BEDMINSTER, N.J. – Jubilant Therapeutics Inc, a biopharmaceutical company advancing small molecule precision therapeutics to address unmet medical needs in oncology and autoimmune diseases, today announced U.S. Food and Drug Administration (FDA) clearance of the investigational new drug application (IND) for JBI-802, a novel, oral, potent and selective dual inhibitor of LSD1 and HDAC6, for the treatment of small-cell lung cancer (SCLC), treatment-induced neuroendocrine prostate cancer (NEPC) and other mutation-defined neuroendocrine tumors.
The Phase 1/2a trial is an open-label, two-part dose-escalation and expansion study designed to define the safety profile and preliminary activity of JBI-802 in participants with advanced solid tumors. The study population will include patients with locally advanced or metastatic solid tumors whose disease has failed prior to standard therapy. Expansion cohorts of participants with SCLC, NEPC, and other neuroendocrine-derived cancers will be enrolled to obtain additional safety and efficacy data.
Mr. Hari S Bhartia, Chairman, Jubilant Therapeutics said, “We are proud to see our fully in-house discovered program lead our transformation to clinical stage biotech. This validates the powerful biotech platform that we have built. Jubilant’s objective is to leverage our decades of internal drug discovery and development expertise to create important new medicines by advancing novel molecules against validated targets or first-in-class molecules against newly discovered targets.”
“JBI-802 is our most advanced drug candidate and our first to enter into clinical development from a broad pipeline of truly innovative molecules. Our chosen tumor types have high unmet medical needs that can translate to faster approval paths,” said Syed Kazmi, Chief Executive Officer of Jubilant Therapeutics.
JBI-802 is a novel, oral, potent, and selective dual inhibitor of two epigenetic targets of the CoREST complex: LSD1 and HDAC6. It targets stem cell modulation by inhibiting LSD1 and modulates immune suppression with isoform-selective HDAC6 inhibition. Preclinical research has demonstrated its synergistic anti-tumor activity, which is superior compared to inhibiting either target alone and has a favorable safety profile with no significant safety concerns or accumulation. It will be evaluated in both solid tumors, such as small cell lung cancer and neuroendocrine prostate cancer, and hematological cancers such as acute myelogenous leukemia, myelodysplastic syndrome, and other myeloproliferative cancers.
About Jubilant Therapeutics
Jubilant Therapeutics Inc. is a patient-centric biopharmaceutical company advancing potent and selective small-molecule modulators to address unmet medical needs in oncology and autoimmune diseases. Its advanced discovery engine integrates structure-based design and computational algorithms to discover and develop novel, precision therapeutics against both first-in-class and validated but intractable targets in genetically defined patient populations. The company is progressing its most advanced program – first in class dual inhibitor of LSD1/HDAC6 to Phase 1/2a, followed by additional INDs with novel brain-penetrant modulators of PRMT5 and PDL1, as well as PAD4 inhibitors in oncology and inflammatory indications. Jubilant Therapeutics is headquartered in Bedminster, NJ, and is guided by a globally renowned scientific advisory board and key opinion leaders. For more information, please visit www.jubilanttx.com or follow us on Twitter @JubilantTx and LinkedIn.
Robert Flamm / Katie Larch / Dr. Grace Kim
Eric Goldstein / Brian Hicks