Immunicum AB: Immunicum Received FDA Orphan Drug Designation for Ilixadencel as Treatment of Gastrointestinal Stromal Tumors (GIST)
Immunicum AB (“Immunicum” publ; IMMU.ST), a biopharmaceutical company focused on tumor recurrence and hard-to-treat established tumors, announced today that it has been granted an Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for ilixadencel in the treatment of Gastrointestinal Stromal Tumors (GIST). This designation confirms the need and potential for ilixadencel as a new treatments for patients with GIST, which is a rare and difficult to treat subgroup of cancers reffered to as Soft Tissue Sarcoma (STS).
“We continue to interact with agencies on development of treatments for hard-to-treat tumors,” commented Jeroen Rovers, M.D., Ph.D., Chief Medical Officer at Immunicum. “This ODD will support further development of ilixadencel, including a Phase II trial which Immunicum is currently preparing with ilixadencel in combination with tyrosine kinase inhibitors in GIST.”
In January 2021, Immunicum received ODD from the FDA for ilixadencel for treatment of STS. In December 2020, Immunicum announced that it received Fast Track Designation from the U.S. FDA for ilixadencel in GIST.
The Orphan Drug Designation program provides orphan status to medicines for rare diseases that are intended for the treatment, prevention or diagnosis of a rare disease or condition that affects less than 200,000 people in the U.S. Orphan Drug Designation may allow Immunicum to be eligible for a seven-year period of U.S. Marketing exclusivity upon approval of ilixadencel and a waiver of the Prescription Drug User Fee Act (“PDUFA”) filing fees, subject to certain conditions.
ABOUT GASTROINTESTINAL STROMAL TUMORS
Gastrointestinal Stromal Tumors (GIST) are a common type of soft tissue sarcoma (STS) and are highly resistant to conventional radio- and chemotherapy. Although imatinib and other tyrosine kinase inhibitors (TKIs) have revolutionized the medical treatment of unresectable and/or metastatic GIST, TKI resistance still represents a major challenge as therapeutic options for advanced GISTs are limited when the disease progresses.
Ilixadencel is an off-the-shelf cell-based cancer immunotherapy developed for the treatment of solid tumors. To date, ilixadencel has been tested in a range of clinical trials in various solid tumor indications including metastatic Renal Cell Carcinoma (mRCC), hepatocellular carcinoma (HCC) and gastrointestinal stromal tumors (GIST) and in combination with several standard-of-care cancer therapies such as the tyrosine kinase inhibitors Sutent® (sunitinib) and Stivarga® (regorafenib), and the checkpoint inhibitor Keytruda® (pembrolizumab). Ilixadencel has consistently demonstrated signs of efficacy and maintained a positive safety and tolerability profile. Immunicum’s development plans for ilixadencel focus on evaluating ilixadencel in combination with tyrosine kinase inhibitors in GIST.
FOR MORE INFORMATION, PLEASE CONTACT:
Chief Executive Officer
Stern Investor Relations
Telephone: +1 212-362-1200
Telephone: +49 160 9352 9951
ABOUT IMMUNICUM AB (PUBL)
Immunicum is a biopharmaceutical company focused on therapies addressing tumor recurrence and hard-to-treat established tumors, two key challenges in oncology. We are leveraging our unparalleled expertise in allogeneic dendritic cell biology to develop an advanced clinical pipeline of novel, off-the-shelf, cell-based therapies for solid and blood-borne tumors. Based in Sweden and the Netherlands, Immunicum is publicly traded on the Nasdaq Stockholm.
AttachmentTo 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
Sampo plc’s share buybacks 28/06/202229.6.2022 07:30:00 CEST | Press release
SAMPO PLC STOCK EXCHANGE RELEASE 29/06/2022 at 08:30 am Sampo plc’s share buybacks 28/06/2022 On 28/06/2022 Sampo plc (business code 0142213-3, LEI 743700UF3RL386WIDA22) has acquired its own A shares (ISIN code FI0009003305) as follows: Sampo plc’s share buybacksAggregated daily volume (in number of shares)Daily weighted average price of the purchased shares*Market (MIC Code)14,24842.24AQEU24,42242.25CEUX8,67542.27TQEX85,16742.21XHELTOTAL132,51242.22 *rounded to two decimals On 9 June 2022, Sampo announced a share buyback programme of up to a maximum of EUR 1 billion in compliance with the Market Abuse Regulation (EU) 596/2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052. The programme, which started on 10 June 2022, is based on the authorization granted by Sampo's Annual General Meeting on 18 May 2022. After the disclosed transactions, the company owns in total 1,841,919 Sampo A shares representing 0.35 per cent of the total number of shares in Sampo plc. Details of ea
IMCD recognised by Sustainalytics as 2022 ESG Industry Top Performer, ranking first among traders and distributors29.6.2022 07:00:00 CEST | Press release
ROTTERDAM, The Netherlands (29 June 2022) – IMCD N.V., (“IMCD” or “Company”), a leading distributor of speciality chemicals and ingredients, was recognised by Sustainalytics as an ESG Industry Top Rated Company. With a score of 13.8 (low risk) IMCD ranks first (lowest risk) among over 180 international peers in trading and distribution. It places the company in the top seven percent of almost 15,000 companies assessed worldwide. Sustainalytics, a Morningstar company, is a globally recognised provider of ESG research, ratings and data that supports investors around the world with the development and implementation of responsible investment strategies. Its ESG Risk Ratings measure a company's exposure to industry-specific material ESG risks and how well a company is managing those risks. In March 2022, IMCD was also included in the newly launched Dutch ESG AEX index, as one of 25 companies demonstrating best Environmental, Social and Governance (ESG) practices. “We are excited and proud
Roche launches new BenchMark ULTRA PLUS system for cancer diagnostics enabling timely, targeted patient care29.6.2022 07:00:00 CEST | Press release
The BenchMark ULTRA PLUS tissue staining system, with optimised workflow, testing efficiency and environmentally sustainable features, enables pathologists to provide high-quality, time-critical results to doctors and patients.With laboratory diagnostics involved in more than two-thirds of healthcare decision making, innovative laboratory solutions that enable an accurate and timely diagnosis are crucial to successful treatment.About 17 million new cases of cancer are diagnosed worldwide each year, and nearly 10 million people die from the disease.1 Basel, 29 June 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of the BenchMark ULTRA PLUS system, its newest advanced tissue staining platform. The system enables quick and accurate test results so clinicians can make timely decisions regarding a patient’s care journey. “With the BenchMark ULTRA PLUS, we are pleased to offer an advanced tissue staining platform, co-developed with lab professionals,” said Thomas Schinec
SIKA EXPANDS PRODUCTION OF CONCRETE ADMIXTURES IN THE USA29.6.2022 07:00:00 CEST | Press release
SIKA EXPANDS PRODUCTION OF CONCRETE ADMIXTURES IN THE USA Sika is bringing a new manufacturing plant for concrete admixtures on stream in Stafford, Virginia. With the opening of the plant near Washington D.C., Sika is increasing its production capacity in the important American construction market so that it can readily satisfy the strong demand in the Northeast and Mid-Atlantic regions. With over 75 million inhabitants, the urban centers in the Northeast, like New York, Philadelphia, or Boston, are very densely populated and account for more than 25% of US economic output. The new plant is well positioned to support the additional needs of the announced infrastructure program of CHF 200-250 billion in the aforementioned two regions. Sika has been benefiting from the strong demand in the construction sector over recent years. The new facility in Stafford is the second-biggest manufacturing plant for Sika concrete admixtures in the USA. Together with the existing plant in Fairless Hills
TGS ASA and Magseis Fairfield ASA Announce a Recommended Voluntary Exchange Offer by TGS to Acquire All Shares of Magseis29.6.2022 07:00:00 CEST | Press release
OSLO, Norway (29 June 2022) - TGS ASA (“TGS”, OSE: TGS) and Magseis Fairfield ASA (“Magseis”, OSE: MSEIS) announce today that they have entered into a transaction agreement (the "Transaction Agreement") whereby TGS on and subject to certain terms and conditions will put forward a voluntary exchange offer (the “Offer”) to acquire all shares of Magseis for a consideration to the Magseis shareholders in the form of 0.0426 ordinary shares of TGS and NOK 2.30 in cash per Magseis share (the “OfferConsideration”). Based on the closing price of TGS on 28 June 2022, the value of the Offer Consideration is equal to NOK 8.6048 per Magseis share, and the Offer values the total issued share capital of Magseis at approximately NOK 2,333 million. The board of directors of Magseis (the "Board") has unanimously resolved to recommend the Offer. Magseis shareholders, including the largest shareholder, Fairfield MS, LLC, and members of the Magseis Board and management, who collectively own 33.4% of the ou