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): August 6, 2014

TNI BioTech, Inc.

(Exact name of registrant as specified in its charter).

Florida	000-54933	59-3226705
(State or other jurisdiction	(Commission	(IRS Employer
or incorporation)	File Number)	Identification Number)

37 North Orange Avenue, Suite 607, Orlando, Florida 32801

(Address of principal executive offices) (Zip Code)

(888) 613 - 8802

(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 (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))

(1)

1.01 Entry into a Material Definitive Agreement.

On August 6, 2014, TNI BioTech, Inc. (the “Company”) entered into a Supplementary Agreement on New Drug Methionine – Enkephalin Cooperation (the “Amendment”) with Hubei Qianjiang Pharmaceutical Co., Ltd., a Chinese listed company (“Qianjiang Pharmaceutical”), amending that certain Venture Cooperation Agreement on New Drug Methionine Enkephalin dated October 18, 2012, as amended by an Addendum to Venture Cooperation and a Supplementary Cooperation Agreement on New Drug Methionine Enkephalin.

The Company and Qianjiang Pharmaceutical executed the Amendment to accelerate clinical trials in both the United States and China, and agreed to immediately initiate three month Good Laboratory Practice (“GLP”) Toxicology Studies (rat and dog) within 30 days of signing the Amendment. The Amendment requires that the GLP Toxicology Studies Trials are conducted in China in accordance with international standards and standards acceptable to the U.S. Food and Drug Administration and that the studies include the following:

Exploratory Toxicology (nGLP)

· Dose range finding studies

· Different species and methods of administration

· Multiple dosing regimens

· Estimate the response vs. dose given

Definitive Toxicology (GLP)

· Performed in collaboration with Calvert Laboratories (USA) and MPI/Medicillon (China)

· General toxicology studies

· Different species and methods of administration

· Immunogenicity study with NHPs

Special Toxicology Studies (planned)

Pursuant to the Amendment, Qianjiang Pharmaceutical will make certain funds available from a co-administrative account, opened by Qianjiang Pharmaceutical for the develop of Methionine [Met5] - enkephalin (“MENK”) in China, in accordance with an approved budget and timeline set forth in the Amendment. A portion of these funds are expected to be used by Cytocom Inc., a wholly-owned subsidiary of the Company (“Cytocom”), to run PK and Dosing trials for MENK in the United States.

The Amendment requires Cytocom and Qianjiang Pharmaceutical to meet with the China State Food and Drug Administration (“SFDA”) to determine that PK and Dosing Trials completed in the United States will be acceptable to the SFDA. All developments and trials run by Cytocom in the U.S. or the European Union will be used for requesting registration approval in China.

On August 6, 2014, Professor Fengping Shan Ph.D., a member of the Company’s Board of Directors, executed an Assignment (the “Assignment”) pursuant to which he transferred his entire right, title and interest in and to the following listed Patents and/or Patent Applications in China to the Company: (1) CN 200710158742.7 Met-enkephalin, its application in in treating leukemia and other blood cancers; (2) CN 200710051586.4 Met-enkephalin, its application in preparation of human and animal vaccine; (3) CN 200610046249.1 A nasal spray formulation containing Met-enkephalin; (4) CN 201210290150.1 Low dose naltrexone, combined with MENK, its application in preparation of anticancer drug; (5) CN 201210302259.2 Low dose naltrexone, combined with MENK, its application in preparation of leukophoresis for anticancer; (6) CN 200810229085.5 Conpound met-enkephalin as a drug for colon cancer and pancreatic cancer using a method of by isolating and enriching a patient’s own immune cells and following an enriching external incubation are transfused back into the patient thereby providing the patient with a passive immunity containing large amounts of auto-amplified immune cells that combat cancer cells; (7) CN 200910011030.1 Naltrexone; and (8) CN 201210302259 Application of combination of low-dose naltrexone and methionine-enkephalin to preparation of anti-cancer drug.

The Amendment is filed as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference. The Assignment is filed as Exhibit 1.2 to this Current Report on Form 8-K and is incorporated herein by reference. The foregoing description of the material terms of the Amendment and the Assignment and the transactions contemplated thereby does not purport to be complete and is qualified in its entirety by reference to such exhibit.

9.01 Financial Statements and Exhibits.

Exhibit 1.1 Supplementary Agreement on New Drug Methionine – Enkephalin Cooperation, dated August 6, 2014, between TNI BioTech, Inc. and Hubei Qianjiang Pharmaceutical Co., Ltd.

Exhibit 1.2 Assignment by Professor Fengping Shan Ph.D. to the Company, executed August 6, 2014.

(2)

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 hereunto duly authorized.

TNI BioTech, Inc.

By: /s/ Noreen Griffin

Noreen Griffin, Chief Executive Officer

EX-1.1

Supplementary AgreementonNewDrugMethionine-Enkephalin Cooperation

In October, 2012,HubeiQianjiangPharmaceuticalCo., Ltd(a Chineselistedcompany)andTNIBiotech, Inc.(an American company)signedCooperation Agreement on NewDrugMethionineEnkephalin in Qianjiang, Hubei Province, China.

In August 5, 2014,HubeiQianjiang PharmaceuticalCo.,Ltd(hereinafter referredtoas "Qianjiang Pharmaceutical ") andTNIBiotech, Inc. (hereinafter referredto as "TNI Biotech") signed SupplementaryCooperationAgreementon New Drug Methionine Enkephalin in America. TNI Biotech has established a great deal of studies since signed the agreements, including basic studies such as pharmaceutical studies, pharma toxicologystudies, clinical trials and new-developed indications. Such trials work smoothly, and several results have got the approval of the Food and Drug Administration.

According tothe reportsof TNIBiotech, TNIBiotech hasestablished phaseIandIIclinical trialsasused for pancreatic cancer, andjoined FDAmeeting inAugust, 2013. In the meeting, FDA approved TNI Biotech in following aspects: developingMENKas lyophilized power and with administration route by iv or subcutaneous approving phase I and II clinical results; holding meeting on End of Phase II anddetermination of Phase III in America after TNI Biotech complement pharmaceutical studies and pharma-toxicology studies on MENK; evaluating the basic studies and trials by TNI Biotech on MENK asused for treating liver cancer. FDA approved a phase IIB study but has required a PK and Dosing Trial be run in parallel with the Phase IIB Trials.

To date,HubeiQianjiangPharmaceuticalCo.,Ltdhasestablishedgreatofmarketing research,andpre-trialsonpharmaceutical and pharma-toxicology studies, which have obtained positiveresults. In ordertoaccelerate clinicaltrials in bothAmericaand Chinaandmany otherresearches and developments,bothparties agree:

1. According to thepreviousagreements,QianjiangPharmaceutical has opened a co-administrationaccount for the development of MENK in China.

2. The parties agree to immediately to initiate 3-mo GLP Toxicology Studies (rat & dog) within 30 days of the signing of this agreement. GLP Toxicology Studies Trials will be run in China in accordance with international standards and acceptable to the FDA. The studies will include

Exploratory Toxicology (nGLP)

• Dose range finding studies

• Different species and methods of administration

• Multiple dosing regimens

• Estimate the response vs. dose given

Definitive Toxicology (GLP)

• Performed in collaboration with Calvert Laboratories (USA) and MPI/Medicillon (China)

• General toxicology studies

• Different species and methods of administration

• Immunogenicity study with NHPs

Special toxicology studies (planned)

3. Qianjiang has raised the funds necessary to for clinical development and marketing of MENK. Expenditure are subject to full budget approval by both Qianjiang and Cytocom and will be approved by Mr. Ye Jige, Qianjiang pharmaceutical, and, authorized by Noreen Griffin, United States.

4. Cytocom and Qianjiang Pharmaceutical will meet immediately with the SFDA to determine that PK and Dosing Trials completed in the US will be acceptable to the SFDA. All developments and trial results run by Cytocom in America or EU will be used for requesting registration approval in China

5. Based on PK, Dosing and Existing Trial results in US, Qianjiang pharmaceutical and Dr. Graham Burton and Dr. Joseph Fortunak will meet with the SFDA to determine what additional data will be required to initiate corresponding trial in China

This amendmentwillbegoingtoeffectaftersignaturebytwoparties

/s/ Ye Jige	August 6, 2014
Mr. YeJige Chief Executive Officer	Date
Hubei Qianjiang Pharmaceutical Co., Ltd
/s/ Noreen Griffin	August 6, 2014
Noreen Griffin	Date
Chief Executive Officer
TNI BioTech Inc
/s/ Noreen Griffin	August 6, 2014
Cytocom Inc Chairman	Date
Noreen Griffin

EXHIBIT A

ESTIMATED DEVELOPMENT MENK BUDGET AND TIMELINE

MENK Development	6 Months		12 Months		18 Months		24 Months		30 Months
PK & Dosing Trial MENK	$	1,200,000
MENK RE; Formulation	$	195,000
MENK CMC Package	$	600,000	$	600,000
MENK Animial Studies	$	850,000
China Lab	$	60,000	$	60,000	$	60,000	$	60,000	$	60,000
Pancaratic / Liver Cancer IIB/III					$	9,375,000	$	9,375,000	$	9,375,000
TOTAL	$	2,905,000	$	660,000	$	9,435,000	$	9,435,000	$	9,435,000

 

EX-1.2

ASSIGNMENT

WHEREAS, Professor Fengping Shan Ph.D., of No.92 North Second Road, Department of Immunology, China Medical University, Shenyang, Liaoning China 110001 (hereinafter Assignor), is the owner of the entire right, title and interest in and to the following listed Patents and/or Patent Applications (hereinafter Patents) in China by previous assignments;

1)化合物蛋氨酸脑啡肽作为制备治疗血液、骨髓造血系统癌 症药物的应用 CN 200710158742.7 Met-enkephalin, its application in in treating leukemia and

other blood cancers;

2)蛋氨酸脑啡肽在制备人或动物接种疫苗中的应用 CN 200710051586.4 Met-enkephalin, its application in preparation of human and animal vaccine;

3)种含有蛋氨酸脑 啡肽的气雾剂 CN 200610046249.1 A nasal spray formulation containing Met enkephalin;

4)纳曲酮联合蛋氨酸脑啡肽作为制备癌症药物中的应用, CN 201210290150.1 Low dose naltrexone, combined with MENK, its application in preparation of anticancer drug;

5)低剂量纳曲酮联合蛋氨酸脑啡呔作为制备抗癌药物的应用 CN 201210302259.2 Low dose naltrexone, combined with MENK, its application in preparation of leukophoresis for anticancer;

6) 化合物蛋氨酸脑啡肽作为制备治疗肠癌、胰腺癌药物的应用CN 200810229085.5

Conpound met-enkephalin as a drug for colon cancer and pancreatic cancer using a method of by

isolating and enriching a patient's own immune cells and following an enriching external

incubation are transfused back into the patient thereby providing the patient with a passive

immunity containing large amounts of auto-amplified immune cells that combat cancer cells.;

7) 纳 络酮及其组合物作为制备治疗癌症药物的应用 CN 200910011030.1 Naltrexone

8) CN 201210302259 Application of combination of low-dose naltrexone and methionine-enkephalin to preparation of anti-cancer drug

WHEREAS, TNI BioTech, Inc. (hereinafter Assignee), a corporation organized and existing under and by virtue of the laws of United States of America, having an office at 618 East South Street #500, Orlando, FL 32801, is desirous of acquiring the entire right, title and interest in and to the inventions described and claimed in said;

NOW, THEREFORE, for good and valuable consideration, the receipt of and sufficiency of which are hereby acknowledged, said Assignor has sold, assigned and transferred and does hereby sell, assign and transfer unto said Assignee, its successors and assigns, its entire undivided right, title and interest in and to the said Patents and the inventions therein contained, including the right to sue for past infringement, to be held and enjoyed by said Assignee, its successors and assigns, the same as it would have been held and enjoyed by said Assignor if this assignment and sale had not been made.

Said Assignor hereby represents and warrants that there are no rights or interests outstanding inconsistent with the rights and interest granted herein and that said Assignor will not execute any instrument or grant or transfer any rights or interests inconsistent therewith, and said Assignor binds itself and its heirs, executors, administrators, employees and legal representatives, as the case may be, to execute and deliver to said Assignee, its successors and assigns, any further documents or instruments and do any and all further acts that may be deemed necessary by said Assignee, its successors and assigns, to file applications for improvements and inventions in any country where it may elect to file such applications, and that may be necessary to vest in said Assignee, its successors and assigns, the title herein conveyed, or intended so to be, and to enable such title to be recorded in the United States and foreign countries where such application or applications may be filed.

AND, said Assignor further covenants and agrees, in consideration of the premises, that it, its executors and administrators, will, at any time upon request, communicate to said Assignee, its successors and assigns, any facts relating to the said invention and improvements and the history thereof, known to it or its successors and assigns, and that it will testify as to the same in any interference or other proceeding when requested to do so by said Assignee, its successors and assigns.

The undersigned hereby grants the law firm of Birch, Stewart, Kolasch & Birch, LLP the power to insert on this Assignment any further identification that may be necessary or desirable in order to comply with the rules of the U.S. Patent and Trademark Office for recordation of this document.

IN TESTIMONY WHEREOF, said Assignor has hereunto set its seal this 5th day of  August, 2014.

/s/Fengping Shan

Fengping Shan Ph.D. (signed August 6, 2014)