On September 11, 2014 Cancer Research UK and Cancer Research Technology (CRT), the charity’s development and commercialisation arm, reported an agreement with Asterias Biotherapeutics, Inc. (OTCBB: ASTY), a biotechnology company in the emerging field of regenerative medicine and a subsidiary of BioTime, Inc. (NYSE MKT: BTX), to take forward their novel immunotherapy treatment AST-VAC2 into clinical trials with non small cell lung cancer patients (Press release, Cancer Research Technology, SEP 11, 2014, View Source [SID1234523224]).

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This is the tenth treatment to enter Cancer Research UK’s Clinical Development Partnerships* (CDP) scheme, with six having progressed into the clinic to date. CDP is a joint initiative between Cancer Research UK’s Drug Development Office (DDO) and Cancer Research Technology, to develop promising anti-cancer agents which pharmaceutical companies do not have the resources to progress through early phase clinical trials.

AST-VAC2 is a non-patient specific (allogeneic) cancer vaccine designed to stimulate patients’ immune systems to attack telomerase, a protein that is expressed in over 95 percent of cancers but is rarely expressed in normal adult cells.

The vaccine was developed following successful early phase trials of a similar Asterias drug, called AST-VAC1, which was designed to treat acute myeloid leukemia and derived from patients’ blood cells.

Unlike AST-VAC1, and other autologous (patient specific) vaccines that are developed from a patient’s own cells, AST-VAC2 is derived from human embryonic stem cells (hESCs), meaning it can be produced on a large scale and stored ready for use, rather than having to produce a specific version of the drug for each patient.

The trial of AST-VAC2 will evaluate the safety and toxicity of the vaccine, feasibility, stimulation of patient immune responses to telomerase and AST-VAC2, and clinical outcome after AST-VAC2 administration in patients with either resected early-stage, or advanced forms of lung cancer.

Pedro Lichtinger, Asterias’ chief executive officer, said: "The Asterias collaboration with Cancer Research UK’s Drug Development Office represents a major step in advancing our proprietary dendritic cell platform for the potential benefit of patients.

"AST-VAC2 is at the forefront of cell-based immune therapies. It is based on a unique mode of action that is complementary and potentially synergistic to other immune therapies. We are delighted to partner with Cancer Research UK to advance this important platform through Phase 1/2 clinical trials. Cancer Research UK’s Drug Development Office has the global recognition of having the quality, capability and track record of successfully advancing development programs. We are excited about the possibility of favorably impacting the lives of patients across multiple cancers and are proud to be working with Cancer Research UK."

Under the agreement, Asterias will complete development of the manufacturing process for AST-VAC2. Cancer Research UK will then produce the vaccine and conduct the phase 1/2 clinical trial. On completion of the clinical trial, Asterias will have an exclusive first option to acquire the data from the trial. If Asterias declines this, CRT will then have an option to obtain a license to Asterias’ intellectual property to continue the development and commercialisation of AST-VAC2 and related products in exchange for a revenue share to Asterias of development and partnering proceeds.

Dr Jane Lebkowski, president of R&D at Asterias, said: "The use of human embryonic stem cells to derive allogeneic dendritic cells for cancer immunotherapy has the potential to dramatically improve the scalability, consistency, and feasibility of cellular cancer vaccines. We believe this collaboration will enable the acceleration of clinical studies of AST-VAC2 and the collection of important proof-of-concept data for the entire hESC-DC immunotherapy platform."

Nigel Blackburn, Cancer Research UK’s Director of Drug Development, said: "Recent advances in cancer immunotherapy have demonstrated the exciting potential of these treatments to improve outcomes in devastating diseases such as lung cancer. Better treatment options for lung cancer are badly needed and it is through collaborations such as this that we can save more lives sooner."

On October 9, 2014 Eleison Pharmaceuticals LLC, a specialty pharmaceutical company developing life-saving therapeutics for rare cancers, reported that it has completed enrollment in the first stage of its ongoing Phase II study of ILC (Inhaled Lipid-complexed Cisplatin), for the treatment of patients with pediatric osteosarcoma (bone cancer) (Press release, Eleison Pharmaceuticals, SEP 10, 2014, View Source [SID1234517399]). The single-arm trial employs a Simon two-stage design and is evaluating the safety and efficacy of ILC. The Company has commenced enrollment in the second stage of the ongoing study and is enrolling patients at 15 of the leading U.S. hospitals and medical centers.

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On September 10, 2014 MabVax Therapeutics reported it has entered into agreements with Memorial Sloan Kettering Cancer Center (MSK) and Juno Therapeutics (Juno) for the development of novel therapeutic products using antibody targeting sequences derived from the fully-human antibodies discovered using the Company’s internally developed antibody discovery platform (Press release MabVax, SEP 10, 2014, View Source [SID:1234500743]).

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Under the agreements, MabVax will supply unique targeting sequences from the fully-human antibodies to MSK. Pursuant to the agreement with MSK, researchers at MSK will conduct the early stage research and development of Chimeric Antigen Receptor (CAR) T-cell therapeutics using the MabVax antibody sequences and then test them both in vitro and in animal models with the objective of producing anti-cancer therapeutics targeting certain solid tumors.

MabVax and Juno entered into an exclusive option agreement giving Juno the right to negotiate a license agreement for exclusive rights to any CAR T-cell therapeutic products using the antibody sequences provided to MSKCC.

J. David Hansen, Chief Executive Officer of MabVax, said, "We are excited that this research opportunity has come together. We think that the human targeting sequences derived from our antibody program and incorporated into the very unique and promising CAR T-cell technology developed at MSKCC holds real promise for patients suffering from certain solid tumor cancers. We are very pleased to be able to be involved with Juno, a leader in this new and important therapeutic area."

MabVax’s antibody discovery effort has resulted in a pipeline of fully human antibodies to eleven separate cancer targets consistently overexpressed on solid tumor cancers. The lead antibody 5B1 has been the subject of multiple recent press releases, including the announcement of the receipt of a $1.5 million National Institutes of Health contract to develop a radiolabeled version of the antibody as a novel PET imaging agent for pancreatic cancer.

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."