Our novel, proprietary biodegradable, non-immunogenic, polymeric nanoparticle delivery system has numerous advantages:
- Preferential uptake by tumors
- Decreased RES clearance
- Slow and sustained release
- Based on FDA Inactive Ingredients Data Base (IIDB) components (PLA, PPG, PEG)
- Continuous flow manufacturing
Our therapies are designed to improve the safety, efficacy, and dosing of cancer therapies by enhancing bioavailability at the tumor site and extending duration of action, while protecting healthy cells and tissues from off-target toxicity. Encapsulation in our tetra-block polymeric nanoparticle offers the potential to significantly improve the profile and therapeutic window of both existing and novel cancer drugs. Our polymeric nanoparticles are degradable and are comprised of FDA-recognized inactive ingredients. The technology allows small molecules, cytokines, peptides and genes to be delivered.
Our lead programs include tumor necrosis factor-alpha, salinomycin and FDA-approved bortezomib and paclitaxel. Bortezomib and paclitaxel are significantly de-risked from a safety and efficacy standpoint. They are also expected to follow the FDA's 505(b)(2) regulatory pathway, which leverages existing clinical data and is anticipated to significantly shorten the development timeline and lower overall costs. We are seeking Orphan Drug designation for our lead products which would provide additional market exclusivity upon potential approval.
HSB-114 encapsulates tumor necrosis factor-alpha which can be injected intratumorally or administered systemically for surgically unresectable metastatic soft tissue sarcoma. HSB-1216 is an injectable formulation of salinomycin, a first-in-class small molecule drug with a novel mechanism of action that we plan to develop as a therapy for multiple high need solid tumors. HSB-407 (bortezomib) has the potential to become highly differentiated and improved product within the global bortezomib market where annual sales are currently approximately $1.2 billion. HSB-384 is a next generation paclitaxel enhanced injectable suspension which has shown efficacy in paclitaxel resistant metastatic breast cancer.
Our formulations and technology have patent protection and new chemical entity (NCE) patent protection that creates heightened barriers to market entry, beyond manufacturing process know how.
HSB-114 encapsulates tumor necrosis factor-alpha for a non-viral biodegradeable delivery. High-dose tumor necrosis factor-alpha can be administered intratumorally or systemically which concentrates in tumors. The initial indication is surgically unresectable metastatic soft tissue sarcoma (mSTS). There are 12,000 new cases of metastatic soft tissue sarcoma in the United States each year and about 5,000 deaths.
A nanoparticle formulation of salinomycin, a small molecule new chemical entity (NCE) with a newly described mechanism of action against cancer. It was identified as the most potent cancer stem cell (CSC) inhibitor known to-date. CSCs represent an elusive population of tumor cells that are believed to reproduce and sustain cancer. HSB-1216 enables tumor-specific drug delivery, achieving high concentrations of drug within tumors even at low doses, which minimizes the risk of systemic toxicity. We plan to complete preclinical studies and commence human clinical trials of HSB-1216 beginning with small cell lung cancer (SCLC) in 2020.
A novel, proprietary, nanoparticle formulation of bortezomib designed to deliver improved dosing, safety, and efficacy. The nanoparticle-encapsulated bortezomib builds on approximately two decades of experience and is designed to overcome bortezomib’s narrow therapeutic index and severe side effect profile. Specifically, HSB-407 is anticipated to lower the incidence of peripheral neuropathy, which is commonly reported by up to 50% of patients and often leads to a reduced dose, and therefore, potentially decreased efficacy. Potential combinations with immuno-oncology / PD-1 therapies in the same nanoparticle can further improve safety and efficacy of both drugs synergistically.