NewLink Genetics
NewLink Genetics
About New Link:
NewLink Genetics is staffed by world-class scientists and professionals with exceptional biomedical and bioinformatics expertise. The company has assembled this distinguished network of individuals sharing nearly a decade of productive working relationships. The scientists and board members have current or prior associations with many prestigious research Universities including Stanford, Harvard, Northwestern, Moscow State, Kyoto and Iowa State as well as the National Cancer Institute, the National Human Genome Research Institute, the Royal London Hospital and the Imperial Cancer Research Fund.
The core groups of scientists at NewLink are NIH-trained with expertise in computational biology, cancer biology, virology, gene therapy, medical oncology, immunology, and viral vector development. The company has state of the art molecular biology laboratory facilities as well as immediate access to animal laboratories, clinical sites and in house cGMP manufacturing facilities. Several members of the scientific staff have successfully carried out phase I clinical trials and are experienced in the manufacturing of clinical grade biologics and have extensive experience in clinical trial design.
NewLink Genetics Corporation is a biopharmaceutical company developing novel drugs and functional genomics solutions with a primary focus on cancer.
The successful completion of the Human Genome Project signals a new age in medical discovery centered around protein research. The rapidly growing knowledge base of the human genome provides an unprecedented opportunity to launch a revolutionary paradigm for drug discovery based on protein analysis.
NewLink remains steadfast in its primary focus to take novel treatments and diagnostics through the clinical trials process and bring products to market. The Company has already manufactured cancer drugs at its facilities in Iowa. The Company received an approval for an Investigational New Drug (IND) application from the Food and Drug Administration to initiate clinical trials using the Company's HyperAcute vaccine technology for the treatment of non-small cell lung cancer and breast cancer.
Clinical Trials:
NewLink has several cutting edge, patented technologies already in its clinical development pipeline. Dr. Charles Link, founder of NewLink Genetics, has been investigating HyperAcute technology as a novel method for cancer treatment since 1995. HyperAcute is entering clinical trials as our lead technology at the National Cancer Institute and other clinical centers.
On October 8, 2003, the Food and Drug Administration notified NewLink that we may proceed with treatment of lung cancer patients with HyperAcute-Lung cancer vaccine. Patient enrollment at the National Cancer Institute was opened in January, 2004.
For breast cancer patients, NewLink received an approval from the Food and Drug Administration in late December, 2003 for our HyperAcute-Breast cancer vaccine. This trial will be conducted in Iowa and will target women with recurrent breast cancer. During 2004, we intend to launch two additional trials with novel drugs for the treatment of patients with prostate and melanoma/skin cancer.
Core Technologies:
HyperAcute vaccine technology exploits one of the strongest known naturally acquired human immune responses, which represents an enormous advantage over other immunostimulatory cancer drugs in development. The approach is well supported by animal models and human clinical trials showing anti-tumor activity and survival benefit for similar compounds. The pharmacological mechanism in HyperAcute is believed to activate both the humoral and cellular branches of the immune system to produce a response that enables a patient's immune system to destroy established tumors. We believe that this approach may potentially be far more effective than other cancer drugs in development which could lead to expedited approval and widespread use.
The high mutagenicity of cancer cells combined with multiple redundant cellular signaling pathways and patient to patient variation in the mutations responsible for cancer are proving to be a difficult challenge for many of the newer classes of cancer drugs designed to interfere with biological processes unique to cancer cells. Accordingly, clinical trials for these drugs have produced disappointing results in which very few patients respond and survival benefits are negligible.
In contrast, the polyvalence of HyperAcute confers reactivity to multiple tumor antigens so that the efficacy of the drug is not dependent on any one biological pathway or on the presence of a single tumor antigen. The resulting anti-tumor response is expected to be effective in a larger proportion of patients and more durable over time leading to increased survival.
NewLink Genetics
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