Key Developments For Antigenics Inc.
Antigenics Inc. (AGEN.O) (Consolidated Issue listed on NASDAQ Capital Market)
Antigenics, Inc. Announces European CHMP Formally Adopts Negative Opinion On Oncophage
Antigenics, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), has formally adopted a negative opinion on the marketing authorization application (MAA) for Oncophage (vitespen) as a treatment in earlier-stage, localized renal cell carcinoma (kidney cancer). A negative vote of the CHMP indicating this opinion was verbally conveyed to Antigenics and announced in a press release issued on October 21, 2009. Based on this opinion, Antigenics has decided to withdraw its Marketing Authorization Application and to evaluate its options going forward, including a potential re-filing at a later date. A decision to re-file would be dependent on outcomes following meetings with health authorities in individual European countries and with the EMEA, as well as based on further accumulation and review of clinical data. In the meantime, Antigenics is hopeful that it will be in a position to supply Oncophage, as requested, under a named patient program in Europe, in addition to its ongoing commercial efforts in Russia and named patient programs elsewhere globally.
Antigenics, Inc. Updates On Phase 2 Clinical Trial Of Oncophage (vitespen) For recurrent High Grade Glioma
Antigenics, Inc. announced that the Brain Tumor Research Center at the University of California, San Francisco (UCSF), has presented an update on a Phase 2 clinical trial of Oncophage (vitespen) for recurrent high grade glioma (brain cancer) at the2009 Joint Meeting of SNO (Society for Neuro-Oncology) and AANS/CNS Section on Tumors 2009 in New Orleans, LA. Data were presented in Sunrise Session #6: Immunotherapy: Current Status of Clinical Trials on October 24. Data reported in the first 20 patients treated with Oncophage show a median survival of 10.1 months. While survival data continues to accrue on all patients in the study, to date six patients (30%) have survived at or beyond 12 months. These early data show an improvement in overall survival over the previous long standing historical median survival of 6.5 months, and slightly favorable to the recently reported median survival of 9.2 months1 with bevacizumab (Avastin) in patients with recurrent high-grade glioma. The Phase 2 single-arm trial is designed to enroll about 50 patients with recurrent high-grade glioma. The overall goal of this NIH-sponsored, investigator-initiated, open-label study is to evaluate median overall survival, progression-free survival and immunologic response to vaccine treatment. Patients undergo surgery to remove their tumors, which are then used to manufacture their patient-specific vaccines.
Antigenics, Inc. Announces Negative Vote From CHMP on Oncophage Marketing Application in Europe
Antigenics, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP), of the European Medicines Agency (EMEA), has verbally informed the Company at an oral meeting to anticipate a negative opinion on the marketing authorization application (MAA) for Oncophage (vitespen) in early-stage, localized renal cell carcinoma (kidney cancer). Antigenics will evaluate its options, including an appeal of this decision, after the CHMP has formally adopted an opinion at the November 2009 plenary meeting. The patient population for which approval is being sought represents a major unmet medical need. There are no approved drugs in Europe or the United States for the post-surgical treatment of adjuvant kidney cancer, a disease characterized by a high risk of recurrence. Antigenics believes clinically relevant benefits were demonstrated with Oncophage in both recurrence-free survival and overall survival endpoints and that this benefit has persisted for nearly five years.
Antigenics, Inc. Announces Expansion Of QS-21 License Agreement
Antigenics, Inc. announced that the Company has signed an amended and restated license agreement for the use of the QS-21 adjuvant in a vaccine under development by JANSSEN Alzheimer Immunotherapy, a company which has acquired substantially all of the assets and rights of Elan related to its Alzheimer's Immunotherapy Program (AIP). Under the terms of the Elan agreement, which has now been assigned to JANSSEN Alzheimer Immunotherapy, JANSSEN will have the right to use QS-21 in the development and commercialization of ACC-001, a vaccine for Alzheimer's disease currently in Phase 2 trials. In addition, they will now have the right to manufacture QS-21 for this indication, and Antigenics will have no further supply obligations. Under the terms of the agreement, Antigenics will receive an upfront payment; will be entitled to payments contingent upon successful milestone achievements; and royalties on net sales of ACC-001 for a period of at least 10 years after first commercial sale.
Antigenics, Inc. to Raise $10 Million in Private Placement
Antigenics, Inc. announced that it has entered into definitive agreements to sell in a private placement approximately 4.4 million shares of its common stock at a price of $2.28 per share, resulting in gross proceeds to the Company of $10 million, before deducting placement agent fees and other offering expenses. The investors in this private placement will also receive six-month warrants to purchase up to approximately 2.2 million additional shares of common stock at an exercise price of $2.31 per share and 4 year warrants to purchase up to approximately 2 million additional shares of common stock at an exercise price of $2.50 per share. The warrants are not exercisable for the first six months following closing. The closing of the offering is subject to certain conditions, and is expected to occur on or about August 4, 2009. Rodman & Renshaw, LLC, a wholly owned subsidiary of Rodman & Renshaw Capital Group, Inc., served as the exclusive placement agent for the offering and Wharton Capital Partners, a New York based investment banking firm, served as the Company`s financial advisor for the private placement. Proceeds from the financing will be used primarily for funding key commercial and regulatory efforts.
