John Climaco, CEO of CNS Pharmaceuticals was recently a guest on Benzinga's All-Access.
CNS Pharmaceuticals is a clinical-stage pharmaceutical company developing a pipeline of anti-cancer drug candidates for the treatment of primary and metastatic cancers of the brain and central nervous system (CNS).
The company’s lead drug candidate, Berubicin, is a novel drug that appears to cross the blood-brain barrier. Berubicin is currently in development for the treatment of a number of serious brain and CNS oncology indications including glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer.
CNS Pharmaceuticals is a clinical-stage pharmaceutical company developing a pipeline of anti-cancer drug candidates for the treatment of primary and metastatic cancers of the brain and central nervous system (CNS).
The company’s lead drug candidate, Berubicin, is a novel drug that appears to cross the blood-brain barrier. Berubicin is currently in development for the treatment of a number of serious brain and CNS oncology indications including glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer.
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NewsTranscript
00:00 (upbeat music)
00:02 - All right, John, welcome to Benzinga's All Access.
00:06 How are you doing today?
00:08 - Doing great, thanks for having us.
00:09 - Of course, thanks for taking time
00:11 out of your busy day to join us.
00:12 So before we get started,
00:14 do you mind just telling me what CNS,
00:16 what do you guys do and give us an overview of your company?
00:20 - Sure, so we're a clinical stage drug development company
00:23 and we specialize in neuro-oncology chemotherapy products.
00:27 So we've got a drug in a later stage trial
00:32 for the treatment of glioblastoma.
00:34 And that's really what we're totally focused on right now.
00:37 - Got it, well, I'm gonna call it GBM
00:39 if that's okay with you,
00:40 'cause I'm not as good at pronouncing
00:41 some of these medical scientific things.
00:44 But what is GBM and what are the current treatment options
00:48 and how successful are they?
00:50 - Yeah, so this is,
00:51 so GBM is an absolutely devastating primary brain cancer.
00:57 It's the disease that killed John McCain,
00:59 it killed Ted Kennedy,
01:01 it killed the president
01:04 of the largest cancer research center in the world
01:06 at MD Anderson where our drug was developed.
01:09 It is totally devastating, it's almost universally fatal.
01:13 Average life expectancy from diagnosis is 12 to 16 months.
01:18 It's just, it's awful.
01:21 And really the worst part about it is that today,
01:24 2023, we've got all these incredible advances
01:27 in immunotherapy and various new technologies for cancers.
01:30 And here, six out of 10 patients don't even respond
01:35 to the current standard of care at all.
01:36 They go from radiation directly to hospice.
01:40 So that's really what our mission is,
01:41 is to change that for the better for these patients.
01:45 - Yeah, it sounds like a terrible disease.
01:47 Let's talk about your lead candidate, Barabucin.
01:51 How is it novel and how does it work to treat GBM?
01:55 - Sure, so Barabucin--
01:57 - Oh, sorry, I was worried about that.
01:58 - No problem, no problem.
02:00 Basically, what's exciting about this is Barabucin
02:03 is a member of a class of drugs called anthracycline.
02:07 So these are among the most commonly used chemotherapy drugs
02:10 in the world, they've been around in the clinic for 60 years.
02:13 The limitation is they don't cross the blood-brain barrier.
02:16 And that's this very specialized network of cells
02:19 that surrounds and protects our brain,
02:21 prevents almost all drugs from getting into the brain.
02:23 So once you have a tumor growing,
02:25 you've got a real problem in terms of your ability
02:28 to treat this.
02:29 This drug was designed specifically
02:31 to retain the functionality of 60 years of success
02:35 with anthracyclines, but allow those type of drugs
02:38 to cross the blood-brain barrier.
02:40 So it crosses the blood-brain barrier
02:42 and it basically disrupts the mechanism
02:44 by which these tumor cells divide and proliferate.
02:48 And we had some very exciting phase one data on this drug,
02:53 lots of responses, including one complete response
02:56 that's effectively a cure, somebody's alive
02:59 for over a decade after treatment with this drug.
03:03 So it's a very exciting compound.
03:06 We often say the anthracyclines are sort of the hammer
03:09 in the oncologist's toolkit.
03:11 And now we can bring that hammer to where the nail is
03:15 inside the blood-brain barrier where these tumors grow.
03:18 - Wow.
03:19 What does it mean to be given the green light
03:22 from the Independent Data Safety Monitoring Board
03:26 that your Barubicin, sorry, studies should proceed
03:30 without modification.
03:31 What goes into making this decision?
03:33 - Yeah, so it's huge for us.
03:36 We have almost 260 patients on this study.
03:39 It's fully enrolled at this point.
03:41 Survival, which is basically our patients living longer
03:46 on our drug than they are on the comparator arm.
03:50 And at the midpoint of this study,
03:52 we had a pre-planned analysis where an independent group
03:56 of oncologists reviewed the safety and efficacy data
04:00 essentially to determine was this study futile,
04:04 meaning, were we seeing any signal
04:07 or was there nothing there and we should terminate
04:09 the study.
04:10 So when they gave us the green light to proceed
04:12 without modification, what that says is taken together,
04:16 the safety and efficacy data showed signal
04:18 beyond that threshold and this study was allowed to proceed.
04:22 And it was really the best news that we could have
04:24 because essentially the only other options were either
04:27 to terminate the study or to modify it,
04:29 which would also mean stopping it,
04:31 which would be a disaster.
04:32 So really, this is the best news we could have.
04:36 Again, taken together, we see that the safety
04:38 and efficacy data are showing signal.
04:40 The study should proceed to its conclusion.
04:43 And that's where we are.
04:44 We're as thrilled as we could be by that result.
04:49 - Well, yeah, congratulations on that positive news.
04:51 That's great to hear.
04:52 And then John, I also understand that you just added
04:55 Amy Mary, a veteran of commercialization to the team.
04:59 Why now?
05:00 - Yeah, well, Amy found us.
05:02 She loved the approach that we were taking.
05:06 We were flattered.
05:07 Obviously, she is the chief commercial officer at Roivent,
05:11 so a huge pharmaceutical company.
05:15 Came to this tiny little company
05:16 because I think she really loved the approach
05:19 that we were taking with this drug.
05:20 We saw a signal.
05:21 We said, you know what, let's go straight
05:24 to the primary endpoint that FDA recognizes,
05:27 which is overall survival.
05:28 And to bring someone like Amy on board,
05:31 I think should send a signal
05:33 that we are planning for success.
05:35 We see this drug continuing on to a successful conclusion.
05:39 We had a great interim analysis,
05:40 and a successful conclusion for us is commercialization
05:44 and bringing this drug to patients via an FDA approval.
05:47 So we really brought one of the great leaders
05:50 in our field on board to help us with this next stage
05:54 of the company's development.
05:55 And we're thrilled to have her, really are.
05:59 - Yeah, that's awesome.
06:00 And it's always great to see growing companies
06:02 get those key pieces on their management team
06:05 that can help take the next step.
06:08 John, tell me about your recent public offering.
06:11 What are your plans for the cash raised?
06:13 - Yeah, so it's continuing operations,
06:16 essentially is the objective for the cash raised.
06:19 As I said earlier, the study's fully enrolled,
06:22 so nearly 260 patients on the study.
06:25 So this is a very large study.
06:26 It's a phase two study, but really,
06:28 when you talk about that number of patients
06:31 and an approvable endpoint,
06:32 you're talking about something that looks a lot more
06:34 like a phase three, and that's how we designed it.
06:37 And so the cash is gonna continue for us
06:40 to keep executing this study,
06:43 moving toward top line data in the first half of next year,
06:47 and what we hope will be a successful conclusion
06:50 to many years of effort here on behalf of these patients.
06:54 - Got it.
06:55 And with something like GBM, I mean, like that you mentioned
06:57 it's so deadly.
06:58 Is there any chance that you get a type
07:01 of different rare disease designation
07:04 or any government funding or anything
07:05 to help with these studies?
07:07 - Sure.
07:08 So we do have our orphan designation from the FDA
07:12 along with our fast track designation.
07:14 So from a regulatory perspective,
07:16 we're about as teed up for a speedy
07:19 and successful approach to the end here.
07:22 We have regular communication with FDA on these things.
07:26 Orphan designation, of course,
07:27 gives us seven years of marketing exclusivity,
07:31 beginning on approval, so terrific IP protection.
07:34 And really that's sort of the objective.
07:38 It's been the objective all along,
07:40 go as fast as possible, be as efficient as possible,
07:43 run it as lean as possible,
07:45 and get this thing over the finish line
07:48 and into the hands of patients.
07:50 - Got it.
07:51 Well, John, wrapping up here,
07:52 I wanna ask you for a hot take.
07:54 So everything here in the market,
07:56 people have been talking about AI basically nonstop.
07:59 How is AI changing biotech research?
08:01 And do you think that the technology
08:03 will help make the unsolvable solvable?
08:06 - Yeah, absolutely.
08:07 I mean, drug development is a very complicated business
08:10 and target selection is a huge part of it.
08:13 And we were fortunate this drug was developed
08:16 over a very careful process many years ago,
08:20 very careful targets.
08:21 But when you're looking at a disease like GBM
08:24 and you're pulling apart mountains and mountains of data,
08:27 of course, something like AI is gonna be able in the future
08:30 to help select those targets more effectively
08:33 and find compounds and molecules
08:36 that match with this disease better.
08:38 So unquestionably, it will be in the future,
08:42 in the future, it will be a great help.
08:44 - Yeah, I mean, I'm excited to see the impact that AI has
08:47 on different biotech research
08:49 and really across the board,
08:50 across different industries.
08:52 Well, John, it's been amazing to learn more
08:55 about what CNS is doing.
08:57 And obviously for everyone out there
09:00 who may have family members
09:02 or worried about dealing with GBM themselves,
09:05 we all wish you the best and hope you're successful
09:07 in learning how to solve this problem.
09:10 - Thanks so much.
09:11 Really appreciate you having us.
09:12 (upbeat music)
09:15 (upbeat music)