Tiburio Announces Publication of Preclinical TBR-760 Data in Non-Functioning Pituitary Adenoma in Journal of the Endocrine Society

CAMBRIDGE, Mass., May 11, 2020 (GLOBE NEWSWIRE) -- Tiburio Therapeutics Inc., a clinical stage company developing therapies for rare endocrine diseases, today published new data from a preclinical study in the Journal of the Endocrine Society demonstrating that its lead clinical asset, TBR-760, a dopamine somatostatin chimeric compound, arrests aggressive non-functioning pituitary adenoma (NFPA) growth in a mouse model. The pre-clinical data indicate 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., vice president 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.

Key data from the study included:

• TBR-760 treatment, initiated when the mice had an established tumor, completely arrested tumor growth throughout the 8 week treatment period
• Final average tumor volume in TBR-760-treated mice was 8.5±1.3mm³ vs. 54.61±10.6mm³ in vehicle-treated mice (p<0.05)
• Treatment with equimolar or 10x-higher doses of the individual somatostatin or dopamine, alone or in combination, had little to no effect on tumor growth, except in the lower dose dopamine group where a modest suppression of tumor growth was observed

Michael Culler, Ph.D., scientific founder and chairman of the scientific advisory board, added, “The current in vivo findings support earlier studies in which TBR-760 was observed to inhibit proliferation of cultured human NFPA cells. TBR-760 targets receptors that are highly expressed by NFPAs, making it an ideal potential therapeutic for these tumors.” He concluded, “Ultimately, these results support the development of TBR-760 as a medical therapy to either prevent or arrest the growth of NFPAs, and with the potential to induce NFPA shrinkage. NFPAs are the only type of pituitary adenoma without an approved medical therapy.”

The full text is available here.

About TBR-760
TBR-760 is a dopamine somatostatin chimeric compound that has the potential to be the first and only drug treatment for non-functioning pituitary adenomas. TBR-760 is being developed to shrink or stabilize non-functioning pituitary adenomas and may reduce or eliminate the need for surgery and radiation, both of which are associated with significant morbidity.

About Non-functioning Pituitary Adenomas
Non-functioning pituitary adenomas (NFPAs) are pituitary tumors with an estimated overall prevalence of 135,000 in the United States. NFPAs disrupt critical structures in the surrounding area of the brain due to mass effect. They may cause vision loss, hormone deficiencies, cranial nerve palsies or intractable headaches. Treatment is limited to invasive neurosurgery, damaging radiation and lifelong monitoring. Surgery is not curative and these tumors are at high risk for recurrence, leaving patients in a state of constant concern. Despite the prevalence and unmet need, there is no approved medical therapy for NFPAs.

About Tiburio Therapeutics, Inc.
Tiburio is dedicated to developing transformative treatments for rare endocrine diseases. The company is advancing a unique class of chimeric compounds that has the potential to offer significant advances to rare endocrine diseases. To learn more, visit www.tiburio.com or follow us on Twitter.

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LifeSci Communications
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