Kira Pharmaceuticals to Present New Preclinical Data on Lead Asset KP104 at the 2022 European Complement in Human Disease Conference
The oral presentation characterizes the promising PK/PD properties of KP104 in relevant animal models and supports its further development as a potent bifunctional complement inhibitor suitable for intravenous and subcutaneous administration.
Poster presentations demonstrate the synergistic effects of selective inhibition of alternative and terminal pathways to treat complement-mediated diseases, including data from a novel C3G mouse model
CAMBRIDGE, Mass. and SUZHOU, China, August 26, 2022 /PRNewswire/ — Kira Pharmaceuticals, a global biotechnology company pioneering transformational complement therapies to treat immune-mediated diseases, will present preclinical data supporting its bifunctional approach to complement inhibition at the European conference. 2022 on Complement in Human Diseases (EMCHD). The research, conducted in collaboration with the Perelman School of Medicine in University of Pennsylvania, further supports the clinical advancement of Kira’s lead asset, KP104, a first-in-class biologic with a unique dual-track mechanism of action. Designed to selectively block alternative and terminal pathways, KP104 provides a potent and synergistic method to target validated disease drivers in the complement system.
To take place August 26-29the conference will take place at Bern, Switzerland. Abstracts of presentations are now available for viewing on the conference website.
A complex constellation of protein pathways, the complement system is a key component of innate immunity. Aberrant activity within this system can cause diseases such as autoimmune and inflammatory conditions. Due to the complexity of complement biology, there remains a significant unmet medical need for next-generation and anti-complement drugs with better efficacy and convenience of administration than current therapies. The research presented at EMCHD provides evidence that using a bifunctional approach to target alternative and terminal pathways of the complement system could lead to therapies with greater efficacy, longer lasting effects and improved safety.
“Based on intellectual property licensed and developed by the University of PennsylvaniaKira’s lead product, KP104, is designed to overcome the challenges inherent in complementary drug discovery and, in preclinical models, exhibits superior efficacy and longer-lasting inhibition than current complement-focused treatment options,” said declared Kira President & R&D Manager and Co-founder Song WenruMD, Ph.D. “We are very encouraged that these data underscore the potential of KP104 in the treatment of a range of debilitating diseases and we look forward to initiating phase 2 trials.”
Kira has completed a first-in-man (FIH) Phase 1 study evaluating KP104, in which clinical proof of mechanism (POM) was obtained, and is initiating Phase 2 proof-of-concept (POC) trials in multiple indications . The company plans to present safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) data from the Phase 1 study at a medical conference later this year.
The details of the oral presentation are as follows:
Title: Pharmacokinetics/pharmacodynamics of KP104, a bifunctional antibody fusion protein inhibitor of complement, in humanized C5/FcRn transgenic mice and cynomolgus monkeys
Authors: Jay Ma1, Xiang Gao1, Takashi Miwa2, Damodar Gullipalli2, Sayaka Sato2, Song Wen Chao2, Xihua Zhu3, Jianjun Zhang3, Chaomei he1, Helen Fu1, Richard Lee1, Frederick Beddingfield1.4, Song Wenru1, Ping Tsui*,1
Abstract number: 126
Session title: Scientific Session IV: Therapeutic
Session date and time: August 28, 20229:15 a.m. – 9:30 a.m. EST
Summary and context of the presentation: The data demonstrate an optimal pharmacological profile for KP104 in human C5 transgenic mice and non-human primates (NHPs), supporting its further development as a potent bifunctional complement inhibitor suitable for intravenous and subcutaneous administration.
1Kira Pharmaceuticals, Cambridge MA, 2Department of Systems Pharmacology and Translational Therapeutics, Perelman School of Medicine, University of Pennsylvania, 3Kira Pharmaceuticals, Suzhou China, 4 Department of Medicine, Division of Dermatology, David Geffen School of medicine at UCLA *Authors of correspondence
The details of the poster presentations are as follows:
Title: Design and characterization of KP104, a bi-functional anti-C5 mAb and FH1-5 fusion protein that synergistically inhibits alternative and terminal complement activation pathways
Authors: Takashi Miwa1, Damodar Gullipalli1, Sayaka Sato1, Madhu Golla1, Xihua Zhu2, Jianjun Zhang2Dongqiong Fei2, Ping Tsui3Fengkui Zhang4, Song Wen Chao1
Poster number: 132
Session title: Poster Viewing Session II
Session date and time: August 2811:45 a.m. – 1:30 p.m. CEST
Poster summary and context: This poster describes the design and initial characterization of KP104, a novel biologic designed to optimize PK/PD properties to address unmet medical needs with currently approved complementary drugs. The results of the preclinical study show that KP104 is a potent bifunctional complement inhibitor of alternative and terminal pathways, possessing tissue targeting property for cells with C5b-9 deposition. In addition, the data demonstrates a synergistic effect between the two KP104 fractions, namely the anti-C5 mAb and the FH SCR 1-5.
1Department of Systems Pharmacology and Translational Therapeutics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, 2Kira Pharmaceuticals, Suzhou, China, 3Kira Pharmaceuticals, Cambridge, MA, 4Institute of Hematology, Chinese Academy of Medical Sciences, Tianjin, China
Title: Therapeutic efficacy of a bi-functional anti-C5 mAb/FH1-5 fusion protein in a mouse model of rapidly progressive lethal C3 glomerulopathy
Authors: Sayaka Sato1, Takashi Miwa1, Damodar Gullipalli1, Lin Zhou1, Jianjun Zhang2, Xiaoxia Hu2, Bingbing Jiang2, Ping Tsui3, Song Wen Chao1
Poster number: 174
Session title: Poster Viewing Session II
Session date and time: August 2811:45 a.m. – 1:30 p.m. CEST
Poster summary and context: C3 glomerulopathy (C3G) is a rare kidney disease caused by dysregulated activity of the alternative pathway of the complement system for which there is no approved treatment. Data suggest that a murine surrogate of KP104, a bifunctional anti-C5 mAb/FH1-5 fusion protein entering phase 2 clinical trials, is more effective than a murine anti-C5 mAb in the treatment of established disease in a lethal mouse model of C3G.
1Department of Systems Pharmacology and Translational Therapeutics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, 2Kira Pharmaceuticals, Suzhou, China, 3Kira Pharmaceuticals, Cambridge, MA
Disclosure: Dr. Song Wen ChaoProfessor of Pharmacology in the Department of Systems Pharmacology and Translational Therapeutics at the Perelman School of Medicine in University of Pennsylvania and co-founder of Kira Pharmaceuticals as well as Chairman of Kira’s Scientific Advisory Board, owns stock, receives consulting fees, and receives funding for Kira-sponsored research. Dr. Song is also an inventor of patents held by the University of Pennsylvania and under license to Kira Pharmaceuticals, and as such, Dr. Song and Penn can further benefit financially from the company’s successful product development and commercialization.
About KP104
KP104 is a first-in-class biologic with a unique dual-track mechanism of action designed to selectively block alternative and terminal complement pathways. KP104 provides a powerful and synergistic method to target validated disease drivers in the complement system. KP104 was also designed to have an extended half-life and potency and has a formulation suitable for intravenous and subcutaneous administration. KP104 is entering Phase 2 POC trials in multiple indications, including IgA nephropathy (IgAN), C3 glomerulopathy (C3G), thrombotic microangiopathy secondary to systemic lupus erythematosus (SLE-TMA), and paroxysmal nocturnal hemoglobinuria ( PNH). Phase 2 trials will be conducted around the world, including the United States, China, Australia, and South Korea. KP104 is an investigational agent that is not yet approved for any indication by any health authority.
About Kira Pharmaceuticals
Kira Pharmaceuticals is a global biotechnology company pioneering targeted supplement therapies to treat immune-mediated diseases. Through its LOGIC drug discovery platform, the company is committed to advancing first-in-class, best-in-class therapies to transform the lives of patients. With offices at Cambridge, MAand facilities in Suzhou and Shanghai, Chinaand Australia, Kira Pharmaceuticals is committed to establishing a global footprint and advancing life-changing therapies for patients around the world. More information about Kira can be found at www.kirapharma.com as well as on LinkedIn.
SOURCEKira Pharmaceuticals