Oak Hill Bio has a pipeline that includes two programs with Phase II proof-of-concept data in rare diseases with significant unmet needs.
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With two assets licensed from Takeda, Oak Hill Bio launched with a focus on developing therapeutics for patients and extremely preterm infants who are suffering from rare autoimmune diseases. In addition to assets licensed from Takeda, executives from the Japanese pharma powerhouse will take a leadership role in the company.
The startup, based in Cambridge, Mass., has a pipeline that includes two programs with Phase II proof-of-concept data in rare diseases with significant unmet needs. Its lead therapeutic asset is OHB-607, a former Takeda property known as TAK-607.
OHB-607 is a proprietary, recombinant version of insulin-like growth factor 1 (IGF-1) and its binding protein, IGFBP-3. Insulin-like growth factor 1 is naturally made by the body and is a key driver of fetal growth and development in utero. The fetus does not produce much IGF-1 until about 30 weeks in utero.
However, children born extremely early, less than 28 weeks of gestation, have low levels of IGF-1, which are associated with greater complication rates. As a human IGF-1 replacement, OHB-607 is designed to promote continued development and maturation of vital organs in these infants, as well as vasculature that supports them.
The therapeutics asset has been evaluated in preclinical and clinical studies. A Phase II trial showed a “statistically significant shift towards milder bronchopulmonary dysplasia and a positive trend in reducing intraventricular hemorrhage.” There were no significant safety signals observed in the study.
Victoria Niklas, chief medical officer at Oak Hill Bio and former global program lead for OHB-607 at Takeda, noted that hundreds of thousands of infants are born extremely premature across the globe each year. These children 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. OHB-607 has the potential to be the first breakthrough in more than 30 years to improve outcomes for these infants and their families,” Niklas said.
The other Takeda asset in Oak Hill’s pipeline is OHB-101, formerly known as TAK-752, which is in Phase IIa for the treatment of rare autoimmune diseases. OHB-101 is a soluble recombinant version of the FcγR2B receptor designed to “bind to immune complexes to prevent them from interacting with the fc gamma receptors that drive inflammation and autoimmune cascades,” the company noted.
OHB-101 has been assessed in preclinical studies of lupus erythematosus, a rare autoimmune primary glomerular disease, and immune thrombocytopenia, a rare autoimmune blood disorder.
Oak Hill intends to advance the ongoing Phase IIb clinical study of OHB-607 for premature complications this year and initiate two Phase IIb clinical studies of OHB-101 in rare autoimmune diseases. Additionally, the company plans to begin studies to enable Investigational New Drug applications for some of its preclinical programs, including three novel anti-FCγR2B receptor monoclonal antibodies for autoimmune disease and an oral pKAL inhibitor for diabetic macular edema.
“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,” Josh Distler, president and chief financial officer of Oak Hill Bio said in a statement. “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.”
In addition to Niklas, the other Takeda executives supporting Oak Hill are Norman Barton, who will serve as a scientific advisor to the company and Daniel Curran, head of the rare genetics & hematology therapeutic area unit at Takeda, has joined the company board of directors.
