For patients suffering from gout, a painful form of arthritis caused by excess uric acid in the blood, conventional treatments may not always provide relief. In such cases, Amgen’s biologic drug has been a potential alternative, yet its effectiveness is often limited by the immune system which might recognize the therapeutic protein as foreign, initiating an immune response that neutralizes the medication. GRO Biosciences, a biotech startup based in Cambridge, Massachusetts, endeavors to solve this problem by engineering proteins that the body does not see as foreign, thereby hoping to enhance the treatment’s efficacy.
In this regard, GRO Biosciences has secured $60 million in Series B funding in an effort led by Atlas Venture and Access Biotechnology. The biotech firm utilizes a distinct approach by integrating non-standard amino acids (NSAAs) into proteins, varying from the 20 standard amino acids typically used in protein synthesis. This enables the design of proteins with improved properties such as longer durability and enhanced control over the immune system. Dan Mandell, CEO of GRObio, claims that these modifications could particularly benefit treatments for autoimmune and inflammatory disorders, with gout being the primary target.
Historically, treatment options for gout have included anti-inflammatory drugs and URAT1 inhibitors. However, these solutions are typically short-lived if uricase—an enzyme crucial for breaking down uric acid but naturally absent in humans—is introduced in the body, due to the immune system’s adverse reactions forming antibodies against it. Amgen’s solution, Krystexxa, addresses this by attaching uricase to polyethylene glycol, which diminishes the immune response. Despite an initial benefit, many patients develop anti-drug antibodies that eventually eliminate the effectiveness of the treatment.
In contrast, GRObio’s candidate, ProGly-Uricase, is engineered to outsmart the immune system through the unique placement and composition of glycans (sugar molecules) which cloud the protein, signaling the immune system that the protein is endogenous to the body. This mechanism has shown promise in preclinical trials where it significantly reduced the formation of treatment-neutralizing antibodies compared to Krystexxa.
GRObio, surfaced in 2021 with foundations in the lab of renowned geneticist George Church from Harvard University, employs a technique called genomically recoded organisms. This involves using specially modified E. coli bacteria to produce the NSAA proteins. With $25 million from a Series A funding round, they have been advancing this innovative treatment strategy.
Choosing gout as the lead indication was strategic due to the relatively fast clinical pathway gout offers. The measurable biomarker of uric acid levels in the blood provides a clear endpoint for clinical trials, potentially allowing early-stage successes to propel directly into Phase 3 studies. This is an expedited route previously paved by the journey of Krystexxa, offering a precedent for achieving necessary efficacy data in early testing phases.
The funding will not only facilitate GRObio’s journey through these clinical stages but will also support the scaling up of clinical manufacturing and other preparatory activities for a new drug application. Beyond gout, GRObio is exploring treatments for other conditions such as myasthenia gravis, a rare muscle disease, and is considering how its platform might contribute to the development of antibody drug conjugates (ADCs) for use in oncology and autoimmune diseases.
The funding round saw participation from both new and existing investors including Leaps by Bayer and Redmile Group, raising GRObio’s total funding to more than $90 million. While no specific timelines for clinical trials were disclosed, the ongoing support and financial backing signify robust confidence in GRObio’s potentially revolutionary protein engineering technology.
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