Aurealis Therapeutics and Xbiome enter into a license and collaboration agreement for Aurealis four-in-one diabetic foot ulcer and inflammatory disease cell and gene therapy AUP-16 in Greater China

Aurealis Therapeutics, a synthetic biology company developing groundbreaking four-in-one cell and gene therapies and Xbiome, an AI-based microbiome drug development company, today announced that the two companies have entered into an exclusive license and collaboration agreement for the clinical development and commercialization of Aurealis investigational Diabetic Foot Ulcer (DFU), other chronic wounds, and inflammatory disease therapy AUP-16 in Greater China. Shanghai-based Lynx Financial served as Aurealis’ exclusive financial advisor in this transaction.

Under the terms of the license and collaboration agreement, Xbiome acquires exclusive development and commercial rights for all human use to Aurealis clinical stage DFU drug candidate AUP-16 in Mainland China, Hong Kong, Macao, and Taiwan. Xbiome will be responsible for all clinical and other development, regulatory submissions, and commercialization of the licensed products in the licensed territory. Aurealis retains full rights to AUP-16 outside of the specified territory and will continue to lead the global development of the drug candidate. The companies will collaborate on the joint development for DFU and potentially on other selected indications. As a consideration for the agreement, Aurealis will receive an upfront payment, development milestone payments, and is eligible to receive commercial milestone payments and royalties on product sales, which all taken together could amount to a total consideration of $139 million plus single to double digit ascending royalties on product sales.

“We are extremely happy to partner with Xbiome. We are impressed of their expertise, agility in execution, and commitment to the treatment of diabetes-related diseases and introducing the world’s leading AI microbiome-based treatment methods and drugs into the China market and beyond, of which AUP-16 will be a great example. We believe that this partnership will accelerate the development of AUP-16 as a potential new therapy for DFU and other chronic wound patients.” said Juha Yrjänheikki, Aurealis CEO.

“At Aurealis we develop truly novel GMO cell and gene therapies to improve the lives of millions of patients worldwide. DFUs and other chronic wounds not only cause great pain, but also enormous costs to the society. We are very excited to collaborate with Xbiome and work together to develop a unique cure for these conditions with rapidly growing prevalence in China and around the world. We are honored to embark on this journey together with our colleagues at Xbiome.” continued Roger Meier, Aurealis Chairman of the Board.

Yan Tan, founder and CEO of Xbiome commented, “At Xbiome, we are building a rich and innovative pipeline of products based on our microbiome-based drug development platform. AUP-16 and the underlying novel GMO cell and gene therapy technologies fit perfectly with our platform and longterm strategy. Aurealis is one of the most innovative biotech companies we came across all over the world and most importantly we share the same vision and passion. We are extremely excited to collaborate with Aurealis to bring AUP-16 to DFU and other chronic wound patients in China. This joint effort will accelerate the development of AUP-16 in China and all over the world. It is just the beginning of a long-term partnership of two companies, we are thrilled to embark this journey and explore more possibilities in the future.”

Donald Xu, Managing Partner of Lynx Financial added: “We are witnessing here two young and rising companies join forces to develop a first- and best-in-class therapy for these debilitating chronic wound indications. This synergistic collaboration between a Chinese and a European company truly underscores the global trend in innovation and development within the pharmaceutical and biotech industries.”

About AUP-16

AUP-16 is a genetically engineered Lactococcus lactis, a non-pathogenic, probiotic bacteria, expressing human basic fibroblast growth factor (FGF2, bFGF), interleukin-4 (IL4) and macrophage colony stimulating factor (CSF1, mCSF) – all in one product and accepted as one active pharmaceutical ingredient from regulatory perspective. AUP-16 is topically applied on chronic wounds and covered by wound dressing (e.g. in DFU, venous leg ulcers and pressure ulcers). In the wound AUP-16 acts as millions of immune activating bioreactors producing the therapeutic proteins, which are designed to i) halt the chronic inflammation in the wound and promote M2 inflammatory switch, ii) induce the growth of new blood vessels, and iii) promote the granulation tissue formation and skin re-epithelization – all in one product.

About Aurealis Therapeutics

Aurealis Therapeutics AG is a Swiss-Finnish private clinical-stage synthetic biology company focusing on the development of lactic acid bacteria -based GMO cell and gene therapies. The company’s lead clinical asset is AUP-16, the first-in-class four-in-one cell and gene therapy drug for chronic wounds and other inflammatory degenerative diseases. The product is based on proprietary technology involving genetically engineered lactic acid bacteria acting as millions of small immune activating bioreactors in the human tissue and producing multiple human therapeutic proteins into target tissue to effectively and safely re-educate the distorted host immune microenvironment to proper state.

About Xbiome

Xbiome is an industry-leading clinical stage AI-based microbiome drug development company headquartered in China. The company is dedicated to tackling unmet medical needs through various modalities of microbiome therapeutics including fecal microbiota transplantation (FMT), live biotherapeutic product (LBP), and small molecule microbiome modulator (SMMM). In June of 2021, Xbiome obtained IND approval in US for its lead program XBI-302, an orally administered FMT therapy for graft-versus-host disease (GvHD).

About Lynx Financial

Lynx Financial is an investment firm that specializes in cross-border licensing, partnership transactions and private placements within life sciences and medical technology sectors. With a global outreach and on the ground presence, Lynx Financial fully leverages its expertise in research/deal structuring/investments to help emerging innovative companies from around the world gain access to funding and strategic resources in China.