At the vanguard of advances in the field of immuno-oncology
Phase 2 clinical study for its lead ImmunoBody, SCIB1 planned
Lead Moditope vaccine, Modi-1, aiming for the clinic in 2019
Positive cash balance of £7.6mln at the end of October
Two experienced hires made in January
What Scancell does:
AIM-listed Scancell PLC (LON:SCLP) is at the vanguard of advances in the emerging field of immuno-oncology and is working on two technologies that are showing early promise – they are the ImmunoBody and Moditope platforms.
The former has spawned the company’s most advanced cancer drugs, SCIB-1 and SCIB-2, which target and stimulate existing cells that make up the body’s defence mechanisms.
The UK group is planning to use SCIB1 in harness with Merck’s Keytruda checkpoint inhibitor to treat patients with advanced melanoma.
How is it doing it:
Scancell’s interim results in January showed that the company has the cash to advance its pipeline of immunotherapy products.
The group ended the six-month period to the end of October with a positive cash balance of £7.6mln, down from £10.3mln six months earlier.
The pre-revenue company saw its loss before tax widen to £3.67mln from £2.39mln the year before.
Scancell's focus for the immediate future is to initiate the planned Phase 2 clinical study for its lead ImmunoBody, SCIB1, and to advance its lead Moditope vaccine, Modi-1, towards the clinic.
Back in October 2018, Scancell said it is working closely with the US drugs regulator to address questions raised ahead of the launch of a Phase II clinical study of SCIB1 in combination with Keytruda.
Ahead of the granting investigational new drug status, America’s Food & Drug Administration requested some additional information, with the queries focused on a technology called TriGrid, a delivery system developed by Ichor Medical Systems that is also part of the combination therapy.
Subject to regulatory sign-off, Scancell said it expects patient enrolment for the trial to begin in the first half of this year.
In the same month, Scancell reported that pre-clinical data for its Modi-2 vaccine has the potential to treat different types of cancer to its forerunner, Modi-1.
Modi-2 is the second vaccine developed from Scancell’s Moditope platform, with Modi-1, the lead vaccine due to enter the clinic in 2019.
The two drugs work in slightly different ways, although both stimulate the production of CD4 T cells, which seek out and kill tumour cells that would otherwise be hidden from the immune system.
Modi-1 will be tested as a treatment for breast and ovarian cancers, as well as sarcoma (tumours found in fat, muscle, bone and tendons) when its clinical trial begins next year.
But Scancell thinks Modi-2 has the potential to address different cancer indications to Modi-1, including tumours which work particularly hard to suppress the immune system.
The company received “significant scientific endorsement” of its technology in January 2019 after it and a group of collaborators were shortlisted for a major award.
Scancell teamed up with BioNTech, Genentech and ISA Pharmaceuticals to form Project Blueprint for Cancer Research UK’s Grand Challenge.
The team outlined plans to eradicate established tumours with its unique vaccine, which had Scancell’s Modi-3 treatment at its heart.
As it gears up for its next phase of development, Scancell made two experienced hires in January 2019.
T-cell cloning specialist Dr Samantha Paston was appointed the company’s new head of research, while Dr Adrian Parry will take charge of manufacturing.
Paston arrived in mid-January from Oxford-based biotech unicorn Immunocore, where she made “significant contributions” to the company’s current oncology pipeline.
Before joining Immunocore, she held roles at Medigene, Avidex, NIBSC and GlaxoSmithKline. She gained her PhD at University College London.
Parry joined Scancell on February 1 from Mereo BioPharma, where he was head of small molecule chemistry, manufacturing and controls.
What the boss says - Cliff Holloway
“The shortlisting of our proposal represents a significant scientific endorsement of Scancell's technology and the team remains committed to meeting the challenges of improving cancer vaccines for all patients.”
At the turn of last year, Scancell reported “compelling” results from the Phase I/II melanoma trial of SCIB-1, and now it is waiting to kick off the Phase II clinical study of SCIB1 in combination with Keytruda later this year.
In December 2017, Cancer Research UK agreed to fund and sponsor a Phase I/II lung cancer clinical study of Scancell’s SCIB-2 vaccine, also in combination with a checkpoint inhibitor.
Lung cancer remains one of the most difficult cancers to treat and accounts for more than a quarter of all cancer deaths.
That is more than breast, prostate and colon cancers combined. Around 228,000 people receive a lung cancer diagnosis in the US alone and more than 160,000 will not survive.
In May 2018, investors got behind the business, backing a placing and subscription and open offer of new shares that brought in £8.7mln before expenses.
Those shares were sold at 12p each, but since then, the stock has drifted steadily back, currently trading at 6.30p, valuing Scancell at £25.79mln.
News on the start of the Phase II clinical study of SCIB1 in combination with Keytruda could see it return to the £50mln valuation of the May 2018 placing price.