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14.3.1 This Agreement may not be assigned or otherwise transferred, nor may any right or obligation hereunder be assigned or transferred (except as provided in Section 6.2 (Subcontracting)), whether by operation of law or otherwise, in whole or in part, by either Party without the written consent of the other Party, wh... |
14.3.2 AbbVie agrees that, notwithstanding any provision of this Agreement to the contrary, if AbCellera undergoes a Change of Control, AbbVie will not have any rights under this Agreement with respect to any Patent Right, Know-How or other Intellectual Property Rights or other proprietary rights directed to the Earn-O... |
14.3.3 AbCellera shall not, and shall cause each of its Affiliates not to, ever, anywhere in the Territory, institute or prosecute (or in any way aid any Third Party (other than to the extent required by law, regulation, court order or subpoena) in instituting or prosecuting), at law or in equity, any claim, demand, ac... |
14.4 Force Majeure. Neither Party shall be held liable or responsible to the other Party or be deemed to have defaulted under or breached this Agreement for failure or delay in fulfilling or performing any term of this Agreement when such failure or delay is caused by or results from events beyond the reasonable contro... |
14.5 Notices. Any notice, request, demand, waiver, consent, approval, or other communication permitted or required under this Agreement shall be in writing, shall refer specifically to this Agreement and shall be deemed given only if (a) delivered by hand, (b) sent by facsimile transmission (with transmission confirmed... |
If to AbCellera, addressed to: AbCellera Biologics Inc. Attn: Chief Legal Officer 2215 Yukon Street Vancouver, BC V5Y 0A1 with a copy (which shall not constitute notice) to: legal@abcellera.com If to AbbVie, addressed to: AbbVie Global Enterprises Ltd. c/o Harbour Fiduciary Services Ltd. Thistle House, 4 Burnaby Stree... |
14.6 Export Clause. This Agreement is made subject to any restrictions concerning the export of products or technical information from the United States or other countries that may be imposed on the Parties from time to time. Each Party agrees that it will not export, directly or indirectly, any technical information a... |
14.7 Waiver; Non-Exclusion of Remedies. Any term or condition of this Agreement may be waived at any time by the Party that is entitled to the benefit thereof, but no such waiver shall be effective unless set forth in a written instrument duly executed by or on behalf of the Party waiving such term or condition. The wa... |
14.8 Further Assurance. Each Party shall duly execute and deliver, or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts and things, including the filing of such assignments, agreements, documents, and instruments, as may be necessary or as the other Party ma... |
14.9 Severability. If any provision of this Agreement is held to be illegal, invalid, or unenforceable under any present or future law, and if the rights or obligations of either Party under this Agreement will not be materially and adversely affected thereby, (a) such provision shall be fully severable, (b) this Agree... |
14.10 Equitable Relief. |
14.10.1 Each Party acknowledges and agrees that the restrictions, rights and obligations set forth in Article 9 (Intellectual Property Rights) and Article 10 (Confidentiality) are reasonable and necessary to protect the legitimate interests of the other Party and that such other Party would not have entered into this A... |
14.10.2 AbCellera acknowledges and agrees that the restrictions, rights and obligations set forth in Article 2 (Development; Acquisition Option) and Article 8 (Exclusivity; Change of Control) are reasonable and necessary to protect the legitimate interests of AbbVie and that AbbVie would not have entered into this Agre... |
14.11 Applicability of 11 U.S.C. § 365(n). All rights and licenses granted under or pursuant to this Agreement by a Party to the other, including those set forth in Section 4.1 (Assignments and License Grants to AbbVie), are and shall otherwise be deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code... |
14.12 Entire Agreement; Amendments. This Agreement, together with the Schedules and Exhibits attached hereto, sets forth and constitutes the entire agreement and understanding between the Parties with respect to the subject matter hereof and all prior agreements, understandings, promises, and representations, whether w... |
14.13 Relationship of the Parties. It is expressly agreed that AbCellera, on the one hand, and AbbVie, on the other hand, shall be independent contractors and that the relationship between the Parties shall not constitute a partnership, joint venture, or agency, including for all tax purposes. Neither AbCellera, on the... |
14.14 Headings; Construction; Interpretation. Headings and any table of contents used herein are for convenience only and shall not in any way affect the construction of or be taken into consideration in interpreting this Agreement. The language of this Agreement shall be deemed to be the language mutually chosen by th... |
14.15 Books and Records. Any books and records to be maintained under this Agreement by a Party or its Affiliates or its or their Licensees and/or Sublicensees (other than Dispute Settlement Licensees) shall be maintained in accordance with applicable Accounting Standards. |
14.16 English Language. This Agreement shall be written and executed in, and all other communications under or in connection with this Agreement shall be in, the English language. Any translation into any other language shall not be an official version thereof, and in the event of any conflict in interpretation between... |
14.17 Parties in Interest. Except as provided in Article 12 (Indemnification; Insurance), all of the terms and provisions of this Agreement shall be binding upon, and shall inure to the benefit of and be enforceable solely by the Parties and their respective successors, heirs, administrators and permitted assigns and t... |
14.18 Counterparts. This Agreement may be signed in counterparts, each and every one of which shall be deemed an original, notwithstanding variations in format or file designation which may result from the electronic transmission, storage and printing of copies from separate computers or printers. Facsimile signatures ... |
PROJECT PROPOSAL |
PARTNER AbbVie |
TARGET CD200R1 |
SCOPE AND DELIVERABLE To generate two diverse panels of highly developable, high specificity CD200R1 antibodies that are functionally agonistic or antagonistic based on their ability to diminish inflammation (agonist) or block binding of CD200 ligand and relieve immune suppression (antagonist). The proposed work plan i... |
TARGET BACKGROUND CD200R1 (cell surface glycoprotein CD200 receptor 1, also known as CD200R, CRTR2, MOX2R, OX2R) is an inhibitory receptor that is expressed on myeloid lineage cells and some T cell subsets. Binding of CD200R1 to its ligand (CD200, also a cell surface glycoprotein) triggers tyrosine phosphorylation in i... |
TARGET SEQUENCE Uniprot ID Q8TD46 (325 amino acids) Homology of human CD200R1 to other species: Organism % identity - full protein % identity - ECD Cynomolgus (Macaca fascicularis) 90.1% 90.3% Mouse (Mus musculus) 58.1% 58.6% Rat (Rattus norvegicus) 57.5% 60.1% Sequence alignment with extracellular domain boxed in red: |
PROTEIN STRUCTURE CD200R1 is a single-pass type I membrane protein of 37 kDa (ECD: 24 kDa) composed of two immunoglobulin-like domains forming the extracellular domain, a helical transmembrane domain, and a cytoplasmic signaling domain. The extracellular domain contains eight N-linked glycosylation sites. There are fou... |
DESIRED THERAPEUTIC ANTIBODY PROFILE 1. Binding to human CD200R1 RPQQ and KTHE cell-expressed protein and endogenous target-expressing cells (required) 2. (Antagonist only) Equivalent or superior ligand blocking activity compared to provided benchmark anti-human CD200R1 antagonist antibody (required)* 3. Cross-reactivi... |
IMMUNIZATIONS AND SAMPLES Samples for screening will include spleen, lymph nodes, and/or bone marrow from wild-type and humanized rodents and peripheral blood mononuclear cells from rabbits immunized by AbCellera with protein antigens. |
SINGLE CELL SCREENING ASSAYS Two antibody screening assays are proposed: a cell-binding cross-reactivity assay and a cell based ligand-binding assay. Both assays may be tested during assay development and will be carried out in parallel during single-cell screening pending successful assay development. A successfully d... |
RESEARCH ACTIVITIES STAGE 1 ACTIVITIES PREFERRED STAGE 1 ADVANCEMENT CRITERIA |
Assay Set-up (All activities to be performed by AbCellera) ● Transfer or procurement of reagents ● QC of reagents ● Assay development and reagent validation for primary screening and recombinant mAb screening assays ● Test screen from antibody secreting cells to assess antigen-specific frequency ● All reagents must pas... |
Immunization (All activities to be performed by AbCellera) ● Immunization of up to 17 animals using soluble protein antigen o Five (5) Alloy, five (5) Trianni and five (5) wild-type mice o Two (2) rabbits ● Titre assessment on cells by flow cytometry and selection of the animals with best immune responses for screening... |
STAGE 2 ACTIVITIES PREFERRED STAGE 2 ADVANCEMENT CRITERIA |
Antibody Discovery (All activities to be performed by AbCellera) ● Single-cell screening of up to eight (8) selected animals and tissues, representing diverse species. ● Single-cell screening assays are cell binding and ligand binding assays ● Recovery of at least 192 single cells per screen when warranted given the re... |
STAGE 3 ACTIVITIES PREFERRED STAGE 3 ADVANCEMENT CRITERIA |
Antibody Validation & Characterization (All activities to be performed by AbCellera) ● Small-scale expression and purification performed on up to 184 project antibodies using AbCellera's high-throughput production platform, selected to maximize sequence diversity from several animals ● All recombinant antibodies to be ... |
Antibody Validation & Characterization (continued) ● Polyreactivity evaluated on a subset of antibodies using baculovirus particle (BVP)-ELISA ● Antibody binding properties confirmed using the same assay format used during initial screening, including binding to cells expressing human CD200R1 RPQQ and KTHE ● Antigen bi... |
STAGE 4 Pre-opt in Activities (To be performed by AbbVie) STAGE 4 Functional Characterization Data Summary |
Candidates from hit generation with ideal physicochemical and agonistic/antagonistic characteristics will be further functionally characterized in the following assays (performed at mid-scale). Candidate agonistic antibodies to be produced as human IgG4 isotype and antagonistic antibodies to be produced as human IgG1 L... |
FUNCTIONAL ASSAY WORKFLOW **AbbVie Functional Characterization Activities |
ESTIMATED TIMELINES STAGE 1 Assay Set-up & Immunization *Timeline does not include reagent sourcing and acquisition 8-12 weeks STAGE 2 Antibody Discovery 8-12 weeks STAGE 3 Antibody Validation & Characterization 16-18 weeks STAGE 4 Functional Characterization Performed by AbbVie TBD TOTAL (Stages 1-3) 32-42 weeks |
DELIVERABLES Stage 1 Deliverables 1. Representative images from in vitro binding of AbbVie-provided and commercial control antibodies, as well as fluorescently labelled CD200 ligand, to CD200R1-expressing cells on AbCellera's screening device. 2. Flow cytometry analysis of titre assessments from immunized animals. 3. A... |
Stage 2 Deliverables 1. Antigen-specific frequencies of recovered hits and representative images of binding observed from single-cell screens. 2. High confidence paired heavy and light chain sequences from single-cell binding screens. 3. Bioinformatic analysis of sequences, plus binding specificity assessments from sin... |
Stage 3 Deliverables 1. Cell-binding validation data delivered as an electronic report and static visualizations of antibody binding properties overlaid onto sequence data from Stage 2, as generated by AbCellera's custom software Celium™. 2. Analysis of results from biosensor-based assays (kinetics and epitope binning)... |
APPENDIX 1: REAGENTS & MATERIALS. ADDITIONAL REAGENTS MAY BE ADDED AT A LATER STAGE |
CELL LINES Cell lines for screening (AbbVie): ● Human CD200R1-expressing cell lines (RPQQ and KTHE) ● Cyno CD200R1-expressing cell line ● Cyno CD200R2-expressing cell line ● Syngeneic parental cell line (control) Cell lines for functional assays (AbbVie): ● Human CD200R1 U937 KTHE Reagent requirements: minimum two (2) ... |
PROTEINS Protein reagents (AbbVie): ● Recombinant human CD200R1 protein (RPQQ and KTHE) o Fc-tagged: 3 mg required (of each variant) o His-tagged: 3 mg required (of each variant) ● Recombinant cyno CD200R1 protein o Fc-tagged: 5 mg required o His-tagged: 1 mg required ● Fluorescently labelled human CD200 ligand (Alexa ... |
CONTROL ANTIBODIES Control antibodies (AbbVie): ● Antagonistic anti-human CD200R1 ● Agonistic anti-human CD200R1 (cyno cross-reactive) ● Anti-cyno CD200R1 ● Anti-cyno CD200R2 Reagent requirements: 1 mg of each control antibody Commercial control antibodies ● Mouse anti-human CD200R1, clone OX108 (Biolegend; preferred c... |
VECTORS AND SEQUENCES Human CD200R1 KTHE variant (NM_138806.4 translation-KTHE) MLCPWRTANLGLLLILTIFLVAEAEGAAQPNNSLMLQTSKENHALASSSLCMDEKQITQNYSKVLAEVNTSWPVKMATNAVLCCPPIALRNLIIITWEIILRGQPSCTKAYKKETNETKETNCTDERITWVSRPDQNSDLQIRTVAITHDGYYRCIMVTPDGNFHRGYHLQVLVTPEVTLFQNRNRTAVCKAVAGKPAAHISWIPEGDCATKQEYWSNGTVTVKSTCHWEVHNVSTVTCH... |
ANIMALS ● Alloy and Trianni humanized mice ● Wild-type mice ● Wild-type rabbits |
FUNCTIONAL ASSAYS Assays to be performed by AbCellera at high-throughput scale, contingent on availability of sufficient antibody material Functional assays ● Receptor binding via flow cytometry on CD200R1 overexpressing cells ● Receptor binding via a biosensor-based binding assay ● Epitope binning via a biosensor-base... |
APPENDIX 2: HIGH-THROUGHPUT ANTIBODY ASSESSMENT ANALYTICAL AND PHYSICOCHEMICAL ASSAY DATA AND DESIRED PROFILES TO INFORM SELECTION OF LEAD ANTIBODY PANEL WITH LOW DEVELOPABILITY RISK |
Physicochemical Property Method of Analysis Desired Results Purity and integrity CE-SDS Used to assess purity and integrity of antibody material and suitability for use in functional assessment or other assays. Higher purity is desired. Purity levels of >95% purity are desired for most downstream assays. The majority o... |
Hydrodynamic properties and aggregation DLS Used to assess the hydrodynamic properties and aggregation state of antibody material and suitability for use in functional assessment or other assays. Hydrodynamic radius values in the range of ~5.2-6.3 nm with low levels of detectable aggregation are desired. The majority o... |
Size, homogeneity, and aggregation aSEC Used to assess purity and estimate size and aggregation state of antibody samples. Higher levels of monomer and low levels of high molecular weight (HMW) and low molecular weight (LMW) species are desired. Purity levels of >90% monomer and <5% HMW are desired for most downstream ... |
Identity and homogeneity MS Used to confirm the identity of antibody samples by matching observed mass to sequence predicted mass. Mass confirmation within the expected mass error range of the mass spectrometer is desired to confirm molecular identity. The majority of antibodies produced through AbCellera's high-throug... |
Hydrophobicity and homogeneity aHIC Used to assess the hydrophobicity and heterogeneity of antibody samples. Higher levels of a single species (main peak) having shorter retention time indicative of low hydrophobicity is desired. Hydrophobicity is benchmarked against published antibodies in clinical development. The ma... |
Thermal stability nDSF Used to assess the thermal stability of antibody samples. Tm and Tagg data are provided, where Tm is the thermal stability as measured by intrinsic fluorescence, and Tagg is the thermal stability as measured by the onset of light scattering due to temperature-induced aggregation. Higher thermal s... |
Propensity for self-interaction AC-SINS Used to assess the propensity for antibodies to self-interact. Lower AC-SINS scores are desired. AC-SINS scores are benchmarked against published antibodies in clinical development. The majority of antibodies produced through AbCellera's high-throughput production platform have l... |
Polyreactivity BVP-ELISA Used to assess the propensity for antibodies to demonstrate nonspecific binding. Lower BVP scores are desired. BVP scores are benchmarked against published antibodies in clinical development. The majority of antibodies produced through AbCellera's high-throughput production platform have low BV... |
PROJECT PROPOSAL |
PARTNER AbbVie |
TARGET Pathological α-Synuclein (α-Syn) |
SCOPE The scope of this collaboration is to generate a best-in-class α-Syn antibody with excellent biophysical profiles as well as an ability to interfere with the cell-to-cell spreading of pathological α-Syn in vitro and in vivo models. The antibody is aimed to be developed as passive immunization therapy to treat pat... |
TARGET BACKGROUND α-Syn is a neuronal protein that regulates synaptic vesicle trafficking and neurotransmitter release. It is expressed in the central nervous system, but can also be found peripherally in heart, muscle, and bodily fluids including saliva, plasma, and cerebrospinal fluid. α-Syn is an intrinsically disor... |
TARGET SEQUENCE Uniprot ID P37840 (140 amino acids) Homology of human α-Syn to other species: Organism % identity Cynomolgus (Macaca fascicularis) 98.6% Mouse (Mus musculus) 95% Rat (Rattus norvegicus) 95% Alpaca (Vicugna pacos) 92.1% Rabbit (Oryctolagus cuniculus) 89.26% Sequence alignment: |
Homology of human α-Syn to human paralogues: Paralogue % identity β-Syn 60.96% γ-Syn 55.12% Sequence alignment: |
PROTEIN STRUCTURE α-Syn is an intrinsically disordered monomer. The monomer contains a non-amyloid component (NAC), a hydrophobic domain within α-Syn required for fibril formation. Pathological α-Syn forms larger aggregates that are heterogenous. |
DESIRED THERAPEUTIC ANTIBODY PROFILE 1. Binding to human α-Syn aggregates (required)* 2. Binding to human α-Syn monomer (required)* 3. No cross-reactivity to human β-Syn or γ-Syn (required)* 4. Sub nM apparent affinity binding to α-Syn aggregates (required) 5. >1000 fold selective for aggregate over monomer (desired) a... |
IMMUNIZATIONS AND SAMPLES Samples for screening will include spleen, lymph nodes, and/or bone marrow from wild-type mice, KO mice (pending availability), humanized mice immunized, rats* and / or rabbits* immunized with AbbVie's proprietary PD-templated human α-Syn aggregates (PD-PFF). *Pending reagent production at Abb... |
SINGLE-CELL SCREENING ASSAYS To identify antibodies binding to human aggregate α-Syn, two antibody selection assays are proposed for evaluation: a multiplexed bead-based cross reactivity assay and an unconjugated antigen assay. Feasibility of these assays will be tested during assay development. * 1. Multiplexed bead-b... |
ACTIVITIES PREFERRED STAGE ADVANCEMENT CRITERIA |
RESEARCH ACTIVITIES STAGE 1 ACTIVITIES |
Reagent and Assay Set-up (All activities to be performed by AbCellera) Transfer or sourcing/generation of reagents AbbVie to transfer internal reagents and AbCellera to procure all commercially available and custom peptides for assay setup and immunization. Prior to initiation of Stage 1 activities, extensive QC of agg... |
Assay Development (Assay development is being performed at AbCellera in collaboration with AbbVie) Assessment of reagent conjugation to beads for microfluidic screening No aggregation (etc) of assay reagents in assay format, and confirmation of specific target engagement with control antibodies. In case full multiplexi... |
Immunization (All activities to be performed by AbCellera) ● Immunization of up to 20 rodents using soluble protein antigen ● Five (5) Alloy ● Five (5) Trianni ● Five (5) wild-type mice ● Five (5) α-Syn KO mice (pending availability of KO mice) ● Five (5) wild-type rats* ● Two (2) wild-type rabbits* ● Titre measurement... |
STAGE 2 ACTIVITIES |
Antibody Discovery (All activities to be performed by AbCellera) ● Single-cell screening of up to eight (8) selected animals and/or tissues ● Recovery of up to 192 single cells per screen ● Sequencing of antibody heavy/light chain sequences from recovered cells ● Bioinformatic analysis to determine high confidence pair... |
STAGE 3 ACTIVITIES |
Antibody Validation and Characterization (All activities to be performed by AbCellera) ● Small-scale expression and purification performed on up to 184 project antibodies using AbCellera's high-throughput production platform Generation of up to hundreds of microgram quantities of antibody for agreed upon validation and... |
● Purity and integrity analysis on a subset of project antibodies using microcapillary electrophoresis (ce-SDS) ● Antibody identity and heterogeneity analyzed using mass spectrometry (intact mass) ● Aggregation evaluated for a subset of antibodies using dynamic light scattering (DLS) ● Aggregation and heterogeneity eva... |
● Stability evaluated for a subset of antibodies using nanoscale differential scanning fluorimetry (nDSF) ● Heterogeneity and hydrophobicity evaluated on a subset of antibodies using hydrophobic interaction chromatography (aHIC) Evaluation of recombinant antibody stability and hydrophobicity as specified in Appendix 2. |
● Self-association evaluated on a subset of antibodies using affinity-capture self-interaction nanoparticle spectroscopy (AC-SINS) ● Polyreactivity evaluated on a subset of antibodies using baculovirus particle (BVP)-ELISA Evaluation of self-association and polyreactivity as specified in Appendix 2. |
● Kinetics, affinity, and specificity on monomeric and aggregated α-Syn evaluated for a subset of antibodies using a biosensor-based binding assay (SPR) ka, kd and KD data will be provided (1:1 Langmuir fit with monomeric α-Syn) or apparent ka, kd and KD data obtained (avidity data for aggregated α-Syn are force-fit to... |
● Epitope binning performed using α-Syn monomers for a subset of antibodies using a biosensor-based assay, pending successful assay development Epitope bin and community data will be provided to demonstrate epitope diversity of discovered antibodies. Preference for broad epitope coverage with at least five (5) unique e... |
● In silico immunogenicity prediction performed on a subset of antibodies using EpiVax ISRPRI® platform or alternative platform to be decided at the JGC Immunogenicity predictor score to be comparable to benchmark control with known no/low immunogenicity. |
● Antibody binding properties confirmed using the same assay format as used during initial screening ● Non-specific binding validation to be performed on α-Syn knockout cell line ● Validation data delivered as an electronic report and static visualizations of antibody binding properties overlaid onto sequence data from... |
AbbVie will complete functional characterization and validation studies and notify AbCellera when activities are complete |
ESTIMATED TIMELINES *Estimated timelines do not include optional activities STAGE 1 Assay Set-up & Immunization Timeline does not include reagent generation, acquisition & QC 6-12 weeks per cohort 14-20 weeks total Due to staggered cohorts STAGE 2 Antibody Discovery 8-10 weeks per cohort 16-20 weeks total*Due to stagge... |
DELIVERABLES Stage 1 Deliverables 1. Representative images from in vitro binding of AbbVie-provided and commercial control antibodies to antigen conjugated on beads and/or soluble antigen captured on beads on AbCellera's screening device. 2. Flow cytometry analysis of titre assessments from immunized animals. 3. Antige... |
Stage 2 Deliverables 1. Antigen-specific frequencies of recovered hits and representative images of binding observed from single-cell screens. 2. High confidence paired heavy and light chain sequences from single-cell binding screens. 3. Bioinformatic analysis of sequences, plus binding specificity assessments from sin... |
Stage 3 Deliverables 1. Bead-binding validation data delivered as an electronic report and static visualizations of antibody binding properties overlaid onto sequence data from Stage 2, as generated by AbCellera's custom software Celium™. 2. Analysis of results from biosensor-based assays (kinetics and epitope binning)... |
APPENDIX 1: REAGENTS & MATERIALS ADDITIONAL REAGENTS MAY BE ADDED AT A LATER STAGE |
Reagent Source Amount required Human SNCA knockout 293-T cells Abcam ab255433 N/A AbbVie proprietary PD-templated human α-Syn aggregates (PD-PFF) No tag AbbVie For immunization: 7 mg for 20 mice, 2 mg for 5 rats and 1.5 mg for 2 rabbits (total 11 mg including overage) AbbVie proprietary PD-templated human α-Syn aggrega... |
APPENDIX 2: HIGH-THROUGHPUT ANTIBODY ASSESSMENT ANALYTICAL AND PHYSICOCHEMICAL ASSAY DATA AND DESIRED PROFILES TO INFORM SELECTION OF LEAD ANTIBODY PANEL WITH LOW DEVELOPABILITY RISK |
Physicochemical Property Method of Analysis Desired Results Purity and integrity CE-SDS Used to assess purity and integrity of antibody material and suitability for use in functional assessment or other assays. Higher purity is desired. Purity levels of >95% purity are desired for most downstream assays. The majority o... |
Hydrodynamic properties and aggregation DLS Used to assess the hydrodynamic properties and aggregation state of antibody material and suitability for use in functional assessment or other assays. Hydrodynamic radius values in the range of ~5.2-6.3 nm with low levels of detectable aggregation are desired. The majority o... |
Size, homogeneity and aggregation aSEC Used to assess purity and estimate size and aggregation state of antibody samples. Higher levels of monomer and low levels of high molecular weight (HMW) and low molecular weight (LMW) species are desired. Purity levels of >90% monomer and <5% HMW are desired for most downstream a... |
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