Amphera, a Dutch biotechnology company has been developing a new immunotherapy for pleural mesothelioma—MesoPher. In March 2019, the company announced they have recruited the first patients to participate in their Phase 2/3 study to investigate MesoPher as a second-line treatment option for pleural mesothelioma.
Currently, chemotherapy using a mixture of Alimta® (pemetrexed) and cisplatin drugs is the only drug combination therapy approved by the FDA to treat pleural mesothelioma. Amphera is attempting to change this by developing a secondary pleural mesothelioma therapy. If successful, it would give patients another treatment option if they stop responding to chemotherapy or experience complications.
Because of the limited treatment options for pleural mesothelioma, news of any new clinical trial investigating other therapies is exciting for the mesothelioma community.
Studying MesoPher Immunotherapy for Pleural Mesothelioma
DENIM is the name of Amphera’s new study looking into the immunotherapy for pleural mesothelioma drug called MesoPher. The study received funding from Horizon 2020, the European Union’s research and innovation program. A total of 230 adults with pleural mesothelioma have been recruited to participate at 6 mesothelioma centers in 5 European countries.
The Phase 2/3 clinical trial is open-labeled, meaning both researchers and participants will know which study group is receiving the treatment and which group is receiving standard chemotherapy. DENIM is also randomized, so study participants will be divided between the control and treatment groups randomly.
Participants in the treatment group (Arm A) will receive 3 bi-weekly injections of MesoPher with chemotherapy, along with 2 additional doses of MesoPher at weeks 18 and 30. Participants in the control group (Arm B) will only receive chemotherapy.
The primary goal is to research how well MesoPher works in targeting tumors and its effectiveness as a maintenance treatment after chemotherapy. The result the researchers are looking most closely at is the overall length of patient survival.
Ilona Enninga, COO of Amphera, communicated her enthusiasm for the successful trial recruitment in an Amphera press release. “We are delighted to announce that the first patients have been recruited in our pivotal study. For Amphera, the start of the study is a major milestone in our strategy to bring our therapy [sic.] to patients.”
About MesoPher Immunotherapy
MesoPher is made of immune system cells with heightened tumor-detecting and killing capabilities. Researchers develop a tailored MesoPher therapy for each individual patient.
The procedure starts with researchers collecting a blood sample. Immature dendritic cells (immune cells) are taken from the sample and loaded with PheraLys, which contain mesothelioma tumor-associated substances. The addition of PheraLys to these immature immune cells creates activated mature dendritic cells. The activated immune cells get injected back into the patient, causing an immune response for cells to attack the tumor.
In an earlier phase 1/2 MesoPher study, the therapy was well-tolerated by patients. The study showed that MesoPher caused an immune response in all patients. All patients benefitted from the treatment, either showing stable disease or partial response on imaging tests.
Amphera is currently leading 3 clinical programs to test MesoPher. Their most advanced program is this current phase 2/3 study on immunotherapy for pleural mesothelioma. The second study is a Phase 2 trial for peritoneal mesothelioma—in the abdominal cavity. The third study entering clinical phase is researching an undisclosed cancer type.
Amphera is a biotechnology company that works to develop immunotherapies, specifically dendritic cell therapies to treat cancer.
The company was established in the Netherlands in 2012 and has since been involved in several clinical programs to investigate the effectiveness of their most promising therapy, MesoPher.
The Search for Effective Mesothelioma Maintenance Drugs
Even though chemotherapy is the only approved drug therapy for pleural mesothelioma, a high number of patients stop responding to it after a while and experience bad side effects.
New approaches to mesothelioma therapy are needed more than ever to improve the prognosis and quality of life for patients. New clinical trials investigating secondary therapies, such as MesoPher immunotherapy for pleural mesothelioma, will support patients who have already gone through chemotherapy and have either stopped seeing results or have relapsed.
If you are interested in undergoing new mesothelioma therapies, please speak with your mesothelioma specialist. Or contact our Patient Advocates to be connected with a top mesothelioma doctor or clinical trial near you.