CDAK Codiak BioSciences Inc.
Upcoming Catalysts
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exoIL-12
Cutaneous T cell lymphoma
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Phase 1
Phase 1
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exoSTING
Solid tumors
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Phase 1/2
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Latest News
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CAMBRIDGE, Mass., Feb. 25, 2021 /PRNewswire/ -- Cellarity, a life sciences company founded by Flagship Pioneering to develop a new method of drug discovery targeting the cell, announced today that it raised $123 million in Series B financing. The round included contributions from funds and accounts managed by BlackRock, The Baupost Group, Banque Pictet on behalf of their clients and eight other investors alongside Flagship Pioneering.
Founded in 2017 within Flagship Labs, Cellarity's new approach to drug discovery is based on the computational modeling of cell behavior, leading to a more complete understanding of system and network biology to uncover cell-behavior-targeted medicines for a wide variety of diseases.
Cellarity's medicines are developed to address disease at the level of the cell and are not aimed at single molecular targets, the approach pursued in much of traditional drug discovery. The successful financing round validates the strength of Cellarity's science and its potential to redefine drug discovery through its cell-centric approach.
"All diseases stem from a disorder at the cellular level, but until now most drug discovery efforts have relied upon single molecular targets that overlook the potent networked relationships of biology," said Fabrice Chouraqui, CEO of Cellarity and a CEO-Partner at Flagship Pioneering. "By working at the level of the entire cell, Cellarity's drug discovery platform harnesses the complexity of human biology to uncover breakthrough treatments in a wide range of disease areas."
Cellarity is generating unprecedented biological insights by combining its unique expertise in network biology, high-resolution data, and machine learning. The result is a new understanding of the cell's trajectory from health to disease, and how cells relate to one another in tissues. Because the cell and its network of transcripts and proteins offer a more complete view of the complexity of human biology than any individual molecular target, Cellarity's approach allows for more efficient drug discovery and is designed to drive higher rates of clinical success. Already, the company has seven drug discovery programs underway in diverse therapeutic areas that range from metabolic disease to immuno-oncology.
"Cellarity's cell-centric platform has the potential to engineer a shift in how the world approaches the discovery of medicine," said Noubar Afeyan, CEO of Flagship Pioneering and Co-founder and Chairman of the Board of Cellarity. "It is another example of Flagship Pioneering's relentless efforts to push the boundaries of the life sciences to uncover breakthrough technologies and identify innovative treatments that will change the lives of patients."
About Cellarity
Cellarity's mission is to bring breakthrough medicines to patients by completely redefining the way drugs are discovered. Founded by Flagship Pioneering in 2017, Cellarity is designing medicines against the cell as opposed to a single molecular target. The company has developed a unique combination of expertise across system and network biology, high-resolution data, and machine learning to unlock treatments in a large number of therapeutic areas.About Flagship Pioneering
Flagship Pioneering conceives, creates, resources, and develops first-in-category life sciences companies to transform human health and sustainability. Since its launch in 2000, the firm has, through its Flagship Labs unit, applied its unique hypothesis-driven innovation process to originate and foster more than 100 scientific ventures, resulting in over $50B in aggregate value. To date, Flagship has deployed over $2.2B in capital toward the founding and growth of its pioneering companies alongside more than $18B of follow-on investments from other institutions. The current Flagship ecosystem comprises 41 transformative companies, including Axcella Health (NASDAQ:AXLA), Codiak Biosciences (NASDAQ:CDAK), Denali Therapeutics (NASDAQ:DNLI), Evelo Biosciences (NASDAQ:EVLO), Foghorn Therapeutics (NASDAQ:FHTX), Indigo Ag, Kaleido Biosciences (NASDAQ:KLDO), Moderna (NASDAQ:MRNA), Rubius Therapeutics (NASDAQ:RUBY), Sana Biotechnology (NASDAQ:SANA), Seres Therapeutics (NASDAQ:MCRB), and Sigilon Therapeutics (NASDAQ:SGTX).
View original content to download multimedia:http://www.prnewswire.com/news-releases/cellarity-raises-123-million-in-series-b-funding-to-pioneer-a-new-approach-to-drug-discovery-treating-disease-at-the-level-of-the-cell-as-opposed-to-a-single-molecular-target-301235332.htmlSOURCE Cellarity
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CAMBRIDGE, Mass., Feb. 17, 2021 (GLOBE NEWSWIRE) -- Codiak BioSciences, Inc. (NASDAQ:CDAK) ("Codiak"), a clinical-stage biopharmaceutical company focused on pioneering the development of exosome-based therapeutics as a new class of medicines, today announced the closing of its previously announced underwritten public offering of an aggregate of 3,162,500 shares of its common stock at a public offering price of $21.00 per share, which includes the exercise in full of the underwriters' option to purchase 412,500 additional shares. Gross proceeds, before deducting underwriting discounts and commissions and estimated offering expenses, are anticipated to be approximately $66.4 million. The offering of the shares is expected to result in approximately $62.0 million in net proceeds to Codiak after deducting underwriting discounts and commissions and other estimated offering expenses payable by Codiak.
Goldman Sachs & Co. LLC, Evercore ISI and William Blair acted as joint book-running managers for the offering and as representatives of the underwriters. Wedbush PacGrow acted as lead manager for the offering.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About Codiak
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 Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including among other things, statements regarding the anticipated use of proceeds from the public offering, and other statements identified by words such as "could," "expects," "intends," "may," "plans," "potential," "should," "will," "would," or similar expressions and the negatives of those terms. Forward-looking statements are not promises or guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, market risks and uncertainties and the satisfaction of customary closing conditions for an offering of securities. These and other risks are described under the heading "Risk Factors" in our most recent Quarterly Report on Form 10-Q filed with the SEC and in other filings that Codiak makes with the SEC. Our actual results could differ materially from the results described in or implied by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements.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., Feb. 11, 2021 (GLOBE NEWSWIRE) -- Codiak BioSciences, Inc. (NASDAQ:CDAK) ("Codiak"), a clinical-stage biopharmaceutical company focused on pioneering the development of exosome-based therapeutics as a new class of medicines, announced today the pricing of its underwritten public offering of 2,750,000 shares of its common stock at a public offering price of $21.00 per share, for gross proceeds of approximately $57.8 million, before deducting underwriting discounts and commissions and offering expenses. All of the shares are being offered by Codiak. In addition, Codiak has granted the underwriters a 30-day option to purchase up to an additional 412,500 shares of its common stock, at the public offering price, less underwriting discounts and commissions. All the shares to be sold in the proposed offering will be sold by Codiak.
The offering is expected to close on February 17, 2021, subject to customary closing conditions.
Goldman Sachs & Co. LLC, Evercore ISI and William Blair are acting as joint book-running managers for the offering and as representatives of the underwriters. Wedbush PacGrow is acting as lead manager for the offering.
A registration statement relating to these securities has been filed with the Securities and Exchange Commission ("SEC") and became effective on February 11, 2021. This offering is being made only by means of a prospectus. Copies of the final prospectus may be obtained, when available, on the SEC's website at http://www.sec.gov or by contacting Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, telephone: 1-866-471-2526, or by email: [email protected]; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, telephone: (888) 474-0200, or by email: [email protected]; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, telephone: 1-800-621-0687, or by email: [email protected].
This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any offer or sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.
About Codiak
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.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., Feb. 09, 2021 (GLOBE NEWSWIRE) -- Codiak BioSciences, Inc. (NASDAQ:CDAK) ("Codiak"), a clinical-stage company focused on pioneering the development of exosome-based therapeutics as a new class of medicines, announced today that it has commenced an underwritten public offering of 2,500,000 shares of its common stock. Codiak intends to grant the underwriters a 30-day option to purchase an additional 375,000 shares of its common stock, at the public offering price, less the underwriting discounts and commissions. All the shares to be sold in the proposed offering will be sold by Codiak. The offering is subject to market and other conditions, and there can be no assurances as to whether or when the offering may be completed, or as to the actual size and terms of the offering.
Goldman Sachs & Co. LLC, Evercore ISI and William Blair are acting as joint book-running managers for the offering and as representatives of the underwriters. Wedbush PacGrow is acting as lead manager for the offering.
A registration statement relating to these securities was filed with the Securities and Exchange Commission ("SEC") on February 9, 2021 but has not yet been declared effective. These securities may not be sold nor may offers to buy these securities be accepted prior to the time that the registration statement becomes effective. This offering is being made only by means of a prospectus. Copies of the registration statement and the preliminary prospectus relating to this offering may be obtained, when available, on the SEC's website at http://www.sec.gov or by contacting the offices of Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, telephone: 1-866-471-2526, or by email: [email protected]; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, telephone: (888) 474-0200, or by email: [email protected]; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, telephone: 1-800-621-0687, or by email: [email protected].
This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any offer or sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.
Forward Looking Statements
This press release contains forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including among other things, statements regarding the anticipated timing, size and completion of the proposed public offering, and other statements identified by words such as "could," "expects," "intends," "may," "plans," "potential," "should," "will," "would," or similar expressions and the negatives of those terms. Forward-looking statements are not promises or guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, market risks and uncertainties and the satisfaction of customary closing conditions for an offering of securities. These and other risks are described under the heading "Risk Factors" in our most recent Quarterly Report on Form 10-Q filed with the SEC and in other filings that Codiak makes with the SEC. Our actual results could differ materially from the results described in or implied by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements.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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– Pharmacodynamic results confirm localized exoIL-12 pharmacologic activity
without systemic IL-12 exposure –
– Plan to initiate multi-dose study in CTCL patients, with data anticipated by year-end 2021–
CAMBRIDGE, Mass., Feb. 04, 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 pharmacodynamic (PD) activity results from the healthy volunteer portion of its randomized, placebo-controlled, double-blind Phase 1 trial of the company's clinical candidate, exoIL-12. Analyses of skin punch biopsies bordering the subcutaneous injection site of exoIL-12 revealed local retention of immunologically detectable IL-12 at the injection site, and localized pharmacological activity as measured by levels of the T cell attractant chemokine, IP-10, in the skin. IL-12 was not detected in plasma at any dose of exoIL-12 tested and plasma IP-10 was only detectable at the highest, 12 μg dose. Results confirmed the desired localization and retention of IL-12 at the injection site for at least 24 hours, as well as prolonged IP-10 production for 8-15 days depending upon dose.
exoIL-12 is the first engineered exosome therapeutic candidate to be evaluated in humans and one of two Codiak programs currently in clinical development. exoIL-12 was engineered using the company's proprietary engEx™ Platform and designed to display functional IL-12 – a potent anti-tumor cytokine – on the exosome surface using the exosomal protein, PTGFRN, as a scaffold.
"We now have clinical evidence in healthy volunteers of local, IL-12-driven pharmacology without detectable systemic exposure to IL-12 or drug-related adverse events for exoIL-12," said Benny Sorensen, M.D., Ph.D., Senior Vice President and Head of Clinical Development, Codiak. "These results further support the target profile that we are hoping to achieve with this candidate and have enabled us to identify the optimal dose for the next phase of our clinical program in patients with active, early-stage CTCL. Moreover, this data further validates the capacity of our engEx Platform to engineer precise properties into our exosome-based therapeutic candidates that potentially expand their therapeutic index."
These results are consistent with Codiak's preclinical testing and confirm exoIL-12's target product profile of local drug retention at the injection site, prolonged local pharmacodynamic activity, and lack of systemic IL-12 exposure. Codiak plans to initiate the next portion of the Phase 1 clinical trial, evaluating the safety and efficacy of exoIL-12, in CTCL patients at the dose of 6 μg, which Codiak believes to be the optimal pharmacologically active dose based upon this healthy volunteer data and prior preclinical data with exoIL-12.
"We are pleased with the data we have obtained with exoIL-12 in healthy human volunteers and look forward to the initiation of trials in CTCL patients," said Douglas E. Williams, Ph.D., President and Chief Executive Officer, Codiak. "It is heartening to see one of the founding principles of Codiak validated in the current trial, namely that engineered exosomes can offer the opportunity to tailor therapeutic payloads to provide an active biological response while at the same time limiting unwanted side effects."
Pharmacodynamic Data from Healthy Volunteers
A total of five cohorts each with five subjects were enrolled, randomized 3:2 active drug to placebo, and dosed in the first part of the Phase 1 study. Each cohort received a subcutaneously administered single ascending dose of exoIL-12: 0.3 μg, 1.0 μg, 3.0 μg, 6.0 μg or 12.0 μg, respectively.PD measurements including skin IL-12 levels post-injection and IL-12 receptor-mediated signaling assessed by induction of IP-10, were measured in skin punch biopsies at a 1.5 cm radius from the subcutaneous injection site. Samples were collected immediately prior to dosing (placebo or exoIL-12) and at 24 hours, Day 8 and Day 15 after administration. Results showed detectable IL-12 near the injection site as much as 24 hours post injection at the 6 μg dose. Samples collected at the 8-day and 15-day time points did not have detectable IL-12. In contrast, doses from 1.0 μg to 12μg (not 0.3 μg) showed significant induction of IP-10 production in the skin detectable for 8-15 days confirming robust and durable local pharmacology. At the highest 12 μg dose, IP-10 was also detectable in the plasma, but not at any of the lower doses. As previously described, no detectable IL-12 was present in plasma and no drug-related adverse events were observed across the entire dose range. These results confirm the prolonged, local activation of the IL-12 signaling cascade and give us confidence that 6 μg is the optimal dose to move forward in the next phase of clinical testing in CTCL patients.
During the planned part two of the Phase 1 trial, repeat doses of exoIL-12 at 6 μg will be administered into the lesions of stage IA-IIB CTCL patients. Patients will be monitored for safety, pharmacokinetic, and PD effects through analysis of blood and tumor biopsies, and for local and systemic anti-tumor efficacy using validated CTCL assessment criteria, including CAILS and mSWAT scores. The study is being conducted in the United Kingdom. Given COVID-19-related restrictions involving new study initiation, Codiak is working closely with study sites to open enrollment and commence dosing of patients when allowable and appropriate. Safety, biomarker and preliminary anti-tumor efficacy results are anticipated by the end of 2021.
In prior clinical trials conducted by others of recombinant IL-12 (rIL-12), CTCL patients have shown single-agent treatment responses (56-74% overall response rate and up to 22% complete responses1). However, the utility of rIL-12 has been greatly limited due to serious adverse events caused by systemic exposure. To overcome these limitations, exoIL-12 was designed to facilitate dose control of IL-12 and limit systemic exposure and associated toxicity by localizing IL-12 in the tumor microenvironment in order to potentially expand the therapeutic index.
There is currently no standard of care treatment for early-stage CTCL. Physicians often employ a variety of non-specific interventions, including repetitive radiation therapy, photo therapy, high-potency steroids and local chemotherapy to inhibit tumor growth and halt disease progression. There is a need for treatments that can induce local as well as systemic anti-tumor activity.
About exoIL-12™
exoIL-12 is Codiak's exosome therapeutic candidate engineered to display fully active IL-12 on the surface of the exosome, using the exosomal protein, PTGFRN, as a scaffold, and designed to facilitate potent local pharmacology at the injection site with precisely quantified doses. By limiting systemic exposure of IL-12 and associated toxicity, Codiak hopes to enhance the therapeutic index with exoIL-12, delivering a more robust tumor response, dose control and an improved safety profile.Codiak intends to focus development of exoIL-12 on tumors that have, in previous clinical testing, shown clinical responses to rIL-12 used as a monotherapy. This list includes CTCL, melanoma, Merkel cell carcinoma, Kaposi sarcoma, glioblastoma multiforme, triple negative breast cancer, among others.
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 exoIL-12, including expected design of clinical trials and timing of commencement of part two of Codiak's Phase 1 clinical trial in CTCL patients, 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 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.1 Gokhale MS, Vainstein V, Tom J, et al. Single low-dose rHuIL-12 safely triggers multilineage hematopoietic and immune-mediated effects. Exp Hematol Oncol. 2014;3(1):11. Published 2014 Apr 11. doi:10.1186/2162-3619-3-11
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]