MAIA Biotechnology has strengthened its scientific leadership by appointing two internationally recognized hepatocellular carcinoma (HCC) specialists to its Scientific Advisory Board as the company prepares for Phase 2 clinical trials of its lead candidate ateganosine in liver cancer.
The clinical-stage biopharmaceutical company announced the appointments of Dr. Claudia Fulgenzi and Dr. David J. Pinato, both from Imperial College London, who will advise on trial designs and protocols for MAIA's company-sponsored trial in HCC. The drug candidate will be studied in sequence with checkpoint inhibitors.
Strategic Timeline and Regulatory Status
"By the end of this year, we expect to have all required approvals to begin enrolling patients in a HCC trial," said MAIA Chairman and CEO Dr. Vlad Vitoc. The company received Orphan Drug Designation from the FDA for ateganosine as an HCC treatment in 2022, which can provide up to seven years of market exclusivity.
Dr. Vitoc emphasized the strategic value of the new advisory board members, stating: "Drs. Pinato and Fulgenzi are scientific experts on inflammation as a pathogenic and prognostic mechanism in primary liver cancers. Together, their research has focused on improving the treatment of HCC, particularly with the use of anti-cancer immunotherapy."
Expert Credentials and Research Focus
Dr. David Pinato serves as Director of Developmental Cancer Therapeutics at Imperial College London and leads a translational research program focused on early clinical implementation of novel experimental anticancer therapies, with particular emphasis on anti-cancer immunotherapy. His research efforts in liver cancer have been recognized by the American Society of Clinical Oncology (ASCO) and the Society for Immunotherapy of Cancer (SITC).
Dr. Pinato has received awards from the British Society of Pharmacology and the Royal Society of Medicine, along with fellowships from the European School of Oncology and Fulbright Program. His research has been published in leading journals including the Journal of Clinical Oncology, Annals of Oncology, and Hepatology.
Dr. Claudia Fulgenzi specializes in medical oncology at Imperial College London with dedicated focus on immune-oncology and gastro-intestinal cancers, particularly hepatic-biliary malignancies. She has received prestigious recognition including the ASCO Merit Award and the Young Investigator award from the International Liver Cancer Association (ILCA).
Currently serving as an honorary consultant in oncology at Chelsea and Westminster Hospital and as a specialty doctor in the early phase clinical trial unit at Hammersmith Hospital, Dr. Fulgenzi conducts clinical and translational research while contributing to clinical trial design.
Disease Burden and Market Opportunity
Hepatocellular carcinoma represents the most frequently occurring primary liver tumor, accounting for approximately 90% of all liver cancers. The disease currently ranks 5th by incidence and 3rd by mortality on a global scale, highlighting the significant unmet medical need that MAIA's therapeutic approach aims to address.
Ateganosine Mechanism and Development
Ateganosine (THIO, 6-thio-dG or 6-thio-2'-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development. The modified nucleotide induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death.
The drug's mechanism involves accumulation of ateganosine-damaged telomeric fragments in cytosolic micronuclei, which activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. Sequential treatment of ateganosine followed by PD-(L)1 inhibitors has demonstrated profound and persistent tumor regression in advanced in vivo cancer models through induction of cancer type-specific immune memory.
While ateganosine is currently being developed as a second or later line treatment for non-small cell lung cancer (NSCLC) patients who have progressed beyond standard-of-care checkpoint inhibitor regimens, the expansion into HCC represents a significant broadening of the drug's therapeutic potential.
The advisory board members will guide both company-sponsored trials and may participate in future investigator-sponsored trials as MAIA advances its clinical program in hepatocellular carcinoma.
