UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): December 8, 2014

 

ADVAXIS, INC.

(Exact name of registrant as specified in its charter)

 

Delaware		00028489		02-0563870
(State or other jurisdiction		(Commission		(IRS Employer
of incorporation)		File Number)		Identification No.)

 

305 College Road East Princeton, New Jersey		08540
(Address of principal executive offices)		(Zip Code)

 

Registrant’s telephone number, including area code: (609) 452-9813

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

[  ]   Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

[  ]   Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

[  ]   Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

[  ]   Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 

Item 7.01 Regulation FD Disclosure.

 

A copy of the press release of Advaxis, Inc. (the “Company”) dated December 8, 2014 relating to the announcement discussed in Item 8.01 below is attached hereto as Exhibit 99.1.

 

The information furnished pursuant to this Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities under that Section and shall not be deemed to be incorporated by reference into any filing of the Company under the Securities Act of 1933 or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

 

Item 8.01 Other Events.

 

On December 8, 2014, the Company announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug application to conduct a Phase 1/2 clinical study to evaluate the combination of ADXS-PSA (ADXS31-142) with KEYTRUDA® (pembrolizumab), marketed by Merck & Co., Inc., in patients with previously treated, metastatic castration-resistant prostate cancer (mCRPC). The clinical trial, which will be the first-in-human study of the Company’s lead Lm-LLO immunotherapy product candidate in prostate cancer, is expected to begin patient enrollment in the first quarter of 2015.

 

Exhibit No.		Description
99.1		Press Release dated December 8, 2014.

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

	ADVAXIS, INC.
	By:	/s/ Daniel J. O’Connor
	Name:	Daniel J. O’Connor
	Title:	Chief Executive Officer

 

Date: December 10, 2014

 

 

EXHIBIT INDEX

 

Exhibit No.		Description
99.1		Press Release issued by the Company on December 8, 2014.