0:00

I'm Matt Pillar , host of the Business of Biotech podcast

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haven't heard that we've launched a new Business

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the listen and watch tab and choose

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business of biotech in the

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dropdown . So here's a personal story to kick off

0:56

today's episode . For the past five years or so , my dad has had

0:58

non-muscular invasive bladder cancer Benjamin Davies

1:00

, who's a professor at the University

1:03

of Pittsburgh School of Medicine , chief

1:05

of urology at UPMC and program

1:07

director of the Urologic Oncology

1:10

Fellowship there . At

1:18

each visit , dr Davies tells my dad's stories while he runs a cystoscopy to assess the lining

1:20

of my dad's bladder . The last few times we've been to visit , my old man is at a

1:22

clean checkup , but that's not always

1:24

the case . On several occasions

1:26

, dr Davies' scope has revealed cancer's

1:28

return . Those appointments

1:30

are followed by a transurethral

1:32

resection to remove the cancerous

1:34

tumor cells in my dad's bladder , followed

1:37

by several weeks of intravesical

1:40

chemotherapy to thwart its return

1:42

, and

1:46

the frequency of our visits ratchets up to three-week intervals . That's the standard

1:48

of care , and while it's kept my dad

1:50

in the game , it's neither physically nor mentally

1:52

convenient . Whether or not the cancer

1:54

has returned is a gamble , often a

1:57

losing one , as recurrence rates in

1:59

resectable bladder cancers are incredibly

2:01

high . I'm Matt Pillar . This

2:03

is the Business of Biotech , and my

2:05

guest on today's show is a man whose company is

2:07

very , very close to changing the

2:09

standard of care paradigm for people like

2:11

my dad . Dr Sandeep

2:13

" is chief medical

2:15

officer at Immunity Bio , whose

2:17

lead candidate an interleukin-15

2:20

super agonist fusion protein the company

2:22

calls ANKTIVA is

2:24

squaring up for a likely approval this

2:26

year . On today's episode

2:28

, we're going to learn about Dr Reddy and that

2:31

candidate , how he shepherded it to

2:33

the goal line , how the company is preparing

2:35

for commercial success and

2:38

more . Dr Reddy , a heartfelt thank you

2:40

, not only for the work that you're doing , but

2:42

also for joining us today on the business of biotech

2:44

.

2:45

Yeah , thanks for having me , Matt . You

2:47

know sorry to hear about your dad , but I'm glad that

2:49

you know he's alive . Today , when we have

2:52

new therapies coming we hope

2:54

plenty of new therapies coming it's much

2:56

better , you know , options and opportunities

2:58

for patients .

3:00

For sure and I appreciate that . My dad , by the

3:02

way , is doing considerably well . He's

3:04

doing well in between these

3:07

treatments . But , as I said , you

3:09

know , for a guy of his age it's

3:13

not just physically holding taxing

3:16

, but it's also mentally taxing

3:18

to go through the not knowing and then

3:20

the knowing and then the repeat procedures

3:22

. So it's really exciting

3:24

for me personally to see development

3:26

and progress in this space . I

3:30

want to start out getting a little

3:32

we're going to get to know you and what

3:34

led you into this space in a little bit

3:37

. But I want to start with the candidate itself and

3:39

I want to kind of pick up on . I understand

3:41

that you've been working on this candidate

3:43

pretty much since it was considered

3:46

developable . Tell us a little bit about your history

3:48

with N803 or ANKTIVA

3:51

aware

4:08

of it about 2017 or 18 .

4:10

I think they had presented some of their early data , their phase

4:12

one data , and there was a whole slew at that

4:14

time of therapies that were in

4:16

development , looking at how

4:18

we could bolster the immune response

4:20

, and checkpoint

4:23

inhibitors had been out for a while . I

4:26

had been a practicing oncologist for many

4:28

years and I had used checkpoint inhibitors

4:30

and what we saw with

4:32

that class of therapy is tremendous

4:35

, tremendous improvements

4:38

over where we worked before . For

4:41

example , in lung cancer . You know

4:43

we would almost never see a five-year survivor

4:45

who had metastatic disease , and now

4:47

it was . I wouldn't say routine

4:49

, but you know it's relatively common to see

4:51

people that were three , four , five plus

4:54

years out , um , and

4:56

so there was a real , there's a story

4:59

there . But we also saw the majority

5:01

of people relapsing . So the question was okay , what

5:03

can we add ? What's coming down the

5:05

pipeline to forestall

5:08

those recurrences , delay them and

5:10

possibly prevent them ? So the

5:12

whole theory was can

5:14

you boost the immune response

5:17

just enough to get over that threshold

5:19

, right , that relapse threshold ? And

5:21

the thought was well , there's

5:24

secondary immune checkpoints

5:26

. So the checkpoint inhibitors , like pavrolizumab

5:29

or the volumetritopdivo , those

5:32

were the first ones approved and they block

5:34

PD-1 . There's other checkpoints

5:36

. So the thought was okay , can we target those other ones

5:39

? And so ongoing clinical trials

5:41

are happening . But the second theory

5:43

was can you just

5:45

non-specifically boost

5:47

all of the immune response , get more

5:50

out of the T-cells you have ? You

5:52

know , the T-cell's working , it's

5:54

killing the cancer , but then it stops

5:57

working . Is it because those T-cells

5:59

become exhausted the word we use technically is

6:01

exhausted , they're tired , and can

6:04

you boost that ? And there's good data

6:07

to say that that can happen . So when I

6:09

was in training , I trained

6:11

at City of Hope and we did hematologic

6:13

transplant , bone marrow transplant , but we also were

6:16

a center for high-dose interleukin-2

6:18

and high-dose interferon for

6:21

kidney cancer and melanoma , and

6:23

that is a very , very , very toxic

6:25

therapy . But at the time I don't

6:27

want to date myself , but you know 25

6:30

plus years ago there wasn't a lot of other options

6:32

and so you know we would

6:34

give people very high dose therapy , would make them very

6:36

, very sick and

6:38

if they , you know , sufficiently recovered , there

6:40

was a small percentage less than 10%

6:43

who would be cured of

6:45

their disease . So it's very exciting

6:48

. So the promise was there , but

6:50

those were very toxic medicines and

6:52

we were trying to do it all on its own

6:54

. So the theory was maybe

6:56

you could go with something that's less toxic and

6:59

add it to something else that's already working

7:01

, so you don't have to be as toxic

7:03

and you can still get the benefit . So the theory

7:05

was there . So they presented their data and

7:08

immediately what struck me when

7:10

I saw the data was this concept

7:12

of wow , this is

7:14

actually what we've been waiting for , something that isn't

7:17

going to kill the patient with

7:19

toxicity but could add

7:22

to what we already have . So it

7:24

was a very rational

7:26

and , I would say , attractive concept

7:29

. So I immediately got involved

7:31

and started talking to the team

7:33

there and followed

7:36

their work and then eventually , when I joined the

7:38

company , started

7:40

to promote that and push that forward

7:42

in terms of our pipeline .

7:44

Yeah , how did your first exposure

7:46

to the molecule happen ? Just give

7:49

us a little bit of context , like , did you

7:51

meet them at a conference or did you

7:53

have some colleagues there ? How'd that kind of come to fruition

7:55

?

7:55

Yeah , yeah , so I did . I met them at a conference

7:58

and it was a small kind

8:00

of . It wasn't one of the big ASCO conferences

8:03

, a smaller conference , so it

8:05

was the kind of situation where you could actually go and

8:07

talk to the presenters and so

8:09

the data was being presented from the bladder program

8:11

and what was striking

8:14

is in the early phase one

8:16

, they saw responses

8:18

. And traditionally , when you're doing a phase

8:20

one clinical trial , what you're looking for is to

8:22

establish safety and

8:24

a dose to go forward

8:26

and you don't expect to see responses

8:29

. And what they saw was responses

8:32

in all of the nine

8:34

people that were treated . So

8:36

that was , you know , wow , a nine

8:38

out of nine , 100% . Now

8:41

, I'm not traditionally someone . I'm not

8:43

a urologist by training , I'm a hematologist , oncologist

8:45

. I don't treat bladder cancer or non-muscle

8:48

invasive bladder cancer , so

8:50

100% . I said , okay

8:52

, that's pretty exciting , but what would you

8:54

expect ? So I went

8:56

and I talked to the presenter and I said , well

8:58

, what would you expect ? And they said , well , we would expect to

9:00

see maybe 80% , but not

9:02

durable . We would expect

9:05

that BCG works and

9:07

exactly the story that you've already given

9:09

right , it works , but it's not durable

9:11

, that at some point you'll relapse from that the

9:13

majority of people relapse . So I said , okay , well , what

9:16

do you think ? He said , well , 60%

9:18

. We would think that at two years , 60%

9:21

might still be in remission , 40%

9:23

would relapse , but we have 100%

9:25

. So we think something's happening there . Yeah

9:27

, okay , it's a good story . I'm

9:29

intrigued . Tell me more . And you know , we just

9:31

we started corresponding and I

9:34

became very interested because I

9:36

could see and I was , of course

9:38

, selfishly not thinking about bladder cancer , because I don't treat

9:40

bladder cancer I was thinking , well , what about

9:42

solid tumors and lung cancer

9:44

, pancreas cancer , et cetera ? And that's , you know , that's

9:46

the thought would be . It would be very similar

9:49

.

9:49

Yeah , and I should note at this point

9:51

, dr

9:58

Reddy , that you know obviously the lead candidate , the one that's closest , is your bladder

10:00

cancer candidate . Obviously , I have a bias , but you've got a much deeper and richer pipeline . We'll

10:02

talk a little bit about that later on

10:04

. You know where these therapies go next and

10:06

what other cancers you guys are looking to target

10:09

. When you joined

10:11

so you officially joined the company in what ? 2020

10:14

? Correct ?

10:15

Yeah , right around COVID times .

10:24

Right around .

10:25

COVID times . Yeah , it's an interesting time to make changes right . What was your charge

10:27

when you officially joined the company ? Yeah

10:35

, I mean it was exactly so to shepherd the NA-03 program forward . So I mean backing up the company

10:37

, as you mentioned , as a

10:39

whole series of assets that are in various

10:41

stages of development and

10:44

I would sort of vibricate them into

10:46

sort of three key pillars . So

10:49

one pillar is the N803

10:51

or ANKTIVA program , the

10:54

second is the cell program , the natural

10:56

killer cell program , and the third is the vaccine program

10:58

. So my charge at that point

11:00

was really integrating the three

11:02

. So clinical trials

11:04

that would integrate the three . And

11:08

specifically I was focused on the vaccine

11:10

program and the anti-dose three program . And

11:13

I had come from a prior

11:16

background . The last two companies

11:18

that I worked for were

11:21

diagnostic companies and

11:23

we were focused on doing next-generation

11:26

sequencing . So Karis Life Sciences and Nant

11:28

Health , and we had

11:30

built this bioinformatic

11:33

pipeline to identify

11:35

mutations . But the purpose

11:37

of identifying those mutations was

11:40

to ultimately use

11:42

that information to build better cancer

11:44

therapies and specifically a cancer vaccine

11:46

. So , coming

11:49

to Immunity Bio , the

11:52

whole purpose was

11:54

to identify these mutations

11:57

, create vaccines and then

11:59

bolster that vaccine immune

12:01

response with a drug like NNO3

12:04

. And we've done some early work and we're

12:06

moving towards that . But along that

12:08

journey we saw really

12:10

profound early

12:13

benefit , as I mentioned , from the phase one and then

12:15

into the phase two and early on in the phase

12:17

two and turned

12:19

our attention to okay , this is a product that

12:21

in and of itself is going to work . We

12:23

don't need to add a vaccine , we

12:26

are adding BCG . I mean it works in combination

12:29

with BCG .

12:30

Right .

12:30

And so we said , all right , let's prioritize

12:32

that because we can get that out , we

12:35

can get that to patients earlier and

12:38

we know it can help people and it appears

12:40

to be safe at that time . Certainly , the

12:42

further studies have indicated it's very safe . So

12:44

, you know , really doubled down on our efforts

12:47

to move that more rapidly .

12:49

Yeah , yeah , yeah , and you were willing to embrace

12:51

that shift in your anticipated

12:54

responsibilities .

12:55

Yeah , yeah , yeah , sometimes , you know you

12:58

can't always , you know

13:00

. I say it's like you're the captain of the ship , but you have to go where

13:02

the wind takes you . So the wind was taking us there . Yeah

13:04

, you know , I say it's like you're the captain of the ship , but you have to go where the wind takes you , so the wind was taking us there .

13:05

Yeah , there'll be time for tacking the ship

13:07

later , that's right . That's right . Yeah , when

13:10

you joined in 2020 officially

13:13

. So my job here and

13:15

we have a limited amount of time to do this , so I'm

13:18

going to give up the reins to

13:20

you to lead a little bit , because what I want to

13:22

do is I want to get a story . I

13:24

want to hear the story about where the molecule

13:26

was when you joined and the

13:29

progression that's led us to the point

13:31

where we're looking at an anticipated

13:34

approval here this year . So where

13:37

was it when you officially joined the company

13:40

and took on that responsibility ?

13:41

Yeah . So it had gotten through

13:44

. As I mentioned , they had started

13:46

their phase one . They had basically completed accrual

13:48

in their phase one . The phase two

13:51

programs were submitted

13:53

to the FDA , they had been reviewed

13:56

and they'd been approved and we were starting

13:58

to enroll in those

14:00

trials . Unfortunately

14:03

, as I said , it was COVID and

14:06

that was a whole different universe for clinical trial operations

14:08

. It was challenging

14:11

to be able to complete the normal

14:13

sort of course of business in terms of monitoring

14:15

of the trial , startup , training

14:18

of the investigators , even patients

14:21

coming in . There was times I mean

14:23

we now look at it in

14:25

the rearview mirror , but at the time , you remember

14:27

it was pretty scary

14:30

. So if somebody had a non-lethal

14:32

disease in terms of their bladder cancer , at that

14:34

point let's say it's in remission they

14:37

were saying I don't know if I want to go to the hospital

14:39

right now to have a procedure

14:41

for something that's non-lethal , when there's

14:43

a chance I could go , be sitting in the hospital

14:45

and get a lethal infection .

14:47

Sure , it certainly resonates . I mean the personal

14:49

story that I tell about my dad . Like

14:52

we did that through COVID , we were traveling down

14:54

to Pittsburgh , you know , going into the hospital and going

14:56

through all the protocols during that . So it resonates

14:58

entirely . Anyone who was dealing with a chronic condition

15:00

during that time or enrolled in a clinical

15:03

trial can certainly relate .

15:10

Yeah , so it was tough , but you know , so we had to look at , you know , the new technologies

15:13

that have become available and the way that all of us adapted to that . So the

15:15

use of remote monitoring , the use

15:17

of more telemedicine capabilities

15:20

to be able to collect the data

15:22

and stay on top of it . So that

15:24

was you . So at that point that's where

15:26

the program was , and then it was also

15:28

we were starting the solid tumor program

15:31

, so we're getting into lung cancer and pancreas

15:33

cancer as well . From

15:36

the bladder perspective , it was

15:38

also a time

15:40

and it's been an ongoing history of

15:42

something called the BCG shortage . So

15:44

that started roughly around 2016

15:46

in the United States but has been

15:48

on and off essentially throughout

15:51

, and it's highly location-dependent

15:55

, meaning , at a given moment , in a certain

15:57

reach of the United States , there may be acute shortages

15:59

of BCG supply , whereas at others

16:02

there isn't and it just sort of moves around . And

16:06

so this has been a challenge because , as part of our clinical trial , we

16:09

provide the BCG , so we're only

16:11

given a certain allotment and we

16:13

buy as much as we can , because we want

16:15

to put more people on trial , and we have a good problem

16:18

, and our problem is this the people

16:20

on our trial are doing well

16:22

, so they stay on , but that means

16:24

they're consuming all of our BCG . So

16:27

there was that issue of trying to manage the supply

16:29

and the demand and thinking

16:31

about how strategically we could open the

16:34

trial at certain locations . So

16:36

in that sort of complex milieu we were

16:39

able to push forward and complete

16:41

the phase

16:45

two BCG unresponsive

16:47

trial and we really prioritize

16:50

that . And now we're pushing our resources into

16:52

the BCG naive population

16:54

. The reason we did

16:57

the BCG unresponsive is that's a

16:59

single arm trial , whereas

17:01

the other trials randomized . So

17:03

if you have limited BCG

17:05

supply , you know I

17:09

can get to the finish line faster in

17:11

a single arm than a two arm and that's

17:13

really how we prioritize it .

17:15

Yeah , yeah . And that

17:17

BCG unresponsive

17:20

trial can you share with us ? I mean I've

17:22

read some of the statistics and some of the results of those studies Can you share with

17:24

us ? I mean I've read some of the statistics and some of the results of those studies

17:26

. Can you share with us some of the successes you've

17:28

seen there ?

17:29

Yeah , absolutely . I mean this is now public

17:31

data . We were

17:33

able to publish this late 2022

17:36

in New England Journal of Evidence

17:38

. The first author is Kareem Chamey

17:40

. He was the lead accruer from UCLA

17:43

and

17:45

Sam Chang was the second lead accruer and he

17:47

said Vanderbilt , and

17:50

what we showed is , when we give

17:52

BCG to

17:54

people who basically , you

17:57

know the BCG is unresponsive

17:59

In other words , they had a full course of BCG

18:02

and a full course of maintenance BCG

18:04

and yet their cancer has recurred

18:06

. If we give them back the same BCG

18:09

but add N803

18:11

given directly into the bladder

18:13

. For people with carcinoma

18:15

in situ , which is

18:17

one of the higher risk

18:19

we have in bladder cancer

18:21

non-muscle-beating bladder cancer we divide it up

18:24

into low risk , intermediate risk and

18:26

high risk . So this is considered high risk disease

18:28

, high

18:36

risk for recurrence or progression . In that population . What we saw was a 71%

18:38

complete response rate at any time . Now what does any time mean

18:40

? It means that when you get

18:42

the drug , as you know , you

18:45

get the drug a couple weeks in a row and then

18:47

you come back to be reevaluated

18:49

after three months with that cystoscopy

18:51

in the office . If , at

18:54

that point in time , you've achieved a complete response

18:56

, you've got a complete response . Funder . One

18:59

of the unique aspects of our clinical trial

19:01

design was we also allowed

19:03

what's called re-induction . So

19:05

in normal clinical

19:08

practice of medicine , people will get

19:10

a course of BCG six weeks

19:12

in a row and then be evaluated

19:14

six weeks after that . So it's a three-month

19:16

period of time . If

19:18

they haven't achieved a complete response , you

19:21

can give them another course of BCG , because

19:23

sometimes you

19:25

need more time for

19:27

your immune system to really kick into

19:29

gear and this has been shown and this has been

19:32

demonstrated historically . So

19:34

we allow that . So we give another six

19:36

weeks of BCG and then we give

19:38

the 803 , the N803

19:41

ativa . We call it . N-803 is the shorter chemical

19:43

name for it . The long chemical name is

19:45

painful . It's nogopendicin

19:48

in bacchuset alpha

19:50

, so we'll just say N-803 .

19:53

I'm sure you've said that several times , but I still give

19:55

you credit for nailing it just now . It is a tongue

19:57

twister .

20:00

So what we do is we give that second course and

20:03

we'll achieve a remission

20:05

, a complete remission in about half of

20:07

that additional group . So

20:09

that gets you about 55% up front

20:11

and another half and you put those two together

20:14

and you get to a 71%

20:16

where the cancer has effectively

20:18

completely gone away . And that's

20:20

without surgically removing it . That's

20:23

just the drug going into your bladder , essentially

20:25

killing the cancer . So , that's good

20:27

. That's good . But the important

20:29

thing , as I said earlier , is not that

20:32

it works , because we know BCG works . It's

20:35

does it keep working Right

20:37

. And what's exciting

20:39

is we're seeing duration here . So

20:42

in the published paper the median

20:44

duration was over two

20:46

years , but we have now updated

20:48

data and we have press release where

20:50

we , in our filing with the FDA , we've extended

20:53

this beyond three years , and

20:55

so that is as

20:58

I said in the very beginning . What was exciting for me

21:00

was immunotherapy

21:02

as a class was really

21:04

different than chemotherapy . When

21:06

I was in training , the only thing we had was

21:08

chemotherapy and we were starting to do , you

21:11

know this , high-dose interleukin and high-dose interferon

21:14

. But chemotherapy works

21:16

. It kills cancer , but then

21:18

the cancer comes back and then ultimately

21:20

our patients succumb to the disease

21:22

. So what's exciting here

21:25

is when the immunotherapy works . It's

21:27

training your own immune system to

21:30

continuously fight that cancer

21:32

and prevent it from coming back , and

21:34

that leads to this long plateau of

21:36

durability , which it's too early to say

21:38

. We don't want to say the C word , but we hope

21:40

that's indicative of a cure .

21:42

Yeah , yeah , it's incredible , and I mean just contrasting

21:45

that with the standard of care that I described

21:47

and that so many bladder cancer

21:49

patients have experienced . I mean

21:52

, I believe it's one of the top five most

21:55

common cancers in

21:58

the United States , particularly among

22:00

men . Am I getting that right ?

22:03

Sadly , it is far more common in men

22:05

than women . However

22:08

, women tend to have

22:10

a worse prognosis . They get diagnosed

22:12

later . So it's important that women

22:14

and you know female

22:17

urologists and

22:20

urogynecologists

22:22

who specialize in this for women are

22:24

aware , so that we don't have that delay

22:26

in diagnosis so maybe

22:28

we can have at least the same outcomes or better

22:31

outcomes for women .

22:32

Yeah , yeah . But as I was saying , I mean , just contrast

22:34

it with the standard of care . It's cause

22:37

for great hope . Your

22:41

activity leading up to the BLA

22:43

was this had you had experience

22:46

with BLA submissions in prior

22:48

roles ?

22:49

No , so in my prior

22:52

life I had done a lot of work in terms

22:54

of regulatory submissions for devices

22:56

. As I mentioned , I come from two diagnostic

22:59

companies . We had a FDA . We had the

23:01

only at that point we had submitted

23:03

and got approved . The only FDA

23:05

cleared whole exome to our

23:08

normal sequencing test , which was a really

23:10

high complexity . In a past

23:12

life at Keras , we had relatively simple devices

23:14

and had worked with many , many companies that

23:16

were working on companion diagnostics . So

23:21

moving into the drug

23:24

product world was quite different . So

23:27

this has been my first BLA experience

23:29

and there's

23:32

a lot of similarities , right , but

23:34

there's a lot of differences as well .

23:36

Well , you're the perfect person to answer this question and

23:39

answer it to the perfect audience , because the bulk of

23:41

our audience are folks who are in perhaps

23:45

discovery , preclinical , very

23:47

early stage , and many of our listeners

23:49

, like you , haven't

23:52

had the opportunity to work

23:55

through a BLA submission . So I

23:57

guess I'd just ask you to maybe share some introspection

24:00

and thoughts on that process , how it went

24:02

for you , maybe some learnings and advice

24:04

that you'd offer to someone stepping in

24:06

a role , just like you did back in 2020

24:08

and seeing this through .

24:10

Yeah , I think I mean . The first thing I'd

24:13

say is you have to have a good team . You can't

24:15

, like , no one does this alone . Obviously it's a massive

24:17

undertaking . You need a

24:19

really good team . You have to have a solid team that has

24:21

knowledge and experience . They're people

24:23

that you trust and can work with , and

24:25

I'm fortunate to have that

24:28

supportive network . The chairman

24:31

of our company , patrick

24:33

Tsumshan that's one of the key reasons I had come to

24:35

the company is Patrick has tremendous experience

24:37

and knowledge , has had multiple drugs

24:39

approved , not just at the path

24:41

we should take and there might be okay , there's two or three

24:44

or four other

24:46

options and let's think about that and

24:48

discuss that

25:04

, and that resource is tremendously

25:06

valuable . I think without that

25:08

team it can't be done . I

25:11

think the second thing I would say is device and

25:13

drug are different , so you

25:15

have to sometimes unlearn what you

25:17

know . Experience is

25:19

always helpful . Knowledge and experience is always

25:22

helpful , but you always have to be open and willing

25:24

to say oh , we did it this

25:26

way , but

25:29

we have to consider doing it that way instead

25:32

if we're going to be successful . So having that

25:34

internal flexibility

25:37

is important

25:39

, but the

25:41

regulatory landscape in

25:44

general is pretty

25:46

slow to move and change and

25:50

so you kind of understand your playing

25:52

field . But you have

25:54

to know in advance things can

25:56

change and you have to try to build and feel

25:58

safe . So , in terms of a program

26:01

development , you have to anticipate . Not

26:03

only are there going to be competitors , but the regulatory landscape

26:05

could shift . So , for example , when we started the

26:07

program , one of the key things

26:09

was that in bladder cancer there was guidance

26:12

from the FDA that a

26:14

single arm trial could be adequate for

26:16

this indication . But

26:20

we also know that , for example

26:22

, for papillary disease . So I mentioned

26:24

carcinoma and cytotrophic . But for papillary disease we

26:26

ran a phase two single arm and

26:28

the FDA said , well , that's nice , but you

26:30

need to do a randomized trial . So we've

26:33

built it in that program , we know what that looks

26:35

like and we can go to that once

26:37

we complete our other studies because

26:39

, as I mentioned , there's only a limited amount of BCG

26:43

and , knowing

26:45

those things , having early conversations

26:47

with the FDA , having frequent interaction , we were

26:49

fortunate we had achieved breakthrough

26:52

designation and I would say , anyone

26:54

in drug development , if you can get it , take it , because

26:56

the ability to have frequent

26:59

, meaningful dialogue with regulatory

27:01

agencies , health authorities globally

27:03

, is going to help tremendously . Sometimes

27:06

it seems like , oh , that's , oh

27:08

that's , you know , an extra burden ? Absolutely

27:10

not . It's certainly helpful

27:13

and can steer

27:15

you in the right direction . Even when you

27:17

think you're going in the right direction , you might

27:19

find that you're actually lost in the woods . It can

27:22

get you back on the path .

27:24

If you can get it , take it . So what

27:26

went into getting it Like in

27:28

your experience ? What did Immunity Bio

27:30

need to do or choose to do

27:32

to achieve breakthrough designation ?

27:34

Yeah , I mean , when we took a look

27:36

at the interim

27:39

analysis , we

27:42

saw a tremendous signal for

27:45

both efficacy and safety and

27:48

we reached out to the

27:50

agency and asked the question of is

27:52

this appropriate for possible breakthrough

27:55

designation ? And in that submission

27:58

, what , beyond this preliminary

28:00

data set , do you want to see ? And they were actually

28:02

very helpful and gave us feedback about what

28:06

was going on in our other programs and

28:08

what data they would like to see from those , and

28:12

together we sort of moved forward

28:14

. We put together that package we presented to them

28:16

and they gave us breakthrough . And I think it's

28:19

very telling because the regulatory

28:22

agencies really are there to help . I mean , their

28:24

charter is to have

28:26

new therapies safe and

28:28

effective new therapies available

28:30

for the American people , and so they

28:32

want you to succeed . They

28:40

want because any company , anybody in development , if you can come up with a better mousetrap , that is

28:42

a benefit to the American people and that's their job . So they want you to

28:44

succeed and they're there to help you get

28:46

there as quickly and

28:48

as safely as possible , because that's the key

28:51

. We want to make it safe for

28:53

the patients that are out there . We also want to make

28:56

it fast because unfortunately

28:58

, you know , people are sick , people

29:01

are having practiced , having been a

29:03

practitioner who's joined industry .

29:20

I talk to MDs all the time who

29:22

joined industry , but it's

29:24

, I guess , more rare for

29:27

those MDs to get back

29:29

to a point through industry , through

29:31

drug development , where they

29:33

get to feel the

29:35

patient impact that you're so close

29:37

to feeling again right as an MD

29:39

, like back in

29:42

your . I mean , I don't want to make assumptions

29:44

here , but in your soul of soul , your mind , of minds

29:46

, right , you were a practicing physician

29:49

, in fact , you were chief of staff at Los

29:52

Alamitos Medical Center , were

29:59

chief of staff at Los Alamitos Medical Center . Two-part question One how does that

30:01

experience sort of feed your worldview in

30:03

industry ? And then two

30:05

, I guess just

30:07

some personal , how does it feel

30:10

at this point for Dr Bobby

30:12

Reddy to be on the cusp of having

30:15

that sort of patient impact again ?

30:18

Yeah , no , it's super gratifying , right , but I

30:20

mean , as I said , I'm just a small

30:22

cog in a big machine . I recognize that I

30:24

try to do my part . It takes a big , big

30:26

, big village to make this happen . Having

30:30

said that , you know one of the reasons

30:32

that I moved away from

30:35

practicing ? Because I , you know if

30:37

you'd asked me 30 years ago . Well , you know , you're exposed

30:39

to research and that exposes your mind

30:58

to new questions and new opportunities

31:01

, and I was very fortunate . My

31:03

location where I trained and then where

31:05

I worked , was Southern California . I

31:07

was close to the San Diego biotech corridor

31:10

, which was again at this

31:12

period of time you know we're talking late 1990s , early

31:14

2000s was really starting to explode

31:16

, not just in terms of new novel

31:19

therapeutics but specifically diagnostics

31:21

around sequencing

31:24

technologies Early it was PCR

31:26

and then later sequencing and so I

31:28

had an exposure to that and I was a

31:30

consultant for many of the big companies and it just

31:32

led me into that world . And

31:36

there was a point

31:38

where I said I can

31:40

probably do more with

31:42

my knowledge and expertise by

31:54

crossing over and really trying to move the needle there than here , and I think at that time also

31:56

we were seeing a bit of a change in the way that medicine

31:58

was being practiced , where

32:01

there was a lot more

32:04

consolidation of

32:07

medicine into large entities

32:09

with very

32:11

defined sort of pathways

32:13

and algorithms and a

32:16

little bit less of the sort of

32:18

. What I was looking for was

32:20

really precision medicine , which I would also

32:22

argue is personalized medicine , which I still

32:25

passionately believe in , I think , in terms of cancer , where

32:28

an understanding of the given individual

32:30

, their specific genome

32:33

and how that interacts with

32:36

their tumor process , because cancer

32:39

is different than , say , an infectious disease . An infectious

32:41

disease , that's an external organism

32:43

that we need to eliminate , but

32:45

the cancer is you . Technically

32:48

that's you and it's transformed

32:50

. So it's definitely smarter than an external

32:52

organism and it's much more complicated

32:54

and difficult . So we have to have that fundamental understanding

32:57

of both the host and

32:59

the disease , and

33:02

so we were sort of moving away from that . I felt like I

33:04

could do more by sort of crossing over

33:06

into industry and so I went in that direction . But

33:08

definitely it's

33:10

gratifying to see , you know , hopefully

33:12

, an approved product get to market

33:15

so it can help more patients . But even in the clinical

33:17

trials , when we see good responses , when

33:19

we see complete

33:21

responses and some difficult to treat

33:23

tumors pancreatic cancer , glioblastoma

33:26

. It's very exciting . It's early , it's

33:28

small . We need more . You know there's

33:31

certainly plenty of opportunity

33:33

. I don't think anyone's on the cusp of curing

33:35

cancer , but if you'd asked me 20 years

33:37

ago when I was in training , or 30 years ago

33:39

, is that a reality ? Is that something

33:42

that's going to happen in your lifetime

33:44

? I would have said no , and now I

33:46

wouldn't say that I think it is a reality , I think it's a possibility

33:49

. I think we're getting closer . We're

33:56

seeing so many advances with cellular therapy , with CAR-Ts and now TIL therapies being approved

33:58

that if we can bring all these pieces together , we

34:01

have the tools that can really transform

34:03

and change

34:06

the trajectory for most patients . It's a really

34:08

exciting time .

34:09

Yeah , it sure is . Unfortunately

34:12

, this is where I want to shift a little bit into sort of commercialization

34:15

efforts . Unfortunately you can . Where I want to shift a little bit into sort of commercialization efforts . Unfortunately you

34:17

can have all the tools in the toolbox but a

34:20

lot of therapies struggle

34:22

with commercialization and some of that

34:24

is self-inflicted . I've seen plenty of biopharma

34:27

companies , and even big pharma

34:29

companies , suffer

34:31

some self-inflicted fate

34:34

at the commercialization

34:36

level . So I'm curious about that . I want to ask

34:38

you a few questions about sort

34:40

of what your role has been

34:42

as CMO in the lead

34:44

up to commercialization efforts , what those efforts

34:47

look like and

34:49

how you anticipate ensuring the

34:52

post-commercial success of

34:54

the therapy . So maybe

34:57

start , if you wouldn't mind , dr Reddy , maybe start

34:59

with I'm curious about , like what is

35:01

at this stage in Immunity Bio's

35:03

, you know sort of trajectory what is

35:05

the CMO's role in pre-commercialization

35:08

efforts ?

35:09

Sure , yeah , I mean I think that the key role

35:11

is to continue

35:13

to advance sort of

35:15

the medical communications aspect of

35:18

it . So knowledge and

35:21

communications in terms of the presentations

35:23

that we're making , the

35:25

data that's being presented , publication

35:27

strategy . So we recently , a

35:30

few months ago , we had a paper on the quality

35:33

of life that was seen in the phase

35:35

two , the pivotal

35:37

trial for which we're going to be commercialized

35:39

, showing that there is essentially

35:41

no decremented quality

35:44

of life with

35:46

the drug when added to BCG and

35:48

these BCG unresponsive patients and we know

35:50

historically people do very badly

35:53

because ultimately their bladder is getting

35:55

worse and worse with all these surgeries , as

35:57

you mentioned , multiple TURVTs , and

36:01

then certainly if you progress to have your

36:03

bladder removed , your quality of life decreases

36:05

. So it's exciting to see the quality of life

36:07

can be maintained and

36:10

you're not having toxicity-related

36:13

decrement in your quality of life , for example

36:16

. So it's things like this where getting

36:18

those messages out there and

36:21

then helping to lead the medical affairs

36:23

effort

36:26

, academic

36:30

physicians working to establish collaborations

36:33

in

36:36

new areas of research

36:38

, whether it be preclinical or clinical , that

36:40

are not necessarily what

36:42

the company is doing . We have company-sponsored trials , of

36:44

course , areas that we think are

36:48

the next opportunity for an approval

36:50

. But that doesn't limit who we are as a company

36:53

. We like to think that no pun

36:55

intended , but that the science is in our DNA

36:57

and that we're really looking at what

36:59

works . Again

37:02

, our founder , patrick Sun Chung , is an MD by training

37:04

. He's a physician . He's not

37:06

looking at things necessarily from

37:08

is this going to bring the most

37:11

immediate , highest commercial

37:13

return ? He's looking at , is

37:15

this going to be the best thing for a patient

37:17

? If this was my patient , how can

37:19

we best treat their

37:22

disease ? And when we take

37:26

that lens , we might do some investigator

37:29

initiated trials . That

37:31

might seem wait , how

37:33

does that fit in your strategy ? But it does , because our strategy

37:35

isn't limited to just promoting

37:38

the one product . We have several

37:40

, as you mentioned . We have several products in the pipeline

37:42

and can we bring those forward ? And if

37:44

we knew that the one product could cure bladder cancer

37:47

, we would be done

37:49

. But we know it doesn't . So , and that's our goal

37:51

we need to cure , we need to really drive

37:53

to that cure . 71% is a great

37:55

number , but it's not 100% . So

37:58

that's really my charge is can we take've

38:00

got this one ? That's pre-commercial ?

38:21

getting ready to become commercial . You've got another one that I think is just entering phase

38:23

three and then some mid-clinical candidates . What is the

38:25

commercialization effort and the assemblance

38:28

of a medical affairs effort ? What

38:30

does that do to a company immunity

38:33

, bio , size , organizationally

38:35

and how do you manage through it ?

38:37

Well , it's a culture change , right ? It's different to go

38:40

from a free commercial

38:42

company to a commercial company . You

38:46

know , we've started having compliance training

38:48

for everyone in the company so they understand

38:50

the rules and regs , understanding

38:53

things like the Sunshine Act

38:55

I mean , these are all things I'm familiar with

38:57

from my background but for

38:59

others in the company , even people who are in

39:01

manufacturing , for example , to understand , oh okay

39:04

, what is this ? And I think these are all good

39:06

things for them . The second

39:08

piece is that , as we bring on the

39:11

commercial enterprise , we shift to look at

39:13

how

39:26

we , as I said , not just

39:29

medical communications but all communications , how we communicate

39:31

the message of who we are in the United States in

39:33

terms of our healthcare delivery system , is making

39:35

sure that there is a positive

39:38

formulary determination , a positive

39:40

coverage determination , we think , for this product

39:42

when approved , because

39:45

certainly , if it's not being paid

39:47

for , it's not going to be given to any patients

39:49

, right ? So it's important

39:51

that that value proposition is realized

39:53

. You mentioned something earlier about the frequency of bladder

39:55

cancer . I think what's maybe

39:58

scarier is that bladder cancer

40:00

is actually the most expensive cancer

40:02

to treat in the

40:05

United States and the underlying

40:07

reason and you hinted at

40:09

it is the chronicity you know

40:11

. So in a way that's a good thing . I mean , it's

40:13

very bad to have , say , lung

40:15

cancer , because people

40:18

aren't living long , but

40:20

with bladder cancer they're living a long time , but

40:22

they're living with their disease and with

40:24

the side effects of their disease and multiple

40:26

treatments , multiple surgeries

40:29

, and all of that adds up over

40:31

time . And then there's a big surgery , sometimes at the end

40:33

of that , which is to remove the bladder , which is a huge

40:36

, very expensive surgery , and then the downstream

40:38

cost of that . So you

40:40

know , as a society , one of

40:42

the things that we look at is , you

40:45

know , if we can even have

40:47

a small dent in

40:49

that , if we can take away 5% of people

40:51

losing their bladder , it could be huge

40:53

savings to the health plans and to the

40:56

United States as a whole . So it's an exciting opportunity

40:58

that

41:14

to see if indeed , can we actually not only make new medicines , but can we make new medicines

41:16

that are affordable for everyone in the country . It can't be just for

41:18

the 1% , it has to be for everyone .

41:20

Yeah , yeah . How do you communicate

41:22

? I mean , these are some complex equations

41:24

, complex

41:27

projections . How do you communicate that to

41:29

the stakeholders who need to hear it ?

41:32

Yeah , so it's . I mean , it's the

41:34

old fashioned way of boots on the ground and

41:37

face-to-face meetings . You know we're

41:40

meeting by Zoom , but you know , one day I'd love to meet you

41:42

face-to-face .

41:43

We'll make it happen .

41:44

Zoom I spent I joke that , you

41:47

know , I just spent my entire day in Zoom land . So

41:49

I don't , you know , I don't know where

41:51

I am physically located because I'm in Zoom

41:53

land , right

41:56

, but I think there's no better way

41:59

than actually just getting out there and discussing

42:01

with people and answering their questions face-to-face

42:03

. That's why I was happy to be able to talk to you . And

42:05

then the second thing , as I mentioned earlier , is publications

42:07

. I mean , there's nothing better than having a peer-reviewed

42:10

, peer-refereed journal where

42:12

someone else it's not me saying it , it's not the

42:14

company saying it this is data

42:16

, objectively , it's been vetted

42:19

, it's true , you can trust it .

42:25

And then people can make their own conclusions

42:27

from that data . I'm looking at the clock here , dr Reddy . I

42:29

can't believe how much time has passed already since we started talking . I want

42:31

to be respectful of your time , so I

42:33

do want to shift a little bit and

42:35

discuss what the manufacturing paradigm

42:38

looks like in

42:40

a pre-commercial organization

42:43

like Immunity Bio right now . What

42:46

is your approach ? Are you manufacturing

42:48

in-house ? Are you outsourcing ? How do you

42:50

anticipate maintaining

42:52

supply ?

42:53

Yeah , so for N803 , we

42:55

currently are outsourcing the manufacturing

42:58

. We have a long-term goal of being

43:00

able to potentially bring that in HAPS . Initially

43:04

no , and with the current

43:06

CDMO we have

43:08

contracts to be able to supply plenty of drug

43:10

, I mean one of the other drugs in this space

43:13

. There were some issues in terms of being able to manufacture

43:15

and produce that . We

43:17

do not anticipate that being an issue

43:19

at the time of launch . We'll have enough drug for

43:22

anybody who needs it . I

43:24

think that's an important thing . As

43:44

a second piece , though , that I will add

43:46

, we have other components

43:48

to our organization , which I said was

43:51

the cell therapy . That's

43:53

something which-how is a

43:56

little bit different , but close

43:58

enough that we can translate it to being able to

44:00

bring in other drug production

44:02

under one roof but

44:05

across different

44:08

locations that we own and maintain . So

44:10

that's our ambition for N803 , but

44:16

initially it is through an external manufacturer . But we do not anticipate any type of supply chain

44:18

disruptions or shortages . We should be able to produce adequate

44:20

drug supply .

44:21

Yeah , that brings to mind another question . I wanted to ask

44:23

you about the intent from the

44:25

outset . Now I know that you've only been with Immunity

44:27

Bio officially for like

44:30

four years now , but

44:32

you've got a history beyond that . So

44:35

many preclinical

44:37

and early clinical companies that I talk to when we talk

44:39

about like beginning with the end in mind , companies

44:42

are increasingly transparent about their intentions

44:44

. We're going to take this thing through phase two and

44:47

then we're going to work like hell to sell it off

44:49

and then we're going to start another project , but we never want

44:51

to go commercial . We're never going to manufacture

44:53

. Was it always Immunity

44:55

Bio's intent to take drugs

44:57

to the finish line and potentially manufacture

45:00

them in-house and become a full

45:02

service biopharmaceutical company ?

45:05

Yeah , I mean , I would say that that's you have to

45:07

. I mean , you're right , you could plan that

45:09

. That's not your intent , but if you plan

45:11

that way , then you're sort of painted yourself into

45:13

a very tight core . Instead

45:16

, our plan was like we want to have all

45:18

the options available . We want to be able to do this

45:21

. We're planning for long-term success

45:23

, not just for this but , as I said , for the other products

45:25

. We don't intend to be a one

45:27

and done enterprise . Having

45:30

said that , we are a public company and

45:32

we have fiduciary responsibility to listen to offers

45:34

. So if someone out there wants to throw us

45:36

a very attractive , very gaudy

45:38

offer , I think we would be absolutely

45:41

poised to listen to that . But

45:44

at this point , we do have the capabilities

45:46

to do it ourselves . We're

45:49

confident in that , have the capabilities to do it ourselves . We're

45:51

confident in that , and that is our plan , not just for today

45:53

, but for tomorrow and really the foreseeable

45:55

future .

45:56

Yeah , we do get a

45:58

healthy crop of VCs and

46:01

folks in the finance community who listen to

46:03

the show . So there you go . Hopefully

46:06

they're hearing the message . In

46:10

the time that we've got left , let's talk a little bit about

46:12

the other programs that are coming on

46:14

the heels of N803

46:19

.

46:20

Yeah , so I'll start with the cell

46:22

program . I mean , we have two lead

46:24

candidate cell products . One is autologous

46:27

, one is allogeneic . So the

46:29

autologous program is in phase one . Currently

46:31

we call it MSANC . What we're doing there

46:33

is it's memory cytokine , enhanced natural

46:35

killer , cell memory-like , and

46:42

so the idea is that we take your autologous cells for resupplation and then we expose

46:44

them to a variety of cytokines , one of which is the N803

46:47

IL-15 product , and we

46:49

get a differentiated cell out of that . It's

46:51

more effective at killing

46:53

and because

46:56

it's autologous

46:58

it may persist longer and

47:00

go on being able to exhibit

47:02

long-term you know durable tumor control

47:04

. It's early , it's phase one . I

47:07

have no data to discuss at this point , but you

47:09

but I'm hoping that maybe by the

47:11

end of the year in something like ASH , we might be able to present

47:13

some public data . The other

47:15

program is a little bit more mature , which is the allogeneic

47:18

cell , and

47:20

that's now basically in its third edit . So

47:22

we started with something called the NK92

47:25

, which was a patient-derived

47:27

cell . Line is

47:29

a patient-derived cell line and normally NK cells have a ratio

47:32

of killer inhibitor molecules

47:35

on their cell surface and

47:38

normally the ratio is 50-50

47:40

in sort of yours and mine and average NK

47:42

cells In this individual patient

47:44

the ratio is 95-5 , favoring the

47:47

kill , and so it's a very

47:49

potent cell . That

47:53

cell line was then immortalized and some edits were

47:56

done . So the first edit was to introduce

47:58

an endogenous IL-2 receptor so

48:00

that essentially the cell could feed itself

48:03

, it could self-propagate and

48:05

self-stimulate . Number two we

48:08

added a high affinity CD16

48:10

receptor . Cd16 partners

48:13

with monoclonal antibodies , so this would

48:15

enhance the ability to have ADCC

48:17

, or antibody-dependent cytotoxic

48:20

killing . And then the third

48:22

added recently is the CAR . So

48:24

the CARs that are in clinic right now

48:26

are PD-L1 . And

48:29

so we have an alternative

48:31

potentially to checkpoints . And then the

48:33

second is CD19 . So that phase

48:35

one is just getting ready to kick off and I'm very excited

48:38

about that because we've seen , of course

48:40

, cd19 CAR T-cells

48:42

have transformed the way we treat ALL

48:46

, for example , or refractory lymphoma

48:48

. So a CAR-NK

48:51

cell could be a very attractive

48:53

bridge to a

48:55

CAR-T cell . You know , when I was

48:57

treating patients we'd send them off and you'd

49:00

have to wait for the CAR-T cell to be

49:02

produced . And that's a very sort

49:04

of emotionally difficult time

49:06

for the patient , the family who knows

49:09

that that person is actively progressing

49:11

usually . And then sometimes we

49:13

give them largely ineffective chemotherapy

49:15

. We know it's ineffective , but we have no choice . We're

49:18

trying to do something to bribe us time . And

49:20

then the worst case scenario is small

49:22

minority percentage , but it still happens . It's

49:25

getting better , but it still happens . They cannot

49:27

produce CAR T cells . So

49:29

this will give us an option in those patients . So it's

49:31

very exciting . It's very early , it's just getting

49:33

ready to open , but I'm very hopeful . That's

49:36

the cell program , then the vaccine

49:38

program . We have a second generation

49:40

adenovirus , though different than , say

49:42

, the Chadox or Johnson Johnson adenoviruses

49:44

from COVID . The key

49:47

with the second generation is we've eliminated

49:49

something called E2B . The

50:05

key with the second generation is we've

50:07

eliminated something calledchallenge . But

50:10

with this , because you've eliminated that viral fiber

50:12

, we can give it again and again and again

50:14

. And in a phase two trial in colorectal

50:16

cancer where we give an

50:19

adenovirus with a CEA insert

50:21

, we actually saw 13 months of overall

50:23

survival in people who had failed

50:25

standard of care , basically third-line

50:27

patient , third and fourth-line patients

50:30

, which is comparable to

50:32

what's out there now . It's actually better than , say

50:34

, even the more recent approval

50:36

of Bevacizumab and Lonser in that

50:39

setting . So we think that there's certainly

50:41

an opportunity , particularly if we partner

50:43

that with N803 . And so right now the NCI

50:45

is doing a trial in patients

50:47

with Lynch syndrome as a cancer

50:50

prevention using the adenovirus

50:52

to CEA plus N803

50:55

. So that's an exciting opportunity for us to get it

50:57

to prevention and

50:59

use that information to help inform another

51:01

trial in colorectal cancer . So these

51:04

programs , if we put them together you can see there

51:06

could be overlapping synergies and in fact we did

51:08

that in pancreatic cancer where we gave

51:10

all of these together and what we saw in late-line

51:12

pancreas cancer . In a trial called Quilt88

51:15

that we presented at ASCO last year we

51:18

saw a doubling

51:20

effectively of overall survival

51:22

in people with third-line pancreatic

51:25

cancer . So it's a single-arm trial , it's not randomized , but

51:27

we got survival to go beyond six months

51:30

and historically in that setting

51:32

it's about three months . So proof of principle that

51:34

the concept works . And now we're going

51:36

back to the drawing board and see if we can refine it , make

51:38

it a little bit easier to satisfy some regulatory

51:41

requirements and move

51:43

that program forward . Yeah .

51:45

Yeah , share with me just a couple

51:47

of thoughts on sort of the . I

51:50

mean , obviously it's a very diverse

51:53

but at the same time kind

51:55

of interwoven approach , right , many

51:57

modalities , a lot of overlap

51:59

. Share with me some

52:01

thoughts on how a company organizes

52:04

to be able to swallow

52:06

that ocean to use a bad cliche

52:09

right Like to have the , the IP

52:11

, the , the personnel , the skill

52:13

, the talent , uh to to be able to to

52:15

kind of maneuver through and

52:18

, I guess , maintain the vision for how

52:20

the , how all of these different uh approaches

52:22

come together , cause I , you

52:25

know , I I'm just saying like I talked to biotech

52:28

founders and CEOs every day of my life

52:30

and not everyone's cut out for that .

52:33

Yeah , I mean , I think it's definitely

52:35

challenging . Some of it is we're fortunate

52:37

, I mean when Patrick so

52:40

I'll just back up the company itself Immunity

52:42

Bio was produced with

52:44

the merger of Altor with E2Bix

52:53

, with Globimmune and with NatCell

52:56

, and so you have different

52:58

pieces , different strengths , being brought to the table

53:01

, and what that allows you to do is retain

53:03

certain strengths and lose

53:05

certain other things

53:07

that maybe aren't strengths . So you build

53:09

through this kind of approach

53:18

and you get to , I think , a situation where the whole is definitely greater than the sum of its parts

53:20

. And Patrick had been building this for 10 , 12

53:22

years . It's not an overnight . It's like the old

53:24

story of an overnight success , but it

53:26

was 20 years in the making . So this

53:28

is years and years of bringing people

53:31

in who could do the IP part

53:33

, who could do the contracting , who could do the science

53:35

, who could do all the other

53:37

pieces finance , et cetera and

53:41

it's finally coming together . But

53:43

, as I said in the very beginning , it's a big team . It

53:45

really is . It's a big team . We have several

53:47

hundred employees and that's how

53:49

we can achieve . What we've achieved is

53:52

partly it's through his vision and his determination

53:55

, but everybody rowing in the same direction

53:57

.

53:58

Yeah , all right . Final question

54:00

, and then I promise I'll let you off the hook

54:02

. You're talking

54:05

like . Here's the content . You're talking directly

54:07

to an aspiring CMO

54:09

who is contemplating

54:11

, or has already stepped into , a role

54:14

similar to what you stepped into four

54:16

years ago . You know what's your . The

54:19

questions may be cliche , but what's your , what's your

54:21

pithiest advice for said aspiring

54:24

CMO ? Yeah , pithiest advice

54:26

.

54:26

Well , I guess you know

54:28

, don't give up . No , I think the key

54:31

is honestly and

54:33

I have to say it's just be humble

54:36

and ask questions , you know , recognize that

54:38

you don't know what you don't know , and

54:40

be willing to take advice

54:43

or input from a

54:45

lot of people around you and people outside the

54:47

company . It's amazing

54:49

how , as I said , people want you

54:52

to succeed . They really do , because

54:54

we're not making a better

54:56

widget , we're trying to make a better treatment

54:58

for human beings , so

55:00

people actually do want you to succeed . Whether

55:03

it's Xtrella , you're

55:07

going to be able to find input

55:09

. You solicit that input and

55:11

you have to carefully weigh that

55:14

. But it's much

55:16

better to get multiple sources

55:18

of input and data and then make an informed

55:21

decision than assume that

55:23

you know the answer . And sometimes

55:25

, a lot of times , I would say I

55:27

think I know the answer , but I double check , triple

55:30

check , and sometimes

55:32

it does change and that becomes and

55:34

those are big aha moments that you don't know

55:36

until you know . So that would

55:38

be my pithiest advice . I appreciate

55:41

that .

55:42

Like I said , I'll let you off the hook , but I

55:44

want to thank you both

55:46

professionally and personally . Like I said , the work that

55:48

you're doing is near and dear to my heart

55:50

and I appreciate the time

55:52

that you've spent with us and our audience and sharing

55:55

the insight so transparently , and

55:58

we'll be keeping an eye on things . Hopefully you'll

56:00

agree to come back post-commercialization

56:03

, maybe a year down the road , when we've got stories

56:05

to tell about the product and the market .

56:08

Sure thing . I would appreciate that , matt , thank you . Thanks for the

56:10

time and the opportunity .

56:11

Thank you for joining me , dr Reddy . So

56:14

that's Immunity Bios . Dr Bobby Reddy

56:17

, I'm Matt Pillar and you just listened to the Business

56:19

of Biotech . We're produced by Life Science

56:21

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56:40

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