GENEIUS is focused on the development & commercialization of innovative autologous, adoptive T-cell therapies, which offer a more robust immune response to cancer compared to current approaches.
Clinical Efficacy in Human Trials
An academic sponsored, proof-of-concept study of the same T cells showed:
70% overall response rate (ORR); and
50% complete response (CR) with complete remissions after 5 years for half of those patients
in human, clinical trials. We believe that prior academic results, as well as our preclinical and manufacturing data suggest a high probability of success in Epstein-Barr Virus (EBV+) lymphoma.
Works in Solid Tumors
Evidence of efficacy in solid tumors; and
Highly durable response rates without significant toxicities in lymphoma
have been demonstrated in proof-of-concept clinical studies by academic centers in humans using natural T cells, like those produced by Geneius, by attacking a viral antigen associated with cancer. In contrast, CAR-T cells have not shown evidence of clinical effectiveness for solid tumors.
Mild Flu-Like Symptoms are the Only Side Effect
Patients treated with natural T cells, like those produced by Geneius, experience only mild flu-like symptoms as a side effect.
Cost is reasonable at 1/8th that of CAR-T
Community oncologists can provide this treatment. The physician does not lose the revenue from the patient as the physician does with other protocols whose severe side effects require the patient transfer to a major cancer center.
For 90% of cancer patients, we are meeting our FDA release criteria when we manufacture T cells from a patient’s blood draw for that patient. We expect to validate that these T cells manufactured by our improved commercial process will be as effective combating cancers as the same T cells were in the academic studies having been manufactured by their sub-optimal process. If we can continue to validate anywhere near this high level of being able to manufacture T cells for patients from their own blood, then we have the real potential to treat a far higher percent of patients than PD-1s like Merck’s Keytruda or Bristol-Myer Squibb’s Opdivo.