Pfizer is returning the rights to rindopepimut (CDX-110), a therapeutic cancer vaccine, to Celldex Therapeutics. Pfizer, which gained rights to the drug as part of $440 million deal in 2008, says it’s returning the rights because the drug is “no longer a strategic priority” for the company, raising questions about the viability of the program and sending Celldex’s stock down sharply. Researchers are evaluating rindopepimut as a potential treatment for glioblastoma multiforme, a common type of brain tumor.

Celldex will regain full worldwide rights to develop and commercialize rindopepimut. The company says it plans to move ahead with more trials of the drug. TheStreet notes that as of June 30, Celldex had $65.8 million in its coffers; it will have to draw upon that nest-egg to fund late-stage trials of rindopepimut.

The general prognosis for anyone diagnosed with malignant glioma is poor, and patients generally have up to three years to live following diagnosis. “There is a significant need for new therapies for GBM and we are fully committed to developing rindopepimut for the patients who suffer from this fatal disease,” says Celldex President and CEO Anthony Marucci. “[T]he program has advanced significantly, including the completion of a multi-center Phase II study, the development of a diagnostic companion product, the manufacture of drug supply for clinical studies, and the execution of discussions with regulatory agencies on the design of a global controlled study.”

Source: FierceBiotech

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Plenty of more early-stage and mid-stage study results came to light at ASCO over the past day. Here are some of the highlights:

• ArQule said that its lung cancer drug flunked a mid-stage study, but it flagged some positive results for a subset of patients taking the therapy. About two thirds of the patients taking a combination of ARQ-197 and Tarceva demonstrated an improvement in survival rates, but that wasn’t enough to give it a significant statistical edge over Tarceva alone. Patients with non-squamous tumors, though, had a 47 percent increase in progression-free survival.

• Celldex Therapeutics reported yesterday that its skin cancer drug CDX-011 met its goals in a mid-stage study. Researchers tracked a 15 percent overall response rate among the 34 patients enrolled in the study. More frequent dosing was also linked to higher response rates.

• GTx, meanwhile, reported that its drug Ostarine improved the quality of life among patients suffering from muscle loss. The drug was linked to improved functional performance and increased muscle mass in a mid-stage study. GTx plans to map out a late-stage study this summer.

• Ariad Pharmaceuticals produced promising early-stage results for a leukemia drug. Researchers say that they have recorded promising signs of “beneficial and durable” responses among patients taking the drug. A pivotal trial is planned later this year.

Source: FierceBiotech

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Last night’s data dump ahead of ASCO produced a treasure trove of information, but few signs of any dramatic leap or pratfall. Among the highlights:

Eli Lilly reported that a handful of patients in a small mid-stage study of its melanoma drug tasisulam demonstrated a partial response–in which a tumor or lesion shrank–to the therapy. Tested in patients with metastatic melanoma, a virtual death sentence, 24 of 68 patients experienced no disease progression after two treatment cycles, 25 saw their condition worsen during treatment, and 11 couldn’t be fully evaluated. Median overall survival hit 9.6 months.

Exelixis’ VEGF blocker XL184-which is partnered with Bristol-Myers Squibb-helped a majority of patients fight the deadly brain cancer glioblastoma. Patients who had no prior therapy went 16 weeks without disease progression, slightly more than twice as long as the patients who had been previously treated. And 82 percent demonstrated a response, with at least partial tumor shrinkage. In addition to VEGF, XL184 also blocks mesenchymal epithelial transition growth factor, which has been linked to faster tumor growth.

Eisai released some promising data on its cancer drug eribulin, with positive results in three trials for breast, colon and urinary cancer. Twenty-one percent of the 81 breast cancer patients in one trial demonstrated a response to the drug, while close to half of the sarcoma patients went three months before tumors began to grow again. Slightly more than a third of the 40 patients treated for urological cancer demonstrated a response. Eisai has already filed for approval in the U.S., Europe and Japan with hopes of seeing the drug go on to achieve blockbuster status.

Celldex Therapeutics reported that a small mid-stage study of an experimental brain cancer vaccine demonstrated that a solid majority of patients–70 percent–were alive and free of any sign of disease progression after 5.5 months. The developer’s chief medical officer told Reuters that usually only 40 percent of brain cancer victims would be at that mark after 5.5 months, but analysts and investors appeared rather skeptical and Celldex shares dropped 20 percent in after-hours trading.

A Phase II study of Amgen’s AMG 386 for recurrent ovarian cancer demonstrated an improvement in median progression-free survival when it was combined with chemotherapy compared with chemotherapy alone. At a high dose patients achieved a 7.2-month median for progression-free survival compared with 5.7 months for the lower dose and 4.6 months for the group receiving only chemotherapy. The therapy works by stunting the growth of blood vessels to tumors.

Bristol-Myers Squibb released new data showing a modest benefit for its lung cancer drug ipilimumab. Median progression-free survival was slightly longer for that drug in combination with chemotherapy compared to a group which had been restricted to chemotherapy alone.

Source: FierceBiotech

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Tomorrow night, the folks at ASCO will do their big abstract dump, showering the biotech world with an advance glimpse at the data that will make a few fortunes and lose others as share prices gyrate in response.

Anyone looking for a primer on how this will play out should check out Adam Feuerstein’s excellent take on TheStreet. Feuerstein notes that Celldex Therapeutics, Keryx and Delcath Systems have already seen their share prices surge ahead of the big science meeting. More tentative increases have been noted for Pharmacyclics, Ziopharm, Arqule and Sunesis.

ASCO offers a closely watched stage for most of the big advances developers make in cancer therapies. Up until recently it limited distribution of the abstracts to its members, and the wizards on Wall Street wasted no time in figuring how to break into that loosely guarded system. As a result, ASCO came up with the public dump.

There will be a lot of scrambling tomorrow as analysts rush to glean who will be this year’s winners and losers. But as Feuerstein observes, the abstracts often provide only a crude and incomplete look at studies that will get a much closer review at the actual meeting.

Source: FierceBiotech

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–CDX-1307 well tolerated with good immune responses observed–

NEEDHAM, Mass. — Celldex Therapeutics, Inc. (CLDX) announced initial results from multi-center Phase 1 clinical trials of its cancer vaccine candidate, CDX-1307, combined with GM-CSF, at the International Society for the Biologic Therapy of Cancer (iSBTc) annual meeting in San Diego. These data provide the basis for the ongoing assessment of CDX-1307 combined with more potent adjuvants with data expected in the first half of 2009.[ad]

“These CDX-1307 data provide further support for the tolerability and immunogenicity of Celldex’s novel Precision Targeted Immunotherapy Platform,” said Thomas Davis, M.D., Chief Medical Officer of Celldex Therapeutics. “We believe that specific immunotherapy combinations will provide even more potent clinical effects and, based on the safety and immunogenicity seen in these dose escalation studies, Celldex is now evaluating CDX-1307 in combination with the experimental Toll-Like Receptor agonists that the Company recently accessed.”

CDX-1307 is a dendritic cell targeted immunotherapy designed to focus the immune system against hCG Beta, which is frequently expressed in epithelial tumors and has been associated with poor prognosis. The Phase 1 studies are open-label, dose-escalating clinical trials in patients with incurable breast, bladder, pancreatic, or colorectal cancer, all tumors that can express hCG Beta. The studies evaluated the safety and immunogenicity of multiple dosing of CDX-1307 alone and in combination with GM-CSF at multiple dose levels. In one dose escalation scheme 25 patients have received CDX-1307 by local intradermal injection at up to 2.5mg, and in the other Phase 1 study 25 patients have received CDX-1307 systemically via intravenous injection at higher doses of up to 30 mg.

CDX-1307 has been well tolerated at all doses and via both routes of administration without any Dose Limiting Toxicity. The most frequent treatment related toxicities were mild flu-like symptoms and mild local reactions associated with the intradermal injections. The hCG Beta was shown to be localized in antigen presenting cells of the skin in post-treatment biopsies following intradermal administration of CDX-1307. Even in the absence of potent adjuvants, humoral immune responses were seen in approximately half of patients at the higher dose levels despite circulating hCG Beta antigen, with reduction or clearance of hCG Beta in some patients. Enhancement of CD8 T-cell responses after vaccination was also seen in some patients. Despite advanced disease in the majority of patients, 2 patients experienced stable disease for at least 6 months and a minor response was seen in a patient with pancreatic cancer.

Based on the safety and immunogenicity seen in the dose escalation studies, Celldex is now evaluating CDX-1307 in combination with the experimental Toll-Like Receptor (TLRs) agonists that the Company recently accessed (poly-ICLC, a TLR 3 agonist, and resiquimod, a TLR 7/8 agonist) and expects results by mid-2009. Celldex then expects to initiate a Phase 2 clinical trial of CDX-1307 in combination with selected TLR agonists in the second half of 2009.

“The CDX-1307 data define the feasibility and tolerability of Celldex’s novel antibody-targeting platform for cancer vaccines, allowing the flexibility to add novel adjuvant combinations such TLR agonists. This will enable the Company to uniquely advance its broad immunotherapy portfolio across a range of disease indications,” added Anthony S. Marucci, President and Chief Executive Officer of Celldex Therapeutics, Inc.

About the CDX-1307 Vaccine

The Company has developed an APC Targeting Technology(TM) that utilizes fully human monoclonal antibodies to directly target specialized types of immune system cells, known as antigen presenting cells. The Company is advancing several clinical and preclinical product candidates that use APC Targeting Technology(TM) to manipulate critical types of antigen presenting cells, known as dendritic cells and macrophages, which are key cells within the immune system. Because these cells are largely responsible for initiating the immune system’s disease-fighting mechanisms, the Company believes that product candidates using its technology will create more potent immune responses than standard vaccination strategies.

The Company’s lead APC Targeting Technology(TM) product candidate, CDX-1307, is in development for the treatment of epithelial tumors such as colorectal, pancreatic, bladder, ovarian and breast cancers. CDX-1307 targets the beta chain of human chorionic gonadotropin, known as hCG-Beta, which is an antigen often found in epithelial tumors. The presence of hCG-Beta in these cancers correlates with a poor clinical outcome, suggesting that this molecule may contribute to tumor growth. Normal adult tissues have minimal expression of hCG-Beta; therefore, targeted immune responses are not expected to generate significant side effects.

About Celldex Therapeutics, Inc.

Celldex Therapeutics is an integrated biopharmaceutical company that applies its comprehensive Precision Targeted Immunotherapy Platform to generate a pipeline of candidates to treat cancer and other difficult-to-treat diseases. Celldex’s immunotherapy platform includes a complementary portfolio of monoclonal antibodies, antibody-targeted vaccines and immunomodulators to create novel disease-specific drug candidates. For more information, please visit http://www.celldextherapeutics.com.

Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995: This release includes forward-looking statements that are subject to a variety of risks and uncertainties and reflect Celldex’s current views with respect to future events and financial performance. There are a number of important factors that could cause the actual results to differ materially from those expressed in any forward-looking statement made by Celldex. These factors include, but are not limited to: (1) the successful integration of the businesses, multiple technologies and programs of Celldex; (2) the ability to adopt Celldex’s APC Targeting Technology(TM) to develop new, safe and effective vaccines against oncology and infectious disease indications; (3) the ability to adapt Celldex’s vectoring systems to develop new, safe and effective orally administered vaccines against disease causing agents; (4) the ability to successfully complete product research and further development, including animal, preclinical and clinical studies, and commercialization of CDX-110, CDX-1307, CholeraGarde(R) (Peru-15), Ty800,ETEC E. coli vaccine, and other products and Celldex’s expectations regarding market growth; (5) the cost, timing, scope and results of ongoing safety and efficacy trials of CDX-110, CDX-1307, CholeraGarde(R) (Peru-15), Ty800, ETEC E. coli vaccine and other preclinical and clinical testing; (6) the ability to negotiate strategic partnerships or other disposition transactions for Celldex’s cardiovascular programs, including TP10 and CETi; (7) the ability of Celldex to manage multiple clinical trials for a variety of product candidates; (8)the volume and profitability of product sales of Megan(R)Vac 1, Megan(R)Egg and other future products; (9)GlaxoSmithKline’s, or Glaxo’s, process of obtaining regulatory approval for the sale of Rotarix(R) in major commercial markets, as well as the timing and success of worldwide commercialization of Rotarix(R) by Glaxo, which is not within our control; (10)Glaxo’s strategy and business plans to launch and supply Rotarix(R) worldwide, including in the U.S. and other major markets, which is not within our control, and its payment of royalties to Celldex; (11)Pfizer’s and our strategy and business plans concerning the continued development and commercialization of CDX-110; (12) Celldex’s expectations regarding its technological capabilities and expanding its focus to broader markets for vaccines; (13) changes in existing and potential relationships with corporate collaborators; (14) the availability, cost, delivery and quality of clinical and commercial grade materials produced at Celldex’s own manufacturing facility or supplied by contract manufacturers and partners; (15) the timing, cost and uncertainty of obtaining regulatory approvals; (16) Celldex’s ability to develop and commercialize products before competitors that are superior to the alternatives developed by such competitors; (17) Celldex’s ability to retain certain members of management;(18) Celldex’s expectations regarding research and development expenses and general and administrative expenses; (19) Celldex’s expectations regarding cash balances, capital requirements, anticipated royalty payments, revenues and expenses, including infrastructure expenses; (20)the ability to obtain substantial additional funding; (21) Celldex’s belief regarding the validity of our patents and potential litigation; and (22) certain other factors that might cause Celldex’s actual results to differ materially from those in the forward-looking statements including those set forth under the headings “Business,” “Risk Factors” and Management’s Discussion and Analysis of Financial Condition and Results of Operations” in each of Celldex’s Annual Report on Form 10-K, its current Reports on Form 8-K, as well as those described in Celldex’s other press releases and filings with the Securities and Exchange Commission, from time to time. You should carefully review all of these factors, and you should be aware that there may be other factors that could cause these differences. These forward-looking statements were based on information, plans and estimates at the date of this press release, and Celldex does not promise to update any forward-looking statements to reflect changes in underlying assumptions or factors, new information, future events or other changes.

Source: Celldex Therapeutics, Inc.

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