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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.
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