Ultimovacs Receives FDA Fast Track Designation for UV1 Cancer Vaccine for the Treatment of Patients with Unresectable Mesothelioma

• Fast Track designation is granted for UV1 in combination with ipilimumab and nivolumab for the treatment of patients with unresectable malignant pleural mesothelioma to improve overall survival
• The designation was granted by the U.S. Food and Drug Administration (FDA) based on results from the randomized Phase II clinical trial NIPU, which showed improved overall survival with UV1 vaccination as an add-on to ipilimumab and nivolumab immunotherapy
• UV1 as add-on therapy had previously received Orphan Drug designation for the treatment of mesothelioma and Fast Track designation for unresectable or metastatic melanoma
  
  

Oslo, February 5, 2024: Ultimovacs ASA ("Ultimovacs”) (OSE ULTI), a clinical-stage biotechnology leader in novel immunotherapeutic cancer vaccines, today announced that the U.S. Food and Drug Administration (FDA) had granted Fast Track designation to the company’s therapeutic cancer vaccine UV1 in combination with ipilimumab and nivolumab for the treatment of patients with unresectable malignant pleural mesothelioma to improve overall survival, including first-line patients. The designation was granted based on results from the Phase II clinical trial, NIPU, evaluating UV1 in patients with unresectable malignant pleural mesothelioma, which were presented at the ESMO Congress 2023.

"We are pleased that the FDA has granted Fast Track designation for UV1 in two separate advanced indications, which underlines the potential of our cancer vaccine approach. UV1 demonstrated a positive safety profile and encouraging signs of improvement in overall survival in combination with the checkpoint inhibitors, ipilimumab, and nivolumab, in malignant mesothelioma, a hard-to-treat cancer indication with significant unmet need,” said Carlos de Sousa, CEO of Ultimovacs. "We expect to announce topline results from our randomized Phase II trial INITIUM in the coming month of March, and we are looking forward to reporting important data from our broad UV1 Phase II clinical trial program with UV1 over the course of 2024 and beyond.”

As defined by the FDA, Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions with the goal of bringing important new drugs earlier to patients. The Fast Track designation enables Ultimovacs to have more frequent interactions with the FDA to discuss the UV1 development path for the treatment of mesothelioma. For more information on the Fast Track process, please visit the FDA’s official website.

The impact of UV1 vaccination in patients with unresectable malignant pleural mesothelioma has been evaluated in a randomized Phase II clinical trial, NIPU. In the study, UV1 was combined with checkpoint inhibitors ipilimumab and nivolumab and compared to ipilimumab and nivolumab alone as a second-line treatment, after first-line treatment with platinum-based chemotherapy. The results from the study demonstrated a clinically meaningful improvement in overall survival for UV1 with no added toxicities. The NIPU study is sponsored by Oslo University Hospital with support from Bristol-Myers Squibb and Ultimovacs.

Mesothelioma is a rare and aggressive form of cancer with a high mortality rate and few therapeutic options. Patients with mesothelioma commonly have a history of occupational or environmental exposure to asbestos, and it typically takes decades for this specific form of cancer to develop.

In October 2023, UV1 received Orphan Drug Designation by the FDA for the treatment of mesothelioma. In December 2021, the FDA granted Orphan Drug Designation for UV1 for the treatment of stage IIB-stage IV melanoma. In October 2021, the FDA granted Fast Track designation for UV1 as an add-on therapy to ipilimumab or pembrolizumab for the treatment of unresectable or metastatic melanoma.

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About NIPU
NIPU (Nivolumab and Ipilimumab Plus/minus UV1 vaccination) is a randomized, multi-center phase II trial in which Ultimovacs’ universal cancer vaccine, UV1, is evaluated in combination with Bristol-Myers Squibb’s checkpoint inhibitors, nivolumab and ipilimumab, as second-line treatment of malignant pleural mesothelioma. The trial sponsor is Oslo University Hospital, supported in the preparation and execution of the trial by Ultimovacs and Bristol-Myers Squibb. The 118 patients are randomized 1:1 into two treatment arms. All participants receive treatment with nivolumab (240 mg every 2 weeks) and ipilimumab (1 mg/kg every 6 weeks) until disease progression, unacceptable toxicity, or for a maximum of 2 years. Patients randomized to the experimental arm received 8 intradermal injections of UV1 vaccine during the first three months of treatment. The objective of the study was to achieve a clinically meaningful progression-free survival (PFS) benefit in patients with malignant pleural mesothelioma (MPM) after progression on first-line standard platinum doublet chemotherapy. Subsequent events emerging in patients in both arms of the NIPU study will continue to be monitored beyond the read-out of the primary endpoint. The ipilimumab and nivolumab combination has been approved as first-line treatment for patients with malignant pleural mesothelioma in Europe and the U.S.

About Mesothelioma

Mesothelioma is a rare and aggressive type of cancer that occurs in the thin layer of tissue that surrounds the lungs and inside of the chest. Mesothelioma accounted for 30 870 new cancer cases and 26 278 cancer deaths worldwide in 2020, according to the International Agency for Research on Cancer (Globocan 2020). Pleural mesothelioma is a disease with a high unmet medical need, especially in industrialized countries. The median overall survival is approximately 1 year. Occupational asbestos exposure is the No. 1 cause of the disease, and several occupations, like firefighters, military veterans, construction, and industry workers, are at risk. This cancer usually takes several decades to develop after a person’s first exposure to asbestos. Most patients are diagnosed after age 70 because of the long latency period. Even though the use of asbestos, to a large extent, is banned in many countries today, new incidences of mesothelioma will continue to be a medical and public health challenge because of the long latency period typical of the illness. For patients with inoperable disease, few treatment options are available after first-line chemotherapy. The combination of ipilimumab and nivolumab has recently shown increased survival compared to standard chemotherapy, but most patients do not respond, and improvements are called for. Telomerase is expressed in mesothelioma cells and is, therefore, a relevant target for therapeutic vaccination.

About Ultimovacs
Ultimovacs is a clinical-stage biotechnology leader in novel immunotherapeutic cancer vaccines with broad applicability. Ultimovacs’ lead candidate, UV1, is an off-the-shelf therapeutic cancer vaccine 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 a patented technology owned by Ultimovacs.

In addition, Ultimovacs holds all rights to the proprietary TET technology platform for any possible future use of formulations 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 off-the-shelf 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 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 and 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 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.

About UV1
UV1 is an off-the-shelf therapeutic 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 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 see www.ultimovacs.com or contact:

Carlos de Sousa, CEO
Email: carlos.desousa@ultimovacs.com
Phone: +47 908 92507

Anne Worsøe, Head of IR
Email: anne.worsoe@ultimovacs.com
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 February 5, 2024 at 07:00 CET.