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10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

RestorGenex has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, RestorGenex, APR 3, 2015, View Source [SID1234502920]).

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Columbia Laboratories, Inc. to Become Juniper Pharmaceuticals, Inc.

On April 2, 2015 Columbia Laboratories, Inc. (Nasdaq: CBRX) (the "Company"), reported that it will adopt Juniper Pharmaceuticals, Inc. as its new corporate brand (Press release, Juniper Pharmaceuticals, APR 2, 2015, View Source;p=irol-newsArticle&ID=2031852 [SID:1234510481]). The name change will become effective Friday, April 10, 2015, and the Company’s common stock will begin trading on the Nasdaq Stock Exchange under the new ticker symbol — "JNP" — on Monday, April 13, 2015. The Company will also unveil its new logo and launch its new website, www.juniperpharma.com, on April 13, 2015.

"Adopting the Juniper Pharmaceuticals brand marks the next step in the Company’s return to developing specialty products in women’s health. We are committed to anticipating and addressing unmet medical needs and developing important therapeutics for patients," said Frank Condella, President and CEO.

The Company’s wholly owned subsidiary, Molecular Profiles Ltd. based in Nottingham, England, will also begin operating as Juniper Pharma Services on April 13, 2015.

"The single Juniper brand formalizes the synergies we have built across our CRINONE franchise, services business and proprietary product development programs," concluded Mr. Condella.

As planned, in March the Company filed an Investigational New Drug application for its lead product candidate, COL-1077, a 10% lidocaine bioadhesive gel. The Company expects the first patient will enter a Phase II clinical trial later this quarter. The trial is a randomized, double-blinded, placebo controlled study that will enroll 150 patients at fifteen U.S. sites that intends to evaluate the efficacy of COL-1077 for use as an acute anesthetic for women undergoing transvaginal pipelle-directed endometrial biopsy.

The Company recently announced the licensure of worldwide exclusive rights to a novel intra-vaginal ring ("IVR") technology that enables the delivery of one or more pharmaceuticals at different dosages and release rates in a single segmented ring. This patient administered device will be utilized as a key drug delivery platform for the Company’s emerging proprietary product pipeline. The IVR technology was developed by renowned scientists Dr. Robert Langer from the Massachusetts Institute of Technology and Dr. William Crowley from Massachusetts General Hospital and Harvard Medical School. Drs. Langer and Crowley have joined the Company as strategic scientific advisors to guide R&D initiatives and drug development strategy.

The Company’s value creation strategy is to support the continued growth of the CRINONE franchise by its partners Merck Serono and Actavis, expand and maintain a profitable services business by providing unique pharmaceutical development capabilities to global pharmaceutical customers, and invest operating cash flow into a proprietary product pipeline to build long-term shareholder value.

Coronado Biosciences Forms New Subsidiary, DiaVax Biosciences, to Develop Novel Immunotherapies for Cytomegalovirus

On April 2, 2015 Coronado Biosciences reported it has formed a new subsidiary company, DiaVax Biosciences, to develop novel immunotherapies for the prevention and treatment of cytomegalovirus (CMV), a common virus that affects people of all ages (Press release, Coronado Biosciences, APR 2, 2015, View Source;FID=1500070190 [SID:1234503562]). According to the U.S. Centers for Disease Control and Prevention (CDC), while CMV is typically asymptomatic in healthy individuals, it can cause serious, often life-threatening disease in those with weakened or uneducated immune systems (including developing fetuses exposed to the virus in utero).

The licensed immunotherapies were developed in the laboratory of Don J. Diamond, Ph.D., Chair of the Department of Experimental Therapeutics at City of Hope National Medical Center in Duarte, California. Dr. Diamond will chair the Scientific Advisory Board of DiaVax. Under the agreement with City of Hope, DiaVax secured worldwide rights to two T-cell immunotherapeutic vaccines for controlling CMV in allogeneic hematopoietic stem cell transplant (HSCT) and solid organ transplant (SOT) recipients. Known as Triplex and PepVax, the programs are expected to enter Phase II clinical studies later this year and are supported by grants from the National Cancer Institute. In connection with the licensing of Triplex and PepVax, DiaVax further entered into an option agreement with City of Hope for exclusive worldwide rights to Pentamer, a universal immunotherapeutic vaccine being developed for the prevention of CMV transmission in utero. If DiaVax exercises its option, and successfully develops and commercializes PepVax, Triplex and Pentamer, City of Hope could receive in excess of $100MM in upfront, milestone and other payments.

Dr. Lindsay A. Rosenwald, Chairman and CEO of Coronado Biosciences, stated, "We are pleased to enter into this collaboration with City of Hope and Dr. Don Diamond. Studies have shown that CMV reactivation in HSCT recipients is linked to low levels of CMV-specific CD8+ T-cells. The vaccines we have licensed represent a promising new T-cell-based, immunotherapeutic approach for controlling CMV in patients with weakened immune systems, particularly those undergoing bone marrow and solid organ transplants. Current antiviral therapies used in this context are often toxic and merely suppress CMV during treatment. An effective vaccine could educate the body’s immune system to fight CMV. We look forward to commencing Phase II studies later this year."

George Megaw, City of Hope’s Director of the Office of Technology Licensing stated, "We are thrilled to partner with Coronado Biosciences on the formation of DiaVax Biosciences and the advancement of these exciting CMV immunotherapies. The executive team at Coronado has an impressive track-record of designing and executing clinical studies across multiple therapeutic areas in a diligent and effective manner. We are confident this collaboration will further the mission of City of Hope to alleviate human suffering and disease, particularly as it relates to CMV."

MD Anderson, Astellas Pharma Sign Option Agreement for Monoclonal Antibody Drug Targeting Acute Myeloid Leukemia

On April 3, 2015 Astellas Pharma and The University of Texas MD Anderson Cancer Center reported the signing of an option agreement to research and develop a new treatment for patients with acute myeloid leukemia (AML) (Press release, Astellas, APR 3, 2015, View Source [SID:1234502918]).

The collaboration grants Astellas an option to firstly negotiate an exclusive, worldwide license at the end of Phase Ib, with both Phase Ia and Phase Ib studies to be conducted by MD Anderson. The agreement also includes up to $26 million as an option premium and research and development funding.

The collaboration will focus on h8F4 technology, a humanized monoclonal antibody invented by Jeffrey Molldrem, M.D., professor of Stem Cell Transplantation and Cellular Therapy at MD Anderson. The antibody h8F4 targets an HLA-restricted peptide called PR1/HLA-A2, which is expressed in cancer cells and cancer stem cells. Molldrem will lead these research efforts with Carlo Toniatti, M.D., Ph.D., executive director of MD Anderson’s Oncology Research for Biologics and Immunotherapy Translation (ORBIT) platform.

"Current treatments for aggressive leukemias are often toxic," said Molldrem. "We desired to develop a safer, yet more potent, therapy for these aggressive cancer types that currently have poor survival outcomes. Unfortunately, advancing novel discoveries from the laboratory to drug development has been historically challenging. We hope that this important collaboration will allow us to deliver much-needed antibody-based treatment to the patient’s bedside more quickly."

"h8F4 has a radically novel anti-tumor activity and this collaboration provides MD Anderson and Astellas with a great opportunity to potentially deliver a first-in-class antibody drug to patients with AML," commented Yoshihiko Hatanaka, president and CEO of Astellas. "Astellas continues to focus on developing novel therapies in areas of unmet medical need through in-house developments and external collaborations."

While monoclonal antibodies are very common in oncology, generating antibodies against HLA-restricted peptides has proven difficult. To develop viable antibody drugs, MD Anderson created ORBIT for its Moon Shots Program to centralize this type of research. The program is an ambitious initiative to accelerate the conversion of scientific discoveries into clinical advances and significantly reduce cancer deaths.

"This is an outstanding addition to MD Anderson’s Moon Shots Program to deliver accelerated solutions for cancer treatment," said Ronald DePinho, M.D., president of MD Anderson. "These are exciting times for cancer drug development and I’m proud that eminent scientists like Drs. Molldrem and Toniatti are leading the way. While it’s true that myeloid cancer has not responded well to standard therapies, this novel solution looks promising."

BIND Therapeutics Announces Extension of Global Collaboration with Pfizer Inc. to Develop and Commercialize Multiple Accurins

On April 2, 2015 BIND Therapeutics reported an extension of the terms of its global collaboration with Pfizer to create Accurins that optimize the therapeutic potential of two molecularly targeted oncology drugs in Pfizer’s pipeline (Press release, BIND Therapeutics, APR 2, 2015, View Source [SID:1234502916]). The collaboration was originally established in April 2013 and the timeline for Pfizer to exercise its option to acquire the exclusive license for the first program continues to be September 2015. Both companies agreed to an extension of the timeline for the second program through March 2016.

“We have made a great deal of progress in this collaboration and have shown promising preclinical results with Accurins containing each of the two compounds,” said Andrew Hirsch, president and chief executive officer, BIND Therapeutics. “Pfizer has been a terrific partner and the results to date have provided evidence that we are on track with the collaboration goals. We mutually agreed to extend the research terms for the second of the two selected compounds in order to ensure it is fully evaluated and well-positioned to enter IND-enabling studies.”

A development milestone was achieved for the first program in December 2014. The 2015 option target date on the first compound remains unchanged and this extension allows BIND and Pfizer an additional year to complete preclinical research evaluating the second program.

“Our Accurin development programs are active and of high interest to both companies,” said Robert Abraham, Ph.D., Senior Vice President and Chief Scientific Officer, Oncology Research Unit, Pfizer. “We are pleased to continue working with BIND under terms of the amended agreement.”

Under terms of the original agreement, Pfizer has the exclusive option to pursue development and commercialization of the Accurins selected. Both companies will work together on preclinical research, and if Pfizer exercises its option, Pfizer will have responsibility for development and commercialization of the selected Accurins.

BIND received an upfront payment of $4.0 million in 2013, a $1.0 million preclinical development milestone in December 2014, and has the potential to receive payments up to $88.5 million upon the achievement of additional specified development and regulatory events. BIND may also receive additional payments up to $110 million for specified commercial events as well as royalties in the low single to high single digit percentages on potential future sales of each Accurin commercialized, if any.