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[Corrected 2/8/16, 11:20 am. See below.] In a deal that consolidates its position as a leader in developing a stem cell-derived treatment for diabetes, San Diego’s ViaCyte says today it is absorbing…
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ViaCyte Acquires Rights to BetaLogics Assets, Expanding and Extending Industry-Leading Portfolio for Stem Cell-Derived Approaches to Type 1 Diabetes
– Preliminary data of STEP ONE clinical trial are promising –
SAN DIEGO, Feb. 3, 2016 /PRNewswire/ — ViaCyte, Inc., a leading, privately-held regenerative medicine company with the first pluripotent stem cell-derived islet replacement therapy for the treatment of type 1 diabetes in clinical-stage development, today announced that ViaCyte and Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, have agreed to consolidate the assets of the Janssen BetaLogics group into ViaCyte. The agreement provides ViaCyte with an exclusive license to all BetaLogics intellectual property in the field of metabolic disease, including diabetes, and the transfer of related assets to ViaCyte.
“For more than a decade BetaLogics and ViaCyte have been independently working toward a stem cell-derived therapy for diabetes. By combining the intellectual property and other assets of BetaLogics with ViaCyte, we will further strengthen our advanced program focused on insulin-dependent diabetes and solidify our leadership in the field,” said Paul Laikind, PhD, President and CEO of ViaCyte. “We look forward to delivering effective new treatments for this difficult disease.”
ViaCyte’s clinical-stage VC-01™ product candidate is composed of human pancreatic progenitor cells, called PEC-01™ cells, contained in a semi-permeable encapsulation device, called the Encaptra® drug delivery system. The Encaptra system is designed to deliver the cells to the patient and protect them from attack by the patient’s immune system. This first-in-class cell replacement therapy for the treatment of type 1 diabetes is currently being evaluated in a Phase 1/Phase 2 clinical trial called STEP ONE (Safety, Tolerability, and Efficacy of VC-01 Combination Product in Type One Diabetes). If successful, the VC-01 product candidate has the potential to provide a functional therapeutic for type 1 diabetes and to become an important treatment for the large number of insulin-requiring patients with type 2 diabetes as well.
ViaCyte recently presented preliminary results from the STEP ONE clinical trial of the VC-01 product candidate. The company is currently evaluating the candidate at a sub-therapeutic dose to establish safety and develop the procedures for successful implantation. Results presented at Biotech Showcase™ 2016 in San Francisco last month demonstrated that the company is making progress translating the promising results observed in pre-clinical models to patients.
“JDRF has been a long time, proud supporter of the work that ViaCyte is doing to transform the way we treat type 1 diabetes,” said Derek Rapp, JDRF President and CEO. “The recent clinical data, while preliminary, are encouraging and move us closer to our goal of a world without type 1 diabetes.”
C. Randal Mills, PhD, President and CEO of the California Institute for Regenerative Medicine (CIRM), which is supporting ViaCyte’s clinical trial, said “At CIRM, our mission is to accelerate stem cell therapies to patients with unmet medical needs, which is perfectly aligned with the excellent work being done by our partners at ViaCyte. Finding an effective treatment for a disease like type 1 diabetes would be transformational for millions of people around the world, so the latest clinical data from ViaCyte are very encouraging and a clear sign of progress.”
The combination of the ViaCyte and BetaLogics regenerative medicine platforms enhances ViaCyte’s already robust intellectual property. As a result of the agreement, ViaCyte gains exclusive access to an additional 145 issued patents, 15 of which are in the United States, and an additional 565 pending patent applications, for a combined portfolio of the companies of 360 issued patents, including 75 in the United States, and 710 pending applications. Financial terms of the deal were not disclosed. The BetaLogics team will work closely with ViaCyte to ensure an effective integration. ViaCyte remains independent and no commercialization rights to future products were conveyed as a result of this transaction.
Type 1 diabetes remains a challenging disease that, despite insulin treatment, often leads to long term complications, including premature death. In addition, continuously monitoring blood glucose, diet, and exercise, and managing insulin administration has a substantial impact on quality of life. Cell replacement therapy has the potential to transform the way the disease is managed, potentially reducing or eliminating the reliance on constant glucose monitoring and insulin injections, while providing a more physiological regulation of blood glucose.
The STEP ONE clinical trial is underway in both the United States and Canada. For more info on the clinical trial, visit www.clinicaltrials.gov.
ViaCyte is a privately-held regenerative medicine company focused on developing a novel cell replacement therapy for the treatment of diabetes. ViaCyte is conducting a Phase 1/2 clinical trial of the Company’s lead VC-01 product candidate in patients with type 1 diabetes who have minimal to no insulin-producing beta cell function. ViaCyte’s VC-01 combination product candidate is based on the production of pancreatic progenitor cells derived from human pluripotent stem cells. These progenitor cells are implanted in a durable and retrievable encapsulation device. Once implanted and matured, these cells are designed to secrete insulin and other regulatory factors in response to blood glucose levels. The VC-01 product candidate is being developed as a potential long-term diabetes treatment with the goal of reducing the risk of hypoglycemia and diabetes-related complications without requiring long-term immune suppression.
ViaCyte is headquartered in San Diego, California with additional operations in Athens, Georgia. The Company is funded in part by the California Institute for Regenerative Medicine (CIRM) and JDRF.
SOURCE ViaCyte, Inc.
Like many small biotechs, San Antonio, TX-based GenSpera has plenty of options for developing its cancer drug and limited resources to do so. While GenSpera’s treatment, called mipsagargin or G-202,…
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Human Longevity, Inc. (HLI) Hires Key Oncology Leader, Kenneth J. Bloom, M.D., to Head Oncology and Immunotherapy Program
Stephen P. Schoenberger, Ph.D., to head cancer vaccine program and Ezra Cohen, M.D. is staff oncologist
SAN DIEGO, Feb. 3, 2016 /PRNewswire/ — Human Longevity, Inc. (HLI), the genomics-based, technology-driven company, announced today the appointment of several key people for its oncology genomics program. Kenneth J. Bloom, M.D. will join the company as the new head of oncology and immunotherapy; Stephen P. Schoenberger, Ph.D. will lead cancer vaccine efforts and Ezra Cohen, M.D., who is also Associate Director and Professor of Medicine, Moores Cancer Center, University of California, San Diego, will be a staff oncologist.
HLI recently announced its oncology program which includes the development of comprehensive whole germline and tumor genome analysis, as well as tumor and germline exome analysis products.
“We are excited to have Ken, Stephen and Ezra on the HLI team and are confident their combined clinical and scientific expertise will greatly enhance our oncology program. We have been working over the last year on developing our oncology program with help from Ezra. We will look to Ken and his team to further develop and commercialize this important area of our business,” said J. Craig Venter, Ph.D., Co-founder and CEO, HLI.
Dr. Bloom has more than 30 years of clinical and business experience and has been an early adopter and big proponent of information technology to revolutionize pathology and other areas of medicine. He is also a prolific and renowned researcher and lecturer in pathology, cancer, telemedicine, and informatics.
He comes to HLI most recently from GE Healthcare where he was since 2011 as Chief Medical Officer, In Vitro Diagnostics, Life Sciences. There he had oversight of Medical Affairs, Clinical Pathology Services, Pharma Pathology Services, Bioinformatics and Research and Development. He was also President and CEO of Clarient Pathology Services, the professional group contracted to provide pathology services to Clarient Diagnostic Services and SeqWright. In these roles he led the overall development and execution of the medical and scientific strategy, aligning them with the overall GE mission and business strategy. Prior to Clarient, Dr. Bloom was with US Labs where he was Senior Medical Director since 2002.
In addition to Dr. Bloom’s extensive business experience, he has held a series of impressive academic medical posts including Clinical Professor of Pathology at University of Southern California, Keck School of Medicine; and Associate Professor of Pathology at Rush Medical College. During the last 15 years he has held more than 10 appointed positions at Rush Presbyterian-St. Luke’s Medical Center, one of the leading cancer research hospitals in the United States, including Director of Laboratory Operations, Director of Immunohistochemistry, and Director of Information Services for Rush Cancer Center.
Dr. Bloom received his M.D. from Rush Medical College and his B.A. from Grinnell College.
Ezra Cohen, M.D., is a board-certified oncologist and cancer researcher who cares for patients with all types of head and neck cancers, including esophageal, thyroid and salivary gland cancers. Dr. Cohen is also an internationally recognized expert on novel cancer therapies and co-leads the Solid Tumor Therapeutics program at Moores Cancer Center. Much of his clinical work has focused on squamous cell carcinomas and cancers of the thyroid, salivary gland, and HPV-related oropharyngeal cancers. Dr. Cohen has been consulting with HLI for approximately a year as the company has been developing its oncology program and will continue this work in his new part time role.
Dr. Cohen serves as co-chair of the National Cancer Institute Head and Neck Cancer Steering Committee, which oversees NCI-funded clinical research in this disease. He is also editor-in-chief of Oral Oncology, the most respected specialty journal in head and neck cancer. A frequent speaker at national and international meetings, he has authored more than 150 peer-reviewed papers and has been the principal investigator of multiple clinical trials of new drugs in all phases of development.
Dr. Cohen earned his medical degree at University of Toronto. He completed residencies in family medicine at the University of Toronto and in internal medicine at Albert Einstein College of Medicine. He completed a hematology/oncology fellowship at the University of Chicago and was a member of the faculty there for 12 years until moving to UC San Diego in January 2014.
Stephen Schoenberger, Ph.D., an expert in immunology and oncology, is heading the cancer vaccine efforts at HLI. He is also currently Professor in Cellular Immunology at the La Jolla Institute for Allergy and Immunology and an Adjunct Professor of Medicine in the Division of Hematology and Oncology at UC San Diego, Moores Cancer Center. Schoenberger has authored nearly 100 scientific papers, along with numerous reviews and book chapters. He received his Doctor of Philosophy in Microbiology and Molecular Genetics and his BS in Microbiology from the University of California, Los Angeles.
About Human Longevity, Inc.™
Human Longevity, Inc. (HLI) is the genomics-based, technology-driven company creating the world’s largest and most comprehensive database of whole genome, phenotype and clinical data. HLI is developing and applying large scale computing and machine learning to make novel discoveries to revolutionize the practice of medicine. HLI’s business also includes the HLI Health Nucleus, a genomic powered clinical research center which uses whole genome sequence analysis, advanced clinical imaging and innovative machine learning, along with curated personal health information, to deliver the most complete picture of individual health. For more information, please visit http://www.humanlongevity.com or http://www.healthnucleus.com.
SOURCE Human Longevity, Inc.
SAN DIEGO, Feb. 3, 2016 /PRNewswire/ — MabVax Therapeutics Holdings, Inc. (OTCQB: MBVX), a clinical-stage immuno-oncology drug development company, announces that President and Chief Executive Officer David Hansen is scheduled to present a corporate overview at the 18th Annual BIO CEO & Investor Conference on Tuesday, February 9, 2016, at 10:30 a.m. Eastern time (7:30 a.m. Pacific time). The conference is being held at The Waldorf Astoria New York hotel in New York City.
“This is an exciting time at MabVax with preparations underway to begin Phase I clinical trials with our fully human antibody product HuMab-5B1 as both a therapeutic agent and a new generation PET scan cancer imaging agent,” said David Hansen, MabVax’s President and Chief Executive Officer. “We anticipate reporting an interim safety assessment and determination of a maximum tolerated dose in the therapeutics trial and an initial set of disease images in the imaging trial by mid-year 2016. These near-term interim data could provide additional validation for our proprietary approach to immune-oncology. We look forward to updating investors on our progress and upcoming milestones at this well-attended conference.”
A live webcast of the presentation will be available on Company’s website at http://www.mabvax.com/investor-relations.php. A replay of the presentation will be available for 90 days.
About BIO CEO & Investor Conference:
The BIO CEO & Investor Conference is the largest investor conference focused on established and emerging publicly traded and select private biotech companies. The event features plenary sessions, fireside chats, business roundtables, therapeutic workshops, company presentations and One-on-One PartneringTM meetings.
MabVax Therapeutics Holdings, Inc. is a clinical-stage biotechnology company focused on developing antibody-based products and vaccines to address unmet medical needs in the treatment of cancer. MabVax has discovered a pipeline of human monoclonal antibody products based on the protective immune responses generated by patients who have been immunized against targeted cancers with the Company’s proprietary vaccines. In December 2015, MabVax received authorization from the U.S. Food and Drug Administration (FDA) to proceed with the Company’s fully human antibody product, HuMab-5B1, in a Phase I trial as a therapeutic treatment for patients with pancreatic cancer. MabVax plans to begin this Phase I trial in the first quarter of 2016. On February 1, 2016, MabVax announced that it had received authorization from the FDA to proceed with a second Phase I trial for 89Zr-HuMab-5B1, a next-generation PET imaging agent for pancreatic cancer. MabVax also has the exclusive license to several therapeutic vaccines from Memorial Sloan Kettering Cancer Center. MabVax has two cancer vaccines targeting recurrent sarcoma and ovarian cancer in proof-of-concept Phase II multicenter clinical trials. Additional information is available at www.mabvax.com.
Forward Looking Statements:
This press release contains “forward-looking statements” regarding matters that are not historical facts, including statements relating to the Company’s two authorizations to proceed with Phase I clinical trials and product development pipeline. We have no assurance that all of the product development pipeline will be fully developed by the Company. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “anticipates,” “plans,” “expects,” “intends,” “will,” “potential,” “hope” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon current expectations of the Company and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release relating to the Company may be found in the Company’s periodic filings with the Securities and Exchange Commission, including the factors described in the section entitled “Risk Factors” in its annual report on Form 10-K for the fiscal year ended December 31, 2014, as amended and supplemented from time to time and the Company’s Quarter Reports on Form 10-Q and other filings submitted by the Company to the SEC, copies of which may be obtained from the SEC’s website at www.sec.gov. The parties do not undertake any obligation to update forward-looking statements contained in this press release.
Senior Vice President
SOURCE MabVax Therapeutics Holdings, Inc.
Dave Purcell meant to stay retired after he ended his 23-year stint with Encad, a San Diego company he co-founded to manufacture large-format inkjet printers capable of printing poster-size images…
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SAN DIEGO, Feb. 3, 2016 /PRNewswire/ — OncoSec Medical Incorporated (“OncoSec”) (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, announced today that members of its leadership team will be making presentations at several high-profile events in February, including:
- The 18th Annual BIO CEO & Investor Conference
- Source Capital Group’s 2016 Disruptive Growth & Healthcare Conference
- Biocom’s Global Life Science Partnering Conference
- 4th Annual Sachs Cancer Bio Partnering & Investment Forum
The 18th Annual BIO CEO & Investor Conference
Punit Dhillon, President and CEO, will present a corporate overview at The 18th Annual BIO CEO & Investor Conference on February 8 at 11:00 AM ET at The Waldorf Astoria in New York City. To view to the live webcast, please access the following link at the time of the presentation: http://www.veracast.com/webcasts/bio/ceoinvestor2016/76113125724.cfm. An archived version of the webcast will be available for 90 days on OncoSec’s website: http://www.oncosec.com.
In its eighteenth year, The BIO CEO & Investor Conference is the largest investor conference focused on established and emerging publicly traded and select private biotech companies. Companies are able to present their company story to an audience of target investors and meet one-on-one with new and current investors, analysts, investment bankers, and other potential corporate partners. The conference also provides a platform to network with peers, investors, and potential partners attending the conference. For more information, please visit: https://www.bio.org/events/conferences/bio-ceo-investor-conference.
Source Capital Group’s 2016 Disruptive Growth & Healthcare Conference
Mr. Dhillon will present a corporate overview at Source Capital Group’s 2016 Disruptive Growth & Healthcare Conference on February 10 at 12:30 PM ET at Convene in New York City.
The 2016 Disruptive Growth & Healthcare Conference will feature presentations from life science companies focusing on solutions to unmet medical needs and growth companies with disruptive technologies and business models. Attendees will include over 400 institutional investors, accredited investors, family offices, analysts, registered investment advisors, wealth managers, Source representatives, and their clients. The panels will cover a variety of topics, including regenerative medicine, immunotherapy, diagnostics, disruptive innovations, and business models. For more information, please visit: www.sourcecapitalconference.com.
Biocom’s Global Life Science Partnering Conference
Mr. Dhillon will present a corporate overview at Biocom’s Global Life Science Partnering Conference taking place February 24-25 at The Lodge at Torrey Pines in La Jolla, CA.
Biocom’s 6th Annual Global Life Science Partnering Conference is an exclusive global partnering and networking forum that brings together senior executives, bankers, venture capitalists, and business development professionals from leading pharmaceutical and biotech companies. The conference will include panel discussions on relevant topics with senior industry leaders, start-up company presentations, one-on-one meetings, and numerous networking opportunities. For more information, please visit: https://www.biocom.org.
4th Annual Sachs Cancer Bio Partnering & Investment Forum
Robert H. Pierce, MD, Chief Scientific Officer, will present a corporate overview at the 4th Annual Sachs Cancer Bio Partnering & Investment Forum on February 24 at 2:40 PM ET at the New York Academy of Sciences in New York City.
The 4th Annual Sachs Cancer Bio Partnering & Investment Forum is designed to bring together thought leaders from cancer research institutes, patient advocacy groups, pharmaceutical, and biotech to facilitate partnering and funding/investment. The conference will attract approximately 250 delegates and 30 company presentations by listed and private biotechnology companies seeking licensing and investment opportunities. The event provides a platform for one-on-one meetings and dedicated meeting facilities to make the event more productive. For more information, please visit: http://www.sachsforum.com/.
About OncoSec Medical Incorporated
OncoSec is a biotechnology company developing DNA-based intratumoral immunotherapies with an investigational technology, ImmunoPulse™, for the treatment of cancer. ImmunoPulse™ is designed to enhance the local delivery and uptake of DNA-based immune-targeting agents, such as IL-12. In Phase I and II clinical trials, ImmunoPulse™ IL-12 has demonstrated a favorable safety profile and evidence of anti-tumor activity in the treatment of various skin cancers as well as the potential to initiate a systemic immune response. OncoSec’s lead program, ImmunoPulse™ IL-12, is currently in Phase II development for several indications, including metastatic melanoma, squamous cell carcinoma of the head and neck, and triple-negative breast cancer. In addition to ImmunoPulse™ IL-12, the Company is also identifying and developing new immune-targeting agents for use with the ImmunoPulse™ platform. For more information, please visit www.oncosec.com.
OncoSec Medical Incorporated
SOURCE OncoSec Medical Incorporated
It’s been a real pleasure writing my guest op-ed pieces for Xconomy for the past six years. I’ve enjoyed sharing my thoughts about a wide spectrum of biopharma topics, and appreciated the feedback I…
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Invetech to design and supply automated production systems for commercialization of autologous cell therapy based on Celyad’s cardiopoiesis technology platform
SAN DIEGO, Feb. 3, 2016 /PRNewswire/ — Invetech, a global leader in instrument development, custom automation and contract manufacturing, and Celyad SA, (CYAD.BR) (“Celyad”), a biopharmaceutical company focused on identification and development of specialized cell-based therapies with product candidates in oncology and cardiology, today announced that they have entered into an agreement under which Invetech will develop and supply manufacturing systems to support production needs for C-Cure®, Celyad’s most advanced product candidate based on the cardiopoiesis technology platform. Under the terms of the agreement, Invetech will provide Celyad with a range of advanced design and manufacturing services to support development of customized manufacturing systems for commercial production of C-Cure®.
“Our feasibility study for automated manufacturing of C-Cure® delivered excellent results and provided strong support for the continued development of this promising automation platform. Importantly, this program also builds on and expands our expertise in core cell therapy development,” said Dieter Hauwaerts, vice president, operations, Celyad.
In this collaboration, the system design and production teams at Invetech will supply Celyad with a modular, readily scalable and highly automated production suite able to facilitate simultaneous processing of multiple patient-specific therapies. The manufacturing system is designed to be rapidly expandable to accommodate anticipated increases in production volume to support future global commercialization pending regulatory approvals.
“We are pleased to be supporting Celyad in the translation of their exciting C-Cure® product from clinical trials to commercial production. Our experience with automating manual processes has enabled us to design a GMP compliant manufacturing system that meets Celyad’s need for efficient manufacturing combined with patient safety,” said Richard Grant, Global Vice President, Cell Therapy, at Invetech. “This agreement reflects Invetech’s ability to adapt biopharmaceutical process design methodologies to address the unique demands and challenges presented by the cell therapy industry.”
C-Cure® is Celyad’s most advanced product candidate based on its cardiopoiesis platform and is being developed for heart failure indications. The Company expects to release the full clinical data set for CHART-1, its Phase III trial in Europe and Israel, in the middle of 2016. The research underlying this technology was originally conducted at Mayo Clinic by the research team of Professor André Terzic and Atta Behfar, and has been published in numerous peer-reviewed publications. C-Cure® consists of a patient’s own cells harvested from bone marrow, treated with cardiopoietic growth factors and then re-injected into the heart. It is designed to produce new autologous heart muscle cells that behave identically to those lost as a result of infarction, without the risk of rejection. C-Cure®’s potential has been demonstrated in a multi-center randomized controlled Phase II trial conducted in Europe. Results of the C-Cure® Phase II trial were published in April 2013 in the Journal of American College of Cardiology.
Celyad, previously Cardio3 BioSciences, is a biopharmaceutical company focused on translating breakthrough cell-based research into innovative therapeutics to improve the outcome of severe diseases. The Company is currently developing clinical stage cell therapies in cardiology and oncology, two healthcare segments with high unmet medical needs.
Invetech has been creating breakthrough products and custom automation systems for more than 30 years. With experience drawn from more than 5000 projects globally, Invetech partners with global leaders in industry to deliver product design and development, contract manufacturing and custom automation services. The company has experience in a broad range of market sectors including cell therapy production automation systems, laboratory diagnostics, point of care diagnostics, life sciences, industrial and consumer products.
Berry & Company Public Relations
Ph +1 212.253.8881
SAN DIEGO, Feb. 2, 2016 /PRNewswire/ — Orexigen® Therapeutics, Inc. (Nasdaq: OREX) today announced that management will be presenting at two upcoming investor conferences. The details are as follows:
BIO CEO & Investor Conference
Tuesday, February 9, 2016
3:00 p.m. Eastern Time
New York, NY
Leerink Swann Global Healthcare Conference
Thursday, February 11, 2016
10:45 a.m. Eastern Time
New York, NY
To listen to live webcasts of each presentation or to a replay of the discussions, please visit the Investors section of the Company’s Web site at www.orexigen.com. A replay will be available for 14 days after the event.
VP, Corporate Communications and Business Development
SOURCE Orexigen Therapeutics, Inc.