Stichting Onderzoek Cancer Center Amsterdam

A pivotal Boston Scientific study’s results were presented at the Heart Rhythm Society’s annual meeting and published in The New England Journal of Medicine. A six-month trial showed that Boston Scientific’s pairing of modular, wireless implants for managing discordant cardiac rhythms—and correcting dangerous ones—could be a successful approach, and the devicemaker has its heart set on an FDA approval for the system in 2025. The company linked its leadless Empower pacemaker with its Emblem subcutaneous implanted defibrillator. The approach allows one device to keep the heart from beating too fast or too slow, while the other stands by to deliver a shock to interrupt potentially fatal arrhythmias. The Emblem’s design aims to avoid some of the long-term complications seen with traditional implantable cardioverter defibrillators (ICDs) that have generators wired into the heart through the veins, such as infections; its less invasive route places leads under the skin but outside the rib cage. However, that prevents the device from also addressing bradycardia and tachycardia with direct pacing support.  That’s where Empower comes in. The leadless pacemaker, currently under development, is embedded inside the heart’s chambers to painlessly help get its beat back on track. The two devices communicate with each other wirelessly to sense abnormal rhythms, trigger the appropriate therapy and monitor the result. According to the pivotal study’s results—which were presented at the Heart Rhythm Society’s annual meeting and published in The New England Journal of Medicine—communication tests showed a success rate of 98.8%, and 97.5% of the trial’s 162 evaluated patients saw no major leadless pacemaker complications during implantation or after half a year. In addition, 61.3% of arrhythmia episodes were successfully stopped by antitachycardia pacing, with no cases in the remaining 38.7% being attributed to communication failure. “It is the first system in which medical devices, which are implanted separately in the body, are in contact with each other and work together,” said study leader Reinoud Knops, M.D., Ph.D., a professor of cardiology at Amsterdam UMC. “Its development will reduce the number of complications and invasive procedures all while maintaining patient safety.” “These findings are noteworthy, as high percentages of communication success and pain-free termination of spontaneous arrhythmia episodes indicate a potential upgrade pathway for patients currently implanted with [a subcutaneous ICD] who develop a need for [anti-tachycardia] or pacing,” said Knops.  According to Boston Scientific, all Emblem devices, with more than 130,000 already implanted worldwide, could be paired in the future with a newly placed Empower pacemaker. The company estimates that about 75% of ICD patients do not require pacing support at the time of their first implant procedure, while about 2% develop the need for it annually. “Instead of subjecting all patients to the risks of more invasive approaches, such as placing leads in the heart or tunneling them under the sternum to provide therapies they might not require, these data indicate physicians may have the opportunity to tailor therapy to the patient's individual needs and health,” Boston Scientific’s global chief medical officer, Kenneth Stein, M.D., said in a statement.

Press Release Stockholm, Sweden, December 4, 2023 Mendus AB (“Mendus” publ; IMMU.ST), a biopharmaceutical company focused on immunotherapies addressing tumor recurrence, today announced it will host a virtual KOL Event on December 14, 2023 at 9:00 AM ET, featuring Dr. Arjan van de Loosdrecht, Professor of Hematology at Amsterdam UMC and Principal Investigator of the ADVANCE II trial, who will discuss the current treatment landscape for patients with Acute Myeloid Leukemia (AML) and the development of Mendus’ lead product candidate vididencel as a potential AML maintenance therapy. To register, click here. The event will focus on the new survival data being presented at the American Society of Hematology (ASH) Annual Meeting, taking place December 9-12, 2023. The results will include relapse-free and overall survival data from the ongoing ADVANCE II monotherapy Phase 2 trial and immunomonitoring data. A live question and answer session will follow the formal presentations. About Dr Arjan van de LoosdrechtDr. Arjan van de Loosdrecht, Professor of Hematology at Amsterdam UMC, passed Medical School (cum laude) in 1989 at the VU University Medical Center in Amsterdam (VUmc), The Netherlands. After a 4th years scientific laboratory training in cell biology, immunology and hematology he received his PhD graduation (cum laude) in 1993 at the department of Hematology (VUmc) on the thesis; ‘Monocyte mediated cytotoxicity in acute myeloid leukemia; Mechanisms and clinical implications’. In 1995 he graduated in Immunology. From 1993-1998 he followed clinical training in Internal Medicine followed by a fellowship in hematology (Department of Internal Medicine and Hematology at the Groningen University Medical Center, Groningen, Netherlands). From 2000, he is a staff member, since 2009 an associate professor and since 2012 a full professor of hematology at the department of Hematology, Amsterdam UMC, location VUmc, Amsterdam. His particular scientific experiences and interests are on translational hematology. He is project leader/principal investigator of the preclinical and translational immunotherapy programs in myeloid leukemia (AML) and myelodysplastic syndromes (MDS). The major research lines focus on the immunopathogenesis of MDS/AML and on the development of leukemic dendritic cell vaccines for active specific immunization in patients with minimal residual disease (MRD) in AML and MDS. Since 2016 he is coordinator of HORIZON2020, AML-VACCiN program dealing with Dendritic Cell vaccination in AML and PI of the clinical program. He is project leader/principle investigator of clinical (translational) programs dealing with the treatment of low and high risk MDS. Regarding MDS, research focuses on the implementation of flow cytometry in the diagnosis, prognostication and monitoring of MDS. As such he is participant of the HORIZON2020 MDS-Right program. He is chair of the working group MDS of the Dutch Society of Cytometry on the implementation of flowcytometry in MDS and initiated a platform within the ELN on the implementation of flowcytometry in MDS in Europe. In addition, he is chair of the Database Sharing Committee of the International Working Group for Prognosis of MDS (IWG-PM) who developed the revised-IPSS for MDS.​ For more information, please contact:Erik Manting, CEOE-mail: ir@mendus.com 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/ ABOUT VIDIDENCELVididencel is an off-the-shelf immunotherapy which is being developed as a cancer maintenance treatment, aimed at improving disease-free survival following first-line treatment. Vididencel is currently studied in a Phase 2 monotherapy trial in acute myeloid leukemia (AML) and a Phase 1 safety and feasibility trial in ovarian cancer. In December 2022, positive results from the ADVANCE II monotherapy Phase 2 trial in AML were presented at the American Society of Hematology (ASH) Annual Meeting. The analysis demonstrated the potential of vididencel to induce durable relapse-free survival in the majority of patients. Vididencel has received Orphan Drug Designation in Europe and the US and Fast Track Designation in the US for the treatment of AML. Mendus has secured a manufacturing alliance with NorthX Biologics for large-scale production of vididencel. Attachment 231204_Mendus KOL Event_ENG

Press Release Stockholm, Sweden, November 3, 2023 Mendus Phase 1 vididencel clinical trial results in AML and high-risk MDS patients published in peer-reviewed medical journal Publication provides additional clinical evidence that vididencel has strong potential as a new maintenance therapy in AML and high-risk MDS patientsPatients with low disease burden have the best chance to respond to vididencel treatment, supporting the maintenance therapy setting currently pursued in the ADVANCE II Phase 2 trialPatients with adverse cytogenetic risk profile may still respond to vididencel therapyResults also indicate that vididencel can be safely and effectively combined with azacitidine Mendus AB (“Mendus” publ; IMMU.ST), a biopharmaceutical company focused on immunotherapies addressing tumor recurrence, today announced the publication of additional Phase 1 clinical trial data on its lead development program vididencel in the peer-reviewed medical journal HemaSphere. The data supports the potential of vididencel as a novel acute myeloid leukemia (AML) maintenance therapy and provides valuable insights for the current and future clinical trials with vididencel in AML and high-risk MDS. The publication, titled “Durable Responses and Survival in High-Risk Myelodysplastic Syndrome and Acute Myeloid Leukemia Patients Receiving the Allogeneic Leukemia-derived Dendritic Cell Vaccine DCP-001”, and written by researchers from the Amsterdam UMC, Cancer Center Amsterdam and Erasmus University Medical Center, describes the long-term follow up data and additional patient characteristics from the Phase 1 clinical trial evaluating vididencel (DCP-001) in acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS). “There remains a high medical need for new treatment options in AML and MDS. The Phase 1 study with vididencel demonstrated promising signs of efficacy and a benign safety profile, supporting the continued evaluation of this novel immunotherapy as a maintenance treatment, either as a monotherapy or in combination with other treatments,” said Prof. Dr. Arjan van de Loosdrecht, Professor of Hematology at Amsterdam UMC and Principal Investigator in the trial. “Since the completion of the Phase 1 trial, the knowledge in the medical community with respect to relapse dynamics, MRD and maintenance therapy in general has improved and we hope to see the combined impact of this more profound body of expertise in subsequent studies, including the ongoing ADVANCE II trial.” “In addition to a positive overall outcome based on safety and feasibility of vididencel in AML and high-risk MDS, the Phase 1 trial data support the positioning of vididencel as a maintenance therapy for patients with low tumor burden, but with a high risk of disease relapse. This is the basis of our ongoing ADVANCE II Phase 2 monotherapy study, which has demonstrated the potential of vididencel to reduce residual disease and prolong disease-free survival in AML patients in complete remission, but with measurable residual disease (MRD). The Phase 1 trial data also indicate that vididencel can be safely and effectively combined with azacitidine,” said Jeroen Rovers, MD, PhD, Chief Medical Officer at Mendus. In the Phase 1 clinical trial 12 patients were treated with vididencel (product ID: DCP-001), six patients with AML, three patients with AML with prior MDS and three patients with MDS with excess of blasts. Seven out of twelve patients showed a response to treatment; five patients showed progression of disease. The main discriminating variables in favor of response were patients who entered the study either in complete remission or who had stable disease status and a low percentage of blasts in the bone marrow at study entry. Importantly, there was no association found between response and disease risk classification with the majority of responding patients having an adverse cytogenetic risk profile, which is highly encouraging given the difficulty in effecting positive outcomes for these patients with a poor prognosis. In the seven responders, a median relapse free survival (RFS) of 420 days (≈ 14 months) and a median overall survival (OS) of 1090 days (≈ 36 months) was observed as compared to a median OS of 144 days in the five non-responders. The longest surviving patient experienced an RFS of 1,849 days (≈ 5 years) and OS of 2,160 days (≈ 5.9 years) after treatment with vididencel. In a subset of three patients, who initially responded to vididencel but later relapsed, post-vaccination treatment with azacitidine was evaluated and resulted in one complete remission and two partial responses. The data suggest that azacitidine and vididencel may act synergistically. The publication is available on the HemaSphere website. For a link to the article, please click here. FOR MORE INFORMATION, PLEASE CONTACT: Erik Manting, CEO E-mail: ir@mendus.com 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/ ABOUT VIDIDENCEL Vididencel is an off-the-shelf immunotherapy which is being developed as a cancer maintenance treatment, aimed at improving disease-free survival following first-line treatment. Vididencel is currently studied in a Phase 2 monotherapy trial in acute myeloid leukemia (AML) and a Phase 1 safety and feasibility trial in ovarian cancer. In December 2022, positive results from the ADVANCE II monotherapy Phase 2 trial in AML were presented at the American Society of Hematology (ASH) Annual Meeting. The analysis demonstrated the potential of vididencel to induce durable relapse-free survival in the majority of patients. Vididencel has received Orphan Drug Designation in Europe and the US and Fast Track Designation in the US for the treatment of AML. Mendus has secured a manufacturing alliance with NorthX Biologics for large-scale production of vididencel. Attachment 231103 Mendus_HemaSphere_Publication_ENG_FINAL