FDA selects RayzeBio to Participate in the Inaugural CDRP Program to Expedite Commercial Manufacturing Readiness for RYZ101 in GEP-NETs
24 Outubro 2023 - 9:00AM
RayzeBio, Inc. (Nasdaq: RYZB), a targeted radiopharmaceutical
company developing an innovative pipeline against validated solid
tumor targets, today announced the FDA has selected RYZ101
(Actinium-225 DOTATATE) into the inaugural Chemistry,
Manufacturing, and Controls (CMC) Development and Readiness Pilot
(CDRP) program. The CDRP program was created by the FDA to
facilitate CMC readiness for selected therapies with accelerated
clinical development timeframes based on the anticipated clinical
benefits of earlier patient access to the therapy. Under the
program, the FDA will work closely with RayzeBio to facilitate CMC
development of RYZ101 for the treatment of somatostatin receptor
positive (SSTR+) gastroenteropancreatic neuroendocrine tumors
(GEP-NETs) that have progressed following prior Lutetium-177
labelled somatostatin analogue therapy.
“We are thrilled to collaborate with the FDA on this important
initiative,” said Eric Bischoff, SVP of Development and Operations
at RayzeBio. “Radiopharmaceuticals is an emerging modality and
requires a highly specialized manufacturing process. Our lead
program, RYZ101, has the potential to be the first approved
Actinium-225 based therapy. We look forward to working with the FDA
on ensuring the commercial manufacturing readiness for
RYZ101.”
“We applaud the FDA for undertaking this initiative to partner
with pioneers in emerging modalities. We are making significant
investments to ensure commercial readiness for RYZ101, including
building our own manufacturing facility in Indianapolis. RYZ101 has
already demonstrated encouraging preliminary response data and is
now enrolling in a registrational Phase 3 clinical trial. We are
eager to collaborate with the FDA as we aim to develop and bring
this important therapy to market,” said Ken Song, M.D., President
and CEO of RayzeBio.
About gastroenteropancreatic
neuroendocrine tumorsGastroenteropancreatic neuroendocrine
tumors (GEP-NETs) are rare tumors with an incidence of
approximately 18,000 patients annually in the United States. As
many GEP-NETs follow an indolent disease course, the
prevalence of GEP-NETs in the United States is
approximately 200,000 patients. SSTR2 is expressed
in 80-90% of GEP-NET tumors. Tumors can be
aggressive and resistant to therapy, with metastatic disease
present at diagnosis in 40-76% of cases. Lutathera is a
targeted radiopharmaceutical therapy comprised of a somatostatin
analog peptide labeled with the beta-emitting radioisotope
Lutetium-177 (Lu177), which received regulatory approval for
treatment of adult patients with SSTR+ GEP-NETs in Europe and the
United States in 2017 and 2018, respectively. However, most
patients who receive Lu177-based somatostatin therapies eventually
experience tumor progression and have limited subsequent treatment
options.
About RYZ101RYZ101 is an investigational
targeted radiopharmaceutical therapy, designed to deliver a highly
potent radioisotope, Actinium-225 (Ac225), to tumors expressing
SSTR2. RYZ101 is being evaluated in clinical studies for patients
with SSTR+ GEP-NETs who have previously been treated with
Lu177-based somatostatin therapies and also in patients with newly
diagnosed extensive stage small cell lung cancer. Details of the
studies can be found at
https://clinicaltrials.gov/ct2/show/NCT05477576 and
https://clinicaltrials.gov/ct2/show/NCT05595460.
Ac225 for the study was provided by multiple sources including
the U.S. Department of Energy Isotope Program.
About RayzeBioRayzeBio is building a vertically
integrated radiopharmaceutical therapeutics (RPT) company to treat
various cancers, with its lead program in a Phase 3 clinical trial.
RayzeBio has created a pipeline of multiple drug candidates in
therapeutic areas with significant market opportunities. Much like
antibody drug conjugates emerged as a new and transformative
treatment modality in certain cancers, the company sees an
opportunity for innovative radiopharmaceutical therapeutics to
follow a similar path. RayzeBio believes its strategic investments
in building a robust product pipeline, development capabilities,
and manufacturing infrastructure position the company to be an
industry-leading pioneer in the broad application of RPT for
cancer.
Forward-Looking StatementsThis press release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. Statements in
this press release that are not statements of historical fact are
forward-looking statements. Such forward-looking statements
include, without limitation, statements regarding the potential
benefits of RYZ101 based on preliminary response data, the
anticipated development timeline of RYZ101, the expected benefits
of the CDRP program, and the ability of RayzeBio to expedite
commercial manufacturing readiness for RYZ101. Words such as
“believe,” “anticipate,” “plan,” “expect,” “intend,” “will,” “may,”
“goal,” “potential” and similar expressions are intended to
identify forward-looking statements, though not all forward-looking
statements necessarily contain these identifying words. These
forward-looking statements are based on the beliefs of the
management of the company as well as assumptions made by and
information currently available to the company. Such statements
reflect the current views of the company with respect to future
events and are subject to known and unknown risks and
uncertainties, including business, regulatory, economic and
competitive risks and uncertainties about the company, including,
without limitation, risks inherent in developing drug candidates,
future results from the company’s ongoing and planned clinical
trials, the company’s ability to obtain adequate financing to fund
its planned clinical trials and other expenses, risks that future
clinical trial results may not be consistent with interim, initial
or preliminary results or results from prior preclinical studies or
clinical trials, trends in the industry, the legal and regulatory
framework for the industry and future expenditures. In light of
these risks and uncertainties, the events or circumstances referred
to in the forward-looking statements may not occur. The actual
results may vary from the anticipated results and the variations
may be material. Other factors that may cause the company’s actual
results to differ from current expectations are discussed in the
company’s filings with the Securities and Exchange Commission (the
“SEC”), including the section titled “Risk Factors” in the
company’s Registration Statement on Form S-1 filed with the SEC on
September 11, 2023. You are cautioned not to place undue reliance
on these forward-looking statements, which speak only as of the
date this press release is given. Except as required by law, the
company undertakes no obligation to publicly update any
forward-looking statements, whether as a result of new information,
future events or otherwise.
Contact: Arvind
KushEmail: info@rayzebio.com
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