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Eleison Announces Completion of Enrollment in Stage 1 of its Phase II Trial of ILC (Inhaled Lipid-complexed Cisplatin) for Pediatric Bone Cancer

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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MabVax Therapeutics Enters Agreements with Memorial Sloan Kettering Cancer Center and Juno Therapeutics for Development of Anti-Cancer Therapeutics

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]).

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.

U.S. FDA Approves New Indication for the Use of XTANDI(R) (Enzalutamide) Capsules for Patients With Metastatic Castration-Resistant Prostate Cancer

On September 10, 2014 Medivation and Astellas Pharma reported that the U.S. Food and Drug Administration (FDA) approved a new indication for the use of XTANDI (enzalutamide) capsules to treat patients with metastatic castration-resistant prostate cancer (CRPC) (Press release Medivation, SEP 10, 2014, View Source [SID:1234500737]). This new approved use follows a priority review of the supplemental New Drug Application (sNDA) that was based on results of the Phase 3 PREVAIL trial.

The FDA initially approved XTANDI, an oral, once-daily androgen receptor inhibitor, in August 2012 for use in patients with metastatic CRPC who previously received docetaxel (chemotherapy). The new indication approves XTANDI for use in men with metastatic CRPC who have not received chemotherapy. Metastatic CRPC is defined as a cancer that has spread beyond the prostate gland and has progressed despite treatment to lower testosterone (i.e., with a gonadotropin-releasing hormone (GnRH) therapy or with removal of the testes).

“The FDA’s priority review and approval of this new indication for XTANDI now enables the use of an important therapy by patients with metastatic castration-resistant prostate cancer at all stages of their disease,” said Sef Kurstjens, M.D., Ph.D., chief medical officer of Astellas Pharma Inc. and president of Astellas Pharma Global Development, Inc. “We are pleased that these patients now have XTANDI available as a treatment option.”

“All of us at Medivation extend our thanks to the clinicians and patients who participated in the PREVAIL clinical trial culminating in today’s approval,” said David Hung, M.D., founder, president and chief executive officer, Medivation, Inc. “As a company dedicated to the rapid development of novel therapies to treat serious diseases, we are pleased to see XTANDI approved in this important patient population.”

In the Phase 3 PREVAIL trial, men receiving XTANDI and GnRH therapy exhibited a statistically significant improvement in both overall survival and delayed time to radiographic progression or death as compared to those on placebo and GnRH therapy.

XTANDI significantly reduced the risk of radiographic progression or death by 83% compared with placebo (HR=0.17; p < 0.0001). XTANDI significantly reduced the risk of death by 29% compared with placebo (HR=0.71; p < 0.0001). When compared to placebo, treatment with XTANDI also delayed time to initiation of chemotherapy and time to a skeletal related event. The safety profile for XTANDI was updated to reflect data from both the AFFIRM and PREVAIL Phase 3 trials. Seizure occurred in 0.9% of patients receiving XTANDI who previously received docetaxel and 0.1% of patients who were chemotherapy-naive. The most common adverse reactions ( ≥ 10%) that occurred more commonly ( ≥ 2% over placebo) in the XTANDI-treated patients from the two randomized clinical trials were asthenia/fatigue, back pain, decreased appetite, constipation, arthralgia, diarrhea, hot flush, upper respiratory tract infection, peripheral edema, dyspnea, musculoskeletal pain, weight decreased, headache, hypertension, and dizziness/vertigo. "Enzalutamide has been studied and is approved for patients with metastatic prostate cancer that is resistant to primary hormonal therapy, a disease state we call castration-resistant prostate cancer. In this setting, enzalutamide has been shown to extend overall survival and significantly delay the progression of prostate cancer," said Tomasz M. Beer, M.D., F.A.C.P., co-principal investigator of the PREVAIL study, deputy director of the Knight Cancer Institute and professor of medicine at Oregon Health & Science University. "Furthermore, in the PREVAIL trial, the median time to initiating chemotherapy was delayed by 17 months with enzalutamide treatment as compared to placebo, so the result is a meaningful period of time during which men have their disease controlled without the need for chemotherapy." A variation application to amend the European Marketing Authorization Application based on the results of PREVAIL was validated for review by the European Medicines Agency on April 24, 2014. The approval of this new indication for XTANDI triggers $90 million in milestone payments to Medivation under its collaboration agreement with Astellas.

Seattle Genetics and Genmab Enter Into New Antibody-Drug Conjugate Collaboration

On September 10, 2014 Seattle Genetics and Genmab reported that the companies have entered into an additional antibody-drug conjugate (ADC) collaboration (Press release Genmab, SEP 10, 2014, View Source [SID:1234500735]). Under the new agreement, Genmab will pay an upfront fee of $11 million for exclusive rights to utilize Seattle Genetics’ auristatin-based ADC technology with Genmab’s HuMax-AXL, an antibody targeting AXL which is expressed on multiple types of solid cancers. Seattle Genetics is also entitled to receive more than $200 million in potential milestone payments and mid-to-high single digit royalties on worldwide net sales of any resulting products. In addition, prior to Genmab’s initiation of a Phase III study for any resulting products, Seattle Genetics has the right to exercise an option to increase the royalties to double digits in exchange for a reduction of the milestone payments owed by Genmab. Irrespective of any exercise of option, Genmab remains in full control of development and commercialization.

“This collaboration with Genmab further extends the reach of our industry-leading ADC technology for use with novel oncology targets, while providing us with a compelling financial value proposition as the program advances,” said Natasha Hernday, Vice President, Corporate Development at Seattle Genetics. “Genmab’s impressive track record in the development of antibody-based therapies for the treatment of cancer, including an ADC in a Phase I clinical trial for solid tumors utilizing Seattle Genetics technology from our first agreement, make them a strong partner for this new collaboration.”

“This new collaboration with Seattle Genetics adds another ADC program to our innovative pre-clinical pipeline of antibodies developed using the latest technological advances in cancer therapeutics. Pre-clinical work identified AXL as an excellent target for an ADC therapeutic approach,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “Accessing state-of-the art technology of companies such as Seattle Genetics who are experts in their field provides another means for Genmab to develop differentiated cancer therapeutics while retaining maximal ownership of our therapeutic products.”

Seattle Genetics and Genmab entered into an ADC collaboration for HuMax-TF-ADC in September 2010. HuMax-TF-ADC, targeting the Tissue Factor antigen, is in a Phase I trial for solid tumors. Seattle Genetics has the right to exercise a co-development option to share all future costs and profits for HuMax-TF-ADC at the end of Phase I.

Today’s news will not impact Genmab’s 2014 financial guidance.

TNI BioTech Announces Results of Annual Shareholders Meeting

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]).

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.