This Biotech Reprogrammes Our Own Cells To Heal The Body

Benzinga

Oren Hershkovitz, Ph.D., CEO of Enlivex Therapeutics Ltd. was recently a guest on Benzinga's All-Access.  Enlivex is a clinical-stage biotechnology company focused on macrophage reprogramming that intends to develop and commercialize a drug pipeline for macrophage reprogramming in solid cancers, sepsis and other indications.  The company's therapy, AllocetraTM, is being tested as a cure for sepsis, one of the biggest unmet needs in healthcare. Sepsis is the third leading cause of death in hospitals today.

Transcript

00:00 (upbeat music)

00:02 - All right, again, Oren Hershkovits,

00:06 the CEO of Enlivex.

00:08 How are you doing today?

00:10 - I'm doing great.

00:10 How are you doing, Aaron?

00:12 - I'm good.

00:12 Thank you for asking, man.

00:13 Well, thank you for taking time out of your busy day

00:15 to join us.

00:17 Let's hop right into it. - Thanks for having me.

00:18 - Yeah, of course, man.

00:20 Let's hop right into it.

00:21 What, why don't you just give us a brief overview

00:24 of Enlivex before we get into the specifics?

00:27 - Okay, so Enlivex is a publicly traded company

00:31 in the NASDAQ, under the ticker ENLV.

00:33 We are a cell therapy company,

00:36 so we develop cell therapies to treat

00:39 unmet medical condition, life-threatening conditions

00:42 and diseases and debilitating diseases

00:45 with a very unique technology or platform

00:50 that targets specific immune cells

00:52 that we can get into in a second, I guess.

00:54 - Yeah, let's do it.

00:57 I mean, so one of the things I know you guys

00:59 are specializing in and doing is reprogramming macrophages.

01:03 And I was hoping you could explain that a little bit to me

01:05 and explain why it is so effective to do that.

01:07 - Glad to do so.

01:10 So macrophages are key regulator of the key immune cells,

01:14 primary immune cells playing a role

01:16 in housekeeping activities,

01:19 but also in defending against pathogens and so on.

01:23 So they're very, very, very important cells.

01:25 However, in some conditions, some diseases,

01:28 they go out of control.

01:29 They become like negatively reprogrammed

01:32 by the condition of the disease.

01:34 And as such, they become part of the disease

01:37 and they kind of aggravate or promote disease progression.

01:41 So in those condition, if we would have a trick

01:46 or a way to kind of reprogram them back into normal state,

01:50 what we call the most static state,

01:52 that will be the most holistic, sensible strategy.

01:57 And this is exactly what we're doing at Enelabics.

01:59 We have an off the shelf cell therapy

02:03 that target those macrophages.

02:06 And once we give them our cells,

02:08 it's kind of a food for this type of cells.

02:12 They identify our cells,

02:14 they identify the cells that we inject to the patient,

02:16 they engulf them, they eat our cells,

02:19 and they go through a reprogramming

02:21 back into a most static controlled state.

02:25 And once they are in that state,

02:27 they can bring back the immune system

02:29 into regulated, normal, controlled state as well.

02:34 So that's the differentiating factor

02:37 of Enelabics being a cell therapy company

02:39 that know how to reprogram macrophages.

02:42 - Yeah, it's so interesting.

02:43 I mean, it's incredible that you guys are able to do that.

02:46 I know, and forgive me if I pronounce this wrong,

02:49 but Alicetra or Alicetra?

02:52 - Alicetra.

02:52 - Alicetra, I had it right the first time.

02:54 Alicetra is being tested for orphaned indications.

02:58 How does that change the calculus

03:00 and what are the differences in regulations

03:02 and the path toward commercialization?

03:04 - So it's not just about actually orphaned indication,

03:09 it's more unmet medical conditions.

03:12 - Okay.

03:13 - So we're a clinical stage company.

03:15 So we're already completed several clinical studies.

03:19 We're talking about in sepsis,

03:21 as well as in COVID-19, oncology and so on.

03:26 But I think the leading clinical programs

03:28 that we currently have that it's worth mentioning

03:30 and that viewers needs to hear about

03:34 is a little bit is the, first of all, the sepsis.

03:36 So sepsis is a huge unmet medical condition.

03:40 It's the third leading cause of mortality

03:42 in hospitals in the US.

03:44 - Wow, I didn't know that.

03:46 - Yes, it's really a true pandemic to be honest.

03:50 And it's sepsis actually,

03:52 it starts off with some kind of an infection.

03:54 It could be a bacteria or viral infection or such

03:58 and eventually develop into a dysregulated immune response

04:02 where the body is just attacking everything.

04:04 It's not discriminating anymore

04:06 between healthy self and non-self infected and so on.

04:10 And that results eventually in morbidity and mortality.

04:14 So macrophages play their critical role.

04:18 That's why I will say it makes perfect sense

04:20 to use those cells to treat those septic patient.

04:24 So we've completed now, we've announced in last December

04:27 that we've completed the phase two,

04:29 randomized controlled study.

04:30 It's a study that we ran in leading centers

04:32 and countries around the globe.

04:35 And we're now kind of in the processing of the data

04:40 and we're expecting to get the top line data

04:43 by end of March or by the second week of April the latest.

04:48 That's the current plan and we're very, very excited.

04:52 It's a blinded randomized controlled study.

04:55 So we don't know the data yet.

04:57 We do know that we have a very promising phase one data

05:00 in septic patient where we treated 10 septic patient

05:03 all recovered completely from the condition

05:06 and discharged swiftly from the hospital.

05:08 So we're hopeful that we'll be able to generate

05:11 similar data in this phase two randomized controlled study.

05:15 So that's one.

05:16 And the other programs that we focus currently

05:18 are actually in osteoarthritis.

05:20 So osteoarthritis is a chronic debilitating condition

05:25 where you have arthritis in the knee, in the shoulder,

05:29 different locations, different joints.

05:31 We started off with treating osteoarthritis,

05:33 neo-osteoarthritis patients that are end stage,

05:36 kind of a, they don't have good therapy

05:38 and they're about to get a surgery

05:40 for knee replacement therapy.

05:42 So we gave them, we're giving them a Lusetra

05:44 in direct injection into the knee.

05:46 Wow.

05:47 And we're already now opening another

05:49 randomized controlled statistically powered study

05:53 that in the segment, in the majority of segment

05:56 of neo-osteoarthritis patient.

05:57 We're talking about, again, the numbers are surprising.

06:00 They were surprising to me when I have discovered the number.

06:03 So one out of 10 adults in the US

06:07 is suffering from a neo-osteoarthritis.

06:09 Really? Really?

06:10 Yes.

06:11 So there's like 1 million surgeries a year.

06:15 Holy cow.

06:16 In knee replacement therapy surgeries.

06:18 That's, those are huge number.

06:19 The market are huge and really there's poor treatment.

06:23 And again, macrophages in this condition

06:26 plays a critical role in the development

06:29 and the chronic low inflammatory condition

06:31 of those patients.

06:32 And again, it makes perfect sense to try

06:35 to treat this disease with Lusetra.

06:37 Yeah, I mean, it sounds like two huge markets there

06:39 between sepsis and as well as in the, you know,

06:43 knee surgeries and stuff like that.

06:44 So Oren, I understand that you recently received approval

06:48 for a patent for composition and manufacturing of Lusetra.

06:53 How important was this to receive that patent

06:55 and how well protected is your IP here?

06:58 So I'll say in general, you know,

07:00 we've been in drug development for many, many years.

07:03 Now myself as the CEO of Enlivex,

07:05 the chairman of Enlivex, Mr. Shainovic,

07:07 we've collaborated in previous company

07:09 that was acquired in a half a billion dollar deal

07:14 and eventually did a licensing agreement

07:16 in the previous company over the leading asset with Pfizer,

07:19 a drug that is currently approved.

07:21 So we know how important is to build

07:24 really a robust IP platform.

07:27 And that's exactly what we did with Lusetra

07:30 in all the various aspects from composition,

07:33 from method of use, from manufacturing,

07:36 from different indications.

07:38 There's a very, very robust IP there.

07:40 And this is another layer of that robust IP

07:44 that we've been working from the day

07:45 the company started working.

07:47 Got it.

07:48 Have you seen a change in how research is being conducted

07:51 as AI tools start to come into their own?

07:54 How much do you think this will accelerate research

07:56 in the biotech space?

07:57 Definitely.

08:00 I mean, it's gonna affect the life of all of us

08:02 and definitely in the research, in the development,

08:06 in the development of drugs,

08:08 AI will become a tool that all of us use

08:12 in various aspects and various applications eventually.

08:17 So that's very critical and important.

08:20 As a cell therapy currently, we're not using AI tools,

08:25 but it is something that you're looking,

08:27 and if there come an interesting opportunity

08:30 that's something we'll take into account for sure.

08:34 Yeah, I mean, it's interesting to see

08:36 how different biotech companies,

08:37 some are using it for drug discovery,

08:38 some are using it for other things,

08:40 but I mean, like you said,

08:41 it's gonna impact every industry,

08:43 at least that's how it seems right now.

08:45 All right, well, we're running up on the clock here,

08:48 Oren, I'll ask you a final question for a hot take.

08:51 With the markets kind of heating up here in 2024,

08:53 have you seen more money start to flow back into biotech?

08:57 Yes, definitely.

08:58 I think they're, finally, we're seeing some good signals

09:03 for some initial recovery.

09:05 And definitely, I believe that this will continue.

09:07 I think that we are now, at Tenlivex,

09:11 from a capital perspective,

09:14 we're well-funded all the way to the end of '25,

09:16 that's important to say.

09:17 And we have several clinical milestone and inflection points,

09:22 the nearest term one that we were talking about,

09:24 sepsis, top-line data, just around the corner,

09:27 but additional ones with the osteoarthritis in '24 and '25.

09:31 So we're really excited and hopeful,

09:34 you know, some of this data will become leverageable

09:38 and we'll take the opportunity

09:40 and do additional fundraising to continue to grow

09:43 and live it's an L-set platform.

09:45 And when can investors expect that catalyst?

09:47 I mean, when is that data coming out for the sepsis trial?

09:51 So sepsis is like by the mid of April.

09:54 Okay, so pretty soon, a couple months.

09:56 Very, very couple of months.

09:57 In the second half of '24,

09:59 we'll have additional data from the open label

10:02 for osteoarthritis studies that I've described.

10:05 Yeah.

10:06 And in '25 Q3, we'll have top-line data

10:10 from that randomized blinded control osteoarthritis study.

10:13 So several inflection point, you know,

10:16 throughout '24 and '25, the coming 18 months or so.

10:19 And all of this is well-funded

10:21 with the current cashflow that we have at Enlivex.

10:25 Beautiful, love to hear that.

10:26 Well, all right, Oren Hershkowitz,

10:28 again, the CEO of Enlivex.

10:30 Ticker is up there on the screen, ENLV.

10:32 Thank you again for hopping on with us today.

10:34 Thank you.

10:35 Thank you very much, Aaron.

10:36 (upbeat music)

10:39 (upbeat music)

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