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.
To view an infographic of this editorial, click here.
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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