Genprex – FDA Grants Fast Track Approval For Promising New Cancer Gene Therapy
Genprex is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. Genprex’s technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches.
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00:00 (upbeat music)
00:02 - Thank you so much for joining the show.
00:06 We appreciate your time.
00:07 And I know we've got a lot of things to get to,
00:09 but before we get to the nitty gritty,
00:11 I'd love for our viewers to know
00:12 if you could explain it to me like I'm five,
00:13 what is it that your company does?
00:15 - At GenPrex, we're developing gene therapies
00:20 to treat cancer and diabetes.
00:23 These are leading edge gene therapies.
00:25 The cancer technology is based on inventions
00:30 and developments at MD Anderson Cancer Center.
00:34 And the diabetes technology comes
00:37 from the University of Pittsburgh.
00:39 Both of them are designed to treat patients
00:41 who are basically without other options.
00:45 - Now at GenPrex, I know there's a lot of things
00:47 that you have companies that might be kind of competitors
00:50 and different things like that.
00:51 When you're looking to treat these types of things,
00:53 what do you kind of feel gives your company
00:54 the biggest edge to be successful and take market share?
00:57 - Well, in oncology, we're a leading gene therapy.
01:03 We're not aware of any other cancer gene therapy
01:08 that's as far along as we are.
01:10 And certainly no other cancer gene therapies
01:13 are similar to ours.
01:15 Ours is unique and leading edge.
01:18 We've had multiple prior clinical trials,
01:21 two prior clinical trials,
01:23 and we're in three clinical trials,
01:25 or excuse me, two clinical trials right now
01:28 with another soon to start.
01:30 Our technology is designed to deliver therapeutic genes
01:36 to tumors where they replace the function
01:42 of missing or deficient tumor suppressor genes
01:47 that are found naturally in the body.
01:48 So basically we're supplementing
01:51 or replacing deficient functions of the body itself.
01:55 And this is very exciting.
01:59 In diabetes, we have a gene therapy
02:02 to attack both type one and type two diabetes.
02:06 And we have recent non-human primate data
02:11 that was presented by the University of Pittsburgh
02:14 at an international conference
02:16 showing that our diabetes gene therapy
02:19 has the potential to reduce the need,
02:24 if not eliminate the need for insulin
02:27 and control glucose levels
02:31 with a dose of this gene therapy.
02:34 We don't know yet how long it will last in patients,
02:38 but the data so far is very promising.
02:41 - Now, what's interesting to me is the fact
02:43 that you're kind of wanting to take care
02:45 of cancer and diabetes.
02:46 Is it the same approach for both
02:47 or are there different approaches for both of these?
02:50 - There are different approaches.
02:52 - Okay.
02:53 - Cancer technology a lot relies on a lipid nanoparticle
02:57 to deliver the therapeutic genes targeting tumors.
03:01 There's up to a 33-fold uptake
03:06 of these therapeutic genes into tumors
03:10 as opposed to normal tissues.
03:11 So they target tumors wherever,
03:13 the drug targets tumors wherever they are.
03:17 The diabetes gene therapy, on the other hand,
03:21 uses a viral delivery system
03:24 similar to many other gene therapies
03:27 to deliver two genes to the pancreas
03:29 that replace damaged or destroyed beta cells
03:38 and causes them to produce insulin again.
03:44 - Now, have you been able to fast track anything
03:46 with the FDA?
03:47 And if so, what does that mean for like
03:48 the future availability of the drug
03:50 to the common individual?
03:52 - Well, we have in our oncology program,
03:55 we actually have three FDA fast track designations.
04:00 We recently got a new one just a few weeks ago
04:03 for our third clinical trial,
04:05 which is a combination of our gene therapy
04:07 with a test centric,
04:10 a Roche's cancer drug in small cell lung cancer.
04:16 Again, we just received that a couple of weeks ago,
04:18 but we have two prior fast tracks as well.
04:22 The benefit of the fast track is that it provides
04:27 more frequent interaction with the FDA,
04:31 more cooperation, more support
04:33 in conducting clinical trials
04:36 and moving the drug forward towards approval.
04:39 And we've seen with our prior fast track
04:42 that that really is beneficial.
04:45 So we're very excited to have three FDA
04:48 fast track designations,
04:50 all for different drug combinations and populations
04:55 with our gene therapy, Recorsa.
04:59 - So let's talk about that one, the Recorsa.
05:01 Your phase one trial, right?
05:04 How effective was it?
05:05 How safe was it?
05:06 Any insight on that?
05:08 - Well, our most recent phase one trial,
05:11 we've actually had several before,
05:13 but our most recent one,
05:15 which we designate as a claim one
05:17 is for use of Recorsa in combination with Tegrisso,
05:23 AstraZeneca's drug.
05:24 And we just announced data on that
05:27 at the ASCO convention just a couple of months ago.
05:32 And the phase one showed that our drug
05:37 has a very favorable safety profile
05:42 with regard or in comparison to other cancer drugs.
05:46 There were a few side effects
05:48 and minimal side effects with our drug.
05:51 And that was consistent with findings
05:53 in prior clinical trials as well.
05:56 So the phase one data showed a favorable safety profile
06:01 and strong indications of efficacy
06:08 and the independent data safety board
06:13 composed of physicians not employed by GenPrex
06:17 determined to move the claim one trial on to phase two,
06:23 which we do expect to commence enrolling patients
06:27 in the near future in the phase two portion.
06:30 - So in the phase two portion, right?
06:33 How affordable do you believe it'll be
06:35 for the consumer to go ahead and take?
06:36 'Cause my concern whenever I talk to companies
06:38 is always it's great that what you're doing,
06:40 obviously it's much needed in the world that we live in,
06:42 but if folks can't afford that,
06:44 whether that's with insurance or without insurance,
06:46 we're still not taking care of the main issue,
06:48 which is of the human being.
06:49 So how affordable do you see this drug being
06:51 when it is available and passes all the phases?
06:56 - Well, we believe that on approval,
06:59 our drug is going to be cost on par
07:05 with other existing lung cancer drugs,
07:09 such as Tegresso and Keytruda.
07:14 We can't at this time give an exact price, of course,
07:18 we're a long way away,
07:19 but we think it's gonna be of that magnitude
07:21 rather than one of these drugs
07:24 that costs a huge amount for each dose.
07:27 There are some gene therapies
07:28 that cost a million dollars, $2 million,
07:30 and we don't expect that to be the case at all
07:33 because of the way our drug is manufactured.
07:37 It's much more in line with the other existing cancer drugs.
07:42 - And have you gotten any like government aid
07:44 or any grants or anything like that
07:46 to help with the process of developing this drug,
07:48 or do you see that happening in the future
07:49 to take some of that financial stress off?
07:52 - Well, we have received grants in the past.
07:55 We received one grant for four and a half million dollars
07:59 early in the company's development,
08:01 which really helped us move the technology forward.
08:05 We've received some other smaller NIH grants
08:08 as well in the hundreds of thousands of dollar range.
08:13 Also, our collaborator at the University of Pittsburgh
08:16 has received a large, I think, $2.1 million NIH grant
08:21 to advance the diabetes technology.
08:24 So we've had several significant government grants
08:30 and we're always on the lookout for those opportunities.
08:35 - Now, let me talk about, we talked about the grants
08:38 and taking off a little bit of financial stress.
08:40 I'm gonna ask about a couple more questions
08:41 before I turn it over to you.
08:43 What would you say is kind of like the financial health
08:45 of the company?
08:45 'Cause having R&D like this,
08:47 going through clinical trials and whatnot,
08:49 it's quite expensive, I'm sure.
08:51 - Yes, well, of course, we will need to raise money
08:57 to complete these trials.
08:58 They are quite expensive and going forward,
09:03 we will need to do that.
09:05 - All right, got that.
09:06 And then do you see what y'all are doing, right?
09:09 With the processes, with the face trials and everything else,
09:11 do you see that affecting oncology and practice
09:14 in any way, shape or form, for the better, of course?
09:17 - Well, of course, we believe that our gene therapy
09:20 will become a part of the standard of care in lung cancer
09:27 and possibly other cancers,
09:29 and that it will lead the way for other gene therapies
09:34 as well to become part of the standard of care.
09:37 And we believe that we're going to see gene therapy
09:41 be part of the standard of care,
09:46 both standing alone against numerous types of cancers
09:50 and also used in combination
09:53 with other approved cancer drugs.
09:56 - Do you see when,
09:57 so we talked about the phase one clinical trial,
10:00 this is my last one.
10:01 When do you expect, if you have like a timeline
10:03 in terms of like, hey, here's when we can expect
10:05 phase two trial results or anything like that,
10:07 would it be at the end of the year, next year?
10:09 What are we looking at timeline-wise?
10:10 So potential investors that are watching right now
10:12 can have a bit of an idea.
10:13 I know you can't give me an exact date,
10:14 but any inkling on that?
10:16 - Well, again, we expect to begin enrolling
10:21 the phase two portion of that trial this year.
10:26 And I think it's a little early to be predicting
10:30 when we will have the readouts.
10:31 There will be an interim readout.
10:33 There are two arms of the phase two trial,
10:36 and there'll be an interim readout from each of them,
10:40 which we think will be likely next year.
10:45 - I appreciate that.
10:48 Well, Rodney, we've talked about the past, the present,
10:50 the future as well, but I wanted to kind of give you
10:52 the floor in case there's anything else
10:54 that you wanted to talk about with our viewers
10:56 that I did not get a chance to bring up.
10:57 The floor is yours.
10:59 - Well, thank you.
11:01 Again, I would remind the readers, the listeners,
11:04 that we have three clinical trials in lung cancer,
11:09 two of them already ongoing, another soon to begin.
11:14 We have three FDA fast track designations
11:17 for those three clinical trials.
11:19 And we have an exciting diabetes program developed
11:24 at a stellar academic medical research institution,
11:28 the University of Pittsburgh.
11:30 And this diabetes program is recognized widely
11:35 to be a really leading edge.
11:39 And the data that we released in February
11:42 has created a lot of excitement,
11:44 being that it's in non-human primates
11:48 and showed a significant potential for benefit
11:53 of reducing or eliminating insulin needs.
11:57 So again, these are huge markets.
12:02 The lung cancer market is in excess of 20 billion a year.
12:07 And diabetes, I don't even know a number,
12:11 but about 10% of the population has diabetes.
12:15 So huge markets that we're addressing.
12:18 We're teamed with leading academic institutions
12:23 in developing these therapies.
12:25 And we've made real progress in coming this far,
12:31 getting these fast track designations,
12:37 getting the leading edge data
12:38 from non-human primates and diabetes.
12:42 And I just think that we're much farther along
12:47 than many people realize.
12:50 And that we haven't been recognized for that in the markets.
12:55 And we think that upon a broader understanding
13:02 of what we have, that we will get more recognition
13:06 and appreciation in the markets.
13:08 Awesome, thank you so much for joining us, Rodney,
13:10 who is the CEO, chairman and president of GenPrex.
13:13 Ticker on NASDAQ is GNPX.
13:16 Rodney, thank you so much for being on.
13:18 All right, thank you very much for the opportunity.
13:20 (upbeat music)
13:22 (upbeat music)