Key Developments: Vical Inc (VICL.OQ)
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Latest Key Developments (Source: Significant Developments)
Vical Inc Announces Appointment Of Acting CFO-Form 8-K
Vical Inc reported in its Form 8-K that as previously reported, Jill M. Broadfoot resigned from her positions as the Company’s Senior Vice President, Chief Financial Officer (CFO) and Secretary effective as of the close of business on April 1, 2013. On April 12, 2013, the Board of Directors appointed Vijay B. Samant, the Company’s President and Chief Executive Officer (CEO), as acting Chief Financial Officer (CFO) while the Company engages in a search for a permanent Chief Financial Officer. Full Article
Vical Inc Announces Resignation Of CFO-Form 8-K
Vical Inc reported in its Form 8-K that on March 15, 2013, Jill M. Broadfoot notified that she was resigning as the Company’s Senior Vice President, Chief Financial Officer (CFO) and Secretary. On the same date, the Company entered into a separation agreement with Ms. Broadfoot. Pursuant to the terms of the separation agreement, Ms. Broadfoot’s last day of employment will be April 1, 2013. Full Article
Vical Inc Licenses DNA Immunization Technology And Vaxfectin ADJUVANT TO Bristol-Myers Squibb For Use In Antibody Production
Vical Inc announced a worldwide, nonexclusive license to Bristol-Myers Squibb Company of Vical's patented platform DNA immunization technology and its Vaxfectin adjuvant for use in the production of antibodies. Under the agreement, Bristol-Myers Squibb will use Vical's technology to generate antibodies with potential therapeutic uses in humans. Vical will also provide specified quantities of the Vaxfectin adjuvant to Bristol-Myers Squibb from time to time. Financial terms of the agreement were not disclosed. Full Article
U.S. Navy Advances Dengue DNA Vaccine Using Vical Inc's Vaxfectin Adjuvant
Vical Inc announced that the Naval Medical Research Center (NMRC) has initiated a Phase 1 human clinical trial of a tetravalent dengue DNA vaccine formulated with the company's Vaxfectin adjuvant. The trial is based on exciting efficacy data from a nonhuman primate study recently published in the journal Vaccine1. Vical manufactured the vaccine and the adjuvant for both the preclinical and clinical studies, and is providing regulatory and clinical staff to NMRC for the dengue program. Under a prior Collaborative Research and Development Agreement (CRADA) with Vical, NMRC developed a tetravalent DNA vaccine (TVDV) containing genes encoding the pre-membrane and envelope proteins for all four serotypes of dengue virus, and formulated with Vical's Vaxfectin adjuvant. Both Vaxfectin formulated and unformulated vaccines are being evaluated in Phase 1 human testing. A total of 40 subjects will be assigned to three dose groups: a low dose TVDV without adjuvant, a low dose TVDV with Vaxfectin adjuvant, or a high dose TVDV with Vaxfectin adjuvant. Vaccines will be administered by intramuscular injections on days 0, 30 and 90, with follow-up through approximately one year. Full Article
Vical Incorporated Prices Public Offering Of Common Stock
Vical Incorporated announced the pricing of an underwritten public offering of 13,333,334 shares of its common stock at a price to the public of $3.75 per share. The gross proceeds to us from this offering are expected to be approximately $50 million, before deducting underwriting discounts and commissions and other estimated offering expenses payable by us. The offering is expected to close on or about January 11, 2012, subject to customary closing conditions. Citigroup, Credit Suisse Securities (USA) LLC and Leerink Swann LLC are acting as joint book-running managers and Rodman & Renshaw, LLC is acting as co-manager in the offering. Vical has granted the underwriters a 30-day option to purchase up to an aggregate of 2,000,000 additional shares of common stock. Vical anticipates using the net proceeds from the offering for general corporate purposes, including clinical trial expenses, research and development expenses and other working capital. Full Article
Vical Incorporated Announces Proposed Public Offering Of Common Stock
Vical Incorporated announced that it intends to offer and sell shares of its common stock in an underwritten public offering. Citigroup, Credit Suisse Securities (USA) LLC and Leerink Swann LLC are acting as joint book-running managers and Rodman & Renshaw, LLC is acting as co-manager in the offering. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. The securities described above are being offered by Vical pursuant to two shelf registration statements previously filed with and declared effective by the Securities and Exchange Commission (the SEC) on May 20, 2009, and January 29, 2010. Full Article
Vical Incorporated Reports Prophylactic and Therapeutic Efficacy With Herpes Simplex Vaccines In Guinea Pig Model
Vical Incorporated announced that its Vaxfectin-formulated plasmid DNA (pDNA) vaccines against herpes simplex virus type 2 (HSV-2) provided complete protection in guinea pigs against both primary and recurrent HSV-2 disease. The vaccines also significantly reduced genital lesion recurrence and viral shedding as well as latent infection in the central nervous system. Data from multiple prophylactic and therapeutic animal studies demonstrated; Prophylactic pDNA vaccines encoding HSV-2 glycoprotein D (gD) alone or encoding gD plus the HSV-2 tegument proteins UL46 and UL47 provided complete protection from both primary and recurrent disease (p<0.001); Both prophylactic vaccines significantly reduced viral replication at the primary infection site (p<0.001); Both prophylactic vaccines significantly reduced detectable HSV-2 infection at the latent site (p<0.001 for gD alone and p<0.0001 for gD/UL46/UL47); The therapeutic pDNA vaccine encoding gD plus UL46 and UL47 significantly reduced the frequency of genital lesion outbreaks in animals with pre-established HSV-2 infections (p<0.05); The therapeutic vaccine significantly reduced the frequency of genital viral shedding (p<0.05). Vical is collaborating with the University of Washington School of Medicine and the Sealy Center for Vaccine Development at the University of Texas Medical Branch under a previously disclosed grant on the preclinical development of a HSV-2 vaccine formulated with Vical's Vaxfectin adjuvant. Full Article
Vical Incorporated's Allovectin Demonstrates Synergistic Efficacy With Anti-CTLA-4 Antibody In Melanoma Animal Model
Vical Incorporated announced encouraging animal data demonstrating a synergistic improvement in efficacy using a combination of the Company's Allovectin immunotherapy with an anti-CTLA-4 antibody. Treatment with Allovectin plus anti-CTLA-4 antibody provided a synergistic reduction of tumor growth compared with either treatment alone (both p<0.001). Synergy became evident about 12 days after treatment initiation, suggesting a likely two-step process in which Allovectin first directs T cells to target the melanoma tumor and anti-CTLA-4 antibody then maximally activates these T cells. Treatment with Allovectin plus anti-CTLA-4 antibody provided a positive trend in survival compared with either treatment alone. Allovectin alone significantly reduced tumor growth and significantly increased survival time compared with anti-CTLA-4 antibody treatment alone and compared with no treatment (all p<0.001). The study was conducted in a well-accepted melanoma mouse model using a standard mouse equivalent of human anti-CTLA-4 antibodies such as ipilimumab. Cohorts included untreated mice, mice treated with Allovectin alone, mice treated with anti-CTLA-4 antibody alone, and mice treated with Allovectin plus anti-CTLA-4 antibody. Dosing for Allovectin was a single cycle of once per day for the first four days. The study tracked growth of implanted melanoma tumors and survival. Results were encouraging and support further evaluation of such combination treatment in human clinical trials. Full Article
Vical Incorporated Announces Key International Patents For Vaxfectin Adjuvant
Vical Incorporated announced the issuance of Canadian Patent Number 2,365,416 and Japanese Patent Number 4,800,485 covering Vical's cationic lipid/co-lipid adjuvant, Vaxfectin. Specific claims include composition of the Vaxfectin adjuvant, composition of Vaxfectin-formulated vaccines, and methods for their use. The new patents add to Vical's existing U.S. and European patent coverage for Vaxfectin and to Vical's family of core technology patents broadly covering gene-based vaccines and therapeutics. Full Article

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