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This branch of our Sponsor Atlas series focuses on young pharmaceutical and biotechnology companies that are in early stages or stealth mode. In the next edition of Sponsor Atlas: Discovering Biotech Startups, we’re looking at Tiburio Therapeutics, exploring the current affairs and future orientation of this emerging Cambridge - based biotech company. We will give a business overview of their current operations, summarize their outsourcing needs, map out their development goals and decision-makers, and highlight their current strategies for capturing innovation. If you haven’t already read our other blogs on new biotech startups, be sure to check them out here.
Tiburio Therapeutics is a developer of drug compounds intended to treat tumors and rare endocrine diseases. The company's compounds aid in the treatment of non-functioning pituitary adenoma using a dopamine-somatostatin chimeric molecule that has the potential to shrink or halt tumor growth, providing patients with effective treatment for rare neuroendocrine tumors and endocrine diseases.
Located near the Massachusetts Institute of Technology in Cambridge, Tiburio Therapeutics was founded in 2018. The company was launched out of an orphan drug accelerator Cydan, with financing from life science investors NEA, Lundbeckfonden Ventures, Longitude Capital, and Alexandria Venture Investments. Tiburio’s core business is to develop transformative treatments for patients with rare endocrine diseases. They have a very detailed website with information about their current research, product pipeline, and executive team.
Tiburio will advance two compounds licensed from Ipsen, TBR-760 for the treatment of non-functioning pituitary adenoma (NFPA), and TBR-065 for the treatment of additional rare endocrine diseases. As part of their initial launch, Tiburio raised a $31M Series A financing that will fund the company’s lead compound, TBR-760, through human proof-of-concept studies for NFPA, and further clinical assessment of TBR-065 as a treatment for rare endocrine diseases. Tiburio is the third orphan drug company launched by Cydan specifically for creating new therapies for orphan diseases.
“Patients suffering from rare neuroendocrine tumors and endocrine diseases represent a significantly underserved patient population due to the lack of effective treatment options,” said Abraham N. Ceesay, CEO of Tiburio. “TBR-760 and TBR-065 represent potential breakthroughs in the treatment of debilitating neuroendocrine diseases and we, at Tiburio, are intently focused on advancing these compounds for the benefit of patients. We will immediately begin Phase 2 enabling studies with TBR-760 and anticipate enrolling patients with NFPA in a Phase 2 study in the 2nd half of 2019.” 
Considering Tiburio's innovative platform of dopamine-somatostatin chimeric compounds that are currently under development, we think they are in a great position to fund a ton of outsourcing work. They have a few lead candidates already in clinical trials (with more on that in the next section). Their prospective pipeline will consist of therapies for treating rare endocrine diseases, and any experience with drug development for orphan drugs would be of tremendous benefit to Tiburio Therapeutics at this point.
Some of the ways service providers can get their foot in the door would be to support Tiburio in the following general areas: CMOs for Phase I/II clinical trial supplies, bioanalytical CROs, and preclinical CROs with animal model development for rare endocrine diseases.
Tiburio’s Pipeline and R&D Focus
Tiburio’s main focus is on developing TBR-760, a clinical-stage dopamine-somatostatin chimeric compound, for the treatment of non-functioning pituitary adenomas (NFPAs). Tiburio’s development-stage pipeline also includes TBR-065, another dopamine-somatostatin chimeric compound for other rare endocrine diseases.
NFPAs are benign growths in the pituitary gland that do not produce any excessive hormone into the blood and are not cancerous. NPFAs account for 15% of all pituitary adenomas, with approximately 70-90 cases per one million people.  NFPAs are known to disrupt vital activities within the brain on account of mass impact. They can easily trigger imaginative and prescient loss, hormone deficiencies, cranial nerve palsies, or other intractable complications. Current remedies prescribed include invasive neurosurgery, damaging radiation, and lifelong monitoring. Additionally, current surgical procedures do not heal these tumors and are known to cause an excessive risk of tumor recurrence.
TBR-760 has the potential to be the primary drug remedy for NFPAs. TBR-760 is being developed to shrink or stabilize non-functioning pituitary adenomas and should cut back or remove the necessity for surgical procedures and radiation, each of which is related to vital morbidity. Key knowledge from their initial research concluded that TBR-760 fully arrested tumor progress all through the eight-week remedy interval in mice with longtime tumors. During the study, it had successful results with the common tumor quantity in TBR-760-treated mice being 8.5±1.3mm3 vs. 54.61±10.6mm3 in vehicle-treated mice (p<0.05). 
- Abraham N. Ceesay - CEO of Tiburio Therapeutics, Abraham has over 17 years of experience in leading biopharmaceutical companies and commercializing innovative therapeutic products. Before joining Tiburio, he served as a chief operating officer at scPharmaceuticals where he developed and led all operational and commercial aspects of the company. He was integral in raising more than $140 million in private and public capital as well as closing the company’s initial public offering. Before joining scPharmaceuticals, he served as vice president, sales, marketing, and commercial operations at Keryx Biopharmaceuticals and spent four years at Ironwood Pharmaceuticals as vice president of marketing. He also held responsibility for the management of the U.S. P&L, the leadership of the Linzess® brand team, and co-promotion collaboration with Forest Laboratories/Allergan. Previously, Abraham was at Genzyme/Sanofi, initially as a field sales specialist and ultimately as the director, Renal Global Marketing, in which capacity he led the global launch of Renvela® and held global marketing responsibility for the company’s renal franchise (Renagel®, Renvela®, Hectorol®). Abraham serves on the Board of Advisors for Life Science Cares and the Board of Directors for Food for Free. He holds a bachelor’s degree from Ithaca College and a Master of Business Administration from Suffolk University’s Sawyer School of Management. 
- Heather Halem, Ph.D. - Vice President, Research of Tiburio Therapeutics, Heather brings more than 17 years of pharmaceutical experience to Tiburio with strong expertise in rare endocrine and metabolic diseases, oncology, and in developing pharmacology models of disease. A senior, cross-functional project team leader, Heather has direct experience leading research programs that have taken molecules from early identification to clinic candidates. Heather earned her B.A. in biology from Macalester College in St. Paul, Minnesota, and Ph.D. in biology from Boston University. She holds two patents and has authored numerous papers in leading peer-reviewed journals. 
- Nerissa Kreher, M.D. - CMO of Tiburio Therapeutics, Dr. Nerissa Kreher is an accomplished physician executive and pediatric endocrinologist with more than a decade of biotech experience in Clinical Development and Medical Affairs. She has held leadership roles in both private, start-up biotechnology and public, large biotech companies. Her expertise is in the development of products for rare diseases spans across multiple therapeutic areas. Nerissa holds multiple degrees, including an Executive MBA from Northeastern University, an M.D. from East Carolina University School of Medicine, and an M.S. in Clinical Research from Indiana University. She is certified in Pediatric Endocrinology by the American Board of Pediatrics. 
- Imran Babar, Ph.D. - Co-Founder and Chief Business Officer of Tiburio Therapeutics, and the Chief Business Officer of Cydan, Imran co-founded Tiburio Therapeutics and played a key role in the company’s Series A financing. Imran joined Cydan from the venture capital team at OrbiMed Advisors where he was involved with a range of companies including Audentes (public), 89bio (public), resTOR bio (public), Dimension (acquired), True North (acquired), Neurogastrx, NeRRe, Arvinas (public), Synlogic (public), and others. Before joining OrbiMed, Imran was a Biotechnology Associate at Cowen & Company where he covered over 20 companies. Imran also co-founded and serves as the Chief Scientific Officer for Rare Genomics Institute (RG), a nonprofit dedicated to helping rare disease patients since 2011. Imran completed his Ph.D. in Molecular Biology at Yale University, where he was an HHMI Fellow and a Harvey Fellow. Before Yale, he completed his B.A. in Biology at Carleton College and researched at MIT and NIH. 
In May 2020, Tiburio Therapeutics published new data from a preclinical study in the Journal of the Endocrine Society demonstrating that its lead compound, TBR-760, successfully arrested NFPA growth in a mouse model. The pre-clinical data indicated that TBR-760 completely arrested tumor growth in the pro-opiomelanocortin (POMC) gene knock-out (KO) mouse model of NFPA. Additionally, notable tumor shrinkage was observed in 20% of the mice treated with TBR-760.
“TBR-760 completely arrested tumor growth in a mouse model that spontaneously develops aggressive non-functioning pituitary adenomas,” said Heather Halem, Ph.D., VP of Research. “The pituitary tumors that form in the POMC-KO mice express similar levels of dopamine and somatostatin receptors as human NFPA, making this study fundamental in supporting the potential for tumor shrinkage in our planned phase 2 trial in adult patients with NFPA,” she continued. 
We think that Tiburio Therapeutics is on track to create some breakthroughs in the biotech industry over the next few years. Be sure to keep them on your contact list and look out for our next edition in this series coming soon.
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