US Biotech noch etwas weit von Vermarktung, aber geil .... - 500 Beiträge pro Seite

[dottore]

NEEDHAM, Mass.--(Business Wire)--
Celldex Therapeutics, Inc. (NASDAQ: CLDX) today announced that the first patient
has been dosed in a Phase 1/2 study of its vaccine candidate, CDX-1401, in
patients with malignant solid tumors that express NY-ESO-1. CDX-1401 is a fully
human monoclonal antibody designed to selectively deliver the NY-ESO-1 antigen
to dendritic cells to generate a robust immune response against cancer cells
expressing NY-ESO-1. NY-ESO-1 is a tumor-associated antigen (TAA) expressed by
several different types of cancers including lung, ovarian, prostate, bladder,
melanoma, liver and esophageal cancers as well as multiple myeloma.

The Phase 1/2 study is a dose-escalating clinical trial aimed at determining the
optimal dose for further development based on the safety, tolerability, and
immunogenicity of the CDX-1401 vaccine. The trial will evaluate three different
doses of the vaccine in combination with resiquimod, an activator of toll-like
receptors 7 and 8. The study will accrue approximately 36 patients with solid
tumor cancers expressing the NY-ESO-1 antigen and will follow each subject for
six months post-treatment. The study is being conducted at multiple clinical
sites in the United States, including Yale University, Henry Ford Health System
and Cornell University.

"CDX-1401 is Celldex`s third clinical product and the second program generated
by the Company`s proprietary Precision Targeted Immunotherapy (PTI) Platform,"
stated Anthony Marucci, President and CEO of Celldex Therapeutics. "The PTI
Platform embodies what we believe to be the future of treatment for life
threatening and debilitating diseases through a combination immunotherapy
approach."

"NY-ESO-1 is an excellent target for Celldex`s PTI Platform because it is
expressed in many cancers and is known to be one of the most immunogenic tumor
antigens - creating a promising clinical opportunity," said Tom Davis, MD, Chief
Medical Officer of Celldex Therapeutics. "Our PTI Platform includes proprietary
immunomodulators and human monoclonal antibodies to dendritic cell receptors,
which are used to deliver antigens directly to dendritic cells in the body. This
technology takes advantage of many important characteristics of monoclonal
antibodies, including their specific targeting capability, which helps focus the
immune system on the cancer."

Celldex`s PTI Platform combines synergistic technologies to fuel the rational
design of new therapeutics and targeted treatment regimens that maximize the
beneficial aspects of the immune system. The Company`s focus is on the use of
tumor-specific targets and human monoclonal antibodies to precisely deliver
therapeutic agents through their novel targeted immunization approach. Celldex`s
deep pipeline consists of product candidates in varying stages of development,
with lead candidate CDX-110, partnered with Pfizer, currently undergoing
evaluation in a Phase 2 clinical trial in newly diagnosed glioblastoma
multiforme (GBM), CDX-1307, currently enrolling in a Phase 1 study in epithelial
tumors and now CDX-1401, currently enrolling in a Phase 1/2 study in malignant
solid tumors that express NY-ESO-1.

About the CDX-1401 Vaccine

CDX-1401 is a cancer vaccine designed to activate the patient`s immune system
against cancers that express the tumor marker, NY-ESO-1. The product consists of
a fully human monoclonal antibody with specificity for the dendritic cell
receptor, DEC-205, genetically linked to the NY-ESO-1 tumor antigen. Celldex has
accessed NY-ESO-1 through a multi-year clinical research collaboration with the
international Ludwig Institute for Cancer Research. By selectively delivering
the NY-ESO-1 antigen to dendritic cells in the body, this product is intended to
induce robust immune responses against the antigen-expressing cancer cells. This
is the first DEC-205 targeted vaccine to enter clinical trials and will be
combined with resiquimod (a toll-like receptor 7/8 agonist) as an adjuvant

[Latinl]

Antwort auf Beitrag Nr.: 37.976.900 von dottore am 14.09.09 18:58:21

aber geil

ja ich muß sagen .. da kribbelt schon was in mir

[yxcv1234]

Antwort auf Beitrag Nr.: 37.979.551 von Latinl am 15.09.09 09:28:12

Achtung NEWS !!!

Heute könnte der Kurs noch stark anspringen, wenn die Wallstreet öffnet:

December 14, 2009 1:37 AM

Celldex Therapeutics presents positive results
from Ph. 2 study of the antibody-drug conjugate product candidate CDX-011 in advanced breast cancer Co announces the results of a positive Phase 2 study of CDX-011 (formerly CR011-vcMMAE), in patients with heavily pre-treated, locally advanced or metastatic breast cancers. As presented at the 32nd Annual CTRC-AACR San Antonio Breast Cancer Symposium, the primary efficacy endpoint for the study has been met with significant antitumor activity in patients whose tumors express the target GPNMB. In addition, encouraging results were seen in patients with "triple-negative disease" where treatment options are relatively limited due to lack of hormone receptor or HER2-neu expression.

[yxcv1234]

Antwort auf Beitrag Nr.: 38.562.022 von yxcv1234 am 14.12.09 12:13:17

Nach starkem Start ist leider nur ein mikrikes Plus geblieben. Mal schauen ob der Kurs dennoch in Kürze anspringt.
In anderen ähnlichen Fällen sind Investoren (u.a. durch Börsenbriefe) erst Tage später aktiv geworden.