Finch Therapeutics Regains Full Rights to FIN-524 and FIN-525 Targeted Microbiome Product Candidates in Development for IBD
25 Agosto 2022 - 10:30PM
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
it will regain full development and commercial rights to FIN-524
(previously known as TAK-524) and FIN-525 from Takeda
Pharmaceutical Company Limited (“Takeda”). Following a review of
its pipeline, Takeda informed Finch of its decision to terminate
its collaboration with Finch, effective November 17, 2022,
resulting in the return to Finch of worldwide rights to develop and
commercialize FIN-524, FIN-525, and any other microbiome product
candidates for inflammatory bowel disease (IBD). FIN-524 and
FIN-525 are investigational, orally administered targeted
microbiome product candidates composed of bacterial strains
selected for their potential immuno-modulatory properties.
“We are grateful for Takeda’s substantial
investment in the FIN-524 and FIN-525 programs and want to thank
our dedicated colleagues at Takeda who have worked alongside us to
develop these innovative product candidates. We look forward to
exploring collaboration opportunities to continue the advancement
of these assets, which we believe hold the potential to fulfill the
need for a disease-modifying, orally delivered, well-tolerated
therapy for IBD patients who are not well served by existing
options,” said Mark Smith, PhD, Chief Executive Officer of Finch
Therapeutics. “We are currently conducting a review of our
portfolio and assessing the financial and strategic impact of the
discontinuation of our collaboration with Takeda.”
Finch has received more than $44 million from
Takeda during the course of the collaboration, including an upfront
payment of $10 million, $4 million in milestone payments, and more
than $30 million in reimbursement of research and development
expenses. Upon termination, Finch will receive a royalty-free
license to all data and intellectual property generated during the
collaboration, including full rights to a large library of
characterized bacterial isolates, data from multiple ex vivo and in
vivo studies, a suite of pharmacokinetic and pharmacodynamic
assays, and a significant body of chemistry, manufacturing, and
controls (CMC) data generated during the investigational new drug
(IND)-enabling phase of development.
About FIN-524 & FIN-525 for
Inflammatory Bowel Disease
FIN-524 and FIN-525 are investigational, orally
administered targeted consortia product candidates composed of both
spore-forming and non-spore-forming bacterial strains selected for
the treatment of ulcerative colitis and Crohn’s disease,
respectively. The product candidates are designed to include
strains that target multiple mechanisms of action combined with
donor strains linked to remission following microbiota
transplantation in patients with inflammatory bowel disease (IBD).
The design of FIN-524 and FIN-525 leverage Finch’s machine-learning
based platform and data from microbiota transplantation studies in
patients with IBD. The manufacture of FIN-524 and FIN-525 is donor
independent, with the strains grown from master cell banks.
About Inflammatory Bowel
Disease
Ulcerative colitis and Crohn’s disease are the two
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 approximately three million
people in the U.S. Symptoms of IBD include severe, chronic
abdominal pain, diarrhea, GI bleeding, weight loss, and fatigue.
Current treatment options are ineffective for many people living
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 has 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 and has received
Breakthrough Therapy and Fast Track designations from the U.S. Food
and Drug Administration. Finch’s pipeline also includes FIN-211 for
children with autism spectrum disorder and significant
gastrointestinal symptoms, FIN-524 for the treatment of ulcerative
colitis, and FIN-525 for the treatment of Crohn’s disease. Finch
routinely posts information that may be important to its investors
on its website at www.finchtherapeutics.com. Finch encourages
investors to consult the “Investors & News” section of its
website regularly.
Human-First Discovery® is a registered trademark
of Finch Therapeutics Group, Inc.
Forward-Looking Statements
This press release includes “forward-looking
statements.” Words such as “will,” "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: the
potential and future development of the FIN-524 and FIN-525
programs and the Company’s other product candidates, the potential
for collaboration opportunities to continue the advancement of
these programs; the financial and strategic impact of termination
of Finch’s collaboration with Takeda; and Finch’s ability to
develop a novel class of orally administered biological drugs.
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, those related to: 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 and the potential
impact of termination of Finch's collaboration with Takeda on such
funding requirements and Finch's ability to obtain funding; Finch’s
dependence on the success of its lead product candidate, CP101; the
possibility that Finch may be delayed in initiating, enrolling or
completing any clinical trials; 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
may not generate the benefits to patients that are anticipated;
results of clinical trials may not be sufficient to satisfy
regulatory authorities to approve Finch’s product candidates in
their targeted or other indications (or such authorities may
request additional trials or additional information); Finch’s
ability to comply with regulatory requirements; ongoing regulatory
obligations and continued regulatory review may result in
significant additional expense to Finch and Finch may be subject to
penalties for failure to comply; competition from third parties
that are developing products for similar uses; Finch’s ability to
maintain patent and other intellectual property protection and the
possibility that Finch’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 Annual Report on Form 10-K for the year ended
December 31, 2021 filed with the SEC on March 31, 2022, as
supplemented by Finch’s Quarterly Reports on Form 10-Q filed with
the SEC on May 16, 2022 and August 11, 2022, 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.
Investor Contact:
Stephen Jasper Gilmartin Group (858) 525-2047
stephen@gilmartinir.com
Media Contact:
Jenna Urban Berry & Company Public Relations
(212) 253-8881 jurban@berrypr.com
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