On Dec. 28, 2021, Regor Therapeutics, a clinical-stage biotech company, announced today authorization from the US Food and Drug Administration (FDA) to proceed with Regor's Phase 1 clinical development plans for RGT-419B.

RGT-419B is a new generation CDK2/4/6, small molecule inhibitor with an optimized kinase activity spectrum. It is expected to improve the safety of and combat the resistance to currently approved CDK4/6 inhibitors that are given in combination with endocrine-based therapy for treatment of pre/perimenopausal or postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer. In cell model experiments, RGT-419B has demonstrated single agent activity with greater suppression of ER+ tumor cell growth when compared to abemaciclib and palbociclib. In ER+ breast cancer cells with acquired resistance to currently approved CDK4/6 inhibitors, RGT-419B has demonstrated full suppression of cancer cell proliferation. In these experiments, RGT-419B’s tumor cell suppression was further augmented when combined with a selective estrogen receptor degrader or a PI3K signaling pathway inhibitor.

As a single agent and in combination with other approved therapies, RGT-419B will initially be developed for the treatment of patients with HER2-, ER+ breast cancer who have primary or acquired resistance to currently approved CDK4/6 inhibitors.

As CDK4/6 inhibitors are widely adopted in clinical practice, refractory and relapsed patients previously treated by CDK4/6 inhibitors are becoming a greater and clinically significant unmet medical need. RGT-419B’s clinical development programs will address this resistance to CDK4/6 and other hormone receptor modulation therapy, providing a new opportunity to improve the survival and quality of life in breast cancer patients with advanced disease.

RGT-419B is the first of many innovative oncology drugs being developed by Regor. Dr. Xiayang Qiu, Founder and CEO of Regor Therapeutics, said, “This milestone marks Regor’s success in entering into the area of oncology therapeutics. Achieving an optimal selectivity profile against several CDKs by leveraging Regor’s proprietary CARD platform, this innovative drug is entering clinical stage development in the U.S. We are excited by this opportunity to bring new and differentiated treatment options to the many patients suffering from breast cancer worldwide.

About breast cancer

HER2-, HR+ breast cancer is the most common type of breast cancer. Globally, breast cancer is one of the most common cancers affecting approximately 2.3 million women in 2020 and is the leading cause of death due to cancer in women. In China breast cancer ranks 4th amongst solid tumor types with over 400,000 new cases annually. Breast cancer poses a tremendous healthcare burden in China and across the world as well as a having a significant negative impact on patients and their families.

Source:

Du et al. Journal of Hematology & Oncology. The application and prospect of CDK4/6 inhibitors in malignant solid tumors. Presented at the San Antonio Breast Conf in Dec 2020. Available at: https://jhoonline.biomedcentral.com/articles/10.1186/s13045-020-00880-8

About Regor Therapeutics Group

Regor Therapeutics is a clinical stage company dedicated to the discovery and development of innovative and clinically differentiated medicines by leveraging the proprietary CARD (Computer Accelerated Rational Discovery) Platform. The company focuses mainly on three therapeutic areas, oncology, immunology, and metabolic disorders. By seamlessly integrating CARD with structural biology, computational chemistry, therapeutic biology, medicinal chemistry, and clinical development. Regor has successfully assembled a world-class scientific team and established a highly efficient new drug innovation engine to enable the discovery and development of best- and first-in-class molecules. For more information, please click www.regor.com

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  Email: ir@regor.com

INDIANAPOLIS and SHANGHAI, Dec. 10, 2021 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Regor Therapeutics Group have entered into a multi-year research collaboration and licensing agreement to discover, develop and commercialize novel therapies for metabolic disorders.

Under the terms of the agreement, Lilly will have a license to select Regor intellectual property with an option to extend the license. Lilly will be responsible for clinical development, manufacturing and commercialization worldwide, except for People's Republic of China, Macau, Hong Kong and Taiwan, where Regor will maintain these rights and responsibilities. The agreement will allow each company the opportunity to fully leverage both parties' existing compounds and technologies globally to maximize patient treatment choice.

"Through this collaboration, we will have the opportunity to expand treatment options available to patients suffering from metabolic disorders," said Ruth Gimeno, Ph.D., vice president, diabetes research and clinical investigation at Lilly. "Regor's technology will also allow Lilly to further accelerate innovation and deliver breakthrough therapies in obesity and diabetes."

"In a little over three years, Regor has established a world-class research organization exemplified by our Computer Accelerated Rational Discovery platform. This collaboration is a recognition for Regor's core technology and research capabilities, but more importantly, it is an extraordinary opportunity to discover, develop and commercialize novel therapeutics to help the millions of patients in the world, "said Xiayang Qiu, Ph.D., founder CEO of Regor. "We are pleased to establish this strategic collaboration with Lilly, a top global leader in metabolic disorders such as diabetes and obesity."

Regor will receive an upfront payment of up to $50 million, which partially includes an equity investment by Lilly in Regor, subject to the parties entering into standard equity agreements. The company is also eligible to receive up to $1.5 billion in potential payments based on the achievement of prespecified preclinical, clinical development and commercial milestones, as well as tiered royalties from low-single to low-double digits on sales resulting from the agreement.

This transaction will be reflected in Lilly's reported results and financial guidance according to Generally Accepted Accounting Principles (GAAP). There will be no change to Lilly's 2021 non-GAAP earnings per share guidance as a result of this transaction.

About Regor Therapeutics Group

Regor Therapeutics is a clinical stage company dedicated to the discovery and development of innovative and clinically differentiated medicines by leveraging the proprietary CARD (Computer Accelerated Rational Discovery) Platform. The company focuses mainly on three therapeutic areas, oncology, immunology, and metabolic disorders. By seamlessly integrating CARD with structural biology, computational chemistry, therapeutic biology, medicinal chemistry, and clinical development, Regor has successfully assembled a world-class scientific team and established a highly efficient new drug innovation engine to enable the discovery and development of best- and first-in-class molecules. To learn more about Regor, please visit us at www.regor.com

About Eli Lilly and Company

Lilly is a global healthcare leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com. C-LLY

Lilly Forward-Looking Statement

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about the benefits of a collaboration between Lilly and Regor Therapeutics, Lilly's research and development strategy, and potential payments to Regor in connection with the collaboration and reflects Lilly's current beliefs and expectations. However, as with any such undertaking, there are substantial risks and uncertainties in the process of drug research, development and commercialization. Among other things, there can be no guarantee that Lilly will realize the expected benefits of the collaboration, that the collaboration will yield commercially successful products or that Lilly will execute their strategy as expected. For a further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, please see Lilly's most recent Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

Refor to

  Jordan Bishop; jordan.bishop@lilly.com; 317-473-5712 (Media)

  Kevin Hern; hern_kevin_r@lilly.com; 317-277-1838 (Investors)

  Lauren Xuan; communications@qlregor.com; +86-21-31168236 (Regor Media)

  Min Zhong; min.zhong@qlregor.com; +86-21-31168226 (Regor Investors)

www.regor.com

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Regor’s discovery team under Dr. Wenge Zhong’s leadership, in collaboration with Professor Eric Xu at the Shanghai Institute of Materia Medica and other academic teams at Fudan University and Zhejiang University, published Structural Biology work on the human glucagon-like peptide-1 receptor (GLP1R). Using cryo-electron microscopy, the teams were able to solve three complex structures, providing structural basis and deep molecular insights on the ago-allosteric modulation of the GLP1 receptor.

The article can be accessed here

HemOnc Today spoke with Marjorie Zettler, PhD, MPH, and other experts about FDA’s accelerated approval program, and their recent decision to re-evaluate the evidence for several oncology drugs after confirmatory trials failed.

FDA’s accelerated approval program: Reevaluating the need for speed (healio.com)

SHANGHAI, Feb. 18, 2021 /PRNewswire/ -- Regor Therapeutics, a clinical stage biotechnology company dedicated to the discovery of innovative medicines to treat cancer, immune disorders and metabolic diseases, announces the successful completion of $90 million Series B financing.

Founded in July of 2018 by a group of veteran drug hunters with extensive research and executive leadership experiences at top multinational pharmaceutical companies, Regor aims to establish world-class innovation capabilities and is committed to delivering clinically differentiated, best- and first-in-class drugs to serve patients globally.  By leveraging CARD, Computer Accelerated Rational Discovery, a proprietary enabling technology platform, the team has successfully advanced numerous discovery programs in a dramatically accelerated fashion, including from ideas to a clinical start in two years.  

The Series B financing was led by Lilly Asia Ventures and included participation from Loyal Valley Capital, Lanting Capital, TF Capital and Vertex Ventures China. Regor Therapeutics was established with initial series A strategic investment from Qilu Pharmaceutical Group, a well-known Chinese pharmaceutical company.

"We are very pleased with the strong support from leading life science investment firms in this financing round. We are now in a strong position to advance pre-clinical and clinical studies of multiple programs," said Dr. Xiayang Qiu, Founder and CEO of Regor. "We are looking forward to long-term collaborations with our investors, as we aim to improve the treatment outcomes for worldwide patients of chronic diseases, cancer and other life-threatening diseases."

"We are proud to support Regor Therapeutics' world-class team to expand its efforts across a larger number of programs and therapeutic areas to develop tomorrow's life-saving treatments," said Dr. Yi Shi, managing partner of Lilly Asia Ventures.

"With the next decade comes a historical moment for China's leap upwards. We are delighted to collaborate with veteran scientists, leading entrepreneurs and investment partners in biopharma industry. Together we are working hard for a better world by innovative and transformative medicines which make meaningful impacts to patients globally," said Mr. Andy Lin, founding partner of Loyal Valley Capital.

About Regor Therapeutics Group

Regor Therapeutics is a clinical stage company dedicated to the discovery and development of innovative and clinically differentiated medicines by leveraging the proprietary CARD (Computer Accelerated Rational Discovery) Platform, seamlessly integrating structural biology, computational chemistry, therapeutic biology, medicinal chemistry, and clinical development. Regor has assembled a world-class scientific team and demonstrated high efficiency in producing best- and first-in-class molecules.

About Lilly Asia Ventures

Lilly Asia Ventures (LAV) is a leading biomedical venture capital firm founded in 2008, with offices in Shanghai, Hong Kong, and Palo Alto. Our vision is to become the trusted partner for exceptional entrepreneurs seeking smart capital and to build great companies developing breakthrough products that treat diseases and improve human health.

About Loyal Valley Capital

Loyal Valley Capital ("LVC"), founded in 2015, is a thematic, research-oriented private equity firm that has been a "partner of choice" for China's most promising companies. LVC has left a mark in leading players such as Tik Tok, Didi, Bilibili, Junshi, InnoCare, Akeso, Pop Mart, SUPCON. In 2020, LVC was honorably awarded the "Top 10 Most Influential Private Equity Firms in China", "Top 20 Healthcare Investor in China", "Top 10 Innovative Drug Investor in China", and "Top 20 Consumer Investor in China".

About Lanting Capital

LanTing Capital (LTC) is a cross-border, pharmaceutical-focused strategic private equity firm. Founded by pharmaceutical veterans and asset management experts, LTC leverages our unparalleled industry knowledge and network plus deep financial market know-how across the USA, China and Europe to unlock unique cross-border growth opportunities for our portfolio companies and investors. LanTing is currently operating in Princeton (USA), Milan (Italy), Saanen (Switzerland), and Hangzhou (China).

About TF Capital

TF Capital focuses on investment in the life sciences industry, primarily investing in early-stage companies with high potential.  Through strategic investments in various key areas and right partnerships, TF Capital hopes to capture opportunities in the rapidly expanding Chinese life sciences market. Our investment team has vast experience and resources in industry to assist our portfolio companies.

About Vertex Ventures China

Vertex Ventures is a global network of venture capital funds, who is a member of Tamasek Holdings. The operator-investors manage portfolios in China, the U.S., Israel, India and Southeast Asia. Vertex Ventures China, founded in 2008, has offices in Beijing, Shanghai and Shenzhen. It is currently managing both Dollar and RMB funds, with assets under management of over ¥10 billion. Vertex Ventures China invests in high-growth innovative start-ups across mainland China, covering the fields of deep tech, new digital economy and healthcare. Some of its notable investments include 91 Wireless, Chipscreen, mobike, Horizon Robotics, Harbour Biomed, Changba, Edge Medical, Inmagene, Infinovo, etc. 

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