Candel Therapeutics, Inc. · NASDAQ:CADL
Candel Therapeutics — Technical Presentation (January 2024)
46 slides from Candel Therapeutics's technical presentation, Jan 17, 2024
Slide 1: PrTK03 Coordinator Training
PrTKO3 Coordinator Training ©7e2e@e@eeeene Confidential 2024
Slide 2: Trial Overview
Trial Overview ~ CANDEL 2 THERAPEUTICS,
Slide 3: CAN-2409: Mechanism of Action
CAN-2409: Mechanism of Action 3
Slide 4: PrTK03 Patient Population
PrTK03 Patient Population • Patients whose first line of treatment is external beam radiation treatment. AJCC TNM Clinical Staging Criteria Intermediate Risk – Any of the following: PSA 10-20 ng/ml Gleason score = 7 T2b-T2c (OR) Single High Risk factor: PSA> 20 ng/ml Gleason score 8-10 T3a • Patient
Slide 5: Ongoing phase clinical trial of CAN-2409
Ongoing phase 3 clinical trial of CAN-2409 CAN-2409 + Valacyclovir Placebo + Valacyclovir ° (3 injection courses + radiotherapy) in newly diagnosed, intermediate/high risk prostate cancer (3 injection courses + radiotherapy) Primary Endpoints Disease free survival (DFS) Secondary Endpoints PSA freed
Slide 6: PrTK03 Study Treatment Schedule
PrTK03 Study Treatment Schedule • Once patient was enrolled, received their first injection about 2-8 weeks prior to radiotherapy • First course of valacyclovir taken over course of 14 days • Treatment Assessment (TA) visits occurred ~2 weeks after each injection • Second injection was on the day of
Slide 7: PrTK03 Time and Event Table
PrTK03 Time and Event Table (as per SOC) 7
Slide 8: Valacyclovir Prodrug
Valacyclovir Prodrug • On the day of each CAN-2409 or placebo injection, the patient received the valacyclovir tablets for this course and diary (PA form). Patient was to start taking valacyclovir the day after their first injection. • The dose of valacyclovir was 2 grams orally three times per day
Slide 9: Pre-Treatment Phase
Pre-Treatment Phase ~ CANDEL 3 THERAPEUTICS,
Slide 10: Patient Recruitment and Consenting
Patient Recruitment and Consenting • Prior to consenting, the patient confirms they are willing to participate in all study related requirements and to complete the 24-month biopsy two years after they finish radiation treatment for their prostate cancer. • Prior to consenting a patient on the study
Slide 11: Enrollment Log
Enrollment Log • Enrollment Log is needed and important for keeping track of patient information with their assigned patient identifiers • Connects Site ID and Protocol Case Number (PCN) with patient information • Site Screening ID should be assigned for each patient using your site’s two letter cod
Slide 12: PrTK03 CRF Submission Schedule
PrTK03 CRF Submission Schedule • Send all data to crf@candeltx.com within 2 weeks of patient’s completed visit • Refer to the Data Submission SOP for in depth instructions on submitting patient data CRF Dictionary • Please make sure all CRFs are taken directly EC Eligibility Checklist PA Prodrug Adm
Slide 13: Patient Enrollment and EC CRF
Patient Enrollment and EC CRF EC Packet will include: • Completed EC CRF • PSA report (specific assay included) – within 6 months of enrollment date • Pathology Report – within 12 months of enrollment date • Lab report – within 4 weeks of 1st injection date • H & P – within 4 weeks of 1st injection
Slide 14: Patient Registration
Patient Registration • Patient Registration (PR) form is sent from Candel to site at time of enrollment. • This CRF is not required to be filled out or submitted by site. • PCN will be assigned on this form and the enrollment log will need to be updated once received. • 1st injection date and radiat
Slide 15: Treatment Phase
Treatment Phase ~ CANDEL 1s THERAPEUTICS,
Slide 16: Drug Accountability and Documentation
Drug Accountability and Documentation • DA Forms are used as a verification to confirm that drug on site matched pre- populated vial numbers and the prodrug lot number assigned to study patients. • Since the study is closed to enrollment, there should be no drug remaining on site. • All DA forms sho
Slide 17: Injection Form (VP-CRF)
Injection Form (VP-CRF) • VP Forms were submitted once per injection. • Ex: if patient had 3 injections, there should be 3 VP Forms. • Ensure all fields are signed and dated by the appropriate party • Sections A and C should be completed and signed by investigator. • All investigators who have perfo
Slide 18: Post-Injection
Post-Injection • Post-injection instructions of alternating between acetaminophen and ibuprofen for 24-48 hrs after procedure were provided to patients along with the diary and valacyclovir bottle. • Patients were informed of the potential flu-like symptoms. Fever and chills were potentially expecte
Slide 19: Treatment Assessment
Treatment Assessment • Treatment Assessment visits occurred ~2 weeks following each injection procedure. • Visit encouraged to happen day of, prior to their next injection. • Labs were required to be drawn to determine the patient’s creatinine clearance, an important measurement that determined the
Slide 20: Radiation Summary
Radiation Summary • RA CRF was to be completed after patients finished their radiation and ADT (when applicable). • Total radiation dose to PTV and radiation regimen on CRF and attached source documentation (radiation summary) should have been included. • A single RA CRF per patient is expected to b
Slide 21: After-Treatment Phase
After-Treatment Phase ~ CANDEL a THERAPEUTICS,
Slide 22: After-Treatment Follow Up
After-Treatment Follow Up • After-Treatment assessments should occur along SOC radiation follow-up visits (3m, 6m, and every 6 months up to 5 years post completion of radiation). • Quality of Life questionnaire is required for each after-treatment assessment visit up to the 24-month visit. • Section
Slide 23: After-Treatment Follow Up: New Medical Problems
After-Treatment Follow Up • New Medical Problems (NMPs) are to be reported at time of patient’s AT visits if a new diagnosis has occurred. • NMPs are NOT to be reported if it has been previously reported as an AE or at baseline. • Refrain from duplicating New Medical Problems on page 3 (Gastrointest
Slide 24: After-Treatment Follow Up: GI/GU Symptoms
After-Treatment Follow Up • GI/GU symptoms (if present) are to be reported at the time of the visit, even if symptom was first present at previous visit. • Please ensure that this page is consistent with Section B on page 1. 24
Slide 25: 24-Month Biopsy Collection
24-Month Biopsy Collection • Patients are required per the protocol to undergo a biopsy 2 years post-radiation completion (equivalent to their 24-month visit) • Throughout the course of their participation on the study and at each of their visits, they should be reminded that a biopsy will need to b
Slide 26: Pathology Slides
Pathology Slides • After filling out the PT CRF, please keep the wet-ink original and include a copy in the slide shipment. • You are encouraged to bulk ship slides with multiple patients packaged in one shipment to Candel but please make sure pathology slides are de-identified with PCN and slide id
Slide 27: Long-Term Follow Up
Long-Term Follow Up • Long term follow-up typically starts 5 years post- radiation. • LT visits have no defined window, so long as it happens within the year of the last visit that occurred. • This form can be used to provide follow-up for patients that were deemed a treatment failure. • If a patien
Slide 28: Critical Forms
Critical Forms ~ CANDEL 28 THERAPEUTICS,
Slide 29: Adverse Event Reporting
Adverse Event Reporting • Adverse event (AE) reporting is required during the patients Acute Toxicity Monitoring Period: initiation of study treatment until 30 days after the last administration of valacyclovir. • There are no longer any patients within this time period, however there should still b
Slide 30: Adverse Event Reporting
@ Adverse Event Reporting e the Onset date is the injection date, indicate if it is before (B) or after (A) the injection Adverse Events Date* | Resolved Date* Contributing e |___ (CTC Designation) mMvppryy | MMppivy_| Grd | Relation’) rnctors® Reported As: Renal and Urinary Disorders e@ Cystitis no
Slide 31: Serious Adverse Event
Serious Adverse Event • Patients are no longer in the acute toxicity phase, only SAEs considered related to the study drug should be reported to the Candel team on an SAE form. • For any patient that underwent an SAE, please ensure all source documentation is on file and available to access. 31
Slide 32: Deviation Reporting
Deviation Reporting • Variance forms are to only be filled out when there are deviations from the protocol. If you are unsure if a deviation has occurred, please reach out to the CRA team. VR forms are also queried for by Candel. • A variance report should not be used as a form of documenting note t
Slide 33: Treatment Failure
Treatment Failure • This is a critical event to report to the Candel team ASAP. • The FDA does not recognize a rising PSA or abnormal DRE as a treatment failure • Further SOC assessments, such as Imaging, and/or Biopsy should be done to confirm treatment failure has occurred • Results of assessments
Slide 34: New Treatment Form
New Treatment Form • This is a one-time form to be completed for patients who have clinical progression/recurrence and go on to receive additional treatment • It is to document the first new treatment start date and treatment type • A query will be opened to submit a NT-CRF when it’s indicated on a
Slide 35: Monitoring & Invoicing
Monitoring & Invoicing ~ CANDEL as THERAPEUTICS,
Slide 36: Monitoring Overview
Monitoring Overview • Monitoring reports are sent during the first week of every month. • Items included in the report may include: • Patient summary • Query reports • Overdue visit reports • Pathology slide reports • Please send in data in a timely manner when a patient visit has occurred or notify
Slide 37: Patient Overview
Patient Overview Sei) THERAPEUTICS A B Cc D E F G H i] J K L M N Course 1 Course 2 Course 3 Protocol Case Clinic Name Enrollment | Date of last Discontinuation Overdue Open Patient Status vP1 TAL vp2 TA2 vp3 TA Number Date | Followup | Withdrawal visits | queries 1234CA Candel Therapeutics 01/02/345
Slide 38: Example Query Report
Example Query Report PCN Clinic Name Form Name Tx Phase 1234CA——Candel Therapeutics AT 3 year 1234CA——Candel Therapeutics TA Course 3 1234CA ——Candel Therapeutics AT 18 months 1234CA —Candel Therapeutics AT 24 months -CANDEL THERAPEUTICS Date of event Item Description Please submit the PSA report fo
Slide 39: Example Pathology Slide Query Report
Example Pathology Slide Query Report 39
Slide 40: Example Overdue Visit Report
Example Overdue Visit Report 40
Slide 41: Invoicing
Invoicing • We invoice on a quarterly basis, at the beginning of the last month in the quarter, your CRA will notify you the cut-off date to submit data. The data must be submitted by that date in order to be paid out for that quarter. • Sites are invoiced based on quality and quantity of data that
Slide 42: Example Invoice
Example Invoice ~CANDEL prtko3 Therapeatics 17 Kendrick St Suite 450, Ncdham, MA 02495 Ph: 617-916:5445 Pas remit invoices to: accounspavaheGicandc com vice Date: 12/15/2¢ Mee ea me ee ne ne aa >? lPlelelPel] llr] ele le poe oP Pl > [>e)>Plele)rPle|w |e I I poe Pre lP e ye lPle le lel le I I PoP oP
Slide 43: GDP and Investigator Portal Access
GDP and Investigator Portal Access ~ CANDEL 43
Slide 44: Good Documentation Practices Refresher
Good Documentation Practices Refresher • Multiple versions of one document on site with wet ink on various copies • Ensure you are only working off one original document. All changes and corrections should be made to the original document. If you need to copy a document for any reason, it should be
Slide 45: Investigator Portal Access
Investigator Portal Access • The Investigator Portal can be accessed via the following address: https://www.candeltx.com/investigator-login/ • To request access, follow the above link and sign up as a new user. • Once registration has been completed, Candel will grant access to the new user. • Inves
Slide 46: Thank You!
Thank You! -CANDEL Fy PEUTICS
Candel Therapeutics — Technical Presentation (January 2024) on 6ix