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Venetoclax Plus Fulvestrant Did Not Improve Outcomes Compared to Fulvestrant Alone in ER+/HER2- Breast Cancer – Cancer Network

Posted: June 6, 2021 at 2:03 am

Venetoclax (Venclexta) plus fulvestrant (Faslodex) did not lead to better outcomes compared to fulvestrant alone in patients who had locally advanced or metastatic estrogen receptor (ER)-positive, HER2-negative breast cancer that was previously treated with a CDK4/6 inhibitor, according to findings from the phase 2 VERONICA trial (NCT03584009), which was presented during the 2021 ASCO Annual Meeting.

At a median follow-up of 9.9 months, the clinical benefit rate (CBR)was 11.8% (95% CI, 4.44%-23.87%) with venetoclax/fulvestrant vs 13.7% (95% CI, 5.7%-26.26%) with fulvestrant alone, translating to a risk difference of -1.96%(95% CI, -16.86%-12.94%).

The primary analysisof VERONICA revealed a largely endocrine-refractory population of patients. Venetoclax added to fulvestrant did not improve CBR orprogression-free survival [PFS], [nor did]overall survival [OS]favor [the combination],lead study author Geoffrey J. Lindeman, MD,joint head of the, Stem Cells and Cancer Division at The Walter and Eliza Hall Institute of Medical Research,saidin a virtual presentation of the data.

Despite the use of the combination of aCDK4/6 inhibitorandchemotherapy, whichhas become the standard frontline therapy for patients withmetastaticER-positive, HER2-negative breast cancer, disease progressionis inevitable.

BCL-2 is a pro-survival protein that is overexpressed in the majority of primary and relapsed ER-positive breast cancers.The BCL-2 inhibitor venetoclaxhas shown promising activity in patients withendocrine-nave, ER-positive, BCL-2positive metastatic breast cancer.

To that end, investigators evaluated the activity of adding the BCL-2 inhibitor to fulvestrant in patients withprogressive ER-positive, HER2-negative disease.

Eligibility criteria stipulated that females,18 years of age or older,had to have locally advanced or metastatic ER-positive, HER2-negativebreast cancer, received 2 or fewer lines of therapy in the locally advanced or metastatic setting without chemotherapy, received a CDK4/6 inhibitorat least 8 weeks before enrollment, and have measurable disease.

Patients were randomized 1:1 to 800 mg of oral, dailyvenetoclax (n = 51) plus 500 mg of intramuscular fulvestrant on day 1 and 15 of cycle 1 and day 1 ofeach 28-day cycle thereafteror fulvestrant alone (n = 52). Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end.

CBR,defined as thetotal complete response(CR), partial response(PR), and stable disease rate after at least 24 weeks, served as the primary end point of the study. Secondary end pointsincludedPFS, OS, objective response rate (ORR)defined as the total CR and PR rateand duration of response (DOR).

Additional end points included safety and tolerability, biomarker analysis, pharmacokinetics, and patient-reported outcomes.

The primary analysis took place on August 5, 2020, and the updated analysis took place in April 2021.

Regarding baseline demographics, the median age was 58 years in thevenetoclax arm vs 59.5 years in the fulvestrant-alone arm.Approximately half of all patients had an ECOG performance status of 0 in both arms,at 54.9% and 59.6%, respectively. Moreover, in both arms, the majority of patients were White(78.4% vs 88.5%, respectively), had ductalhistology(78.4% vs 65.4%, respectively), at least 1 visceral metastatic lesion(92.2% vs 82.7%, respectively), and 1 prior line of endocrine therapy in the metastatic setting(80.4% vs 82.7%, respectively).

All patients had received prior endocrine therapy in the venetoclax and fulvestrant-alone arms, whereas approximately half had receivedadjuvant chemotherapy (58.8% vs 51.9%, respectively), and less than a quarter had received prior neoadjuvant chemotherapy (23.5% vs 13.5%, respectively).

The median duration of exposure to prior treatment with a CDK4/6 inhibitorin the metastatic settingwas 15 months in the venetoclax arm vs 16.5 months in the fulvestrant-alone arm,with palbociclib (Ibrance; 56.9% vs 75%, respectively) and ribociclib (Kisqali; 43.1% vs 25%, respectively).

Regarding BCL-2 status, more patients had high expressionin the venetoclax and fulvestrant-alone arms (64.7% vs 65.4%, respectively) thanlow expression (35.3% vs 34.6%, respectively).

Biomarker statusin the venetoclax and fulvestrant-alone arms, respectively,indicated the presence ofmutations in the PIK3CA (39.6% vs 30.4%),ESR1 (43.8% vs 41.3%),TP53 (47.9% vs 34.8%), andRB1 (18.8% vs 8.7%)genes.

Additional results demonstrated that the ORR was3.9% in the venetoclax arm vs 5.9% in the fulvestrant-alone arm and consisted all of PRs.

The median PFS was 2.69 months (95% CI, 1.94-3.71) in the venetoclax arm vs 1.94 months(95% CI, 1.84-3.55)in the fulvestrant-alone arm (HR, 0.94; 95% CI, 0.61-1.45;P= .7853).The 6-month PFS rates were 12.3% vs 18.8%, respectively.

The OS data were not mature at the time of the primary analysis but did not favor the venetoclax arm. The median OS was 16.76 months (95% CI, 10.12-not evaluable [NE]) in the venetoclax arm vs NE (95% CI, 16-NE) in the fulvestrant-alone arm (HR, 2.56; 95% CI, 1.11-5.89;P= .0218).The updated analysis showed comparable results, with a numerically lower hazard ratio of 1.85(95% CI, 1.01-3.39).

Notably, similar CBR and PFS was observed between arms,irrespective of BCL-2 expression.

However, increased CBR and PFS was reported in thePIK3CAwild-type subgroupin an exploratory analysis. Here, the CBR was20.7% in the venetoclax arm(n = 29) vs 9.7% in the fulvestrant-alone arm(n = 31).The median PFS was 3.71 months (95% CI, 1.94-4.53)vs 1.87 (95% CI, 1.74-3.55), respectively(HR, 0.66; 95% CI, 0.38-1.17;P=.1549).

Ahigher number of deaths was reported in the venetoclax arm vs the fulvestrant-alone arm primarily because of progressive disease at least 28 days after the last dose of study treatment. A similar trend was reported in the updated analysis.

The safety profile of the combination was consistent with the known safety profile of each agent alone, and no new signals were identified.

The occurrence of at least 1 adverse effect (AE) was reported in 94% of patients in the venetoclax arm vs 76.5% of patients in the fulvestrant-alone arm. Grade 3 or 4 AEs were reported in 26% vs 11.8% of patients, respectively.Serious AEs occurred in 8% vs 2% of patients, respectively.One case of urosepsis leading to death occurred in the venetoclax arm but was unrelated to the study drug.

Treatment-related AEs leading to drug withdrawal occurred in 8% of patients in the venetoclax arm vs 0% of patients in the fulvestrant-alone arm.AEs leading to dose modification or interruption occurred in 44% vs 2% of patients, respectively.

The most common grade 3 or 4 AEs in the venetoclax arm included fatigue (6%), neutropenia (12%), lymphopenia (4%), and dyspnea (4%)vsa 2% incidence of grade 3 or 4 fatigue in the fulvestrant-alone arm.

It remains unclear whether a BCL-2 inhibitor would be effective in an endocrine therapyresponsive, CDK4/6 inhibitornave setting, concluded Lindeman.

Reference

Lindeman GJ,Bowen R, Jerzak KJ,et al. Results from VERONICA: a randomized, phase II study of second-/third-linevenetoclax + fulvestrant vs. fulvestrantalone in estrogen receptor-positive, HER2-negative, locally advanced, or metastatic breast cancer.J Clin Oncol. 2021;39(suppl 15):1004.doi:10.1200/JCO.2021.39.15_suppl.1004

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Venetoclax Plus Fulvestrant Did Not Improve Outcomes Compared to Fulvestrant Alone in ER+/HER2- Breast Cancer - Cancer Network

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Magenta Therapeutics (MGTA) Announces Additional Preliminary Positive Results from Ongoing Phase 2 Clinical Trial of MGTA-145 and Plerixafor in…

Posted: June 6, 2021 at 2:03 am

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Magenta Therapeutics (Nasdaq: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of stem cell transplants to more patients, today announced additional positive results from a Phase 2 clinical trial of MGTA-145 and plerixafor in patients with multiple myeloma at the American Society of Clinical Oncology (ASCO) Annual Meeting, being held virtually June 4-8, 2021.

We are very pleased to see continued favorable results for MGTA-145 and plerixafor for stem cell mobilization and collection in patients with multiple myeloma, said Jason Gardner, D.Phil., President and Chief Executive Officer, Magenta Therapeutics. These results build on those previously disclosed from this study and the Phase 1 trials to further demonstrate MGTA-145 and plerixafors potential as a rapid, reliable, well-tolerated approach to stem cell mobilization and collection, which has positive implications for patients and donors.

Additional Results MGTA-145 Multiple Myeloma Phase 2 Clinical Trial

The investigator-initiated, 25-patient Phase 2 clinical trial is designed to evaluate the ability of MGTA-145, in combination with plerixafor, to mobilize and collect hematopoietic stem cells for autologous stem cell transplant in patients with multiple myeloma. This study is led by Surbhi Sidana, M.D., Assistant Professor of Medicine in the Division of Blood and Marrow Transplantation and Cellular Therapy at Stanford University School of Medicine.

Previously reported results from this trial were announced on May 12, 2021, in a published abstract for the European Hematology Association (EHA) Congress and provided preliminary data from the initial cohort of 10 patients.

Summary of cumulative results through data cut-off date:

As indicated previously, this trial has broad and clinically representative inclusion criteria and includes patients that represent the general transplant-eligible population of patients with multiple myeloma. Patients enrolled in this trial included those patients with risk factors that could impact stem cell mobilization and collection, such as myeloma-directed therapies that are known to impact stem cell collection, previous malignancy treated with chemotherapy and/or radiation, and other co-morbid conditions. Mobilization agents may be less effective in patients with multiple risk factors. Final clinical data from this trial are anticipated by the end of 2021. MGTA-145 is also being evaluated for its ability to mobilize and collect stem cells from donors for allogenic transplant in patients with acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) in a Phase 2 trial, and an additional Phase 2 study is planned to initiate in patients with sickle cell disease in the second half of 2021.

ASCO Poster Presentation

Title: Phase 2 Study of MGTA-145 + Plerixafor for Rapid and Reliable Hematopoietic Stem Cell (HSC) Mobilization for Autologous Stem Cell Transplant in Multiple Myeloma (Abstract #8023)

Author: Surbhi Sidana, M.D., Assistant Professor of Medicine in the Division of Blood and Marrow Transplantation and Cellular Therapy, Stanford University School of MedicinePoster Session: Hematologic Malignancies Plasma Cell DyscrasiaDate/Time: All e-posters are now available in the ASCO Annual Meeting virtual platform

These results will also be presented as an encore at the EHA Virtual Congress, available via the conferences virtual platform on Friday, June 11 at 3:00am EDT / 9:00am CEST.

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Magenta Therapeutics (MGTA) Announces Additional Preliminary Positive Results from Ongoing Phase 2 Clinical Trial of MGTA-145 and Plerixafor in...

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On systemic sources of early life stress, and empathetic responses – MIT News

Posted: June 6, 2021 at 2:00 am

A powerful series of speakers at the Picower Institute for Learning and Memorys biennial Spring Symposium, Early Life Stress and Mental Health, blended personal stories and rigorous research to demonstrate that while remedying the lifelong toxic stress and disadvantage many people incur during childhood can be difficult, it is by no means intractable.

Picower Institute Director Li-Huei Tsai opened the symposium, co-produced with the JPB Foundation led by Barbara Picower, with the observation that while problems such as poverty, racism, injustice, and child abuse have been around for a long time, finding and implementing ways to fight the health problems that can result has become increasingly urgent.

This feels especially so right now, as we grapple with a time in which many of us have seen young people endure historic stresses, she said. The many tragedies and disruptions of the Covid-19 pandemic and stark examples of racial and social injustice have made this a particularly difficult time to grow up.

Stories of systemic stress

Educator Geoffrey Canada, founder and president of the Harlem Childrens Zone, emphasized that the current moment is especially crucial in the Black community.

If I am right about what I suspect is going to happen in this country, I can just say for those of us who care about toxic stress we haven't seen nothing yet, he said. What's coming, in my opinion, is sort of unprecedented.

Early Life Stress and Mental Health - Geoffrey Canada

Canada, who grew up in the impoverished South Bronx, New York, recounted several episodes in which generations of his family encountered racism, sometimes at the hands of police and health care providers. Many Black people have come to regard such stresses as the price of living in America, he said. But after observing the disproportionately terrible impacts of Covid-19 in his and other communities of color, his concern is heightened further.

I think it's very clear in this country, your race determines largely whether you lived or died, whether you got sick, whether you ended up working at home or being on the front lines, he said, whether your children got an education, and whether or not you're going to have anything that looks like a recovery from this experience.

Moreover, the murder of George Floyd and other police killings were seared into the psyche, adding even more to the stresses black children now face.

Lawyer Bryan Stevenson, founder of the Equal Justice Initiative, called out other harms the justice system has inflicted, particularly on women and children. But he also recommended a prescription for the nation to reconsider policies that have led to mass incarceration and prosecution of children as adults.

Over the last 25 years, the percentage of women going to jails and prisons has increased 800 percent, he said. Eighty percent of the women that we put in our jails and prisons are single parents with minor children, which means that the lives of a generation of children are being disrupted by these carceral policies.

Moreover, in a country where one-in-three Black and one-in-six Latino boys are projected to be in prison during their lives, Stevenson said that when he sits down with preteens in poor communities, theyll say things that break my heart. Ive talked to too many children who tell me that they expect to be in jail.

He called for more people to get proximate to families struggling with poverty, addiction, and other difficulties because proximity promotes understanding and empathy and provides an opportunity to provide the affirmation, care, safety, and opportunity that children growing up among violence need. Proximity, for instance, can help undo the discredited but persistent narrative that juveniles accused of crimes are somehow super predators and not still children. It can combat the politics of fear and anger, he said, that led the country to treat addiction disorders through the legal system rather than as a health care problem. And it can dispel, he said, a sense in America, lingering since slavery and the genocide of Indigenous Americans, of a racial hierarchy.

Jose Antonio Vargas put a similar emphasis on inspiring empathy through storytelling. The organization he founded, Define American, is a culture change organization that uses the power of narrative to humanize conversations about immigrants. Vargas, who came to the United States from the Philippines as a child, discovered his undocumented status when he was a teenager. As difficult as living undocumented can be under typical circumstances he drew a parallel between limitations on travel many felt during the Covid pandemic with the restrictions undocumented people consistently face becoming a public advocate amid intense policy debate can add to that stress.

Early Life Stress and Mental Health - Jose Antonio Vargas

Define American has therefore spearheaded research with the University of Massachusetts at Amherst, funded by the National Geographic Society, to survey immigration advocates for signs of post-traumatic stress disorder, stress, depression, and other signs of mental health troubles, as well as resilience. Full results, he said, will be published this summer, but reflect high rates of both trauma and resilience.

Science begets solutions

Several symposium speakers emphasized that much as personal stories and proximity can aid reveal the roots of toxic stress, scientific data and research can also lead to remedies by discovering the mechanisms that underlie health problems.

Picower Institute neuroscientist Gloria Choi, associate professor in the MIT Department of Brain and Cognitive Sciences (BCS), for example, shared her research tracing a long-observed but never explained link between pregnant women getting sick from infection and the emergence of autism-like symptoms in their children. Her research in mouse models showed that when specific bacteria are in the gut microbiome of pregnant dams, infection during a specific time of pregnancy stimulates the release of cytokine molecules from immune cells. Those cytokines reach neurons in the S1DZ region of the cortex of the fetus, disrupting the development of inhibitory neurons. That in turn leads to hyperactivity of circuits governing social behaviors, causing the autism-like neurodevelopmental disorder.

By achieving this kind of detailed, causal understanding, Choi said, scientists pinpoint targets for therapeutic interventions.

We scientists, to be able to help children, I think we need to understand at mechanistic levels as to how mother's health can shape that of her child, she said.

At a population level, as well, extracting cause and effect from data can help guide public health and policy remedies, said social epidemiologist Mariana Arcaya, associate professor in MITs Department of Urban Studies and Planning. She made the case that while many researchers have shown that neighborhood characteristics such as poverty and violence can undermine health, fewer have studied what may be an equally important link existing health conditions can make it harder for families to move. Appreciating this bidirectional relationship between health and geography should not be overlooked in devising interventions, she said. Her research has helped to document it.

If poor health is a factor that is going to limit socioeconomic and geographic mobility, and we know that there's huge baseline disparities in health in the United States, Arcaya said, then we really need to be concerned about the co-production of health and neighborhood and housing conditions and how some families may be in a kind of cyclical disadvantage for both health outcomes and socioeconomic and neighborhood outcomes.

As the first surgeon general of the State of California, physician Nadine Burke Harris has galvanized a science-based statewide response to the public health crisis of adverse childhood experiences (ACEs), such as abuse, neglect, or disruptions in home life. More than 60 percent of adults have experienced at least one ACE and 15.8 percent have experienced four or more. Research shows that ACEs accumulate to raise the risk of serious health problems, including Alzheimers disease and suicide. In all, ACE-related health problems, she said, add $112.5 billion to annual health-care costs in California and more than $1 trillion across North America and Europe as a whole. On top of those, poverty and racism are also risk factors for future health difficulties.

Early Life Stress and Mental Health - Nadine Burke Harris

Over the last several decades weve begun to explore the biological mechanisms for how this happens, she said. Weve heard that trauma, especially in childhood, is damaging to our physical health, our mental health, but now we want to understand why, because when we understand the mechanism, that gives us tools to be able to unpack this.

In affected people, she said, ACEs trigger toxic stress an abnormally sustained stress hormone and immune system response as well as epigenetic changes that alter expression of genes. These factors, many of which act directly on the brain, lead to health risks. They can be mitigated, however, by providing safe, stable, and nurturing relationships and environments, as well as with stress management and medication.

So California has launched programs that have trained more than 17,000 primary care providers to screen more than 300,000 patients for ACEs and toxic stress risk. From there, doctors can help families with strategies to better manage the response. Moreover, the state has invested more than $30 million this year in grants covering 27 counties to link medical, social, educational, and community service providers together in trauma-informed networks of care that support families more broadly.

Extending opportunities

In a panel discussion moderated by Laura Schulz, a professor in BCS and the departments associate head for Diversity, Equity Inclusion and Justice Initiatives, the symposium also highlighted another dimension of harmful inequity that prevents people from reaching their full potential: the lack of diversity in science, technology, engineering, and mathematics, or STEM. Mirroring the focus other speakers put on seeking solutions, the panel featured people at MIT who are working to improve diversity in STEM, and participants in some of those programs who described what involvement has meant for them.

Picower Institute postdoc Hctor De Jess-Corts, a member of Picower Professor Mark Bears lab, for example, described how his participation as a student in Puerto Rico in the NIH-funded Minority Access for Research Careers program enabled him to do full-time research and to launch his scientific career. That and other opportunities inspired him to co-found the Sagrado MIT Neuroscience Pre-College Program, which helps high school students all over Puerto Rico to gain more exposure to science and knowledge about science careers. Of the 11 juniors who participated last year, many are now headed for colleges such as Stanford University, Yale University, Emory University, Cornell University, and Georgia Tech, he said.

Early Life Stress and Mental Health - Panel

The MIT Office of Engineering Outreachs three programs are currently serving about 365 high-achieving pre-college students from underrepresented groups and disadvantaged backgrounds. In all, OEOP has served more than 5,000 students, said Executive Director Eboney Hearn. About 80 percent have gone on to earn at least bachelors degrees in STEM fields, she said, including many at MIT.

Our alumni tell us that our programs have helped to level the playing field and helped them to get to places in their academic and personal journeys that didnt seem possible, she said.

Schulzs lab has been an active locus within BCS for inspiring and mentoring students at various stages. Graduate student Junyi Chu, for instance, described how last year she helped to launch the labs high school internship program, in partnership with Somerville High School and Black Girls Code. The lab has already engaged 17 students in the labs work studying cognition in babies. Interns also learn about science careers and publishing.

Panelist Liora Jones, from Torrington, Connecticut, was a Schulz lab intern. She just graduated high school and will study cognitive science at Wellesley College in the fall. Inspired by the fields of human-computer interaction, psychology, and artificial intelligence, she said she saw the internship as a way to learn more about cognition and to gain research skills. She did, and in the process met a mentor, new friends, and attended her first research conference.

Chu has also mentored college students in the MIT Summer Research Program. Among them is Kailande Cassamajor, who just graduated from Howard University with a degree in biology and psychology, and will attend a masters program in data science at Columbia University in the fall. Cassamajor said she enjoyed the chance to meet fellow MSRP students from other schools as well as to work with graduate students, like Junyi, who exposed her to cognitive and computational neuroscience. She greatly expanded her experience using a new programming language, for example.

In his remarks, panelist Tyler Bonnen provided vivid, personal representation of many of the themes of the day. Now a fifth-year neuroscience graduate student at Stanford, he described his adolescence in Miami Dade County, Florida, as mired within the criminal justice system: rehabs, hospitals, jail cells, psych wards, detention centers. But he had a good judge and was lucky enough to be picked for a study in which he and his family were helped. He got out of the institutions in which he was being harmed, he said, did social justice work, and then found his way to community college, where he encountered a program that would finance his education if he would study science.

After earning a degree at Columbia, he studied at MIT as a BCS postbaccalaureate scholar with Schulz and Professor Rebecca Saxe. Now hes dedicating his multidisciplinary research to studying how memory works, with the goal of better understanding trauma and helping people overcome it. Hes bringing his stories and science together to help others overcome acute stresses of their own.

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Novo Nordisk partners with Heartseed on heart failure cell therapy – PMLiVE

Posted: June 6, 2021 at 1:58 am

Danish pharma company Novo Nordisk has announced a new collaboration and licence agreement with Japans Heartseed to develop the companys investigational cell therapy HS-001 for heart failure.

HS-001, Heartseeds lead asset, is an investigational cell therapy using purified cardiomyocytes derived from induced pluripotent stem cells (iPSC). The therapy is currently being developed as a treatment for heart failure.

Heartseed is already planning to launch a phase 1/2 study of HS-001 in Japan in the second half of 2021, which will evaluate the safety and efficacy of the therapy for the treatment of heart failure caused by ischaemic heart disease.

Under the terms of their agreement, Novo Nordisk will gain exclusive rights to develop, manufacture and commercialise HS-001 globally, excluding Japan where Heartseed will retain the rights to solely develop the therapy.

However, Novo Nordisk has the rights to co-commercialise HS-001 with Heartseed in Japan, with equal profit and cost sharing.

In return, Heartseed is eligible to receive up to a total $598m, with $55m earmarked in upfront and near-term milestone payments.

The Japanese biotech company is also eligible to receive tiered high single-digit to low double-digit royalties of annual net sales on the product outside Japan.

"We are delighted to have a company with the expertise and resources of Novo Nordisk as our partner for development and commercialisation of HS-001, and are also honoured that Novo Nordisk has recognised the innovativeness and high potential of our technology," said Keiichi Fukuda, chief executive officer of Heartseed.

"We believe that the partnership with Novo Nordisk is very valuable as we seek to disseminate our Japan-origin innovation globally as early as possible, he added.

Through this important collaboration with Heartseed, we aim to pioneer novel treatment solutions for people with cardiovascular disease, said Marcus Schindler, chief scientific officer, EVP research and early development at Novo Nordisk.

We [will] gain access to an innovative clinical asset, underlying technology and deep expertise within the field of iPSC biology and cardiac cell transplantation, which can be combined with our knowledge and capabilities in stem cell biology and manufacturing, he added.

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WWE Hall Of Famer To Receive Stem Cell Therapy – Wrestling Inc.

Posted: June 6, 2021 at 1:58 am

WWE Hall of Famer Diamond Dallas Page and his girlfriend, Payge McMahon, announced they are heading to Bio Excellorator in Colombia to receive total body stem cell therapy.

The WWE Hall of Famer posted a video on his Twitter, revealing he is looking to get stem cell therapy for his neck, back, shoulders, and knees.

Hey guys its me, Diamond Dallas Page, WWE Hall Of Famer. After years of pro wrestling beating up my body, I cant tell you how excited I am to be heading to Medellin, Colombia to see my good friends at BIO Excellorator, DDP said.

Because they are gonna hook me up with some serious stem cells, in my neck, in my back, in my shoulders, and in my knees. I am looking for bio accelerator to take me from 65 years old to 65 years young. And thats a fact.

DDP also posted a photo at the airport as he and his girlfriend began their trip to Columbia.

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Dr. Ghosh on the Role of Off-the-Shelf CAR T-Cell Therapy in Myeloma June – OncLive

Posted: June 6, 2021 at 1:58 am

Monalisa Ghosh, MD, discusses the role of off-the-shelf CAR T-cell therapy in patients with multiple myeloma.

Monalisa Ghosh, MD, a clinical assistant professor at the University of Michigan, discusses the role of off-the-shelf CAR T-cell therapy in patients with multiple myeloma.

These products are promising in many ways and provide several advantages, including a decreased manufacturing time, Ghosh says. Experts in the field can request and receive off-the-shelf CAR T-cell products from a bank, she explains.This eliminates the need to wait for patient cell collection, which puts the patient at some degree of risk, and decreases the manufacturing time that ordinarily takes several weeks. The decreased treatment timeline can also be beneficial to patients with rapidly progressive disease, Ghosh notes.

However, challenges exist with this therapy, as allogenic cells may cause certain adverse effects, such as a graft-versus-host reaction that is similar to reactions observed with stem cell transplantation, Ghosh says. Currently, certain methods of T-cell receptor engineering may be able to mitigate this risk, she adds.Additionally, some hosts may reject the cells, a possibility that has been observed in early studies, wherein cells have not demonstrated long-term persistence.It may be possible to overcome this through multiple cell infusions, Ghosh notes.

Overall, the accessibility of off-the-shelf CAR T-cell products to a large group of patients with multiple myeloma appears promising, Ghosh concludes.

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Dr. Ghosh on the Role of Off-the-Shelf CAR T-Cell Therapy in Myeloma June - OncLive

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Gift of Life Biologics – The Boca Raton Observer

Posted: June 6, 2021 at 1:58 am

Advancing Next Generation Cell And Gene Therapy

Cancer doesnt stop for COVID-19 or anything else, says Jay Feinberg and neither does he.

The founder of the nonprofit Gift of Life Marrow Registry in Boca Raton is determined to democratize and redefine cell and gene therapy to save lives.

A leading global stem cell donor registry with three decades of experience curing cancers like leukemia with stem cell transplants, Gift of Life will launch a new, for-profit biotech subsidiary this year: Gift of Life Biologics. Groundbreaking innovations in this field have led to a significant demand from biopharmaceutical firms for these same donor stem cells, useful as building blocks for next generation living drugs to treat cancer and other life-threatening diseases.

Our goal is to be a single source for the new era of therapeutics by tapping into our donor registry, collection center, cell therapy laboratory, quality systems and information technology all housed under one roof at Gift of Lifes 32,000 square-foot headquarters, says Feinberg.

Companies creating revolutionary treatments will find a tremendous resource in Gift of Life Biologics, which will deliver high-quality cell products and solutions advancing medical therapies at any stage of development from research through commercialization.

While many advancements have been made in cellular therapy treatments, certain critical barriers still impede success for patients, said Feinberg, who survived leukemia thanks to a bone marrow transplant 25 years ago.

As a majority owner of the Biologics company, Gift of Life will use revenues earned to fund the growth of the registry in order to save even more lives. Biologics is seeking impact investors in an initial raise of $5 million to help start the venture.

In November 2020, the organization also launched the nonprofit Gift of Life Center for Cell and Gene Therapy. The laboratory processes and freezes donor stem cells in a BioBank making them available off the shelf for faster transplants.

Our goal is to ensure that every patient has an equal opportunity to receive a transplant and other lifesaving therapies, says Feinberg, who is constantly looking for new ways to help patients in need, and procuring charitable funding to grow the donor registry and additional operations.

Gift of Life Biologics, 5901 Broken Sound Parkway N.W., Ste. 600, Boca Raton, FL 33487, 561-982-2900, giftoflifebio.org

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Canine Stem Cell Therapy Market 2021 Analysis and Precise Outlook Therapeutics, Medivet Biologics, Okyanos The Courier – The Courier

Posted: June 6, 2021 at 1:58 am

Canine Stem Cell Therapy Market research report documents in-depth analysis of the global and the regional markets on various parameters that drives the market. Market analysis, factual data, and market forecasts are few areas covered in this report. This report also outlines the growth of the markets over the span of years, the changing dynamics of the markets, rules, and laws that govern the regional and international markets, revenue generation and production cost variations, and much more.

The Canine Stem Cell Therapy was valued at 48500 Billion US$ in 2021 and is projected to reach 59700 Billion US$ by 2025, at a CAGR of 6.3% during the forecast period.

The non-invasive stem cell obtaining procedure augmented the possibility of accomplishing high-quality cells, and the lower price of therapy coupled with a high success rate of positive outcomes have collectively made allogeneic stem cell therapy a preference for veterinary physicians. Moreover, allogeneic stem cell therapy is 100% safe, which further supports its demand on a global level. Pet owners are identified to prefer allogeneic stem cell therapy over autologous therapy, attributed to its relatively lower costs and comparative ease of the entire procedure.

Top Key Players Profiled in This Report:VETSTEM BIOPHARMA, Cell Therapy Sciences, Regeneus, Aratana Therapeutics, Medivet Biologics, Okyanos, Vetbiologics,

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The purpose of this study is to define the overview of the Rising Demand for Canine Stem Cell Therapy Market with respect to market size, shares, sales patterns, and pricing structures. Primary and secondary research refer collect the desired data of the target market. Different global regions such as North America, Latin America, Asia-Pacific, Africa, and the Middle East are examined to evaluate the facts about productivity.

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Which are the global opportunities for expanding the Rising Demand for Canine Stem Cell Therapy Market?

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Canine Stem Cell Therapy Market 2021 Analysis and Precise Outlook Therapeutics, Medivet Biologics, Okyanos The Courier - The Courier

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CAR T Cells Have Reshaped the Hematologic Cancer Landscape – Targeted Oncology

Posted: June 6, 2021 at 1:58 am

Michael Bishop, MD, a professor of medicine and director of Hematopoietic Stem Cell Transplantation Program at The University of Chicago Medicine, discussesthe different settings where chimeric antigen receptor (CAR) T-cell therapy are used.

Bishop thinks CAR T-cell therapy made a significant impact upon patient care. CAR T cells are indicated for 3 main groups of patients. The first is for non-Hodgkin lymphoma and for pediatric and young adult acute lymphoblastic leukemia (ALL), which has FDA-approved agents. More recent approvals have been for patients with mantle cell lymphoma. Physicians are waiting for what they expect to be the first indication for CAR T-cell therapy in multiple myeloma.

Starting with ALL for the pediatric population, CAR T cells have been a game changer, according to Bishop. These young patients have median overall survivals of less than 6 months, but the high response rates with CAR T are enabling them to potentially go on to an allogeneic stem cell transplant and in some cases, be free of disease.

In the non-Hodgkin lymphoma setting, there are now 3 products indicated for advanced B-cell non-Hodgkin lymphoma, which is significant for patients with totally refractory disease. There is this therapeutic option that is potentially curative. Bishop says investigators are seeing patients out to 5 years without any further therapy after receiving CAR T cells.

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CAR T Cells Have Reshaped the Hematologic Cancer Landscape - Targeted Oncology

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In Some Heavily Pretreated Patients with R/R MM Ide-Cel Continues to Show Deep and Durable Responses – Targeted Oncology

Posted: June 6, 2021 at 1:58 am

Long-term follow-up data from the KarMMa trial found that treatment with the chimeric antigen receptor (CAR) T-cell therapy, idecabtagene vicleucel (ide-cel; formerly bb2121; Abecma), continues to demonstrate improved survival among heavily pretreated patients with relapsed/refractory multiple myeloma, according to a presentation presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.1

The favorable benefit risk profile of ide-cel, regardless of the number of prior lines of therapy, supports its role as a treatment option for heavily pretreated relapse refractory multiple myeloma, Larry D. Anderson, MD, PhD, associate professor, UT Southwestern Medical Center, said during a presentation of the poster.

At the December 21, 2020, data cutoff, the median follow-up was 24.8 months (range, 1.7-33.6).

Overall response rate (ORR) was 73% in the overall population, including a 33% complete response rate (CRR; complete response [CR] or stringent complete response [sCR]), 20% with a very good partial response (VGPR), and 20% who had a partial response (PR). ORR rates were 50%, 69%, and 81%, respectively, across the 150, 300, and 450 million CAR T cell-dose arms, including CR/sCR rates of 25%, 29%, and 39%.

Of note, ORR did not vary by the number of prior lines of therapy received. For those who received 3 prior lines of therapy (n = 15), the ORR was 73%, including a CRR of 53% and VGPR of 20%, compared with an ORR of 73% in those who received 4 (n = 112) lines of therapy, including a CRR of 30%, VGPR of 23%, and PR of 20%.

Median duration of response (DOR) was 10.9 months (95% CI, 9.0-11.4), including 9.9 months for the 300 million CAR T cells-dose arm and 11.3 months for the 450 million CAR T cells-dose arm -dose arm. Median DOR was 21.5 months in patients who experienced a CR or sCR. Median DOR by response were 21.5 months (95% CI, 12.5 to not estimable [NE]) among those who experienced a CR, 10.4 months (95% CI, 5.1-12.2) for those with VGPR, and 4.5 months (95% CI, 2.9-6.7) in those with PRs.

Moreover, the rate of event-free 24-month DOR appeared to be similar in patients who received 3 or 4 or more lines of therapy. For those who received 3 lines of prior therapy, median DOR was 8.0 months (95% CI, 3.3-11.4), compared with 10.9 months (95% CI, 9.2-13.5) in those who received 4 or more lines of therapy.

Median progression-free survival (PFS) was 8.6 months (95% CI, 5.6-11.6) across all target doses, including 5.8 months for the 300 million CAR T cells-dose arm and 12.2 months for the 450 million CAR T cells-dose arm -dose arm. Similarly, median PFS was similar among those who previously received 3 lines of therapy, compared with 4 or more prior lines of therapy (8.6 months (95% CI, 2.9-12.1) vs 8.9 months (95% CI, 5.4-11.6)]

The median time to first response was 1 month (range, 0.5-8.8), with a median time to CR of 2.8 months (range, 1.0-15.8).

Median overall survival (OS) was 24.8 months (95% CI, 19.9-31.2), including a median OS of 22.0 months (95% CI, 10.-NE) in those who received 3 lines of prior therapy and 25.2 months (95% CI, 19.9-NE) in those who received 4 or more lines of prior therapy. Moreover, OS was 20 months or longer across several key high-risk subgroups, including those aged 65 or older (21.7 months; 95% CI, 17.1-31.2), those with extramedullary disease (20.2 months; 95% CI, 15.5-28.3), and those with triple refractory disease (21.7 months; 95% CI, 18.2-NE).

In regards to safety, cytokine release syndrome (CRS) and neurotoxicity were similar, regardless of prior lines of therapy received, and were mostly low grade. In total, 85% and 18% of the overall population experienced at least 1 CRS or neurotoxicity event, respectively.

The safety profile of ide-cel was consistent with long-term follow-up, with similar rates of infections and secondary primary malignancies, and no unexpected gene therapy related toxicities were observed. The most common grade 3 to 4 adverse events (AEs) in the overall population were neutropenia (89%), anemia (61%), thrombocytopenia (52%), leukopenia (39%), lymphopenia (27%), and infections (27%).

Long-term results from the KarMMA trial continue to demonstrate frequent, deep, and durable responses in heavily pretreated patients with [relapsed/refractory multiple myeloma], the study authors write in the poster. ORR, CRR, DOR, and PFS were consistent with previous reports and patients received similar benefit regardless of the number of prior lines of therapy.

In his presentation, Anderson presented data on long-term efficacy and safety following treatment with ide-cel in the pivotal phase 2 KarMMa trial (NCT03361748)-including overall data and by prior line of therapy that patients had received (3 vs 4), since the FDA label is requiring at least 4 prior lines, and this study only required 3, he added.

In total, 140 patients who had received at least 3 prior lines of therapy for multiple myeloma including an IMiD, a PI, and an anti-CD38 antibody and were refractory to their last treatment regimen, were enrolled in the study. However, only 128 patients received infusion with ide-cel.

Patients were treated with ide-cel across the target dose range of 150 (n = 4), 300 (n = 70), and 450 (n = 54) million CAR T cells.

ORR served as the primary end point of the study. Secondary end points included CRR, safety, DOR, PFS, OS, pharmacokinetics, minimal residual disease, quality of life, and health economics and outcomes research.

At baseline, the median patient age was 61 years (range, 33-78) and patients had a median of 6 years (range, 1-18) since their diagnosis. A majority of the patients were male (59%), had high tumor burden (51%), B-cell maturation antigen (BCMA) expression 50% at screening (85%), ECOG performance status of 1 (53%), and Revised International Staging System disease stage of II (70%). Thirty-five percent of patients had high-risk features.2

The median number of prior therapies was 6 (range, 3-16) and 94% had previously undergone at least 1 autologous hematopoietic stem cell transplant (94%). Eighty-eight percent of patients required bridging therapy. Eighty-nine percent of patients had double-refractory disease, 84% were triple-refractory, and 26% were penta-refractory.

Patients who had received 3 prior lines of therapy had similar baseline characteristics, compared with those who received 4 prior lines, including differences in extramedullary disease, high-risk cytogenetics, prior refractoriness, and time since the initial diagnosis to screening.

Patients with relapsed/refractory multiple myeloma previously exposed to immunomodulatory agents, protease inhibitors, and anti-CD38 antibodies have poor outcomes with subsequent therapy using previously approved regimens, with expected response rates in the 26% to 31% range, PFS in the 2- to 4-month range, and overall survival less than 9 months, Anderson explained.

However, the BCMA-directed CAR T-cell therapy previously demonstrated favorable tolerability with deep, durable responses in patients who were heavily pretreated with relapsed/refractory multiple myeloma.2 As a result, the FDA approved the agent for the treatment of adult patients with relapsed or refractory multiple myeloma after 4 or more prior therapies, including an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody, representing the first BCMAdirected CAR T-cell therapy approved.3

The study authors noted that ide-cel is being explored in ongoing clinical trials, including the following:

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In Some Heavily Pretreated Patients with R/R MM Ide-Cel Continues to Show Deep and Durable Responses - Targeted Oncology

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