Nonclinical reproductive and developmental safety evaluation of the MAGE-A3 Cancer Immunotherapeutic, a therapeutic vaccine for cancer treatment

- Evaluation of the potential toxic effects of the MAGE-A3 Cancer Immunotherapeutic.
- Combination of a cancer-specific antigen (MAGE-A3) with an immunostimulant (AS15).
- Male mating performance (rats) or fertility (rats and monkeys) were unaffected.
- Embryo-fetal or offspring development (rats) were not affected by treatment.
- Repeated injections of MAGE-A3 in animals did not indicate reproductive toxicity.

We assessed potential toxic effects of the MAGE-A3 Cancer Immunotherapeutic on female fertility and embryo-fetal, pre- and post-natal development in rats and on male fertility in rats and monkeys. Three groups of 48 female (Study 1) or 22 male (Study 2) CD rats received 5 or 3 injections of 100 μL of saline, AS15 immunostimulant, or MAGE-A3 Cancer Immunotherapeutic (MAGE-A3 recombinant protein combined with AS15) at various timepoints pre- or post-mating. Male Cynomolgus monkeys (Study 3) received 8 injections of 500 μL of saline (n = 2) or the MAGE-A3 Cancer Immunotherapeutic (n = 6) every 2 weeks. Rats were sacrificed on gestation day 20 or lactation day 25 (Study 1) or 9 weeks after first injection (Study 2) and monkeys, 3 days or 8 weeks after last injection. Injections were well tolerated. Female rat mating performance or fertility, pre- and post-natal survival, offspring development up to 25 days of age, and male mating performance (rats) or fertility parameters (rats and monkeys) were unaffected.