– Preclinical data demonstrate pharmacodynamic activity of KRIYA-586, an investigational gene therapy which encodes for an anti-IGF1R antibody –
– Kriya anticipates advancing KRIYA-586 into the clinic in 2025 to evaluate its safety and efficacy in people suffering from TED –
PALO ALTO, CA and RESEARCH TRIANGLE PARK, NC, USA I September 12, 2024 I Kriya Therapeutics, Inc., (Kriya), a biopharmaceutical company developing gene therapies to address common diseases affecting millions of people around the world, today announced preclinical data from its gene therapy program for thyroid eye disease (TED). The data are being presented at the 42nd Annual Meeting of the European Society of Ophthalmic Plastic & Reconstructive Surgery (ESOPRS) being held September 12-14 in Rotterdam, the Netherlands.
KRIYA-586 is an investigational adeno-associated virus (AAV) gene therapy product engineered to express an antibody that inhibits Insulin-Like Growth Factor 1 Receptor (IGF1R), a key target implicated in the pathogenesis of TED. Currently, the only medicine approved in the U.S. for the treatment of TED is an intravenously infused human monoclonal antibody that blocks IGF1R. KRIYA-586 is designed for one-time delivery through a focal peribulbar injection performed in the office—with the goal of providing local and durable expression of anti-IGF1R antibody from transduced periorbital fat and muscle cells to help address the ocular manifestations of TED while minimizing systemic toxicities.
“We are excited to present these preclinical results that demonstrate the robust activity of KRIYA-586 in blocking IGF1R activity,” said Shankar Ramaswamy, M.D., Co-Founder and CEO of Kriya. “These data support the potential of KRIYA-586 to address the unmet medical needs in thyroid eye disease, and we look forward to advancing KRIYA-586 into the clinic in 2025.”
The Kriya ESOPRS presentation, “Activity of an adeno-associated virus (AAV)-derived anti-Insulin-like Growth Factor 1 Receptor (IGF1R) in vitro and pharmacodynamic activity in an IGF1R+ Human Colon Carcinoma Xenograft Mouse Model”, is outlined below.
The study was designed to:
- demonstrate in vitro secretion of a human antibody with anti-IGF1R activity, and
- compare in vivo pharmacodynamic activity of the anti-IGF1R antibody (produced by KRIYA-586) to weekly teprotumumab administration in a humanized xenograft mouse model.
The study demonstrated:
- A vectorized antibody capable of blocking IGF1R to a similar degree as teprotumumab; and
- In a preclinical in vivo model, anti-IGF1R antibody produced by KRIYA-586 demonstrated a similar reduction in levels of IGF1R and downstream activity as teprotumumab.
To date KRIYA-586 has been characterized in multiple in vitro and in vivo pharmacodynamic models, including the study described above.
About KRIYA-586
Kriya has designed KRIYA-586 for TED with the following potential goals:
- One-time administration: One-time, in-office peribulbar injection to eliminate the burdensome requirement for multiple intravenous infusions.
- Focal delivery: Localized antibody expression in extraocular muscles and fat tissue, with low systemic exposure to limit the potential for side effects.
- Long-term durability: AAV-mediated anti-IGF1R expression to deliver sustained improvements in proptosis and diplopia as well as other key manifestations of Thyroid Eye Disease.
KRIYA-586 has not been approved for use by the U.S. Food and Drug Administration. The clinical safety and efficacy of KRIYA-586 for the treatment of Thyroid Eye Disease has not yet been established.
About Thyroid Eye Disease (TED)
TED is an autoimmune disease that causes inflammation and enlargement of the muscle and fat tissue behind the eye. This results in proptosis and diplopia which can significantly impact quality of life of patients with TED. The only FDA approved therapy for the treatment of TED is an intravenously administered monoclonal antibody that works by blocking IGF1R. There is a need for safe and durable treatments that can address the approximately one million patients in the United States and the European Union who have TED.
About Kriya Therapeutics
Our mission is to revolutionize medicine, with the ultimate goal of eliminating human suffering and enabling people to live without the burden of disease. Kriya is a biopharmaceutical company developing gene therapies to address common diseases affecting millions of people around the world. With operations in Palo Alto, California and Research Triangle Park, North Carolina, Kriya has raised over $600 million, which will be used to advance a broad pipeline of gene therapies for ophthalmology, metabolic disease and neurology. For more information, please visit www.kriyatx.com and follow us on LinkedIn and X.
SOURCE: Kriya Therapeutics
Post Views: 3,910
– Preclinical data demonstrate pharmacodynamic activity of KRIYA-586, an investigational gene therapy which encodes for an anti-IGF1R antibody –
– Kriya anticipates advancing KRIYA-586 into the clinic in 2025 to evaluate its safety and efficacy in people suffering from TED –
PALO ALTO, CA and RESEARCH TRIANGLE PARK, NC, USA I September 12, 2024 I Kriya Therapeutics, Inc., (Kriya), a biopharmaceutical company developing gene therapies to address common diseases affecting millions of people around the world, today announced preclinical data from its gene therapy program for thyroid eye disease (TED). The data are being presented at the 42nd Annual Meeting of the European Society of Ophthalmic Plastic & Reconstructive Surgery (ESOPRS) being held September 12-14 in Rotterdam, the Netherlands.
KRIYA-586 is an investigational adeno-associated virus (AAV) gene therapy product engineered to express an antibody that inhibits Insulin-Like Growth Factor 1 Receptor (IGF1R), a key target implicated in the pathogenesis of TED. Currently, the only medicine approved in the U.S. for the treatment of TED is an intravenously infused human monoclonal antibody that blocks IGF1R. KRIYA-586 is designed for one-time delivery through a focal peribulbar injection performed in the office—with the goal of providing local and durable expression of anti-IGF1R antibody from transduced periorbital fat and muscle cells to help address the ocular manifestations of TED while minimizing systemic toxicities.
“We are excited to present these preclinical results that demonstrate the robust activity of KRIYA-586 in blocking IGF1R activity,” said Shankar Ramaswamy, M.D., Co-Founder and CEO of Kriya. “These data support the potential of KRIYA-586 to address the unmet medical needs in thyroid eye disease, and we look forward to advancing KRIYA-586 into the clinic in 2025.”
The Kriya ESOPRS presentation, “Activity of an adeno-associated virus (AAV)-derived anti-Insulin-like Growth Factor 1 Receptor (IGF1R) in vitro and pharmacodynamic activity in an IGF1R+ Human Colon Carcinoma Xenograft Mouse Model”, is outlined below.
The study was designed to:
- demonstrate in vitro secretion of a human antibody with anti-IGF1R activity, and
- compare in vivo pharmacodynamic activity of the anti-IGF1R antibody (produced by KRIYA-586) to weekly teprotumumab administration in a humanized xenograft mouse model.
The study demonstrated:
- A vectorized antibody capable of blocking IGF1R to a similar degree as teprotumumab; and
- In a preclinical in vivo model, anti-IGF1R antibody produced by KRIYA-586 demonstrated a similar reduction in levels of IGF1R and downstream activity as teprotumumab.
To date KRIYA-586 has been characterized in multiple in vitro and in vivo pharmacodynamic models, including the study described above.
About KRIYA-586
Kriya has designed KRIYA-586 for TED with the following potential goals:
- One-time administration: One-time, in-office peribulbar injection to eliminate the burdensome requirement for multiple intravenous infusions.
- Focal delivery: Localized antibody expression in extraocular muscles and fat tissue, with low systemic exposure to limit the potential for side effects.
- Long-term durability: AAV-mediated anti-IGF1R expression to deliver sustained improvements in proptosis and diplopia as well as other key manifestations of Thyroid Eye Disease.
KRIYA-586 has not been approved for use by the U.S. Food and Drug Administration. The clinical safety and efficacy of KRIYA-586 for the treatment of Thyroid Eye Disease has not yet been established.
About Thyroid Eye Disease (TED)
TED is an autoimmune disease that causes inflammation and enlargement of the muscle and fat tissue behind the eye. This results in proptosis and diplopia which can significantly impact quality of life of patients with TED. The only FDA approved therapy for the treatment of TED is an intravenously administered monoclonal antibody that works by blocking IGF1R. There is a need for safe and durable treatments that can address the approximately one million patients in the United States and the European Union who have TED.
About Kriya Therapeutics
Our mission is to revolutionize medicine, with the ultimate goal of eliminating human suffering and enabling people to live without the burden of disease. Kriya is a biopharmaceutical company developing gene therapies to address common diseases affecting millions of people around the world. With operations in Palo Alto, California and Research Triangle Park, North Carolina, Kriya has raised over $600 million, which will be used to advance a broad pipeline of gene therapies for ophthalmology, metabolic disease and neurology. For more information, please visit www.kriyatx.com and follow us on LinkedIn and X.
SOURCE: Kriya Therapeutics
Post Views: 3,910
