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Advances in Treating Non-Small Cell Lung Cancer – GlobeNewswire

July 28, 2020 17:09 ET | Source: Family Features

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MISSION, Kan., July 28, 2020 (GLOBE NEWSWIRE) -- (Family Features) Despite progress in treating lung cancer, it is the leading cause of cancer deaths and impacts communities across the United States. The most common form of lung cancer is non-small cell lung cancer (NSCLC). NSCLC is a complex disease that can be challenging to treat, which may feel overwhelming and unsettling for people facing the disease.

Advanced lung cancer is devastating, so the fact that additional treatment options are now available that have the potential to extend the lives of patients gives us hope, said Bonnie J. Addario, lung cancer survivor and co-founder and chair, GO2 Foundation. Its exciting that this is a combination of immunotherapies, which brings a whole new approach for patients and physicians to consider when discussing treatment options.

A Chemo-Free Treatment Option A first-of-its-kind, chemotherapy-free treatment option was recently approved by the U.S. Food and Drug Administration as a first treatment for certain adults with advanced NSCLC, or NSCLC that has spread to other parts of the body. This treatment is a prescription medicine that is a combination of two immunotherapies, Opdivo (nivolumab) and Yervoy (ipilimumab), and it can be used for adults newly diagnosed with advanced NSCLC that tests positive for PD-L1 but do not have an abnormal EGFR or ALK gene.

Opdivo can cause problems that can sometimes become serious or life threatening and can lead to death. Serious side effects may include lung problems (pneumonitis); intestinal problems (colitis) that can lead to tears or holes in your intestine; liver problems (hepatitis); hormone gland problems (especially the thyroid, pituitary, adrenal glands, and pancreas); kidney problems, including nephritis and kidney failure; skin problems; inflammation of the brain (encephalitis); problems in other organs; severe infusion reactions; and complications of stem-cell transplant that uses donor stem cells (allogeneic). Additional serious side effects of Yervoy alone include: nerve problems that can lead to paralysis; eye problems; and complications of stem-cell transplant that uses donor stem cells (allogeneic). Please see Important Facts about side effects for Opdivo and Yervoy below.

The Chance for a Longer Life In a study of 793 previously untreated patients whose tumors tested positive for PD-L1, 396 were given the immunotherapy combination of Opdivo + Yervoy and 397 were given platinum-based chemotherapy. Treatment with the immunotherapy combination reduced the risk of death by 21%, with half of patients treated with the immunotherapy combination still alive at 17.1 months and half of patients treated with platinum-based chemotherapy still alive at 14.9 months. This analysis was conducted at a minimum follow-up of 29.3 months.

In additional analyses, 63% of patients treated withthe immunotherapy combinationand 56% treated with platinum-based chemotherapy were alive at one year, and 40% and 33% at two years, respectively.At three years, 33% of patients treated withthe immunotherapy combination and 22% of those treated with platinum-based chemotherapy were still alive. The analysis at these time points was not designed to show a difference between Opdivo + Yervoy and platinum-based chemotherapy.

The most common side effects of OPDIVO, when used in combination with YERVOY, include: feeling tired; diarrhea; rash; itching; nausea; pain in muscles, bones, and joints; fever; cough; decreased appetite; vomiting; stomach-area (abdominal) pain; shortness of breath; upper respiratory tract infection; headache; low thyroid hormone levels (hypothyroidism); decreased weight; and dizziness. The most common side effects of YERVOY include: feeling tired; diarrhea; nausea; itching; rash; vomiting; headache; weight loss; fever; decreased appetite; and difficulty falling or staying asleep. Please see Important Facts about side effects for Opdivo and Yervoy below.

As an oncologist who treats patients facing this particularly challenging disease, the fact that Opdivo plus Yervoy has shown overall survival at three years is important, said Hossein Borghaei, D.O., chief of thoracic medical oncology division at Fox Chase Cancer Center and an investigator in the clinical study.

Being diagnosed with lung cancer can be challenging and life-changing. Advancements in NSCLC bring additional treatment options that may enable certain patients a chance to live longer lives.

For more information, visit Opdivo.com or talk to you doctor about treatment options.

INDICATION Opdivo (nivolumab) is a prescription medicine used in combination with Yervoy (ipilimumab) as a first treatment for adults with a type of advanced stage lung cancer (called non-small cell lung cancer) when your lung cancer has spread to other parts of your body (metastatic) and your tumors are positive for PD-L1, but do not have an abnormal EGFR or ALK gene.

It is not known if OPDIVO is safe and effective in children younger than 18 years of age.

OPDIVO (10 mg/mL) and YERVOY (5 mg/mL) are injections for intravenous (IV) use.

IMPORTANTSAFETYINFORMATION forOPDIVO(nivolumab) + YERVOY(ipilimumab)

OPDIVO is a medicine that may treat certain cancers by working with your immune system. OPDIVO can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death. These problems may happen anytime during treatment or even after your treatment has ended. Some of these problems may happen more often when OPDIVO is used in combination with YERVOY.

YERVOY can cause serious side effects in many parts of your body which can lead to death. These problems may happen anytime during treatment with YERVOY or after you have completed treatment.

Serious side effects may include:

Additional serious side effects observed during a separate study of YERVOY alone include:

Get medical help immediatelyif you develop any of these symptoms or they get worse. It may keep these problems from becoming more serious. Your healthcare team will check you for side effects during treatment and may treat you with corticosteroid or hormone replacement medicines. If you have a serious side effect, your healthcare team may also need to delay or completely stop your treatment.

OPDIVO and OPDIVO + YERVOY can cause serious side effects, including:

Pregnancy and Nursing:

Tell your healthcare provider about:

The most common side effects of OPDIVO, when used in combination with YERVOY, include: feeling tired; diarrhea; rash; itching; nausea; pain in muscles, bones, and joints; fever; cough; decreased appetite; vomiting; stomach-area (abdominal) pain; shortness of breath; upper respiratory tract infection;headache; low thyroid hormone levels (hypothyroidism); decreased weight; and dizziness.

These are not all the possible side effects. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visitwww.fda.gov/medwatch or call 1-800-FDA-1088.

Please see U.S. Full Prescribing Information and Medication Guide for OPDIVO and YERVOY.

Michael French mfrench@familyfeatures.com 1-888-824-3337 editors.familyfeatures.com

About Family Features Editorial Syndicate A leading source for high-quality food, lifestyle and home and garden content, Family Features provides readers with topically and seasonally relevant tips, takeaways, information, recipes, videos, infographics and more. Find additional articles and information at Culinary.net and eLivingToday.com.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/5c174110-3d0e-4a76-a2bc-46e0ebc4e6a5

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Advances in Treating Non-Small Cell Lung Cancer - GlobeNewswire

Stem Cell Antibody Market Booming Demand Leading To Exponential CAGR Growth By 2026 | Industry Growth Insights – My Kids Health

IndustryGrowthInsights (IGI), one of the worlds prominent market research firms has announced a novel report on Global Stem Cell Antibody Market. The report contains vital insights on the market which will support the clients to make the right business decisions. This research will help both existing and new aspirants for Stem Cell Antibody market to figure out and study the market needs, market size, and competition. The report incorporates data regarding the supply and demand situation, the competitive scenario, and the challenges for market growth, market opportunities, and the threats faced by key players during the forecast period of 2020-2026.

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Impact of COVID-19 on Stem Cell Antibody Market

The report also includes the impact of ongoing global crisis i.e. COVID-19 on the Stem Cell Antibody market and what the future holds for it. It provides an analysis of the effects of the pandemic on the global economy. The outbreak has directly disturbed the demand and supply chain. The report also analyzes the financial impact on firms and financial markets. IndustryGrowthInsights (IGI) has gathered insights from several delegates of the industry and got involved in the primary and secondary research to provide the clients with data and strategies to combat the market challenges during and after COVID-19 pandemic.

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Some of the major companies that are covered in this report:

PLAYERS

*Note: Additional companies can be included on request

The market scenario is likely to be fairly competitive. To analyze any market with simplicity the market is fragmented into the following segments:

By Application:

APPS

By Type:

TYPES

By Geographical Regions

Asia Pacific: China, Japan, India, and Rest of Asia Pacific Europe: Germany, the UK, France, and Rest of Europe North America: The US, Mexico, and Canada Latin America: Brazil and Rest of Latin America Middle East & Africa: GCC Countries and Rest of Middle East & Africa

Segmenting the market into smaller components helps in analyzing the dynamics of the market with more clarity. Another key component that is included in the report is the regional analysis to assess the global presence of the Stem Cell Antibody market. You can also opt for a yearly subscription of all the updates on the Stem Cell Antibody market.

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Below is the TOC of the report:

Executive Summary

Assumptions and Acronyms Used

Research Methodology

Stem Cell Antibody Market Overview

Global Stem Cell Antibody Market Analysis and Forecast by Type

Global Stem Cell Antibody Market Analysis and Forecast by Application

Global Stem Cell Antibody Market Analysis and Forecast by Sales Channel

Global Stem Cell Antibody Market Analysis and Forecast by Region

North America Stem Cell Antibody Market Analysis and Forecast

Latin America Stem Cell Antibody Market Analysis and Forecast

Europe Stem Cell Antibody Market Analysis and Forecast

Asia Pacific Stem Cell Antibody Market Analysis and Forecast

Asia Pacific Stem Cell Antibody Market Size and Volume Forecast by Application

Middle East & Africa Stem Cell Antibody Market Analysis and Forecast

Competition Landscape

If you have any questions on this report, feel free to reach us! @ https://industrygrowthinsights.com/enquiry-before-buying/?reportId=214552

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Stem Cell Antibody Market Booming Demand Leading To Exponential CAGR Growth By 2026 | Industry Growth Insights - My Kids Health

Another Voice: Terminally ill New Yorkers need a peaceful dying option – Buffalo News

The other one of us, Deborah Stern, suffers from myelodysplastic syndrome/chronic myelomonocytic leukemia. I want very much to live as long as I can and to be there for my family and friends. I am on weekly chemo to try to give myself more time. Ultimately, the only possibility of a cure for me would be a stem cell transplant and so far there have been no donor matches for me located in the world registries.

I dont believe God wants people to suffer. Knowing I have a peaceful dying option would enable me to live the rest of my life with a much better quality of life, taking the worry of increased suffering off the table.

It gave us great comfort that Gov. Andrew M. Cuomo recognized our reality when he announced his support for the Medical Aid in Dying Act last year: Pass the bill the older we get and the better medicine gets, the more weve seen people suffer for too, too long, he said. But we need our Assembly and Senate representatives to act before its too late for us.

Most New Yorkers, including doctors, agree. They also support medical aid in dying, according to recent polling by Quinnipiac University and Medscape-WebMD, respectively.

Washington, D.C., and nine states allow terminally ill adults to have the option of medical aid in dying, including New Yorks neighbors in Maine, New Jersey and Vermont.

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Another Voice: Terminally ill New Yorkers need a peaceful dying option - Buffalo News

Cleave Therapeutics Announces Commencement of a Phase 1 Clinical Study of CB-5339, A Valosin-Containing Protein (VCP)/p97 Inhibitor, in Patients with…

Details Category: Small Molecules Published on Tuesday, 28 July 2020 17:27 Hits: 114

SAN FRANCISCO, CA, USA I July 28, 2020 I Cleave Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on VCP/p97 as a novel target in oncology, announced today that the first patient has been dosed with CB-5339 in a Phase 1 clinical trial of patients with relapsed/refractory acute myeloid leukemia (AML) or relapsed/refractory intermediate or high-risk myelodysplastic syndrome (MDS). CB-5339 is a potent and selective, second-generation, oral small molecule inhibitor of VCP/p97.

We are pleased to begin patient enrollment of our clinical study in AML and MDS, which marks an important milestone in evaluating the initial safety and potential therapeutic benefit of VCP inhibitors for patients with cancer, said Amy Burroughs, president and chief executive officer of Cleave. This clinical program stems from more than a decade of research by scientists who have identified VCP/p97 as a pan-cancer core fitness target that is essential for cancer cell growth and survival.

The primary objectives of the Phase 1 study are to characterize the safety and tolerability and determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose of CB-5339. Additional objectives are to examine the pharmacokinetic parameters and estimate the anti-tumor effects of CB-5339. CB-5339 is administered orally for four days, followed by a three-day treatment-free period weekly in successive 28-day cycles. The trial is expected to enroll 50 to 60 patients in the United States and Australia and does not select or exclude patients based on tumor genetic profile.

Despite several new drug approvals in the last several years, there remains an urgent need for well-tolerated, effective therapies for patients with myeloid malignancies, said Courtney DiNardo, MD, MSCE, associate professor, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center. We are eager to study CB-5339 as a unique oral therapy that could benefit our AML and MDS patients perhaps even regardless of their mutational status - by disrupting stress pathways that are critical to cancer cells.

In addition to the AML/MDS trial, the National Cancer Institute (NCI), part of the National Institutes of Health, is sponsoring a Phase 1 clinical trial with CB-5339 in solid tumors and lymphomas. For more information on both of these trials, please visit the AML/MDS study or the Solid Tumors/Lymphomas study at http://www.clinicaltrials.gov.

About Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)

Acute myeloid leukemia is a type of cancer of the blood and bone marrow, caused by mutations in the genetic material (DNA) of myeloid stem cells which result in the formation of leukemic cells. These cells, also referred to as AML cells, cannot mature into fully functional blood cells, and they multiply uncontrollably. Nearly 20,000 newly diagnosed acute myeloid leukemia patients and 12,000 deaths are expected from AML in the U.S. this year. Myelodysplastic syndromes are a group of diverse bone marrow disorders in which the bone marrow does not produce enough healthy blood cells. Nearly 15,000 newly diagnosed cases of MDS are expected per year.

About Cleave Therapeutics

Cleave Therapeutics is a clinical-stage biopharmaceutical company focused on VCP/p97 as a novel target in protein homeostasis and cellular stress pathways for therapeutic use in cancer. The privately held company, based in San Francisco, is studying CB-5339, its second-generation, small molecule VCP/p97 inhibitor, in a Phase 1 clinical trial in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), while the National Cancer Institute (NCI) is sponsoring and evaluating CB-5339 in a Phase 1 clinical trial of patients with solid tumors and lymphomas. Cleave investors include 5AM Ventures, Bristol-Myers Squibb, Orbimed, U.S. Venture Partners (USVP), Arcus Ventures, Astellas Venture Management, and Osage University Partners. For additional information, visit http://www.cleavetherapeutics.com.

SOURCE: Cleave Therapeutics

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Cleave Therapeutics Announces Commencement of a Phase 1 Clinical Study of CB-5339, A Valosin-Containing Protein (VCP)/p97 Inhibitor, in Patients with...

Trump looks to hammer down drug prices with 4 executive orders – Endpoints News

President Donald Trump signed 4 executive orders targeting the pharmaceutical industry Friday afternoon, four months before voters head to the polls.

The presidential directives are part of Trumps long-standing goal to reduce prescription drug prices in the US. As the calendar turns toward November, the president has shifted to executive action over working with Congress to reach this objective.

Whether or not such action will result in any meaningful changes before the election remains to be seen, as thepharma industry continues to be a lobbying force on Capitol Hill. The executive orders are also likely to be challenged in court.

The most controversial order reportedlyattempts to cap some prices Medicare pays to the price in foreign countries, which are usually significantly lower. The text wasnt immediately available.

These most-favored nations clauses are akin to price controls in pharma circles, and Trump threatened drug companies by imposing this order within a month if the companies didnt lower prices on their own. How Trump can enact the clause without Congress remains unclear.

One of pharmas most influential lobbyist groups, PhRMA, unsurprisingly reacted negatively to the developments. Heres PhRMA president Stephen Ubl:

In his 2020 State of the Union Address, President Trump declared that we will never let socialism destroy American health care.

Yet, in the middle of a global pandemic, when nearly 145,000 Americans have lost their lives and millions of others have suffered untold economic hardships, this administration has decided to pursue a radical and dangerous policy to set prices based on rates paid in countries that he has labeled as socialist, which will harm patients today and into the future.

The research-based biopharmaceutical industry has been working around the clock to develop therapeutics and vaccines to treat and prevent COVID-19. The administrations proposal today is a reckless distraction that impedes our ability to respond to the current pandemic and those we could face in the future. It jeopardizes American leadership that rewards risk-taking and innovation and threatens the hope of patients who need better treatments and cures.

The presidents attempt to open our country up to socialized health care sets America, our economic recovery and scientific progress back at a time when we need them most.

BIOs chief Michelle McMurry-Heath also slammed the move, saying she was dumbfounded that the Trump administration would seek to cripple the industry trying to end the COVID-19 pandemic.

During the press conference Trump said top pharma executives will meet with administration officials next week.

A second order is an extension of a plan introduced late last year that would allow states, drug wholesalers and pharmacies to re-import drugs from Canada at a lower cost. Pharma lobbyists claim that such plans would not be able to guarantee the safety of the US drug supply chain, a stance that has been met with skepticism, while Canada isnt particularly interested in acting as a proxy between drug companies and states.

The other two orders target insulin pricing and the rebates drug wholesalers and pharmaceutical benefit managers receive when selling to insurers.

The lobbyist group PCMA has already come out in opposition to the latter measure, with president JC Scott saying in a statement, This policy does nothing to address drug prices, it only serves to create uncertainty and raise premiums for seniors while imposing nearly $400 billion in additional taxpayer costs, all at a time when taxpayers are already footing additional costs to counter the pandemic and the national debt is at record levels.

Drug prices have been a pet issue for Trump, and the president reportedly expressed his frustration with HHS secretary Alex Azar in January saying the Democratic Party will kill us on the issue. The COVID-19 pandemic has further complicated the issue, as Trumps approval regarding how hes handling the coronavirus is deep in the red, and the White House has been funneling cash into the industry to fuel the research and development of potential vaccines.

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Trump looks to hammer down drug prices with 4 executive orders - Endpoints News

Stem Cell Assay Market Growth, Size, Analysis, Outlook by 2020 Opportunities and Forecast to 2027 – Market Research Posts

Stem Cell Assay Market Report is an objective and comprehensive study of the current state expected at the major drivers, market strategies, and key vendors growth. The study also includes the important achievements of the market, Research & development and regional growth of the leading competitors operating in the market.

This report also explain the numerous factors that form a significant element of the market. It includes the definition and the scope of the market with a detailed explanation of the market drivers, opportunities, restraints, and threats.

Get Sample Report (including full TOC, Tables and Figures): https://www.coherentmarketinsights.com/insight/request-sample/1632

Leading players of Stem Cell Assay Market:

Merck & Co., Thermo Fisher Scientific, GE Healthcare, Agilent Technologies, Bio-Rad Laboratories, Promega Corporation, Cell Biolabs, PerkinElmer, Miltenyi Biotec, HemoGenix, Bio-Techne Corporation, STEMCELL Technologies, and Cellular Dynamics International.

Stem Cell Assay Geographical Segmentation Includes:

North America (U.S., Canada, Mexico)

Europe (U.K., France, Germany, Spain, Italy, Central & Eastern Europe, CIS)

Asia Pacific (China, Japan, South Korea, ASEAN, India, Rest of Asia Pacific)

Latin America (Brazil, Rest of L.A.)

Middle East and Africa (Turkey, GCC)

The research report includes an exploration of the competitive landscape present in the Stem Cell Assay Market. It includes an import of the current and future trends that players can invest in. Likewise, it also includes an estimation of the business outlooks of the players and explains the nature of the competition.

Stem Cell Assay Market Segmentation

By Product Type-InstrumentsReagents & KitsBy Cell Type Adult Stem CellsInduced Pluripotent Stem CellsMesenchymal Stem CellsNeural Stem CellsHematopoietic Stem CellsUmbilical Cord Stem CellsHuman Embryonic Stem CellsBy Process Cell CultureEngineeringDifferentiationCharacterizationOthersBy Application -ResearchDrug Discovery & DevelopmentRegenerative Medicine

The plus point of this research study is that it includes the impact of COVID-19 to the Stem Cell Assay market. The data summarized within this research study includes forecast from 2020 to 2027. COVID-19 has significantly impacted each and every market on the global platform. If you have any specific requirement then Please get in touch with us. Our Expert team will provide as per report customized to your requirement.

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Important Features of the report:

Reasons for buying this report:

It offers the regional analysis of the Stem Cell Assay Market along with the business profiles of several stakeholders.

Some Major TOC Points:

Chapter 1. Stem Cell Assay Market Report Overview

Chapter 2. Stem Cell Assay industry Growing Trends

Chapter 3. Market Share by Key vendors

Chapter 4. Stem Cell Assay Market Breakdown Data by Type and Application

Chapter 5. Stem Cell Assay Market by End Users/Application

Chapter 6. COVID-19 Outbreak: Stem Cell Assay Industry Impact

Chapter 7. Opportunity Analysis in Covid-19 Crisis

Chapter 9. Market Driving Factors

And Many More

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Thanks for reading this article, you can also get individual chapter wise section or region wise report version like North America, LATAM, West Europe, MENA Countries, Southeast Asia or Asia Pacific.

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Iterion Therapeutics Initiates Enrollment of Phase 2a Dose Expansion Study of Tegavivint in Patients with Desmoid Tumors – BioSpace

HOUSTON, July 28, 2020 /PRNewswire/ --Iterion Therapeutics, Inc., a venture-backed, clinical stage biotechnology company developing novel cancer therapeutics, announced today that enrollment has commenced in its multicenter Phase 2a dose expansion clinical study of Tegavivint, a novel, potent and selective nuclear -catenin inhibitor, in patients with desmoid tumors. The Phase 2a trial builds on a recently completed open-label, non-randomized Phase 1 study that established safety and initial clinical efficacy of Tegavivint in patients with progressive desmoid tumors.

Nuclear -catenin is a highly-studied oncology target associated with numerous cancer types. Tegavivint is unique among nuclear -catenin inhibitors in that it binds to TBL1 (Transducin eta-like Protein One), a novel downstream target in the Wnt-signaling pathway. As such, Tegavivint enables silencing of Wnt-pathway gene expression without affecting other Wnt/-catenin functions in the cell membrane, thus avoiding toxicity issues common to other drugs in this pathway.

Desmoid tumors are rare, non- metastasizing sarcomas that overexpress nuclear -catenin. An estimated 1,500 patients in the US are newly diagnosed with desmoid tumors each year. Desmoids are most commonly diagnosed in young adults between 30-40 years of age and are associated with significant morbidities, including severe pain, disfigurement, internal bleeding and organ damage, range of motion loss and, in rare cases, death. Iterion has received Orphan Drug Designation for Tegavivint to treat desmoid tumors, a disease for which there are no FDA approved therapies.

"We are very pleased to advance the clinical development of Tegavivint in desmoid tumors as this disease target is greatly underserved and provides an optimal indication for demonstrating the drug's safety and potential clinical utility in multiple cancer settings," said Rahul Aras, CEO of Iterion. "Desmoid tumors are driven primarily by nuclear -catenin signaling, a historically 'undruggable' oncology target implicated in cell proliferation, differentiation and immune evasion. Efforts to develop inhibitors of -catenin through drugging upstream targets in the Wnt-signaling pathway have been plagued by toxicity issues, greatly limiting their therapeutic use. Research suggests that these toxicity concerns can be negated by targeting TBL1, a novel downstream target necessary for -catenin's oncogenic activity. Our development plan for Tegavivint is to advance its development in desmoid tumors as a launching point for additional programs in acute myeloid leukemia, non-small cell lung cancer, and certain pediatric cancers for which nuclear -catenin signaling has been identified as a potential therapeutic target."

The Phase 2a trial in desmoid tumors is expected to enroll up to 25 patients who will be treated with the recommended Phase 2 Dose (RP2D), which was established based on pharmacokinetic exposure levels and clinical responses in the recently completed Phase 1 study.

In addition to desmoid tumors, Iterion is preparing to initiate clinical programs to investigate Tegavivint in acute myeloid leukemia (AML), non-small cell lung cancer (NSCLC), and pediatric cancers, including sarcomas, lymphoma and other solid tumors. These cancers are often characterized by nuclear -catenin overexpression, providing potential high-value target expansions for Tegavivint. The RP2D established in the desmoid tumor program is expected to be utilized in the planning and execution of the clinical trials in these additional indications, offering the potential to expedite the advancement of the individual clinical studies.

About Iterion Therapeutics Iterion Therapeutics is a venture-backed, clinical stage biotechnology company developing novel cancer therapeutics. The company's lead product, Tegavivint, is a potent and selective inhibitor of nuclear -catenin, a historically "undruggable" oncology target implicated in cell proliferation, differentiation, immune evasion and stem cell renewal. Research demonstrating potent anti-tumor activity in a broad range of pre-clinical models indicate that Tegavivint has the potential for clinical utility in multiple cancer types. Tegavivint is currently the subject of a Phase 2a clinical trial in patients with progressive desmoid tumors. Iterion is also pursuing clinical programs in additional cancers where nuclear -catenin signaling has been shown to play a role, including acute myeloid leukemia (AML), non-small cell lung cancer (NSCLC), and pediatric cancers, including sarcomas, lymphoma and other solid tumors. This research/clinical trial was supported with a $15.9 million grant from the Cancer Prevention & Research Institute of Texas. For more information on Iterion, please visit https://iteriontherapeutics.com.

Tiberend Strategic Advisors, Inc. Ingrid Mezo (Media) 646-604-5150 imezo@tiberend.com

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SOURCE Iterion Therapeutics

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Iterion Therapeutics Initiates Enrollment of Phase 2a Dose Expansion Study of Tegavivint in Patients with Desmoid Tumors - BioSpace

Unproven ‘stem cell’ therapies for COVID-19 pose harm to public, says UB expert – UB Now: News and views for UB faculty and staff – University at…

Be wary of stem cell therapy as a preventative treatment for COVID-19, warns Laertis Ikonomou, a UB expert on stem cell and gene therapies.

While stem cell therapy, such as bone marrow transplantation, may be used to treat a limited number of diseases and conditions, there are currently no clinically tested or government-approved cell therapies available for the treatment or prevention of COVID-19, says Ikonomou, associate professor of oral biology in the School of Dental Medicine.

He urges the public to exercise caution as the nation experiences a rise in businesses offering direct-to-consumer, unproven and unsafe stem cell therapies that promise to prevent COVID-19 by strengthening the immune system or improving overall health.

What these patients are actually sold is false hope, he says. These businesses are continuously transforming and reinventing themselves, but the common thread is that they offer potentially dangerous treatments based on unproven science.

Ikonomou is also the chair of the International Society for Cell and Gene Therapy (ISCT) Presidential Task Force on the Use of Unproven and/or Unethical Cell and Gene Therapy.

Stem cell therapy involves the conversion of stem cells into specific types of cells, such as heart or blood cells. These cells are then transplanted into a patient to promote healing.

While there are companies that carefully develop cell-based treatments following established regulatory and ethical standards, there has also been an explosion of businesses since the mid-2000s that advertise directly to consumers and evade regulations to provide unsafe and ineffective treatments, he says.

These businesses operate in gray regulatory areas, frequently branding stem cell therapies as medical interventions rather than therapeutic drugs to avoid the need for U.S. Food and Drug Administration (FDA) approval, Ikonomou says, adding that according to published research, there are more than 1,000 of these unsafe businesses in the U.S.

They offer purported stem cell therapies for nearly every condition imaginable, from diabetes and autism to Alzheimers disease. There are also reports of people suffering physical harm including blindness and death from unsafe stem cell interventions, such as drawing and reinjecting patients with their own fat cells, he says.

Im not surprised that a lot of these businesses went into COVID treatments, says Ikonomou. They went where the money is and took advantage of peoples fears.

The treatments range in price from a few thousand to tens of thousands of dollars, and often patients are encouraged to receive the expensive infusions every few months. Many people go into severe debt to acquire these ineffective treatments, he says.

This year, the FDA has issued several letters to offending businesses, including those advertising cell therapies for COVID-19, says Ikonomou. The Federal Trade Commission has also cracked down on misleading advertising from stem cell therapy clinics, he says.

However, many of these clinics are small and difficult to track. Patient prudence is key to avoiding harmful interventions, he says.

Ikonomou shares a list of steps the public can take to ensure a stem cell therapy is safe, proven and ethical.

Ikonomou also urges patients to share any questions they have with their physicians, who often are the gatekeepers for medical treatment. His best advice to patients: If something sounds too good to be true, it probably isnt true.

For information on safe and ethical cell therapies, visit the ISCT website.

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Unproven 'stem cell' therapies for COVID-19 pose harm to public, says UB expert - UB Now: News and views for UB faculty and staff - University at...

Gilead’s Kite snares a landmark FDA OK on a $373000 CAR-T therapy which comes with bragging rights to the first true franchise op – Endpoints News

Bob Nelsen had been quietly wondering how to eradicate viruses for years, before one day in 2015, he welcomed a pair of immunologists into the ARCH Venture Partners offices on the 34th floor of Seattles Wells Fargo Building.

Louis Picker and Klaus Frh, professors at Oregon Health & Science University, had by then spent 5 years running around the country in search of funding for their startup, TomegaVax, and Frh, at least, was nearing wits end. The Gates Foundation was interested but told them they needed other investors. Investors told them to come back with more data, pharmaceutical executives said theyre in the wrong game too little money to be made fighting infectious disease. Still, a well-connected board member named Bob More landed them a meeting with the coveted venture capitalist, and so, in a narrow conference room overlooking the Puget Sound, Picker prepared to again explain the idea he had spent 15 years on: re-engineering a benign microbe into the first vaccines for HIV and better ones for hepatitis and tuberculosis.

This lightbulb went on his head, Picker recalled in a recent interview. Most of them just didnt get it. And Bobs hit.

By that point, Nelsen was more than just a venture capitalist. Scraggly and greying but no less opinionated at 52, he was mobbed at biotech conferences, having earned a reputation for crass wisdom and uncanny foresight, for making big bets on big ideas that changed medicine. Those ideas included DNA sequencing, which he first cut a check for in the 90s, and leveraging the immune system to tackle cancer. He earned millions making billion-dollar companies.

Yet for years he had harbored an almost singular obsession: I hate viruses, he told Forbes in 2016. He told me he was pissed off at them. The obsession drove him to his first biotech investment in 1993, for an inhalable flu vaccine approved a decade later and still in use. And it drove him to invest in CAR-T as a potential cure for HIV, years before it proved a wildly effective treatment for some cancers.

Now, listening to Picker talk about T cells and antibodies and the curious biology of cytomegalovirus, Nelsen began wondering if it was time for another bet. Pickers technology was not only promising, he reasoned, it could be the basis of a company that changed how researchers approached viruses. Instead of trying to come up with an antidote for every pathogen, you could do what cancer researchers had learned to do, and harness the immune system to do the work for you.

This wasnt a popular opinion at the time. Its like the least trendy idea in the world, Nelsen told me. People would say, Why the hell are you going into infectious disease?

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Gilead's Kite snares a landmark FDA OK on a $373000 CAR-T therapy which comes with bragging rights to the first true franchise op - Endpoints News

Fun facts about South Africa Here are 25 things you probably didnt know – The South African

We already love South Africa, but here are a few more reasons to be proud of the country. From medical breakthroughs and ecological wonders to industrial and cultural factoids, here are 25 things you may not have known about our beautiful corner of the globe.

South Africa is rich in remains and artefacts of early hominids. The Cradle of Humankind was declared as aWorld Heritage siteback in 1999. It currently occupies approximately 47 000 hectares of land.

In addition,UNESCO Fossil Hominids Siteslist five separate locations and traces archaeological evidence of human evolution back to least 2.5 million years ago. ,

Some countries have deserts or grasslands, other countries have wetlands or subtropical forests. But that is no match for the country we call home.

South Africa has a diverse range of biomes: from deserts, wetlands, grasslands and bush, to subtropical forests, mountains and escarpments. In addition, our climate is as varied as our biomes, ranging from desert to subtropical weather.

Our flora and fauna are also among the most biologically diverse in the world.

Dr Chris Barnard famouslyperformed the worlds first hearttransplant in 1967 on Louis Washkansky, who volunteered for the groundbreaking surgery.

The success of the first heart transplant turned Dr Barnard into somewhat of a celebrity on the international scene, and he performed ten more transplants throughout his career.

On 3 March 2019, Professor Mashudu Tshifularo became the first person to transplant 3D-printed bones for reconstructive middle ear implants, at the Steve Biko Academic Hospital.

Prof Tshifularo, who is the head of the Department of Ear, Nose, and Throat and Head and Neck Surgery at theOtorhinolaryngologyDepartment of theUniversity of Pretoria, developed the technology during his PhD studies.

The worlds firstdigital laserwasinvented by doctoral candidate, and CSIR researcher, Dr Sandile Nqcobo, and the former minister of Science and Technology cited it as a testimony to the calibre of scientists that South Africa has.

The laser is used in the health sector, and its numerous applications could also be used to improve the communication sector.

The scanner wascreated by Lodox Systems,a South African company that created the full-body scanner from technology that was initially designed for the security sector for the detection of stolen diamonds.

The use of the full-body scanner was written into the storyline of Greys Anatomy during the shows ninth season when the Grace Mercy West Hospital installed the scanner in their new ER department.

The CSIRs Gene Expression and Biophysics groupdesigned the first induced pluripotent stem cells in Africa, which opened the door for researchers to investigate various diseases and cures.

Stem cells could be used to restore sight or repair cells affected by heart disease, amongst other things. The possibilities are endless and are still being explored.

We sure do like our booze, that is no secret. One just has to look at the uproar generated by the recent alcohol bans in South Africa amid the COVID-19 pandemic and subsequent lockdowns.

But did you know that SAs brewery, SABMiller ranks, by volume, as the largest brewing company in the world? Approximately 50% of SABs production ships off to supply Chinas beer market.

Nearly three decades after the Cold War ended, there are still about 23 000 nuclear warheads in the world. South Africas nuclear weapons programme was established in 1967.

From the late sixties to the late eighties, South Africa researchedweapons of mass destruction, including nuclear, biological and chemical weapons. The nuclear weapons programme came to an end in 1989.

However, South Africa is the first and only country in the world to have built nuclear weapons and then voluntarily dismantle its entire nuclear weapons programme.

According to Statista, South Africa is the largest producer of platinum in the world by a significant margin, with a production of between 94 and 130 metric tons each year from 2010 to 2019.

In 2014 South Africa produced approximately 110 000kg, which is more than four times the amount of the worlds second-biggest producer, Russia. The latter produced between 23 metric tons and 22 metric tons each year between 2010 and 2018.

On 25 January 1905, the Cullinan diamond was found in the Premier Mine in Pretoria, South Africa. At 603 grams (or 1.33 pounds) it was the largest diamond in the world.

The 3 106-carat stone was later cut into nine large pieces and about 100 smaller ones. The largest of the nine, the Cullinan I or Great Star of Africa, was an impressive 530.2 carats. It is currently in the Queen of Englands Sceptre. And the rest?

Until 2019, South Africa was the only country in theworld to have hosted the Soccer, Cricket and Rugby World Cup. England joined us in the ranks last year, and is also the only country to have won all three World Cups.

Nowhere else in the world will you find that two Nobel Peace Prize laureates lived on the same street. Both Nelson Mandela and Archbishop Desmond Tutu lived onVilakazi Streetin the Orlando West township in Soweto.

Desmond Tutu was awarded the Nobel Peace Prize in 1984 for his nonviolent opposition to apartheid, followed by Nelson Mandelas shared Nobel Peace Prize in 1993 with F.W. de Klerk, for their role in the peaceful end of apartheid.

Table Mountain in Cape Town is one of the oldest mountains in the world, just over 260 million years to be exact. It also has more than 2 200 species of plants and approximately 900 different routes to climb or hike.

Lets put that in perspective: Table mountain alone has more plant species than the entire United Kingdom. In addition, the Cape Floral Region represents less than 0.5% of the area of Africa, but is home to 20% of the continents flora.

Each of the eight UNESCO World Heritage Sites in South Africa reflects an important aspect of its cultural and natural landscape. Thesitesinclude cultural treasures such as hominid fossils, the earliest indigenous kingdom of South Africa, the cave paintings of the San people.

In addition, it also includes the traditional use of the land by the Nama and the prison that housed political prisoners, including Nelson Mandela. Other sites protect the natural uniqueness of South Africa from the Cape Floral Region and the iSimangaliso Wetlands to the Vredefort Dome.

Speaking of UNESCO World Heritage sites, South Africa is home to the oldest meteor scar in the world the Vredefort Dome in Parys. A meteor the size of a mountain fell to Earth around 2 030 million years ago.

The 10km-wide meteor left a crater 300km across and is the oldest crater made by either a comet or meteorite. Its also reportedly the site of the largest energy release in history.

Despite a recent Australian discovery, we can still claim the largest visible crater in the world. In 2015, scientists found a bigger crater measuring 400km wide underground in the Australian outback.

South Africas Cape Winelands is the worlds longest wine route, with a meandering road spanning 850 kilometres. Route 62 runs between Cape Town, Constantia to Port Elizabeth, via Oudtshoorn and the Garden Route, passing by 200 cellars and kilometres of vines.

The hunter-gather Sans and pastoral Khoi become known as the KhoiSan and lived in what is present-day Western Cape around 300AD. Zulu and Xhosa tribes established large kingdoms in the region during the 15th century.

The South African fish migration is so huge it can be seen from space between May and July every year. Millions of small silver fish travel in vast shoals from the cold waters off South Africas Cape Point up to the coastlines of the northern Eastern Cape and southern KwaZulu-Natal.

This annual event is known as the Sardine Run. The shoals are so big 15km long, 3.5km wide and up to 40m deep they can be seen by satellite. In their wake come hundreds of birds, sharks, whales, dolphins, all eager to catch a bite.

The Karoo region in the Western Cape is home to some of the bestfossils of early dinosaurs. In fact, it is estimated that some 80% of the mammalian fossils found to date were found in the Karoo.

The University of South Africa (Unisa) which was founded in 1873 as the University of the Cape of Good Hope is the largest correspondence university in the world.

Unisa became the first public university in the world to teach exclusively by means of distance education in 1946. Today, the university has more than 400 000 students from 130 countries.

Adrenaline junkies will be eager to fling themselves off the worlds highest commercial bridge bungee in the world at Bloukrans Bridge in the Tsitsikamma region between the Eastern and Western Cape.

At a dizzying 216 metres high, the popular jump sees thrill-seekers plunge towards the Bloukrans River below before bouncing to a stop.

For centuries, the South African coastline has claimed the lives of thousands of sailors. Today, all shipwrecks are protected under South African law. A list of the shipwrecks along the coast can be viewed here.

In 2006, South Africa became the first African country and the fifth country in the world to recognise same-sex marriage. The prohibiting of discrimination based on sexual orientation is even written into their constitution.

Cape Town is also referred to as the Gay Capital of the World.

A segment of the infamous Berlin Wall, which was torn down in November 1989, was gifted to our late president Nelson Mandela following his visit to Berlin in 1996. Today, this piece of history sits atop the St Georges Mall outside Mandela Rhodes Place.

Not only is South Africa a prime film destination, but we also have the second oldest film industry in the world. The firstfilmstudio inSouth Africa, KillarneyFilmStudios, wasestablishedin 1915 in Johannesburg; Hollywood was founded in 1903.

Some of the most famous Hollywood movies shot in South Africa include Avengers: Age of Ultron, Mandela: Long Walk to Freedom, Safe House, District 9, Blood Diamond, Homeland, Outlander, Resident Evil: The Last Chapter, The Dark Tower, Black Sails, The Maze Runner: The Death Cure and Tomb Raider.

The AngloGold Ashantis Mponeng gold mine near Johannesburg is the deepest gold mine in the world. It takes more than an hour to travel from the surface right down to the bottom.

The temperature of the rock so deep down gets very hot and the air in the tunnels is cooled by pumping slurry ice into the depths.

South Africa has 12 official languages: English, Afrikaans, isiZulu, isiXhosa, Sesotho, Setswana, Sepedi, Xitsonga, siSwati, isiNdebele, Tshivenda, and Sign Language, whichwas officially recognised as a homelanguagein 2018.

As per the 2011 census, 22.7% of South Africans speak isiZulu as their native language, making it the most commonly spoken language. English is the most common language used in business.

The only other country with more languages than South Africa is India with 18 official languages. However, each language is recognised as the official language of a certain area, and not the country as a whole.

South Africa is the only country in the world with three capitals, and no, Pretoria is not the capital. Pretoria is the administrative capital while Cape Town is the legislative capital and Bloemfontein the judicial capital.

The only city specified in the Constitution of South Africa is Cape Town, the seat of Parliament. Most foreign embassies are in Pretoria, but many countries also have consulates in the other cities.

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Fun facts about South Africa Here are 25 things you probably didnt know - The South African