Jubilant Therapeutics Inc, a biopharmaceutical company, announced US 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 neuro-endocrine prostate cancer (NEPC) and other mutation-defined neuroendocrine tumours.

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 tumours. The study population will include patients with locally advanced or metastatic solid tumours whose disease has failed prior standard therapy.  Expansion cohorts of participants with SCLC, NEPC, and other neuroendocrine-derived cancers will be enrolled to obtain additional safety and efficacy data.

Hari S Bhartia, chairman, Jubilant Therapeutics said “We are proud to see our fully in-house discovered program lead our transformation to a 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 tumour 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-tumour activity, which is superior compared to inhibiting either target alone, and has a favourable safety profile with no significant safety concerns or accumulation. It will be evaluated in both solid tumours, such as small cell lung cancer and neuroendocrine prostate cancer, and haematological cancers such as acute myelogenous leukaemia, myelodysplastic syndrome, and other myeloproliferative cancers.

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.