On May 10, 2022 Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company committed to identifying and accelerating the development of life-transforming therapies for patients with severe and rare diseases, reported that it has obtained worldwide exclusive rights to Sanofi’s KY1066, which will be referred to as RLYB331 going forward, a preclinical potentially first-in-class antibody (Press release, Sanofi, MAY 10, 2022, View Source [SID1234614177]). RLYB331 has the potential to address a significant unmet need for patients with severe anemia with ineffective erythropoiesis and iron overload, such as beta thalassemia (BT) and a subset of myelodysplastic syndromes (MDS), amongst others. The transaction expands Rallybio’s pipeline, is strategically consistent with Rallybio’s existing focus on hematology, and aligns with its mission to accelerate the development of life-transforming therapies for patients with severe and rare disorders.
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"With our strong focus on portfolio expansion, the in-licensing of RLYB331, our first as a public company, marks a pivotal moment for Rallybio. We believe RLYB331 is differentiated from all programs in clinical development based on its mechanism of action, with the potential to be first-in-class. We expect that RLYB331 may address a significant unmet need by correcting ineffective erythropoiesis, improving hemoglobin, reducing red blood cell transfusions and reducing iron overload in multiple hematological disorders such as beta thalassemia and myelodysplastic syndromes," said Martin Mackay, Ph.D., Chief Executive Officer of Rallybio. "This product candidate is a natural fit with our R&D expertise and our focus on hematological disorders. Along with our existing pipeline it provides an additional opportunity to leverage our deep expertise in rare diseases and to identify and accelerate the development of transformative therapies for patients with severe and rare diseases. We look forward to integrating RLYB331 into our portfolio and ultimately deliver this therapy to transform the treatment of patients with severe benign hematological disorders."
RLYB331 is a monoclonal antibody that inhibits Matriptase-2 (MTP-2). The inhibition of MTP-2 significantly increases levels of hepcidin, decreases iron load and treats ineffective erythropoiesis. The standard of care for many such hematological disorders leaves a significant unmet need in iron overload associated anemias with patients experiencing significant morbidity and consequent mortality.
Rallybio plans to prosecute preclinical activities for RLYB331 including CMC, and dose-range finding and toxicity studies, which will then support transition of the asset into clinical development.
Under the terms of the license agreement, Rallybio will make an upfront cash payment of $3 million to Sanofi, in addition to development and commercial milestones, and mid to high single digit royalties on net sales.