Data suggest gene, cell therapy trial initiations in Europe lag behind North America here’s why – Endpoints News

Over the last few years, as CRISPR/Cas9 gene editing tech became the AK47 of academic labs a handy, powerful weapon that could be pointed at multiple targets there has been a growing chorus of skeptics pointing to what they see as severe limitations to the technology. And gradually, some of the leaders in the field began to move to refinements aimed at whisking away the fretful doubts that had begun to nag at the pioneers.

But while superstar scientists like Feng Zhang were working on CRISPR 2.0, a small band of scientists has been hatching their own plans around creating a whole new branch of the disease editing field RNA editing. And the second startup in 3 months is now popping up to take its place in what it hopes will be a vanguard platform tech that can go places in vivo where CRISPR may be off limits.

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Data suggest gene, cell therapy trial initiations in Europe lag behind North America here's why - Endpoints News

Unum Therapeutics Announces Strategic Focus on Developing Best-in-Class Cellular Therapies for Solid Tumor Cancers | DNA RNA and Cells | News Channels…

DetailsCategory: DNA RNA and CellsPublished on Tuesday, 05 November 2019 10:32Hits: 189

- Solid tumor cancers represent the greatest unmet medical need for targeted cell therapies; Unums goals are to more selectively target solid tumors with its ACTR platform candidates and improve T cell functionality in the solid tumor microenvironment with its BOXR platform candidates -

- Priorities moving forward include completing its ongoing Phase 1 trial with ACTR707 in HER2+ cancers, filing an IND for BOXR1030, and expanding its BOXR platform for further pipeline expansion -

- Company to deemphasize hematologic programs with plans for limited dose-escalation in Phase 1 non-Hodgkin lymphoma trial and suspension of Phase 1 multiple myeloma trial -

CAMBRIDGE, MA, USA I November 04, 2019 I Unum Therapeutics Inc. (NASDAQ: UMRX), a clinical-stage biopharmaceutical company focused on developing curative cell therapies for cancer, today announced a strategic shift to focus development on its ACTR and BOXR product candidates in solid tumors and supportive platform capabilities.

We are uniquely positioned to address the challenge of treating solid tumor cancers, and now is the time to focus our efforts, having recently validated our ACTR technology in the hematologic setting and with preclinical data emerging from BOXR1030, the first product candidate from our BOXR platform. Our ACTR technology enables selective T cell targeting for on-tumor attack, while our BOXR platform makes it possible to overcome solid tumor immunosuppression, the fundamental challenge that has limited the effectiveness of cell therapies, said Chuck Wilson Ph.D., President and Chief Executive Officer of Unum. Our priorities in solid tumors include completing the ongoing Phase 1 trial of ACTR707 in HER2+ cancers; advancing BOXR1030 towards the clinic with an anticipated IND filing in 2020; and expanding our BOXR platform to accelerate discovery of new product candidates across a broad range of immune cell therapies, including both autologous and allogeneic approaches.

ACTR707 was engineered for properties that optimize its function in solid tumors including increased proliferation, cytokine secretion, and persistence. With Unums focus on developing therapies for solid tumors, the company will de-prioritize investment in its hematologic programs. Testing through the first four dose levels in the ongoing ATTCK-20-03 Phase 1 trial in non-Hodgkin lymphoma has now established proof-of-concept for ACTR707. Given favorable tolerability to date at relatively low doses, Unum is announcing today plans to continue limited dose escalation to inform potential future development of the program in 2020.

Separately, Unum and its partner, Seattle Genetics, Inc., have suspended further dose-escalation of the ATTCK-17-01 Phase 1 trial of ACTR087 with SEA-BCMA in multiple myeloma pending a further review of this program. No dose-limiting toxicities (DLTs) following ACTR087 administration were reported and no severe adverse events of cytokine release syndrome (CRS) or neurologic events have been observed to date.

Solid Tumor Program Highlights

Hematologic Program Highlights

About Unum Therapeutics

Unum Therapeutics is a clinical-stage biopharmaceutical company focused on developing curative cell therapies to treat a broad range of cancer patients. Unums novel proprietary technologies include Antibody-Coupled T cell Receptor (ACTR), an autologous engineered T-cell therapy that combines the cell-killing ability of T cells and the tumor-targeting ability of co-administered antibodies to exert potent antitumor immune responses, and Bolt-On Chimeric Receptor (BOXR), designed to improve the functionality of engineered T cells by incorporating a bolt-on transgene to overcome resistance of the solid tumor microenvironment to T cell attack. Unum has multiple programs in Phase 1 clinical testing and preclinical testing, including; ACTR707 used in combination with trastuzumab in adult patients with HER2+ advanced cancer and used in combination with rituximab in adult patients with r/r NHL; and BOXR1030 expressing the GOT2 transgene and targeting GPC3+ solid tumor cancers. The Company is headquartered in Cambridge, MA.

SOURCE: Unum Therapeutics

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Unum Therapeutics Announces Strategic Focus on Developing Best-in-Class Cellular Therapies for Solid Tumor Cancers | DNA RNA and Cells | News Channels...

Lineage Cell Therapeutics to Report Third Quarter 2019 Financial Results and Provide Business Update on November 12, 2019 – Business Wire

CARLSBAD, Calif.--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, announced today that it will report its third quarter 2019 financial and operating results on Tuesday, November 12, 2019, following the close of the U.S. financial markets. Lineage management will also host a conference call and webcast on Tuesday, November 12, 2019, at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its third quarter 2019 financial results and to provide a business update.

Interested parties may access the conference call by dialing (866) 888-8633 from the U.S. and Canada and (636) 812-6629 from elsewhere outside the U.S. and Canada and should request the Lineage Cell Therapeutics Call. A live webcast of the conference call will be available online in the Investors section of Lineages website. A replay of the webcast will be available on Lineages website for 30 days and a telephone replay will be available through November 19, 2019, by dialing (855) 859-2056 from the U.S. and Canada and (404) 537-3406 from elsewhere outside the U.S. and Canada and entering conference ID number 1473397.

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineages programs are based on its proprietary cell-based therapy platform and associated development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally-differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed either to replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineages clinical assets include (i) OpRegen, a retinal pigment epithelium transplant therapy in Phase I/IIa development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase I/IIa development for the treatment of acute spinal cord injuries; and (iii) VAC2, an allogeneic cancer immunotherapy of antigen-presenting dendritic cells currently in Phase I development for the treatment of non-small cell lung cancer. Lineage is also evaluating potential partnership opportunities for Renevia, a facial aesthetics product that was recently granted a Conformit Europenne (CE) Mark. For more information, please visit http://www.lineagecell.com or follow the Company on Twitter @LineageCell.

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Lineage Cell Therapeutics to Report Third Quarter 2019 Financial Results and Provide Business Update on November 12, 2019 - Business Wire

Allogene Therapeutics Reports Third Quarter 2019 Financial Results – Yahoo Finance

SOUTH SAN FRANCISCO, Calif., Nov. 05, 2019 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) therapies for cancer, today provided a corporate update and reported financial results for the quarter ended September 30, 2019.

I am very pleased with the progress we have made in a short period of time. While we leveraged the research from Pfizer to launch Allogene, we have built the company from the ground up. In parallel, we have initiated the build-out of in-house manufacturing capabilities, successfully progressed AlloCAR T programs into Phase 1 clinical development while creating next generation therapies and entering into agreements that will keep us at the forefront of cell therapy, said David Chang, M.D., Ph.D., President, CEO and Co-Founder of Allogene Therapeutics. With the initiation of our ALLO-715 Phase I UNIVERSAL trial in multiple myeloma, we have achieved all of the clinical goals that we set out for ourselves at the beginning of 2019. I am very proud of our teams accomplishments and firmly believe that the time and investment Allogene is making in research, next generation technologies, manufacturing and personnel will provide us with the key building blocks needed to support our goal of being the first to bring an AlloCAR T therapy to patients.

Pipeline HighlightsALLO-501 (anti-CD19 AlloCAR T)

ALLO-715 (anti-BCMA AlloCAR T)

Additional Pipeline Updates

Corporate Highlights

Third Quarter Financial Results

Conference Call and Webcast DetailsAllogene will host a live conference call and webcast today at 5:30 AM Pacific Time/8:30 AM Eastern Time to discuss financial results and provide a business update. To access the live conference call by telephone, please dial 1 (866) 940-5062 (U.S.) or 1 (409) 216-0618 (International). The conference ID number for the live call is 2747063. The webcast will be made available on the Company's website at http://www.allogene.com under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company's website for approximately 30 days.

About Allogene TherapeuticsAllogene Therapeutics, with headquarters inSouth San Francisco, is a clinical-stagebiotechnology company pioneering the development of allogeneic chimeric antigen receptor Tcell (AlloCAR T) therapies for cancer. Led by a world-class management team with significantexperience in cell therapy, Allogene is developing a pipeline of off-the-shelf CAR T cell therapycandidates with the goal of delivering readily available cell therapy on-demand, more reliably, and atgreater scale to more patients. For more information, please visitwww.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.

Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the timing and ability to progress the ALLO-501 ALPHA trial and ALLO-715 UNIVERSAL trial, the timing and Serviers ability to progress the CALM and PALL trials to potential registrational trials, the ability to manufacture AlloCAR T therapies, the ability to initiate and progress additional clinical trials of AlloCAR T therapies, the potential benefits of AlloCAR T therapy and the 2019 financial guidance. Various factors may cause differences between Allogenes expectations and actual results as discussed in greater detail in Allogenes filings with the Securities and Exchange Commission (SEC), including without limitation in its Form 10-Q for the quarter ended June 30, 2019. Any forward-looking statements that are made in this press release speak only as of the date of this press release. Allogene assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

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ALLOGENE THERAPEUTICS, INC.SELECTED FINANCIAL DATA(unaudited; in thousands, except share and per share data)

STATEMENTS OF OPERATIONS

SELECTED BALANCE SHEET DATA

Allogene Media/Investor Contact:Christine CassianoChief Communications Officer(714) 552-0326Christine.Cassiano@allogene.com

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Allogene Therapeutics Reports Third Quarter 2019 Financial Results - Yahoo Finance

RESTORE Consortium to Host the 1st Advanced Therapies Science Meeting, Aiming to Translate Promising Research into a Game Changer in Healthcare -…

HAIFA, Israel, Nov. 04, 2019 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced that the RESTORE Consortium is hosting its 1st Advanced Therapies Science Meeting (ATSM), which is being held November 25-26, 2019 in Berlin. As a leading member of the large-scale research initiative, Pluristem, along with additional respected members, is committed to accelerating the availability of advanced therapies to all those in need, a main motivation standing behind RESTORE.

Led by Charit-Universittsmedizin Berlin, and coordinated by Professor Hans-Dieter Volk from the BIH-Center for Regenerative Therapies in Berlin, RESTORE aims to promote groundbreaking research, drive Europe to the forefront in advanced therapies and deliver a pipeline of potentially transformative cures to patients in need. Advanced Therapies are a potential game changer in health care, aiming to shift our focus from chronic treatment of disease to regeneration of health, said Prof. Volk. We are determined to translate promising research findings into safe therapies, and we are working across disciplines and national borders in order to achieve this goal. The 1st Advanced Therapies Science Meeting provides the opportunity to discuss the still numerous obstacles in the way of implementing these promising therapies in routine clinical care.

This initiative may hold the key for changing the approach towards medicine in Europe, and advancing solutions for patients in need, said Zami Aberman, Executive Chairman of Pluristem. The European Commission is poised to make a significant investment of up to 1 billion in a consortium of companies that can drive forward the development of novel regenerative therapies, and we are pleased to be a leading part in this effort. Given our proprietary cell manufacturing technology and broad, late-stage pipeline, we believe we can play a key role toward making the transforming promise of advanced therapies into a reality.

The 1st ATSM will bring together experts from industry, patient organizations and academia to discuss the challenges within the field of advanced therapies, which include gene and cell therapies and tissue-engineering approaches. The ATSM is focused on trying to drive forward a concerted interdisciplinary effort, making use of science, infrastructure and funding within Europe to make regenerative therapies available to the broadest possible patient population.

The two-day program will include talks from Nobel Prize winner Ada Yonath (Director of Weizmann Institute of Science, Israel), Michele De Luca (University of Modena, Italy), Timothy OBrien (National University of Ireland, Galway, Ireland), Maksim Mamonkin (Baylor College of Medicine, USA), Manuela Gomes (University of Minho, Portugal) and others.

RESTORE partners include the Charit Universittsmedizin Berlin and Berlin Institute of Health (Germany), the University of Zurich (Switzerland), Cell and Gene Therapy Catapult (United Kingdom), TissUse GmbH (Germany), Pluristem (Israel), Miltenyi Biotec GmbH (Germany), INSERM Institut National de la Sant et de la Recherche (France), Innovation Acta S.r.l. (Italy), Fondazione Telethon Milan (Italy), and the University of Minho (Portugal).

About Pluristem TherapeuticsPluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy product candidates. The Company has reported robust clinical trial data in multiple indications for its patented PLX cell product candidates and is currently conducting late stage clinical trials in several indications. PLX cell product candidates are believed to release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders and radiation damage. The cells are grown using the Company's proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching. Pluristem has a strong intellectual property position; a Company-owned and operated GMP-certified manufacturing and research facility; strategic relationships with major research institutions; and a seasoned management team.

Safe Harbor StatementThis press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, Pluristem is using forward-looking statements when it discusses the potential for the RESTORE Consortium to receive up to a 1 billion award by the European Commission and the timing of the potential award, that RESTOREs aim is to promote groundbreaking research, drive Europe to the forefront in advanced therapies and deliver a pipeline of potentially transformative cures to patients in need, that RESTORE and the 1st ATSM may hold the key for changing the approach towards medicine in Europe, and advancing solutions for patients in need, and its belief that given its proprietary cell manufacturing technology and broad, late-stage pipeline, it believes it can play a key role toward making the transforming promise of advanced therapies into a reality. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristems products may not be approved by regulatory agencies, Pluristems technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristems process; Pluristems products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristems patents may not be sufficient; Pluristems products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.

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RESTORE Consortium to Host the 1st Advanced Therapies Science Meeting, Aiming to Translate Promising Research into a Game Changer in Healthcare -...

50 years ago, cancer vaccines were a dream – Science News

Immune response and cancer therapy, Science News, November 8, 1969

The dream of a cancer vaccine is still just that a dream. But experimenters at Emory University in Atlanta have shown that the basic mechanism stimulation of an immune response can take place.

Researchers have devised several ways of getting the immune system to prevent or control cancer. Vaccinations against human papillomavirus, or HPV, prevent infections that cause cervical and other cancers. Hepatitis B vaccines may head off some forms of liver cancer.

Other strategies, like CAR-T cell therapy and PD-1 blockade therapy (SN: 7/11/15, p. 14), prompt T cells of the immune system to go after tumors. The U.S. Food and Drug Administration approved the first PD-1 blockade therapy in 2011 and then two CAR-T cell therapies in 2017 for patients with certain types of cancers (SN: 12/23/17 & 1/6/18, p. 29). Overstimulating the immune system can produce severe side effects, so scientists are working to develop safer options (SN: 7/7/18, p. 22).

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50 years ago, cancer vaccines were a dream - Science News

Cell Therapy Technologies Market Rising Demand | Impressive Business Opportunities, Analysis and Forecast by 2026 – Health News Office

A detailed segmentation-wise analysis included in the study highlights key segments of the Dental Imaging Market, and offers associated market numbers that allude at their growth potential at present as well as in the assessment period. Moving ahead, a regional study of the Dental Imaging Market has been offered to give a brief idea of opportune potential of various regional markets for sales of Dental Imaging .

Government expenditure on healthcare infrastructure and facilities continues on an upward spiral worldwide, in a bid to offer quality care to the increasing geriatric population and combat the rise of various communicable and non-communicable diseases. Additionally, there has been a remarkable rise in FDA approvals in the recent past. A paradigm shift is being witnessed in the pharmaceutical & healthcare industry, with leading companies putting efforts to combat key concerns, namely, intensifying competition, high cost of hiring skilled professionals, and lower reimbursements in Medicaid and Medicare.

ThisPress Release will help you to understand the Volume, growth with Impacting Trends. Click To get SAMPLE PDF (Including Full TOC, Table & Figures) athttps://www.persistencemarketresearch.com/samples/4447?source=atm

Notable transformations have been seen in the pharmaceutical & healthcare industry, which include the growing palpability of healthcare technology companies, increasing emphasis on reimbursements in innovative care delivery models, and the rise in virtual care. The legacy practices are undergoing drastic changes, as the focus on saving costs while improving patient outcomes continue to influence the industry dynamics.

The pharmaceutical & healthcare industry is entering a phase of turbulent growth, making its way through myriad challenges that include constantly growing drug prices, changing industry landscape influenced by rapid growth of biosimilar, confined R&D productivity, and healthcare technology disruptions.

Dental Imaging Market Report Summary

This Persistence Market Research report on the Dental Imaging Market gives a long-term viewpoint of the market during the forecast period. The main objective of the report is to offer readers with a broader perspective of the Dental Imaging Market so as to enable them in making factual decisions for triumphant growth of their business. Incisive insights into the Dental Imaging Market have been covered, along with a study of the market dynamics that have a notable impact on the market prospects.

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Some of the major companies operating in the global dental imaging market are Danaher Corporation, Carestream Health, Inc., Dentsply International Inc., LED Medical Diagnostics Inc., Yoshida Dental Mfg. Co., Ltd., Sirona Dental Systems, Inc., Planmeca Oy, Midmark Corporation, Vatech Co., Ltd., and FLOW Dental Corporation.

Key geographies evaluated in this report are:

Key features of this report

The report incorporates a scrutinized study of supply & demand patterns, pricing strategies of leading players, and supply chain of the Dental Imaging Market. Historical values have been offered for the period, which have been considered as the base for deducing forecast values of the Dental Imaging market. In order to make readers understand the volatility of the Dental Imaging Market, impact of past and current trends on the market growth has been covered in the report.

The report concludes with a brief assessment of the Dental Imaging Markets competitive landscape, wherein key companies that have a significant contribution to the market growth are identified & profiled in detail. Analysis on recent developments, R&D activities, innovative strategies, and product portfolio, has been offered for each player profiled in the report.

What does the Dental Imaging Market research hold for the readers?

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To support companies in overcoming complex business challenges, we follow a multi-disciplinary approach. At PMR, we unite various data streams from multi-dimensional sources. By deploying real-time data collection, big data, and customer experience analytics, we deliver business intelligence for organizations of all sizes.

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Cell Therapy Technologies Market Rising Demand | Impressive Business Opportunities, Analysis and Forecast by 2026 - Health News Office