Immunicum AB: Immunicum Publishes Phase II MERECA Trial Results of Ilixadencel in Kidney Cancer in European Urology Open Sciences
Immunicum AB (“Immunicum” publ; IMMU.ST), a biopharmaceutical company focused on therapies addressing tumor recurrence and hard-to-treat established tumors, has published the results of the Phase II MERECA study evaluating ilixadencel in advanced kidney cancer in European Urology Open Sciences, a peer reviewed, open access journal. The MERECA study showed that the combination of ilixadencel with the tyrosine kinase inhibitor sunitinib was safe and associated with a positive trend for improved tumor response rate and overall survival, compared with sunitinib monotherapy (control group).
“The results of the MERECA study have further increased our understanding of the biology and therapeutic combination potential of ilixadencel with tyrosine kinase inhibitors such as sunitinib,” commented Jeroen Rovers, M.D., Ph.D., Chief Medical Officer at Immunicum. “This will support the design of future clinical studies, including the Phase II trial which Immunicum is currently preparing to evaluate ilixadencel in combination with tyrosine kinase inhibitors in gastrointestinal stromal tumors (GIST).”
A total of 86 patients were treated within this study, of which 56 were given ilixadencel intratumorally, followed by surgery to remove the kidney tumor and standard treatment with sunitinib, and 30 patients were only given sunitinib after surgery. The published data show proof-of-concept for ilixadencel in kidney cancer with improved overall response rate (ORR) and overall survival (OS). The 18 months survival rate as primary endpoint of the study showed no significant differences between combination arm and control group. However, the median OS was 35.6 months for the ilixadencel + sunitinib combination arm, as compared to 25.3 months in the control group, showing an improved survival over time. Ilixadencel in combination with sunitinib was associated with a numerically higher confirmed response rate, including complete responses, compared with sunitinib monotherapy. Confirmed ORR was 42.2 % (19 out of 45) in the combination arm, including 3 patients with confirmed complete response (CR). Two additional patients in the combination arm developed a CR at the last follow-up CT scan at 18 months (non-confirmed CR). The ORR in the control group was 24.0% (6 out of 25) with no confirmed CR. One patient in the control arm had a CR observed at the last 18-months CT follow-up. The five patients who achieved a CR in the combination arm were all still alive at the latest survival follow up while the one patient with a non-confirmed CR in the control group had died. The addition of ilixadencel to sunitinib did not increase toxicity and the safety profile was consistent with previous experience with ilixadencel in combination with TKIs across a range of tumor types. The study continues to follow up patients for long-term survival.
The publication “Ilixadencel, a cell-based immune primer, plus sunitinib versus sunitinib alone in metastatic renal cell carcinoma: A randomized phase 2 study” is available on the European Urology Open Sciences website. For more, please click here.
ABOUT THE MERECA STUDY
MERECA is an exploratory, international, randomized, controlled and open-label Phase II clinical trial in which newly diagnosed, intermediate and poor risk metastatic renal cancer patients were enrolled. Based on a 2-to-1 randomization, patients received either two intratumoral doses of ilixadencel before nephrectomy (surgical removal of the tumor-affected kidney) and subsequent treatment with sunitinib or sunitinib therapy alone post-nephrectomy. The primary objectives of the study are to evaluate median OS and 18-months survival rates. Secondary objectives include evaluation of safety and tolerability, tumor response and immunological profiling including T cell infiltration.
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 gastrointestinal stromal tumors (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 blood-borne and solid tumors. Based in Sweden and the Netherlands, Immunicum is publicly traded on the Nasdaq Stockholm. www.immunicum.com
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
Mandalay Resources Corporation Announces the Results of Its Annual General Meeting of Shareholders25.5.2022 23:32:49 CEST | Press release
TORONTO, May 25, 2022 (GLOBE NEWSWIRE) -- Mandalay Resources Corporation ("Mandalay" or the "Company") (TSX: MND, OTCQB: MNDJF) is pleased to announce the results of its Annual General Meeting of Shareholders (the “Meeting”) held today virtually. All the resolutions presented at the Meeting were approved by the shareholders, with the votes cast by proxy representing 67.63% of the total shares outstanding as of the record date. Election of Directors The number of directors was fixed at seven members and each of the seven nominees listed in the Company’s Management Information Circular dated April 14, 2022, were re-elected to the Company’s Board of Directors. Abraham Jonker remains the lead independent director and Bradford Mills continues as Chair. Results of the votes cast by proxy are set out below. ResolutionVotes Cast by Proxy For% ForVotes Cast by Proxy Withheld% WithheldBradford A. Mills61,552,12099.95329,1930.047Abraham Jonker61,551,31399.95130,0000.049Amy Freedman61,547,53899.94
Galapagos to showcase commitment to rheumatoid arthritis care at the upcoming European League Against Rheumatism congress25.5.2022 22:01:00 CEST | Press release
Celebrating EULAR’s 75thanniversary with focus on a new era of rheumatoid arthritis care Mechelen, Belgium;25 May 2022, 22.01CET;Galapagos NV (Euronext & Nasdaq: GLPG) will present 11 abstracts at the European League Against Rheumatism (EULAR) congress 2022, 01-04 June, taking place in Copenhagen, Denmark. The broad range of abstracts include trial data analyses supporting the efficacy and safety profile of filgotinib andreal-world clinical data around alignment of prescribing between physicians and rheumatoid arthritis (RA) patients. Galapagos is also hosting a hybrid symposium: “Evolving patient care in RA: Can JAK inhibitors meet patient and physician expectations for RA treatment?”, which will include a discussion focused on aligning physician and patient treatment goals, looking at what is meant by ‘comprehensive care’ and how to ensure that people living with RA are part of treatment and care goal setting. A meet-the-expert session, “Patient-centred care in RA: cutting through th
trivago N.V. Announces Annual General Meeting of Shareholders25.5.2022 21:39:06 CEST | Press release
trivago N.V. (NASDAQ: TRVG) announced today that its annual general meeting of shareholders will be held on June 30, 2022 at the offices of NautaDutilh N.V., Beethovenstraat 400, 1082 PR Amsterdam, the Netherlands. The meeting will start at 3:00 p.m. CEST. The convening notice and explanatory notes for the general meeting are available free of charge in the Investor Relations section of trivago N.V.'s corporate website at ir.trivago.com. About trivago N.V. trivago is a leading global hotel search platform focused on reshaping the way travelers search for and compare hotels and alternative accommodations. Incorporated in 2005 in Düsseldorf, Germany, the platform allows travelers to make informed decisions by personalizing their hotel search and providing them access to a deep supply of hotel information and prices. trivago enables its advertisers to grow their businesses by providing access to a broad audience of travelers via its websites and apps. As of March 31, 2022, trivago has est
Correction: Changes in Nokia Corporation's own shares25.5.2022 19:20:00 CEST | Press release
Nokia Corporation Stock Exchange Release 25 May 2022 at 20:20 EEST Correction: Changes in Nokia Corporation's own shares Espoo, Finland – This is a correction to "Changes in Nokia Corporation's own shares" stock exchange release that was published today at 19:30 EEST. A total of 183 965 Nokia shares (NOKIA) held by the company were today transferred without consideration to participants of Nokia's equity-based incentive plans in accordance with the rules of the plans. The transfer is based on the resolution of the Board of Directors to issue shares held by the company to settle its commitments to participants of the plans as announced on 3 February 2022. The number of own shares held by Nokia Corporation following the transfer is 61 262 561. This version is otherwise identical but now includes an updated total number of Nokia shares transferred (incorrect number was 188 636). About Nokia At Nokia, we create technology that helps the world act together. As a trusted partner for critical
Ultimovacs’ Clinical Data in Journal for ImmunoTherapy of Cancer Show Long-term Dynamic T Cell Responses with UV1 and Checkpoint Inhibitor Synergy25.5.2022 18:45:00 CEST | Press release
Data from three trials of UV1 show dynamic T cell responses, lasting up to 7.5 years UV1-specific immune responses associated with longer clinical survivalSynergy between UV1 vaccination and checkpoint inhibition Oslo, 25 May2022: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical stage leader in immune stimulatory vaccines for cancer, announced the publication of long-term follow-up data on UV1 in the Journal for ImmunoTherapy of Cancer (JITC). The data show that dynamic UV1 specific immune responses last up to 7.5 years, are associated with longer survival and are enhanced when UV1 is used in combinations with checkpoint inhibitors. “It is important to be able to share this validating data with our research and clinical colleagues through JITC. The data demonstrate highly durable UV1-induced immune responses that are associated with substantially longer overall survival and boosted by checkpoint inhibitors. This is strong support for Ultimovacs’ broad Phase II program combining UV1