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Off target assessment using Retrogenix cell microarray technology |
PK and ADA methods |
Development of the PK and ADA methods in rat and mouse (4 week study), with validation of methods to support the 13-week GLP tox study (rat only). |
Extension of validation for PK and ADA methods up to 300 mg/kg in monkey |
Development and validation of the PK and ADA methods in human |
Proposed PD biomarkers for clinical phase 1 |
On skin biopsies (after LPS challenge in Healthy Volunteers): - IHC (3 panels: neutrophils, macrophages and NETosis (eg CITH3)). Validation needed. - RNA seq (3 gene expression signatures product-related available in human on whole blood, neutrophils and macrophages; 3 gene expression signatures linked to the mechanism... |
On whole blood: - PBMC subsets - ex vivo LPS challenge (multiplex cytokines). No validation needed for the multiplex cytokines portion on the ex vivo LPS challenge. |
On skin exudates from blister suctions: -NETosis (Validation needed). - Multiplex cytokines (No validation needed). |
CMC¹ |
New OSE230 GMP Drug Substance (DS) batch Manufacturing & release |
Stability studies for new GMP DS batch |
Analytical method transfer and partial validation of methods for Drug Product (DP) release |
OSE230 clinical GMP DP batch manufacturing & release |
Stability studies for clinical DP batch |
Compatibility & in-use stability study (design to be discussed with AbbVie depending on clinical trial use) |
Placebo batch manufacturing & release |
TBC= To be confirmed ¹ See Appendix A for CMC documentations to be provided by OSE. In the event that a replacement GMP batch is needed due to nonconformity, OSE would not be responsible for the cost of more than one replacement batch. |
Transition Development Plan Timeline² |
[Timeline chart image] |
*PD biomarkers requiring validation before Phase 1 start ²Timelines based on vendor projections summarized in the Workplan Table |
Transition Development Budget |
Study |
TOXICOLOGY PACKAGE |
4-w preli study in mice |
Revised 65 965€ signed -ERBC + TK and ADA- planned at Nantes |
4-w preli study in rat |
Revised 77 565 signed- ERBC |
SD GLP Resp Study in Rats |
13-w additional GLP study in monkey |
1 186 860€ signed ERBC |
QPS Bioanalysis (ADA and PK) |
77 900€ +11 550€ validation of new dose, signed QPS |
10 000 € Cytokines Kit- Nantes |
PK modeling Calvagone (PK analysis) 6 600 |
Total 1 292 910€ revised |
Off target assessment |
13-w GLP rat study |
+ 250 k€ bioanalysis at QPS |
378 530€ revised (number of animals reduced 148 vs 250 confirmed) + 6K€ QPS validation PK ADA 102 930€ (60 370+ 42 560) + bioanalysis 78090 € |
Total revised 565,590€ |
PHASE 1 HUMAN PK/BIOMARKERS |
Total 1,200 k€ still estimated |
PK and ADA methods |
Cytokine and biomarkers assessment |
CMC |
Additional GMP 250L DS batch |
Catalent Madison 1 576 000$ 1 321 000$ already paid Additional stability cost updated |
DP-related activities (production, analytical method validation, stability, Placebo) |
TOTAL |
Appendix A: CMC Documentations |
Item # |
1 |
2 |
3 |
4 |
5 |
6 |
³ Work may be performed at AbbVie or a CMO(s) selected by AbbVie. |
Schedule 10.2.1 Existing Patents |
List of Patents |
[Table with patent information including IP family references, filing numbers, dates, etc.] |
Schedule 10.2.10 Third Party Agreements |
ACTIVE BIOMARKER |
1. Amendment 1 to the Project Order 1 between OSE Immunotherapeutics and Active Biomarkers, effective as from June 15th, 2022 (executed) |
2. Amendment 2 to the Project Order 1 between OSE Immunotherapeutics and Active Biomarkers, effective as from July 18th, 2022 (executed) |
3. Project Order 1 between OSE Immunotherapeutics and Active Biomarkers, as from May 3rd, 2022 (executed) |
AGRO-BIO |
4. Contract for the provision of services (Contrat de prestation de services) between OSE Immunotherapeutics and Agro-Bio, effective as from August 11, 2023 (French language) (executed) |
5. Contract for the provision of services (Contrat de prestation de services) between OSE Immunotherapeutics and Agro-Bio, effective as from June 9, 2022 (French language) (executed) |
6. Contract for the provision of services between OSE Immunotherapeutics and Agro-Bio, effective as from June 9, 2022 (translation from French) |
7. Contract for the provision of services between OSE Immunotherapeutics and Agro-Bio, effective as from August 11, 2023 (translation from French) |
Ambiotis |
8. Patent Assignment Agreement (Contrat de Cession de Droits sur les brevets) between OSE Immunotherapeutics and Ambiotis, effective as from April 3, 2018 - in French |
9. Patent Assignment Agreement between OSE Immunotherapeutics and Ambiotis, effective as from April 3, 2018 - Translation from French |
ANAPATH |
10. Services Agreement between OSE Immunotherapeutics and AnaPath Research S.A.U, effective as from April 5th, 2022 (executed) |
B&S |
11. Engagement letter (Lettre de mission) OSE Immunotherapeutics - Accompagnement dans la définition et la mise en œuvre opérationnelle de la stratégie PI - January 1st, 2023 (French language) (executed) |
12. Engagement letter OSE Immunotherapeutics - Support in the definition and operational implementation of the IP strategy - January 1st, 2023 (translation from French) |
BIOTEM |
13. Contract for the provision of services (Contrat de prestation de services) between OSE Immunotherapeutics and Biotem, effective as from July 31, 2020 (French language) (executed) |
14. Contract for the provision of services between OSE Immunotherapeutics and Biotem, effective as from July 31, 2020 (translation from French) |
CALVAGONE |
15. Consulting Agreement between OSE Immunotherapeutics and Calvagone Sarl, effective as from April 27th, 2021 (executed) |
16. Amendment 2 to the Consulting Agreement between OSE Immunotherapeutics and Calvagone Sarl, effective as from June 13th, 2022 (executed) |
17. Services Agreement between OSE Immunotherapeutics and Calvagone SAS, effective as from December 23rd, 2022 (executed) |
18. Services Agreement between OSE Immunotherapeutics and Calvagone SAS, effective as from September 26, 2023 (executed) |
19. Services Agreement between OSE Immunotherapeutics and Calvagone SAS, effective as from January 10, 2024 (executed) |
CATALENT FRANCE LIMOGES |
20. Customized Solution for OSE Immunotherapeutics - Clinical Program Phase 1 for OSE 230 Product - 9 March 2022 (executed) |
21. Solution for OSE Immunotherapeutics - Cancellation and Postponement fees for OSE 230 Product - 23 March 2023 (executed) |
CATALENT MADISON US |
22. Statement of Work (SOW) - QTE-9193180 - OSE Immunotherapeutics SA - Catalent Pharma Solutions LLC - OSE 230 - April 28, 2021 |
23. Statement of Work (SOW) - QTE -9194626- OSE Immunotherapeutics SA - Catalent Pharma Solutions LLC - OSE 230 - June 4, 2021 |
24. Statement of Work (SOW) - QTE 9188753- OSE Immunotherapeutics SA - Catalent Pharma Solutions LLC - OSE 230 - September 29, 2021 |
25. Statement of Work (SOW) - QTE-9201531 - OSE Immunotherapeutics SA - Catalent Pharma Solutions LLC - OSE 230 - November 10, 2021 |
26. Statement of Work (SOW) - QTE-9209608 - OSE Immunotherapeutics SA - Catalent Pharma Solutions LLC - OSE 230 - July 21, 2022 |
27. Statement of Work (SOW) - QTE-9188753 - OSE Immunotherapeutics SA - Catalent Pharma Solutions LLC - OSE 230 - September 26, 2022 |
28. Statement of Work (SOW) - QTE-9209608 - OSE Immunotherapeutics SA - Catalent Pharma Solutions LLC - OSE 230 - October 28, 2022 |
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