One biotech’s mission to change the standard of cancer care
Pedro Lichtinger, CEO and chairman of biotech Starton Therapeutics, speaks to EPM about the company’s mission to improve cancer care using transdermal technology.
At some point during a cancer patient’s treatment pathway there can come a trade-off between the desired level of drug they’re taking and just how well they tolerate the side-effects that inevitably come with treatment.
For people with cancer, the choice between extending their lives on a drug that will cause extremely unpleasant side-effects, versus forgoing treatment for a better remaining quality of life, is obviously a tough one.
Pedro Lichtinger has worked in the pharma industry for most of his professional life, leading Pfizer’s global primary care business and managing two biotechs in his time. Four years ago, he and colleagues launched Starton Therapeutics, an oncology-focused start-up that is looking towards transdermal delivery as a means of treatment for cancer patients.
“We believe in our focus in using our technology to transform outcomes for patients. Basically, improving efficacy and the tolerability of drugs [in cancer care],” he tells me during a telephone interview.
Whilst transdermal patches aren’t a new technology, their use, as Lichtinger tells me, has primarily been used as a means for convenience, rather than for any clinical benefit.
“Transdermal patches don’t offer a true clinical benefit, they offer non-inferiority to the original molecule but they’re more convenient to the patient and hopefully they improve compliance,” Lichtinger says. In cancer care that model doesn’t work. “Payers are not willing to pay for convenience. Therefore, there are very few transdermal patches that have significantly impacted patients, he adds.”
“What people don’t realise is that when you go from 25mg to 15mg, you reduce the period of extended life for that patient. That’s the story of a very large number of drugs where doses are reduced because patients cannot tolerate it."
This is something that Starton wants to change. The company has developed a transdermal delivery system for approved drugs in a bid to increase their efficacy and make them more tolerable for patients so that they can receive continuous treatment. The company has several products in both the pre-clinical and clinical stages of development, but perhaps most interesting is its project involving a blockbuster cancer drug and a new indication for it.
Revlimid is one of the highest selling drugs in the world. It is an immunomodulatory drug (IMiD) used as a standard of care therapy for people with multiple myeloma.
Through its STAR-LLD project, Starton is taking Revlimid and turning it into a therapy that can be taken via a skin patch. The indication? Chronic lymphocytic leukaemia (CLL), the most common form of leukaemia in adults.
Whilst Revlimid is one of the most successful drugs in the world, its method of delivery brings with it many of the issues that are found in other oncology treatments – those of efficacy, tolerability, and resistance.
“Revlimid has a three-hour half-life and it’s taken every 24 hours. We know by modelling that at 12 hours you fall below the minimum efficacious level and at 14 hours you start having no detectable levels in the cancer patient. What that means is you are giving, every single day, the cancer cells the opportunity to create resistance and to recover from the attack of the medicine.”
Starton wants to avoid this by delivering Revlimid in a continuous manner through its transdermal technology. Specifically, the treatment would consist of a low dose of Revlimid, delivered continuously so that patients always have an efficacious level of drug in their system.
One of the biggest impacts of cancer on both the patient and their friends and families is just how seriously the adverse effects of cancer treatments can be.
“When you look at the average, treatments [for cancer] extend life relatively shortly – 18 months, three years,” Lichtinger says. “After that they really start to impact quality of life. We all have members of our families or friends that have gone through cancer and their treatment can make them miserable. They are sick, they’re nauseous, they have infections – it’s very sad, that quality of life.”
However, pivoting to a continuous delivery method could reduce the high levels of a Revlimid found in a patient’s plasma, helping to improve tolerability and therefore, improving a patient’s quality of life.
In a drug like Revlimid, which sees many patients opting to reduce their dosage due to its side-effects, this is crucial.
“What people don’t realise is that when you go from 25mg to 15mg, you reduce the period of extended life for that patient. That’s the story of a very large number of drugs where doses are reduced because patients cannot tolerate it,” Lichtinger says.
Starton hopes that if people can tolerate Revlimid in a continuous dose, then CLL could become akin to something like a chronic disease, increasing a person’s lifespan and offering them a healthy quality of life.
Of course, as it stands, this is all theoretical, but Lichtinger is encouraged by proof-of-concept studies in mice which showed that continuous infusion of Revlimid displayed superior efficacy to a standard of care approach.
Starton’s journey so far has been somewhat different to other biotechs. The company opted not to raise funding through traditional means such as venture capital firms and instead has a cohort of 250 individual investors. This year, the company became one of the first biotechs to raise funding through the reality investing show, Unicorn Hunters, on Amazon Prime.
Lichtinger himself pitched Starton before the show’s judges, asking for between $20-30 million to further develop the company’s transdermal technology and progress towards clinical studies. Two of the judges took Lichtinger up on his offer and now he believes Starton is in a good position to expand its operations before it plans on making an initial public offering (IPO) in the coming months.
But, despite the novelty of Starton’s journey, Lichtinger is adamant that he wants Starton to be a biotech that caters to patients by avoiding high pricing (as seen in the US with Revlimid) and by increasing its access across the globe.
“Part of our strategy is to work with different regions and countries to make this available to patients. We are not going to follow the traditional model of very high pricing, focused only on the US. We want to make this available to many countries and are developing a strategy for access that will allow that,” Lichtinger says.