Nuvig secures $161M for upcoming Phase 2 autoimmune study

Nuvig Therapeutics, an immunomodulatory startup based in Menlo Park, CA, recently announced securing a substantial $161 million in Series B funding. The company is focused on developing innovative autoimmune disease treatments that minimize inflammation without relying on immunosuppressive methods. Nuvig's foundational work originates from research at Rockefeller University and initially surfaced with a $47 million Series A round in May 2022.

Sanofi, a company with a strong emphasis on immunology, co-led this recent funding round alongside Blue Owl Healthcare Opportunities and Norwest Venture Partners. Additional contributions came from Bristol Myers Squibb, Novo Holdings, and Bayer’s corporate venture arm, among other investors. This significant financing highlights the growing importance of companies dedicated to autoimmune disease treatments in the realms of business development and startup investments.

Nuvig's primary scientific strategy focuses on regulating immune responses in B cells and myeloid cells via the upregulation of a checkpoint receptor known as Fc gamma R2B. Additionally, the company's therapeutic candidates aim to expand T regulatory cells. Chief Scientific Officer Pamela Conley emphasized that this approach is distinct from other methods that merely lower IgG levels or deplete B cells entirely.

Pamela Conley, who co-founded Nuvig, previously served as an executive at Portola Pharmaceuticals until its acquisition by Alexion for approximately $1.4 billion in 2020. Initially leading Nuvig as CEO, she later passed the role to Julie Smith in early 2023. Smith has since transitioned out of the company, and Nuvig is currently seeking a new CEO to guide the company through and beyond its Phase 3 trials.

Nuvig's leading drug candidate, NVG-2089, is a recombinant Fc fragment immunomodulator that targets type II Fc receptors. This 18-member biotech team expects to advance NVG-2089 into Phase 2 trials for chronic inflammatory demyelinating polyneuropathy (CIDP) early next year. CIDP is a neurological autoimmune disorder that affects the protective sheaths of nerves, impacting five to seven individuals per 100,000 people.

The company also plans to initiate a proof-of-concept trial for immune thrombocytopenia (ITP). The current standard treatment for both CIDP and ITP involves intravenous immunoglobulin (IVIg), which requires patients to endure large doses. Conley noted that this is a burdensome process for those with chronic conditions. Preclinical studies suggest that Nuvig’s molecule is significantly more potent than IVIg, with a potency ranging from 10 to 20 times higher.

Nuvig aims to improve patient experience by reducing infusion times to about an hour, compared to the six to eight hours required for IVIg. NVG-2089 has shown promising tolerance in Phase 1 trials, with no anticipations of common side effects like flu-like symptoms or headaches associated with the large protein loads in IVIg treatments.

The field of CIDP has garnered considerable interest from various pharmaceutical companies in recent years. Takeda and argenx both received FDA approvals for CIDP therapies this year. Additionally, Sanofi is advancing a late-stage complement inhibitor, riliprubart, while Dianthus Therapeutics and Immunovant are also developing CIDP treatments.

Conley pointed out that current approaches, such as FcRn inhibitors, reduce circulating IgG levels significantly, which can increase infection risks over time. Complement inhibitors also pose some degree of immunocompromisation.

Beyond its primary program, Nuvig is also researching treatments in rheumatology, dermatology, and neurology, showcasing their broad commitment to developing novel solutions for autoimmune diseases.