Akamis Bio, a clinical-stage oncology company, has raised $60 million in Series A funding that will drive continued development of NG-350A, a new gene therapy based on its proprietary tumor-specific immuno-gene (T-SIGn®). The new funding will support efforts to take the therapy through a Phase Ib clinical proof-of-concept study in patients with locally advanced rectal cancer.
The financing round was led by venture capital firm Sedgwick Yard. As part of the round, Richard Shen and Adrian Chan, both managing directors at Sedgwick Yard, will join Akamis Bio’s board of directors. In a separate transaction, Akamis Bio signed a licensing agreement that grants Xuanzhu Biopharma rights to NG-350A in the Greater China region. The terms state that Akamis Bio is eligible to receive undisclosed upfront payments plus regulatory and sales milestones, as well as tiered royalties from sales in the region.
Delivered intravenously, NG-350A is a transgene-armed gene therapy designed to drive intratumoral expression of a CD40 agonist monoclonal antibody in primary and metastatic epithelial-derived solid tumors. Akamis Bio aims to test it in a Phase Ib study, dubbed FORTRESS, which will evaluate clinical complete response rates to NG-350A in combination with chemoradiotherapy in adult patients with LARC and at least one risk factor for local or distant recurrence.
Clinical data from earlier studies “have shown the consistent safety profile of T-SIGn, as well as the potential of intravenously-delivered NG-350A to drive sustained transgene expression capable of altering the tumor microenvironment,” said Howard Davis, PhD, CEO of Akamis Bio. “Our aim over the next 12–18 months is to deliver clinical proof-of-concept data for NG-350A via the FORTRESS study,” Davis said.
The company recently published a paper in the Journal for ImmunoTherapy of Cancer titled, “First-in-human clinical outcomes with NG-350A, an anti-CD40 expressing tumor-selective vector designed to remodel immunosuppressive tumor microenvironments.” In that paper, the scientists presented data from the FORTITUDE first-in-human dose escalation study in patients with metastatic/advanced epithelial tumors. That paper provided initial proof-of-mechanism for NG-350A and highlighted the advantages of its intravenous route of administration as well as its safety profile.
They reported that patients showed sustained persistence of NG-350A up to seven weeks after intravenous dosing was completed, particularly at higher dose levels. They also observed a dose-dependent pattern with systemic delivery, resulting in four patients remaining positive for vector DNA in biopsies nearly two months after receiving the treatment. They were also able to detect transgene messenger RNA from replicating NG-350A in nearly half the patients with intravenous treatment but only in one patient that had received intratumoral injection. Sustained increases in inflammatory cytokines were also observed following dosing, particularly with higher intravenous dose levels.
