Stem Cell Clinic

Elidah Becomes the Only US Company to Win a Top Ten Prize in a Global Start-up Competition, Advancing Recognition for Women’s Health – PRNewswire

By Gene Therapy Clinics

MONROE, Conn., Dec. 16, 2020 /PRNewswire/ --Elidah, maker of ELITONE, a home-use treatment for incontinence, announced it was selected out of 7500 entries from 159 countries to win a Top Ten award from the global SLINGSHOT 2020 start-up competition. Elidah was the only company from the United States awarded this distinction, and one of two start-ups in the life science category.Normally held in Singapore,this year the event was virtual and offered a record $750,000 in cash prizes by StartUpSG. One hundred companies pitched at the live event, and from those ten finalists were selected. The award winners included start-ups from all over the world including Israel, United Kingdom, Singapore, and India, among others.

"We sometimes have the mindset that successful start-ups must come from Silicon Valley," said Gloria Kolb, co-founder and CEO of Elidah, "but innovation is flourishing in the rest of the world as entrepreneurial support systems expand. I was impressed by the other finalists, advancing technologies such as biometric security, artificial intelligence, and gene editing." Although the top prize went to another start-up, Ms. Kolb, as the only female entrepreneur in the finals, was happy to see a company focused on women's health receive recognition. "Women's health should not be a taboo subject, and I hope that investors realize it presents a large market, ripe for innovation."

ELITONE is the first home-health device that performs the hard-to-do pelvic floor exercises for women. It operates externally, without the invasiveness of vaginal probes. Exercises are needed to tone the pelvic floor muscles, but they can be hard to do correctly. The wearable nature of ELITONE allows women to do other activities while getting treatment at home, saving time, cost, and risk of infection. In a time when the clinics and pelvic floor physical therapy offices have shut down, at-home over-the-counter devices like ELITONE provide much-needed access to effective FDA-cleared treatments.

About Elidah

Elidah is a women-owned FemTech company established to develop technologies that integrate recent advances in wearable devices, biomaterials, and mobile interfaces to deliver innovative therapeutic solutions.Elidah is led by entrepreneur Gloria Kolb, Founder and CEO, an MIT and Stanford trained engineer whose previous accolades include Boston's 40 under 40 and MIT Technology Review's World Top Innovators Under 35 (TR35). To learn more visit elitone.com.

Contact: Gloria Kolb [emailprotected] 810 Main St., Ste C, Monroe, CT 06468 978-435-4324

SOURCE Elidah

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Elidah Becomes the Only US Company to Win a Top Ten Prize in a Global Start-up Competition, Advancing Recognition for Women's Health - PRNewswire

Explained: Process of transporting stem cell from donor to patient for a successful transplant – Firstpost

By Stem Cell Medical Center

Patrick PaulDec 17, 2020 15:08:12 IST

A successful stem cell transplant from a matching blood stem cell donor can be lifesaving for patients who suffer from diseases like blood cancer, Thalassemia or Aplastic Anemia. Finding a matching stem cell donor is only half the battle and it is also equally important for the stem cells of the donor to actually reach the patient on time as delays in transplant can be life-threatening for a patient. Blood stem cells are collected from a donor in the same way a blood platelet donation is done.

But what happens to the stem cells after it has been collected from a donor?

Deepika is a donor from DKMS BMST registry who has successfully donated her blood stem cells for a patient suffering from blood cancer. Image credit: DKMS BMST Foundation India

Once a potential donor comes up as a match for a patient, the blood stem cells are collected via peripheral blood stem cell collection method, post which the medical team waits for the stem cell count from the laboratory. The amount of stem cell count which is to be collected from a donor is related to the number of stem cells required by the recipient. The stem cells cannot be released for transport unless the stem cell count has been sent from the lab and clearance has been given from the Collection centre physician.

The stem cells are stored at 2-8 degrees Celsius after the collection. As per the World Marrow Donor Association (WMDA) guidelines, the product must be transported between +1-10 degree Celsius and the viability of the stem cells between said temperatures is 72 hours.

The stem cells are transported in a special package called a Credo Box that is prepped in advance to 4 degrees Celsius. The credo box maintains a temperature of 2-8 degrees Celsius for 100 hours. There are two temperature loggers on this box that records the temperature of the inside of the box every 15 minutes.

The transportation of stem cells is a carefully guided process that takes precision and training by the courier personnel. An interesting fact is that only a human courier can carry the product. The reason for this is that the viability of stem cells is 72 hours, which means that once the patient has been conditioned or their body has been prepped for a transplant, their immunity is very low. They should receive a transplant within that time frame or the consequences can be life-threatening. Therefore, it is extremely critical for the stem cells to be securely transported and delivered to the Transplant Centre within this timeframe.

Blood stem cells are collected from a donor in the same way a blood platelet donation is done. Image credit: Wikipedia

Some guidelines followed while transporting blood stem cells are:

The process differs for domestic and international transplants. If the stem cells is for the international Transplant centre, the Transplant centre decides for the transport of the product. If the product is for a national Transplant centre, the local stem cell registry is responsible for the transport of the product from the Collection Centre to the Transplant Center.

After the product reaches the Transplant centre, it is brought back up to room temperature and infused into the patient. If the donor has consented to cryopreservation, then the product is cryopreserved and infused at the later date. With cryopreservation on -80 degree Celsius on carbon dioxide or -196 degree Celsius on liquid nitrogen blood stem cells can be stored for a long time.

The stem cells are transported in a special package called a Credo Box that is prepped in advance to 4 degrees Celsius and maintains a temperature of 2-8 degrees Celsius for 100 hours. Image credit: Wikipedia

The COVID-19 pandemic created a lot of challenges concerning blood stem cell donations due to the closing of borders, travel restrictions, quarantine guidelines, etc. Stem cell registries like DKMS-BMST came up with a unique solution of transporting the products without courier personnel but via the pilot in the cockpit. The product was handed over to the pilot via a courier at the airport, and the pilot would take the product into the cockpit. This also meant that most of the planes could be utilized, even cargo planes without constraints of flight schedules.

With rising blood cancer cases in India, a successful blood stem cell donation from a matching donor can help blood cancer patients receive a second chance at life. The first step to ensuring this is that people are aware of the process of blood stem cell donation and register as a potential blood stem cell donor!

The author is the CEO of the NGO DKMS BMST Foundation, India

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Explained: Process of transporting stem cell from donor to patient for a successful transplant - Firstpost

Research That Saves Lives: Four COVID-19 Therapies Being Tested at UVA – University of Virginia

By Stem Cell Medical Center

Regeneron: Preventing Infection Among Households

Regeneron: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy and Safety of Anti-Spike SARS-CoV-2 Monoclonal Antibodies in Preventing SARS-Cov-2 Infection in Household Contacts of Individuals Infected with SARS-CoV-2

In this multisite trial, researchers are working to determine if monoclonal antibodies made by the drug company Regeneron Pharmaceuticals can prevent COVID-19 infection among people who have been exposed by someone in their household, but have not yet developed the disease. The trial is testing the same antibody cocktail given to President Donald Trump when he was hospitalized with COVID-19, though with a different use.

In this case, the antibodies are intended to prevent people from getting sick if they have a household member with COVID, Enfield said. So far, UVA has done a good job with recruitment, which is particularly tricky in this case as you have to find people who have been exposed to COVID in their household, but who do not yet have COVID.

UVA is recruiting 40 participants for the study, each of whom will receive four injections of either the antibodies or a placebo. Participants must have been exposed to COVID-19 by someone in their household within the previous 96 hours and continue to live with that person for a month.

Its been a rapid process, and a testament to the multidisciplinary team involved, from infectious disease clinicians and researchers to cell therapy, pulmonary critical care and several other departments, Sturek said. Its been all-hands-on-deck.

As results from these and other clinical trials continue to come in, Sturek also expressed hope that we will see widespread and effective vaccine distribution sooner, rather than later.

There is a lot on the horizon, from news around vaccines to getting the first wave of vaccines to high-risk people like health care workers, he said. Every day we learn something new, and its important to stay humble, to be able to adapt and change on the fly.

Fighting this pandemic has been a huge, multidisciplinary effort, and so many people joined in to help contribute and bring new treatments to our patients, and bring new research to the field. That doesnt get done without a huge team of nurses, clinical research coordinators, pharmacists, respiratory therapists and many, many others. It is impossible to overstate the importance of all of that teamwork.

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Research That Saves Lives: Four COVID-19 Therapies Being Tested at UVA - University of Virginia

Even if You’ve Had COVID-19 You Still Need the Vaccine – Healthline

By Stem Cell Medical Center

COVID-19 is currently the leading cause of death in the United States killing more people each day than heart disease or cancer.

To help stem the tide of this life-threatening disease, scientists around the world have been working to develop vaccines.

Last week, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the first of these vaccines, developed by Pfizer and BioNTech.

The EUA allows for the distribution of the Pfizer-BioNTech COVID-19 vaccine across the United States. This vaccine has been developed to prevent COVID-19 in people age 16 years and older.

Getting 2 doses of the vaccine may drastically reduce your chances of developing COVID-19.

Even if youve had COVID-19, getting the vaccine may help prevent reinfection and lower your risk of getting sick again.

Were really happy to have a safe and effective tool [against COVID-19], Dr. Iahn Gonsenhauser, chief quality and patient safety officer at The Ohio State University Wexner Medical Center in Columbus, Ohio, told Healthline.

Were encouraging everybody to explore their opportunity to access the COVID vaccine as soon as thats made available to them, he said.

When someone develops COVID-19, their immune system learns to recognize the virus and begins to produce antibodies to fight against it.

If that person recovers from the disease, they may have immunity against reinfection with the virus for a period of time afterwards.

However, questions remain about how long that immunity lasts.

We dont know how long the immunity triggered by infection persists, and someone infected in the spring may no longer be immunologically protected now in December, Dr. David Hirschwerk, an infectious disease specialist at Northwell Health in Manhasset, New York, told Healthline.

It does stand to reason that somebody with COVID-19 infection is likely immune for 3 to 4 months at least, he said, but we dont have firm data to support this yet.

Cases of reinfection with the virus that causes COVID-19 have been reported.

Getting vaccinated may help to strengthen immunity against COVID-19.

In an ongoing clinical trial, Pfizer and BioNTech have studied their vaccine in people with and without a history of exposure to the virus.

Their research to date has found the vaccine is 95 percent effective at preventing COVID-19.

Their findings suggest it may help prevent reinfection in people who have already been exposed to the virus, as well as lowering the risk of infection in people with no history of exposure.

Data from the phase 2/3 trial for the Pfizer-BioNTech vaccine suggest that the vaccine is safe and likely effective in persons with previous evidence of SARS-CoV-2 infection, said Dr. Miriam Smith, chief of infectious disease at Long Island Jewish Forest Hills in Queens, New York.

[The] vaccine should be offered to all persons regardless of history of prior symptomatic or asymptomatic infection, she said.

The Centers for Disease Control and Prevention (CDC) currently advises that people with a known history of COVID-19 may wait up to nearly 90 days after their prior infection to get vaccinated, if they prefer to do so.

While more research is needed, available evidence suggests that reinfection with this virus is rare within 90 days of initial infection.

If someone currently has active symptoms of COVID-19, the CDC recommends they wait to get vaccinated until theyve recovered and met the criteria for ending isolation.

The Pfizer-BioNTech COVID-19 vaccine carries some risk of side effects.

However, ongoing research suggests the side effects tend to be mild and short-lived.

The way that we generally approach these questions in healthcare is through risk-benefit analysis, Gonsenhauser said.

In this case, the risk of some adverse response to the vaccine is low, and the benefit of knowing that you have a potentially extended or refreshed immunity to COVID is significant, he said.

With that, were recommending that people get the vaccine, even if theyve already had a COVID exposure and infection, he continued.

The most commonly reported side effect associated with the Pfizer-BioNTech COVID-19 vaccine is pain around the injection site.

Some people who received the vaccine developed other side effects such as fatigue, headache, and muscle aches, which tend to resolve within a day or so.

The risk of severe adverse events following the vaccine appears to be very low. However, some groups of people might face higher risk of adverse reactions than others.

For example, if you have a history of severe allergic reaction to any of the ingredients contained in the vaccine, the FDA recommends that you not receive it.

Talk with your doctor to learn more about the potential benefits and risks of getting vaccinated against COVID-19.

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Even if You've Had COVID-19 You Still Need the Vaccine - Healthline

Physio Logic Brings Cutting-edge Regenerative Treatments for Sport Injuries and Arthritis to New York City – PRNewswire

By Stem Cell Treatment

NEW YORK, Dec. 17, 2020 /PRNewswire/ -- Physio Logic, a leading provider of integrated health services in New York City and surrounding areas, continues to demonstrate its commitment to excellence in the field of Regenerative Medicine and Stem Cell Therapy by entering into a collaboration with Regenexx, a worldwide network of specially trained physicians providing the world's most advanced, research-driven, regenerative medicine and stem cell therapy treatments. The partnership brings cutting-edge regenerative treatments to New York City residents suffering from sports injuries or degenerative diseases.

The Regenerative Medicine division of Physio Logic is led by Dr. Tanuj Palvia, MD, a specialist in regenerative medicine and interventional orthopedics focused on the treatment of musculoskeletal injuries and degenerative orthopedic conditions.

"Stem Cell Therapy is one of the most innovative treatments available today but, being so new, patients need to know they're receiving the best possible care. As a physician, I hold myself and my practice to the highest standards and, being aligned with Regenexx adds that extra assurance patients need to know they're in good hands. Whether it's a nagging sports injury or slow degeneration, you're going to get the highest quality of integrated care right here at Physio Logic," said Dr. Palvia.

Interventional Orthobiologics is a specialty that focuses on using your body's natural healing agents to treat orthopedic injuries with the goal of reducing pain and improving joint function. The variety of orthobiologics available to Regenexx physicians, such as bone marrow stem cells and platelet-rich plasma (PRP), allow them to create a treatment plan to best support your recovery. It can be used in the treatment of conditions such as arthritis and injury to ligaments, tendons, cartilage, or bone.

"Being selected to represent the Regenexx brand in New York City speaks to the quality of our facility, our providers, and the care we give our patients," said Dr. Rudy Gehrman, CEO & Founder of the Brooklyn based clinic. "Physio Logic is raising the standard of healthcare in New York and our partnership with Regenexx is an extension of the quality, integrative care we provide to every patient that walks through our door."

Regenexx physicians are required to have thousands of hours of experience performing precise, injection-based treatments using image guidance for a range of body parts and injuries. Their strict acceptance criteria means that Regenexx only chooses the most qualified physicians to join their network. Physio Logic's Interventional Pain Specialist, Dr. Tanuj Palvia, MD, is ranked among them.

To learn more about Physio Logic and Regenerative Medicine, go to https://physiologicnyc.com/regenerative-medicine/

About Physio Logic Physio Logic brings together an expert team of open-minded medical doctors, physical therapists, chiropractors, acupuncturists, massage therapists, nutritionists, health coaches, biohackers, and Pilates instructors. Our unique collaborative approach, coupled with our ability to assess patients holistically, is used to create a custom care plan tailored to patients' needs. For more information on Physio Logic, visit https://physiologicnyc.com or call (718) 260-1000.

About Regenexx Regenexx is a nationwide network of physicians who practice Interventional Orthopedics, a new specialty that focuses on using the most advanced regenerative protocols available as an alternative to many orthopedic surgeries. Regenexx has published roughly half of the research worldwide on the use of orthobiologics for treating orthopedic injuries, and our patented treatment lab-processing and treatment protocols allow us to achieve unmatched results. Our procedures use your body's natural healing agents including blood platelets and bone marrow concentrate to repair damaged bone, muscle, cartilage, tendons and ligaments. For more information on Regenexx, visit https://regenexx.com.

Media contact: Alan Sott [emailprotected] (718) 260-1000

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Physio Logic Brings Cutting-edge Regenerative Treatments for Sport Injuries and Arthritis to New York City - PRNewswire

Therapeutic Solutions International Files Investigational New Drug Application (IND) with FDA for Treatment of Chronic Traumatic Encephalopathy Using…

By Stem Cell Treatment

OCEANSIDE, Calif., Dec. 17, 2020 /PRNewswire/ -- Therapeutic Solutions International, Inc., (OTC Markets: TSOI), announced today filing of an Investigational New Drug (IND) application seeking permission from the Food and Drug Administration (FDA) to initiate a Phase I/II clinical trial assessing safety and signals of efficacy for treatment of Chronic Traumatic Encephalopathy (CTE) patients with JadiCells.

The JadiCell is a type of umbilical cord derived mesenchymal stem cell which possesses superior therapeutic activity as compared to other stem cell types based on laboratory and clinical studies. The JadiCell was recently reported to possess therapeutic activity against COVID-19 in a recently published clinical trial1. The Company previously obtained an exclusive license for use of JadiCells for CTE and Traumatic Brain Injury (TBI)2,3.

"My team and myself are extremely excited about the potential of using our unique novel cell therapy for treatment of CTE, which is the cause of countless deaths, as well as chronic disabilities" said Dr. Amit Patel, inventor of the JadiCell. "Having worked over the past several years with the multidisciplinary team assembled by Timothy Dixon, I look forward to progress in this area of medicine, for which currently there are limited options."

Chronic Traumatic Encephalopathy (CTE) is caused by repetitive concussive/sub-concussive hits to the head sustained over a period of years and is often found in football players4. The condition is characterized by memory loss, impulsive/erratic behavior, impaired judgment, aggression, depression, and dementia. In many patients with CTE, it is anatomically characterized by brain atrophy, reduced mass of frontal and temporal cortices, and medial temporal lobe. TSOI has previously filed several patents in the area of CTE based on modulating the brain microenvironment to enhance receptivity of regenerative cells such as stem cells.

Suicide is a major cause of death in military veterans, approximately 20 deaths per day5. It is widely known that TBI and CTE are associated with increased propensity for suicide6,7. Furthermore, studies show that cytokines associated with brain inflammation, such as IL-6 and TNF-alpha are found in higher levels in patients with suicidal tendencies8.

"To our knowledge, this is the first therapeutic intervention addressing CTE using stem cells and we are tremendously excited to finally move into clinical testing for this terrible disease that not only affects athletes but our military and law enforcement as well" said Timothy Dixon, President and CEO of the Company. "Having worked over the last 2 years in developing the preclinical data supporting this IND, we are extremely pleased to file this new drug application today."

About Therapeutic Solutions International, Inc.

Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases. The Company's corporate website is http://www.therapeuticsolutionsint.com, and our public forum is https://board.therapeuticsolutionsint.comand Campbell Neurosciences at https://www.campbellneurosciences.com

1https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3696875

2https://www.globenewswire.com/news-release/2019/07/01/1876699/0/en/Therapeutic-Solutions-International-2Obtains-Exclusive-License-for-Patented-Clinical-Stage-Adult-Stem-Cell-for-Treatment-of-Military-and-Sports-Brain-Injuries.html

3https://patents.google.com/patent/US9803176?oq=9803176

4https://www.nytimes.com/interactive/2017/07/25/sports/football/nfl-cte.html

5https://en.wikipedia.org/wiki/United_States_military_veteran_suicide

6https://www.psychcongress.com/news/traumatic-brain-injury-tied-increased-risk-suicide

7https://sbindependent.org/nfl-athletes-with-cte-who-committed-suicide/

8https://www.ncbi.nlm.nih.gov/pubmed/20951793

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SOURCE Therapeutic Solutions International

therapeuticsolutionsint.com

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Therapeutic Solutions International Files Investigational New Drug Application (IND) with FDA for Treatment of Chronic Traumatic Encephalopathy Using...

AlloVir Announces FDA Clearance of Investigational New Drug Application for ALVR106, an Allogeneic, Off-the-Shelf, Multi-Virus Specific T Cell Therapy…

By Stem Cell Treatment

Dec. 17, 2020 12:30 UTC

Proof-of-concept phase 1/2 trial to initiate in 2021 to treat severe respiratory viral infections in patients following hematopoietic stem cell transplantation

ALVR106 designed to target devastating diseases caused by four respiratory viruses: respiratory syncytial virus, influenza, parainfluenza virus, and human metapneumovirus

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- AlloVir (Nasdaq: ALVR), a late clinical-stage cell therapy company, announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for ALVR106, an allogeneic, off-the-shelf virus-specific T cell therapy (VST) designed to target infections and diseases caused by respiratory syncytial virus (RSV), influenza, parainfluenza virus (PIV), and human metapneumovirus (hMPV). The IND enables AlloVir to initiate a Phase 1/2 proof-of-concept clinical study in allogeneic and autologous hematopoietic stem cell transplant (HSCT) patients with respiratory infections caused by RSV, influenza, PIV or hMPV.

Respiratory viruses are a leading cause of morbidity and mortality in HSCT patients, and based on evidence from our preclinical studies, we believe ALVR106 could transform the treatment and prevention of respiratory infections and substantially reduce the associated morbidity and mortality of these infections in the future, said Ercem Atillasoy, M.D., Chief Regulatory and Safety Officer of AlloVir. The clearance of the IND for ALVR106 advances our third program into clinical trials further exploring the power of our proprietary virus-specific T cell therapy platform.

Respiratory tract infections due to RSV, influenza, PIV, and hMPV are a major public health concern and are detected in up to 40 percent of allogeneic HSCT patients. These viral infections can progress from upper respiratory tract infections to more serious lower respiratory tract infections, which are associated with mortality rates of 20-45 percent in HSCT patients.

As previously disclosed, this proof-of-concept clinical trial will initiate in 2021 as the company is assessing the impact of the COVID-19 pandemic on the incidence, diagnosis, and treatment of the respiratory viral infections which ALVR106 targets.

About ALVR106

ALVR106 is an allogeneic, off-the-shelf, multi-virus specific VST investigational therapy designed to target infections and diseases caused by the respiratory syncytial virus (RSV), influenza, parainfluenza virus (PIV), and human metapneumovirus (hMPV). In vitro data demonstrate that ALVR106 has antiviral activity against each of the targeted viruses with minimal or no activity against non-virus-infected cells. This preclinical data supports the potential for antiviral benefit and safety of ALVR106 when administered to patients.

About AlloVir

AlloVir is a leading late clinical-stage cell therapy company with a focus on restoring natural immunity against life-threatening viral diseases in patients with weakened immune systems. The companys innovative and proprietary technology platforms leverage off-the-shelf, allogeneic, multi-virus specific T cells targeting devastating viruses for patients with T cell deficiencies who are at risk from the life-threatening consequences of viral diseases. AlloVirs technology and manufacturing process enables the potential for the treatment and prevention of a spectrum of devastating viruses with each single allogeneic cell therapy. The company is advancing multiple mid- and late-stage clinical trials across its product portfolio. For more information visit http://www.allovir.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding AlloVirs development and regulatory status of our product candidates and its strategy, business plans and focus. The words may, will, could, would, should, expect, plan, anticipate, intend, believe, estimate, predict, project, potential, continue, target and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on managements current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those related to AlloVirs financial results, the timing for completion of AlloVirs clinical trials of its product candidates, whether and when, if at all, AlloVirs product candidates will receive approval from the U.S. Food and Drug Administration, or FDA, or other foreign regulatory authorities, competition from other biopharmaceutical companies, and other risks identified in AlloVirs SEC filings. AlloVir cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. AlloVir disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent AlloVirs views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.

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AlloVir Announces FDA Clearance of Investigational New Drug Application for ALVR106, an Allogeneic, Off-the-Shelf, Multi-Virus Specific T Cell Therapy...

ONK Therapeutics Announces Three Exclusive Option License Agreements, Which Extend and Strengthen its Dual-Targeted NK Cell Therapy Pipeline -…

By Stem Cell Treatment

Dec. 17, 2020 08:30 UTC

GALWAY, Ireland, & SAN DIEGO, Calif.--(BUSINESS WIRE)-- ONK Therapeutics Ltd, an innovative natural killer (NK) cell therapy company, today announced that it has secured three new exclusive option license agreements which strengthen its off-the-shelf, dual-targeted natural killer (NK) cell therapy platform and extend its pre-clinical pipeline to four programs across both hematological and solid tumors.

The first option agreement, with Cellerant Therapeutics, gives exclusive rights to a humanized CLEC12A scFv binder. CLEC12A is strongly expressed by blasts in the majority of AML patients. The option to license has enabled ONK to expand its pre-clinical product portfolio, launching a fourth program (ONKT104). This dual-targeted approach combines the CLEC12A CAR with a TNF-related apoptosis-inducing ligand variant (TRAILv) targeting death receptor 4 (DR4).

While expressed on leukemic stem cells, CLEC12A is absent from normal hematopoietic stem cells and we thus expect that our dual-targeted NK cell therapy approach should enable safe targeting, with a reduced risk of prolonged aplasia in AML, said Prof Michael ODwyer MD, ONK Therapeutics co-founder, and CSO.

The second agreement in-licenses a humanized, tumor-specific antibody targeting an aberrantly glycosylated tumor-associated form of MUC1 (TA-MUC1) from Glycotope GmbH. Multiple solid tumor types express the mucin MUC1, including non-small cell lung cancer, breast cancer, and ovarian cancer. This antibody will be integrated into ONKs pre-clinical program ONKT103, for solid tumors.

Non-selective targeting of MUC1 could be problematic since the target is also expressed by healthy tissues, but ODwyer explains how ONKs dual-targeted approach can be used to address this. We have designed a CAR tailored to the glycosylation pattern distinct to tumor-associated MUC1 with specific recognition of the carbohydrate antigens Tn and T on MUC1, the expression of which is restricted to cancer cells. Glycotope has identified the glycosylation pattern as a way to unlock the potential of TA-MUC1 as a solid tumor target. ONK is thus set to bring the natural benefits of NK cells over T cells to bear on TA-MUC1, in a tumor-specific fashion, while also further boosting efficacy and countering resistance through the use of our TRAIL variant targeting DR5, he said.

ONKs unique platform approach combines the expression of a chimeric antigen receptor (CAR) and a high affinity, membrane-bound TRAILv. The incorporation of these two humanized scFvs has the potential to minimize the risk of immunogenicity in the allogeneic setting.

ONK is also exploring several innovative strategies to improve the homing of NK cells. This is an important consideration as ex-vivo expansion can lead to changes in chemokine receptor expression. Through this new license agreement with the NIH, ONK plans to enforce the expression of CCR7, which is downregulated on NK cell expansion. This may improve the homing of NK cells to lymph nodes and is expected to be particularly useful for ONKs off-the-shelf CD19 program targeting B cell lymphoma, ONKT101, which is partnered with Avectas.

ONK is making rapid progress since it announced its most recent financing in October. Chris Nowers, ex Kite Pharma Head of Europe, who joined at that time as Chief Executive Officer, said: The recent American Society of Hematology meeting highlighted the NK cell therapy area as offering great hope as the next generation of advanced cell therapies. We believe our best-in-class off-the-shelf, dual-targeted NK cell therapy platform has the potential to improve performance and overcome some of the shortcomings seen with earlier approaches. These new licensing activities strengthen and expand our programs and illustrate our ambition and strategy to become a leader in this exciting field.

The company recently expanded its operations into the USA, moving into JLABS @ San Diego, Johnson & Johnson Innovations flagship facility, at the heart of San Diegos precision medicine and cell therapy cluster. This represents a second facility that complements its main R&D team and operations in Galway, Ireland. The companys recruitment drive across both facilities has been rapid and the company continues to expand its capability in key areas, including NK cell biology, construct design, gene editing, and process development.

-Ends-

ONK Therapeutics http://www.onktherapeutics.com ONK Therapeutics Ltd is an innovative cell therapy company dedicated to developing the next generation of off-the-shelf, dual-targeted NK cell therapies targeting solid and hematological cancers.

The company was founded in 2015, by Prof. ODwyer MD, of NUI Galway, an expert in translational multiple myeloma research, the tumor microenvironment, and exploitation of NK cells as cellular immunotherapy. Its core proprietary platform is based on a dual-targeted NK cell expressing both a chimeric antigen receptor (CAR) targeting a known tumor antigen and a TNF-related apoptosis-inducing ligand variant (TRAILv) targeting the death receptor pathway (i.e. DR4 or DR5). This unique approach has the potential to enhance efficacy by addressing both intrinsic (e.g. CAR engagement of a tumor-specific antigen) and extrinsic (e.g. signaling through the death receptor pathway) apoptotic pathways and to reduce the susceptibility to possible target antigen escape through the engagement of tumor antigen-independent TRAILv.

Its pre-clinical pipeline comprises four programs;

In addition to the unique dual-targeted NK cell therapy platform, the company has a strong research focus on strategies to enhance homing and persistence, and overcome exhaustion, including the exploration of proprietary gene edits, such as the deletion of checkpoint inhibitory receptors in NK cells.

ONK Therapeutics is headquartered in the med-tech hub of Galway, Ireland, with a wholly-owned US subsidiary, ONK Therapeutics, Inc. based at JLabs @ San Diego. Shareholders include Acorn Bioventures, ALSHC (principally Seamus Mulligan), and Enterprise Ireland.

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About Avectas - http://www.avectas.com Avectas is a cell engineering technology business that has developed a unique delivery platform, Solupore to enable the ex vivo manufacture of cell therapy products, which have high in-vivo functionality.

Glycotope http://www.glycotope.com Glycotope is a biotechnology company utilizing a proprietary technology platform to develop highly tumor-specific monoclonal antibodies called GlycoBodies. GlycoBodies bind to targets (GlycoTargets) tumor-specific carbohydrate structure dependent, enabling the development of highly-specific immunotherapies across a broad range of cancer indications. Glycotope has to date discovered in excess of 150 GlycoTargets with GlycoBodies against eight of these targets currently under development.

Each GlycoBody can be developed in an array of modalities with different modes of action providing a unique offering in the (immuno) oncology space. Currently, six clinical and pre-clinical programs based on the GlycoBody technology are under development by Glycotope or its licensing partners.

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Mesoblast shares fall on trials mixed results with heart injection treatment – Stockhead

By Stem Cell Treatment

Mesoblast (ASX:MSB) shares have dropped more than 12 per cent to a nearly one-month low after a six-year trial investigating using its stem cell treatment to treat advanced chronic heart failure delivered confusing results.

The injection of stem cells into the heart appeared to prevent deaths in patients with mild symptoms but not hospitalisations. That was the primary goal of the study, which Mesoblast says is the largest and most rigorous cell therapy trial ever performed.

In the Phase III trial involving 537 patients with advanced chronic heart failure, the group treated with an injection of rexlemestrocel-L had 60 per cent fewer heart attacks and strokes than those treated with a sham treatment.

Also, in the 206 patients with mild heart failure symptoms, those who received rexlemestrocel-L suffered 60 per cent fewer deaths than those in the placebo group.

But the trial failed to meet its predefined primary endpoint in that the treatment failed to reduce hospitalisations during the follow-up period, which lasted an average of 30 months.

At 11.36am, MSB shares were down 12.3 per cent to $3.98, their lowest level since mid-November.

But Mesoblast said that overall the study was incredibly positive and that it would seek regulatory approval in the United States as well as a large commercial partner to meet what it sees as a huge market opportunity.

On a conference call with analysts this morning, Mesoblast chief executive Dr Silviu Itescu said that rexlemestrocel-L had delivered a dramatic reduction in mortality that may change the paradigm of how patients with advanced cancer may be treated.

He said Mesoblast planned to meet again shortly with the US Food and Drug Administration and ask for drug approval of rexlemestrocel-L, (REVASCOR), which consists of an injection of 150 million mesenchymal precursor cells directly into the heart.

This is a very surprising finding and quite dramatic, he said. And I think that any therapy that has this degree of reduction in mortality in a well-conducted randomized placebo-controlled study of this size has to be taken seriously in terms of its ability to completely change the natural course of the disease.

So, we will be having those discussions. I think there are clear pathways towards accelerated approval.

Dr Itescu said that the rexlemestrocel-L injection may not have reduced recurrent hospitalisations because advanced heart failure patients are brittle and may need hospital treatment to be stabilised.

It appears our therapy does not have an impact on those types of outcomes, he said.

Mesoblast believes that the stem cell injection works to reduce severe inflammation in the heart muscle.

Other drugs in this patient population have reduced mortality by less than 20 per cent, Dr Itescu said.

The drug would be aimed at patients with class 2 heart disease mild symptoms such as shortness of breath or angina, but who did not yet have problems walking short distances.

That would be our target market in the patient journey, in terms of that being a very large market opportunity, Dr Itescu said.

Clearly, we will be looking for a strategic commercial partner that has strength and commitment in the commercial channels that will be required to make this product available to these large numbers of patients. We have ongoing discussions with a number of large pharmaceutical companies in this space.

Dr Itescu said that a rexlemestrocel-L injection would not displace other therapies, but would be a single delivery of a therapeutic that gives three o=o four years at least, of mortality benefit and reduction in major vascular events like heart attacks and stroke.

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Mesoblast shares fall on trials mixed results with heart injection treatment - Stockhead

Mesoblast shares savaged on poor COVID trial results – Sydney Morning Herald

By Stem Cell Treatment

Stem cell biotech Mesoblast has had its share price smashed after the company emerged from a trading halt on Friday to reveal its COVID-19 treatment trial was unlikely to meet its primary goal.

Shares in the biotech plunged 41 per cent at the start of trading before recovering some lost ground during the day to close 36 per cent lower at $2.41, shaving its market value by $800 million to $1.4 billion.

Mesoblast chief executive Silviu Itescu. The company was hoping to show its flagship product, remestemcel-L, would help patients with moderate to severe respiratory distress because of coronavirus.Credit:Credit: Arsineh Houspian

In a single-page ASX release, Mesoblast told investors that an independent data safety monitoring board had reviewed interim results from its coronavirus trial. The company was hoping to show its flagship product, remestemcel-L, could help patients with moderate to severe respiratory distress because of coronavirus.

On the same morning that Sydneysiders were thrown into major uncertainty due to a new outbreak of the virus on the northern beaches, Mesoblast noted the trial is not likely to meet the 30-day mortality reduction endpoint for the study.

The company will still complete the study, which had been aiming to recruit 300 patients, using the 223 patients already enrolled.

Chief executive Silviu Itescu insisted the news, while disappointing, was not the end of the road for the project.

He claimed that recruiting patients for the trial, which was run with the US National Institutes of Health, had been tough and that the most recent patients recruited to the trial were older than the earlier recruits.

He argued that as the pandemic wore on, many critically ill patients had also already received a number of experimental treatments and this could have impacted the results.

We have no ability to prevent other experimental drugs to be given to these patients, he said.

Its the second piece of tough news for Mesoblast, which is backed by high-profile investors including billionaire Alex Waislitz, to be released this week, after phase 3 trial results of its heart failure drug caused the stock to plunge at the start of the week. The company released data on Tuesday showing its other key product, Revascor, showed reduction in mortality of up to 60 per cent in heart failure patients.

However, the study missed its primary goal, which was to show that the drug reduced the incidence of trips to hospital for non-fatal heart failure events.

Mesoblast is also continuing to negotiate with the US Food and Drug Administration over approvals for its remestemcel-L product for the treatment of graft-versus-host disease. The product was blocked at the final hurdle this year when US regulators requested more data on the treatments effectiveness prior to giving the green light.

Shares in the company are still above where they started 2020, at $2.05 on January 2. The share price has swung wildly throughout the year, gaining or losing more than 30 per cent of its share price in a number of individual sessions as investors reacted quickly to corporate updates, particularly around COVID-19.

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Shares hit a high of $5.50 at the end of September on optimism for the COVID trial and its research pipeline.

Mesoblast raised $138 million from investors earlier this year in anticipation of scaling up manufacturing capabilities for the COVID-19 project.

It also entered into a partnership with pharmaceuticals giant Novartis for the development of its products for treating COVID-19 and other respiratory diseases, which included a $US50 million ($65.6 million) upfront payment, including $US25 million in equity in the business. Mesoblast reported a $US24.5 million loss for the September quarter.

Mr Itescu said nobody likes to not achieve an endpoint in a research project, but he expected the company to keep working with Novartis to comb through the research data and collaborate on future work on the treatment.

Novartis has partnered with us for many indications [uses of remestemcel-L], he said.

Analysts were reviewing their models for the stock on Friday morning, with Bell Potters team, which had a speculative buy recommendation on the stock, labelling the news very disappointing.

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Emma reports on healthcare companies for The Age and Sydney Morning Herald. She is based in Melbourne.

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Mesoblast shares savaged on poor COVID trial results - Sydney Morning Herald

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