Preserving health
and quality of life

Mendus applies dendritic cell biology to design off-the-shelf immunotherapies that enable the body’s own immune system to build up active, long-lasting immunity against tumor cells.

Vididencel comprises irradiated leukemic-derived dendritic cells derived from a proprietary leukemic cancer cell line (DCOne). Upon intradermal injection, vididencel is phagocytosed by antigen-presenting cells present in the skin, which subsequently trigger broad immune responses against the tumor antigens carried by vididencel.

The intratumoral immune primer ilixadencel comprises pro-inflammatory dendritic cells from healthy donors, which are administered directly into the tumor. This leads to local inflammation in the tumor microenvironment and the triggering of anti-tumor immune responses.

Our preclinical pipeline focuses on the use of the DCOne platform for ex vivo expansion of immune cells for therapeutic purposes and the exploration of novel combination therapies.

Patient stories and reflections from leading researchers and experts in immuno-oncology, providing insight into medical needs, treatment experiences and emerging therapeutic advances.

Interview Tariq Mughal, Chief Medical Officer of Mendus 

Uncovering the future of immuno-oncology in blood cancers

Dr Tariq Mughal joined Mendus as Chief Medical Officer last May. He brings a combination of cademic and industry experience in hematology, oncology and pharmaceutical R&D to support the company’s late-stage clinical development strategy follow­ing successful Phase 2 data with the lead product vididencel in acute myeloid leukemia (AML).

Dr. Mughal, can you briefly introduce yourself and your journey into oncology?

TM: My career spans over 35 years across clinical practice, academia, and industry. I trained in London and later in the U.S., gaining board certification in hematology and medical oncology. I have dedicated much of my career to under­standing and treating blood cancers, especially chronic myeloid leukemia (CML). My early work alongside the late Professor John Goldman – one of the pioneers in CML and stem cell transplantation – was foundational. We helped shape treatment pathways that turned CML from a fatal disease into one of the most manageable cancers today, thanks largely to tyrosine kinase inhibitors like imatinib. In acute myeloid leukemia (AML), stem cell transplantation is still considered the only potentially curative treatment.

Why did you join Mendus, and what excites you about its mission?

TM: What drew me in was the opportunity to work on innovative immune-based therapies that can help achieve long term remissions and potential cure in diverse cancers. The lead product, vididencel, has the potential to improve outcomes in AML – an area where relapse is common and long-term survival remains very poor. Allogeneic stem cell transplantation, in which the immune system of the patient is replaced by a donor immune system, is a form of immunotherapy but its application is limited due to serious side effects, including transplant-related mortality and graft-versus-host disease. The long-term survival observed in a significant portion of patients treated with vididencel, combined with a robust safety profile makes it an attractive drug candidate. For me, joining Mendus was a chance to apply my clinical and industry insights to help shape and bring to market this therapy that can truly change lives.

What are the biggest unmet needs in blood cancer treatment today?

TM: In AML, even after initial successful chemotherapy, many patients relapse due to tiny traces of cancer [termed measurable residual disease (MRD)] that evade treatment and ‘dormant’ (quiescent) stem cells that are resistant to chemotherapy. This is a critical unmet need underscoring the critical need for effective post-remission therapies that can eliminate residual disease safely and effectively. In CML, despite impressive progress, only about a quarter of patients can stop therapy with tyrosine kinase inhibitors at 10 years without relapse—a concept known as treat­ment-free remission (TFR). The majority of patients either cannot safely discontinue their therapy or relapse soon after discontinuation and need to go back on treatment. These gaps are where active immunotherapies like vidi­dencel could make a transformative difference, allowing more patients to be cured without the need for life-long treatment.

Tell us more about the CADENCE trial and vididencel’s role in AML.

TM: The AMLM22-CADENCE trial, now underway in Australia with support from the Australasian Leukaemia and Lymphoma Group (ALLG), is a randomized Phase IIb trial evaluating vididencel in combination with oral azacitidine in high-risk AML patients who are in hematological remission but not eligible for a stem cell trans­plant procedure. The goal is to establish safety of the combined treatment and to demonstrate feasibility based on improved disease-fee survival. This follows the Phase IIa proof-of-concept data from the ADVANCE II trial in Europe, which showed that vididencel can significantly prolong survival in MRD-positive patients and represents a step-up towards a registration trial with vididencel in AML. Unlike traditional drugs, vididencel works by stimu­lating the immune system to recognize and target residual leukemia cells, offering a novel approach to establish long-term disease control in a relatively safe manner, with minimal impact on health and quality of life.

How is Mendus approaching treatment-free remission (TFR) in CML?

TM: Achieving and sustaining TFR is a major goal in CML management. Currently, around half of patients relapse when tyrosine kinase inhibitors (TKIs) are stopped. We believe vididencel could help by training the immune system to suppress residual disease, making remission more durable. We’re planning first-in-human trials in CML patients who have already reached deep molecular response, to test whether vididencel can either enable more patients to stop treatment or help maintain TFR longer. This could reduce both the physical burden of chronic drug use and the economic cost. We and many global CML leaders are optimistic vididencel can play a significant role in battling blood-borne tumors.

What are your initial thoughts about the development strategy for vididencel in AML and CML?

TM: Vididencel has shown to deliver long-term survival in AML and all the data we have collected so far indicate that it is a safe and broadly applicable post-remission treatment. We have not observed any serious product-related side effects and the vididencel mode of action as an active immunotherapy does not depend on specific mutations. It can therefore be combined with different AML backbone drugs and is broadly applicable across all subtypes of AML for patients in complete remission. The medical need in CML to improve TFR is high and CML offers a relatively large market opportunity. Our strategy to develop vididencel will therefore be focused on market registration in AML, while broadening the addressable patient populations in AML and opening up the CML indication. To capture the vididencel opportunity in myeloid malignancies, both acute and chronic, is the absolute priority for the company. In order to accomplish our mission we work closely with academic and industry experts, to validate our clinical trial strategy and deliver the associated milestones in the best possible way.

On a personal note, what keeps you motivated in this work?

TM: It always comes back to the patients. Working with patients in clinical practice for decades has shown me the real impact of safe and effective treatment – both its power and its limitations. I also co-founded a foundation in Tanzania in memory of my late mother, focused on CML care in under-resourced settings. It’s a full-circle moment – honoring where my family came from while advancing care globally. That dual perspective keeps me grounded and passionate about finding solutions that matter in the lives of people diagnosed with cancer.

Mendus presented updated survival data from the ADVANCE II Phase 2 trial during the American Society of Hematology (ASH) conference last December, which showed that the majority (13/20) of patients treated with vididencel were alive at a median follow-up of 41.8 months, with 11 out of the 20 patients still in first complete remission, without relapse. To hear first-hand what vididencel treatment can mean for AML patients, Mendus Director Clinical Operations Annelies Legters had a meeting in Bergen, Norway with Jacob, one of the participants in the ADVANCE II trial.  

 Jacob’s coughing started in March 2017 and by August it was continuous and now severe backpain and night sweats were making him miserable. He already struggled with heart and lung issues, but his health continued to decline further, and he became very sick. His wife, Ann, suspected something was seriously wrong and joined him at the doctor’s in Norway. Days after the appointment, Jacob was diagnosed with acute myeloid leukemia (AML). Due to his lung fibrosis, he was kept in a coma for six weeks during the first round of chemo.  

 With the first round over, he slowly woke and could only move his eyes, communicating with Ann and the medical team by blinking during the following months. A half year later he moved to rehab to regain some of the 20kg he had lost and to learn to walk and eat again. But with Jacob still battling AML, there were few options but to try a second round of chemo. This time he would undergo the treatment at home with Ann managing his care for the following months. Their children wore protective clothing when visiting to reduce the chance of infection. 

 “Going through chemo to fight my AML was incredibly difficult because of the painful side effects,” said Jacob. “I wouldn’t have made it if it weren’t for Ann supporting me during those difficult months.”   

 Still, after seven months of the second chemo round, Jacob wasn’t able to completely shake the disease as marked by the MRD (measurable residual disease). A fresh approach was crucial. In 2019 the hematologist in Oslo mentioned a new treatment in Bergen at the Haukeland University Hospital run by professor Bjørn-Tore Gjertsen. Jacob and Ann met with Bjørn to learn about the Advance II clinical trial, which used Mendus’ drug vididencel as a maintenance therapy for AML patients diagnosed with MRD.  

 “Hearing there was another option that could possibly work was fantastic news,” he said. “After two rounds of chemo and the horrible side effects, we were excited by  this opportunity.”  

 The treatment consisted of a series of injections of vididencel, a drug designed to use the body’s own immune system to build up active, long-lasting immunity against tumor cells. The biggest side effect was redness and some swelling around the injection site for a few days, far easier to manage than the side effects from his months on chemo.  

 “Bjorn and his team were very kind to us, and the experience of going through this clinical trial was well worth it given the close attention they received. The MRD is gone and while I still struggle with effects from the earlier chemo and my lung and heart issues, my quality of life has improved,” Jacob said. “Ann and I exercise every day together, taking walks in the forest or at the gym. We take this day by day and with our first grandchild set to join us in August we have a lot to look forward to.”