Founder Profile: LEAH Labs

LEAH Labs was born out of the fruits of academic research and the drive of our CEO, Wes Wierson, to “create his own job” after graduate school. During his PhD, Wes began collaborations with some vets at Iowa State to apply the gene editing tech he created to their academic work. 

Simultaneously, two FDA approvals for CAR-T cell therapy in humans came through. While working with an academic mentor at Mayo Clinic, Dr. Steve Ekker, Wes was introduced to Dr. Saad Kenderian, who develops novel CAR-T strategies in his lab and treats human patients with CAR-T cell therapy at Mayo Clinic. 

Dogs get the same types of cancers as humans do. In particular B cell lymphoma in dogs is a clinical analog of non-Hodgkin’s lymphoma in humans. Non-Hodgkin’s lymphoma is one of the types of blood cancers that CAR-T cell therapy is FDA approved to treat in humans.  

Over a collaborative coffee meeting, we realized the gene editing technology Wes developed could enable the translation of CAR-T cell therapy from humans into dogs, following the models of numerous human therapies that have been co-opted for our canine companions, and the idea for LEAH Labs was born. 

Anywhere from 4,500,000 to 6,000,000 dogs die of cancer every single year. The specific therapy we are first developing only targets one type of cancer, B cell lymphoma. However, with the modularity inherent to CAR-T cell therapy, once we have one therapeutic up and running we will be able to modify the CAR in order to target other cancer types.

Imagine typing a paragraph, but forgetting to type a sentence. You use a computer mouse to click where you want to add, and either type in or paste the new sentence exactly where you want. In essence, you’ve given that paragraph new information, perhaps altering the intent of what was written. We can do the same thing with gene editing technology. Gene editing is the process by which scientists specifically alter the genetic code at a predetermined genomic locus, often with base pair resolution. We use CRISPR (the computer mouse) to find a gene and direct DNA repair activity to that specific spot in order to “type in” or “paste” new genetic information. 

In our case, we insert the genetic information encoding for a chimeric antigen receptor (CAR) into T cell genomes. T cells are native immune cells that kill foreign invaders or virus infected cells, but they tend to leave cancer alone. When we program T cells with a CAR, we give them the information to find and bind to specific shapes found on cancer, called antigens. Thus, CAR-T cells are “super powered” immune cells that now recognize cancer, and they use their natural killing ability to destroy these cancer cells.

The biggest roadblock we’ve encountered is raising the capital needed to make our mission a reality. All of our technical science works in principle; we’ve translated the gene editing tech developed in academia into T cells, and we’ve made CAR-T cells/showed they kill canine cancer in a test tube, but we need more funding to optimize this killing and gene editing, scale it, and bring it to sick animals.

This depends heavily on the amount we raise, however we are moving forward currently with the assumption that we will raise at least $350,000. This gets us a year of R&D and will bring us to the point of testing our therapy in sick animals. See below for breakdown (as listed on Wefunder)

“$150,000 towards research and development (optimization of our technology in vitro, involving the purchase of research consumables, DNA sequencing, cell culture materials, and enzymes needed for molecular and cellular biology), $50,000 towards proof of concept studies, $104,000 towards maintaining and hiring talent, $25,000 towards business development, $21,000 towards the Wefunder intermediary fee”

Our competition to date is that of the standard of care chemotherapies for the treatment of canine B cell lymphoma. 250,000-300,000 dogs die of B cell lymphoma every year, and only 50,000 are treated yearly because the standard of care is poor. This standard of care, CHOP based chemotherapy, costs $7,000-12,000, takes 12-16 vet visits for treatment spaced out over 5 months, and only prolongs life for 10-12 months. 

We are different in that we are literally using living cells as a therapy instead of static molecules/chemotherapy. Moreover, we are aiming to enter the market under half the price, with only 2 trips to the vet. CAR-T is able to induce long-term remissions, and even “cures” in humans, and we predict the same in dogs.

Any system that has living T cells that could be reprogrammed into CAR-T cells is amenable to this type of therapy. Lymphoma is the #1 killer of cats, and we would love to bring this therapy to them as well. 

Moreover, studying the effects of CAR-T cell therapy in canines provides an ability to use spontaneous cancer as a model for human CAR-T cell preclinical development. The data we generate will be valuable to human pharma and we may even bring in deals to test preclinical CAR-T strategies in dogs that are destined for humans.

Our non-viral CAR-T cell manufacturing platform and gene editing technology is also of interest to the future of human CAR-T cell manufacturing.

We sell direct to veterinary oncologists. When a sick dog is a candidate for our therapy and a vet recommends it, we will ship our product to them for infusion. We aim to bring our therapy to market with at least 5x margin, and hope for 10x at scale.

Additionally, a recent chemotherapeutic to come to market for dogs with B cell lymphoma was developed by a company called “VetDC” but the commercial licensing rights were handed to Elanco. This sets a precedent for us to build our therapy and platform and then license the commercial rights to a pet conglomerate.

Yep, pet insurance will cover our therapy.

Our therapy is regulated by the USDA, not the FDA. To get our treatment on the market, we must pass an 8 dog safety study before we can treat client owned, sick pets. Upon completion of this study, we can enroll in combined safety and efficacy trials. One great thing about our therapy and the USDA path of approval is that we don’t need to treat pets with placebo; all dogs in a trial will get our experimental therapy and we can compare our results to historical life expectancy data. After increasing life expectancy in 30-50 dogs, our product can be conditionally licensed by the USDA while we continue to amass data towards full licensure.

There is strong consolidation in the pet industry right now, and we are excited for that to continue. 

A comparable exit in the pet therapeutics space, Aratana, just sold to Elanco for ~$250M. We aim to have at least 1 product on the market in the next 3-5 years, and be bringing two more through USDA approvals, positioning us to exit in a similar fashion.

When we get to market and are profitable, we also envision an IPO, enabling us to continue our dream of becoming “the animal health genome editing company”.