(Press-News.org) SRI’s Targeted Antigen Loaded Liposomes (TALL) — a treatment that expands the benefits of immunotherapy such as check-point inhibitors — has been granted Orphan Drug Designation (ODD) for pancreatic ductal adenocarcinoma (PDAC) by the U.S. Federal Drug Administration (FDA).
As a result, SRI’s future strategic partners can gain tax credits for qualified clinical trials and potentially receive market exclusivity for a period of seven years after the drug’s approval, among other benefits.
“FDA's orphan drug designation brings worthy attention to the demonstrated impact of SRI's TALL biotherapeutic for pancreatic cancer,” said Kathlynn Brown, president of SRI’s biosciences division. “This milestone fuels SRI’s deep commitment to pioneering health and precision medicine solutions that bring hope to patients and their families."
Treating resistant cancer
Pancreatic cancer is difficult to detect in early stages and has the highest mortality rate of all major cancers with only a 3% relative-survival-rate at 5-years for the advanced form. Pancreatic tumors are highly resistant to chemotherapy and radiation and there are limited treatment options. SRI’s TALL is a novel immunotherapy with the potential to overcome these and other challenges and greatly extend the benefits to more patients.
“SRI is to be congratulated for advancing to this pivotal step,” said Dr. Timothy Cote, former head of the FDA ODD Program and current CEO of Only Orphans Cote. “Their science in this field is strong and the FDA has affirmed that they are providing a genuine orphan drug. SRI’s work in the precision medicine domain sets a standard for the industry and offers life-changing solutions for those in need.”
An orphan drug is intended for use in rare diseases. More than 7,000 rare diseases have been identified, and an estimated one in 10 Americans lives with a rare disease; half are children. Still, roughly 95% of these diseases don’t have FDA approved treatments. To encourage organizations to address patient unmet needs, the federal government passed the Orphan Drug Act in 1983. As a key function of the Act, organizations can apply to be ODD approved for specific treatments.
“This greatly streamlines the go-to-market process toward final FDA clinical drug approval,” said Brown. “We are looking forward to working with our strategic partners to offer the ability to take advantage of the tremendous cost savings and other benefits that come with this designation, including tax credits for clinical trials and a faster go-to-market timeline.”
Tricking cancer cells to attract therapy
TALL is designed to trick the immune system into recognizing tumor cells as pathogen-infected cells. Essentially, TALL makes cancer cells look like they have the measles, exploiting the biological phenomenon known as recall immunity to encourage the human immune system to seek out and kill an invader it already knows how to fight.
SRI created TALL using the company’s novel FOX Three platform, which was developed to solve another critical drug development challenge: biotherapeutic compounds that have traditionally been difficult to deliver to the inside of cells and therefore make the targets inside those cells undruggable. FOX Three employs proprietary processes to identify unique peptide delivery agents (known as Molecular Guidance Systems, or MGS) that home to targeted cell types and deliver a therapeutic payload in a cell-specific fashion.
For application as immunotherapy, a synthetic peptide derived from the measles virus is packed into neutral, stealth particles known as liposomes. Then, a tumor-targeting FOX Three MGS is attached to the surfaces of the liposomes. The MGSs home to tumor cells and, once there, the liposomes are transported into the tumor cells.
The measles-derived peptide is then released inside the diseased cells and eventually presented on their surfaces, flagging them for the immune system. The measles ‘infected’ tumor cells are then targeted and killed by memory T cells, and the patient’s immune system clears the tumor. Data showing TALL given as a co-therapy to check-point inhibitors has demonstrated increased tumor reduction for tumors that have been traditionally resistant to check-point inhibitor therapies. TALL essentially turns a cold tumor to hot and enables drugs to work more effectively.
“The FDA ODD program and its potential brings hope to many cancer patients fighting this horrible disease and we look forward to reaching more patients through the accelerated process.” Brown concluded.
Please visit SRI at the Bio International Convention in San Diego, CA, June 3-6. To arrange a meeting, please contact us.
SRI is an independent nonprofit research institute headquartered in Menlo Park, Calif., with a rich history of supporting government and industry. We create and deliver world-changing solutions for a safer, healthier, and more sustainable future. For more than 75 years, we have collaborated across technical and scientific disciplines to discover and develop groundbreaking products and technologies and bring innovations and ideas to the marketplace. Learn more at www.sri.com
END
SRI earns FDA Orphan Drug Designation for pancreatic cancer
The designation accelerates clinical development of SRI’s TALL® immunotherapy and brings more affordable therapies to market faster.
2024-05-21
ELSE PRESS RELEASES FROM THIS DATE:
A new gene-editing system tackles complex diseases
2024-05-21
The human genome consists of around 3 billion base pairs and humans are all 99.6% identical in their genetic makeup. That small 0.4% accounts for any difference between one person and another. Specific combinations of mutations in those base pairs hold important clues about the causes of complex health issues, including heart disease and neurodegenerative diseases like schizophrenia.
Current methods to model or correct mutations in live cells are inefficient, especially when multiplexing — installing multiple point mutations simultaneously across the genome. Researchers from the University of California San Diego ...
Tracking down toxic metals from tobacco smoke
2024-05-21
Cigarette smoke has been studied for years, revealing a multitude of contaminants, including toxic metals. But exactly which of those metals can be traced to secondhand or thirdhand smoke? Solving this problem has been a challenge for the research community because many of the metals found in tobacco smoke could also come from industrial or naturally occurring pollutants contaminating indoor and outdoor air.
Now, a recent study by scientists at Lawrence Berkeley National Laboratory (Berkeley Lab) has identified 28 trace metals in tobacco smoke. The findings reported in the journal ...
Clarifying the cellular mechanisms underlying periodontitis with an improved animal model
2024-05-21
TMDU researchers have developed a technique that allows a detailed analysis of periodontitis development over time
Tokyo, Japan – Periodontal disease, represented by periodontitis, is the leading cause of tooth loss and affects close to one in five adults worldwide. In most cases, this condition occurs as a result of an inflammatory response to bacterial infection of the tissue around teeth. As the condition worsens, the gums begin to pull away, exposing teeth roots and bone. Notably, the incidence of periodontitis becomes more prevalent with age and with populations worldwide living ...
Age, race impact AI performance on digital mammograms
2024-05-21
OAK BROOK, Ill. – In a study of nearly 5,000 screening mammograms interpreted by an FDA-approved AI algorithm, patient characteristics such as race and age influenced false positive results. The study’s results were published today in Radiology, a journal of the Radiological Society of North America (RSNA).
“AI has become a resource for radiologists to improve their efficiency and accuracy in reading screening mammograms while mitigating reader burnout,” said Derek L. Nguyen, M.D., assistant professor at Duke University in Durham, North Carolina. ...
SwRI leads courses at 2024 Society of Tribologists & Lubrication Engineers Annual Meeting
2024-05-21
SAN ANTONIO — May 21, 2024 —As a leader in fuels and lubricants research, Southwest Research Institute is home to a world-class tribology laboratory and expert staff that are developing advanced techniques and technology to study wear, friction and lubrication. SwRI tribologists will share their expertise at the 2024 Society of Tribologists and Lubrication Engineers (STLE) Annual Meeting May 19-23 in Minneapolis.
The STLE Annual Meeting and Exhibition invites members of the lubricant industry ...
Hope for a cure for visceral leishmaniasis, an often fatal infectious disease
2024-05-21
Hope for a cure for visceral leishmaniasis, an often fatal infectious disease
A discovery by Simona Stäger’s team could help come up with a treatment to the most serious form of leishmaniasis.
Leishmaniasis is a tropical disease affecting a growing number of people worldwide. Each year, between 700,000 and 1 million new cases are reported. Caused by a protozoan parasite of the genus Leishmania, which is transmitted to humans by the simple bite of a sand fly, leishmaniasis comprises three clinical forms, of which the visceral ...
How AI helps programming a quantum computer
2024-05-21
Generative models like diffusion models are one of the most important recent developments in Machine Learning (ML), with models as Stable Diffusion and Dall.e revolutionizing the field of image generation. These models are able to produce high quality images based on some text description. “Our new model for programming quantum computers does the same but, instead of generating images, it generates quantum circuits based on the text description of the quantum operation to be performed”, explains Gorka Muñoz-Gil from the Department of Theoretical Physics of ...
New research reveals that prehistoric seafloor pockmarks off the California coast are maintained by powerful sediment flows
2024-05-21
New MBARI research on a field of pockmarks—large, circular depressions on the seafloor—offshore of Central California has revealed that powerful sediment flows, not methane gas eruptions, maintain these prehistoric formations. A team of researchers from MBARI, the United States Geological Survey (USGS), and Stanford University published their findings today in the Journal of Geophysical Research: Earth Surface. This work provides important information to guide decision-making about responsible use and management of the seafloor off California, including site assessments for the development of offshore wind farms.
The Sur Pockmark Field—an area about the size ...
AI can help improve ER admission decisions, Mount Sinai study finds
2024-05-21
New York, NY [May 21, 2024]—Generative artificial intelligence (AI), such as GPT-4, can help predict whether an emergency room patient needs to be admitted to the hospital even with only minimal training on a limited number of records, according to investigators at the Icahn School of Medicine at Mount Sinai. Details of the research were published in the May 21 online issue of the Journal of the American Medical Informatics Association (JAMIA/DOI: 10.1093/jamia/ocae103).
In the retrospective study, the researchers analyzed records from seven Mount Sinai Health System hospitals, using both structured data, such as vital signs, ...
Matcha mouthwash inhibits bacteria that causes periodontitis
2024-05-21
Highlights:
Periodontitis is linked to tooth loss and other health concerns.
Past studies suggest that green tea products can act against P. gingivalis, which causes periodontitis.
In a new study, researchers tested matcha extract, made from green tea, against the pathogen.
Lab studies suggest matcha inhibits the growth of the bacteria.
A clinical trial showed that matcha mouthwash inhibited P. gingivalis populations in saliva.
Washington, D.C.—Periodontitis is an inflammatory gum disease driven by bacterial infection and left untreated it can lead to complications including tooth loss. ...
LAST 30 PRESS RELEASES:
Insulin resistance is linked to over 30 diseases – and to early death in women, study of people in the UK finds
Innovative semaglutide hydrogel could reduce diabetes shots to once a month
Weight loss could reduce the risk of severe infections in people with diabetes, UK research suggests
Long-term exposure to air pollution and a lack of green space increases the risk of hospitalization for respiratory conditions
Better cardiovascular health in early pregnancy may offset high genetic risk
Artificial intelligence method transforms gene mutation prediction in lung cancer: DeepGEM data releases at IASLC 2024 World Conference on Lung Cancer
Antibody–drug conjugate I-DXd shows clinically meaningful response in patients with extensive-stage small cell lung cancer
IASLC Global Survey on biomarker testing reveals progress and persistent barriers in lung cancer biomarker testing
Research shows pathway to developing predictive biomarkers for immune checkpoint inhibitors
Just how dangerous is Great Salt Lake dust? New research looks for clues
Maroulas appointed Associate Vice Chancellor, Director of AI Tennessee
New chickadee research finds cognitive skills impact lifespan
Cognitive behavioral therapy enhances brain circuits to relieve depression
Terasaki Institute awarded $2.3 Million grant from NIH for organ transplantation research using organs-on-a-chip technology
Atoms on the edge
Postdoc takes multipronged approach to muon detection
Mathematical proof: Five satellites needed for precise navigation
Scalable, multi-functional device lays groundwork for advanced quantum applications
Falling for financial scams? It may signal early Alzheimer’s disease
Integrating MRI and OCT for new insights into brain microstructure
Designing a normative neuroimaging library to support diagnosis of traumatic brain injury
Department of Energy announces $68 million in funding for artificial intelligence for scientific research
DOE, ORNL announce opportunity to define future of high-performance computing
Molecular simulations, supercomputing lead to energy-saving biomaterials breakthrough
Low-impact yoga and exercise found to help older women manage urinary incontinence
Genetic studies reveal new insights into cognitive impairment in schizophrenia
Researcher develops technology to provide cleaner energy and cleaner water
Expect the unexpected: nanoscale silver unveils intrinsic self-healing abilities
nTIDE September 2024 Jobs Report: Gains in employment for people with disabilities appear to level off after reducing gaps with non-disabled workers
Wiley enhances NMR Spectral Library Collection with extensive new databases
[Press-News.org] SRI earns FDA Orphan Drug Designation for pancreatic cancerThe designation accelerates clinical development of SRI’s TALL® immunotherapy and brings more affordable therapies to market faster.