Biologic therapies have gained a lot of attention in the last two decades for their role in treating diseases for which no treatments previously existed. For many patients, however, intravenous (IV) delivery is currently the only option for taking these lifesaving medicines but this often involves the use of IV needles to administer liquid medications into the veins of patients. Infusions are performed in an in-patient setting of either a hospital or an infusion center. That process comes at the expense of time and comfort as the treatment can take multiple hours to administer and can be a painful experience.
This process naturally raises questions such as, “How are these treatments impacting the quality of patients’ lives?” IV delivery of biologics can be time-consuming and also painful and costly. This makes it challenging for everyone involved.
Comera Life Sciences is a life sciences company that leverages the power of high-precision science and engineering to support patients in gaining back their freedom. Through its investigational self-injectable innovative subcutaneous (SQ) biologics, patients may have access to an alternative therapeutic delivery option in the future that can potentially aid in improving their quality of life.
In contrast to IV delivery, SQ delivery involves a single brief injection through a smaller syringe designed to cause less pain and discomfort. It enables self-administration at home, sparing patients from traveling to frequent appointments and reducing healthcare costs for supplies, storage and staffing. Moreover, an SQ injection has lower healthcare delivery costs and can be administered within the comfort of patients’ homes. According to the majority of physicians that Comera has surveyed, SQ dosing is strongly preferred over IV, if available.
Jeff Hackman, the Chairman and CEO of Comera Life Sciences, is leading the company as it advances a promising clinical pipeline aimed to improve patient experience, potentially increase patient adherence and reduce the overall cost of care during their course of treatment.
Let’s learn more about the innovative work Comera is doing to advance SQ therapeutics and how it has the potential to improve patients’ lives.
A Brief on Comera Life Sciences
Comera Life Sciences aims to give patients the freedom to self-administer life-saving products at home, a mission that is important to Jeff on a personal level. His wife, who passed away from breast cancer, had to endure various intravenous (IV) therapeutics during her ten-year treatment journey.
Millions of patients needing IV drugs must spend hours at a hospital or infusion center with a large needle in their arm. It’s painful, time-consuming and costly. Intending to change this reality for people like his wife, Jeff joined the successful team at Comera as the CEO in 2021.
Journey to Inception
The company was founded in 2014 as ReForm Biologics and recently rebranded as Comera Life Sciences to reflect the vision of bringing about a compassionate new era in medicine. Comera is built on the belief that true medical advances are inspired by compassion. Its team of innovators sees itself in patients and their families and is working to make meaningful changes to how people take medicines.
From the outset, Comera’s goal has been to develop novel excipients—substances added to a biologic drug to aid in manufacturing, delivery and stability—that can transform biologics from IV infusions to subcutaneous (SQ) injections that can be easier for patients to use. Since Jeff joined Comera, the company has expanded its focus to go beyond formulation science, and it is now reimagining the impact that its science could have on healthcare and the patient experience.
Jeff and the team at Comera, together, are working with industry partners to accelerate the development of SQ formulations of monoclonal antibodies (mABs) that can substantially impact millions of patients while also developing their pipeline of candidates. This ambitious mission led them to take the company public in May 2022.
Comera’s focus is to help patients who depend on IV biologics for treating significant diseases. That’s why the company has set out to maximize the true potential of life-changing biologics by empowering patients to administer their own medicine via a single, simple injection wherever they feel most comfortable.
The SQore™ Technology Approach to Transform Medicines
Comera is not the only one studying excipient technology, but its team is one of the first to pursue this science for antibody reformulation and potential patient care at home. Foundational to the company’s approach is its SQore™ technology, a proprietary excipient formulation platform that aims to transform medicines from IV to SQ form.
A longstanding challenge to developing viable SQ biologics is viscosity. A lower volume of medicine in an SQ formulation requires increasing the drug concentration, often to the extent that biological molecules aggregate or stick together so that they can no longer be delivered through a syringe. To date, few companies have been able to develop effective excipients to reduce the viscosity of antibodies for SQ delivery. However, the SQore platform potentially solves this dilemma through proprietary techniques using excipients to decrease the viscosity of IV drugs so that they can be delivered subcutaneously while maintaining their stability and efficacy.
Unlike other excipient approaches that have been unsuccessfully applied for decades, SQore technology does not alter the structure or form of antibodies in solution, reducing drug product development uncertainty, time and expense. Comera is working to transform IV biologics into SQ versions that can be administered by syringe in a single dose, potentially increasing patient compliance and quality of life.
Unique Products and SQ Solutions at Comera
The biologics market is estimated to grow to $422 billion in 2025, and patients worldwide rely on IV drugs for various conditions. In fact, seven of the top ten global medicines are biologics and most are administered intravenously, so there’s an opportunity to improve how these patients receive their medicines significantly.
Comera has over 200 excipients that it is using to reformulate marketed IV biologics for SQ administration. It has a number of novel and proprietary excipients, and its lead excipient is caffeine. In its SEQURUS-1 and SEQURUS-2 preclinical studies, Comera’s team has demonstrated that a caffeine excipient can reduce the viscosity of the mAB ipilimumab without affecting its bioactivity.
The company also has a pipeline of three wholly owned candidates: CLS-001, an SQ formulation of the mAB vedolizumab in preclinical development for inflammatory bowel syndrome; CLS-002, a SQ formulation of an unannounced mAB in preclinical development for immuno-oncology; and CLS-003, a candidate in the research stage for an unannounced indication. CLS-001 and CLS-002 are currently in IND-enabling studies, with filings anticipated in 2024.
SQ delivery, when available, is generally preferred by patients and healthcare providers and can result in reduced drug delivery-related healthcare costs and resource use.
Advancement of Therapeutic Pipeline
In addition to its internal pipeline, Comera is advancing a pipeline of therapeutic reformulations through partnerships. Comera has three ongoing partnerships with other companies to develop SQ drug formulations using its innovative proprietary SQore formulation platform.
Comera has a research collaboration with Regeneron, a leading U.S. biotechnology company, with high-priority assets in development. Recently, Comera extended and broadened this collaboration, which includes a right to negotiate a license after further technical evaluation is complete. A second partnership is with an undisclosed top 10 global pharmaceutical company for a drug that is commercialized globally and grants Comera the options to license after further technical evaluation is complete.
Through its collaborations with pharmaceutical and biotechnology companies, Comera is leveraging the SQore platform to enhance both commercial biologics and those in the early development stages. Its proprietary platform supports others in the industry to address formulation challenges and make biologics more easily administered subcutaneously. All these initiatives aim to bring this important therapeutic modality closer to the patients who need it.
Looking ahead, Comera will continue its two-pronged approach of growth through its internal pipeline and partnerships, complemented by a sizable patent portfolio protecting its technology.
Representing a massively growing market, biologics are at the vanguard of cutting-edge biomedical technology and driving the next generation of treatments for patients. For this reason, the company will continue to focus on high-value collaborations with near-term milestone potential. Comera currently has three ongoing partnerships all of which include options to license after the technical evaluation of the asset is complete.
The goal will be to get an SQ-based biologic into clinical trials. Comera’s team is headed in that direction with IND-enabling studies ongoing in 2023. Their approach to reformulating known biologics demonstrates the potential for a faster development timeline and lower development costs.
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