Affimed enrolls first patients in Phase I Hodgkin's Lymphoma Study
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Affimed Therapeutics AG /
Affimed enrolls first patients in Phase I Hodgkin's Lymphoma Study
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First in man TandAb® antibody enters the clinic
Heidelberg, Germany; November 15, 2010: Affimed Therapeutics AG, the therapeutic
TandAb® antibody company, today announced that the first patients with Hodgkin's
Lymphoma have been treated with the AFM13 TandAb® antibody in a Phase I clinical
study.
The Phase I repeat dose escalation study will enroll approximately 40 Hodgkin's
Lymphoma patients across two centers in Europe and the US. The first patients
have now been treated with Affimed's lead product AFM13 and will receive a total
of four doses in weekly intervals. In the initial dosing the antibody was well
tolerated. Results from the trial will become available on a patient by patient
basis and complete data are expected by Q4 2011.
AFM13 is an innovative tetravalent, bispecific antibody based on Affimed's
proprietary RECRUIT-TandAb® technology. It binds the CD30 target molecule on the
surface of Reed- Sternberg tumor cells and simultaneously activates natural
killer cells (NK cells). Preclinical data suggests that RECRUIT-TandAbs® are
able to identify and selectively destroy tumor cells in the human body. AFM13
has been granted Orphan Drug designation in Europe and the US.
The European and US Phase I study will primarily assess safety, tolerability and
the pharmacokinetics of AFM13 plus first indications of biologic activity.
Principal investigator in Europe is Prof. Dr. Andreas Engert, Chairman of the
German Hodgkin Study Group and professor of internal medicine, hematology, and
oncology at The University Hospital of Cologne. Principal investigator in the US
is Professor Dr. Anas Younes (Director, Clinical and Translational Research
Program, Department of Lymphoma/ Myeloma, Division of Cancer Medicine, M. D.
Anderson Cancer Center, Houston).
"With the first TandAb® antibody entering the clinic Affimed has achieved a very
important milestone towards the clinical validation of our TandAb® platform",
said Dr. Rolf Günther, CEO of Affimed. "We are very happy that both FDA and the
Paul-Ehrlich-Institute supported our IND and CTA application and look forward to
advancing the treatment of Hodgkin's Lymphoma and other cancers by exploiting
the unique advantages of our technology."
Professor Dr. Melvyn Little, CSO of Affimed added: "The application of
tetravalent, bispecific antibodies to treat cancer is a first in humans and has
the potential to create new and exciting treatment options for a wide range of
diseases. TandAbs® are expected to have major advantages over first generation
antibodies. Advanced Hodgkin's Lymphoma is a severe disease and there are only
few treatment options available or in development."
For further information please contact:
Affimed Therapeutics AG MC Services AG
Dr. Rolf Günther (CEO) Birte Stein
Phone: +49 6221 65307-0 Phone: +49 89 210 228 12
Fax: +49 6221 65307 77 Fax: +49 89 210 228 88
E-Mail:R.Guenther(at)affimed.com E-Mail:Birte.Stein(at)mc-services.eu
About Affimed:
Affimed Therapeutics AG is a therapeutic antibody company developing unique
antibody therapeutics as novel treatments for life threatening diseases with
high unmet medical need. The company has been generating a growing pipeline of
anticancer drug candidates based on its proprietary TandAb® technology platform.
Affimed's lead product candidate AFM13 for the treatment of Hodgkin's disease is
in phase I clinical development. Both AFM11 and AFM15 to treat Non-Hodgkin's
lymphoma and autoimmune diseases, respectively, are currently in preclinical
development. Further novel product candidates are being developed for the
treatment of solid tumors, autoimmune diseases and asthma. Affimed's proprietary
and highly productive TandAb® technology enables the company to generate unique
tetravalent, bispecific, fully human antibody formats that promise increased
therapeutic potential and superior profiles compared to monoclonal antibodies.
The private company Affimed, which employs 27 people in Heidelberg, is a spin-
off from the German Cancer Research Centre (DKFZ), Heidelberg.
About TandAbs®:
TandAbs®, which were invented and developed by Affimed scientists, are
tetravalent bispecific antibody formats that have two binding sites for each
antigen. They bind to target molecules on the surface of, for example, tumor
cells and can activate immune effector cells like cytotoxic T-cells or natural
killer (NK) cells. TandAbs® possess the same avidity and affinity for each
target as an IgG. Combined with their bispecificity, this format represents a
potent further development of therapeutic monoclonal antibodies and,
potentially, a superior alternative to first generation antibody
formats/scaffolds. A robust production process for AFM13 has been established
with excellent stability of the drug product. Affimed has developed different
kinds of TandAbs® for specific indications. While RECRUIT-TandAbs® are applied
to oncology, BiBLOCK- and PROLONG-TandAbs® are developed for the treatment of
autoimmune and inflammatory diseases.
About Hodgkin's Lymphoma:
Hodgkin's Lymphoma is a malignant type of cancer targeting the lymphatic system,
with the highest incidence among those aged between 20-40 years, and over 70
years. According to estimates by the American Cancer Society, Hodgkin's Lymphoma
has a yearly incidence of about 8,500 patients in the US alone. Despite the
strong potential for recovery at the early stage of the disease, only
insufficient therapeutic approaches have so far been developed, particularly
with regard to those patients who do not respond to aggressive chemo- and
radiotherapy, or those who relapse. Due to the severe side effects and the
toxicity of this combinedchemo- and radiotherapy, there is a great medical need
for new treatments.
[HUG#1462349]
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Affimed Therapeutics AG
Im Neuenheimer Feld 582 Heidelberg Germany
Press release (PDF):
http://hugin.info/142251/R/1462349/401302.pdf
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Source: Affimed Therapeutics AG via Thomson Reuters ONE
Unternehmensinformation / Kurzprofil:
Datum: 15.11.2010 - 09:00 Uhr
Sprache: Deutsch
News-ID 48768
Anzahl Zeichen: 7431
contact information:
Town:
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Kategorie:
Business News
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