Cancer Biotech G1 Therapeutics Files for $115 Million IPO

Published: Apr 19, 2017

Cancer Biotech G1 Therapeutics Files for $115 Million IPO April 18, 2017
By Alex Keown, BioSpace.com Breaking News Staff

RALEIGH, N.C. – G1 Therapeutics, a clinical –stage oncology company developing breast cancer treatments, is looking to raise up to $115 million in an initial public offering.

The company announced its intentions in a filing with the U.S. Securities and Exchange Commission, however it did not indicate what price the stock will be offered.

G1 Therapeutics is developing cyclin-dependent kinases (CDKs), with a particular focus on CDK4 and CDK6. In its filing, G1 said it believes it is the “only company with two distinct clinical-stage CDK4/6 inhibitors, trilaciclib and G1T38, each of which has the potential to be the backbone therapy of multiple combination regimens.”

Trilaciclib, which is G1’s most advanced candidate, is a potential first-in-class intravenous CDK4/6 inhibitor designed to preserve hematopoietic stem and progenitor cells (HSPCs) and enhance immune system function during chemotherapy. While chemotherapy has proven to be effective in treating cancer, G1 said it can damage HSPCs and the immune system, leading to severe adverse effects and limiting anti-tumor activity. Adding trilaciclib to the mix could maximize chemotherapy while minimizing “the deleterious side-effects of myelosuppression and immunosuppression.”

Trilaciclib is being evaluated in three Phase II clinical trials: a study in newly diagnosed, treatment-naive small-cell lung cancer patients, a study in previously treated small-cell lung cancer patients and a study in patients with triple-negative breast cancer.

G1T38 is a potential best-in-class oral CDK4/6 inhibitor being developed to be used in combination with other targeted therapies to treat multiple cancers, according to company data. The company initiated a Phase I/II trial in ER+, HER2- breast cancer (in combination with chemotherapy drug Faslodex) in January of this year. Preliminary results from the first six patients enrolled in the Phase I/II trial suggest that G1T38 may be able to address the shortcomings of the other CDK4/6 inhibitors, the company said.

In addition to those two drugs, G1 is also developing G1T48, a proprietary selective estrogen receptor degrader (SERD). In preclinical studies, G1T48 has been shown to be more potent than Faslodex and to have superior anti-tumor efficacy versus other SERDs in development. G1T48 is currently in IND-enabling studies and is on track for Phase I clinical development in the fourth quarter of 2017, the company said.

Breast cancer in women is the second most common type of cancer in the United States. The National Cancer Institute estimates that 232,670 American women were diagnosed with breast cancer and 40,000 died from the disease in 2014. G1’s drugs will compete with established CDK4/6 drugs including Pfizer’s Ibrance, which was approved in 2015 and is the company’s fastest growing revenue driver. In 2016, Ibrance generated $2.1 billion in sales, which was a massive jump from $723 million the drug brought in 2015. The drug received an expansion approval by the FDA last year.

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