Affimed Therapeutics and The Leukemia & Lymphoma Society Partner to Advance AFM13 in a Phase 2 Trial for Refractory and/or Relapsed Hodgkin Lymphoma Patients
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Affimed Therapeutics AG /
Affimed Therapeutics and The Leukemia & Lymphoma Society Partner to Advance
AFM13 in a Phase 2 Trial for Refractory and/or Relapsed Hodgkin Lymphoma
Patients
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The issuer is solely responsible for the content of this announcement.
Heidelberg, Germany, and White Plains, NY, USA, September 16(th), 2013: Affimed
Therapeutics AG and The Leukemia & Lymphoma Society (LLS) today announced a
partnership to co-fund a phase 2 trial with the Recruit-TandAb AFM13, a novel
tetravalent bispecific antibody directed against human CD30 and CD16A in Hodgkin
Lymphoma (HL) patients for whom currently available treatments have failed.
AFM13 is a first-in-class immunotherapy drug designed to treat HL patients and
patients with CD30-positive malignancies. LLS has committed to investing up to
$4.4 million over 2 years to support the project.
Dr. Richard Winneker, SVP Research for LLS, stated, "Though the cure rate for
Hodgkin Lymphoma is high compared to other types of blood cancers, refractory
and relapsed patients have few therapeutic options. More importantly current
treatments for HL patients involve cytotoxic drug therapies and radiotherapy,
which are likely responsible for secondary tumors and other considerable long
term side effects developing later in a patient's life, leaving open a critical
need for safer and more durable therapies. LLS is committed to advancing
breakthrough therapies, particularly for patients with unmet medical needs, and
Affimed's immunotherapy is emerging as a promising therapeutic option for HL
patients."
"The partnership between Affimed and LLS is a significant validation of the high
potential of our TandAb platform and reinforces our strategy to develop this
novel bispecific construct for hematological tumors", said Dr. Adi Hoess, CEO of
Affimed AG. "We very much welcome LLS's commitment to AFM13, and we look forward
to an accelerated development of this therapy for patients with limited
treatment options to date."
In a phase 1 trial, AFM13 has shown a good safety profile, as it was well
tolerated at all dose levels tested. Furthermore, AFM13 showed clear and
meaningful signs of efficacy in some patients deemed to have a poor prognosis,
including patients who had not benefited from the recently approved CD30
targeting drug, brentuximab vedotin (Adcetris®, Seattle Genetics). These
encouraging data warrant the further investigation of AFM13 in a phase 2 trial
to further assess its efficacy. Moreover, these trials could provide proof of
concept for using bispecific antibodies to elicit natural killer (NK) cells,
vital lymphocytes of the innate immune system, to effectively kill cancer cells.
For further information please contact:
Affimed Therapeutics AG MC Services AG
Dr. Adi Hoess (CEO) Anne Hennecke
Tel.: + 49 6221 65307 0 Tel.: +49 89 210 228 18
Fax: + 49 6221 65307 77 Fax: +49 89 210 228 88
a.hoess(at)affimed.com anne.hennecke(at)mc-services.eu
The Leukemia & Lymphoma Society
Andrea Greif
Tel.: +1 914 821 8958
andrea.greif(at)lls.org
About The Leukemia & Lymphoma Society
The Leukemia & Lymphoma Society ® (LLS) is the world's largest voluntary health
agency dedicated to blood cancer. The LLS mission: Cure leukemia, lymphoma,
Hodgkin's disease and myeloma, and improve the quality of life of patients and
their families. LLS funds lifesaving blood cancer research around the world and
provides free information and support services.
Founded in 1949 and headquartered in White Plains, NY, LLS has chapters
throughout the United States and Canada. To learn more, visit www.LLS.org.
Patients should contact the Information Resource Center at (800) 955-4572,
Monday through Friday, 9 a.m. to 6 p.m. ET.
About TandAbs and AFM13
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 tumor cells and
specifically activate immune effector cells such as cytotoxic T-cells or natural
killer (NK) cells in the presence of tumor 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.
The TandAb® AFM13 is specifically designed to treat CD30-positive malignancies.
It targets CD30 on malignant cells and CD16A on NK-cells. The simultaneous
binding to both cells leads to an effective lysis of the tumor cells. In
cytotoxicity assays, AFM13 has been shown to possess higher potency than
antibody-dependent cell-mediated cytotoxicity (ADCC)-enhanced CD30 IgGs. A
robust production process for AFM13 has been established with excellent
stability of the drug substance and drug product.
About Hodgkin Lymphoma
Hodgkin lymphoma (HL) 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. HL has a yearly incidence of about 9,000 new patients in the US.
Despite the strong potential for recovery at the early stage of the disease,
therapeutic approaches have so far been insufficient with regard to those
patients who do not respond to aggressive chemo- and radiotherapy. Due to the
severe side effects and the toxicity of this combined chemo- and radiotherapy,
there is a great need for new and less toxic medical treatments.
About Affimed Therapeutics AG
Affimed Therapeutics AG is developing unique bispecific antibody therapeutics as
novel treatments for life threatening diseases with high unmet medical needs.
The company has generated a growing pipeline of drug candidates based on its
proprietary TandAb® antibody platform. Affimed's product candidates are
developed for the treatment of CD19-positive (AFM11) and CD30-positive tumors
(AFM13). Further novel product candidates are in development to treat solid
tumors and autoimmune diseases. Affimed's 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. Affimed, through its subsidiary
Amphivena, recently entered into a collaboration with Janssen Biotech to develop
a bispecific TandAbs® for the therapy of an undisclosed hematologic tumor. The
private company Affimed, which employs 33 people in Heidelberg, is a spin-off
from the German Cancer Research Centre (DKFZ), Heidelberg.
Press release (PDF):
http://hugin.info/142251/R/1729189/577749.pdf
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Source: Affimed Therapeutics AG via Thomson Reuters ONE
[HUG#1729189]
Unternehmensinformation / Kurzprofil:
Datum: 16.09.2013 - 09:38 Uhr
Sprache: Deutsch
News-ID 296733
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contact information:
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