GlobeNewswire

Ultimovacs Announces Further Positive Topline Results from Phase I UV1 Cancer Vaccine Combination Study in Metastatic Melanoma

Share
  • Cohort 2 showed 60% objective response rate, 30% complete response rate
  • 90% overall survival rate at 12 months follow-up
  • Cohort 2 results reinforce results seen in cohort 1
  • Good safety and tolerability profile supports use of UV1 in combination treatments

Oslo, 12 August 2021: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical stage leader in immune stimulatory vaccines for cancer, announced positive topline results from the second cohort of 10 patients after one year of its ongoing U.S.-based Phase I clinical trial evaluating the Company's universal cancer vaccine, UV1, in combination with the checkpoint inhibitor pembrolizumab as a first-line treatment in metastatic malignant melanoma. The primary endpoint of safety and tolerability was achieved with strong initial signs of clinical response.

Tumor shrinkage was evident in six of the 10 patients, a 60% objective response rate. In three of the patients, the tumors were reduced to undetectable levels, a 30% complete response rate. These levels of tumor destruction in response to treatments with the combination of UV1 and pembrolizumab were similar to those seen in the first cohort of 20 patients from the same study.

The overall survival (OS) rate after one year was high and consistent across both patient cohorts, with a 90% OS rate in cohort 2 and 85% in cohort 1. Median progression-free survival (mPFS) was not reached in either cohort at 12 months, a positive outcome indicating that the disease status had either improved or was stable in at least half of the participating patients in both parts of the study.

“The emerging picture is that the UV1-pembrolizumab combination has a strong safety profile and provides consistently high levels of clinical response in advanced melanoma,” said Jens Bjørheim, Chief Medical Officer of Ultimovacs. “This latest data adds to the accumulating body of evidence demonstrating that UV1 is safe and can mobilize the immune system to play a transformative role in the treatment of solid tumors.”

The study* is ongoing in the U.S. and, as previously announced, the topline 2-year follow-up data on the first patient cohort is still expected in Q4 2021.

“These latest results are compelling, and in line with the data presented at ASCO from the first group of patients in this study,” said Carlos de Sousa, CEO of Ultimovacs. “We will discuss these results further when we present the company’s Q2 2021 financial results to shareholders on 20 August, 2021. We also plan to share more detailed results of the study at a major clinical oncology meeting in 2022.”

* ClinicalTrials.gov Identifier: NCT03538314. Treatments in cohort 1 and cohort 2 of the study differed only in the levels of GM-CSF administered as an adjuvant with UV1.

==ENDS==

About Ultimovacs
Ultimovacs is developing immune-stimulatory vaccines to treat a broad range of cancers. Ultimovacs’ lead universal cancer vaccine candidate UV1 targets human telomerase (hTERT), present in over 80% 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, Ultimovacs aims to clinically demonstrate UV1’s impact in multiple cancer types in combination with other immunotherapies. 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

Hans Vassgård Eid, CFO
Email: hans.eid@ultimovacs.com
Phone: +47 482 48632

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 Hans Vassgård Eid, CFO at Ultimovacs ASA, on 12 August, 2021 at 07:45 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

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

https://globenewswire.com

GlobeNewswire 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

Subscribe to all the latest releases from GlobeNewswire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire

Repurchase of shares in Millicom24.9.2021 23:00:00 CEST | Press release

Repurchase of shares in Millicom Luxembourg, September24, 2021 - During the period September 16, 2021 – September 22, 2021, Millicom repurchased a total of 122,612 of its Swedish Depository Receipts (SDRs), hereinafter referred to as shares within the framework of the repurchase program announced on July 29, 2021 (the Repurchase Program), details of which are shown in the table below. DateNumber of shares repurchasedWeighted average repurchaseprice (SEK) excluding commissionsTotal daily transaction value (SEK), excluding commissions 16/09/2021 17,000 315.2166 5,358,682.20 17/09/2021 13,000 316.9849 4,120,803.70 20/09/2021 47,000 310.3055 14,584,358.50 21/09/2021 22,000 312.2228 6,868,901.60 22/09/2021 23,612 311.9609 7,366,020.77 All purchases were carried out on Nasdaq Stockholm by Citigroup Global Markets Limited on behalf of Millicom. Following the purchases, as of September 22, 2021, Millicom holds 915,037 treasury shares and has repurchased 739,438 shares under the Repurchase Prog

Jotul Holdings SA's direct subsidiary Jøtul AS issues senior secured floating rate bonds of NOK 475,000,00024.9.2021 18:00:00 CEST | Press release

Jotul Holdings SA's direct subsidiary Jøtul AS has successfully issued senior secured floating rate bonds in an amount of NOK 475,000,000 under a framework of up to NOK 750,000,000 with ISIN NO0011104069. The bonds were issued at par, are due in October 2024 and carry a floating interest rate of NIBOR 3m + 6.95 per cent. The proceeds from the bond issue will be used to finance, redemption of existing debt including Jotul Holdings SA's existing bond loan with ISIN NO0010815749, as well as general corporate purposes. Pareto Securities AB acted as sole arranger and bookrunner in connection with the bond issue. For more information, please visit Jotul Holdings SA’s website at www.intl.jotul.com/investor-relations or contact: Pareto Securities in capacity of Sole Bookrunner and Financial Advisor: Markus Wirenhammar, Head of Investment Banking Tel: +46 708 72 51 86 Jotul Holdings SA: Nils Agnar Brunborg, Chief Executive Officer Tel: +47 90 60 55 7869 35 90 00 Mail: Nils.Brunborg@jotul.no Thi

Nordic American Tankers Ltd (NAT) – Board Members of NAT buy stock in NAT24.9.2021 16:28:10 CEST | Press release

Friday, September 24, 2021 Dear Shareholders and Investors, All Board Members of NAT have recently increased their shareholdings in the company. The Founder, Chairman & CEO, Herbjorn Hansson, Norway, bought 75,000 shares in NAT September 17. Board Member Alexander Hansson, Monaco, bought 100,000 shares in NAT August 31, and 50,000 shares September 20. Board Member Jim Kelly, New York, has also adjusted his holding upwards to 175,000 shares in NAT. Doug Penick of Dallas, Texas, joined the Board at the NAT AGM July 19, 2021. He has already accumulated 125,000 shares in NAT. It is a strong sign of confidence that board members buy stock in our company. The Hansson family is the third largest shareholder group in NAT. Sincerely, Herbjorn Hansson Founder, Chairman & CEO Nordic American Tankers Ltd. www.nat.bm CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS Matters discussed in this press release may constitute forward-looking statements. The Private Securities Litigation Reform Ac

CONDITIONS FOR RIKSBANK BID PROCEDURE KOMMUNINVEST BONDS24.9.2021 16:20:00 CEST | Press release

Bid procedure, 2021-09-28BondsKOMMUNINVEST I SVERIGE: 2410. SE0010469205. 2024-10-02 KOMMUNINVEST I SVERIGE: 2602, SE0013745452, 2026-02-04 BidsBids on interest and volume are entered via Bloomberg Bond Auction SystemBid date2021-09-28Bid times10.00-11.00 (CET/CEST) on the Bid dateRequested volume (corresponding nominal amount)2410: 1500 mln SEK +/-750 mln SEK 2602: 1000 mln SEK +/-500 mln SEK Highest permitted bid volume (corresponding nominal amount)2410: 1500 mln SEK per bid 2602: 1000 mln SEK per bid Lowest permitted bid volume (corresponding nominal amount)SEK 50 million per bidExpected allocation timeNot later than 11.15 (CET/CEST) on the Bid dateDelivery and payment date2021-09-30Delivery of bondsTo the Riksbank's account in Euroclear Sweden AB's securities settlement system 1 4948 6383General Terms and ConditionsGeneral Terms and Conditions General Terms and Conditions för the Riksbank’s Purchases of Bonds via Bid Procedure 2020:3. dated 20 November 2020 (see the Riksbank´s web

CONDITIONS FOR THE RIKSBANK´S PURCHASES OF COMMERCIAL PAPER24.9.2021 16:20:00 CEST | Press release

Bid procedure, 2021-09-29CertificateCommercial paper issued in SEK by non-financial companies with their registered office in Sweden and with a remaining maturity of up to six months on the Bid date. i.e. with the latest maturity date as of 2022-03-29 Delivery may not be made in commercial paper purchased by the Counterparty from the issuer less than one week prior to the date for announcing the Special terms, i.e. the purchase may not have been made after 2021-09-17 BidsCounterparties may make one bid per Credit rating class and maturity class. Bids are made to tel 08-696 69 70 and confirmed by e-mail to EOL@riksbank.se.Bid date2021-09-29Bid times09.00-09.30 (CET/CEST) on the Bid dateRequested volume (corresponding nominal amount)SEK 4 billionHighest permitted bid volume (corresponding nominal amount)The total bid volume from one Counterparty for the two Credit rating classes may not exceed SEK 4 billion. No bid may contain Commercial paper in excess of SEK 250 million issued by the s

CONDITIONS FOR RIKSBANK REVERSED AUCTIONS SEK GOVERNMENT BONDS24.9.2021 16:20:00 CEST | Press release

Bid procedure, 2021-10-01BondsSWEDISH GOVERNMENT: 1062. SE0013935319. 2031-05-12 SWEDISH GOVERNMENT: 1063, SE0015193313, 2045-11-24 Bid date2021-10-01Bid times09.00-10.00 (CET/CEST) on the Bid dateRequested volume (corresponding nominal amount)1062: 500 mln SEK +/-250 mln SEK 1063: 500 mln SEK +/-250 mln SEK Highest permitted bid volume (corresponding nominal amount)1062: 500 mln SEK per bid 1063: 500 mln SEK per bid Lowest permitted bid volume (corresponding nominal amount)SEK 50 million per bidExpected allocation timeNot later than 10.15 (CET/CEST) on the Bid dateDelivery and payment date2021-10-05Delivery of bondsTo the Riksbank's account in Euroclear Sweden AB's securities settlement system 1 4948 6383 Stockholm, 2021-09-24 This is a translation of the special terms and conditions published on www.riksbank.se. In the case of any inconsistency between the English translation and the Swedish language version, the Swedish language version shall prevail. Complete terms and conditions c

CONDITIONS FOR RIKSBANK REVERSED AUCTIONS SEK COVERED BONDS24.9.2021 16:20:00 CEST | Press release

Bid procedure, 2021-09-30BondsSWEDBANK HYPOTEK AB: 196. SE0015244991. 2026-03-18 STADSHYPOTEK AB: 1587, SE0010441303, 2023-06-01 SWEDISH COVERED BOND: 147, SE0009383664, 2026-06-17 SKANDINAVISKA ENSKILDA: 575, SE0010546572, 2022-12-21 LANSFORSAKRINGAR HYPOTEK: 516, SE0009190390, 2023-09-20 DANSKE HYPOTEK AB: 2512, SE0013877214, 2025-12-17 NORDEA HYPOTEK AB: 5534, SE0012230415, 2024-09-18 Bid date2021-09-30Bid times09.00-10.00 (CET/CEST) on the Bid dateRequested volume (corresponding nominal amount)196: 400 mln SEK +/-200 mln SEK 1587: 1900 mln SEK +/-950 mln SEK 147: 700 mln SEK +/-350 mln SEK 575: 500 mln SEK +/-250 mln SEK 516: 600 mln SEK +/-300 mln SEK 2512: 500 mln SEK +/-250 mln SEK 5534: 400 mln SEK +/-200 mln SEK Highest permitted bid volume (corresponding nominal amount)196: 400 mln SEK per bid 1587: 1900 mln SEK per bid 147: 700 mln SEK per bid 575: 500 mln SEK per bid 516: 600 mln SEK per bid 2512: 500 mln SEK per bid 5534: 400 mln SEK per bid Lowest permitted bid volume (co