Mother and preterm baby first touch
[Source: IvanJekic/Getty Images]

For the second time six months, Takeda Pharmaceutical Co. has launched a new company by seeding it with Phase II clinical candidates, today announcing the formation of Oak Hill Bio which has licensed candidates from Takeda in extreme preterm births (OHB-607) and rare autoimmune diseases (OHB-101).  In late July, Takeda also spun out new company HilleVax to develop and commercialize HIL-214 (formerly TAK-214) a norovirus vaccine candidate that has shown promising results in Phase II studies.

Under the terms of the agreement, whose value was not disclosed, Takeda will take an ownership stake in Oak Hill Bio, receive an upfront payment, and will be eligible for milestone payments and royalties of the licensed programs. In addition to the two clinical-stage drugs in development, Takeda has licensed four other preclinical programs to the startup.

“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, co-founder, president, and CFO 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.”

In addition to seeding Oak Hill with an active R&D pipeline of potential therapeutics, Oak Hill will also take on a handful of Takeda executives at launch. Victoria Niklas, becomes the chief medical officer and Norman Barton is a senior scientific advisor. Niklas was most recently VP and global program leader of R&D in plasma-derived therapies and leader of the TAK-607 program, while Barton was Takeda’s head of clinical sciences in rare genetic and immunological diseases and neonatology. Joining the Oak Hill board of directors is Daniel Curran who heads the rare genetics and hematology therapeutic area unit at Takeda.

Of the two clinical candidates in Oak Hill’s portfolio, the most advanced is OHB-607, a recombinant version of insulin-like growth factor 1 (IGF-1) whose naturally occurring version has been shown to drive fetal growth and development in utero. The potential drug is intended to be treat extremely premature birth babies—delivered before 28 weeks—to aid development and maturation of vital organs and the vasculature that supports them.

“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 Niklas, in a press release. “OHB-607 has the potential to be the first breakthrough in more than 30 years to improve outcomes for these infants and their families.”

A Phase II trial of OHB-607 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.

The second clinical stage drug licensed from Takeda is OHB-101, currently in a Phase IIa study that is investigating its use across a broad swath of 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.

The company expects to launch Phase IIb studies of both OHB-607 and OHB-101 later this year. In addition, Oak Hill has also licensed four preclinical programs—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,” noted board member Curran in a prepared statement. “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.”

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