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Technology Name: Reduction of Chemotherapy­Induced Myelosuppression (“Chemoprotection”)

Company Background

G1 Therapeutics (G1, or the Company) is a clinical-stage oncology company using a small molecule-based approach to attenuate multi-lineage bone marrow suppression due to chemotherapy. G1 was founded by Ned Sharpless, MD (Director, UNC Cancer Center), and Kwok-Kin Wong, MD, PhD (Director, Belfer Institute/DFCI/Harvard), to capitalize on their research into how certain cyclin-dependent kinases (CDKs) control the production of blood cells by hematopoietic stem and progenitor cells (HSPCs) in the bone marrow. The Company’s lead program, G1T28-1, is a highly potent and selective CDK4/6 inhibitor that is currently in Phase 1 clinical trials. G1 has assembled a team of accomplished drug discovery and development scientists with extensive experience in bringing innovative oncology drugs to market. The Company has 10 full-time employees and is based in Research Triangle Park, NC.

Technology Overview 

Bone marrow suppression (also known as myelosuppression) is a severe side effect of chemotherapy, resulting in the loss of red blood cells (anemia), white blood cells (neutropenia) and platelets (thrombocytopenia). Patients can experience fatigue due to anemia, infections due to neutropenia and bleeding due to thrombocytopenia. While oncologists expect chemotherapy to remain the standard treatment regimen for many kinds of tumors, the current treatments for myelosuppression have significant liabilities and shortcomings.

G1T28-1 induces a transient, reversible arrest of HSPCs, making them resistant to DNA damaging insults. Preclinical data has demonstrated that protecting the bone marrow from damage results in a quicker recovery of all blood lineages and mitigates bone marrow exhaustion. G1T28-1 has the potential to enhance anti-tumor efficacy by maintaining chemotherapy dose density and schedule, and to improve quality of life and to positively impact pharmacoeconomics by reducing transfusions, preventing hospital admissions due to infection, and attenuating the incidence of secondary hematological malignancies.

Market Potential

G1’s clinical candidate, G1T28-1, will enter the bone marrow supportive care market which includes growth factors (biologics) such as Neulasta, Epogen, Procrit, Neupogen, and Aranesp with combined 2013 sales of $8.4 billion in the United States alone. The Company has a target chemotherapy patient population of up to 300,000 per year in the US alone.

Competitive Advantage

G1's first-in-class chemoprotectant, G1T28-1, is differentiated from current treatments for myelosuppression because it protects all hematopoietic lineages: red cells, platelets, granulocytes and lymphocytes. While growth factors stimulate single-lineage bone marrow progenitor cells that have already been damaged by chemotherapy, G1T28-1 protects all hematopoietic stem and progenitor cells (HSPCs) before damage is done, potentially changing the treatment paradigm.

Financial Overview

Since inception, G1 has raised over $5 million from non-dilutive sources and closed a Series A financing of $12.5M in October 2013. The Company is currently seeking a $15M Series B for conducting a Phase 1b/2a trial to demonstrate reduction of chemotherapy-induced myelosuppression in cancer patients.

Intellectual Property

G1 has broad freedom to operate for its novel compounds and their methods of use. G1 has five issued composition-of-matter US patents covering compounds (including G1T28-1) related to the Company’s first proprietary scaffold. Additionally, G1 has multiple pending applications for composition-of-matter and methods-of-use on all three of its novel kinase inhibitor scaffolds.  

Commercialization Strategy

G1 is focused on developing G1T28-1, for chemoprotection. The Company plans to first demonstrate early proof of concept of bone marrow protection in a rapid and straightforward clinical trial in patients with small cell lung cancer.  Following this trial, G1 plans to conduct additional Phase 2 trials to demonstrate efficacy in other cancer types.

Additionally, there has been heightened interest in drugs that target CDK4/6 as antineoplastic agents. The Company is currently in active discussion with several potential partners for G1’s proprietary CDK4/6 inhibitors used as antineoplastics.

Pipeline Products

G1 Therapeutics is advancing a portfolio of proprietary drug candidates for both antineoplastic and chemoprotection indications.  The Company’s lead program, G1T28-1 is currently in Phase 1 clinical testing.  PK/PD data from this trial will inform dose and schedule for Phase 1b/2a trials in cancer patients that are planned for Q2 2015.  In addition, G1 has back-up/follow-on compounds for both chemoprotection (G1T30-1) and antineoplastic use (G1T38-1).

Management Team

·   CEO Mark Velleca MD, PhD was instrumental in founding, building, and leading CGI Pharmaceuticals. He forged a major drug discovery/development collaboration with Genentech and an acquisition of the company by Gilead.

·   CMO Raj Malik MD is an oncologist with more than 20 years of drug development experience in academics (University of Virginia), large pharma (BMS), and small biotech (Agennix).

·   CBO Greg Mossinghoff, MBA has extensive operational, financial, and deal-making experience in small biotech and big pharma. As President of Inspire (from inception through IPO), he established significant corporate partnerships.

·   CSO Jay Strum PhD brings more than 20 years of drug discovery experience to G1. He was a key leader of programs in cancer and metabolic diseases at GSK that led to marketed therapeutics such as Tykerb.

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