BioMedWire Editorial Coverage: Gene therapy is hot on the trail of killing cancer, and companies that deliver cures could see blockbuster returns.
Pioneering a new paradigm in cancer therapeutics, Genprex Inc. (NASDAQ: GNPX) (GNPX Profile) is leveraging its patented technology platform to deliver powerful tumor-suppressing genes directly into cancer cells. Calithera Biosciences Inc. (NASDAQ: CALA) is looking for cures for cancer and other life-threatening diseases by discovering, developing and commercializing novel, small-molecule drugs that target tumor and immune cell metabolism. Adaptimmune Therapeutics plc (NASDAQ: ADAP) is developing novel cancer immunotherapy products for cancer patients by engineering T-cells to target and destroy cancer. Agenus Inc. (NASDAQ: AGEN) is working on the discovery and development of therapies that engage the body’s immune system to fight cancer by pursuing combination approaches that leverage a broad range of antibody therapeutics, proprietary cancer vaccine platforms and adoptive cell therapies. G1 Therapeutics Inc. (NASDAQ: GTHX) is advancing three clinical-stage programs designed to enable more effective combination treatment strategies and improve patient outcomes across multiple oncology indications.
- Cancer remains one of the most frustratingly difficult diseases to cure.
- New gene-based therapeutic paradigms are now in play.
- With breakthrough technologies, gene therapy is on the cusp of curing the incurable.
- Biotech companies that deliver these cures could also deliver blockbuster returns.
Even though gene therapy is closing in on cancer, it remains as yet an unpredictable industry. However, biotech companies are in a feverish hunt for breakthroughs, and gene therapy could hold the keys. Tremendous advances have been made in gene-based therapeutics, and companies, such as Genprex Inc. (NASDAQ: GNPX), with the potential to make breakthroughs could deliver blockbuster returns.
Genprex is collaborating with MD Anderson Cancer Center to further develop and test its patented multimodal technology, currently in a Phase II clinical trial. The company recently caught the attention of a research-driven investment bank, Noble Financial, which initiated coverage of Genprex with an Outperform rating and a price target that’s about triple current levels.
Unlike other gene therapy approaches, Genprex’s method doesn’t inject a patient with a genetically modified virus and doesn’t edit or modify a patient’s genes. Instead, the company’s revolutionary technology encapsulates a powerful proven cancer-suppressor gene (TUSC2) in cholesterol nanoparticles (nanovesicles) engineered to target cancer cells. Since the body is familiar with breaking down cholesterol, Genprex’s lead product, Oncoprex(TM), delivers its TUSC2 gene directly to the targeted cells, readily passing through the small blood vessels that form around tumors. Like a magnet, the encapsulated cancer suppressor genes are first attracted to the opposite electrical charge of tumors then enter malignant cells to begin their work.
The loss of tumor-suppressor genes is the most common genetic mutation in cancer cells. When delivered to a cancer cell, the TUSC2 gene has been shown to restore the genetic coding required to produce more tumor suppressors. TUSC2 has been shown to be well tolerated by healthy cells, and importantly, the payload is taken up by tumor cells at up to 25 times the rate they’re taken up by normal cells. Genprex hopes its gene therapy technology will restore normal expression levels of tumor suppressor genes, inducing cell death (apoptosis), inhibiting tumor progression and subsequently prolonging survival of cancer patients.
Due to its unprecedented dual mechanism of action (gene therapy and immunotherapy), Genprex’s Oncoprex is identified as an immunogene therapy. Oncoprex is designed to restore the genetic coding of tumor suppressor genes in cells (gene therapy) plus stimulate the body’s natural anti-cancer immune response (immunotherapy).
Most currently approved cancer regimens target only single molecules, or a single specific genetic abnormality. Oncoprex’s multimodal mechanism of action interrupts cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes the pathways for cell death in cancer cells and modulates the immune response against cancer cells. Genprex clinical data indicate that Oncoprex, in combination with targeted therapies and immunotherapies, is significantly more effective than single drugs alone. Oncoprex has also demonstrated fewer side effects and less toxicity than many other lung cancer drugs.
Currently approved targeted therapies for advanced non-small cell lung cancer are only effective in a minority of patients, and eventually most patients become resistant to the treatments. Roughly 80% of lung cancers are non-small cell lung cancer, and the dismal 1% five-year survival rates haven’t improved in over a quarter century.
Genprex is well into Phase II clinical trials with Oncoprex for the treatment of the deadliest type of tumor, non-small cell lung cancer (NSCLC). Preliminary results from the ongoing trial to date are encouraging. Using Oncoprex in combination with Roche’s erlotinib showed disease control rates of 78%, which substantially exceed the 58% disease control rates demonstrated in other drug combination trials.
In addition, more than 40% of patients had tumor regression, and one patient — out of nine evaluated to date in Genprex’s Phase II drug combination trial — experienced what’s called a complete response. The patient, suffering with metastatic NSCLC, had complete disappearance of both the lung primary tumor as well as the metastasized cancer in the lung, liver and lymph nodes.
Genprex’s cutting-edge platform for the targeted delivery of gene therapeutics also has wide-ranging potential applications for the treatment of various other types of cancer, such as head and neck, renal cell (kidney), glioblastoma and soft-tissue cancer, among others.
Genprex holds more than 30 patents and 2 patents pending for its platform technologies and targeted molecular therapies. The company’s promising pipeline includes Oncoprex in combination with another cancer drug, Tarceva, in a Phase II clinical trial; and Oncoprex Immunogene therapy in preclinical development.
The company is conducting ongoing research to find biomarkers to identify patients most likely to benefit from Genprex treatments, as well as other drugs that will be synergistic with Genprex gene therapies. Given the enormous potential and vast unmet medical need, Genprex plans to apply for Fast Track, Breakthrough or RMAT designation from the FDA.
Preliminary results show that Oncoprex has the potential to become an effective add-on therapy for the treatment of deadly non-small cell lung cancer. Genprex plans to expand the current erlotinib-Oncoprex trial to multiple research centers and conduct more new trials.
If Phase II results are as positive as preliminary indications, it could spark a rally in the shares and possibly even lure a large biotechnology or pharma company to sign a high-value partnership with Genprex. Should such a strategic partnership to commercialize Genprex’s technology transpire, it could potentially generate enormous value for the company’s shareholders.
Without any of this in the bank, Noble Financial has already pegged the stock to reach $5 a share, nearly triple from today’s closing price. With such positive preliminary results and blockbuster potential, it is possible that Noble’s target price might even be low. Genprex is certainly one to watch.
Seeking Biotech Cancer Cures
Other companies are also clamoring for attention in the potential cancer-cure space.
Calithera Biosciences Inc. (NASDAQ: CALA) is a clinical-stage biopharmaceutical company focused on fighting cancer and other life-threatening diseases by discovering, developing and commercializing novel small-molecule drugs that target tumor and immune cell metabolism. The company believes certain small-molecule drugs can slow tumor growth through controlling key metabolic pathways in the tumor and immune cells. Tumor metabolism and tumor immunology are promising new interrelated fields for cancer drug discovery. Recent clinical successes have demonstrated the potential to slow abnormal cell growth and create fundamentally new therapies for cancer patients.
Adaptimmune Therapeutics plc (NASDAQ: ADAP) is a clinical-stage biopharmaceutical company researching the development of novel cancer immunotherapy products for cancer patients. The company’s unique Specific Peptide Enhanced Affinity Receptor (SPEAR) T‑cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors. Adaptimmune’s affinity-enhanced T-cell therapies work with the immune system to improve detection and targeting of cancer cells, resulting in destruction of those cancer cells. The company has clinical trials ongoing for three wholly owned SPEAR T-cells in multiple solid-tumor indications.
Agenus Inc. (NASDAQ: AGEN) is a clinical-stage immuno-oncology company examining the discovery and development of therapies that engage the body’s immune system to fight cancer. The company vision is to expand the patient populations benefiting from cancer immunotherapy by pursuing combination approaches that leverage a broad range of antibody therapeutics, proprietary cancer vaccine platforms and adoptive cell therapies. Agenus believes that combination therapies and a deep understanding of each patient’s cancer will be key drivers of success in substantially expanding the benefits from current immuno-oncology therapies.
G1 Therapeutics Inc. (NASDAQ: GTHX) is a clinical-stage biopharmaceutical company working 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 and lerociclib are designed to enable more effective combination-treatment strategies and improve patient outcomes across multiple oncology indications. G1T48 is a potential best-in-class oral selective estrogen receptor degrader (SERD) for the treatment of ER+ breast cancer. G1 also has an active discovery program focused on cyclin-dependent kinase targets.
With cancer killing more than 600,000 people in 2018, companies involved in the work of curing this dreaded disease are certain to capture the attention of those looking to invest in technology with the potential to save.
For more information on Genprex, visit Genprex Inc. (NASDAQ: GNPX)
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