ProPhase Labs, Inc. (NASDAQ: PRPH) (“ProPhase”), a next-generation
biotech, genomics and diagnostics company, today provided an update
regarding its progress and development strategy for Linebacker-1
(LB-1). Linebacker is a small molecule, multi-kinase inhibitor that
is being developed by the Company’s wholly owned subsidiary,
ProPhase BioPharma, Inc. (“PBIO”), as a potential mono-therapy and
co-therapy option for hard-to-treat cancers. Originally viewed as a
co-therapy, the pre-clinical data generated has given PBIO reason
to believe that LB-1 will also be very effective as a mono-therapy.
In Q1 of 2023, ProPhase collaborated with
Eurofins, a globally recognized leading drug discovery company, to
execute an in-depth analysis (KINOMEscan™ Profiling Service) of
Linebacker-1 to determine how many cancer-relevant kinases were
affected by Linebacker-1 out of a possible 468 enzymes. ProPhase
was excited to learn that numerous critically important kinase
targets were inhibited more than 99%. Some of the most inhibited
pathways are those well known to promote tumorigenesis, such as the
phosphoinositide 3-kinase family (e.g., PIKfyive, PIP5k1 and 2) and
the mitogen-activated protein kinase family (e.g., MEK3, 4, and
5).
Importantly, the Eurofins analysis
revealed several unique targets affected by Linebacker-1 that
cancer research organizations highlight as critically important,
for which no other pharmaceutical company has developed drugs to
treat. We believe the unique interplay of Linebacker with multiple
cancer-dependent pathways will be a true differentiator within
current treatment paradigms.
Kinase families have been explored since the
very beginning of targeted cancer therapies, as they are often
upregulated and/or dysregulated in a number of cancer situations.
There are 538 kinases encoded into the human genome and many of
them have already been targeted as key areas for intervention in
this multi-billion-dollar space. The largest targeted drugs
starting with Novartis’s Gleevec and extending to Nexavar, Xalkori,
Tasigna, and many others have led the way toward treating many
types of cancers as chronic conditions. Billions of development
dollars have gone into this area, but there are still many
untargeted areas in the kinase space, providing a unique
opportunity for Linebacker-1 to become a breakthrough drug in the
fight against cancer.
In line with these impressive results,
Linebacker-1 has demonstrated strong preclinical potential in a
number of difficult diseases, including tough-to-treat lung and
gastric cancers. As development continues, we intend to position
Linebacker-1 as a potential new option for cancer patients
suffering from a current lack of quality treatment options.
At ProPhase we believe in following biological
foundations. Often times, scientific data is under appreciated in
the pharmacological space. The decision to further mine existing
results for valuable and directed data is therefore a priority for
us. Analyzing the current Linebacker results against over 200
cancer models and 500 protein-protein interactions, ProPhase will
now embark into a cutting-edge, machine learning stage in which all
Linebacker-driven interactions and outcomes will be
cross-referenced in a manner that further elucidates specific
pathways particularly impacted by this one-of-a-kind molecule. This
will allow for a more accurate and more likely-to-succeed path
towards the clinic, ultimately saving time, money, and most
importantly, patients’ lives.
We intend to focus a majority of 2023 on
developing a more in-depth understanding of the unique pathways we
believe Linebacker may impact, as well as taking the necessary
steps to meet the requirements for an IND submission to the FDA
including:
- Cross-over analysis and machine
learning to elucidate most affected signaling pathways
- Maximum Tolerated Dose (MTD)
studies and safety confirmations
- Opportunities for synergies with
existing, but underwhelming, commercial medicines
- Optimization of treatable
neoplastic conditions within unsaturated areas
“The two-year bear market for microcap companies
has led to some phenomenal opportunities in the biotech and life
sciences space and specifically for our company,” said Ted Karkus,
CEO of ProPhase Labs. “The financial success of our diagnostic
business over the past two years enabled us to acquire some
fantastic under-valued assets, while strengthening our company’s
core infrastructure. We are confident that we will be able to
leverage this infrastructure and platform to develop our new,
exciting initiatives with multi-billion-dollar potential, including
our development of the Linebacker portfolio. These continuing
positive preliminary results from the Linebacker-1 pre-clinical
studies continue to bolster our confidence and support the new
directions that we are taking with our company with the goal of
continuing to significantly grow the underlying value. We look
forward to providing updates in the coming weeks on additional
Linebacker pre-clinical studies that are being conducted in
parallel. We also look forward to providing updates on other
strategic initiatives that have so much potential.”
About LinebackerLinebacker is a
modified polyphenol. Polyphenols are substances found in many nuts,
vegetables and berries. Linebacker compounds are modified
Myricetin, which is a common plant-derived flavonoid. Myricetin
exhibits a wide range of activities that include strong
antioxidant, anti-cancer, antidiabetic and anti-inflammatory
activities. It displays activities that are related to the central
nervous system.
LB-1 is Mono-chlorinated Myricetin with a
Chlorine atom substituted for the Hydroxy group at 5’ (position 5
on the B-ring). LB-2 is Di-chlorinated Myricetin with Chlorine
atoms substituted for the Hydroxy groups at 5’ and 7 (position 5 on
the B-ring and position 7 on the A-ring).
About EurofinsEurofins
Discovery has supported Drug Discovery research for over 40 years.
They are recognized as the industry leader for providing drug
discovery researchers with the largest and most diverse portfolio
of standard and custom in vitro safety & pharmacology assays
and panels for drug screening and profiling. In addition to
their in vitro safety pharmacology strengths, they also
offer a broad portfolio of over 3500 drug discovery services and
1800 products. These include medicinal and synthetic
chemistry, in vitro pharmacology, safety pharmacology
& efficacy, ADME-Tox, cell-based phenotypic assays, and custom
proteins and assay development capabilities. Eurofins supports a
variety of drug discovery targets such as GPCRs, Kinases, Ion
Channels, Nuclear Hormone Receptors and other proteins &
enzymes. Their broad global service capabilities and decades of
experience in providing drug discovery services result in the
delivery of high quality, reproducible study performance with few
repeats and high client satisfaction. Eurofins Discovery's
capabilities, expertise, knowledge and skill sets enable them to
provide their clients with the benefit of being able to work with a
single outsourcing provider (CRO) for their drug discovery
programs.
About ProPhase Labs
ProPhase Labs, Inc. (Nasdaq: PRPH) (“ProPhase”)
is a next-generation biotech, genomics and diagnostics company. Our
goal is to create a healthier world with bold action and the power
of insight. We’re revolutionizing healthcare with industry-leading
Whole Genome Sequencing solutions, while developing potential game
changer diagnostics and therapeutics in the fight against cancer.
This includes a potentially life-saving cancer test focused on
early detection of esophageal cancer and potential breakthrough
cancer therapeutics with novel mechanisms of action. Our
world-class CLIA labs and cutting-edge diagnostic technology
provide wellness solutions for healthcare providers and consumers.
We develop, manufacture, and commercialize health and wellness
solutions to enable people to live their best lives. We are
committed to executional excellence, smart diversification, and a
synergistic, omni-channel approach. ProPhase Labs’ valuable
subsidiaries, their synergies, and significant growth underscores
our multi-billion dollar potential.
Forward Looking Statements
Except for the historical information contained
herein, this document contains forward looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, including statements regarding our strategy, plans,
objectives and initiatives and our beliefs regarding the potential
of Linebacker-1 to treat various hard-to-treat cancers. Management
believes that these forward-looking statements are reasonable as
and when made. However, such forward-looking statements involve
known and unknown risks, uncertainties, and other factors that may
cause actual results to differ materially from those projected in
the forward-looking statements. These risks and uncertainties
include but are not limited to our ability to obtain and maintain
necessary regulatory approvals, general economic conditions,
consumer demand for our products and services, challenges relating
to entering into and growing new business lines, the competitive
environment, and the risk factors listed from time to time in our
Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and any
other SEC filings. The Company undertakes no obligation to update
forward-looking statements except as required by applicable
securities laws. Readers are cautioned that forward-looking
statements are not guarantees of future performance and are
cautioned not to place undue reliance on any forward-looking
statements.
For more information, visit
www.ProPhaseLabs.com.
Media Relations and Institutional
Investor Contact: ProPhase Labs, Inc.
267-880-1111investorrelations@prophaselabs.com
Retail Investor Relations
Contact:Renmark Financial CommunicationsJohn
Boidman514-939-3989Jboidman@renmarkfinancial.com
Source: ProPhase Labs, Inc.
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