Kira Pharmaceuticals to Present New Preclinical Data on Lead Asset KP104 at the 2022 European Meeting on Complement in Human Disease Conference

Oral presentation characterizes promising PK/PD properties of KP104 in relevant animal models and supports its further development as a potent bifunctional complement inhibitor suitable for both intravenous and subcutaneous administration

Poster presentations demonstrate synergistic effects of selectively inhibiting both the alternative and terminal pathways to treat complement-driven diseases, including data from a new C3G mouse model

CAMBRIDGE, Mass. and SUZHOU, China, Aug. 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 2022 European Meeting on Complement in Human Disease (EMCHD) Conference. The research, conducted in collaboration with the Perelman School of Medicine at the University of Pennsylvania, further supports the clinical advancement of Kira's lead asset, KP104, a first-in-class biologic with a unique dual-approach mechanism of action. Designed to selectively block the alternative and terminal pathways, KP104 provides a powerful and synergistic method of targeting validated drivers of disease in the complement system.

Taking place August 26-29, the conference will be held in Bern, Switzerland. Presentation abstracts are now available for viewing at the conference website.

An intricate constellation of protein pathways, the complement system is a key component of innate immunity. Aberrant activity within this system can be a driver of 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 result in therapies with greater efficacy, longer lasting effects, and improved safety.

"Based on intellectual property licensed from and developed at the University of Pennsylvania, Kira's leading product KP104 is designed to overcome the inherent challenges of complement drug discovery and in preclinical models, exhibits superior efficacy and longer-lasting inhibition than current complement-focused treatment options," said Kira President & Head of R&D and Co-founder Wenru Song, M.D., Ph.D. "We are highly encouraged that these data underscore the potential of KP104 in treating a range of debilitating diseases and we are looking forward to initiating Phase 2 trials."

Kira has completed a Phase 1 first-in-human (FIH) study evaluating KP104, in which clinical proof-of-mechanism (POM) was achieved, and is initiating Phase 2 proof-of-concept (POC) trials across multiple indications. The company plans to present safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) data from the Phase 1 study at a medical conference later this year.

Details for the oral presentation are as follows:

Title: Pharmacokinetics/pharmacodynamics of KP104, a bi-functional antibody fusion protein inhibitor of complement, in C5/FcRn-humanized transgenic mice and Cynomolgus monkeys
Authors: Jay Ma¹, Xiang Gao¹, Takashi Miwa², Damodar Gullipalli², Sayaka Sato², Wen-Chao Song², Xihua Zhu³, Jianjun Zhang³, Chaomei He¹, Helen Fu¹, Richard Lee¹, Frederick Beddingfield^1,4, Wenru Song¹, Ping Tsui^*,1
Abstract Number: 126
Session Title: Scientific Session IV: Therapeutics  
Session Date and Time: August 28, 2022, 9:15 – 9:30 CEST
Presentation Summary and Background: 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 both 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 *Correspondence authors

Details for 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 pathways of complement activation 
Authors: Takashi Miwa¹, Damodar Gullipalli¹, Sayaka Sato¹, Madhu Golla¹, Xihua Zhu², Jianjun Zhang², Dongqiong Fei², Ping Tsui³, Fengkui Zhang⁴, Wen-Chao Song¹
Poster Number: 132
Session Title: Poster Viewing Session II
Session Date and Time: August 28, 11:45 – 13:30 CEST
Poster Summary and Background: This poster describes the design and initial characterization of KP104, a novel biologic engineered to optimize PK/PD properties to address unmet medical needs with currently approved complement drugs. Pre-clinical study results show KP104 to be a potent bifunctional complement inhibitor of the alternative and terminal pathways, possessing tissue-targeting property for cells with C5b-9 deposition. In addition, the data demonstrate a synergistic effect between the two moieties in KP104, namely the anti-C5 mAb and FH SCR 1-5.

¹Department of Systems Pharmacology and Translational Therapeutics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, 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 progressing lethal C3 glomerulopathy 
Authors: Sayaka Sato¹, Takashi Miwa¹, Damodar Gullipalli¹, Lin Zhou¹, Jianjun Zhang², Xiaoxia Hu², Bingbing Jiang², Ping Tsui³, Wen-Chao Song¹ 
Poster Number: 174
Session Title: Poster Viewing Session II
Session Date and Time: August 28, 11:45 – 13:30 CEST
Poster Summary and Background: C3 glomerulopathy (C3G) is rare kidney disease caused by dysregulated activity of the complement system's alternative pathway for which no approved therapy exists. Data suggests that a murine surrogate of KP104, a bifunctional anti-C5 mAb/FH1-5 fusion protein entering phase 2 clinical trials, is more efficacious than a murine anti-C5 mAb in treating established disease in a lethal mouse model of C3G.

¹Department of Systems Pharmacology and Translational Therapeutics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, ²Kira Pharmaceuticals, Suzhou, China, ³Kira Pharmaceuticals, Cambridge, MA

Disclosure: Dr. Wen-Chao Song, a Professor of Pharmacology in the Department of Systems Pharmacology and Translational Therapeutics at the Perelman School of Medicine at the University of Pennsylvania and co-founder of Kira Pharmaceuticals as well as Chair of the Kira Scientific Advisory Board, owns equity, receives consultant fees and benefits from sponsored  research funding from Kira. Dr. Song is also an inventor of patents owned by the University of Pennsylvania and licensed to Kira Pharmaceuticals, and as such, both Dr. Song and Penn may further benefit financially from the successful development and commercialization of products by the company. 

About KP104
KP104 is a first-in-class biologic with a unique dual-approach mechanism of action designed to selectively block both the alternative and terminal complement pathways. KP104 provides a powerful and synergistic method of targeting validated drivers of disease in the complement system. KP104 has also been engineered to have an extended half-life and potency and has a formulation suitable for both intravenous and subcutaneous administrations.  KP104 is entering Phase 2 POC trials across multiple indications, including IgA nephropathy (IgAN), C3 glomerulopathy (C3G), thrombotic microangiopathies secondary to systemic lupus erythematosus (SLE-TMA) and paroxysmal nocturnal hemoglobinuria (PNH).  Phase 2 trials will be conducted globally including in the U.S., China, Australia, and South Korea. KP104 is an investigational agent not yet approved for any indication by any health authority.

About Kira Pharmaceuticals
Kira Pharmaceuticals is a global biotechnology company pioneering complement-targeted therapies to treat immune-mediated diseases. Enabled by its LOGIC drug discovery platform, the company is committed to advancing first-in-class and best-in-class therapies to transform the lives of patients. With offices in Cambridge, Massachusetts, and facilities in Suzhou and Shanghai, China, and Australia, Kira Pharmaceuticals is committed to establishing a global footprint and advancing life-changing therapies to patients around the world. More information on Kira can be found at www.kirapharma.com as well as on LinkedIn.

SOURCE Kira Pharmaceuticals