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00:00Deeply affected by the death of a young colleague,
00:06I just can't forget his eyes.
00:08Two Sydney scientists took up his challenge to solve the riddle of cancer.
00:13He pointed his finger like this to us. You can do it.
00:17Cancer drugs cause horrendous toxicity.
00:19They have discovered a bacterial nanocell that could revolutionise cancer treatment.
00:24Called the EDV, it has taken these scientists on a rollercoaster ride
00:29through the worlds of science, medicine and finance.
00:32Scientists have to understand the businessman's point of view,
00:35and the business person's got to understand the scientist's point of view,
00:38otherwise it doesn't work.
00:39Money speaks, and money is important.
00:42So we need to partner with a major pharmaceutical company to get it onto the market.
00:47We will run out of cash in probably two months' time.
00:50Ten years later, they are still fighting to bring their discovery to the cancer patient.
00:55Their technology is very novel, is scientifically solid,
00:59which I think has a very high chance of working.
01:02I am killing them in one of 13 years.
01:05You are all too cousin.
01:06I have done everything in my heart to save my death.
01:08So I appeal to you.
01:10I am all afraid that this is truly a breakthrough of all your hard work.
01:14We are from the chamber public world.
01:17We can fly to Australia immediately.
01:19We are not giving up yet.
01:21The news about your cancer drug is like a beacon of hope.
01:24She broke down trying.
01:25She is scared.
01:26She does not want to die.
01:27One in five people will suffer from cancer in their lifetime.
01:39Many will not survive it.
01:45For most cancer patients, the only hope they have is chemotherapy.
01:55Chemotherapy delivers toxic chemicals to the body randomly, affecting not only cancer cells, but also healthy cells.
02:04The holy grail of cancer research is to find a solution to the dangerous side effects of chemotherapy.
02:17Will you come down and get some blood taken?
02:19We have got some funds in the bank, although we are really ripping through them,
02:22because once you get into the clinical side of things and have all these consultants helping you, that costs a lot.
02:29If I am going to bleed, I am better off taking as much as possible in one batch.
02:34Today, the staff are literally giving their blood to help save the company.
02:39And just hold your hand in a fist, don't pump.
02:42So do you want to pirate as well, H?
02:44Yeah, that's fine.
02:45Work never stops for Jennifer and Himanchu, and they are currently trying to negotiate a deal with a pharmaceutical company.
02:56Stuart Boardman-Brown has stepped down, and a new chairman, Will DeLatte, has been appointed by Jennifer and Himanchu.
03:03I think the boardman needs to have a little more confidence given the financial situation.
03:07At something past midnight, I get a telephone call this morning, and, you know, the guy says it's so-and-so, and I'm going so-and-so.
03:16A major American pharmaceutical company is expressing interest.
03:19He said, I wanted to make sure that our preferred option is a complete acquisition.
03:25No pharma has done acquisition deals like this pharma.
03:29And we have a golden opportunity sitting right in front of us.
03:32Yes.
03:33But if we can get these current people over the line, that will give us that runway that we need, you know, to keep going towards the end of the year.
03:39Correct, yep.
03:40And obviously fund the trial that we're now starting.
03:42Yeah.
03:43This could actually mean that the technology will be acquired by a pharma and taken forward for the development of EDV-based therapeutics.
03:54The deal, which they have nicknamed Bradman, looks so promising that American board member Merv Turner flies in from New York.
04:02The unique attribute I bring to Enginic is proximity.
04:06Enginic is a long way away from the big pharma companies that are based in the US, and the Enginic voice gets muffled across 6,000 miles of the Pacific.
04:19The company's been around 10 or 11 years now, and that's a long time for the existing investors.
04:24They've been very patient.
04:26Fortunately, we did find a company who did find the story compelling, and they've asked to take a much deeper look at the company to make what we hope will be a really transformational investment.
04:38Not a moment too soon, a $3 million holding deal arrives from the American Pharmaceutical Company.
04:45There we go.
04:48Phew, a few bucks.
04:50A life-saving document.
04:52I always am cautious about deals. Deals have a habit of going south. It's just the way it is. As I said, a deal is a rare and precious thing.
05:02This deal will bring them the money they desperately need. But venture capitalist and major investor Stuart Wardman Brown has reservations.
05:11The risk of the exclusivity is that we do what we've done in the past, which is put all of our eggs in one basket.
05:18And so far, those baskets have never held out.
05:25And Genick's brain trial is now in progress in Melbourne.
05:30There are real tensions developing between the scientists and the lead clinician.
05:36Clearly they're not clinicians. Clearly they're not even brain tumour doctors.
05:41So understanding what's going on from a clinical perspective is very much my area of expertise and the control and running of a clinical trial. That's what I do.
05:51A board meeting has been called because data from the Melbourne trial has not been produced on time by the clinicians.
05:59And ultimately, I think it might be that the investigators give an opinion and the biotech company can take it or leave it.
06:08So when they complete their phase one trial in Melbourne, they take their next trial to Johns Hopkins in America.
06:15Johns Hopkins is regarded as one of the best trial facilities in the world.
06:20However, the costs of doing a brain trial in America puts pressure on raising the money.
06:29U.S. patent attorney Stephen Bent arrives in Sydney because there are now big problems with the pharmaceutical company's deal.
06:37We were all very excited because a major U.S. pharmaceutical company who we nicknamed Bradman, and that name was coined on our brain cancer dog.
06:48Bradman was promising enough money free of strength.
06:52From my perspective, it was like the devil offering you, you know, here you can have anything you want while you're alive, but once you're dead, your soul is mine.
06:59From their side, oh, delays, delays.
07:03We thought we'd better put them on the phone and talk this thing over.
07:08And he said, oh, you know, I've got bad news for you.
07:11We've had new clinical people join the company, and they have not bought into this technology.
07:23So sorry about that, but, you know, we're not proceeding.
07:27Did they do something that was unethical? Yes, no question about it, actually.
07:31It was, um, we actually contemplated, you know, would it be worthwhile taking legal action?
07:36I mean, they have patients lining up.
07:39That all crashed and burned, so we've got money in the bank, but it's not going to sustain us through our clinical program.
07:49We've got to now go and do the Oliver Twist number again, take our eye off the things that matter, like the clinical development and the scientific backing up of that, and fundraise.
08:03This shock, when all parties had agreed a deal was finally coming, provokes the scientists to try a totally new tactic.
08:17Here we are in New York City to try and find some money in the US.
08:22Through Stephen Bent, Foley and Ladner has arranged a hectic schedule of meetings with a new type of investor.
08:29No longer big pharmaceutical companies, but bankers and financiers, in a bid to list an IPO, an initial public offering, on the US stock exchange later in the year.
08:42These inventors, I think, are unique because they display business sense, as well as a great deal of scientific acumen, and they have a sense of what the commercial opportunity is, but are also, in that same vein, very altruistic, which is something that you don't often find in the biotech industry.
09:04But it's very true that a lot of biotech CEOs, they're scammers and snake oil salesmen, and they take advantage of the fact that a lot of the diseases that biotech companies typically target are significant unmet medical needs, and the patients are desperate.
09:21And I believe that Himanshu and Jennifer have the requisite melding of skill sets in order to be successful.
09:32But it's definitely true that many investors regard with scepticism people with PhDs who've done work in the lab trying to lead companies.
09:42The punishing pace keeps up as Jennifer and Himanshu change heads and make a quick trip to Baltimore to see clinician Gary Gilear.
09:51He is going to be the principal investigator for the Johns Hopkins brain trial.
09:56The novelty of the therapeutics, the findings that they've had in their first in-man study, the findings in the phase one in glioma, as well as the science behind the technology,
10:06all of that together underscores the excitement that we have for moving this into patients with brain tumors.
10:14The investors in the U.S., when you mention Johns Hopkins, that that's where you're going to do trials, they all sit up and take notice.
10:20You could cure everybody in Australia, but it's not the same as 10 Americans at Johns Hopkins.
10:26I think one thing that's important to remember is that most of our trials are not successes.
10:33Is there going to be extensive pharmacology?
10:36Right.
10:37Let me go back to the glioblastoma issue for a minute.
10:41So in three decades worth of extensive clinical research, we have one drug that has been shown to significantly improve survival in this patient population.
10:54There have been hundreds of trials.
11:03A potential big investor requests a day of meetings and conference calls.
11:07This is the next Apple, this is the next Microsoft of medicine.
11:11I've done medical deals my entire career, and I've never encountered the opportunity to exist here.
11:17It's a total platform, and we're just talking about cancer, but this goes well beyond cancer.
11:22The investor is full of promises.
11:25They will go right to the FDA, and we'll get a fast track and get an early approval.
11:30If you get an early approval on a case like that, there's no price you can put on the value of this thing.
11:37As hopeful as this appears, experience has by now taught Jennifer and Hamanju to remain cautious.
11:44I'm just hopeful that, you know, in 13 years we've been exhilarated, despondent, and I just don't want this one to turn out to be a furphy.
11:54No, me either.
12:00Back in New York, there's good news.
12:03The first five million is in.
12:05We're signing the term sheet to provide us with some bridging finance till we make the big bucks.
12:12Buoyed by success, Hamanju and Jennifer return to Sydney with significant news.
12:17The overarching resolution is that by accepting the term sheet, we have agreed to flip up and make an American entity
12:27and re-domicile there or elsewhere as advised by the Americans.
12:32You know, we won't have any American money.
12:35The board eventually agrees to domicile in America.
12:39I think it's important that we share it with shareholders and it's important that they know what it's going to be.
12:44While most investors support the strategy of the US move, some dissenters have concerns over control of the company
12:52and, more importantly, dilution of their shareholdings.
12:56Jennifer and Hamanju come up with a last-minute strategy for the AGM
13:00and fly five of the potential US partners out to convince the shareholders to vote in favour of the US move.
13:07I think it was a great idea that we came out here and met everybody face-to-face.
13:10There was a lot of confusion, I think, concern that people had about what we're planning to do.
13:16What they need to understand is we're here to help.
13:19We're not here as a corporate raider to take over the company and steal it from under the Australians.
13:26Australians will still own 75% of the company after an IPO.
13:31Redomiciling to the United States is now a reality.
13:35And Ingenic opens an office in the centre of New York.
13:39Over the next six months in America, the scientists learn some hard lessons.
13:48Their roadshow does earn $20 million, but not one of the big players delivers on their promises.
14:00The decision to go to the US, I think, was the right decision.
14:03I think, you know, all the evidence at the time suggested that that's what we needed to do
14:08to be able to list the company on Nasdaq.
14:12If the current strategy is successful, then we will sell down 40% of our stake now.
14:18It's actually a relatively easy decision to take,
14:21despite the, you know, the emotional attachment of being involved with Ingenic
14:26through an incredible journey with plenty of ups, but, you know, more than its fair share of downs.
14:32A collaborative trial has started in Sydney tackling mesothelioma, an incurable asbestos-related cancer.
14:42Because it's classified as an unmet need, with positive results,
14:46it has a chance to be fast-tracked through the regulators in Australia and the US.
14:51This technology that we've got is a once-in-a-lifetime technology.
14:56It is amazing what it's able to do.
14:59What we are seeing in the animals and what we think we are seeing in the humans is truly startling.
15:09It has huge potential.
15:11This is just before dosing, and then after only eight weekly doses, look at this.
15:18It's completely disappeared.
15:20It's disappeared.
15:21A tiny little dot.
15:23Never would one have thought that this is even remotely feasible.
15:28From this to that, in less than eight weeks, with no toxic side effects.
15:36I know he's a bit younger, so his immune system...
15:38This has to be the immune system.
15:40His immune system is more active than the older people.
15:43Even though this is a remarkable result, bigger trials are necessary to demonstrate scientific significance.
15:58Just formatting an application to the FDA can cost a million dollars and take several months to prepare.
16:04After months and months of anxious waiting, their Hopkins glioblastoma brain trial is finally approved by the FDA.
16:17With FDA approvals granted, another road show begins in earnest.
16:32The big push now is to list on the US stock exchange.
16:38A trip to Boston includes a licensing conversation to set up experiments with an interested pharmaceutical company.
16:45We're very optimistic about a potential partner, because that project is going well, so we're seeing them.
16:52But that optimism is offset by dissent amongst their investors.
16:57There are some who believe Jennifer and Himanshu should now step down as CEOs.
17:02People who say, you cannot manage a company, you cannot do manufacturing, you cannot travel, you cannot raise money,
17:08they've done it all.
17:09They raised 45 million on their own in Australia.
17:11They built a CGMP manufacturing plant.
17:13They discovered this EDV and turned it into something that actually has cured fully a case of mesothelioma,
17:20one of the most vicious lung cancers in the world, in Australia.
17:24So, every one of their critics has to shut up, because they did it.
17:28When you take the step to go public, there will be much more scrutiny, especially in the US.
17:34I think once they realize that running the business is going to be a full-time job, they will find a way to make it work,
17:43which is step aside and have someone else be the CEO.
17:47Westchester Ground, 525 Whiskey Charlie. Information Victor for Taxi. Please be up on 022.
17:52And at some point they'll have to make a decision as to whether they want to sort of play the business side of it or stay in the research side.
17:59And I strongly believe they're both going to stay in the research side, because that's where their passions are.
18:03The timing from a market standpoint is terrible. I mean, the biotech market just had a correction of over 30%.
18:11You know, people are very skeptical right now, having had some big losses in other companies.
18:17So their work is cut out for them as they come public.
18:21Until that time, the endless pitching is not without frustration.
18:26Some of these doctors are just staggeringly stupid.
18:30How's it targeted? Oh, well, by specific targeting. Oh, yeah, yeah, of course, everyone's got that.
18:35Everyone's got that. I was trying my level best to control myself. I was trying to be nice.
18:40But there was a point where it was better to put him out of his misery and shoot him.
18:49Then he got all defensive. Oh, you will meet people like me in America because we ask questions before you start.
18:56We ask the hard questions. Yeah, it's in the finance thing too.
18:58Everywhere, everywhere.
18:59Normally, if you didn't need money, you wouldn't pee on these people if they're on fire, you know.
19:0410% are fantastic individuals, but 90% are morons.
19:09And then, you know, we walked into the building and I saw Bruce and suddenly I felt happy.
19:16Yeah.
19:17A company like Ingenic at that stage at the moment, they need to have everybody know about their technology.
19:24And I think actually the most critical will be done by constantly trying early stage clinical trials is to find the sweet spot where their technology will work spectacularly well.
19:38And that will garner a lot of attention to the company. And I think it's important now that they keep moving forward by doing clinical studies in the United States.
19:51As winter approaches, the scientists begin forming the US board.
19:57Merv Turner's long history in pharmaceutical development make him an obvious choice to transition from the Australian to the US board.
20:06I'm really looking forward to starting the glioblastoma trial at Johns Hopkins and to getting more patient experience under our belt.
20:16I'm by nature cautious in the drug discovery and development business.
20:21I'm anxious about engaging with US investors. I'm anxious about engaging with US clinicians.
20:29And I'm right to be anxious. You should worry about these things.
20:34Because there's no guarantee of success in this business.
20:40On this trip to America, the big leap forward is the first meeting of the new board.
20:48Against advice, Jennifer and Hamanchu decide to go it alone.
20:52And Jennifer will act as the board's chair.
20:55The company has attracted two big players.
20:59Ed Miller, former CEO of Johns Hopkins.
21:02And Yvonne Pearlberg, retired auditor from Amgen.
21:06Both have significant profiles in the biotech industry.
21:10The clinical highlights, we've shown safety and greatly increased overall survival in phase one recurrent glioma trials.
21:19We have an ongoing phase one trial in mesophilioma patients who have totally run out of treatment options.
21:26And we've had an excellent response rate being a complete response, a partial response in nine patients with stable disease.
21:37The production of trial data is the way forward for the company right now.
21:41We've talked a lot about financial people and the difficulties with raising money and the arrogance and ego driven industry that it is.
21:56And we thought when we started in the clinic that clinicians would be so anxious to try a new modality in end stage patients who had no treatment options that we would be able to just be all friendly and disappointingly.
22:12And almost to the point of being heart sick, one finds that that is not necessarily the truth.
22:19And I think almost to a man, we've had issues with clinicians starting trials.
22:25We wouldn't try and dose it into the patient without the oncologist.
22:29And why would the oncologist think that, you know, they can go ahead independently in a phase one first in man trial setting?
22:36It would be stupid to do that.
22:38Back in Australia, Ingenic is embarking on a novel experiment, aiming to defeat cell resistance by reawakening the body's immune system.
22:48This will add an immunotherapy component to the EDV, increasing its effectiveness in killing cancer cells.
22:56There is not a single cancer treatment that can, in a completely safe way, deliver toxic payload to the cancer, kill some cancer cells.
23:08And at the same time, the residual particles build up this immune system and trigger it off.
23:15That's why we call it a cyto-immunotherapy.
23:19All other technologies are either cytotoxic, which means killing tumor cells, or immunotherapeutic, which means stimulate the immune system.
23:27But nothing can do both.
23:29This science, for us, it is the most enjoyable part.
23:34There is this amazing hope in our hearts.
23:38We are getting closer and closer to doing something amazing for cancer patients.
23:45By the end of the year, however, the trial activities have exhausted their funds once again.
23:56These winter days are full on, as Jennifer and Hemantiu have to jump repeatedly from science to finance and back again.
24:03The business is all about meeting and greeting. This is one of the major events of that time in New York City.
24:11I'm very happy to be able to present the Ingenic story.
24:15The story of our remarkable platform technology that's a first-in-class cyto-immunotherapeutic.
24:22We have called it the EDV platform, and it's globally unique, different from all other immunotherapeutics.
24:29We have given over 650 doses safely to 57 people.
24:35The macrophages are a renewable population, and the new guys coming in are all armed and ready for action.
24:46It's half an hour, and someone knocks on the door, and you rush off to the next room.
24:50I don't find it all that wonderful myself.
24:53And display the tumor-associated antigens.
24:56Everyone else is trying to wake these.
24:58Wake this, exactly.
24:59They all say, oh, wonderful, excellent, this is very outside the box, it's most interesting.
25:05You don't know if that's lip service or real.
25:09One of the delegates from a big bank does come to further investigate their remarkable results in mesothelioma.
25:17It's less of a platform.
25:19In our mesothelioma trial, many people had multiple doses, and the median overall survival was 41 weeks.
25:25Normal life expectancy at that stage is only about four to eight weeks max.
25:31But we did have one case study that was a complete remission.
25:35Oxygen therapy was no longer required, and even in eight weeks of only replacing the microRNA, there was 84% reduction in tumor volume.
25:47It's certainly cool.
25:49So I would say, you know, if you had this in pancreatic cancer, it would be easy.
25:54Yeah.
25:55That's not what you think.
25:56I'm a little unsure of your decision.
25:58I mean, your best data is with a payload that you're not going to continue to use.
26:03Because the thing is that we think we can do a lot better than this, but this is okay.
26:08Tell this guy, you know, you wish you hadn't dosed him because you have a better payload in the closet.
26:16That's right.
26:17But wouldn't it be better to tell 80% of them that we've got a better payload?
26:21No, I think it would be better to sell this.
26:23Yeah, that's right.
26:25Legal preparations for the stock exchange listing, financing several trials, continuing experiments and new patents are all in progress.
26:36Money is burning.
26:39The enormity of the task becomes apparent.
26:44It's 10am and Jennifer and Amanchu are nowhere to be seen.
26:49They have been up all night putting out bushfires on the other side of the world.
26:54A component of the new experiment in the Australian lab has failed and puts pressure on their deal with Takeda Pharmaceuticals.
27:03I can't breathe.
27:09This was bad for us because now we have to, of course, repeat the experiment in Australia and it'll be another six weeks.
27:16These experiments are exceedingly difficult.
27:20We need to make these collaborations work and then we'll be in position to hit them for a deal.
27:27But we can't do that unless we get the scientific results.
27:32These cells in the human body are notorious in constant mutations and changing and becoming resistant to virtually anything you can throw at it.
27:44And now we have got data which is so exciting that we have managed to plummet those colorectal tumours.
27:52And the pharma people are also shocked. Our chances of success in the patient is very, very high.
27:58This is now enough to trigger funding from Takeda.
28:02You do know that this is the first deal we've signed with Big Pharma.
28:07Oh, that's very good.
28:09With actually a signature.
28:14The problem is this has already taken 15 years.
28:19And if you look at all cancer products that are on the market today,
28:23if you trace back the history of all these cancer products,
28:27they've all taken in excess of 20 years before they got to market.
28:32Meanwhile, one in five people will get cancer in their lifetime.
28:38Ingenic's first in human trials began 10 years ago.
28:43Delays with regulatory bodies, hospital ethics committees and clinical schedules
28:48can set progress back not for months but for years.
28:52This groundbreaking platform technology could reduce those statistics.
28:57But will it get the chance?
29:00In a devastating development, even after successful experiments,
29:05a new research team at Takeda took a different direction and dropped the deal.
29:10Our champion who was with them, they actually ended up buying another biotech company
29:17and so they fired the champion.
29:19So the clinical trial guy was also gone.
29:22Our champion was gone.
29:23And there was hardly anybody left.
29:25We couldn't believe it.
29:28Within months of the devastating rejection of their immunotherapy results,
29:33Ingenic scientist Scott Patterson arrives in America to begin the Johns Hopkins trial.
29:39This technology started in Australia with two scientists that had an idea.
29:44And that has, over nearly a decade, been translated into a trial for humans at Johns Hopkins.
29:53I think that is remarkable.
29:55So we're in sunny Baltimore at Johns Hopkins Hospital.
29:59We're here with an FDA registered trial.
30:03It's a phase one safety trial.
30:04But we're in the big time now.
30:06And we've worked so hard to get to this point.
30:08More trials means more data.
30:12And of course the need for more money.
30:15This is a $30 billion company because of the platform nature of what they're doing.
30:20And because they've patented it for so long into the future.
30:24And the breadth of those patents is such that if indeed this takes off, the sky's the limit.
30:31I mean, this company could be involved in every cancer that's in a solid form and could be a partner with every existing chemotherapeutic that's out there.
30:43They've had interest from some very deep pocketed investors that could have effectively provided them with everything they needed until the next end point.
30:52But those came with some conditions that they chose not to accept.
30:57And I respect that.
30:58But it's not in many cases that they can't do it.
31:01It's just that they don't want to play by the rules of the game.
31:08Back in New York, everyone is waiting for news of the first patient.
31:14The Hopkins lead investigator Gary Gilear has seen results and is optimistic.
31:20When we've really seen very minimal side effects and toxicity from the therapy.
31:24So I think in terms of safety profile, this is a very safe agent.
31:28And, you know, we're escalating to the second dose with the next patient.
31:35A thousand doses have already gone into patients.
31:38In several cancers, we have shown that people who were almost on the verge of death have, at the minimum, stabilized.
31:48And some of them, their tumors have almost disappeared.
31:52The second generation EDV stimulates the immune system as well as killing cancer cells.
31:58They get an opportunity to test it in a one-off compassionate use trial.
32:03We've known Jenny and Ian McDiarmid for more than 40 years.
32:09Because Mark was one of the few suits in town that they knew and trusted, they asked him to help them raise their first tranche of money.
32:18So it was just an extraordinary convergence that I was diagnosed with pancreatic cancer.
32:27Compassionate use enables the scientists to create a first-in-world trial quickly to treat Carolyn with the new EDV.
32:36Compassionate access is quite common in oncology because we often explore the conventional treatments fairly early on in people's disease course.
32:44And then we're really looking for something new that might offer hope either for that individual or for cancer patients in general.
32:52But once people have failed a first-line treatment in pancreas cancer, we know that they're usually going to die.
32:58Early trials often have limited success because only end-stage patients are eligible to go on them.
33:05Often their bodies are too damaged by the effects of cancer or chemotherapy to even complete the cycle.
33:12If you're going to use a new treatment, it's better to use it while people are well and able to tolerate the treatment
33:17because we know that if you give my types of treatment in terms of chemotherapy to someone who's sick, all you do is make them sicker.
33:25For some cancers, of course, where there are no good treatments available at the moment and survival without treatment is maybe 5% or 10%,
33:32you tend to choose a disease where you can very rapidly find out if there's a benefit because the disease itself is virtually uncurable without a treatment.
33:40In a rare moment of recognition, Jennifer is nominated in the prestigious 100 Women of Influence Awards in Australia and she wins the award for innovation.
33:58Further recognition comes, this time in the US, when their science is published in the leading peer-reviewed scientific journal for cancer response.
34:08It's like a dream of a scientist to get published even once in cancer cells is like a big thing.
34:17To get the cover art as well as the article published is like a very tall order. This is the second time we've done that.
34:24People watch everybody else. That's why peer review occurs and people who work in the same area as you will have a feeling for whether something sounds right, looks right, feels right.
34:36And believe me, if something comes up which is way off track, people will go to inordinate lengths to prove that it's wrong.
34:43The Johns Hopkins trial is currently ongoing. So it's a very slow trial. Very slow.
34:52Why does it have to be this hard? And you understand the system. They can't have charlatans out there with, you know, mustard gas or something, you know, curing people.
35:02You should be able to do ten people straight away. Somebody gives you a bit of money for that, you get five of them in remission, bang, zero, but you can't.
35:12And if you do do a trial system, you can't change anything.
35:17This has now happened at Johns Hopkins. To include Ingenix Immunotherapy Advance in the EDV technology, the trial stops while Gary Gilear reapplies to the trial board.
35:31Last time this happened, it delayed the trial for a year.
35:35Trials are probably way too complicated and way too expensive, but they've been done a certain way for a very long time.
35:44It's the basis on which the FDA benchmarks all of the other drugs.
35:48And in the end, they're intended to keep everybody safe.
35:51When someone comes to you and she is a close friend, it hits home.
35:56How are you going? I'm doing all right. Thank you.
35:59I really had run out of conventional options, and that's a terrible feeling.
36:06The medical profession can give you more of the same, of more chemotherapy or a different chemotherapy,
36:15but basically your condition is incurable and your lifespan is very limited.
36:22When we prepare human doses, it always feels like you're doing something very worthwhile.
36:31When it's someone like Carolyn who has contributed to Ingenix, you know, everyone takes them very seriously.
36:39Carolyn and her husband had great faith in us.
36:43If it wasn't for them, we probably wouldn't be here today.
36:46This is Carolyn's dose for tomorrow.
36:49Ready to go? Ready to go.
36:51This is to run over 20 minutes, which we've loaded at 4 and expires at 6pm.
36:55Lovely. Thank you.
36:57We're going to be very realistic with you because, you know, it's a tough call.
37:04Well, the next three weeks is going to be harrowing weeks for us because she either stabilises or she goes.
37:13Just seeing her in the hospital lying back as white as the sheets, you thought,
37:19Jesus, we are embarking on something pretty big here.
37:26I am a fortunate woman.
37:29You may not think so, but I'm very fortunate to be here, to be still alive, and to be with you all here tonight on this wonderful evening.
37:40It's less than a month since I began Ingenix treatment.
37:44Not only has my cancer marker dropped dramatically, but it has given me hope of more life.
37:54And not just existence, but actually a real quality of life.
38:05On Friday, you know, she held the hopes of the whole room on her shoulders somewhat.
38:11Everyone was willing her on.
38:17You know, she looked so fabulous having makeup and her wig on and everything.
38:22It was a great gift to Ingenix because she was the first person who we were able to administer the full gamut of the EDV technology,
38:38which is the ability to kill cancer cells and the ability to lift the immune system to augment the anti-tumor efficacy.
38:46Heartbreakingly, seven months into her treatment, Carolyn sustained a fatal injury when she fell in the shower.
39:01That the EDV had been able to extend her life by seven months was scientifically significant.
39:08But her passing was hard on everyone.
39:17Adding pancreatic cancer to their platform is simply astounding.
39:22And to do it with a cancer that has been so impossible, really, to treat.
39:27The people that have invested and continue to invest are very happy with what they've done so far.
39:33And if all they did was what they've done now and got that to the final stages of FDA approval or a deal with a pharmaceutical company,
39:41the return for the investors is more than most would expect.
39:46So the good news from the financial perspective for Jennifer and Imanchu is they won't have to worry again.
39:53Despite the good news and Tim's optimism, a downturn in the market prevents them from listing on the stock exchange.
40:00Jennifer and Imanchu have been let down many times in America with broken promises, so they are now turning their attention to Asia.
40:10Jennifer and Imanchu were promised some substantial funds from the US before Christmas, well before Christmas in fact.
40:19And we would never have to worry about money again, quote, etc.
40:23And once again in January when we had a shareholders meeting in America, the same people promised that money.
40:32But all the excuses in the world about the political situation such, if you had the money, you had the money.
40:39You know, it's not, it doesn't evaporate. You never had the bloody money is the bottom line.
40:44It's now 15 years since Ingenic's first in human trials.
40:48Despite their relentless efforts, progress is slow and frustrating.
40:54What becomes apparent is that without the backing of a large pharmaceutical company, moving on to bigger trials is extremely difficult.
41:03I'm disappointed it has taken as long as it has.
41:07I'm frustrated with the speed of the pharmaceutical companies and the willingness of people to look at something this new.
41:18In these 15 years of trials, in Australia and the US, Ingenic has given 2,000 doses in 164 patients with no adverse effects.
41:30In over 60% of these patients, they have prolonged life for a scientifically significant period.
41:37Jennifer and Himanshu have a vision of oncology and how to treat cancers, which does not align with conventional wisdom in the field.
41:49That doesn't mean they're wrong.
41:51There are an extraordinary number of clinical trials in progress in the United States.
41:56I think it's 1,300 clinical trials going on here around us in New York City, for example.
42:04And that's actually putting pressure on the hospitals to find patients to put into clinical trials.
42:11And one way that people accomplish that for their particular product is they pay.
42:16They pay a lot of money per patient and we haven't been able to afford that.
42:21It's really hard at this stage of a company trying to persuade someone to put down enough money that you can build the clinical trials infrastructure that you really need to build if you're going to compete in this space.
42:35Yeah, we'd love to invest.
42:43I think being here this week has just cemented in my mind that our strategy to seek monies in Asia is a good one.
42:52Sad as it may be, we will have to edge our bets and diversify.
42:57It's a drain on us because, you know, you can't focus on the main game which is in the clinics, the research.
43:05The constant move from laboratory to the marketplace may be unconventional, but Hemantiu and Jennifer remain convinced that they are the best people to get their discovery to market.
43:17It's unique in my experience that the innovators of a technology are still with it 17 years later, still guiding the company.
43:24Bruce Stillman from the Coalspring Harbour Laboratories checks in on NGNIC's progress.
43:33Yeah, when you're in New York, I'd like to have you meet some of the clinical immunologists.
43:39We've just seen one of the bladder cancer patient, his tumour has completely resolved with this one.
43:45So that's a good sign.
43:46And these are all stage four?
43:48Yes, all end stage.
43:49I think their tightrope at the moment is the financial tightrope.
43:52But on the science and clinical side, I think they're in the sweet spot because this is the time when they're just going to take off if the clinical trials are what I expect them to beat.
44:05And NGNIC's 20 years of scientific research has had many unforeseen setbacks.
44:12Key milestones in their work have been confounded by global events.
44:189-11, the global financial crisis, the Fukushima tsunami, the emergence of Trump and MAGA, and then the COVID pandemic.
44:33Not a good time for investment in biotech.
44:38Over the last year, you know, we've been going from a couple of months to the next couple of months.
44:49The money is going out of the door almost at a million dollars a month.
44:53I mean, if we had a lot more money, we could have moved faster. That's the bottom line. We are what we are though. And frankly, everything we predicted is true about this nanocell.
45:06It is very frustrating because, for us, it's a no-brainer.
45:12And to see our technology actually save such people, not only did it give us a fantastic high, but it also told us what the future was going to be.
45:26That one patient surviving like that meant that possibly thousands down the track will survive.
45:34The darkest fears would be that you can't raise money and everything collapses.
45:39That's what I've been thinking for six months.
45:45Just in time, a new investor arrives.
45:50When you're in the pharmaceutical business, you know all the numbers.
45:53You know that projects cost hundreds of millions of dollars.
45:56You know that the timeframes are in decades.
46:00You know that nine out of ten projects fail.
46:04So, you know, we all know that, but we kiss a lot of frogs in our careers and we don't find too many princesses.
46:12And I guess when you've kissed a few frogs, you kind of get the feeling when you've got a princess coming along.
46:18In the next month, five million bucks would be fabulous.
46:23I was able to assemble a few friends together and we did a sort of quick and dirty five or seven million dollars, which got them, kicked them down the road a little bit further.
46:32What we are going to do is, as soon as we get this into the FDA, we're going to put in the breakthrough status.
46:38The FDA says it's a breakthrough. It's a breakthrough and it has potential.
46:44And so that gets the business to the next level of doing a Phase 2B trial in the United States in a high quality institution.
46:52And that leads to big licensing deals with big pharma.
46:55The large pharmaceutical companies, they want to see a blinded clinical trial with positive results before they'll really entertain a type of therapy.
47:07Most people are not cured of cancer. Their life is extended.
47:10And you want to know by how much their life is extended.
47:17And the only way to do that in an objective fashion is to compare two treatments.
47:24The standard of care and a novel treatment.
47:28And if the novel treatment outperforms, then you know you've got something very special.
47:35Another opportunity to test the EDV comes in Los Angeles, when an oncologist requests its use for one of his Stage 4 patients.
47:46The oncologist said to us, can we have some of your EDV therapeutics to see if it might work in this patient.
47:54It's amazing. It's not just a pancreatic patient, it's an end stage pancreatic patient.
48:00It is spectacular and that's what we keep saying. We are making a difference in end stage.
48:06It was a big, big deal day.
48:09And all the staff came.
48:12Look at you.
48:14Then they did what they needed to do and made sure that it was being delivered correctly.
48:18And yeah, I was tired the next day, but I wasn't feeling sick.
48:25I wasn't nauseous. I wasn't anything.
48:29I'm like, gosh, this is great. I can do this.
48:33I think in comparison to regular chemotherapies, it's really convenient for the patient.
48:38It causes less toxicity and then, of course, it's more efficacious because the drug is being delivered right to the site of the tumor cell.
48:47Blood work looks amazing.
48:49All of it. Your hemoglobin is up, albumin is up, sodium is up.
48:54Everything shows that there's basically no disease, which is, again, an advanced stage pancreatic cancer, pretty unheard of.
49:02We didn't just extend her life for her to have a poor quality of life.
49:07We extended her life so she could have a wonderful life.
49:11After two and a half years, Anne is the first person in the world with end stage pancreatic cancer to report a complete recovery.
49:23My blood's also much better. Everything is, like, going the right way.
49:29This is the best treatment. The easiest treatment.
49:35It's amazing. The quality of your life, isn't it?
49:37And the quality of life is, like, I can do everything.
49:42You know, she walks on the beach with her dog. She does Pilates. She's a pretty remarkable woman.
49:49And I was fit and I ran half marathons. I mean, to run for me.
49:54Oh, I want to do that again. I don't want to go far. I don't want to run a marathon. Just let me run a little bit.
50:03But when people ask me, you know, how are you? How are you doing?
50:08I'm like, I'm fine. Can you not see? I'm here having breakfast with you or coffee.
50:13Or, I'm fine. It's fine. I'm going to be a grandma.
50:19Pancreatic adenocarcinoma is the worst killer of its kind.
50:24Normally, a pancreatic cancer patient, at that point in time, when that person's got nothing left, will barely survive a couple of months.
50:34Instead, many of the lesions, cancer lesions, in this patient have disappeared.
50:44The oncologist believes that that patient is in remission.
50:49You can't do those ad infinitum. You can't do hundreds of one-off programs.
50:54In the end, you need to get your drug into a large trial and be able to say to the world, look at this. Look what this has done.
51:02Here is the irrefutable evidence that we've got something that's really going to change the course of this disease.
51:08If you got $60 million on day one, where we got $2 million, I think, when we started, then you could plan better and you could rush forward.
51:22You could have more staff, do trials earlier, but it is what it is. That's what we had to do, and that's why it's taken so long.
51:29You can't imagine how difficult it is for a private company to raise funding, even if you've got the best technology in the world.
51:38At the eleventh hour, when Ingenic is struggling to fund a new laboratory and keep the doors open,
51:44one of the Asian investors who has been watching Ingenic for many years makes a move that will change the future of the company profoundly.
51:51My philosophy is you can't do it alone, because we are never smart enough. And two brains are better than one, and three brains are better than two.
52:03We certainly think that they are very, very close, and what sort of excites me is that there are so many people that can benefit from this.
52:15It is now more than 70 years since the first anti-cancer drugs were discovered.
52:2212 to 15 million people died every year from that dreaded disease, and nothing has changed.
52:28If I can play a little part in helping or pushing and supporting this technology to reach the market,
52:35I think the main beneficiaries are the cancer patients.
52:39These investors have a financial strategy that will support big trials to provide enough data to take the EDV to market.
52:50I am excited about the fact that now they're being able to move forward.
52:56And as I said before, it's still not pro forma. I mean, they have to do the clinical trials properly.
53:02But if it's as effective as I imagine it will be, I'm actually very confident that they're going to move forward with positive results.
53:11And I just can't wait to see the data. That's the reality of it.
53:19I was trying to think how many times we've actually been here. It's a lot.
53:2224 years now of engineering. And I'd say 19 of those 24 years, we would have been here at least once, if not twice a year.
53:32Yeah.
53:35The year has been terrible because we were desperate for money.
53:40We were taking it from wherever we could find it.
53:42And to have Dr. Jeng and his cohorts come in, the timing couldn't have been better.
53:50They saved us from our faces in the mud.
53:54It's a brutal business, yeah.
53:56You know, the extraordinary thing about Jennifer and Himanshu, let's face it, is their astounding persistence.
54:01They are Mr. and Mrs. Wobbly Man.
54:04You know those wobbly toys you knock over and they come bounding back up?
54:07You can't knock Jennifer and Himanshu down.
54:11And without that attitude, Ngenic would have gone under many years ago.
54:17They have gone through a lot of ups and downs, more downs than ups.
54:23So I think with the Asia context and the attention that Asia can give,
54:28we hope that this is where Ngenics will shine in the whole of Asia.
54:37When they finally get that body of whatever it is, I think it will be pancreatic cancer probably,
54:43that will cause everybody to stand up and cheer.
54:46You know, then the fact that you're from Australia or from the moon, they don't care.
54:50Speed to market is the key, you know.
54:51And we think that American clinical trial, if we can get this bloody thing moving here,
55:01FDA has already given us fast track.
55:05Completely unmet medical need, pancreatic cancer.
55:08It's been extremely frustrating and it makes so much sense.
55:13It's a safer, better way to treat people.
55:16We have dancing ladies and we have, you know, brain tumors that have disappeared right down the street from here.
55:23And it's not enough yet.
55:24The moment we do the proper randomised control trial, the FDA should be able to see clearly, this is miles better than what we have.
55:34Therefore, you should be able to get the second tick from the FDA, which will be breakthrough.
55:43We always thought we'd have to come to America to do trials, and we do.
55:46But recent developments are terrific in a way, because the whole rest of the world is open.
55:53And there's a lot of people who get cancer and a lot of people we can help.
55:58Correct.
55:59Not just China, but Asia's been on our minds.
56:02Because the population is so large and it's just, they're begging for novel therapies.
56:08Oh, I think there's fantastic potential for Asia.
56:11China and India and Southeast Asia makes up about half the world's population.
56:18And if we can use Singapore as a hub, we can connect nearly two and a half billion people within a seven hour flying time.
56:30So let's get this going.
56:33Let's get all the trials completed.
56:35And I think this project deserves a lot of attention and deserves a lot of support.
56:44Cheers.
56:46Cheers.
56:48This will make a mark if it is given the opportunity.
56:52We've already made a mark.
56:54I recovered.
56:56And it's like, miraculous.
57:00I'd like to see that smile on the cancer patient's face.
57:09I want to see it with my own eyes.
57:14That's what I feel.
57:16That's what I feel.
57:17That's what I feel.
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