Agennix AG (AGX) plunged as much as 79
percent in Frankfurt trading after an experimental treatment for
lung cancer failed to meet targets in a late-stage trial.
Talactoferrin, a replica of the human protein lactoferrin,
didn’t meet its primary endpoint of improving overall survival,
Agennix said in a statement yesterday.
“We are extremely disappointed and surprised with today’s
results, especially considering the earlier promising results,”
said Rajesh Malik, chief medical officer. “We plan to
thoroughly analyze the data to better understand these
Agennix dropped 76 percent to 44 cents at 9:45 a.m., giving
the company a market value of 22.6 million euros ($28.1
million). The stock’s intraday decline was the biggest since
2009, when the company was created through a merger of GPC
Biotech AG and Agennix.
Tests of the drug involved 720 patients worldwide whose
non-small cell cancer hadn’t responded to two previous
therapies. The primary target of the trial was overall survival
and the secondary goal was the drug’s effectiveness in delaying
or halting the spread of the disease.
The company is taking “immediate steps to conserve cash
while we evaluate our business options,” said Torsten Hombeck,
chief financial officer at Agennix, which is based in the Munich
suburb of Martinsried.
Positive data from the trial, called Fortis-M, would have
been “transformative” for the company, Malik said in an
interview in July. Agennix’s only other products are RGB-286638,
in early-stage testing for cancer, and a topical gel form of
talactoferrin for diabetic foot ulcers, also still in an
Lung cancer is the most prevalent type of tumor, with 1.6
million people diagnosed in 2008 and more than half of new cases
in developing countries, according to Cancer Research U.K. In
the U.S. there will be an estimated 226,160 new cases diagnosed
this year and 160,340 deaths, the leading cause of cancer
fatalities there, according to the American Cancer Society.
Drugs approved for treatment include Roche Holding AG’s
Avastin and Tarceva and Eli Lilly Co.’s Alimta.
Talactoferrin is an immunotherapy, which stimulates a
person’s immune system to fight off disease. The Agennix
treatment, administered as a drinkable liquid, targets dendritic
cells, a type of white blood cell, in the gut. The drug is
designed to prompt the dendritic cells to identify tumor cells
as invaders and signal the immune system to destroy them.
Median overall survival for patients in the study who got
talactoferrin was 7.5 months compared to 7.7 months for placebo,
Agennix said in reporting the trial results.
Agennix is also conducting a late-stage trial called
Fortis-C to test talactoferrin as an early treatment of lung
cancer. The company said on July 30 that it won a U.S. patent
for talactoferrin’s use in non-small cell lung cancer and renal
cancer in combination with other care, including chemotherapy,
radiotherapy and surgery.
“Harnessing the body’s immune system is very promising,”
Malik said in the July 17 interview. “There’s nothing like
using your own immune system to attack your own tumor.”
The company stopped a study in February of talactoferrin
for severe sepsis because more patients receiving the treatment
died than those who got a placebo.
Agennix’s biggest shareholder is Dievini Hopp BioTech
Holding GmbH, owned by SAP AG (SAP) co-founder Dietmar Hopp. Chief
Financial Officer Hombeck said in July that the company had
enough cash to continue operating through the middle of the
fourth quarter and is looking at selling either more shares or
debt to fund increased spending into 2013.
To contact the reporter on this story:
Allison Connolly in Frankfurt at
To contact the editor responsible for this story:
Phil Serafino at