Munich-based biotech, Medigene, has been given permission to begin clinical trials for its T cell receptor therapy, MDG1011, in patients with various blood cancers.
Medigene is developing personalized T cell-based immunotherapies, which have the potential to treat both solid tumors and blood cancers. The company has been given the go-ahead by the relevant regulatory and ethics committees to begin a Phase I/II study with its lead modified T cell receptor therapy, MDG1011. This means that the manufacturer of Medigene’s modified T cells will now begin to produce the materials required for the study. This news has resulted in an increase in the biotech’s stock price by around 6%.
Led by its CEO, and one of the best female entrepreneurs in biotech, Dolores Schendel, Medigene has developed T cell receptor (TCR) technology that arms T cells with tumor-specific receptors, boosting their capacity to detect and kill cancers. It is hoped that this immunotherapy approach will overcome the patient’s tolerance for cancer cells and the tumor-induced immunosuppression by modifying the patient’s T cells.
The Phase I part of the trial will be a dose-escalation study, testing MDG1011 in three indications, acute myeloid leukemia, myelodysplastic syndrome, and multiple myeloma. Once treatment is complete, all patients will be monitored over a 4-week period to see if they meet the study’s endpoints, which will look at safety, feasibility, and overall response rate, with further follow-ups at 3 and 12 months.
In Phase II, two indications will be taken forward and MDG1011’s capacity to treat the conditions will be looked at more closely. The study will again look at safety and overall response rate, but also consider secondary endpoints, including the duration of response, time to progression, progression-free survival, overall survival, and quality of life.
TCRs are one of the exciting new immunotherapy approaches being developed for the treatment of cancer alongside CAR-T cell therapies. One company that is working on them is Adaptimmune, whose customizable technology has attracted investment from GSK and is being tested in Phase I/II trials. Cell Medica acquired Catapult Therapy TCR, a company set up by UK’s Cell & Gene Therapy Catapult, meaning the British biotech now has the rights to its TCR candidate for solid tumors. Meanwhile, BioNTech hopes to combine CAR-T and TCR technology with mRNA to produce personalized cancer immunotherapies.
Following the FDA approvals of Novartis’ Kymriah and Gilead’s Yescarta in 2017, TCR technology is playing catch up with CAR-T. However, with concerns over its safety, with devastating side effects like cytokine storm observed in some patients, TCR may have a way into the market if it can prove itself to be a safer alternative.
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