Immunooncology Society Ultimovacs is developing the vaccine UV1 which the company hopes will strengthen the immune system of cancer patients to fight the disease. UV1 is a storable peptide-based vaccine that induces a specific T-cell response against telomerase, an antigen expressed in 85–90 percent of all cancer types. This property makes the vaccine universal.
The company's latest interim report clearly shows that the clinical validation of UV1 is progressing according to plan. The candidate is currently being evaluated in one Phase I study and five Phase II studies. In addition, Ultimovacs has an ongoing Phase I study with its cancer vaccine adjuvant technology – TET (Tetanus-Epitope Targeting). This study is also progressing according to plan.
Clinical progress
Recruitment is currently underway in four of the five Phase II studies. The leading studies INITIAL, in metastatic malignant melanoma, and NIPU, in mesothelioma, have recruited 137 of 154 and 78 of 118 patients, respectively. Both are proof-of-concept-studies testing the triple combination consisting of UV1 and checkpoint inhibitors ipilimumab (Yervoy) and nivolumab (Opdivo). This means that the company is well on track towards its recruitment goals, and topline data for both studies is expected in H1 2023.
At the same time, preparations are underway for the initiation of LUNG VACstudy, where UV1 will be evaluated in combination with the checkpoint inhibitor pembrolizumab in patients with non-small cell lung cancer (NSCLC). The first patient is expected to be enrolled in H1 2022.
The company also recently presented data from a 7 1/2-year follow-up study of over 50 patients from three previous Phase I trials of UV1. The results, which were presented at the annual meeting of the Association for Cancer Immunotherapy (CIMT) on May 10-12, 2022, demonstrate dynamic T-cell responses that persist throughout the evaluation period. The data clearly indicate that the patient's immune responses are UV1-specific and can persist in immune memory. These results are highly relevant to Ultimovac's ongoing Phase II program as well as future clinical development.
Promising new adjuvant technology platform
During Q1, Ultimovacs also made progress with its cancer vaccine adjuvant technology – TET, which is being evaluated in Phase I. TENSEstudy. An adjuvant is a substance that increases or modulates the antigen-specific immune response generated by a vaccine. TET thus aims to improve new cancer vaccines under development.
Ultimovacs announced in February that it had completed treatment of the second dose cohort in TENDU, with no safety concerns reported. The study has since continued into the third dose cohort, with the first two of three patients enrolled. Interim safety data will be published six months after treatment of the third patient in cohort three, as previously communicated.
Ultimovacs also presented a poster with positive preclinical data regarding TET at the annual conference of the American Association for Cancer Research (AACR) that took place last month. The results indicate that the adjuvant platform effectively and safely primes T cells, supporting the clinical transition to the ongoing TENDU Phase I trial of TET in prostate cancer patients.
The data also suggest that TET could be used as a basis for developing multiple therapeutic vaccines targeting solid tumors. By combining cancer antigens and the vaccine adjuvant in the same molecule, the TET platform can generate vaccine candidates with a favorable safety and administration profile, providing the opportunity to treat patients at an early stage of the disease.
Validation from the US Patent Office
During the quarter, Ultimovacs also received good news from the United States Patent and Trademarks Office (USPTO) with a Notice of Allowance regarding a patent application for the use of vaccine checkpoint inhibitor combinations to treat cancer until at least June 2037. As the company continues to advance clinically, the prospects for commercialization increase. The validation from the USPTO adds value to Ultimovac's commitment to delivering innovative contributions to combination immunotherapies in cancer treatment. Read more here.
Strong relationship with shareholders
Despite significant volatility in the biotech stock market in recent months, Ultimovacs has demonstrated why the company continues to have a strong relationship with its shareholders. The diversified pipeline of clinical projects continues to advance in line with expectations, and preclinical as well as Phase I data continue to support the company's ambition to help cancer patients. With solid funding through the first part of 2024, which should include topline data from the first four Phase II studies, it does not look like Ultimovac's relationship with shareholders will change for the worse anytime soon.