OHB-607

  • 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. These complications can go on to 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.

    There must be a strong commitment to looking for solutions for this vulnerable population.

    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-607 is a straightforward replacement therapy approach. 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.* IGF-1 is crucial for organ development.

    OHB-607, as a human IGF-1 replacement, is designed to make up for the deficiency that occurs in extremely preterm birth and thereby 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. It has shown broad-based improvements in preclinical studies.

    In a Phase 2a clinical trial, OHB-607 showed a statistically significant improvement in preventing severe bronchopulmonary dysplasia and a positive trend in reducing intraventricular hemorrhage (pre-specified secondary endpoints), with no significant safety signal observed.*


    *Hellström A, et al. Acta Paediatr 2016, 105: 576-586

    *Ley D, et al. J Pediatr 2019;206:56–65.

    OHB-607 is now in a Phase 2b study - current trial: Footprints

    A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants

    https://clinicaltrials.gov/study/NCT03253263

OHB-101

 

  • Rare autoimmune diseases represent a significant unmet medical need. These conditions arise when the immune system mistakenly attacks the body, triggering chronic inflammation and immune system cascades. With over 80 immune complex-driven autoimmune diseases affecting areas such as hematology, nephrology, rheumatology, dermatology, and vasculitis, patients often face debilitating long-term effects with limited treatment options—many of which come with serious side effects.

    For example, in IgA nephropathy (IgAN), a progressive kidney disease, nearly half of all patients will advance to end-stage renal disease, requiring dialysis or a kidney transplant. Similarly, conditions like lupus and idiopathic thrombocytopenic purpura (ITP) can have severe, life-altering consequences. Addressing these diseases requires innovative approaches that go beyond traditional immunosuppressive treatments.

  • OHB-101 (Valziflocept, formerly SM101, TAK-752) is a Phase 2 investigational therapeutic designed to be a potential breakthrough in the treatment of a broad range of immune complex-driven autoimmune diseases. As a first-in-class Fcγ receptor decoy, OHB-101 is a soluble recombinant version of the FcγR2B receptor that prevents immune complexes from engaging Fc gamma receptors, thereby disrupting the inflammatory signals that drive inflammation and autoimmune cascades.

    Early clinical studies have shown promising safety and efficacy in multiple autoimmune conditions, including systemic lupus erythematosus (SLE) and idiopathic thrombocytopenic purpura (ITP). Notably, a short course of treatment has shown sustained benefits, underscoring its potential for durable disease modification.

    Additionally, novel biomarker research conducted in collaboration with academic partners supports a precision medicine approach, potentially identifying patients most likely to benefit from treatment. This biomarker-driven strategy could differentiate OHB-101 from competitors and enhance its potential to deliver targeted, effective therapies.

    With its novel mechanism of action, OHB-101 may have the potential as both standalone and combination therapy in areas of hematology, nephrology, rheumatology, dermatology, and vasculitis - findings further supported by nonclinical research. Our focus remains on advancing OHB-101 in indications with a clear development path and significant potential to improve patient outcomes.

    References

    1. Skokowa, J., et al. "I. Immunol." 2005.

    2. Werwitzke, S., et al. "Annals of the Rheumatic Diseases." 2008; 67:154-161.

    3. Iwata, Y., et al. "Journal of Investigative Dermatology." 2015.

    4. Magnusson, S., et al. "Clinical Immunology." 2008.

    5. Tillmanns, S., et al. "SM101, a novel recombinant, soluble, human FcγIIB receptor, in the treatment of systemic lupus erythematosus: Results of a double-blind, placebo-controlled multicenter study." ACR Meeting Abstracts. 2014. ISRCTN84672048.

    6. Konstaninova, T., Ivanova, L., Hellmann, A., Kyrcz-Krzemien, S., Tillmanns, S., Sondermann, P., & Buckel, P. "Interim Results From a Phase Ib/IIa Clinical Trial with the Soluble Fc-Gamma IIb Receptor SM101 for the Treatment of Primary Immune Thrombocytopenia." Blood. 2012 Nov 16; 120. doi: 10.1182/blood.V120.21.3388.3388.

    7. Sondermann, P. "The FcγR/IgG Interaction as Target for the Treatment of Autoimmune Diseases." Journal of Clinical Immunology. 2016 May; 36 Suppl 1:95-9. doi: 10.1007/s10875-016-0272-7. PMID: 27039179.

    8. Zuercher, A. W., Spirig, R., Baz Morelli, A., Rowe, T., & Käsermann, F. "Next-generation Fc receptor–targeting biologics for autoimmune diseases." Autoimmunity Reviews, 2019, 18(10), 102366.

Preclinical Programs

 

Oak Hill Bio’s preclinical programs bring exciting potential. OHB-201, OHB-211 and OHB-301 are companion programs to OHB-101. They provide nuanced mechanisms compared to OHB-101 that create the potential for success in different indications. OHB-401 leverages Takeda's significant franchise in pKAL inhibition with a potential best-in-class oral small molecule.