Ultimovacs ASA

Ultimovacs provides update from Phase I study in malignant melanoma: Continued strong overall survival in patients treated with UV1 cancer vaccine and pembrolizumab ·     All patients in the trial who were alive at 3 years remain alive at 4 years (69.5%) with a minimum follow-up period of 4 years (median 53.0 months) ·      The expected next key milestone for UV1 is the readout of the FOCUS trial during Q3 2024, in which the treatment combination is the same as in the UV1-103 trial     Oslo, June 11 2024: Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical-stage biotechnology company developing immunotherapeutic cancer vaccines, today announced encouraging overall survival (OS) data from both cohorts in the UV1-103 Phase I clinical trial in malignant melanoma. The UV1-103 study evaluates Ultimovacs’ universal cancer vaccine, UV1, in combination with the anti-PD-1 checkpoint inhibitor pembrolizumab, as first-line treatment in patients with advanced non-resectable or metastatic malignant melanoma. The study enrolled 30 patients in the U.S. in two cohorts that differed only in the concentration of GM-CSF used as vaccine adjuvant. With a minimum follow-up of 4 years (median 53.0 months), the updated OS results show that all patients who were alive at the 3-year mark remain alive at 4 years, with an OS rate of 69.5%   Ultimovacs has previously reported data showing a complete response rate in the UV1-103 study of 33% (complete disappearance of tumors) and an objective response rate of 57% (complete or partial disappearance of tumors). Biomarker analyses reported in October 2022 showed robust clinical responses in patients treated with the combination of UV1 and pembrolizumab, regardless of patients’ PD-L1 status. The safety profile of UV1 in combination with pembrolizumab is comparable to that of pembrolizumab alone.   “We are encouraged by the strong overall survival rate observed in this Phase I study,” said Jens Bjørheim, Chief Medical Officer at Ultimovacs. “The data show a high survival rate among patients enrolled in the UV1-103 trial, even after a minimum of 4 years of follow-up. We look forward to the read-out of the FOCUS trial in head and neck cancer, where the same treatment combination has been used”.

Video interview from ASCO 2024 with INITIUM investigator Paul Lorigan, Professor of Medical Oncology, University of Manchester: https://lnkd.in/dxMShhNG

The data from the Phase II clinical trial INITIUM (NCT04382664) was presented in a poster session at the 2024 ASCO Annual Meeting, taking place May 31 – June 4, 2024, in Chicago, IL & Online. The poster presentation features key findings and analyses after a minimum 18-month follow-up of the patients in the trial. The poster is available online in the Investor section of the Ultimovacs' website. The late-breaking abstract can be found on the 2024 ASCO website: https://lnkd.in/gasA-piZ Presentation Details: Abstract Number: LBA9519 Abstract Title: Ipilimumab and nivolumab plus UV1, an anticancer vaccination against telomerase, in advanced melanoma. Session Title: Poster Session – Melanoma/Skin Cancers Poster Board: 303 Date and Time: June 1, 2024, 1:30 PM – 4:30 PM (CT) Presenter: Paul Lorigan, Professor of Medical Oncology at the University of Manchester and Investigator in the INITIUM study

– Vi ble overrasket og skuffet over INITIUM-resultatene, men dette har ikke svekket vår besluttsomhet eller troen på UV1s muligheter i andre indikasjoner. Det sier medisinsk direktør Jens Bjørheim i Ultimovacs ASA i dette HealthTalk-intervjuet, der han blant annet peker på to studier han og selskapet anser som lovende - FOCUS-studien på hode- og halskreft og DOVACC-studien på eggstokkreft:

  Ultimovacs Implements Operational Adjustments to Support Continuous Advancement of the UV1 Vaccine Phase II Program   ·     Due to the broad diversity in the UV1 Phase II program and the encouraging results from previous UV1 trials, Ultimovacs remain confident in UV1’s potential and are strongly committed to bringing the company across the next important data points; the readout from FOCUS in Q3 2024 and DOVACC results in H1 2025 ·     Activity level adjustments and operational prioritization are implemented to sustain the financial runway, including a workforce reduction of approximately 40% ·     The operational adjustment plan extends anticipated cash runway to the fourth quarter of 2025, through the readout from the Phase II DOVACC trial     Oslo, April 16, 2024: Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical-stage biotechnology company developing immunotherapeutic cancer vaccines, today announces a plan to optimize its business operations to support the continuous advancement of UV1 and long-term business growth. “We remain dedicated to our investigation of the potential impact of UV1 vaccine across several cancer indications and immunotherapy combinations, and we are prepared for both challenges and accomplishments along the way. We anticipate potential growth catalysts both in 2024 and 2025,” said Carlos de Sousa, CEO at Ultimovacs. “Our objective is to create value for both patients and our shareholders while safeguarding the financial stability of the company. Aligning with this goal requires us to reduce the level of activity and make prioritization adjustments, including reducing our workforce. I wish to thank the departing employees for their incredible dedication to helping cancer patients and for their contribution to our mission.” The operational adjustments enable an extension of the financial runway to the fourth quarter of 2025, beyond the anticipated topline readout from the Phase II DOVACC trial. Based on current plans and forecasts, the cash burn rate is estimated to be approximately NOK 15 million per quarter towards the end of 2025, prior to the initiation of potential new activities towards new clinical trials or other projects. The company will host a webcast presentation and provide a business update on Wednesday, April 17, 2024, at 11:00 (CET). Link to webcast: https://lnkd.in/gsKCssJw

American Association for Cancer Research (#AACR) Annual Meeting 2024 is taking place April 5-10, 2024, in San Diego, CA. Professor Sara Mangsbo PhD, will be there to present the poster: "CT108 / 16 - Phase I data from TENDU-101, a first-in-human trial of a novel synthetic peptide conjugate cancer vaccine platform assessed in recurrent prostate cancer patients before salvage treatment". Session Title: First-in-Human Phase I Clinical Trials 1 Date and Time: Monday April 8, 2024, 1:30 – 5:00 PM Location: Poster Section 48, Poster Board Number: 16 Clinical trial abstracts are under embargo and will be released at 3:00 PM ET on Friday, April 5. 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: Poster title: 7044 / 11 - Transcriptome and TCR repertoire in human telomerase reverse transcriptase peptide vaccine treated metastatic prostate cancer patients Session Title: Genomics and Immunooncology Date and Time: Wednesday April 10, 2024, 9:00 – 12:30 PM Location: Poster Section 16 Poster Board Number: 11 Presenter: Reetta Nätkin Abstract: https://lnkd.in/dWXbembq #cancerresearch #immunooncology #cancervaccine

Dear Ultimovacs community, Yesterday, we announced the unexpected and disappointing data from the randomized Phase II trial INITIUM evaluating ipilimumab and nivolumab with or without the UV1 vaccine as treatment for patients with advanced melanoma. The study did not meet its primary and secondary endpoints. This was undoubtedly a tough hit for all of us, with a significant impact, especially on our shareholders who have suffered losses. The results were surprising, as UV1 has shown positive effects in previous clinical studies. Ultimovacs remains confident in the UV1 vaccine's potential and its promise in specific therapeutic combinations and indications. INITIUM is one of several UV1 studies to read out in the coming 18 months. The next data, expected in the third quarter of 2024, will be results from the FOCUS study on head and neck cancer, evaluating UV1 in combination with pembrolizumab. Ultimovacs will implement cash preservation initiatives to ensure that the available financial resources will sustain the company into 2025, enabling the achievement of upcoming key inflection points. We are truly grateful for your understanding and continued support during this challenging time. https://lnkd.in/dc9AXu3X

We're in the month of March, and we're all waiting for the topline results from our randomized UV1 Phase II trial INITIUM in advanced melanoma. In the study, the efficacy of UV1 vaccination is investigated as an add-on to the standard of care ipilimumab + nivolumab, and compared to the efficacy of treatment with ipilimumab + nivolumab alone. 156 patients from 40 sites in the US, UK, Belgium, and Norway participated in the trial. To learn more about the UV1 vaccine, listen to our CMO Jens Bjørheim, in this interview with Soo Romanoff, Healthcare Managing Director of Edison Group: https://lnkd.in/e-7xDmeE

Congrats to the investigator team of the randomized Phase II trial NIPU with publication in the European Journal of Cancer! #mesothelioma #phase2 #cancerresearch

https://lnkd.in/drC4xYPV via OncLive