DURABLE VACCINE–INDUCED T-CELL RESPONSES OBSERVED IN THE MAJORITY OF VIDIDENCEL-TREATED PATIENTS
Mendus AB (“Mendus” publ; IMMU.ST), a biopharmaceutical company focused on immunotherapies addressing tumor recurrence, today announced the presentation of new clinical data from the Phase 1 ALISON ovarian cancer trial at the American Association for Cancer Research (AACR) Annual Meeting 2023 taking place April 14-19, 2023, in Orlando, FL, USA.
“The ALISON study is progressing well, and the initial read-out with respect to improvements in the patients’ immune cell status and T-cell responses induced by our vaccine are encouraging. As the data matures further in 2023, we plan to update the medical community as more immunomonitoring data and increasingly efficacy data becomes available,” commented Jeroen Rovers, MD PhD, Chief Medical Officer of Mendus. “Overall, the ALISON study continuous to represent an important step forward in adressing solid tumor indications with vidicencel and indicate the program’s potential as a novel immunotherapy option in ovarian cancer.”
The Phase 1 ALISON trial is a single-center, open-label trial evaluating safety and efficacy of vididencel (DCP-001) in High-Grade Serous Ovarian Cancer (HGSOC) patients, a patient population faced with a higher risk of chemotherapy resistance and disease relapse. The ALISON trial evaluates the use of Mendus’ cell-based relapse vaccine to prevent disease recurrence after primary treatment with chemotherapy and debulking surgery. The primary endpoint of the trial is the number of patients with vididencel induced antigen-specific T cells responses in peripheral blood after treatment. Key secondary endpoints include safety and tolerability after repeated vididencel dosing, as well as recurrence free survival (RFS) and overall survival (OS) during a 2-year follow-up period.
Vididencel is administered after standard of care treatment, which includes chemotherapy and surgery, and is initiated after a wash-out period of 6 weeks following the last cycle of chemotherapy. Patients receive 4 bi-weekly vaccinations and 2 additional booster vaccinations, resulting in a 22-week treatment period. At the data cut-off for AACR abstract submission, a total of 7 patients had been included in the trial and 6 had already completed the full vaccination schedule. All but 1 patient showed at least one sustained vaccine induced T-cell response to either of 4 tumor-associated antigens measured in the study. Further analysis of the immune profiles of these patients during the vaccination showed a general activation of the innate and adaptive immune system. At the week 22-visit, 4 out of 6 patients had no clinical signs of progressive disease, while 2 patients had progressed during the treatment. Vididencel continued to be well-tolerated, with only mild to moderate adverse events observed in the trial.
Data will be presented as a poster presentation. The corresponding poster abstract was released by the conference organizer AACR on March 14, 2023.
Program: Vididencel (DCP-001)
Abstract title: Evaluation of immune response to tumor associated antigens in patients with highgrade serous ovarian cancer vaccinated intra-dermally with DCP-001, an allogeneic, cancer cell-based vaccine
Abstract Number: 2600
Session category: Clinical Research Excluding Trials, Immunology
Session title: Immunomodulatory Agents and Interventions
Date and time: Apr 18, 2023 9:00 AM – 12:30 PM ET
ABOUT THE AACR ANNUAL MEETING
The AACR Annual Meeting is the focal point of the cancer research community, where scientists, clinicians, other health care professionals, patients, and advocates gather to share the latest advances in cancer science and medicine. From population science and prevention; to cancer biology, translational, and clinical studies; to survivorship and advocacy; the AACR Annual Meeting highlights the work of the best minds in cancer research from institutions all over the world.
ABOUT MENDUS AB (PUBL)
Mendus is dedicated to changing the course of cancer treatment by addressing tumor recurrence and improving survival outcomes for cancer patients, while preserving quality of life. We are leveraging our unparalleled expertise in allogeneic dendritic cell biology to develop an advanced clinical pipeline of novel, off-the-shelf, cell-based immunotherapies which combine clinical efficacy with a benign safety profile. Based in Sweden and The Netherlands, Mendus is publicly traded on the Nasdaq Stockholm under the ticker IMMU.ST. http://www.mendus.com/
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