--Data Strongly Support Ongoing Phase 3 Clinical Program--
--Data Presented at Society for Neuro-Oncology's (SNO) 17th Annual Scientific Meeting and Education Day--
|Rindopepimut Overall Survival (OS) Across Three Phase 2 Studies in EGFRvIII-Positive Glioblastoma vs Independent Control Datasets|
|Rindopepimut Phase 2 Studies (all data from study entry)|
|OS 3 years|
|ACT III (n=65)||21.8||26%|
|ACT II (n=22)||20.5||23%|
|Independent Control Datasets (all data from study entry)|
MD Anderson EGFRvIII-positive patients matched1 to
ACTIVATE patient population (n=17)
(contemporary with ACTIVATE)
(contemporary with ACT III)
RTOG 0525 study - all EGFRvIII-positive patients treated with
standard dose temozolomide (n=62)
(contemporary with ACT III)
RTOG 0525 study - EGFRvIII-positive patients matched1 to
ACT III/IV patient population (n=29)
(contemporary with ACT III)
1Controls are closely matched to rindopepimut patient criteria including gross total resection of patient tumor and ~3 months without disease progression at time of study entry; 2In order to provide comparable timeframes across datasets, data have been estimated assuming study entry at three months from diagnosis.
"The long-term survival data across all three rindopepimut Phase 2
clinical trials are consistent and suggest that rindopepimut is
providing long-term survival beyond what is historically seen in this
subset of EGFRvIII-expressing glioblastoma patients—a group that
typically has more aggressive disease associated with a worse prognosis
than the general glioblastoma patient population," said
In addition to the presentation of updated survival data, Celldex also announced the presentation of data from a retrospective analysis of EGFRvIII expression status and associated clinical outcome in the Phase 3 Radiation Therapy Oncology Group's (RTOG) 0525 study. This analysis was conducted by The University of Texas MD Anderson Cancer Center in cooperation with RTOG to provide an assessment of the prognosis for patients with EGFRvIII-positive disease contemporary with the ACT III data.
"The RTOG 0525 data continue to demonstrate that patients with
EGFRvIII-positive glioblastoma fare worse than the general glioblastoma
patient population, particularly when it comes to long-term survival,"
"The results presented at SNO provide further validation for the
rindopepimut clinical program," said
The data announced today were presented at the Society for
Neuro-Oncology's (SNO) 17th Annual Scientific Meeting and Education Day
Rindopepimut is an investigational immunotherapeutic vaccine that targets the tumor-specific molecule epidermal growth factor receptor variant III (EGFRvIII). EGFRvIII is a mutated form of the epidermal growth factor receptor (EGFR) that is only expressed in cancer cells and not in normal tissue and is a transforming oncogene that can directly contribute to cancer cell growth. Expression of EGFRvIII is linked to poor long-term survival regardless of other factors such as extent of resection and age. EGFRvIII is expressed in approximately 30% of glioblastoma tumors. Celldex is actively enrolling two clinical studies of rindopepimut—a Phase 3 international study called ACT IV in patients with newly diagnosed EGFRvIII-positive glioblastoma and a Phase 2 study called ReACT in patients with recurrent EGFRvIII-positive glioblastoma. Drs. Sampson and Mitchell have a patent that has been licensed by Celldex and may receive royalties related to sales of this immunotherapeutic vaccine.
Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995: This release contains "forward-looking statements" made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including those related to the Company's strategic focus and the future development and commercialization (by Celldex and others) of rindopepimut (CDX-110), CDX-011, CDX-1135, CDX-1401, CDX-1127, CDX-301, Belinostat and other products. Forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our limited cash reserves and our ability to obtain additional capital on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials that we have initiated or plan to initiate; our ability to adapt APC Targeting TechnologyTM to develop new, safe and effective vaccines against oncology and infectious disease indications; our ability to successfully complete product research and further development of our programs; the uncertainties inherent in clinical testing; our limited experience in bringing programs through Phase 3 clinical trials; our ability to manage research and development efforts for multiple products at varying stages of development; the timing, cost and uncertainty of obtaining regulatory approvals; the failure of the market for the Company's programs to continue to develop; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and other factors listed under "Risk Factors" in our annual report on Form 10-K.
All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise.
Vice President of IR & Corp Comm
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