MARLBOROUGH, Mass.,
Jan. 16, 2018 /PRNewswire/
-- RXi Pharmaceuticals Corporation (NASDAQ: RXII) a
clinical-stage company developing a new class of RNAi-based
therapeutics outlined its 2018 business strategy during a webcast
presentation at the Biotech Showcase conference which brought
together over 3,500 life science decision makers and investors from
over 50 countries to collaborate and discuss industry
trends.
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"After a thorough review of our business operations, development
programs and financial resources, a decision was made to focus our
efforts on RXi's expanding and promising immuno-oncology programs
to accelerate growth and in turn support a return on investment for
our shareholders," said Dr. Geert
Cauwenbergh, President and CEO of RXi Pharmaceuticals.
He stated that: "The positive clinical results recently announced
from our Phase 2 dermatology study validate the safety and efficacy
of our sd-rxRNA therapeutics in humans. These outcomes coupled with
robust preclinical results in our immuno-oncology program, further
affirm the Company's focused development path. With a
much-improved regulatory landscape for the development of cancer
therapeutics, we believe that there is great potential for our
sd-rxRNA compounds to provide major advances that could change the
paradigm in cancer treatments. Furthermore, the feedback that we
have received, through relationships with leading cancer centers,
potential business partners as well as institutional investors, in
the context of last week's Biotech Showcase meeting, endorses our
sharpened strategy. It is our goal to develop novel
immuno-oncology treatments to benefit patients as well as our
long-term shareholders and business partners."
2018 Business Strategy
RXi will focus development initiatives on novel immuno-oncology
therapeutics using its proprietary sd-rxRNA platform. Focusing the
development portfolio on Immuno-oncology, with a near term focus on
Adoptive Cell Transfer (ACT), will streamline and reduce our
quarterly burn-rate for 2018. The Company is aiming to enter the
clinic with at least one of our compounds in the next 18 months,
targeting a large multi-billion dollar market. This will be
achieved by:
- Accelerating the development of RXI-762 and RXI-804, sd-rxRNA
compounds targeting PD-1 and TIGIT respectively, for use in the
treatment of solid tumors in the context of ACT. Finalize cGMP
manufacturing of lead compound.
- Expanding internal development efforts and external
collaborations with various existing cell-based approaches,
evaluating hematopoietic stem cells, NK cells, TILs, CAR T, TCR and
engineered NK cells.
- Developing immuno-oncology targets beyond checkpoint
inhibition, i.e. cell differentiation.
- Expanding our research efforts to further demonstrate that our
technology is ideally suited to be combined with existing immune
effector cell expansion/manufacturing.
Monetize Existing Dermatology and Ophthalmology
Franchises:
Relating to the operational review, RXi intends to
partner/out-license both its Dermatology and Ophthalmology
Franchises. Successfully completing these transactions should
provide non-dilutive funding for the Company's focused development
path in Immuno-oncology.
Each of these Franchises is comprised of preclinical and
clinical-stage assets broadly covered by a robust intellectual
property estate. These assets include:
Dermatology
- RXI-109: Phase 2 asset for dermal hypertrophic scarring with
positive and statistically significant results addressing a
USD 1-3B market.
- RXI-231: Topical cosmetic ingredient in a proprietary
formulation with positive results reducing a change of skin tone
(pigmentation) triggered by UV (p< 0.04) addressing an estimated
USD multi-billion dollar market.
- RXI-185: Cosmetic ingredient that reduces collagenase in in
vitro models. May be developed as a cosmetic to improve the
appearance of aging skin.
- Samcyprone™: Phase 2 small molecule topical
immuno-therapy, with proven efficacy in cutaneous warts with an
estimated market size USD
2-4B.
- Access to the self-delivering platform for human therapeutic
and diagnostic use in the field of dermatology, providing access to
new compounds targeting proteins of relevance for the treatment of
skin diseases.
The intellectual property estate for RXi's Dermatology Franchise
is comprised of 14 patent families covering: RXI-109, RXI-231,
RXI-185 and Samcyprone™. Importantly, this
estate includes 18 granted patents broadly covering the sd-rxRNA
platform, including RXI-109 in the US, Europe, Japan
and China and Samcyprone™ in the
US.
Ophthalmology
- RXI-109: Phase 1/2 asset with proven safety, using intra-ocular
injections, for wet AMD with estimated market size USD 3-5B. Readouts
expected Q1 2018.
- Preclinical data package supporting development of RXI-109 by
intraocular injection or topical application to the eye for retinal
or corneal scarring indications.
- Patented set of sequences against a variety of relevant
proteins for targeting ocular disorders. Also, sd-rxRNA compounds
against targets which may be involved in retinoblastoma or retinal
or corneal scarring.
- Preclinical intra-ocular asset (sd-rxRNA targeting VEGF) with
dose-dependent effects and tolerability demonstrated in a rodent
model.
- Access to the self-delivering platform for human therapeutic
and diagnostic use in the field of ophthalmology, providing ready
access to new compounds targeting proteins of relevance for the
treatment of ophthalmic diseases.
RXi's Ophthalmology intellectual property estate includes 21
patent families. This estate includes 73 patents covering the
composition and methods of use the sd-rxRNA platform and targets
and sequences from the OPKO assets, including the use of RXI-109
for the treatment of ocular scarring in the US, Japan and China.
The webcast presentation took place on January 8, 2018, and the relating slides and
audio may be found on the Company's website, www.rxipharma.com.
About RXi's self-delivering RNAi (sd-rxRNA) technology
platform
sd-rxRNA, RXi's proprietary self-delivering RNAi platform, is a
single chemically modified compound with delivery and therapeutic
properties built directly into the compound itself. The compound is
asymmetrical with a phosphorothioate backbone and contains chemical
modifications that provide for efficient cellular uptake and gene
silencing. These compounds are potent, stable and specific, and
demonstrated to be safe and active in a clinical setting.
RXi's novel sd-rxRNA technology differs from natural and most
synthetic RNA interference (RNAi) molecules in that they are
chemically modified to allow for efficient internalization of the
compounds by cells and silencing of the targeted genes.
Importantly, unlike other naked siRNA compounds, delivery of
sd-rxRNAs are not limited to a specific cell type. For local
delivery and ex vivo cell-based therapeutic applications,
our compounds do not require delivery vehicles. This is a
significant advantage since delivery vehicles can have related
toxicity that affects cell viability. sd-rxRNA has demonstrated
nearly 100 percent transfection efficiency with high cell viability
in numerous cell types.
About RXi Pharmaceuticals
RXi Pharmaceuticals Corporation (NASDAQ: RXII) is a
clinical-stage company developing innovative therapeutics that
address significant unmet medical needs. Building on the pioneering
discovery of RNAi, scientists at RXi have harnessed the naturally
occurring RNAi process which can be used to "silence" or
down-regulate the expression of a specific gene that may be
overexpressed in a disease condition. RXi developed a robust
RNAi therapeutic platform, including self-delivering RNA
(sd-rxRNA®) compounds, that have the ability to highly
selectively block the expression of any target in the genome, thus
providing applicability to many therapeutic areas. Our current
programs include dermatology, ophthalmology, and cell-based
immunotherapy. RXi's extensive patent portfolio provides for
multiple product and business development opportunities across a
broad spectrum of therapeutic areas, and we actively pursue
research collaborations, partnering and out-licensing opportunities
with academia and pharmaceutical companies. For additional
information, visit the Company's website, www.rxipharma.com.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Such statements include, but are not limited to, statements
about: our ability to successfully develop RXI-109,
Samcyprone™, RXI-762, RXI-804 and our other product
candidates (collectively "our product candidates"); the future
success of our clinical trials with our product candidates; the
timing for the commencement and completion of clinical trials; our
ability to enter into strategic partnerships and the future success
of these strategic partnerships; and our ability to deploy our
sd-rxRNA® technology through partnerships, as well as
the prospects of these partnerships to provide positive returns.
Forward-looking statements about expectations and development plans
of RXi's product candidates and partnerships involve significant
risks and uncertainties, including the following: risks that we may
not be able to successfully develop and commercialize our product
candidates; risks that product development and clinical studies may
be delayed, not proceed as planned and/or be subject to significant
cost over-runs; risks related to the development and
commercialization of products by competitors; risks related to our
ability to control the timing and terms of collaborations with
third parties; and risks that other companies or organizations may
assert patent rights preventing us from developing or
commercializing our product candidates. Additional risks are
detailed in our most recent Annual Report on Form 10-K and
subsequent Quarterly Reports on Form 10-Q under the caption "Risk
Factors." Readers are urged to review these risk factors and
to not act in reliance on any forward-looking statements, as actual
results may differ from those contemplated by our forward-looking
statements. RXi does not undertake to update forward-looking
statements to reflect a change in its views, events or
circumstances that occur after the date of this release.
Contact
RXi Pharmaceuticals Corporation
Tamara McGrillen
508-929-3646
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SOURCE RXi Pharmaceuticals Corporation