Dr. Howard Burman, Ph.D, CEO of Coya Therapeutics Inc., were guests on Benzinga’s All Access.
Coya is a clinical-stage biotechnology company focused on developing proprietary new therapies to enhance the function of regulatory T cells. The company is currently developing multi-modality Treg therapies for neurodegenerative, autoimmune and metabolic diseases.
Coya has secured key financing that is funding its research and development to enhance the body’s T cells.
Coya is a clinical-stage biotechnology company focused on developing proprietary new therapies to enhance the function of regulatory T cells. The company is currently developing multi-modality Treg therapies for neurodegenerative, autoimmune and metabolic diseases.
Coya has secured key financing that is funding its research and development to enhance the body’s T cells.
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NewsTranscript
00:00 (upbeat music)
00:02 - Dr. Berman, good morning.
00:05 Thank you for joining me.
00:06 - It's a pleasure to be here.
00:08 Thank you.
00:08 - Absolutely.
00:10 I'm glad we can have a conversation again.
00:12 I know it's been a minute.
00:13 So if you could give us a refresher,
00:15 explain it to me like I'm five,
00:16 what is it that Coya Therapeutics does?
00:19 - Sure.
00:20 We're developing biologic therapeutics
00:22 that treat neurodegenerative diseases
00:24 and we target inflammation.
00:27 I think what makes us very unique
00:29 is that we use combination immunotherapies
00:32 and we've tested this already in a number of patients
00:36 in ALS and in Alzheimer's disease
00:38 and the results are quite striking
00:40 in terms of being able to stop the progression
00:43 in our early studies.
00:44 And now we're pushing forward very quickly
00:47 to move into a double-blind randomized trial.
00:50 So we're moving quickly and we've had a great 2023.
00:54 - And I know you have,
00:56 there's a little bit of news that came out,
00:57 but I'm curious to know about
00:58 if you could define TREX for us
01:01 and elaborate on the significance
01:02 of the regulatory T-cells in treating these diseases.
01:06 - So T-regs are a type of cell, regulatory T-cells.
01:10 They are the sort of the master regulators of inflammation.
01:14 So when T-regs aren't working properly,
01:16 they're dysfunctional, inflammation goes up
01:19 and that's very bad in these neurodegenerative diseases.
01:22 We're sort of leading the field
01:24 in understanding how these T-regs work in these conditions.
01:28 And I can tell you that the drugs that we have
01:31 and that we put together are really good
01:34 in propping up those T-regs in the blood
01:36 and making sure that they stay functional
01:39 for a long period of time.
01:40 And that's what we think is a key
01:42 in terms of slowing or stopping these diseases.
01:45 - Now, let's go ahead and move on to ALS
01:47 in the sense that I know your company
01:49 has been working on COIA-302,
01:51 which is therapy initially aimed at treating ALS.
01:54 Any key findings there, whether it's in the trials
01:57 or any progression that you have,
01:58 especially with the T-regs that you just mentioned?
02:01 - Right, so again, I wanna state
02:03 that these are complex diseases
02:05 and much like in oncology and in viral disease
02:10 where combination therapy is really where the future
02:12 that patients are now living a long time,
02:15 same goes for these neurodegenerative diseases.
02:19 So we're using these combination biologics.
02:22 We're putting these into,
02:23 we've already put these into patients
02:25 and in a cohort of patients that we ran
02:28 who were progressing pretty quickly,
02:30 what we saw is after four weeks,
02:32 the patients stopped progression and they stayed.
02:34 They stayed stable for a long period of time
02:37 over the course of treatment.
02:39 So that's a very important finding.
02:42 When we measured their blood
02:43 and we looked at the different markers,
02:44 we saw that the markers went down
02:46 in terms of the inflammation and the oxidative stress
02:50 and the T-regs went up.
02:51 So all of the features that you wanna see were there
02:55 and that's very exciting.
02:57 We also have some data in Alzheimer's disease,
02:59 which is of course a very big issue.
03:02 And what we've done is we've tested it
03:05 in a cohort of eight patients
03:07 and we showed that in fact patients do better.
03:10 They do better, their cognitive function improved.
03:13 And moreover, the Gates Foundation saw this data
03:16 and they've now funded a large,
03:18 a double-blind randomized trial
03:21 and that data should read out this summer.
03:23 I believe you've also got something
03:25 in the works with Parkinson's disease
03:27 with COIA-302 as well, correct?
03:30 Parkinson's disease and a disease
03:31 called frontotemporal dementia.
03:33 So we look at COIA-302 as they say a pipeline in an asset.
03:38 So we think that it can treat multiple indications.
03:41 We started with ALS, we're now moving to FTD,
03:45 frontotemporal dementia.
03:47 Bruce Willis has that by the way.
03:49 And then of course Parkinson's disease
03:51 and there's other conditions,
03:52 but where these are the top three.
03:55 And I know you're working
03:56 with Dr. Reddy's laboratories as well.
03:58 I'm interested in the fact of how agreements
04:00 are working with other countries.
04:02 So not just the United States, but also Canada, the EU,
04:05 the UK, 'cause obviously, unfortunately people deal
04:07 with this around the world as well.
04:08 Where are we at in terms of that for trials
04:11 and any of the regulatory approvals?
04:12 Yeah, well, what's amazing is Dr. Reddy's,
04:15 you may know they're an Indian generic company,
04:18 multi-billion dollar company.
04:20 And what people don't know is that they're now branching
04:23 into biologics and branded therapeutics
04:26 and they're moving into a much bigger arena.
04:29 So they signed a deal with us last year
04:31 for over $700 million in gross deal terms.
04:36 And that was a transformative deal for Koya.
04:39 They've taken the rights for ALS,
04:41 only ALS for the United States and for Europe.
04:45 And Koya retains other rights in terms of Japan
04:48 and other countries.
04:49 So we've joined hands with Dr. Reddy's.
04:53 They're very financially capable
04:56 and we're very proud to have them as partners.
04:58 It leaves us also the opportunities to develop FTD
05:02 and Parkinson's by ourself if we want,
05:04 or as we're having numerous discussions,
05:07 consider collaborations in FTD, Parkinson's
05:10 and other disorders.
05:11 So this is a sort of a pipeline in terms of other strategic
05:16 opportunities that will arise in 2024.
05:20 Yeah, that's definitely a great partnership to have,
05:22 especially when it's a proven record
05:24 of what they've been able to do.
05:25 We talked about 302, let's talk about Koya 301.
05:27 Tell us a little bit about that
05:29 and what it's supposed to help with.
05:30 Yeah, so 301 is the low dose IL-2.
05:33 It's the one of the components of 302, right?
05:37 So that is a function of enhancing the Tregs.
05:41 The low dose IL-2 component increases the number
05:44 and enhances the function in the body
05:46 in a well-tolerated manner.
05:48 It's a low dose format, so we don't anticipate any issues
05:53 in terms of side effects and toxicity.
05:55 And that is a drug that we look to be an adjuvant.
05:59 When I say adjuvant, in combination with many other drugs,
06:03 like we've done with Dr. Reddy's Beta Cep, CTLA-4.
06:07 So we look at it as a future platform to combine it
06:11 with many other drugs, with many other companies.
06:14 We are doing this trial in Alzheimer's disease
06:17 with low dose IL-2 by itself.
06:20 And we'll wait for that data this summer.
06:22 But again, we anticipate that the combination therapeutics
06:26 are the future of treating neurodegenerative conditions.
06:29 And low dose IL-2 serves as that mantelpiece, if you will.
06:33 Yeah, it's kind of like attacking different situations
06:35 with different types of doses
06:36 based on what the needs might be.
06:38 Last one for me, and then we'll wrap things up.
06:40 When it comes to core therapeutics and the approach
06:43 that you have in the current landscape,
06:44 when it comes to biotech or pharmaceuticals,
06:47 where do you feel like you have the advantage
06:48 over your competitors?
06:49 Well, in neurodegenerative conditions,
06:52 we're targeting multiple pathways
06:56 and we're combination biologics,
06:57 and we're sort of leading the field in that arena.
07:01 We're also in the Treg space,
07:03 one of the only companies
07:04 that are targeting neurodegeneration.
07:06 Most other Treg companies are focused
07:08 on the autoimmune condition.
07:12 And lastly, we're the experts in neurodegenerative diseases.
07:16 We have some of the top leadership.
07:18 We have people who have taken blockbuster drugs
07:21 into the clinic.
07:23 We've got the leaders on,
07:25 the thought leaders in neurodegeneration
07:27 and the people who discovered Tregs are on our company.
07:30 So I really think that we're in front.
07:34 Plus we have a balance sheet now
07:35 with the deal with Dr. Reddy's
07:37 that are just gonna take us into 2026.
07:39 So we're well capitalized
07:41 and we have our eyesight now on additional capital
07:45 in terms of the milestones from Dr. Reddy's.
07:48 So I think the future is very bright
07:49 in terms of where we are and where we're trading.
07:52 Yeah, I mean, look, it's not cheap
07:54 to do what you guys are looking to accomplish
07:55 and what you already have.
07:56 So I'm glad the balance sheet is looking pretty for you there
07:59 but thank you so much for joining us.
08:00 Look forward to more conversations as more news comes out.
08:02 (upbeat music)
08:05 (upbeat music)