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 existing 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 QUATRAMER delivery platform offers the potential to significantly improve the profile and therapeutic window of both existing and novel cancer drugs. Our QUATRAMER 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 programs include salinomycin, tumor necrosis factor - alpha, and FDA-approved bortezomib and paclitaxel. Bortezomib and paclitaxel are significantly de-risked from a safety and efficacy standpoint. They are 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-1216, is a novel formulation of salinomycin, a potent cancer stem cell inhibitor, which also uses the company’s proprietary QUATRAMER delivery platform and targets both cancer stem cells and non-cancer stem cell chemo resistant tumors. Salinomycin kills cancer stem cells by sequestering iron in lysosomes. HSB-114 is a next generation immunotherapeutic agent of a previously developed predecessor compound. The QUATRAMER drug delivery encapsulates tumor necrosis factor - alpha which can be injected intratumorally or given systemically for metastatic soft tissue sarcoma (mSTS). HSB-501 is a CRADA in collaboration with the National Center of Advancing Translational Sciences (NCATS), part of the National Institutes of Health, enabling NCAT’s use of the Hillstream BioPharma’s QUATRAMER drug delivery technology to develop formulations of HDACC6-PI3Kδ dual inhibitors for the treatment of rare cancers. 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.
Formulation of salinomycin, a small molecule new chemical entity (NCE) encapsulated within QUATRAMER drug delivery with a newly described mechanism of action against cancer. Salinomycin was identified as the most potent cancer stem cell (CSC) inhibitor known to-date. CSCs represent an elusive population of tumor stem 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 pre-clinical studies and commence human clinical trials of HSB-1216 beginning with small cell lung cancer (SCLC) in 2020.
Encapsulates tumor necrosis factor – alpha (TNF-α) within the QUATRAMER drug delivery technology for a non-viral biodegradable delivery. High dose TNF-α can be injected intratumorally or given systemically which concentrates in tumors. The initial target 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.
HSB-501 is a CRADA in collaboration with the National Center of Advancing Translational Sciences (NCATS), part of the National Institutes of Health, enabling NCAT’s use of the Hillstream BioPharma’s QUATRAMER drug delivery technology to develop formulations of HDACC6-PI3Kδ dual inhibitors for the treatment of rare cancers including acute myeloid leukemia (AML) and acute lymphoid leukemia (ALL). Studies have shown that by disrupting multiple compensatory cyto-protective pathways, phosphatidylinositol 3- kinases (PI3K) inhibitors in combination with histone deacetylase (HDAC) inhibitors might have potential therapeutic value.
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.