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8-K - FORM 8-K - SELLAS Life Sciences Group, Inc. | b85913e8vk.htm |
EX-10.3 - EX-10.3 - SELLAS Life Sciences Group, Inc. | b85913exv10w3.htm |
EX-10.2 - EX-10.2 - SELLAS Life Sciences Group, Inc. | b85913exv10w2.htm |
EX-10.1 - EX-10.1 - SELLAS Life Sciences Group, Inc. | b85913exv10w1.htm |
Exhibit 99.1
RXi Pharmaceuticals Aggressively Moves into Late-Stage Clinical Development with the Agreement to Acquire Apthera, Inc.
NeuVax(TM) is slated to commence Phase III clinical trials in low-to-intermediate HER2+ breast cancer patients, not eligible for Herceptin(R), in 1H 2012
RXis first RNAi product candidate, RXI-109 which targets CTGF (connective tissue growth factor), scheduled to commence human clinical trials in anti-scarring in early 2012
WORCESTER, Mass., Mar 31, 2011 (BUSINESS WIRE) RXi Pharmaceuticals
Corporation (Nasdaq: RXII), a recognized leader in RNAi-based therapeutic
discovery and development, and Apthera, Inc., a private biotechnology company
developing a pipeline of peptide-based immunotherapies for the adjuvant
treatment of HER2-positive breast and other cancers, announced today the
signing of a definitive merger agreement under which RXi will acquire Apthera.
The acquisition provides RXi with a late stage product candidate,
NeuVax(TM), a
peptide-based immunotherapy for low-to-intermediate HER2+ breast cancer, not
eligible for Herceptin(R), which is expected to enter Phase III clinical trials
in the first half of 2012. The Companys first RNAi product, RXI-109 for
anti-scarring, remains on track for an investigational new drug (IND)
application filing this year.
Under the terms of the agreement, Apthera shareholders will initially receive
approximately 4.8 million shares of RXis common stock. Aptheras stockholders
will also be entitled to contingent payments based on the achievement of
certain development and commercial milestones relating to
Aptheras NeuVax(TM)
product candidate.
In connection with the acquisition, Mark J. Ahn, PhD, currently a member of
RXis Board of Directors, will succeed Noah D. Beerman as President and Chief
Executive Officer of RXi and will lead the combined company, which will operate
out of RXis current headquarters. Mark Ahn brings significant experience and
leadership in developing and commercializing major oncology and immunology
therapeutics, said Sanford Hillsberg, RXis Chairman of the Board. We want to
thank Noah Beerman for his excellent service as RXis President and Chief
Executive Officer during our transition from a research to a product oriented
company. We are delighted that Noah will be assisting us in the coming months
as a consultant to the Company and wish him well in his future endeavors.
Dr. Ahn, 48, has over 20 years of experience in the biopharmaceutical industry.
He most recently served as Principal at Pukana Partners, Ltd., which provides
strategic consulting to life science companies; and academic positions at the
Atkinson Graduate School of Management, Willamette University and Chair,
Science & Technology Management, Victoria University at Wellington, New
Zealand. Dr. Ahn was also the founder, President, and Chief Executive Officer
of Hana Biosciences. Prior to Hana, he served as Vice President, Hematology and
corporate officer at Genentech, Inc., as well as having held senior corporate
positions at Amgen and Bristol-Myers Squibb Company. Dr. Ahn has also served on
multiple public and venture capital-backed boards of directors.
The RXi-Apthera merger represents an exciting turning point in which we are
advancing from being a technology platform company to a late stage product
development company aimed at blockbuster therapeutic markets. Acquiring
Aptheras cancer vaccine product candidates builds upon the promising RNAi
based pre-clinical work related to cancer vaccines that we have recently been
doing at RXi, stated Mark Ahn, President & CEO. With this successful
transition we have streamlined our operations, integrated the RXi and Apthera
management teams, and reduced our early stage RNAi research and development
activities that will free up financial and other resources as part of focusing
our sights on bringing our first RNAi product to commence human clinical trials
in anti-scarring in early 2012. We are also initiating NeuVax into a Phase III
clinical trial in breast cancer, which is targeted for the first half of 2012.
I believe the combination of Aptheras late stage breast cancer candidate and
RXis experience will accelerate the progress of NeuVax into the clinic stated
Dr. Mark W. Schwartz, President and CEO of Apthera, who will become the
Executive Vice President and Chief Operating Officer of RXi following the
merger. The combined companies will accelerate the development of the compound
for the benefit of patients and physicians in treating this significant
disease.
About NeuVax
Discovered at and licensed from the M.D. Anderson Cancer Center, NeuVax
consists of the E75 peptide derived from HER2 combined with the immune adjuvant
granulocyte macrophage colony stimulating factor (GM-CSF). Treatment with
NeuVax stimulates cytotoxic (CD8+) T cells in a highly specific manner to
target cells expressing any level of HER2. NeuVax is given as an intradermal
injection once a month for six months, followed by a booster injection once
every six months. Based on a successful Phase II trial, which achieved its
primary endpoint of disease free survival (DFS), the Food and Drug
Administration (FDA) granted NeuVax a Special Protocol Assessment (SPA) for a
Phase III clinical trial in adjuvant therapy of women with low-to-intermediate
HER2+ status.
According to the National Cancer Institute, over 200,000 women are diagnosed
with breast cancer annually in the US alone in 2010. Of these women, about 75%
test positive for Human Epidermal growth factor Receptor 2 (IHC 1+, 2+ or 3+).
Only 25% of all breast cancer patients, those with HER2 3+ breast cancer
patients are eligible for Herceptin(R) (trastuzumab; Roche-Genentech) which had
revenues of over $5 billion in 2010. NeuVax targets the remaining 50% of HER2
positive patients, those who are HER2+ patients (HER2 1+ and 2+), who achieve
remission with current standard of care, but have no available HER2 targeted
adjuvant treatment options to maintain their disease free status.
About RXI-109
RXi Pharmaceuticals has initiated development of clinical candidate RXI-109, a
self-delivering RNAi compound (sd-rxRNA) for the reduction of dermal scarring
in planned surgeries. RXI-109 is designed to reduce the expression of CTGF
(connective tissue growth factor) a critical regulator of several biological
pathways involved in fibrosis, including scar formation in the skin. RXi is
beginning manufacturing activities with an experienced cGMP oligonucleotide
manufacturer to support its IND enabling toxicology program, and is preparing a
pre-IND package for submission to the FDA. Pending FDA review, the company
intends to use an innovative clinical trial design to study safety and
tolerability as well as initial efficacy in its first clinical trial targeted
for 2012.
About RXi Pharmaceuticals Corporation
RXi Pharmaceuticals is a recognized leader in RNAi-based therapeutic discovery
and development with a comprehensive therapeutic platform that includes both
RNA interference (RNAi) compounds and delivery methods. The company is
leveraging this broad and integrated RNAi therapeutic platform to build a
pipeline of RNAi therapeutics for the treatment of a number of disease areas,
including its core focus of developing treatments for anti-scarring and retinal
disorders as well as a continued interest in oncology and indications
accessible by spinal cord delivery. RXi Pharmaceuticals believes it is well
positioned to compete successfully in the RNAi therapeutics market based on the
strength of its next generation therapeutic platform, experienced management
team, accomplished Scientific Advisory Board, including Nobel Laureate, Dr.
Craig Mello, and its broad intellectual property position in RNAi chemistry and
delivery. For more information, visit www.rxipharma.com.
About Apthera, Inc.
Apthera, Inc. is a private biotechnology company founded in July 2005 to
develop and commercialize a pipeline of peptide-based immunotherapies for the
adjuvant treatment of HER2-positive cancers. Currently, Apthera has products in
clinical trials, all of which are aimed at reducing disease recurrence rates
for breast and prostate cancers. For more information, visit
www.apthera.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 the timing and completion of the
Apthera merger, future expectations, plan and future development of RXi
Pharmaceutical Corporations and Aptheras products and technologies. These
forward-looking statements about future expectations, plans and prospects of
the development of RXi Pharmaceutical Corporations and Aptheras products and
technologies involve significant risks, uncertainties and assumptions,
including the risk that the development of NeuVax or our RNAi-based
therapeutics may be delayed or may not proceed as planned and we may not be
able to complete development of any RNAi-based product, the risk that the
reduction in our early stage RNAi research and development activities may
adversely affect our ability to effectively develop our RNAi technologies, to
develop existing or new RNAi product candidates or to enter into or effectively
continue collaborations or strategic alliances in this field, the risk that the
FDA approval process may be delayed for any drugs that we develop, risks
related to development and commercialization of products by our competitors,
risks related to our ability to control the timing and terms of collaborations
with third parties and the possibility that other companies or organizations
may assert patent rights that prevent us from developing our products. Actual
results may differ materially from those RXi Pharmaceuticals Corporation
contemplated by these forward-looking statements. RXi Pharmaceuticals
Corporation does not undertake to update any of these forward-looking
statements to reflect a change in its views or events or circumstances that
occur after the date of this release.
CONTACT:
RXi Pharmaceuticals
Tamara McGrillen, 508-929-3605
ir@rxipharma.com
RXi Pharmaceuticals
Tamara McGrillen, 508-929-3605
ir@rxipharma.com
or
Investors
S. A. Noonan Communications
Susan Noonan, 212-966-3650
susan@sanoonan.com
S. A. Noonan Communications
Susan Noonan, 212-966-3650
susan@sanoonan.com
or
Media
Rx Communications Group
Eric Goldman, 917-322-2563
egoldman@rxir.com
Rx Communications Group
Eric Goldman, 917-322-2563
egoldman@rxir.com