Gilead: On the road towards realizing its goals. A new collaboration for fibrotic diseases

Gilead Sciences (GILD) and Scholar Rock Holding Corporation (SRRK) announced entering into a strategic collaboration to discover and develop highly specific inhibitors of transforming growth factor beta (TGFβ) activation for the treatment of fibrotic diseases.

Under the terms of the agreement

Gilead has exclusive options to license worldwide rights to product candidates that emerge from the following three Scholar Rock TGFβ programs: 

– Inhibitors that target activation of latent TGFβ1 with high affinity and specificity,

– Inhibitors that selectively target activation of latent TGFβ1 localized to extracellular matrix and

– A third TGFβ discovery program.

Scholar Rock is responsible for antibody discovery and preclinical research through product candidate nomination, after which, upon exercising the option for a program, Gilead will be responsible for the program’s preclinical and clinical development and commercialization.

Scholar Rock will retain exclusive worldwide rights to certain TGFβ inhibitors for oncology and cancer immunotherapy.

Scholar Rock will receive: 

– $80 million in upfront payments comprised of $50 million cash and $30 million purchase of Scholar Rock Holding Corporation common stock,

– A one-time milestone payment of $25 million in case of successful completion of specific preclinical studies,

– Eligibility to receive up to an additional $1,425 million in potential payments aggregated across all three programs; based on the successful achievement of certain research, development, regulatory and commercialization milestones,

– A high single-digit to low double-digit tiered royalties on sales of potential future products originating from the collaboration.

Prohost Observations

The agreement with Scholar Rock is part of Gilead’s commitment to developing novel treatments for fibrotic diseases which include: diabetic kidney complications and non-alcoholic steatohepatitis. Nagesh Mahanthappa, Ph.D., President and CEO of Scholar Rock stated, “Gilead’s commitment to developing innovative therapies for fibrotic diseases makes the company an ideal partner to maximize the value of candidates from our TGFβ program. This collaboration also emphasizes our belief in the tremendous potential of Scholar Rock’s broad pipeline of highly specific modulators targeting the TGFβ superfamily, with potential applications in a wide range of serious diseases, including neuromuscular disorders, cancer, fibrosis, and anemia.”

Fibrosis is debilitating when it occurs in diseases that cause scars to tissues and vital organs; sometimes becoming a major cause of morbidity and mortality.

TGFβ-driven signaling might be considered a major regulator of fibrosis.

Inhibitors of TGFβ signaling, discovered by Scholar Rock’s proprietary platform, have prevented the activation of the growth factor in the fibrotic matrix in vitro and in preclinical models. By targeting the disease microenvironment, these highly specific inhibitors of TGFβ activation may offer a new approach to suppressing pro-fibrotic signaling in multiple organs. 

About Scholar Rock

According to its own description of itself, Scholar Rock is a clinical-stage biopharmaceutical company that discovers and develops new therapies for serious fibrotic diseases in which signaling by protein growth factors plays a fundamental role.

Scholar Rock is assembling a pipeline of novel product candidates for a wide range of serious diseases including: neuromuscular disorders, cancer, fibrosis and anemia. Scholar Rock has a proprietary platform for the discovery and development of monoclonal antibodies that locally and selectively target the culprit signaling proteins at the cellular level.

For more information visit www.ScholarRock.com or follow Scholar Rock on Twitter (@ScholarRock) and LinkedIn (https://www.linkedin.com/company/scholar-rock/)

We remind our readers that on December 20, Gilead signed another collaboration agreement upon which it entered into an immuno-oncology (I-O) partnership with Agenus (AGEN). We posted an article under News & Comments on the same date.  The partnership with Agenus is focused on developing and commercializing up to five novel I-O therapies.

Under the terms of the agreement, Agenus is entitled to receive a $120 million upfront cash payment and a $30 million equity investment.

Gilead’s goals are ambitious.

Gilead is doing whatever it takes to realize its ambitious goals.

Gilead is among the way undervalued superior biotech companies.    

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