More than half of U.S. households include pets, but there has been a lack of medical treatments developed specifically for small animals. Biotech companies are working to change that with new treatment options that both borrow from and, potentially, advance human health discoveries.
More than half of U.S. households include pets, but there has been a lack of medical treatments developed specifically for small animals. Biotech companies are working to change that with new treatment options that both borrow from and, potentially, advance human health discoveries.
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Theresa Brady (00:47):
66% of US households are home to pets, and most pet owners consider their dogs, cats, and other animals to be members of the family. So it's no surprise that biotech companies have sprung up to develop vaccines and medical treatments for our animal companions.
(01:06):
We tend to think of pharmaceutical and medical discoveries to improve human health. But advances in biotechnology are extending and improving life for our four-legged friends as well. Today we talk with two biotech companies that are developing exciting preventions and treatments for diseases that threaten dogs and cats, and we learn how improving the lives of our furry friends just might extend life for people as well. I'm Theresa Brady, and you're listening to I Am Bio.
(01:54):
The Veterinary Cancer Society estimates that one in four dogs will be diagnosed with cancer, one of their most common causes of death. Tammie Wahaus is with a company that is working to give dogs with cancer a longer leash on life.
Tammie Wahaus (02:11):
I'm Tammie Wahaus, the chief executive officer for Elias Animal Health.
Theresa Brady (02:17):
Tammie explains why her company decided to focus on better treatments and outcomes for canine oncology.
Tammie Wahaus (02:23):
Elias was founded in 2014 with a specific mission to address an unmet medical need in veterinary medicine, which is oncology. There are about six million dogs in the US alone diagnosed each year with a form of cancer. And about three and a half million of those are actually being treated by veterinary specialists that have an expertise in cancer therapeutics.
(02:54):
Canine cancer treatment has been primarily the use of human-approved products in an off-label fashion, which is acceptable for the veterinary community in the absence of approved products specifically for their patients.
(03:12):
We believe that there is a significant gap in, uh, the medical therapeutics available for the treatment of cancer in companion animals, and dogs are not just little people; dogs have their own genome, and they respond differently to all therapeutics, but in particular, they can respond differently to cancer therapeutics. What we set out to do was bring a novel immunotherapy to the veterinary marketplace, which can provide an effective and safer, uh, treatment option for companion animals.
Theresa Brady (03:48):
Elias Animal Health is specifically focused on developing a new treatment for bone cancer, one of the most prevalent and painful cancers in dogs, especially larger breeds such as Labrador and golden retrievers. Tammie explains what life is like for a dog with bone cancer and their family.
Tammie Wahaus (04:07):
Bone cancer represents about 10% of all cancers diagnosed in dogs, but it is actually much more prevalent in the large breeds. Uh, it tends to form in the long bones, so the legs, and current standard of care is primarily surgery or amputation to remove the affected limb, so that the pain that is being caused by the bone cancer can be addressed immediately.
(04:36):
Unfortunately, dogs aren't able to actually tell us what's wrong, we have to notice that there's a limp, and the limp's getting worse, or there's some licking, or he's very much attending to a pain point. And the first step for a pet owner a- of course is to take him to the veterinarian to see what's wrong.
(04:57):
The second thing is that cancer is often a disease of aging, which osteoarthritis is also a disease of aging. So oftentimes people assume that the dog has arthritis, and they wait, and wait, and wait, and they try supplements. Ultimately, they do end up with a veterinarian, hopefully that it's before the bone breaks, because the bone cancer is causing deterioration of the bone, which is r- really the reason why amputation is often the first step, is we have a risk of breakage and so we need to deal with that, which is, of course, even more painful than the bone cancer itself.
Theresa Brady (05:41):
It's heartbreaking for dog owners to watch their animal suffer. But now, there's hope for a cure for canine bone cancer.
Tammie Wahaus (05:48):
At Elias, we're focused on, primarily, our initial product, which is an adoptive cell therapy, which essentially is designed to train the immune system to not only be aware of the cancer, so not only to recognize the cancer, but also, then, through our activated T-cells, give it the power to kill cancer cells.
(06:13):
The therapy that we're bringing to market, it is an immunotherapy, and immunotherapies we're seeing, in humans as well as the dogs, are showing promising results in 20 to 30% of the patients that are treated, which is actually a great win for cancer. If we can generate 20% long-term survivors, that's a great first product.
Theresa Brady (06:37):
Most veterinary drugs are regulated by the US Department of Agriculture. The department recently determined that Elias's clinical trial was successful in treating bone cancer in dogs, a major regulatory milestone. Tammie explains how the treatment works.
Tammie Wahaus (06:54):
So our first product, the Elias cancer immunotherapy that was recently approved by the USDA is administered actually in two phases, similar to dialysis, if you wanna think about it that way. Where the patient goes in, their blood is filtered to collect those immune cells, those cells are sent to us, and we manufacture a personalized, activated T-cell infusion.
(07:17):
So the T-cells are administered via IV infusion, typically on an outpatient basis. Dog goes in in the morning, gets his infusion, hangs out for the day, everything looks good, he goes home at the end of the day. And then they follow that with a series of low-dose interleukin-2, which is just administered to help keep those T-cells happy and proliferating while they're getting settled into the patient, and then he's done.
(07:43):
And what we're excited about with this particular [inaudible 00:07:47] therapy is right now it's the only one that has a safety profile that enables you to put it in via IV. The other ones you've got to do intratumoral, or intraperitoneal so that you're just putting it directly where that tumor is so that you're not exposing the entire body to the toxicity associated.
(08:11):
This particular one does not have that toxic profile. And so you can actually do an IV infusion, which is fantastic in veterinary medicines, 'cause we're talking small patients. And sometimes the location of the tumor isn't always accessible, and w- if it is, we're gonna surgically remove it. And now, what we wanna get rid of is any circulating metastatic cells. And just like our T-cells, we need that cancer killer in the bloodstream so that it can more rapidly find the locations of the tumor cells.
Theresa Brady (08:50):
We'll come back to Tammie later to talk more about the amazing potential of immunotherapy for treating cancer. But first, we talk with another biotech company about its work to develop a vaccine to protect dogs from the growing threat of valley fever.
Dave Bruyette (09:05):
My name is Dave Bruyette, I'm chief medical officer at Anivive Life Sciences.
Theresa Brady (09:10):
Valley fever is a serious respiratory infection, caused by a fungus that's endemic in the American southwest. David says the threat is spreading due to climate change.
Dave Bruyette(09:22):
So there's several different types of fungal organisms that are in the United States, as well as throughout the world, that have the ability to cause really serious disease in both humans and animals.
(09:33):
Valley fever is one of those systemic fungal diseases. It occurs primarily in the western part of the United States, and it causes significant disease not only in people living in the endemic regions, but also in dogs, and also pretty much in any mammal that lives in those areas.
(09:53):
Valley fever is a threat, and it is expected to become more common, a- and spread n- not just in the western part of the United States, but also through the central parts of the US, and extending up into Canada, and down into Mexico and South America. It's impacted by climate change, as the organism is a spore, and it lives in the soil. And when it lives in the soil, it prefers environments that are hot and dry, and as those parts of the country w- start to become hotter and dryer as a result of climate change, then it'll be easier for the spores to survive in those areas.
Theresa Brady (10:28):
As David says, valley fever affects humans as well as dogs. But dogs are more likely to inhale the fungal spores. David tells us how dogs catch it and how the disease affects them.
Dave Bruyette(10:41):
The disease, valley fever, in both people and animals is very similar. So you inhale it, you inhale the spores from the environment. It's not infectious from person to person or dog to dog, so you can't transmit it to anybody else. Usually what happens is that you either have a very low-grade response, like you don't feel well for a few days, you may have a fever, you may have a mild cough, and that could be the end of it.
(11:07):
But what typically happens in dogs particularly is that they develop pneumonia, and then if they go undiagnosed, or if they don't respond to current treatment, then about 25% of infected dogs develop disseminated disease, meaning that the fungus leaves the lung and goes to other parts of the body, and particularly it has a predisposition to go to places like bone and to the central nervous system.
(11:34):
Once a dog develops symptoms, if he's not treated, he likely will succumb to valley fever. Because he'll either die of pneumonia or it will disseminate to other parts of his body. Dogs are much more commonly affected than people, and more severely affected than people. There's a bunch of reasons why that may be, some of it may be genetic differences between dogs and people. But I think a lot of it simply has to do with the fact that dogs inhale more spores, because they're lower to the dirt. They're down in the ground, they're playing in the dirt, they're digging in the dirt, and it's quite likely when they get infected, it's because they inhaled a lot more organisms than a person would ever inhale.
Theresa Brady (12:12):
Anivive is working to receive USDA approval for valley fever vaccine for dogs. David shares how the vaccine was first discovered.
Dave Bruyette(12:21):
The valley fever vaccine that we've been working on is sort of a story of how different groups can get together to achieve a common goal. So what had happened was a group of researchers were working on a corn fungus that affects plants, and they discovered that that fungus was able to cause disease because it had a gene known as CPS1. And when they removed CPS1, that gene from the corn fungus, it was no longer harmful to corn. And so they published that work, and not a whole lotta people who are interested in fungal diseases outside of corn paid much attention.
Theresa Brady (13:02):
You might be wondering how anyone would connect the dots from a corn fungus to a respiratory disease in mammals. In a stroke of good luck for Anivive and their collaborators at the University of Arizona, researchers working on these infections saw a connection.
Dave Bruyette(13:17):
The University of Arizona is really ground zero for much of the research that's been done on valley fever. So they asked the, the groups, "Does that same CPS1 gene exist in the organism Coccidioides that causes valley fever?" And they discovered that, in fact, it did carry that gene, and when they removed that gene from Coccidioides, it was no longer pathologic, it was no longer able to cause disease in mice, but it did stimulate a very strong immune response in the mouse.
(13:51):
So the basis behind the vaccine is it is a modified live, genetically altered, spore-based vaccine that we're working on at Anivive for approval through the USDA for the vaccination of dogs. The vaccine is intended as a prophylactic, as a preventative, for dogs living in the endemic regions, or for those pet owners and dogs who travel to the endemic regions.
(14:18):
So one of the big problems that we see both in human and dogs with Cocci is that they may live in Massachusetts, but they go on vacation to the Grand Canyon, and then they go back home, and a couple months later the owner or the dog starts coughing. And unless the veterinarian and the physician start to ask questions about travel, it can go really undiagnosed. So vaccination would be indicated for, for travelers as well as for those living in these endemic regions.
Theresa Brady (14:51):
Don't worry, cat moms and dads: there's biotech for cats, too. David shares that Anivive is also working to save cats from a deadly disease, feline infectious peritonitis, or FIP.
Dave Bruyette(15:05):
Feline infectious peritonitis is probably one of the deadliest diseases that cats face, unfortunately, both in the US as well as worldwide. It is an infectious disease. The staggering numbers for FIP are about one in 300 cats will die of FIP. And that's very consistent across US, Canada, Europe, pretty much wherever you see a large cat population, you're gonna see these high mortality rates. Because the virus itself, the benign virus is so common, about 80% of cats that come out of a cattery or out of a shelter will test positive for the benign virus, and about 50% of pet cats that don't live in an environment with lots of other cats will also test positive. So all of those cats are at risk for acquiring the mutation that subsequently will result in that virus causing FIP.
Theresa Brady (16:02):
David says that an FIP diagnosis is devastating for cats and their owners, and there has been a lack of effective treatment options, until now.
Dave Bruyette(16:12):
The problem with FIP is that since it was first recognized, and up until now, the mortality rate is about 100%. It's very uncommon that a cat would survive FIP. So what we've been working on is a antiviral treatment specific for the coronavirus that causes FIP in cats. It is a disease caused by a coronavirus, but it is not the COVID coronavirus. And this medication is highly active, not only against the virus inside of a dish, but also against the virus in pet-owned cats, who are infected and are ill as a result of FIP.
(16:51):
And we're looking at not only making cats feel better, but we're also looking at a drug that has the potential to cure them of FIP, which is really something that has not been possible before now.
Theresa Brady (17:03):
Anivive is working to bring this first effective FIP treatment to market.
Dave Bruyette(17:08):
So we have gotten what's called, um, the efficacy technical section letter, saying that, "You don't have to do any more clinical trials." And where we are right now is we're working with our manufacturing partners to be able to manufacture the drug in quantities that we think'll be used commercially, and be able to show that those products are not only safe and effective, but also that they're pure, and they can be produced, and kept, and they're quite stable. So the manufacturing component is what we're gonna be working on now for the next year or so, and we would be hoping that the drug, assuming that everything goes swimmingly well, that the drug would be approved and on the market in 2026.
Theresa Brady (17:50):
Clearly, we're on the cusp of exciting biotechnology innovations to improve the health of our pets, and keep them purring and wagging their tails as long as possible.
(18:08):
After the break, we talk with Tammie and David about how these breakthroughs draw from advancements in human health, and their potential to turn around and advance disease prevention and treatment in people as well.
(18:31):
In just two weeks, Bio will host its first ever Agriculture & Environment Summit, featuring discussions on regulatory priorities, and the latest developments in animal, plant, microbial, and industrial biotechnology. Attendance is free, and if you're involved in agriculture and environmental biotechnology, you don't wanna miss it. Visit bio.org/events to learn more about this event, taking place April 17th and 18th in Washington, DC. Register to attend.
(19:16):
We've talked about three devastating diagnosis that no pet parent wants to hear, but also about new hope to extend our pets' lives. Biotechnology is at the heart of all these developments. David Bruyette, chief medical officer for pet pharmaceutical company Anivive, says that biotechnology is revolutionizing animal health, much as it has for human health. But he also explains the challenge of bringing these innovations to a healthcare sector that's largely a cash business and not supported by health insurance.
Dave Bruyette(19:50):
Well, biotechnology, I think in the small animal space, in the space that we're operating in for dogs and cats, is becoming more and more of the norm. Therapeutics that initially were developed for dogs and cats tended to focus on things like flea, tick, and heartworm, because obviously those are big problems and those are things that we wanna get fixed.
(20:12):
But what we're looking at now is that about 80% of diseases that occur in dogs and cats have no approved drug. So veterinarians are having to use human drugs, off-label, in an attempt to treat those diseases.
(20:25):
So the way that you can circumvent that is that if you wanna bring novel drugs to the market, you have to be able to identify and predict with pretty high accuracy, that a drug that you choose is going to be safe, it's gonna be effective, and it can be manufactured in such a way that people can afford it. And the only way that we've really been able to do this effectively is to rely on software. We're a very software-driven company, so we use software not only to help us find drugs and sift through the hundreds of thousands of compounds that are out there, but it also helps us move from choosing a drug, to going through clinical trials, to eventually going through commercialization and marketing.
(21:08):
And what that allows us to do is we can basically go through and screen a lot of compounds fairly early on, throw out the ones that we think are not gonna be viable, focus on a handful that we think do show promise for being able to fulfill those types of goals, and what that allows us to do is that we can bring drugs to market faster and less expensively than the old model.
Theresa Brady (21:31):
Research has shown that owning a pet is good for our health. Whether it's increasing opportunities to get out for a walk, or helping us feel less alone and stressed. But those aren't the only connections between us and our pets. A concept called One Health is focused on the connections between humans, animals, plants, and the environment. And in the spirit of One Health, Tammie says veterinary medicine borrows lessons from human medicine, and vice-versa.
Tammie Wahaus (22:01):
We're really a One Health company. We're focused on not only improving the products available for veterinary medicine, but also working with the human health companies where we've licensed our technologies from, helping them advance their products for the good of humans as well.
(22:19):
One example of that is when we ran our preliminary clinical trial in bone cancer, we were able to collaborate with the human health company who used that data, dog data, in their FDA submissions and their application for fast-track designation. So that's really interesting, right? I'm working in bone cancer, they're working in brain cancer. And it's essentially the same technology with some appropriately-modified manufacturing methods for dogs versus humans. And it's a different regulator, so we're subject to different rules, but at the end of the day, it's a personalized medicine that what we're demonstrating, and what we're focused on demonstrating, is that if you give us the cancer cell, we will make a vaccine to enable your body to recognize the cancer cell.
(23:09):
Then if you give us those primed immune cells that were generated by the vaccine, we will give you an activated T-cell infusion to fight the cancer. It may not matter what your cancer is or what your species is. Really leveraging the immune system to do the work that it's designed to do, but outnumbered, when we're talking about cancer.
Theresa Brady (23:33):
David says the human biopharma world is taking notice of the discoveries in veterinary medicine. He's excited about the potential of his company's valley fever vaccine to help human patients.
Dave Bruyette(23:45):
We're also working on the vaccine to get it approved for use in humans. And we're currently working with folks at NIH, as well as the National Institutes of Allergy and Infectious Disease to help move the dog vaccine forward towards clinical trials in people. What we're seeing now is a great deal of interest in biotech companies, universities, even small pharmaceutical companies who are working on therapies for people, we can go to them and say, "You know what? That disease you're trying to work on a treatment for, and man, that's a disease that we care about for dogs and cats. The therapeutics that you're working on might actually be translatable down to dogs and cats."
(24:27):
And so we can partner with them to leverage the data that they've already generated. Whether it's safety data, or toxicity data, even dosing data that might exist, in order to de-risk that as a product to be able to be developed for use in veterinary medicine. And it can also go the other way. We really work at both ends of the leash to bring therapeutics forward.
Theresa Brady (24:52):
Everyone in biotechnology is working to ensure that life-changing innovations can reach the people, and now pets, that need them. David says the potential of biotechnology for our pets is massive, if companies can make treatments affordable.
Dave Bruyette(25:07):
We're always having to look at what are the cool science things that are out there that we can rely on biotech to help expose us to? But at the end of the day, I have to be able to bring it to the marketplace, and veterinary medicine's a cash business, largely. So, you know, the owners, if they're paying for treatment, they're paying for the treatment, you know. So they have to be able to look at something that they can afford to do for their pet.
Theresa Brady (25:32):
Tammie says cost is an important consideration for her company, as well.
Tammie Wahaus (25:37):
I- in terms of bringing a product to market, and in our case, the recently approved product at an affordable price, one of the metrics that we're looking at is what does current standard of care cost, and can we get this product to market at a price that is not significantly more than current standard of carTheresa Brady (26:36):
It's exciting to think about how the concept of One Health is bringing a new approach to science and healthcare that's focused on the connections between people, animals, plants, and the environment, and how to achieve the best health outcomes for all living things. And when we think about the many ways our pets make our lives better, it's great to know that biotech companies are making discoveries that will help us make our pets' lives better too. And as a dog owner, I couldn't be more excited. I want to thank David and Tammie for sharing their passion for the healthcare of pets, as well as their compassion for pet owners and veterinarians who want to provide the best care possible. And thank you all for listening.
(27:20):
I'm Theresa Brady, and I produced this episode with help from Lynn Finnerty an Courtney Gastonell. It was engineered and mixed by Jay Goodman, with theme music created by Luke Smith and Sam Brady. Make sure to subscribe, rate, and/or review this podcast, and follow us on X, formerly Twitter, Facebook, and Instagram @IAmBiotech, and subscribe to Good Day Bio at bio.org/goodday.