Roivant Sciences (Nasdaq: ROIV) and Pfizer Inc. (NYSE: PFE) today
announced formation of a new Vant to develop and commercialize
PF-06480605 (now RVT-3101). RVT-3101 is a fully human monoclonal
antibody targeting TL1A, which is currently in Phase 2b development
in ulcerative colitis (UC). The Vant has the exclusive option to
collaborate with Pfizer on a next-generation TL1A directed antibody
which recently entered Phase 1.
RVT-3101 is a potential first-in-class agent
that targets both inflammatory and fibrotic pathways by inhibiting
TL1A, which has been shown to modulate the location and severity of
inflammation and fibrosis by stimulating TH1 and TH17 pathways, in
addition to activating fibroblasts. As such, RVT-3101 has the
potential to provide greater efficacy by hitting multiple
inflammatory pathways as well as fibrotic pathways.
RVT-3101 has been evaluated in an earlier Phase
2 study (TUSCANY) in 50 patients, and is being evaluated in a large
global Phase 2b study (TUSCANY-2) in 245 adult participants with
moderate to severe ulcerative colitis. The induction portion of
TUSCANY-2 is complete, and the maintenance portion remains
ongoing.
“Our internally discovered antibody against
TL1A, could potentially be the first agent to bring
biomarker-selected precision medicine to people living with
inflammatory bowel disease,” said Mikael Dolsten, Pfizer’s Chief
Scientific Officer, President, Worldwide Research, Development and
Medical. “We are very excited about the preliminary data from
the TUSCANY-2 study and for this new Vant to drive the advancement
of this asset. At the same time, it enables Pfizer to bring
additional innovative breakthrough medicines and vaccines to
patients in need more quickly, allowing us to serve more
people.”
“We believe in RVT-3101’s potential to transform
the inflammatory bowel disease landscape, which has long been in
need of new, innovative therapies with greater efficacy,” said
Mayukh Sukhatme, President and Chief Investment Officer of Roivant.
“We are excited about this collaboration with Pfizer on a potential
first-in-class program, which we intend to pursue in both
ulcerative colitis and in additional inflammatory and fibrotic
diseases. TUSCANY-2 builds on the earlier TUSCANY data with many
firsts for the class – TUSCANY-2 is the first study with
subcutaneous efficacy data and the first dose-ranging study – and
is among the largest Phase 2b studies ever conducted in the
indication. We are encouraged by the preliminary data and look
forward to presenting our data and to seeing other results from the
class.”
Inflammatory bowel diseases are chronic
inflammatory diseases of the gastrointestinal tract. It is
estimated that up to 2 million US adults suffer from inflammatory
bowel diseases, which include ulcerative colitis and Crohn’s
disease. There is significant unmet treatment need for patients
with inflammatory bowel disease. High rates of treatment failure
mean that approximately 50% of patients are cycling off a given
therapy within 6 to 12 months and are unlikely to achieve sustained
remission. The commercial markets for these diseases for advanced
therapies is nearly $15 billion per year in the US alone and
growing. Available treatments have very low remission rates, and
thus there is a large need for an efficacious and safe therapy.
Terms of
Collaboration
A new Vant or Roivant subsidiary has been
created to develop and fund these programs. The Vant will be fully
responsible for funding global development of RVT-3101 in UC and in
additional inflammatory and fibrotic diseases and holds commercial
rights in the US and Japan. Pfizer owns a 25% equity position in
the Vant and maintains commercial rights outside of the US and
Japan as well as representation on the company’s Board of
Directors.
In addition, the Vant has the exclusive option
to collaborate with Pfizer on a next-generation TL1A directed
antibody which recently entered Phase 1. The Vant will have the
right to enter into an agreement for global development with a
50/50 cost share as well as co-commercialization rights with Pfizer
prior to Phase 2 (expected in 2025).
About Roivant Sciences
Roivant's mission is to improve the delivery of healthcare to
patients by treating every inefficiency as an opportunity. Roivant
develops transformative medicines faster by building technologies
and developing talent in creative ways, leveraging the Roivant
platform to launch Vants – nimble and focused biopharmaceutical and
health technology companies. For more information, please
visit www.roivant.com.
About Pfizer: Breakthroughs That Change Patients’
Lives
At Pfizer, we apply science and our global resources to bring
therapies to people that extend and significantly improve their
lives. We strive to set the standard for quality, safety and value
in the discovery, development and manufacture of health care
products, including innovative medicines and vaccines. Every day,
Pfizer colleagues work across developed and emerging markets to
advance wellness, prevention, treatments and cures that challenge
the most feared diseases of our time. Consistent with our
responsibility as one of the world’s premier innovative
biopharmaceutical companies, we collaborate with health care
providers, governments and local communities to support and expand
access to reliable, affordable health care around the world. For
more than 170 years, we have worked to make a difference for all
who rely on us. We routinely post information that may be important
to investors on our website at www.Pfizer.com. In addition, to
learn more, please visit us on www.Pfizer.com and follow us on
Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us
on Facebook at Facebook.com/Pfizer.
Roivant Sciences Forward-Looking
Statements
This press release contains forward-looking statements.
Statements in this press release may include statements that are
not historical facts and are considered forward-looking within the
meaning of Section 27A of the Securities Act of 1933, as amended
(the “Securities Act”), and Section 21E of the Securities Exchange
Act of 1934, as amended (the “Exchange Act”), which are usually
identified by the use of words such as “anticipate,” “believe,”
“continue,” “could,” “estimate,” “expect,” “intends,” “may,”
“might,” “plan,” “possible,” “potential,” “predict,” “project,”
“should,” “would” and variations of such words or similar
expressions. The words may identify forward-looking statements, but
the absence of these words does not mean that a statement is not
forward-looking. We intend these forward-looking statements to be
covered by the safe harbor provisions for forward-looking
statements contained in Section 27A of the Securities Act and
Section 21E of the Exchange Act.
Our forward-looking statements include, but are not limited to,
statements regarding our or our management team’s expectations,
hopes, beliefs, intentions or strategies regarding the future, and
statements that are not historical facts, including statements
about the clinical and therapeutic potential of our products and
product candidates, the availability and success of topline results
from our ongoing clinical trials and any commercial potential of
our products and product candidates. In addition, any statements
that refer to projections, forecasts or other characterizations of
future events or circumstances, including any underlying
assumptions, are forward-looking statements.
Although we believe that our plans, intentions, expectations and
strategies as reflected in or suggested by those forward-looking
statements are reasonable, we can give no assurance that the plans,
intentions, expectations or strategies will be attained or
achieved. Furthermore, actual results may differ materially from
those described in the forward-looking statements and will be
affected by a number of risks, uncertainties and assumptions,
including, but not limited to, those risks set forth in the Risk
Factors section of our filings with the U.S. Securities and
Exchange Commission. Moreover, we operate in a very competitive and
rapidly changing environment in which new risks emerge from time to
time. These forward-looking statements are based upon the current
expectations and beliefs of our management as of the date of this
press release, and are subject to certain risks and uncertainties
that could cause actual results to differ materially from those
described in the forward-looking statements. Except as required by
applicable law, we assume no obligation to update publicly any
forward-looking statements, whether as a result of new information,
future events or otherwise.
Pfizer Disclosure
Notice
The information contained in this release is as
of December 1, 2022. Pfizer assumes no obligation to update
forward-looking statements contained in this release as the result
of new information or future events or developments.
This release contains forward-looking
information about, among other things, PF-06480605 (now RVT-3101),
an additional antibody asset and a collaboration between Pfizer and
Roivant and a new biopharmaceutical company, including their
potential benefits, that involves substantial risks and
uncertainties that could cause actual results to differ materially
from those expressed or implied by such statements. Risks and
uncertainties include, among other things, the uncertainties
inherent in research and development, including the ability to meet
anticipated clinical endpoints, commencement and/or completion
dates for clinical trials, regulatory submission dates, regulatory
approval dates and/or launch dates, as well as the possibility of
unfavorable new clinical data and further analyses of existing
clinical data; the risk that clinical trial data are subject to
differing interpretations and assessments by regulatory
authorities; whether regulatory authorities will be satisfied with
the design of and results from the clinical studies; whether and
when any applications may be filed for any potential indications
for PF-06480605/RVT-3101 or the additional antibody asset in any
jurisdictions; whether and when regulatory authorities may approve
any such applications that may be filed for PF-06480605/RVT-3101 or
the additional antibody asset, which will depend on myriad factors,
including making a determination as to whether the product’s
benefits outweigh its known risks and determination of the
product’s efficacy and, if approved, whether PF-06480605/RVT-3101
or the additional antibody asset will be commercially successful;
decisions by regulatory authorities impacting labeling,
manufacturing processes, safety and/or other matters that could
affect the availability or commercial potential of
PF-06480605/RVT-3101 or the additional antibody asset; whether the
collaboration with Roivant will be successful; uncertainties
regarding the impact of COVID-19 on Pfizer’s business, operations
and financial results; and competitive developments.
A further description of risks and uncertainties
can be found in Pfizer’s Annual Report on Form 10-K for the fiscal
year ended December 31, 2021 and in its subsequent reports on Form
10-Q, including in the sections thereof captioned “Risk Factors”
and “Forward-Looking Information and Factors That May Affect Future
Results”, as well as in its subsequent reports on Form 8-K, all of
which are filed with the U.S. Securities and Exchange Commission
and available at www.sec.gov and www.pfizer.com.
Contact: Stephanie Lee
Stephanie.lee@roivant.com
Roivant Sciences (NASDAQ:ROIV)
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