Q1 saw Norwegian immuno-oncology company Ultimovacs advance on a number of fronts. The company’s clinical programmes with universal cancer vaccine UV1 and adjuvant platform TET have continued to progress steadily. Moreover, milestones were reached at the preclinical level as well as the intellectual property level.
Immuno-oncology biotech Ultimovacs develops a vaccine, UV1, that the company hopes will enhance a cancer patient’s immune system to help it fight off the cancer. UV1 is an off-the-shelf peptide-based vaccine that induces a specific T-cell response against telomerase, an antigen expressed in 85-90 per cent of all cancer types. This property makes the vaccine universal.
From the company’s latest interim report, it is quite clear that the clinical validation for UV1 is advancing on schedule, without any hiccups. One phase I trial and five phase II trials are ongoing for evaluating the candidate. Additionally, Ultimovacs has an ongoing phase I trial with its cancer vaccine adjuvant technology – TET (Tetanus-Epitope Targeting). This trial is also progressing smoothly.
Progress in the clinic
Four of the five phase II trials are currently recruiting patients. Lead trials INITIUM, in metastatic malignant melanoma, and NIPU, in mesothelioma, have recruited 137 out of 154 patients and 78 out of 118, respectively. Both trials are two proof-of-concept studies testing the triple combination of UV1 with checkpoint inhibitors (CPIs) ipilimumab (Yervoy) and nivolumab (Opdivo) .This means the company is well on the way to its recruitment goals, and topline data readouts for both trials are still expected for H1 2023.
Meanwhile, preparations are underway for the initiation of the LUNGVAC trial, where UV1 will be evaluated incombination with the CPI pembrolizumab in non-small cell lung cancer (NSCLC) patients. The first patient is expected to be included during H1 2022.
The company has also recently presented data from a 7.5-year followup study of over 50 patients from three prior phase I trials with UV1. The results presented at the Annual Meeting of Association for Cancer Immunotherapy (CIMT) from May 10-12 2022 show dynamic T-cell responses lasting throughout the evaluation period. The data clearly indicate that the patient’s immune responses are UV1-specific and may be retained in immune memory. These results are highly relevant to Ultimovacs’ ongoing phase II programmes as well as future clinical development.
Novel adjuvant technology platform shows preclinical promise
During Q1, Ultimovacs also made progress with its cancer vaccine adjuvant technology – TET, which is being evaluated in the phase I TENDU study. An adjuvant is a substance that increases or modulates the antigen-specific immune response driven by a vaccine, so TET is aimed at enhancing novel cancer vaccines in development.
Ultimovacs announced in February that treatment of the second dose cohort in TENDU had been completed, and no safety concerns were reported. Since then, the trial has continued to the third dose cohort – the first two patients out of three patients have been enrolled. Interim safety data will be published six months after the treatment of the third patient in cohort three, as previously communicated.
Ultimovacs presented a poster with positive preclinical data on TET at the annual American Association for Cancer Research (AACR) conference that took place last month. The results indicate that the adjuvant platform efficiently primes T-cells, and it does so safely, thus supporting the clinical transition to the ongoing TENDU phase I trial with TET in prostate cancer patients.
The data also suggest that TET could be used as a basis for developing multiple therapeutic vaccines targeting solid tumours. Moreover, by combining cancer antigens and the vaccine adjuvant in the same molecule, the TET platform can generate vaccine candidates with a beneficial safety and administration profile, presenting an opportunity to treat patients at an early stage of their disease.
Validation from US patent office
During the quarter, Ultimovacs also got good news from the United States Patent and Trademarks Office (USPTO) with a Notice of Allowance on a patent application for the use of vaccine-checkpoint inhibitor combinations to treat cancer at least until June 2037. As the company continues to advance in the clinic, the prospects of commercialisation increase, and this form of validation from the USPTO drives up the value of Ultimovacs’ work as it strives to deliver innovative contributions to combination immunotherapies in cancer.
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Strong relationship with shareholders
Despite the significant volatility in biotech stocks during the last few months, Ultimovacs has shown why it continues to have a strong relationship with its shareholders. The diversified pipeline of clinical projects continues to move forward on par with expectations, and preclinical as well as phase I data continues to support the company’s ambition to help cancer patients with unmet need. With solid financing until the first part of 2024, which should cover topline readouts for the first four phase II trials, it doesn’t look like Ultimovacs’ relationship with shareholders will be shaken any time soon.