnology leader in novel immunotherapeutic cancer vaccines, today announced that the last patient enrolled in the INITIUM trial has now been followed for 18 months, thereby enabling readout of the primary endpoint. The Company expects to announce topline results from the randomized Phase II clinical trial in March this year.
The first patient was enrolled in INITIUM in June 2020, and the trial completed enrollment of 156 patients in July 2022. As per the original study protocol, data analysis was planned to be initiated after disease progression or death had been verified in 70 patients, which was initially estimated to occur by the first half of 2023. It has taken longer than anticipated for the participants in INITIUM to experience disease progression or death compared with the historical reference data.
The INITIUM protocol was therefore amended late 2023 to allow data readout based on a minimum of 18 months of follow-up of all evaluable patients. The amendment was agreed to by the relevant regulatory authorities in the countries where the trial has been conducted. The protocol amendment will maintain the integrity of the study statistics without materially affecting the scientific value of the clinical trial.
The patients in the INITIUM trial have been followed for a range of 18 to 42 months with an expected median observation time of approximately 24 months. The patients will continue being followed for survival for an additional two years.
“The initiation of the process for the INITIUM readout marks a noteworthy milestone in Ultimovacs’ clinical development program for UV1. We look forward to announcing the topline results in March this year and plan to present the full data thereafter at a medical conference and in a publication in a peer-reviewed medical journal,” said Carlos de Sousa, CEO of Ultimovacs. “There remains an unmet need in the treatment of metastatic melanoma, and UV1 has shown significant potential to be a therapeutic option for these advanced-stage patients. The INITIUM results and additional upcoming Phase II data readouts will be the basis for our next steps in advancing UV1, as we seek to bring UV1 to the patients as quickly as possible.”
The INITIUM clinical trial (NCT04382664) evaluates Ultimovacs’ universal cancer vaccine, UV1, as first-line treatment in unresectable or metastatic malignant melanoma in combination with PD-1 checkpoint inhibitor nivolumab and CTLA-4 checkpoint inhibitor ipilimumab. Nivolumab and ipilimumab are considered the “gold standard” treatment for patients with unresectable or metastatic melanoma who can tolerate the potential toxicity.
The randomized Phase II clinical trial results will provide comparative data on the efficacy and safety of UV1 vaccination added to the standard-of-care immunotherapy. The primary endpoint of the INITIUM trial is progression-free survival (PFS) as per RECIST 1.1. Secondary endpoints include overall survival (OS), objective response rate (ORR), duration of response (DOR), and safety of UV1 vaccination in combination with nivolumab and ipilimumab.
Ultimovacs has received a dual Fast Track designation from the FDA, granted in October 2021, for UV1 in combination with checkpoint inhibitors in the treatment of unresectable or metastatic melanoma – either as add-on therapy to pembrolizumab or as add-on therapy to ipilimumab. In December 2021, UV1 was granted Orphan Drug designation from the FDA for treatment of stage IIB-IV melanoma.
INITIUM is an Ultimovacs-sponsored randomized, comparative, multicenter Phase II clinical trial in which the universal cancer vaccine UV1 will be evaluated in combination with the checkpoint inhibitors ipilimumab and nivolumab for first-line treatment of patients with unresectable or metastatic malignant melanoma. The first patient received treatment in the INITIUM trial in June 2020, and the last patient was enrolled in July 2022. The trial is being conducted at 39 hospitals across the U.S., U.K., Belgium, and Norway. The initial study design called for enrollment of 154 patients. Two additional patients were enrolled, bringing the total number of patients to 156.
Ultimovacs is a clinical-stage biotechnology leader in novel immunotherapeutic cancer vaccines with broad applicability. Ultimovacs’ lead cancer vaccine candidate UV1 is directed against human telomerase (hTERT), an antigen present in 85-90% of cancers in all stages of tumor growth. A broad clinical program, with Phase II trials in five cancer indications enrolling more than 670 patients, aims to demonstrate UV1’s impact in combination with other immunotherapies in multiple cancer types expressing telomerase and where patients have unmet medical needs. UV1 is universal, off-the-shelf and easy to use. UV1 is a patented technology owned by Ultimovacs.
In addition, Ultimovacs holds all rights to the proprietary TET technology platform for any possible future formulations use in various solid tumor indications. The Company is listed on the Euronext Oslo Stock Exchange (OSE: ULTI).
About the UV1 Phase II program
The immunotherapeutic cancer vaccine UV1 is investigated in combination with checkpoint inhibitors in patients with various cancer indications with diverse tumor biology. The diversity of the UV1 Phase II program places Ultimovacs in a favorable position to capture the cancer vaccine’s potential broad applicability when combined with checkpoint inhibitors:
- INITIUM: Evaluating UV1 in combination with ipilimumab and nivolumab as first-line treatment for patients with malignant melanoma. Enrollment of 156 patients completed in July 2022. Expected readout in March 2024. Sponsored by Ultimovacs.
- NIPU: Evaluating UV1 in combination with ipilimumab and nivolumab as second-line treatment for patients with malignant pleural mesothelioma. Enrollment of 118 patients completed in January 2023. Data presented at the ESMO Congress in October 2023 showed that UV1, as an add-on to ipilimumab and nivolumab, demonstrated a statistically significant and clinically meaningful improvement in overall survival versus ipilimumab and nivolumab alone. 31% of the patients receiving the UV1 vaccine experienced an objective response, compared to 16% in the control arm. The investigator-initiated trial is led by Oslo University Hospital and supported by Bristol-Myers Squibb and Ultimovacs.
- FOCUS: Evaluating UV1 in combination with pembrolizumab as first-line treatment for patients with head and neck cancer. The enrollment of 75 patients was completed in August 2023, and the expected readout is H2 2024. The investigator-initiated trial is led by Halle University in Germany, supported by Ultimovacs.
- DOVACC: Evaluating UV1 in combination with olaparib and durvalumab as maintenance therapy in non-BRCA mutated patients with advanced ovarian cancer. 25% of 184 patients enrolled as of Q3 2023 reporting, and the expected readout is H2 2024. The investigator-initiated trial is led by NSGO-CTU and supported by ENGOT, AstraZeneca, and Ultimovacs.
- LUNGVAC: Evaluating UV1 combined with cemiplimab as first-line treatment of non-small cell lung cancer patients. ~10% of 138 patients enrolled as of Q3 2023 reporting, expected readout H2 2025. The investigator-initiated trial is led by Vestre Viken (Drammen Hospital) and supported by Ultimovacs.
UV1 is a universal cancer vaccine designed to induce a specific T-cell response against telomerase. UV1 consists of long, synthetic peptides representing a sequence in the reverse transcriptase subunit of telomerase (hTERT), shown to induce CD4+ T-cells. These CD4+ T-cells have the potential to provide inflammatory signals, and T-cell support is believed to be critical for triggering a strong anti-tumor immune response. Following intradermal injection, antigen-presenting cells (APCs) in the skin are exposed to the vaccine peptides. These APCs will process the peptides and present vaccine epitopes on Human Leukocyte Antigen (HLA) molecules to naïve T-cells in the lymph nodes. Activated vaccine-specific T-cells will then enter the circulation and search for cells displaying their cognate antigen in the context of HLA molecules.
The UV1 peptides contain several epitopes, shown to be non-restrictive in terms of (HLA) alleles for presentation. It is, therefore, not required to perform HLA pre-screening of patients, which potentially enables broad population utilization of the vaccine. UV1 is administered over three months with eight intradermal injections and the immune-modulator GM-CSF.
For further information, please contact:
Carlos de Sousa, CEO
Phone: +47 908 92507
Anne Worsøe, Head of Investor Relations
Phone: +47 90686815
This information is considered to be inside information pursuant to the EU Market Abuse Regulation and is subject to the disclosure requirements pursuant to Section 5-12 in the Norwegian Securities Trading Act. This stock exchange announcement was published by Anne Worsøe, Head of Investor Relations at Ultimovacs ASA, on January 16, 2023 at 07:00 CET.