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VetDC Achieves Key Regulatory Milestone, Nears FDA Approval of TANOVEA for Canine Lymphoma

<p>FORT COLLINS, Colo.--(BUSINESS WIRE)--VetDC, Inc., a veterinary cancer therapeutics company, today announced that the Company has received three major technical section complete letters for <a target="_blank" href="http://cts.businesswire.com/ct/CT?id=smartlink&#38;url=http%3A%2F%2Fvet-dc.com%2Fproducts%2Ftanovea-for-lymphoma%2F&#38;esheet=51407378&#38;newsitemid=20160824005909&#38;lan=en-US&#38;anchor=TanoveaTM+%28rabacfosadine%29&#38;index=1&#38;md5=35b471ee02ebc3f44ba3ecc3c8f89c77" rel="nofollow">Tanovea<sup>TM</sup> (rabacfosadine)</a> from the U.S. Food and Drug Administration&#8217;s Center for Veterinary Medicine (FDA-CVM). Upon approval, Tanovea will be the first on-label therapeutic option for use in dogs with lymphoma, one of the most common cancers afflicting companion animals today. </p><br><a href="http://mms.businesswire.com/media/20160824005909/en/540837/4/VetDC-logo-vertical_RGB_JPEG_HI.jpg"><img src="http://mms.businesswire.com/media/20160824005909/en/540837/21/VetDC-logo-vertical_RGB_JPEG_HI.jpg"></a> <p> The three major technical section complete letters are required to file an administrative New Animal Drug Application for approval with the FDA-CVM. VetDC plans to submit the administrative filing later this year. Once Tanovea receives FDA approval, VetDC intends to commence commercialization in early 2017. </p> <p> &#8220;This is a significant milestone for VetDC, as we are one step closer to introducing the first FDA-approved drug for use in dogs with lymphoma,&#8221; stated Steven Roy, VetDC&#8217;s President and CEO. &#8220;There is a clear unmet need for new therapeutic alternatives to address this common and devastating cancer in pets. Given Tanovea&#8217;s demonstrated anti-tumor effects, rapid onset of action, generally well&#8211;tolerated profile and a substantial reduction in pet owner visits to the veterinarian, our market research suggests that Tanovea has the potential to achieve peak sales of at least $40 million annually in a rapidly growing market.&#8221; </p> <p> <b>About Tanovea</b> </p> <p> Tanovea<sup>TM</sup> (rabacfosadine) is a novel small molecule drug designed to preferentially target and attack cancer cells implicated in lymphoma, one of the most common and deadly cancers impacting pets today. In multiple clinical studies in over 300 client-owned dogs with naturally occurring lymphoma, Tanovea has consistently demonstrated substantial anti-tumor activity in both na&#239;ve and relapsed cases, with a generally well-tolerated safety profile. Tanovea has a rapid onset of action, with responses observed in as few as 7 to 21 days. Tanovea is being investigated as a convenient, every-three-week treatment for up to five doses, representing a substantial reduction in client visits relative to non-approved &#8216;human&#8217; generic chemotherapy regimens commonly utilized in dogs. </p> <p> VetDC has an exclusive North American license from Gilead Sciences to develop and commercialize Tanovea for companion animal cancer. </p> <p> <b>About VetDC, Inc.</b> </p> <p> VetDC (<a target="_blank" href="http://cts.businesswire.com/ct/CT?id=smartlink&#38;url=http%3A%2F%2Fwww.vetdc.com&#38;esheet=51407378&#38;newsitemid=20160824005909&#38;lan=en-US&#38;anchor=www.vetdc.com&#38;index=2&#38;md5=f3a57e896375a5eaf5f8a4ec41c3c7fc" rel="nofollow">www.vetdc.com</a>) is changing the way new cancer medicines are developed for companion animals, leveraging novel advancements from human biotechnology that have demonstrated success in animal studies. VetDC currently has two programs in development, Tanovea for lymphoma and VDC-597 for multiple cancers. </p> <p> </p> <p> </p><br><b>Contacts</b> <br><p> <b>VetDC</b><br>Steven Roy, 303-859-2072<br></p>

24 Aug 2016, 21:30
Visterra to Present New Clinical Results of VIS410 at the Options IX for the Control of Influenza Conference

<p> <i>- Includes Clinical Data from the Phase 2a Influenza Virus Challenge Study of VIS410 and Preclinical Data that Demonstrated VIS410 Does Not Cause Antibody-Dependent Enhancement -</i> </p> <p> </p><br><a href="http://mms.businesswire.com/media/20160824005110/en/338876/2/Visterra_Logo.jpg"><img src="http://mms.businesswire.com/media/20160824005110/en/338876/2/Visterra_Logo.jpg"></a> <p>CAMBRIDGE, Mass.--(BUSINESS WIRE)--Visterra, Inc., a clinical-stage biotechnology company, today announced that two posters and one oral presentation related to the Company&#8217;s lead product candidate, VIS410, a novel monoclonal antibody in development for the treatment of seasonal and pandemic influenza A, will be presented at the Options IX for the Control of Influenza Conference in Chicago, Illinois, on August 24 &#8211; 28, 2016. </p> <p> The data presented at the Options IX Conference will detail efficacy, resistance testing, and pharmacokinetic results from a Phase 2a influenza viral challenge study of VIS410. Data also will be presented that demonstrates that, in preclinical mouse models, VIS410 did not cause antibody-dependent enhancement, which is a phenomena where non-neutralizing antibodies can bind to the virus and enhance the disease. </p> <p> &#8220;We look forward to sharing these encouraging clinical and preclinical data on VIS410 at this important international meeting of leaders in the influenza field,&#8221; said Jos&#233; Trevejo, MD, PhD, Vice President of Development of Visterra. &#8220;We are very pleased by the results of our Phase 2a influenza viral challenge study, which we believe support the continued development of VIS410 as a single administration treatment for hospitalized patients with influenza A infection. Furthermore, our clinical progress to date with VIS410 demonstrates the potential value of our innovative drug discovery and development platform and its ability to create novel therapeutic candidates aimed at meeting important unmet medical needs.&#8221; </p> <p> The Options for the Control of Influenza Conference is held every three years and is the largest international scientific conference exclusively devoted to influenza. The VIS410 data presentations at the Options IX Conference are as follows: </p> <p> <b>Poster Number P-33:</b> Pharmacokinetics of the Hemagglutinin (HA) Stalk-Binding Antibody, VIS410, in a Human Challenge Model of Infection with a p2009 H1N1 Virus<br><b>Date:</b> Thursday, August 25, 2016<br><b>Location:</b> Exhibit Hall A &#38; B, Sheraton Grand Chicago Hotel<br><b>Viewing Time:</b> 10:30 am &#8211; 12:30 pm; 3:30 pm &#8211; 7:30 pm<br><b>Presentation Time:</b> 6:00 pm &#8211; 7:30 pm </p> <p> <b>Poster Number P-422:</b> Treatment with a Hemagglutinin (HA) Stem-binding Monoclonal Antibody, VIS410, Does not Cause Antibody Dependent Enhancement (ADE) in Preclinical Models of Influenza A Virus Infection<br><b>Date:</b> Friday, August 26, 2016<br><b>Location: </b>Exhibit Hall A &#38; B, Sheraton Grand Chicago Hotel<br><b>Viewing Time:</b> 10:30 am &#8211; 12:30 pm; 3:30 pm &#8211; 7:30 pm<br><b>Presentation Time:</b> 6:00 pm &#8211; 7:30 pm<br></p> <p> <b>Oral Presentation Title:</b> Evaluation of Efficacy and Emergence of Resistance to VIS410, a Human Monoclonal Antibody, in a Human Challenge Model of Infection with a p2009 H1N1 Virus<br><b>Publication Number:</b> O-71<br><b>Date:</b> Saturday, August 27, 2016<br><b>Session:</b> Oral Abstract Session: Clinical Science<br><b>Session Time:</b> 11:00 am &#8211; 12:30 pm<br><b>Presentation Time:</b> 11:15 am </p> <p> <b>About VIS410</b><br>VIS410 is a monoclonal antibody that Visterra is developing as a single-dose administration for the treatment of hospitalized patients with influenza A, regardless of the viral strain. Visterra is planning to advance VIS410 into additional clinical trials in patients with influenza A to further evaluate efficacy and safety. Visterra believes that VIS410 has the potential to effectively treat severe disease caused by all strains of influenza A, including those caused by mutated and recently emerged strains. VIS410 is directed against a Hierotope on hemagglutinin, which is a surface protein of influenza viruses used for binding and entry into cells. VIS410 is designed to prevent fusion of the virus cell membrane with the membrane of infected cells by binding to hemagglutinin and thereby terminating the viral replication cycle. </p> <p> <b>About Influenza</b><br>Influenza is an infectious disease that causes illness in humans worldwide with symptoms that range in severity from mild to life-threatening. The majority of seasonal influenza infections result in mild illness; however, some infections result in severe disease, which can involve rapidly progressive pneumonia, respiratory failure and, in some cases, death. Severe disease is more commonly observed in high-risk groups, including infants, pregnant women, the elderly, patients with underlying medical conditions, and patients with disease- or treatment-related immunosuppression. According to the CDC, approximately 35 million people suffer from influenza infections in the United States each year, resulting in as many as 400,000 hospitalizations and as many as 49,000 deaths. The World Health Organization reports that globally there are as many as five million severe influenza cases annually, leading to as many as 500,000 deaths. In addition to seasonal infections, epidemics that spread across countries and continents, or pandemics, are caused by influenza strains that have high rates of human-to-human transmission and, if the strain causes severe disease, can lead to a high mortality rate. Evolving avian influenza viruses (bird flu), such as H5N1 and H7N9, which have a high associated mortality rate and the potential to infect and readily transmit in humans, pose a major health risk. The avian H7N9 influenza strains that emerged in 2013 have mortality rates as high as 42% in infected individuals. </p> <p> <b>About Visterra</b><br>Visterra is a clinical-stage biopharmaceutical company that uses its novel Hierotope&#8482; platform to identify unique disease targets and to design and engineer innovative antibody-based therapies. Visterra&#8217;s technology enables the design and engineering of product candidates which target a specific region of an antigen, or Hierotope, on a pathogen that is common across all strains of the pathogen and is resistant to mutation. The company believes these Hierotopes are critical to the structural and functional integrity of the pathogen, making them highly attractive therapeutic targets. The company is currently focused on developing therapeutics for infectious and non-infectious diseases and its lead product candidate, VIS410, is a human monoclonal antibody being developed for the treatment of hospitalized patients with influenza A, regardless of viral strain. The company&#8217;s second product candidate, VIS513, is a human monoclonal antibody for the treatment of dengue that has been shown in preclinical studies to be effective against all four serotypes of the dengue virus. Visterra was founded on the research into the fundamentals of viral evolution and epitope characterization by our scientific founder, Dr. Ram Sasisekharan at MIT. For more information, please visit <a target="_blank" href="http://cts.businesswire.com/ct/CT?id=smartlink&#38;url=http%3A%2F%2Fwww.visterrainc.com&#38;esheet=51406745&#38;newsitemid=20160824005110&#38;lan=en-US&#38;anchor=www.visterrainc.com&#38;index=1&#38;md5=038003384c1708f9e6ec8e90a4107577" rel="nofollow">www.visterrainc.com</a>. </p> <p> </p><br><b>Contacts</b> <br><p> <span><b>Media contact:</b></span><br>The Yates Network<br>Barbara Yates, 781-258-6153 </p> <p> </p>

24 Aug 2016, 20:00
Biothera Pharmaceuticals Expands Relationship with Merck, Enters Collaboration for Combination Cancer Immunotherapy Trials in Multiple Indications

<p> Biothera&#8217;s Imprime PGG and Merck&#8217;s anti-PD-1 inhibitor KEYTRUDA<sup>&#174;</sup> (pembrolizumab) to be evaluated in combination for patients with either advanced melanoma or metastatic triple negative breast cancer (TNBC) </p> <p> Under previous agreement, Big Ten Cancer Research Consortium (BTCRC) plans to initiate a Phase 1b/2 Imprime PGG/KEYTRUDA trial in patients with non-small cell lung cancer (NSCLC) </p> <p>EAGAN, Minn.--(BUSINESS WIRE)--<a href="https://twitter.com/hashtag/Biothera?src=hash" target="_blank">#Biothera</a>--Biothera Pharmaceuticals, Inc. today announced a collaboration with Merck, known as MSD outside the United States and Canada, to expand the companies&#8217; ongoing clinical program evaluating KEYTRUDA<sup>&#174;</sup> (pembrolizumab), Merck&#8217;s anti-PD-1 inhibitor, in combination with Biothera&#8217;s Imprime PGG, a Pathogen Associated Molecular Patterning molecule, or PAMP. Imprime PGG acts as an immunological &#8220;ignition switch&#8221; enlisting the innate immune system to enhance the therapeutic efficacy of tumor targeting, anti-angiogenic, and immune checkpoint inhibitor antibodies. </p><br><a href="http://mms.businesswire.com/media/20160824005821/en/527602/4/Biotherapharma_logo.jpg"><img src="http://mms.businesswire.com/media/20160824005821/en/527602/21/Biotherapharma_logo.jpg"></a> <p> Under this new collaboration, a Phase 2 clinical trial is anticipated to enroll up to 95 patients who have either advanced melanoma no longer responding to initial treatment with a checkpoint inhibitor therapy or TNBC whose disease has progressed following treatment with one or more lines of therapy for metastatic disease. Biothera will be the sponsor of the study, which is planned to begin in the fourth quarter of 2016. Merck will provide clinical supplies of KEYTRUDA for the planned studies. Other terms of the collaboration were not disclosed. </p> <p> Biothera previously announced an agreement in December 2015 for Merck to supply KEYTRUDA for a Phase 1b/2 clinical study testing combination therapy with Imprime PGG in NSCLC patients. The Big Ten Cancer Research Consortium will conduct the multi-center trial, which is expected to commence this fall. </p> <p> Barry Labinger, Chief Executive Officer of Biothera, stated, &#8220;Combination therapies with breakthrough medicines such as KEYTRUDA are potentially the next major advance in the treatment of cancer. We believe that Imprime PGG is uniquely suited to complement immune checkpoint inhibitor therapy and meaningfully enhance patient outcomes. The trial will assess safety and efficacy, as well as provide biomarker and pharmacodynamic data that will inform the design of potential Phase 3 pivotal studies.&#8221; </p> <p> Eric Rubin, M.D., Vice President and Therapeutic Area Head, Oncology Early-stage Development, Merck Research Laboratories, commented, &#8220;As a leading innovator in the field of immuno-oncology, Merck is dedicated to advancing breakthrough science by continuing to identify novel combinations with potential to improve the care for people with cancer. We are pleased to expand our partnership with Biothera as we explore the potential for combining KEYTRUDA with their lead candidate.&#8221; </p> <p> <b>About Biothera Pharmaceuticals, Inc.</b><br>Biothera Pharmaceuticals is a privately held biotechnology company developing Imprime PGG, a first-in-class, mid-clinical stage cancer immunotherapy that orchestrates an integrated anti-cancer immune response in combination with checkpoint inhibitors and tumor-targeting and anti-angiogenesis monoclonal antibodies. Imprime PGG has been well-tolerated in trials in over 400 subjects and has established proof of concept in multiple clinical studies, including single-arm and randomized phase 2 studies in NSCLC, colorectal cancer, and chronic lymphocytic leukemia. </p> <p> KEYTRUDA<sup>&#174;</sup> is a registered trademark of Merck Sharp &#38; Dohme Corp., a subsidiary of Merck &#38; Co., Inc. </p> <p> </p><br><b>Contacts</b> <br><p> <b>Biothera Pharmaceuticals, Inc.</b><br>David Walsh, 651-256-4606<br>SVP Communications<br><a target="_blank" href="mailto:dwalsh@biothera.com">dwalsh@biothera.com</a> </p> <p> </p>

24 Aug 2016, 19:25
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