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Stem Cell Research on the Ballot: A Closer Look at Prop 14 – Fullerton Observer

Posted: October 15, 2020 at 11:57 pm

Californians are voting on a number of propositions that deal with a wide variety of issues this election season. Heres a closer look at Proposition 14, which deals with stem cell research. This is a summary of information taken from the official California voters guide and the website Ballotpedia.

Prop 14: Authorizes Bonds Continuing Stem Cell Research. Initiative Statute.

This ballot initiative would issue $5.5 billion in general obligation bonds for the California Institute for Regenerative Medicine (CIRM), which was created to fund stem cell research. In 2004, voters approved Proposition 71, which created CIRM, issued $3.00 billion in bonds to finance CIRM, and established a State constitutional right to conduct stem cell research.

As of October 2019, CIRM had $132 million in funds remaining. On July 1, 2019, CIRM suspended applications for new projects due to depleted funds.

This ballot initiative would require CIRM to spend no more than 7.5% of the bond funds on operation costs. The remaining bond funds would be spent on grants to entities that conduct research, trials, and programs related to stem cells, as well as start-up costs for facilities.

Dedicates $1.5 billion to research and therapy for Alzheimers, Parkinsons, stroke, epilepsy, and other brain and central nervous system diseases and conditions.

An Independent Citizens Oversight Committee (ICOC) is responsible for governing CIRM.

Arguments in Favor

Nearly half of all California families include a child or adult with medical conditions who could benefit from stem cell research, treatments, and cures.

Prop 14 provides continued funding to develop treatments, advance clinical trials, and achieve new scientific breakthroughs for Californias patients with Cancer, Diabetes, Heart Disease, Alzheimers, Parkinsons, HIV/AIDS, ALS, MS, Sickle Cell Disease, Lung Diseases, Kidney Disease, Bubble Baby Disease, Age-Related Blindness and Genetic Blindness, Epilepsy, Stroke, Schizophrenia, Autism, other Mental Health and Brain Conditions, and Infectious Diseases like COVID-19.

Californias original stem cell funding, which runs out this year, has already led to significant progress in the development of treatments and cures, including 92 FDA-approved clinical trials for chronic disease and injuries, over 2,900 medical discoveries, and demonstrated benefits for patients and research on chronic diseases including Cancer, Diabetes, Heart Conditions, Blindness, HIV/AIDS, ALS, Children with Immune Deficiencies, Paralysis, and Kidney Disease.

New revenues, economic activity and jobs are generated by this funding that will contribute to Californias economic recovery.

Chronic diseases, conditions and injuries are cutting lives short and costing Californians billions in healthcare costs. We must continue our investment, developing stem cell treatments to improve the health and reduce the suffering of millions of Californians.

Arguments Against

We cant afford to waste billions. In the middle of an economic crisis, with soaring unemployment and budget shortfalls in the tens of billions of dollars, we dont have money to burn.

And thats on top of the nearly $3 billion this troubled State agency has spent over the past 15 yearswith poor results. After an extensive analysis of spending by the State agency handing out billions in grants, the San Francisco Chronicle concluded that, The predicted financial windfall has not materialized. Only a few federally approved therapies have resulted.

Prop 14 funds a bureaucracy with serious problems. Some have questioned the integrity and independence of the State agency overseeing these funds.

Others can do this job better. The National Institute of Health provides $1.5 billion a year in grants to fund the same type of research. Private investors and companies, including many in California, have made great strides in using stem cells to cure diseasesusing private funds, not tax dollars.

Paying back Prop 14s costs of $7.8 billion could mean huge tax increases at a time when our economy is on its knees. Or laying off thousands of nurses and other heroes who do the real work of keeping California healthy.

Groups supporting Prop 14 include:

California Democratic Party

JDRF (Juvenile Diabetes Research Foundation)

University of California Board of Regents

Top donors to Yes on 14:

Robert N. Klein II ($3,625,000)

Dagmar Dolby ($2,059,000)

Juvenile Diabetes Research Foundation ($1,750,000)

Open Philanthropy Action Fund ($580,000)

Ann S. Tsukamoto ($500,000)

Groups opposed to Prop 14 include:

Editorial boards of The Orange County Register, The Bakersfield Californian, Mercury News & East Bay Times, San Francisco Chronicle, and Los Angeles Times

Top donors to No on 14:

None reported

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Sorrento Adds Mesenchymal Stem Cell Program (MSC) That Has Been Cleared for a Phase 1 Trial by the FDA to the Pipeline of COVID-19 Focused Rescue…

Posted: October 15, 2020 at 11:57 pm

SAN DIEGO, Oct. 12, 2020 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") announced today that it has entered into an exclusive license agreement with Personalized Stem Cells, Inc. (PSC) to acquire global rights to its adipose derived mesenchymal stem cells (MSCs) for patients suffering from acute respiratory distress syndrome (ARDS) associated with COVID-19, which have been cleared for a Phase 1 clinical trial by the FDA.

The study is a single arm, non-randomized Phase 1 study of the safety and preliminary efficacy of an adipose-derived allogeneic MSC product candidate. The outcome data will be compared to contemporaneous non-enrolled patients at the same clinical site(s) as the enrolled patients. The primary objective is to evaluate the safety of intravenous infusion of allogeneic adipose stem cells in patients with COVID-19 and in respiratory distress. The secondary objective is to evaluate a set of safety and efficacy outcome variables to give guidance regarding the risk/benefit ratio in patients with COVID-19 respiratory distress.

More information on the Phase 1 trial can be found at:

https://clinicaltrials.gov/ct2/show/NCT04486001?term=coronastem&draw=2&rank=1

Sorrento will be assuming responsibility for executing the Phase 1 trial, which is targeted to enroll about 20 hospitalized COVID-19 patients in California. Pending the results of the Phase 1 trial, Sorrento expects to expand into Phase 2 trials in multiple relevant geographies as may be determined in consultation with applicable regulatory authorities.

Stem cells have been demonstrated to support resolution of symptoms in multiple disease settings and have the potential to reduce the long-term effects associated with pulmonary tissue damage for these patients. More information on the potential use and benefits of MSCs for patients with COVID-19 can be found in the recently published review at:

https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-020-02380-2

Stem cells represent a treatment modality with high potential to help in the fight against COVID-19 as a stand-alone therapy or in synergy with other product candidates in Sorrentos pipeline, including small molecules (abivertinib or salicyn-30) and neutralizing antibodies (STI-1499 or STI 2020).

Until a time where early treatments are more readily available, it is important to provide patients severely afflicted with COVID-19 multimodal solutions that can help increase survival, reduce the time spent in the hospital and reduce long-term sequelae. The long-term lingering effects of COVID-19 on the body can persist for months after patients leave the hospital, especially for patients that received ventilator support. Shortness of breath, difficulty doing simple tasks and pulmonary fibrosis are among the common complaints of long-term effects of the disease on COVID-19 patients leaving the ICU.

Dr. Robert Harman, CEO of PSC stated, We are delighted to be working with a company such as Sorrento, that has the vision and expertise to take our program through the next steps in the clinical development process. Sorrento saw the translational value of our decades of work in animal health and has acknowledged the extensive manufacturing and regulatory work we have done in bringing human cell lines to a Phase 1 FDA clearance. We are looking forward to collaborating on this initiative and beyond.

Dr. Henry Ji, Chairman and CEO of Sorrento stated, Stem cells were a missing piece in our comprehensive portfolio of potential solutions against COVID-19. We now cover multiple stages of the continuum of care from prevention to potential therapeutic solutions for the most advanced stages of the disease. With PSCs Phase 1 product candidate, we hope to move quickly through the next clinical trials, and, if successful, be able to provide a supportive therapy that may save the lives of the most advanced patients and may also ensure patients who have to undergo intensive care can benefit from a therapy with the potential to minimize the long-term effects of the disease due to the lung damage created by the virus early in the infection.

About Sorrento Therapeutics, Inc.

Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to treat cancers and COVID-19. Sorrentos multimodal, multipronged approach to fighting cancer is made possible by its extensive immuno-oncology platforms, including key assets such as fully human antibodies (G-MAB library), clinical stage immuno-cellular therapies (CAR-T, DAR-T), antibody-drug conjugates (ADCs), and clinical stage oncolytic virus (Seprehvir, Seprehvec). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including COVIDTRAP, ACE-MAB, COVI-MAB, COVI-GUARD, COVI-SHIELD, COVI-AMG and T-VIVA-19; and diagnostic test solutions, including COVI-TRACK, COVI-STIX and COVI-TRACE.

Sorrentos commitment to life-enhancing therapies for patients is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule, resiniferatoxin (RTX), and ZTlido (lidocaine topical system) 1.8% for the treatment of post-herpetic neuralgia. RTX has completed a phase IB trial for intractable pain associated with cancer and a phase 1B trial in osteoarthritis patients. ZTlido was approved by the FDA on February 28, 2018.

For more information visit http://www.sorrentotherapeutics.com

Forward-Looking Statements

This press release and any statements made for and during any presentation or meeting contain forward-looking statements related to Sorrento Therapeutics, Inc., under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding the safety and efficacy of an adipose-derived allogeneic MSC product in patients with COVID-19 and in respiratory distress; the clinical testing of an adipose-derived allogeneic MSC product; the expected enrollment of the Phase 1 trial; the potential commencement of any future clinical trials for an adipose-derived allogeneic MSC product; the ability of an adipose-derived allogeneic MSC product to work as a stand-alone therapy or in synergy with our other product candidates; the ability of an adipose-derived allogeneic MSC product to support healing and reduce the long-term effects associated with pulmonary tissue damage for COVID-19 patients; our ability to provide a supportive therapy for COVID-19 patents using an adipose-derived allogeneic MSC product; the ability of an adipose-derived allogeneic MSC product to potentially save lives of COVID-19 patients and to potentially minimize the long-term effects of COVID-19; our ability to cover all stages of the continuum of care for COVID-19; and our potential position in the antiviral industry. Risks and uncertainties that could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: risks related to Sorrento's and its subsidiaries', affiliates and partners technologies and prospects and collaborations with partners, including, but not limited to risks related to seeking regulatory approval for any adipose-derived allogeneic MSC product; clinical development risks, including risks in the progress, timing, cost, and results of clinical trials and product development programs; risk of difficulties or delays in obtaining regulatory approvals; risks that clinical study results may not meet any or all endpoints of a clinical study and that any data generated from such studies may not support a regulatory submission or approval; risks that prior test, study and trial results may not be replicated in future studies and trials; risks of manufacturing and supplying drug product; risks related to leveraging the expertise of its employees, subsidiaries, affiliates and partners to assist Sorrento in the execution of its COVID-19 therapeutic product candidate strategies; risks related to the global impact of COVID-19; and other risks that are described in Sorrento's most recent periodic reports filed with the Securities and Exchange Commission, including Sorrento's Annual Report on Form 10-K for the year ended December 31, 2019, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press release except as required by law.

Media and Investor Relations

Alexis Nahama, DVM (SVP Corporate Development)

Telephone: 1.858.203.4120

Email: mediarelations@sorrentotherapeutics.com

Sorrento and the Sorrento logo are registered trademarks of Sorrento Therapeutics, Inc.G-MAB, COVI-GUARDTM, COVI-SHIELD, COVI-AMG, COVIDTRAP, T-VIVA-19, COVI-MAB, ACE-MAB, COVI-TRACK, COVI-STIX and COVI-TRACE are trademarks of Sorrento Therapeutics, Inc.

ZTlido is a trademark owned by Scilex Pharmaceuticals Inc.All other trademarks are the property of their respective owners. 2020 Sorrento Therapeutics, Inc. All Rights Reserved.

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Was Trump’s Regeneron ‘Cure’ Developed Using Stem Cells and Fetal Tissues? – Snopes.com

Posted: October 15, 2020 at 11:57 pm

As governments fight the COVID-19 pandemic, Snopes is fighting an infodemic of rumors and misinformation, and you can help. Read our coronavirus fact checks. Submit any questionable rumors and advice you encounter. Become a Founding Member to help us hire more fact-checkers. And, please, follow the CDC or WHO for guidance on protecting your community from the disease.

As the world raced to find a treatment that would alleviate the global pressure of the coronavirus pandemic, U.S. President Donald Trump contracted the virus in early October 2020 and developed COVID-19, the respiratory disease caused by SARS-CoV-2. In the days following his diagnosis and public release from Walter Reed Hospital, where he received world-class treatment, Trump touted the powers of a miracle drug called Regeneron, which he promised to make available to the American people.

A video shared in tweet by the president on Oct. 7 claimed that Regeneron was a cure.

I spent four days there [at Walter Reed] and I went in, I wasnt feeling so hot. And within a very short period of time, they gave me Regeneron. Its called Regeneron. And other things too but I think this was the key. But they gave me Regeneron, and it was like, unbelievable. I felt good immediately. I felt as good three days ago as I do now.

So, I just want to say, we have Regeneron. We have a very similar drug from Eli Lilly, and theyre coming out and were trying to get them on an emergency basis. Weve authorized it. Ive authorized it. And if youre in the hospital and youre feeling really bad, I think were going to work it so that you get them and youre going to get them free.

Shortly after the president praised what he deemed a cure for his COVID-19 infection, some social media users pushed the claim that the drug Trump was given was developed using fetal tissue a practice in direct conflict with the administrations pro-life platform.

To clarify, Trump was treated with REGN-COV2, a novel anti-viral antibody cocktail created by Regeneron Pharmaceuticals, a New York-based company that has openly stated it uses stem cell and fetal tissues as part of its research and development on new pharmaceutical treatments. This knowledge, and open support from a pro-life president, incited social media pushback from users who argued that the companys use of stem cells and fetal tissues for scientific research goes against pro-life platforms and policies.

REGN-COV2 is a combination of two human-made proteins, or monoclonal antibodies, known as REGN10933 and REGN10987. These two monoclonal antibodies were specifically designed to block the ability of SARs-CoV-2 to infect human cells. The biotechnology company further went on to describe the development of REGN-COV2 as follows:

To develop REGN-COV2, Regeneron scientists evaluated thousands of fully-human antibodies produced by the companys VelocImmune mice, which have been genetically modified to have a human immune system, as well as antibodies identified from humans who have recovered from COVID-19. The two potent, virus-neutralizing antibodies that form REGN-COV2 bind non-competitively to the critical receptor binding domain of the viruss spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population.

While it is true that Regeneron has used stem cells for some of its research, no human stem cells or human embryonic stem cells were used in the development of REGN-COV2, according to Alexandria Bowie, a spokesperson for the company. An April 2020 statement issued by Regeneron confirmed that research using stem cells helps its scientists model complex diseases, test new drug candidates, and lead to scientific insights that may help spur the creation of new medicines but the company contends that embryonic cells were not used in the production of REGN-CO2.

In short: we did not use human stem cells or human embryonic stem cells in the development of REGN-COV2, Bowie told Snopes in an email.

But its not quite that cut and dried.

In the research and development of pharmaceutical therapeutics, many companies turn to what is known as a cell line. These are cultures of human or animal cells that are derived from a living organism and cultured and propagated repeatedly, and, in some cases, used indefinitely. The development of REGN-COV2 utilized HEK293T a cell line that is derived from human fetal embryonic kidney tissues to create a pseudovirus that mimics a spike Protein found in SARS-CoV-2 in order to test the drugs ability to neutralize and ultimately treat the novel coronavirus.

HEK293s are considered immortalized cells (not stem cells) and are a common and widespread tool in research labs. This cell line was originally derived by adenovirus transformation of human embryonic kidney cells in 1977, explained Bowie, adding that HEK293 were further transformed at Stanford in the 1980s with SV40 large T antigen, a solution that is used by researchers to initiate and maintain DNA replication necessary for creating cell lines.

Fetal tissues were not directly used n the development of REGN-COV2, but cell lines from decades-old embryonic kidney tissues were. Fetal tissues are used to develop cell lines. Embryonic stem cells, on the other hand, are different than adult stem cells in that they are undifferentiated and regenerative cells, which means that they have not been assigned a key task in the human body. As such, researchers have uncovered ways to direct their use in creating human tissues that allow for a variety of uses, including testing new pharmaceuticals.

Opposition to the use of fetal tissue and embryonic stem cell research has been at the heart of the pro-life platform due to the way in which these cells are obtained and its association with using living fetuses either inside (in utero) or outside of the uterus (ex utero). Pro-life groups like March for Life have even gone so far as to pressure the Trump administration to halt funding for research that requires aborted fetal organs and tissues. In summer 2019, the president required any federally funded research using fetal tissue to undergo an ethics review, and has since stocked his cabinet with other similarly-minded officials.

REGN-COV2 is currently in late-stage clinical trials for various populations, including non-hospitalized and hospitalized patients as well as for the potential prevention in individuals who may have had close household exposure to COVID-19. According to a news release published on Sept. 29, the company announced that the antibody cocktail was shown to reduce the viral load and alleviate symptoms in non-hospitalized patients with COVID-19. REGN-COV2 also showed positive trends in reducing medical visits. However, it is important to note that the research included a relatively small sample size of just 275 patients.

The greatest treatment benefit was in patients who had not mounted their own effective immune response, suggesting that REGN-COV2 could provide a therapeutic substitute for the naturally-occurring immune response. These patients were less likely to clear the virus on their own and were at greater risk for prolonged symptoms, said Regeneron President and Chief Scientific Officer Dr. George D. Yancopoulos in a statement.

As of Oct. 12, Regeneron had submitted an emergency use authorization (EUA) to the U.S. Food and Drug Administration in early October, and noted REGN-COV2s early, promising clinical data paired with the continued, pressing unmet need of COVID-19 meets the FDA standard for emergency use authorization.

Regeneron told Snopes that it cant speculate on potential timing for an EUA. We will update when such is available.

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Vanderbilt researchers make counterintuitive discoveries about immune-like characteristics of cells, chemotherapys impact on tissue growth -…

Posted: October 15, 2020 at 11:57 pm

Vanderbilt University researchers have reported the counterintuitive discovery that certain chemotherapeutic agents used to treat tumors can have the opposite effect of tissue overgrowth in normal, intact mammary glands, epidermis and hair follicles. The researchers also are the first to report the discovery of an innate immune signaling pathway in fibroblaststhe spindle-shaped cells responsible for wound healing and collagen productionthat causes cells to proliferate. Such signaling pathways previously were attributed only to immune cells.

The article describing the research, DNA Damage Promotes Epithelial Hyperplasia and Fate Mis-specification via Fibroblast Inflammasome Activation, was published in the journal Developmental Cell on Oct. 13.

The findings of this work, led by postdoctoral fellow Lindsey Seldin and Professor and Chair of the Department of Cell and Developmental Biology Ian Macara, have broad implications for diseases associated with the immune system like psoriasis, as well as cancer and stem cell research.

Understanding the functionality of stem cells and the way that their behavior is regulated has been a longstanding research interest for Seldin. Normal stem cells have an amazing ability to continuously divide to maintain tissue function without forming tumors, she explained. We wanted to understand what happens to these cells in their native environment when subjected to damage, and if the response was connected to a specific tissue.

By testing perturbations to the epidermis, mammary gland and hair follicles vis--vis mechanical damage or DNA damage through chemotherapeutic agents, the researchers saw a paradoxical response: Stem cells, which otherwise would divide slowly, instead divided rapidly, promoting tissue overgrowth.

When the tissues were subjected to DNA damage, their stem cells overly proliferated, giving rise to different cells than they normally would. This was a very perplexing result, said Seldin, the papers lead author. We were determined to figure out if this was a direct response by the stem cells themselves or by inductive signals within their environment. The key clue was that stem cells isolated from the body did not behave the same way as in intact tissuean indication that the response must be provoked from signals being sent to the stem cells from other surrounding cell types.

The investigators turned their attention to fibroblasts, the predominant component of the tissue microenvironment. When fibroblasts in the epidermis were removed, the stem cell responsiveness to DNA damage was diminished, indicating that they played an important role. RNA sequencing revealed that fibroblasts can signal by way of inflammasomescomplexes within cells that help tissues respond to stress by clearing damaged cells or pathogens, which also in this case caused stem cells to divide. This is an astounding discovery, said Macara. Inflammasome signaling has previously been attributed only to immune cells, but now it seems that fibroblasts can assume an immune-like nature.

Seldin intends to replicate this work in the mammary gland to determine whether fibroblasts initiate the same innate immune response as in the epidermis, and more broadly how fibroblasts contribute to the development of cancer and other diseases associated with the immune system.

This work was supported by NCI/NIH grants R35CA132898, F32CA213794 and T32CA119925, as well as American Cancer Society grant PF-18-007-01-CCG.

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Biomedical Engineering Team Contributes to High-impact Study on Metabolism – University of Arkansas Newswire

Posted: October 15, 2020 at 11:57 pm

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An international team of researchers has published a study showing how the control of stem cell metabolism is critical to maintaining hair follicles. The study appeared in the high-impact journal Cell Metabolism.

University of Arkansas researchers included Kyle Quinn, associate professor of biomedical engineering, and Olivia Kolenc, a graduate student in Quinn's lab. The project was led by Sara Wickstrm, associate professor at the University of Helsinki, and included researchers from the research groups of Professor Sabine Eming at the University of Cologne and Martin Denzel at the Max Planck Institute for Biology of Ageing in Germany.

The team studied how the metabolism of stem cells in hair follicles is critical to the growth and long-term maintenance of hair. The follicles are unique in mammals because unlike most organs or tissues, they naturally regenerate and cycle through phases of rest, growth and degeneration. Those cycles are maintained by stem cells. Kolenc used advanced non-invasive skin imaging to monitor hair follicle metabolism in live mice.

Kolenc's work showed how the metabolism of stem cells changes as the follicle transitions to a growth phase, which provided a critical foundation to the study's larger goal of discovering the cell signaling pathways associated with the metabolic control of stem cell fate and hair follicle cycles.

The study provides insight into how our organs are maintained by stem cells and how aging can result in conditions such as hair loss. Kolenc said hair follicle stem cells aren't like some stem cells, which can transform into a wide variety of different cell types. Instead, she said, they can transform to match the surrounding area in the skin tissue.

"Hair follicle stem cells are able to differentiate into a subset of what's in their surrounding area," she said. "They can't just create any other cell, but they can contribute to regeneration and increasing the number of cells within the skin tissue."

Kolenc said hair follicle stem cells are unique among the cells in our skin because they can contribute to repair and regeneration of the skin.

"There are few populations of stem cells known to exist within the skin, so this is really a big target to help skin wound healing," she said.

Kolenc said the opportunity to contribute to such a large-scale project was special.

"It's a bit humbling," she said. "I contributed a small part to a large project that was conducted over many years. It's a cool feeling to see something like that with my name on it."

"Olivia played an important role in this study by monitoring hair follicle stem cells within their natural environment in live skin," Quinn said. "The insights she gained during this work will be very helpful as she continues studying how our metabolic imaging techniques can be applied to aging and wound healing research."

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Novellus Therapeutics Exclusively Licenses Induced Mesenchymal Stem Cells (iMSCs) to NoveCite for COVID-19 Related Acute Respiratory Distress Syndrome…

Posted: October 15, 2020 at 11:57 pm

Novellus Therapeutics Exclusively Licenses Induced Mesenchymal Stem Cells (iMSCs) to NoveCite

"Novellus's iMSCs have the potential to be a breakthrough in the field of cellular therapy for acute respiratory conditions because of their high potency as demonstrated in our pre-clinical studies, as well as our ability to cost-effectively provide high doses and repeat doses." said Myron Holubiak, CEO of Citius.

"We are excited to be developing iMSCs because of their promise to save lives and reduce long term sequelae in patients with devastating respiratory diseases such as ARDS caused by COVID-19," said Matt Angel, Chief Science Officer of Novellus. He continued, "Our iMSCs have multimodal immunomodulatory mechanisms of action that make them promising for treatment of acute respiratory diseases."

About Novellus Therapeutics LimitedNovellus is a pre-clinical stage biotechnology company developing engineered cellular medicines using its patented non-immunogenic mRNA, high-specificity gene editing, mutation-free & footprint-free cell reprogramming and serum-insensitive mRNA lipid delivery technologies. Novellus is privately held and is headquartered in Cambridge, MA. For more information, please visit http://www.novellustx.com.

About NoveCite, Inc.NoveCite, Inc. is a newly formed subsidiary of Citius Pharmaceuticals, a late-stage specialty pharmaceutical company dedicated to the development and commercialization of critical care products, with a focus on anti-infectives and cancer care. For more information, please visit http://www.citiuspharma.com.

Contact: [emailprotected]

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Black History Month The struggle to find a lifesaving stem cell donor – Keep the Faith

Posted: October 15, 2020 at 11:57 pm

Every 20 minutes someone in the UK is diagnosed with blood cancer and the register of stem cell donors who are needed to save thousands of patients lives does not currently meet the demand. Only 1 in 3 patients will find a donor match within their family and so every year over 2,000 people in the UK are left searching for a matching blood stem cell donor each year.

Blood cancer patients from Black, Asian or minority ethnicity groups face lower survival odds due to the lack ofdonordiversity. These patients have just a 20% chance of finding the best possible stem cell donor match, compared to 69% for northern European backgrounds.

This is due in part to the low numbers of donors registered from those Black, Asian or ethnic minority backgrounds. Donors from minority ethnic backgrounds make up just 13.1% of the UK stem cell register and because Black, Asian or ethnic minority patients tend to have more varied tissue meaning there is an even more specific biological requirement needed of a donor than for a white patient.

The global pandemic has made this situation even worse. Only 2% of stem cell registrations with DKMS came from black people during lockdown, falling by 20% compared to the same time the previous year.

Vaughn Scott is a patient who received a lifesaving donation from a stranger.

Vaughn Scott (34 years old) lives in Bristol and is grateful to the generous stranger who helped save his life. Theyve given him more time with his two children and the chance to marry his now wife last summer in a beautiful ceremony. Vaughn was incredibly fit and active, playing all kinds of sports and serving in the Navy. It was whilst on deployment across the world that he was urgently flown back to the UK and shockingly diagnosed with acute lymphoblastic leukaemia (ALL).

Vaughn said:

Hearing the diagnosis was the biggest blow Ive ever heard. My mind raced straight to my children and partner. When we learnt there was a way I could go into remission, I was excited that there was a way I could get better but very nervous too. With no family members as a match, all my faith was in a complete stranger that may have registered as a potential stem cell donor. Thankfully my match was found, Im now married and enjoying life with my family and Im so grateful. So many people arent as lucky as me. If you can, please register and give other people the second chance at life that I have been given.

To request a swab kit and register as a potential donor click HERE.

About blood cancer

Blood cancer is the third most common cause of cancer death in the UK but there is a lot of fear around stem cell donation of the process itself and of having a depleted supply of stem cells. This isnt the case. After donation, stem cells regenerate within 2 weeks so the donor wont lose anything. Blood stem cell donation is easy to do and similar to blood donation. Around 90% of all donations are made through a method called peripheral blood stem cell (PBSC). In this method, blood is taken from one of the donors arms and a machine extracts the blood stem cells from it. The donors blood is then returned to them through their other arm. This is an outpatient procedure that is usually completed in 4-6 hours. In just 10% of cases, donations are made through bone marrow collection. This is under general anaesthetic so that no pain is experienced.

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How changing the stem cell response to inflammation may reverse periodontal disease – Bite magazine

Posted: October 15, 2020 at 11:57 pm

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US scientists have discovered that a specific type of molecule may stimulate stem cells to regenerate, reversing the inflammation caused by periodontal disease.

The current treatment for periodontal disease involves opening the infected gum flaps and adding bone grafts to strengthen the teeth.

But in research published inFrontiers in Immunology, scientists from the Forsyth Institute in Massachusetts have discovered that a specific type of molecule may stimulate stem cells to regenerate, reversing the inflammation caused by periodontal disease.

This finding could lead to the development of new therapeutics to treat a variety of systemic diseases that are characterised by inflammation in the body.

For the study, the team removed stem cells from previously extracted wisdom teeth and placed the stem cells onto petri dishes. They then created a simulated inflammatory periodontal disease environment in the petri dishes. Next, they added two specific types of synthetic molecules called Maresin-1 and Resolvin-E1, both specialised pro-resolving lipid mediators from omega-3 fatty acids.

The scientists found that Mar1 and RvE1 stimulated the stem cells to regenerate even under the inflammatory conditions.

Both Maresin-1 and Resolvin-1 reprogrammed the cellular phenotype of the human stem cells, showing that even in response to inflammation, it is possible to boost capacity of the stem cells so they can become regenerative, Dr Alpdogan Kantarci said.

This finding is important because it allows scientists to identify the specific protein pathways involved in inflammation. Those same protein pathways are consistent across many systemic diseases, including periodontal disease, diabetes, heart disease, dementia, and obesity.

Now that we understand how these molecules stimulate the differentiation of stem cells in different tissues and reverse inflammation at a critical point in time, the mechanism we identified could one day be used for building complex organs, Dr Kantarci said.

There is exciting potential for reprogramming stem cells to focus on building tissues.

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AIVITA Biomedical’s Stem Cell Therapeutic in Vision Loss Published in Investigative Ophthalmology & Vision Science – BioSpace

Posted: October 15, 2020 at 11:57 pm

IRVINE, Calif., Oct. 9, 2020 /PRNewswire/ --AIVITA Biomedical Inc., a private biotechnology company developing personalized vaccines for the treatment of cancer and COVID-19, announced today the publication of the peer-reviewed manuscript, "Retina organoid transplants develop photoreceptors and improve visual function in RCS rats with RPE dysfunction,"in the journal Investigative Ophthalmology & Visual Science. The study, led by researchers at AIVITA Biomedical and the Sue & Bill Gross Stem Cell Research Center of the University of California, Irvine, used 3D-retina organoids generated from human stem cells developed by AIVITA to provide insight into the potential use of transplanted retina organoids as a therapeutic option for blinding diseases.

In the study, transplanted retina organoid sheets were examined to determine if human stem cell-derived photoreceptors coulddevelop, survive and function in vivo without the support of healthy retina pigment epithelium (RPE). Visual function was examined through a variety of tests, including optokinetic testing (OKT), electroretinogram (ERG), and superior colliculus (SC) brain recording. These tests concluded that retina organoid transplantations demonstrated significant improvement in visual function compared to non-surgery and sham surgery controls, supporting the application of AIVITA's stem cell technologies in visual disease therapeutics.

"Leveraging our expertise in stem cell growth and differentiation, I'm excited to see the promise of our technology platform in potential therapeutics for vision loss," said Hans Keirstead, Ph.D., chief executive officer of AIVITA and a contributing author to the paper. "To our knowledge, this study is the first to show that it's possible for photoreceptors derived from stem cells to survive and function after transplantation when a host has a dysfunctional RPE."

This work is supported by funding from the California Institute for Regenerative Medicine (CIRM) and National Institutes of Health (NIH).

About AIVITA Biomedical AIVITA Biomedical is a privately held company engaged in the advancement of commercial and clinical-stage programs utilizing curative and regenerative medicines. Founded in 2016 by pioneers in the stem cell industry, AIVITA Biomedical utilizes its expertise in stem cell growth and directed, high-purity differentiation to enable safe, efficient and economical manufacturing systems which support its therapeutic pipeline and commercial line of skin care products. All proceeds from the sale of AIVITA's skin care products support the treatment of people with cancer.

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SOURCE AIVITA Biomedical, Inc.

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AIVITA Biomedical's Stem Cell Therapeutic in Vision Loss Published in Investigative Ophthalmology & Vision Science - BioSpace

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Cuba, study on the effects of COVID-19 in the lungs: use stem cells – Emergency-Live

Posted: October 15, 2020 at 11:57 pm

Dr. Odalis Mara de la Guardia Pea, a second degree specialist in Immunology, has defined as promising the preliminary results obtained at the end of the first phase of the clinical trial for the use of mother cells in patients who have suffered lung lesions due to COVID-19.

The study began in March this year at the Institute of Hematology and Immunology (IHI) and aims to eliminate or soothe inflammatory interstitial or fibrotic lesions resulting from COVID-19 disease, which often force surviving patients to long periods of pulmonary rehabilitation.

If the study using stem cells will be successful, say Dr. Odalis Mara de la Guardia Pea and the other authors, it will be possible to generalize the treatment and extend it to patients of other diseases with equal legacy on the patients body.

The target organs of the coronavirus are different: it affects, is a verified scientific fact, heart, kidney, brain, vascular system, and nervous system (especially the peripheral of the lower limbs).

But it is the lung that seems to feel the effects of the infection.

At least in terms of frequency, if not gravity.

A study that was carried out directly in the patients homes: 130 homes were visited in about three months, from May to June; 141 patients were interviewed and 50 among them were studied.

In the essay were added 20 patients, the amount determined.

During the investigation, several consequences of COVID-19 were appreciated, although the most frequent was lung damage.

In some cases the appearance of signs of pulmonary fibrosis was noted, a problem that cannot be fully corrected and that can only be treated to increase lung capacity and improve the quality of life, explained the head of External Services of the IHI.

The study is in the process of being finalized. The first part is finished, but it takes some time to make the final assessment of the patient.

What we can say is that so far we are very happy with the results we have observed, which are promising, said the doctor.

Read the italian article

Our respiratory system: a virtual tour inside our body

Gramma

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