PIPELINE
Nuvation Bio is focused on tackling some of the toughest challenges in cancer treatment. Our clinical trial programs include taletrectinib (ROS1 inhibitor), safusidenib (mIDH1 inhibitor), and our Drug-Drug Conjugate (DDC) program.
Program
Therapeutic Area(s)
Current Stage of Development
Preclinical
Phase 1
Phase 2
Pivotal
Approved
Anticipated Milestones & Recent Updates
Taletrectinib1
(ROS1)
Advanced ROS1+ NSCLC
(treatment line agnostic)
• Approved by the U.S. FDA, Japan's MHLW, and China's NMPA
• Enrolling TRUST-IV study for early-stage ROS1+NSCLC
Safusidenib2
(mIDH1)
Diffuse IDH1-mutant glioma
• Enrolling pivotal SIGMA study for high-risk or high-grade
IDH1-mutant astrocytoma
• Enrolling non-pivotal single-arm cohort for grade 3
IDH1-mutant oligodendroglioma
Drug-drug conjugate
(DDC) Program
Solid tumors
• Currently evaluating preclinical candidates
ROS1
Taletrectinib is a highly selective, next-generation oral ROS1 tyrosine kinase inhibitor (TKI) designed to address some of the outstanding challenges of treating ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC). For more information, visit the Our Medicine page.
Each year, more than one million people globally are diagnosed with NSCLC, the most common form of lung cancer. It is estimated that approximately 2% of people with NSCLC have ROS1+ disease. About 35% of people newly diagnosed with metastatic ROS1+ NSCLC have tumors that have spread to their brain. The brain is also the most common site of disease progression, with about 50% of previously treated patients developing central nervous system metastases. Despite recent progress for patients with ROS1+ NSCLC, there remains a need for treatment options that address some of the outstanding challenges of treating the disease.
mIDH1
Safusidenib is a novel, oral, potent, brain penetrant, targeted inhibitor of mutant IDH1 (mIDH1).
Safusidenib is being evaluated in a pivotal, Phase 3 study for the treatment of patients with high-grade and high-risk IDH1-mutant glioma. Safusidenib has shown high blood-brain barrier penetration in both pre-clinical and clinical studies and demonstrated anti-tumor activity and tolerability in Phase 1 and 2 clinical studies. Gliomas are the most common type of adult brain cancer worldwide. In the U.S., nearly 2,400 people are diagnosed with IDH1-mutant gliomas each year. Most patients are diagnosed in their 30s and 40s. While patients with IDH1 mutations generally have longer survival times than those with wild-type IDH1, gliomas are not currently curable and prognosis worsens for those with high grade tumors.
DDC
Our proprietary, small molecule DDC’s leverage a novel therapeutic approach within the drug-conjugate class of anti-cancer therapies.
The platform is designed to selectively deliver potent anti-cancer therapeutics to cancer cells to exert greater toxicity against these target tumor cells than against healthy non-target tissues.
Utilizing this technology, we are able to design potent oncology-focused chimeric small molecules which combine tumor-targeting specificity with anti-cancer activity of known oncology agents. We believe our DDC technology will be broadly applicable and can be replicated across many existing therapies to transform the standard-of-care in multiple oncology indications.
