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2021
December 2021 | Download as pdf
* StemBioSys expanding product portfolio and talent pipeline [ more ]
The SA company has high hopes for its newest commercial opportunity
San Antonio-based StemBioSys Inc. is expanding its product portfolio and its core research talent. The company, which is pursuing a range of commercial applications for its cell-based technology, is targeting a product roll out directed at researchers in the neuronal, or nerve, space.
The centerpiece of StemBioSys’ technology is CELLvo Matrix, a cell-derived microenvironment that allows a variety of cells to replicate more rapidly. The new product, Neuro Matrix, will involve neuronal cells and is expected to assist researchers working in multiple disease areas.
“We recognized that there was a big unmet need for providing a better way for growing neuronal cells for research,” StemBioSys CEO Bob Hutchens said. “This matrix supports growth of a broad range of neuronal cells. There are applications in a range of neuronal diseases such as Alzheimer’s and Parkinson’s Disease.”
StemBioSys has applied for a National Institutes of Health-funded grant for the new matrix product, which is plans to bring to market in early 2022. It’s also secured more expertise to support that expanded commercialization, adding Dr. Jeanne Loring, professor emeritus of the Scripps Research Institute, to its Scientific Advisory Board. Loring is also the founding director of the Center for Regenerative Medicine at Scripps and of Aspen Neuroscience. Hutchens said Loring, a pioneer in stem cell research, has extraordinary research credentials and deep experience in an area where StemBioSys sees plenty of untapped potential.
"It will give us access to a whole new market and new set of researchers,” Hutchens said. “We view this as a major growth area for the company. The early interest we have had from academic researchers ... is a clear sign that this could be really important for us."
Source: https://www.bizjournals.com/sanantonio/news/2021/12/20/stembiosys-expanding-product-portfolio.html
December 20th 2021
September 2021 | Download as pdf
* StemBioSys Inc. gets millions to boost globalization [ more ]
SAN ANTONIO – Privately-held StemBioSys, Inc., based in San Antonio, announced today that it had closed on an oversubscribed $6.6 million Series C Preferred Stock financing in August. According to StemBioSys CEO Bob Hutchens, the company is investing the proceeds to support the ongoing development and commercialization of its proprietary technologies. In November of 2020, StemBioSys announced the publication of data demonstrating that its CELLvo Matrix Plus Technology supports development of an advanced testing protocol for determining the cardiac safety of drugs in development. Hutchens noted that the technology is currently being evaluated by over a dozen biopharmaceutical companies and academic laboratories in the United States and Europe. The company launched this final phase of its Series C financing round in mid-February. Hutchens noted that “By mid-April we were close to full subscription. We elected to close the round at that point to new investors and ensure that existing investors could invest if they chose to.” The company was looking to raise up to $1.7 million with this final phase of Series C. The company ended up raising over $2.3 million. “It took us a few months to get the documents in place to accommodate the oversubscription” Hutchens stated. The company has used the funds from the oversubscription to provide additional investment in automating key elements of the product manufacturing process. The company has also increased investments in sales and marketing activities to continue to grow the top line. Hutchens noted that “revenues for 2021 have already exceeded full year 2020, and we are optimistic about the remainder of this year and 2022. We have a number of customers completing their evaluation of various parts of technology and we believe that this bodes well for the future”.
About StemBioSys, Inc.
StemBioSys, Inc. is a privately-held biomedical company. Our technologies represent the next evolution in cell research and are branded to the research market under the CELLvo™ label. The centerpiece of these technologies is our CELLvo™ Matrix. This cell derived microenvironment allows a variety of cells to replicate (multiply in number) more rapidly and express markers indicative of potency beyond that seen with traditional tissue culture substrates. The company also has several cell products isolated and expanded on our matrix. StemBioSys has also developed a novel approach for preclinical cardiac safety testing. This novel approach is currently being used by several commercial customers. Details of this approach were described in Nature Scientific Reports in November 2020. To build its depth in the cardiac toxicity testing arena, the company acquired Cartox in January of 2020. Cartox, a spin out company of The University of Michigan, brings world class drug cardiac toxicity testing capabilities to StemBioSys.
For more information, contact Bob Hutchens, bob.hutchens@stembiosys.com or 914-661- 2077.
Source: https://www.bizjournals.com/sanantonio/news/2021/09/30/stembiosys-investment.html
September 30th 2021
September 2021 | Download as pdf
* Bluegrass Vascular Announces Decision by Medicare to Assign a New Technology Ambulatory Payment Classification (APC) for the Surfacer® System Procedure [ more ]
CMS creates new billing code and new technology APC assignment for the insertion of central venous catheter using a reverse central venous recanalization device, with fluoroscopic image guidance
SAN ANTONIO, Sept. 20, 2021 /PRNewswire/ -- Bluegrass Vascular Technologies (Bluegrass Vascular), a private medical technology company focused on innovating lifesaving devices and methods for vascular access procedures, announced today that the Centers for Medicare & Medicaid Services (CMS) has finalized a new Healthcare Common Procedure Coding System (HCPCS) code and New Technology Ambulatory Payment Classification (APC) assignment for use of the Surfacer® Inside-Out® Access Catheter System (Surfacer System) procedure. The new code is C9780, Insertion of central venous catheter through central venous occlusion via inferior and superior approaches (e.g., inside-out technique), including imaging guidance. It is assigned to New Technology APC 1534, with a national average payment rate of $8,250.50. As a result of this decision, hospitals and ambulatory surgery centers (ASCs) will be able to utilize HCPCS code C9780 to report the Inside-Out procedure when performed with the Surfacer System beginning on October 1, 2021.
The Surfacer System employs a novel Inside-Out approach and is the first FDA cleared medical device to facilitate upper body central venous access in patients with venous obstructions or other conditions that preclude access by conventional methods.
"The CMS decision to assign a New Technology APC for the Surfacer System is a major milestone and will ensure that our innovative technology will be reimbursed for Medicare beneficiaries. This is a significant development, given the prevalence of thoracic central venous obstruction in patients dialyzing via a central venous catheter," stated Gabriele Niederauer, Ph.D., CEO and President of Bluegrass Vascular. "This decision is a testament to the positive clinical evidence and cost data that support the use of the Surfacer System as a critical, lifesaving technology."
Thoracic central venous obstruction occurs in roughly 40% of patients where hemodialysis is performed via a central venous catheter.1 While permanent arteriovenous fistulas are the preferred form of vascular access for hemodialysis patients, central venous catheters continue to serve as an important bridge to securing long-term access for life-saving hemodialysis treatment. The current approach for most patients with central venous obstructions is to use an alternative vein, which reduces the ability to place and mature a functioning fistula, resulting in increased catheter days and costs.
According to CMS, more than 62.4 million Americans are enrolled in the Medicare program.2 Approximately 80% of patients on hemodialysis are covered by Medicare fee-for-service as primary payer or by a Medicare Advantage managed care plan.3 Patients who live with kidney failure represent 1% of the total U.S. Medicare population yet account for 7% of the Medicare costs.4
The use of the Surfacer device also avoids left-side catheter placement, better enabling the maturation of permanent arteriovenous access options in the left arm and minimizing unnecessary access-related procedures and complications. The National Kidney Foundation's current Kidney Disease Outcomes Quality Initiative (KDOQI) Clinical Practice Guidelines for Vascular Access recommend that the ideal access site for hemodialysis catheters is the right internal jugular vein. This preferred right-sided access path is supported by the Surfacer System's novel Don't Go Left™ approach.
The Surfacer System received FDA De Novo clearance in the US in February and is CE marked in Europe. The device is available in North America, Europe and other territories.
About the Surfacer® Inside-Out® Access Catheter System
The Surfacer System is designed to reliably, efficiently and repeatedly gain central venous access by inserting the Surfacer System through the right femoral vein and navigating it up through the patient's venous system with an exit point in the right internal jugular vein, the optimal location for placing a central venous catheter. This proprietary Inside-Out approach allows for the placement and maturation of permanent arteriovenous access options that are associated with improved patient outcomes and reduced cost of care for both hospitals and hemodialysis providers.
About Bluegrass Vascular Technologies
Bluegrass Vascular Technologies is a medical technology company dedicated to developing and commercializing lifesaving devices and methods that address shortcomings in vascular access procedures. For more information, please visit www.bluegrassvascular.com
Source: https://www.prnewswire.com/news-releases/bluegrass-vascular-announces-decision-by-medicare-to-assign-a-new-technology-ambulatory-payment-classification-apc-for-the-surfacer-system-procedure-301379905.html
September 20th 2021
September 2021 | Download as pdf
* DNAtrix Announces the Appointment of David Liebowitz, M.D., Ph.D., as Chief Medical Officer [ more ]
HOUSTON, Sept. 14, 2021 /PRNewswire/ -- DNAtrix, a biotech company advancing virus-driven immunotherapies for cancer, today announced the appointment of David Liebowitz, M.D., Ph.D., an industry veteran with over 20 years of experience in oncology drug and viral vaccine development, as chief medical officer.
"We are thrilled to welcome Dave to the executive leadership team at DNAtrix," said Jeffrey Knapp, chief executive officer of DNAtrix. "Dave has expertise in developing products that elicit immune responses against targets of interest through various therapeutic modalities, including viral-based vaccines. His deep experience leading oncology drug development programs for innovative, young, as well as established biopharmaceutical companies ¬¬-- such as Amgen -- will prove invaluable as we advance our pipeline with multiple product candidates being studied in several tumor types and two programs in pivotal stage development."
Prior to joining DNAtrix, Dr. Liebowitz was most recently vice president of Clinical Oncology at Xencor, Inc. From 2012 to 2018, he served as the chief medical officer for Vaxart, Inc., a novel vaccine development company. He was previously the Chief Scientific and Medical Officer for Vivaldi Biosciences, an influenza vaccine and therapeutics biotechnology company. Prior to that, he was the executive vice president of Research and Development at Galileo Pharmaceuticals, and he also served as co-CEO of Galileo for a period of time. Prior to joining Galileo, Dr. Liebowitz was at Amgen, where he was the director of research responsible for all oncology and vascular biology drug discovery and development programs at their Washington research site. He also managed external development collaborations and licensing activities. Dr. Liebowitz joined Amgen through their acquisition of Immunex, where he held several senior positions in clinical and preclinical development. Prior to joining Immunex, he was an associate investigator in the Abramson Cancer Institute at the University of Pennsylvania, where he was director of their immunotherapy and cellular therapy programs targeting cancer and chronic viral diseases. Dr. Liebowitz was an early recipient of a grant from the Bill and Melinda Gates foundation. He began his academic career as an assistant professor of Medicine and Virology at the University of Chicago, and was the director of the Bone Marrow Transplantation Program. Dr. Liebowitz has B.S. and M.S. degrees in Biology from Emory University, an M.D. with honors and a Ph.D. in Molecular Genetics and Cell Biology, both from the University of Chicago.
Dr. Liebowitz added, "I am impressed by the compelling clinical data for the company's lead drug candidate, DNX-2401, in diffuse intrinsic pontine glioma (DIPG) and recurrent glioblastoma (rGBM), two tumor types that have been notoriously difficult to treat and where therapeutic advances are desperately needed. Given the promise demonstrated with these programs, I also believe there is tremendous potential to leverage DNAtrix's oncolytic adenoviral platform further for the treatment of other tumor types, and the company has studies underway evaluating therapeutic activity in additional cancers, such as colorectal cancer."
About DNAtrix
DNAtrix is a privately held biotech company developing virus-driven immunotherapies to treat cancer. Its proprietary adenovirus platform is based on an engineered version of the common cold virus that is designed to selectively infect and kill cancer cells while leaving healthy cells unharmed. The company's lead product candidate is DNX-2401, which will enter into a global pivotal Phase 3 clinical study for patients with recurrent glioblastoma. DNX-2401 is also being evaluated in a Phase 1 study for diffuse intrinsic pontine glioma, for which it has received FDA Fast Track and Rare Pediatric Disease designations. A second product candidate, DNX-2440, is in Phase 1 clinical testing in patients with colorectal and other cancers with liver metastasis. The company's investors include Morningside Ventures and Mercury Fund. For more information, please visit the company website at www.DNAtrix.com
Source: https://www.prnewswire.com/news-releases/dnatrix-announces-the-appointment-of-david-liebowitz-md-phd-as-chief-medical-officer-301373136.html
September 14th 2021
June 2021 | Download as pdf
* SA company picked for elite global medtech accelerator [ more ]
Alamo City biotech among 50 companies to be part of international cohort
As Bluegrass Vascular Technologies Inc. looks to further commercialize its initial medical device in the U.S., the San Antonio-based biotech is gaining priceless recognition and exposure on a global scale.
Bluegrass Vascular, which moved from Kentucky to San Antonio in 2014, is one of 50 entities chosen to participate in the 2021 MedTech Innovator Accelerator Cohort, the largest program of its kind in the world.
“Being selected was a quite an honor,” Bluegrass Vascular President and CEO Gabriele Niederauer said.
Only 4% of applicants were invited to participate in the four-month showcase and accelerator program, which features some of the world’s most transformative device, diagnostic and digital health technologies. Bluegrass Vascular's innovative technology was validated by independent judges with deep medtech expertise.
The goal of the cohort is to “find the most promising medical innovations and make sure they actually reach the patients who need them,” MedTech Innovator CEO Paul Grand said.
The program will provide participating companies with resources and mentorship. The startups will also receive international visibility and access to leading manufacturers, providers, investors and other industry stakeholders.
Bluegrass Vascular’s initial product, the Surfacer Inside-Out Access Catheter System, is now in use in the U.S., but for the company to fully penetrate the American commercial market, it needs a reimbursement code from the Centers for Medicare & Medicaid. The company applied for such a code more than a year ago.
In the interim, the Alamo City biotech will look to make the most of its participation with an elite global cohort. Niederauer said the selection process began in January, with 1,100 applicants from more than 50 countries being narrowed to 195 candidates that were invited to pitch to corporate partners and judges. Bluegrass Vascular presented multiple times at a midstage company pitch event on May 6.
Selected companies will collaborate with MedTech Innovator’s partners, participating in exclusive virtual networking events and interactive workshops. The program will culminate in late September when all 50 companies will present in showcase panels and gain access to exclusive partnering and roundtables.
"We continue to receive a lot of interest in our leading product,” Niederauer said. “We also are seeking additional financing to support our commercialization efforts."
Source: https://www.bizjournals.com/sanantonio/news/2021/06/17/bluegrass-vascular-chosen-for-medtech-accelerator.html?s=print
June 17th 2021
March 2021 | Download as pdf
* Storm didn’t freeze this SA biotech out of record start to 2021 [ more ]
The brutal winter storm that put much of Texas’ economy on ice in February, took a toll on StemBioSys Inc. Yet, the San Antonio-based biotech expects to set a new benchmark for business in the first quarter of 2021 and expects more significant gains over the rest of the year.
"We will still achieve record revenues for Q1," StemBioSys CEO Bob Hutchens said.
The company lost the last two weeks of February to power outages and other challenges tied to Winter Storm Uri. The storm affected the shipment of StemBioSys products, which were lost in transit. It also lost some research work that was underway when snow, ice and sub-freezing temperatures wiped out power.
There were signs late last year that the Alamo City company was finding its groove. In November, I reported that StemBioSys had completed research validating that its core stem cell expansion technology, CELLvo Matrix Plus, can predict the safety of cardiac drugs in early-stage development. That validation has upped the company’s commercial viability nationally and internationally.
"We have seen significant traction for our Matrix Plus product,” Hutchens said. “We had four big-name pharma companies purchase the product in January with the intent to conduct initial testing."
At press time, StemBioSys was preparing for discussions with two additional major companies about its technology. Hutchens did not disclose the names of those entities.
StemBioSys has launched a new extension of its Series C funding round and expects to raise an additional $1.5 million to expand its research and development operations, as well as its marketing capabilities. That new raise comes on the heels of an upbeat end to 2020.
"December was a record month for the company and we already have orders we have received that put us on a great trajectory for 2021,” Hutchens said. “It is going to be an interesting year ahead for us."
Source: https://www.bizjournals.com/sanantonio/news/2021/03/15/stembiosys-record-start-to-2021-despite-winter-sto.html
March 15th 2021
March 2021 | Download as pdf
* DNAtrix Announces First Patient Dosed in Clinical Study of DNX-2440, an OX40 Ligand Expressing Immunotherapy, in Colorectal Cancer and Other Cancers with Liver Metastasis [ more ]
HOUSTON, March 4, 2021 /PRNewswire/ -- DNAtrix, a biotech company advancing virus-driven immunotherapies for cancer, today announced the treatment of the first patient in a Phase 1 dose-escalation and dose-expansion study of DNX-2440, an OX40 ligand encoding oncolytic adenovirus, in patients with resectable liver metastasis. Expression of OX40 ligand on the surface of tumor cells is expected to enhance anti-tumor immune responses by providing costimulatory signals to T cells within the tumor microenvironment.
"We are excited to clinically explore the potential of one of our immunotherapy drug candidates, which is based on our proprietary adenovirus platform technology, in additional cancer indications," said Jeffrey Knapp, chief executive officer of DNAtrix. "Our preclinical work with DNX-2440 has demonstrated that infection of human tumor cell lines with this agent leads to viral replication, high level expression of OX40 ligand on tumor cells and effective tumor cell killing. Mouse tumor models showed specific anti-tumor immune memory, abscopal effect, and improved survival. This two-part clinical study is designed to directly demonstrate the activity of DNX-2440 and potential as therapy for colorectal cancer, as well as data with other tumor types where liver metastases occur."
The Phase 1 clinical trial of DNX-2440 will be conducted in 24-30 patients with resectable multifocal (>2 lesions) liver metastasis, who are scheduled to have liver resection with curative-intent. Patients will receive two sequential (2 weeks apart) intra-tumoral injections of DNX-2440 into a liver metastasis prior to surgery for liver resection to evaluate safety and biological endpoints. The first part of the Phase 1 study is a dose-escalation phase evaluating three different dose levels of DNX-2440 in 12-18 patients with liver metastasis from tumors of various origins. Following the completion of dose-escalation, the selected dose will be further evaluated in an expansion phase where DNX-2440 will be administered using the same schedule to 12 patients with colorectal cancer liver metastasis. The primary endpoint of the study is to establish safety and identify a maximum tolerated dose. Secondary endpoints include evaluating tumor cell killing of injected and uninjected tumors, determining viral replication in the injected tumor and measuring local and systemic anti-tumor immune responses.
Daniel A. Anaya, M.D., FACS, head of the Hepatobiliary Group and chief of the Division of GI Surgery in the Department of Gastrointestinal Oncology at the Moffitt Cancer Center, and principal investigator of the study, added, "DNX-2440 is an innovative therapy that has shown promising preclinical results, including durable tumor responses. As a leading cancer center, we are committed to providing cutting-edge treatment approaches in our fight against cancer and are pleased to launch this collaborative clinical study."
About DNX-2440
DNX-2440 is an oncolytic adenovirus expressing the immune modulator OX40 ligand, a powerful costimulatory molecule known to enhance T cell responses directed to tumors. DNX-2440 is in Phase 1 clinical testing following the demonstration of anti-cancer activity in preclinical studies, including tumor reductions, immune memory, and abscopal effect.
About DNAtrix
DNAtrix is a privately held biotech company developing virus-driven immunotherapies to treat cancer. Its proprietary adenovirus platform is based on an engineered version of the common cold virus that is designed to selectively infect and kill cancer cells while leaving healthy cells unharmed. The company's lead product candidate is DNX-2401, which will enter into a global pivotal Phase 3 clinical study for patients with recurrent glioblastoma. DNX-2401 is also being evaluated in a Phase 1 study for diffuse intrinsic pontine glioma, for which it has received FDA Fast Track and Rare Pediatric Disease designations. A second product candidate, DNX-2440, is in Phase 1 clinical testing in patients with colorectal and other cancers with liver metastasis. The company's investors include Morningside Ventures and Mercury Fund. For more information, please visit the company website www.DNAtrix.com.
Source: https://www.prnewswire.com/news-releases/dnatrix-announces-first-patient-dosed-in-clinical-study-of-dnx-2440-an-ox40-ligand-expressing-immunotherapy-in-colorectal-cancer-and-other-cancers-with-liver-metastasis-301240246.html
March 4th 2021
February 2021 | Download as pdf
* DNAtrix Appoints Industry Veteran Herb Cross to its Board of Directors [ more ]
HOUSTON, Feb. 18, 2021 /PRNewswire/ -- DNAtrix, a biotech company advancing virus-driven immunotherapies for cancer, today announced the appointment of Herb Cross, a seasoned financial and operational executive, to its board of directors.
"We are delighted to have Herb join our board at this pivotal time for DNAtrix," said Jeffrey Knapp, chief executive officer of DNAtrix. "Herb, who will also become a member of our audit committee, offers a wealth of experience in managing finance and operational needs for growing companies, both private and public. We look forward to his guidance as we advance our clinical programs into both early and late-stage development and build on the company's progress and momentum."
Mr. Cross added, "This is an exciting time for DNAtrix, a unique private stage company in the biopharma industry with an impressive virus-driven immunotherapy pipeline that includes a Phase 3 program in recurrent glioblastoma. The company is well positioned in the oncology field with a differentiated and proven technology with significant potential. I look forward to working with Jeff and the rest of the management team to prepare for the company's success."
Mr. Cross is currently chief financial officer of Atreca, Inc and has more than 20 years of experience in executive leadership roles with responsibility for strategic financial management and corporate operations. He also currently serves on the board of directors, and is the chair of the audit committee, of Apexigen, Inc., a privately held immuno-oncology company focused on developing antibody therapeutics for solid tumors. His operating experience includes leading the successful initial public offering of Atreca in 2019 as well as serving in other chief financial officer roles at a number of life sciences companies, including ARMO BioSciences, Balance Therapeutics, KaloBios Pharmaceuticals and Affymax. Earlier in his career, he also served as vice president of Finance at Neoforma, PDL BioPharma and Facet Biotech. While at ARMO, Mr. Cross led all administrative functions and corporate development in driving their successful 2018 initial public offering as well as the subsequent acquisition of the company by Eli Lilly for $1.6 billion. Mr. Cross received a B.S. in Business Administration from the University of California, Berkeley and is a certified public accountant.
About DNAtrix
DNAtrix is a privately held biotech company developing virus-driven immunotherapies to treat cancer. Its proprietary adenovirus platform is based on an engineered version of the common cold virus that is designed to selectively infect and kill cancer cells while leaving healthy cells unharmed. The company's lead product candidate is DNX-2401, which will enter into a global pivotal Phase 3 clinical study for patients with recurrent glioblastoma. DNX-2401 is also being evaluated in a Phase 1 study for diffuse intrinsic pontine glioma, for which it has received FDA Fast Track and Rare Pediatric Disease designations. A second product candidate, DNX-2440, is in Phase 1 clinical testing in patients with colorectal and other cancers with liver metastasis. The company's investors include Morningside Ventures and Mercury Fund. For more information, please visit the company website at www.DNAtrix.com.
Source: https://www.prnewswire.com/news-releases/dnatrix-appoints-industry-veteran-herb-cross-to-its-board-of-directors-301230725.html
February 18th 2021
February 2021 | Download as pdf
* DNAtrix Announces Preclinical Data Demonstrating Anti-Tumor Activity of DNX-2401 in Models of Pediatric Tumors (AT/RT and CNS-PNET) Published in Clinical Cancer Research [ more ]
HOUSTON, Feb. 11, 2021 /PRNewswire/ -- DNAtrix, a biotech company advancing virus-driven immunotherapies for cancer, today announced preclinical data evaluating the use of DNX-2401 against the pediatric brain malignancies atypical teratoid/rhabdoid tumor (AT/RT) and primitive neuroectodermal tumors (PNETs) was published in Clinical Cancer Research. The data demonstrate that the oncolytic immunotherapy, DNX-2401 (tasadenoturev; Delta-24-RGD), induces a potent anti-tumor immune response, hinders the development of disseminated disease, and leads to longer survival in these difficult-to-treat tumors.
"These preclinical data for DNX-2401 show encouraging signals of anti-tumor activity against devastating CNS cancers that we had not previously studied," said Jeffrey Knapp, chief executive officer of DNAtrix. "We now have preclinical and clinical data of DNX-2401's efficacy across a range of difficult-to-treat adult and pediatric tumors, thus further establishing the activity of this potent immunotherapy. We look forward to the continued advancement of DNX-2401, as well as our pipeline of other oncolytic immunotherapies being developed for the treatment of solid tumors."
The administration of DNX-2401 resulted in extended overall survival in early and advanced PNET and AT/RT mouse models, including models of disseminated disease. Importantly, DNX-2401 also generated a proinflammatory environment at tumor sites by boosting anti-tumor immune responses and inducing the secretion of damage-associated molecular patterns (DAMPs) into the extracellular medium by infected tumor cells.
Marta Alonso, Ph.D., associate professor at the Clinic University of Navarra-CIMA in Pamplona,Spain, added, "AT/RTs and CNS-PNETs are aggressive pediatric brain tumors that are associated with poor survival and have few therapeutic options. Based on promising clinical data of DNX-2401 in adult glioblastoma and pediatric diffuse intrinsic pontine glioma (DIPG), we evaluated its activity in AT/RT and CNS-PNET. These preclinical data demonstrate in vivo efficacy of DNX-2401 in established models that recapitulate important features of these tumors, including models for disseminated AT/RT lesions and in immunocompetent humanized mice. These data underscore the therapeutic potential of DNX-2401 and provide a strong foundation for translation to the clinical setting for these indications."
About DNX-2401
DNX-2401 is an oncolytic adenovirus engineered specifically to infect, replicate in, and directly kill cancer cells, as well as elicit a broader anti-tumor immune response. DNX-2401 is currently being evaluated as a potential treatment for highly aggressive brain tumors, including recurrent glioblastoma in adults and newly-diagnosed diffuse intrinsic pontine glioma (DIPG) in children. Clinical studies have demonstrated that DNX-2401 was well tolerated and extended survival for patients with recurrent glioblastoma. DNX-2401 has been granted Fast Track and Orphan designation by the FDA and PRIME and Orphan designation by the EMA.
About DNAtrix
DNAtrix is a privately held biotech company developing virus-driven immunotherapies to treat cancer. Its proprietary adenovirus platform is based on an engineered version of the common cold virus that is designed to selectively infect and kill cancer cells while leaving healthy cells unharmed. The company's lead product candidate is DNX-2401, which will enter into a global pivotal Phase 3 clinical study for patients with recurrent glioblastoma. DNX-2401 is also being evaluated in a Phase 1 study for diffuse intrinsic pontine glioma, for which it has received FDA Fast Track and Rare Pediatric Disease designations. A second product candidate, DNX-2440, is in Phase 1 clinical testing in patients with colorectal and other cancers with liver metastasis. The company's investors include Morningside Ventures and Mercury Fund. For more information, please visit the company website at www.DNAtrix.com.
Source: https://www.prnewswire.com/news-releases/dnatrix-announces-preclinical-data-demonstrating-anti-tumor-activity-of-dnx-2401-in-models-of-pediatric-tumors-atrt-and-cns-pnet-published-in-clinical-cancer-research-301226689.html
February 11th 2021
January 2021 | Download as pdf
* San Antonio Spurs Deploy Xenex Germ-Zapping Robots; First NBA Team to Use LightStrike Robots to Disinfect Arena [ more ]
San Antonio – January 14, 2021 – The 2020-21 NBA season is underway and the San Antonio Spurs have added powerful new teammates with extraordinary germ-zapping capabilities. As part of its comprehensive strategy to minimize risk for fans, arena employees, team personnel and players from exposure to SARS-CoV-2 (the virus that causes COVID-19), the Spurs purchased LightStrike™ Germ-Zapping Robots™ to disinfect rooms and areas within the AT&T Center.
Manufactured by San Antonio-based Xenex Disinfection Services, the world leader in ultraviolet (UV) light disinfection for hospitals, LightStrike robots use pulsed xenon to create intense bursts of broad spectrum UV light that quickly destroys viruses and bacteria on surfaces. The intense UV light produced by a LightStrike robot does four types of cellular damage to the SARS-CoV-2 virus, rendering it unable to mutate or reproduce.
LightStrike robots work quickly (2-minute cycles) and require no warm-up or cool-down time, which enables the Spurs to disinfect dozens of rooms per day (per robot). The robots are already in heavy rotation throughout the AT&T Center – disinfecting meeting rooms, locker rooms, rehabilitation areas, suites, restrooms, offices, concession areas, elevators, and much more.
"Our goal is to have the AT&T Center be the cleanest, safest arena in the NBA and the LightStrike robot is an invaluable tool in helping us achieve this distinction,” said Casey Heverling, Vice President and General Manager of the AT&T Center. “We spent a lot of time reviewing hundreds of different technologies, and, when we came across the LightStrike robot and the UV technology it deploys, we knew we had to have that here because of its effectiveness in killing the coronavirus and creating the safest, cleanest environment possible."
University researchers and healthcare facilities (including the Mayo Clinic and MD Anderson Cancer Center) have published more than 40 peer-reviewed studies validating the efficacy of the LightStrike robot technology, which is proven to deactivate Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19. Researchers at the Texas Biomedical Research Institute reported that the LightStrike robot achieved a 99.99% level of disinfection on surfaces against SARS-CoV-2 in two minutes. As a result of the pandemic and the world’s focus on combatting coronavirus and other pathogens, non-healthcare entities such as schools, hotels, airports, police stations and correctional facilities, office buildings–and now the San Antonio Spurs–are utilizing LightStrike robots to quickly disinfect surfaces in their facilities. The NFL Carolina Panthers were the first professional sports team to deploy LightStrike robots as part of their re-opening strategy.
Irene Hahn, senior vice president of global sales and marketing for Xenex, said, “Being chosen to be part of the San Antonio Spurs’ disinfection strategy is a significant honor for Xenex for many reasons, but especially because it’s our hometown team and we love our Spurs. It’s exciting to know that our robots are in use at the AT&T Center, helping provide players, personnel and fans with the cleanest possible arena."
About Xenex
Xenex is a world leader in UV technology-based disinfection strategies and solutions. Frost & Sullivan named Xenex the 2020 Global Company of the Year for its patented technology and being at the vanguard of the fight against SARS-CoV-2. Xenex's mission is to save lives and reduce suffering by destroying the deadly microorganisms that can cause infections. Xenex is backed by well-known investors that include EW Healthcare Partners, Piper Sandler, Malin Corporation, Battery Ventures, Targeted Technology Fund II, Tectonic Ventures and RK Ventures. For more information, visit xenex.com.
Source: https://www.nba.com/spurs/san-antonio-spurs-deploy-xenex-germ-zapping-robots-first-nba-team-use-lightstrike-robots-disinfect
January 14th 2021
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