On April 6, 2015 Advaxis reported that it is entering into a clinical trial collaboration agreement with the Radiation Therapy Oncology Group (RTOG) Foundation to evaluate the safety and efficacy of Advaxis’s lead cancer immunotherapy, ADXS-HPV (ADXS11-001), in a pivotal Phase 2/3 anal cancer trial, which will be run by NRG Oncology (Press release, Advaxis, APR 6, 2015, View Source [SID:1234502925]). ADXS-HPV is an investigational Lm-LLO immunotherapy bioengineered to generate an immune response to the HPV-associated tumor specific oncogene. Schedule your 30 min Free 1stOncology Demo! Under the proposed collaboration, RTOG Foundation, through its partnership with NRG Oncology, will conduct an adequate and well-controlled Phase 2/3 clinical trial of concurrent chemotherapy of mitomycin C/5FU and radiation therapy (CCRT) compared to CCRT combined with ADXS-HPV in the adjuvant treatment of high-risk locally advanced anal cancer.
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Walter J. Curran, Jr., MD, RTOG Foundation Chairman of the Board and NRG Oncology Group Chair, commented, "The ability of ADXS-HPV to generate an immune response to the HPV-associated tumor specific oncogene offers the potential to benefit multiple cancers that are known to be caused by the HPV infection, including cervical cancer and anal cancer. We look forward to initiating this Phase 2/3 study in anal cancer and mirroring the encouraging results that the Gynecologic Oncology Group, now a part of NRG Oncology, has had in its clinical study of ADXS-HPV in cervical cancer."
David J. Mauro, MD, PhD, Executive Vice President and Chief Medical Officer of Advaxis, stated, "We are excited to enter this collaboration agreement with NRG Oncology and look forward to building on the initial results observed in the ongoing Phase 1/2 study of ADXS-HPV in anal cancer being conducted by Professor Howard Safran MD of Brown University Oncology Group. Although a relatively rare tumor, virtually all cases of squamous cell cancer of the anus are caused by HPV infection, and ADXS-HPV offers the potential to treat this often fatal malignancy."
About RTOG Foundation, Inc.
The Radiation Therapy Oncology Group (RTOG) has been an international leader in conducting Phase 2 and 3 multi-institutional clinical trials with a focus on radiation oncology issues. During its forty-plus year history, the group has repeatedly defined new standards of cancer care to improve the survival and quality of life of cancer patients and developed new processes for the study and application of innovative radiotherapy technologies. RTOG Foundation, Inc. is a Philadelphia based 501(c)(3) organization that continues its National Cancer Institute (NCI) funded research activities through NRG Oncology as one of its three founding members. RTOG also joins with corporate partners to conduct multicenter clinical trials systematically testing novel radiotherapy approaches combined with new classes of anti-cancer therapies and targeted agents. The group has completed a number of practice- and paradigm-changing trials in its primary disease sites: central nervous system, head & neck, lung, gastrointestinal (esophagus, stomach, pancreas, anal canal, and rectum), genitourinary (bladder and prostate), breast, and cervix.
About NRG Oncology
NRG Oncology conducts practice-changing, multi-institutional clinical and translational research to improve the lives of patients with cancer. Founded in 2012, NRG Oncology is a Pennsylvania-based nonprofit corporation that integrates the research strengths of the National Adjuvant Breast and Bowel Project (NSABP), the Radiation Therapy Oncology Group (RTOG) and the Gynecologic Oncology Group (GOG). The research organization seeks to carry out clinical trials with emphases on gender-specific malignancies including gynecologic, breast, and prostate cancers and on localized or locally advanced cancers of all types. NRG Oncology’s extensive research organization is comprised of multidisciplinary investigators including medical oncologists, radiation oncologists, surgeons, physicists, pathologists, and statisticians and encompasses more than 1300 research sites located world-wide with predominance in the United States and Canada. NRG Oncology is supported primarily through grants from the National Cancer Institute (NCI) and is one of five research groups in the NCI’s National Clinical Trials Network.
About ADXS-HPV
ADXS-HPV is Advaxis’s lead Lm-LLO immunotherapy product candidate for the treatment of HPV-associated cancers. It is currently under investigation in three HPV-associated cancers: invasive cervical cancer, head and neck cancer, and anal cancer. In cervical cancer, a completed Phase 2 study, ADXS-HPV demonstrated prolonged survival, objective tumor responses, and a manageable safety profile alone or in combination with chemotherapy, supporting further development of this Lm-LLO immunotherapy. The U.S. Food and Drug Administration granted an orphan drug designation for ADXS-HPV for HPV-associated Stage II-IV cervical cancer, head and neck cancer, and for anal cancer.
Year: 2015
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.
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"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).
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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]). Schedule your 30 min Free 1stOncology Demo! 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.
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.
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"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."