Skin cancer is the fifth most common cancer in the UK with around 13,000 new cases of melanoma diagnosed annually and 2,000 deaths a year.
In fact, recent studies have found that malignant melanoma diagnoses hit 10,000 a year for over 55s alone, compared with just 3,100 cases two decades ago, an increase of 155%.
Dr Anton Alexandroff, a consultant dermatologist at Leicester Royal Infirmary, said the increase was likely due to “reckless” lifestyles and improper protection from the sun, which is the main cause of most skin cancers.
There is hope for those with this deadly type of cancer though, with Scancell Holdings Plc’s (LON:SCLP) SCIB1 immunotherapy continuing to produce remarkable survival data from the ongoing phase I/II clinical trial.
Priming the body to fight cancer
Scancell’s immunotherapy vaccine primes the patient’s immune system to recognise and kill specific cancer cells.
SCIB1 – and now SCIB2 – targets and stimulates existing cells that make up the body’s defence mechanisms, in particular the dendritic cells already present at the site of the cancer.
Dendritic cells are found in all tissues that are in contact with the external environment, such as the skin, lungs and intestines.
The main function of these cells is to process antigens - foreign or toxic material - and present them to the immune system. Once activated, they migrate to the lymph nodes where the antigen is destroyed by the body’s T cells.
“Compelling” clinical trial results so far
At the turn of the year, Scancell reported the “compelling” results of a phase I/II trial of SCIB1, and the immunotherapy has continued to impress since.
Overall, 18 of the 20 stage III/IV melanoma patients with resected disease (i.e. some or all of the tumour has been surgically removed in the past) remain alive and have lived significantly longer than the ‘established norms’.
Of the 16 resected patients who received 2-4 milligram (mg) doses of SCIB1, only six patients have had a recurrence of their disease while only two have died.
The median observation time for this group of patients is edging up towards five years, with seven patients in the trial surviving for longer than that since starting treatment.
Remarkably, four of those have managed to live for that period without having the disease return.
One patient with unresected disease has also been able to survive for longer than five years since starting treatment with SCIB1 despite the disease progressing.
Two of four resected patients who received stronger 8mg doses of SCIB1 have experienced disease recurrence although none have died, Scancell added.
“We are pleased to report that most patients with resected disease enrolled in the SCIB1 clinical trial are still alive and without disease recurrence, including the majority of patients who were previously undergoing continuation treatment,” said chief executive Richard Goodfellow.
Next study will be in the States
Investors have known for a while that next up is a SCIB1/ checkpoint inhibitor combination study which will be carried out in the United States.
A new batch of the drug has been manufactured and will be released for clinical use later this quarter.
That will coincide with the submission of the investigational new drug (IND) application to the US Food and Drug Administration for a phase II trial, which is on track to be submitted before the end of September.
“Our next study, which will be in the US, will assess the potential for an increase in response rate in patients with malignant melanoma when treated with SCIB1 and a checkpoint inhibitor,” said Goodfellow.
Not just skin cancer treatments though…
While SCIB1 is furthest along the pipeline, Scancell also has a non-small cell lung cancer (NSCLC) treatment – SCIB2 – which is progressing well.
In November,Cancer Research UK agreed to fund and sponsor a Phase I/II clinical trial of its SCIB2 lung cancer vaccine.
Scancell said the tie-up was a “significant endorsement” of its ImmunoBody platform – the underlying technology behind both SCIB1 and SCIB2 which helps to prime a patient’s immune system to recognise and kill specific cancer cells.
Collaborations with the Addario Lung Cancer Medical Institute (ALCMI) and the Bonnie J Addario Lung Cancer Foundation are already in place.
ALCMI will assist Scancell with the design and development of the study, which is set to get underway this year and complete around 18 months later.
Lung cancer remains one of the most difficult cancers to treat and accounts for more than a quarter of all cancer deaths.
That’s 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.
CD4+ another area of collaboration
Another collaboration with European firm BioNTech will focus on the development of T-cell therapies for the treatment of cancer.
Moditope, Scancell's platfrom, is a new class of potentially potent immunotherapy agent that naturally stimulates the production of cancer killer CD4+ T cells.
The research will combine the Moditope immunotherapy platform and BioNTech’s platform technology for high-throughput cloning and characterisation of naturally selected T-cell receptors.
At 11.35p, Scancell is valued at £35.9mln.