Dolly the Sheep pioneer on brink of cancer treatment breakthrough

Now Ms Scott, co-founder at TC BioPharm, is on the brink of another groundbreaking discovery aimed directly at the patient.

The firm, currently worth “hundreds of millions” and aiming to become a $1 billion tech entity, also known as a unicorn, said the move could be a market changer and represent a massive step forward in healthcare.

The discovery pushes the existing apex of treatment in this context beyond being restricted to using a patient’s own cells, to being able to use those of any healthy donor.

The firm has created “bio-banks” that will be used to develop more cost-effective, safe and efficacious cancer treatments, and has won a €4 million grant that is is the largest such EU award to any UK firm for development of a healthcare therapeutic product, from Horizon2020.

READ MORE: Scots firm creates first bio-banks for “off-the-shelf” cancer treatments

Its cell banks are collected from donors and stored, providing a source for scientists to manufacture next-generation “off-the-shelf” cell therapies for future clinical product development, which is expected to be available within two years after final-stage trials.

She said: “I joined the sector as an 18-year-old and went to work for the Imperial Cancer Research Fund, which was based at the Western General Hospital in Edinburgh, and I very naively thought that on joining, and in my first position, I would be able to cure cancer, until I realised cancer is really a multiple of diseases, that it was always going to be an impossible task.

“I very much worked on all of these therapies and drugs available at the time, some of which are still being used.

“At that time nobody had thought about stem cells, immunotherapy – that just wasn’t around. I knew there had to be something we could do it just wasn’t evident what it was.

“So that is where I started my career and I stayed with them for about 10, 11 years, and then moved to PPL Therapeutics. That is where I became part of the team with Dolly The Sheep, which is probably what I’m known for.

“I was there again for another 10, 11 years and managed a variety of programmes there, all of which were very exciting. From there, I moved to contract manufacturing, where I would take client’s process from the early stages, where they thought perhaps these would be therapies in the future."

She said: “I’ve brought a lot of cell therapies to the clinic. I’ve covered most of the disciplines and we started the company in 2014.

“We felt the joint expertise at the point could allow us to set up a firm that would move rapidly into being able to make cell therapies and get them into the clinic, because until that point, the closest took 15 years to get to the clinic and we knew that didn’t have to be the case.

“So we raised about £32m at that point, including about £8m in grants and £16m from non-dilutive partners, and we got a lot of SE (Scottish Enterprise) support in the early stages with funding.

“We now have a rough value of hundreds of millions, but really we’re wanting to be that $1bn company.”

READ MORE: Cancer therapy firm lands heavyweight backing

Asked on timescales, she said: “We’ve been preparing for IPO (Initial Public Offering) because that’s the way the company wants to go. We feel that’s the best opportunity.”

Acquisition has not been ruled out.

She said: “I think you can plan for an IPO – you can’t plan for an acquisition of course. But either way, we have to position ourselves, so this year is all about positioning ourselves, and with a view to 2020, looking to IPO.

“One of the reasons we can do that is because we have all the frameworks in place to be able to manufacture that product and deliver it. We have that under one roof.

“So for the patient, this is a good treatment. For the clinicians it’s very good, because we manufacture the whole product. So all we want to deliver then is the final product.”

The final product is given in the form of a drip infusion. She said: “You send it out to the clinical site. They just hook it up using the normal methods and give it to the patient.

“That ease of delivery, the manufacturing all under one roof helps to drive that cost down. So the clinicians are really engaged with this. They love the idea of immunotherapies that are easy to deliver. It’s just a drip. We call it an infusion.”

Reaching that level of expertise in research had started out in a different, unconnected process.

Dolly The Sheep, the world’s first cloned animal, stunned the scientific community as well as the wider populace, and, she was a surprise to her “parents” also.

READ MORE: Experts say legacy of Dolly the sheep still influencing science 20 years on

Ms Scott said: “The cells that were intended for use had been contaminated through a third party. So I had some cells that could be used. Then popped them across.

“To be fair, it was never the intention they would take, because you’ve now got a fully formed adult cell and asking it to become an embryonic cell, right back to becoming a cell at the beginning. It’s turning back the clock effectively.

“It actually took. So we implanted the cell into a sheep, into a surrogate mother.

“When Dolly was born, nobody could quite believe it.

“We obviously had to inform the Home Office Dolly had been born. As great a scientific breakthrough as it was, it would have been quite controversial at the time.

“We named her Dolly, after Dolly Parton basically. Because the cells that we used came from, they were mammary cells, breast cells basically.

“We had to go to Dolly [Parton] and ask for her permission to name her Dolly, and she was delighted.

“There was a lot of positives, I think Dolly became almost like a wee film star.

“She knew the cameras were coming. There was some negativity too of course.

“As you always expect. But yeah, she was very popular worldwide.

“It was a great breakthrough, it was a fantastic breakthrough.”

READ MORE: Scottish life sciences companies join forces to develop cancer treatments

It paved the way for a series of career milestones that led to the setting up of TCB with Dr Mike Leek, whom she already knew.

She said: “I remarried Mike 10 years ago. We divorced and remarried.”

Her role is “more operational, and Mike’s more on the commercial side”.

“Mike is my mentor, I have to say, and I want to give him that credit,” she said.

The parents of two also enjoy down-time together and have been to 120 music concerts in six years, including from Phil Collins to Oasis.

Edinburgh-born of Italian parents, Ms Scott, 55, loves cooking and being surrounded by family. “I’m going to be grandmother shortly.”

Talking shop again, she said: “So we’re happy, both Mike and I are very happy at how the company has grown.

“We’re up to 85 staff now.

“All the different disciplines come together. It’s nice that we’re under one roof. You see that product coming out the door, going to the clinic. You know that’s going to a patient.

“There’s absolutely nothing that makes me more content, and makes everything, all the work so worthwhile, than when you see that happening. I’m very proud when that happens.”

It now has offices in Glasgow, Edinburgh and Japan.

Asked about how it is framed amid talk of curing cancer, Ms Scott said: “How do I position it? Our intention is to improve patients’ quality of life.

“I would see this as a treatment for patients to improve their quality of life.

“I think the word cure, you’re right, has to be used very carefully, especially when we’re dealing with cancer.

“Certainly, will we be treating cancer effectively in the future? Absolutely.

“I think to be fair, we’re starting to do that now.”

Q&A

What countries have you most enjoyed travelling to, for business or leisure, and why?

Leisure: I love Italy, specifically  the Amalfi coastline along the south edge of Italy’s Sorrentine Peninsula hosting lemon groves and vineyards in a rustic backdrop.  Although I was born in Edinburgh (which I love) my parents were Italian so I am blessed with wonderful memories of spending school holidays in Italy. For Business I love travelling to Boston, it has many similarities with Edinburgh with great historic sites.

When you were a child, what was your ideal job? Why did it appeal?

I wanted to be a scientist curing cancer. This was my passion from an early age, biology was my favourite subject being simply  fascinated with the structure of cells.

What was your biggest break in business?

Being a key member of the ground-breaking team that cloned Dolly the Sheep (above) – my time at PPL in Edinburgh opened so many doors and provided a ‘stamp of credibility’ - this really helped my future career development.

What are your worst moments in business?

The recurring realisation that, no matter how passionate I am about treating patients and improving quality of life, some individuals try to derail the vision - sometimes for personal gain and greed.

Who do you most admire and why?

Keith Campbell – the intellectual and ethical powerhouse behind Dolly the Sheep – he was inspirational, his humility often left him overlooked.

What book are you reading and what music are you listening to? What was the last film you saw?

Books – wish I had time, loved the Bohemian Rhapsody film and always go back to Queen, on vinyl of course.

Above: TC BioPharm lab

SOME OF THE SCIENCE ...

The firm is a developer of CAR-T (chimeric antigen receptor T-cells) immuno-oncology products, including gamma delta T (GDT) cell therapies and its GDT cell banks are collected and stored from healthy donors, providing a source for to manufacture next-generation “off-the-shelf” GDT cell therapies for future clinical product development.

Using material that is allogeneic – not from the same individual - from healthy donors offers several advantages over conventional autologous CAR-T therapies, which use the patient’s own cells to treat their tumor, as the firm’s proprietary allogeneic CAR-T cells are not prone to “on-target, off-tumor” toxicities.

The larger population of cancer patients can be treated with a single reproducible product, “campaign-manufactured” in bulk to keep costs lower, increasing accessibility and reducing financial burden for healthcare systems.

Obtaining H2020 support, the company is rapidly progressing its clinical evaluation of allogeneic therapies. Having recently demonstrated safety and efficacy of large-dose autologous – from a particular individual - gamma-delta T cells in cancer patients, is commencing treatment of cancer patients with an allogeneic variant.

By building on its own CAR-T platform, the company also plans to treat leukemia patients with an allogeneic CD19-directed GDT CAR-T product.

TC BioPharm works with clinical centres of excellence to treat cancer patients in the UK and Europe.