TLC Announces Development and License Agreement with Birdie Biopharmaceuticals for NanoX™ Immunotherapy Product

SOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, June 25, 2019 (GLOBE NEWSWIRE) -- Taiwan Liposome Company, Ltd. (“TLC”) (Nasdaq: TLC, TWO: 4152), a clinical-stage specialty pharmaceutical company dedicated to the development and commercialization of novel nanomedicines designed to target areas of unmet medical need in osteoarthritis, pain management, ophthalmology and oncology, today announced the signing of a development and license agreement with Birdie Biopharmaceuticals Inc. (“Birdie”), a wholly owned subsidiary of Seven and Eight Biopharmaceuticals Corp. Birdie and Seven and Eight Biopharmaceuticals are clinical stage biotech companies focused on the development of immunotherapy to treat cancer.

Under the agreement, Birdie will engage TLC in the development and manufacturing of a liposomal formulated dual agonist product against toll-like receptors 7 and 8 (TLR7/8) utilizing TLC’s NanoX™ technology. Birdie will be responsible for the product’s preclinical and clinical development, regulatory filing and commercialization. TLC will be responsible for the formulation development and manufacturing. TLC will receive an upfront payment and is eligible to receive up to US$49 million in potential milestone payments. In addition, TLC is also eligible to royalties based on the net sales.

“This agreement leverages our expertise and gives further validation to our technology platform’s capability to expand into other areas such as immunotherapy for the treatment of cancer,” commented TLC President George Yeh. “Our NanoX liposome technology has distinct advantages of achieving desirable pharmacokinetic profiles and preferential distribution to tumor tissues. We are delighted to partner with Birdie and working together on this collaboration to bring a potential new innovative therapy to cancer patients.”

“TLR7/8 are amongst the most promising targets for immuno-oncology and our dual agonists have demonstrated the ability to stimulate specific types of innate immune response, generating enhanced anti-tumor immunity,” said, Walter Lau, Ph.D., Chief Executive Officer of Birdie and Seven and Eight Biopharmaceuticals. “Following our recent announced collaboration with a major pharma partner on combination trials with established checkpoint inhibitors, we are excited to be working with TLC to develop a potential best-in-class next generation product. We believe that the robust, scalable and replicable manufacturing process of TLC’s NanoX technology formulates a sustainable competitive advantage and the potential to commercialize worldwide.”

About TLC

TLC (Nasdaq: TLC, TWO: 4152) is a clinical-stage specialty pharmaceutical company dedicated to the research and development of novel nanomedicines that maximize the potential of its proprietary lipid-assembled drug delivery platform (LipAD^®). TLC believes that its deep experience with liposome science allows TLC to combine onset speed and benefit duration, and improve active drug concentrations while decreasing unwanted systemic exposures. TLC’s BioSeizer^® technology is designed to enable local sustained release of therapeutic agents at the site of disease or injury; its NanoX™ active drug loading technology is designed to alter the systemic exposure of the drug, potentially reducing dosing frequency and enhancing distribution of liposome-encapsulated active agents to the desired site. These technologies are versatile in the choice of active pharmaceutical ingredients and scalable with respect to manufacturing. TLC has a diverse, wholly owned portfolio of therapeutics that target areas of unmet medical need in pain management, ophthalmology, and oncology. TLC is consistently ranked in the top 5% among all listed companies in Taiwan’s Corporate Governance Evaluations.

About Birdie and Seven and Eight

Birdie Biopharmaceuticals Inc., together with its parent holding company Seven and Eight Biopharmaceuticals Corp., are private, clinical-stage biotech companies focused on the development and commercialization of novel immunotherapies for cancer treatment. The companies have built a comprehensive global intellectual property portfolio in the category of toll-like receptor modulators. Managed by a seasoned team of professionals, Seven and Eight is progressing a proprietary pipeline of therapeutic products, with the lead product in Phase I clinical trials in the U.S., including a clinical collaboration of combination trial with Roche’s Tecentriq^® (atezolizumab), a monoclonal antibody against the checkpoint target of PD-L1, in treating solid tumors. Key institution investors of Birdie and Seven and Eight include YF Capital, Cenova Capital, Wuxi Ventures, Eight Roads and UMC Ventures.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements contained in this press release include, without limitation, statements regarding TLC’s expectations regarding the development and commercialization of products utilizing its NanoX technology platform. Words such as “may,” “believe,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are not guarantees of future performance and involve a number of risks, assumptions, uncertainties and factors, including risks that the outcome of any clinical trial is inherently uncertain and product candidates may prove to be unsafe or ineffective, or may not achieve commercial approval. Other risks are described in the Risk Factors section of TLC’s prospectus dated November 21, 2018 filed pursuant to Rule 424(b)(4) with the U.S. Securities and Exchange Commission. All forward-looking statements are based on TLC’s expectations and assumptions as of the date of this press release. Actual results may differ materially from these forward-looking statements. Except as required by law, TLC expressly disclaims any responsibility to update any forward-looking statement contained herein, whether as a result of new information, future events or otherwise.

 

TLC Media Contact:
                    Dawn Chi
                    Corporate Communications
                    +886 2 2655 7377 ext. 136
                    dawn@tlcbio.com
                    
                    TLC Investor Contact:
                    Xuan Yang
                    Solebury Trout
                    +1 646 378 2975
                    xyang@troutgroup.com