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Roswell Park Team Shows Dendritic-Cell Vaccines Can Be Paired With Standard Therapy for Breast Cancer – Newswise

By adminJuly 22, 2021Stem Cell Treatment

Newswise BUFFALO, N.Y. A research team led by Fumito Ito, MD, PhD, FACS, of Roswell Park Comprehensive Cancer Center reports new data on the promise of combining standard treatment for breast cancer with a particular form of cancer immmunotherapy dendritic-cell (DC) treatment vaccines. This study, published in the Journal for ImmunoTherapy of Cancer, is the first to demonstrate that in situ dendritic-cell vaccines can improve the effectiveness of radiation therapy for some aggressive and treatment-resistant forms of breast cancer.

Although immunotherapy with primary conventional dendritic cells is a promising approach, obtaining a sufficient number of circulating conventional dendritic cells has proved difficult, says Dr. Ito, who is Associate Professor of Surgical Oncology at Roswell Park. Use of induced pluripotent stem cells (iPSCs) has been proposed to overcome that limitation, but the feasibility of this approach had not previously been demonstrated.

The teams results show that intratumoral administration of iPSC-DCs significantly enhanced antitumor efficacy of local irradiation, which is commonly incorporated into treatment plans for patients with breast cancer.To better understand the potential of this approach, Dr. Ito and colleagues conducted laboratory studies to assess the antitumor efficacy of intratumoral injection of iPSC-DCs, or dendritic cells derived from iPSCs, and radiotherapy in models of triple-negative breast cancer that have shown resistance to anti-PD-L1 checkpoint inhibition immunotherapy.

The researchers demonstrate that radiation therapy increased the trafficking of intratumorally injected iPSC-DCs to the tumor-draining lymph nodes and augmented the activation of tumor-specific T cells. Their work shows that this multimodal intralesional therapy can control growth of distant tumors and render some breast cancers responsive to anti-PD-L1 therapy

While our work to develop this strategy is at an early stage and will need to be studied further, we show that these two approaches, radiotherapy and intratumoral iPSC-DC administration, can work synergistically to control not only local tumor growth but also distant tumors. And we saw evidence of systemic tumor-specific immunological memory, suggesting a potential for long-term tumor control, says Dr. Ito.

This study sheds light on the antitumor efficacy of in situ administration of iPSC-DCs when integrated with radiotherapy against poorly immunogenic tumors. These findings align with another study from Dr. Ito and his team, recently published in Nature Communications, that showed potent systemic antitumor immunity caused by combinational multimodal intralesional therapy.

Currently, efficacy of immunotherapy against breast cancer is limited, adds Dr. Ito. Our hope is to improve clinical outcomes for patients with advanced unresectable and metastatic breast cancer.

This work, In situ delivery of iPSC-derived dendritic cells with local radiotherapy generates systemic antitumor immunity and potentiates PD-L1 blockade in preclinical poorly immunogenic tumor models, was supported by several grants from the National Cancer Institute (project numbers P30CA016056, K08CA197966, and R50CA211108), as well as the Melanoma Research Alliance, Sarcoma Foundation of America and Uehara Memorial Foundation.

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For an online version of this release, please visit: https://www.roswellpark.org/newsroom/202107-roswell-park-team-shows-dendritic-cell-vaccines-can-be-paired-standard-therapy

Roswell Park Comprehensive Cancer Center is a community united by the drive to eliminate cancers grip on humanity by unlocking its secrets through personalized approaches and unleashing the healing power of hope. Founded by Dr. Roswell Park in 1898, it is the only National Cancer Institute-designated comprehensive cancer center in Upstate New York. Learn more at http://www.roswellpark.org, or contact us at 1-800-ROSWELL (1-800-767-9355) or [emailprotected].

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Roswell Park Team Shows Dendritic-Cell Vaccines Can Be Paired With Standard Therapy for Breast Cancer - Newswise

Introducing the 3D bioprinted neural tissues with the potential to ‘cure’ human paralysis – 3D Printing Industry

By adminJuly 22, 2021Stem Cell Treatment

Researchers at the Chinese Academy of Sciences and University of Science and Technology of China have devised a novel bioprinting-based method of curing previously untreatable spinal cord injuries.

Using a custom bio-ink, the Chinese team have managed to 3D bioprint neural stem cell-loaded tissues capable of carrying instructions via impulses from the brain, much like those seen in living organisms. Once implanted into disabled rats, the scaffolds have shown the ability to restore movement in paralyzed limbs, and the scientists now believe their approach could find human applications in future.

There is no known effective cure for spinal cord injury, Zhijun Zhang, a nanobiomedical engineer at the Chinese Academy of Sciences told the Scientist. The 3D bioprinting strategy weve developed, may represent a general and versatile strategy for rapid and precise engineering of the central nervous system (CNS), and other neuronal tissues for regenerative medicine.

The SCI injury conundrum

A Spinal Cord Injury or SCI is a blanket term used to describe any damage caused to the bundle of cells and nerves that send signals to and from the brain along the human spinal cord. While the damage itself can be caused either by direct injury, or from bruising to the surrounding vertebrae, the result is often the same: a partial or complete loss of sensory and locomotor function below the affected area.

While theres no current known cure for SCI, a number of promising cell-based therapies are now being developed, with the regeneration of functional neurons seen as central to their future success. In effect, such approaches involve re-establishing links between neurons throughout the injured area in order to restore nerve functionality, but repairing damaged cells continues to be problematic.

Where neural stem cells have previously been implanted into SCI sites, theyve also shown poor viability and uncontrolled differentiation, leading to low therapeutic efficacy. More recent efforts have seen scientists bioprint cell-loaded scaffolds, capable of creating a suitable microenvironment in which neurons can flourish, yet this has raised further issues around printability and initiating cellular interaction.

To get around these problems, the Chinese researchers have now developed a novel bio-ink that gels together at body temperature to prevent neurons from differentiating into cells that dont produce electrical impulses, and can be 3D bioprinted into scaffolds that not only mimic the white matter appearance of the spine, but encourage cell-to-cell interactions.

A paralysis cure in-action

To begin with, Zhang and his team formulated their bio-ink from natural chitosan sugars, as well as a mixture of hyaluronic acids and matrigel, before combining them with rat neural stem cells. The scientists then used a BioScaffolder 3D bioprinter to deposit the resulting concoction into cell-laden scaffolds, which were later stored in culture plates for further testing.

Prior to their implantation, the teams different samples were incubated for three, five and seven days respectively, during which they proliferated and formed connections. Interestingly though, the researchers found that the higher the concentration of hyaluronic acid, the lower levels of interaction they observed, showing that their bio-ink can be tweaked to achieve desired tissue characteristics.

When injected into paraplegic lab rats, the scaffolds exhibited a cell viability of 95% while promoting neuron regeneration to the point that they enabled the rats to regain control over their hind legs. Over a 12-week observation period, the treated animals also showed a revived ability to move their hips, knees and ankles without support, and kick pressure sensors with markedly enhanced muscle strength.

As a result, the scientists have concluded that their approach offers a versatile and powerful platform for building precisely-controlled complex neural tissues with potential human applications, although they concede that more precise regulation of cell differentiation will be needed to achieve this, in addition to further testing on more clinically-relevant injury models.

Overall, this study clearly demonstrated for the first time the feasibility of the 3D bioprinted neural stem cell-laden scaffolds for SCI repair in-vivo, concluded the team in their paper, which, we expect, may move toward clinical applications in the neural tissue engineering, such as SCI and other regenerative medicine fields in the near future.

3D bioprinting in CNS treatments

Thanks to constant advances in flexible electronics and 3D bioprinting technologies, its now becoming increasingly possible to produce neural implants, with the potential to treat complex CNS injuries. Last year, a project started at TU Dresden led to the creation of 3D printed neural implants, capable of linking the human brain to computers as a means of treating neurological conditions such as paralysis.

In a similar study, engineering firm Renishaw has worked with pharmaceuticals expert Herantis Pharma to assess the performance of its 3D printed neuroinfuse drug delivery device. Designed to deliver intermittent infusions into the parenchyma, an organs functional tissue, the platform could be used as a future treatment for Parkinsons disease.

With regards to treating spinal injuries specifically, researchers at the University of California San Diego have also managed to repair spinal cord injuries in rats. By implanting 3D printed two-millimeter-wide grafts into test subjects, the team have been able to facilitate neural stem cell growth, restore nerve connections and ultimately help recover limb functionality in rodent test subjects.

The researchers findings are detailed in their paper titled 3D bioprinted neural tissue constructs for spinal cord injury repair. The study was co-authored by Xiaoyun Liu, Mingming Hao, Zhongjin Chen, Ting Zhang, Jie Huang, Jianwu Dai and Zhijun Zhang.

The nominations for the 2021 3D Printing Industry Awards are now open. Who do you think should make the shortlists for this years show? Have your say now.

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Are you looking for a job in the additive manufacturing industry? Visit 3D Printing Jobs for a selection of roles in the industry.

Featured image shows the researchers 3D bioprinted scaffolds after 7 and 21 days culturing. Images via the Biomaterials journal.

New CEO, check. $172M round, check. Wugen’s off-the-shelf cell therapies are ready for takeoff – FierceBiotech

By adminJuly 22, 2021Stem Cell Clinic

When Dan Kemp was plottinghis next move after Takeda, he was blown away by data from Wugen, a biotech working on off-the-shelf natural killer (NK) cell therapies. Now, after four months in the CEO seat, hes ready to take those treatments to the next level with a $172 million financing.

The proceeds will bankroll the development of the companys memory NK cell platform and advance its lead program, WU-NK-101, through a phase 1/2 trial in acute myeloid leukemia (AML) and into new studies in solid tumors. The funding will also support Wugens broader pipeline, including an allogeneic CAR-T treatment for T-cell leukemia and lymphoma.

Wugen is one of several biotechs pursuing NK cell therapies to go where CAR-T treatments cannot. Despite its success in blood cancers, CAR-T has faced challenges in solid tumors. And all four of the FDA-approved CAR-T treatments are autologous, meaning theyre made from a patients own cells, which stops them from being widely available.

RELATED: Catamaran Bio sets sail with $42M to create off-the-shelf CAR-NK treatments

The biggest differentiator [of NK cell treatments] from CAR-T is the fact that there is this continual concern around safety. Cytokine release syndrome or neurotoxicity appear to be unavoidable consequences of CAR-T cell therapy, Kemp said, referring to side effects of CAR-T that happen when the treatment activates the immune system too strongly.

T-cell therapy developers have learned to expect these effects and try to manage them rather than avoid them. But NK cell treatments may become a safer alternative.

On the NK side of things, weve seen no toxicity at all; its a pristine safety profile, Kemp said. Thats consistent with other NK cell products that are in the clinic as well.

And thats not allWugen reckons its approach could have an advantage over other NK cell treatments. Its platform generates memory NK cells, which are better at killing cancer cells and last longer in the body than conventional NK cells.

RELATED: Sanofi inks $358M Kiadis takeover to acquire NK-cell platform

Conventional NK cells, like those derived from stem cells, cord blood or peripheral blood, must be engineered to provide sufficient potency to drive any clinical efficacy, Kemp said. Memory NK cells and WU-NK-101 have shown significant efficacy in AML without any engineering at all.

We essentially prime the cells into a superpotent phenotype and expand them so we can actually leverage the innate ability of NK cells themselves to have true clinical potency, he added.

That said, the company plans to combine its NK cell treatments with other cancer-fighting drugs and make engineered NK cell products that could work even better, Kemp said.

Moving forward, Wugen will start a global, multicenter study for WU-NK-101 and file an IND for its CAR-T program in T-cell leukemia and lymphoma later this year, Kemp said. Trials of WU-NK-101 in solid tumors will follow in 2022. As it ramps up its pipeline, the company will aggressively build its team. It currently has 40 staffers across sites in St. Louis and San Diego.

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New CEO, check. $172M round, check. Wugen's off-the-shelf cell therapies are ready for takeoff - FierceBiotech

Arbor Strengthens Focus on Therapeutics with Key Additions to Leadership Team – Yahoo Finance

By adminJuly 22, 2021Stem Cell Clinic

- Pam Stetkiewicz, Ph.D., Appointed Chief Operating Officer - Kathryn McCabe, Ph.D., Named SVP, Head of Business Development

CAMBRIDGE, Mass., July 20, 2021 (GLOBE NEWSWIRE) -- Arbor Biotechnologies, an early-stage life sciences company discovering and developing the next generation of genetic medicines, announced today the appointments of Pam Stetkiewicz, Ph.D., as Chief Operating Officer, and Kathryn McCabe, Ph.D., as SVP, Head of Business Development. These appointments further expand Arbors leadership team and strengthen its focus on therapeutics.

Bringing Pam and Katy on at this time represents a significant milestone for Arbor as we drive our genetic medicines portfolio to the clinic and partner with leading companies to bring engineered cell therapies to patients, said Devyn Smith, Ph.D., CEO, Arbor Biotechnologies. Their scientific expertise, business acumen, and extensive experience in cell therapy and gene editing will help us execute on this strategy to develop therapeutics with our tailored library of CRISPR-based genetic editors and modifiers.

Pam Stetkiewicz is joining Arbor from Flagship Pioneering, where she was Senior Vice President, Global Program Leader at Flagship Pioneering Medicines. Dr. Stetkiewicz brings more than 20 years of extensive life-sciences pharmaceutical experience with recent experience at Editas Medicine as Vice President, Program and Alliance Management. At Editas, she led the team that filed the first IND for an in vivo CRISPR therapeutic (EDIT-101 for LCA10). Prior to Editas, Dr. Stetkiewicz worked at Novartis Institute of Biomedical Research for 13 years, in a variety of roles across science, alliance, project and portfolio management. Her last role at Novartis was as Executive Director, in Strategic Alliances which involved early business development and collaborations with external companies. She received her Ph.D. from Johns Hopkins University and a B.S. from the University of Rhode Island.

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Im thrilled to be joining Arbor at this exciting time, said Dr. Stetkiewicz. The company has made significant progress in the discovery and development of innovative therapies, particularly in the genetic medicines space, and I am looking forward to helping fulfill the therapeutic promise of Arbors already impressive discoveries.

Kathryn (Katy) McCabe is joining Arbor from Roche where she was Senior Director of Business Development based in Cambridge, MA. Over the last 20 years, she has combined her scientific knowledge, entrepreneurial spirit, and business experience to help transform novel modalities into new medicines at Roche, Lilly, Baxalta and GSK. Dr. McCabe has focused much of her attention on cell and gene therapy and has closed deals for CAR-T, diabetes cell therapy, in vivo gene editing, and gene therapy as well as led large strategic initiatives in these areas. In addition, she has had close interactions with a number of venture funds as the scientific lead for Lillys limited partnerships. Early in her career, Dr. McCabe led a team of senior scientists to develop stem cells for retina and corneal transplantation. She was a Postdoctoral Fellow in Dr. Marianne Bronners lab at Caltech, received her Ph.D. in Neuroscience and Behavior from the University of Washington, and her B.A from the University of Pennsylvania.

I look forward to finding partners that share our vision of bringing curative therapies to patients, said Dr. McCabe.

About Arbor Biotechnologies Arbor Biotechnologies is an early-stage life sciences company discovering and developing the next generation of genetic medicines. Co-founded by Feng Zhang and David Walt, Arbor uses its proprietary discovery engine to uncover unique CRISPR-based genetic modifiers with differentiated genetic editing and delivery capabilities. Following its strategic partnership with Vertex Pharmaceuticals to accelerate the path to the clinic for Arbors technologies, Arbor recently announced an agreement with Lonza. These partnerships further validate the breadth of applications of Arbors gene editing platform that can be custom tailored to address the underlying pathology of each genetic disease. Arbors pipeline of genetic medicines is focused on bringing curative therapies to all patients with genetic disease.

Media Contact: Kelly Friendly press@arbor.bio

For Patients with HIV and Cancer, a Multidisciplinary Treatment Approach is Critical – Targeted Oncology

By adminJuly 22, 2021Stem Cell Clinic

As a medical oncologist with a particular interest in the intersection of HIV and cancer, I have seen how cultural taboos as well as economic and demographic forces can still affect care. I have treated patients who dont wish to disclose that they have HIV, and who are willing to drive a hundred miles or more to refill medications in a different town or state to ensure their anonymity. Economically disadvantaged patients often dont have a complete care network, instead relying on their primary care physician and/or a cancer specialist for their treatment.

In 2018, the National Comprehensive Cancer Network (NCCN) published new NCCN Clinical Practice Guidelines in Oncology intended to help make sure people living with HIV who also receive a cancer diagnosis receive safe, necessary treatment.1 The guidelines highlight the disparities in cancer care for people living with HIV and point to the special considerations these patients require.

At Miami Cancer Institute, part of Baptist Health South Florida, we have opened a new HIV/Cancer Clinic to provide these particularly complex patients with better access to new clinical trials as well as coordinated, multidisciplinary care in one location. The program has also been accepted to the AIDS Malignancy Consortium (AMC), which is funded by the National Cancer Institute, to support our clinical trials and enhance our information sharing with other AMC members.

At various points during their treatment, patients at the Miami Cancer Institute HIV/Cancer Clinic will encounter a full spectrum of specialists including oncologists, infectious disease specialists, pharmacists specialized in oncology and infectious disease, nurse practitioners, clinical nurses, medical assistants, palliative care specialists, oncology dentists, psychologists, social workers and case managers. Our cancer clinics operate under one roof so that patients can see multiple specialists and caregivers in one visit. The team essentially assumes the role of primary care provider for the patient, coordinating every aspect of care and meeting periodically as a team to review the patients status.

Physicians who wish to refer HIV-positive patients for cancer care should seek out centers that have the expertise and capabilities to deal with complex cases. For example, Miami Cancer Institute has already performed an allogeneic stem cell transplant on a patient who has both HIV and an aggressive form of plasmablastic lymphoma. The procedure involved finding a matching donor who also had a specific mutation in a gene that offers resistance to HIV infection. Typically, it can take up to two years before a patient such as this can be declared cured, however, the patient is currently doing well six months after transplantation.

Lastly, I recommend that referring physicians look for centers that have a robust clinical trials program. At Miami Cancer Institute, we are presently recruiting HIV patients for seven clinical trials soon to increase to ten for various conditions including Kaposis Sarcoma, lymphomas, cervical cancer, and lung cancer. Even patients with very aggressive lymphomas may be good candidates for a clinical trial.

Reference:

Reid E, Suneja G, Ambinder R, et al. Cancer in people living with HIV, Version 1.2018, NCCN Clinical Practice Guidelines in Oncology.J Natl Compr Canc Netw. 2018;16(8):986-1017. doi. 10.6004/jnccn.2018.0066.

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For Patients with HIV and Cancer, a Multidisciplinary Treatment Approach is Critical - Targeted Oncology

Stemming the tide of stem-cell treatment scams – Houston Chronicle

By adminJuly 22, 2021Stem Cell Medicine

Michael Roizen, M.D., and Mehmet Oz, M.D.

July 21, 2021Updated: July 21, 2021 1:56p.m.

Q: Im considering having my own stem cells injected into me to improve physical and mental problems that I am having post-COVID-19 infection. What do you think?

James D., Huntington, N.Y.

A: Theres been a lot of talk about using what are called autologous stem cells (your own) to fight off COVID-19 long-haul symptoms, as well as to treat everything from torn ligaments to Alzheimers disease. None is approved by the Food and Drug Administration. The only stem-cell-based products that are FDA-approved come from blood-forming stem cells (hematopoietic progenitor cells) derived from cord blood and theyre for treating disorders involving production of blood (the hematopoietic system). A list is at fda.gov; search for Approved Cellular and Gene Therapy Products.

In fact, stem cell/regenerative medicine treatment scams are so prevalent that this spring the FDA finally told manufacturers and marketers that they had to comply with regulations on human cell and tissue products. Unfortunately, a June report from Pew Trust found compliance by the companies and enforcement from the FDA to be anemic.

What the report did find was that more than 700 clinics in the U.S. offer unapproved stem-cell and regenerative medicine interventions for conditions such as Alzheimers, muscular dystrophy, autism, spinal cord injuries and, most recently, COVID-19. They also found post-injection infection happens frequently and is likely because of sloppily manufactured products and failure to properly screen for diseases such as HIV and hepatitis B and C.

If youre considering stem-cell treatment, the FDA urges you to ask the clinic for the following info before getting it even if the stem cells are your own:

Proof the FDA has reviewed and approved the treatment. Have your primary care doc confirm the information.

If the clinic is claiming it has an FDA-issued Investigational New Drug application number, ask for it and ask to review the FDA communication acknowledging the IND.

Stem-cell treatment has great potential, but when used for unapproved therapies outside a clinical trial, its risky (and expensive). To search for a trial, go to clinicaltrials.gov.

Q: My doctor says my high blood pressure puts me at increased risk for dementia. I think hes just trying to get me on one more med. Is there really a connection?

Lacie R., Sacramento, Calif.

A: Dementia means that you have cognition problems that cause trouble with memory, thought and everyday tasks. That could result from mini- or regular strokes, and we know that high blood pressure increases your stroke risk. In fact, one Harvard study found that high blood pressure increases a mans risk of stroke by 220 percent; another found that each 10 mmHg rise in systolic pressure (the top number) boosts your risk of ischemic stroke by 28 percent and of hemorrhagic stroke by 38 percent.

Even if your high blood pressure doesnt trigger a stroke, it can lead to impaired cognition and dementia. The 2018 SPRINT-MIND trial found that intensive control of high blood pressure (getting the top number below 120) lowered the risk of mild cognitive impairment by 19 percent compared with standard blood pressure control. Now, a new study in the journal Hypertension indicates that certain antihypertensive medications ACE inhibitors and ARBs (and angiotensin II receptor blockers) can cross the blood-brain barrier and lower dementia risk. Tracking almost 13,000 people for three years, the researchers found that folks taking those meds showed less memory loss than folks taking other sorts of antihypertensive medications.

You dont indicate how high your blood pressure is, but if it is only slightly elevated you may be able to bring it down through changing your diet, losing weight if you need to and exercising for 30 to 60 minutes five days a week. If it is above 125 (top number) or above 85 (bottom number), a combo of those self-care techniques and medication may be the safest choice. But either way, bringing your blood pressure to around 115/75 will protect your brain, as well as your heart, kidneys and eyes.

Contact Drs. Oz and Roizen at sharecare.com.

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Stemming the tide of stem-cell treatment scams - Houston Chronicle

FDA gives speedy review to Bayer’s Parkinson’s stem cell therapy – – pharmaphorum

By adminJuly 22, 2021Stem Cell Medicine

Bayer subsidiary BlueRock Therapeutics has been granted a fast-track review by the FDA for DA01, its stem cell-based therapy for Parkinsons disease which is currently in early-stage clinical testing.

The FDA designation allows for benefits such as more frequent meetings and communication with the regulator during clinical development, and a truncated six-month review time.

Those are all considerations for the future as the first patients only started to be treated with DA01 in a phase 1 trial aimed primarily at showing the safety of the therapy, which is trying to replenish the dopaminergic neurons that progressively die away in Parkinsons and lead to slow, laboured movement, tremors and other symptoms.

The therapy involves implantation of dopamine-producing cells under general anaesthesia into a part of the brain called the putamen, which is particularly affected by neuron loss in Parkinsons and is responsible for regulating movement as well as some types of learning.

Patients take immune-suppressing drugs to prevent their body rejecting the transplanted cells, and the safety and tolerability of the procedure as well as the ability of the transplant to survive will be monitored for two years.

BlueRock is also hoping to demonstrate some evidence of efficacy, and will look at clinical measures such as motor function over the same time period. It is the first trial in the US to study pluripotent stem cell-derived dopaminergic neurons in patients with Parkinsons, according to the company.

The first patient in the trial, which will eventually enrol 10 subjects with advanced Parkinsons, was treated at Memorial Sloan Kettering Cancer Centre in June, and others will be recruited at Weill Cornell Medical Centre, the University of California, Irvine, and the University of Toronto.

Our objective is to use authentic cells, to have them integrate entirely into the brain and restore lost physiologic function, said BlueRock chief executive Emile Nuwaysir, as the first patient was treated.

If successful, this new therapeutic modality could have implications for the Parkinsons community and beyond, he added.

Bayer took control of BlueRock in 2019, three years after backing the formation of the company as joint venture with private equity group Versant, in a deal that valued the biotech at $1 billion.

DA01 is Bluerocks lead cell therapy programme, but the company is also working on treatments for other neurological disorders, degenerative heart disease, and autoimmune disorders.

Bayer is also developing a gene therapy for Parkinsons originated by Asklepios Bio (AskBio), which it acquired for $2 billion upfront last year with another $2 billion tied to milestones, and has pledged to make cell and gene therapies a pillar of its R&D strategy.

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FDA gives speedy review to Bayer's Parkinson's stem cell therapy - - pharmaphorum

Creative Medical Technology Holdings Announces MyeloCelz The Company’s Second Regenerative Immunotherapy Product – PRNewswire

By adminJuly 22, 2021Stem Cell Medicine

PHOENIX, July 20, 2021 /PRNewswire/ -- (OTC CELZ)Creative Medical Technology Holdings Inc. announced today the launching of its second Regenerative Immunology product, MyeloCelz.

In contrast to the Company's ImmCelz product, which utilizes primarily T cells and B cells to induce activation of the body's own stem cells and healing processes, MyeloCelz utilizes the innate immune system, particularly cells of the monocyte/macrophage lineage.

"Immunotherapy is the future of medicine. In the field of oncology immunotherapy it has saved thousands of lives and resulted in the Nobel Prize in Medicine." Said Thomas Ichim, Ph.D, Chief Scientific Officer, and Co-Founder of the Company. "We believe that in using ImmCelz and MyeloCelz, we are in the position to advance immunotherapy for treatment of degenerative conditions, an approach that we term "Regenerative Immunotherapy". This is a first-in-class therapeutic direction that leverages the specificity, amplification, and memory of the immune system in order to accelerate the body to restore its function."

"The unique thing about MyeloCelz, like ImmCelz, is that the cellular product is personalized and the patient is receiving their own cells back into themselves. This not only significantly increases the safety of the procedure, but also conceptually may increase efficacy because the body's own cells know best how to interact with the body." Said Dr. Courtney Bartlett, Director of Clinical Development.

"Having recently joined the Scientific Advisory Board of the Company, I am astonished at the expedience, innovation, and productivity of the team assembled by Dr. Thomas Ichim, Chief Scientific Officer of the Company." Said Dr. Camillo Ricordi. "MyeloCelz, which is a parallel immunotherapy approach to ImmCelz, is another paradigm shifting product and to my knowledge, is covered by one of the most comprehensive patent applications in cell therapy."

The Company's first regenerative immunotherapy product, ImmCelz was demonstrated effective in numerous animal models of autoimmunity and is the subject of a filed and pending FDA IND for use in stroke. ImmCelz was featured at the international stem cell conference, The World Stem Cell Summit, with the presentation available at this link https://www.youtube.com/watch?v=LTHUxz_xN5w .

"I am grateful for our team of scientific advisors and collaborators, who have worked diligently and ingeniously to develop a cellular therapy that leverages aspects of the innate immune system in stimulating the body to heal itself naturally. The addition of MyeloCelzto our Regenerative Immunotherapy portfolio, which includes ImmCelz and multiple patent filings on the treatment of specific indications, clearly demonstrates our dedication to the immunotherapy space." Said Timothy Warbington, President and CEO of the Company.

About Creative Medical Technology HoldingsCreative Medical Technology Holdings, Inc. is a commercial stage biotechnology company specializing in regenerative medicine/stem cell technology in the fields of immunotherapy, urology, neurology and orthopedics and is listed on the OTC under the ticker symbol CELZ. For further information about the company, please visitwww.creativemedicaltechnology.com.

Forward Looking StatementsOTC Markets has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This news release may contain forward-looking statements including but not limited to comments regarding the timing and content of upcoming clinical trials and laboratory results, marketing efforts, funding, etc. Forward-looking statements address future events and conditions and, therefore, involve inherent risks and uncertainties. Actual results may differ materially from those currently anticipated in such statements. See the periodic and other reports filed by Creative Medical Technology Holdings, Inc. with the Securities and Exchange Commission and available on the Commission's website at http://www.sec.gov.

Creativemedicaltechnology.com http://www.StemSpine.com http://www.Caverstem.com http://www.Femcelz.com http://www.MyeloCelz.com http://www.OvaStem.com http://www.ImmCelz.com

SOURCE Creative Medical Technology Holdings, Inc.

http://creativemedicaltechnology.com

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Creative Medical Technology Holdings Announces MyeloCelz The Company's Second Regenerative Immunotherapy Product - PRNewswire

John Theurer Cancer Center Investigators Participated in ZUMA-7 Study Showing Value of CAR T-Cell Therapy as Second-Line Treatment for Relapsed Large…

By adminJuly 22, 2021Stem Cell Medicine

July 19, 2021

A new study has found that using CAR T-cell therapy as the second line of treatment for diffusing large B-cell lymphoma (DLBCL) that has returned or continued to grow after initial treatment was more effective than the standard second-line regimen of care for improving event-free survival (EFS / defined as disease progression, needing to start a new lymphoma treatment, or death from any cause). Investigators from Hackensack Meridian/Hackensack University Medical Centers John Theurer Cancer Center (JTCC), a part of Georgetown Lombardi Comprehensive Cancer Center, participated in the multicenter international study, called ZUMA-7.

With a median follow-up of two years, the study showed that patients with DLBCL who received a one-time infusion of axicabtagene ciloleucel (Yescarta) experienced a 60% improvement in EFS compared with patients who received standard care with chemotherapy and autologous stem cell transplantation. Patients in the CAR T-cell therapy group also experienced a better overall response rate. The study is continuing with additional follow-up to assess the effect of the treatments on overall survival and other key endpoints.

Axicabtagene ciloleucel is currently approved by the U.S. Food and Drug Administration for the treatment of large B-cell lymphoma that relapses after or fails to respond to at least two prior regimens of therapy.

This is a very exciting paradigm shift for the treatment of large B-cell lymphoma, explained hematologist-oncologist Lori Leslie, M.D., who led JTCCs participation in the ZUMA-7 study. A 60% improvement in event-free survival is more dramatic than one would anticipate and suggests that early relapsers and some patients at high risk of relapse after initial treatment may benefit from proceeding directly to CAR T-cell therapy.

About 40% of patients with DLBCL will need a second regimen of treatment.

CAR T-cell therapy is a form of treatment which involves removing white blood cells called T cells from the patient, modifying them in the laboratory to train them to see a protein (called CD19) on lymphoma cells, and then multiplying them to much larger numbers. When given back to the patient intravenously, they expand further, ideally identifying and killing cancer cells anywhere in the body.CAR T-cell therapy is a form of immunotherapy and has been called a living therapy because the newly trained T cells continue to find and destroy cancer cells in the body.

As a leader in CAR T therapy, we are proud to be a part of this new development in research that will continue to reshape the landscape of relapsed/refractory aggressive lymphoma who fail standard regimens of chemoimmunotherapy, said Andre Goy, M.D., M.S., chairman and executive director of John Theurer Cancer Center. The ZUMA-7 study began in 2017 and includes 359 patients with DLBCL at 77 medical centers around the world, 30% of whom were 65 years or older. Side effects observed in the study were consistent with or even more favorable than the safety profile previously established for axicabtagene ciloleucel. The use of CAR T-cell therapy as second-line treatment did not result in any new safety concerns. Yescarta has been instrumental in transforming outcomes for DLBCL patients in third line setting. It is likely the paradigm will continue to shift towards earlier timing in patients with early failures.

The contributions that the John Theurer Cancer Center made toward identifying a better therapy for the research and treatment of lymphoma further establishes its position as a leading center, said Ihor Sawczuk, MD, FACS, president, Northern Region, and chief research officer, Hackensack Meridian Health. Hackensack Meridian Health isproud to have been involved in this pivotal study.

We are dedicated to continuing to provide the latest research-based treatments to the members of our communities, added Mark D. Sparta, FACHE, president and chief hospital executive, Hackensack University Medical Center and executive vice president of Population Health, Hackensack MeridianHealth. John Theurer Cancer Center was the first center in New Jersey to be certified to offer CAR T-cell therapy and was active in research assessing its use long before its first FDA approval. We are very excited to see these promising results, which show how this powerful immunotherapy may benefit more people.

Kadimastem Patent for cell selection of beta cells to Treat and Potentially Cure Diabetes was Granted in Japan – Yahoo Eurosport UK

By adminJuly 22, 2021Stem Cell Medicine

Kadimastem Ltd 21-Jul-2021 / 15:46 CET/CEST

Kadimastem Patent for cell selection of beta cells to Treat and Potentially Cure Diabeteswas Granted in Japan

NEWS RELEASE BY KADIMASTEM LTD

Ness Ziona, Israel | July 21, 2021 09:00 AM Eastern Daylight Time

Cell therapy company KadimastemLtd (TASE:KDST) has received its patent approval from the Japanese Patent Office for IsletRx, the company's innovative treatment for diabetes.

IsletRx comprises an expanded population of clinical grade pancreatic islet-like cluster (ILCs) cells, derived from human stem cells, that have the ability to secrete insulin when blood sugar is low and glucagon, a hormone secreted to prevent hypoglycemia, when blood sugar levels drop in response to varying sugar levels (glucose) in the blood. This particular function of IsletRX is similar to a "healthy" pancreas and functions to treat insulin-dependent diabetes, such as Type 1 diabetes also known as juvenile diabetes.

The patent announced today protects Kadimastem's cell selection and enrichment technology, that enables it to identify and fortify the best cells in the expanded population. The patent also covers the use of the company's special production process, where it can remove cells that are not necessary or may impair the efficiency of the transplanted cells. These capabilities are important in achieving the maximum therapeutic effect for potential future insulin-dependent diabetic patients.

In addition, this method of production and cell selection enables the ILCs to be transplanted using a variety of platforms, including very small devices that are more suitable and more convenient for patients.

Kadimastem CEO Asaf Shilonisaid, "Receiving the patent in Japan further strengthens our intellectual property position. The market, in Southeast Asia in general, and the Japanese market, are large and important for the company's future products. Registering the patent in Japan gives Kadimastem a much-welcomed priority status in this territory. We look forward to further developing business collaborations with key players in the pharmaceutical industry in Japan, both for our diabetes and ALS products."

The Japanese market is one of the most significant markets for stem cell-derived cell therapies. In Japan, 7.9% of the population is diabetic and there are more than 2.7 million insulin-dependent diabetic patients. Treatment of these patients is currently estimated at $ 29 billion.

Japan has strategic importance in the field of stem cell therapy, as it is one of the world's most prominent countries in promoting innovation and products in the field of cell therapy. In November 2014, the Japanese Parliament approved a special lawto facilitate clinical trials in the field of cellular medicine, with the aim of expediting approvals of intracellular therapies and quickly bringing them to market.

Social Media:LinkedIn,Twitter,Facebook

Company Contacts:

Asaf Shiloni

CEO

a.shiloni@kadimastem.com

Press Contact:

Marjie Hadad

General Manager

Must Have Communications

917-790-1178 marjie@mhc-pr.com

About Kadimastem:

Kadimastem is a clinical stage cell therapy company, developing and manufacturing "offthe-shelf", allogeneic, proprietary cell products based on its technology platform for the expansion and differentiation of Human Embryonic Stem Cells (hESCs) into functional cells. Kadimastem is focusing on two promising products, AstroRx(R) and IsletRX. AstroRx(R), the Company's clinically advanced product, is an astrocyte cell therapy in clinical development as a treatment for ALS and other neurodegenerative diseases. IsletRx, is comprised of functional Stem Cell derived pancreatic islet cells intended to cure patients with insulin dependent diabetes. IsletRx demonstrated safety and efficacy in preclinical studies. Kadimastem was founded by Professor Michel Revel, CSO of the Company and Professor Emeritus of Molecular Genetics at the Weizmann Institute of

Science. Professor Revel received the Israel Prize for the invention and development of Rebif(R), a multiple sclerosis blockbuster drug sold worldwide. Kadimastem is traded on the Tel Aviv Stock Exchange (TASE: KDST).

Forward Looking Statement:

This document may include forward-looking information as defined in the Securities Law,

5728 1968. Forward-looking information is uncertain and mostly is not under the Company's control and the realization or non-realization of forward-looking information will be affected, among other things, by the risk factors characterizing the Company's activity, as well as developments in the general environment and external factors affecting the Company's activity. The Company's results and achievements in the future may differ materially from any presented herein and the Company makes no undertaking to update or revise such projection or estimate and does not undertake to update this document. This document does not constitute a proposal to purchase the Company's securities or an invitation to receive such offers. Investment in securities in general and in the Company in particular bears risks. One should consider that past performance does not necessarily indicate performance in the future.

Asaf Shiloni

+972 73-797-1613

s.herzl@kadimastem.com

https://www.kadimastem.com/

Dissemination of a CORPORATE NEWS, transmitted by EQS Group. The issuer is solely responsible for the content of this announcement.

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Kadimastem Patent for cell selection of beta cells to Treat and Potentially Cure Diabetes was Granted in Japan - Yahoo Eurosport UK