ImmuPharma (LON:IMM) said it has held discussions with a “number of possible partner companies” for its potential blockbuster Lupuzor.
However it has used its interim results this morning to showcase the potential of its cancer treatment as it outlined plans for its further development.
ImmuPharma said IPP-204106 has begun further clinical trials with the next generation of "polyplexed Nucant".
This formulation has shown “impressive efficacy” of about 10 times over the previous version in pre-clinical cancer models.
The first patients have started dosing in this new phase I/II clinical trial, ImmuPharma said.
Initially it is planned to re-evaluate the safety in a preliminary phase I dose ranging tolerability study with the new formulation.
This will be followed by a phase II efficacy study designed to treat various cancers in around 30 patients to identify appropriate biomarkers.
This trial will be conducted in three hospitals in Europe including the prestigious Institute Jules Bordet in Belgium, which is totally dedicated to cancer.
Chief scientific officer Dr Robert Zimmer said: "The clinical development of our cancer programme continues to be a key priority for ImmuPharma. It is therefore extremely encouraging to see the first patients dosed in this new trial.
“The improved formulation of the "polyplexed Nucant" is a great achievement for both ImmuPharma and our partner, the CNRS, and further strengthens our position in this field."
Separately, the interim results marked a transformational period for ImmuPharma in which it was able to take back the rights to lupus treatment Lupuzor following the takeover of partner Cephalon by generic drug maker Teva.
Lupuzor was then given the green light to start phase II clinical trials under Special Assessment Protocol and with a fast-track designation.
This SPA is an important sign-off on the company’s clinical trial protocols.
The agency is essentially saying that, assuming no unforeseen issues, it will approve the drug if it matches or exceeds certain criteria.
Since this all happens before the data is generated, the FDA tends to be conservative when handing out SPAs.
ImmuPharma has also received sign-off in Europe and Japan that will allow it move into the final clinical trial stage.
Navid Malik, the respected head of life sciences at City broker Cenkos, last week pointed out that ImmuPharma is in an enviable position for a biotech in having a “phase-III ready asset”.
Taking it through the clinical stages of development to phase III means the group is in a position to maximise the value when it does finally find a partner willing to take on the further development of Lupuzor.
Cenkos said it has analysed Lupuzor and believes it has blockbuster potential.
This is primarily because it may eventually prove more efficacious than treatments currently on the market, such as the recently launched GlaxoSmithKline drug, Benlysta, and those currently making their way out onto the market.
The broker is predicting peak sales potential of US$2 billion based on some fairly conservative assumptions.
The unveiling of a partner for Lupuzor would undoubtedly be a major catalyst for the stock.
ImmuPharma’s previous deal with Cephalon was worth as much as US$500 million in milestone and revenue payments.
Cenkos believes ImmuPharma could go down a similar route and find a new commercial partner willing to make a significant upfront payment, milestones and royalties to acquire the Lupuzor rights. However there is an alternative.
“If it were to fund the product and complete the last phase of clinical trials using a contract research organisation, then instead of seeing a ‘teens’ based royalty on sales, we could see a much larger share of the potential upside – perhaps a revenue share model where net sales were split 50:50 and a contract sales force (specialist) was used to market the product,” Malik said.
“We already know that the bulk of sales in similar indications tend to come from specialist doctors and this often requires a much smaller and focused sales force – which means that there isn’t always a requirement for a large pharma sales team.”
The interim results revealed ImmuPharma made an operating loss of £1.96 million and has cash of £10.1 million.