Ultimovacs Announces Publication of Phase I Melanoma Trial Data in Journal of Translational Medicine
- Comprehensive characterization of phase I UV1-checkpoint inhibitor combination trial
- Clinical responses seen in patients with favored and less favored baseline characteristics
- T cell activation observed post-treatment in tumors of responding patients
Oslo, September12, 2022: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical stage leader in immune stimulatory vaccines for the treatment of cancer, announced today the publication of data from its phase I melanoma trial in Journal of Translational Medicine.
The clinical data give details of potential additional benefit in the treatment of patients with malignant melanoma from using the company’s universal cancer vaccine, UV1, in combination with the checkpoint inhibitor ipilimumab.
The new data demonstrated highly positive clinical outcome signals. Vaccine-induced immune responses were apparent in 91% of evaluable patients, with strong T cell proliferation demonstrated in peripheral blood, and vaccine-related T cell receptor clones detected in blood and in tumor biopsy. Patients who responded clinically to treatment with UV1 and ipilimumab, also demonstrated an increase in the tumor interferon-gamma signature, a generally accepted predictor for the efficacy of checkpoint inhibitors.
The research team observed clinical responses to the UV1-ipilimumab combination not only in patients with baseline characteristics of high tumor immunogenicity (‘hot’ tumors) but also in patients without (‘cold’ tumors). This breadth of response is noteworthy since ’cold’ tumors are more difficult to treat with checkpoint inhibitors, suggesting that the addition of UV1 vaccination may extend clinical efficacy against these tumor types.
These clinical data further expand upon the previously published safety and feasibility findings from an open-label phase 1/2a clinical trial (NCT02275416) of the combination of UV1 with the CTLA-4 checkpoint inhibitor, ipilimumab. The combination of UV1 and ipilimumab produced an overall response rate (ORR) of 33%. The median progression-free survival (mPFS) among patients treated with UV1 and ipilimumab was 6.7 months, and the median overall survival (mOS) was 66.3 months.
Ultimovacs’ phase II trial, INITIUM, evaluates the combination of the UV1 vaccine combined with both ipilimumab and the PD-1 inhibitor, nivolumab, in the first-line treatment of patients with advanced malignant melanoma. Ultimovacs completed enrollment in INITIUM in June 2022. Topline progression-free survival data from INITIUM are expected in H1 2023.
The new data were published in the Journal of Translational Medicine (JTRM), an open access, peer-reviewed journal. The link to the article can be found on the Company’s website.
Ellingsen, E.B., Bounova, G., Kerzeli, I. et al. Characterization of the T cell receptor repertoire and melanoma tumor microenvironment upon combined treatment with ipilimumab and hTERT vaccination. J Transl Med 20, 419 (2022). https://doi.org/10.1186/s12967-022-03624-z
About the phase I trial with UV1 and ipilimumab in malignant melanoma
This clinical trial evaluated a novel telomerase-targeting therapeutic cancer vaccine, UV1, in combination with ipilimumab, in twelve patients with metastatic melanoma. The trial was an open-label, single-center phase I/IIa study. Eligible patients had unresectable metastatic melanoma. Patients were followed up for progression-free survival (PFS) and overall survival (OS).
The U.S. Food and Drug Administration (FDA) granted orphan drug designation (ODD) for UV1 for the treatment of stage IIB – IV melanoma, and Fast Track designation in the treatment of unresectable or metastatic melanoma – either as add-on therapy to pembrolizumab or as add-on therapy to ipilimumab. Ultimovacs is currently evaluating UV1 as add-on therapy to ipilimumab and nivolumab as first-line treatment for unresectable or metastatic melanoma in a Phase II study named INITIUM.
Ultimovacs is an immunotherapy company developing immune-stimulatory vaccines to treat a broad range of cancers. Ultimovacs’ lead universal cancer vaccine candidate UV1 targets human telomerase (hTERT), present in 85-90% of cancers in all stages of tumor growth. By directing the immune system to hTERT antigens, UV1 drives CD4 helper T cells to the tumor to activate an immune system cascade and increase anti-tumor responses. With a broad Phase II program in five cancer indications enrolling more than 650 patients, Ultimovacs aims to clinically demonstrate UV1’s impact in multiple cancer types, in combination with other immunotherapies, for patients with unmet needs. Ultimovacs’ second technology approach, based on the proprietary Tetanus-Epitope-Targeting (TET) platform, combines tumor-specific peptides and adjuvant in the same molecule and entered Phase I studies in 2021.
For further information, please see www.ultimovacs.com or contact:
Carlos de Sousa, CEO
Phone: +47 908 92507
Anne Worsøe, Head of Investor Relations
Phone: +47 906 86 815
Mary-Ann Chang, LifeSci Advisors
Phone: +44 7483 284 853
To view this piece of content from www.globenewswire.com, please give your consent at the top of this page.
To view this piece of content from ml-eu.globenewswire.com, please give your consent at the top of this page.
About GlobeNewswire by notified
One Liberty Plaza - 165 Broadway
NY 10006 New York
GlobeNewswire by notified is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.
Subscribe to releases from GlobeNewswire by notified
Subscribe to all the latest releases from GlobeNewswire by notified by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from GlobeNewswire by notified
CNH Industrial: Periodic Report on $1 Billion Buyback Program6.12.2023 22:30:00 CET | Press release
CNH Industrial: Periodic Report on $1 Billion Buyback Program Basildon, December 6, 2023 CNH Industrial N.V. (NYSE: CNHI / MI: CNHI) announces that under the €400 million component (the “First Component”) of its $1 billion share buyback program the Company completed transactions in the period November 27, 2023 through November 28, 2023, reported in aggregate, as set forth in the table below. After the purchases announced today and considering those previously executed under the First Component, the total invested amount in the First Component is approximately €187,597,638.20 ($203,388,077.50) or a total amount of 20,060,075 common shares purchased. DateNumber of common shares purchasedAverage price per share excluding feesConsideration excluding fees Consideration (*) excluding fees(€)(€)($) November 27,2023 1,500,000 9.3947 14,092,050.00 15,432,203.96 November 28,2023 1,000,000 9.5264 9,526,400.00 10,430,455.36 2,500,000 - 23,618,450.0025,862,659.32 (*) All translations determined fro
Study results of psilocybin treatment in bipolar II depression published in JAMA Psychiatry6.12.2023 22:00:09 CET | Press release
Believed to be first ever psilocybin clinical trial for treatment of bipolar II depression LONDON, Dec. 06, 2023 (GLOBE NEWSWIRE) -- Compass Pathways plc (Nasdaq: CMPS) (“Compass”), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, today announced the publication of a paper in JAMA Psychiatry that demonstrates the potential for investigational COMP360 psilocybin treatment in treatment-resistant bipolar type II disorder (bipolar II). Results from the investigator-initiated open-label study were first presented at the Annual Meeting of the American College of Neuropsychopharmacology in 2022. The study, which was conducted by Dr Scott Aaronson at Sheppard Pratt, Baltimore, and funded by Compass, investigated the safety and efficacy of a single 25mg dose of COMP360 psilocybin treatment in participants with treatment-resistant bipolar II. The primary endpoint was change in Montgomery-Åsberg Depression Rating Scale (MADRS) total s
SustainableIT.org Announces Commitment to Elevate Technology Leadership in Global Sustainability Efforts at COP286.12.2023 20:25:50 CET | Press release
REDWOOD CITY, California, Dec. 06, 2023 (GLOBE NEWSWIRE) -- SustainableIT.org, a leading nonprofit organization championed by technology executives, today affirmed its commitment to advancing global sustainability through information technology innovation and leadership. This announcement comes as a strategic response to the ongoing COP28 United Nations Climate Change Conference, emphasizing the need for a stronger technology presence in sustainability dialogues and decision-making processes. The COP28 event underscores the urgent need for a global conversation on sustainability strategy. However, it also highlights a significant gap: the limited involvement of digital, data, and information technology leaders in these critical discussions. Floor Bleeker, Group Chief Technology Officer of Accor and member of SustainableIT.org’s European Advisory Board, is one of the technology executives participating in this year's conference. Bleeker will be speaking on a panel with ServiceNow on Dec
Final results of the Offer for Beter Bed Holding: 98.44% of the Shares obtained6.12.2023 20:00:00 CET | Press release
JOINT PRESS RELEASE This is a joint press release by Beter Bed Holding N.V. ("Beter Bed Holding" or the "Company") and 959 B.V. (the "Offeror"), a company controlled by Torqx Capital Partners ("Torqx"). This joint press release is issued pursuant to the Article 16, paragraphs 1 and 2, Article 17 paragraph 1 and Article 4, paragraph 3 of the Netherlands Decree in Public Takeover Bids (Besluit openbare biedingen Wft, the "Decree") in connection with the recommended public offer by the Offeror for all the issued and outstanding shares in the capital of the Company (the "Offer"). This press release does not constitute an offer, or any solicitation of any offer, to buy or subscribe for any securities in the Company. Any offer is only made by means of the offer memorandum (the "Offer Memorandum"), dated 4 October 2023, approved by the Dutch Authority for the Financial Markets (Autoriteit Financiële Markten, the "AFM"). Terms not defined in this press release will have the meaning as set fort
Kvika banki hf.: Change of Managing Director at Kvika Securities Ltd.6.12.2023 19:26:26 CET | Press release
Gunnar Sigurðsson has requested to resign as Managing Director of Kvika Securities Ltd. in London ("KSL" or the "Company"), a subsidiary of Kvika banki hf. ("Kvika" or the "Bank"). Alongside his resignation Gunnar will leave the Executive Committee of Kvika group and the number of positions in the Executive Committee will also be reduced by one. The Board of KSL has appointed Richard Beenstock as the new Managing Director of Kvika Securities Ltd. Gunnar has led the development of Kvika's UK operations since its establishment in 2017. He will continue to carry out certain tasks for KSL and support the Company during the management change. Richard Beenstock, who graduated from the University of Birmingham and is a Chartered Accountant, has over 20 years of experience in the UK financial markets in lending and investment activities. In 2013, Richard co-founded among others Ortus Secured Finance, an alternative credit provider specialising in property backed lending, that was later acquire