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Novel Interleukin-2 Variants And Bifunctional Fusion Molecules Thereof CANADA 3143038 6/13/2020 12/08/2021 6/14/2019 Pending |
Novel Interleukin-2 Variants And Bifunctional Fusion Molecules Thereof CHINA N/A 6/13/2020 6/14/2019 Pending |
Novel Interleukin-2 Variants And Bifunctional Fusion Molecules Thereof EPC 20823570.5 6/13/2020 01/04/2022 6/14/2019 Pending |
Novel Interleukin-2 Variants And Bifunctional Fusion Molecules Thereof JAPAN 2021-573426 6/13/2020 12/10/2021 6/14/2019 Pending |
Novel Interleukin-2 Variants And Bifunctional Fusion Molecules Thereof KOREA 10-2022-700354 6/13/2020 01/13/2022 6/14/2019 Pending |
Novel Interleukin-2 Variants And Bifunctional Fusion Molecules Thereof UNITED STATES 17/608,207 6/13/2020 12/10/2021 6/14/2019 Pending |
Novel Interleukin-2 Variants And Bifunctional Fusion Molecules Thereof UNITED STATES 62/861,484 6/14/2019 N/A Closed |
Novel Interleukin-2 Variants And Bifunctional Fusion Molecules Thereof WIPO PCT/US2020/037648 6/13/2020 6/14/2019 Closed |
SCHEDULE 1.116 |
IN-LICENSE SCHEDULE |
WuXi Agreement |
SCHEDULE 1.123 |
INDICATIONS |
The following would be treated as separate Indications: |
• Systemic Lupus Erythematosus |
• Lupus Nephritis |
• Type I diabetes |
• Type II diabetes |
• Atopic Dermatitis |
• Ulcerative Colitis |
• Crohn's disease |
• Psoriasis |
• Rheumatoid Arthritis |
• Ankylosing Spondylitis |
• Sjogren's syndrome |
• Behcet's disease |
• Sclerosing cholangitis |
• Granulomatosis with polyangiitis |
• Takayasu's disease |
• Autoimmune hepatitis |
• Allergic Anaphylaxis |
• Alopecia Areata |
• ANCA Vasculitis |
• Celiac Disease |
• Chronic Fibrosing Lung Disease |
• COVID-19 |
• Dermatomyositis |
• Graft Versus Host Disease |
• Hidradenitis Suppurativa |
• IgG4-related Systemic Disease |
• Idiopathic Pulmonary Fibrosis |
• Multiple Sclerosis |
• Primary Biliary Cirrhosis |
• Polymyositis |
• Psoriatic Arthritis |
• Systemic Sclerosis (including Systemic Sclerosis-associated Lung Disease) |
• Vitiligo |
SCHEDULE 1.126 |
INITIAL DEVELOPMENT PLAN AND BUDGET |
AbbVie contributors/principal owners: Discovery Raj Kamath |
Development Alan Friedman |
DMPK James Sheridan |
CPPM Wei Liu |
DMPK/ Toxicology Kennan Marsh, David Honor |
Stats Zailong Wang |
Biologics Discovery Blaine Stine |
CMC – R&D John Morris, Hans_Juergen Krause, Omon Herigstad |
Project Management Shelly Ziemelis |
CSL Rachele Jareb |
IP Sonali Srivastava |
BD Jake Cournoyer |
S&E Gordon Ng |
Regulatory Lee Muraoka |
OVERALL PLANS AND GOALS |
Completion of the CUG252 Phase I Clinical Trial reported in the USA FDA IND 152972 following FDA notice to proceed (dated November 12, 2021) |
The overall objective of this development plan is to assess the therapeutic potential, safety, PK-PD of CUG252 in a first-in-human Single Ascending Dose (SAD) Phase Ia Clinical Trial in healthy volunteers (HV), explore in an early proof of concept (ePoC) Multiple Ascending Dose (MAD) Phase Ib Clinical Trial in adult pa... |
The following Gantt chart describes the key clinical, pre-clinical, and CMC activities that will be performed as part of the Initial Development Plan and Budget as defined in that certain Collaboration and License Option Agreement, dated May 6, 2022 (Agreement) between AbbVie Global Enterprises Ltd. (AbbVie) and Cugene... |
CUG252 Development Plan Gantt Chart |
[Chart described but not fully visible in text form] |
I. ADMINISTRATION/OPERATIONS |
A. Monthly Updates and Quarterly Reporting at Least Through Start-Up |
Monthly meeting updates are to contain the following as available: |
• General study progress update Quarterly reports are to contain the following as available: |
• Program conduct and metrics o Site activation status, recruitment updates, screening data, follow-up visits and subject dispositions, number of open queries, number of forms completed, number of SDV done, number of forms locked) |
• Raw (unmonitored) data, including: o Safety (e.g., SAEs) o PK, ADA, pharmacodynamic and exploratory biomarker data |
• Any new CMC information received by Cugene o CMC timelines provided with any changes o Stability and characterization data, quality issues |
• Note: All analyses shall be performed using SAS version 9.4 or later (SAS Institute Inc., Cary, NC 2726) under the UNIX operating system. |
• Any new regulatory information with Regulatory Authorities and IP |
• Open meeting minutes and outputs of Safety Data Monitoring Committee (DSMB) |
Exception from monthly updates is any clinical safety issues (e.g., SUSARs, IND annual reports, DSURs) or safety signals (e.g., hypersensitivity reactions) to be shared immediately with IRBs and/or Regulatory Authorities. |
Semiannual reports are to contain the following as available: |
• Efficacy clinical data (SDTM-Study Data Tabulation Model SAS data sets) |
• Analysis Data Model (ADAM) SAS data sets and summarized data outputs (Tables, Listings and Figures) based on pre-specified SAP (Statistical Analysis Plan) and timelines for the Phase Ib Clinical Trial and, to the extent available, for the Phase Ia Clinical Trial |
B. Cugene Readiness and Operational Plan |
Cugene shall provide an operational plan that contains elements to reasonably demonstrate that Cugene shall have adequate resources and expertise to execute the Initial Development Plan and Budget. This includes: |
Profiles of staff and hiring profiles of needed staff along with consultants that are consistent with industry practice for similar preclinical and clinical representative positions for a program at this stage of Development. |
Reasonably detailed timelines and budgets (including FTE-based staffing costs) for the Development activities along the timelines agreed to by the Parties. |
Copies of Cugene's quality training program documentation, quality standard operating procedures and quality information systems documentation, which AbbVie shall have the right, during normal business hours and upon at least five Business Days' notice, to inspect and to discuss with appropriate employees and represent... |
CRO proposals outlining study objectives, plans and deliverables. |
Operational Plan |
Activity/Objective Deliverables Timeline |
Business and Operational Plan (BO Plan) Cugene will have adequate resources and expertise to execute the Initial Development Plan and Budget. The BO Plan provided to AbbVie will include: Profiles of staff and hiring profiles of needed staff along with consultants that are consistent with industry practice for similar p... |
Quality Program During the conduct of the activities under the Initial Development Plan and Budget, Cugene will retain QA consultants to monitor the ongoing activities to ensure compliance with SOPs and relevant regulations: Code of Federal Regulations (CFR) Title 21, Part 210: Current Good Manufacturing Practice CFR T... |
Responsibility Matrix |
Party for execution of activities Advisory |
IND 152972 Sponsor Cugene |
CMC AbbVie (on Items identified below) |
1. DS/DP Process and Formulation Development Cugene (subcontracted to WuXi) AbbVie |
2. DS Manufacture (GLP and GMP batches) Cugene (subcontracted to WuXi) AbbVie |
3. DP Manufacture (GLP and GMP batches) Cugene (subcontracted to WuXi) AbbVie |
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