Cytocom’s’ Business Development priorities are:
- Development of IRT-103 for Pediatric and Adult Crohn’s that can reach Phase III within 12 months.
- Request Fast Track and Break through therapy for Pediatric Crohn’s Disease
- Request Rare Pediatric Disease Priority Review Voucher Program for Crohn’s Disease as well as other orphan indication we are qualified for.
- The in licensing or co-development of clinical stage IRT-103 for targeted indications with high unmet medical need in oncology.
- The in licensing or co-development of highly innovative IRT-103, with potential to be used either as a stand along therapy or in conjunction with existing therapies that can reach Phase III within 12 months.
- Co development IRT-101 and IRT-103, using immune modulating properties for autoimmune disease
The Business Case for Cytocom Immuno-Therapies:
The repurposing of drugs remains one of the most attractive investment areas in the biopharmaceutical industry.
- Established Patent Protection
- Promising Pipeline with phase II clinical data
- The recent US Healthcare Law provided a minimum of 7 years marketing exclusivity for orphan drugs.
The market for therapeutic immunology therapies continues to grow and it estimated to reach 34 billion by 2017.
Highly Efficient Pathway to Commercialization
- Repurposed drugs have a 50% higher development success rate with the FDA, according to the Tufts Center for the Study of Drug Development.
- 505(b)(2) pathway therapies have a faster clinical development and regulatory review,
- Orphan Drug Designation has a faster clinical development pathway and regulatory review process.
IRT-101 and ITR-103 are attractive since they can be used as a stand-alone therapy or in conjunction with existing therapies.
IRT-101 and IRT-103 offer opportunities for distinctive innovation and continued reduction in manufacturing costs.