Intel is shipping its first discrete GPU in over two decades -- but the initial benchmarks are underwhelming.
When you're making a decision about when to claim your Social Security benefits, there are a lot of factors to weigh. You can choose to start your benefits as soon as you become eligible at 62, and doing so may be attractive if you're eager for early retirement or you want to enjoy your money when you're young and healthy. The money you get from the Social Security Administration is probably going to be your only guaranteed source of lifetime income that's protected against inflation.
CAMBRIDGE, Mass., Dec. 05, 2020 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc. (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today announced that preclinical data with FTX-6058 for the treatment of sickle cell disease will be presented in three posters at the virtual 62nd American Society of Hematology (ASH) Annual Meeting and Exposition taking place December 5-8, 2020. FTX-6058 is a highly potent small molecule EED inhibitor that induces expression of fetal hemoglobin (HbF). Elevating HbF can compensate for the mutated adult hemoglobin that has been identified as the root cause of several hemoglobinopathies and can ameliorate or eliminate the symptoms of sickle cell disease. “We are encouraged by the robust preclinical data package and unique mechanism of action of FTX-6058, which has the potential to be a transformative therapy for sickle cell patients,” said Owen B. Wallace, Ph.D., Fulcrum’s chief scientific officer. “Through internal research and discussions with key opinion leaders, we have identified areas within the sickle cell disease landscape where FTX-6058 has the potential to address significant unmet need. Enrollment has begun in our Phase 1 trial in healthy volunteers and we look forward to progressing FTX-6058 in clinical development.”FTX-6058 Results at ASH Preclinical data with FTX-6058 showed an increase in HbF levels up to approximately 30% of total hemoglobin, demonstrating the potential to have a significant impact in patients with sickle cell disease. FTX-6058 inhibits PRC2 via binding to EED, which induces a robust HbF protein expression in cell and murine models. Increasing HbF has the potential to prevent or reduce disease-related pathophysiology, resulting in reduction of recurring events such as vaso-occlusive crises and hemolysis. Human genetic data indicates that individuals with the sickle cell mutation but who have high HbF levels may have asymptomatic disease, underscoring the protective effect of increased HbF.Key highlights include: * Demonstrated potent target engagement and HbF induction in vivo in animal models at plasma concentrations reasonably expected to be achieved in the clinic. * Pharmacological activity in target cells can be readily monitored in the clinic since target engagement in bone marrow correlates with target engagement in peripheral monocytes in animals. * Demonstrated an impressive preclinical pharmacological profile with the potential to be a disease-modifying therapeutic for sickle cell patients. The posters will be available in the “Publications” section of fulcrumtx.com following the sessions.About FTX-6058 FTX-6058 is a highly potent small molecule inhibitor of EED capable of inducing robust HbF protein expression in cell and murine models. Fulcrum believes the pharmacokinetics and human dose simulations support that FTX-6058 may be given as a once daily oral compound. The validation of EED as a target for sickle cell disease and the discovery of FTX-6058 as a novel HbF-inducing small molecule were conducted using Fulcrum’s proprietary Product Engine. The company’s composition of matter patent covering FTX-6058 and related structures has been granted. Preclinical data with FTX-6058 showed an increase in HbF levels up to approximately 30% of total hemoglobin. Fulcrum has initiated a Phase 1 trial with FTX-6058 in healthy volunteers.About Sickle Cell Disease Sickle cell disease (SCD) is a genetic disorder of the red blood cells caused by a mutation in the HBB gene. This gene encodes a protein that is a key component of hemoglobin, a protein complex whose function is to transport oxygen in the body. The result of the mutation is less efficient oxygen transport and the formation of red blood cells that have a sickle shape. These sickle shaped cells are much less flexible than healthy cells and can block blood vessels or rupture leading to anemia. SCD patients typically suffer from serious clinical consequences, which may include anemia, pain, infections, stroke, heart disease, pulmonary hypertension, kidney failure, liver disease and reduced life expectancy.About Fulcrum Therapeutics Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases in areas of high unmet medical need. Fulcrum’s proprietary product engine identifies drug targets which can modulate gene expression to treat the known root cause of gene mis-expression. The company has advanced losmapimod to Phase 2 clinical development for the treatment of facioscapulohumeral muscular dystrophy (FSHD) and Phase 3 for the treatment of COVID-19. Fulcrum has also advanced FTX-6058, a small molecule designed to increase expression of fetal hemoglobin for the treatment of sickle cell disease and beta thalassemia, into Phase 1 clinical development.Please visit www.fulcrumtx.com.Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties, including statements regarding the development status of the Company’s product candidates and the potential advantages and therapeutic potential of the Company’s product candidates. All statements, other than statements of historical facts, contained in this press release, including statements regarding the Company’s strategy, future operations, future financial position, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, risks associated with Fulcrum’s ability to obtain and maintain necessary approvals from the FDA and other regulatory authorities; continue to advance its product candidates in clinical trials; initiate and enroll clinical trials on the timeline expected or at all; correctly estimate the potential patient population and/or market for the Company’s product candidates; replicate in later clinical trials positive results found in preclinical studies and/or earlier-stage clinical trials of losmapimod and its other product candidates; advance the development of its product candidates under the timelines it anticipates in current and future clinical trials; obtain, maintain or protect intellectual property rights related to its product candidates; manage expenses; and raise the substantial additional capital needed to achieve its business objectives. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, see the “Risk Factors” section, as well as discussions of potential risks, uncertainties and other important factors, in the Company’s most recent filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date hereof and should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so.Contact:Investors: Christi Waarich Director, Investor Relations and Corporate Communications 617-651-8664 firstname.lastname@example.orgStephanie Ascher Stern Investor Relations, Inc. email@example.com 212-362-1200Media: Kaitlin Gallagher Berry & Company Public Relations firstname.lastname@example.org 212-253-8881
Kite, a Gilead Company (Nasdaq: GILD), today announced follow-up results from the pivotal ZUMA-2 trial of Tecartus™ (brexucabtagene autoleucel, formerly KTE-X19) in adult patients with relapsed or refractory mantle cell lymphoma (MCL). At a median follow-up of 17.5 months (n=60 evaluable for efficacy), 92 percent of patients had achieved a response, including 67 percent with a complete response (CR). Secondary endpoints of median duration of response, progression-free survival (PFS) and overall survival (OS) all were not yet reached. These data were presented at the 62nd ASH Annual Meeting and Exposition (Abstract 1120).
Kite, a Gilead Company (Nasdaq: GILD), today announced four-year follow-up data from the pivotal ZUMA-1 trial of Yescarta® (axicabtagene ciloleucel) in adult patients with refractory large B-cell lymphoma (LBCL). Among Yescarta-treated patients (modified intent to-treat analysis, n=101) with a minimum follow-up of four years after a single infusion of Yescarta (median follow-up of 51.1 months), the Kaplan-Meier estimate of the four-year overall survival (OS) rate was 44 percent. The data were presented today at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition (Abstract 1187).
The holiday shopping season is gearing up, so it's a great time to make smart plans for your spending. If you're serious about making your money go as far as possible, one of the best ways is to use credit cards for your holiday spending. Using credit cards can get you in trouble if you don't have your spending under control and you charge a lot that you can't repay.
There's a once-in-a-century pandemic happening in the world, but you wouldn't know it from looking at Okta's (NASDAQ: OKTA) latest earnings numbers. The cloud-based identity and security specialist has been steady as a rock as the company continues to deliver strong revenue growth and increasing cash flow like clockwork. What stood out about this quarter is that Okta's making significant headway with legacy institutions like banks that are traditionally late adopters of new technology.
Data support novel approach to develop and manufacture a best-in-class, durable medicine for people living with hemoglobinopathies IND filing for EDIT-301 planned by end of 2020CAMBRIDGE, Mass., Dec. 05, 2020 (GLOBE NEWSWIRE) -- Editas Medicine, Inc. (Nasdaq: EDIT), a leading genome editing company, today announced preclinical data and successful development of a large-scale manufacturing process for EDIT-301, a potentially best-in-class, one-time, durable, autologous cell therapy medicine to treat sickle cell disease and beta-thalassemia. EDIT-301 is the first experimental medicine in development generated using CRISPR/Cas12a gene editing. The Company reported these data today at the 62nd Annual Meeting and Exposition of the American Society of Hematology (ASH) being held virtually.The data showed that high levels of editing in CD34+ cells from normal donors and sickle cell patients were achieved with CRISPR/Cas12a at the HBG1 and HBG2 promoters, leading to robust fetal hemoglobin (HbF) induction in their erythroid progeny in a pan-cellular fashion. Red blood cells derived from edited sickle cell patient CD34+ cells showed remarkable correction of sickle cell disease phenotypes, including a reduction in sickling and improved rheological properties when deoxygenated.In addition, the Company’s large-scale manufacturing process was shown to be consistent and robust. When infused into immunodeficient mice, edited CD34+ cells from normal donors manufactured at large-scale led to long term multi-lineage hematopoietic reconstitution that was comparable to unedited control cells. The engraftment was stable and highly polyclonal with high levels of editing detected throughout the course of the study.“These findings are very encouraging and further support our novel approach to developing and manufacturing EDIT-301 as a best-in-class and durable medicine for the potential treatment of sickle cell disease and beta-thalassemia,” said Charles Albright, Ph.D., Executive Vice President and Chief Scientific Officer, Editas Medicine. “If these preclinical results translate to the clinic, we believe our editing approach may yield a safer and more effective medicine, addressing a significant unmet need for a transformative, durable treatment with the potential to transform the lives of people living with sickle cell disease and beta-thalassemia. ”Editas Medicine continues to prepare for a Phase 1/2 clinical trial evaluating EDIT-301 for the treatment of sickle cell disease. The Company has completed preclinical toxicology studies, identified a lead principal investigator, and engaged a contract research organization (CRO). Clinical trial materials are being manufactured by Editas Medicine. The Company remains on track to file an IND for the treatment of sickle cell disease by the end of 2020.About Sickle Cell Disease Sickle cell disease is an inherited blood disorder caused by a mutation in the beta-globin gene that leads to polymerization of the sickle hemoglobin protein (HbS). In sickle cell disease, the red blood cells are misshapen, in a sickle shape instead of the disc shape. The abnormal shape causes the cells to block blood flow causing anemia, pain crises, organ failure, and early death. There are an estimated 100,000 people in the United States currently living with sickle cell disease. Fetal hemoglobin (HbF) protects against sickle cell disease by inhibiting HbS polymerization.About EDIT-301 EDIT-301 is an experimental, autologous cell therapy medicine under investigation for the treatment of sickle cell disease. EDIT-301 is comprised of sickle patient CD34+ cells genetically modified using a highly specific and efficient CRISPR/Cas12a (also known as Cpf1) ribonucleoprotein (RNP) that targets the HBG1 and HBG2 promoters in the beta-globin locus where naturally occurring fetal hemoglobin (HbF) inducing mutations reside. Red blood cells derived from EDIT-301 CD34+ cells demonstrate a sustained increase in HbF production, which has the potential to provide a durable treatment benefit for people living with sickle cell disease.About Editas Medicine As 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 www.editasmedicine.com.Forward-Looking Statements This 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 Company’s plans and expectations for EDIT-301, including filing an IND for EDIT-301 by the end of 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 Company’s 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 Company’s 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 Company’s 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 speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements, whether because of new information, future events or otherwise. CONTACT: Contacts: Media Cristi Barnett (617) 401-0113 email@example.com Investors Mark Mullikin (617) 401-9083 firstname.lastname@example.org
* Lead immuno-oncology development candidate NTLA-5001 shows high anti-tumor activity as promising cancer treatment in proof-of-concept mouse models of acute leukemias * Proprietary process enhances tumor control in preclinical models and enables efficient, scalable genome editing and T cell manufacturing for NTLA-5001 * First-in-human trial will evaluate safety and activity of NTLA-5001 in AML patients CAMBRIDGE, Mass., Dec. 05, 2020 (GLOBE NEWSWIRE) -- Intellia Therapeutics, Inc. (NASDAQ:NTLA), is presenting new preclinical data in support of NTLA-5001, the company’s wholly owned Wilms’ Tumor 1 (WT1)-directed T cell receptor (TCR)-T cell therapy candidate for the treatment of acute myeloid leukemia (AML), at the 62nd American Society of Hematology (ASH) Annual Meeting, taking place virtually from December 5-8, 2020. NTLA-5001 capitalizes on how natural T cells recognize and respond to tumors. The target, WT1, is highly overexpressed in AML, a cancer of the blood and bone marrow that is often fatal despite existing treatments (NIH SEER Cancer Stat Facts: Leukemia – AML). The new preclinical data being presented today highlight the faster expansion and superior function of T cells manufactured by Intellia’s proprietary approach, compared to a standard genome editing process. Specifically, NTLA-5001’s lead TCR-T cells resulted in significantly higher anti-tumor activity in mouse models of acute leukemias than that observed in mice treated with cells engineered using the standard process.“NTLA-5001 is the first potential CRISPR-based cancer treatment engineered using Intellia’s proprietary process. Based on our preclinical results, we believe our process will result in a pipeline of safer and more efficacious oncological products, with reduced manufacturing time and, importantly, reduced vein-to-vein time, compared to currently available approaches. Showing in vivo efficacy in acute leukemia mouse models, as presented today at ASH, is extremely encouraging and an important steppingstone to entering the clinic next year,” said Intellia President and Chief Executive Officer John Leonard, M.D. “In our first-in-human trial, we plan to establish the safety and activity that will enable us to move quickly to a pivotal investigation of NTLA-5001 for the treatment of AML, which is the most common type of acute leukemia in adults.”NTLA-5001 is being developed using Intellia’s proprietary process to treat AML patients regardless of the genetic subtype of a patient’s leukemia. Intellia plans to submit an Investigational New Drug (IND) application or equivalent for NTLA-5001 in the first half of 2021, subject to the impact of the COVID-19 pandemic, with the first-in-human trial planned to evaluate safety and activity in patients with persistent or recurrent AML who have previously received first-line therapies. Additional efforts are underway to evaluate the potential use of NTLA-5001 to treat WT1-positive solid tumors.Presentation DetailsTitle: “NTLA-5001, a T Cell Product Candidate with CRISPR-Based Targeted Insertion of a High-Avidity, Natural, WT1-Specific TCR, Shows Efficacy in In Vivo Models of AML and ALL” Publication Number: 1435 Session Name: 703\. Adoptive Immunotherapy: Poster I Presenting Author: Birgit Schultes, Ph.D., vice president of Intellia’s Cell Therapy groupWith Intellia’s proprietary T cell engineering process, CRISPR/Cas9 in combination with adeno-associated virus (AAV) is used to insert a WT1-directed TCR in locus, while eliminating the expression of the endogenous TCRs. Benefits of Intellia’s approach include the following: * Intellia’s proprietary T cell engineering process enables multiple, sequential gene edits and is a significant improvement over standard engineering processes commonly used to introduce proteins and nucleic acids into cells. * Sequential editing maintains high T cell viability and may result in safer T cell products because treated cells have minimal levels of translocations, similar to unedited cells, and do not cause graft-versus-host disease (GvHD). * The observed faster T cell expansion with favorable T cell memory phenotype could lead to a reduced vein-to-vein time and better T cell persistence in patients, respectively. T cells engineered using Intellia’s proprietary process to express the lead TCR to the WT137-45 epitope are efficacious, durable and safe in vivo in gold-standard mouse models of AML and acute lymphocytic leukemia (ALL). In collaboration with Chiara Bonini’s team at IRCCS Ospedale San Raffaele (OSR), the AML mouse model was developed using patient-derived primary AML blasts. WT1-specific T cell administration inhibited tumor growth more significantly and durably in blood, bone marrow and spleen than T cells edited using an industry standard electroporation process. Researchers additionally used an aggressive ALL model in immunocompromised mice engineered to express T cell-supporting cytokines at levels comparable to those in patients post-conditioning regimen, or post-lymphodepletion. In the ALL model, WT1-specific T cells also bestowed significant tumor control.The presentation can be found here, on the Scientific Publications & Presentations page of Intellia’s website.About Intellia TherapeuticsIntellia Therapeutics is a leading genome editing company, focused on the development of proprietary, potentially curative therapeutics using the CRISPR/Cas9 system. Intellia believes the CRISPR/Cas9 technology has the potential to transform medicine by both producing therapeutics that permanently edit and/or correct disease-associated genes in the human body with a single treatment course, and creating enhanced engineered cells that can treat oncological and immunological diseases. Intellia’s combination of deep scientific, technical and clinical development experience, along with its leading intellectual property portfolio, puts it in a unique position to unlock broad therapeutic applications of the CRISPR/Cas9 technology and create new classes of therapeutic products. Learn more about Intellia Therapeutics and CRISPR/Cas9 at intelliatx.com. Follow us on Twitter @intelliatweets. Forward-Looking StatementsThis press release contains “forward-looking statements” of Intellia Therapeutics, Inc. (“Intellia”, “we” or “our”) within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding Intellia’s beliefs and expectations regarding its: plans to submit an investigational new drug (“IND”) application or similar clinical trial application for NTLA-5001, its first T cell receptor (“TCR”)-directed engineered cell therapy development candidate for its acute myeloid leukemia (“AML”) program in the first half of 2021; plans to advance and complete preclinical studies and other animal studies supporting other in vivo and ex vivo programs, including its AML program; development of a modular platform to advance its complex genome editing capabilities, such as gene insertion; further development of its proprietary cell engineering process for multiple sequential editing; presentation of additional data at upcoming scientific conferences, and other preclinical data in 2020; advancement and expansion of its CRISPR/Cas9 technology to develop human therapeutic products, as well as its ability to maintain and expand its related intellectual property portfolio; ability to demonstrate its platform’s modularity and replicate or apply results achieved in preclinical studies, including those in its AML program, in any future studies, including human clinical trials; ability to develop other in vivo or ex vivo cell therapeutics of all types, and those targeting WT1 in AML in particular, using CRISPR/Cas9 technology; ability to execute on its preclinical and clinical development plans relating to NTLA-5001 and other in vivo and ex vivo programs in view of the COVID-19 pandemic; and statements regarding the timing of regulatory filings and clinical trial execution, including dosing of patients, regarding its development programs; and the potential commercial opportunities, including value and market, for our product candidates.Any forward-looking statements in this presentation are based on management’s current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: risks related to Intellia’s ability to protect and maintain its intellectual property position; risks related to Intellia’s relationship with third parties, including its licensors and licensees; risks related to the ability of its licensors to protect and maintain their intellectual property position; uncertainties related to regulatory agencies’ evaluation of regulatory filings and other information related to its product candidates; uncertainties related to the authorization, initiation and conduct of studies and other development requirements for its product candidates; the risk that any one or more of Intellia’s product candidates, including those that are co-developed, will not be successfully developed and commercialized; the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies; and the risk that Intellia’s collaborations with Novartis or Regeneron or its other ex vivo collaborations will not continue or will not be successful. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Intellia’s actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in Intellia’s most recent annual report on Form 10-K as well as discussions of potential risks, uncertainties, and other important factors in Intellia’s other filings with the Securities and Exchange Commission (“SEC”). All information in this presentation is as of the date of the presentation, and Intellia undertakes no duty to update this information unless required by law.Intellia Contacts:Media: Lynnea Olivarez Director External Affairs & Communications +1 956-330-1917 email@example.comInvestors: Lina Li Associate Director Investor Relations +1 857-706-1612 firstname.lastname@example.org
* Interim analysis from the investigational ELARA study shows, 65% of patients with r/r follicular lymphoma evaluated for efficacy achieved a complete response and the overall response rate was 83%1 * Longer-term median follow-up of 40 months from the JULIET study showed a 33% two-year progression-free survival rate in patients with r/r DLBCL2 * Both ELARA and JULIET trials reaffirm safety profile of Kymriah with no new short- or long-term safety signals identifiedBasel, December 5, 2020 — Novartis announced analyses from two separate trials with Kymriah® (tisagenlecleucel) in patients with certain advanced lymphomas. In the interim analysis of the investigational Phase II ELARA study, Kymriah led to a complete response (CR) in 65% of patients with relapsed or refractory (r/r) follicular lymphoma (FL) and an overall response rate (ORR) of 83% after at least three months of follow-up. These patients continued to relapse or have refractory disease despite exposure to numerous lines of therapy (median four prior lines of therapy [range 2-13]) prior to Kymriah infusion1. The second analysis – a 40-month median follow-up from the Phase II JULIET trial – reported that the two-year progression-free survival (PFS) rate was 33% in patients with r/r diffuse large B-cell lymphoma (DLBCL), an important finding given these patients have limited treatment options that provide durable responses2. The JULIET study continued to show the effectiveness and well-characterized safety profile of Kymriah for these patients. These results were presented today during the 62nd American Society of Hematology Annual Meeting & Exposition (ASH).“For people who have follicular lymphoma that continues to relapse or does not respond after treatment with many lines of therapy, response to therapy becomes less likely with each additional treatment,” said Nathan H. Fowler, MD, Department of Lymphoma and Myeloma, Division of Cancer Medicine at MD Anderson Cancer Center. “We are encouraged by these interim results from the ELARA trial, as there is a great need for potentially definitive options and an alternative to stem cell transplant. We look forward to continuing to learn more about how Kymriah may provide benefit for these patients.”In the interim analysis of the investigational ELARA clinical trial, in which 52 patients were evaluable for efficacy with a median follow-up of 9.9 months, Kymriah led to responses for the majority of patients treated. Specifically, after at least three months of follow-up, 65% (99.5% CI, 45.1-82.4) of patients achieved a complete response, meeting the primary endpoint. The overall response rate was 83% (95% CI, 69.7-91.8). For those who had a complete response, the vast majority (90%) sustained responses for six months or more.Safety results from this analysis of the ELARA trial suggest there was no emergence of new safety signals for Kymriah in the 97 patients evaluable for safety. No patients experienced grade 3/4 CRS, as defined by the Lee Scale, and any grade CRS occurred in 49% of patients (29% grade 1; 20% grade 2). To treat CRS, 15% of patients required tocilizumab and 3% required steroids. One percent of patients experienced grade 3/4 NEs and any grade NEs occurred in 9% of patients. Median time to CRS and severe NE onset was four and 8.5 days respectively, with respective median time to resolution of four and two days. All neurological and CRS events resolved with appropriate management. Three patients died from progressive disease and no deaths were treatment-related. Kymriah was administered in the outpatient setting for 18% of patients in the ELARA trial1.Results from the primary analysis of the ELARA study, with data from 90 patients followed up for at least 6 months, will be presented at an upcoming medical meeting.“Novartis is dedicated to continuing to explore the safety and efficacy of Kymriah for patients with advanced blood cancers who do not achieve long-term remissions despite multiple prior lines of therapy,” said John Tsai, MD, Head of Global Drug Development and Chief Medical Officer, Novartis. “As we go deeper with our research in CAR-T cell therapies, these new analyses showcase the potential to rewrite cancer survival in patients with certain advanced lymphomas.” New updated efficacy results from pivotal JULIET clinical trialNew updated efficacy results from a 40-month median follow-up analysis demonstrated continued durable responses for patients with r/r DLBCL treated with Kymriah in the JULIET trial (n=115). Among the 61 patients who responded to treatment, the relapse-free probability was 60% at 24 and 36 months; median DOR was not reached (95% CI, 10-not estimable [NE])3. Two-year progression-free survival rate was 33% 2. Survival probability at 24 and 36 months was 40% and 36%, respectively. Importantly, no new safety signals were observed after more than three years of long-term follow-up observation3.“Before the availability of Kymriah, long-term responses to treatment for those living with relapsed or refractory DLBCL were rare,” said Ulrich Jaeger, MD, Medical University of Vienna, Vienna, Austria. “With these results from the JULIET trial, including biomarker analysis to better define patient subgroups who may benefit the most from CAR-T cell therapy, we are providing further evidence that Kymriah may be a definitive option for some patients. Additionally, with no new safety signals observed, physicians can continue to confidently refer their patients to certified centers to be treated with Kymriah.”The relationship between biomarkers, such as baseline Myc overexpression in tumors and tumor microenvironment (TME) characteristics, and response to Kymriah was also assessed in this analysis. Outcomes were better for those with negative Myc expression compared to those who had Myc overexpression, which leads to an unfavorable immunosuppressive TME with a restricted T-cell response. These results are consistent with historical outcomes for patients with Myc- and Myc+ expression4. Analyses to further identify biomarkers for response to CAR-T cell therapy are ongoing.More information about Novartis activities at ASH can be found on the Novartis 2020 ASH Annual Meeting virtual portal.About Follicular Lymphoma Follicular lymphoma, the second most common form of non-Hodgkin lymphoma (NHL), is an indolent lymphoma, and represents approximately 22% of NHL cases5,6. Despite new treatments that improve overall survival, FL is regarded as an incurable malignancy with a relapsing and remitting pattern7,8. Throughout the lifetime of a patient with relapsing FL, they may be exposed to a median of five lines of prior treatment, with an upper range of 12 lines9,10. Although patients in third or later line treatment for FL have multiple systemic therapies available, the efficacy of these regimens drops off rapidly in later lines5. Additionally, because of this relapsing and remitting pattern, patients who are refractory to treatment or quickly relapse may exhaust available treatment options8.About the ELARA trial ELARA is a Phase II, single-arm, multicenter, open-label trial investigating the efficacy and safety of Kymriah in adult patients with r/r FL. This international trial has enrolled patients from over 30 sites in 12 countries worldwide. The primary endpoint is CRR based on best response by central review (Lugano 2014 criteria). Patients evaluable for efficacy had measurable disease at infusion and more than six months of follow-up from infusion or discontinued early. After infusion, disease assessments were performed every three months. Secondary endpoints include overall response rate, duration of response, progression-free survival, overall survival and safety.In Q2 2020, the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to Kymriah in r/r FL, based on preliminary results from the ELARA trial. RMAT designation is intended to expedite the development and review of Kymriah as a regenerative therapy for this underserved patient population. Kymriah also has Orphan Drug designation from the FDA for this indication. About the JULIET Trial JULIET was the first multi-center global registration study for Kymriah in adult patients with r/r DLBCL. JULIET, led by researchers at the University of Pennsylvania, enrolled patients from 27 sites in 10 countries across the US, Canada, Australia, Japan and Europe, including Austria, France, Germany, Italy, Norway and the Netherlands.About Kymriah Kymriah is the first-ever FDA-approved CAR-T cell therapy, and the first-ever CAR-T to be approved in two distinct indications. It is a one-time treatment designed to empower patients’ immune systems to fight their cancer. Kymriah is currently approved for the treatment of r/r pediatric and young adult (up to 25 years of age) acute lymphoblastic leukemia (ALL), and r/r adult DLBCL11.About Novartis Commitment to Oncology Cell & Gene Novartis has a mission to reimagine medicine by bringing curative cell & gene therapies to patients worldwide. Novartis has a deep CAR-T pipeline and ongoing investment in manufacturing and supply chain process improvements. With active research underway to broaden the impact of cell and gene therapy in oncology, Novartis is going deeper in hematological malignancies, reaching patients with other cancer types and evaluating next-generation CAR-T cell therapies that focus on new targets and utilize new technologies.Novartis was the first pharmaceutical company to significantly invest in pioneering CAR-T research and initiate global CAR-T trials. Kymriah, the first approved CAR-T cell therapy, developed in collaboration with the Perelman School of Medicine at the University of Pennsylvania, is the foundation of Novartis’ commitment to CAR-T cell therapy. Kymriah is currently approved for use in at least one indication in 27 countries and at more than 270 certified treatment centers, with the ambition for further expansion to help fulfill the ultimate goal of bringing CAR-T cell therapy to every patient in need.The Novartis global CAR-T manufacturing footprint spans seven facilities, across four continents. This comprehensive, integrated footprint strengthens the flexibility, resilience and sustainability of the Novartis manufacturing and supply chain. Commercial and clinical trial manufacturing is now ongoing at Novartis-owned facilities in Stein, Switzerland, Les Ulis, France and Morris Plains, New Jersey, USA, as well as at the contract manufacturing sites at Fraunhofer-Institut for cell therapy and immunology (Fraunhofer-Institut für Zelltherapie und Immunologie) facility in Leipzig, Germany, and now FBRI in Kobe, Japan. Manufacturing production at Cell Therapies in Australia and Cellular Biomedicine Group in China is forthcoming.Kymriah® (tisagenlecleucel) US Important Safety information Kymriah may cause side effects that are severe or life-threatening, such as Cytokine Release Syndrome (CRS) or Neurological Toxicities. Patients with CRS may experience symptoms including difficulty breathing, fever (100.4°F/38°C or higher), chills/shaking chills, severe nausea, vomiting and diarrhea, severe muscle or joint pain, very low blood pressure, or dizziness/lightheadedness. Patients may be admitted to the hospital for CRS and treated with other medications.Patients with neurological toxicities may experience symptoms such as altered or decreased consciousness, headaches, delirium, confusion, agitation, anxiety, seizures, difficulty speaking and understanding, or loss of balance. Patients should be advised to call their healthcare provider or get emergency help right away if they experience any of these signs and symptoms of CRS or neurological toxicities.Because of the risk of CRS and neurological toxicities, Kymriah is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called Kymriah REMS.Serious allergic reactions, including anaphylaxis, may occur after Kymriah infusion. Kymriah can increase the risk of life-threatening infections that may lead to death. Patients should be advised to tell their healthcare provider right away if they develop fever, chills, or any signs or symptoms of an infection.Patients may experience prolonged low blood cell counts (cytopenia), where one or more types of blood cells (red blood cells, white blood cells, or platelets) are decreased. The patient's healthcare provider will do blood tests to check all of their blood cell counts after treatment with Kymriah. Patients should be advised to tell their healthcare provider right away if they get a fever, are feeling tired, or have bruising or bleeding.Patients may experience hypogammaglobulinemia, a condition in which the level of immunoglobulins (antibodies) in the blood is low and the risk of infection is increased. It is expected that patients may develop hypogammaglobulinemia with Kymriah, and may need to receive immunoglobulin replacement for an indefinite amount of time following treatment with Kymriah. Patients should tell their healthcare provider about their treatment with Kymriah before receiving a live virus vaccine.After treatment with Kymriah, patients will be monitored lifelong by their healthcare provider, as they may develop secondary cancers or recurrence of their cancer.Patients should not drive, operate heavy machinery, or do other dangerous activities for eight weeks after receiving Kymriah because the treatment can cause temporary memory and coordination problems, including sleepiness, confusion, weakness, dizziness, and seizures.Some of the most common side effects of Kymriah are difficulty breathing, fever (100.4°F/38°C or higher), chills/shaking chills, confusion, severe nausea, vomiting and diarrhea, severe muscle or joint pain, very low blood pressure, dizziness/lightheadedness, and headache. However, these are not all of the possible side effects of Kymriah. Patients should talk to their healthcare provider for medical advice about side effects.Prior to a female patient starting treatment with Kymriah, their healthcare provider may do a pregnancy test. There is no information available for Kymriah use in pregnant or breast-feeding women. Therefore, Kymriah is not recommended for women who are pregnant or breast feeding. Patients should talk to their healthcare provider about birth control and pregnancy.Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.After receiving Kymriah, patients should be advised that some commercial HIV tests may cause a false-positive test result. Patients should also be advised not to donate blood, organs, or tissues and cells for transplantation after receiving Kymriah. Please see the full Prescribing Information for Kymriah, including Boxed WARNING, and Medication Guide at www.Kymriah.comDisclaimer This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “seek,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.About Novartis Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 110,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com.Novartis is on Twitter. Sign up to follow @Novartis at https://twitter.com/novartisnews For Novartis multimedia content, please visit https://www.novartis.com/news/media-library For questions about the site or required registration, please contact email@example.com References 1. Fowler, N., et al. Efficacy and Safety of Tisagenlecleucel in Adult Patients with Relapsed/Refractory Follicular Lymphoma: Interim Analysis of the Phase 2 ELARA Trial. 62nd American Society of Hematology Annual Meeting and Exposition. Abstract 1149. 2. Jaeger U., et al. Myc Expression and Tumor-Infiltrating T Cells Are Associated With Response in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (r/r DLBCL) Treated With Tisagenlecleucel in the JULIET Trial. 62nd American Society of Hematology Annual Meeting and Exposition. Poster 1194. 3. Jaeger, U., et al. Myc Expression and Tumor-Infiltrating T Cells Are Associated with Response in Patients (Pts) with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (r/r DLBCL) Treated with Tisagenlecleucel in the JULIET Trial. 62nd American Society of Hematology Annual Meeting and Exposition. Abstract 1194. 4. Li, L., Li, Y., Que, X. et al. Prognostic significances of overexpression MYC and/or BCL2 in R-CHOP-treated diffuse large B-cell lymphoma: A Systematic review and meta-analysis. Sci Rep. 2018;8(1):6267. 5. The Non-Hodgkin’s Lymphoma Classification Project. Blood. 1997;89:3909–3918. 6. Anderson J., et al. Epidemiology of the non-Hodgkin’s lymphomas: distributions of the major subtypes differ by geographic locations. Non-Hodgkin’s Lymphoma Classification Project. Ann Oncol. 1998;9(7):7;17–720. 7. Wudhikarn, K., et al. Comparative effectiveness research in follicular lymphoma: current and future perspectives and challenges. J Comp Eff Res. 2014. 8. Sutamtewagul, G. & Link, B.K. Novel treatment approaches and future perspectives in follicular lymphoma. Ther Adv Hematol. 2019;10:1–20. 9. Data on File, Novartis, 2020. 10. Schuster, S., et al. Chimeric antigen receptor T cells in refractory B-cell lymphomas. NEJM. 2017;377(26):2545–2554. 11. Kymriah Prescribing Information. Novartis Media Relations E-mail: firstname.lastname@example.orgAnja von Treskow Novartis External Communications +41 79 392 8697 email@example.com Eric Althoff Novartis US External Communications +1 646 438 4335 firstname.lastname@example.orgFiona Phillips Novartis Oncology Communications +1 862 217 9396 email@example.com Novartis Investor Relations Central investor relations line: +41 61 324 7944 E-mail: firstname.lastname@example.orgCentral North America Samir Shah+41 61 324 7944Sloan Simpson+1 862 778 5052 Thomas Hungerbuehler +41 61 324 8425 Isabella Zinck+41 61 324 7188
Rhizen Pharma Announces Interim Results of Phase I/II study of Tenalisib (RP6530) in Combination with Romidepsin in R/R T-Cell Lymphoma at ASH 2020
PHILADELPHIA, Dec. 05, 2020 (GLOBE NEWSWIRE) -- Kehoe Law Firm, P.C. is investigating potential securities claims on behalf of investors of Northern Dynasty Minerals Ltd. (“Northern Dynasty” or the “Company”) (NYSE: NAK) to determine whether the Company engaged in securities fraud or other unlawful business practices. INVESTORS WHO PURCHASED, OR OTHERWISE ACQUIRED, THE SECURITIES OF NORTHERN DYNASTY MINERALS BETWEEN DECEMBER 21, 2017 AND NOVEMBER 25, 2020, BOTH DATES INCLUSIVE (THE “CLASS PERIOD”), AND SUFFERED LOSSES GREATER THAN $250,000 ARE ENCOURAGED TO COMPLETE KEHOE LAW FIRM’S SECURITIES CLASS ACTION QUESTIONNAIRE OR CONTACT KEVIN CAULEY, DIRECTOR, BUSINESS DEVELOPMENT, (215) 792-6676, EXT. 802, KCAULEY@KEHOELAWFIRM.COM, SECURITIES@KEHOELAWFIRM.COM, TO DISCUSS THE SECURITIES INVESTIGATION OR POTENTIAL LEGAL CLAIMS. On December 4, 2020, a class action lawsuit was filed against Northern Dynasty in United States District Court, Eastern District of New York.According to class action complaint, throughout the Class Period, the Northern Dynasty defendants made false and/or misleading statements and/or failed to disclose that the Company’s Pebble Project was contrary to Clean Water Act guidelines and to the public interest; Northern Dynasty planned that the Pebble Project would be larger in duration and scope than conveyed to the public; (3) as a result, the Company’s permit applications for the Pebble Project would be denied by the U.S. Army Corps of Engineers; and (4) as a result, the Northern Dynasty Defendants’ public statements were materially false and/or misleading at all relevant times. When the true details entered the market, the lawsuit alleges that investors suffered damages.On November 25, 2020, Northern Dynasty stated that “. . . its 100%-owned, US-based subsidiary Pebble Limited Partnership . . . received formal notification from the US Army Corps of Engineers . . . that its application for permits under the Clean Water Act and other federal statutes has been denied. The lead federal regulator found Pebble’s ‘compensatory mitigation plan’ as submitted earlier this month to be ‘non-compliant’, and that the project is ‘not in the public interest’.”On this news, Northern Dynasty’s stock price fell $0.40 per share, or 50%, to close at $0.40 per share on November 25, 2020.Kehoe Law Firm, P.C., with offices in New York and Philadelphia, is a multidisciplinary, plaintiff–side law firm dedicated to protecting investors from securities fraud, breaches of fiduciary duties, and corporate misconduct. Combined, the partners at Kehoe Law Firm have served as Lead Counsel or Co-Lead Counsel in cases that have recovered more than $10 billion on behalf of institutional and individual investors. This press release may constitute attorney advertising.
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