To mark its 10th anniversary, Drug Discovery & Development magazine invited pharmaceutical and biotechnology companies to reflect on the history and made predictions about future of the industry. Featured here are verbatim comments from this company.
Gemin X Pharmaceuticals
Headquarters
Malvern, Pa.
Location(s)
Malvern, Pa. (drug development, executive headquarters); Montreal, QC (drug discovery)
Years in Drug Research
10 years
Spokesperson
Glenn Gormley, MD, PhD, President and Chief Executive Officer
Web site
| Areas of research |
•
|
Small Molecule |
|
|
Biological |
|
|
|
| Functions performed by the company’s (organization’s) employees |
| • |
Disease Research |
|
• |
Pre-clinical Studies |
•
|
Target Identification |
|
•
|
IND Submission |
•
|
Target Validation |
|
|
Drug Sample Manufacturing |
•
|
Lead Identification |
|
•
|
Clinical Trials |
•
|
Early Safety Tests |
|
•
|
NDA Submission |
•
|
Lead Optimization |
|
|
Post-marketing Studies |
|
Drug Delivery |
|
|
Other |
About the company/organization
Gemin X Pharmaceuticals is a privately held company dedicated to the discovery, development and commercialization of novel, targeted cancer therapeutics to improve the lives of patients. Gemin X is developing first-in-class cancer therapeutics based on activating the natural process of programmed cell death, or apoptosis, and inducing growth-inhibiting metabolic changes in cancerous cells. The Company currently has three clinical development programs underway, ranging from Phase 2 clinical trials for its lead product candidates obatoclax (GX15-070), an innovative pan Bcl-2 inhibitor, and GMX1777, a novel inhibitor of NAD+ synthesis, to preclinical studies for its Telomere Capping program. Initial treatment indications for the full scope of pipeline programs span a broad range of hematological and solid tumors, including elderly acute myeloid leukemia (AML), mantle cell lymphoma (MCL), melanoma, glioblastoma and small cell lung cancer (SCLC). Founded in 1998, Gemin X has drug development and executive headquarters in Malvern, Pennsylvania and drug discovery operations in Montreal, Canada.
A 10-year perspective: Advances and roadblocks
Ten years ago, Gemin X was founded based on exciting technology developed by Gordon Shore, Ph.D. and Philip Branton, Ph.D., leading oncology researchers who recognized the potential to treat cancer by re-establishing the natural process of programmed cell death, or apoptosis.
Today, Gemin X is a clinical-stage drug development company with a robust pipeline addressing critical unmet medical needs for cancer patients. Lead compounds include pan Bcl-2 inhibitor Obatoclax and metabolic inhibitor GMX1777.
Novel and exciting therapeutic approaches that improve selective targeting of cancers have emerged over the past ten years. More than ever, research and drug development are leading to treatments that can be matched to the right patient. For example, we now know more about the regulation of apoptosis and have learned how to direct Obatoclax to the right targets. We have also uncovered the cellular mechanism of GMX1777 that accounts for its activity against cancer.
R&D Challenges in the next 10 years
At Gemin X, it will be important to prioritize the many development opportunities in oncology for our rich pipeline of small molecules.
More broadly, while the clinical research enterprise in the U.S. has long been viewed as world-class, and innovation is yielding an ever-increasing volume of promising new drug candidates, we face significant challenges that could compromise our ability to deliver new treatment options to patients. Over the next decade, initiatives such as the Clinical Trials Transformation Initiative (CTTI) will address these challenges, resulting in: greater efficiencies in clinical research utilizing new methods such as adaptive seamless designs and more tailored data collection; an expanded, upgraded clinical research infrastructure to handle the increasing complexity and volume of trials; enhanced post-marketing safety surveillance utilizing large interconnected databases; enhanced training and support programs that encourage growth in the number of experienced clinical investigators; and enhanced public confidence in medical research.
Business/regulatory challenges for the next 10 years
At Gemin X, we have rich pipeline of novel small molecules designed to address unmet medical needs for cancer patients, by either re-establishing the natural process of programmed cancer cell death (apoptosis) or interfering with critical metabolic processes. Prioritization of clinical pathways, oncology market opportunities and potential strategic collaborations will be important over the coming years.
More broadly, we need to address the growing inefficiency of drug discovery, development and commercialization. We are committed to increasing collaboration and communication across the multiple stakeholders, as new and innovative ways to improve clinical research, drug approval, and post-marketing safety surveillance are established. An example is the recently launched Clinical Trials Transformation Initiative (CTTI), a public-private partnership started by Duke University and the FDA, and involving sectors such as : industry, government, patient advocates, trade organizations, professional societies, academia, and non-academic investigators.
Bold Prediction: Where will the company/organization be in 10 years?
In ten years, Gemin X will be a successful public company with at least two first-in-class cancer drugs on the market: our first ever pan Bcl-2 inhibitor Obotoclax, and our metabolic inhibitor GMX1777.
We will be a leader in advancing cancer therapies that selectively leverage the power of apoptosis and metabolic inhibition.
Bold Prediction: Where will the industry will be in 10 years?
In ten years, the industry will have significantly enhanced the public trust by increasing transparency of clinical trial results, implementing effective new approaches to monitoring and interpreting post-market safety data, and improving on the cost and time efficiencies of developing breakthrough new drugs for patients in need.