Record Revenues, Milestone Achievements Indicate Strength, Potential of Biotech Sector

NetworkNewsWire Editorial Coverage: Biotech and biopharma industry leaders are posting record financials and hitting milestone markers in their research and growth, good indicators of a strong market with potential for robust returns on investment.

Genprex Inc. (NASDAQ: GNPX) (GNPX Profile) has completed key steps in its overall strategy to expand its clinical development programs and bring Oncoprex(TM) immunogene therapy, its lead drug candidate, to commercialization. Over the past five years, Amgen Inc. (NASDAQ: AMGN) has invested nearly $19 billion in R&D and, as a result, is now advancing a record number of clinical assets. Biogen Inc. (NASDAQ: BIIB) has added four new programs to its pipeline this quarter alone as the company continues to diversify and build depth within neuroscience and pursue therapeutic adjacencies. Celgene Corporation (NASDAQ: CELG) announced recently that its stockholders voted to approve the company’s proposed combination with Bristol-Myers Squibb Company (NYSE: BMY). This key milestone brings the two complementary biopharmaceutical companies one step closer to combining their efforts on a shared mission of discovering, developing and delivering innovative medicines for patients with serious diseases.

• Biotech sector has posted 10-year annual returns of more than 15%.
• Genprex has reached significant milestones in its work to expand clinical development programs, bring Oncoprex to commercialization.
• Core to GNPX’s success is its lead product candidate, Oncoprex.

Billion-Dollar Paydays

Investing in biotech, while often an uncertain endeavor, brings rewards far beyond the financial returns that accompany success. Traditionally, only 10% of clinical drug trials ever make it to market, but those that do often produce billion-dollar paydays for parent companies. And even more satisfying for many investors is the opportunity to be involved in a work that both saves lives and improves the quality of life for those battling serious diseases such as cancer.

However, while the investment risks are real, the sector has established an impressive track record, consistently performing well in recent years and posting 10-year annual returns that are up more than 15% — more than double the increase for the S&P 500. This decade-long upward trend makes a compelling argument for taking a closer look at biotech potential.

Interactive Timeline Touts Genprex Achievements

Biotech companies such as Genprex Inc. (NASDAQ: GNPX), are experiencing exciting growth and reaching mile markers in their work to research and develop life-changing options for patients. Geneprex recently outlined significant achievements it has completed on a newly launched, interactive corporate website timeline.

“Since Genprex’s IPO last year, we have made significant progress in many areas of the company, including progress toward expansion of our clinical programs and sponsored research, our manufacturing process development and scalability, and the growth of our team to support these initiatives,” said Genprex Chairman and CEO, Rodney Varner. “These accomplishments have set the stage for us to continue on our path of growth and expansion, enabling our efforts to bring our drug candidate to market for lung cancer patients who cannot benefit from today’s therapies.”

Highlights on the Genprex timeline include:

• Q2 2019
  • Announced positive preclinical findings from MD Anderson Cancer Center-sponsored research agreement studying the effects of TUSC2 with pembrolizumab at American Association of Cancer Research meeting
  • Developed Oncoprex and immunotherapy combination clinical trial design
  • Collaborated with Addison Whitney for drug nomenclature branding program and submission of nonproprietary, drug-name selections
  • Initiated manufacturing process development with key manufacturing partners to support clinical expansion and manufacturing scale-up processes
  • Completed manufacturing of TUSC2 DNA plasmid to support clinical trial ramp-up
• Q1 2019
  • Appointed senior eirector of Pharmaceutical Sciences & Manufacturing and senior manager of Communications & Marketing
  • Added two USPTO-issued patents to the company’s intellectual property portfolio
  • Identified potential new clinical sites for expansion of Oncoprex and erlotinib combination clinical trial
• Q4 2018
  • Appointed vice president of Clinical Operations
  • Completed clinical data reconciliation within a CDISC/SDTM-compliant database
• Q3 2018
  • Initiated clinical site selection and expansion program with CRO partner
  • Initialization of sponsored preclinical research with MD Anderson Cancer Center to evaluate TUSC2 with immunotherapies including immune checkpoint inhibitors anti-PD1 and CTLA-4
• Q2 2018
  • Continued execution and enhancement of strategy for manufacturing technology transfer and scale-up initiatives.

Potential for Life-Changing Treatment

A key element of Genprex’s growth and success is its lead product candidate, Oncoprex. This potentially life-changing cancer treatment consists of a TUSC2 gene encapsulated in a nanovesicle made from lipid molecules with a positive electrical charge. Oncoprex is injected intravenously and can specifically target cancer cells, which generally have a negative electrical charge.

Once Oncoprex is taken up into a cancer cell, the TUSC2 gene is expressed into a protein that is capable of restoring certain defective functions arising in the cancer cell. Oncoprex has a multimodal mechanism of action whereby it interrupts cell-signaling pathways that cause replication and proliferation of cancer cells; re-establishes pathways for programmed cell death, or apoptosis, in cancer cells; and modulates the immune response against cancer cells. Oncoprex has also been shown to block mechanisms that create drug resistance.

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 is in the process of expanding the current erlotinib-Oncoprex trial to multiple research centers and is planning to conduct additional trials.

Current Successes Pave Path for Future Milestones

With significant milestones being met, Genprex is pressing forward with its strategy objectives to reprogram the course of cancer. The company plans on continuing to conduct ongoing and new clinical trials as well as pursue strategic partnerships with organizations whose missions align with its own. One of these existing partnerships — with manufacturing partner Aldevron — recently resulted in the successful completion of the manufacturing of the TUSC2 plasmid DNA.

Genprex is also preparing to commercialize Oncoprex. Most recently, the company announced that it has initiated the first phase of branding the immunogene therapy and has completed the creation and submission of nonproprietary drug name selections to the American Medical Associations’ United States Adopted Names Council.

In addition, Genprex is planning to investigate the effectiveness of Oncoprex in other cancers as well as further develop platform technology.

Milestones, Record Revenues Bode Well for Bio

One of the world’s leading biotech companies, Amgen Inc. (NASDAQ: AMGN) is dedicated to transforming new ideas and discoveries into medicines for patients with serious illnesses. Amgen has a blossoming, early-stage oncology pipeline with 20 molecules in development; the company added 10 new, first-in-human molecules to its portfolio in 2018 alone. In the last two years, Amgen has filed 20 investigational new-drug application, with 70% of those being first-in-class, or based on a new mechanism of action. Three of the company’s programs have reached Phase 3, and Amgen continues to invest heavily in what it believes is a differentiated approach to human genetics, with a pipeline that is 75% genetically validated to various degrees, up from 15% five years ago. Human genetic validation provides the company with earlier, better insights into which of its proposed new therapies have the greatest potential for approval and success.

One of the world’s first global biotechnology companies, Biogen Inc. (NASDAQ: BIIB) posted 2Q 2019 total revenues of $3.6 billion, an 8% increase from 2Q 2018. That revenue was driven in part by the company’s continued global launch of SPINRAZA(R) and by biosimilars revenues, primarily IMRALDI(TM). In addition, the company’s acquisition of Nightstar Therapeutics has provided Biogen with two potentially first-in-class, mid- to late-stage gene-therapy programs in specialty ophthalmology. The company has also initiated two new studies in its priority areas of multiple sclerosis and amyotrophic lateral sclerosis.

Celgene Corporation (NASDAQ: CELG) has more than 300 clinical trials at major medical centers using its compounds. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer.

A significant step toward building that global biopharmaceutical corporation appears to be on the horizon, with both Celgene and Bristol-Myers Squibb Company (NYSE: BMY) stockholders voting to approve a proposed acquisition of Celgene by Bristol-Myers. “Bristol-Myers Squibb reaffirms the significant value creation opportunity of the acquisition of Celgene,” a recent company press release read. “Together with $2.5 billion of cost synergies, a compelling pipeline and a strong portfolio of marketed products, the company continues to expect growth in sales and earnings through 2025. The company is continuing to develop its promising immunology pipeline asset, tyrosine kinase 2 (TYK2) inhibitor, in several autoimmune diseases, including psoriasis. Bristol-Myers Squibb looks forward to advancing its leadership in core areas of focus, including immunology, and delivering highly innovative medicines that bring meaningful benefits to patients as a combined company.” Bristol-Myers just posted second-quarter revenues of $6.3 billion, an increase of 10%.

As the biotech and biopharmaceutical space continues to explore its life-saving potential, leaders in the industry are leveraging their strengths and expertise to make the most of the opportunity to save lives and reward investors at the same time.

For more information on Genprex, visit Genprex Inc. (NASDAQ: GNPX)

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