GlobeNewswire by notified

Ultimovacs Expands High Dose Cohort Size in TENDU Phase I Prostate Cancer Trial after Safety Review

Share
  • The TENDU interim safety results from nine patients show no safety concerns
  • Trial extended to enroll up to three additional patients at the highest dose level
  • TENDU designed to evaluate the Tetanus-Epitope Targeting (TET)-platform in patients with prostate cancer

Oslo, 18August 2022: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical stage leader in immune stimulatory vaccines for cancer, has completed treatment of three patients at the highest dose cohort in the phase I TENDU trial without any safety concerns. Based on these results, the company plans to enroll up to three additional patients at the highest dose level.

The Drug Safety Monitoring Board, a group of experts set up to monitor patient safety during a clinical trial, found no safety concerns in any of the three dose cohorts. A total of nine patients have now been treated; three at each dose level (40 mcg, 400 mcg and 960 mcg). Ultimovacs plans to enroll up to three additional patients at the highest dose level (960 mcg) providing a broader base of early safety data for the TET platform.

“We are very encouraged by the continuing progress of the phase I safety evaluation of the TET platform. With no safety concerns at any dose, we have decided to enroll up to three additional patients at the highest dose level, providing extended data from TENDU on the safety and tolerability of TET for prostate cancer patients.” said Jens Bjørheim, Chief Medical Officer of Ultimovacs. “The data from TENDU, in turn, may provide insights that are useful in Ultimovacs’ broader plans for the development of the TET platform.”

The TET platform, an innovative adjuvant technology, allows for the design and production of multiple therapeutic cancer vaccines. It can potentially be used to strengthen and increase T cell responses to cancer cells by targeting antigens that are specific to one type of cancer or common to many tumor types. The vaccine used in the TENDU study contains prostate cancer-specific antigens. By combining cancer antigens and the vaccine adjuvant in the same molecule, the TET platform can generate vaccine candidates with a potential beneficial safety and administration profile, including presenting an opportunity to treat patients at an earlier stage of their disease.

The TENDU study is a first-in-human, dose-escalation study designed to generate initial safety and immune activation data. This study is investigating a prostate cancer-specific therapeutic TET-based vaccine in patients who have relapsed following radical prostatectomy.

==ENDS==

About the TET-platform
All vaccines consist of two components, adjuvant and antigen. The adjuvant activates the immune system so that a relevant immune response can occur. The antigen directs the quality of the immune response. Together the adjuvant and the antigen ensure a specific and effective immune response.

The Tetanus-Epitope Targeting (TET)-platform offers an approach to strengthen and increase T cell responses against cancer-specific peptides by combining cancer-specific antigens and vaccine adjuvant in the same conjugated molecule, allowing for a beneficial safety profile and simplifying administration. The platform generates new, first-in-class cancer vaccine candidates that harness pre-existing antibody responses resulting from standard tetanus vaccinations. TET vaccine candidates can be tailored to many types of cancer, and to infectious diseases.

About TENDU
The TENDU clinical trial (NCT04701021) is a first-in-human, phase I study and the first clinical trial of a vaccine from Ultimovacs' Tetanus-Epitope Targeting (TET)-platform. The trial is being conducted at the Oslo University Hospital, Norway, and evaluates the safety of the vaccine in prostate cancer patients who have relapsed after radical prostatectomy. The primary objective of the study is to evaluate the safety and tolerability of three different doses of the vaccine. Patients will receive the vaccine prior to obtaining standard-of-care treatment consisting of radiation and antihormone therapy and will be followed for 6 months after the last dose of the vaccine to assess immunological responses such as the activation of T cells and anti-tumor activity.

About Ultimovacs
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
Email: carlos.desousa@ultimovacs.com
Phone: +47 908 92507

Anne Worsøe, Head of IR & Communication
Email: anne.worsoe@ultimovacs.com
Phone: +47 90686815

Mary-Ann Chang, LifeSci Advisors
Email: mchang@lifesciadvisors.com
Phone: +44 7483 284 853

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 Joachim Midttun, Finance Manager at Ultimovacs ASA, on 18August, 2022 at 08:00 CET.


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

GlobeNewswire by notified
GlobeNewswire by notified
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://notified.com

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

Remuneration of Director by distribution of Millicom (Tigo) shares23.9.2022 23:00:00 CEST | Press release

Remuneration of Director by distribution of Millicom (Tigo) shares Luxembourg, September 23, 2022 – Millicom International Cellular S.A. ("Millicom") announces that, in accordance with the resolution of its shareholders at the annual general meeting held on May 4, 2022, it has distributed a total of 1,150 shares to one of the members of its Board of Directors as part of their non-executive director remuneration for the period from the date of the 2022 AGM to the 2023 AGM, to be held in May 2023. Details of the distributions are disclosed on Millicom’s website. -END- For further information, please contact Press: Yocasta Valdez, Sr. Manager Digital Media & Corporate Communications press@millicom.comInvestors: Michel Morin, VP Investor Relations Sarah Inmon, Director Investor Relations investors@millicom.com About Millicom Millicom (NASDAQ U.S.: TIGO, Nasdaq Stockholm: TIGO_SDB) is a leading provider of fixed and mobile telecommunications services in Latin America. Through our TIGO® and

Enento Group signed EUR 180 million syndicated loan agreement23.9.2022 16:00:00 CEST | Press release

ENENTO GROUP PLC, INVESTOR NEWS ON 23 SEPTEMBER 2022 AT 5.00 P.M. EET Enento Group signed EUR 180 million syndicated loan agreement Enento Group has today signed a new long-term financing agreement to be used for refinancing of its current financing arrangement. The financing agreement consists of a EUR 150 million long-term loan as well as a EUR 30 million revolving credit facility. The agreement is for three years and includes two one-year options for extension of the loan period. The loan replaces the financing agreement that was signed in October 2018 of a EUR 160 million long-term loan and a EUR 20 million revolving credit facility. The revolving credit facility has been unutilised. The margins of the financing agreement are linked to Enento Group´s financial covenants and include an option to link the margin also to sustainability criteria in the future. OP Corporate Bank, Danske Bank and Nordea Bank were acting as Mandated Lead Arrangers and Bookrunners. OP Corporate Bank acted

Nordic American Tankers Ltd (NYSE: NAT) – Solid rates and earnings23.9.2022 14:55:12 CEST | Press release

Friday, September 23, 2022 Dear Shareholders and Investors, This is to reconfirm that the business of NAT(rates, earnings) is solid and prospects are good. For contacts, please see at the end of this communication. Sincerely, Herbjorn Hansson Founder, Chairman & CEO Nordic American Tankers Limited CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS Matters discussed in this press release may constitute forward-looking statements. The Private Securities Litigation Reform Act of 1995 provides safe harbor protections for forward-looking statements in order to encourage companies to provide prospective information about their business. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements, which are other than statements of historical facts. The Company desires to take advantage of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and

Rolf Jansson appointed acting Managing Director of Leipurin23.9.2022 12:00:00 CEST | Press release

Aspo Plc Stock exchange release September 23, 2022 at 1 p.m. Rolf Jansson appointed acting Managing Director of Leipurin The last workday of Heli Arantola, CEO of Aspo Group subsidiary Leipurin, has been specified as September 30, 2022. As announced on Aspo’s stock exchange release on June 27, 2022, Arantola has resigned to join another company. Aspo Group’s CEO Rolf Jansson will take on the role of acting Managing Director of Leipurin from October 1, 2022. In addition, Aspo’s Vice President of Corporate Development Mikko Heikkilä takes responsibility for Leipurin’s selected strategic projects. The selection process for Leipurin’s new Managing Director is underway. Aspo Plc Rolf Jansson CEO Further information, please contact: Rolf Jansson, CEO, Aspo Plc, tel. +358 400 600 264, rolf.jansson@aspo.com Distribution: Nasdaq Helsinki Key media www.aspo.com Aspo creates value by owning and developing business operations sustainably and in the long term. Our companies aim to be market leaders

Norsk Hydro: Primærinnsider Helena Nonka selger aksjer23.9.2022 11:20:00 CEST | Pressemelding

Helena Nonka, konserndirektør for Corporate Development, har den 23. september 2022 solgt 1528 aksjer til 59,58 kroner per aksje. I mai 2022, ble Helena Nonka tildelt disse 1528 aksjene under langtidsinsentivprogrammet (LTI) som medlem av konsernledelsen. Helena Nonka har besluttet å forlate Hydro, og hennes siste dag vil være 30. september 2022. Provenyet fra salget skal tilfalle Norsk Hydro ASA. Denne opplysningen er informasjonspliktig etter verdipapirhandelloven §5-12. Investorkontakt: Line Haugetraa +47 41406376 line.haugetraa@hydro.com Mediakontakt: Halvor Molland +47 92979797 Halvor.Molland@hydro.com Vedlegg KRT 1500 Helena Nonka 2022 23 09