CDAK Codiak BioSciences Inc.
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exoSTING
Solid tumors
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exoIL-12
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CAMBRIDGE, Mass., May 11, 2021 (GLOBE NEWSWIRE) -- Codiak BioSciences, Inc. (NASDAQ:CDAK), a clinical-stage biopharmaceutical company focused on pioneering the development of exosome-based therapeutics as a new class of medicines, today announced new preclinical data from programs from its engEx™ Platform showing the broad potential therapeutic applications of engineered exosomes. The data, which include results from the IND-enabling studies for exoASO™-STAT6, immune evasion data from Codiak's exoAAV™ gene therapy platform, data showing the versatility of Codiak's exoVACC™ vaccine platform, and Codiak's ability to engineer specific cell uptake were presented today at the virtual 24th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT).
"These data highlight the power and flexibility of our engineering platform to build on the natural biology of exosomes with distinct and intentionally-chosen features," said Douglas E. Williams, Ph.D., President and Chief Executive Officer of Codiak. "By using exosomes to enhance the therapeutic index, we can pursue previously undruggable pathways and targets in multiple disease areas. Our lead programs are in immuno-oncology where we currently have two clinical trials underway in patients, and based on our continuing preclinical work, we see potential to advance programs in a broad array of therapeutic applications."
Codiak's proprietary engEx Platform enables the company to engineer exosomes – naturally occurring, extracellular nanoparticle vesicles – with distinct properties, load them with various therapeutic molecules and alter tropism so they reach specific cellular targets. Codiak has two programs in clinical development and expects to file an IND for exoASO-STAT6 – a novel exosome therapeutic carrying an antisense oligonucleotide (ASO) to target the transcription factor, STAT6 – by the end of the year.
exoASO-STAT6 Demonstrates Immune-Mediated Anti-Tumor Activity
Data presented at ASGCT from Codiak's exoASO-STAT6 program confirm results presented earlier this year showing potent local and systemic anti-tumor activity. Exosome-mediated delivery of an ASO results in enhanced uptake and improved silencing of STAT6 in tumor associated macrophages (TAMs) compared to ASO administration without an exosome (e.g., "free"). This activity, which was evident both in vitro and in vivo and across species, was persistent for up to 10 days and resulted in effective reprogramming of immunosuppressive macrophages to a pro-inflammatory phenotype. Efficacy studies of exoASO-STAT6 in multiple tumor models revealed dose-dependent single-agent activity, including 94% tumor growth inhibition and 60% complete responses at the efficacious dose in a CT26 tumor model and 62% reduction in tumor mass and complete elimination of tumor lesions in an orthotopic model of HCC unresponsive to other immunotherapies.exoVACC Induces Robust, Tunable and Broad Immune Response
exoVACC is Codiak's proprietary and modular vaccine system that utilizes the unique properties of exosomes to deliver antigens, adjuvants and immunomodulators simultaneously and selectively to antigen presenting cells. The data presented at ASGCT show that this platform enables antigen-specific immune responses that can be modulated through antigen orientation and adjuvant loading. Further, multiple exoVACC vaccine constructs induced superior systemic and tissue-resident immune responses via various routes of administration compared to conventional vaccine formulations in animal models of both infectious disease and oncology. Specific to SARS-CoV-2, an exosome loaded with a receptor-binding domain on the surface generated robust neutralizing antibodies against the virus without requiring adjuvants. Codiak is collaborating with the Ragon Institute of MGH, MIT and Harvard to investigate the potential of the exoVACC platform in SARS-CoV-2 and HIV.Immune-Silent Nature of Exosomes Provides Potential Strategy to Enhance AAV Delivery
Codiak presented new data at ASGCT that show that exosomes also have potential utility in overcoming the limitations of current adeno-associated virus (AAV) vectors used for the delivery of gene therapies. In in vitro studies, AAV encapsulated in an exosome (exoAAV) demonstrated increased potency compared to "free" AAV and resistance to neutralizing antibodies, which, if present, prevent treatment with gene therapy or readministration after an initial dose.Engineered Exosomes with Altered Cellular Tropism Instigate Preferential Uptake in Neuronal Cells
Results from multiple in vitro and in vivo studies have demonstrated the ability of the engEx Platform to modulate exosome tropism and drive uptake into specific cell types. Illustrating the potential for exosome-based therapeutics in neurology indications, the data presented at ASGCT show that exosomes engineered to express different targeting ligands at high density result in increased uptake in various cell types of interest in the nervous system, such as neuroblastoma cell lines.About the engEx™ Platform
Codiak'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 BioSciences
Codiak is a clinical-stage biopharmaceutical company focused on 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 disease areas, spanning oncology, neuro-oncology, neurology, neuromuscular disease and infectious disease.Forward-Looking Statements
This 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 the Company's engEx Platform, engEx product candidates and engineered exosomes generally, including future development plans, regulatory filings, releases of data and timing with respect thereto. 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, 2020, 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 Taylor VP, Investor Relations and Corporate Communications T: 617-949-4220 E: [email protected] Media Contact: Lindy Devereux Scient PR T: 646-515-5730 E: [email protected]
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– Former Principal Investigator at MD Anderson Cancer Center and immuno-oncology drug developer at Novartis joins Codiak leadership –
– Benny Sorensen, M.D, Ph.D. named SVP, Strategic Projects –
CAMBRIDGE, Mass., May 10, 2021 (GLOBE NEWSWIRE) -- Codiak BioSciences, Inc. (NASDAQ:CDAK), a clinical-stage biopharmaceutical company focused on pioneering the development of exosome-based therapeutics as a new class of medicines, today announced the appointment of Jennifer Wheler, M.D., an industry leader in targeted oncology and immunotherapy drug development, as Chief Medical Officer. Dr. Wheler, who joins the company's Executive Leadership Team and reports to president and CEO Douglas Williams, Ph.D., will provide leadership and direction for Codiak's pipeline of clinical development programs through early-stage trials to global regulatory submissions.
Benny Sorensen, M.D., Ph.D., who has led the preclinical to clinical translational work and clinical strategy for Codiak for the past five years, advancing exoSTING™ and exoIL-12™ through IND/CTA and into the current Phase 1 trials, will become Senior Vice President, Strategic Projects. Dr. Sorensen will report to president and CEO Douglas Williams and continue as a member of Codiak's Executive Leadership Team. He will help direct business development and other strategic external partnering projects and continue to provide support for the ongoing clinical trials.
"In the past year, our clinical team, led by Benny, has initiated two clinical programs and we expect to file an IND for a third program later this year, all of which are evaluating the potential for engineered exosomes to engage the immune system in novel ways to attack intractable cancers. With the anticipated advancement and intensified focus in oncology, we believe it is an ideal time for us to expand our team for the next phase of growth," said Dr. Williams. "As a clinical oncologist with many years of patient treatment and drug development experience, Jennifer knows this space incredibly well and will bring valuable leadership and deep domain expertise to the outstanding team that we already have in place."
Dr. Wheler brings more than 20 years of experience in industry and academic clinical research to Codiak, including a strong track record of successful early-stage oncology drug development. A board-certified oncologist, she served most recently as chief medical officer of Bicara Therapeutics, where she designed and led the first-in-human Phase I/II trial for the company's bi-functional antibody candidate, including building the clinical trial infrastructure, clinical operations team and KOL network. Previously, Dr. Wheler led first-in-human studies for novel immuno-oncology assets at Novartis Institutes for BioMedical Research. From 2006 to 2015, she worked in the Department of Investigational Cancer Therapeutics at the University of Texas MD Anderson Cancer Center where she served as Principal Investigator on more than 30 Phase 1 trials, including one of the first published trials of randomized data demonstrating benefit for treating patients with therapy matched to their tumor's molecular profile. She is co-author on more than 145 peer-reviewed publications. Dr. Wheler completed fellowships in breast cancer medicine at Memorial Sloan Kettering Cancer Center and in oncology at Yale Cancer Center and her internal medicine residency at Columbia University Irving Medical Center and New York-Presbyterian Hospital. She received her A.B. from Princeton University and her M.D. from Weill Cornell Medical College in New York. With a background in the arts, Dr. Wheler also founded Collage, a nonprofit organization that brings personalized and innovative art programs to patients living with cancer.
"Codiak has a rich pipeline of first-in-class molecules that leverages a deep understanding of exosome biology and engineering. These exquisitely constructed molecules combine targeted and immunomodulatory approaches that have previously been elusive - the potential to impact the lives of patients with cancer and other diseases is immense," said Dr. Wheler. "As an oncologist who has spent much of my career investigating new drugs designed to improve outcomes for patients, I see this as an tremendous opportunity: the science is compelling, the early clinical data support the desired product profile and the team is superb. I am excited to lend my experience to help lead the current clinical programs and work to guide the next programs into the clinic."
"I'm excited to welcome Jennifer to Codiak," said Dr. Sorensen. "With two oncology-focused programs now in the clinic and a third on track for IND this year, her background and experience will be incredibly valuable as we continue to advance these candidates. I look forward to collaborating with her as Codiak remains focused on moving the exoSTING and exoIL-12 clinical trials toward expected data read-outs later this year and prepares for the planned exoASO-STAT6 IND submission."
About Codiak BioSciences
Codiak is a clinical-stage biopharmaceutical company focused on 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 disease areas, spanning oncology, neuro-oncology, neurology, neuromuscular disease and infectious disease.Forward-Looking Statements
This 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 the Company's engEx Platform, engEx product candidates and engineered exosomes generally, including future development plans, regulatory filings, data releases and timing with respect thereto. 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, 2020, 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 Taylor VP, Investor Relations and Corporate Communications T: 617-949-4220 E: [email protected] Media Contact: Lindy Devereux Scient PR T: 646-515-5730 E: [email protected]
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– Key clinical data from first in-human studies of engineered exosome therapeutic candidates, exoIL-12™ and exoSTING™, expected this year –
– Data from multiple preclinical programs to be presented at ASGCT 2021 showing broad potential applications for engineered exosomes –
CAMBRIDGE, Mass., May 06, 2021 (GLOBE NEWSWIRE) -- Codiak BioSciences, Inc. (NASDAQ:CDAK), a clinical-stage biopharmaceutical company focused on pioneering the development of exosome-based therapeutics as a new class of medicines, today reported first quarter 2021 financial results and operational progress.
"We are making excellent progress with our clinical and preclinical programs, which continue to generate further confirmatory evidence that our engEx exosome engineering and manufacturing platform can harness exosomes as delivery vehicles for potent and selective therapeutics, not only in immuno-oncology, but potentially in vaccines, gene therapy and neuro-oncology/neurology as well," said Douglas E. Williams, Ph.D., President and Chief Executive Officer of Codiak. "We remain on track to deliver safety, biomarker and preliminary efficacy data from our exoIL-12 and exoSTING clinical programs in oncology and file an IND for our third program, exoASO-STAT6, later this year."
First Quarter 2021 and Recent Highlights
- Reported positive Phase 1 results for exoIL-12 confirming local pharmacology and dose selection for safety and efficacy trial in patients with early-stage cutaneous T cell lymphoma (CTCL)
- Progressed with subject dosing in the Phase 1/2 clinical trial of exoSTING for the treatment of advanced/metastatic, recurrent and injectable solid tumors
- Continued to advance exoASO™-STAT6 for the intravenous treatment of myeloid-rich cancers through IND-enabling studies
- Detailed versatility of Codiak's engEx™ Platform in manuscript published in Molecular Therapeutics, a Cell partner journal
- Presented pharmacokinetic/pharmacodynamic and tolerability data from healthy volunteer portion of the exoIL-12 Phase 1 clinical trial and preclinical data from the exoASO-STAT6 program at the American Association for Cancer Research (AACR) Annual Meeting, April 10-15
- Published manuscript highlighting the exoSTING preclinical program in Communications Biology, a Nature Research publication
Anticipated Milestones and Events
- Four poster presentations at the American Society of Gene and Cell Therapy (ASGCT) 24th Annual Meeting on May 11, including new preclinical data on exoAAV™, exoVACC™, exoASO-STAT6, and the ability of engineered exosomes to direct tropism to neuronal cells of interest
- Safety, biomarker and preliminary pharmacodynamics and efficacy data from the exoSTING Phase 1/2 clinical trial in patients with solid tumors continue to be expected mid-2021, within the third quarter
- Investigational New Drug (IND) application filing for exoASO-STAT6 anticipated during the second half of 2021 to enable initiation of clinical trials
- Safety, biomarker and preliminary pharmacodynamics and efficacy data in CTCL patients from the exoIL-12 Phase 1 trial expected by year-end 2021
First Quarter 2021 Financial Results
Total revenues for the quarter ended March 31, 2021 were $13.2 million, compared to $0.1 million for the same period in 2020. This increase was primarily due to the mutual agreement between the Company and Jazz Pharmaceuticals to discontinue their work on exoASO™-STAT3, one of five oncogene targets subject to the Collaboration and License Agreement by and between Codiak and Jazz Pharmaceuticals. The Company recognized the remaining $10.9 million in deferred revenue allocated to this target as revenue during the three months ended March 31, 2021.
Net loss for the quarter ended March 31, 2021 was $10.3 million, compared to a net loss of $22.5 million for the same period in 2020. Net loss for the quarter was driven primarily by clinical development, general and administrative, and personnel expenses, and ongoing development of the engEx Platform, offset in part by the $10.9 million in deferred revenue described above.
Research and development expenses were $16.6 million for the quarter ended March 31, 2021 compared to $18.4 million for the same period in 2020. The decrease in research and development expenses was driven primarily by lower manufacturing and preclinical costs as our lead assets progressed into the clinic during the second half of 2020.
General and administrative expenses were $6.6 million for the quarter ended March 31, 2021 compared to $4.2 million for the same period in 2020. The increase was driven primarily by an increase in personnel costs and costs associated with transitioning to a public company.
As of March 31, 2021, Codiak had cash, cash equivalents, and marketable securities of approximately $130.3 million.
About Codiak BioSciences
Codiak is a clinical-stage biopharmaceutical company focused on 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 disease areas, spanning oncology, neuro-oncology, neurology, neuromuscular disease and infectious disease.Forward-Looking Statements
This 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 exoSTING and exoIL-12, including timing of release of data, statements concerning the development of exoASO-STAT6, including the timing of IND filing and initiation of its clinical program, 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 quarter ended December 31, 2020, 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.CODIAK BIOSCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share data)
(unaudited)MARCH 31,
2021DECEMBER 31,
2020Assets Current assets: Cash and cash equivalents $ 130,272 $ 88,915 Prepaid expenses and other current assets 4,405 4,843 Total current assets 134,677 93,758 Property and equipment, net 30,885 31,410 Restricted cash, net of current portion 4,170 4,170 Operating right-of-use assets 21,767 22,003 Total assets $ 191,499 $ 151,341 Liabilities and Stockholders' Equity Current liabilities: Accounts payable $ 2,162 $ 2,018 Accrued expenses 6,805 8,870 Deferred revenue 4,345 5,281 Operating lease liabilities 2,230 1,482 Total current liabilities 15,542 17,651 Long-term liabilities: Deferred revenue, net of current portion 46,008 57,416 Note payable, net of discount 25,095 24,960 Operating lease liabilities, net of current portion 35,931 36,540 Other long-term liabilities 207 207 Total liabilities 122,783 136,774 Commitments and contingencies Stockholders' equity: Common stock, $0.0001 par value; 150,000,000 shares authorized as of March 31, 2021 and December 31, 2020; 21,996,886 and 18,787,579 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively 2 2 Additional paid-in capital 367,112 302,655 Accumulated deficit (298,398 ) (288,090 ) Total stockholders' equity 68,716 14,567 Total liabilities and stockholders' equity $ 191,499 $ 151,341 CODIAK BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share data)
(unaudited)THREE MONTHS ENDED
MARCH 31,2021 2020 Revenue: Collaboration revenue $ 13,191 $ 134 Total revenue 13,191 134 Operating expenses: Research and development 16,550 18,391 General and administrative 6,588 4,233 Total operating expenses 23,138 22,624 Loss from operations (9,947 ) (22,490 ) Other income (expense): Interest expense (698 ) (295 ) Interest income 5 223 Other income 332 60 Total other expense, net (361 ) (12 ) Net loss $ (10,308 ) $ (22,502 ) Cumulative dividends on redeemable convertible preferred stock — (3,419 ) Net loss attributable to common stockholders $ (10,308 ) $ (25,921 ) Net loss per share attributable to common stockholders, basic and diluted $ (0.51 ) $ (8.64 ) Weighted average common shares outstanding, basic and diluted 20,333,398 3,001,660 Comprehensive loss: Net loss $ (10,308 ) $ (22,502 ) Other comprehensive loss: Unrealized loss on investments, net of tax of $0 — (41 ) Total other comprehensive loss — (41 ) Comprehensive loss $ (10,308 ) $ (22,543 ) Investor Contact: Christopher Taylor VP, Investor Relations and Corporate Communications T: 617-949-4220 E: [email protected] Media Contact: Lindy Devereux Scient PR T: 646-515-5730 E: [email protected]
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CAMBRIDGE, Mass., April 27, 2021 (GLOBE NEWSWIRE) -- Codiak BioSciences, Inc. (NASDAQ:CDAK), a clinical-stage biopharmaceutical company focused on pioneering the development of exosome-based therapeutics as a new class of medicines, today announced that the company will present data from its engEx™ Platform at the 24th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT), which is being held virtually from May 11-14, 2021. Codiak scientists will present four abstracts detailing results from numerous preclinical studies evaluating the potential utility of engineered exosomes in multiple settings, including oncology, infectious disease, gene therapy and neurology.
"In addition to our current clinical programs that are testing engineered exosome therapeutic candidates in immuno-oncology, we see broad opportunity for our platform to create novel, targeted therapeutic approaches in multiple disease areas," said Douglas E. Williams, Ph.D., President and Chief Executive Officer of Codiak. "The data to be presented at ASGCT highlights the power of the engEx platform to engineer specific features into exosomes for immune evasion, targeted cell tropism, and potent engagement of previously undruggable pathways, characteristics that serve as the foundation of a new class of medicines."
Poster Presentations - May 11, 2021; 8:00 a.m. – 10:00 a.m. ET:
exoVACC™: A Novel Exosome-Based Vaccine Platform That Induces Robust, Tunable Cellular and Humoral Immune Responses in Animal Models
Abstract number: 721
Session: Immunological Aspects for Gene Therapy and VaccinesOptimization of AAV Loading Into Extracellular Vesicles as Method to Avoid Neutralizing Antibodies
Abstract number: 320
Session: AAV Vectors – Virology and VectorologyEngineered Exosomes Efficiently Deliver STAT6 Antisense Oligonucleotides to Tumor Associated Macrophages (TAMs) Resulting in Potent Local and Systemic Anti-Tumor Activity
Abstract number: 444
Session: Oligonucleotide TherapeuticsEngineering Exosomes With Altered Cellular Tropism for Neuronal Cell Targeting
Abstract number: 808
Session: Vector Product Engineering, Development or ManufacturingAbout the engEx™ Platform
Codiak'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 BioSciences
Codiak is a clinical-stage biopharmaceutical company focused on 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 disease areas, spanning oncology, neuro-oncology, neurology, neuromuscular disease and infectious disease.Forward-Looking Statements
This 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 exoIL-12 and exoASO-STAT6, including future development plans and regulatory filings and timing with respect thereto. 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, 2020, 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 Taylor VP, Investor Relations and Corporate Communications T: 617-949-4220 E: [email protected] Media Contact: Lindy Devereux Scient PR T: 646-515-5730 E: [email protected]
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– exoSTING has demonstrated enhanced potency, preferential activation of antigen presenting cells, and systemic anti-tumor immunity in vivo –
– Novel engineered exosome therapeutic candidate currently in Phase 1/2 clinical trial with initial proof-of-concept data expected mid-year –
CAMBRIDGE, Mass., April 22, 2021 (GLOBE NEWSWIRE) -- Codiak BioSciences, Inc. (NASDAQ:CDAK), a clinical-stage company focused on pioneering the development of exosome-based therapeutics as a new class of medicines, today announced the online publication of a new manuscript, exoSTING, an extracellular vesicle loaded with STING agonists, promotes tumor immune surveillance, in Communications Biology, a Nature Research publication. exoSTING is a novel engineered exosome therapeutic candidate currently being investigated in a Phase 1/2 clinical trial as a single agent for the treatment of multiple solid tumors. This publication details the findings from the preclinical development program and highlights the potential of exoSTING to stimulate a broad immune response without the detrimental effects on intratumoral T cells observed with other STING agonists.
"We believe exoSTING represents a novel strategy to harness and improve upon the natural properties of exosomes in the tumor microenvironment and may overcome the limitations of off-target delivery, poor tumor retention and systemic inflammation which have hindered prior drug development of free STING agonist molecules targeting this well-validated pathway," said Sriram Sathyanarayanan, PhD, SVP, Preclinical Research, Codiak. "This publication describes the therapeutic potential of this candidate based on the preclinical evidence and demonstrates the capability of our exosome engineering platform to leverage the natural biology of exosomes to expand the therapeutic index of attractive yet historically challenging cancer immunotherapy agents."
exoSTING is one of two Codiak programs currently in clinical development. Engineered using the company's proprietary engEx™ Platform to provide targeted delivery of Codiak's STING agonist to antigen presenting cells (APCs) in the tumor microenvironment, exoSTING demonstrates greater than 100-fold increased potency in in vivo tumor models and increased tumor retention and lower levels of systemic inflammatory cytokine production as compared to free STING agonist (delivered without exosomes). Additionally, exoSTING demonstrates CD8 T-cell preservation, expansion, Th1 polarization and establishment of systemic antigen-specific T-cell mediated immune responses across a wide dose range without evidence of immune ablation as seen with free STING agonists.
A Phase 1/2 dose escalation clinical trial of exoSTING is currently underway investigating safety, tolerability, pharmacological activity, and objective tumor response in patients with advanced/metastatic, recurrent, injectable solid tumors, with a focus on tumors likely to be enriched in APCs. Examples of such tumors include metastatic head and neck squamous cell cancer (HNSCC), triple negative breast cancer (TNBC), anaplastic thyroid carcinoma (ATC), and cutaneous squamous cell carcinoma (cSCC). Safety, biomarker and preliminary efficacy data from the dose-escalation phase of the trial are expected in mid-2021.
About exoSTING™
exoSTING is Codiak's exosome therapeutic candidate engineered to incorporate a proprietary STING (stimulator of interferon genes) agonist inside the lumen of the exosome while expressing the exosomal protein, PTGFRN, on the exosome surface to facilitate specific uptake in tumor-resident antigen presenting cells (APCs). Codiak believes that exoSTING has the potential to overcome certain limitations of free STING agonists, and enhance the therapeutic index and selectivity of delivery to desired cells in the tumor microenvironment.Codiak is developing exoSTING for the treatment of multiple solid tumors enriched in the target APCs. exoSTING has demonstrated encouraging activity in preclinical models and is now being evaluated in a Phase 1/2 clinical trial in patients with advanced/metastatic, recurrent, and injectable solid tumors. Future development of exoSTING may be expanded to neuro-oncology indications such as glioblastoma and leptomeningeal cancer disease.
About the engEx™ Platform
Codiak'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 BioSciences
Codiak is a clinical-stage biopharmaceutical company focused on 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, neurology, neuromuscular disease and infectious disease. For more information, visit http://www.codiakbio.com and follow @CodiakBio.Forward-Looking Statements
This 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 exoSTING and exoIL-12, 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, 2020, 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 Taylor VP, Investor Relations and Corporate Communications T: 617-949-4220 E: [email protected] Media Contact: Lindy Devereux Scient PR T: 646-515-5730 E: [email protected]