8-K

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): November 1, 2010

NEOGENIX ONCOLOGY, INC.

(Exact name of Registrant as Specified in its Charter)

Maryland	0-53963	16-1697150
(State or other jurisdiction of incorporation or organization)	(Commission File Number)	(I.R.S. Employer Identification No.)

445 Northern Boulevard, Suite 24 Great Neck, NY	11021
(Address of Principal Executive Offices)	(Zip Code)

(516) 482-1200

Registrant’s telephone number, including area code

Not Applicable

(Former name or former address, if changed since last report)

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:

¨ 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 8.01. Other Events.

In a letter received by us on October 27, 2010, the United States Food & Drug Administration (FDA) notified us that it has lifted the partial clinical hold placed on the Phase I clinical trial of our lead antibody candidate NPC-1C and that new patients may be enrolled in the trial. The FDA also informed us that it has approved the amendment to our investigational drug application (IND) that we submitted to the FDA on October 7. We believe that new patients will begin to be enrolled in the clinical trial of NPC-1C during the upcoming month.

Also, on November 1, 2010, we issued a press release announcing that the FDA has granted Orphan Drug Designation to our lead antibody candidate NPC-1C (ensituximab) for treatment of pancreatic cancer. A copy of the above referenced press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

See Index to Exhibits attached hereto.

Certain statements in this report are forward looking in nature or “forward looking statements” as defined in the Private Securities Litigation Reform Act of 1995. When used herein, the words “anticipate,” “expect,” “believe,” “intend,” “plan” and “estimate” and similar expressions as they relate to us or our management, are intended to identify forward looking statements. Such statements are based on current expectations about future events, which we have derived from information currently available to us, and involve a number of risks, uncertainties, and other factors that could cause the amendments to the clinical trial protocol or our IND, if any, to differ materially from those stated. A number of those risks, trends and uncertainties are discussed in the company’s SEC reports, including the company’s registration of securities on Form 10 and quarterly report on Form 10-Q. Any forward looking statements in this report should be evaluated in light of these important risk factors. Any forward looking statement speaks only as of the date of this report and, except to the extent required by applicable securities laws, the company expressly disclaims any obligation to update or revise any of them to reflect actual results, any changes in expectations or any changes in events. If the company does update one or more forward looking statements, no inference should be drawn that it will make additional updates with respect to those or any other forward looking statements.

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Signature

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

NEOGENIX ONCOLOGY, INC.
By:	/S/    DR. PHILIP ARLEN
	Dr. Philip Arlen
	Chief Executive Officer

Date: November 1, 2010

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Index to Exhibits

Exhibit Number	Description
99.1	Press Release of the Company dated November 1, 2010

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EX-99.1

Exhibit 99.1

November 01, 2010 10:34 AM Eastern Daylight Time

Neogenix Oncology® Receives FDA Orphan Drug Status for Ensituximab (NPC-1C) for Treatment of Pancreatic Cancer

GREAT NECK, N.Y.—(BUSINESS WIRE)—Neogenix Oncology, Inc. (Neogenix) announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the company’s product candidate ensituximab (monoclonal antibody NPC-1C) for the treatment of pancreatic cancer. The Company initiated in December 2009 a multi-center Phase I clinical trial of ensituximab (NPC-1C) for the treatment of advanced pancreatic and colorectal cancer.

“Receiving orphan drug designation from the FDA is a significant step for Neogenix Oncology in development of ensituximab (NPC-1C),” said Philip M. Arlen, M.D, President and CEO of Neogenix Oncology. “With pancreatic cancer awareness month upon us, receiving orphan status underscores the importance of our clinical research goals along with our partners at The Johns Hopkins Hospital, Duke University Medical Center and North Shore LIJ. We are committed to improving treatment options for this deadly disease.”

Orphan status entitles Neogenix Oncology to seven years of marketing exclusivity for ensituximab (NPC-1C) for the treatment of pancreatic cancer upon regulatory approval, as well as the opportunity to apply for grant funding from the U.S. government to defray costs of clinical trial expenses, tax credits for clinical research expenses and potential exemption from the FDA’s application user fee. The United States Orphan Drug Act of 1983 was created to promote the development of new drug therapies for the treatment of diseases that affect fewer than 200,000 individuals in the United States.

According to the American Cancer Society (ACS), cancer of the pancreas is the fourth leading cause of cancer-related death overall in the United States. The ACS estimates that annual incidence of pancreatic cancer in the United States to be greater than 43,000 cases, and more than 36,000 people are expected to die from the disease in 2010. The 1- and 5-year survival rates for people in the United States diagnosed with any stage of pancreatic cancer are 25 percent and 6 percent, respectively, according to the ACS.

About Neogenix Oncology

Neogenix Oncology is a clinical stage biotechnology company focused on developing and commercializing therapeutic and diagnostic products for the early detection and treatment of pancreatic, colorectal, lung, cervical, ovarian, prostate, and other cancers. The company’s portfolio includes monoclonal antibodies that are designed to be specific to cancer cells by recognizing epitopes that are tumor specific, that is, found on cancer cells, but not normal cells. Founded in late 2003 and headquartered in Great Neck, NY, the company conducts its research and development work in its laboratories in Rockville, MD. The company is presently conducting a clinical study to establish certain of its antibodies as a serum diagnostic for pancreatic and colorectal cancers, and in December 2009 began a multicenter Phase I therapeutic trial to evaluate the clinical safety of ensituximab (NPC-1C antibody) in patients with metastatic pancreatic and colorectal cancer.

Forward Looking Statements

Certain statements contained in this release are forward-looking statements that relate to future events. These statements are based on current expectations only and are subject to known and unknown risks, uncertainties and other factors which may cause the actual results to be materially different from any future results express or implied by such forward-looking statements, including those risk factors discussed in the company’s SEC reports, including the company’s Form 10 and quarterly reports on Form 10-Q. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts

RMT PR Management

RoseMarie Terenzio, 212-414-1909

C: 917-913-7226

rterenzio@rmtpr.com

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