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an outsourcing partnership quite as

1:00

unique as the one we're digging into

1:02

today , as unique as the one we're digging into today . I'm Matt

1:04

Pillar . This is the Business of Biotech and on today's

1:06

show we're talking with CTMC

1:08

co-founder and CEO , Dr

1:10

. Jason Bock , and clinical stage

1:13

cell therapy company KSQ

1:15

Therapeutics chief technology Thomas Leitch ,

1:23

about the unique beginnings of a boutique CDMO , the even more unique aspects of its partnership

1:26

model and how the collaboration has accelerated the development of KSQ's

1:28

TIL program . Jason and

1:30

Tom , welcome to the show .

1:33

Thanks so much , Matt , for having us .

1:35

Great to be here . It's good to see you again , Matt .

1:37

Oh , it's great to see you guys too . I'm really looking forward

1:39

to this one and I'm honored that you've chosen to

1:41

spend your time with us and sharing the story

1:43

with us and the story , the origin

1:45

story of CTMA . So normally I wouldn't do

1:47

this , you know , normally I'd be like , hey , this is

1:49

all about the sponsor . I'm going to ask the outsourcer

1:52

, the CDMO , to chime in

1:54

a little bit here and there . But

1:56

in this case , because CTMC's origins

1:58

are so interesting , that origin

2:00

story is so interesting . That's where I want to start

2:02

, jason . So I want to begin with you and I

2:05

just want to ask you to tell us that origin

2:07

story sort of about the way that

2:09

CTMC became , came

2:11

to be an enabler of translation

2:14

from academic science to industrial therapeutic

2:16

development . I mean that that transition that happened

2:18

there .

2:19

Yeah , that's a great description . So

2:21

thanks for the opportunity . So

2:24

, leading up to starting

2:26

CTMC , I had over

2:28

a 20 year career in small , medium

2:30

, large size biotech and biopharma , developing

2:33

biologics , protein therapeutics

2:35

mostly antibody therapeutics , and

2:38

with the commercial

2:40

approval of the first generation CAR-Ts

2:43

, I saw this tremendous potential

2:45

of this new therapeutic modality and

2:48

yet I could also tell that

2:50

the biggest challenge of this was

2:52

not clinical efficacy . It

2:54

was amazing in terms of curing cancer

2:56

in late

2:59

stage patients and yet the

3:01

manufacturing challenges were going to be

3:03

the thing that limited the potential

3:06

of this field . And that's

3:08

what I had spent a long time

3:10

developing in biologics and

3:12

seeing antibody field develop from , you

3:15

know , over the course of 20 years . So

3:18

I wanted to find some way of

3:20

accelerating cell

3:23

therapy as a field , of

3:25

accelerating cell therapy

3:28

as a field , and

3:32

, coincidentally , some of the leadership from MD Anderson Cancer Center had reached

3:34

out to me and talking about how we could potentially work together , and

3:37

so we put our heads together and

3:39

decided to try something very new and

3:42

I moved my family down

3:44

to Houston , texas and

3:46

took a position within MD Anderson to

3:49

essentially create a

3:51

internal biotech focused

3:54

on cell therapy that

3:56

would work with the

3:59

academicians

4:01

at MD Anderson closely

4:04

, take their research concepts

4:06

, help them to industrialize that

4:10

manufacture . Those handle regulatory

4:12

interactions in a very industrial way and

4:14

then bring those into the MD Anderson Clinic to

4:17

establish proof of concept .

4:19

Yeah , jason , I want to interrupt you there

4:21

real quick because , as

4:24

you describe this , it

4:28

occurs to me . I have a lot of conversations with academicians . I have a lot of conversation

4:31

with sort of translational stage

4:33

biotech builders , aspirational

4:36

biotech builders . This

4:43

concept that you're describing right now is novel in and of itself because I'm always

4:45

amazed at the gap that that

4:47

at least I perceive , based on what I hear the

4:49

gap between molecular

4:52

discovery in any modality , and

4:54

how do I make this into a

4:56

business , like , how do I take this thing to , you

4:58

know , to to the point where I feel like I can

5:00

reach some , you know , develop

5:03

it to reach some patients , do you

5:05

see ? I mean , is that a thing , or is it just my imagination

5:07

?

5:07

A thousand percent , a billion percent . I

5:10

couldn't agree more and it's amazing

5:12

because it's just an

5:14

aspect of exposure

5:17

. These professors are incredibly

5:20

smart , much smarter than me

5:23

, but they just haven't

5:25

had exposure to industrialization

5:29

and therapeutics

5:31

development and quality by design , and

5:33

how to really approach regulatory

5:36

interactions . And especially I

5:38

think this is especially

5:40

true in cell therapy , where it

5:43

was in the purview of academic

5:45

medical centers for 20 years until

5:48

the last seven , maybe

5:51

10 years , where it started to get

5:53

more industrialized and

5:55

so it , and , and even

5:58

more to that extent , in

6:00

manufacturing , where a lot of the manufacturing

6:03

for these cell therapies

6:05

were in academic medical centers

6:07

run by super

6:10

smart professors , often in like

6:12

stem cell transplant group , where there's

6:14

some adjacencies , but

6:17

there's a gap between that and

6:19

therapeutics development

6:22

with commercial intent . And

6:25

that was , I think , the insight

6:30

that the leadership at MD Anderson

6:32

had about creating this internal

6:34

group and I should say , to give

6:36

them full credit , they had sort

6:39

of even test modeled this , if

6:41

you will , with small molecules previously

6:43

and built an industrial group to

6:45

do this with small molecules , and

6:48

that had been successful in generating , over

6:51

the course of six or seven years

6:53

, seven or eight clinical

6:56

candidates that went to IND and ended

6:58

up being partnered with biotech

7:01

companies along the way

7:03

. So we've had a little bit of precedence

7:05

for this at MD Anderson . But

7:08

then doing it with self-therapy , where

7:10

we were going to really , you

7:14

know , take control of the manufacturing , was a whole

7:16

different level of approach

7:18

and I really credit MD

7:20

Anderson sort

7:22

of vision and leadership for willing to do

7:24

big things . You know , you often hear about

7:27

that being the motto of Texas

7:29

and it

7:32

really is true . You know , md

7:35

Anderson , one of their slogans is do

7:37

no small things , and

7:40

they really . They are the number one cancer

7:42

center in the world

7:44

and take that very seriously

7:46

and not just try and like , ok , let's just incrementally

7:49

do that , let's do things that maybe

7:51

we're the only ones who can do . That's

7:54

a little bit was when , when

7:57

we got together and we started brainstorming

7:59

, that was my number one question question and I

8:01

don't want to go too far down this , this rabbit hole

8:03

. But , um , when I was being recruited , I

8:05

got , um , uh , about

8:08

15 minutes with the president of md anderson

8:10

and it's like what do you want ? Now

8:12

? My , my only question for you is

8:15

are you willing to do big things , or

8:17

is this going to be an academic initiative that

8:19

we announce and , you know

8:21

, fund through , uh , you

8:24

know , hundred thousand dollar grants and things

8:26

? Yeah , and he was like we

8:29

want to do .

8:29

He's like , he's like . You're in texas , man . Yeah

8:33

, everything we do is big we do no

8:35

small things here .

8:35

We want to . We , we own that

8:38

, we're the number one cancer center and

8:40

we want to use that to likeel

8:43

things forward with bold

8:45

initiatives , step changes . So

8:49

to that end and I won't go too far

8:52

, but OK

8:54

, so then you flash forward just a couple of

8:56

months , I take the job , start

8:58

working at MD Anderson , we

9:00

identified a local cell

9:03

therapy development and manufacturing facility

9:05

that I'm sitting in

9:07

today . That was just a

9:10

couple hundred yards down the

9:12

road from MD Anderson 60,000

9:14

square foot industrial facility that

9:17

Bellicom Pharmaceuticals had built

9:19

to very high standards to use

9:21

for their clinical manufacturing

9:23

and even for their plans for their

9:25

launch . Like

9:32

a lot of especially cell therapy , biotech companies had made the decision that they want

9:34

to divest their facility . And we became aware

9:36

of it and jumped to the front of the line . And

9:38

then I came back to that and , being interested in

9:41

president , I'm like hey , remember when you

9:43

said you wanted to do big things , how

9:45

about we buy a facility ? And

9:49

he said yes , so that was how we

9:51

really got started .

9:53

And that was that the point with like was

9:55

that sort of the inflection point that you look back

9:57

on and say , like that that's when we started turning the corner

9:59

from sort of being this translational enabler

10:02

to something more akin to a CDMO

10:04

. Well or

10:08

would you not ? Am I unfairly characterizing

10:12

when I use the CDMO term ?

10:15

Yeah , I don't , I don't really like CDMO term , it's

10:17

. It's more we're see

10:20

. And I'll just , like you , started

10:22

with this origin story . We were created as an internal

10:24

biotech to help md anderson

10:27

professors develop their products . So rather

10:29

than for every uh

10:31

, you know , like traditionally the

10:33

path is an academic has an

10:35

idea and said spins it out as

10:37

a biotech company tries to raise money , like

10:40

md anderson had enough resources

10:42

to try and do a lot of this and almost like incubate

10:45

these companies internally . And so

10:47

we would play the role of that

10:49

early stage biotech , of

10:51

working with the academic

10:53

discovery , industrializing

10:55

it , carrying out I&D , enabling studies

10:57

, supporting regulatory interactions

11:00

and then designing

11:02

a clinical study with MD

11:04

Anderson clinicians to get to clinical

11:07

proof of concept . So

11:09

manufacturing

11:11

is , you know , especially for

11:13

cell therapies , was a key part of that , was like

11:15

foundational part of that . But

11:17

there are many other supportive elements

11:20

of it to to help get

11:22

the interesting discoveries

11:25

to patients in

11:27

a robust way .

11:28

Yeah , all right . So I think , thomas

11:31

, I did bring you on the show for a reason .

11:34

Sorry , matt , once you get me started , you know .

11:37

I love it . It's all good stuff , it's terrific

11:39

stuff , and Thomas's story

11:41

and sort of the origin

11:44

story of the CTMC-KSQ

11:47

relationship will , I think , illustrate

11:49

a lot of what you were just talking about , jason . So , thomas

11:51

, I want to turn to you and I want to learn a

11:53

little bit about KSQ and specifically

11:55

where KSQ was in terms

11:58

of your transition from target

12:00

exploration to therapeutic development back

12:02

in the days before you met Jason

12:05

Sure .

12:06

Well , I think the origin story that

12:08

Jason described came along at the

12:10

perfect time for KSQ Therapeutics . At

12:13

the time , our gene-edited

12:15

TIL programs were at a really

12:17

crucial point . We were very , very

12:19

far along in the discovery process and we'd

12:22

done a ton of really terrific process and analytical

12:24

development work , but we were not yet

12:26

to an IND clearance for

12:28

our first therapy , and I think maybe

12:30

to take a step back and talk about

12:32

the origins of KSQ would

12:35

help explain , maybe , why that is

12:38

. We were founded on this idea that there could

12:40

be a better way to uncover optimal

12:43

targets for oncology and

12:50

with the emergence of CRISPR gene editing technology years ago , we believed that we could do

12:52

an unbiased genome widescreen that would reveal the best performing

12:54

gene targets Not what we thought

12:56

the best targets should be , but the actual

12:59

best performing targets and that's exactly what we did

13:01

. And then we applied it in a number of different ways

13:03

and we found that when we systematically

13:05

knocked out each gene and then looked at the performance

13:07

across a range of different

13:09

cancer models , those

13:12

experiments revealed a collection of high-value

13:14

targets that up until that time had been largely

13:16

overlooked . So now fast

13:18

forward some of those targets we're pursuing

13:20

with partners and some of those targets

13:22

we're developing ourselves , and just last year

13:25

we announced that we had executed

13:27

out licensing deals with Roche and Ono

13:29

Pharmaceuticals , and

13:31

we've also maintained a long running research collaboration

13:34

with the terrific team at Takeda

13:36

. But in addition to the ones that

13:38

we're outsourcing , there are a number of those targets that

13:40

we're actually developing ourselves . Our

13:43

two lead candidates are gene-edited TIL

13:46

cell therapies , and this is where

13:48

we arrive at the partnership with

13:50

Jason's team at CTMC . By

13:52

late 2022 , when Jason and

13:54

I first met KSQ001EX

13:57

, which is a single-edit gene knockout , and

14:00

KSQ004EX , a dual-edit therapy , the

14:03

team at KSQ had done a terrific job of developing

14:05

both of those to the point where we had an

14:07

early version of our manufacturing process

14:10

and we needed to

14:12

take the next step and then secure a clinical

14:14

supply , and that's what brought us together

14:16

with CTMC . Our

14:18

platform led us to some unique

14:20

and very promising targets but , as

14:22

you alluded to earlier , matt

14:25

, having a target is not the same thing

14:27

as having a therapy , and having a therapy

14:29

is not the same thing as delivering a patient

14:31

outcome , and our partnership with CTMC

14:33

has really helped us accelerate those leads from target

14:35

to therapy , to uninterrupted supply and

14:37

, ultimately , patient outcomes .

14:39

Yeah , yeah . I'm not going

14:41

to put words in your mouth

14:43

, I'm going to paraphrase . The last

14:46

time we spoke , you were telling me you're giving me a little bit of

14:48

color on the development of

14:50

those candidates internally

14:53

. Can you elaborate

14:55

on that a little bit ? Tell us what were the challenges

14:58

that you were struggling with ? That made the introduction

15:01

to Jason fortuitous .

15:03

Sure Well , for starters , self-therapy

15:05

is not for the faint of heart , right , there is no shortage

15:08

of difficulties when it comes to

15:10

developing complex therapies like this . But

15:13

we were confident

15:15

in the targets . We felt good

15:17

about the process and analytics that we

15:19

had developed up until that point . But

15:22

our main difficulty and something that

15:24

is something that was really not uncommon

15:26

to biopharma companies we were really

15:29

struggling to identify a partner

15:31

that could support our program timelines

15:33

with supply , and in all

15:35

of our conversation with potential partners it went something

15:38

like we can slot you in at

15:40

this future date or we can start to

15:42

work at this site and then transition it to a

15:44

new site midstream . And

15:47

that is completely understandable , I get

15:49

it . Those are common business constraints that everyone

15:51

faces and I've had those conversations

15:53

more than a few times over

15:55

my career . And no CMO

15:58

wants to delay a therapy from getting

16:00

to patients . No one wants to do that . But

16:02

with every option that we were looking at , our

16:05

program timelines would get pushed out and our

16:07

patients would be left waiting , and we just had

16:09

to find a different way , and CTMC helped

16:11

us find it .

16:13

Were those timeline challenges , some of

16:15

those challenges you said you've run into many times in

16:18

your career . Were they relative

16:20

at all to the time , to

16:22

the year you know , 2020 , or

16:25

, given your experience pre and post COVID

16:27

and everything , all the disruption that that caused

16:29

? Is that more chronic than just sort

16:31

of that point in time

16:33

issue ?

16:34

COVID didn't help . That's for sure . Right , Nothing

16:36

got faster during COVID . But

16:39

I would also say that when

16:42

we look at the late teens , there

16:44

was still a

16:47

capacity that was

16:49

being brought online across cell therapy

16:51

and the capacity was still catching

16:54

up with a lot of the discovery work and clinical

16:56

demand that was emerging . And so

16:58

I don't think that we're in necessarily

17:00

that same place today , but at

17:02

the time late teens , early 20s

17:04

yeah , we were still chasing capacity

17:07

. It was trying to catch up with a lot of the

17:09

groundbreaking discovery work that

17:11

was happening .

17:14

If I could just add Matt to that

17:16

, just to add on to what Tom was saying

17:18

about cell now as a field and processes

17:20

of becoming platform and

17:22

the like . But

17:32

until the

17:36

manufacturing platforms are still

17:38

huge differentiators , because it's

17:41

a big challenge from a

17:43

scientific point of view to take a piece of a patient's

17:45

tumor and extract the lymphocytes

17:47

from that , those lymphocytes have been

17:50

beaten up , have been beaten up down

17:52

sideways and

17:54

are not that healthy . And so

17:56

, specifically

17:59

, md Anderson and CTMC

18:01

have developed specific processes

18:03

to enhance that , more so than

18:05

the traditional what's called the

18:08

Rosenberg or NCI process

18:10

that's been used for more

18:12

than 20 years to enhance

18:15

the success

18:18

rate in that extraction and

18:20

the number of lymphocytes that

18:22

can be expanded . And so

18:24

that was also a part of what helped

18:26

the acceleration by being able to

18:29

leverage that

18:31

manufacturing platform

18:33

and combine it with all

18:35

the impressive work KSQ had

18:37

done before .

18:38

Yeah , Thomas . What was

18:41

your first exposure to Jason

18:43

and CTMC ?

18:46

Well , I think in the field of TILs , we were well

18:48

aware of them and what they could do . I

18:50

mean , I could let Jason talk about the specifics

18:52

, but they've been doing important work on TILs

18:54

going back for quite a few years and in

18:56

fact there are some folks on their team that have been working

18:58

in TILs for a decade plus

19:00

. So it's a really , really experienced

19:03

group and through conference and industry

19:05

meetings we

19:12

knew each other's work really well and when the opportunity presented itself to work together .

19:14

that wasn't a particularly hard decision , so how did the opportunity present

19:16

itself ?

19:18

Well , the reality was that we were searching

19:24

for a home for clinical supply , and it was

19:26

at one of those industry conferences where

19:29

we we had what was an

19:31

ongoing series of discussions and

19:33

realized that we weren't just talking

19:36

about the science of the discovery or the the

19:38

the field of tills , that there was an opportunity to

19:40

actually collaborate here , and it took off very

19:42

quickly from there .

19:44

Yeah , yeah , and I want to get into we'll get into some of the details

19:47

around that collaboration . But before

19:49

the collaboration happened , you know , you , you

19:51

, thomas , you you've stated quite

19:53

eloquently that CTMC's work

19:55

sort of proceeded itself , like you know , you

19:58

knew the reputation was there , you knew the work that they did

20:00

. When you , when you decided

20:02

to really dig in and

20:04

evaluate the potential for collaboration

20:06

, decided to really dig in and evaluate

20:08

the potential for collaboration , did you feel like a lot of that sort of evaluation

20:11

work had already been done because you knew

20:13

the body of work that they had been working

20:15

on , or was there a concerted evaluation

20:17

process that KSQ

20:19

?

20:20

You know it . Actually . It

20:23

actually it wasn't a foregone conclusion

20:25

, just just based on the

20:27

body of work that they had done . When

20:29

we started looking at the at CTMC

20:32

at CTMC as a potential partner what

20:34

it came down to to us was

20:37

culture and technical capability and

20:39

in that order , and obviously

20:42

CTMC has proved to be exceptional

20:44

in both areas . But there's

20:46

a really uncommon cultural fit among

20:48

our teams , and I'm not talking about just Jason

20:51

and me . We obviously get on very well

20:53

, but that fit permeates

20:55

at every level of the organization . We

20:57

believe in the same things when it comes

21:00

to how we ought to work together and

21:03

the first time we actually met that team , one

21:05

of my teammates at KSQ leaned over to

21:08

me in the meeting and said these guys are one of

21:10

us , and I think that that turned out

21:12

to be true . All that other stuff you said is

21:14

absolutely valid . Like I would advise any company

21:17

evaluating a potential supply

21:19

partner to consider a wide variety

21:21

of factors like just depending upon what your

21:24

specific needs are . And if you

21:26

don't have that experience internally , there

21:28

are more than a few consultants that

21:30

can support you but also

21:32

understand that things like geography

21:35

and room sizes and process fits and

21:37

equipment . Those factors

21:39

are necessary but not sufficient to

21:41

ensure success . When

21:44

things go wrong and they will go wrong

21:46

it's gonna be culture and capability

21:48

that get you through to the other side of it .

21:51

How do you ? I want to stay there for a

21:53

minute . I don't want to go too far down this rabbit hole

21:55

but I want to hang here for a minute because just recently

21:58

I was exposed to a very

22:00

complex and comprehensive decision

22:03

tree matrix whatever you want to call

22:05

it to your point , thomas that a consultant

22:07

uses in helping

22:09

sponsors evaluate cdmo capabilities

22:12

, and it's rote , I mean , it's

22:14

like you know it's , it's concrete

22:16

, uh , and that's wise for

22:18

sure . You know , evaluating granular

22:20

specifics around . You know supply chain

22:23

redundancy and and vendor certifications , and these are all you know supply chain redundancy

22:25

and vendor certifications , and these are all you know very

22:27

, very important things in this business . Uh

22:29

, boxes to check , um , the

22:32

I , I , I . I did not

22:34

see any allusion

22:36

to cultural , uh

22:38

, you know to , to , to cultural alignment

22:41

on this scientific matrix

22:43

that the consultant offered up to give me a

22:45

look . How do you like ? Besides

22:48

the field culture is always a tricky

22:50

discussion for me to have with guests on the business

22:52

of biotech because it just gets fuzzy and

22:54

, you know , makes you feel good

22:56

. But it's difficult to kind of wrap your

22:59

arms around some concrete measurements

23:01

of ensuring that that cultural match

23:03

is going to to your point , thomas , and it's a very

23:05

important point , ensuring that that

23:07

cultural match is going to to your point , thomas , and it's a very important

23:10

point ensuring that that cultural match is going to be what gets you through the hard

23:12

times . So I don't know , I don't even know what I'm asking you guys

23:14

right now . I'm asking you for some . I'm

23:16

asking you for some . You know , jason

23:20

, I'm going to stop talking and

23:22

you know where I'm going . I do . Yeah

23:25

, tom , do you want to ?

23:25

go first I can going , I do . Tom , do you want to go first ? I can start

23:27

. So , matt , you're exactly right . Squishy

23:30

, fuzzy , fluffy

23:32

those are all words that we talk about it , but

23:34

I will tell you it is

23:36

on our selection matrix and

23:42

I would encourage folks to add it to theirs , because

23:45

you know it when you see it and you feel it when you don't have it . To

23:48

try to make it concrete , one of the examples that I consistently see at the

23:50

working team level it's not only just

23:52

how we choose to interact with one another in

23:54

terms of authenticity or just being

23:56

respectful , but there's just a really

23:58

deep focus on the fundamental science

24:00

on both sides of the collaboration . The

24:03

other day and Jason , I don't know if you were actually on this

24:05

call the other day , I can't remember the team at KSQ

24:07

was reviewing some experimental results with the team

24:10

at CTMC and it was a really

24:12

, really detailed , granular

24:14

, technical topic . Detailed and technical to

24:16

the point where , with some partners , I'm

24:18

not sure that there'd be a lot of interest in having

24:21

that level of depth of discussion . But

24:23

what I saw in the discussion with our teams

24:25

was really different than what I've experienced

24:28

in my past . The KSQ team is

24:30

amazing . They are so talented and so

24:33

experienced and CTMC

24:35

matches that and in that

24:37

discussion I was referring to , the CTMC

24:39

folks were really drilling down into

24:41

the details and in-depth technical discussions

24:43

to the point where they were stopping and interrupting

24:46

the KSQ presenter with questions based

24:48

on their own previous experiences Wait , why did

24:50

you handle the cells that way ? Or oh , that

24:52

makes sense . That makes sense . You know . That

24:55

explains some results that we saw in our labs

24:57

when we did X

24:59

, y and Z last year and what

25:02

I saw in those interactions were really

25:04

engaged , super passionate

25:06

, experienced teammates who were really building

25:08

on one another's ideas to advance kind

25:11

of our shared understanding . If

25:13

you have that in a partner , yeah

25:15

, you've got something special

25:17

. But , matt , ultimately you're right

25:19

. It feels squishy and fluffy and you just

25:21

know it when you see it .

25:25

Yeah , so well articulated . And

25:28

, Matt , I would say , though , that

25:30

also you have that cultural

25:32

alignment , but then you need to like

25:35

undergird that with a

25:38

business arrangement that helps support it and

25:40

doesn't detract from it . And

25:42

that's fundamentally why I think , especially

25:46

for self-therapy and when you asked

25:48

me before about CDMO , which often uses like

25:50

a fee-for-service model , we

25:52

don't do that Because

25:54

it detracts exactly from this . It's

25:56

like you

25:59

get what you incentivize , right , and so

26:01

if your incentive is

26:03

to just do services , to get

26:06

fees , okay , like , okay

26:08

, are we getting ? You

26:11

know , you have a culture of that scientific

26:13

collaboration that Tom alluded

26:16

to , but it's hard

26:18

to support you know that over a long

26:20

period of time if you're not getting paid for

26:22

it somehow . Yeah , so what

26:24

we came up with in

26:26

, in addition to the connection with MD Anderson

26:28

and the depth of scientific knowledge , is we wanted

26:30

to have a business structure that enabled

26:33

that kind of collaboration and

26:35

essentially aligned our incentives so

26:38

that we're all rowing

26:41

in the same direction and we can really

26:43

act as almost like an

26:45

internal part of KSQ's development

26:48

and

26:50

structure it so that there's

26:52

. I

26:54

think it's true that over the last

26:59

year and a half we've been working together

27:01

there's been zero change orders . That's right . No

27:04

change orders , no discussion

27:07

of business terms at

27:09

all . We worked through the contract

27:11

, we signed that and

27:14

that was the last time we discussed . And

27:19

what I would say is you know

27:21

, not everything has gone technically perfectly

27:23

. As with any project , there's been

27:25

some challenges . Okay , how are we

27:27

going to overcome this ? We saw that and

27:29

what I love about this model again

27:32

why I don't think we're really a CDMO

27:34

. Is we just all right ? We need to do another experiment

27:37

?

27:37

Let's do that experiment . How do you think we should ?

27:39

design it . What should be the controls ? What arm should we

27:41

do ? Oh , that's a great idea

27:43

, do it this way . But none

27:45

of those discussions involved like , oh

27:47

, let me go back and look at the scope of work

27:49

and see how many experiments

27:52

we were we budgeted for

27:54

, and let me go talk to the BD guys

27:56

and see if , if we can do this and

28:05

that is part of what enables the speed , because it's just letting the

28:08

science lead .

28:08

Yeah , yeah , I want to sort of rewind a

28:10

little bit and

28:13

talk a little bit . You talked about the contracting

28:15

and how being on the hook and

28:18

incentives are a little bit different than the

28:20

normal post-contract experience

28:22

, but we kind of skipped over

28:25

the tech transfer type

28:27

stuff . Right , like I want to learn about how

28:30

that process redesign

28:32

and tech transfer and this IND

28:34

submission process . It's also unique

28:37

to me . I'm not like super , super

28:39

experienced on the CDMO side , so I don't know

28:41

how common

28:44

it is for . I'll quit saying

28:46

CDMO , jason . I'll . I'll try to stop

28:48

saying CDMO .

28:49

It's okay ? Do I ? Do I like ? Do

28:51

I Twitch every time you say that or something ? Sorry ?

28:53

Manufacturing partner . I don't know

28:55

to what degree that the prevalence of that you

28:57

know . Go go into the IND submission

29:00

uh process , arm

29:02

and arm and in lockstep is is common

29:04

with with an outsource manufacturing uh

29:06

collaboration . So tell me a little bit about that

29:08

, like when the trigger was

29:10

pulled and you had to do some

29:12

process and tech transfer type stuff and then

29:14

ultimately , leading up to

29:16

the IND submission process , I'm

29:18

going to open it up to either one of you to start

29:20

and kind of walk through

29:22

that process .

29:24

I can start . I love telling the

29:27

story and I'll tell it to anybody that will

29:29

listen .

29:29

Well , I'm listening .

29:31

It's been an amazing

29:33

ride . So I first met

29:35

the CTMC team in November of 2022

29:37

. Subsequent

29:39

to that and it was shortly before the Thanksgiving

29:42

holiday we completed the contracting

29:44

work , our plan transition

29:46

to a next-gen manufacturing process , developed

29:49

all the analytics associated with it , executed

29:52

engineering and then GMP batches

29:54

, and then authored and submitted an IND

29:56

, and 11 months after Jason and I shook

29:58

hands for the first time in Houston , the IND

30:00

for our lead candidate , KSQ001EX

30:03

, was cleared by FDA . So

30:06

, yeah , it's been a ride

30:08

and it's been fun all

30:10

along the way .

30:12

Thomas , how does that ? I mean ? You

30:14

know I'm sure it's apples to oranges to bananas

30:17

, comparisons along the trajectory of your career

30:19

, the history of your career . But how does that experience

30:21

kind of align or

30:24

compare to previous

30:26

experiences ?

30:28

It's , it's certainly faster . Um , and

30:30

you know , there's there's really no normal when it comes

30:33

to uh , a cell therapy

30:35

and the there's no

30:37

normal , especially when it's a company's first foray

30:39

into a , into a , into a cell therapy . Uh

30:42

, ind submission , yeah .

30:43

Jason , I mean , that's a uh Thomas

30:45

brings up . He asked

30:47

the next question for me because you , you , you know the , the story

30:50

that you tell about the origin of CTMC

30:52

and the fact that you had great resources and great

30:55

people and super , you know , super smart scientists

30:57

and you know all the all this research

30:59

. That's all fantastic , like you can sit around

31:01

doing all sorts of super smart stuff

31:03

, but unless you have some processes

31:06

and procedures , you're not going to be able to stick to a timeline

31:09

like the one that Thomas just

31:11

described . So tell us a little bit about , like , what's

31:13

the setup at CTMC that

31:15

sort of leads to or enables

31:17

that kind of speed .

31:21

That's great lead up . The

31:24

simple thing I can say is everything

31:26

about how , you know , I had a great opportunity

31:29

to like design ctmc

31:31

basically from the ground up . It was like

31:33

a you know . So it was a personally

31:36

for me to have seen

31:38

all sorts of good , bad , ugly

31:40

ways of doing things and being able to create

31:43

something brand new , um

31:45

, that was fit for purpose . Solution

31:47

was this amazing opportunity with

31:49

MD Anderson . How we approach contracting

31:51

, how we structure partnerships

31:54

, is designed to accelerate

32:09

projects moving from research stage

32:12

to clinical

32:14

proof of concept . So we're to

32:18

not only getting

32:20

to that IND , which everyone always focuses

32:23

on and is super important to

32:25

get there very quickly , but then to

32:27

be able to start the clinical study very

32:29

quickly and not have that painful

32:33

period where you're doing all the important

32:35

things to set up clinical operations , but get

32:37

those set up so we can start getting the product to patients

32:40

. And then even how we can

32:42

accelerate enrollment and

32:44

make sure we get to 10 , 15

32:47

patients of clinical data as

32:49

quickly as possible . And so

32:51

part of that is the regulatory

32:53

process , and so we

32:58

leverage

33:00

MD Anderson's amazing relationship

33:04

with FDA , and

33:06

MD Anderson for

33:08

the most part acts as sponsors for First

33:11

in Human Studies , even with our biotech

33:13

partners . Even with

33:15

our biotech partners and we at CTMC

33:18

have a mature regulatory

33:20

group , experienced regulatory group that

33:23

authors documents

33:25

in Viva

33:27

in electronic format

33:31

fully transparently with partners

33:33

. They can edit , they

33:36

have full editorial control of what goes into those submissions and final

33:38

decision making . But

33:40

we have a really good starting point to

33:42

get them there . And

33:44

then that process

33:47

within MD Anderson of starting up an MD

33:49

Anderson sponsored trial is

33:51

quicker than the external

33:53

sponsored trial , and so then

33:56

we're able to get

33:58

to first patient in quicker

34:00

as well . So it's eliminating as

34:03

much of this white space as

34:05

we can , of sort

34:08

of non-value

34:10

what I would call sort of non-value

34:13

added activities for the therapy . Right

34:15

, you're doing , you're . You're doing important

34:17

things when you're setting up clinical operations and

34:19

activating a site , but you haven't really added

34:21

any value to the therapy until

34:23

you dose a patient , see

34:25

a response . Then you're talking

34:28

value creation , yeah

34:30

.

34:30

Yeah , when

34:33

, when , our , when , our mutual

34:35

friend and and

34:37

colleague , Kelly Beal , pitched

34:39

this story to me I'm

34:42

going to get this wrong , so I'm not even going to attempt

34:44

it but she made an allusion in the pitch to

34:46

the value of the

34:49

physical

34:51

proximity to MD Anderson , and I find

34:53

it really terrific , jason , those of you

34:55

who are watching this episode versus listening to it . Md Anderson is , and I find it really it's terrific , jason

34:57

, those of you who are watching this , uh , this episode versus listening to it

34:59

. You know , md Anderson is directly

35:01

over Jason's left shoulder and that is not a

35:03

, an AI generated background

35:06

, um , which . But she , there

35:08

were some specifics in there about like in in

35:10

the pitch , about , like , the

35:12

logistical advantages and the

35:14

way that materials are even transported yeah , give me

35:16

some color on that . And and the way that materials are even transported yeah , give

35:18

me some color on that . And the advantages

35:21

, you know , thomas , feel free to jump in here too

35:23

Like the advantages , even perceived

35:25

and down the road , advantages of

35:27

that sort of proximity .

35:30

Right , exactly . You

35:32

know , this started

35:36

when I was talking

35:38

to some biotech colleagues

35:40

at startup cell therapy companies

35:43

this is five years ago about

35:45

how they were starting up a clinical study and they

35:47

would have multiple sites and

35:49

running an autologous cell therapy trial

35:52

can be challenging because you really unlike

35:54

almost all of the modalities

35:56

. Be

35:59

challenging because you really unlike almost all of the modalities . There's this coupling

36:01

of the clinical trial and the manufacturing . It's all on-demand manufacturing and

36:03

especially when you're in a dose escalation or first

36:06

human multi-site , everyone's talking oh

36:08

, I got a patient . Um , okay

36:10

, line up a manufacturing slot . Okay

36:12

, work out the logistics of getting the product

36:15

from you know , from

36:17

the patient Right , that's the starting material

36:19

to the

36:21

manufacturing site and then working out ways

36:24

to get it back . And these

36:26

are unfortunately very sick cancer patients

36:28

that oftentimes can drop out of

36:30

the study and things , and then that screws up all

36:32

your logistics . And so because

36:34

we were running these studies already with

36:37

MD Anderson , for we've

36:41

done many of these studies , we've got all those logistics

36:43

worked out . And so for our partners

36:45

, they don't have to bother

36:49

with any of it . Just

36:51

we coordinate directly with MD Anderson

36:53

Clinic . When they have a patient , we

36:56

work out that , we make sure we have a slot and

36:58

we manufacture that product and then keep

37:01

them informed and get that product back to the

37:03

clinicians to

37:05

infuse into the patients , and so

37:07

partners like KSQ have

37:10

full visibility into what's going on

37:12

but have really no accountability

37:14

. You don't have to worry about all those logistics

37:17

, which can be a big thing , especially

37:21

for , like

37:24

I mentioned before , I talked to some smaller companies . They would

37:26

have five , six , seven , eight people in their logistics

37:28

group to manage all these different

37:31

things going on in the clinic , because it's complicated

37:33

with cell therapies , and

37:35

so that alleviates just that whole

37:38

complexity Again

37:40

, allowing the science to come through

37:42

, allowing the product to declare itself without

37:45

having to worry about all these

37:47

logistics .

37:50

I think it's difficult to overstate the

37:52

importance of just the logistical advantages that

37:55

CTMC has there , the importance of just the

37:57

logistical advantages that CTMC has there , being

38:00

just down the street in the Texas Medical Center . They

38:04

have established labeling and chain of custody and serialization that's

38:06

already integrated with MD Anderson's system so that CTMC knows what

38:08

to give them and MD Anderson's ready to receive

38:10

it in a way that's frictionless for us

38:12

and that's important for

38:15

a first-in-human trial like this for

38:20

us and that's important for a first in human trial like this .

38:22

Tom , I want to stick with you for a minute because I'm curious about whether or

38:24

not there was at any point in

38:26

your evaluation , a concern around

38:29

. And I'm going to put this like very simply , in a very

38:31

rudimentary way Was

38:34

there ever any concern ? Jason

38:37

just mentioned you know the high

38:39

headcount that it takes to manage

38:41

the logistics of a clinical trial . Very small

38:44

companies . You know a company of 12 having six

38:46

people you know working on clinical

38:48

trials and in my experience a lot of that has just

38:50

sort of been a cost of doing business . Trials are

38:52

distributed . Finding patient populations requires

38:55

a lot of logistical effort

38:57

and getting

39:02

back to the question , as opposed

39:04

to that , like this very simple perspective

39:07

that I have is , like KSQ

39:09

says , well , we're going to go do this thing at MD

39:11

Anderson , we're going to effectively put all

39:14

of our eggs in one basket , if

39:16

you understand what I'm saying . Like , was that ever a concern

39:18

? Like we know they're great . We know

39:20

they're great , we know it's a fantastic

39:22

team , we know the partnership down there is super

39:24

strong , but we're still kind of putting

39:27

all our eggs in one basket .

39:28

Yeah , it's , it's . It's a factor that we consider

39:30

. But we also have to acknowledge like this is a starting

39:33

point and the start

39:35

of the purpose of the starting point is

39:37

to let the product declare itself and the therapy

39:39

declare itself . If

39:42

we get the results that we hope to see from

39:44

there , it's very easy then to

39:47

go into more of a standard multi-center

39:49

trial where the clinical

39:52

development plan would increase

39:54

significantly in scope . We knew it

39:56

was a risk , or I wouldn't even call it a risk . We knew it was a risk or I wouldn't even call it a risk

39:58

. We knew it was a factor , understood

40:01

it , but the way to mitigate that

40:03

factor was to just develop those relationships

40:06

with Jason and with the PIs at MD Anderson

40:08

ahead of time so that we could get comfortable with the fact

40:10

that this was going to be our starting place and

40:13

then we can expand from there when the time's right

40:15

in the clinical development program .

40:21

Yeah , I think the last time we chatted about this , I think I alluded to that question and , jason , I want

40:23

, I want to give you the opportunity to , to , to give me some color

40:25

that you gave me the last time we talked , because now I'm

40:27

remembering that conversation

40:29

and and and I'm not going to put words in your mouth

40:32

, but I think your response was like you

40:34

have to understand that most of the eggs are in

40:36

this basket , right Followed with my

40:38

right . So give us a little

40:40

bit on that , jason .

40:41

I think you know , matt , when I

40:44

initially started talking

40:46

to MD Anderson everyone sort of knows MD . Anderson

40:48

by reputation and knows the

40:50

number one cancer center . It's

40:59

amazing when you actually look at the scale and magnitude of their

41:01

impact in oncology and specifically oncology

41:03

research and development of novel products

41:05

. So a few

41:07

stats for you . 80%

41:10

of patients that are treated

41:12

at MD Anderson are on a clinical

41:14

trial . So

41:17

there's not many standard of care . 60%

41:20

of all oncology

41:24

products that are approved in the US

41:26

have run a clinical study at

41:28

MD Anderson . So

41:31

all roads lead to

41:33

MD Anderson . If you look at the number of patients

41:35

on clinical trials at MD Anderson

41:37

versus other medical

41:40

centers . MD Anderson is number one , as I've alluded

41:42

to , but they have more patients

41:44

on clinical trials than numbers two and three

41:46

put together , and so

41:48

the scale and magnitude of

41:50

the clinical operation at MD

41:52

Anderson is just like incredible

41:55

. And MD Anderson is just like incredible

41:57

, and so that mitigates these risks , or

41:59

, you know , instead

42:02

of a risk you almost see it as a strength . Where

42:05

you have the patient

42:08

volume . You know there's always risk when

42:10

you run multiple site

42:12

studies of are you going to get consistent results

42:14

, all those sites ? You know not only logistical

42:17

challenges but practical . Are you

42:19

going to treat

42:22

the samples the same way , and everything by having

42:24

a single site , we can eliminate a lot of those

42:26

variables and again , like tom said , let

42:28

the product declare itself . and

42:32

the other thing I would just note

42:34

that's really important for cell therapy

42:36

as opposed to other traditional modalities

42:39

is basically in the first

42:41

10 to 15 patients you can see

42:43

efficacy signals , can

42:46

most often do Sometimes

42:48

in the first patient . Now

42:50

, so that's amazing . You know

42:53

, as opposed to antibodies , where we intentionally

42:55

dose self-efficacy doses , do

42:57

single dose cohorts

43:00

to begin to really explore safety

43:02

, because

43:12

these are single dose treatments

43:15

seen an effect

43:17

in 15 patients , people

43:21

are going to start to be concerned . You know , it's not

43:23

like an antibody where you do

43:25

that for 45 patients before

43:27

you know whether it works . And the

43:30

last thing I'll say is on

43:32

this topic is these

43:35

are very powerful therapies . Uh

43:38

, you know cell therapies and you

43:40

know , um , there can

43:42

be , uh , you know , extreme

43:44

, severe adverse events . Having

43:49

a clinical team that is

43:51

extraordinarily experienced with

43:54

these modalities and how to deal

43:56

with those adverse

43:58

events and limit the impact

44:01

of those and blunt the

44:03

impact of those and turn a

44:05

significant

44:08

event and prevent it from becoming , unfortunately

44:11

, like a debt , is super

44:13

critical for companies in this delicate

44:16

first 15 patients , when

44:18

you're still establishing and laying the product

44:20

to clear itself . And so that's

44:24

another thing that actually mitigates

44:26

the risk . You're not

44:28

going to get better care and better care

44:30

of the patients on a clinical

44:32

trial anywhere in the world

44:34

than MP Anderson , I can confidently

44:36

say .

44:44

Yeah , thomas , anything that you would add to the , I guess

44:46

, advantages specific to KSQ of that logistical connection

44:48

between CTMC and MD Anderson and projections on how you think that'll

44:50

continue to benefit KSQ as you get deeper

44:52

into clinical trials ?

44:54

Other than to just say

44:56

how terrific are the PIs

44:58

that we get to work with

45:01

there . They are fantastic

45:03

to work with . They know how to rapidly identify

45:06

a patient and progress them

45:08

through screening and enrollment so that they can

45:11

get to a therapy that gives them the best chance

45:13

of a positive outcome , and they know how to do it quickly . So

45:16

it's been , it's been , a really positive experience in working

45:18

with the PIs there . We feel fortunate . Yeah , we're .

45:23

I just looked at the clock and realized that we're running

45:25

a little bit tight on time here , guys . It's . I

45:28

feel like we probably should have made this a three

45:30

hour episode . There's lots

45:32

to talk about and you guys are fantastic . But

45:38

let me stop right now , uh , before we get into uh sort of next steps , and ask you

45:40

what haven't I asked

45:42

you if I were doing a better job here about

45:44

the , the , the partnership , the relationship

45:46

, where , where , where it stands right now

45:48

, um , what , what ? What

45:50

part of the story are we missing ? What haven't I asked you

45:52

that I should have ? Or

45:55

did I do such a bang-up job that we're

45:57

like Matt

46:00

, it was an amazing job you did . let me just

46:02

say Everything

46:04

that comes before the butt is a lie , they say .

46:08

That's why I said um ? Did I say bye-bye , um ? I

46:15

mean , I think what's

46:18

interesting for me for next

46:20

steps and lifecycle

46:22

of CTMC is

46:25

what comes after positive

46:29

first in human results and

46:32

how do we enable patients

46:34

, or how do we enable partners to

46:37

move to the next stages of development most

46:41

efficiently ? And our approach

46:43

to that is to basically

46:46

provide optionality . So

46:48

one of the reasons I didn't quite get a chance to mention

46:51

this early on , but almost

46:55

two years ago we spun out from

46:57

being part of MD Anderson into a joint

46:59

venture , that's a 50

47:01

50 joint venture between MD Anderson and

47:03

National Resilience . And

47:06

so resilience is a

47:08

really innovative , ambitious company trying

47:12

to revolutionize complex biologics

47:14

manufacturing and has self-therapy

47:16

capabilities , revolutionize complex biologics manufacturing

47:19

and has self-therapy capabilities . And

47:22

so we enable an on-ramp

47:24

to resilience . We

47:29

enable , if partners want to build internal capabilities , we would

47:31

help them design and tech transfer to their own facility . Or

47:34

we also have capabilities

47:37

in the facility to carry out late stage

47:39

and , uh , perhaps

47:41

one day even launch uh products

47:43

, uh . So I think it's an important

47:46

thing to understand

47:48

that we've really thought about this . We don't

47:50

want it to be a dead end like oh , wow , this is amazing

47:52

, you get to uh , you know

47:54

, see that your product like we've talked about

47:56

a few times declares itself it's a fantastic product

47:59

and then we're stuck and have to reverse

48:01

out of a dead end and go somewhere else . We've

48:04

really thought a lot about that . As

48:08

the partnerships mature

48:10

that we have and they get to more mid-stage

48:13

trials , we'll be able to showcase some more

48:15

of how we've thought about that as well .

48:19

Yeah , one thing I failed to ask and

48:21

I think we briefly touched on this

48:23

the last time we all chatted was sort of

48:26

the win-together , lose-together

48:28

elements of the partnership

48:30

, and I don't remember exactly what

48:33

the details were there , but is there some

48:35

element of like hey , you know , if KSQ wins

48:39

, ctmc wins beyond , just you

48:41

know , winning for the patient from a business

48:44

perspective , and if KSQ

48:46

loses , we're going

48:48

to lose a little bit too . We got skin in the game

48:50

. Am

48:52

I making that up , or was that a real part

48:54

of this conversation ?

48:55

I don't know if we talked about it , but I agree with it

48:57

. Aligned incentives in our collaboration

48:59

drive all the right behaviors , but

49:02

there's really not a lot that feels

49:04

transactional about the collaboration

49:06

that we have . I think the result of that mindset

49:09

is that when

49:11

something unexpected happens and we talked about this

49:13

the unexpected things are going to happen . The

49:16

first and really only questions that we

49:18

focus on are what's the right thing to do here

49:20

for the long term interest of the program , and

49:23

I think that it's amazing how fast you

49:25

can go together when , when you don't necessarily

49:27

let other things get in the way .

49:30

Yeah , it reinforces

49:34

that kind of culture that we talked about

49:36

, in that trust that , like you

49:38

know , if

49:41

it's just human nature , if

49:43

you're incentivized to do more

49:45

services and you say , hey , I really

49:47

think we should do more services , when

49:49

we have this problem , it's only natural

49:52

for the partner to say , do

49:55

they really think that or do they just want

49:57

to charge us more fees ? But

50:08

here we align things so that you know , if we didn't , if we didn't

50:10

bring the first product to IND , we would have , you know , honestly

50:13

, lost money on the collaboration . So

50:16

we would have been , you know , in the hole , um

50:18

, and that's okay , I'm

50:20

fine . Like we looked at everything , that case

50:23

you had , we felt really confident that we could

50:25

help accelerate , then get into the clinic

50:27

, um , and so we I don't

50:29

know , we put our money where our mouth is .

50:32

Yeah , yeah . And again , not

50:34

not having like intimate knowledge

50:36

of all sorts of outsourced manufacturing

50:38

partner relationships . That sounds pretty unique

50:41

to me , Tom . Is that pretty unique ?

50:44

I think you

50:47

can craft there . There are an infinite number of ways to craft

50:49

an agreement . I think Jason has gone all

50:51

in . Jason and his team have gone really

50:54

all in on that model team have

50:56

gone really all in on that model and

51:00

it's driven the cultural and scientific and collaboration things that

51:03

we've been talking about for

51:05

the last hour .

51:05

Yeah , super cool . All right , like I said , I got to wrap things up . We're going to have

51:07

to do a part two if there's more to talk about and there will

51:09

be more to talk about regardless , because you know this is

51:11

this project has got a long

51:14

way to run , so we will . I'm

51:16

going to put you on the hook to do a part

51:18

two . Just to say , because you gave that

51:20

lead in , I know we're super out of time .

51:22

But that's the neat thing about

51:24

autologous cell therapy too , or

51:26

at least the difference too . Unlike antibodies

51:29

, like these partnerships

51:31

, you are together every

51:33

step of the way . Every single patient is

51:36

a new . You know , a new

51:38

patient comes in . More manufacturing has to be

51:40

done , so it's like an ongoing relationship

51:42

unlike an antibody , where

51:45

you work with a CMO , they make

51:47

a big batch and then you don't talk

51:49

to them for three years as you run your clinical

51:51

study , and maybe you call them up two years from now like , hey

51:53

, we need another batch , you make one . So

51:55

it's a very different relationship and

51:58

it's just important to recognize those

52:00

differences . Okay , sorry

52:03

, I'll let you . That's good

52:05

, Jason .

52:05

No , no , you're , you're , you're more than welcome . It's

52:08

your time . I mean , you know , yeah , I know you've got things

52:10

to do this afternoon

52:12

.

52:12

I got to do some work for Tom .

52:16

I think . But yeah , that's great segue

52:19

. Work for Tom . What's that ? Work until in

52:21

the immediate future , Like

52:24

what's on your near-term horizon in terms

52:26

of next steps or big projects between the two of you

52:28

?

52:29

Well , I can start . I think that

52:31

we're really excited

52:34

about things , both in the near term and long

52:36

term . For starters , we talked about

52:38

the platform earlier on . There's

52:40

more that our platform can reveal about potential

52:43

targets . We're not done . I

52:45

think also out there on the horizon as we start

52:47

to build a clinical data set for

52:50

our existing candidates 001EX

52:52

and 004EX , there are some really

52:54

powerful correlative analyses that

52:56

we can do to feed back in to

52:58

the process and improve our process

53:01

and potentially even guide future

53:03

clinical development . So that's way out there

53:05

. But if we think even more near term

53:07

, we're excited to be able to move both 001

53:10

EX and eventually

53:12

004 EX into the clinic and for that

53:14

lead candidate , 001 , that first

53:16

engineered tilt therapy that's already

53:19

had its IND cleared up

53:21

. Next for us is clinical enrollment and data

53:23

readouts and we feel

53:25

like with Jason's team , we've de-risked

53:27

it as much as we can . We've

53:30

controlled what we can control . The team at KSQ

53:32

has been fantastic , the team at CTMC

53:34

has been fantastic , been fantastic . The team at cmc , ctmc has been fantastic

53:36

and we're now ready to execute

53:38

. And as patients

53:46

enroll and clinical outcomes start to become available , I think you , me , clinicians

53:48

at nd anderson and patients from all around the country and and research researchers around

53:50

the globe , for that matter are going to see what

53:53

we see , so stay , and I

53:55

think the next chapter might be a pretty exciting part of

53:57

the story .

53:58

Yeah

54:00

, I mean , tom said that so well . And if we even

54:02

zoom out further , you

54:05

know KSQ has developed

54:07

. You know some of the leading

54:09

, you know what I would

54:11

call like second generation optimized

54:13

tills . Tills as

54:15

a field is at a super exciting stage

54:18

. I won't unpack that whole thing , but we

54:20

know that Iovance had

54:22

the first commercial TIL approved a

54:24

couple months ago . These are

54:26

the first cell therapies approved

54:29

for solid tumors . Tils

54:32

have the ability to work in

54:34

multiple tumor types and

54:36

indications . Solid

54:40

tumors represent 90%

54:42

of all cancers . So CaseQ is in an amazing catbird

54:45

seat . I think of having

54:47

really

54:49

fantastic technology

54:51

, having a

54:54

solid manufacturing and clinical

54:56

setup to , you

54:59

know , evaluate

55:02

the real power of these next

55:04

generation tills .

55:06

Yeah , you mentioned IO Vance

55:08

, episode 78 of the Business Biotech Podcast

55:10

. There's a shameless plug here featured

55:13

Sumit Verma and Audrey

55:15

Greenberg . This was back in 2021

55:18

. You might say that we gave them a platform

55:20

, you know , for their approval

55:22

. I have to pat myself

55:24

on the back .

55:25

Okay , so 2021 , so three years

55:27

. So we'll start the clock for KSQ .

55:30

Jason , I was thinking exactly the same thing .

55:35

Yeah , this is a good place to be . We

55:37

have not yet determined we're two , two , we're

55:39

200 plus episodes into this podcast . We have not

55:42

yet determined a sports

55:44

illustrated cover curse yet . I

55:46

don't , I don't . I think we're doing more , more

55:48

good than harm .

55:49

So yeah , let's . Let's flip that around , Like

55:51

all the good things that come from the companies you've

55:53

talked to .

55:55

Tom , the next chapter that you reference

55:58

. I'm

56:02

looking forward to covering it . I do mean it . I'd love to have you guys back a little bit down

56:04

the road to talk about further progress and more benefits of the collaboration

56:06

and partnership down there , but for

56:08

now , I want to thank you for

56:10

coming on the show . You're both fantastic . I

56:13

appreciate the time that you spent with us , the great

56:15

insight , the transparent insight into the

56:17

relationship , and I

56:19

think we probably made a whole lot of people out there mad

56:21

about their current partnership situation . So

56:24

we'll call that a job well done .

56:26

It's been a pleasure .

56:28

If we can help people figure

56:30

out ways of accelerating cell therapies

56:32

, that would be fantastic . So , matt thanks for giving

56:35

us the platform and thanks for the discussion . Really

56:37

enjoyed it . I look forward to doing it again .

56:39

Yeah , we will . Thanks , guys . So

56:41

that's CTMC co-founder and Jason

56:44

Bock , and KSQ chief

56:46

technology Thomas Leitch . I'm

56:49

Matt Pillar and you just listened to the Business of Biotech

56:51

. We're produced by Life Science Connect and it's

56:53

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