??? CR011 gegen Brustkrebs - encouraging results from Curagen ??? - 500 Beiträge pro Seite

[[KERN]Codex]

Curagen 911839



Pipeline

CR011-vcMMAE
CR014-vcMMAE

CuraGen to Present CR011-vcMMAE Data at ASCO
-- - Update from Advanced Breast Cancer and Melanoma Studies -- - Conference Call to be Hosted on Wednesday, June 3, 2009 at 11:00 am

BRANFORD, Conn., May 28, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- CuraGen Corporation (Nasdaq: CRGN) today announced plans for three data presentations from its ongoing clinical trials of CR011-vcMMAE, an antibody-drug conjugate that targets GPNMB, in patients with advanced breast cancer and melanoma at the 2009 Annual Meeting of the American Society of Clinical Oncology (ASCO) in Orlando, Florida.

The titles, dates, and times of the presentations are as follows:

#9032 A phase I/II study of CR011-vcMMAE, an antibody-drug conjugate targeting glycoprotein NMB in patients with advanced melanoma. Sunday, May 31, 2009, poster presentation from 8:00 AM - 12:00 PM with a discussion session from 11:30 AM - 12:30 PM.

#9063 Pharmacokinetics of CR011-vcMMAE, an antibody-drug conjugate, in a phase I study of patients with advanced melanoma. Monday, June 1, 2009, poster presentation from 8:00 AM - 12:00 PM.

#1067 A phase I/II study of CR011-vcMMAE, an antibody-drug conjugate, in patients with locally advanced or metastatic breast cancer. Monday, June 1, 2009, poster presentation from 1:00 PM - 5:00 PM.

Abstracts are available and can be viewed on the ASCO Web site at www.asco.org.

http://www.curagen.com/

STRONG BUY

Conclusions:

CR011-vcMMAE is a fully-human monoclonal antibody-drug
conjugate that targets GPNMB, a protein overexpressed in
melanoma and other cancers
Preliminary data in this ongoing study demonstrate that CR011-
vcMMAE is active in patients with advanced melanoma
Objective responses and tumor reduction were observed
4.5 month PFS in this advanced population is favorable
compared with historical data
Skin rash is associated with prolonged progression-free
survival
GPNMB expression in patient biopsies is being evaluated
Half-life (~40 hours) supports exploration of more frequent
dosing



Curagen – Impressive activity in breast cancer

Curagen (CRGN) will present data from a phase II study evaluating its only clinical candidate, CR011-vcMMAE (CR011). CR011 is an antibody drug conjugate (ADC) that targets a protein called GPNMB, which has been recently implicated in breast cancer. It comprises a potent drug linked to an antibody that binds specifically to cancer cells and release its toxic payload once inside the cell. CR011 has already shown encouraging activity in melanoma, but the real catalyst could be results from a phase II study in breast cancer.

We decided to add Curagen to the biotech portfolio several months ago, after the company stated it was seeing early signs of activity in the trial. The abstract submitted by the company includes only preliminary results, but it certainly looks like Curagen’s drug has activity in breast cancer. The abstract reveals marked tumor shrinkage in two out of 10 evaluable patients. The first responder had a 51% shrinkage but shortly relapsed while the second responder had a 37% tumor shrinkage which was yet to be confirmed as an objective response due to short follow up.

Albeit preliminary, the results are extremely positive due to several reasons. The patients on this study represented a particularly challenging patient population with terminal stage, highly resistant disease. Patients who enroll to early stage clinical trials are typically patients who have been pretreated with several lines of approved treatments, but exhausted all available treatment options. The CR011 trial included patients who had received a median of 7(!) prior regimens, a high number even in comparison to other clinical trials in this setting. In addition, Curagen enrolled patients regardless of whether they express GPNMB, the target that CR011 binds. Tumors that do not express high levels of the protein will probably be less sensitive to CR011, similarly to the case with Herceptin and its target, Her2.

GPNMB is believed to be highly expressed only in a subset breast cancer cases (~25%), so statistically, the majority of patients cannot derive benefit from the drug. In light of this fact, tumor shrinkage in two out of 10 patients is highly encouraging. The abstract mentions that GPNMB expression was measured during the trial, so it would be interesting to see whether a correlation between response and expression level of the protein was observed.

Curagen will probably present results for additional patients at the conference itself. If CR011 signs of activity are observed in additional patients, Curagen, which owns the global commercial rights for the drug, could find itself with one of the hottest agents in the industry. The next step would be signing a lucrative partnership deal, in order to finance late stage clinical development.

Another stock that could benefit from strong CR011 data is Seattle Genetics (SGEN), who provided the underlying technology for this ADC. In addition, Seattle Genetics will have data from a phase I trial for its wholly owned ADC, SGN-35.

http://seekingalpha.com/article/139756-top-biotech-picks-for…

grüße

[Larry_1]

Antwort auf Beitrag Nr.: 37.277.421 von [KERN]Codex am 28.05.09 22:51:29

Danke für den Hinweis

[[KERN]Codex]

6:55AM CuraGen to be acquired by Celldex Therapeutics in a tax-free stock-for-stock transaction, which values CuraGen at approximately $94.5 mln (CRGN) 1.25 : Celldex Therapeutics (CLDX) announces it has entered into a definitive agreement to acquire CRGN. Celldex will acquire CuraGen in a tax-free stock-for-stock transaction, which values CuraGen at approximately $94.5 mln, subject to certain adjustments described within the definitive agreement. The purchase price payable in this transaction is subject to certain adjustments described within the definitive agreement, including a collar of between 32.5% and 58% of Celldex's outstanding common stock. The transaction, which is subject to the receipt of CuraGen and Celldex stockholder approvals and other customary closing conditions, is expected to be completed in the third quarter of 2009. CuraGen is expected to deliver $68.6 mln in cash, net of acquisition-related costs, including transaction fees and severance payments and a closing balance sheet adjustment. At the close of the transaction, Celldex will assume $14.1 mln of CuraGen's 4% convertible debt due in February 2011, resulting in an expected $54.5 mln of net cash. The Boards of Directors of each of Celldex and CuraGen have approved the transaction and unanimously recommended that their stockholders approve the transaction.

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