Comera Life Sciences Announces Favorable Preclinical Topline Safety Results of Lead SQore Excipient
Comera Life Sciences Holdings, Inc. recently announced favorable topline results from its recently completed SEQURUS-1 study. The results of this preclinical study provide supportive evidence of safety of Comera’s lead caffeine-based SQore excipient when administered as a subcutaneous (SQ) biologic drug product formulation with a monoclonal antibody (mAb).
Many mAb therapies are delivered by intravenous (IV) injection because the solutions exhibit high viscosity at elevated concentrations, preventing manufacturing and injecting of concentrated drug at volumes needed for SQ administration. Using its proprietary formulation platform, SQore, Comera is developing excipients that make SQ delivery possible. The addition of excipients, such as caffeine, interrupts intermolecular interactions to reduce viscosity of high concentration mAb formulations.
The SEQURUS-1 study was designed to evaluate the safety of caffeine when administered SQ in combination with ipilimumab, a mAb therapy that works to activate the immune system by targeting CTLA-4 to treat melanoma, as a model protein. SEQURUS-1 demonstrated no evidence of local or systemic toxicity of caffeine when administered subcutaneously with ipilimumab in animals. Furthermore, a rapid clearance of caffeine was seen within 8 hours from test animals, in line with modeled predictions. Initial data also demonstrate no evidence of caffeine impact on ipilimumab absorption.
“Our previously published data on this SQ drug product showed favorable viscosity reduction and stability achievement,” said Robert Mahoney, PhD, Chief Scientific Officer of Comera. “The positive topline results from this SEQURUS-1 study validate the safety in animal models of our lead SQore excipient, caffeine. The product demonstrated caffeine’s rapid clearance and no impact on the absorption of ipilimumab. We look forward to the continued evaluation in vivo, to further support the potential value of our proprietary excipient technology platform to bring alternative options to patients.”
The study evaluated three different SQ test formulations, including a caffeine-containing ipilimumab formulation, ipilimumab-only formulation (no caffeine), and caffeine-only formulation (no ipilimumab). A control IV ipilimumab formulation with no caffeine was included as a reference group. Local toxicity was assessed by visualization and palpation of the injection site and systemic toxicity was assessed by body weight and viability. Additional exploratory data were collected on ipilimumab pharmacokinetic (PK) parameters to assess impact of caffeine on ipilimumab absorption, distribution, and clearance.
A larger study, SEQURUS-2, has been initiated to provide a statistically robust evaluation of caffeine on the PK of SQ-administered ipilimumab, and was designed to expand on the exploratory PK analysis completed in SEQURUS-1. Comera plans to present topline study results from SEQURUS-2 at the 14th Annual Bioprocessing Summit to be held in Boston from August 14-18, 2022.
The in vivo data generated by the two SEQURUS studies complement Comera’s previously published in vitro analytical results in the Journal of Pharmaceutical Sciences demonstrating the achievement of favorable viscosity reduction and stability meeting criteria for a viable SQ drug product formulation. The monoclonal antibody ipilimumab (branded as Yervoy) was chosen for evaluation as a representative example of a commercially successful, widely used monoclonal antibody for which no SQ formulation is commercially available.
Leading a compassionate new era in medicine, Comera Life Sciences is applying a deep knowledge of formulation science and technology to transform essential biologic medicines from intravenous (IV) to subcutaneous (SQ) forms. The goal of this approach is to provide patients with the freedom of self-injectable care, reduce institutional dependency. and to put patients at the center of their treatment regimen. For more information, visit https://comeralifesciences.com/.
Total Page Views: 592