Akamis Bio Secures $60 Million for Cancer Gene Therapy Development and Partners with Xuanzhu Biopharma

Akamis Bio, a clinical-stage oncology company, has raised $60 million in Series A funding to further develop NG-350A, a novel gene therapy based on its proprietary tumor-specific immuno-gene (T-SIGn®). This funding will primarily support a Phase Ib clinical proof-of-concept study targeting patients with locally advanced rectal cancer (LARC).

Funding and Board Changes The investment round was spearheaded by venture capital firm Sedgwick Yard, with Richard Shen and Adrian Chan, managing directors at Sedgwick Yard, joining Akamis Bio’s board of directors as part of the deal.

Licensing Agreement with Xuanzhu Biopharma In a significant move, Akamis Bio has signed a licensing agreement with Xuanzhu Biopharma, granting the latter rights to NG-350A in the Greater China region. The agreement includes undisclosed upfront payments, regulatory and sales milestones, and tiered royalties from sales in the region.

About NG-350A NG-350A is an intravenously delivered, transgene-armed gene therapy designed to induce intratumoral expression of a CD40 agonist monoclonal antibody in primary and metastatic epithelial-derived solid tumors. The upcoming Phase Ib study, named FORTRESS, aims to evaluate the clinical complete response rates of NG-350A in combination with chemoradiotherapy in adult patients with LARC and at least one risk factor for local or distant recurrence.

Clinical Data and Future Goals Howard Davis, PhD, CEO of Akamis Bio, highlighted the consistent safety profile of T-SIGn and the potential of NG-350A to drive sustained transgene expression, altering the tumor microenvironment. The company aims to deliver clinical proof-of-concept data for NG-350A through the FORTRESS study within the next 12–18 months.

Recent Publication Akamis Bio recently published findings in the Journal for ImmunoTherapy of Cancer, showcasing data from the FORTITUDE first-in-human dose escalation study. The study demonstrated sustained persistence of NG-350A up to seven weeks post-dosing, dose-dependent systemic delivery, and sustained increases in inflammatory cytokines, particularly at higher intravenous dose levels. These results underscore the therapy's safety profile and the advantages of its intravenous administration route.