Our Company
Pioneering Oncology Therapies that Expand What is Possible
Our mission is to advance the development of innovative treatments at the frontiers of cancer biology and anemia. We are developing potential first-in-class medicines for life-altering and life-threatening conditions, including anemia associated with lower-risk myelodysplastic syndrome (LR-MDS) and metastatic castration-resistant prostate cancer (mCRPC).
Our Clinical Candidates:
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Roxadustat in LR-MDS
Kyntra Bio is currently exploring the potential to initiate a Phase 3 study of roxadustat in LR-MDS. Patients with LR-MDS frequently develop chronic anemia due to ineffective erythropoiesis, leading many to require regular transfusions. This dependence can result in iron overload and significantly impact quality of life.
Roxadustat is an oral small molecule inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase, the enzyme that regulates HIF activity. By transiently inhibiting the enzyme, roxadustat induces the body’s natural response to hypoxia, stimulating red blood cell production and enhancing iron absorption, mobilization, and transport.
This mechanism may offer a novel alternative to currently available treatments, particularly for patients who are unresponsive to or ineligible for erythropoiesis-stimulating agents.
Previous clinical studies have shown promising efficacy in reducing transfusion dependence and improving hemoglobin levels in LR-MDS patients with high transfusion burden, suggesting roxadustat could play an important role in addressing the unmet needs of this population.
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FG-3246 and FG-3180 in mCRPC
FG-3246 is an investigational, first-in-class, fully human antibody-drug conjugate (ADC) under development by Kyntra Bio for a potential role in treating mCRPC. In-licensed from Fortis Therapeutics, FG-3246 targets CD46, a receptor overexpressed in prostate cancer and other tumor types but minimally expressed in most normal tissues, making it an ideal candidate for ADC development.
The therapy combines the anti-CD46 antibody YS-5 with monomethyl auristatin E (MMAE), an anti-mitotic agent and clinically validated ADC payload. FG-3246 is designed to bind and internalize in CD46-expressing cells, enabling targeted delivery of its cytotoxic payload.
Preclinical and Phase 1 studies conducted by Fortis demonstrated encouraging results that support further investigation.
FG-3246 is currently being evaluated in a Phase 2 monotherapy trial in mCRPC, with initial data expected in 2026.
As part of this program, Kyntra Bio is also assessing FG-3180, an associated CD46-targeted positron emission tomography (PET) biomarker and imaging agent to evaluate its potential to detect CD46-positive lesions and assess the correlation of CD46 expression and response to FG-3246, which could inform patient selection in subsequent trials.
FG-3246 is an investigational drug and has not been approved for marketing by any regulatory authority. FG-3180 is an investigational imaging agent and has not been approved for marketing by any regulatory authority.