We expedite the development of advanced medicinal products, from preclinical research to clinical trials to regulatory approval.
Thirty-seven million people live with HIV, including 1.8 million children.
Twenty million new cancer cases in 2020 with over 9.7 million deaths worldwide.
Six thousand genetic disorders, many of which are fatal or debilitating.
Only 25% of eligible patients receive CAR-T cell therapies in the United States
Less than 1% of patients in low- and middle-income countries receive life-saving cellular gene therapies
The price for a one-time advanced therapy is at least $350,000 and can be more than $3,000,000, and that does not including hospital costs.
These are just some of the reasons why there is an urgent need for affordable, accessible advanced medicines.
Advanced Medicines Research and Development
As technology evolves, it is important that they are developed and manufactured affordably so they become accessible to all in need.
We innovate technologies that support the development and implementation of advanced medicinal candidates for specific diseases.
Here’s how we do this:
- Conducting, collaborating, and supporting basic research
- Design and develop advanced medicinal candidates at our laboratories and with our collaborating partners
- Conducting and facilitating pre-clinical studies to prepare curative medicinal candidates for clinical testing
- Collaborating with our network of clinical centers to establish safety and efficacy of advanced medicinal candidates in clinical trials
- Working with our partners to facilitate distributive or place-of-care manufacturing for approved autologous gene-modified cell products at hospitals
- Conducting and supporting pivotal clinical trials and regulatory approval of advanced medicinal candidates
Enabling innovation and implementation of technologies that are important for affordable manufacture and distribution of advanced medicinal cures.
CAR-T Cell Therapy for HIV
CAR-T cells have shown tremendous success in treating cancer and autoimmune disease. Our team is developing an anti-HIV CAR-T cell therapy for HIV-1, the virus that causes AIDS if left untreated to replicate in the body and kill CD4+ T cells. This therapeutic candidate is presently being evaluated for safety an efficacy in a phase I/II clinical trial in the USA.
Stem Cell gene therapy for Sickle Cell Disease (SCD) and Beta-Thalassemia (BT)
Stem cell gene therapy cures for Sickle Cell Disease (SCD) and a related condition, Beta-Thalassemia (BT) have been developed and approved by the FDA in the US, but at a cost of over $2,000,000 for the product, there are significant issues for affordable access to these products. Our team is developing affordable versions of these advanced medicines at a fraction of the cost.
CAR-T cell therapy for Leukemia and Lymphoma
CAR-T cell therapy for the treatment of Leukemia and Lymphoma have been developed and FDA approved products are available in the USA. However, these therapies target a single protein on the surface of cancer cells, where the target on the protein can be lost, resulting in relapse of the disease. Our team has developed a multi-targeted CAR-T cell therapeutic candidate for treatment leukemia and lymphoma that addresses relapse due to the loss of the target on the protein.
