Rezolute, Inc.
(“Rezolute” or the “Company”) (OTCQB:ANTB), a
clinical stage biopharmaceutical company specializing in the
development of innovative drug therapies for metabolic and orphan
diseases, and
XOMA Corporation
(“XOMA”) (NASDAQ:XOMA), a pioneer in the
discovery, development and licensing of therapeutic antibodies,
announced today that they have executed a license agreement that
provides Rezolute with the exclusive global rights to develop and
commercialize RZ358 (formerly XOMA 358) for Congenital
Hyperinsulinism (CHI), an ultra-orphan indication.
RZ358 is a first-in-class fully human monoclonal antibody that
counteracts the effects of elevated insulin via allosteric
modulation of the insulin receptor, making it well-suited as a
therapy for severe, persistent hypoglycemia caused by
hyperinsulinemic conditions such as CHI. XOMA demonstrated clinical
proof-of-concept through Phase 2a studies and Rezolute plans to
advance clinical development in 2018. The compound has received
designated orphan status in the US and European Union.
“We are excited about the addition of RZ358 to our growing
product pipeline and for the opportunity to take a Phase 2 program
forward with the hope of being able to offer a significantly better
treatment option for a disease that is the most frequent cause of
severe, persistent hypoglycemia in newborn babies and children,”
said Nevan Elam, Chairman and Chief Executive Officer of Rezolute.
“XOMA has generated compelling safety data and proof-of-concept for
RZ358 and we look forward to advancing its development.”
Under the terms of the agreement, Rezolute will assume the
global development, regulatory filings, manufacturing and
commercialization for RZ358. In turn, XOMA will receive a total of
$18 million in the form of cash and shares of Rezolute common stock
and will be eligible to receive up to an aggregate of $222 million
in clinical, regulatory and sales milestones. In addition, XOMA is
entitled to receive royalties ranging from the high single digits
to the mid-teens based upon annual net sales of RZ358. Finally,
under the terms of the agreement, Rezolute will pay XOMA low single
digit royalties on sales of the company’s other products.
“Having established proof-of-concept for XOMA 358 earlier this
year, we now look forward to Rezolute continuing the clinical
development of the program,” stated Jim Neal, Chief Executive
Officer of XOMA. “Our license agreement with Rezolute places this
important drug asset in the hands of a very capable
endocrine-focused team, provides XOMA with the potential to receive
future milestones and royalties, and is an important milestone in
the continued transformation of our programs to fully-funded
status. We welcome Rezolute to our broad portfolio of partners,
including Novartis, Five Prime and NanoTherapeutics, who continue
the development of our product candidates.”
CHI is a rare genetic disorder that affects one in 50,000
newborns. Ordinarily, beta cells in the pancreas secrete just
enough insulin to keep blood sugar in the normal range. With CHI,
the secretion of insulin is not properly regulated as the beta
cells secrete too much insulin resulting in excessive low blood
sugar (severe hypoglycemia). In infants and young children, these
episodes are characterized by lethargy, irritability and difficulty
feeding. Repeated episodes of hypoglycemia increase the risk of
serious complications such as breathing difficulties, seizures,
developmental delays and intellectual disability, vision loss,
brain damage, coma and possibly death. CHI is the most common cause
of persistent hypoglycemia in children and about 60 percent of
infants with CHI experience a hypoglycemic episode within the first
month of life. Other affected children develop hypoglycemia by
early childhood. A significant number of patients cannot be
adequately treated with or do not tolerate existing medical
therapies. Surgical removal of all or part of the pancreas is a
cornerstone of management for many patients, but is invasive and
diabetes-inducing.
The Company’s new name reflects its transition as a developer of
potentially paradigm-shifting therapies for treating metabolic
diseases and orphan indications with high unmet medical needs.
Under this strategy, the Company also exclusively licensed
ActiveSite Pharmaceuticals’ oral plasma kallikrein inhibitor (PKI)
portfolio in August and is developing RZ402 for Diabetic Macular
Edema and RZ602 for Hereditary Angioedema, an orphan
indication.
“The name change conveys our dedication to identifying and
developing therapies that are transformative and target well-known
genetic pathways and mechanisms,” stated Mr. Elam. With the recent
licensing agreements executed with XOMA Corporation for a
monoclonal antibody to treat CHI, an ultra-orphan indication, and
ActiveSite Pharmaceuticals for our oral PKI portfolio, we have
evolved into a company advancing a robust pipeline of innovative
solutions for patients and providers.”
About Rezolute, Inc. Rezolute is a clinical
stage biopharmaceutical company specializing in the development of
innovative drug therapies to improve the lives of patients with
metabolic and orphan diseases. Rezolute is advancing a diversified
pipeline including: RZ358 (Phase 2), an antibody for the
ultra-orphan indication of Congenital HyperInsulinism (CHI), with
an abbreviated path-to-market strategy; AB101 (Phase 1), a
once-weekly injectable basal insulin with the potential to
transform the treatment landscape in diabetes management by
reducing the therapeutic burden for patients and improving
compliance; and a Plasma Kallikrein Inhibitor (PKI) portfolio with
two lead compounds, RZ402 (plan to file IND in H2 2018) targeting
Diabetic Macular Edema (DME) and RZ602 (plan to file IND in H1
2019) targeting Hereditary Angioedema (HAE), an orphan indication.
For more information, visit: www.rezolutebio.com.
About XOMA CorporationXOMA has an extensive
portfolio of products, programs, and technologies that are the
subject of licenses the Company has in place with other biotech and
pharmaceutical companies. Many of these licenses are the result of
the Company's pioneering efforts in the discovery and development
of antibody therapeutics. There are more than two dozen such
programs that are fully funded by partners and could produce
milestone payments and royalty payments in the future. For more
information, visit www.xoma.com.
Forward-Looking Statements This release, like
many written and oral communications presented by Rezolute, Inc.
and our authorized officers, may contain certain forward-looking
statements regarding our prospective performance and strategies
within the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. We intend such forward-looking statements to be covered by
the safe harbor provisions for forward-looking statements contained
in the Private Securities Litigation Reform Act of 1995, and are
including this statement for purposes of said safe harbor
provisions. Forward-looking statements, which are based on certain
assumptions and describe future plans, strategies, and expectations
of the Company, are generally identified by use of words such as
"anticipate," "believe," "estimate," "expect," "intend," "plan,"
"project," "seek," "strive," "try," or future or conditional verbs
such as "could," "may," "should," "will," "would," or similar
expressions. Our ability to predict results or the actual effects
of our plans or strategies is inherently uncertain. Accordingly,
actual results may differ materially from anticipated results.
Readers are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date of this
release. Except as required by applicable law or regulation,
Rezolute undertakes no obligation to update these forward-looking
statements to reflect events or circumstances that occur after the
date on which such statements were made.
Source: Rezolute, Inc.
Rezolute, Inc. Contact:
Noopur Liffick
VP of Corporate Development
(650) 549-4175
investor-relations@rezolutebio.com
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