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MOLOGEN AG: Cancer immune therapy MGN1703 shows outstanding long-term responses

DGAP-News: MOLOGEN AG / Key word(s): Study
MOLOGEN AG: Cancer immune therapy MGN1703 shows outstanding long-term
responses

30.06.2014 / 08:13

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MOLOGEN AG: Cancer immune therapy MGN1703 shows outstanding long-term
responses

- Two presentations at ESMO WCGI 2014

- Three MGN1703 patients still progression-free

- Pivotal IMPALA trial to start recruitment

Berlin, June 30, 2014 - Two posters about the cancer immune therapy MGN1703
of the biotechnology company MOLOGEN AG have been presented at the ESMO
16th World Congress on Gastrointestinal Cancer (WCGI) in Barcelona. In the
first one data on four patients in colorectal cancer were presented. These
patients continued treatment with the immunotherapy MGN1703 after the end
of the IMPACT study in compassionate use programs. Three of these patients
are still free of progression of their disease in excess of 32 to 40
months. This highlights the long-term efficacy and safety of prolonged
treatment with MGN1703. In the second poster, the study design of the
confirmatory IMPALA trial has been presented. All the evidence from the
IMPACT study results has been integrated. Patient recruitment will start in
the third quarter 2014.

IMPACT was a phase II, randomized, placebo-controlled, double-blind and
multicenter clinical study. Notably, some tumor responses on MGN1703
monotherapy were observed during the study, two of these being observed as
late as nine months after induction chemotherapy was interrupted and
MGN1703 treatment started. At the end of the study four patients, all from
the MGN1703 arm, were still free of progression and continued treatment on
MGN1703 monotherapy in compassionate use programs. The outcome of these
patients was reported in the poster "A subgroup of metastatic colorectal
cancer patients with very prolonged disease control under maintenance
therapy with the TLR-9 agonist MGN1703".

Three of these four patients were still progression-free for 32, 36 and 40
months as of April 2014 and continue treatment with MGN1703. This prolonged
disease control is the more remarkable knowing that median overall survival
for metastatic colorectal cancer is usually in the range of 24 and 30
months. It is also remarkable that no severe side effects were reported
during the compassionate use programs; evidence for excellent tolerability
and safety of the drug.

"One of the four long-term responders is my patient and he has the disease
now for more than three years. Outstanding that he is still