G1 Therapeutics and Genor Biopharma Announce Exclusive License Agreement for Lerociclib in Asia-Pacific Region

Rhea-AI Summary

G1 Therapeutics has announced a significant partnership with Genor Biopharma for the exclusive licensing of lerociclib, an oral CDK4/6 inhibitor, in the Asia-Pacific region. G1 will receive a $6 million upfront payment and up to $40 million in milestone payments, along with tiered royalties based on sales. This partnership aims to address the unmet medical needs of HR+, HER2- breast cancer patients in Asia. Preliminary data suggest lerociclib offers a better safety profile compared to existing treatments, potentially improving patient experience.

Positive

• G1 to receive $6 million upfront payment.
• Potential for additional $40 million in milestone payments.
• Tiered royalties from Genor based on annual sales of lerociclib.
• Lerociclib demonstrates a differentiated safety and tolerability profile.
• Partnership facilitates access to Asian markets for G1's oncology therapies.

Negative

• None.

- G1 to receive $6 million upfront payment, sales royalties and up to $40 million in future milestone payments
- Genor to lead clinical development, regulatory submissions and commercialization of lerociclib in Asia-Pacific

RESEARCH TRIANGLE PARK, N.C. and SHANGHAI, China, June 22, 2020 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, and Genor Biopharma Co. Inc., a pre-commercial stage biopharmaceutical company focused on developing and commercializing immune-oncology therapeutics, today announced an exclusive license agreement for the development and commercialization of lerociclib in the Asia-Pacific region (excluding Japan).

Discovered and developed by G1, lerociclib is a differentiated oral CDK4/6 inhibitor designed to enable more effective combination treatment strategies. Genor is currently developing eight novel, clinical-stage oncology compounds and recently completed a $160 million Series B financing led by Hillhouse Capital and Temasek Holdings.

“CDK4/6 inhibitors have emerged as an important therapeutic option for women with ER+, HER2- breast cancer, the most common form of the disease. We designed lerociclib to improve upon the clinical profiles of currently available CDK4/6 inhibitors, and preliminary data from our Phase 1b/2 clinical trial have shown a differentiated safety and tolerability profile along with efficacy consistent with marketed CDK4/6 inhibitors,” said Mark Velleca, M.D., Ph.D., Chief Executive Officer. “This agreement is an important component of our corporate strategy to form partnerships that enable global access to our promising oncology therapies. We are excited to collaborate with Genor, a leading innovator in oncology with the development and commercialization expertise to advance this therapy on behalf of patients in China and other Asia-Pacific countries.”

Under the terms of the agreement, G1 will receive an upfront cash payment of $6 million and be eligible to receive up to an additional $40 million in development and commercial milestone payments. In addition, Genor will pay G1 tiered royalties ranging from high single to low double-digits based on annual net sales of lerociclib. Genor will have exclusive development and commercialization rights for lerociclib in the Asia-Pacific region (excluding Japan).

“We see significant unmet medical need in Asian patients with HR+, HER2- breast cancer in both adjuvant and metastatic settings, especially among intermediate and high-risk patients whose longer treatment duration requires therapeutics with better tolerability. Lerociclib is a potentially best-in-class CDK4/6 inhibitor, with robust efficacy and a differentiated safety profile when compared with marketed products,” commented Guo Feng, Ph.D., Chief Executive Officer of Genor. “With lerociclib as a strategic fit in our portfolio, we look forward to working with G1 to maximize the potential of this compound in the APAC region.”

About Lerociclib
Lerociclib is a differentiated oral CDK4/6 inhibitor being developed for use in combination with other targeted therapies in certain types of breast and lung cancer. Preliminary clinical data in estrogen receptor-positive, HER2-negative (ER+, HER2-) breast cancer have demonstrated proof-of-concept of the differentiated clinical profile of lerociclib versus currently marketed CDK4/6 inhibitors, with improved tolerability and less neutropenia. Neutropenia is one of the main toxicities associated with CDK4/6 inhibition. Current treatments require frequent blood testing for neutropenia. Less monitoring would mean fewer office visits and blood draws, improving the experience for patients and reducing the burden on physician offices and costs to the healthcare system.

About G1 Therapeutics
G1 Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the discovery, development and delivery of innovative therapies that improve the lives of those affected by cancer. The company is advancing three clinical-stage programs. Trilaciclib is a first-in-class FDA-designated Breakthrough Therapy designed to improve outcomes for patients being treated with chemotherapy. Rintodestrant is a potential best-in-class oral selective estrogen receptor degrader (SERD) for the treatment of ER+ breast cancer. Lerociclib is a differentiated oral CDK4/6 inhibitor designed to enable more effective combination treatment strategies.

G1 Therapeutics is based in Research Triangle Park, N.C. For additional information, please visit www.g1therapeutics.com and follow us on Twitter @G1Therapeutics.

About Genor Biopharma
Genor Biopharma is a pre-commercial stage biopharmaceutical company located in Zhangjiang, Shanghai, China. Genor is focused on the therapeutic areas of oncology and autoimmune diseases. The Company delivers a portfolio of novel therapies built to address unmet medical needs. The Company’s leading product candidates are late stage innovative monoclonal antibodies. Under the leadership of a management team with more than 20 years of experience in global biopharmaceutical companies such as Pfizer, Merck, Amgen, and AbbVie, Genor currently has about 400 employees across 3 sites in China - Shanghai Zhangjiang, Yunnan Yuxi, and Beijing office, as well as a lab in South San Francisco, US, among which more than 80% are R&D specialists.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "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. Forward-looking statements in this press release include, but are not limited to, those relating to the therapeutic potential of trilaciclib, rintodestrant and lerociclib, rintodestrant’s potential to be best-in-class oral SERD, lerociclib’s differentiated safety and tolerability profile over other marketed CDK4/6 inhibitors and the impact of pandemics such as COVID-19 (coronavirus), and are based on the company’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause the company’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in the company’s filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein and include, but are not limited to, the company’s ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates; the company’s initial success in ongoing clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials; the inherent uncertainties associated with developing new products or technologies and operating as a development-stage company; and market conditions. Except as required by law, the company assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

Contacts:
Jeff Macdonald
G1 Therapeutics, Inc.
Senior Director, Investor Relations & Corporate Communications
919-907-1944
jmacdonald@g1therapeutics.com

Na Meng
Genor Biopharma
Director, Corporate Strategy and Investor Relations
Na.Meng@genorbio.com

FAQ

What is the significance of the partnership between G1 Therapeutics and Genor Biopharma for lerociclib?

The partnership allows G1 to expand the commercial reach of lerociclib in the Asia-Pacific region, providing a $6 million upfront payment and the potential for $40 million in future milestone payments.

How much will G1 Therapeutics earn in royalties from the partnership with Genor Biopharma?

G1 Therapeutics will earn tiered royalties ranging from high single to low double-digits based on annual net sales of lerociclib.

When was the partnership for lerociclib announced?

The partnership was announced on June 22, 2020.

What type of cancer is lerociclib targeted for?

Lerociclib is targeted for treating estrogen receptor-positive, HER2-negative breast cancer.

What benefits does lerociclib offer over existing CDK4/6 inhibitors?

Lerociclib is designed to have a differentiated safety and tolerability profile, potentially leading to fewer side effects compared to existing treatments.