On September 9, 2014 TNI BioTech, Inc. (OTC-BB: TNIB) ("we" or the "Company"), a biotechnology company pioneering the manufacturing and marketing of innovative therapies for autoimmune diseases in emerging nations, reported the results of its 2014 annual general meeting of shareholders (Press release, TNI BioTech, SEP 9, 2014, View Source [SID:1234514757]).

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The shareholders of the Company have approved all the matters submitted to them at the Company’s 2014 annual general meeting held at 10:00 a.m., Eastern Daylight Time, on Thursday, September 4, 2014. A total of 68,872,388 shares were represented in person or by proxy at the Company’s 2014 annual general meeting, representing a quorum of approximately 76.24% of the Company’s outstanding shares. During the meeting, the following resolutions were duly passed:
(i) Election of members of the Board of Directors, to serve a term until the 2015 Annual Meeting of Shareholders and until their successors are duly elected and qualified;
(ii) Ratification of the appointment of Turner Stone & Company LLP as the Company’s independent registered public accounting firm for the fiscal year ending December 31, 2014;
(iii) Approval of the Company’s 2014 Stock Incentive Plan; and
(iv) Approval of the name change of the Company to Immune Therapeutics, Inc.

Ms. Noreen Griffin, the Company’s CEO and Chairman, stated, "On behalf of management, I would like to thank shareholders for their support and confidence in TNI BioTech, Inc. We will continue to focus on enhancing shareholder value through our strategic plan of the manufacturing, marketing and distribution of our immunotherapies for the treatment of cancer, HIV/AIDS and autoimmune diseases in emerging and developing nations."

Ms. Griffin announced that in addition to the election of four new members to the Company’s Board of Directors, the Company is in the process of appointing a search committee to find a new CEO and COO for the Company. Ms. Griffin stated, "Mr. Pearce and I will continue to be involved in the company but feel the role of CEO and COO could be better served by an individual with an extensive background in manufacturing, marketing and distribution in the pharmaceutical industry in emerging and developing nations."

The transcript of the Company’s 2014 shareholder meeting will be available online for a limited time at: www.tnibiotech.com.

CYTOCOM INC. SPIN OUT
We have received numerous calls concerning the Cytocom Inc. dividend and below is additional information for shareholders.
Our shareholders will receive one common share of Cytocom Inc. for every one share of Company common stock held by such shareholders as of 5:00 p.m., Eastern Time, on September 30, 2014, which is the "record date" for the distribution.
However, to the extent that a shareholder of the Company sells a portion or all of that stockholder’s shares of our common stock prior to the record date, such stockholder also will be pro-rata selling the right to receive common shares of Cytocom Inc. through the distribution.

To receive the Cytocom Inc. share dividend, all shareholders must surrender all existing share certificates to the Company’s transfer agent. Shares in Street Name will need to be in the name of the shareholder when presented to the transfer agent for the dividend.

There is no electronic transfer so shareholders must obtain Company certificates in their name from their broker and present them to our transfer agent, Guardian Register & Transfer Inc.: 7951 South West 6th Street, Suite 216 Plantation, FL 33324, Tel: (954) 915-0105, Email:[email protected],

The below link will provide a sample letter to brokers that can be sent to your broker to convert your shares back into certificate form :View Source
When shareholders present their Company share certificates to our transfer agent, our transfer agent will then send to each such shareholder proof of Cytocom Inc. common stock ownership, as of the record date. Cytocom Inc. shares will be kept in book entry until a Registration Statement on Form S-1 is declared effective by the Securities and Exchange Commission unless a shareholder requests differently. Once the transfer agent books the ownership of Cytocom Inc. common stock, as of September 30, 2014, the Company share certificates will be returned to the shareholder.

On September 5, 2014 Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense reported the acquisition of a novel orphan drug candidate, known as SGX301 (synthetic hypericin) (Press release, Soligenix, SEP 5, 2014, View Source [SID:1234512914]). SGX301 is poised to enter pivotal Phase 3 clinical testing for the treatment of cutaneous T-cell lymphoma (CTCL) and is highly synergistic with the company’s existing development pipeline. As part of the acquisition, Soligenix acquired all rights for synthetic hypericin, including intellectual property, and preclinical and clinical data.

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SGX301 is a novel, first-in-class, photodynamic therapy utilizing safe visible light for activation. The active ingredient, synthetic hypericin, is a potent photosensitizer which is topically applied to skin lesions and activated by fluorescent light. This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging chemotherapeutic drugs and other photodynamic therapies that are dependent on ultraviolet A (UVA) exposure. Topical hypericin has demonstrated safety in a Phase 1 clinical study in healthy volunteers. In a Phase 2, placebo-controlled, clinical study in CTCL patients, the drug was safe and well tolerated, with 58.3% of the CTCL patients responding to topical hypericin treatment compared to only 8.3% receiving placebo (p ? 0.04). These clinical data fully support advancing this therapy to a pivotal Phase 3 clinical trial in CTCL. The Phase 3 clinical protocol of SGX301 for the treatment of CTCL is currently in final review with the US Food and Drug Administration (FDA).

SGX301 has received orphan drug designation by the FDA for the treatment of CTCL, which provides for 7 years of market exclusivity upon approval in the US. SGX301 is being developed pursuant to discoveries made at New York University Medical Center together with the Yeda Research and Development Company, Ltd., which is the commercial arm of the Weizmann Institute of Science in Rehovot, Israel.

In addition to SGX301, the acquired technology package includes preclinical and clinical data supporting other potential indications for hypericin photodynamic therapy, such as psoriasis. Psoriasis is an autoimmune inflammatory disease that is similarly characterized by cutaneous accumulation of T-cell lymphocytes but without cancerous transformation. It is a common disease that affects over 7 million adults in the US. Photodynamic therapy is a frequently employed initial therapy for psoriasis, despite the need for ultraviolet light exposure and its attendant risk of melanoma and non-melanoma skin cancer. The Phase 2 clinical study has shown that hypericin and visible light phototherapy is also effective in treating these lesions.

"We are very excited by the acquisition of this late-stage technology which has the potential to be the first photodynamic therapy approved for CTCL," stated Christopher J Schaber, PhD, President & Chief Executive Officer of Soligenix. "With SGX301 we will be able to leverage our clinical development expertise in cancer and cancer supportive care. We also anticipate the potential for a number of federal funding opportunities for SGX301 in this orphan disease, as well as for expansion into other indications of unmet medical need."

On September 4, 2014 Merck reported that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA (pembrolizumab) at a dose of 2 mg/kg every three weeks for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor (Press release Merck & Co, SEP 4, 2014, View Source [SID:1234500721]). This indication is approved under accelerated approval based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

KEYTRUDA is the first anti-PD-1 (programmed death receptor-1) therapy approved in the United States and received FDA’s Breakthrough Therapy designation for advanced melanoma, which was granted based on the significance of early study findings and the unmet medical need. For the recommended 2 mg/kg dose based on data in 89 patients, the overall response rate was 24 percent (95% CI: 15, 34), with one complete response and 20 partial responses (21/89). At the time of analysis, 86 percent (18/21) of patients with objective responses had ongoing responses with durations ranging from 1.4+ to 8.5+ months, including eight patients with ongoing responses of 6 months or longer. Fourteen percent (3/21) had progression of disease 2.8, 2.9, and 8.2 months after initial response.

KEYTRUDA is a humanized monoclonal antibody that works by increasing the ability of the body’s immune system to fight advanced melanoma. KEYTRUDA blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, and may affect both tumor cells and healthy cells. Immune-mediated adverse reactions occurred with KEYTRUDA including pneumonitis, colitis, hepatitis, hypophysitis, nephritis, hyperthyroidism, and hypothyroidism. Based on the severity of the adverse reaction, KEYTRUDA should be withheld or discontinued and corticosteroids administered. Based on its mechanism of action, KEYTRUDA may cause fetal harm when administered to a pregnant woman. Female patients of reproductive potential should be advised of the potential hazard to a fetus. For more information regarding immune-mediated adverse reactions and use in pregnancy, see "Selected Important Safety Information" below.

"KEYTRUDA embodies Merck’s unwavering commitment to pursue breakthrough science to help people who are facing the most challenging diseases," said Kenneth C. Frazier, chairman and chief executive officer, Merck. "We are grateful to the people with advanced melanoma who participated in our trials, and the scientific and medical community for the shared effort that has led to the accelerated approval of KEYTRUDA."

"The accelerated FDA approval of KEYTRUDA is a meaningful development for patients with advanced melanoma," said Dr. Omid Hamid, Director of the Melanoma Center at The Angeles Clinic and Research Institute, and a principal investigator for the pembrolizumab melanoma clinical program. "Our new ability to target the PD-1 pathway with KEYTRUDA is a very exciting step in the immunotherapy field."

Merck is conducting ongoing Phase 2 and 3 clinical studies in advanced melanoma, which are designed to provide further confirmatory evidence for KEYTRUDA in this indication. Merck plans to make KEYTRUDA available within one week from today’s FDA approval.