INNOVATION
Small-molecule chemotherapeutics are potent and effective against a variety of malignancies, but common and severe side effects restrict their clinical applications. Nanodrug approaches represent a major focus for improving chemotherapy, but have met limited success. To resolve the bottleneck of chemotherapy drugs, a novel single protein encapsulation (SPE) -based drug formulation and delivery platform is developed.
Pioneering Next Generation Nanodrugs for Targeted Treatments of Cancers
Our team has built a robust pipeline of potential first-in-class and/or best-in-class nanodrug for targeted therapeutics. We have an ongoing drug discovery research focus in single protein encapsulation(SPE) – a new generation nanodrug with high potency and low toxicity and low production cost. Our most advanced pipeline programs include SPEDOX, a single protein encapsulated Doxorubicin. The preclinical study has completed and also it is scientifically-validated via publication, potentially much more indications would be applied due to its higher potency, higher dosing and lower toxicity.
Since inception, Sunstate Biosciences’ research focus has been to exploit the concept of single protein encapsulation, an approach for indirectly targeting oncogenic pathways, it does not involve nanoparticle assembly and modifications to either small-molecule drugs or HSA, may open up a new avenue for developing new drug delivery systems to improve anticancer therapeutics.
We have established calibration with Cedars-Sinai, City of Hope, USC & Caltech to develop the clinical pipelines, SPEDOC, SPEDOXDOC, TRACAM. We are aggressively pursuing federal government grants, SBIR (NCI & NSF), DOD breast cancer breakthrough awards & NIH R01 academic/industry collaboration research grants.
Sunstate Biosciences is located in Monrovia, California.
Management
Research Collaborators
Prof. of cancer biology at Department of Surgery, Samuel Oschin Comprehensive Cancer Institute, Cedars Sinai Medical Center
Professor of Oncology at Rosewell Park Comprehensive Cancer Center, Editorial board member of J Exp Clin Can Res, Am J Transl Res, and Int J Mol Sci.
Collaborations
Cedars-Sinai Medical Center
University of Southern California
Roswell Park Comprehensive Cancer Center
University of California Irvine
California Institute of Technology
University of Southern Mississippi
Scientific Advisors
Provost Professor in the Department of Biomedical Engineering and the Department of Biological Science at the University of Southern California
Adjunct Professor at Case Western Reserve University and California Institute of Technology, Emeritus President at Taipei Medical University in Taiwan
Professor Emeritus in the Department of Ophthalmology at UCSF, Director of the Retina Service at the San Francisco VAMC
Single Protein Encapsulation
A novel drug delivery platform
SPE Technology Advantages:
(I), No nanoparticles (NP). After encapsulating small-molecule drugs, the proteins do not change either their sizes or their monomeric states, resulting in non-existence of the nanoparticles. Therefore, there is a very low probability of activating immune responses in humans, which is in stark contrast to many synthetic polymer- and NP-based systems.
(II), No chemical modifications to either drug or protein molecules. The physical interactions between drug and protein molecules warrant the integrity of drug and protein molecules, which eliminates the cleavable linkers and completely retains the full functions of both drug and protein molecules.
(III), Robustness in the manufacturing processes. Because of no nanoparticles and no chemical modifications, the productions of SPE-DRUGs in large quantity under cGMP have been extremely simplified, requiring no separations and no purifications. Therefore, the quality of the final drug products is consistently excellent.
Protein Molecules: Human serum albumin (HSA) & other albumins, monoclonal antibodies, polyclonal antibodies
Drug Molecules: Anticancer drugs, antiviral drugs, antifungal drugs, etc.
Drug Molecules:
The SPE technology is very versatile and can be applied to a broad spectrum of therapeutics. The drug molecules include, not limited to, (A) Anticancer drugs, such as doxorubicin, epirubicin, docetaxel, topotecan, camptothecin, daunorubicin, mitoxantrone, idarubicin, vincristine, vinblastine, vinblastine, SN-38, MMAE, MMAF, exatecan, ixabepilone, eribulin, etc; (B) Antiviral drugs, such as remdesivir, ivermectin, ritonavir, Lopinavir, Umifenovir, etc. (C) Antibiotics and antifungal drugs, such as rifampicin, clofazimine , amphotericin B , etc.
Protein Molecules:
Various proteins can be used for the encapsulations of various drug molecules. The proteins include, not limited to, (A) Albumins, such as human serum albumin (HSA), bovine serum albumin (BSA), horse serum albumin, other mammal albumins; (B) Monoclonal antibodies, such as trastuzumab, sacituzumab, belantamab, enfortumab, polatuzumab, moxetumomab, inotuzumab, moxetumomab, gemtuzumab, brentuximab , etc.; (C) Polyclonal antibodies, such as human Immunoglobulin G, etc.
Pipeline
Latest News and Publication
News:
1. Sunstate Biosciences collaborates with Dr. Cui from Cedars-Sinai hospital to to advance the development of SPEDOX-6 and SPE-SN38. The partnership is expected to accelerate the development of new treatment options for cancer patients and ultimately improve their quality of life.
2. FDA has granted orphan drug designation to SPEDOX-6 for the treatment of soft tissue sarcoma on 11/15/2022.
https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=808521
3. Cedars-Sinai investigators test SPEDOX-6, showing it is safer for the heart than the current formulation. Their study published in the peer-reviewed journal Stem Cell Reports.
Publication:
Enclosing drugs inside a protein molecule shows potential as a method to safely deliver more cancer-fighting treatment directly to the tumor, according to a recent multi-institutional study. In tests performed in laboratory mice, the buffering method unleashed powerful tumor-killing drugs into cancer cells while leaving healthy tissues alone. If results from the study are duplicated in human trials, the protein-capsule delivery method potentially could be developed into a treatment that ferries more anticancer drugs to tumor sites and improves outcomes for patients with aggressive cancers. >>>>
