Aurealis Therapeutics and Xbiome Enter License and Collaboration Agreement for AUP-16 Aurealis Four-in-One Cell and Gene Therapy for Diabetic Foot Ulcer and Inflammatory Disease in Greater China

BASEL, SwitzerlandKUOPIO, Finlandand Shenzhen, China, January 29, 2022 /PRNewswire/ — Aurealis Therapeutics, a synthetic biology company developing breakthrough four-in-one cell and gene therapies, and Xbiome, an AI-based microbiome drug development company, announced today that the two companies had entered into an exclusive license and collaboration agreement for the clinical development and commercialization of the investigational diabetic foot ulcer Aurealis, other chronic wounds and inflammatory disease treatment AUP-16 in Greater China. ShanghaiAurealis-based Lynx Financial acted as exclusive financial advisor to Aurealis in this transaction.

Under the terms of the license and collaboration agreement, Xbiome acquires the exclusive development and commercialization rights for all human uses of the clinical-stage DFU Aurealis drug candidate AUP-16 in mainland China, hong kong, Macau, and Taiwan. Xbiome will be responsible for all clinical and other development, regulatory submissions and commercialization of Licensed Products in the Licensed Territory. Aurealis retains all 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 of DFU and potentially other selected indications. In 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 together could amount to full consideration of $139 million plus rising single- and double-digit royalties on product sales.

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

“At Aurealis, we are developing real new 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 society. We are very excited to collaborate with Xbiome and work together to develop a unique cure for these conditions with a rapidly growing prevalence in China and around the world. We are honored to embark on this adventure with our colleagues at Xbiome.” more Roger MeierAurealis Chairman of the Board of Directors.

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

Donald XuManaging Partner of Lynx Financial, added, “Here we are witnessing two young and growing companies joining forces to develop a first-in-class, best-in-class therapy for these debilitating chronic wound indications. This synergistic collaboration between a Chinese company and a European company truly highlights the global trend in innovation and development within the pharmaceutical and biotechnology industries.”

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

About Aurealis Therapeutics
Aurealis Therapeutics AG is a privately-held Swiss-Finnish clinical-stage synthetic biology company focused on the development of lactic acid bacteria-based GMO cell and gene therapies. The Company’s lead clinical asset is AUP-16, the first four-in-one cell and gene therapy drug for chronic wounds and other inflammatory degenerative diseases. The product is based on a proprietary technology involving genetically engineered lactic acid bacteria acting as millions of small immune activation bioreactors in human tissues and producing several human therapeutic proteins in target tissues to safely and effectively re-educate the deformed immune microenvironment from the host to an appropriate state.

About Xbiome
Xbiome is an industry-leading AI-based microbiome drug development company headquartered in China. The Company is dedicated to addressing unmet medical needs through various microbiome therapeutic modalities, including Fecal Microbiota Transplantation (FMT), Live Biotherapeutic Product (LBP), and Small Molecule Microbiome Modulator (SMMM). In June 2021, Xbiome obtained IND approval in the United States 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 specializing in cross-border licensing, partnership transactions and private placements in the life sciences and medical technology sectors. With a global reach and on-the-ground presence, Lynx Financial leverages its expertise in sourcing/deal structuring/investments to help emerging innovative companies around the world access funding and strategic resources in China.

For more information:

Aurealis Therapeutic:
Juha Yrjanheikki, CEO
Tel: +358 458433550
Email: [email protected]

Flora JiBusiness Development Director
Tel: +86 133 2292 5975
Email:[email protected]

Lynx Financial:
Zheng JasperDirector
Tel: +86 18217207750
Email: [email protected]

SOURCE Aurealis Therapeutics AG

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