Nuvig Therapeutics, a biotechnology company focused on developing novel immunomodulatory therapeutics, has announced the closing of a $161 million Series B financing round. The funding will be used to advance its lead candidate, NVG-2089, into Phase 2 clinical trials and to further develop its preclinical pipeline.
Targeting Autoimmune Diseases with Immunomodulation
Nuvig's primary focus is on creating therapies that can address autoimmune dysregulation without causing broad immunosuppression, a common issue with current treatments. Their lead candidate, NVG-2089, is a first-in-class recombinant Fc fragment immunomodulator engineered to bind to type II Fc receptors. This mechanism aims to engage an endogenous regulatory pathway, restoring normal immune homeostasis rather than crippling the immune system.
Pamela Conley, Nuvig’s Chief Scientific Officer and founding CEO, emphasized that their approach could be applied to several chronic conditions. "We're quite distinct in our potential safety profile, and we have a unique mechanism of action," she stated.
Clinical Development and Target Indication
NVG-2089 is slated to enter Phase 2 testing for chronic inflammatory demyelinating polyneuropathy (CIDP), a rare autoimmune disorder where the body mistakenly attacks the myelin sheaths protecting nerve cells, leading to progressive muscle weakness. Current treatments for CIDP include immunosuppressive medicines and intravenous immunoglobulin (IVIg).
Nuvig chose CIDP as an initial indication due to the unmet need for better-tolerated therapies that are not immunosuppressive. Conley noted that while Argenx's Vyvgart Hytrulo, an FcRn blocker, is an alternative, it reduces overall circulating antibodies, potentially increasing infection risk. "An FcRn blocker like Argenx’s drug does nothing to reduce the infiltration of immune cells into myelin," Conley explained, highlighting that NVG-2089 aims to downregulate inflammatory immune cell responses while expanding regulatory T cells (Tregs).
Differentiating from Existing Therapies
Nuvig's approach differs significantly from FcRn blockers. According to Conley, most damage in CIDP is mediated by immune cells infiltrating the myelin, not solely by autoantibodies. NVG-2089 aims to offer a broader approach by modulating immune cell responses and activating Tregs, similar to IVIg but without its downsides and supply limitations. Clinical tests of FcRn blockers have shown a less pronounced overall response in CIDP patients compared to IVIg studies, leading Nuvig to believe that NVG-2089 could offer greater efficacy.
Financial Backing and Future Plans
The Series B round was co-led by Sanofi Ventures, Blue Owl Healthcare Opportunities, and Norwest Venture Partners, with participation from new investors such as B Capital, Leaps by Bayer, and existing shareholders including Novo Holdings and Bristol Myers Squibb. This financing will support clinical proof-of-concept studies for NVG-2089 and advance Nuvig’s preclinical pipeline.
Paulina Hill, Partner at Sanofi Ventures, noted, "Nuvig’s innovative and immunomodulatory approach to inflammatory and autoimmune diseases is well aligned with Sanofi Ventures’ development and investment philosophy... They have not only demonstrated powerful anti-inflammatory effects of their lead candidate NVG-2089 without immunosuppression but have also created a reproducible and scalable recombinant method of recapitulating the effects of IVIg without the downsides and supply limitations of IVIg."
With Phase 1 results showing NVG-2089 to be safe, well-tolerated, and engaging its target, Nuvig is poised to further explore its potential in CIDP and other autoimmune indications.
