Stem Cell Clinic

XIST-Promoter Demethylation as Tissue Biomarker for Testicular Germ Cell Tumors and Spermatogenesis Quality – Beyond the Abstract – UroToday

One of the most remarkable characteristics of germ cell tumors is that they are developmental cancers, meaning that they closely resemble phenomena that occur during embryonic and germ cell development. It is only natural, then, that comprehensive knowledge about developmental biology drives the process of uncovering relevant disease biomarkers with a high likelihood of actual clinical use. This was the case for the classical serum markers AFP and HCG (secreted during embryogenesis), pluripotency factors (such as OCT3/4 and SOX2/17) and embryonic microRNAs (miR-371a-3p), which proved to be true biomarkers of germ cell neoplasms.

Pursuing this strategy, the evolutionary well-known event of X-chromosome inactivation in mammalian cells also resulted in another putative biomarker: XIST. This long non-coding RNA inactivates extra X-chromosome material in female cells, a process that is retained in testicular germ cell tumors as they have a super numerical X-chromosome constitution (because of the initial polyploidization step). Hence, in this work we explored and validated a demethylated XIST fragment (i.e., related to expression of the gene) as a biomarker of these tumors. Two different quantitative methodologies were applied, both with high sensitivity, including high-resolution melting analyses. Importantly, this biomarker was particularly useful in Seminomas, for which informative serum markers commonly used in the clinic are often detected in the normal range. Therefore, the demethylated XIST fragment in serum/plasma could be a promising biomarker for the clinical management of these patients.

Besides applications in the germ cell tumor field, we also demonstrated a valuable use of the demethylated XIST fragment for assessing spermatogenesis extent in testicular parenchyma samples. XIST has been shown to be only and specifically expressed in males during spermatogenesis when the germ cells enter meiosis. This is in line with the higher amount of demethylated XIST promoter identified by us in this study, being of relevance because infertility is a frequent side effect from cancer treatments, with a severe impact on cancer survivors quality of life. This novel finding may help to overcome the limitations of the time consuming and often inaccurate Johnsens score as evaluated by Pathologists to estimate spermatogenesis efficiency in clinical practice. Accordingly, we are pursuing an evaluation of our findings in seminal plasma samples.

Written by:Joo Lobo, MD, Resident in Pathology, PhD student, Cancer Biology & Epigenetics Group, Research Center,Portuguese Oncology Institute of Porto (IPO-Porto) & PhD student in Molecular Pathology and Genetics, Lecturer in Pathology, Master Degree in Medicine,Biomedical Sciences Institute Abel Salazar, University of Porto (ICBAS-UP) & PhD student, Looijenga Group,Princess Mxima Center (PMC) for Pediatric Oncology, Utrecht.

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XIST-Promoter Demethylation as Tissue Biomarker for Testicular Germ Cell Tumors and Spermatogenesis Quality - Beyond the Abstract - UroToday

Perioperative Targeted Therapy Or Immunotherapy In Non-Small-Cell Lung | OTT – Dove Medical Press

Huanlan Sa,1,* Peng Song,2,* Kewei Ma,3 Yong Gao,1 Li Zhang,2 Deqiang Wang1

1Department of Pain Management, Affiliated Hospital of Binzhou Medical University, Binzhou 256603, Peoples Republic of China; 2Department of Respiratory Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Science & Peking Union Medical College, Beijing 100010, Peoples Republic of China; 3Department of Oncology, Cancer Center, The First Hospital of Jilin University, Changchun, 130021, Peoples Republic of China

*These authors contributed equally to this work

Correspondence: Li ZhangDepartment of Respiratory Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, Peoples Republic of ChinaTel +8618811630866Email zhanglipumch@aliyun.com

Deqiang WangDepartment of Pain Management, Affiliated Hospital of Binzhou Medical University, Binzhou 256603, Peoples Republic of ChinaTel +8615066918983Email wangdeqiangbz@163.com

Abstract: Targeted therapy and immunotherapy have changed the treatment modes for advanced non-small cell lung cancer (NSCLC), moving from second-line to first-line treatment and significantly extending patients survival. Surgery and chemoradiotherapy remain the main treatment options for patients with locally advanced lung cancer, but recurrence and metastasis still occur in some patients. The survival rates of conventional perioperative chemotherapy among NSCLC patients have increased by only 5%. Therefore, more studies have begun to explore targeted and immune neoadjuvant/adjuvant therapies in early-stage and locally advanced NSCLC, and the relevant clinical research data have shown good efficacy and safety profiles. This article summarizes several clinical studies of critical importance.

Keywords: non-small-cell lung cancer, targeted therapy, immunotherapy

This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License.By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

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Perioperative Targeted Therapy Or Immunotherapy In Non-Small-Cell Lung | OTT - Dove Medical Press

Maryland Biotech Just Raised $85 Million to Advance its Intelligent Cell Therapy Platform – BioBuzz

October 3, 2019

Arcellx, a privately-held biopharmaceutical company, today announced that it has raised $85 million in an oversubscribed Series B financing. Proceeds will be used to advance the Companys ARC-T + sparX programs, including clinical development of a bivalent BCMA-targeted cell therapy in multiple myeloma, and a CD123-targeted therapy in acute myeloid leukemia. The Series B will also fund earlier stage ARC-T + sparX programs for patients with solid tumors and diseases outside oncology.

Arcellxwas recently featured as one of Five Companies That Are Changing the Landscape for Cell and Gene Therapy and is led by founder David Hilbert, PhD and a veteran team of top-caliber scientists and executives. Earlier this year Arcellx raised $27M in Series A funding from several high caliber investment firms that include NEA, Novo, Takeda Ventures and SR One.

According to the press release;Participants in the Series B include both existing and new investors to Arcellx. New investors Aju IB and Quan Capital co-led the round, followed by Mirae Asset Venture Investment, Mirae Asset Capital, LG Technology Ventures, JVC Investment Partners, and certain funds managed by Clough Capital Partners, L.P. Existing investors Novo Holdings, S.R. One Limited, NEA and Takeda Ventures also participated in the financing.

Concurrent with the financing, Hugo Beekman, Partner at Aju IB, and Lewis (Rusty) Williams, M.D., Ph.D., Venture Partner at Quan Capital, have joined the Arcellx board of directors.

The financial and strategic support from our investors allows Arcellx to accelerate development of a robust pipeline of ARC-T + sparX programs for patients in need, commented David Hilbert, Ph.D., President and Chief Executive Officer of Arcellx. As impressive as conventional CART therapies have been, their safety and efficacy profiles are challenged by severe toxicities, high rates of relapse, and challenging target selection in the solid tumor setting. The ARC-T + sparX platform addresses these concerns by placing ARC-T cells under the control of one or more sparX proteins that uniquely determine how the ARC-T cells recognize tumor, and the speed with which ARC-T cells kill tumor. In the coming months we will begin clinical testing of our lead BCMA-targeted therapy in multiple myeloma.

Rusty Williams, M.D., Ph.D., commented, Arcellx hasreached a positive inflectionin its novel platform and pipeline with the potential to improve efficacy and safety. We are excited to support the company as it advances new cell therapies with the potential to deliver better outcomes for patients.

Hugo Beekman, Partner at Aju IB, commented, Arcellx has invented a differentiated cell therapy platform with ARC-T + sparX that allows simultaneous and sequential targeting of multiple tumor antigens. The ability of sparX proteins to reprogram the specificity of ARC-T cells has the potential to address the high incidence of tumor relapse, as well as the inherent diversity of tumor antigens expressed within solid tumors. The features of this platform, along with scalable and efficient manufacturing processes, are intended to facilitate the Companys development of new therapies in oncology, and more broadly, in autoimmune disease and the transplant setting.

Their vision is to provide cancer patients with adaptive gene cell therapies that are readily silenced, activated, and reprogrammed in order to combat the complexity of human disease. Their technology platform aims to achieve improved efficacy through the reprogramming of the immune systems tumor-targeting receptors to address both newly diagnosed and relapsed cancers. Arcellxs technology will extend to solid tumors as well as autoimmune indications.

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Over the past 8 years, Chris has grown BioBuzz into a respected brand that is recognized for its community building, networking events and news stories about the local biotech industry. In addition, he runs a Recruiting and Marketing Agency that helps companies attract top talent through a blended model that combines employer branding and marketing services together with a high powered recruiting solution.

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Maryland Biotech Just Raised $85 Million to Advance its Intelligent Cell Therapy Platform - BioBuzz

Regulator raids cell therapy makers too often to little avail – Korea Biomedical Review

In the wake of the recall of cell gene therapy Invossa-K, the Ministry of Food and Drug Safety conducted a special inspection of six cell therapy developers. The raid came less than a year since the regulator made an urgent inspection in October last year.

According to industry sources, the ministry started the inspection in early September to enhance the regular monitoring after the cancellation of the Invossa license.

In October last year, the ministry had a special inspection of four cell therapy makers, suspecting that the companies poorly managed allogeneic cell therapies.

Some observers questioned the effectiveness of the inspection because the raid last year could not detect any problem in Kolon Life Sciences management of cell therapy Invossa.

However, six months after the inspection, Kolon found that Invossa contained a cell ingredient different from the authorized label.

If another company has a similar problem, the ministry will find it difficult to identify it even if it carries out an inspection, observers said.

When the ministry had a pharmacist inspection last year, Kolon Life Science had no problem. The government must have been hard to know the mislabeling of Invossa because such pharmacist inspection was based on the data provided by the company, an official at a cell therapy developer said.

The Invossa recall has also toughened regulations on cell therapies. The food and drug safety ministry revised the Regulation on Approval Review for Biologic Products on Sept. 9 to make cell therapy developers mandatorily submit the results of Short Tandem Repeat (STR) testing when seeking approval for cell and gene therapies.

The new rules came after Kolon Life Science said the company belatedly found the mislabeling because it had never conducted STR testing before it applied for the Invossa license.

The government indeed tightened the control over cell therapies and related rules after the Invossa recall, an industry source said. The government is inspecting other companies belatedly, however, as it did so last year.

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Regulator raids cell therapy makers too often to little avail - Korea Biomedical Review

Global Personalized Cell Therapy Market Research Report (2019-2028) by Future Trend, Growth Rate, Opportunity, Industry Experts Analysis – Sound On…

New York City, NY: October 3, 2019 Published via (Wired Release) Global Personalized Cell Therapy Market Research Report is an in-depth and professional document 2019:

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Global personalized cell therapy market segmentation, by technique:

Platelet TransfusionsBone Marrow TransplantationPacked Red Cell TransfusionsOrgan TransplantationGlobal personalized cell therapy market segmentation, by therapeutic area:

Cardiovascular DiseasesNeurological DisordersInflammatory DiseasesDiabetesCancer

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There are 9 Chapters to deeply display the global Personalized Cell Therapy market

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1.1 Personalized Cell Therapy Preface

Chapter Two: Global Personalized Cell Therapy Market Analysis

2.1 Personalized Cell Therapy Report Description

2.1.1 Personalized Cell Therapy Market Definition and Scope

2.2 Personalized Cell Therapy Executive Summary

2.2.1 Personalized Cell Therapy Market Snapshot, [Segment 1]

2.2.2 Personalized Cell Therapy Market Snapshot, [Segment 2]

2.2.3 Personalized Cell Therapy Market Snapshot, [Segment 3]

2.2.4 Personalized Cell Therapy Market Snapshot, [Region Segment]

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3.1 Drivers

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3.4 Trends

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8.1.1 Company Overview

8.1.2 Product Portfolio

8.1.3 Financial Overview

8.1.4 Key Developments

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9.1 Research Methodology

9.2 About Us

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Know-How About New CAR-T Cell Therapies Shifting – Medscape

Chimeric antigen receptor (CAR) T-cell therapies for cancer are still so new and they can be extremely effective, but "it's a therapy that carries a lot of risk," said Lauren Spendley, NP, from the Dana-Farber Cancer Institute and Harvard Medical School in Boston.

At her center, she explained, all patients who have received CAR T-cell therapy are admitted for a minimum of 1week after infusion. A rotating team of advanced practice providers take care of those and other hemo-malignancy patients.

"We realized that we needed a dedicated group to make sure we were able to safely provide quality care for these patients, given the unique toxicity profile" said Spendley, who described her experience as a CAR-T program manager and presented research on associated toxicities from two studies she was involved in (Brain. 2019;142:1334-1348 and JAdv Pract Oncol. 2019;10[suppl3]:11-20).

Typically, the toxicity comes in two waves. "The onset of cytokine release syndrome [CRS] occurs 24 to 48 hours after the cells are infused. It can last about a week. It looks a lot like sepsis," she explained. "Then the neurotoxicity comes on day5 or 6, and can last days to weeks," she said, noting that it usually overlaps CRS.

If patients have severe CRS, "we predict they'll have severe neurotoxicity as well," she added. And patients with a higher burden of disease tend to have higher-grade toxicities. "You can sort of see that coming."

These patients undergo an infection workup, and treatment with antibiotics and tocilizumab usually resolves the infusion reaction. "Having vigilant advanced care at the bedside plays a role in identifying and treating symptoms," Spendley explained. Both CRS and neurotoxicity can be fatal when not treated quickly.

Before CAR T-cell treatment is administered, patients are assessed for comorbidities, performance status, and organ function. "They need to be able to tolerate these toxicities if they become severe," she noted.

But the results of CAR T-cell therapy are nothing short of amazing, she emphasized at the Association of Physician Assistants in Oncology 2019 Annual Symposium in Boston. "That someone suffering so much from their disease can, days to weeks later, be in complete remission is remarkable. It's truly ground-breaking for the lymphoma landscape."

The Centers for Medicare and Medicaid Services recently announced that the costly therapy would be covered for indications approved by the US Food and Drug Administration along with some off-label uses in hospitals that participate in the Risk Evaluation and Mitigation Strategy (REMS) program, as reported by Medscape Medical News.

For children with acute lymphoblastic leukemia, the therapy costs $475,000; for adults with diffuse large B-cell lymphoma, it costs $373,000. Until now, this was out of reach for patients without insurance or other means to foot the bill.

But care teams need to be ready for increased demand. Centers offering the therapy will benefit from a dedicated team, Spendley asserted. "At our center, we can now accommodate a larger volume of patients without missing a beat because we are prepared with the knowledge and experience to know the signs of complications," she said.

The treatment can be highly effective, "making the tumor disappear within days," said Kadee Raser, PA-C, CAR T-cell therapy lead at the University of Michigan Rogel Cancer Center in Ann Arbor.

She described a patient with a tumor on the side of her neck: "Just days after the CAR T-cell therapy, you visibly saw the area shrink dramatically and go away. You don't typically ever see that with standard-therapy radiation."

These patients can end up in the ICU. It's different than your typical transplant or chemo.

However, the toxic effects of the therapy "can get complicated," Raser told Medscape Medical News. These patients "can end up in the ICU. It's different than your typical transplant or chemo."

"We watch these patients very closely," she added.

The Rogel Cancer Center did its first CAR T-cell infusions when the treatment was in its infancy and then developed a dedicated program.

"It helps that our advanced providers were involved from the beginning," said Adrienne Trentacosti, PA-C, outpatient CAR T-cell therapy lead at Rogel. "We have a rapidly growing team of nurse practitioners and physician assistants with CAR-T knowledge who work interchangeably to manage patients."

A physician always performs the preliminary patient consult, Trentacosti said, but once the patient is deemed suitable in a team meeting, advanced practitioners including nurse practitioners and physician assistants set up the therapy and follow the patient through to recovery.

"We're the continuity, the glue, that holds the treatment together, and the daily connection to the patient," she said. That makes it easier to identify any change in the patient. "Assistant practitioners don't rotate; we're always there. Physicians move from inpatient to research to something else."

"We spend more time with the patient than the physicians or nurses are able to," she added.

As the general population ages, oncology will continue to be a growing field for physician assistants. "We're going to see more oncology patients," Trentacosti noted.

Because "the cellular therapy program is fairly new, we're just now hiring dedicated staff, dedicated social workers, and dedicated physician assistants for CAR T-cell therapy," she added. "We're expanding rapidly. I just hired four new people."

There is a lot of interest and excitement about the therapy, Raser confirmed, but she warned that the final results are not in yet. "We're a little early in speaking to the durability of the treatment." she said. "We don't know how long it lasts. We are still learning."

Spendley, Raser, and Trentacosti have disclosed no relevant financial relationships.

Association of Physician Assistants in Oncology (APAO) 2019 Annual Symposium.

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Know-How About New CAR-T Cell Therapies Shifting - Medscape

Advances Of Chimeric Antigen Receptor T Cell Therapy In Ovarian Cancer | OTT – Dove Medical Press

Wenying Yan,1 Hongmei Hu,2 Biao Tang2

1Department of Gynecology, Wangjiang Hospital, Sichuan University, Chengdu, Sichuan Province, Peoples Republic of China; 2Department of Gynecology, Sichuan Maternal and Child Health Hospital, Chengdu, Sichuan Province, Peoples Republic of China

Correspondence: Biao TangDepartment of Gynecology, Sichuan Maternal and Child Health Hospital, No. 290 Shayan West Second Street, Jinyang Road, Chengdu City, Sichuan Province 610041, Peoples Republic of ChinaTel +86 28 8546 3088Email 286546430@qq.com

Abstract: Ovarian cancer, as a common gynecological tumor, is currently recognized as the most lethal gynecological malignancy. In addition to conventional treatment methods such as surgery, radiotherapy and chemotherapy, adoptive immunotherapy represented by modified immune cells also shows good curative effects and is becoming an important method in the treatment of ovarian cancer. Studies have shown that most cancer cells can avoid the recognition of the immune system, thus limiting the anticancer effect of immunotherapy. Chimeric antigen receptor T (CAR-T) cell technology has emerged and has good targeting, killing, proliferation and persistence. A large number of clinical trials also have shown that this technology has achieved great success in improving the quality of life and prolonging the survival time of patients with malignant hematological tumors. CAR-T cell technology has become a research hotspot for immunotherapy. This article mainly reviews various CAR-T cell treatments and their specific mechanisms in the field of ovarian cancer treatment to provide new ideas for the treatment of ovarian cancer.

Keywords: immunotherapy, T cell, ovarian cancer, chimeric antigen receptor, tumor antigens

This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License.By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

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Advances Of Chimeric Antigen Receptor T Cell Therapy In Ovarian Cancer | OTT - Dove Medical Press

The time is now: John Cox assumes CEO post at Flagship-backed Torque, steering cell therapy to clinical trials – Endpoints News

A stealthy Torque Therapeutics is in the midst of raising a Series B round to bankroll an upcoming slate of clinical studies for its cancer cell therapy platform and it will all be overseen by a new CEO.

John Cox, executive chairman since January, is taking over from Bart Henderson as the former chief pursues some other work with Flagship Pioneering.

The appointment marks the first full-time gig for Cox since he flipped Biogens hemophilia-focused spinout Bioverativ to Sanofi for $11.6 billion, earning a payout worth more than $85 million in the process. The little taste he had of cell therapy there, albeit for a distinctly different application, helped convince him that its a modality for the future. He envisions Torque becoming the definitive immuno-oncology cell therapy company, and the time is now to jump in.

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The time is now: John Cox assumes CEO post at Flagship-backed Torque, steering cell therapy to clinical trials - Endpoints News