Breakthrough drug New hope in the fight against blood cancer

German biotech firm Morphosys has reported promising findings from a clinical trial of its Mor208 antibody to treat B-cell lymphoma, boosting the prospects of the drug getting approved — and opening up a potential €800 million market in the US alone.
Quelle: imago/Science Photo Library
What Leukemia looks like from very, very, very close.
(Source: imago/Science Photo Library)

German biotech company Morphosys presented promising new data on its Mor208 antibody candidate to combat blood cancer, which has increased its chances of getting approval for the first drug it has developed itself.

The company’s shares advanced 3 percent on Monday in Frankfurt to €104 after the Munich company gave a positive progress report on Mor208 at the American Society of Hematology. The drug has been one of the main drivers in a stock surge, pushing Morphosys to a market value of more than €3 billion ($3.4 billion). The 26-year-old company also has a Nasdaq listing.

In addition to Mor208, Morphosys is testing four other proprietary substances and pharma industry partners are testing two dozen additional substances that are based on Morphosys technology and would generate license income if they came to market.

Leukemia too

Mor208 targets a common and aggressive form of blood cancer in which mutated B cells gather in lymph nodes. Morphosys is testing the potential drug on patients for whom established treatments aren’t working and who are too old or weak to be put through other therapies such as high-dose chemotherapy. Up until now, there have been few treatment options for them.

The company has launched further studies to test whether Mor208 can also be used for other forms of blood cancer such as chronic lymphocytic leukemia. But those tests are still at an early stage.

The lymphoma study is relatively small, with 81 participants, but the data from the latest interim assessment suggest that the substance could be even more effective against B cell lymphoma than expected.

Morphosys said the data showed a response in 47 out of 81 patients with complete responses in 27 people (33 percent) and partial responses in 20 others (25 percent).

The so-called overall response rate of 58 percent was higher than prior findings. The average survival time without the disease progressing improved to 16.2 months from initial findings showing 11.2 months, which is a good result for this type of disease.

2020

Morphosys said alternative drugs had delayed the disease by just three to eight months in clinical studies. And it doesn’t expect major competition from gene and cell therapies that are also being tested against B cell lymphoma because they’re only applicable for a limited number of people and are extremely costly. In addition, it’s not clear how long those therapies work.

Morphosys plans to present the final data from its own study next year and use them as the basis for seeking approval from the US Food and Drug Administration and the European Medicines Agency. If everything goes according to plan, Mor208 could get approved in 2020.

The FDA has already granted Mor208 so-called breakthrough therapy designation, a classification assigned to drugs that promise a significant improvement in therapy standards and that are therefore assessed through an accelerated process.

Around 130,000 people worldwide are diagnosed with B cell lymphoma every year and in around 40 percent of cases standard therapies can’t be used. Germany has around 1,500 to 2,000 cases per year. Morphosys said Mor208 could be used to treat some 8,500 patients in the US per year.

Cash raised

Based on current prices of more than $100,000 for successful cancer drugs, Morphosys has a potential market of more than $800 million in the US alone. That’s why it plans to set up a sales team for Mor208 in the US.

“If the data so far receive final confirmation, we have a good basis to build up the business,” said Morphosys Chief Financial Officer Jens Holstein.

The company has liquid reserves of €481 million, which give it ample resources to fund its distribution plans. It secured some €200 million by placing shares on Nasdaq and recently received €47 million as part of an alliance with Switzerland’s Novartis, one of the world's largest drugs makers.

Siegfried Hofmann reports on the pharmaceuticals and chemicals branches from Frankfurt. To contact the author: hofmann@handelsblatt.com

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