Comera SPAC Presentation Deck

SQore™: Validated by Scientific Peer-Review Value of concept and strength of science confirmed by recent publication in industry-leading Journal of Pharmaceutical Sciences ● ● ● Use of caffeine-based excipient to reduce viscosity demonstrated for two mAbs, ipilimumab (Yervoy) and infliximab (Remicade) Ipilimumab: caffeine reduced viscosity from 45-78% in three buffers Infliximab: caffeine reduced viscosity by 77% vs. control Caffeine-containing formulations met target stability requirements for a viable drug product No loss of biologic activity for either molecule in the presence of caffeine, confirmed by rigorous analytical demonstration ELSEVIER ARTICLE Pharmaceutics, Drug Delivery and Pharmaceutical Technology Caffeine as a Viscosity Reducer for Highly Concentrated Monoclonal Antibody Solutions INFO Contents lists available at ScienceDirect Yuhong Zeng, Timothy Tran, Philip Wuthrich, Subhashchandra Naik, Juan Davagnino, Daniel G. Greene,¹, Robert P. Mahoney, David S. Soane ReForm Biologics Inc., 12 Gill Street Suite 4650, Woburn, MA 01801, United States DKBI Biopharma Inc., 1101 Hamlin Rd, Durham, NC 27704, United States Article history: Received 5 March 2021 Revised 21 June 2021 Accepted 22 June 2021 Available online 26 June 2021 Keywords: Viscosity Monoclonal antibody(s) High concentration Excipient(s) Formulation Interactions. Stability Journal of Pharmaceutical Sciences journal homepage: www.jpharmsci.org (•)<) ABSTRACT Conclusion: Caffeine-based excipient proven in externally validated, rigorous scientific evaluation to achieve all desired target parameters for a viable SQ formulation Comera Source: "Caffeine as a viscosity reducer for highly concentrated monoclonal antibody solutions", Journal of Pharmaceutical Sciences, 110 (2021) 3594-3604, https://doi.org/10.1016/j.xphs.2021.06.030 LIFE SCIENCES APRA Many monoclonal antibody (mAb) solutions exhibit high viscosity at elevated concentrations, which pre- vents manufacturing and injecting of concentrated mAb drug products at the small volumes needed for sub- cutaneous (SC) administration. Addition of excipients that interrupt intermolecular interactions is a common approach to reduce viscosity of high concentration mAb formulations. However, in some cases widely used excipients can fail to lower viscosity. Here, using infliximab and ipilimumab as model proteins, we show that caffeine effectively lowers the viscosity of both mAb formulations, whereas other common viscosity-reduc- ing excipients, sodium chloride and arginine, do not. Furthermore, stability studies under accelerated condi- tions show that caffeine has no impact on stability of lyophilized infliximab or liquid ipilimumab formulations. In addition, presence of caffeine in the formulations does not affect in vitro bioactivities of infliximab or ipilimumab. Results from this study suggest that caffeine could be a useful viscosity reducing agent that complements other traditional excipients and provides viscosity reduction to a wider range of Ⓒ2021 American Pharmacists Association. Published by Elsevier Inc. All rights reserved. mAb drug products. Check for updates 17

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