• Friday, January 4, 2019 @ 9:15 am

Oculis SA, a clinical-stage biopharmaceutical company developing next-generation topical ophthalmic treatments, has entered into an agreement to in license a novel topical anti-TNF alpha antibody from Novartis. No financial details are disclosed.

The compound, named LME 636, is based on a proprietary single-chain antibody fragment technology specifically designed for topical delivery. Efficacy and safety were evaluated in three clinical trials including controlled studies under IND by Novartis Institute of Biomedical Research. The studies demonstrated a promising profile for treating inflammatory conditions of the anterior segment of the eye, including Dry Eye Disease.

The in-licensing of LME636, which will be renamed OCS-02, expands Oculis’ portfolio of novel topical therapies for major ophthalmic diseases, and offers Oculis the opportunity to address unmet medical needs of patients with potentially the first topical anti-TNF alpha therapy for ophthalmic indications.

Oculis plans to develop OCS-02 in parallel to its other ongoing pipeline programs. It will be supported by new funds raised in the extension of its Series B financing round.

Dr. Riad Sherif, Chief Executive Officer of Oculis, said: “This agreement is part of our ongoing strategy to access multiple sources of technologies and compounds that bolster our portfolio of innovative products to treat eye diseases. We are looking forward to working with the ophthalmology community on the rapid development of this promising therapy.”


New funds to expand portfolio and advance development of novel topical treatments for ophthalmic diseases

Oculis has successfully raised a further CHF15.5 million in an extension of its Series B financing round, announced in January 2018, bringing the total raised to CHF35.5 million. The extension round was led by funds managed by Tekla Capital Management LLC and included Nan Fung Life Sciences, both new investors, as well as Oculis’ current investors.

The funds will be used to expand the company’s portfolio through strategic in-licensing (see below), and to advance the development of its emerging pipeline of novel topical (eye drop) treatments for major ophthalmic diseases. Key among its clinical candidates is OCS-01 (formerly OC-118), currently in clinical trials in patients with Diabetic Macular Edema (DME) and in preparation to enter clinical development for post-surgery ocular inflammation.

Oculis will also use the funds to develop its newly in-licensed asset LME636 from Novartis, a topical anti-TNF alpha antibody.

In conjunction with this fundraising, Henry Skinner, Ph.D., Senior Vice President at Tekla Capital Management, is joining the Oculis Board of Directors as a Non-Executive Director. Dr. Skinner was formerly Managing Director at Novartis Venture Fund and Executive Director, Head Strategic Alliances at Novartis Institute for Biomedical Research. Prior to this, Dr. Skinner was CEO at SelectX Pharmaceuticals, President and CEO at NeoGenesis Pharmaceuticals and also spent four years at Pfizer in its Technology Acquisitions and Operations group.

At the same time, Stefan J. Sveinsson has stepped down from the Board of Directors.

Dr. Riad Sherif, Chief Executive Officer of Oculis, said: “Oculis is evolving and advancing rapidly. With this new fundraising, adding to the CHF20 million we raised a year ago, we have a strong financial position from which to drive our clinical development programs with OCS-01 and LME636/OCS-02 and to advance our portfolio of innovative candidates designed to address serious ophthalmic indications. We welcome our new investors and are delighted with the continued support of our existing investors as we execute our strategy to build a world-class ophthalmic company.”

Peter Bisgaard, Managing Director at Nan Fung Life Sciences, added: “I, and the team at Nan Fung Life Sciences, have been extremely impressed with vision and progress made by Oculis in building a company with the potential to significantly improve the treatment of ophthalmic diseases. By developing eye-drop treatments for both front- and back-of-eye diseases, Oculis is working to develop safe, effective and comfortable treatments for millions of patients. I look forward to working with the team to contribute towards the Company’s further growth and development.”

Anthony Rosenberg, Chairman at Oculis, commented: “Oculis has made great progress in the past year building a strong organisation and advancing the development of its pipeline. These new funds and the new in-licensed clinical candidate further highlight the significant opportunities for Oculis. On behalf of the Board of Directors, I would also like to welcome Henry to the Board and look forward to his valued insights and guidance as we execute our strategy. I would also like the express our thanks to Stefan for his positive contribution to the Company’s early development.”