– Recludix to receive $125 million in near-term payments and potentially more than $1.2 billion subject to future milestones, and up to double-digit royalties on sales –
– Recludix to lead research and development until start of Phase 2 –
– Recludix has an option to participate equally in U.S. profit/loss sharing –
SAN DIEGO, CA, July 20, 2023 – Recludix Pharma, a leader in platform approaches to discover inhibitors of challenging targets for inflammatory disease and cancer, today announced that the company has entered into a strategic collaboration with Sanofi (NASDAQ: SNY) to develop and commercialize first-in-class oral small molecule STAT6 (signal transducer and activator of transcription 6) inhibitors for patients with immunological and inflammatory (I&I) diseases. STAT6 is believed to play a key role in multiple dermatological and respiratory diseases.
“This collaboration for the advancement of a preclinical oral STAT6 inhibitor speaks to our ability to successfully solve the challenge of drugging this attractive, yet elusive, therapeutic target,” said Nancy Whiting, PharmD, CEO of Recludix. “We are proud of the breakthroughs we have made in drugging SH2 domains as demonstrated by the STAT6 program and we are excited to partner with Sanofi, a preeminent global biopharmaceutical company with industry leading I&I therapeutic area expertise and capabilities, who shares our vision for advancing an oral STAT6 inhibitor forward quickly for the benefit of patients. This strategic collaboration empowers the program while ensuring meaningful development participation and economic value for Recludix.”
“Recludix’s approach to targeting STAT6 has significant potential for a number of I&I diseases, especially where a precisely tailored oral therapy could best fit within the patient’s needs at various stages of disease,” said Frank Nestle, Global Head of Research & CSO at Sanofi. “We are excited to partner with the Recludix team to continue to advance innovative strategies for targeting this previously considered undruggable target, aligned with our mission to best serve patients with inflammatory disease.”
Under the partnership, Sanofi will have global rights to small molecule STAT6 inhibitors. Recludix will advance STAT6 inhibitors from preclinical research and development until the start of Phase 2 clinical trials. Sanofi will assume worldwide clinical development and commercialization responsibilities thereafter. Recludix has the option to participate in U.S. profit/loss share, which includes the ability to share equally in the costs, profits and losses, and to certain co-promotion activities for the partnered product in the U.S.
Recludix will receive $125 million in near-term payments, and additionally, Recludix may receive more than $1.2 billion in potential development, regulatory and sales milestones, as well as up to double-digit royalties on possible future product sales.
Signal transducer and activator of transcription (STAT) proteins are both signaling proteins and transcription factors that play a role in cell growth, differentiation and function. STAT6 is a key nodal transcription factor that selectively mediates downstream signaling of IL-4 and IL-13, dominant and central cytokines in the pathophysiology of Type 2 inflammatory diseases. A STAT6 inhibitor offers the potential for a novel first-in-class targeted oral therapy for patients in the treatment of Type 2 inflammatory diseases.
Recludix is a leader in developing platform approaches to discover potent and selective inhibitors of challenging protein targets. The company’s management team includes industry veterans with a track record of success, including former leaders and founding scientific team members of Seagen and Blueprint Medicines. Recludix has developed a unique drug discovery platform that integrates custom generated DNA-encoded libraries, massively parallel determination of structure activity relationships, and a proprietary screening tool to ensure selectivity. The company is employing this approach first in the development of SH2 domain inhibitors. Recludix’s most advanced programs are focused on STAT (signal transducer and activator of transcription) proteins where abnormal activation is found in inflammatory diseases, such as rheumatoid arthritis, asthma, atopic dermatitis, and inflammatory bowel disease, as well as numerous cancer types, such as multiple leukemias and lymphomas. The company has a strategic partnership with Sanofi for the development and commercialization of a STAT6 inhibitor. Recludix is also advancing STAT3 inhibitors for Th17-mediated I&I diseases and oncology indications, as well as additional programs. For more information, please visit the company’s website at https://recludixpharma.com.