VIDIDENCEL ADMINISTRATION LED TO BROAD IMMUNE ACTIVATION WITH INNATE AND ADAPTIVE IMMUNE RESPONSES OBSERVED

Mendus AB ("Mendus" publ; IMMU.ST), a biopharmaceutical company focused on immunotherapies addressing tumor recurrence, presented new clinical data from the Phase 2 ADVANCE II clinical trial in acute myeloid leukemia (AML) maintenance at the European Hematology Association (EHA) 2023 Hybrid Congress. The data demonstrate that vididencel treatment led to increased levels of activated, cancer-killing T cells and reduced levels of inhibitory, immune-suppressive T cells in the majority of patients. Patients with an MRD response, the primary endpoint of the study, had the highest levels of these functional tumor antigen-specific T cells and showed a trend towards higher levels of circulating antigen-presenting cells (APCs) and B cells following vididencel treatment. Altogether, the data provides a clear proof of the mechanism of action of Mendus' lead development program. The EHA 2023 poster is now available on Mendus website via the following link:

"Immunomonitoring is an important part of the ADVANCE II trial, providing in-depth analysis of the interaction between vididencel and the immune system. The results presented at EHA 2023 together with the data recently presented at the CIMT Annual Meeting demonstrate a clear correlation between the patients' immune status and immune responses observed following vididencel administration and the previously reported survival outcomes. Based on these results, priming the immune system to eradicate or control residual disease can be considered an effective strategy in AML", commented Jeroen Rovers, MD PhD, Chief Medical Officer at Mendus. "The ADVANCE II trial continues to evaluate patients in long-term follow-up with updated survival results expected for Q4 2023, while we are also preparing for a next Phase 2 clinical trial, a combination study with oral azacitidine as the current standard of care in AML maintenance."

At the time of the data cut for EHA 2023, analysis of circulating immune cells had been performed in 20 evaluable AML patients to investigate the immune system activation induced upon treatment with vididencel. Functional T-cell analysis showed vaccine induced responses (VIRs) to antigens present in vididencel in 17 out of 20 patients, with highest number of VIRs in MRD responders, providing a positive correlation of VIRs with clinical outcomes. Analysis of individual immune cell populations showed changes in both the innate and adaptive immune cell compartments, with higher levels of tumor-reactive T cells and reduced numbers of inhibiting LAG3-expressing T-cells measured in circulation.

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.

FOR MORE INFORMATION, PLEASE CONTACT:

Erik Manting

Chief Executive Officer

E-mail: ir@mendus.com

INVESTOR RELATIONS
Corey Davis

LifeSci Advisors, LLC

Telephone: + 1 212-915-2577

E-mail: cdavis@lifesciadvisors.com

MEDIA RELATIONS
Mario Brkulj

Valency Communications

Telephone: +49 160 9352 9951

E-mail: mbrkulj@valencycomms.eu

Attachment

• 230612_Mendus_Post_EHA_Update_ENG