ImmuPharma’s (LON:IMM) chief executive said the company is exploring a number of “creative options” in order to bring its breakthrough drug Lupuzor through final clinical trials.

Speaking to journalists and analysts, Dimitri Dimitriou said the drug developer could team up with a contract research organisation, which would fund a phase III study of the drug for the autoimmune disease lupus.

However he was quick to add that a CRO would not be the company’s first choice and that ImmuPharma is now in “due diligence under confidentiality” with a number of companies interested in a licensing deal.

Chairman Richard Warr said: “Our key objectives for 2012 are to secure a new licensing partner for Lupuzor, to advance our cancer programme and to continue to develop the rest of our asset base.”

Dimitriou, meanwhile, revealed very little about how many potential licensing partners are interested in Lupuzor.

However he said it wouldn’t make sense to do a deal with a company smaller than Cephalon, its former partner, which was valued at $6.8 billion when it was taken over by generic drug producer, Teva, last year.

The company is keen to get the drug through its final trial stage after it clawed back the rights to the potential blockbuster from Cephalon.

The news of where the drug is heading at this crucial stage was given alongside the group’s financial results, posted this morning. 

The company revealed it is in a strong financial position with a £12.2 million in the bank. As expected, the firm posted a loss in 2011 of £3.25 million.

The company also had positive news on its cancer treatment drug IPP-204106, which it said has a mechanism like no other in the market and has promising results from its phase 1/11a trial.

IPP-204106 is the result of ImmuPharma’s partnership with France’s state organisation, Centre National de la Recherche Scientifique and has had its patent life renewed until 2027.

Notably the drug was chosen to be on the cover article of the May 2011 issue of leading American medical journal, Cancer Research.

The share price, which has drifted 17 per cent lower in the year to date, fell a further 1.6 pence 69.90 pence as investors were made to wait for more concrete news on the Lupuzor out-licensing.

However City analysts remain upbeat on the company’s prospects and its valuation. 

Singer Capital Market’s Shawn Manning rates the stock a ‘buy’ up to 85 pence, while Panmure Gordon’s Savvas Neophytou has a more punchy 150 pence a share price target.

As at 2pm, the conmpany's shares were down 0.69 per cent, at 71.50 pence.

Teva has a competing drug candidate for Lupus, which means that ImmuPharma has the right – under key provisions of its agreement with Cephalon – to request the return of the rights to Lupuzor after Cephalon’s acquisition was finalised last week.

In 2008, ImmuPharma entered into an option agreement with Cephalon, while it was in the middle of a Phase IIb study designed, managed and funded by ImmuPhama. Cephalon paid ImmuPharma US$15 million, before the results of the study were known, for the exclusive option to enter into a worldwide licence.

Folllowing positive results of the ImmuPharma study in early 2009, Cephalon exercised its option by paying a further US$30 million. This was part of an agreement worth US$500 million in cash milestone payments, plus royalties on product sales.

Now that ImmuPharma has regained all rights to Lupuzor, it and Cephalon will decide the future of the current clinical trials that Cephalon has initiated in Lupus patients in the US and Europe. The firm expects to provide a detailed update of the development of Lupuzor in the near future.

“We are delighted to have Lupuzor back,” said Dimitri Dimitriou, ImmuPharma’s chief executive. “This paves the way for new options for the future of the company.  We appreciate the support of Cephalon in the development of Lupuzor during our collaboration.”

The American biotechnology group is in the throes of being taken over by the generic drug-maker Teva, throwing into doubt its research programmes.

Lupuzor is a potentially blockbuster treatment for the autoimmune disease Lupus, which is in phase IIb trials in the US and Europe.

The data compiled from this research will be part of the package submitted to America’s Food & Drug Administration and other regulatory authorities for approval.  

Benlysta, a rival product launched by GlaxoSmithKline and Human Genome Sciences (GSK-HGS), has underlined the market potential of the treatments in this area of medicine.

Peak sales of Benlysta are estimated to be $4 billion, but with 1.5 million sufferers in the G7 alone, there is plenty of room for a rival such as Lupuzor.

In parallel, the group is also developing a cancer drug called IPP-204106, which is moving into phase I/IIa trials.

The rights for this compound were obtained via a unique research collaboration with the Centre National de la Recherche Scientifique, France's leading scientific research organisation.

The update was contained in the company’s interim results statement, which revealed the ImmuPharma is in a strong financial position with around £14 million in the bank.

The company posted an operating loss of £1.6 million, down from £2.5 million this time last year.

Chief executive Dimitri Dimitriou said: "The first half of 2011 has seen ImmuPharma build on the success of 2010 with Cephalon, our licensee for Lupuzor, moving ahead with a large trial in the US.  

“We look forward to providing an update on Lupuzor's progress once Teva's acquisition of Cephalon is complete.  

“In parallel, we are focusing our own efforts on our promising cancer drug and are pleased to have seen encouraging results so far and to have achieved publication in the journal of the American Association for Cancer Research.  

“We look forward to building on this success during the rest of 2011 and in the coming years."

Yesterday, it emerged that Teva’s Laquinimod drug, a candidate to treat multiple sclerosis, failed to meet its primary endpoint in a phase III trial.

Teva is currently finalising its acquisition of US drug firm Cephalon, which is Immupharma's development partner for the Lupus drug candidate Lupuzor - which is being prepared for its own Phase III clinical trial.

Panmure analyst Savvas Neophytou reckons Teva may now have more interest in the Lupuzor drug as a result of the failed trial, and as such Teva is less likely to back out of Lupuzor's development and pass the rights back to Immupharma.

Results from Teva's two-year phase III trial, to treat relapsing-remitting multiple sclerosis, had been eagerly awaited to provide clinical proof of concept. But the candidate did not significantly reduce annualised relapse rate when compared to placebo.

Teva had been expected to return its rights over Lupuzor once it had completed its acquisition of Cephalon, but Panmure believes that Teva will be motivated to focus its attention on the Lupus drug.

Panmure, which has a ‘buy’ view of ImmuPharma, has conducted a sum-of-the-parts valuation for Lupuzor that it said leads to a price target of 150 pence each for the firm’s shares. 

By 11:30am today, ImmuPharma’s share price was down 2.5 per cent at 78 pence.

Indeed around half of the patients that have undergone treatment with ImmuPharma's IPP-204106 are in stable condition, meaning their disease has stopped progressing.  

These were the highlights of a very encouraging phase I/IIa study being carried out in France on patients in the most advanced stages of cancer.

This current trial is meant to find the optimum dose of 204106 and discover whether it is safe. Doses of 1 milligram per kilogram and 2 milligrams per kilogram showed no drug related side effects, the company revealed. A third dose level is currently being used in a separate group of patients.

At the same time ImmuPharma has already begun development of the next generation of IPP-204106.  

This improved formulation comprising of small particles of the drug candidate has shown an even more impressive efficacy in cancer models.

The company’s other drug, Lupuzor, is a potentially ground-breaking treatment for Lupus, a life threatening auto-immune disease. 

Cephalon, ImmuPharma’s development partner, is currently conducting a large phase IIb trial in the US and Europe. And the potentially company transforming trial results are expected mid-way through the year.

ImmuPharma chief executive Dimitri Dimitriou said this morning: "Having now two drug candidates with positive results in clinical trials is a milestone for ImmuPharma.  

“The latest positive results of our cancer drug candidate clinical trial puts our company in a good position for further major corporate deals such as the one with our partner Cephalon on Lupuzor that is now in a large late-stage clinical trial in the United States.  

“This also marks the fifth anniversary of ImmuPharma's admission to trading on AIM.  With our strong cash position and pipeline, we are excited to continue our success.”

In today’s research report, Edison responded to last week’s update from the company, which is planning to file a new cancer compound (IPP-204106, N6L) as a US Investigational New Drug (IND) in the next few months and start a Phase IIb trial in the first half of 2011.

In a statement published last week, the company said it has now dosed six cancer patients, suffering from either breast cancer, lung cancer or bladder cancer, and no serious drug-related adverse events have been reported.

Two patients were rated as having the disease stabilised.

Edison said the update showed steady phase IIa development progress with six enrolled patients and a move to the second dose level as the 1 miligram (mg)/kilogram (kg) dose has passed and the 2mg/kg dose is being tested.

The report noted that nanoparticles formed from N6L and glycosaminoglycan are potentially tenfold more effective in killing cancer cells, which Edison said was an “interesting, very valuable observation”.

ImmuPharma is running a standard Phase IIa study with advanced-cancer patients with various tumour types to find the maximum tolerated dose, which could be up to 20 mg/kg.

The study is designed to show safety and tolerability and assess the maximum tolerated dose.

The next stage of trials, phase IIb, in four cancers could start as soon as next year.

Pancreatic, brain, melanoma (skin) and castration-resistant prostate cancer targeted by the study are all considered to be hard to treat cancers with no current robust treatment options.

In preclinical work, IPP-204106 showed a dual mode of action: anti-angiogenic and arrest of cancer cell growth with possible apoptosis.

This dose can then be used in specific tumour-type Phase IIb studies to give an initial indication of efficacy.

A US IND (investigational new drug application) might be filed in 2011 to start US clinical work.

The research house gave N6L a risk adjusted of £190 million, or 230 pence per share, compared to an enterprise value of about £50 million.

Edison will revaluate IPP-204106 once the Phase IIa data is released.

The report noted that ImmuPharma remains sensitive to exchange rates as about 75% of its cash is held in US dollars.

Today ImmuPharma’s chief scientist Dr Robert Zimmer will talk to analysts about the current Phase IIa trial.

In a statement published ahead of the presentation, the company said it has now dosed six cancer patients, suffering from either breast cancer, lung cancer or bladder cancer, and no serious drug-related adverse events have been reported.

Immupharma said that two patients have already been rated as having stabilised disease.

Investors welcomed the news, and the stock was trading up 2.3% at 88.75p in afternoon deals on London’s AIM market.

In the trial Immupharma has been escalating dosing in patients with at least one previous treatment failure.

The study is designed to show safety and tolerability and assess the maximum tolerated dose, the company said.

ImmuPharma (LON:IMM) says it continues to talk to potential collaboration partners in a bid to maximise its product pipeline.

Interim results from the biotechnology group revealed it is among the most financially robust companies in the sector.

It has £20 million of cash, down from £22.5 million in December, which at the current burn rate gives it funds for the next four years,

The company’s lead compound is Lupuzor, a treatment for Lupus, a potentially life threatening auto-immune disease.

Its partner on this drug candidate is speciality pharma group Cephalon, which is conducting a large phase IIb trial in the US and Europe.

At the same time ImmuPharma is carrying a phase IIa study on its anti-cancer compound, IPP-204106, which has received investigational new drug approval from Agence Francaise de Securite Sanitaire des Produits de Sante.

The group has three other compounds including one for pain relief and another that could potentially tackle the MRSA superbug.

The operating loss for the six months to June 30 was £2.5m.  Research and development expenditure was £975,454, largely reflecting the costs of development of IPP-204106.  Administrative expenses were £1.5m. 

The company said: “With a strong cash position, the focus of the group is on continuing the development of our strong relationship with our license partner for Lupuzor, Cephalon, and the development of our other pipeline candidates, in particular our promising cancer compound, IPP-204106, and discovery pipeline.  

“We are looking forward to announcing the preliminary results of the Phase IIb trial for Lupuzor and our Phase IIa trial for IPP-204106 in the coming months.  

“Furthermore, in an effort to maximise the value of our development pipeline, ImmuPharma continues to be in discussions with a number of pharmaceutical and biotech companies for potential collaborations.”

Edison Investment Research issued a note on Immupharma, conferring that an analysis of the latest Lupuzor trial shows very enouraging data. It has revised its risk-adjusted net present value to reflect timelines envisaged by the current development plans and is now indicating a valuation of £190 million, which compares to an enterprise value of around £60 million.

Lupuzor, which targets lupus, disease that involves an inappropriate functioning of the immune system, has achieved a clinically significant improvement of 50% in patient response rate at 12 weeks compared to placebo in the intent to treat population, while being well tolerated with a low number of dropouts at just 1 versus 8 in placebo and less serious AEs (adverse events) leading to discontinuation.

The response rate in moderate to severe patients was improved by 60%, which was also statistically significant.

Noble noted the Benlysta dataset produced this year by Human Genome Sciences, which it said had much higher powering due to its larger size, saying Lupuzor’s result were the next best and that the drug appeared to modulate the immune system and improve lupus symptoms. While Benlysta was likely to be the first drug to hit the market, the two could be used in combination as Lupuzor’s T cell approach was complementary to Benlysta’s B cell approach.

Lupuzor accounted for 95% of ImmuPharma’s technology value in Noble’s valuation, which was raised by 10 pence to 230 pence to reflect an improved Lupuzor risk adjustment (25% to 30%), offset by a later assumed launch (2013 to 2014).

The second Phase II-b trial is set to start in early 2010 to test the best Lupuzor doses to move into Phase III trials, also contributing to the regulatory requirements by increasing patient exposure.

ImmuPharma has 5 innovative biological that target that Noble called high unmet needs.

Shares in the company last traded at 111 pence.