Oak Hill Bio, a clinical-stage rare disease therapeutics company developing life-changing medicines for extremely preterm infants and patients suffering from rare autoimmune diseases, today announced the Company’s launch and plans to advance a pipeline of promising clinical and preclinical investigational therapeutics acquired and licensed from Takeda Pharmaceutical Company Limited (“Takeda”).
Under the terms of the agreements, Takeda will receive an upfront payment, an ownership stake in Oak Hill and potential milestones and royalty payments in exchange for the acquired and licensed programs. Takeda will also support the transition for continued research and development of the acquired programs. The pipeline includes two clinical-stage and four preclinical-stage programs.
Two Takeda executives with direct experience working on the acquired programs will join Oak Hill, including Victoria Niklas, M.D., as Chief Medical Officer, and Norman Barton, M.D., as a senior scientific advisor. Daniel Curran, M.D., Head, Rare Genetics & Hematology Therapeutic Area Unit at Takeda, will join the Oak Hill board of directors.
“Oak Hill has a significant opportunity to take these promising programs and advance them through clinical development to bring life-altering new medicines to patients in need,” said Josh Distler, J.D., President and Chief Financial Officer of Oak Hill Bio. “We are confident not only in these potentially transformative compounds, but also in the extraordinary team that has come together to deliver these innovative therapies.”
Oak Hill’s lead therapeutic candidate, OHB-607 (formerly TAK-607), is a proprietary, recombinant version of insulin-like growth factor 1 (IGF-1), the natural version of which is a key driver of fetal growth and development in utero, and its binding protein, IGFBP-3.
Mothers are the primary source of IGF-1 for the developing fetus, with the fetus producing very little of its own until reaching 30 weeks of gestational age. At birth, extremely premature infants, born at less than 28 weeks of gestational age, have low levels of IGF-1 which are associated with greater complication rates. OHB-607, as a human IGF-1 replacement, is designed to help promote continued development and maturation of vital organs and the vasculature that supports them.
OHB-607 has been evaluated in both preclinical and clinical studies. A Phase 2 clinical trial showed a statistically significant shift towards milder bronchopulmonary dysplasia and a positive trend in reducing intraventricular hemorrhage (pre-specified secondary endpoints), with no significant safety signal observed.
“Every year, hundreds of thousands of infants worldwide are born extremely prematurely and, as a result, suffer from severe complications in their lungs, brain, and eyes that hinder their long-term development and quality of life. While prenatal steroids, surfactants, ventilators and improved resuscitation protocols have increased the survival rate of premature infants, there has been little progress in protecting their not fully developed organs from the trauma of life-saving measures at birth, including supplemental oxygen and breathing machines,” said Victoria Niklas, M.D., Chief Medical Officer at Oak Hill Bio and former Global Program Lead for OHB-607 at Takeda. “We are committed to delivering innovation into this area of high unmet medical need for infants born extremely premature. OHB-607 has the potential to be the first breakthrough in more than 30 years to improve outcomes for these infants and their families.”
OHB-101 (Formerly TAK-752), a Phase 2a program, is currently being investigated for the treatment of a wide array of rare autoimmune diseases. It is a soluble recombinant version of the FcγR2B receptor that is designed to bind to immune complexes to prevent them from interacting with the fc gamma receptors that drive inflammation and autoimmune cascades. Preliminary clinical studies have been conducted in multiple autoimmune indications, including systemic lupus erythematosus, a rare autoimmune primary glomerular disease, and immune thrombocytopenia, a rare autoimmune blood disorder.
Oak Hill intends to advance the ongoing Phase 2b clinical study of OHB-607 for complications of premature birth in 2022 and initiate two Phase 2b clinical studies of OHB-101 in rare autoimmune diseases. The company also anticipates commencing IND-enabling activities for certain of its four preclinical programs, which include three novel anti-FCγR2B receptor monoclonal antibodies for autoimmune disease and an oral pKAL inhibitor for diabetic macular edema.
“There is a tremendous need for new therapies to prevent the complications of prematurity and for those suffering from rare autoimmune disorders,” said Dr. Curran. “Making a strategic investment in Oak Hill Bio and their strong leadership team is an ideal path to continue the development of these promising programs.”