GlobeNewswire by notified

Ultimovacs Granted Orphan Drug Designation by FDA for UV1 Cancer Vaccine in Metastatic Melanoma

Share
  • Designation covers UV1 in Metastatic Melanoma as sole agent or part of combination
  • Seven-year market exclusivity after regulatory approval, if received

Oslo, 2December2021: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical stage leader in immune stimulatory vaccines for cancer, today announces that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) for the company’s universal cancer vaccine UV1 for the treatment of stage IIB – IV melanoma. UV1, as add-on therapy to checkpoint inhibitors ipilimumab and nivolumab, is currently being studied as first-line treatment for metastatic melanoma in a Phase II trial named INITIUM.

The FDA Office of Orphan Products Development (OOPD) supports and advances the development and evaluation of new treatments for rare diseases that affect fewer than 200,000 people in the U.S. Orphan drug designation provides certain benefits, including seven-year market exclusivity upon regulatory approval if received, exemption from FDA application fees and tax credits for qualified clinical trials.

In October this year, the U.S. FDA granted Fast Track designation to UV1 as add-on therapy to ipilimumab or to pembrolizumab for the treatment of unresectable or metastatic melanoma.

“We are very pleased to have been granted this orphan drug designation for UV1 in treating metastatic melanoma. The designation underlines the promise of UV1 that has been shown in our clinical studies in metastatic melanoma to date,” said Carlos de Sousa, CEO of Ultimovacs. “We remain committed to further investigating UV1 in our ongoing Phase II clinical studies and to continuing our constructive dialog with regulators to bring UV1 to patients as soon as possible.”

UV1 is being investigated in combination with checkpoint inhibitors in Phase II trials covering advanced malignant melanoma, ovarian cancer, head and neck squamous cell carcinoma, malignant pleural mesothelioma, and non-small cell lung cancer (NSCLC). In total, the five Phase II trials will enroll more than 650 patients at nearly 100 clinical centers across 15 countries.

==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 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, 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.

About Melanoma
Melanoma is the fifth most common cancer in both men and women in the U.S., with more than 100,000 new cases of melanoma diagnosed every year. Ultimovacs’ INITIUM clinical trial uses UV1 in combination with checkpoint inhibitors ipilimumab and nivolumab to treat metastatic melanoma (Stage III – IV melanoma), including the later stages of the disease in which the melanoma has spread to lymph nodes and/or to more distant parts of the body. In addition to surgery or radiation therapy, checkpoint inhibitors have become standard of care treatment for metastatic melanoma. The 5-year survival rate for patients with Stage IV metastatic melanoma is approximately 20-30%.

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 Joachim Midttun, Finance Manager at Ultimovacs ASA, on December2, 2021 at19:00 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

Nordic American Tankers Ltd (NYSE: NAT) – Further Purchase of NAT shares by Board Member Alexander Hansson21.1.2022 16:32:14 CET | Press release

Friday, January 21, 2022 Dear Shareholders and Investors, Alexander Hansson, Board Member in Nordic American Tankers Ltd (NAT) and son of Herbjorn Hansson, the NAT Founder, Chairman and CEO, has today bought 50,000 shares in NAT at $ 1.557 per share. Following the transaction, Alexander Hansson privately owns 1,185,000 shares in NAT. As in the past, the Hansson family is the largest private shareholder in the company. Alexander Hansson commented: "I strongly believe in the future of 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 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, obje

CONDITIONS FOR RIKSBANK REVERSED AUCTIONS SEK TREASURY BILLS21.1.2022 16:20:00 CET | Press release

Bid procedure, 2022-01-26BillsSWEDISH T-BILL: SE0017232689. 2022-04-20 Bid date2022-01-26Bid times10.00-11.00 (CET/CEST) on the Bid dateRequested volume (corresponding nominal amount)SE0017232689: 2000 mln SEK +/-1000 mln SEK Highest permitted bid volume (corresponding nominal amount)SE0017232689: 2000 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 date2022-01-28Delivery of billsTo the Riksbank's account in Euroclear Sweden AB's securities settlement system 1 4948 6383 Stockholm, 2022-01-21 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 can be retrieved at www.riksbank.se.

CONDITIONS FOR RIKSBANK BID PROCEDURE KOMMUNINVEST BONDS21.1.2022 16:20:00 CET | Press release

Bid procedure, 2022-01-25BondsKOMMUNINVEST I SVERIGE: 2311. SE0010948240. 2023-11-13 KOMMUNINVEST I SVERIGE: 2611, SE0012569572, 2026-11-12 KOMMUNINVEST I SVERIGE: 2805, SE0015660139, 2028-05-12 BidsBids on interest and volume are entered via Bloomberg Bond Auction SystemBid date2022-01-25Bid times10.00-11.00Requested volume (corresponding nominal amount)2311: 500 mln SEK +/-250 mln SEK 2611: 500 mln SEK +/-250 mln SEK 2805: 500 mln SEK +/-250 mln SEK Highest permitted bid volume (corresponding nominal amount)2311: 500 mln SEK per bid 2611: 500 mln SEK per bid 2805: 500 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 date2022-01-27Delivery 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 Purchase

CONDITIONS FOR RIKSBANK REVERSED AUCTIONS SEK GOVERNMENT BONDS21.1.2022 16:20:00 CET | Press release

Bid procedure, 2022-01-28BondsSWEDEN I/L BOND: 3109. SE0005703550. 2025-06-01 SWEDEN I/L BOND: 3114, SE0013748258, 2030-06-01 Bid date2022-01-28Bid times09.00-10.00 (CET/CEST) on the Bid dateRequested volume (corresponding nominal amount)3109: 500 mln SEK +/-250 mln SEK 3114: 500 mln SEK +/-250 mln SEK Highest permitted bid volume (corresponding nominal amount)3109: 500 mln SEK per bid 3114: 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 date2022-02-01Delivery of bondsTo the Riksbank's account in Euroclear Sweden AB's securities settlement system 1 4948 6383 Stockholm, 2022-01-21 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 can be

Avance Gas Holding Ltd - Enter into Time Charter Agreement for Avance Capella21.1.2022 14:33:03 CET | Press release

Bermuda, 21 January 2022 - Avance Gas Holding Ltd ("AGAS" or the "Company") announce that we have entered into a Time Charter Agreement for a period of 2 years for our second dual fuel VLGC, Avance Capella, to LPG & Ethylene Shipowner and LPG trader, Petredec. The vessel will commence the time charter shortly after delivery ex-yard in South Korea end of February 2022 and the time charter hire has a mechanism which gives both parties exposure to the spot market rate. This transaction is another step in executing on our strategy to increase our time charter portfolio while also maintaining access to the market upside. For further queries, please contact: Kristian Sørensen, CEO Tel: +47 22 00 48 00 Randi Navdal Bekkelund, CFO Tel: +47 22 00 48 00 About Avance Gas: Avance Gas operates in the global market for transportation of liquefied petroleum gas (LPG). The Company is one of the world's leading owners and operators of very large gas carrier (VLGC) and operates a fleet of thirteen ships

Proposals by the Nomination Board to the Annual General Meeting 2022 of Suominen21.1.2022 13:00:00 CET | Press release

Suominen Corporation's stock exchange release on January 21, 2022 at 2:00 p.m. EET Proposal on the number of the members, on the composition, and on the Chair of the Board of Directors The Nomination Board of Suominen Corporation’s shareholders proposes to the Annual General Meeting that the number of Board members remains unchanged and would be six (6). The Nomination Board proposes to the Annual General Meeting that Andreas Ahlström, Björn Borgman, Jaakko Eskola, Nina Linander and Laura Raitio would be re-elected as members of Suominen Corporation’s Board of Directors. Out of the current Board members, Sari Pajari-Sederholm has informed that she is not available as a candidate for the Board of Directors. In addition, the Nomination Board proposes that Aaron Barsness would be elected as a new member of the Board of Directors. Mr. Aaron Barsness (born 1973, BA (Biology and Environmental Studies), U.S. and Swedish citizen) currently works as the CMO of Fazer Group. He has held a number

Auriant Mining AB (publ.) publishes 12m 2021 operational update21.1.2022 11:20:00 CET | Press release

Highlights: In 12m 2021, total gold production amounted to 910.8 kg (29,283 oz), compared to 964.7 kg (31,014 oz) in 12m 2020, a decrease of 6%, or 53.9 kg (1,731 oz), but in line with the 2021 production plan; Hard rock gold production was 893.3 kg (28,720 oz), compared to 952.7 kg (30,629 oz) in 12m 2020, a decrease of 6%, or 59.4 kg (1,909 oz);Alluvial gold production amounted to 17.5 kg (563 oz), compared to 12.0 kg (386 oz) in 2020, an increase of 46%, or 5,5 kg (178 oz);12m 2021, total gold sales were 818.5 kg (26,316 oz), compared to 946.4 kg (30,428 oz) in 12m 2020, a decrease of 127.9 kg (4,112 oz), or 14%;428,300 tonnes of ore were processed with an average grade of 2.30 g/t;In 12m of 2021, the CIL plant operated for 8,004 hours at an increased throughput rate of 53.5 tonnes per working hour (>50 t/hour) and at the targeted recovery rate of 91.2%;458,500 tonnes of ore were mined in 12m 2021, compared to 387,200 tonnes in 12m 2020, an increase of 71,300 tonnes or 18%. Strippin