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The Cancer Killers (2025) Season 1 Episode 1
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00:00One in five people will suffer from cancer
00:29in their lifetime.
00:34Many will not survive it.
00:41For most cancer patients, the only hope they have is chemotherapy.
00:50Chemotherapy delivers toxic chemicals to the body randomly, affecting not only the cancer
00:54cells but also healthy cells.
00:59The holy grail of cancer research is to find a solution to the dangerous side effects of
01:04chemotherapy.
01:07Scientists Amanchu Brumbat and Jennifer McDiamid are about to realise their dream as they begin
01:13clinical trials on a discovery their peers are claiming will be the magic bullet many
01:19have been searching for.
01:24However, for their small Australian biotech there are many pitfalls.
01:29The cost of taking a biotech discovery to market can be a billion dollars.
01:34The process is complex and only about 8% make it.
01:40Even in the face of desperate need in cancer patients, will this small Australian David
01:46be able to take on the international biotech Goliath?
01:5420 years ago these two molecular biologists met at night for weeks on end to discuss ideas.
02:12A colleague had just died of horrifying cancer and his dying words challenged the pair to find
02:18a solution to the growing problem of cancer.
02:20Jennifer and I were at the hospital and he said, you know, if someone can do it, you can
02:35do it.
02:36He pointed his finger like this to us.
02:41I just can't forget his eyes when he said, just, he's alive, you know, it's just the impact
02:53of that, it's just, it's horrific and I thought, a stupid man, what have I done with my life?
03:02So strongly motivated by the needs of cancer patients and believing they had a revolutionary
03:07idea, they risked everything and set up their own laboratory which they called Ingenic.
03:16This small biotech company with its dedicated staff has produced compelling evidence at lightning
03:22speed to verify its discovery.
03:25Imagine, I have like a hundred mice per experiment and then it went on to a trial for, with the
03:33monkeys and then we went to dog trials and now if we go to a human trial, imagine from
03:39a mouse to a human within the span of seven years.
03:43So to me that is very exciting.
03:47Scottish-born immunologist and former Australian of the Year, Ian Fraser has experienced first-hand
03:57the process of commercialising science.
04:00He created the vaccine Gardasil for cervical cancer.
04:03There's always a risk that a good invention will not make it to market.
04:08Good science may not easily lend itself to getting out into the market place.
04:14People may not understand the need for it yet or the potential may not be there.
04:18In the next month, the Ingenic Dream Vector, or EDV, will be injected into a human for the
04:24first time as the trial process begins.
04:27Never before has a bacterial nanocell been used to carry chemotherapy into the human body.
04:33The pressure is really mounting.
04:35Obviously we've got to get it into people, but it's very scary.
04:40Nothing like this has been given to people, it's not a me-too drug.
04:43That's what's keeping me up at night.
04:45Cancer drugs cause horrendous toxicity.
04:49So somehow, if you're going to put a drug inside the body, if you could encapsulate it
04:56and make sure that it doesn't go into normal cells, then you need something to pack it.
05:05Then you also needed something that's going to prevent that ball from going into normal cells.
05:13So therefore, you needed something on its surface that's going to lock in a cancer cell and not lock into a normal cell.
05:24But the more I looked at it under the microscope, the more you felt that this was not just any ordinary particle.
05:35This was something quite remarkable.
05:39It had a complete membrane structure, it was non-living, it had a capacity inside, it was empty.
05:52It's like a house, you could live in there, something could go in there.
05:57It had structures on its surface, hair-like structures.
06:03These are very important structures because to that you could attach other molecules.
06:09And those molecules can then target something else.
06:13And suddenly, you could see that whole picture unfold.
06:17And Jenic have published their work recently in Nature Biotechnology, which is the prestigious journal in the field.
06:24What that really means is that it has been rigorously peer-reviewed by a group of other scientists who work in that space.
06:31And they've said, A, this is novel, B, it looks like it works, C, it's really of interest.
06:37Because to get into one of the Nature Group journals, it's got to be top stuff.
06:41And what that really says is, they've got a winner.
06:44A team of Sydney scientists has worked out a way to kill cancer tumours.
06:48This Trojan horse might just open the gates on a new cancer treatment.
06:52Drugs were once considered to be the magic bullet.
06:54Now it's the vehicle by which they're given to the patient, taking centre stage.
06:59The international biotech industry is ruthless and cutthroat.
07:03And taking science to market is not for the faint-hearted.
07:07The figure that's widely quoted as the cost for taking a new discovery from the lab right the way through to a product in the marketplace is about one billion US dollars.
07:22A large part of that money is spent in the final studies that will show that the drug works.
07:27But the money is spent over a very long period of time, usually 10 to 15 years.
07:33So quite a substantial part of that money is invested 15 years before there's any prospect of there being a return on it.
07:38Venture capitalist Stuart Wardman Brown is just such a risk-taker.
07:43His company has invested in Ingenic for eight years, and he is currently acting as chairman of the board.
07:50For me, Ingenic is very clearly a business first and crusading against cancer second.
07:56For other people, I can understand that perhaps it's a crusade against cancer,
08:02and that the business aspects are merely one of the things they've had to do in order to raise enough funds
08:09to be able to take that crusade hopefully all the way through and have an impact on cancer.
08:14Clearly positive trial results will increase the value of his shears, and he wants the science to move quickly.
08:23But not as good.
08:25She is tough.
08:28It may have something to do with that Scottish background.
08:33They go out there in that vicious cold, and they will fight to death.
08:39These are valiant fighters.
08:42He has been able to harness a thought process that is almost foreign to me.
08:49You know, he can see the big picture very clearly and develop a thought process which is very exciting to be around.
08:57To prepare for the huge step into human trials, Ingenic has done extensive testing in animals.
09:0427 dogs.
09:07Nobody goes into a human trial having studied so many dogs.
09:11But we have had to go through all of this because we needed to know for ourselves
09:16that was there something that we have missed?
09:23Something that again our conscious mind might have said everything will be fine.
09:27So irrational exuberance is what we have to try to avoid.
09:32However, their successful treatment of dogs is undeniable.
09:36We have got a brain cancer dog that jumps up, grabs the biscuit and, you know, runs around, etc.
09:45And when I look at the dog and I feel that this little nano cell went in there and did all those things,
09:56I still look at it in absolute amazement.
09:59And the dog just stares back at me and says, have you got a biscuit?
10:03Dogs get cancer just like humans do.
10:05And these cancers need to be treated just like they would be in a human.
10:09And they behave very much like they do in a human.
10:11So trials that show that a drug works in an animal model where the cancer is a real and spontaneous one
10:18are much more likely to be representative of what would happen in a human.
10:22Matilda, come and have a look at your brain scan.
10:27And this is the brain tumour she had.
10:30Clearly inoperable because it's right in the middle of the brain.
10:34So here we have where the brain tumour used to be.
10:38This is following five doses of EDVs loaded with doxorubicin and targeted with EGFR.
10:44The bottom panel shows that the tumour is basically totally resolved in Matilda.
10:50After only five weeks of EDV treatment.
10:56To have Matilda come in and it's quite a surprise really.
10:59You sort of all of a sudden go, wow.
11:01This is actually making a difference.
11:04You know, we've cured a dog.
11:06And surely the next step is to cure people.
11:10We've got pressure from the investors.
11:13When's it starting?
11:14When's it starting?
11:15When's it starting?
11:16When's it starting?
11:17And we're saying, well, you know, a week either way to make sure it's right is not going to make a difference.
11:22The clinical trials are being conducted in Melbourne across three hospitals.
11:31Before this can happen, a totally new piece of science like the EDV is extensively scrutinised by clinical and ethical committees.
11:40Finally, the EDV is cleared for first in world human trials.
11:46This is it.
11:47This is the final loophilised EDV preparation that we'll be sending down to Melbourne for the human trial.
11:52Most clinician scientists feel very nervous when they go first into a clinical trial.
11:58It's called first into humans because you just don't know what's going to happen.
12:02You've done all the right homework.
12:03You've done everything you possibly can to make sure the product's safe.
12:06You're usually convinced because of the nature of the product that there shouldn't be any problems.
12:11But having actually put a drug into humans for the first time myself on more than one occasion now,
12:16yes, you get very nervous about that and you take every precaution.
12:20And certainly Jennifer and myself are full of fear at the moment.
12:24We feel, is everything going to be all right?
12:29What happens if something goes wrong, somebody gets a reaction?
12:36Such a system has never been trialled before on this planet.
12:42There's plenty to be anxious about as the science moves from the laboratory to the hospital in preparation for the trial.
12:49Not only do the medical costs soar, but the scientists now have to hand over their precious discovery to the clinicians who carry out the trial.
12:58Professor Mark Rosenthal is on the trial's team.
13:02We were excited three years ago, I think when I first met with Jennifer and Hermanshu.
13:07I suppose we're relatively sanguine about the chances that this really will be a success.
13:13It is quite difficult in a way to be an onlooker in your own trial.
13:20But we're not down there holding hands with the patient, which frankly is what I'd like to be doing.
13:25You know, saying, are you all right? You know, feeling the pulse.
13:29I believe the scientists have to stay well away from the entire program.
13:33They've done their bit. They've made the discovery. They've done the development.
13:38It's now up to the clinicians. And I think it's utterly inappropriate for there to be any link between the scientists and the clinicians in terms of interpretation of data.
13:47What our public, what our patients want is clear-sighted analysis of what this all means.
13:54But the whole focus of the scientists' research is to help patients.
13:59And after nearly ten years of painstaking research, our team finds it impossible to be too far away from their first patient.
14:07I've been thinking about that woman all the way down, really, and how brave she is.
14:13I reckon you'd see, if there was any problems, you'd see it by four o'clock.
14:17By four o'clock, I would have thought, yes.
14:20You're always battling dogma and preconceived ideas about how cancer therapy should be controlled.
14:27It's a battle all the way to get them to change something, even though it's a clinical trial.
14:33It has taken ten years to begin first in human trials.
14:37And today is the culmination of many years' work, and everybody is tense.
14:42The NGNIC team is delivering the first dose, and Jennifer and Amanchu want to be very close in case anything goes wrong.
14:51They've taken a hotel room right next door to the hospital.
14:57They're hopeful the clinicians might relent and give them access to, or at least information about, the patient.
15:05For now, there is nothing left to do but wait.
15:10It's been the longest five hours of my life.
15:20A chance call from the trial pharmacist John Barlow finally brings the news everyone's been waiting for.
15:26He was just over there, just happened to be moseying past there, picking up something for another trial, he said.
15:36Yes, right. But he had a long chat with her.
15:38Oh, yeah, nice.
15:39She's a very charming woman who's very chuffed at being the first person on the trial.
15:46And she said she didn't feel a thing, still doesn't feel a thing, nothing's happening.
15:52She's just laying around reading, waiting to go home.
15:57By the end of the day, it's time to get back to Sydney.
16:00The team knows the beginning of the trial has been a success,
16:03and the first patient has received EDVs without any side effects.
16:08Something really big has begun in Melbourne.
16:13Ingenic now needs a big pharma to invest.
16:16Human testing usually runs over three trials,
16:19each bigger and much more expensive than the last.
16:24But even though they are now testing successfully in animals and humans,
16:28in order to attract a big pharma, they will have to take a backward step,
16:32and produce a test tube result.
16:35What sort of cells?
16:38In the pharmaceutical industry, this is the conventional way
16:41to prove that the science is robust.
16:44Can I have a look at cells only?
16:46Yeah, that's cells only in there.
16:48And these are lung cancer nasty cells.
16:51Have a look.
16:53I'd wake up sometimes early in the morning,
16:55and I could imagine what I would like to see under that microscope.
16:58No.
16:59These are the HCP cells.
17:00Yeah.
17:01OK.
17:02Every cell specifically being hit,
17:04and I could always imagine there's going to be all these dots,
17:08but failure after failure after failure in experimentation.
17:12For five months we failed.
17:14It was absolutely fantastic.
17:26This is so good.
17:27Yeah, let me have a look.
17:28This is fantastic.
17:29Every cell.
17:30Oh, yeah.
17:31This is really good.
17:32This is really exciting because today we've been able to show the EDV locking on to the cells,
17:37the cancer cells specifically, in great numbers, and ready to be engulfed and cause death to the cells.
17:47Even though the first experiment is successful, there's now urgency to repeat it so that pharmaceutical companies are convinced it can be done in any lab.
17:57It's a stressful time for everyone in the company.
18:02The amount of funds required to run this kind of operation is absolutely massive, and investor funds cannot keep on supporting this kind of effort.
18:12So we need to partner with a major pharmaceutical company, one or more, such that in that partnership the big pharmaceutical company has sufficient financial muscle to be able to support,
18:26not only support this research, but develop it quickly to get it into the clinical trials and onto the market if they are successful.
18:33But without that partnership, this company could be in extreme danger because we already are aware that there are certain hawks out there whose intent it is that if we run out of money they will swallow us whole.
18:52Jennifer and Namanchu have become aware that some of these hawks are within the ranks of their own investors.
19:00At this point, some investors believe that the scientists should be replaced as managers of the company.
19:07The science is first-rate, but you've got really almost a fundamental divergence of the commercial imperatives of the investors who want to see this commercialised,
19:22and the scientists who want to see the science progressed in accordance with their own view.
19:30The model with the scientists who've got no commercial experience running the commercial development is not often a model for success.
19:40The difficulty is the scientists have to understand the businessman's point of view, and the business person's got to understand the scientist's point of view, otherwise it doesn't work.
19:48Most small biotech companies that get into trouble early on get into trouble either because they don't recognise they need both bits of the equation to make it work,
19:57and try and do it on their own, either a businessman trying to run the science or a scientist trying to run the business.
20:02Despite opposition in some quarters to their management, Namanchu and Jennifer survived the challenge to their leadership.
20:09They put their case for further funding to their principal investor.
20:14Meanwhile, the human trial in Melbourne is progressing very positively.
20:19While the scientists remain at arm's length, because the science is so new, the clinicians need the scientists to understand the novel technology.
20:28Right from the beginning, our patent attorney said to us, if this turns out to be as good as what it sounds on paper, you are going to end up in court somewhere in the future.
20:49As a consequence of the Nature Biotech article, it becomes obvious that an American copycatter is trying to register an aggressive patent.
20:59Hemanchu has to counter its claims.
21:03The whole business of patenting itself is a very complex one, and getting it right and protecting things will take away a lot of energy from getting on with new science.
21:11Because you've got to get the wording right, that's what patent attorneys are there to do, but you've also got to make sure that you've thought through all the possibilities.
21:19Supposing somebody did it slightly differently, would they be able to get round your patent and leave you in a situation where you had a patent, but it wasn't actually protecting the thing that you needed to protect.
21:29So I think there's a whole industry growing up around the idea of how can we make money out of patents rather than how can we make money out of products.
21:35When you're dealing with situations where people are dying, and there are these sorts of scavengers of society sitting out there smelling money, and they go after you on fraudulent grounds, it makes your blood curdle.
21:54After a long night of answering challenges from patent office examiners, Hemanchu still can't get back into the lab.
22:01God knows who makes these people as examiners in these patent offices, and they can virtually destroy your entire company because, on false grounds, they keep on arguing with you.
22:14They keep on arguing and say that, no, this is all obvious. You don't have an invention.
22:19And they always think everything is invented in the United States. Nobody else has invented anything.
22:24It is, how can I stop you from getting there?
22:29Strangely, such people never seem to get cancer.
22:33In the heat of this copycatting threat, the need to keep proving the science takes on an urgency, and keeps everybody working around the clock.
22:42What we're seeing here is the EDVs still on the outside, but as they take up the EDVs, the cells aren't able to keep doubling.
22:51So eventually they'll die, which is exactly what we're after.
22:55Let's leave it till morning.
22:57In the worst case, we'll see cell death.
22:59We'll see cell death, yeah.
23:00Yeah, if we see cell death, we'll all be happy. Okay.
23:04There are so many emails that have come in about children dying from brain cancer.
23:16And you think, there is no room for resting until we get this out there for such people.
23:29Chairman Wardman Brown arrives for a board meeting in time to see the overnight results.
23:35Look at this one. Even the uninitiated, no offence Stuart, can see that there's a big difference.
23:46It's fantastic. Well done. Yeah, I sure did. Thank God for that.
23:55It's fantastic, and that's what now we can be absolutely confident that in anyone's hands, if you give these EDVs with the SI, it'll work.
24:06The differences between scientific and financial concerns are set to divide the board.
24:12Tensions are mounting again over who should run the company.
24:16Unless we get proactive.
24:18Jesus Christ.
24:19Get proactive.
24:20Oh, get proactive.
24:21Get, get, get, get.
24:23Yeah, this company shouldn't fail. It's just stupid. So if we can find a way of it not failing.
24:28We obviously need a solution by the end of the month.
24:31A scientist generally is regarded as somebody to be put aside after a certain length of time.
24:40And that the real business is in the business development people and the clinical trials coordinator, etc.
24:52It's a worldwide phenomenon and I don't understand it, frankly.
24:57It's just that money, money speaks and money is important.
25:02If we look back at why Jennifer and Amanchu have been so successful with this science, it is because they have been hands-on in terms of planning and executing experiments and therefore hardly anything ever goes wrong.
25:17When it, when it comes to a business, you can't run a business that way.
25:21You, you cannot have a two-man band achieving a very high valuation from a buyer.
25:26And so therefore they are going to have to learn to delegate and learn to let go a little bit in areas where they would probably feel more comfortable if they were, you know, far more hands-on still.
25:37You can't just say, OK, science is finished, commerce is in now, you guys just go and, and make sure our patents are OK.
25:45It's, it, it's not going to work.
25:48Would we lose freedom to operate?
25:49No.
25:50If we were successful in human trials and then unsuccessful in, from a personal view, from an investment perspective, but also from, from getting a product to market, it would be a tragedy, a tragedy.
26:01And so that is, that is my biggest fear because arguably it is within our control.
26:07We have dosed eight people, I think, with over 70 doses.
26:18And we've shown that a biological like this derived from bacteria is not going to cause any ill effects in people at the levels we're, we're dosing.
26:29And probably at therapeutic levels, it's going to be safer than any chemotherapeutic that people get now.
26:39Whilst the downside of publishing leaves one vulnerable to copycatting, the upside for Jennifer and Hermanchu has been the arrival of a nuclear scientist, Professor Dale Bailey.
26:50He read of their work in nature biotechnology and believed that he had an imaging process that could follow the EDV's passage through the body and into the brain.
27:05Today, the team of nuclear scientists and vets are combining with the ENGENIC team in a world first experiment to prove the EDV can target a tumour in the brain.
27:17Images we're looking at on the screen here are the first dog that we've studied with this technique.
27:23What we're trying to do is to see where the mini-cells are actually going in the body.
27:27And so you can see in this combined image that we've got the tumour seen in the MRI scan, but that's exactly where the mini-cells are targeting.
27:34So when this signal you can see here stands out at you and you suddenly see that you've actually got the mini-cells in the target, it's a very exciting time.
27:45The EDV has done the impossible and clearly entered the brain tumour.
27:51The results are staggering in many ways, but they are also what we expected to see because of the strengths of the ENGENIC delivery vehicle.
28:03Armed with successful trial results and a breakthrough brain experiment, the scientists now change gear to continue the pursuit of a pharmaceutical partner in America.
28:16Downtown Manhattan is a long way from the lab.
28:26The next days are stacked full of meetings with venture capitalists, big pharma, clinicians and finally an important scientific ally.
28:35In another world on Long Island, Bruce Stillman is president of Coalspring Harbour, one of the most prestigious laboratories in the world.
28:51I went over, this was soon after the company started and talked to Jennifer Machu and they explained some of their ideas.
29:00And I was very excited about the whole concept of what they were trying to do and particularly the novelty of it.
29:07As co-author of ENGENIC's publications in biotechnology, Stillman is very aware of scientific competition and its implications.
29:18Science moves very rapidly and a competing technology could come along overnight and there's no guarantee that this will actually end up being an approved clinical product, even at this stage.
29:29You do clinical trials in very advanced cancer patients and to try a new drug technology in patients that have effectively failed all current cancer treatments is not a good way to test whether your drug is going to work.
29:48But then you go and talk to the oncologists and the people treating these patients and they say, well, you know, we ethically can't not treat them with, quote, the standard of care, even though the standard of care may not work and has been clinically shown not to work.
30:04Unfit patients for their clinical trials, threats to their leadership and the ever present battle for funding makes commercialising science an uphill battle all the way.
30:15That guy yesterday said, I'm the emperor and you're the gladiators and I do that or that.
30:20Yeah, that's okay.
30:22Oh, okay. Good way to start a meeting. Thanks a lot.
30:27On Wall Street, Jennifer and Emantiu are joined by Chairman Wardman Brown to pitch to venture capitalists.
30:33You have a process here that I don't know anyone's really thought about, but very clever.
30:38Yeah, yes.
30:39So the expectation is that this could be for the current investors, the final round of investing?
30:50I'm confident that they'd be very interested.
30:52At this point, Ingenic has to find either a pharmaceutical or a financial partner with enough funds to invest in the huge cost of the next trials.
31:02In the biotech industry, even though big advances have been made in China and India, all roads still lead to America.
31:11Tomorrow, Stuart is off to pursue venture capitalists in San Francisco, while Jennifer and Emantiu fly to Indianapolis to meet with a leading pharmaceutical company.
31:21Eli Lilly's chief medical officer, Tim Garnett, plays a critical role in selecting partnerships for the company.
31:30I think one of the challenges that face the industry at the moment is that drug development is taking longer, it's costing more money,
31:37and the threshold for getting drugs approved is getting higher and higher.
31:42I think increasingly big pharma companies are looking to small biotech as partners in the drug development process.
31:49Forming an alliance with a company at an early stage is a much more speculative investment, but obviously a much cheaper investment from the pharmaceutical perspective.
31:59Once a drug is in phase three, there's a pretty high chance that it's going to be successful and that it's going to get approved.
32:05So licensing a drug from a partner at that stage of development can be a tremendously expensive undertaking.
32:12And of course, once a drug has already got approval by a regulatory authority, then we're talking about deals that can be hundreds of millions or even billions of dollars.
32:20With such money at stake for pharmaceutical companies, secrecy is paramount, and the scientists meet behind closed doors.
32:29That was really, really good. I reckon that's one of the best sessions we've had.
32:34Yeah.
32:35Don't you?
32:36I think it was fantastic.
32:37And I think it's because we're into humans, but also talk about unmet needs.
32:43They've got a whole bunch of things happening that they need a resolution to.
32:48The next stop for Jennifer in Himantua is Washington to meet with their patent attorney, Stephen Bent.
32:54They're preparing for a meeting with the FDA.
32:57I mean, to some extent, it's a race to the patent office, I suppose.
33:02Many patent systems in the world are, in fact, first to file systems, meaning that the person who gets the application that's effective, a good application on file, will be the patentee.
33:14The American Federal Drug Authority is one of the most rigorous drug regulators in the world.
33:21Jennifer and Himantua have been answering their examiners for many months.
33:26I came to like them very much because they had a certain integrity, I guess.
33:31They were, by far, more concerned about the humanitarian aspect of it because they wanted to get this technology up and running so they could save lives.
33:41So they were brilliant people with good souls and that's not all that common in my business.
33:48Today is their first opportunity to meet the examiner face to face.
33:52Without FDA approval, the EDV cannot proceed.
33:57When they go to a pharmaceutical presentation and are able to speak about what they know best,
34:04which is the science and the potential of this technology, there's nobody any better than them.
34:09That's why the people who are often the best determinants of what will actually work are the people who came up with the invention.
34:14They know their own science better than anybody else.
34:17They will be the best salesperson for it.
34:20After a positive initial meeting with the FDA, Jennifer and Imerchu now focus on a potential clinical trial in Baltimore.
34:28Johns Hopkins is arguably one of the best trial venues in the world and their association with Ingenic will impress both US farmers and the FDA.
34:39Long distance discussions have already begun about the possibility of a brain trial using the EDVs.
34:46We have a very large neuro-oncology centre here and all we do are brain tumours.
34:50In a year we do between 800 and 900 craniotomies, so brain tumour operations for tumours and that's all comers.
34:57The system is set up so that we treat a very large number of patients with brain tumours and the consequence to that,
35:05it's relatively straightforward for us to test therapeutics in a very systematic and rigorous scientific fashion
35:11to figure out if they're beneficial for patient care.
35:14This is the first time we are actually able to do live imaging in such a large animal to detect many cells in the tumour tissue.
35:22The potential of actually delivering radioactivity to a brain tumour, not to any cells, is there with this.
35:30Now you can see where the blood brain barrier is intact. There's no sign of many cells at all.
35:36The white mass is where the tumour is and right in the middle of it you can see the many cells light up.
35:42Neurosurgeon Gary Gilear is keen to introduce the Hopkins superstars, leading brain authority Henry Brem and the trial supremo Skip Grossman.
35:53In 1984, when I came to Hopkins, there was a 20-year period of no drug being approved by the FDA.
35:59And it's a generation, it's a lifetime, that the FDA had not approved anything.
36:03Now, when you speak to the FDA, it's because nothing was presented to them in fashion that they could prove it,
36:09because there was no data that met the criterion.
36:12We have 15 different brain tumour centers around the country that are all on board for us doing phase one, phase two trials.
36:23We've opened over 60 trials.
36:25The realization that we can actually move forward in a clinical trial arena is very, very exciting for me.
36:31I think their technology is very novel, is scientifically very solid, and I think has a very high chance of working.
36:39Our view was that it would be a focused group here at Hopkins.
36:44When I see a patient in the office and I know that I have to have a discussion with them that,
36:49despite maximal therapy at this point in time with surgery and chemotherapy and radiation therapy,
36:55that the median survival is just over a year for them,
36:58I think the opportunity to actually test something that may change that for future generations is very stimulating for me,
37:06and I look forward to this collaboration.
37:09Every meeting has been successful from our point of view.
37:13There is nothing that beats face to face communication.
37:16And Johns Hopkins meeting was spectacular. I think we learnt a lot as well.
37:21The Johns Hopkins team is clearly interested in trialling the EDV for the brain.
37:26However, Ingenic has to fund the trial at a minimum cost of $5 million,
37:31and it can't proceed without regulatory permission from the FDA.
37:38As soon as they touch down in Sydney, they meet Stuart to present the results of their trip to the board.
37:45Although meetings in America have been positive, no US pharmaceutical company has yet stepped up to the plate.
37:52We quite simply cannot start the brain cancer trial without sufficient funds.
37:58So we can't start that trial without raising $15 million rather than $5 million.
38:04However, with financial stress on all fronts, the board is forced to raise interim funds to keep the company afloat.
38:11We've been directing our efforts more towards Asia, and we are making reasonable progress, but it's slow progress.
38:23And, you know, every month that goes by for Ingenic uses up roughly another half a million dollars.
38:29Yeah, it's pretty tough at the moment, absolutely.
38:35We will run out of cash in probably two months' time.
38:38What we as a board then have to do is really focus the resources on what we must achieve in the next nine months
38:51to give ourselves the best possible chance of getting a partner across the line.
38:57After much debate, the board decides that their best option is to raise five of the $15 million with a new share issue to their original investors.
39:07In blue are people who like us. So far, I've only found two.
39:14I'm finding it very stressful at the moment because we are back in fundraising mode.
39:22The deals that we're working on, as usual, won't overlap when we run out of money.
39:31So we've got to find some funds, at least for the interim period.
39:37Emotionally, it is very draining because we don't have the resources.
39:42We're just about 30 people.
39:44And we're constantly being asked, why haven't you commercialised everything?
39:47Why haven't you made your billion dollars? What billion dollars?
39:51There's nothing really that we ever disagree on as far as strategy or way to proceed or who to talk to.
39:58Right now, we'd talk to Attila the Hun if he came in with some money, so...
40:06In the middle of all this, Stephen Bent, the company's patent attorney, arrives from the US with another set of concerns.
40:13Everything is converging on a point. Nobody's pulling in one direction.
40:17And for a small Australian company to have to pull that weight is asking an awful lot.
40:24That's why I'm trying to tell you that what's happening right now within Genic is absolutely critical,
40:29because it's at this point where IP stuff and regulatory stuff, the wheels come off in many companies and they go belly up.
40:36If we were to lose the umbrella patent argument, would we lose freedom to operate in the US?
40:42No. You're not doing anything that would infringe those claims.
40:45Are there places where you can make errors? Yeah, yeah, just about every place, actually.
40:49And that's part of the problem and part of the challenge, that they have to really make all the decisions correctly,
40:57because, unfortunately, at this point in the game, wrong decisions could be fatal.
41:03You're working with the right group, you're getting federal support so that you're not taking on that risk in toto.
41:09These are the things that can make or break a company.
41:12For Macho and Jennifer, I think one of the things that has come home to them is that their science, which is top notch, will not serve.
41:23It is not enough. It's not even half enough.
41:27The old song, you know, if you build a better moral strap, the world will come to you.
41:31That's all baloney. That's not true.
41:33You don't need great science to succeed. You do need great management to succeed.
41:39You cannot make it without it. One will not carry the other.
41:44Stephen Bent leaves two days later, wondering if his cautions have been heard.
41:51Unfortunately, there are other worries as well.
41:54The fundraising from the original investors has only bought in three of the $5 million they need for the Hopkins trial.
42:01It's only at the last minute their major investor champ Ventures comes to the rescue.
42:06And partly that's what I'm thinking. If we can catch up and say, you know, we're in for two, you know, we now need to wrap up this part of the round because then we're going to go quiet for a while.
42:17It does take a weight off our shoulders.
42:21So it gives us the time to potentially bring in a farmer deal. And then hopefully after that we won't have to do any further fundraising.
42:36With $5 million in the bank, Jennifer and Amancha return to the US to search for the additional funds they will need to start the brain trial.
42:44New York proves to be anything but bright lights.
42:51Biotech investment has completely stalled.
42:54A bleak economic forecast means Nginx potential deal partners have been unable to raise their own funds.
43:01Yes, it does take a long time to get something up and running.
43:06Although Jennifer and Amancha work day and night, it seems night has fallen on US investment, particularly for offshore companies.
43:15In this market, only 0.4% of companies like Nginx are making it to market. And many scientific innovations are being lost.
43:30Meanwhile, the World Health Organization confirms that cancer is the world's leading cause of death and predicts 22 million deaths to cancer between 2012 and 2030.
43:43This silent pandemic is set to overwhelm public health systems.
43:52Back at home base after an unsuccessful fundraising trip, Amancha's health buckles and he's ordered to take two weeks complete rest.
44:06Preparations for the second FDA meeting carry on without him.
44:10How's Amancha doing?
44:12Yeah, he's good, thanks. He's coming good, feeling better.
44:16Do you think it's important to have Johns Hopkins represented there?
44:20Yes.
44:22The FDA are the gods of all things medicinal in the US and you have to run the gauntlet there to put anything into a human.
44:31Days later, Jennifer is back on a plane to the FDA meeting in Washington with board member Bob Graham standing in for Amancha.
44:42By the time they return, Amancha is back on deck and anxiously awaits their report.
44:49You can't have much better endorsement of what we're doing.
44:54Everyone we went to could see that this technology had enormous power and that we've already crossed the hurdles to show that it is a therapeutically feasible technology in humans.
45:05If we can show any hint of efficacy, whether that's target engagement or real efficacy, I think we're really home and hosed.
45:14Everyone hosed to.
45:20I do believe in Ingenics potential, I still wouldn't be on the board.
45:24You can't help but feel disappointed about where we are.
45:33Clearly the expectation was that we would be further ahead in terms of commercial success.
45:44Ingenic at the moment is in what is commonly called the biotech valley of death, which is depressing, and you have to get over the chasm and it's starting to cost a lot.
46:01There is an intensifying funding crisis and critics are gathering.
46:06There are a couple of ways to go.
46:11One is actually to seek to sell the company or to sell the IP to somebody pretty quickly to get it out there.
46:23The other is that the company will, regrettably, there is a prospect of some kind of administration if they can't get the money.
46:34I've had sleepless nights, and I'm sure Hemantiu has too, but we haven't got the luxury to be scared.
46:41And we've got enough people around the place dropping their decks and, you know, and saying,
46:47oh, we'll all be ruined.
46:49We can't afford it because we've got a lot of mouths to feed and we've got a bigger purpose.
46:54Obviously there is the scenario we're trying to avoid, which is for the company to fall over.
47:04But then some snippet of the technology or a piece of data comes through and you think, we've just got to find a way around this because, you know, it's every bit as exciting as it was 11 years ago.
47:16It's arguably more exciting because we've got more tangible data. It's no longer just a dream. We need to make sure it doesn't end up being a nightmare.
47:27Frustrations run high as the scientists leave yet again for America.
47:32It's a whistle-stop tour, that's for sure. We're going to San Francisco where we've got a couple of meetings, Boston, New York.
47:41This US trip finally yields a big fish.
47:47I couldn't help being attracted to NGNIC when I met Jennifer and Hermanshu. Their dedication, their devotion, their commitment, their energy comes burning through.
48:00Merv Turner has been the licensing manager for Merck, one of the world's biggest pharmaceutical companies, for 30 years.
48:07He's come to Sydney because he likes this science.
48:11And I really thought they had a tremendously novel and interesting idea.
48:15It really challenged a lot of the orthodoxies in our business.
48:20And that made it interesting to me.
48:25And generally speaking, the big breakthroughs that you see come from unorthodox approaches.
48:31To us, he is a heavy hitter who totally believes in the technology and he has commercial savvy.
48:39Do you take the scans? Every six weeks.
48:42Good boy!
48:43The NGNIC approach uses so-called bacterial mini-cells, small fragments of bacteria.
48:51It's generally assumed that administering bacterial fragments to patients is a bad idea.
48:59Those bacterial fragments, they're loading with drug.
49:02That is something that no one has attempted before or people thought possible before.
49:10So that flies in the face of conventional wisdom.
49:14They're assuming that those bacterial fragments loaded with drug can now be targeted to tumours.
49:21People have not done that before.
49:22Those particles would be considered by conventional wisdom too large to be transported across blood vessels to the site of the tumour.
49:33He had the first seizures in December.
49:37So when you put all these uncertainties together, you can see the kind of cliff that they have to climb in order to gain the confidence of investors and gain the confidence of clinicians, gain the confidence of regulators in their ideas.
49:53One of the areas in which I operate on is adrenal cancer and it's one of the most lethal cancers known to man.
50:04Unfortunately for people who have this cancer, they're generally young.
50:08Last one, then let Charlie do it.
50:09The more I've worked with them and the more I've looked at what other people around the world have to offer in terms of nanoparticle delivery, we realise that they really are on something special.
50:22Stan Sidhu's belief in the EDV delivers the team their biggest challenge yet, when he clears one of his patients for compassionate use.
50:31A young woman of 27, she has been told that she has three days to live.
50:36We're hand-making every single dose because no one's ever done this sort of thing before.
50:43It's exciting, sobering and it's scary.
50:48You can't help but get emotionally involved with the poor little thing lying there at mid-twenties with a whole life ahead of her and no life ahead of her at the same time.
50:59We're building platforms and then the next stage is to stabiliser, which we believe we've done and then the next stage after that is to cure it.
51:10This patient was 26 years of age, ovaries, uterus, everything resected. It was a pretty horrific situation.
51:19Hamanchu meets with Ian Fraser to discuss these remarkable results.
51:25The patient was already in palliative care, on morphine and the day when we actually came in with the first dose, we even had the priest standing there with the cross.
51:35We started and we cleared 13 weeks with clinically stable disease.
51:42We delivered 25 doses in 13 weeks in this patient.
51:46And most interestingly, the tumours were responding. Most of the metastases, they had stopped growing.
51:53This was the independent oncologist's view. The patient's not being hurt at all. And the disease is in clinically stable conditions.
52:04I'm very impressed, I have to say. It's come a long way since I last spoke with you.
52:08Yeah, it has. The only thing is the patient was very heavy on morphine and the addiction really got bad.
52:14At which stage, the patient decided, I just don't want to do anything.
52:18And enough of it.
52:19Yeah, so therefore, we lost that.
52:21You have a patient who is days away from death.
52:24That's where almost virtually all cancer patients eventually end up.
52:30And that's when we currently say that, no, hope you pass away in peace.
52:38No, we are not saying that anymore.
52:42We strongly now believe that to the last day, if there's a will to fight, there is a way to fight.
52:48And this fight can be successful.
52:51we can be successful.
52:52.
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