On January 06, 2016 OXiGENE, Inc. (Nasdaq:OXGN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to CA4P for the treatment of neuroendocrine tumors (Press release, OXiGENE, JAN 6, 2016, View Source [SID:1234508675]). The designation provides for seven years of marketing exclusivity following product approval. CA4P has previously received orphan drug designation from the FDA for the treatment of ovarian cancer. Schedule your 30 min Free 1stOncology Demo! "I am pleased that the FDA has provided the orphan designation to CA4P for neuroendocrine tumors," stated William D. Schwieterman, M.D., President and Chief Executive Officer of OXiGENE. "Their grant of this designation is timely, as we have recently completed enrollment in our phase 2a clinical trial of CA4P in both gastrointestinal and pancreatic neuroendocrine tumors. We expect final data from this trial to be available later in 2016." Know more, wherever you are: Orphan designation can be granted by the FDA to product candidates that are intended to treat rare diseases that generally affect fewer than 200,000 people in the United States.
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Year: 2016
MabVax Therapeutics Files IND for a Phase I Clinical Trial with 89Zr-HuMab-5B1
On January 6, 2016 MabVax Therapeutics Holdings, Inc. (OTCQB: MBVX), a clinical-stage oncology drug development company, reported the filing of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for 89Zr-HuMab-5B1, the Company’s fully human antibody product, as a new generation PET scan cancer imaging agent (Press release, MabVax, JAN 6, 2016, View Source [SID:1234508673]). Schedule your 30 min Free 1stOncology Demo! Subject to FDA authorization to proceed, MabVax plans to initiate the Phase I clinical trial in patients with pancreatic cancer in early 2016.
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The 89Zr-HuMab-5B1 imaging agent has demonstrated high-resolution images of tumors in xenograft animal models, potentially making it an important new tool to aid in the diagnosis, monitoring and assessment of pancreatic cancer patients and an attractive companion diagnostic for the HuMab-5B1 therapeutic product. In December 2015, MabVax received the FDA’s authorization to proceed with HuMab-5B1 in a Phase I trial as a therapeutic treatment for patients with pancreatic cancer.
This second planned Phase I trial will evaluate the safety, pharmacokinetics and biodistribution of 89Zr-HuMab-5B1 in cancer patients. The trial will also determine the ideal dose and conditions for an optimal PET scan image using the new imaging agent.
David Hansen, MabVax’s President and Chief Executive Officer, said, "With the submission of this second IND in late December, we have achieved our objective of filing both INDs for our HuMab-5B1 based products during 2015. We are making preparations to begin the Phase I trial with HuMab-5B1 as a therapeutic agent and, subject to FDA authorization to proceed with this second clinical trial, will begin dosing our first patients in the 89Zr-HuMab-5B1 Phase I trial soon thereafter."
"We anticipate that the Phase I trial with 89Zr-HuMab-5B1 will produce an initial set of images by mid-year 2016. This will be an important interim milestone in our continued development of this diagnostic product and could have a positive impact on our future commercial and corporate development activities. We expect to complete patient enrollment in this trial before the end of 2016," added Mr. Hansen. "We are excited about the potential applicability of our dual-product development approach in other cancers with HuMab-5B1, as well as with follow-on antibodies under development at MabVax."
About HuMab-5B1:
MabVax’s HuMab-5B1 antibody is fully human and was discovered from the immune response of cancer patients vaccinated with an antigen-specific vaccine during a Phase I trial at Memorial Sloan Kettering Cancer Center. In preclinical research, the HuMab-5B1 antibody demonstrated high specificity and affinity, and has shown potent cancer cell killing capacity and efficacy in animal models of pancreatic, colon and small cell lung cancers. The antigen the antibody targets is expressed on more than 90% of pancreatic cancers making the antibody potentially broadly applicable to most patients suffering from this type of cancer.
Accelerator Corporation Launches First Startup in New York City Portfolio
On January 6, 2016 January 6, 2016 Accelerator Corporation, a leading life science investment and management firm, reported the Series A financing of Petra Pharma Corporation to develop small molecule inhibitors for the treatment of cancer and metabolic diseases in alliance with Weill Cornell Medicine (Press release, Petra Pharma, JAN 6, 2016, View Source [SID:1234508672]). The investors participating in the $48 million Series A investment in Petra Pharma include Accelerator New York’s investment syndicate partners: AbbVie, Alexandria Venture Investments, ARCH Venture Partners, Eli Lilly and Company, Harris & Harris Group, Inc., Innovate NY Fund, Johnson & Johnson Innovation – JJDC, Inc., The Partnership Fund for New York City, Pfizer Venture Investments, Watson Fund and WuXi PharmaTech.
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"Following the launch of Accelerator in New York in 2014, we are delighted to now be financing our first startup life science company here in New York City," said Thong Q. Le, chief executive officer of Accelerator. "We believe that the scientific advancements pioneered by co-founders Drs. Lewis Cantley and Nathanael Gray, combined with an alliance with Weill Cornell Medicine in New York and our management team’s operational capabilities, provide a tremendous platform for a biotech company with significant growth potential in the City. This first launch is illustrative of the kind of support we expect to continue to bring to the local life sciences community in the months ahead."
Founders and Research Alliance
Petra Pharma’s co-founders include two world-leading researchers who have contributed to numerous breakthrough advances in cancer:
• Lewis Cantley, Ph.D., a foremost expert in understanding the biochemical pathways linking cancer and energy metabolism, discovered the signaling pathway phosphoinositide 3-kinase (PI3K) in 1984. Dr. Cantley is the Director of the Sandra and Edward Meyer Cancer Center at Weill Cornell Medicine and a member of the National Academy of Sciences, the Institute of Medicine of the National Academies and American Academy of Arts and Sciences.
• Nathanael Gray, Ph.D., responsible for the discovery of numerous first-in-class kinase inhibitors, also pioneered the use of synthetic chemistry and functional small molecule discovery to modulate biological pathways important in cancer. Dr. Gray is a professor of biological chemistry and molecular pharmacology at Harvard Medical School and Dana-Farber Cancer Center.
"Petra Pharma’s approach interrogates the novel enzyme targets responsible for a variety of important cellular processes, including cell division, growth, trafficking and signaling to develop therapies to improve patient health," stated Dr. Cantley, co-founder of Petra Pharma, who owns equity in Petra Pharma. "The support of Accelerator at the seed stage, coupled with an expanded syndicate financing offered by Accelerator New York’s investors, puts Petra Pharma in a strong position to advance this promising research avenue, translate critical discoveries into next-generation treatments and ultimately make a difference in the clinic."
Petra Pharma has entered into a multiyear research alliance with Weill Cornell Medicine, a stakeholder in the company, to further examine and elucidate certain biological pathways related to the targets being researched in Dr. Cantley’s lab. Weill Cornell Medicine’s Office of BioPharma Alliances and Research Collaborations is dedicated to proactively generate, structure and market translational research alliances with industry in order to advance promising research projects that have commercial potential.
"Accelerator’s collaborative investing model brings to New York City an attractive opportunity to translate the early-stage, innovative science coming out of our medical college into new therapies for patients," said Larry Schlossman, managing director of BioPharma Alliances and Research Collaborations at Weill Cornell. "We are delighted to be the first institution to partner with Accelerator New York and launch Petra Pharma under Weill Cornell’s unique biopharma alliance program."
Unique Model of Business Operations
Under Accelerator’s unique and proven investment and operations management model, the early operations of Petra Pharma will be overseen by Accelerator’s core management team. Accelerator has assembled a team of talented professionals with deep investment, operational and scientific expertise to build high-quality life science startup companies. By leveraging Accelerator’s capabilities, Petra Pharma will be highly focused on achieving key value-building scientific milestones, while the Accelerator management team will handle all aspects of business management and scientific oversight.
"Accelerator has a unique incubation strategy that helps mitigate the challenges associated with early-stage discovery efforts, leading to the creation of innovative new companies," said Greg Plowman, M.D., Ph.D., vice president of oncology research at Eli Lilly and Company. "As an investor in Accelerator and Petra Pharma, we are excited about Accelerator’s first New York City-based startup and the opportunities that Petra Pharma will bring to the City’s life science ecosystem."
Petra Pharma’s office and lab headquarters will be located within Accelerator’s facilities at the Alexandria Center for Life Science, New York City’s first and only premier life science park. Since its establishment, The Alexandria Center for Life Science has become the leading commercial destination in New York City for world-class life science entities to translate innovative discoveries into breakthrough products for patients with significant unmet medical needs.
About Accelerator Corporation
Accelerator Corporation, established in 2003 with operations in Seattle and New York City, is a biotechnology investment and management company. Formed by a syndicate of top-tier venture capital investors and a world-class research institution, Accelerator identifies, evaluates, finances, and manages the development of emerging biotechnology opportunities. Accelerator has built a unique solution that addresses many of the key problems associated with investing in early-stage biotechnology by providing access to venture capital, management, scientific expertise, and facilities. For more information, please go to: www.acceleratorcorp.com.
Chugai and Novartis Pharma to Terminate Co-Marketing Agreement of Aromatase Inhibitor “Femara® Tablets 2.5 mg,” a Treatment for Breast Cancer after Menopause
On January 6, 2016 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that Chugai and Novartis Pharma K.K. have agreed to terminate the agreement regarding co-marketing of aromatase inhibitor "Femara tablets 2.5 mg" (generic name: letrozole, hereafter Femara), a treatment for breast cancer after menopause in Japan, as of January 31, 2016 (Press release, Chugai, JAN 6, 2016, View Source [SID:1234508670]). Schedule your 30 min Free 1stOncology Demo! Novartis Pharma will be solely responsible for the distribution and commercialization of Femara in Japan from February 1, 2016.
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Chugai and Novartis Pharma will cooperate to accomplish a smooth transition. During the transition period, both companies will maintain the same level of product supply and adequate commercial activities to satisfy any medical needs.
ARTSaVIT Ltd. Completes $6.3 Million Series A Financing
On January 5, 2016 Israeli cancer apoptosis company ARTSaVIT LTD reported that it has completed a $6.3 million Series A round of financing led by Arkin Bio Ventures and Pontifax, with participation of M Ventures, Carmel Innovation and Carmel – Haifa University Economic Corporation Ltd (Press release, ARTSaVIT, JAN 5, 2016, View Source [SID1234561842]).
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ARTSaVIT was co-founded by Carmel, the economic corporation of the University of Haifa, Carmel Innovations Fund and Professor Sarit Larisch from the University of Haifa, Israel. Prof. Larisch has identified and characterized ARTS, a protein which regulates the levels of several important anti-apoptotic proteins by promoting their degradation. Apoptosis is a highly regulated process of natural cell death. Faulty regulation of apoptosis is implicated in many human diseases, including cancer. Moreover, resistance to apoptosis is a hallmark of most human cancers.
The insights gathered by Prof. Larisch and the unique function of ARTS led to the establishment of the company, which is developing small molecule ARTS mimetics designed to selectively induce apoptosis in cancer cells. The company received seed investment from the Carmel Innovations Fund, which supported the research and development of the company to its current stage.
ARTSaVIT will move from its facilities at Carmel, University of Haifa, to the state-of-the-art facilities at the M Ventures Israel BioIncubator, which will support the development of the start-up with its infrastructure and a wide range of incubation facilities and services.
Dr. Rom Eliaz, Head of the M Ventures Israel BioIncubator commented: "We are excited to join forces with Arkin Bio Ventures, Pontifax and Carmel and would like to welcome ARTSaVit to our BioIncubator. Following the completion of this fundraising, the company is now well positioned to reach its next value inflection point".
Elka Nir, CEO of Carmel Ltd, the economic corporation of the Haifa University and CEO of Carmel Innovations Fund, noted: "We are proud and excited that M Ventures together with Arkin Bio Ventures and Pontifax invested in ARTSaVIT. It demonstrates the excellent quality and potential of the research and researchers at the University of Haifa. It is another great success for the Carmel Innovation Fund and its business model, which is funding seed companies, supporting them to a stage of significant value "