Mendus is focused on developing active immunotherapies to improve long-term survival in cancers, including blood-borne tumours, that are underserved by current immunotherapies, such as immune checkpoint inhibitors. The company’s lead clinical programme, vididencel, is an off-the-shelf cellular immunotherapy that is being developed as a maintenance therapy for acute myeloid leukaemia (AML).
There are five key reasons why Mendus may be considered an attractive investment opportunity.
First, the clinical data for vididencel in AML to date has been very encouraging.
Mendus’s most recent update, from the Phase II ADVANCE II trial testing vididencel as an AML maintenance therapy, showed favourable survival outcomes across the 20 patients in the trial. AML is a highly deadly disease, associated with high relapse rates following initial treatment success due to residual cancer cells. In the ADVANCE II trial, patients in first complete remission following high-intensity chemotherapy but with measurable residual disease were treated with vididencel. Importantly, at a median follow-up of 42 months, the majority of patients were alive and disease-free, with 11/20 patients in complete remission. Vididencel’s efficacy is believed to stem from its mechanism as an active immunotherapy, leading to long-term immune control over residual disease by the patient’s own immune system.
Second, vididencel is an off-the-shelf therapy.
It is stored frozen, shipped to hospitals on demand, and can be easily administered via intradermal injection, strongly supporting wide uptake and accessibility, assuming regulatory approval. The product is derived from the company’s proprietary DCOne cell line, meaning it does not require a patient’s own biological material. This offers strong competitive advantages compared to patient-derived cell therapies, which is what the cancer cell therapy market is currently limited to. The final vididencel end-product may be produced in large batches, offering improved scalability, tighter control in the supply chain and less susceptibility to external challenges, compared to products dependent on sourcing input material from patients.
Third, a key differentiating characteristic of Mendus is its manufacturing capabilities.
The company has developed a robust and scalable manufacturing process for vididencel. It is also engaged in a manufacturing alliance with NorthX Biologics, which is set up to support the production of vididencel from the pivotal stages of clinical development through to eventual commercialisation. This should mitigate the challenges faced by many cell therapy companies, such as those related to supply chain and delivery bottlenecks.
Fourth, the company has multiple upcoming inflection points.
The main near-term milestone will be reaching pivotal-stage readiness from the second half of 2025, including large-scale good manufacturing practice (GMP) production. This will support the launch of a global registrational trial from early 2026. Additional milestones include the next read-out of its ovarian cancer trial based on two-year survival follow-up, expected in the fourth quarter of 2025, and the potential launch of additional trials in the blood-borne tumour space.
Fifth, Mendus has a broad offering, mitigating its exposure to binary risk events.
Beyond the registrational trial preparations, the company is exploring vididencel’s potential in other AML settings, as well as in additional haematological malignancies. The ongoing Phase I trial in ovarian cancer has shown favourable initial data and the anticipated upcoming survival read-out may unlock the development of vididencel in this indication. Beyond vididencel, Mendus is also seeking partnering opportunities for its second clinical candidate, ilixadencel, which has shown promise in various solid tumours, and is developing a preclinical pipeline based on the use of its technology to expand natural killer (NK) cells for therapeutic purposes. Collectively, these additional programmes may deliver further upside to Mendus’s value proposition.
Published 2 April 2025
