US-based Eleison Pharmaceuticals seeks to extend hope to cancer sufferers
By James Brewer
Patients with rare, life-threatening cancers may be offered new hope by therapeutic drugs which are in an advanced stage of development at a US private pharmaceutical company.
The company, Eleison Pharmaceuticals LLC, is targeting pancreatic cancer, osteosarcoma (bone cancer), and lung cancer. Its name recalls the Greek expression Kyrie eleison used in prayers for mercy in the Roman Catholic, Greek Orthodox and other churches.
Eleison chief executive Edwin Thomas said of those who patients who suffer after initial treatment has failed: “With a relapse, there is not much you can do. We are working on a drug that is trying to address that.” Mr Thomas has been meeting investors in London and Switzerland to detail Eleison’s mission to develop, acquire and commercialise clinical- stage candidate drugs that attack “orphan” cancers.
“There are very few private companies in this late stage of development” of the products the company is championing, said Mr Thomas. The pharmaceutical giants keen to market financial blockbuster drugs tend to leave it to smaller outfits to pursue new solutions.
Founded by Mr Thomas in 2009 and headquartered in St Petersburg, Florida, his company is setting out to address unmet needs in a trio of serious ailments (pancreatic, bone and non-small cell lung cancer).
Furthest ahead is the drug candidate Glufosfamide, which is being evaluated under a Phase III clinical protocol for patients with pancreatic cancer previously treated with gemcitabine (one of the drugs approved for first-line therapy). The trial is being conducted at hospitals and cancer treatment centres in the US, and there will be trials in Europe and Asia subject to Eleison raising further capital of some $15m. The company’s main current focus is to get Glufosfamide from Phase III into registration with the US Food and Drug Administration.
“I think that there is a high degree of confidence that this product will be able to prove its efficacy,” Mr Thomas said in London.
Until recently there has been little in the way of therapeutic options for second line pancreatic cancer, despite the 46,000 new cases in the US each year and 80,000 in Europe. In commercial terms, this indicates the market potential for an approved drug could be up to $1bn, Mr Thomas estimates.
At present, surgery, radiation, and chemotherapy provide usually only palliative benefit, as five-year survival rates are just 6%. “Eventually, almost all patients will fail first-line therapy. There are no approved mono-therapies for second-line pancreatic cancer in the US. We will see if we can get the survival rate up to 40,” remarked Mr Thomas.
Additional applications foreseen for Glufosfamide could be for first-line pancreatic cancer, testicular cancer, sarcoma, lung cancer and lymphoma. Prolonged survival for breast cancer might be achieved.
The company says that it has a strong competitive position amid probably at least 50 drugs in this category in various stages of development.
Mr Thomas – who has worked in the biotech sector since 1993 – said that Eleison’s extensive clinical database for Glufosfamide indicated that the compound is safe and active in many indications. The ongoing Phase III study of the compound involving 480 patients at 20 sites in the US was learning lessons from previous tests sponsored by San Francisco-based Threshold Pharmaceuticals. The current trial has a Special Protocol Assessment (SPA) agreement letter from the Food and Drug Administration, and this reduced regulatory risk.
The prior Threshold study failed to achieve statistical significance, said Mr Thomas, because there were not enough patients and some of them were taking insulin, resulting in a much lower median survival.
Final data was expected in 2018, and with FDA fast-track status, that is the year the company hopes for official approval of the drug.
Eleison owns exclusive worldwide rights to Glufosfamide, but has sub-licensed marketing rights to a leading pharmaceutical company in China and to the second largest pharmaceutical company in South Korea. The Chinese partner is putting between $6m and $8m into Phase III trials. Eleison received approval in May 2016 from the China Food and Drug Administration to enrol patients.
The Eleison chief explained how Glufosfamide works. A new chemical entity, it is an analogue of ifosfamide, a chemotherapeutic commonly prescribed for several cancers. It was created by chemically bonding glucose to the active agent in ifosfamide. Many cancer types use glucose to for tumour growth, and Glufosfamide was a “Trojan horse.” Once inside the cancer cell, the compound releases its cell-killing chemotherapeutic agent.
The trials are under the guidance of renowned experts, with Dr Howard Hochster of Yale as key opinion leader, and Dr Richard Kim of Moffitt Cancer Center of Tampa, Florida, as principal investigator.
Eleison is developing a second drug candidate, for which it says it has no direct competitors. This is ILC, a lipid-complexed cisplatin administered via inhalation. ILC is being evaluated under a Phase II clinical protocol for patients with osteosarcoma (bone cancer).
Bone cancer is a rare but debilitating and dangerous disease. About 500 children and young adults are diagnosed each year in the US. Most patients are otherwise healthy teenagers. Eleison says that ILC is potentially the first lifesaving breakthrough in the treatment of bone cancer in more than a generation.
For paediatric osteosarcoma, with around 1,300 new cases a year in total in the US and EU, the drug market potential is up to $100m in the US, and $300m worldwide.
The only approved drugs for first-line therapy in paediatric osteosarcoma are methotrexate, doxorubicin and cisplatin. Some 35% of patients will fail first-line therapy with these treatments, said Mr Thomas, and there had been no improvement in the past 30 years in patient survival rates.
Standard therapy, a combination of surgery and chemotherapy, is difficult and with serious side-effects, but nearly all patients experience at least an initial remission. Sadly, 30-35% of patients are hit by a recurrence, usually in the first year or two after diagnosis, but sometimes five or more years later. Although tumour recurrence may occur anywhere in the body, this is most commonly in the lungs. The prognosis for relapsed patients with pulmonary tumours is poor, with five-year survival of less than 25%.
ILC has been evaluated in 89 patients in four clinical studies, with evidence of efficacy in several cancer types including lung and bronchoalveolar, the company has said.
In a prior phase II study of ILC, 10 of 19 children with pulmonary recurrence achieved a clinical benefit. Of a group of three patients treated with ILC after a complete surgical removal of their pulmonary tumours and one patient with micronodular disease, three remained disease-free after one year (normally there is recurrence in under six months).
Eleison has sub-licensed the marketing rights of ILC for the Chinese market to an emerging Hong Kong-based pharmaceutical company.
A Phase II/III osteosarcoma study could potentially begin in 2017, and a new Phase II study in non-small cell lung cancer is expected in 2017, with the formal New Drug Application process to be initiated in 2019 or 2020. The NDA step is a move towards commercialisation.
Treatment of paediatric bone cancer is said to be a $100m market ($300m worldwide). Worldwide market potential of ILC in treating non-small cell lung cancer is said to be $10bn annually.
Eleison, which has a pre-money valuation of $30m, is working on the last financing it needs before going to the public markets. If market conditions warrant, the directors will seek in 2017 to take the company public, possibly on Nasdaq.
The funding goal to support 30 months of operations is $15m through private placement, of which $10m will be used to complete the phase III study of Glufosfamuide; $1m to initiate a pivotal phase III study for ILC; and the rest for working capital and other purposes.
This is to follow funding to date of $13m, capitalised to the tune of $8m in private equity, $2m from family offices and founders, and $3m from partners. All but $600,000 has been used up, but existing backers are likely to put more into the pot in the next round.
Mr Thomas insists that his company’s abundant data and rare-disease focus mitigates the development and regulatory risks, while offering exceptional investment upside. It has “highly experienced drug development leadership and world class scientific advisors to provide expertise to efficiently advance product development.”
He added: “We are more diversified than most biotech companies. We are looking to acquire a variety of products.”
Further information is at www.eleison-pharma.com