Vlad Vitoc, MD, MBA; CEO & Chairman of MAIA Biotechnology, was a guest on Benzinga’s All Access.
MAIA is a targeted therapy immuno-oncology company focused on developing and commercializing drugs targeting cancers with novel mechanisms of action.
The company’s lead program is THIO. The novel therapy “opens” the telomere cap of cancerous DNA, leading to rapid cell death.
MAIA is a targeted therapy immuno-oncology company focused on developing and commercializing drugs targeting cancers with novel mechanisms of action.
The company’s lead program is THIO. The novel therapy “opens” the telomere cap of cancerous DNA, leading to rapid cell death.
Category
🗞
NewsTranscript
00:00 (upbeat music)
00:02 - Good morning, Vlad.
00:06 - Good morning, Zonaid.
00:07 - How are you?
00:08 Appreciate you joining us this morning.
00:10 - Thank you, it's great to be here.
00:12 - Absolutely, and I know we've got some things
00:14 to dive into, but before we do that,
00:16 I'd love for you to give us a little bit of a background
00:18 on you and how your company was founded
00:21 and what is it that y'all do?
00:22 - Yes, so a bit of background on me.
00:26 I am a physician by my first training,
00:28 a businessman by my second training
00:30 and have spent my entire career in oncology,
00:34 in pharma and biotech.
00:36 About 25 years now, 50/50 on the medical
00:41 and commercial side.
00:42 I had the privilege to work for some extraordinary
00:47 oncology companies launching drugs
00:49 that were paradigm shifts in their day.
00:52 But in 2018, decided to found Maya Biotechnology
00:57 as a company to discover and develop
01:00 and ultimately commercialize novel mechanism
01:03 of action drugs.
01:05 And this happened with the licensing of the drug
01:09 we now call Thio, T-H-I-O, from University of Texas in 2018.
01:14 So now we're going on the sixth year here with Maya.
01:18 We went public in 2022 and are now traded
01:25 on Neurostar Exchange.
01:27 - Yeah, you mentioned Thio,
01:29 which is the next question I wanted to go to,
01:31 especially as it's a proprietary drug
01:33 that I believe is currently in the clinical development
01:37 stage of it.
01:38 Can you walk us behind the science on how that works?
01:41 - Yes, so Thio is a first of its kind.
01:45 It's the world's first telomere targeting agent,
01:49 also with an extraordinary immunogenic capability.
01:54 So the way it works, first we need to understand
01:57 the biology of the telomeres in cancer for a little bit.
02:00 You have, imagine the chromosome,
02:03 typically represented as an X,
02:05 that contains our DNA, our genetic information.
02:09 And at the end of the chromosome arms
02:11 are the telomeres, our target.
02:15 The telomeres are also DNA sequences,
02:19 but much shorter and with a very specific function
02:22 to protect the chromosome in the cell division cycle.
02:27 They are built and maintained by an enzyme called telomerase,
02:31 which is present in all normal cells
02:34 in the first year of life.
02:35 At about age one, telomerase goes away.
02:39 And at that point, the telomeres reach their maximum length.
02:43 And from then on each cell division cycle,
02:45 they lose a little until in the old age,
02:48 they become critically short,
02:50 can no longer protect the chromosome
02:53 and mutations begin to appear,
02:56 diseases of the old age, including cancer.
02:58 Now in cancer cells, something extraordinary happens.
03:02 The enzyme telomerase is turned back on.
03:05 So the cancer cells regain their ability
03:08 to elongate their telomeres
03:10 and reach a state of replicative immortality,
03:13 meaning they continue to divide
03:15 and the tumor grows in the aging body.
03:18 That is exactly where Thio comes in.
03:22 Thio is picked up by telomerase.
03:25 It's put in the structure of the telomere.
03:28 It creates a faulty unstable structure.
03:31 The telomere collapses, the DNA unwinds
03:34 and the cancer cell dies.
03:36 This process is fast and efficient.
03:40 It happens in 24 to 72 hours
03:43 and Thio directly kills 70 to 90% of the cancer cells.
03:49 Then follows its immunogenic effect.
03:53 Of the telomeric fragments, Thio forms micronuclei,
03:57 small incomplete nuclei that carry these fragments
04:00 and present them to the immune cells,
04:03 triggering an immune response that is so effective.
04:07 If you follow Thio with an immune therapy,
04:10 a checkpoint inhibitor, you see complete response,
04:14 no recurrence and anti-tumor immune memory.
04:18 What we want.
04:19 We have seen this type of cure
04:21 in multiple preclinical models,
04:23 in lung, in colorectal, in liver, in brain,
04:27 with Thio followed by different checkpoint inhibitors,
04:31 Liptio, Frageneron, but also Ketruda of Merck,
04:34 the centric of Genentech.
04:37 And the first go to market is with Liptio of Frageneron.
04:40 - Now you mentioned stats that you had brought up.
04:43 I believe it was about 70 to 90%
04:46 of the cancer cells are killed.
04:47 Now is that what you've identified to be true
04:50 with the Thio 101 clinical trial?
04:53 - Those stats are from a preclinical setting.
04:57 What we've seen in the clinic, in the Thio 101 trial,
05:01 is even more extraordinary.
05:03 We have seen the first,
05:05 there are several metrics of success in a clinical trial.
05:08 And the first metric that shows is called disease control.
05:13 Disease control is measured in the first scan.
05:16 So this is after six weeks,
05:17 two cycles of treatment after six weeks.
05:20 And disease control is very closely associated
05:25 with overall survival advantage down the line.
05:28 The type of disease control we have seen,
05:32 this is a very heavily pretreated cancer patients
05:35 and very advanced disease.
05:37 In second line of therapy, we have seen,
05:41 we have reported a TESMO 100% disease control.
05:45 This is not gonna be always 100,
05:49 because from one, there is only one way to go.
05:51 We think it's going to end up in the 90s.
05:54 So that compares to the standard of care in second line,
06:00 which is chemotherapy, 50 to 60%.
06:03 It's far, far greater.
06:05 In third line of therapy, even more striking a difference.
06:09 It's we have 80% and third line chemo is 30%,
06:13 more than double.
06:15 In fact, even in first line,
06:17 when you look at the market leader results,
06:19 Ketruda, the best selling drug of all time
06:23 in non-small lung cancer,
06:25 their disease control is in the 70 to 80% range
06:29 in first line of therapy, treatment naive patients.
06:32 And we are better than that in third line.
06:35 The trial, yeah.
06:38 - I'm sorry, go ahead, go ahead.
06:39 - The trial is continuing
06:41 and we're seeing these patients living
06:44 through their benchmarks and confirming, yes.
06:49 - Now we've got about three to four minutes here.
06:51 So I wanna talk about what else is kind of in the pipeline
06:53 that you're able to tell us,
06:54 especially with the other, you know,
06:56 immuno-oncology therapies for difficult to treat cancers.
07:01 Any brief overview on how you're looking
07:03 to address the pipelines that's in there right now?
07:06 - Yes, so we have two types of pipeline.
07:10 It's the pipeline for Thio.
07:11 We have trials planned for Thio
07:13 to take it to market in non-small cell lung cancer.
07:16 But we also are planning trials in liver cancer,
07:20 in colorectal and in brain cancer.
07:23 Some of these trials are gonna be company sponsored,
07:25 others are investigator sponsored.
07:27 We have quite a number of investigators
07:30 interested in sponsor this from all over the world.
07:32 So, and in terms of the next generation
07:37 of telomere targeting agents,
07:39 we developed 84 new molecules in-house.
07:43 They all work, same mechanism of action,
07:46 telomere targeting with immunogenic effect.
07:49 And seven of them have proven to be
07:51 an order of magnitude superior to the original
07:55 in certain tumor types in preclinical setting.
07:58 We are moving them forward in development.
08:00 Two of them are on their way to IND.
08:03 We hope to get them to the clinic
08:05 in the next 12 months or so.
08:07 A third one is ready to start
08:09 and we have four more in reserve.
08:11 We will build a franchise.
08:13 And speaking of building,
08:14 I know you have Thio that's received
08:16 three orphan drug designations.
08:18 Can you quickly give us a brief overview of that?
08:21 Yes, that is a huge endorsement from the US FDA.
08:26 Out of three applications,
08:28 we got three orphan drug designations.
08:31 This is truly extraordinary.
08:34 One in liver cancer, another one in lung cancer,
08:38 small cell lung cancer, the deadliest form of lung cancer.
08:41 And the other one, just most recent in glioblastoma,
08:46 the most prevalent form of brain cancer.
08:48 These are difficult to treat and Thio can do very well.
08:54 So an orphan drug designation like this
08:58 means that the FDA have reviewed the data,
09:00 they endorse it, they give us the orphan drug designation
09:05 that ensures seven years of marketing exclusivity
09:10 and certain lower fees for development.
09:15 So the net of it is it's about $2.9 million in savings
09:20 as well per indication.
09:22 And then, as you go ahead and develop these drugs,
09:25 as you go through the clinical trials,
09:27 last question for me,
09:28 is there anything that potential investors,
09:31 the viewers and investors already in my biotechnology
09:34 is that they can look forward to for 2024 and beyond?
09:38 What can they expect?
09:39 Yes, so 2024 is a big year.
09:43 We're going to start our final part of Thio 101
09:48 to take Thio to market.
09:53 We hope it will be commercial by 2026.
09:55 So we are about two years prior to commercial.
09:58 We are looking also to expand our partnerships.
10:03 We are in deep dive due diligence
10:06 with three major pharmaceutical companies as we speak.
10:10 And we anticipate a co-development
10:13 or XUS licensing type of deal
10:18 to happen in some point in the course of this year,
10:21 probably in Q2,
10:22 but based on how discussions are going.
10:24 Awesome, I look forward to having you back on
10:28 for those conversations
10:29 when you publicly release that information,
10:31 but thank you so much for joining us.
10:33 Thank you as well, Zunayd.
10:35 Good to be here and thank you.
10:36 (upbeat music)
10:39 (upbeat music)