Our Science: IGX12
FIRST POTENTIAL mAb TREATMENT FOR INFERTILITY
Igyxos’ initial clinical candidate is IGX12, a first-in-class humanized monoclonal antibody (mAb) with a unique mechanism of action that enhances the activity of Follicle Stimulating Hormone (FSH). Evaluated in rigorous pre-clinical models, IGX12 is supported by a foundation of compelling data supporting its future advancement into the clinic. In these studies, IGX12 has been shown to:
• Increase FSH potency and efficacy in cellular signaling
• Enhance FSH potency across several in vivo female animal models
• Boost seminal vesicle weight and spermatogenesis in male rat and murine models
With its unique MOA for increasing FSH potency and efficacy, IGX12 has potential to be a transformational therapy in the treatment of infertility.
TARGETING UNMET FERTILITY SOLUTION NEEDS IN MEN AND WOMEN
Initial infertility treatment indications for IGX12 are Oligoasthenoteratospermic (OATS) males and in vitro fertilization (IVF) in women.
By boosting the efficacy and potency of FSH, IGX12 has broad potential to significantly improve spermatogenesis in men with oligozoospermia where, as of now, no treatment is available. IGX12 would then offer a new path in men infertility treatment whereas today, the only possibility is to treat women even if the cause of infertility comes from men.
IGX12 can also improve IVF treatment and outcomes by increasing the success rate of ovulation, while reducing FSH injections. The treatment burden of IVF requires multiple FSH injections with a success rate of only 40 to 50 % of birth in couples after an average of four-to-five treatments.
We are also evaluating IGX12 in the orphan indication of fertility treatment in HH, a life-altering disease characterized by the production of little or no sex hormones that can lead to little or no spermatogenesis.
IND-ENABLING STUDIES UNDERWAY
We have commenced IND-enabling studies for IGX12 and entered clinic in the third quarter of 2023 by a Single Ascending Dose study in both female and male volonteers. We have partnered with global industry leaders for the generation of IGX12 clinical material. Our key partners include Merck Biodevelopment/EMD Millipore and Baccinex for chemistry, manufacturing, and controls (CMC) development, ERBC from preclinical studies and CRS (Berlin) for clinical studies.