Startup at the PABC nets SBIR grant from National Cancer Institute to continue work on a new GI drug
Doylestown, July 23, 2024 – Biotech entrepreneur and Blumberg Institute professor Kunwar Shailubhai, PhD, the pioneer of therapeutic applications of guanylate cyclase-C (GC-C) signaling and an inventor of the widely prescribed medicine Trulance(R), has been awarded a Phase 1 SBIR grant from the National Cancer Institute to continue to conduct GC-C related research, which could potentially lead to development of a new drug for colorectal cancer (CRC), ulcerative colitis (UC) and other gastrointestinal (GI) diseases.
This grant provides approximately $400,000 for two years to Dr. Shailubhai’s third startup company, Nous Biosciences Inc., which is located at the Pennsylvania Biotechnology Center (PABC).
Dr. Kunwar Shailubhai
Dr. Shailubhai discovered in the late 1990s that GC-C receptor signaling is defective in GI diseases due to the universal loss of the endogenous ligand uroguanylin (UG) and guanylin (GN) in patient with GI diseases, and that this deficiency might be one of the underlying causes of GI inflammation and malignancy. This discovery opened a new avenue for drug discovery and development to develop therapeutic modalities to correct the deficiency and to treat GI diseases.
Subsequently, Dr. Shailubhai co-founded Synergy Pharmaceutical, a start-up biotechnology company to further develop his pioneering discovery in GC-C research. The company is among the first success stories from the PABC and it was listed on NASDAQ (Symbol: SGYP). His team discovered plecanatide, an analog of UG, and conducted all discovery, preclinical, non-clinical research here at the PABC. His team also supported clinical development for eventual approval of TRULANCE® by the FDA for treatment of chronic idiopathic constipation (CIC) and irritable bowel syndrome-constipation (IBS-C) in 2016.
As a pioneer of therapeutic applications of GC-C agonists, Dr. Shailubhai’s next passion was to discover a superior and a proteolytically resistant analog of UG suitable for treatment of UC and Crohn’s disease (CD). In this pursuit, he discovered other GC-C agonists, including dolcanatide, which appear to be more effective for oral treatment of other GI diseases such as UC, CD and CRC. The phase 1 and phase 2 clinical studies with dolcanatide strongly indicated that it could be developed as a safe treatment of UC and opioid-induced constipation (OIC). Safe treatment for OIC is an important urgent medical need due to consumption of opioids. These pioneering research programs so far have produced many publications and about 30+ issued patents and several patent applications. The company SGYP created more than 100 high-paying jobs stimulating the regional economy. Dr. Shailubhai also received recognition from Pennsylvania state officials for his efforts.
After the approval of Trulance, Dr. Shailubhai became the chief executive officer (CEO) of another startup biotech company, Tiziana Life Sciences, to pursue his other scientific passion to explore alternative routes of treatment with antibodies. Traditionally treatment with antibodies is conducted by injection at doctor’s office or in hospital setting, which is cost-prohibitive for poor patients. Hence, Dr. Shailubhai has been interested in development of treatment with antibodies through ‘Take home’ pills, nasal sprays and inhalation pumps, which can be less costly and affordable to poor patients. Dr. Shailubhai is the inventor of the first-ever issued patent for these alternative routes of antibody administration. Importantly, his invention on nasal administration of antibodies has already advanced to clinical development and it was clinically validated for treatment of secondary progressive multiple sclerosis (SPMS).
The publicly disclosed clinical data from the ongoing clinical trial in patients with SPMS suggest that the nasal treatment with Foralumab, an anti-CD3 monoclonal antibody, is providing remarkable clinical benefits to SPMS patients. This is an exciting and revolutionary, game-changing development for immunotherapies. Tiziana Lifesciences was another success story and it was eventually listed on NASDAQ (symbol: TLSA).
Dr. Shailubhai opted to retire from CEO position at TLSA in 2022, and he is now excited to pursue his other scientific passions as a professor at the Blumberg Institute. He also is the founder and CEO of Nous Biosciences, located at the PABC. He is actively helping other aspiring entrepreneurs at the PABC to follow their scientific dreams to develop new therapeutic modalities.
About the Pennsylvania Biotechnology Center (PABC): Nearly 100 companies belong to the PABC, which is a nonprofit life sciences incubator and accelerator providing a collaborative ecosystem and state-of-the-art laboratory and office space. There are nearly 70 early stage biotech companies onsite at its two locations. Along with its campus in Doylestown, where a new building with labs and offices opened two years ago, the PABC operates B+labs at Cira Centre in University City, Philadelphia. B+labs, which was launched in 2022, is a partnership with Brandywine Realty Trust. The PABC uses a highly successful services-based approach to nurture and guide its member companies to success, advancing biotechnology, maximizing synergies among nonprofit scientists and their commercial colleagues, and launching new ideas and discoveries. PABC companies account for 17% of all National Institutes of Health SBIR grants awarded in Pennsylvania and over the years have created billions of dollars in market value from IPOs, acquisitions and commercial valuations.