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*RWG may augment to include single cell RNA sequencing and RNA analysis as appropriate. Single cell RNA sequencing requires additional method development. |
Note, FTO search to be conducted prior to or in parallel with pooled CI study. |
Table 3 - Data Package Elements – First and Secondary Pooled Candidate Identification Studies for each of SCS, IVT, and IC |
Category Analysis Assay Results Responsible Party NHP Benchmarked vector genome residence of each variant Viral DNA amplified for NGS by PCR Capsida Biodistribution Viral DNA from the pool as a whole assayed for copy number per diploid genome via qPCR from tissues also characterized via NGS Capsida Protein expression T... |
*Immunogenicity assays are optional and would be conducted as agreed by RWG, and may be utilized in investigational manner. |
**FTO search to be conducted by Capsida prior to or in parallel with pooled CI study. |
Note: Capsid specific binding antibody assay, neutralizing antibody assay, and IFN-y ELISpot can be tech transferred after selection of development candidate. |
Table 4 –Final Pooled Candidate Identification Studies for each of IVT, SCS, IC |
Category Analysis Assay Results Responsible Party NHP Benchmarked vector genome residence of each variant Viral DNA amplified for NGS by PCR Capsida Biodistribution Viral DNA from the pool as a whole assayed for copy number per diploid genome via qPCR from tissues also characterized via NGS Capsida Protein expression T... |
*Immunogenicity assays with exception of in vitro assays on individual capsid candidates are optional and would be conducted as agreed by RWG, and may be utilized in investigational manner. |
**In vitro immunogenicity assays and in silico T cell epitope prediction would be conducted in parallel with in-life for this study as part of risk assessment. |
***FTO search to be conducted prior to or in parallel with pooled CI study. |
Note: some immunogenicity in vitro assays are still under development and will be completed prior to completion of pooled candidate identification study. For all in vitro assays, outputs include analysis of cell death and multiplex cytokine response. Capsid specific binding antibody assay, neutralizing antibody assay, ... |
Table 5 –Final Ophthalmology Data package Elements - Single Variant Characterization Studies for each of SCS, IVT, and IC |
Category Analysis Assay Results Responsible Party NHP Biodistribution Viral DNA assayed for copy number per diploid genome via qPCR from tissues also characterized via NGS Capsida Protein expression To be further clarified and agreed upon by RWG (e.g. western blot, IHC, or ELISA) AbbVie Single cell RNA sequencing Chara... |
*To be conducted in parallel with in-life for Single Variant Characterization Study |
Note: Capsid-specific binding antibody assay, neutralizing antibody assay, and IFN-y ELISpot can be tech transferred after selection of development candidate. |
Budget |
Exhibit E Initial Target List |
# Gene Target Name Aliases Gene ID Notes: |
1 SEMA3A Semaphorin3A 10371 |
2 RTN4R Reticulon 4 Receptor NOGOR 65078 |
3 OSMR Oncostatin M OSM 9180 |
4 NTRK1 Neurotrophic Receptor Tyrosine Kinase 1 TRKA, TRK1 4914 |
5 NTRK2 Neurotrophic Receptor Tyrosine Kinase 2 TRKB 4915 |
6 CNTFR Ciliary Neurotrophic Factor Receptor CNTFR-alpha 1271 |
7 GFRA1 GDNF Family Receptor Alpha1 2674 |
8 C5 Complement Component 5 727 |
9 CFI Complement Factor I 3426 |
10 RGMa Repulsive Guidance Molecule BMP Co-Receptor A 56963 |
11 ANGPT2 Angiopoietin 2 285 |
12 TEK Tyrosine Kinase with Ig and EGF Homology Domains-2 Tie2 7010 |
13 APOE Apolipoprotein E 348 |
14 MMP1 Matrix Metalloproteinase 1 CLG, CLGN 4312 |
15 MMP9 Matrix Metalloproteinase 9 CLG4b, GELB 4318 |
16 MMP3 Matrix Metalloproteinase 3 4314 |
17 FASLG Fas Ligand CD178, CD95L, TNFSF6 356 |
18 TREM2 Triggering Receptor Expressed on Myeloid Cells 2 54209 |
19 DCN Decorin 1634 |
20 |
1 |
SCHEDULE 1.56 |
Trademarks and logos |
Logo: |
Trademark: |
Capsida Biotherapeutics trademark filed (pending): WIPO Ref. 1424582701 |
1 |
SCHEDULE 1.75 |
B10, B22, C1, C2, C3 |
1 |
SCHEDULE 1.88 |
FTE Rate |
Research & Discovery: $425,000 Development: $375,000 Manufacturing: $375,000 Commercial: $425,000 Med Affairs: $350,000 |
1 |
SCHEDULE 5.1.2 |
Existing CMO Agreements |
Vendor Name Type of Agreement Description Assignable / Sublicensable |
DNA TwoPointO Inc (ATUM) Material Transfer Agreement with workorders under MTA Plasmid synthesis Assignable by Capsida |
Aldevron Master Services Agreement with workorders under MSA Plasmid production Assignment requires written consent (Capsida standard terms) |
Charles River Master Services Agreement with workorders under MSA QC Testing / Release Assignment requires written consent (Capsida standard terms) |
Millipore Sigma (BioReliance Corporation) Master Services Agreement with workorders under MSA QC Testing / Release Assignment requires written consent (Capsida standard terms) |
KBI Master Services Agreement with workorders under MSA Analytical services Assignment requires written consent (Capsida standard terms) |
AdVec License 293 cells Can sublicense with written permission from AdVec |
Life Tech / Thermo License HEK293 GMP cells Can sublicense for a fee |
1 |
SCHEDULE 6.3.3 |
Co-Promotion Readiness Plan |
Elements of Co-Promotion Readiness Plan |
A. Elements of Co-Promotion Readiness. The Co-Promotion Readiness Plan prepared by Capsida and provided to AbbVie pursuant to Section 6.3.3(a) must contain all of following elements to demonstrate that Capsida will have adequate resources and expertise to co-promote the Co-Promotion Product during the applicable Co-Pro... |
1. Upon delivery by Capsida to AbbVie of the Co-Promotion Option Exercise Notice for the Co-Promotion Product and the Co-Promotion Readiness Plan, Capsida must have: a. Hired a Chief Commercial Officer or equivalent position, which individual has adequate prior experience managing the promotion of a neurological diseas... |
2. Upon delivery by Capsida to AbbVie of the Co-Promotion Option Exercise Notice for the Co-Promotion Product and the Co-Promotion Readiness Plan, or, if such Exercise Notice occurs before the delivery by AbbVie to the JGC of the ALS Commercialization Plan, within sixty (60) days of delivery by AbbVie of such plan, the... |
3. At the United States BLA submission date for the Co-Promotion Product, the foregoing elements (in items 1 and 2) must continue to be satisfied and Capsida must have: a. A functioning sales force operations system that is consistent with industry practice and capable of tracking and measuring complete sales force met... |
4. Within two (2) months after the United States BLA submission date for the Co-Promotion Product, the foregoing elements (items 1-3) must continue to be satisfied and Capsida must have: a. Completed hiring of all sales representatives allocated to Capsida in the then-current ALS Commercialization Plan provided by AbbV... |
5. At least two (2) months prior to the date established by FDA pursuant to the Prescription Drug User Fee Act for completing the review of the BLA for the Co-Promotion Product in the United States, the foregoing elements (items 1-4) must continue to be satisfied and Capsida must have: a. Completed training and testing... |
6. From and after receipt of Regulatory Approval of the BLA for the Co-Promotion Product in the United States, the foregoing elements (items 1-5) must continue to be satisfied and Capsida must: a. Conduct all co-promotion activities with respect to the Co-Promotion Products in the United States in accordance with the t... |
B. Consequences of Non-Compliance with Co-Promotion Readiness. If AbbVie reasonably determines pursuant to Section 6.3.3 that Capsida is not in compliance with, or is not reasonably likely to comply with, the Co-Promotion Readiness Plan, AbbVie shall deliver written notice of such determination to Capsida (each, a "Non... |
1. If AbbVie reasonably determines that Capsida has not satisfied or is not reasonably likely to satisfy each of the elements of the Co-Promotion Readiness Plan identified in A.3.a, A.3.c (with respect to hiring sales trainers and legal, regulatory and ethics/compliance sales support), A.3.d, and A.5.a (such elements, ... |
2. If AbbVie reasonably determines that Capsida has satisfied each of the Co-Promotion Compliance Readiness Elements as of the required date but has not satisfied or is not reasonably likely to satisfy any of the other elements of the Co-Promotion Readiness Plan as of the required date, AbbVie shall have the right to r... |
a. If AbbVie reasonably determines that Capsida has not satisfied or is not reasonably likely to satisfy element A.3.c (with respect to first- and higher-level managers for the sales force) or element A.4.a of the Co-Promotion Readiness Plan as of the required date, but Capsida has hired in excess of fifty percent (50%... |
3. If AbbVie reasonably determines that Capsida has not satisfied or is not reasonably likely to satisfy (a) any element of the Co-Promotion Readiness Plan (other than element A.3.c (with respect to first- and higher-level managers for the sales force), element A.4.a or the Co-Promotion Compliance Readiness Elements) o... |
1 |
SCHEDULE 11.5A |
Press Release |
2 |
Capsida Biotherapeutics Debuts with $140 Million of Capital |
– Versant, Westlake Village BioPartners launch next-generation gene therapy company with $50 million Series A – |
–Collaboration with AbbVie provides $90 million in up front and equity investment capital to create tissue-targeted gene therapies for three CNS disease targets – |
THOUSAND OAKS, Calif., April XX, 2021 – Versant Ventures and Westlake Village BioPartners today announced the emergence from stealth mode of Capsida Biotherapeutics Inc., a biotechnology company using an adeno-associated virus (AAV) engineering and cargo development platform to develop tissue-targeted gene therapies fo... |
"Our high-throughput AAV engineering platform is designed to identify differentiated capsids and cargos that will successfully deliver gene therapies with superior cell and tissue targeting and safety profiles than current-generation products in both CNS and non-CNS diseases," said Robert Cuddihy, M.D., chief executive... |
A next-generation AAV and cargo platform |
Although current gene therapy approaches have shown dramatic efficacy in several rare diseases, the medicines are hindered by imprecise targeting, an inability to transduce a number of cell types and tissues effectively, and safety liabilities. Specifically, most current-generation approaches use naturally occurring se... |
As a result, many monogenetic and sporadic neurodegenerative disorders yet remain unaddressed by this therapeutic modality. |
Capsida is addressing these concerns with its AAV engineering platform that generates capsids optimized to target specific tissue types and limits transduction of tissues and cell types that are not relevant to the target disease, allowing for improved efficacy and safety. In addition, Capsida is developing proprietary... |
The platform originated from groundbreaking research in the laboratory of Viviana Gradinaru, Ph.D., Professor of Neuroscience and Biological Engineering, Heritage Medical Research Institute Investigator, and Director of the Center for Molecular and Cellular Neuroscience at the Tianqiao and Chrissy Chen Institute for Ne... |
The company's engineered capsids have demonstrated markedly enhanced tissue tropism for neurons versus astrocytes, glia, and other CNS cell types, thus demonstrating potential to unlock treatments for disorders requiring neuronal transduction that exceeds the performance of first-generation AAV9-based therapies. |
"With our long-standing track record in the gene therapy space, it is gratifying to help launch Capsida, which is taking a novel approach to developing genetic medicines," said Clare Ozawa, Ph.D., managing director at Versant and a Capsida board member. |
Collaboration with AbbVie |
Capsida's newly announced collaboration with AbbVie will use the biotech's platform to identify and advance clinically translatable capsids paired with an innovative therapeutic approach from AbbVie to create tissue-targeted gene therapies for three CNS disease targets. |
Under the terms of the agreement, Capsida will receive $80 million up front in cash and a $10 million equity investment. For targets one and two, upon AbbVie exercising its option, Capsida is eligible to receive $530 million in option and development milestone payments excluding commercial milestone payments. Capsida i... |
For the third disease target, upon AbbVie exercising its option, Capsida will have the right to develop through human proof-of-concept, and AbbVie would lead late-stage development and commercialization. Following human proof-of-concept, the parties would enter into a 50/50 cost:profit share with Capsida having the opt... |
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