Immutep to enter late stage trials for blockbuster cancer drug

The ASX-listed biotech – which counts Lucy Turnbull as a director and big investor – is entering late stage development for an immunotherapy drug to treat lung cancer patients.

Immutep director and major investor Lucy Turnbull. Picture: Adam Yip

Immutep, an immunotherapy-­focused biotech, says it is eyeing a multibillion-dollar opportunity after releasing compelling clinical data for a new drug aimed at treating lung cancer patients.

The ASX-listed company – which counts Lucy Turnbull as a director and one of its biggest investors – has completed phase 2 trials with pharmaceutical giant Merck, four years after they struck a partnership.

In the study, the number of lung cancer patients who responded successfully to Merk’s drug Keytruda effectively doubled when used in combination with Immutep’s lead product efti.

The results look promising for Immutep, considering Keytruda is one of the world’s biggest selling medicines, generating $4.8bn in sales in the first quarter of this year. Combined with efti, the hope is to grow those sales, given the significant need to treat patients with non-small cell lung cancer.

Despite the successful phase 2 study and scale of the potential market opportunity, Immutep shares have fallen more than 6 per cent to 30c in the past week.

Analysts have been lukewarm on the company, expecting it will launch a capital raising as it prepares for late stage development.

Immutep chief executive Marc Voigt – who has travelled to Australia from his base in Berlin ahead of the company’s annual meeting on Wednesday – said the group was well-funded, with $73.9m in cash as of the end of September, and was “coming from a position of strength”. It also received a $1m research and development tax rebate from the federal government last week, which followed a €1.8m ($2.8m) French R&D tax incentive in September. The company will use those funds on further clinical trials for efti.

Immutep chief executive Marc Voigt said the company is planning late stage trials in the second half of next year.

“As a biotech company, we can’t definitely rule out a potential capital raise but right now we are really focused on the execution of our business,” Mr Voigt said.

“We are coming from a very good balance sheet. We are aware of the difficulties of the market – why the share price goes up or down. We can speculate for hours.

“Of course, we believe there’s more intrinsic value, but we will be … out there to discuss what we are doing … (we) appreciate it’s a little more complex to understand.”

Immunotherapy is becoming a key treatment for cancer patients, alongside the more conventional treatments of chemotherapy and surgery, which have become the gold standard in past decades.

Mr Voigt said Immutep’s drug wasn’t aimed at replacing therapies but creating a “new attacking point”.

“It was believed 20 years ago to be a ridiculous idea that our own little T cells could destroy a tumour. Now you’ll see one kilo of lung tumour melting away under attack of our own CD8 T cells,” he said. “So it’s an ongoing revolution and has modernised the way we treat oncology, many different cancer indications across the board. Still there are, of course, big unmet medical needs … this is why you typically treat patients with combinations of different drugs.

“Because cancer is very diverse you need to come from multiple different attacking points.

“To work with a patient’s immune system, I believe, is a very natural idea and if you can do that in a safe manner, you have good chances to actually even get eradication of the tumour compared to other therapies.”

The results of the phase 2 trial were selected from 1500 abstracts to be presented at the Society for Immunotherapy of Cancer conference. Immutep had also reported positive data for efti in lung cancer at the American Society of Clinical Oncology conference in June.

The company is hoping to begin a late-stage trial in the second half of next year. It has been working under a clinical trial collaboration and supply agreement with Merck for its phase 2 trial. “We are right now in preparation for late stage development,” Mr Voigt said.

“These preparations entail discussions with key opinion leaders, such as doctors, hospitals, physicians – you would like to make sure that medically you are on target. And with regulators – for most the (Food and Drug Administration) – the US is the most important healthcare market globally.”