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Item 7.01 – Regulation FD Disclosure
On November 16, 2021, Codiak BioSciences, Inc. (the “Company”) issued a press release announcing initial data for exoSTING, 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. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.
On November 16, 2021, the Company also hosted a conference call and webcast, during which the Company reviewed a presentation on this initial data for exoSTING. A copy of this presentation is attached as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated by reference herein.
The information under this Item 7.01 is being furnished herewith and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall such information be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 - Financial Statements and Exhibits
|99.1||Press release, dated November 16, 2021, by Codiak BioSciences, Inc.|
|99.2||Presentation, dated November 16, 2021, by Codiak BioSciences, Inc.|
|104||Cover Page Interactive Data File (embedded within the Inline XBRL document).|
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|Date: November 17, 2021||Codiak BioSciences, Inc.|
|Name:||Douglas E. Williams, Ph.D.|
|Title:||Chief Executive Officer and President|
Codiak Reports Positive Initial Data for exoSTING Phase 1/2 Trial Indicating Tolerability, Immune Activation, and Evidence of Tumor Shrinkage in Injected and Non-Injected Tumors
in the First Three Dose Escalation Cohorts
exoSTING resulted in localized STING pathway activation and dose-dependent immune activation
Intratumoral administration of exoSTING was well tolerated and demonstrated tumor retention, no systemic exposure to STING agonist, and in a subset of patients, tumor shrinkage in injected and distal non-injected lesions
Data on objective response rate and recommended Phase 2 dose selection for expansion anticipated 1H 2022
Codiak to host conference call and webcast today at 8:00 am ET
CAMBRIDGE, Mass., November 16, 2021 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 positive initial data for exoSTING, 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.
We are excited to see that the initial foundational data from our exoSTING program are consistent with the pharmacologic activity that we observed with the candidate preclinically, and point to a differentiated mechanism of action afforded by the engineered exosome-based delivery of the STING agonist, said Doug Williams, PhD, CEO of Codiak. The targeted delivery and tumor retention observed so far appear to effectively engage the STING pathway, and at tested doses, exoSTING was well tolerated and showed initial signals of clinical activity. These data also reinforce our conviction that our engineering platform enables the specific design of therapeutic molecules with desired attributes to effectively modulate important targets that have not been successfully drugged before.
In the first three dose cohorts of trial participants treated with exoSTING in this ongoing dose-escalation study, evidence of local STING pathway activation and stimulation of both innate and adaptive immune responses were observed at all tested doses (0.3 mcg, 1.0 mcg, and 3.0 mcg). Intratumoral injection of exoSTING did not lead to systemic exposure to the STING agonist and was well tolerated at all dose levels tested. Additionally, pharmacodynamic data indicated that intratumoral administration of exoSTING was >100-fold more potent than data reported in prior published STING agonist clinical studies. Analysis of blood cells after exoSTING dosing showed the migration of activated cells from the tumor, and in some subjects, substantial induction of Interferon Stimulated Genes (ISG), which are involved in interferon response and activation of antigen presenting cells (APCs). Tumor shrinkage of injected and non-injected lesions were noted in a subset of subjects.
exoSTING is one of the first engineered exosome therapeutic candidates to be evaluated in humans and one of two Codiak programs currently in clinical development. exoSTING was engineered with the companys proprietary engEx Platform and designed to deliver Codiaks proprietary STING (Stimulator of Interferon Genes) agonist specifically to tumor-resident APCs to locally activate the innate immune response and to generate an adaptive immune response by presenting tumor antigens to T cells.
The STING pathway is a validated drug target, yet therapeutic development has been generally limited by lack of tumor retention, tolerability issues due to systemic exposure to the agonist and T-cell ablation in the tumor at higher agonist doses, resulting in the inability to effectively engage the pathway. In preclinical models of exoSTING, the targeted delivery of a STING agonist to tumor resident APCs promoted localized innate immune activation, T cell attraction and expansion in the tumor, and the development of systemic immunity not observed with a STING agonist delivered without exosomes (e.g., free).
Initial Data from Dose Cohorts 1-3
The initial data are being reported from the first three ascending dose cohorts (0.3 mcg, 1.0 mcg, and 3.0 mcg) enrolled in the Phase 1/2 study. Trial participants (n=11) were administered exoSTING intratumorally and all subjects had received at least two prior therapies prior to study entry with most (73%) having progressed on checkpoint inhibitors.
Plasma pharmacokinetic (PK) measurements of subjects that received exoSTING showed no systemic exposure to the agonist. Further, analyses of available plasma biomarkers indicated a lack of systemic inflammatory cytokines detectable in blood after exoSTING administration.
Within the first three dose cohorts, exoSTING was generally well tolerated and no treatment-related adverse events were observed through the 28-day follow-up period and beyond.
Blood biomarker assessments conducted post dosing showed evidence of dose-dependent activation of the STING pathway and Type I INF induction along with CXCL10, indicating activation of the innate immune response. Paired tumor biopsies available from two subjects showed evidence of an adaptive immune response and CD8 effector T cell infiltration into the tumor, as well as an increase in PD-L1 expression.
Finally, in subjects evaluable for early signs of antitumor activity (n=8), tumor shrinkage was observed in injected as well as distal, non-injected tumors, in a subset of subjects.
Enrollment in cohorts 4 (6 mcg) and 5 (12 mcg) of the exoSTING trial is ongoing. Data from all five cohorts including objective response data are expected in the first half of 2022, which will enable identification of a recommended Phase 2 dose.
exoSTING Development and Ongoing Phase 1/2 Clinical Trial
The Phase 1/2 dose escalation clinical trial of exoSTING is designed to investigate 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. As part of the Phase 2 portion of the trial, Codiak intends to enroll further expansion cohorts of patients at the optimal exoSTING dose to be identified in the Phase 1 portion of the clinical program.
exoSTING is Codiaks 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. Codiak believes that exoSTING has the potential to overcome certain limitations of free STING agonists, and to enhance the therapeutic index and selectivity of delivery to desired cells in the tumor microenvironment.
Conference Call and Webcast
Codiak will host a conference call and webcast today at 8:00 a.m. ET. The webcast may be accessed through the News & Events page in the Investors & Media section of Codiaks website at https://ir.codiakbio.com/news-events. A PDF of the accompanying slides will be available for download. Phone participants in the U.S and Canada may dial (800) 385-9715 and refer to conference ID 8863323 (international callers please use (409) 937-8965). To ensure timely access to the event, participants are encouraged to connect to the call 10 minutes before the start time or to use the webcast link for listen-only access.
The archived webcast will be available on Codiaks website beginning approximately two hours after the event and will be available for replay for at least 90 days after the event.
About Codiak BioSciences
Codiak 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.
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, including expected design of clinical trials and timing of availability and release of data, and statements regarding the capabilities and potential of Codiaks engEx Platform and engineered exosomes generally. In addition, Codiak has not conducted any head-to-head clinical studies that compare exoSTING to another drug product, whether investigational or approved. Information regarding other drug products in this news release is meant to provide context for illustrative purposes only. Because there are no head-to-head clinical studies, no conclusions should be made based on cross study comparison. Any forward-looking statements in this press release are based on managements 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 Codiaks 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 Codiaks 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.
VP, Investor Relations and Corporate Communications
EXOSTINGTM FIRST-IN-HUMAN CLINICAL TRIAL UPDATE N o v e m b e r 1 6 , 2 0 2 1 EXOSTINGTM FIRST-IN-HUMAN CLINICAL TRIAL UPDATE N o v e m b e r 1 6 , 2 0 2 1
Forward-Looking Statements and Disclaimers These slides and the accompanying presentation contain forward-looking statements and information within the meaning of the Private Securities Litigation Reform Act of 1995. The use of words such as may, might, will, should, expect, plan, anticipate, believe, estimate, project, intend, future, potential, or continue, and other similar expressions are intended to identify forward-looking statements. In addition, Codiak has not conducted any head-to-head clinical studies that compare exoSTING to another drug product, whether investigational or approved. Information regarding other drug products in this presentation is meant to provide context for illustrative purposes only. Because there are no head-to-head clinical studies, no conclusions should be made based on cross study comparison. All forward-looking statements are based on current expectations of future events, estimates and assumptions by our management that, although we believe to be reasonable, are inherently uncertain. All forward-looking statements are subject to a number of risks and uncertainties that may cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including those risks and uncertainties that are described under the heading Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2020, as well as discussions of potential risks, uncertainties and other important factors in our subsequent filings with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. PROPRIETARY INFORMATION OF CODIAK BIOSCIENCES | 2
exoSTINGTM: Proof of Mechanism and Clinical Activity Signal Data from First-in-Human Phase 1 Study (cohorts 1-3 of 5) demonstrates: ? Tumor retention of STING agonist, no systemic exposure ? No systemic inflammatory cytokine related AEs ? Favorable safety and tolerability profile at doses tested ? Innate and adaptive immune activation ? Antitumor activity in both injected and distal lesions PROPRIETARY INFORMATION OF CODIAK BIOSCIENCES | 3
The STING Pathway: Bridging Innate and Adaptive Immunity Step 1: Innate immune response STING activation leads to Type I 1 Interferon (IFN) production Leads to Chemokine production (CXCL10) 2 Step 2: APC activation and migration IFN activates Antigen Presenting Cells (APCs) APCs migrate via blood to lymph nodes and activate CD8+ T cells 3 Step 3: Adaptive immune response CD8+ T cell infiltration in the tumor to kill cancer cells PROPRIETARY INFORMATION OF CODIAK BIOSCIENCES | 4
STING? Pathway Validation and Outstanding Challenges Clinical validation of the STING pathway Challenges of Free STING agonists (FSAs) ?Oncolytic virus MOA via STING activation Rapid efflux/leakage from tumor to circulation ?Immune surveillance STING mediated via exosomes Systemic inflammatory cytokine release ?PARP7 activity STING mediated Poor tolerability ?Extensive pharma interest in STING pathway Dose selection, T cell ablation - 22 STING agonists in development Limited single agent activity (MK-1454, ADU-S100) - 2 new clinical programs in 2021 PROPRIETARY INFORMATION OF CODIAK BIOSCIENCES | 5
exoSTING?Novel, Differentiated STING Agonist: Preclinical Results ? STING agonist targeted to tumor APC Engineered to express high levels ? Precise dosing, drug retention of PTGFRN ? Lack of systemic STING agonist exposure ? Innate and adaptive immune activation Loaded with proprietary CDN ? T-Cell expansion/preservation ? Local and distal tumor responses = Cyclic Di-Nucleotide Jang et al Communications Biology (CDN): STING agonist 2021 PROPRIETARY INFORMATION OF CODIAK BIOSCIENCES | 6
exoSTING First-in-human data PROPRIETARY INFORMATION OF CODIAK BIOSCIENCES | 7
exoSTINGTM Phase 1/2 Trial: Study Design exoSTINGTM (CDK-002) Phase 1 dose escalation Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 0.3 mcg 1 mcg 3 mcg 6 mcg 12 mcg ? ? ? Enrolling DOSE ESCALATION, 3+3 DESIGN Cycle 1 Cycle 2 Cycle 3+ Screening Dosing Intratumoral injection in 1-3 lesions Serial biopsies and blood for robust CDK-002 Dosing biomarker plan Labs Tumor scans every 8 weeks Biomarkers PK/PD Biopsy Phase 2 dose selection Clinical DLT Activity CT Scan Safety PROPRIETARY INFORMATION OF CODIAK BIOSCIENCES | 8
exoSTING? Phase 1/2 Trial Strategic Objectives Endpoint Measures Desired Outcome PK STING agonist Plasma levels low/absent for STING agonist Low levels of systemic inflammatory cytokines AEs SAFETY STING Pathway activation and Type I IFN St 1 Cytokines/ BLOOD activation Chemokine BIOMARKERS Nanostring Evidence of APC activation/migration St 2 IFNâ CD8 STING pathway activation Adaptive immune response signals in tumor TISSUE BIOMARKERS CD68 CXCL9/10 CD8 T cell infiltration/activation TCF7 Anti-tumor functional CD8 T cells St 3 Nanostring CT scans RESPONSE Single agent antitumor activity (RECIST 1.1, ASSESSMENT (as part of complete dose escalation cohorts) iRECIST, itRECIST) PROPRIETARY INFORMATION OF CODIAK BIOSCIENCES | 9
exoSTINGTM Phase 1/2: Patient Demographics Cohorts 1-3 Baseline Patient Characteristics Characteristic All Patients (N = 11)* Median age, years (range) 61 (42-77) Sex, n (%) Male 5 (45.5) Female 6 (54.5) Race, n (%) Caucasian 9 (81.8) Black 1 (9.1) Asian 0 (0.0) Other/unknown 1 (9.1) ECOG PS, n (%) 0 2 (18.2) 1 9 (81.8) Prior Therapy with CPI, n (%) 73% of Patients progressed on yes 8 (72.7) checkpoint inhibitor no 3 (27.3) Number of prior regimens, n (%) 0 0 1 0 100% of Patients received at 2 11 (100) least 2 prior therapies * 2 patients were not evaluable for DLT PROPRIETARY INFORMATION OF CODIAK BIOSCIENCES | 10
exoSTING?No Systemic Exposure at Evaluated doses exoSTINGFree STING Agonist (FSA) Pharmacokinetics of exoSTING (C1D1) ADU-S100 o ns 100 ti 0.3 mcg tra ] 1.0 mcg e n /mL c g 10 3.0 mcg [ n con a st i m n as 1 o l LOQ 10 20 30 Meric-Bernstam et al., Clinc Cancer Res 2021 Time [Hours] Doses: 50, 100, 200, 400, 800. 1600, All data points in 3 cohorts below LOQ 3200 and 6400 mcg ved ? 1 dose at the intended dose level N=9* N=47 Codiak has not conducted a clinical comparison. PROPRIETARY INFORMATION OF CODIAK BIOSCIENCES | 11
exoSTING? Lack of Systemic Inflammatory Cytokine Induction exoSTINGFree STING Agonist (FSA) Minimal <2-fold IL-6 Induction Significant IL-6 Induction ADU-S100 (800 mcg) Day1 Day 8 15 22 Cycle 1 Day 1 0.3 mcg 1 mcg 3 mcg Change Fold SITC 2018 Time (hrs) Significant induction of IL-6; IFN-â, MCP-1 Similar results observed for TNF?; MCP-1 N=9* observed at 6 hr compared to baseline *all patients who received ? 1 dose at the intended dose level Codiak has not conducted a clinical comparison. PROPRIETARY INFORMATION OF CODIAK BIOSCIENCES | 12
exoSTING? Well-Tolerated at Tested Doses exoSTINGFree STING agonist (MK-1454) Treatment Related Adverse Events Total N=11* Adverse event, N (%) ?1 any AE 6 (54.5) Led to discontinuation 0 (0) Grade ? 3 0 (0) Led to death 0 (0) AEs ? 10% of patients Fatigue 2 (18.2) Tumor pain 2 (18.2) *all patients who received ? 1 dose Abstract, ESMO 2019 No significant AEs associated with Significant systemic inflammatory systemic inflammation AEs fever (65%), chills (39%) Codiak has not conducted a clinical comparison. PROPRIETARY INFORMATION OF CODIAK BIOSCIENCES | 13
exoSTING?Dose Dependent STING Activation: Confirmation of Step 1 1 Innate immune exoSTINGFree STING Agonist (FSA) response Dose Dependent CXCL10 mRNA induction MK-1454 IP-10/ CXCL10 Baseline from ge Chan Fold 0.3 1.0 3.0 Abstract, ESMO 2019 Dose [mcg] STING pathway activation at doses Dose expansion at 540 mcg >100-fold lower N=10* *all patients who received ? 1 dose with available PD biomarker data Codiak has not conducted a clinical comparison. PROPRIETARY INFORMATION OF CODIAK BIOSCIENCES | 14
exoSTING? Dose Dependent Induction of Type I Interferon Signaling in Peripheral Blood: Confirmation of Step 2 2 Activation/Migration of the APC into peripheral blood Pre 6hr 24hr 3.0 mcg 1.0 mcg 0.3 mcg Cycle 1 Pre 6hr 24hr Induction of Interferon Stimulated Genes (ISGs) Induction of APC activation and maturation genes *all patients who received ? 1 dose with available PD biomarker data (N=10) PROPRIETARY INFORMATION OF CODIAK BIOSCIENCES | 15
exoSTING? CD8 T Cell Infiltration and Activation: Confirmation of Step 3 3 Adaptive immune response Adaptive immune response with 3 and 11- fold Before After (Week 6) increase in CD8 T cells in 2/2 patients with paired DAPI biopsies CD8 PD-L1 Recruit stem-like progenitor effector CD8+/TCF7+ TCF7 T Cells (non-exhausted) Merged CD68 PD-L1 Negative tumor to PD-L1 Positive Strong correlation with preclinical data CD8 Pre-Clinical Mouse Tumor Data FSA exoSTINGTM - L1 PD Cohort 2: 1 mcg dose level Jang SC et al., Communications Biology 2021 PROPRIETARY INFORMATION OF CODIAK BIOSCIENCES | 16
exoSTING? Interferon Response in Blood Cells May Correlate with Clinical Antitumor Signal 100 Pre 6hr 24 hr # 90 Chondrosarcoma Parotid Gland Ca cSCC (Case #1) (Case #2) (Case #3) 80 70 # Signature 60 ISG 50 of 40 30 * Induction 20 Fold 10 0 Cohort 1 (0.3 mcg) Cohort 2 (1 mcg) Cohort 3 (3 mcg) * Only received 1st dose # On study therapy at data cutoff ISG signature: Genes involved in IFN response and APC activation PROPRIETARY INFORMATION OF CODIAK BIOSCIENCES | 17
exoSTING? Case Study #1, Cohort 1 (0.3 mcg) Shows Immune Activation 57 yo male with Chondrosarcoma Progression on 2 lines of therapy including combination PD-1 inhibitor / chemotherapy Chondrosarcoma Treatment at lowest dose exoSTINGTM in 100 patient with cold tumor resulted in: 80 FROM Stable disease 60 CHANGE 40 80-fold increase in IFN-stimulated 20% growth genes: STING pathway activation BASELINE 20 0 Injected Non-injected Non-injected Non-injected Non-injected PERCENTAGE -20 (1) (2) (3) (4) -40 VISIT - CYCLE 3 DAY 1 PROPRIETARY INFORMATION OF CODIAK BIOSCIENCES | 18
exoSTING? Case Study #2, Cohort 2 (1 mcg) Clinical Signal in Non-injected Distal Lesion 42 yo female with Parotid Gland Carcinoma On study drug for >7 months in heavily pretreated patient Progression on 4 lines of chemotherapy 74% decrease in non-injected tumor Parotid Gland Carcinoma (distal effect) 60 Injected tumor with 3-fold increase in FROM 40 20% growth Injected tumor CD8 T cell infiltration and 43-56% LESION 20 decrease in tumor cell content (%) 0 TARGET -20 Baseline Cycle 3 Day 1 Cycle 5 Day 1 Cycle 7 Day 1 Consistent with pseudo-progression IN BASELINE -40 30% decrease PD-L1 negative to PD-L1 positive lesion -60 e CHANGE -80 VISIT Target Injected Lesion Target Non-injected Lesion (1) Target Non-injected Lesion (2) Target Non-injected Lesion (3) PROPRIETARY INFORMATION OF CODIAK BIOSCIENCES | 19
exoSTING? Case Study #3, Cohort 3 (3 mcg) Clinical Signal in Injected Lesion 75 yo male with Cutaneous Squamous Cell Carcinoma (cSCC) Progression on 3 lines of therapy including PD-1 inhibitor cSCC 40 77% decrease in injected tumor #2 20% 20 Baseline increase 11-fold increase in T cell influx in 0 from injected tumor #1 -20 30% PD-L1 low tumor to PD-L1 high Change -40 decrease -60 Injected lesion #1: stable size and Percentage -80 decreased tumor Injected lesion #2: pain 77% decrease -100 Visit Cycle 3 Day 1 Pre-treatment After treatment PROPRIETARY INFORMATION OF CODIAK BIOSCIENCES | 20
exoSTINGTM: Proof of Mechanism and Clinical Activity Signal Data from First-in-Human Phase 1 Study (cohorts 1-3 of 5) demonstrates: ? Tumor retention of STING agonist, no systemic exposure ? No systemic inflammatory cytokine related AEs ? Favorable safety and tolerability profile at doses tested ? Innate and adaptive immune activation ? Antitumor activity in both injected and distal lesions PROPRIETARY INFORMATION OF CODIAK BIOSCIENCES | 21
exoSTINGTM?Future Direction Complete enrollment in cohorts 4 and 5 in 1H22 Determine Recommended Phase 2 Dose in 1H22 Assess antitumor activity from dose escalation in 1H22 Plan to submit data at scientific/medical conference in 1H22 Opportunities for single agent and combination strategies: Single agent indications like Parotid Gland tumors, cSCC, Sarcomas Combination with PD-1 inhibitor or exoIL-12 (SITC Presentation) Leptomeningeal Disease (SITC Presentation) PROPRIETARY INFORMATION OF CODIAK BIOSCIENCES | 22
exoSTING?Clinical Results Highlight Novel, Differentiated Profile ? Encouraging human clinical data supports advancement of exoSTINGTM program ? exoSTINGTM is a potent and active molecule with a wide therapeutic index ? Multiple opportunities as both single agent and in combination ? Encouraging initial safety and tolerability data with repeat dosing ? Foundational data demonstrates promise of engineered exosome therapeutics PROPRIETARY INFORMATION OF CODIAK BIOSCIENCES | 23