While Paul Romness played a hand in quite a few therapeutic wins over the course of his 25 years in Big Bio , and while he exited Big Bio 10 years ago to scratch an entrepreneurial itch , it's unlikely to have crossed his mind at the time that 10 years later he'd be scratching that itch via leadership of a clinical stage biotech developing vaccines and antibody drug
conjugates for cancer patients . It's unlikely , because Paul is a big bio , government affairs and public policy guy and when he left Big Pharma to run his own business , that business was a consultancy that fits squarely in the wheelhouse of his expertise .
But just a couple of years into that endeavor , life threw a curveball that inspired the launch of OS Therapies , the biotech Paul now leads as chairman and CEO . I'm Matt Pillar .
This is the Business of Biotech and on today's show we're getting to know Paul Romnes sharing the inspirational story of OS Therapy's launch and learning how that inspiration has fueled the small but mighty company's ongoing success .
Paul welcome to the show . Thank you so much , Matt . What a thoughtful intro .
Well , I appreciate that the thoughts were all correct . I got that right , all right , good deal .
Yeah , definitely wasn't . Definitely wasn't looking for osteosarcoma .
I didn't think so , although you know we're going to get into the story and it's kind of a neat story given your long history with osteosarcoma , you know , prior to dedicating effectively your entire professional life to it , and we'll get into those details here in just a bit .
But I just I want to let you know that I'm super excited to have you on the show , paul and I had the chance to talk a few weeks ago and after hearing about the work that he's doing and why you know it was a no brainer I had to get Paul on the show . So thanks for being here , thank you . So you get your start years back .
We're going to rewind the clock way back . You get your start in life sciences as a salesman , you know , as a lot of execs often do , right . You started selling orthopedic devices for J&J . That kind of served as your springboard into a career in government relations and policy leadership .
That career spanned companies like J&J , amgen , bering or Ingelheim , and we'll revisit those years as we talk , because I want to see you know , I want to learn how they kind of informed your career . But I don't want to start there .
I want to start with the personal and professional inflection point that came much later , in around 2017 , in the form of a young woman named Olivia Aggie . So , rather than fill in the blanks , I'm going to ask you to start there . Tell us her story and tell us how it inspired yours .
I feel like that movie with Cuba Gooding Jr Not going to make me cry , man .
I don't know , we'll see , I might cry .
It's a very impressive story . Olivia was diagnosed with osteosarcoma in February of 2017 . She lives about two doors from us . She's my daughter's best friend and I like to tell the end of the story and take away a little suspense , because Olivia is doing great .
Even though she was diagnosed with osteosarcoma very deadly bone cancer she is seven years cancer free and she sits on the board of directors of our now publicly traded company .
She and my daughter both graduated from the University of Virginia last May and she's since taken her MCATs and her MCATs are really good , and so she will be going to medical school next year .
That's amazing , but unfortunately , through our journey and before we started OS Therapies , we started OS Collaborative OSCollaborativeorg to really change the trajectory of osteosarcoma , and Olivia's father and I helped start the nonprofit .
We started shaving our heads to raise money for St Baldrick's and , other than Olivia's dad and me , all the parents involved in all of the nonprofits around osteosarcoma , and it turns out most childhood diseases have lost their child to the disease , and so that's been a real inspiration for us .
And then , you know , with some of the money that we raised from the nonprofit , we brought in KOLs from across the country and really wanted them to start pushing genetic testing because standard of care and osteosarcoma was a good five years behind any other cancer .
They just had no idea what the genetic makeup of the cancers were , and at that meeting Dr Richard Gerlach of MD Anderson put up a slide about the most promising new technologies and our future technology was up there .
I had happened to read about it about a week before the meeting and so that was the first check that you know we were kind of going the right direction .
And then the next day I emailed eight of these really , really busy probably the busiest people in the world , right , because they're treating kids , they're researching and they're flying around the world trying to make a difference in this really bad disease . And I emailed eight of them the next morning . I said we're going to start a company .
We're going to in-license that canine osteosarcoma . I used to call it the dog treatment because dogs get osteosarcoma a lot more than humans . I said we're going to start a company , we're going to in-license that technology . Will you be on our scientific advisory board ? All eight of them emailed me back that day , that day .
That day , that day , and that was check number two we're going in the right direction . I might not be the brightest , but when these signs are given to me , it's pretty obvious we're going in the right direction . So the next month I met with the company that was out licensing the technology . They had in-licensed it from the University of Pennsylvania .
I met Dr Robert Pettit across the table . He was as passionate about this technology as I was about the disease . He's now our chief medical and scientific officer and it's great to have the founding scientists for not only that platform technology the HER2 technology but also our ADC technology . We have the founding scientists on our team for that as well .
So really vast amount of resources in these founders . And six months , eight months later , we didn't license the technology . About two years , on March 15th 2020 , the beginning of COVID , we started our weekly clinical trials call . We still do that every Monday . And then on October 21st 2021 , we put our first kid in the trial . Four weeks ago .
Yesterday , the last kid got his last dose . So 41 kids have been in our trial and we expect the readout on the data the week after Thanksgiving .
Yeah , it's a I mean . So that's an incredible story and there are a whole bunch of details in there that I want to , I want to dig out a little bit . I mean you . You find yourself , like I said , your , your career to this point has been quite successful . You've made a name for yourself in government and public policy affairs .
In big bio , you know , a wise and probably well-planned move into consultancy . After doing that for 25 years , Setting yourself up for a likely , a good you know a good business , a good , probably lifestyle business .
It's going to , you know , serve you well , and then , and then this comes along , this experience comes along , Olivia comes along and you feel motivated to do something .
Tell us how you tell us about your preparedness to do that thing , or lack thereof , if you don't mind , like you know , sharing a little bit about , like how you , before you , even before we even get into , where's the money going to come from ? How am I going to get the experts that I need ?
How did you reconcile in your mind All right , I'm going to grab , you know , I'm going to have to grab the shifter and make a shift here . How did you wrap your mind around this ? Like I'm going to go do this . We're going to . We're going to go do this .
Well , matt , I've said a couple of times , uh , startups are no country for old men , um , but it reminds me , um , bernie Marcus and uh is uh , ken Langone didn't start Home Depot until they were 55 .
And I think it is the experience and the past , the network , the hard knocks , the challenges , the inspiration of great leaders that I've had in the past that prepared me . I certainly wasn't looking for it .
You know , when I started my career selling orthopedic implants and then transferring over to the biotech division of J&J , I met a great network of people and I often say there's only one thing I know about getting old that's good and that's watching your friends do .
Well , the folks that I worked with at OrthoBiotech and Johnson Johnson and at Bering or Ingelheim and Amgen , have spread across the entire industry and are running the industry to as we develop our platform technologies , to partner with them , because I think we do have a lot to offer with both our platforms to big biotech , big pharma , with HER2 , we really believe
that adding our cancer-killing vaccine to Herceptin or Trituzumab , we can increase the effectiveness of Perceptin or Trituzumab , but we also prevent patients from getting resistance to that therapy because Trituzumab keeps the cancer down . Our vaccine comes in and underneath and kills it . And so and then on the ADC technology , we our special sauces .
Special sauces were wrapping the payloads with silicone and then attaching the payloads , multiple payloads , to the ADC with silicone . The beauty of silicone is it doesn't get broken down by proteins , it gets broken down by pH levels and it turns out cancer has a higher pH level .
All of this came from different experiences through my career , starting with orthopedic implants London or England you know different places Tom Temple , who's down at Florida Atlantic they are some of the pioneers of limb salvage , so a lot of these kids can keep their limbs when they get osteosarcoma in their long bones .
So that was a great experience watching leaders like that and then being at Johnson Johnson . They were the ones that inspired me to go back to graduate school and paid for my master's of health policy .
It was Amgen that gave me the opportunity to really use that degree and my biggest goal in the entire industry Matt was to someday run a Washington office for the biopharmaceutical industry , and I got the opportunity to run government affairs for Bering-Ringelheim .
And after that , one really dangerous thing I think about being a good leader is not having a goal , and so I'd hit my goal and I didn't know what else there was . I had been inspired by great CEOs at Johnson Johnson and at Beringer Ingelheim with Marty Carroll and Paul Fontaine , but I never really envisioned doing that .
As a friend of mine who worked at NASDAq said to me did you ever think you'd take a company public ?
and I said absolutely not yeah and so , uh , after bi , some former co-workers are from j and j and bearing time and a friend of mine from metamune astrazeneca got together and we said we should really look to start a company to take , you know , phase two , phase three assets that aren't big enough for big pharma , big buy-in , take them off the shelf , reanalyze
them with new data analytics and then see if we can , you know , make a go of products like that . And we had a couple , you know know , we were all busy at the time so it ended up not happening . But when olivia got sick , that's I knew what we had to do .
Because the survival rate if it came back to her lungs or her brain , if it metastasized , like any other cancer , when it metastasizes , when is when you drop the survival from pretty good to horrible , right , and they say it's 13% . And so I knew we had to do something about that .
And that's when I read in pink sheets that this company was giving up this asset from University of Pennsylvania and I knew why they were giving it up . It was only 1,000 patients a year , yeah , you know the incidence rate . And that's when you know the idea of taking something off the shelf and getting it through the FDA and so it was phase two be ready .
We in licensed it and we now have the rights to that , and we finished the clinical trial and we'll be submitting to the FDA here in the next few months and I'm very confident that at least a conditional approval is on the horizon short horizon for us through the event free survival data , but then once they see the overall survival , I think we'll be able to
get to full approval . But either way , as you know , the priority review vouchers that could really help a company like us and it falls back to my old job , right , public policy and government affairs and that the intended consequences of the priority review voucher were to get companies like ours to seek commercialization of products for rare and pediatric diseases .
That's what we're doing , and by giving us a transferable voucher that we can sell to Big Pharma so that they can cut in line by four months is just a great win-win one . We're getting new commercial products out to for rare and pediatric diseases and you know , big bio , big pharma , that's in line four months .
It's kind of like clear or global access and they get on the market four months sooner , which people always think oh , it's four more months of sales . Yes , it's four more months of sales .
It's also four more months ahead of your competition , but it's also the biggest thing is four more months of growing your forecast and if you extrapolate that out two , three , five , seven years , your forecast is even larger because of those extra four months on the front end .
Yeah , so you know the , the , all of my worlds and all of my experience and and all of the great people that I've worked with in the in the industry for a long time and , yeah , frankly , some of the board leaders that I worked with you learn from them as well and you hope you don't repeat their probably their mistakes .
Yeah , yeah , in in retrospect , looking back on it um , what , what would you say , gave you the most pause at the time ?
You know , when you , when you , when you fired off those emails and said , hey , we're going to , we're going to get this thing and we're going to start a company , when you , when you fired off those emails and said , hey , we're going to , we're going to get this thing and we're going to start a company , was there a particular spot that you were like , yeah ,
that's maybe maybe my weak spot , maybe my blind spot ? Like , was there anything that gave you pause about making that move ?
Actually , absolutely not , matt , because it it seemed like all of the messages , all of the signs were going in the right direction . And when I started to reach out to friends and family hey , I'm going to start this company Um , you know they were willing to stand up and and fund the company . Um , there were some tight times . You know .
It's been written that . You know been written that my daughter's college funds were put into this company . They were . My retirement was put into this company and obviously my wife and I had conversations about that .
But we strongly believe that doing good will always lead to doing well and so I think you know I've never , matt , I've never taken a job for the money and I hope I never do , but it's getting things done that need to be done . I truly buy into the whole J&J credo and that it's patients first , right , and it's caregiver second .
It's community third , it's the shareholders fourth , and if the first three are taken care of , then the fourth will be taken care of . And you talk about beginning of career back in the career .
Having started with J&J , we just recently moved into the Johnson Johnson J-Labs because of the opportunity to be in that incubator and it turns out they don't let you into J-Labs unless they are interested in your technology .
I can imagine .
Our ADC technology . As someone said , big pharma , big bio is only interested if you have wickedly crazy new science , which I don't think that's crazy . We're just wrapping the payloads and connecting them to the ADC with silicon dioxide or if it gets them out of a bind .
And , as you know , with ADCs the weak link are the linkers and so if we can help Big Pharma with the linkers we may get through some toxicology trials . But once we get through that I think we'll be a huge outlicensing opportunity machine for the company .
But also we're wrapping the payloads and , you know , think of cytotoxins or even monoclonal antibodies or mRNA being able to protect that payload until it gets into the cancer environment or into whatever disease state environment we're targeting .
And then that coating being eaten off by the low pH , high acidity , will really make the ADCs a much more successful and large part of the pharma community .
I think AbbVie came out during ASCO this year that they believe that ADCs will replace all chemotherapy and cancer , and certainly our delivery system by keeping the chemotherapy , the cytotoxins , inactive until they get into the cancer environment , will be a part of that .
Yeah , before you began developing the ADC program , I mean before you even expanded the original product beyond osteosarcoma you had mentioned that , yeah , you knew why Big Bio wasn't necessarily interested in it , because it was a small patient population .
How did you like , when you were getting the company off the ground and it was like we're going to go tackle osteosarcoma with this product , how did you reconcile that risk that you know that that product sort of patient population calculation- Well , I think it was twofold really .
One One we saw that ROST HER2 was preventing metastasis in osteosarcoma and in the dogs . And , as we talked about earlier , the dogs get osteosarcoma 30,000 to 40,000 dogs a year in the United States , as opposed to only thousand kids a year 20 000 kids globally .
So we saw that it was preventing metastasis and even though it's only half the patients that metastasize , you really don't know which patient's going to metastasize . So we didn't see the entire market in the us is 500 , we saw it as a thousand and we saw the global market not as 10,000 patients but 20,000 patients . And we've done this .
We've done everything with our phase 2B trial , with in-licensing both technologies , with advancing both technologies . We've done all this even post-IPO . With $25 million , most companies would have spent $120 , $150 , $250 million and so we've been very cost-effective .
And we see , just with the osteosarcoma indication , a potential market of $400 to $500 million a year in the United States and we fully intend to commercialize the osteosarcoma indication ourselves in the United States .
And then , if and we fully intend to commercialize the osteosarcoma indication ourselves in the United States , but we are looking for a global partner to reach the other 19,000 patients a year . But we also see that pivoting to other solid tumors like breast cancer , pivoting to other solid tumors like breast cancer .
To be fair , matt , when we first started the company , the only indication we had was osteosarcoma , so we had to make it work . We have since expanded to all the other indications , any other solid tumor that HER2 expresses , and it turns out most solid tumors express HER2 when they're metastasizing because the cancer is using that HER2 expresses .
And it turns out most solid tumors express HER2 when they're metastasizing because the cancer is using that HER2 to set up vascularization in the lungs and the brain . So what we're going to do is quickly pivot to a phase three , either bundle or breast cancer trial , and that's obviously a huge unmet market . You know unmet medical need .
There are still at least 40,000 people a year dying of breast cancer . We see colorectal cancer as an opportunity . But , to your point , when we started we were a one-hit wonder . And if it hadn't worked , uh , if the , if the , you know it looks like clinical trials working pretty well and the side effects are very minimal .
But if it hadn't worked we would have been out of luck .
And so that's why we added the ADC technology and then we had the opportunity to add the canine indication , which has been provisionally approved by the USDA , and then we added all the other indications which has been provisionally approved by the USDA , and then we added all the other indications , and so it was about de-risking , it was about more shots on goal .
But when we first started I don't know how to answer your question how did I know that we could make it on osteosarcoma ? I don't know why I was so confident that we could . But I am now very confident that if we only had osteosarcoma we'd be okay . But now that we have all the other indications , we could have a real impact on other solid tumors .
Yeah , you mentioned . A couple minutes ago . You referenced your cash conservancy . A couple of minutes ago you referenced your cash conservancy . Um , open up the curtain a little bit there . Give us , give us some insight into , uh , how you've done so much with with so little , where you know most companies would have spent a lot more money .
Uh , what's , what are sort of some of the central tenets of uh , of preserving your cash runway ?
Well , one of my favorite investors said Paul , you can stretch a dollar like nobody I've ever seen . So , one we've done a lot with vendors and two we've had a lot of our vendors and two we've had a lot of our vendors contribute in kind . I think the first couple of quotes I got for a 20 patient phase two trial were in the $20 million range range .
I ended up we did a 41 patient phase two trial for under 6 million and yeah , when I got that bid for the 20 million for 20 patients , I said , well , why don't we just have a central location and fly all the families and their patients , the kids , in to a central location on private jet ? It would be cheaper . Yeah , yeah .
It just didn't make sense to me and so obviously we didn't go with that proposal . But we did end up partnering with the CRO that's doing our trial . George Clinical and Children's Oncology Group that's also helping us run the trial has been a huge supporter .
We have seven nonprofits that have invested into the company because they believe in our mission and even if our clinical trial had failed which really seems like it is not they would have advanced science in osteosarcoma , but now that we seem to be having a trial that's making positive effects for patients , at least from around event-free survival and overall survival .
If we can commercialize this and these nonprofits benefit financially , like the Cystic Fibrosis Foundation did with Vertex , where CFF sold their royalty stream for either 4.3 or 5.3 billion can't remember which but if these nonprofits that invested have some sort of return to them , have some sort of return to them , they can not only be proud to say that they supported
a company that brought a new treatment in osteosarcoma for the first time in 40 years , because they're still using doxorubicin , methotrexate and cisplatin like they have for the last 40 years , and it's really toxic and it's for nine months , and it's really toxic and it's for nine months and it's really brutal on kids .
But they can say one we've been involved and helped bring a new treatment . But then they can take the finances and work towards not only treatment but cures and someday prevention . Only treatment but cures and someday prevention .
So you know , that's what nonprofits , that's what disease state organizations are meant to do , and if we can help them do that , the better . Yeah .
What's the community involvement look like today . I mean , this started like as grassroots as I can probably imagine , right like you know , you and olivia's dad saying , hey , you know , let's , let's put some work into this . Um built a community like you said . I mean , I saw the pictures online too the , the head shaving ceremonies and that kind of stuff .
Um , now you're what ? Six , seven years in ?
yeah , and and the community has been phenomenal from the beginning . As I said , I emailed those eight doctors and they all emailed the next morning . Two of them email and say , hey , we can't be on your scientific advisory board because we're conflicted , but we'll do anything we can for you .
And that was Richard Gerlach from MD Anderson , who always responds to emails . He's just hugely supportive . And Dr Katie Janeway of Harvard and Boston Children's , who goes out of her way to help us . I mean , she was moving into a new house in Boston in July without air conditioning and took an investor call , an investor call .
So I mean , yeah , just that commitment . You know the physicians , the parents . We have a patient advocacy advisory board that will go to the FDA with us . They include the father of Tyler Trent , Tony Trent . Tyler was the young man from ESPN who was the honorary coach for Purdue when they beat number one ranked Ohio State .
Apologize to some of the folks on here that may be the Ohio State fans , but I'm happy to revisit that story .
My son's a sophomore at Penn State , so anytime Ohio State loses , we're happy to talk about it .
So I mean , uh , scott van pelt a lot of the folks at espn really really took tyler under their wing and it was just some emotional times for the disease . Laura sobiak , the children's cancer research fund , is involved on the advisory back to the advisory board .
Olivia's on that A young lady who finished our clinical trial , which means she did not metastasize in the 48 weeks she was receiving our therapy . She's on our patient advisory board . Mr Matt Titchener , one of our bigger investors , who is a very large venture capital in the biotech industry . He was the largest shareholder of Peloton when they sold to Merck .
He got into biotech venture capital because his son , willie , passed away of osteosarcoma over 20 years ago . So we're all trying to use a really horrible disease and make it better and hopefully make some other cancers better .
So , yeah , yeah , um , your , your background , as I said , I mean you , you , you focused on , on public policy and government affairs , how , like I've I've talked to , I've talked to CEOs and founders of biotechs that have come from every angle , from every facet . This might be a first , I don't know that .
I've had a founder on who you know , built as a as a founder and CEO of a biotech . Like , do you , do you find yourself leaning into that ? I mean , obviously , the network . You build a great network in that , in that position . But what other , I guess , elements of of that expertise serve you well in the role that you're in now ?
Well , little tongue in cheek , but I , you know , know I'd much rather be doing something easy , like trying to create a new treatment for a really challenging pediatric cancer , than dealing with politicians these days . But no , I think you know the opportunity to have served every department in a major biotech pharma company .
Bering-gilheim at the time was the largest privately held biopharmaceutical company in the world and our department supported every single department , from research development , the commercialization side , the HR , legal , and so being involved with those product developments , along with some others at DI , we were the first to really push the quality measurements way into the
clinical research to make sure that eventually you know that product would get reimbursed , to make sure that eventually that product would get reimbursed .
So supporting the development of these products and making sure that their launches were successful and that the access to these medicines life-saving medicines from Big Pharma and Big Biotech really did prepare me and the rest of our team for getting stuff done .
That's , you know , the beauty of being in a small company , small biotech , is that you get things done , and so that's one thing we've been talking about a lot recently matt post ipo , which was about 48 days ago , 50 days ago , and that is , as we grow , making sure that we keep a very entrepreneurial and collegiate culture .
All of us that work at os therapies really enjoy the work environment and the culture , but we also realize that it's much more productive than meetings upon meetings upon meetings take , take , take that a little bit deeper .
like more productive than meetings upon meetings upon meetings ? What does that sort of that , that collegial culture , entail ? Like what ? How are we spending our time in a more constructive way ?
It's . It's all about getting things done , making sure that the data is prepared you know , to prepare to , to , to get to the FDA . It's about getting supplies to the trials so that the patients receive the therapies . It's about making sure that investor calls and bankers are well aware of what the company is doing .
About transparency of the government of the company . It's all about execution and making sure that we're executing on our strategy and that's why we've been able to do so much with such limited funds and such um in such an efficient way .
Yeah , Um , what would you be doing if ? What do you think you'd be doing right now ? If , uh , if you , if , if not for Olivia , would you still be consulting ?
I don't , I don't . You know ? There's a uh , luke Bryan , luke Combs song . What would you be doing now if you weren't doing this ? I haven't heard that one . He basically says I'd still be singing my music in a bar , which is what I'm doing now . Right , but I would hope that I would have found something as inspirational as this to do .
We started with what's small rare cancer , and look , matt , if I were to be able to get rid of this nasty chemo for a small rare disease like osteosarcoma and the community that I'm so close with , that would be absolutely a life check . Right , put me in the ground tomorrow . Good , but just think if we can significantly affect other solid tumors .
You know and I congratulate the industry and the folks that have worked on the blood tumors we in the solid tumor world have a lot further way to go , and so that inspires me , that inspires my entire team , all of the vendors that we work with . Either they have the passion and the focus and the commitment to what we're doing or they're not involved .
Yeah , there's a , you know two . You can start with either either of these tracks you'd like . It's sort of a two part story we're telling here between the , the osteo , the , the , the vaccine candidate and the ADC candidate . And they're , you know , they're , they're considered .
But I imagine there's a challenge , and inherent challenge , in managing the go-forward plans for both of those , because they're very different go-forward plans in very different markets . Look at the ADC space right now . You talked about your differentiating technology around the linker , but it's a very crowded space .
I mean , there's a lot of activity in that ADC market right now . So , yeah , maybe , since I'm setting it up that way , we'll dwell on that one for a minute . What is your like ? You bring this ADC technology in . It's unique , it's differentiated , it's novel . Give us the high level go forward plan with that .
Canada , as I said , in the context of a pretty busy ADC biotech space .
Well , they're both . Both platform technologies are very dependent on each other . Even though they are very different , they dovetail nicely , right ? Because the HER2 is preventing metastasis , which in the long run is going to have the most significant effect on increasing survival .
And then the ADC is debulking large solid tumors and so there's the thought that maybe we could use the ADCs at some point for osteosarcoma even our original mission of the company . But as I often describe it , matt , it's like having two children and you love them both , but you love them differently . Yeah , I always say the first one .
The HER2 is going to be the workhorse . It's further along in the pipeline . We've finished phase 2b trial . We believe that to be a registration trial . We get a priority review voucher from that . We use that to pivot to phase three and breast and lung cancer and other solid tumors , which would be a huge expansion in the company .
All the while we're developing the ADC , that's maybe further back . And as soon as we get through two-week in GLP toxin and if we prove that our linkers and the coding really does work the way it has in our in vivo trials , then that becomes an out-licensing opportunity while not even jeopardizing our therapeutic developments in the ADC space .
So , and all along that , you know there's the potential of us being bought out , either for one platform or the other or both , and so you know we're a go forward . You know commercialization we're looking to partner in certain places . We certainly want to out-license the canine osteosarcoma to a large animal health company .
Osteosarcoma is the single largest disease killer of dogs , second only to automobiles . So big market opportunity for an animal health company . And again , don't want to distract ourselves and the company from our mission around humans and around osteosarcoma and then all the solid tumors .
So yeah , the ADC space is crowded but there are still a lot of problems and that market is going to be huge . As I said a couple of years ago and people thought I was crazy , adcs are now what monoclonal antibodies were 10 years ago . Anyone , not in the industry . You just look at a tv ad and it's whatever the generic .
It is up the the brand name is . The generic ad ends with uh , nab . So you know , monoclonal antibodies are all over the place . I think that's where adcs will be in next six , eight , ten , 10 years .
Yeah , as you think about the optionality that you have moving forward . I mean , you know it's . I'm not going to ask you to share your ideal , you know situation , but any of them short of you know , taking the ball all the way to the finish line yourself involves some degree of of letting go of something that I mean change .
Change your life right , change the trajectory of your , of your , of your life . How do you feel about that ? Like what is ? You know , what level of involvement will Paul Romness retain , regardless of the outcome here ? I have said from the beginning , regardless of the outcome here .
I have said from the beginning , this disease is bigger than any one person , and so the other thing I've said is it will take all of us getting involved and it means our investors , our vendors , patients , their parents , the clinicians . It will take all of us doing everything we can to be successful .
So look , there have been a thousand places where this could have derailed before the clinical trial , before the in-licensing , during all that process , the IPO . There are a thousand places , to be honest , going forward , where things could go wrong , but we've tackled every single one of those . We've done everything we said we would do .
Obviously , it took more money and more time than you'd ever think , but we have executed and delivered on everything we said we would and we're gonna do the same moving forward .
But , whether that includes me or anyone else , I've always said everyone is replaceable and if there's a time where someone can carry this mission further than me , the mission is bigger than any one person .
Immediate horizon . What's on the immediate horizon for each of these candidates ? Like , what should we be looking out for ? I mean , you talked a bit about the clinical trial and wrapping that up Like what's the next step there ?
Yeah , so the phase two B clinical trial finished technically finished is not October 1st , but the last kid got his last dose four weeks ago , yesterday .
We should have the data and the case match control ready by the week after Thanksgiving and we're an open label , company-sponsored trial so we will most likely share that data , obviously taking that data with the case maps control to the FDA . We're hoping for breakthrough designation . We're hoping for approval by the end of second quarter next year .
That's on the human osteosarcoma . The canine osteosarcoma uh has been conditionally approved by the USDA . We do need to do a quick shedding trial two week , two week trial . That uh measures if there's any residual biologic infection coming out of the dogs .
Uh , you certainly don't want to have one dog um urinating , listerinating listeria or secreting listeria and another dog getting it . So in the previous trials with the canines it has been checked , each dog's been checked to make sure they don't have listeria , but it was never measured .
So we have to do that and submit that to USDA for full approval and then we look to our license that and find a partner who can commercialize that globally . We also will then quickly pivot next year into a phase three trial with standard of care along with ROSD HER2 in either breast cancer and or a bundle trial for that .
And then , as soon as we get through GLP tox for the ADCs , we'll look to partner on developing three to five ADCs to get INDs for and get into the clinic for that as well .
Yeah , very exciting Lots on your plate . You wouldn't have it any other way , though , would you ? You mentioned from the outset , when you told Olivia's story , that she's doing well and she goes into pediatric oncology . She's working now at a pediatric physician's office here in the area , and they just love her .
So I think you know when you dodge a bullet like osteosarcoma again , as I mentioned earlier , most people most kids and their families , parents run from the disease , but some of the kids that have survived osteosarcoma have channeled that back into the disease and pediatric oncology .
There was , I think , a physician's assistant from St Jude's that actually went up in one of the um space flights and you know there's a young lady that had a really bad genetic uh mutation of her osteosarcoma . It's called mick amplification , myc , and it turns out she had a biologic kind of like what we're doing for our patients , and she survived .
Otherwise , mycoplasma is a very , very poor diagnosis . She's now a pediatric oncology nurse and so I see I could see Olivia doing that and be full circle , that's for sure . Yeah , yeah , I feel it feels kind of funny to talk about her without her here . I think the next time I see I could see Olivia doing that and be full circle , that's for sure .
Yeah , yeah , I feel it feels kind of funny to talk about her without her here . I think the next time we have you on Paul , we'll have to bring Olivia on as well .
Oh , it'd be great . She would definitely tell it like it is , matt . Yeah , that's , that's fantastic .
Well , I appreciate you coming on , paul . This has been very insightful . It's super inspiring work that you guys are doing . Thanks for sharing the story with us and , you know , with everything coming down the pipe here in the next 12 , 18 months , I'd love to have you back on for an update .
You know , maybe sometime next year when there's data to talk about and next steps , and learn a little bit more about how you navigated that .
That'd be great , Matt . Thank you very much for your thoughtful approach .
I appreciate it . So that's OS Therapies CEO and Chair , Paul Romnes . I'm Matt Pillar , and you just listened to the Business of Biotech . We're produced by Life Science Connect in support of a deep community of learning , solving and sourcing solutions for biotech and life sciences leaders .
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