VAXIMM AG
VAXIMM Announces First Results from Phase I/II Trial in Progressive Glioblastoma with Oral T-cell Immunotherapy VXM01 in Combination with PD-L1 Inhibitor Avelumab to be Presented at ASCO20 Virtual
DGAP-News: VAXIMM AG
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VAXIMM Announces First Results from Phase I/II Trial in Progressive Glioblastoma with Oral T-cell Immunotherapy VXM01 in Combination with PD-L1 Inhibitor Avelumab to be Presented at ASCO20 Virtual – Results from first nine patients include three objective responses – Two of these patients are progression-free >6 months – VXM01 in combination with avelumab was safe and produced specific immune responses – Results accepted for an oral presentation at conference Basel (Switzerland) and Mannheim (Germany), May 14, 2020 – VAXIMM AG, a Swiss/German biotech company focused on developing oral T-cell immunotherapies, today announced that the safety run-in results from a Phase I/II study in progressive glioblastoma with its lead product candidate, oral VXM01, in combination with the PD-L1 inhibitor avelumab are being presented as an oral presentation at the 2020 American Society of Clinical Oncology (ASCO) Virtual Meeting being held May 29-31, 2020. The trial is part of a collaboration with Merck KGaA, Darmstadt, Germany and Pfizer Inc. The presentation, entitled, “Oral DNA vaccination targeting VEGFR2 combined with anti-PD-L1 avelumab in patients with progressive glioblastoma: Safety run-in results-NCT03750071,” will be given as part of the Developmental Therapeutics – Immunotherapy Oral Session. The abstract (#3001) is available on the ASCO website here, and the presentation will be available on demand beginning Friday, May 29th at 8:00 AM ET/2:00 PM CET. The multicenter, open-label Phase I/II trial (EudraCT #: 2017-003076-31) is designed to evaluate the safety and tolerability of VXM01 in combination with the PD-L1 inhibitor avelumab in 30 patients with recurrent glioblastoma at multiple clinical sites in Europe. Secondary endpoints include objective response rate (ORR), clinical response using immune-response assessment in neuro-oncology (iRANO) criteria and immunological assays. Nine patients treated with VXM01 and avelumab in 2 dose groups had completed the safety run-in phase. No treatment-related toxicities were observed in the 9 patients treated. Three partial responses according to iRANO criteria with tumor reductions of 58, 81 and 95% to baseline were reported. Two of these patients have been progression free for more than 6 months. Furthermore, significant VEGFR2-specific T-cell responses were measured in several patients, and pre-existing intra-tumoral T-cells were positively associated with the effectiveness of the immunotherapy combination. Prof. Wolfgang Wick, MD, Chairman, Department of Neurology, Heidelberg University Hospital, Heidelberg, Germany, and principal investigator of the study, commented: “We are excited to see these highly encouraging initial results, including three partial responses, from this combination trial. The data seen so far support the scientific rationale that PD-L1 checkpoint inhibition may enhance the activity of the VXM01 vaccine. There is an urgent need for effective treatments for this deadly form of brain cancer.” Avelumab Approved Indications The US Food and Drug Administration (FDA) granted accelerated approval for avelumab (BAVENCIO(R)) for the treatment of (i) adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (mMCC) and (ii) patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. These indications are approved under accelerated approval based on tumor response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials. Avelumab is also currently approved for patients with mMCC in 50 countries globally, with the majority of these approvals in a broad indication that is not limited to a specific line of treatment. Avelumab Important Safety Information from the US FDA-Approved Label Common adverse reactions (reported in at least 20% of patients) in patients treated with BAVENCIO(R) monotherapy include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, peripheral edema, decreased appetite/hypophagia, urinary tract infection and rash. Common adverse reactions (reported in at least 20% of patients) in patients receiving BAVENCIO(R) in combination with axitinib include diarrhea, fatigue, hypertension, musculoskeletal pain, nausea, mucositis, palmar-plantar erythrodysesthesia, dysphonia, decreased appetite, hypothyroidism, rash, hepatotoxicity, cough, dyspnea, abdominal pain and headache. Grade 3-4 clinical chemistry and hematology laboratory value abnormalities reported in at least 10% of patients treated with BAVENCIO(R) monotherapy include hyponatremia, lymphopenia, GGT increased; in patients receiving BAVENCIO(R) in combination with axitinib, grade 3-4 clinical chemistry and hematology laboratory value abnormalities included blood triglyceride increased and lipase increased. For full Prescribing Information and Medication Guide for BAVENCIO(R), please see www.BAVENCIO.com. About VAXIMM VAXIMM also has a neoantigen program currently in preclinical development; the Company’s platform allows for fast generation and delivery of personalized T-cell cancer vaccines and may overcome key issues faced by other neoantigen approaches. VAXIMM has a strategic clinical trial collaboration with NEC Corporation for the development of personalized neoantigen cancer vaccines. VAXIMM also has a collaboration agreement with China Medical System Holdings (CMS), granting CMS full rights in China and other Asian countries (excluding Japan) to VAXIMM’s existing programs. VAXIMM’s investors include: BB Biotech Ventures, BCM Europe, BioMed Partners, CMS, M Ventures, NEC and Sunstone Capital. VAXIMM AG is headquartered in Basel, Switzerland. Its wholly owned subsidiary, VAXIMM GmbH, located in Mannheim, Germany, is responsible for the Company’s development activities. For more information, please see www.vaximm.com. Contact:
14.05.2020 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG. |