Eli Lilly, Biolojic to Develop Antibody Therapies for Diabetes

Eli Lilly and Company and Biolojic Design recently announced a research agreement to discover and develop potential novel antibody therapies for the treatment of diabetes.

The collaboration and license agreement will focus on a multi-specific antibody, which is a human antibody that is computationally engineered to bind two or more targets at each of its arms, Eli Lilly and Company explained. 

Fine-tuning the affinity and competition of the targets on the multi-specific antibody can produce therapies with differential activities. But this varies based on tissue localization and metabolic parameters. 

The specific targets that the companies will study through the collaboration were not disclosed.

"Lilly continues to seek out novel methods for developing new medicines, and Biolojic's multi-specific antibody platform is a promising approach," Ruth Gimeno, PhD, vice president of diabetes and metabolic research at Eli Lilly and Company, said in the announcement. 

"We look forward to working closely with the scientific team at Biolojic and leveraging their expertise to discover and develop a potential antibody-based therapy for people with diabetes,” Gimeno continued.

The partnership will leverage Biolojic’s artificial intelligence-based platform, which enables the design and development of an entirely new type of therapeutic antibodies with novel mechanisms of action.

Specifically, the platform designs single and multi-specific antibodies that are able to precisely target predefined epitopes to execute novel biological programs that were not possible with conventional antibodies.

Epitope specific antibodies bind and affect cryptic epitopes, ion channels, and other challenging targets, the company explained. 

"Although our internal pipeline is focused on computationally designed antibodies for use in oncology and autoimmune disease, we are excited to partner with Lilly and apply our platform to design potential therapies for diabetes,” said Yanay Ofran, PhD, chief executive officer at Biolojic.

“Our research with Lilly is another example of how our platform could allow reimagining of therapeutic approaches that have not been possible before,” Ofran continued. 

Under the agreement, Eli Lilly and Company will pay research fees associated with the collaboration, while Biolojic is eligible to receive up to $121 million, based on potential development and commercialization milestones. 

Biolojic is also eligible to receive tiered royalties in the low-to mid-single digits on product sales if Eli Lilly and Company successfully commercializes a therapy from the collaboration. 

Over 30 million Americans have diabetes, and 90 to 95 percent of them have type 2 diabetes, according to the CDC. These individuals may suffer from serious medical complications such as nerve damage, kidney and eye damage, sleep apnea, and heart and blood vessel disease.

Although there are 74 FDA-approved treatments for diabetes across 12 classes, health systems continue to work to tackle the ongoing diabetes battle in the US. 

Last January, the American Pharmacists Association (APhA) Foundation announced a partnership with Tabula Rasa HealthCare (TRHC) to expand the National Diabetes Prevention Program to pharmacies across the US.

The partnership will leverage pharmacies to grow the CDC’s National Diabetes Prevention program. The evidence-based lifestyle change strategies will help at-risk individuals reduce their risk of developing type 2 diabetes. 

Then in March 2020, FDA issued new draft guidance evaluating the safety of two new drugs for Type 2 diabetes and removing previous requirements for standardized clinical trials for diabetes drugs.

The draft guidance, “Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control,” replaces the FDA’s 2008 guidance and proposes a broader safety evaluation approach before drug approval beyond ischemic cardiovascular disease, as well as inclusion of a broader scope of human subjects.

This includes individuals with chronic kidney disease who may be more vulnerable to drug-related side effects. The proposed approach allows for broader and more valuable safety information for these medications.