Regen BioPharma Inc focuses on the development of regenerative medical applications and cancer immunotherapies. The company intends to license, develop internally, or acquire therapies and advance them through Phase I and Phase II clinical trials. It seeks to either sell or license these applications or advance them further to Phase III trials based on efficacy indications from early trials.
Regen BioPharma Inc generates revenue through licensing agreements and potential…
Regen BioPharma Inc focuses on the development of regenerative medical applications and cancer immunotherapies. The company intends to license, develop internally, or acquire therapies and advance them through Phase I and Phase II clinical trials. It seeks to either sell or license these applications or advance them further to Phase III trials based on efficacy indications from early trials.
Regen BioPharma Inc generates revenue through licensing agreements and potential future commercialization of its therapeutic candidates. The company has entered into license agreements with Zander Therapeutics Inc and Oncology Pharma Inc for the development and commercialization of certain intellectual property. Revenue is expected from upfront payments, annual fees, royalties on net sales, and consideration from sublicensees.
The company operates through the following segments: HemaXellerate, dCellVax, tCellVax, DiffronC, DuraCar, and small molecule drugs.
- HemaXellerate: This segment involves a cellular composition of autologous stromal vascular fraction derived from adipose tissue containing endothelial progenitor cells and mesenchymal stem cells. It is intended to regenerate bone marrow function when re-infused into patients. The company filed an Investigational New Drug application with the FDA for HemaXellerate to treat drug-refractory aplastic anemia and has sought Orphan Drug Designation for this indication.
- dCellVax: This segment comprises autologous dendritic cells treated with an siRNA inhibitor of indoleamine-2,3-dioxygenase (IDO), an immunosuppressive enzyme. The company believes this enables the patient’s cells to attack cancers, particularly breast cancer. An IND application has been filed with the FDA to initiate a Phase I/II clinical trial for dCellVax in metastatic breast cancer.
- tCellVax: This segment involves removing immune cells from the patient, treating them with siRNA to inhibit NR2F6, and re-infusing them. The company believes blocking NR2F6 activates the immune system to kill tumors. An IND application has been filed with the FDA to initiate a Phase I clinical trial for tCellVax in patients with metastatic or inoperable solid tumors.
- DiffronC: This segment uses proprietary siRNA in vivo to inhibit cancer growth and activate T cells by targeting NR2F6. The company is currently in pre-clinical testing of this drug to optimize its delivery. DiffronC is intended to suppress tumor growth and enhance immune response.
- DuraCar: This segment consists of CAR-T cells treated with shRNA targeting the NR2F6 gene. The company expects these cells to have greater efficacy and persistence than conventional CAR-T cells. Pre-clinical testing is underway with contract research organizations to assess inhibition of NR2F6 and enhanced tumor-killing activity.
- Small molecule drugs: This segment includes patented small molecules that can both activate and inhibit NR2F6 activity. The company is currently in pre-clinical testing of these compounds. Inhibiting NR2F6 is expected to activate immune cells and kill tumors, while activating NR2F6 may suppress the immune system for autoimmune disorder treatment.
Regen BioPharma Inc operates in the highly competitive pharmaceutical and biologics industry, characterized by rapid technological advancement and significant resource disparities among competitors. The company aims to gain a competitive advantage by leveraging expert consultation to focus resources on high-potential projects. Its competitive position relies on its intellectual property portfolio and strategic licensing approach.
Regen BioPharma Inc serves patients with severe medical conditions such as drug-refractory aplastic anemia, metastatic breast cancer, and solid tumors. The company’s therapies are intended for individuals requiring advanced regenerative medicine and immunotherapy solutions. Specific customer names are not disclosed in the filing.