DGAP-News: Affimed Therapeutics AG / Key word(s): Study
Affimed Therapeutics AG: Affimed Highlights Further Data on AFM13, a
Bispecific CD30/CD16A TandAb in Development to Treat Hodgkin Lymphoma,
at the 2014 AACR Annual Meeting
10.04.2014 / 09:00
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Phase 1 trial showed that AFM13 has a favorable safety profile and activity
in terms of pharmacodynamics and tumor response
Heidelberg, Germany, April 10, 2014 - Affimed Therapeutics AG announced
today further results from its phase 1 clinical trial of AFM13 as
monotherapy for the treatment of patients with advanced
relapsing/refractory (R/R) Hodgkin lymphoma. AFM13 is a bispecific TandAb
antibody recruiting host natural killer (NK) cells via its CD16A-binding
domains to engage and kill CD30-positive malignant cells.
In the clinical phase 1 study, 28 heavily pretreated patients suffering
from R/R Hodgkin lymphoma received infusions of AFM13 with increasing doses
in the range of 0.01 mg/kg up to 7 mg/kg. AFM13 was administered once
weekly over 4 weeks in the majority of the patients. Primary endpoints were
safety and tolerability. Secondary endpoints were pharmacokinetics,
pharmacodynamics and clinical efficacy. The data were presented by Max
Topp, Professor of Medicine at the University of Wuerzburg, at the AACR
Annual Meeting 2014, San Diego, CA, USA, on April 8, 2014. The presentation
is being made available by AACR via Webcast.
Key Data from AFM13
- AFM13 binds selectively to NK cells through CD16A (FcγRIIIA);
neutrophils carrying CD16B (FcγRIIIB) are not bound
- Cytotoxic potency of AFM13 is consistently higher than those of the
Fc-enhanced and native anti-CD30 IgGs
- Each of the intravenously administered doses of AFM13 was considered
safe and well tolerated, a maximum tolerated dose was not reached
- AFM13 treatment resulted in a significant increase of activated NK
cells in peripheral blood, which was more pronounced at dose levels >=
1.5 mg/kg
- Soluble CD30 values decreased during treatment with AFM13; this effect
was pronounced in patients receiving dose levels >= 1.5 mg/kg AFM13
- Pharmacokinetic data revealed a dose proportional increase of systemic
exposure with a half-life of 10-22 hours
- Clinical activity was observed over all dose levels and included
patients that received prior brentuximab vedotin. Clinical activity was
more pronounced at higher dose levels, and all partial responses (PRs)
were observed at doses >= 1.5 mg/kg
"The clinical phase 1 trial met its primary endpoint and demonstrated that
AFM13 can be administered safely. Clear activity could be demonstrated with
the potential to further maximize the effect by optimizing the dose regimen
and extending the treatment duration," said Jens-Peter Marschner, MD, Chief
Medical Officer of Affimed. "These data are promising, in particular
because there is no alternative treatment option for patients in this
setting. A phase 2 study investigating an optimized dose regimen will be
initiated this year."
For further information please contact:
Affimed Therapeutics AG
Doris Sommer
Phone: +49 6221 65307-0
Fax: +49 6221 65307-77
E-Mail: d.sommer@affimed.com
MC Services AG
Anne Hennecke
Phone: +49 211 529252-22
Fax: +49 211 529252-29
E-Mail: anne.hennecke@mc-services.eu
About Affimed
Affimed Therapeutics AG develops cancer therapies that direct the immune
system to eliminate tumor cells. Its next generation multifunctional
antibodies (TandAbs(R), FlexiBodies(R)) engage two of the most potent
cytotoxic cells of the immune defense arsenal (T-cells or natural killer
(NK) cells) and link them with high affinity and precision to a tumor cell,
thus triggering an attack by the immune cell that ultimately results in the
destruction of the tumor cell. The company is positioned in the promising
and dynamic field of cancer immunotherapy with two fully owned TandAb
products in clinical development. AFM13 targets CD30-positive malignancies,
such as Hodgkin Lymphoma (HL). This program is co-funded by the Leukemia
and Lymphoma Society (LLS). In a phase 1 study, AFM13 has demonstrated a
promising profile in relapsing/refractory refractory HL patients and is
expected to advance into phase 2 studies late 2014. AFM11 targets
CD19-positive malignancies, such as Non-Hodgkin Lymphoma (NHL). A phase 1
study with AFM11 in refractory NHL patients is expected to start in the
second quarter of 2014. In addition, the company has in preclinical
development a program targeting solid tumors through the selective tumor
target Epidermal Growth Factor Receptor, Variant III (EGFRvIII). For more
information, please visit www.affimed.com.
About Affimed's platform technologies
Affimed develops TandAbs and FlexiBodies, both targeted immunotherapies,
with the aim to provide new treatment options to patients. These therapies
are characterized by strong efficacy and high specificity, combined with a
favorable safety profile. The company has three proprietary platforms based
on antibody variable domains:
- NK cell TandAbs - these are tetravalent, bi-functional molecules that
recognize a specific biologic target and utilizing their second
functionality, bind with high affinity to NK cells and thereby direct
the NK cell to eliminate the cancer cell. Affimed's first-in-class
candidate AFM13, which exploits this mode of action, has already shown
a favorable safety profile and promising activity in a phase 1 clinical
study.
- T cell TandAbs - these are tetravalent, bi-functional molecules that
recognize a specific biologic target and utilizing their second
functionality, bind with high affinity to T cells and thereby direct
the T cell to eliminate the cancer cell. AFM11 belongs to this
platform. It has been shown that a T cell engaging mechanism is
effective in patients: in addition to very high response rates, none of
the tumor cells appeared to have survived treatment, even using the
most sensitive detection methods. Such "deep" responses and the removal
of minimal residual disease may translate into better long-term
outcome.
- Tri-specific molecules for dual targeting of tumor cells - these are
tetravalent, tri-functional structures that can be designed to target
two different antigens/epitopes on the tumor cell and with the third
functionality bind with high affinity to either T cells or NK cells.
End of Corporate News
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262511 10.04.2014
DGAP-News: Affimed Therapeutics AG: Affimed Highlights Further Data on AFM13, a Bispecific CD30/CD16A TandAb in Development to Treat Hodgkin Lymphoma, at the 2014 AACR Annual Meeting
| Source: EQS Group AG