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The Cancer Killers (2025) Season 1 Episode 2
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00:00...of a young colleague, two Sydney scientists took up his challenge to solve the riddle of cancer.
00:08He pointed his finger like this to us. You can do it.
00:12Cancer drugs cause horrendous toxicity.
00:15They have discovered a bacterial nanocell that could revolutionise cancer treatment.
00:20Called the EDV, it has taken these scientists on a rollercoaster ride
00:24through the worlds of science, medicine and finance.
00:27The scientists have to understand the businessman's point of view,
00:29and the business person's got to understand the scientist's point of view, otherwise it doesn't work.
00:34Money speaks, and money is important.
00:36So we need to partner with a major pharmaceutical company to get it onto the market.
00:42We will run out of cash in probably two months' time.
00:45Ten years later, they are still fighting to bring their discovery to the cancer patient.
00:50Their technology is very novel, is scientifically solid, and I think has a very high chance of working.
00:57I am in Chile now, and I have 13 years of my mum, all to Casanova.
01:01I have done everything for my mum to save my dad, and so I appeal to you.
01:05I will not be afraid that this is truly a breakthrough for all your hard work.
01:10We are from the Chamber of Bank.
01:12We can fly to Australia immediately.
01:14We are not giving up yet.
01:16The news about your cancer drug is like a beacon of hope.
01:19She broke all time.
01:20She's scared.
01:21She does not want to die.
01:23One in five people will suffer from cancer in their lifetime.
01:34Many will not survive it.
01:40For most cancer patients, the only hope they have is chemotherapy.
01:46Chemotherapy delivers toxic chemicals to the body randomly, affecting not only cancer cells, but also healthy cells.
01:59The holy grail of cancer research is to find a solution to the dangerous side effects of chemotherapy.
02:06We've got some funds in the bank, although we're really ripping through them, because once you get into the clinical side of things and have all these consultants helping you, that costs a lot.
02:24If I'm going to bleed, I'll be off taking as much as possible in one batch.
02:27Yep.
02:29Today, the staff are literally giving their blood to help save the company.
02:34And just hold your hand in a fist. Don't pump.
02:37So do you want to pirate as well, Hage?
02:39Yeah, that's fine.
02:40Work never stops for Jennifer and Hermanchu, and they are currently trying to negotiate a deal with a pharmaceutical company.
02:47Stuart Boardman-Brown has stepped down, and a new chairman, Will DeLatt, has been appointed by Jennifer and Hermanchu.
02:57I think the board needs to have a little confidence given the financial situation.
03:02At 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...
03:10A major American pharmaceutical company is expressing interest.
03:14He said, I wanted to make sure that our preferred option is a complete acquisition.
03:20No farmer has done acquisition deals like this farmer, and we have a golden opportunity sitting right in front of us.
03:27But 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.
03:34Yep.
03:35And obviously fund the trial that we're now starting.
03:37This could actually mean that the technology will be acquired by a farmer and taken forward for the development of EDV-based therapeutics.
03:48The deal, which they have nicknamed Bradman, looks so promising that American board member Merv Turner flies in from New York.
03:56The unique attribute I bring to Engenic is proximity.
04:02Engenic is a long way away from the big pharma companies that are based in the U.S., and the Engenic voice gets muffled across 6,000 miles of the Pacific.
04:13The company's been around 10 or 11 years now, and that's a long time for the existing investors.
04:19They've been very patient.
04:21Fortunately, 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.
04:33Not a moment too soon, a $3 million holding deal arrives from the American pharmaceutical company.
04:40There we go.
04:41A few, a few bucks.
04:45A life-saving document.
04:47I always am cautious about deals.
04:50Deals have a habit of going south.
04:54It's just the way it is.
04:55As I said, a deal is a rare and precious thing.
04:57This deal will bring them the money they desperately need.
05:01But venture capitalist and major investor Stuart Wardman-Brown has reservations.
05:06The risk of the exclusivity is that we do what we've done in the past,
05:10which has put all of our eggs in one basket, and so far those baskets have never held out.
05:18Ingenic's brain trial is now in progress in Melbourne.
05:23There are real tensions developing between the scientists and the lead clinician.
05:29Clearly they're not clinicians, clearly they're not even brain tumour doctors, so understanding
05:37what's going on from a clinical perspective is very much my area of expertise and the control
05:44and running of a clinical trial, that's what I do.
05:47A board meeting has been called because data from the Melbourne trial has not been produced
05:52on time by the clinicians.
05:55And ultimately, I think it might be that the investigators give an opinion and the biotech
06:01company can take it or leave it.
06:02So, when they complete their phase one trial in Melbourne, they take their next trial to
06:08Johns Hopkins in America.
06:10Johns Hopkins is regarded as one of the best trial facilities in the world.
06:15However, the costs of doing a brain trial in America puts pressure on raising the money.
06:22U.S. patent attorney Stephen Bent arrives in Sydney because there are now big problems with the
06:30pharmaceutical company's deal.
06:31We were all very excited because a major U.S. pharmaceutical company, who we nicknamed
06:38Bradman, and that name was coined on our brain cancer dog.
06:43Bradman was promising enough money, free of strength.
06:47From my perspective, it was like the devil offering you, you know, here you can have anything
06:51you want while you're alive, but once you're dead, your soul is mine, okay?
06:54From their side, oh, delays, delays.
06:57So, I was going to try it.
06:59We thought we'd better put them on the phone and talk this thing over.
07:03And he said, oh, you know, I've got bad news for you.
07:05We've had new clinical people join the company, and they have not bought into this technology.
07:17So, sorry about that, but, you know, we're not proceeding.
07:21Did they do something that was unethical?
07:24Yes, no question about it, actually.
07:26It was, um, we actually contemplated, you know, would it be worthwhile taking legal action?
07:31I mean, they have patients lining up.
07:33That all crashed and burned, so we've got money in the bank, but it's not going to sustain
07:41us through our clinical program.
07:45We've got to now go and do the Oliver Twist number again, take our eye off the things that
07:51matter, like the clinical development and the scientific backing up of that, and fundraise.
07:57This shock, when all parties had agreed a deal was finally coming, provokes the scientists
08:06to try a totally new tactic.
08:08Here we are in New York City to try and find some money in the US.
08:17Through Stephen Bent, Foley and Ladner has arranged a hectic schedule of meetings with
08:23a new type of investor, no longer big pharmaceutical companies, but bankers and financiers, in a bid
08:31to list an IPO, an initial public offering, on the US stock exchange later in the year.
08:40These inventors, I think, are unique because they display business sense, as well as a great
08:45deal of scientific acumen, and they have a sense of what the commercial opportunity is,
08:52that are also, in that same vein, very altruistic, which is something that you don't often find
08:58in the biotech industry.
09:00But it's very true that a lot of biotech CEOs, they're scammers and snake oil salesmen, and
09:07they take advantage of the fact that a lot of the diseases that biotech companies typically
09:12target are significant unmet medical needs, and the patients are desperate.
09:16And I believe that Himanshu and Jennifer have the requisite melding of skill sets in order
09:24to be successful.
09:28But it's definitely true that many investors regard with skepticism people with PhDs who've
09:34done work in the lab trying to lead companies.
09:38The punishing pace keeps up as Jennifer and Himanshu change heads, and make a quick trip
09:43to Baltimore to see clinician Gary Gilear.
09:47He is going to be the principal investigator for the Johns Hopkins brain trial.
09:51The novelty of the therapeutics, the findings that they've had in their first in-man study,
09:56the findings in the phase one in glioma, as well as the science behind the technology,
10:02all of that together underscores the excitement that we have for moving this into patients
10:07with brain tumors.
10:09The investors in the U.S., when you mention Johns Hopkins, that that's where you're going
10:13to do trials, they all sit up and take notice.
10:15You could cure everybody in Australia, but it's not the same as 10 Americans at Johns Hopkins.
10:21I think one thing that's important to remember is that most of our trials are not successes.
10:27Is there going to be extensive pharmacology?
10:31Let me go back to the glioblastoma issue for a minute.
10:36So in three decades worth of extensive clinical research, we have one drug that has been shown
10:45to significantly improve survival in this patient population.
10:49There have been hundreds of trials.
10:57A potential big investor requests a day of meetings and conference calls.
11:01This is the next Apple, this is the next Microsoft of medicine.
11:05I've done medical deals my entire career, and I've never encountered the opportunity
11:11that exists here.
11:12It's a total platform, and we're just talking about cancer, but this goes well beyond cancer.
11:17The investor is full of promises.
11:19They will go right to the FDA, and we'll get a fast track and get an early approval.
11:24If you get an early approval in a case like that, there's no price you can put on the
11:30value of this thing.
11:32As hopeful as this appears, experience has by now taught Jennifer and Himanshu to remain
11:38cautious.
11:39I'm just hopeful that, you know, in 13 years we've been exhilarated, despondent, and I just
11:46don't want this one to turn out to be a furphy.
11:48No, me either.
11:55Back in New York, there's good news.
11:57The first five million is in.
11:59We're signing the term sheet to provide us with some bridging finance till we make the
12:06big bucks.
12:07Buoyed by success, Himanshu and Jennifer return to Sydney with significant news.
12:11The overarching resolution is that by accepting the term sheet, we have agreed to flip up and
12:20make an American entity and re-domicile there or elsewhere as advised by the Americans.
12:27You know, we won't have any American money.
12:30The board eventually agrees to domicile in America.
12:33While most investors support the strategy of the U.S. move, some dissenters have concerns
12:45over control of the company and, more importantly, dilution of their shareholdings.
12:51Jennifer and Himanshu come up with a last-minute strategy for the AGM and fly five of the potential
12:57U.S. partners out to convince the shareholders to vote in favour of the U.S. move.
13:01I think it was a great idea that we came out here and met everybody face-to-face.
13:06There was a lot of confusion, I think, concern that people had about what we're planning
13:10to do.
13:12What they need to understand is we're here to help.
13:15We're not here as a corporate raider to take over the company and steal it from under
13:20the Australians.
13:21Australians will still own 75% of the company after an IPO.
13:26Redomiciling to the United States is now a reality, and Ingenic opens an office in the
13:32centre of New York.
13:34Well, it could be a decoration.
13:36I'm kidding.
13:37Over the next six months in America, the scientists learn some hard lessons.
13:43Their roadshow does earn $20 million, but not one of the big players delivers on their promises.
13:55The decision to go to the U.S. I think was the right decision.
13:59I think all the evidence at the time suggested that that's what we needed to do to be able
14:04to list the company on NASDAQ.
14:07If the current strategy is successful, then we will sell down 40% of our stake now.
14:13It's actually a relatively easy decision to take, despite the emotional attachment of being
14:20involved in Ingenics through an incredible journey with plenty of ups, but more than its
14:25fair share of downs.
14:28A collaborative trial has started in Sydney tackling mesothelioma, an incurable asbestos-related
14:36cancer.
14:37Because it's classified as an unmet need, with positive results, it has a chance to be fast-tracked
14:43through the regulators in Australia and the U.S.
14:46This technology that we've got is a once-in-a-lifetime technology.
14:51It is amazing what it's able to do.
14:54What we are seeing in the animals and what we think we are seeing in the humans is truly
15:03startling.
15:04It has huge potential.
15:06This is just before dosing.
15:09And then after only eight weekly doses, look at this.
15:13It's completely disappeared.
15:15It's disappeared.
15:16A tiny little dot.
15:19Never would one have thought that this is even remotely feasible.
15:24From this to that, in less than eight weeks, with no toxic side effects.
15:30I know he's a bit younger, so this has to be the immune system.
15:35His immune system is more active than the older people.
15:45Even though this is a remarkable result, bigger trials are necessary to demonstrate scientific
15:51significance.
15:53Just formatting an application to the FDA can cost a million dollars and take several
15:58months to prepare.
16:02After months and months of anxious waiting, their Hopkins glioblastoma brain trial is finally
16:08approved by the FDA.
16:21With FDA approvals granted, another road show begins in earnest.
16:26The big push now is to list on the US stock exchange.
16:32A trip to Boston includes a licensing conversation to set up experiments with an interested pharmaceutical
16:39company.
16:40We're very optimistic about a potential partner, because that project is going well, so we're
16:45seeing them.
16:46But that optimism is offset by dissent amongst their investors.
16:52There are some who believe Jennifer and Himanchu should now step down as CEOs.
16:57People who say, you cannot manage a company, you cannot do manufacturing, you cannot travel,
17:02you cannot raise money.
17:03They've done it all.
17:04They raised 45 million on their own in Australia.
17:06They built a CGMP manufacturing plant.
17:09They discovered this EDV and turned it into something that actually has cured fully a case
17:14of mesothelioma, one of the most vicious lung cancers in the world, in Australia.
17:19So every one of their critics has to shut up, because they did it.
17:25When you take the step to go public, there will be much more scrutiny, especially in the
17:29US.
17:30I think once they realize that running the business is going to be a full-time job, they
17:36will find a way to make it work, which is step aside and have someone else be the CEO.
17:42And at some point, they'll have to make a decision as to whether they want to sort of play the
17:51business side of it or stay in the research side.
17:54And I strongly believe they're both going to stay in the research side, because that's
17:57where their passions are.
17:58The timing from a market standpoint is terrible.
18:01I mean, the biotech market just had a correction of over 30%.
18:06You know, people are very skeptical right now, having had some big losses in other companies.
18:12So their work is cut out for them as they come public.
18:15Until that time, the endless pitching is not without frustration.
18:21Some of these doctors are just staggeringly stupid.
18:25How's it targeted?
18:26Oh, well, by specific targeting.
18:28Oh, yeah, yeah, of course, everyone's got that.
18:30Everyone's got that.
18:31I was trying my level best to control myself.
18:33I was trying to be nice.
18:37But there was a point where it was better to put him out of his misery and shoot him.
18:43Then he got all defensive, oh, it's, you will meet people like me in America because we
18:49ask questions before you start.
18:50We ask the hard questions.
18:51Yeah, it's in the finance thing too.
18:53Everywhere, everywhere.
18:54Normally, if you didn't need money, you wouldn't pee on these people if they're on fire.
18:58You know, I mean, it's just...
18:59You, 10% are fantastic individuals, but 90% are morons.
19:04And then, you know, we walked into the building and I saw Bruce and suddenly I felt happy.
19:10Yeah.
19:11A company like Ingenic at that stage at the moment, they need to have everybody know about
19:17their technology.
19:18And I think actually the most critical will be done by constantly trying early stage clinical
19:25trials is to find the sweet spot where their technology will work spectacularly well.
19:32And that'll garner a lot of attention to the company.
19:36And I think it's important now that they keep moving forward by doing clinical studies
19:41in the United States.
19:43As winter approaches, the scientists begin forming the U.S. Board.
19:50Merv Turner's long history in pharmaceutical development make him an obvious choice to transition
19:57from the Australian to the U.S. Board.
19:59I'm really looking forward to starting the glioblastoma trial at Johns Hopkins and to getting
20:07more patient experience under our belt.
20:10I'm by nature cautious in the drug discovery and development business.
20:14I'm anxious about engaging with U.S. investors.
20:19I'm anxious about engaging with U.S. clinicians.
20:23And I'm right to be anxious.
20:25You should worry about these things because there's no guarantee of success in this business.
20:31On this trip to America, the big leap forward is the first meeting of the new board.
20:43Against advice, Jennifer and Hamanchu decide to go it alone, and Jennifer will act as the
20:48board's chair.
20:50The company has attracted two big players.
20:53Ed Miller, former CEO of Johns Hopkins, and Yvonne Perlberg, retired auditor from Amgen.
21:00Both have significant profiles in the biotech industry.
21:04The clinical highlights, we've shown safety and greatly increased overall survival in phase
21:11one recurrent glioma trials.
21:13We have an ongoing phase one trial in mesophilioma patients who've totally run out of treatment
21:20options, and we've had an excellent response rate being a complete response, a partial response
21:27in nine patients with stable disease.
21:31The production of trial data is the way forward for the company right now.
21:36We've talked a lot about financial people and the difficulties with raising money and the
21:47arrogance and ego-driven industry that it is, and we thought when we started in the clinic
21:53that clinicians would be so anxious to try a new modality in end-stage patients who had
21:59no treatment options, that we would be able to just be all friendly and disappointingly, and almost
22:08to the point of being heart-sick, one finds that that is not necessarily the truth, and I think
22:15almost to a man we've had issues with clinicians starting trials.
22:20We wouldn't try and dose it into the patient without the oncologist, and why would the oncologist
22:25think that they can go ahead independently? In a phase one, first-in-man trial setting?
22:31It would be stupid to do that.
22:33Back in Australia, Ingenic is embarking on a novel experiment, aiming to defeat cell resistance
22:39by reawakening the body's immune system. This will add an immunotherapy component to the EDV,
22:46increasing its effectiveness in killing cancer cells.
22:50There is not a single cancer treatment that can, in a completely safe way, deliver toxic payload
22:59to the cancer, kill some cancer cells, and at the same time, the residual particles build up this
23:07immune system and trigger it off. That's why we call it a cyto-immunotherapy. All other technologies
23:15are either cytotoxic, which means killing tumor cells, or immunotherapeutic, which means
23:20stimulate the immune system. But nothing can do both.
23:24This science, for us, it is the most enjoyable part. There is this amazing hope in our hearts.
23:32We're getting closer and closer to doing something amazing for cancer patients.
23:40By the end of the year, however, the trial activities have exhausted their funds once again.
23:50These winter days are full-on, as Jennifer and Hemanchu have to jump repeatedly from science
23:56to finance and back again.
23:58The business is all about meeting and greeting. This is one of the major events of that time
24:04in New York City.
24:05I'm very happy to be able to present the Ingenic story, the story of our remarkable platform
24:12technology that's a first-in-class cyto-immunotherapeutic. We have called it the EDV platform and it's
24:19globally unique, different from all other immunotherapeutics. We have given over 650 doses
24:26safely to 57 people. The macrophages are a renewable population and the new guys coming in are all
24:34armed and ready for action.
24:3758. It's half an hour and someone knocks on the door and you rush off to the next room.
24:44I don't find it all that wonderful myself.
24:47And display the tumour-associated antigens.
24:50Everyone else is trying to wake these. Wake this, exactly.
24:53They all say, oh wonderful, excellent, this is very outside the box, it's most interesting.
24:59You don't know if that's lip service or real.
25:03One of the delegates from a big bank does come to further investigate their remarkable results
25:09in mesothelioma.
25:11It's less of a platform.
25:13In our mesothelioma trial, many people had multiple doses and the median overall survival
25:18was 41 weeks.
25:20Normal life expectancy at that stage is only about 4 to 8 weeks max.
25:25But we did have one case study that was a complete remission.
25:30Oxygen therapy was no longer required.
25:32And even in 8 weeks of only replacing the microRNA, there was 84% reduction in tumour volume.
25:41It's certainly cool.
25:43So I would say, you know, if you had this in pancreatic cancer, it would be easy.
25:48Yeah.
25:49I'm a little unsure of your decision.
25:52I mean, your best data is with a payload that you're not going to continue to use.
25:57Because the thing is that we think we can do a lot better than this.
26:01But this is okay.
26:02Yeah, this is.
26:03Yeah.
26:04Yeah.
26:05Tell this guy, you know, you wish you hadn't dosed him because you have a better payload in the closet.
26:10That's right.
26:11That's right.
26:12But wouldn't it be better to tell 80% of them that we've got a better payload?
26:15No, I think it would be better to sell this.
26:17Yeah, that's right.
26:20Legal preparations for the stock exchange listing, financing several trials, continuing experiments
26:27and new patents are all in progress.
26:30Money is burning.
26:33The enormity of the task becomes apparent.
26:37It's 10am and Jennifer and Amanchu are nowhere to be seen.
26:43They have been up all night putting out bushfires on the other side of the world.
26:49A component of the new experiment in the Australian lab has failed and puts pressure on their deal with Takeda Pharmaceuticals.
26:56I can't breathe.
27:03This was bad for us because now we have to, of course, repeat the experiment in Australia and it'll be another six weeks.
27:11These experiments are exceedingly difficult.
27:14We need to make these collaborations work and then we'll be in position to hit them for a deal.
27:21But we can't do that unless we get the scientific results.
27:26These cells in the human body are notorious in constant mutations and changing and becoming resistant to virtually anything you can throw at it.
27:38And now we have got data which is so exciting that we have managed to plummet those colorectal tumours.
27:46And the pharma people are also shocked. Our chances of success in the patient is very, very high.
27:52This is now enough to trigger funding from Takeda.
27:56You do know that this is the first deal we've signed with Big Pharma.
28:01Ah, that's very good.
28:03With actually a signature.
28:05The problem is this has already taken 15 years.
28:13And if you look at all cancer products that are on the market today,
28:17if you trace back the history of all these cancer products,
28:21they've all taken in excess of 20 years before they got to market.
28:25Meanwhile, one in five people will get cancer in their lifetime.
28:31Ingenic's first in human trials began 10 years ago.
28:37Delays with regulatory bodies, hospital ethics committees and clinical schedules
28:42can set progress back not for months but for years.
28:46This groundbreaking platform technology could reduce those statistics.
28:51But will it get the chance?
28:54In a devastating development, even after successful experiments,
28:59a new research team at Takeda took a different direction and dropped the deal.
29:05Our champion who was with them, they actually ended up buying another biotech company
29:11and so they fired the champion.
29:13So the clinical trial guy was also gone.
29:16Our champion was gone and there was hardly anybody left.
29:19We couldn't believe it.
29:21Within months of the devastating rejection of their immunotherapy results,
29:27Ingenic scientist Scott Petterson arrives in America to begin the Johns Hopkins trial.
29:33This technology started in Australia with two scientists that had an idea.
29:39And that has, over nearly a decade, been translated into a trial for humans at Johns Hopkins.
29:47I think that is remarkable.
29:49So we're in sunny Baltimore at Johns Hopkins Hospital.
29:53We're here with a FDA registered trial.
29:57It's a phase one safety trial but we're in the big time now.
30:00And we've worked so hard to get to this point.
30:05More trials means more data.
30:07And of course the need for more money.
30:09This is a 30 billion dollar company because of the platform nature of what they're doing
30:14and because they've patented it for so long into the future.
30:17And the breadth of those patents is such that if indeed this takes off, the sky's the limit.
30:25I mean this company could be involved in every cancer that's in a solid form
30:30and could be a partner with every existing chemotherapeutic that's out there.
30:34They've had interest from some very deep pocketed investors that could have effectively provided them
30:43with everything they needed until the next end point.
30:46But those came with some conditions that they chose not to accept and I respect that.
30:52But it's not in many cases that they can't do it.
30:55It's just that they don't want to play by the rules of the game.
30:58Back in New York, everyone is waiting for news of the first patient.
31:08The Hopkins lead investigator Gary Gilear has seen results and is optimistic.
31:14We've really seen very minimal side effects and toxicity from the therapy.
31:18So I think in terms of safety profile, this is a very safe agent
31:22and we're escalating to the second dose with the next patient.
31:28A thousand doses have already gone into patients.
31:32In several cancers, we have shown that people who were almost on the verge of death
31:39have at the minimum stabilized and some of them, their tumors have almost disappeared.
31:46The second generation EDV stimulates the immune system as well as killing cancer cells.
31:52They get an opportunity to test it in a one-off compassionate use trial.
31:58We've known Jenny and Ian McDiarmid for more than 40 years.
32:03Because Mark was one of the few suits in town that they knew and trusted,
32:08they asked him to help them raise their first tranche of money.
32:12So it was just an extraordinary convergence that I was diagnosed with pancreatic cancer.
32:22Compassionate use enables the scientists to create a first-in-world trial quickly
32:27to treat Carolyn with the new EDV.
32:31Compassionate access is quite common in oncology
32:33because we often explore the conventional treatments fairly early on in people's disease course.
32:39And then we're really looking for something new that might offer hope
32:43either for that individual or for cancer patients in general.
32:47But once people have failed a first-line treatment in pancreas cancer,
32:50we know that they're usually going to die.
32:53Early trials often have limited success
32:55because only end-stage patients are eligible to go on them.
32:59Often their bodies are too damaged by the effects of cancer or chemotherapy to even complete the cycle.
33:06If you're going to use a new treatment, it's better to use it while people are well and able to tolerate the treatment
33:11because we know that if you give it my types of treatment in terms of chemotherapy to someone who's sick,
33:17all you do is make them sicker.
33:19For some cancers, of course, where there are no good treatments available at the moment
33:23and survival without treatment is maybe 5% or 10%,
33:26you tend to choose a disease where you can very rapidly find out if there's a benefit
33:30because the disease itself is virtually uncurable without a treatment.
33:42In a rare moment of recognition, Jennifer is nominated in the prestigious
33:46100 Women of Influence Awards in Australia and she wins the award for innovation.
33:52Further recognition comes, this time in the US, when their science is published in the leading peer-reviewed scientific journal for cancer research.
34:05It's like a dream of a scientist to get published even once in cancer cells is like a big thing.
34:11To get the cover art as well as the article published is like a very tall order.
34:17This is the second time we've done that.
34:19People watch everybody else. That's why peer review occurs.
34:24And people who work in the same area as you will have a feeling for whether something sounds right, looks right, feels right.
34:31And believe me, if something comes up which is way off track, people will go to inordinate lengths to prove that it's wrong.
34:38The Johns Hopkins trial is currently ongoing, so it's a very slow trial, very slow.
34:46Why does it have to be this hard?
34:48And you understand the system.
34:50They can't have charlatans out there with, you know, mustard gas or something, you know, curing people.
34:56You should be able to do ten people straight away.
34:59Somebody gives you a bit of money for that, you get five of them in remission, bang, zero.
35:05But you can't.
35:06And if you do do a trial system, you can't change anything.
35:11This has now happened at Johns Hopkins.
35:14To include Ingenix immunotherapy advance in the EDV technology, the trial stops while Gary Gilear reapplies to the trial board.
35:24Last time this happened, it delayed the trial for a year.
35:29Trials are probably way too complicated and way too expensive, but they've been done a certain way for a very long time.
35:39It's the basis on which the FDA benchmarks all of the other drugs.
35:42And in the end, they're intended to keep everybody safe.
35:45When someone comes to you and she is a close friend, it hits home.
35:50How are you going?
35:51I'm doing all right. Thank you.
35:54I really had run out of conventional options.
35:57And that's a terrible feeling, that the medical profession can give you more of the same, of more chemotherapy or a different chemotherapy.
36:09But basically, your condition is incurable and your lifespan is very limited.
36:20When we prepare human doses, it always feels like you're doing something very worthwhile.
36:26When it's someone like Carolyn who has contributed to Ingenix, you know, everyone takes them very seriously.
36:34Carolyn and her husband had great faith in us.
36:37If it wasn't for them, we probably wouldn't be here today.
36:40This is Carolyn's dose for tomorrow.
36:43Ready to go?
36:44Ready to go.
36:45This is to run over 20 minutes, which we've loaded at 4 and expires at 6pm.
36:50Lovely. Thank you.
36:51We're going to be very realistic with you because, you know, it's a tough call.
36:59Well, the next three weeks is going to be harrowing weeks for us because she either stabilizes or she goes.
37:08Just seeing her in the hospital, lying back as white as the sheets, you thought,
37:13Jesus, we are embarking on something pretty big here.
37:21I am a fortunate woman.
37:24You may not think so, but I'm very fortunate to be here, to be still alive,
37:30and to be with you all here tonight on this wonderful evening.
37:35It's less than a month since I began the Ingenix treatment.
37:40Not only has my cancer marker dropped dramatically, but it has given me hope of more life.
37:49And not just existence, but actually a real quality of life.
37:55On Friday, you know, she held the hopes of the whole room on her shoulders somewhat.
38:05Everyone was willing her on.
38:07You know, she looked so fabulous having makeup and her wig on and everything.
38:16It 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,
38:32which is the ability to kill cancer cells and the ability to lift the immune system to augment the anti-tumor efficacy.
38:40Heartbreakingly, seven months into her treatment, Carolyn sustained a fatal injury when she fell in the shower.
38:55That the EDV had been able to extend her life by seven months was scientifically significant.
39:02But her passing was hard on everyone.
39:12Adding pancreatic cancer to their platform is simply astounding.
39:17And to do it with a cancer that has been so impossible, really, to treat.
39:22The people that have invested and continue to invest are very happy with what they've done so far.
39:28And 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,
39:36the return for the investors is more than most would expect.
39:40So the good news from the financial perspective for Jennifer and Amashu is they won't have to worry again.
39:47Despite the good news and Tim's optimism, a downturn in the market prevents them from listing on the stock exchange.
39:56Jennifer and Amashu have been let down many times in America with broken promises.
40:02So they are now turning their attention to Asia.
40:05We were promised some substantial funds from the US before Christmas, well before Christmas in fact.
40:13And we would never have to worry about money again, quote, etc.
40:18And once again in January when we had a shareholders meeting in America, the same people promised that money.
40:26But all the excuses in the world about the political situation such, if you had the money, you had the money.
40:32You know, it's not, it doesn't evaporate. You never had the bloody money is the bottom line.
40:38It's now 15 years since Ingenic's first in human trials.
40:43Despite their relentless efforts, progress is slow and frustrating.
40:48What becomes apparent is that without the backing of a large pharmaceutical company, moving on to bigger trials is extremely difficult.
40:57I'm disappointed it has taken as long as it has.
41:01I'm frustrated with the speed of the pharmaceutical companies and the willingness of people to look at something this new.
41:09In these 15 years of trials, in Australia and the US, Ingenic has given 2,000 doses in 164 patients with no adverse effects.
41:24In over 60% of these patients, they have prolonged life for a scientifically significant period.
41:32Jennifer and him Manchu have a vision of oncology and how to treat cancers, which does not align with conventional wisdom in the field.
41:43That doesn't mean they're wrong.
41:45There are an extraordinary number of clinical trials in progress in the United States.
41:51I think it's 1,300 clinical trials going on here around us in New York City, for example.
41:58And that's actually putting pressure on the hospitals to find patients to put into clinical trials.
42:05And one way that people accomplish that for their particular product is they pay.
42:11They pay a lot of money per patient, and we haven't been able to afford that.
42:16It's really hard at this stage of a company trying to persuade someone to put down enough money
42:23that 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.
42:37I think being here this week has just cemented in my mind that our strategy to seek monies in Asia is a good one.
42:46Sad as it may be, we will have to hedge our bets and diversify.
42:52It's a drain on us because you can't focus on the main game, which is in the clinics, the research.
42:59The constant move from laboratory to the marketplace may be unconventional,
43:05but Hermantiu and Jennifer remain convinced that they are the best people to get their discovery to market.
43:11It's unique in my experience that the innovators of a technology are still with it 17 years later,
43:17still guiding the company.
43:22Bruce Stillman from the Coalspring Harbour Laboratories checks in on NGNIC's progress.
43:27Yeah, when you're in New York, I'd like to have you meet some of the clinical immunologists.
43:33We've just seen one of the bladder cancer patients.
43:36His tumour has completely resolved with this one.
43:39So that's a good sign.
43:40These are all stage four?
43:42Yes, all end stage.
43:44I think their tightrope at the moment is the financial tightrope.
43:47But on the science and clinical side, I think they're in the sweet spot.
43:50Because this is the time when they're just going to take off if the clinical trials are what I expect them to beat.
44:01NGNIC's 20 years of scientific research has had many unforeseen setbacks.
44:07Key milestones in their work have been confounded by global events.
44:149-11.
44:16The global financial crisis.
44:19The Fukushima tsunami.
44:22The emergence of Trump and MAGA.
44:25And then, the COVID pandemic.
44:30Not a good time for investment in biotech.
44:37Over the last year, you know, we've been going from a couple of months to the next couple of months.
44:43The money is going out of the door almost at a million dollars a month.
44:47I mean, if we had a lot more money, we could have moved faster.
44:50That's the bottom line.
44:52We are what we are though.
44:53And frankly, everything we predicted is true about this nanocell.
45:00It is very frustrating because, for us, it's a no-brainer.
45:06And to see our technology actually save such people,
45:09not only did it give us a fantastic high,
45:12but it also told us what the future was going to be.
45:16That one patient surviving like that meant that possibly thousands down the track will survive.
45:28The darkest fears would be that you can't raise money and everything collapses.
45:33That's what I've been thinking for six months.
45:39Just in time, a new investor arrives.
45:42When you're in the pharmaceutical business, you know all the numbers.
45:47You know that projects cost hundreds of millions of dollars.
45:51You know that the timeframes are in decades.
45:54You know that nine out of ten projects fail.
45:57So, you know, we all know that, but we kiss a lot of frogs in our careers and we don't find too many princesses.
46:06And I guess when you've kissed a few frogs, you kind of get the feeling when you've got a princess coming along.
46:12In the next month, five million bucks would be fabulous.
46:17I was able to assemble a few friends together and we did a sort of quick and dirty five or seven million dollars,
46:23which got them, kicked them down the road a little bit further.
46:27What we are going to do is as soon as we get this into the FDA, we're going to put in the breakthrough status.
46:33The FDA says it's a breakthrough. It's a breakthrough and it has potential.
46:38And so that gets the business to the next level of doing a Phase 2B trial in the United States in a high quality institution.
46:46And that leads to big licensing deals with big pharma.
46:50The large pharmaceutical companies, they want to see a blinded clinical trial with positive results
46:57before they'll really entertain a type of therapy.
47:00Most people are not cured of cancer. Their life is extended.
47:05And you want to know by how much their life is extended.
47:11And the only way to do that in an objective fashion is to compare two treatments.
47:18The standard of care and a novel treatment.
47:23And if the novel treatment outperforms, then you know you've got something very special.
47:27Another opportunity to test the EDV comes in Los Angeles, when an oncologist requests its use for one of his stage 4 patients.
47:40The oncologist said to us, can we have some of your EDV therapeutics to see if it might work in this patient.
47:48It's amazing. It's not just a pancreatic patient, it's an end stage pancreatic patient.
47:54It is spectacular and that's what we keep saying. We are making a difference in end stage.
47:59It was a big, big deal day.
48:03And all the staff came.
48:06Look at you.
48:08Then they did what they needed to do and made sure that it was being delivered correctly.
48:13And yeah, I was tired the next day, but I wasn't feeling sick.
48:17I wasn't nauseous. I wasn't anything. I'm like, gosh, this is great. I can do this.
48:27I think in comparison to regular chemotherapies, it's really convenient for the patient.
48:33It 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.
48:40Blood work looks amazing. All of it. Your hemoglobin is up. Albumin is up. Sodium is up.
48:49Everything shows that there's basically no disease, which is, again, an advanced stage pancreatic cancer, pretty unheard of.
48:58We didn't just extend her life for her to have a poor quality of life.
49:02We extended her life so she could have a wonderful life.
49:04After two and a half years, Anne is the first person in the world with end stage pancreatic cancer to report a complete recovery.
49:15My blood's also much better. Everything is like going the right way.
49:24This is the best treatment. The easiest treatment.
49:28It's amazing. The quality of your life. And the quality of life is like I can do everything.
49:35You know, she walks on the beach with her dog. She does Pilates. She's a pretty remarkable woman.
49:43And I was fit and I ran half marathons. I mean, to run for me. I want to do that again.
49:50I don't want to go far. I don't want to run a marathon. Just let me run a little bit.
49:57But when people ask me, you know, how are you? How are you doing?
50:02I'm like, I'm fine. Can you not see? I'm here having breakfast with you or coffee.
50:08Or I'm fine. It's fine. I'm going to be a grandma.
50:13I'm fine.
50:15Pancreatic adenocarcinoma is the worst killer of its kind.
50:18Normally, a pancreatic cancer patient, at that point in time, when that person's got nothing left,
50:26will barely survive a couple of months.
50:29Instead, many of the lesions, cancer lesions, in this patient have disappeared.
50:37The oncologist believes that that patient is in remission.
50:43You can't do those ad infinitum. You can't do hundreds of one-off programs.
50:49In the end, you need to get your drug into a large trial and be able to say to the world,
50:54look at this. Look what this has done.
50:56Here is the irrefutable evidence that we've got something that's really going to change the course of this disease.
51:02If you got $60 million on day one, where we got $2 million, I think, when we started,
51:13then you could plan better and you could rush forward.
51:17You could have more staff, do trials earlier, but it is what it is.
51:22That's what we had to do, and that's why it's taken so long.
51:25You can't imagine how difficult it is for a private company to raise funding.
51:29Even if you've got the best technology in the world.
51:33At the eleventh hour, when Ingenic is struggling to fund a new laboratory and keep the doors open,
51:39one of the Asian investors who has been watching Ingenic for many years,
51:43makes a move that will change the future of the company profoundly.
51:47My philosophy is you can't do it alone, because we are never smart enough.
51:53And two brains are better than one, and three brains are better than two.
51:56We certainly think that they are very, very close, and you know, what sort of excites me is that there are so many people that can benefit from this.
52:10It is now more than 70 years since the first anti-cancer drugs were discovered.
52:15Twelve to fifteen million people died every year from that dreaded disease, and nothing has changed.
52:22If I can play a little part in helping or pushing and supporting this technology to reach the market,
52:29I think the main beneficiaries are the cancer patients.
52:33These investors have a financial strategy that will support big trials to provide enough data to take the EDV to market.
52:44I am excited about the fact that now they have been able to move forward.
52:50And as I said before, it's still not pro forma.
52:54I mean, they have to do the clinical trials properly.
52:57But 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.
53:04And I just can't wait to see the data. That's the reality of it.
53:11I was trying to think how many times we've actually been here. It's a lot.
53:1724 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.
53:26Yeah.
53:28The year has been terrible because we were desperate for money.
53:34We were taking it from wherever we could find it.
53:37And to have Dr Jeng and his cohorts come in, the timing couldn't have been better.
53:44They saved us from our faces in the mud.
53:48It's a brutal business, yeah.
53:49You know, the extraordinary thing about Jennifer and Himanshu, let's face it, is their astounding persistence.
53:56They are Mr and Mrs Wobbly Man.
53:58You know those wobbly toys you knock over and they come bounding back up?
54:03You can't knock Jennifer and Himanshu down.
54:05And without that attitude, Nginic would have gone under many years ago.
54:11They have gone through a lot of ups and downs, more downs than ups.
54:16So I think with the Asia context and the attention that Asia can give, we hope that this is where Nginics will shine in the whole of Asia.
54:32When they finally get that body of whatever it is, I think it will be pancreatic cancer probably,
54:37that will cause everybody to stand up and cheer.
54:41You know, then the fact that you're from Australia or from the moon, they don't care.
54:43Speed to market is a key, you know.
54:46And we think that American clinical trial, if we can get this bloody thing moving here, FDA has already given us fast track.
54:59Completely unmet medical need, pancreatic cancer.
55:03It's been extremely frustrating and it makes so much sense.
55:07It's a safer, better way to treat people.
55:11We have dancing ladies and we have, you know, brain tumors that have disappeared right down the street from here.
55:17And it's not enough yet.
55:20The moment we do the proper randomized control trial, the FDA should be able to see clearly,
55:26this is miles better than what we have.
55:28Therefore, you should be able to get the second tick from the FDA, which would be breakthrough.
55:37We always thought we'd have to come to America to do trials, and we do.
55:41But recent developments are terrific in a way because the whole rest of the world is open.
55:47And there's a lot of people who get cancer and a lot of people we can help.
55:52Correct.
55:53Not just China, but Asia's been on our minds.
55:56Because the population is so large and it's just, they're begging for novel therapies.
56:03Oh, I think there's fantastic potential for Asia.
56:07China and India and Southeast Asia makes up about half the world's population.
56:12And if we can use Singapore as the hub, we can connect nearly two and a half billion people within a seven hour flying time.
56:24So let's get this going.
56:27Let's get all the trials completed.
56:30And I think this project deserves a lot of attention and deserves a lot of support.
56:39Cheers.
56:40Cheers.
56:43This will make a mark if it is given the opportunity.
56:46We've already made a mark.
56:48I recovered.
56:50And it's like miraculous.
56:57I'd like to see that smile on the cancer patient's face.
57:04I want to see it with my own eyes.
57:10That's what I feel.
57:11That's what I feel.
57:12That's what I feel.
57:13That's what I feel.
57:15Which is love.
57:16Cheers.
57:21Yeah, that's how I feel.
57:23But the sacrifice takes a lot of the Dubliners' place in this day.
57:28I feel like I'm afraid.
57:30If a chaplain's цар Philippines is behind him, I then can We can find him.
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