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Contract analysis / regulatory-fda-dd-memo.docx
regulatory-fda-dd-memo.docx
1018-00008 · 20 clauses
High · 1 Medium · 1 Standard · 2
I. Executive Summary Standard
⚑ Commercial term
I. Executive Summary This memorandum summarizes the results of our regulatory and FDA compliance due diligence review of Veridian Biosciences, Inc. ("Veridian" or the "Company") in connection with the proposed acquisition by Penterra Pharmaceuticals Corp. ("Penterra" or the "Buyer") of 100% of Veridian's outstanding capital stock (the "Transaction"). The proposed purchase price for the Transaction is $900,000,000 in
II. Company Regulatory Overview
II. Company Regulatory Overview A. Company Background Veridian Biosciences, Inc. is a corporation organized and existing under the laws of the State of Delaware, with its principal office and corporate headquarters located at 550 Gateway Drive, Cambridge, Massachusetts 02142. The Company was founded in 2016 by Dr. Julian Marek and Dr. Priya Chandrasekaran, who currently serve as Chief Executive Officer and Chief Scie
III. Pipeline Overview and Regulatory Status of Each Candidate
III. Pipeline Overview and Regulatory Status of Each Candidate The following section provides an overview of each of the three product candidates in Veridian's development pipeline and the current regulatory status of each as of May 2024. A. VRD-4187 (Lead Candidate) Product Description. VRD-4187 is a bispecific T-cell engager antibody construct developed using Veridian's proprietary VeriTCE platform technology. VRD-
1. Pre-IND Meeting (Type B): Conducted on March 3, 2021 (discussed in Section V.A).
1. Pre-IND Meeting (Type B): Conducted on March 3, 2021 (discussed in Section V.A).
2. IND Submission: June 14, 2021.
2. IND Submission: June 14, 2021.
3. IND Effective (no clinical hold): July 14, 2021.
3. IND Effective (no clinical hold): July 14, 2021.
4. Phase I Initiation (Marlowe Asset Management-1): August 2021.
4. Phase I Initiation (Marlowe Asset Management-1): August 2021.
5. Phase I Completion: December 2022.
5. Phase I Completion: December 2022.
6. End-of-Phase I Meeting (Type B): Conducted on January 24, 2023 (discussed in Section V
6. End-of-Phase I Meeting (Type B): Conducted on January 24, 2023 (discussed in Section V.B).
7. Phase II Initiation (Marlowe Asset Management-2): March 2023. Standard
⚑ Commercial term
7. Phase II Initiation (Marlowe Asset Management-2): March 2023. Clinical Hold Status. As of the date of this memorandum, there are no clinical holds or partial clinical holds on IND 154832. The IND has been in continuous active status since it became effective on July 14, 2021, and has not at any time been subject to a full or partial clinical hold. B. VRD-5923 (Pipeline Candidate #2) Product Description. VRD-5923 i
IV. Detailed IND Review — VRD-4187 (IND 154832)
IV. Detailed IND Review — VRD-4187 (IND 154832) A. IND Submission and Acceptance The original IND application for VRD-4187 (IND 154832) was submitted to the FDA's Center for Biologics Evaluation and Research ("CBER") on June 14, 2021. The IND was submitted to CBER, rather than the Center for Drug Evaluation and Research ("CDER"), because VRD-4187 is a bispecific antibody construct that is expected to be regulated as
1. Protocol Amendment 1 (August 2021): VRD-4187-001, Version 1.1 — Minor administrative c
1. Protocol Amendment 1 (August 2021): VRD-4187-001, Version 1.1 — Minor administrative corrections to the Phase I protocol; no substantive changes to study design or dosing.
2. Protocol Amendment 2 (January 2022): VRD-4187-001, Version 2.0 — Modification of the P
2. Protocol Amendment 2 (January 2022): VRD-4187-001, Version 2.0 — Modification of the Phase I dose-escalation scheme to incorporate a step-up dosing approach for the higher dose cohorts (≥1.0 mg/kg) based on emerging CRS data from the initial dose cohorts. This amendment was filed as a result of early safety observations indicating that more rapid dose escalation was associated with higher rates of Grade ≥2 CRS. Th
3. Protocol Amendment 3 (June 2022): VRD-4187-001, Version 2.1 — Addition of a dose-expan
3. Protocol Amendment 3 (June 2022): VRD-4187-001, Version 2.1 — Addition of a dose-expansion cohort at the 1.5 mg/kg target dose level to further characterize the safety and preliminary efficacy of VRD-4187 at the recommended Phase II dose.
4. Protocol Amendment 4 (February 2023): Submission of the Phase II clinical protocol (VR
4. Protocol Amendment 4 (February 2023): Submission of the Phase II clinical protocol (VRD-4187-002, Marlowe Asset Management-2, Version 1.0), providing for the randomized, open-label Phase II study design.
5. Protocol Amendment 5 (July 2023): VRD-4187-002, Version 2.0 — Addition of three additi
5. Protocol Amendment 5 (July 2023): VRD-4187-002, Version 2.0 — Addition of three additional clinical trial sites in the European Union; modification of the exclusion criteria to permit enrollment of patients with treated, stable brain metastases; clarification of CRS grading and management algorithms.
6. Protocol Amendment 6 (November 2023): VRD-4187-002, Version 3.0 — Revision of the stat
6. Protocol Amendment 6 (November 2023): VRD-4187-002, Version 3.0 — Revision of the statistical analysis plan to reflect updated assumptions regarding ORR based on emerging Phase I efficacy data; update to the DMC charter to clarify the interim analysis trigger and futility boundary.
7. Protocol Amendment 7 (January 2024): VRD-4187-002, Version 3.2 — Minor modifications t
7. Protocol Amendment 7 (January 2024): VRD-4187-002, Version 3.2 — Minor modifications to the informed consent form to reflect updated safety information from the investigator's brochure; addition of a patient-reported outcome questionnaire. We note that the modification to the dose-escalation scheme in Protocol Amendment 2 was a significant and proactive safety measure taken by Veridian in response to real-time cli
V. Pre-IND Meeting and FDA Interactions High
⚑ Non-compete / exclusivity restraint
V. Pre-IND Meeting and FDA Interactions A. Pre-IND Meeting — VRD-4187 Veridian conducted a pre-IND meeting (Type B meeting) with the FDA regarding VRD-4187 on March 3, 2021. The meeting request was submitted on December 15, 2020, in accordance with FDA's meeting management procedures, and the briefing document was submitted on February 3, 2021. The meeting was conducted via teleconference with representatives from FD
VI. Clinical Trial Compliance Medium
⚑ Confidentiality undertaking
VI. Clinical Trial Compliance A. Good Clinical Practice (GCP) Compliance (21 CFR Parts 50, 56, 312) We reviewed Veridian's framework for ensuring compliance with GCP requirements applicable to the conduct of clinical trials under 21 CFR Parts 50, 56, and 312, as well as the International Council for Harmonisation ("ICH") E6(R2) Guideline for Good Clinical Practice. Standard Operating Procedures. Veridian has establis