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- Exclusive agreement allows HanAll to utilize Epigenetic Reprogramming of Aging (ERA^TM) technology for ophthalmic and otic diseases.

- Collaboration aims to leverage HanAll's extensive expertise in ophthalmic and otic diseases and Turn Bio's cellular reprogramming technology to create innovative therapies.

- Deal value can exceed $300 million USD for the initial product.

Rockville, MD, Seoul, KR – May 28, 2024 

HanAll Biopharma Co., Ltd. (KRX: 009420. KS), a global biopharmaceutical company committed to discovering and developing innovative medicines for patients, has signed an exclusive licensing agreement with Turn Biotechnologies, Inc., a pre-clinical stage biopharmaceutical company focused on cellular repair through epigenetic reprogramming.

This agreement expands the relationship between the companies, which began in 2022 when HanAll made an initial investment in Turn Bio. The terms grant HanAll the right to utilize Turn Bio’s Epigenetic Reprogramming of Aging (ERA^TM) technology to research, develop, manufacture, and commercialize medicines for ophthalmic and otic disease.

HanAll anticipates leveraging synergies between ophthalmic and otic fields where it has therapeutic expertise and experience, and drawing on Turn Bio’s knowledge of cellular reprogramming, mRNAs, and lipid nanoparticles.

Aging mitigation and cell reprogramming technologies have been gaining attention for their potential to address the high unmet needs in age-related disorders, particularly in the eye and ear. HanAll has been actively exploring cell reprogramming through open collaborations and a global network.

The ERA^TM technology developed by Turn Bio reverses certain aspects of cellular aging by utilizing a cocktail of mRNA transcription factors specifically designed for transient epigenetic reprogramming. Past attempts at similar technologies have struggled due to the risk of cells differentiating into unforeseen cell types. Turn Bio’s technology aims to overcome these challenges by restoring youthful cell function through precise dosing and timing of ERA^TM while maintaining the original cellular identity, offering promising potential for addressing age-related disorders. Currently, Turn Bio is undertaking pre-clinical research for dermatology and immunology applications.

"We're excited to advance into a new phase of development with Turn Bio to explore the potential of its innovative platform in addressing important age-related conditions. This partnership will enhance HanAll's R&D capabilities in mRNA and LNP product development while also providing an opportunity to explore the potential for pipeline expansion," said Sean Jeong, M.D., MBA, CEO of HanAll Biopharma.

“This agreement is a testament to the vast opportunities ahead globally as the world’s population grows older,” said Turn Bio CEO Anja Krammer. “HanAll’s commitment is recognition that our innovative ERA™ technology has the potential to revolutionize treatments for myriad conditions associated with aging.”

The deal, valued over $300 million USD for the first product, is structured around negotiated milestones.

About HanAll Biopharma

HanAll Biopharma (KRX: 009420.KS) is a global biopharmaceutical company with presence in Korea, the USA, Japan, and Indonesia with the mission of making meaningful contributions to patients' lives by introducing innovative, impactful medicines to address severe unmet medical needs. HanAll has been operating a portfolio of pharmaceutical products in the therapeutic areas of endocrine, circulatory, and urologic diseases for over 50 years.

HanAll has also expanded its focus to immunology, oncology, neurology, and ophthalmology to discover and develop innovative medicines for patients with diseases for which there are no effective treatments. One of its lead pipeline asset, HL161 (INN: batoclimab), an anti-FcRn antibody, is being developed in Phase 3 and Phase 2 trials across the world for the treatment of autoimmune diseases including generalized myasthenia gravis (gMG), thyroid eye disease (TED), chronic inflammatory demyelinating polyneuropathy (CIDP), and Graves’ disease (GD). Another lead asset, HL036 (INN: tanfanercept), a TNF inhibitor protein, is being evaluated in Phase 3 clinical studies in the US and is also being evaluated in China for the treatment of dry eye disease. HL161ANS, an anti-FcRn antibody targeting multiple indications, and HL192 (ATH-399A), a Nurr1 activator currently targeting Parkinson’s Disease, are also being evaluated in Phase 1 clinical studies (healthy volunteers). For further information, visit our website and connect with us on LinkedIn. For any media inquiries, please contact HanAll PR/IR (pr@hanall.com, ir@hanall.com).

About Turn Biotechnologies

Turn Bio is a pre-clinical-stage company focused on repairing tissue at the cellular level and developing transformative drug delivery systems. The company’s proprietary mRNA-based ERA™ reprogramming technology aims to restore optimal gene expression by combatting the effects of aging in the epigenome. This potentially restores cells’ ability to prevent or treat disease and heal or regenerate tissue and helps to fight incurable chronic diseases. Turn Bio’s eTurna™ delivery platform uses unique formulations to precisely deliver cargo to specific organs, tissues, and cell types.

The company is completing pre-clinical research on tailored therapies targeting indications in dermatology and immunology, and developing therapies for ophthalmology, osteo-arthritis, and the muscular system. For more information, see www.turn.bio. or contact Jim Martinez, rightstorygroup / jim@rightstorygroup.com or 1 (312) 543-9026. 

Disclaimer statement 

The contents of this announcement include statements that are, or may be deemed to be, “forward-looking statements.” These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “believes,” “estimates,” “anticipates,” “expects,” “intends,” “may,” “will,” or “should” and include statements HanAll (the company, we) makes concerning its 2024 business and financial outlook and related plans, the therapeutic potential of its product candidates, the intended results of its strategy and the company, and its collaboration partners’, advancement of, and anticipated clinical development, data readouts and regulatory milestones and plans, including the timing of planned clinical trials and expected data readouts, the design of future clinical trials and the timing and outcome of regulatory filings and regulatory approvals. By their nature, forward-looking statements involve risks and uncertainties, and readers are cautioned that any such forward-looking statements are not guarantees of future performance. The company’s actual results may differ materially from those predicted by the forward-looking statements. These may include various significant factors such as our expectations regarding the inherent uncertainties associated with competitive developments, preclinical and clinical trial and product development activities and regulatory approval requirements. In addition, performance may be affected by our reliance on collaborations with third parties, estimating the commercial potential of our product candidates, our ability to obtain and maintain protection of intellectual property of technologies and drugs, our limited operating history, and our ability to obtain additional funding for operations and to complete the development and commercialization of product candidates. A further list and description of these risks, uncertainties and other risks can be found in Korea Stock Exchange (KRX) filings and reports, including in our most recent annual report as well as subsequent filings and reports filed by the company with the KRX. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. We undertake no obligation to publicly or revise the information in this press release, including any forward-looking statements, except as may be required by Korean law and regulations.