Codiak Initiates Patient Dosing in Phase 1 Clinical Trial of exoASO™-STAT6 in Patients with Advanced Hepatocellular Carcinoma, Liver Metastases from Primary Gastric Cancer and Colorectal Cancer
29 Junho 2022 - 9:00AM
Codiak BioSciences, Inc. (NASDAQ: CDAK), a clinical-stage
biopharmaceutical company pioneering the development of
exosome-based therapeutics as a new class of medicines, today
announced the initiation of patient dosing in its Phase 1 clinical
trial of exoASO-STAT6, an engineered exosome precision medicine
candidate designed to selectively deliver antisense
oligonucleotides to disrupt STAT6 signaling in tumor associated
macrophages (TAMs) and induce an anti-tumor immune response.
exoASO-STAT6 is Codiak’s third clinical program and the first to
evaluate a systemically administered exosome-based drug candidate.
“Targeting macrophages is the next great frontier in cancer
immunotherapy and we are encouraged by the monotherapy anti-tumor
activity exhibited by exoASO-STAT6 in preclinical models, which has
not been observed among other approaches to date. We believe this
may indicate the potential to bring transformative treatments to
patients facing intractable forms of cancer,” said Douglas E.
Williams, Ph.D., CEO, Codiak. “The initiation of this trial is also
a significant milestone for our company, as the advancement of
exoASO-STAT6 into the clinic highlights the versatility of our
engineering platform. This candidate is the first of our programs
to target macrophages, the first to carry a nucleic acid and the
first to be administered intravenously.”
The Phase 1 clinical trial will evaluate the safety,
tolerability, biomarkers and preliminary anti-tumor activity of
exoASO-STAT6 in patients with advanced hepatocellular carcinoma
(HCC), patients with liver metastases from primary gastric cancer
and colorectal cancer (CRC). The study is anticipated to enroll
patients across four cohorts at sequentially escalating dose
levels, with subjects in the initial cohorts receiving biweekly
exoASO-STAT6 administered intravenously over the course of 28 days.
Ultimately the trial may enroll up to 30 patients. Initial Phase 1
data are expected in the first half of 2023.
TAMs promote tumor growth by exhibiting an immune suppressive M2
phenotype. Reprogramming TAMs toward a pro-inflammatory M1
phenotype may be a compelling approach to induce anti-tumor
immunity. The M2 phenotype is controlled by key transcription
factors such as STAT6, which have proven difficult to drug
selectively in TAMs using prior approaches. Codiak plans to
initially develop exoASO-STAT6 for primary cancers of the liver,
where STAT6 expression has been correlated with poor survival.
In multiple in vivo preclinical studies, exoASO-STAT6
demonstrated potent single agent activity, including >90% tumor
growth inhibition and 50-80% complete responses. In HCC models,
exoASO-STAT6 induced significant knockdown of STAT6 mRNA,
attenuated tumor growth and induced complete remission of tumor
lesions in 50% of mice. This anti-tumor activity was enhanced (75%
complete remissions) when exoASO-STAT6 was administered with
anti-PD1 antibodies. The monotherapy activity was accompanied by
remodeling of the tumor microenvironment including significant
expansion of M1-like macrophages and induction of an adaptive
anti-tumor immune response, enabling tumor elimination.
About the engEx® PlatformCodiak’s proprietary
engEx Platform is designed to enable the development of engineered
exosome therapeutics for a wide spectrum of diseases and to
manufacture them reproducibly and at scale to pharmaceutical
standards. By leveraging the inherent biology, function and
tolerability profile of exosomes, Codiak is developing engEx
exosomes designed to carry and protect potent drug molecules,
provide selective delivery and elicit the desired pharmacology at
the desired tissue and cellular sites. Through its engEx Platform,
Codiak seeks to direct tropism and distribution by engineering
exosomes to carry on their surface specific targeting drug
moieties, such as proteins, antibodies/fragments, and peptides,
individually or in combination. Codiak scientists have identified
two exosomal proteins that serve as surface and luminal scaffolds.
By engineering the exosome surface or lumen and optimizing the
route of administration, Codiak aims to deliver engEx
exosomes to the desired cell and tissue to more selectively
engage the drug target, potentially enhancing the therapeutic index
by improving potency and reducing toxicity.
About Codiak BioSciencesCodiak is a
clinical-stage biopharmaceutical company pioneering the development
of exosome-based therapeutics, a new class of medicines with the
potential to transform the treatment of a wide spectrum of diseases
with high unmet medical need. By leveraging the biology of exosomes
as natural intercellular transfer mechanisms, Codiak has developed
its proprietary engEx Platform to expand upon the innate properties
of exosomes to design, engineer and manufacture novel exosome
therapeutic candidates. Codiak has utilized its engEx Platform to
generate a deep pipeline of engineered exosomes aimed at treating a
broad range of diseases, spanning oncology, neuro-oncology,
infectious disease and rare disease. For more information,
visit http://www.codiakbio.com and follow @CodiakBio.
Forward-Looking StatementsThis press release
contains “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995, including, among
other things, statements concerning the development and therapeutic
potential of exoASO-STAT6, including timing of release of data, and
statements regarding the capabilities and potential of Codiak’s
engEx Platform and engineered exosomes generally. Any
forward-looking statements in this press release are based on
management’s current expectations of future events and are subject
to a number of risks and uncertainties that could cause actual
results to differ materially and adversely from those set forth in
or implied by such forward-looking statements. For a discussion of
these risks and uncertainties, and other important factors, any of
which could cause our actual results to differ from those contained
in the forward-looking statements, see the section entitled “Risk
Factors” in Codiak’s Annual Report on Form 10-K for the
year ended December 31, 2021, and in subsequent filings with
the Securities and Exchange Commission, as well as discussions of
potential risks, uncertainties and other important factors in
Codiak’s subsequent filings with the Securities and Exchange
Commission. All information in this press release is current as of
the date of this report, and Codiak undertakes no duty to update
this information unless required by law.
Investor Contact:Christopher TaylorVP, Investor
Relations and Corporate CommunicationsT: 617-949-4220E:
investor@codiakbio.com
Media Contact:Cory TrombleeScient PRE:
media@codiakbio.com
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