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OPTIMIZED PNE-BASED CHIMERIC RECEPTOR T CELL SWITCHES AND USES... Hong Kong 18110231.8 8/19/2018 HK1250661 1/11/2019 Published Eric HAMPTON, Travis YOUNG, David RODGERS, Ian Hardy, Chanhyu... 1923.2HK |
OPTIMIZED PNE-BASED CHIMERIC RECEPTOR T CELL SWITCHES AND USES... European Patent Office 16780958.1 4/15/2016 3283113 2/21/2018 Published Travis YOUNG, David RODGERS, Ian Hardy, Chanhyuk KIM, Peter G. S... 1923.2EP |
CHIMERIC RECEPTOR T CELL SWITCHES AND USES THEREOF United States 62/253,467 11/10/2015 Expired Travis YOUNG, David RODGERS, Ian Hardy, Chanhyuk KIM, Peter G. S... 1923.1P |
OPTIMIZED CHIMERIC RECEPTOR CELL SWITCHES AND USES THEREOF United States 62/148,063 4/15/2015 Expired Travis YOUNG, David RODGERS, Ian Hardy, Chanhyuk KIM, Peter G. S... 1923.0P |
CHIMERIC RECEPTOR T CELLS AND USES THEREOF United States 15/561,274 9/25/2017 20180118808 5/3/2018 10,800,828 10/13/2020 Issued Travis YOUNG, Chanhyuk KIM, Peter G. SCHULTZ 1922.1US |
SWITCHABLE NON-scFv CHIMERIC RECEPTOR T CELLS AND USES THEREOF World Intellectual Property Organization PCT US2016/024252 3/28/2016 WO 16/154621 9/29/2016 Expired Travis YOUNG, Chanhyuk KIM, Peter G. SCHULTZ 1922.1PC |
CHIMERIC RECEPTOR T CELLS AND USES THEREOF United States 62/138,901 3/26/2015 Expired Travis YOUNG, Chanhyuk KIM, Peter G. SCHULTZ 1922.0P |
OPTIMIZED CHIMERIC RECEPTOR T CELL SWITCHES AND USES THEREOF United States 15/566,685 4/15/2016 Abandoned Chanhyuk KIM, Travis YOUNG, Jennifer MA, Ji Young KIM, Hui WANG... 1771.3US |
OPTIMIZED CHIMERIC RECEPTOR T CELL SWITCHES AND USES THEREOF World Intellectual Property Organization PCT US2016/027990 4/15/2016 WO 16/168766 10/20/2016 Expired Chanhyuk KIM, Travis YOUNG, Jennifer MA, Ji Young KIM, Hui WANG... 1771.3PC |
CHIMERIC RECEPTOR T CELL SWITCHES FOR HER2 World Intellectual Property Organization PCT US2016/027993 4/15/2016 WO 16/168769 10/20/2016 Expired Yu J. CAO, Travis YOUNG, Peter G. SCHULTZ 1771.2PC |
CHIMERIC RECEPTOR T CELL SWITCHES FOR HER2 United States 62/253,465 11/10/2015 Expired Yu J. CAO, Travis YOUNG, Peter G. SCHULTZ 1771.1P |
CHIMERIC RECEPTOR T CELL SWITCHES FOR HER2 United States 62/148,070 4/15/2015 Expired Yu J. CAO, Travis YOUNG, Peter G. SCHULTZ 1771.0P |
PEPTIDIC CHIMERIC ANTIGEN RECEPTOR T CELL SWITCHES AND USES THE... United States 18/056,554 11/17/2022 Pending Travis YOUNG, Chanhyuk KIM, Peter G. SCHULTZ 1666.6C |
PEPTIDIC CHIMERIC ANTIGEN RECEPTOR T CELL SWITCHES AND USES THE... United States 17/713,489 5/2022 Abandoned Travis YOUNG, Chanhyuk KIM, Peter G. SCHULTZ 1666.6C3 |
PEPTIDIC CHIMERIC ANTIGEN RECEPTOR T CELL SWITCHES AND USES THE... United States 16/532,860 8/6/2019 20200197497 6/25/2020 Abandoned Travis YOUNG, Chanhyuk KIM, Peter G. SCHULTZ 1666.6C2 |
PEPTIDIC CHIMERIC ANTIGEN RECEPTOR T CELL SWITCHES AND USES THE... United States 15/484,477 4/2/2017 20170246270 8/31/2017 10,391,155 8/27/2019 Issued Travis YOUNG, Chanhyuk KIM, Peter G. SCHULTZ 1666.6C1 |
PEPTIDIC CHIMERIC ANTIGEN RECEPTOR T CELL SWITCHES AND USES THE... United States 14/688,899 4/16/2015 20150307564 10/29/2015 9,624,276 4/18/2017 Issued Travis YOUNG, Chanhyuk KIM, Peter G. SCHULTZ 1666.6 |
PEPTIDIC CHIMERIC ANTIGEN RECEPTOR T CELL SWITCHES AND USES THE... World Intellectual Property Organization PCT US14/060684 10/15/2014 WO 15/057834 4/23/2015 Expired Travis YOUNG, Chanhyuk KIM, Peter G. SCHULTZ 1666.5PC |
PEPTIDIC CHIMERIC ANTIGEN RECEPTOR T CELL SWITCHES AND USES THE... Republic of Korea 10-2016-7012414 10/15/2014 20160062760 6/2/2016 10-2339240 12/9/2021 Issued Travis YOUNG, Chanhyuk KIM, Peter G. SCHULTZ 1666.5KR |
PEPTIDIC CHIMERIC ANTIGEN RECEPTOR T CELL SWITCHES AND USES THE... Japan 2020-037808 3/5/2020 20200196604 6/25/2020 Abandoned Travis YOUNG, Chanhyuk KIM, Peter G. SCHULTZ 1666.5JPD1 |
PEPTIDIC CHIMERIC ANTIGEN RECEPTOR T CELL SWITCHES AND USES THE... Japan 2016-522782 10/15/2014 2016533174 10/27/2016 6734477 7/14/2020 Issued Travis YOUNG, Chanhyuk KIM, Peter G. SCHULTZ 1666.5JP |
PEPTIDIC CHIMERIC ANTIGEN RECEPTOR T CELL SWITCHES AND USES THE... Italy 14854285.5 10/15/2014 502020000012146 9/23/2020 Issued Travis YOUNG, Chanhyuk KIM, Peter G. SCHULTZ 1666.5IT |
PEPTIDIC CHIMERIC ANTIGEN RECEPTOR T CELL SWITCHES AND USES THE... Hong Kong 17100359.6 7/17/2023 1226751A 10/6/2017 Published Travis YOUNG, Chanhyuk KIM, Peter G. SCHULTZ 1666.5HK |
PEPTIDIC CHIMERIC ANTIGEN RECEPTOR T CELL SWITCHES AND USES THE... United Kingdom 14854285.5 10/15/2014 3057990 9/23/2020 Issued Travis YOUNG, Chanhyuk KIM, Peter G. SCHULTZ 1666.5GB |
PEPTIDIC CHIMERIC ANTIGEN RECEPTOR T CELL SWITCHES AND USES THE... France 14854285.5 10/15/2014 3057990 9/23/2020 Issued Travis YOUNG, Chanhyuk KIM, Peter G. SCHULTZ 1666.5FR |
PEPTIDIC CHIMERIC ANTIGEN RECEPTOR T CELL SWITCHES AND USES THE... Spain 14854285.5 10/15/2014 3057990 9/23/2020 Issued Travis YOUNG, Chanhyuk KIM, Peter G. SCHULTZ 1666.5ES |
PEPTIDIC CHIMERIC ANTIGEN RECEPTOR T CELL SWITCHES AND USES THE... European Patent Office 14854285.5 10/15/2014 3057990 8/24/2016 3057990 9/23/2020 Issued Travis YOUNG, Chanhyuk KIM, Peter G. SCHULTZ 1666.5EP |
PEPTIDIC CHIMERIC ANTIGEN RECEPTOR T CELL SWITCHES AND USES THE... Germany 14854285.5 10/15/2014 602014070576.6 9/23/2020 Issued Travis YOUNG, Chanhyuk KIM, Peter G. SCHULTZ 1666.5DE |
PEPTIDIC CHIMERIC ANTIGEN RECEPTOR T CELL SWITCHES AND USES THE... China 201480066872.6 10/15/2014 105829349 8/3/2016 ZL 201480066872.6 2/3/2023 Issued Travis YOUNG, Chanhyuk KIM, Peter G. SCHULTZ 1666.5CN |
PEPTIDIC CHIMERIC ANTIGEN RECEPTOR T CELL SWITCHES AND USES THE... Canada 2,927,543 10/15/2014 2927543 4/23/2015 2,927,543 7/20/2021 Issued Travis YOUNG, Chanhyuk KIM, Peter G. SCHULTZ 1666.5CA |
PEPTIDIC CHIMERIC ANTIGEN RECEPTOR T CELL SWITCHES AND USES THE... Australia 2020207804 10/15/2014 2020207804 8/6/2020 Abandoned Travis YOUNG, Chanhyuk KIM, Peter G. SCHULTZ 1666.5AUD1 |
PEPTIDIC CHIMERIC ANTIGEN RECEPTOR T CELL SWITCHES AND USES THE... Australia 2014337367 10/15/2014 2014337367 4/7/2016 2014337367 8/13/2020 Issued Travis YOUNG, Chanhyuk KIM, Peter G. SCHULTZ 1666.5AU |
CHIMERIC ANTIGEN RECEPTOR T CELL SWITCHES AND USES THEREOF United States 14/432,065 3/27/2015 2015-0238631 8/27/2015 Abandoned Chanhyuk KIM, Travis YOUNG, Yu J. CAO, Jennifer MA, Minsoo KIM, St... 1666.4US |
CHIMERIC ANTIGEN RECEPTOR T CELL SWITCHES AND USES THEREOF World Intellectual Property Organization PCT US14/060713 10/15/2014 WO 15/057852 4/23/2015 Expired Chanhyuk KIM, Travis YOUNG, Yu J. CAO, Jennifer MA, Minsoo KIM, St... 1666.4PC |
CHIMERIC ANTIGEN RECEPTOR T CELL SWITCHES AND USES THEREOF Republic of Korea 10-2016-7012417 10/15/2014 20160062761 6/2/2016 10-2357968 1/26/2022 Issued Chanhyuk KIM, Travis YOUNG, Yu J. CAO, Jennifer MA, Minsoo KIM, St... 1666.4KR |
CHIMERIC ANTIGEN RECEPTOR T CELL SWITCHES AND USES THEREOF Japan 2019-186117 10/9/2019 2020015760 1/30/2020 Abandoned Chanhyuk KIM, Travis YOUNG, Yu J. CAO, Jennifer MA, Minsoo KIM, St... 1666.4JPD1 |
CHIMERIC ANTIGEN RECEPTOR T CELL SWITCHES AND USES THEREOF Japan 2016-522791 10/15/2014 2016534995 11/10/2016 6637415 12/27/2019 Issued Chanhyuk KIM, Travis YOUNG, Yu J. CAO, Jennifer MA, Minsoo KIM, St... 1666.4JP |
CHIMERIC ANTIGEN RECEPTOR T CELL SWITCHES AND USES THEREOF Italy 14853242.7 10/15/2014 502019000006215 5/8/2019 Issued Chanhyuk KIM, Travis YOUNG, Yu J. CAO, Jennifer MA, Minsoo KIM, St... 1666.4IT |
CHIMERIC ANTIGEN RECEPTOR T CELL SWITCHES AND USES THEREOF Hong Kong 17100358.7 10/15/2014 HK1226750A 10/6/2017 Abandoned Chanhyuk KIM, Travis YOUNG, Yu J. CAO, Jennifer MA, Minsoo KIM, St... 1666.4HK |
CHIMERIC ANTIGEN RECEPTOR T CELL SWITCHES AND USES THEREOF United Kingdom 14853242.7 10/15/2014 3057991 5/8/2019 Issued Chanhyuk KIM, Travis YOUNG, Yu J. CAO, Jennifer MA, Minsoo KIM, St... 1666.4GB |
CHIMERIC ANTIGEN RECEPTOR T CELL SWITCHES AND USES THEREOF France 14853242.7 10/15/2014 3057991 5/8/2019 Issued Chanhyuk KIM, Travis YOUNG, Yu J. CAO, Jennifer MA, Minsoo KIM, St... 1666.4FR |
CHIMERIC ANTIGEN RECEPTOR T CELL SWITCHES AND USES THEREOF Spain 14853242.7 10/15/2014 3057991 5/8/2019 Issued Chanhyuk KIM, Travis YOUNG, Yu J. CAO, Jennifer MA, Minsoo KIM, St... 1666.4ES |
CHIMERIC ANTIGEN RECEPTOR T CELL SWITCHES AND USES THEREOF European Patent Office 14853242.7 10/15/2014 3057991 8/24/2016 3057991 5/8/2019 Issued Chanhyuk KIM, Travis YOUNG, Yu J. CAO, Jennifer MA, Minsoo KIM, St... 1666.4EP |
CHIMERIC ANTIGEN RECEPTOR T CELL SWITCHES AND USES THEREOF Germany 14853242.7 10/15/2014 602014046575.7 5/8/2019 Issued Chanhyuk KIM, Travis YOUNG, Yu J. CAO, Jennifer MA, Minsoo KIM, St... 1666.4DE |
CHIMERIC ANTIGEN RECEPTOR T CELL SWITCHES AND USES THEREOF China 201480064779.1 10/15/2014 105814083 7/27/2016 Abandoned Chanhyuk KIM, Travis YOUNG, Yu J. CAO, Jennifer MA, Minsoo KIM, St... 1666.4CN |
CHIMERIC ANTIGEN RECEPTOR T CELL SWITCHES AND USES THEREOF Canada 2,926,698 10/15/2014 2,926,698 4/23/2015 2,926,698 6/22/2021 Issued Chanhyuk KIM, Travis YOUNG, Yu J. CAO, Jennifer MA, Minsoo KIM, St... 1666.4CA |
CHIMERIC ANTIGEN RECEPTOR T CELL SWITCHES AND USES THEREOF United States 15/644,657 7/7/2017 201801044535 4/19/2018 Abandoned Chanhyuk KIM, Travis YOUNG, Yu J. CAO, Jennifer MA, Minsoo KIM, St... 1666.4C2 |
CHIMERIC ANTIGEN RECEPTOR T CELL SWITCHES AND USES THEREOF United States 15/363,350 11/29/2016 201801044535 Abandoned Chanhyuk KIM, Travis YOUNG, Yu J. CAO, Jennifer MA, Minsoo KIM, St... 1666.4C1 |
CHIMERIC ANTIGEN RECEPTOR T CELL SWITCHES AND USES THEREOF Australia 2014337385 10/15/2014 2014337385 4/7/2016 2014337385 8/13/2020 Issued Chanhyuk KIM, Travis YOUNG, Yu J. CAO, Jennifer MA, Minsoo KIM, St... 1666.4AU |
CHIMERIC ANTIGEN RECEPTOR T CELLS AND USES THEREOF United States 62/009,056 6/6/2014 Abandoned Yu J. CAO, Chanhyuk KIM, Peter G. SCHULTZ, Travis YOUNG, Jennifer... 1666.2P |
METHODS OF PRODUCING SWITCHABLE CHIMERIC ANTIGEN RECEPTOR T C... United States 61/895,704 10/25/2013 Abandoned Yu J. CAO, Chanhyuk KIM, Peter G. SCHULTZ, Travis YOUNG 1666.1P |
METHODS OF PRODUCING SWITCHABLE CHIMERIC ANTIGEN RECEPTOR T C... United States 61/891,347 10/15/2013 Abandoned Yu J. CAO, Chanhyuk KIM, Peter G. SCHULTZ, Travis YOUNG 1666.0P |
Schedule 1.121: Existing Targets |
• BCMA means B-cell Maturation Antigen. Entrez Gene ID:608. HGNC ID: HGNC:11913 |
• PSMA means Prostate Specific Membrane Antigen. Entrez Gene ID:2346. HGNC ID: HGNC:3788 |
• Her 2 means Human epidermal growth factor receptor 2. Entrez Gene ID:2064. HGNC ID: HGNC:3430 |
• CD20 means Cluster of Differentiation 20. Entrez Gene ID: 931. HGNC ID: HGNC:7315 |
• CD22 means Cluster of Differentiation 22. Entrez Gene ID: 933. HGNC ID: HGNC: 1643 |
• CD123 means Cluster of Differentiation 123. Entrez Gene ID: 3563. HGNC ID: HGNC: 6012 |
• CLL1 means C-type lectin-like molecule. Entrez Gene ID: 160364. HGNC ID: HGNC: 31713 |
• CD3 means Cluster of Differentiation 3. Entrez Gene ID: 917. HGNC ID: HGNC: 1675 |
Schedule 1.129: Failed Target Criteria |
A Research Target shall be deemed a Failed Target if it satisfies at least one of the following conditions: |
1. Those Research Target Products generated and tested with respect to the Research Target campaign does not exhibit an appropriate in vitro selectivity index, defined as at least 10-fold difference in the potency of the Research Target Product on tumor cells expressing the Research Target vs. tumor cells lacking expre... |
2. Those Research Target Products that were advanced into in vivo studies with respect to the Research Target failed to show statistically significant efficacy as judged by comparison to the infusion of sCAR-T cells alone; or |
3. Failure of a Research Target Products with respect to the relevant Research Target to advance past a Decision Point, where the TD-JRC believes in good faith that no Research Target Product could be generated that would advance past such Decision Point given the then-current state of the art. |
Schedule 1.139: FTE Rates |
• For Calibr FTEs, as of the Original Execution Date: $315,000 |
• For AbbVie FTEs, as of the Original Execution Date: $375,000 |
Schedule 1.149: In-License Schedule |
License Agreement between The Scripps Research Institute and California Institute for Biomedical Research dated 1, 2015, as amended. |
Schedule 1.225: PRLR Switch Plan |
[See attached.] |
PRLR Switch Plan |
Plan Rationale and Goals High-level summary of key functional activities for PRLR Switch Plan (ABBV-461+CLBR001) sCAR-T cell therapy for first in human clinical study (Ph1). |
CMC Item # CMC Deliverable, Responsible Party and Notes Activities Timeline (approximate, subject to actual development timelines) |
1 CMC Working Group Calibr and AbbVie A CMC Working Group will be formed by the TD-JRC to discuss project updates, deliverables, and future plans. The CMC working group will meet at least once per Calendar Quarter. Discussion, agreements, and next steps will be documented through meeting minutes. - Any disputes will be... |
2 Contract CLBR001 CMC for clinical readiness SOW#4 (Stage #3-4 Minaris) Calibr will negotiate and finalize with Minaris the contract for Stage 3-4 (Process implementation (Stage 3) and Aseptic Process Simulation and Production Readiness (Stage 4)). Calibr will provide AbbVie with fully executed SOW#4 October 2023 |
3 CLBR001 CMC manufacturing process lock Calibr and Minaris will work together to implement and lock the CLBR001 cell manufacturing protocol prior to initiation of engineering runs in Q1 2024 December 2023 |
4 CLBR001 CMC for clinical readiness SOW#4 (Stage #3-4 Minaris) deliverables Calibr will provide AbbVie documentation supporting Stage 3-4 for CLBR001 CMC including: • Manufacture and testing of non-GMP batches including MBRs, WI / FORMs, and reports • List of NOEs and Deviations for each engineering lot • A Certificat... |
5 Clinical readiness Open GMP suite for clinical manufacturing Calibr and Minaris will complete work to initiate clinical manufacturing (Stage 4 completion) May 2024 |
6 CLBR001 cell product to support nonclinical development (pIND studies) Calibr will be responsible for supplying CLBR001 cell product needed for nonclinical studies to support IND Sept 2023 through IND filing estimated to be May 2024 |
7 ABBV-461 switch to support nonclinical development (pIND studies) Abbvie will be responsible for supplying ABBV-461 switch ENG/tox and DS, DP needed for non-clinical studies to support IND Sept 2023 through IND filing estimated to be May 2024 |
8 Contract CLBR001 CMC for clinical manufacturing (Stage #5 Minaris) Calibr will negotiate and finalize with Minaris the contract for Stage 5 (Clinical Manufacturing). Calibr will provide AbbVie with fully executed SOW#5 March 2024 |
9 CLBR001 CMC Clinical Manufacturing (Stage #5 Minaris) deliverables Calibr will provide AbbVie documentation supporting Stage 5 for CLBR001 CMC including: • Current revisions of all specific GMP documents (MBRs/WI/FORMS/Protocols/Reports) • Executed Batch records for all unit operation steps. • A Certification of Test... |
10 Clinical supplies (CLBR001 cell product) for Ph1 • Calibr will be responsible for the production and delivery to clinical sites of the cell component (CLBR001) of ABBV-461 program for Ph 1 studies (US) • CLBR001 Clinical supplies will be produced under cGMP conditions at Minaris. • Calibr will be responsible for con... |
11 Clinical Supplies (ABBV-461 switch) for Ph1 • Calibr will contract a CRO (ie Sharp) for storage and distribution of ABBV-461. • AbbVie will be responsible for providing drug product with appropriate formulation, vialing, and labeling to storage and distribution CRO selected by Calibr. CRO will be contracted Q1-Q2 20... |
12 ABBV-461 switch stability studies • AbbVie will be responsible for maintaining stability studies of ABBV-461 switch. • AbbVie will provide reports to Calibr as needed to support clinical study. Duration of the Ph1 clinical study |
13 Lentiviral vector (LV1-ENH655-ABBV) • AbbVie will generate and maintain stability studies for the GMP lentiviral vector LV-ENH655-ABBV) used in the CLBR001 CMC process. • AbbVie will provide Calibr with stability reports on LV1-ENH655-ABBV as needed. • AbbVie will be responsible for providing Minaris with LV1-ENH655... |
14 CLBR001 CMC Project Close-out (Stage #6 Minaris) Calibr and Minaris will be responsible for close-out of the CLBR001 CMC after last patient is enrolled and to provide AbbVie: • Calibr will supply to AbbVie the close out report generated by Minaris September 2027, subject to actual clinical trial performance |
15 CMC Regulatory support Calibr will act as the sponsor for IND • Calibr will generate, review, and provide data and reports as needed to support IND. • Calibr will provide Abbvie with data, reports, IND drafts, and final IND as needed • Calibr and AbbVie will jointly participate in responses to Agency on IND question... |
Clinical Item # Clinical Deliverable Activities Timeline |
1 Clinical Phase 1 protocol for CLBR001+ABBV-461 • Calibr will complete the Ph1 clinical protocol for CLBR001+ABBV-461 dose escalation in breast cancer patients for to IND submission • Calibr will provide Abbvie the draft protocol for input, as well as with the final clinical protocol and any amendments. Q2 2024 |
2 KoL and PI interactions Calibr and AbbVie will jointly determine a list of KOLs and potential institutions and investigators who may be approached for feedback and/or participation in the Phase 1 clinical program Q4 2023 |
3 Clinical CRO(s) • Calibr will identify, contract, and manage the clinical CRO(s) and vendors for the Ph1 clinical program (main study + LTFU) • Calibr will provide AbbVie with fully executed contract(s) Q1 2024 |
4 Clinical site identification • Calibr will identify and evaluate clinical sites to participate in the Ph1 clinical program and negotiate/execute contracts with sites via CRO • Calibr will provide AbbVie with final list of sites • Calibr targets first site open to enrollment for the Ph 1 clinical study in Q2/Q3 2024 Q... |
5 Clinical site training • Calibr and clinical CRO will provide clinical sites with protocol-specific training, including sample processing training, that may be required. • Calibr will provide clinical sites with supplies necessary to complete protocol-specific procedures (for example, equipment that may be needed to ... |
6 Phase 1 Clinical trial CBR001+ABBV-461 Dose Escalation in US Calibr will initiate a US-based Phase 1 clinical trial evaluating CLBR001+ABBV-461 dose escalation in breast cancer patients, briefly summarized below: • US-based, phase 1, dose escalation trial to assess the safety and tolerability of the combination of CL... |
7 Long-Term Follow-Up Trial Calibr will establish and serve as Sponsor for a Long-Term Follow-Up clinical trial • Per FDA guidelines, subjects treated with CLBR001+ABBV-461 will be enrolled on the LTFU trial for collection of data on delayed adverse events, including RCL • Additional assessments may also be included af... |
Biomarker and Bioanalytical methods Item # Biomarker Deliverable Activities Timeline |
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