Adaptimmune Reports Fourth Quarter / Full Year 2019 Financial Results and Business Update – BioSpace

- Compelling data in synovial sarcoma in the Phase 1 trial, and continued momentum in the Phase 2 SPEARHEAD-1 trial with goal to launch ADPA2M4 for sarcoma in 2022 -

- Encouraging demonstration of the potential of SPEAR T-cell platform in four new solid tumor indications -

- Co-development and co-commercialization agreement with Astellas to develop stem-cell derived off-the-shelf CAR-T and TCR T-cell therapies -

PHILADELPHIA and OXFORDSHIRE, United Kingdom, Feb. 27, 2020 (GLOBE NEWSWIRE) -- Adaptimmune Ltd. plc(Nasdaq:ADAP), a leader in cell therapy to treat cancer, today reported financial results for the fourth quarter and year endedDecember 31, 2019, and provided a business update.

The last 12 months have been transformative. We reported responses in five different solid tumors, confirming that our SPEAR T-cell platform can treat a wide range of cancers. We also validated the potential of our allogeneic platform by demonstrating that we can generate functional T-cells from stem cells, and by signing our first major strategic deal in five years with Astellas, said Adrian Rawcliffe, Adaptimmunes Chief Executive Officer. With our passionate and skilled teams, and our world class capabilities, we are developing our cell therapy pipeline for a range of tumor indications, aiming to launch our first product in 2022 for people with sarcoma.

Responses in five solid tumor indications demonstrate SPEAR T-cell potential to treat cancerBased on compelling response data in synovial sarcoma from the Phase 1 trial announced in May of last year, and updated at ESMO and CTOS, the Phase 2 SPEARHEAD-1 trial was initiated with ADP-A2M4 in synovial sarcoma and myxoid/ round cell liposarcoma (MRCLS). The product was granted Orphan Drug Designation, for the treatment of soft tissue sarcomas, and Regenerative Medicine Advanced Therapy designation, for synovial sarcoma, by the US FDA. The Company aims to launch ADPA2M4 for sarcoma in 2022.

In January of this year, partial responses in liver, melanoma, gastro-esophageal junction, and head and neck cancers were reported. These early data in multiple indications demonstrate the potential of Adaptimmunes SPEAR T-cell platform across multiple targets and a range of solid tumors. Further updated data will be presented at upcoming medical / scientific meetings.

Partnerships to develop next-generation and off-the-shelf cell therapiesIn January of this year, a co-development and co-commercialization agreement with Astellas, through its wholly owned subsidiary Universal Cells, Inc., was announced for stem-cell derived allogeneic CAR-T and TCR T-cell therapies. The Company has received an upfront payment of $50 million under the agreement and is entitled to receive research funding of up to $7.5 million per year.

This agreement covers the co-development and co-commercialization of up to three T-cell therapies and leverages Astellas Universal Donor Cell Platform and Adaptimmunes stem-cell derived allogeneic T-cell platform. This new collaboration may encompass both CAR-T and TCR T-cell approaches, including Adaptimmunes novel HLA-independent TCR (HiT) platform.

In 2019, Adaptimmune announced agreements with Alpine Immune Sciences and Noile-Immune to develop further next-generation products.

Leadership, manufacturing and financial updates strengthen fully integrated cell therapy company positionAdrian Rawcliffe assumed the role of Chief Executive Officer effective September 1, 2019 and John Lunger became Chief Patient Supply Officer effective August 1, 2019. In January 2020, a series of changes to the R&D leadership were announced, including the appointment of Elliot Norry as Chief Medical Officer. These leadership changes strengthen the scientific and clinical organization from early to late stage and accelerate the application of translational science learnings to therapeutic candidates and trials, as Adaptimmune becomes a late-stage cell therapy company aiming to launch a commercial product in 2022.

Adaptimmunes in-house cell manufacturing facility located at the Navy Yard in Philadelphia, PA, is achieving a 25-day processing time for production of SPEAR T-cells. 95% of patient batches manufactured in 2019 met manufacturing criteria set for those batches. The Navy Yard facility was approved as a manufacturing source for a number of the Companys clinical trials in Europe. The Company also produced its first GMP batch of lentiviral vector using an in-house, proprietary suspension process at its dedicated manufacturing space within the Cell and Gene Therapy Catapult Manufacturing Centre at Stevenage, UK.

Finally, on January 24, 2020, the Company closed an underwritten public offering of 21,000,000 American Depository Shares (ADSs) which, together with the full exercise by the underwriters on February 7, 2020 of their option to purchase an additional 3,150,000 ADSs, generated net proceeds of approximately$89.8 million. Following the agreement with Astellas and the public offering of ADSs described above, the Company is funded into 2H 2021.

Planned 2020 milestonesFirst Half of 2020

Second Half of 2020

Financial Results for the fourth quarter and year ended December 31, 2019

Financial GuidanceThe Company believes that its existing cash and cash equivalents and marketable securities, Total Liquidity, together with the net proceeds received from the underwritten public offering in January 2020, the additional net proceeds generated from the exercise in full of the underwriters option in February 2020 and the upfront payment received under its agreement with Astellas in January 2020, will fund the Companys current operating plan into the second half of 2021.

Conference Call InformationThe Company will host a live teleconference and webcast to provide additional details at 8:00 a.m. EST (1:00 p.m. GMT) today, February 27, 2020. The live webcast of the conference call will be available via the events page of Adaptimmunes corporate website at http://www.adaptimmune.com. An archive will be available after the call at the same address. To participate in the live conference call, if preferred, please dial (833) 652-5917 (U.S. or Canada) or +1 (430) 775-1624 (International). After placing the call, please ask to be joined into the Adaptimmune conference call and provide the confirmation code (6083408).

About AdaptimmuneAdaptimmune is a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapy products for people with cancer. The Companys unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors.

Forward-Looking StatementsThis release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA). These forward-looking statements involve certain risks and uncertainties. Such risks and uncertainties could cause our actual results to differ materially from those indicated by such forward-looking statements, and include, without limitation: the success, cost and timing of our product development activities and clinical trials and our ability to successfully advance our TCR therapeutic candidates through the regulatory and commercialization processes. For a further description of the risks and uncertainties that could cause our actual results to differ materially from those expressed in these forward-looking statements, as well as risks relating to our business in general, we refer you to our Quarterly Report on Form 10-Q filed with the SEC on November 6, 2019, and our other SEC filings. The forward-looking statements contained in this press release speak only as of the date the statements were made and we do not undertake any obligation to update such forward-looking statements to reflect subsequent events or circumstances.

Total Liquidity (a non-GAAP financial measure)Total Liquidity is the total of cash and cash equivalents and marketable securities. Each of these components appears in the Companys Consolidated Balance Sheet. The U.S. GAAP financial measure most directly comparable to Total Liquidity is cash and cash equivalents as reported in the Companys Consolidated Financial Statements, which reconciles to Total Liquidity as follows (unaudited):

The Company believes that the presentation of Total Liquidity provides useful information to investors because management reviews Total Liquidity as part of its management of overall liquidity, financial flexibility, capital structure and leverage. The definition of Total Liquidity includes marketable securities, which are highly liquid and available to use in our current operations.

Consolidated Statement of Operations(unaudited, in thousands, except per share data)

Consolidated Balance Sheets(unaudited, in thousands)

Consolidated Cash Flow Statement(unaudited, in thousands)

Adaptimmune Contacts:

Media Relations:

Sbastien Desprez VP, Communications and Investor RelationsT: +44 1235 430 583M: +44 7718 453 176Sebastien.Desprez@adaptimmune.com

Investor Relations:

Juli P. Miller, Ph.D. Senior Director, Investor RelationsT: +1 215 825 9310M: +1 215 460 8920Juli.Miller@adaptimmune.com

1 Total liquidity is a non-GAAP financial measure, which is explained and reconciled to the most directly comparable financial measures prepared in accordance with GAAP below.

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Adaptimmune Reports Fourth Quarter / Full Year 2019 Financial Results and Business Update - BioSpace

Global Stem Cell Market Poised for Strong Growth as Global Regenerative Medicine Market Poised to Reach US$45 billion by 2025 – P&T Community

DUBLIN, Feb. 27, 2020 /PRNewswire/ -- The "Stem Cell Banking - Market Analysis, Trends, and Forecasts" report has been added to ResearchAndMarkets.com's offering.

The growing interest in regenerative medicine which involves replacing, engineering or regenerating human cells, tissues or organs, will drive market growth of stem cells. Developments in stem cells bioprocessing are important and will be a key factor that will influence and help regenerative medicine research move into real-world clinical use. The impact of regenerative medicine on healthcare will be comparable to the impact of antibiotics, vaccines, and monoclonal antibodies in current clinical care. With the global regenerative medicine market poised to reach over US$45 billion by 2025, demand for stem cells will witness robust growth.

Another emerging application area for stem cells is in drug testing in the pharmaceutical field. New drugs in development can be safely, accurately, and effectively be tested on stem cells before commencing tests on animal and human models. Among the various types of stem cells, umbilical cord stem cells are growing in popularity as they are easy and safe to extract. After birth blood from the umbilical cord is extracted without posing risk either to the mother or the child. As compared to embryonic and fetal stem cells which are saddled with safety and ethical issues, umbilical cord is recovered postnatally and is today an inexpensive and valuable source of multipotent stem cells. Until now discarded as waste material, umbilical cord blood is today acknowledged as a valuable source of blood stem cells. The huge gap between newborns and available cord blood banks reveals huge untapped opportunity for developing and establishing a more effective banking system for making this type of stem cells viable for commercial scale production and supply. Umbilical cord and placenta contain haematopoietic blood stem cells (HSCs). These are the only cells capable of producing immune system cells (red cells, white cells and platelet).

HSCs are valuable in the treatment of blood diseases and successful bone marrow transplants. Also, unlike bone marrow stem cells, umbilical cord blood has the advantage of having 'off-the-shelf' uses as it requires no human leukocyte antigen (HLA) tissue matching. Developments in stem cell preservation will remain crucial for successful stem cell banking. Among the preservation technologies, cryopreservation remains popular. Development of additives for protecting cells from the stresses of freezing and thawing will also be important for the future of the market. The United States and Europe represent large markets worldwide with a combined share of 60.5% of the market. China ranks as the fastest growing market with a CAGR of 10.8% over the analysis period supported by the large and growing network of umbilical cord blood banks in the country. The Chinese government has, over the years, systematically nurtured the growth of umbilical cord blood (UCB) banks under the 'Developmental and Reproductive Research Initiation' program launched in 2008. Several hybrid public-private partnerships and favorable governmental licensing policies today are responsible for the current growth in this market.

Competitors identified in this market include:

Companies Mentioned

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Creative Medical Technology Holdings Inc (OTCMKTS: CELZD) Gets the Extra D – MicroCap Daily

Creative Medical Technology Holdings Inc (OTCMKTS: CELZD) is the new temporary ticker symbol for Creative Medical since the Company affected a 1 for 150 reverse stock split. According to the Company the reverse split of our stock was a decision that did not come lightly. In order to secure more competitive financing terms and to reduce existing convertible debt, the company needed to return to the OTCQB. As the fundamentals of the company continue to expand and commercialization is ramped up, this was determined to be necessary for the long-term benefit to the company and its shareholders. The reverse affected ALL shareholders, including founding shareholders, Officers and Directors, who have substantial holdings in CELZ stock as well said Timothy Warbington CEO.

Microcapdaily has been reporting on CELZ for years; on November 18, 2018 we stated: CELZ is an exciting stock that has attracted legions of shareholders who see big things happening here. CELZ flagship CaverStem has the only procedure to treat Erectile Dysfunction with adult stem cells in the US. CELZ has runner in its blood and a long history of huge moves skyrocketing from $0.002 in March of last year to highs topping $0.07 per share in August, CELZ loves to run and is a volume leader regularly among the top most traded on the OTCBB.

Creative Medical Technology Holdings Inc (OTCMKTS: CELZ)is a commercial-stage biotechnology company focused on Urology and Neurology using stem cell treatments. The companys team consists of leading international researchers in regenerative medicine with a science-first approach to treatments ensuring that all of its treatments are proven to be both safe and effective. CELZ is engaged in stem cell research and applications for use to treat male and female sexual dysfunction, infertility and related issues. It holds a patent for its erectile dysfunction (ED) treatment and was granted a license by Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, a non-profit biomedical research and education institute (LABIOMED), for the infertility treatment. It has also filed a patent application focused on physical manifestations of female sexual arousal disorder, as an extension of the work with stem cell therapies for ED.

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Creative Medical is currently in the commercial stage of its bone marrow based stem cell treatment for Erectile Dysfunction known as CAVERSTEM, which is being marketed both nationally, and internationally. Earlier this year the Company formed the subsidiary CaverStem International LLC for the purpose of commercializing its erectile dysfunction technology to international physicians.

In a recent update on StemSpine Thomas Ichim PhD of CELZ stated StemSpine will surely be welcomed by the over 50 million Americans suffering from CLBP in the United States as a drug free alternative. Currently, there are minimal treatment options for patients that suffer from this debilitating pain, with roughly 50% of patients progressing to opioids and surgery. I have been thrilled with the positive reception of StemSpine across all fronts as we quietly progressed the program forward over the last few months, said Timothy Warbington, President and CEO of Creative Medical Technology Holdings, Inc. I am especially energized by the positive reception from potential healthcare providers who have overwhelmingly confirmed this is a necessary and highly desirable alternative to current treatment options. We look forward to partnering with these providers and bringing this therapy to the forefront in 2020 for the benefit of the many patients that stand to benefit from it and for our shareholders as we think it will drive tremendous value for the organization.

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Currently on the move since affecting a 1 for 150 reverse CELZ is fully reporting OTCBB, has minimal cash in the treasury, $3.9 million in current liabilities and some revenues reporting $169k in sales in 2019. we stated in 2016: CELZ is an exciting Company developing in small caps; CELZ flagship CaverStem has the only procedure to treat Erectile Dysfunction with adult stem cells in the US. The erectile dysfunction market is booming! According to a recent report from ResearchAndMarkets.com, the size of the global erectile dysfunction market is expected to reach $4.25 billion by 2023. CELZ loves to run and is a volume leader regularly among the top most traded on the OTCBB.We will be updating on CELZ when more details emerge so make sure you are subscribed to Microcapdaily so you know whats going on with CELZ.

Disclosure: we hold no position in CELZ either long or short and we have not been compensated for this article.

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Creative Medical Technology Holdings Inc (OTCMKTS: CELZD) Gets the Extra D - MicroCap Daily

If medications fail, surgery option for treating infectious retinitis – Ophthalmology Times

Viral retinitis is a rare disease that implies involvement of Herpesviridae, a family of double-stranded DNA viruses characterized by latency within the hosts cells after the primary infection, according to J. Fernando Arevalo, MD, PhD, FACS.

Dr. Arevalo is the Edmund F. and Virginia Ball professor of ophthalmology, and chairman of ophthalmology, Johns Hopkins Bayview Medical Center, Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore.

The viruses implicated include herpes simplex virus (HSV), varicella zoster virus (VZV), herpes zoster viruses, cytomegalovirus (CMV), and perhaps Epstein Barr virus.

Related: New vitreoretinal tools advancing surgical outcomes

The CMV retinitis virus is the most frequently occurring ocular opportunistic infection in patients with AIDS. Before the advent of combination antiretroviral therapy, CMV retinitis developed in 30% of these patients and afterward in less than 1%.

Patients with AIDS are not the only group in which CMV retinitis can occur. Others include neonates and those in whom immunosuppression was induced, such as after organ transplantation, hematopoietic stem cell transplantation, malignancy, or other causes, Dr. Arevalo noted.

When these patients present, optical coherence tomography can be used to diagnose atrophic retinal detachments resulting from the very thin retinal tissue and exudative retinal detachments in the macula, he advised.

Related: OCT artifacts and pitfalls: In the eye of the beholder

Polymerase chaine reactionAccording to Dr Arevalo, polymerase chain reaction (PCR) can be performed to diagnose the CMV retinitis; while 50- to 100-l tissue samples are ideal, the disease can be diagnosed with as little as 1 l of tissue.

Once diagnosed, CMV retinitis can be treated with intravenous ganciclovir (5 mg/kg every 12 hours for two weeks and 5 mg/kg/day for maintenance) or oral valganciclovir (Valcyte, Genentech) (induction dose, 900 mg twice daily for three weeks and 900 mg once daily for maintenance). Intravitreal antiviral drug implants for CMV retinitis include ganciclovir (2-5 mg/0.05-0.1 l) and foscarnet (Foscavir, Pfizer) (2.4 mg/0.1 l).

According to Dr. Arevalo, retinal detachments develop in about 20% of this patient population. This detachment rate may decrease with improved therapies.

The number of patients in whom CMV retinitis develops has decreased, which, in turn, decreases the number of retinal detachments.

He noted that the extent and activity of the retinitis are risk factors for detachment. It is imperative to monitor this in patients and prepare a treatment plan.

With longer patient survival, the need is great for a surgical strategy that will provide the best long-term visual outcome, he said.

Related: Surgeon provides pearls for handling retinal tears

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If medications fail, surgery option for treating infectious retinitis - Ophthalmology Times

Aspire Regenerative Medical Director Featured on New Podcast – PR Web

Aspire Regenerative

SAN DIEGO (PRWEB) February 27, 2020

Dr. Ryan McNally, the medical director of Aspire Regenerative, is the featured guest on Dr. Hanisha Patels natural health podcast, Mahan Health. The episode, New Year, Younger You?, focuses on the latest developments in medicine and technology that promote aging well and gracefully. It is currently available on all major podcast platforms.

During the lively and informative episode, Dr. McNally shares his expertise in the field of regenerative medicine and how it can help rejuvenate healthy tissues. The ultimate goal of these therapies is to slow down the progression of aging and prolong overall wellness. Subjects that Dr. McNally explores during the podcast include stem cell therapy, platelet-rich plasma (PRP) therapy, and products derived from fetal tissue found in cord blood, placental tissue, and perinatal fluid. One of the most promising new areas of regenerative medicine that Dr. McNally discusses is stem cell derived-exosome therapy, which uses the part of a cell that is rich in growth factors.

Dr. McNally is responsible for guiding the vision of Aspire Regenerative, a state-of-the-art facility in San Diego that delivers integrative and technologically advanced medical care. He also oversees the development and implementation of science, research, and technology at Aspire. Dr. McNally is a licensed naturopathic doctor with multiple certifications in regenerative medicine, aesthetics, and injection therapies. In addition, he is a faculty member at the Academy of Integrative Health and Medicine and an adjunct faculty member at Bastyr University California, where he formerly served as chief medical officer. A sought-after speaker at conferences and universities, Dr. McNally also publishes articles in peer-reviewed professional journals and frequently serves as a guest expert for podcasts, magazines, and newspapers.

About Aspire Regenerative: Aspire Regenerative is a state-of-the-art medical practice offering personalized regenerative treatments and integrative therapies to help patients reach their goals and achieve the best possible results. We have reinvented medical care by incorporating the principle of cell and tissue regeneration, which translates to youthful and vibrant function. Our in-depth expertise and collaboration with researchers allow us to integrate innovative technology into individualized patient care with therapies that are safe and effective. For more information, visit https://aspireregenerativehealth.com/.

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BTK Inhibitors Offer Improved Response Over Chemotherapy in Mantle Cell Lymphoma – Curetoday.com

Patients with relapsed/refractory mantle cell lymphoma saw more favorable responses with the BTK inhibitor Imbruvica (ibrutinib) than with chemotherapy, according to nearly a decade of data.

In an interview with CUREs sister publication, OncLive, Dr. Simon Rule went into greater detail about the pooled findings of this research and the use of BTK inhibitors in MCL.

BTK inhibitors are very exciting drugs, said Rule, of Plymouth University Medical School in England. When you use drugs earlier (in the treatment cycle), you get better responses, and that is what we saw, so it wasnt a surprise. The surprise was how effective they were in the best patients. The patients who are getting the best responses to chemotherapy get even better responses with ibrutinib.

Researchers pooled data from 370 patients over seven and a half years from the SPARK, RAY and PCYC-1104 trials, in which individuals with MCL received a dose of Imbruvica each day until the disease progressed or they experienced unacceptable toxicity. The patients who benefitted from this treatment were then enrolled in the long-term analysis that were presented at ASH.

Patients remained on this targeted therapy for a median of 11.1 months. Nearly a third of patients remained on treatment for at least two years, with about half of those remaining continuing treatment for four years or more.

No new toxicities were seen in patients, which Rule considered encouraging. However, patients experienced grade 3 or higher side effects such as neutropenia (17%), pneumonia (13.5%), atrial fibrillation (5.7%) and dyspnea (4.3%). Additionally, 11.4% of patients developed secondary malignancies, which were primarily nonmelanoma skin cancer.

The median progression-free survival (PFS) was 12.5 months with Imbruvica compared with a median PFS of 10.9 months with each patients most recent prior line of therapy. The researchers also noted that 27% of patients remained progression-free for one year or longer than they did with their prior regimen.

With MCL, when you use chemotherapy, each time you use a different kind of chemotherapy, you get less of a response, said Rule. This is a common complication with lymphomas. With MCL when using ibrutinib, we find that ibrutinib responses are generally better compared with the prior therapy.

In terms of what next steps will be taken as a result of these findings, Rule noted that more research is needed.

Its clear that the earlier we use the drug, the better the outcome, he said. The next steps are using the drugs upfront.

Rule is currently running a trial in United Kingdom comparing the frontline combination of Imbruvica and Rituxan (rituximab) to chemotherapy in older patients. This trial will tell us whether its better than chemotherapy, Rule explained.

It is very clear that early use of drug combinations is the way we are going to be going with this disease, and chemotherapy may very well become a thing of the past.

A version of this article previously appeared on OncLive as Rule Highlights Continued Benefit with Ibrutinib in Relapsed-Refractory MCL

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Global Regenerative Medicine Market Briefing 2020, Trends, Applications, Types, Research, Forecast To 2025 – Bandera County Courier

MRInsights.biz, the leading business intelligence provider, has published its latest research Global Regenerative Medicine Market Growth (Status and Outlook) 2020-2025 which envelopes all-in information of the market and the nature of the market growth over the anticipated period from 2020 to 2025. With reliable and impactful research methodologies, analysts have served critical information pertaining to the growth of the global Regenerative Medicine market. Our experts team of analysts has monitored the current developments within the market. The report contains market dynamics to help you plan effective growth strategies and prepare for future challenges beforehand. It examines the consumption pattern of each segment and the factors affecting the pattern.

Detailed profiles of companies in the market included are in the scope of the report to evaluate their long-term and short-term strategies. Key players in the market include: DePuy Synthes, Osiris Therapeutics, Medtronic, Stryker, Acelity, ZimmerBiomet, UniQure, MiMedx Group, Cellular Dynamics International, Organogenesis, Vericel Corporation, Mesoblast, Guanhao Biotech, Vcanbio, Cytori, Golden Meditech, Bellicum Pharmaceuticals, Celgene, Gamida Cell, Stemcell Technologies

DOWNLOAD FREE SAMPLE REPORT: https://www.mrinsights.biz/report-detail/225335/request-sample

A Brief Introduction On Competitive Landscape:

The report concentrates on leading players working in the global Regenerative Medicine market along with their company information, product profile, product specification, picture, capacity, production, price, cost, global investment plans, and supply-demand scenarios are also included. Additionally, analysis of upstream raw materials, downstream demand and current market dynamics has been provided.

The report contains historical data from 2015 to 2019 along with a forecast from 2020 to 2025 based on revenue. The report identifies opportunities available in the market along with challenges, risks, obstructs, and other issues that may occur in the future. The market is further divided by company, by country, and by application/type for the competitive landscape analysis. Some new, some established players, and a few getting to arrive within the worldwide Regenerative Medicine market are covered in this report. The study analyzes each segment based on their market size, growth rate, and general attractiveness.

This report also shows global Regenerative Medicine market import/export, supply, expenditure illustrations as well as cost, price, industry revenue and gross margin by regions covering Americas (United States, Canada, Mexico, Brazil), APAC (China, Japan, Korea, Southeast Asia, India, Australia), Europe (Germany, France, UK, Italy, Russia, Spain), Middle East & Africa (Egypt, South Africa, Israel, Turkey, GCC Countries)

The product types covered in the report include: Cell Therapy, Tissue Engineering, Biomaterial,

The application types covered in the report include: Dermatology, Cardiovascular, CNS, Orthopedic, Other

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New study identifies trigger that turns dormant cancer stem cells into active ones – Yahoo Finance

A new study released today in STEM CELLS identifies, for the first time, two morphologically and functionally different types of cancer stem cells found in cervical cancer.

DURHAM, N.C., Feb. 26, 2020 /PRNewswire-PRWeb/ --A new study released today in STEM CELLS identifies, for the first time, two morphologically and functionally different types of cancer stem cells found in cervical cancer. Of the two types, one exhibits an overexpression of cPLA2, a key enzyme that triggers the transformation of dormant cancer stem cells into active ones, resulting in cervical cancer metastasis and recurrence. The information in this study could lead to new targets for treatments to halt tumor recurrence and metastatic spread. Also, it might accelerate the development of combination therapies.

The current standard of treatments for cervical cancer the second leading cause of cancer death in young women worldwide is radiotherapy and chemotherapy. However, the cancer's resistance to chemotherapy and radiation, combined with a tendency to metastasis in the lymph nodes or recur in the pelvis, leaves doctors searching for more effective treatments.

Cervical cancer stem cells (CCSCs) are considered the major culprit behind the cancer's ability to overcome these treatments. At the same time, a majority of cancer stem-like cells or tumor-initiating cells remain dormant. It takes a change in their microenvironment to spur them to metastasize.

"The mechanisms responsible for this must be identified to design more suitable therapies for the different subpopulations of cancer stem cells (CSCs) in various tissue-specific cancers," said Hua Guo, Ph.D., who headed up the investigation along with Yuchao He, Ph.D. The two are colleagues at Tianjin Medical University Cancer Institute and Hospital. Researchers at Tianjin University of Traditional Chinese Medicine and at the Center for Translational Cancer Research, Peking University First Hospital, also participated in the study.

Although several cell surface antigens have been identified in CCSCs, these markers vary among tumors because of CSC heterogeneity. However, whether these markers specifically distinguish CCSCs with different functions is unclear. The study published in STEM CELLS sought to resolve this question. And in fact, its findings demonstrate that CCSCs exist in two biologically distinct phenotypes, characterized by different levels of cPLA2 expression.

"Our study showed for the first time that overexpression of cPLA2 results in a phenotype associated with mesenchymal traits, including increased invasive and migration abilities. On the other hand, CCSCs with cPLA2 downregulation show dormant epithelial characteristics," said Dr. Guo. "In addition, cPLA2 regulates the reversible transition between mesenchymal and epithelial CCSC states through PKC, an atypical protein that governs cancer cell state changes."

Dr. He added, "Now that we know cPLA2 triggers this transformation, we believe that cPLA2 might be an attractive therapeutic target for eradicating different states of CCSCs to eliminate tumors more effectively."

"The novel study by Dr. Guo and team is of very high importance in understanding the transition between dormant cancer stem cells, which evade chemotherapy and radiation treatments, and actively dividing cells which can be better targeted, said Dr. Jan Nolta, Editor-in-Chief of STEM CELLS. "I applaud the group for this important discovery which will help researchers develop better treatments for cervical cancer."

###

The full article, "cPLA2 reversibly regulate different subsets of cancer stem cells transformation in cervical cancer," can be accessed at https://stemcellsjournals.onlinelibrary.wiley.com/doi/abs/10.1002/stem.3157.

Figure Caption: This study revealed that there are two morphologically and functionally distinct cancer stem cell populations regulated by cPLA2 in cervical cancer. cPLA2 might be a unique marker to identify different cancer stem cell populations and trigger quiescent epithelial cancer stem cells transform to invasive mesenchymal states. Overexpression of cPLA2 resulted in a CD44+CD24- phenotype with mesenchymal traits, whereas cervical cancer stem cells (CCSCs) with cPLA2 downregulation expressed CD133 and showed epithelial characteristics. cPLA2, as a key role to reversely regulate CCSCs states and EMT, might provide innovative therapeutic strategies intended to halt tumor recurrence and metastasis.

Story continues

About the Journal: STEM CELLS, a peer reviewed journal published monthly, provides a forum for prompt publication of original investigative papers and concise reviews. The journal covers all aspects of stem cells: embryonic stem cells/induced pluripotent stem cells; tissue-specific stem cells; cancer stem cells; the stem cell niche; stem cell epigenetics, genomics and proteomics; and translational and clinical research. STEM CELLS is co-published by AlphaMed Press and Wiley.

About AlphaMed Press: Established in 1983, AlphaMed Press with offices in Durham, NC, San Francisco, CA, and Belfast, Northern Ireland, publishes three internationally renowned peer-reviewed journals with globally recognized editorial boards dedicated to advancing knowledge and education in their focused disciplines. STEM CELLS (http://www.StemCells.com) is the world's first journal devoted to this fast paced field of research. THE ONCOLOGIST (http://www.TheOncologist.com) is devoted to community and hospital-based oncologists and physicians entrusted with cancer patient care. STEM CELLS TRANSLATIONAL MEDICINE (http://www.StemCellsTM.com) is dedicated to significantly advancing the clinical utilization of stem cell molecular and cellular biology. By bridging stem cell research and clinical trials, SCTM will help move applications of these critical investigations closer to accepted best practices.

About Wiley: Wiley, a global company, helps people and organizations develop the skills and knowledge they need to succeed. Our online scientific, technical, medical and scholarly journals, combined with our digital learning, assessment and certification solutions, help universities, learned societies, businesses, governments and individuals increase the academic and professional impact of their work. For more than 200 years, we have delivered consistent performance to our stakeholders. The company's website can be accessed at http://www.wiley.com.

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New study identifies trigger that turns dormant cancer stem cells into active ones - Yahoo Finance

Editas Medicine Announces Fourth Quarter and Full Year 2019 Results and Update – Yahoo Finance

Announcement of first patient dosing with EDIT-101 (AGN-151587) expected in 1Q20

Plan to file IND for EDIT-301 for sickle cell disease by end of 2020

Research collaboration with Sandhill Therapeutics accelerates IND-enabling studies for allogeneic healthy donor NK program to treat solid tumors in mid-2020

CAMBRIDGE, Mass., Feb. 26, 2020 (GLOBE NEWSWIRE) -- Editas Medicine, Inc. (EDIT), a leading genome editing company, today reported business highlights and financial results for the fourth quarter and full year 2019.

We are entering 2020 with strong momentum and a strategic focus on driving our pipeline of in vivo CRISPR and engineered cell medicines forward with the ultimate vision of developing differentiated, transformational medicines for people living with serious diseases, said Cynthia Collins, Chief Executive Officer of Editas Medicine. Our team is making history with the first ever clinical trial of an in vivo CRISPR medicine, advancing our broader pipeline of in vivo CRISPR medicines, and progressing our engineered cell medicines for hemoglobinopathies and cancers. With our recent achievements, I expect our clinical pipeline to yield a robust and sustainable portfolio of differentiated, transformative medicines and ensure the Companys long-term growth.

Recent Achievements and Outlook

In VivoCRISPR Medicines

Engineered Cell Medicines

Corporate

Upcoming Events

Editas Medicine will participate in the following investor events:

Editas Medicine will participate in the following scientific and medical conferences:

Fourth Quarter and Full Year 2019 Financial Results

Cash, cash equivalents, and marketable securities at December 31, 2019, were $457.1 million, compared to $332.6 million at September 30, 2019, and $369.0 million at December 31, 2018.

For the three months ended December 31, 2019, net loss was $37.8 million, or $0.74 per share, compared to $25.1 million, or $0.52 per share, for the same period in 2018.

For the full year 2019, net loss was $133.7 million, or $2.68 per share, compared to $110.0 million, or $2.33 per share, for the same period in 2018.

Conference Call

The Editas Medicine management team will host a conference call and webcast today at 5:00 p.m. ET to provide and discuss a corporate update and financial results for the fourth quarter and full year 2019. To access the call, please dial 844-348-3801 (domestic) or 213-358-0955 (international) and provide the passcode 1609775. A live webcast of the call will be available on the Investors & Media section of the Editas Medicine website at http://www.editasmedicine.com and a replay will be available approximately two hours after its completion.

About Editas MedicineAs a leading genome editing company, Editas Medicine is focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cas12a (also known as Cpf1) genome editing systems into a robust pipeline of treatments for people living with serious diseases around the world. Editas Medicine aims to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for a broad class of diseases. For the latest information and scientific presentations, please visit http://www.editasmedicine.com.

About the Editas Medicine-Allergan AllianceIn March 2017, Editas Medicine and Allergan Pharmaceuticals International Limited (Allergan) entered a strategic alliance and option agreement under which Allergan received exclusive access and the option to license up to five of Editas Medicines genome editing programs for ocular diseases, including EDIT-101 (AGN-151587). Under the terms of the agreement, Allergan is responsible for development and commercialization of optioned products, subject to Editas Medicines option to co-develop and share equally in the profits and losses of two optioned products in the United States. In August 2018, Allergan exercised its option to develop and commercialize EDIT-101 globally for the treatment of LCA10. Additionally, Editas Medicine exercised its option to co-develop and share equally in the profits and losses from EDIT-101 in the United States. Editas Medicine is also eligible to receive development and commercial milestones, as well as royalty payments on a per-program basis. The agreement covers a range of first-in-class ocular programs targeting serious, vision-threatening diseases based on Editas Medicines unparalleled CRISPR genome editing platform, including CRISPR/Cas9 and CRISPR/Cas12a (also known as Cpf1).

Story continues

Forward-Looking StatementsThis press release contains forward-looking statements and information within the meaning of The Private Securities Litigation Reform Act of 1995. The words anticipate, believe, continue, could, estimate, expect, intend, may, plan, potential, predict, project, target, should, would, and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements in this press release include statements regarding the Companys plans with respect to the Brilliance Phase 1/2 clinical trial for EDIT-101 (AGN-151587), including expecting an announcement of dosing in Q1 2020, filing an IND for EDIT-301 by the end of the year and initiating IND-enabling studies for an experimental medicine to treat solid tumors in mid-2020. The Company may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: uncertainties inherent in the initiation and completion of pre-clinical studies and clinical trials and clinical development of the Companys product candidates; availability and timing of results from pre-clinical studies and clinical trials; whether interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; expectations for regulatory approvals to conduct trials or to market products and availability of funding sufficient for the Companys foreseeable and unforeseeable operating expenses and capital expenditure requirements. These and other risks are described in greater detail under the caption Risk Factors included in the Companys most recent Quarterly Report on Form 10-Q, which is on file with the Securities and Exchange Commission, and in other filings that the Company may make with the Securities and Exchange Commission in the future. Any forward-looking statements contained in this press release representCompanysviews only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law,the Companyexplicitly disclaims any obligation to update any forward-looking statements.

Investor ContactMark Mullikin(617) 401-9083mark.mullikin@editasmed.com

Media ContactCristi Barnett(617) 401-0113cristi.barnett@editasmed.com

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Editas Medicine Announces Fourth Quarter and Full Year 2019 Results and Update - Yahoo Finance

On the Road to 3-D Printed Organs – The Scientist

For years, scientists have predicted that 3-D printingwhich has been used it to make toys, homes, scientific tools and even a plastic bunny that contained a DNA code for its own replicationcould one day be harnessed to print live, human body parts to mitigate a shortage of donor organs. So far, researchers also used 3-D printing in medicine and dentistry to create dental implants, prosthetics, and models for surgeons to practice on before they make cuts on a patient. But many researchers have moved beyond printing with plastics and metalsprinting with cells that then form living human tissues.

No one has printed fully functional, transplantable human organs just yet, but scientists are getting closer, making pieces of tissue that can be used to test drugs and designing methods to overcome the challenges of recreating the bodys complex biology.

A confocal microscopy image showing 3-Dprinted stem cells differentiating into bone cells

The first 3-D printer was developed in the late 1980s. It could print small objects designed using computer-aided design (CAD) software. A design would be virtually sliced into layers only three-thousandths of a millimeter thick. Then, the printer would piece that design into the complete product.

There were two main strategies a printer might use to lay down the pattern: it could extrude a paste through a very fine tip, printing the design starting with the bottom layer and working upward with each layer being supported by the previous layers. Alternatively, it could start with a container filled with resin and use a pointed laser to solidify portions of that resin to create a solid object from the top down, which would be lifted and removed from the surrounding resin.

When it comes to printing cells and biomaterials to make replicas of body parts and organs, these same two strategies apply, but the ability to work with biological materials in this way has required input from cell biologists, engineers, developmental biologists, materials scientists, and others.

So far, scientists have printed mini organoids and microfluidics models of tissues, also known as organs on chips. Both have yielded practical and theoretical insights into the function of the human body. Some of these models are used by pharmaceutical companies to test drugs before moving on to animal studies and eventually clinical trials. One group, for example, printed cardiac cells on a chip and connected it to a bioreactor before using it to test the cardiac toxicity of a well-known cancer drug, doxorubicin. The team showed that the cells beating rate decreased dramatically after exposure to the drug.

However, scientists have yet to construct organs that truly replicate the myriad structural characteristics and functions of human tissues. There are a number of companies who are attempting to do things like 3-D print ears, and researchers have already reported transplanting 3-D printed ears onto children who had birth defects that left their ears underdeveloped, notes Robby Bowles, a bioengineer at the University of Utah. The ear transplants are, he says, kind of the first proof of concept of 3-D printing for medicine.

THE SCIENTIST STAFF

Bowles adds that researchers are still a ways away from printing more-complex tissues and organs that can be transplanted into living organisms. But, for many scientists, thats precisely the goal. As of February 2020, more than 112,000 people in the US are waiting for an organ transplant, according to the United Network for Organ Sharing. About 20 of them die each day.

For many years, biological engineers have tried to build 3-D scaffolds that they could seed with stem cells that would eventually differentiate and grow into the shapes of organs, but to a large extent those techniques dont allow you to introduce kind of the organization of gradients and the patterning that is in the tissue, says Bowles. There is no control over where the cells go in that tissue. By contrast, 3-D printing enables researchers with to very precisely direct the placement of cellsa feat that could lead to better control over organ development.

Ideally, 3-D printed organs would be built from cells that a patients immune system could recognize as its own, to avoid immune rejection and the need for patients to take immunosuppressive drugs. Such organs could potentially be built from patient-specific induced pluripotent stem cells, but one challenge is getting the cells to differentiate into the subtype of mature cell thats needed to build a particular organ. The difficulty is kind of coming together and producing complex patternings of cells and biomaterials together to produce different functions of the different tissues and organs, says Bowles.

To imitate the patterns seen in vivo, scientists print cells into hydrogels or other environments with molecular signals and gradients designed to coax the cells into organizing themselves into lifelike organs. Scientists can use 3-D printing to build these hydrogels as well. With other techniques, the patterns achieved have typically been two-dimensional, Eben Alsberg, a bioengineer at the University of Illinois, tells The Scientist in an email. Three-dimensional bioprinting permits much more control over signal presentation in 3D.

So far, researchers have created patches of tissue that mimic portions of certain organs but havent managed to replicate the complexity or cell density of a full organ. But its possible that in some patients, even a patch would be an effective treatment. At the end of 2016, a company called Organovo announced the start of a program to develop 3-D printed liver tissue for human transplants after a study showed that transplanted patches of 3-D printed liver cells successfully engrafted in a mouse model of a genetic liver disease and boosted several biomarkers that suggested an improvement in liver function.

Only in the past few years have researchers started to make headway with one of the biggest challenges in printing 3-D organs: creating vasculature. After the patches were engrafted into the mouses liver in the Organovo study, blood was delivered to it by the surrounding liver tissue, but an entire organ would need to come prepared for blood flow.

For any cells to stay alive, [the organ] needs that blood supply, so it cant just be this huge chunk of tissue, says Courtney Gegg, a senior director of tissue engineering at Prellis Biologics, which makes and sells scaffolds to support 3-D printed tissue. Thats been recognized as one of the key issues.

Mark Skylar-Scott, a bioengineer at the Wyss Institute, says that the problem has held back tissue engineering for decades. But in 2018, Sbastian Uzel, Skylar-Scott, and a team at the Wyss Institute managed to 3-D print a tiny, beating heart ventricle complete with blood vessels. A few days after printing the tissue, Uzel says he came into the lab to find a piece of twitching tissue, which was both very terrifying and exciting.

For any cells to stay alive, [the organ] needs that blood supply, so it cant just be this huge chunk of tissue.

Courtney Gegg, Prellis Biologics

Instead of printing the veins in layers, the team used embedded printinga technique in which, instead of building from the bottom of a slide upwards, material is extruded directly into a bath, or matrix. This strategy, which allows the researchers to print free form in 3-D, says Skylar-Scott, rather having to print each layer one on top of the other to support the structure, is a more efficient way to print a vascular tree. The matrix in this case was the cellular material that made up the heart ventricle. A gelatin-like ink pushed these cells gently out of the way to create a network of channels. Once printing was finished, the combination was warmed up. This heat caused the cellular matrix to solidify, but the gelatin to liquify so it could then be rinsed out, leaving space for blood to flow through.

But that doesnt mean the problem is completely solved. The Wyss Institute teams ventricle had blood vessels, but not nearly as many as a full-sized heart. Gegg points out that to truly imitate human biology, an individual cell will have to be within 200 microns of your nearest blood supply. . . . Everything has to be very, very close. Thats far more intricate than what researchers have printed so far.

Due to hurdles with adding vasculature and many other challenges that still face 3-Dprinted tissues, laboratory-built organs wont be available for transplant anytime soon. In the meantime, 3-D printing portions of tissue is helping accelerate both basic and clinical research about the human body.

Emma Yasinski is a Florida-based freelance reporter. Follow her on Twitter@EmmaYas24.

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On the Road to 3-D Printed Organs - The Scientist