|Seattle Genetics Announces Multiple ADCETRIS® Data on Malignant Lymphoma; BiondVax Announces FDA Acceptance of IND Application|
|By William Kent|
|Wednesday, 17 June 2015 18:33|
Below is a look at some of the headlines for companies that made news in the healthcare sector on June 17, 2015.
Seattle Genetics, Inc. (NASDAQ: SGEN) announced several ADCETRIS (brentuximab vedotin) data presentations at the 13th International Conference on Malignant Lymphoma (ICML) being held June 17 to 19, 2015, in Lugano, Switzerland. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, which is expressed in classical Hodgkin lymphoma (HL), systemic anaplastic large cell lymphoma (sALCL) and several other types of non-Hodgkin lymphoma (NHL). Seven oral presentations and one poster at ICML demonstrate the breadth of the clinical development program for ADCETRIS. Data include an additional analysis of the phase 3 AETHERA clinical trial showing that up to 16 cycles (approximately one year) of ADCETRIS consolidation therapy following autologous stem cell transplant (ASCT) significantly extended progression-free survival (PFS) versus placebo for those patients with primary-refractory HL. In addition, data from several corporate and investigator-sponsored trials with ADCETRIS showed activity in a variety of HL and NHL treatment settings. ADCETRIS is currently approved by the U.S. Food and Drug Administration (FDA) for relapsed HL and sALCL and was granted conditional marketing authorization by the European Commission for relapsed or refractory HL and sALCL.
"Since the initial FDA approval of ADCETRIS in 2011 for the treatment of relapsed HL and sALCL, it has been approved in more than 55 countries, and our clinical development program has expanded to include more than 30 corporate and investigator-sponsored clinical trials in CD30-expressing malignancies," said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "The ADCETRIS data presented at ICML support our broad development plans for ADCETRIS. In the near-term, we anticipate an FDA decision on its use in the AETHERA setting as a post-transplant consolidation therapy, and, ultimately, our goal is to move even earlier into the treatment paradigm and redefine frontline treatment of HL with the addition of ADCETRIS."
Analysis of primary-refractory Hodgkin lymphoma patients in a randomized, placebo-controlled study of brentuximab vedotin consolidation after autologous stem cell transplant (Seattle Genetics and Takeda; Abstract #120, oral presentation Friday, June 19, 2015, at 11:50 a.m. CEST)
Data were reported from an additional analysis of the phase 3 AETHERA clinical trial evaluating PFS by investigator in patients who were refractory to frontline treatment. Previously published data suggest primary-refractory HL patients have poor outcomes following ASCT, as demonstrated by the historical two-year PFS and three-year overall survival rates of less than 40 percent and 50 percent, respectively. Of the 329 patients enrolled in the AETHERA trial, 60 percent (196 patients) were primary-refractory to frontline treatment.
Results of the analysis demonstrated: Two-year PFS rates per investigator among primary-refractory patients on the ADCETRIS and placebo arms were 60 percent and 42 percent, respectively, consistent with the primary analysis in the full intent-to-treat population.
Subgroup analyses of patients by disease characteristics as well as number of risk factors showed that PFS was improved broadly across subgroups, including patients with B-symptoms, extranodal involvement and those who received more than two systemic anticancer treatments pre-ASCT.
Adverse events in primary-refractory patients who received ADCETRIS were consistent with the known safety profile.
Additional AETHERA data were included in a poster presentation reporting the frequency of healthcare resource utilization (HRU) among patients on the two treatment arms of the trial. Preliminary reports suggest a trend toward lower HRU in patients treated with ADCETRIS compared with placebo.
ADCETRIS is currently not approved for use in the AETHERA treatment setting. Based on the positive results from the AETHERA trial, a supplemental Biologics License Application (BLA) for ADCETRIS in the post-ASCT consolidation treatment of HL patients at high risk of relapse or progression was accepted for filing by the FDA. The FDA granted Priority Review for the application and the Prescription Drug User Fee Act (PDUFA) target action date is August 18, 2015.
Additional ADCETRIS corporate and investigator presentations are included below and full abstracts can be found in the ICML Educational and Abstract Book accessed on the ICML website at www.lymphcon.ch.
BiondVax Pharmaceuticals Ltd. (TASE: BVXV, Nasdaq: BVXV), a clinical stage biopharmaceutical company focused on developing and commercializing immunomodulation therapies for infectious diseases, today announced that its Investigational New Drug Application (IND) for its Multimeric-001 vaccine (M-001), has been accepted by the US Food and Drug Administration (FDA), and the Company was notified by its regulatory advisors that the 'study may proceed'. FDA acceptance of an IND provides authorization for the distribution and administration in the U.S. of medical products that have not yet been approved for commercial use for purposes of conducting clinical trials.
This IND continues BiondVax's clinical program, and will allow BiondVax to conduct an FDA approved Phase 2 clinical trial that will involve the administration of M-001, BiondVax's product candidate.
Dr. Ron Babecoff, BiondVax's CEO commented, "FDA acceptance of our IND application is an important milestone, representing a major step forward for BiondVax and for the development program of our universal flu vaccine."
Dr. Tamar Ben-Yedidia, BiondVax's CSO said, "Influenza is a serious global concern - it spreads rapidly, leading to serious illness which can directly or indirectly lead to death, particularly among the elderly. Today's vaccines are far from ideal - they mostly protect against the strains within them, but frequent mismatches between these strains and the circulating ones lead to low vaccine effectiveness. We believe our solution, whereby one vaccine protects against each and every flu strain, will save the lives and suffering of many millions around the world each year."
BioCryst Pharmaceuticals, Inc., (Nasdaq:BCRX) and CSL Limited (ASX:CSL) (USOTC:CSLLY) a pharmaceutical company focused on the development and commercialization of treatments for rare diseases, announced today that it has licensed RAPIVAB (peramivir injection) for the treatment of influenza to CSL Limited, a global biopharmaceutical company.
BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) today announced positive results of a Phase 2 proof-of-concept and dose finding study of BMN 111 (vosoritide), an analog of C-type Natriuretic Peptide (CNP), in children with achondroplasia. Achondroplasia is the most common form of human dwarfism. Vosoritide has Orphan designation in both the United States and Europe.
Capricor Therapeutics, Inc. (Nasdaq:CAPR), a biotechnology company focused on the discovery, development and commercialization of first-in-class therapeutics for the treatment of diseases today announced the appointment of Houman Hemmati, M.D., Ph.D. to the newly created position of Vice President of Medical and Clinical Development for New Therapies.
Cesca Therapeutics Inc. (Nasdaq:KOOL), an autologous cell-based regenerative medicine company, announced today it will report financial results for the fiscal third quarter ended March 31, 2015, on Tuesday, June 23, 2015.
Endologix, Inc. (Nasdaq:ELGX), developer and marketer of innovative treatments for aortic disorders, announced today the presentation of 30-day outcomes for the pivotal cohort from the Company-sponsored investigational device exemption (IDE) clinical investigation, the EVAS FORWARD-IDE Study (www.clinicaltrials.gov, NCT01726257).
LeMaitre Vascular, Inc. (Nasdaq:LMAT) is set to join the Russell 2000(R) and the Russell 3000(R) Indexes at the conclusion of the Russell indexes annual reconstitution on June 26, according to a preliminary list of additions posted June 12.
Lombard Medical, Inc. (Nasdaq:EVAR), a medical device company focused on Endovascular Aneurysm Repair (EVAR) of abdominal aortic aneurysms (AAAs), announced today that it is set to join the Russell Microcap Index at the conclusion of the Russell indexes annual reconstitution on June 26, according to a preliminary list of additions posted June 12 at www.russell.com.
Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company focused on the discovery, development, and commercialization of targeted cancer therapies, today announced that Joshua H. Bilenker, M.D., chief executive officer, will present a corporate overview at the JMP Securities Life Sciences Conference in New York City on Wednesday, June 24, 2015 at 11:30AM Eastern Time.
Medgenics, Inc. (NYSE MKT:MDGN), the developer of a proprietary platform for the sustained production and delivery of therapeutic proteins and peptides in patients using ex vivo gene therapy and their own tissue for the treatment of rare and orphan diseases, today announced that Michael Cola, President and CEO, will present at the JMP Securities Life Sciences Conference 2015 in New York, NY.
Nuo Therapeutics, Inc. (OTCQX:NUOT), a pioneer in biodynamic therapies, today announced its participation in the 35th Annual National Veterans Wheelchair Games (NVWG), presented by the Department of Veterans Affairs (VA) and Paralyzed Veterans of America (PVA), taking place June 21 - 26 in Dallas, TX.
OpGen, Inc. (Nasdaq:OPGN), an early commercial-stage molecular testing and bioinformatics company, today reported financial results for the three months ended March 31, 2015.
Prothena Corporation plc (Nasdaq:PRTA), a late-stage clinical biotechnology company focused on the discovery, development and commercialization of novel protein immunotherapy programs, today presented clinical results from a Phase 1 single ascending dose study of PRX002, a monoclonal antibody for the potential treatment of Parkinson's disease and other related synucleinopathies. PRX002 is the focus of a worldwide collaboration between Prothena and Roche.
Proteon Therapeutics Inc. (Nasdaq:PRTO), a company developing novel, first-in-class therapeutics to address the medical needs of patients with kidney and vascular diseases, today announced that Company management will present at the JMP Securities Life Science Conference on Wednesday, June 24, 2015 at 9:00 am ET.
Spark Therapeutics (Nasdaq:ONCE) announced today that members of its management team will participate in the Roth Capital Partners 2nd Annual ROTH Healthcare Day on Wednesday June 24th as well as the J.P. Morgan Cazenove European Healthcare Conference on Thursday June 25th.
Supernus Pharmaceuticals, Inc. (Nasdaq:SUPN), a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, today announced that it has received notice that, effective following the close of trading on June 15, 2015, New Enterprise Associates (NEA) distributed an aggregate of 3,921,000 shares of Supernus Pharmaceuticals common stock to its partners.
TOMI™ Environmental Solutions, Inc. (OTCQB:TOMZ), a global bacteria decontamination and infection prevention company, announced the United States Agency for International Development (USAID) has awarded the company a grant for approximately $560,000 for the development of SteraMist™ Mobile Decontamination Chambers to fight the Ebola epidemic.
Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) today reported that the U.S. Food and Drug Administration (FDA) has conditionally accepted the proposed trade name Tonmya™ (ton-MY-ah) for TNX-102 SL (cyclobenzaprine HCl sublingual tablets), 2.8 mg, for the management of fibromyalgia.
TRACON Pharmaceuticals (Nasdaq:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, age-related macular degeneration and fibrotic diseases, announced today that Charles Theuer, M.D, Ph.D., President and CEO, will present at the JMP Securities Life Science Conference at 10:00 am EDT on Wednesday, June 24, 2015, at the St. Regis Hotel in New York, NY.
Vascular Solutions, Inc. (Nasdaq:VASC) today announced that it has launched two new versions of its Turnpike catheters for use in complex coronary and peripheral interventions.
Zafgen, Inc. (Nasdaq:ZFGN), a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity, today announced that Thomas Hughes, Ph.D., Chief Executive Officer, will present at the JMP Securities Life Sciences Conference on Tuesday, June 23, 2015 at 11:00 a.m. ET at The St. Regis Hotel in New York.