Finch Therapeutics Announces Takeda to Accelerate Leadership Role in FIN-524 Ulcerative Colitis Development Program
August 10 2021 - 7:00AM
Finch Therapeutics Group, Inc. (“Finch” or “Finch Therapeutics”)
(Nasdaq: FNCH), a clinical-stage microbiome therapeutics company
leveraging its Human-First Discovery® platform to develop a novel
class of orally administered biological drugs, today announced that
Takeda Pharmaceutical Company Limited (“Takeda”) has elected to
accelerate the transition of development responsibility for the
FIN-524 ulcerative colitis development program. Takeda will assume
primary development responsibility for the program, now known as
TAK-524, ahead of the planned initiation of clinical-stage
development. The transition will enable Takeda to leverage its
expertise in inflammatory bowel disease (IBD) throughout the
clinical development of FIN-524/TAK-524.
“Microbiome research is an important pillar of our drug
discovery strategy as we continue to invest in novel approaches to
treat chronic GI disorders,” said Gareth Hicks, PhD, Vice President
& Head of Gastroenterology Drug Discovery Unit at Takeda.
“Through our successful collaboration with our expert partners
Finch, TAK-524 is now poised to become Takeda’s third
clinical-stage program leveraging state-of-the-art approaches to
intervene in the gut microbiome for the treatment of GI
disease.”
“We are thrilled that Takeda, a global leader in the treatment
of IBD, has opted to accelerate its role in advancing TAK-524 for
ulcerative colitis. We believe that Takeda's leadership and
experience in IBD will be a critical asset for the program as
Takeda prepares to advance TAK-524 into clinical development,” said
Mark Smith, PhD, Chief Executive Officer of Finch Therapeutics. “We
look forward to continuing our collaboration with Takeda to support
the TAK-524 program along with our joint discovery work in Crohn’s
disease, while we continue to advance other exciting programs in
our pipeline.”
FIN-524/TAK-524 is an investigational, orally administered
targeted consortia product candidate composed of both spore-forming
and non-spore-forming bacterial strains selected for the treatment
of ulcerative colitis. FIN-524/TAK-524 is designed to treat
ulcerative colitis by harnessing the gut microbiome’s ability to
modulate the host immune system.
About the Collaboration and License
Agreement
In 2017, Finch entered into a worldwide collaboration agreement
with Takeda to jointly develop FIN-524/TAK-524 for the treatment of
inflammatory bowel disease. Under the terms of the agreement, Finch
received an upfront payment of $10 million from Takeda for the
exclusive worldwide rights to develop and commercialize
FIN-524/TAK-524. Finch has received $4 million in milestone
payments to date for FIN-524/TAK-524 and is eligible to receive up
to an additional $176 million in payments upon achievement of
certain development, regulatory, and commercial milestones, as well
as tiered royalties ranging from mid to high-single digits on
worldwide net sales of FIN-524/TAK-524. Under the terms of the
original agreement, Finch was primarily responsible for early-stage
development activities through Phase 2 clinical trials. Under the
terms of an amended agreement executed in August 2021, Takeda will
assume primary development responsibility for FIN-524/TAK-524 prior
to the start of clinical-stage development. After the transition,
Finch plans to provide Takeda with ongoing technical support
through the anticipated Phase 1 trial of FIN-524/TAK-524 in
ulcerative colitis.
About FIN-524/TAK-524 for Ulcerative
Colitis
FIN-524/TAK-524 is an investigational, orally administered
targeted consortia product candidate composed of both spore-forming
and non-spore-forming bacterial strains selected for the treatment
of ulcerative colitis. The consortia is designed to include strains
that target multiple defined mechanisms of action combined with
donor strains linked to remission following fecal microbiota
transplantation (FMT) in patients with ulcerative colitis. The
design of FIN-524/TAK-524 leverages Finch’s machine-learning based
platform and data from FMT studies in ulcerative colitis. Machine
learning was used to identify microbes and microbial functions
deficient in patients with ulcerative colitis. Human FMT data was
leveraged to identify organisms consistently enriched in ulcerative
colitis patients that successfully responded to FMT. Target
organisms were isolated directly from the specific donors whose
samples induced response or remission in clinical studies of FMT
for ulcerative colitis. The manufacture of FIN-524/TAK-524 is donor
independent, with the strains grown from master cell banks.
About Ulcerative Colitis
Ulcerative colitis is one of the most common types of
inflammatory bowel disease (IBD), an autoimmune condition that
causes inflammation of the gastrointestinal (GI) tract.
Approximately 10 million people are affected by IBD worldwide,
including about three million people in the US. Symptoms of IBD
include severe, chronic abdominal pain, diarrhea, GI bleeding,
weight loss, and fatigue. Current treatment options are ineffective
for many people with IBD.
About Finch Therapeutics
Finch Therapeutics is a clinical-stage microbiome therapeutics
company leveraging its Human-First Discovery® platform to develop a
novel class of orally administered biological drugs. With the
capabilities to develop both complete and targeted microbiome
therapeutics, Finch is advancing a rich pipeline of candidates
designed to address a wide range of unmet medical needs. Finch’s
lead candidate, CP101, is in late-stage clinical development for
the prevention of recurrent C. difficile infection (CDI), and has
received Breakthrough Therapy and Fast Track designations from the
U.S. Food and Drug Administration. In June 2020, Finch announced
that CP101 met its primary efficacy endpoint in PRISM3, the first
of two pivotal trials to support the development of CP101 for the
prevention of recurrent CDI. PRISM4, a Phase 3 trial, is designed
to serve as the second pivotal trial of CP101 for recurrent CDI.
Finch is also developing CP101 for the treatment of chronic
hepatitis B virus, and FIN-211 for the treatment of the
gastrointestinal and behavioral symptoms of autism spectrum
disorder. Finch has a partnership with Takeda focused on the
development of targeted microbiome therapeutics for inflammatory
bowel disease.
Forward-Looking Statements
Statements contained in this press release regarding matters
that are not historical facts are “forward-looking statements”
within the meaning of the Private Securities Litigation Reform Act
of 1995, as amended. Words such as "anticipates," "believes,"
"expects," "intends," “plans,” “potential,” "projects,” “would” and
"future" or similar expressions are intended to identify
forward-looking statements. These forward-looking statements
include, but are not limited to, statements regarding: Finch’s
ability to advance the development of a novel class of
therapeutics, including with respect to FIN-524/TAK-524; the
therapeutic value and development of FIN-524/TAK-524 for the
treatment of ulcerative colitis, including Takeda’s ability and
timing to initiate clinical trials; the results of the
Collaboration and License Agreement; Finch’s pipeline and ability
to develop additional product candidates; and the initiation and
timing of Finch’s clinical trials. Because such statements are
subject to risks and uncertainties, actual results may differ
materially from those expressed or implied by such forward-looking
statements. These risks and uncertainties include, among others:
Finch’s limited operating history and historical losses; Finch’s
ability to raise additional funding to complete the development and
any commercialization of its product candidates; Finch’s dependence
on the success of its lead product candidate, CP101; the
possibility that Finch or Takeda may be delayed in initiating,
enrolling or completing any clinical trials; results of clinical
trials may not be sufficient to satisfy regulatory authorities to
approve product candidates in their targeted or other indications
(or such authorities may request additional trials or additional
information); results of clinical trials may not be indicative of
final or future results from later stage or larger clinical trials
(or in broader patient populations once the product is approved for
use by regulatory agencies) or may not be favorable or may not
support further development; Finch’s product candidates, including
FIN-524/TAK-524, may not generate the benefits to patients that are
anticipated; anticipated regulatory approvals may be delayed or
refused; competition from third parties that are developing
products for similar uses; Finch and Takeda’s ability to maintain
patent and other intellectual property protection and the
possibility that Finch or Takeda’s intellectual property rights may
be infringed, invalid or unenforceable or will be threatened by
third parties; Finch’s ability to qualify and scale its
manufacturing capabilities in anticipation of commencement of
multiple global clinical trials; Finch’s lack of experience in
selling, marketing and distributing its product candidates; Finch’s
dependence on third parties in connection with manufacturing,
clinical trials and preclinical studies; and risks relating to the
impact and duration of the COVID-19 pandemic on Finch’s business.
These and other risks are described more fully in Finch’s filings
with the Securities and Exchange Commission (“SEC”), including the
section titled “Risk Factors” in Finch’s Quarterly Report on Form
10-Q filed with the SEC on May 13, 2021, as well as discussions of
potential risks, uncertainties, and other important factors in
Finch’s other filings with the SEC. All forward-looking statements
contained in this press release speak only as of the date on which
they were made. Except to the extent required by law, Finch
undertakes no obligation to update such statements to reflect
events that occur or circumstances that exist after the date on
which they were made.
Human-First Discovery® is a registered trademark of Finch
Therapeutics Group, Inc.
Media Contact:Jenna UrbanBerry & Company
Public Relationsjurban@berrypr.com212-253-8881
Investor Contact:Laurence WattsGilmartin
Group(619) 916-7620laurence@gilmartinir.com
or
Stephen JasperGilmartin Group(858) 525
2047stephen@gilmartinir.com
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