Medigene (FRA:MDG1) has preliminary evidence its bet on autologous dendritic cell vaccines could pay off. The release of encouraging data from an early-phase trial and compassionate-use program sparked a surge in investor interest in Medigene, driving up its stock by more than 30% in a day.
|Medigene CEO Frank Mathias|
Munich, Germany-based Medigene made the gains after its academic partners presented data at the American Society of Hematology meeting. The posters cover a Phase I/II investigator-initiated trial and a compassionate-use program, both of which gave the dendritic cell vaccine in development at Medigene to patients with acute myeloid leukaemia (AML). In the Phase I trial, 6 people who were ineligible for allogeneic stem cell transplantation were treated with the vaccine, which is made by isolating a patient's monocytes, turning them into dendritic cells and adding tumor-specific antigens.
The safety and toxicity profile from the Phase I trial encouraged the researchers to advance the vaccine to the next stage of development, resulting in a the number of patients enrolled in the study rising to 10, half of whom have completed the vaccination schedule. T cell responses related to the dendritic cell vaccination have been identified in the small pool of patients analyzed to date, giving Medigene cause for optimism as the clinical trial starts to gather data on long-term disease control and immunological responses.
Medigene's optimism was further buoyed by a look at responses of AML patients treated with the vaccine on a compassionate-use basis. The program gave the vaccine to four elderly people for whom neither intensive chemotherapy or allogeneic stem cell transplantation were deemed to be appropriate therapies. Immune responses varied from patient to patient. One recipient experienced a strong and persistent CD8 response, while no significant changes were detected in another of the participants. It is now 21 months since the patient who with the CD8 response had chemotherapy.
Collectively, the two studies hint at the potential of the candidate, although other cancer vaccines have shown early promise only to falter when put through larger, more rigorous clinical trials. The dendritic cell vaccine is at the vanguard of Medigene's push to establish itself as a major player in immuno-oncology, a space in which it is perhaps currently best known as the company that spun out Adaptimmune ($ADAP) and Immunocore.