Genprex Inc. (NASDAQ: GNPX) Receives Orphan Drug Designation for Immunogene Therapy for Treatment of SCLC
September 21 2023 - 8:30AM
via InvestorWire —
Genprex Inc. (NASDAQ: GNPX) today
announces its placement in an editorial published by
NetworkNewsWire ("NNW"), one of 50+ trusted brands within the
InvestorBrandNetwork (“IBN”), a multifaceted financial news and
publishing company for private and public entities.
To view the full publication, “Pathways to Progress: How Orphan
Drug Designation Sparks Biotech Transformation,” please visit:
https://nnw.fm/619wq
More than 30 million people in the United States suffer with a
rare disease; most of them are receiving no current treatment.
Supporting the development and evaluation of new treatments,
particularly for rare diseases, is a key priority for the U.S. Food
& Drug Administration. As part of that process, the agency can
grant Orphan Drug Designation (ODD) to a drug or biological product
being developed to prevent, diagnose or treat a rare disease or
condition.
This designation is intended to spark innovation among biotech
companies that are developing treatments for these patient
populations, which by definition affect fewer than 200,000 people
in the U.S., by providing incentives such as tax credits, user-fee
exemptions and up to seven years of market exclusivity after FDA
approval. Last month, Genprex Inc. (NASDAQ: GNPX) was
granted FDA orphan drug designation for its REQORSA(R) immunogene
therapy in development for the treatment of small cell lung cancer
(SCLC).
About Genprex Inc.
Genprex is a clinical-stage gene therapy company focused on
developing life-changing therapies for patients with cancer and
diabetes. Genprex’s technologies are designed to administer
disease-fighting genes to provide new therapies for large patient
populations with cancer and diabetes who currently have limited
treatment options. Genprex works with world-class institutions and
collaborators to develop drug candidates to further its pipeline of
gene therapies in order to provide novel treatment approaches.
Genprex’s oncology program utilizes its systemic, nonviral
ONCOPREX(R) Nanoparticle Delivery System, which encapsulates the
gene-expressing plasmids using lipid nanoparticles. The resultant
product is administered intravenously, where it is taken up by
tumor cells that then express tumor suppressor proteins that were
deficient in the tumor. The company’s lead product candidate,
REQORSA(R) (quaratusugene ozeplasmid), is being evaluated in three
clinical trials as a treatment for non-small cell lung cancer
(“NSCLC”) and small cell lung cancer (“SCLC”). Each of Genprex’s
three lung cancer clinical programs has received a Fast Track
Designation from the Food and Drug Administration (“FDA”), and its
SCLC program has received an FDA Orphan Drug Designation. Genprex’s
diabetes gene therapy approach is comprised of a novel infusion
process that uses an adeno-associated virus (“AAV”) vector to
deliver Pdx1 and MafA genes directly to the pancreas. In models of
type 1 diabetes, GPX-002 transforms alpha cells in the pancreas
into functional beta-like cells, which can produce insulin but may
be distinct enough from beta cells to evade the body’s immune
system. In a similar approach, GPX-003 for type 2 diabetes, where
autoimmunity is not at play, is believed to rejuvenate and
replenish exhausted beta cells.
For more information about the company, visit
www.Genprex.com.
NOTE TO INVESTORS: The latest news and
updates relating to GNPX are available in the company’s newsroom
at http://ibn.fm/GNPX
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