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Thursday, December 12, 2019

Y-mAbs neuroblastoma vaccine nabs accelerated review status in U.S.

The FDA designates Y-mAbs Therapeutics’ (NASDAQ:YMAB) GD2-GD3 Vaccine for neuroblastoma a Rare Pediatric Disease product.
Rare Pediatric Disease status provides for the issuance of a rare pediatric disease priority review voucher following FDA approval. The voucher can be used for accelerated approval of a future application or it can be sold to a third party.
The bivalent vaccine, in-licensed from MabVax Therapeutics Holdings (OTCPK:MBVXQ), is being evaluated in an escalating-dose Phase 1/2 clinical trial in high-risk patients. The estimated completion date is May 2020.

Gritstone down 15% on data on lead candidates

Thinly traded micro cap Gritstone Oncology (GRTS -14.6%) slumps on modestly higher volume in early trade on the heels of preliminary data from early-stage studies evaluating lead candidate GRANITE and candidate #2 SLATE. The results, apparently disappointing investors, were presented at ESMO IO in Geneva.
Interim data from the first stage of the Phase 1/2 GO-004 trial showed that GRANITE induced “large numbers” of CD8+ T cells against multiple neoantigens in four solid tumor patients. No dose-limiting toxicities related to either GRANITE or SLATE were noted.
Safety data from the first stage of the Phase 1/2 GO-005 study are still preliminary with one case of injection site reaction and one case of pruritis (itchy skin) reported in patients receiving SLATE.
GRANITE and SLATE are both personalized neoantigen-based immunotherapies. SLATE, an off-the-shelf alternative to GRANITE, utilizes the same antigen delivery system but contains a fixed set of neoantigens that are shared across a subset of cancer patients rather than neoantigens unique to a particular patient.

Kaleido Bio up 11% on advancement of KB174

Thinly traded micro cap Kaleido Biosciences (KLDO +10.5%) is up on below-average volume, a modest 39K shares, on the heels of its announced advancement of candidate KB174 for the potential treatment of hepatic encephalopathy, a decline in brain function due to severe liver disease.
The company made its decision based on results from a proof-of-concept study that showed a 26% reduction in a biomarker of microbiome ammonia production in patients with well-compensated cirrhosis while being well-tolerated.
KB174, one of the company’s Microbiome Metabolic Therapy (MMT) candidates, is designed to lower ammonia and multidrug-resistant pathogens in the body by modulating the metabolic output and profile of the microbiome.

Critics says government contract gifts NHS data to Amazon

A deal signed in the summer between the UK government and Amazon has been criticised after it emerged NHS data is being provided to the tech giant free of charge.
Back in July, the contract to deploy Amazon’s Alexa voice-assisted technology to provide healthcare information to the public was billed as a way to reduce the pressure on the NHS – particularly GPs and pharmacists – by providing information about common illnesses.
At the time Amazon was expected to gain access only to basic healthcare information on symptoms, causes and medical definitions etc, in order to allow Alexa to offer verified advice.
Since then, freedom of information requests by consumer advocacy group Privacy International has revealed that the terms also give Amazon access to all the content on the NHS website, including “all related copyrightable content, data, information and other materials”, as well as full access to the NHS Application Programming Interface (API).
The contract (now available online) has been heavily redacted so the full extent of what the NHS is granting Amazon may go further still, but is effectively “offering free advertisement to a company with a worrying track record on privacy – as well as on paying taxes,” says the group.
Amazon is also free to create new money-making products and services that could be rolled out in the UK and internationally – using data generated at the UK taxpayer’s expense – with no financial benefit coming back to the NHS.
“As Amazon is already making or planning to make moves into healthcare, we find this alarming,” says Privacy International, and it “also raises questions when it comes to competition regulation of dominant players in the digital era.”
“With their business model relying increasingly on the availability of consumers’ data, dominant online platforms can engage in various forms of data exploitation or even impose unfair terms for consumers,” it adds.
The NHS insists no patient data is being shared with the US tech giant, and Amazon has said that its access to data is restricted to what is on the NHS.uk website.
“Alexa does not have access to any personal or private information from the NHS. General health-related content from the NHS website has been freely available to the public and is now available to Alexa users via voice technology.
The Amazon contract was agreed just before an Ernst and Young report suggested data contained in NHS patient records could be worth several billion pounds to commercial organisations.

AstraZeneca Imfinzi Approved in China for Stage III Nonsmall-Cell Lung Cancer

AstraZeneca PLC (AZN.LN) said Thursday that it has received marketing authorization from China’s national medical products administration for Imfinzi for the treatment of patients with stage III nonsmall-cell lung cancer.
The U.K. pharmaceuticals company said approval of Imfinzi is based on results from the primary analysis of progression-free survival and supported by overall survival from the Phase III Pacific trial.

Wednesday, December 11, 2019

Brain training: resilience program helps student-athletes adjust to college life

Imagine the impact on first-year college student-athletes in highly competitive programs if you could teach them resilience – if they learned skills to cope with high expectations, challenging academic courses, rigorous training and physical injuries, homesickness and even the stressors of life beyond college.
In newly published research, a unique and expanding program at the University of Massachusetts Amherst has been shown to improve decision-making and emotional awareness, lower perceived stress and build resilience among diverse and sometimes at-risk college athletes, according to survey data reported by the student participants, compared to a control group of student-athletes. Part of the research was supported by funding in 2017 from the National Collegiate Athletic Association’s (NCAA) Innovations in Research and Practice Grant Program, which is designed to improve the psychosocial well-being and mental health of the student-athlete.
“Participants gained skills key to victory on and off the field, including a sense of belonging, persistence, leadership and the ability to negotiate for the resources they need,” says lead author Genevieve Chandler, a mental health nurse and UMass Amherst nursing professor who developed the innovative program from studying the effects of resilience for two decades.
The new study, published in the Journal of the American Psychiatric Nurses Association, focused on 47 first-year football players and 15 women’s basketball players in Division 1 programs at UMass Amherst between 2016-2018. The participants were 18 or 19 years old; 66% were African American, and the rest were non-Hispanic white, with the exception of one Hispanic participant. The control group consisted of student-athletes who did not receive the training because they arrived later on campus.
Resilience – the ability to persist through challenges and recover from adversity – is no longer considered a character trait by researchers but a “practiced interaction between person and environment,” the study points out.
“Negative thoughts stick to us like Velcro,” Chandler explains. “We have to train our brain to hang on to the positive things. We are experts in stress, so we need to practice building up the calm side of the brain, the focused side.”
Chandler developed the resilience-building workshop as a one-credit academic course called Changing Minds, Changing Lives to address the predictable stresses students face as they adjust to college life – especially those with a history of adverse childhood experiences (ACEs). ACEs emerging from a child’s social experience within the family and community “have a tremendous impact on future violence victimization and perpetration, and lifelong health and opportunity,” according to the Centers for Disease Control and Prevention.
Initially offered to nursing students, Chandler’s class caught the interest of psychiatric social worker Jim Helling, a UMass Center for Counseling and Psychological Health senior clinician who was then working in the Athletic Counseling Office. Helling thought that in a predominantly white university, black student-athletes in particular could benefit from a new kind of support system better suited to helping them cope with chronic stress exposure. “We needed a new approach, a psychological wellness program that would be culturally resonant for students of color,” Helling says. “Ginny’s work focuses on strengths, celebrates resilience and empowers black athletes to express themselves in their own voice. This model has been a game changer for our students.”
Together, they began teaching the course to first-year football student-athletes, who in turn used their newly developed leadership skills to mentor high school football players in nearby Springfield.
In 2018, Chandler and Helling added basketball players, and interest has now spread across campus to target student groups facing particular stress, such as female and minority engineering students in a program traditionally dominated by white males. They have been featured at conferences and conducted resilience course trainings across the country so other educators can teach the curriculum.
Chandler points out that the 50% of study participants who reported ACEs showed greater increments of positive change in emotional awareness scales than participants without ACEs, illustrating the distinctive importance and benefits of resilience training for an at-risk group. An estimated 60% of the U.S. population has at least one ACE.
“I’d hope that it’s a class that everyone could take, honestly,” says Caeleb Washington, a UMass Amherst defensive lineman from Melbourne, Fla., who took the resilience course and later served as a teaching assistant.
The course is interactive and experiential. The content focuses on what Chandler calls the ABCS: active coping, such as exercise or meditation; building strength by focusing on and advancing one’s aptitudes rather than weaknesses; cognitive awareness, which involves being aware of automatic thinking; and garnering social support. To gain the neuroplastic benefits of repetitive practice, each class follows the same format. It begins with each individual describing a “positive practice exercise” they did as homework. Breathing exercises and yoga poses follow. Relevant research is presented and then students, as well as teachers, complete a five-minute, deeply personal writing reflection related to the research. The writing is read aloud, after which class members share feedback about what they found strong in the writing. Class ends with each participant sharing an affirmation, appreciation or appraisal about that day’s class.
“This class has taught me how to breathe. It taught me about leadership and it taught me how to just stay calm,” says UMass Amherst senior Vashnie Perry, a health administration major from the Atlanta area and co-captain of the women’s basketball team. “It’s the best advice I’ve had since I’ve been in college.”

VistaGen gets nod for first Fast Track tag for treatment of social anxiety disorder

VistaGen Therapeutics, Inc. (NASDAQ: VTGN), a clinical-stage biopharmaceutical company developing new generation medicines for central nervous system (CNS) diseases and disorders with high unmet need, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for development of the Company’s PH94B neuroactive nasal spray for on-demand treatment of social anxiety disorder (SAD).

The FDA’s Fast Track process is designed to facilitate the development and review of new treatments for serious conditions with unmet medical need, such as SAD, with the purpose of getting innovative new treatment options to patients sooner. After successful Phase 2 development, VistaGen is preparing PH94B for Phase 3 development. PH94B has potential to be the first fast-acting, non-sedating, as-needed treatment for as many as 20 million individuals in the U.S. suffering from SAD.
“The FDA’s grant of Fast Track designation for development of PH94B for SAD, which to our knowledge is the FDA’s first Fast Track designation for a SAD drug candidate, is another important regulatory milestone for VistaGen and a key step forward in our development program for PH94B as a new generation anxiolytic. With a high global prevalence of anxiety disorders, including SAD, and alarming increases in dependency, addiction and even deaths associated with misuse of benzodiazepines, the urgency for a new non-addictive, non-sedating, fast-acting, as-needed treatment for SAD and other anxiety disorders is more important now than ever before. Based on clinical studies to date, PH94B, at non-systemic microgram doses, has strong potential to fill the large current treatment gap,” said Shawn Singh, Chief Executive Officer of VistaGen.