Categoría: Geovanny Vicente

AUSTIN, Texas, Aug. 5, 2020 /PRNewswire/ — Elios Therapeutics, a biopharmaceutical company developing innovative personalized therapeutic cancer vaccines, today announced final data from a prospective, randomized, double-blind, placebo-controlled Phase IIb clinical trial evaluating adjuvant use of its personalized tumor lysate, particle-loaded, dendritic cell (TLPLDC) vaccine in patients with Stage III or Stage IV melanoma at high risk of recurrence following complete surgical resection.

«We now have long-term data demonstrating that use of the TLPLDC vaccine for the adjuvant treatment of high-risk melanoma correlates with a 93 percent increase in patients alive at three years without their disease returning. This trial also significantly improves our understanding of the optimal method of vaccine production,» said Buddy Long, chief executive officer of Elios Therapeutics. «These new data, combined with the doubled rate of disease-free survival among patients treated with the vaccine and standard of care checkpoint inhibitors, further strengthen our confidence that the personalized TLPLDC vaccine provides a clinically meaningful benefit for people with high-risk melanoma. We look forward to advancing this vaccine with a registrational Phase III trial that will move us one step closer to bringing this important treatment to patients as soon as possible.»

The TLPLDC vaccine is a personalized treatment that is created using a patient’s own blood and tumor cells. Samples are collected at resection, frozen, and sent to the lab where they are used to create autologous tumor lysate, which is loaded into yeast cell wall particles. This combination is then introduced to the patient’s dendritic cells, leading to the creation of the final TLPLDC vaccine. The time from resection to injection of the vaccine takes approximately three weeks.

The vaccine has been studied in a large randomized Phase IIb trial, and the newly reported data is from the pre-specified 36-month disease-free survival (DFS) and overall survival (OS) assessment by vaccine formulation, stage, and checkpoint inhibition. The analysis included all randomized patients in an intent-to-treat (ITT) analysis. Two versions of the vaccine, one produced by isolating dendritic cells (DCs) from 120 mL of blood (vaccine-A) and one with DCs isolated after a single injection of filgrastim followed by 50-70 mL of blood (vaccine-B), were tested in 144 participants who were randomized to receive either version of the vaccine or placebo to prevent recurrence.

A key finding showed that treatment with vaccine-B resulted in clinical outcomes similar to placebo. Producing the vaccine with filgrastim was intended to increase white blood cell and dendritic cell counts, requiring less blood to be drawn from patients to create the vaccine. While the use of filgrastim increased DC production, it takes only 72-hours to create the vaccine which was not enough time for the DCs to mature, rendering vaccine-B ineffective. 

Importantly, vaccine-A, when compared to vaccine-B and placebo, resulted in a statistically significant improvement in 36-month DFS (51.8% vs. 23.4% vs 27.1%, respectively; p=0.027) and OS (92.9% vs. 62.8% vs 70.3%, respectively; p=0.022) in the ITT population.

Furthermore, the DFS improvement with vaccine-A was seen across both Stage III (49.7% vs. 29.4%; p=0.066) and IV (68.6% vs. 9.4%; p=0.0582) patients. Importantly, the addition of vaccine-A to current standard of care checkpoint inhibitors led to a statistically significant increase in 36-month DFS in the ITT population compared to treatment with checkpoint inhibitors alone (48.5% vs. 24.1%; p=0.039). As previously reported, treatment with the vaccine was well-tolerated with 34.7 percent of patients experiencing a treatment-related adverse event, and >90% being grades 1 or 2.

«To demonstrate a long-term survival benefit with low toxicity in a therapeutic is what we hope for in every clinical trial. Achieving this with an aggressive disease like melanoma offers great promise for patients,» said Mark B. Faries, M.D., co-director of the Melanoma Program and head of Surgical Oncology at Cedars-Sinai at The Angeles Clinic and Research Institute, and principal investigator of the study. «With data showing a two-fold increase in disease-free survival with the vaccine alone and in combination with checkpoint inhibitors, we hope to one day change the narrative for people with melanoma – turning this disease into a chronic condition that can be treated and managed over time.»           

About Melanoma
Melanoma is more likely to grow and spread than other types of skin cancer. When diagnosed and treated at an early stage, melanoma has a high cure rate, however patients with later stages of the disease carry a high risk for melanoma recurrence because some melanoma cells can remain in the body, even after surgery. In the U.S, the incidence of melanoma has increased over the past decades, with 91,270 estimated new cases and 9,320 related deaths in 2018.¹  

About the Phase IIb TLPLDC Study
This Phase IIb study is a prospective, randomized, double-blind, placebo-controlled trial designed to evaluate the safety and efficacy of the TLPLDC (tumor lysate, particle-loaded, dendritic cell) vaccine in patients with resected Stage III and IV melanoma. The primary endpoint of the trial is two-year disease-free survival (DFS), and the secondary endpoint is three-year DFS and overall survival (OS).

In the study, 144 participants were randomized to receive either the vaccine or placebo to prevent recurrence. TLPLDC or placebo vaccines were initiated within three months of completion of standard of care (SoC) therapies and were given at 0, 1, 2, 6, 12, and 18 months. The protocol was amended to allow concurrent checkpoint inhibitor therapy once approved for the adjuvant setting. Study participants were followed for recurrence per SoC. The primary efficacy analysis was performed on the intent-to-treat (ITT) and the per treatment (PT) populations as co-primary analyses given the high early recurrence rate often seen in patients with advanced melanoma. Secondary endpoints include 36-month DFS and overall survival (OS) which will be compared between the vaccinated and control groups as well as by vaccine formulation.

About TLPLDC
The TLPLDC (tumor lysate, particle-loaded, dendritic cell) vaccine is a unique type of immunotherapy, both in how it is made and how it is delivered. The vaccine is personalized, meaning it is made from a patient’s tumor and blood. Every patient’s tumor has a unique antigenic profile unlike any other, and dendritic cells found in the blood are the most potent antigen-presenting cells in the body. Once TLPLDC is administered, it delivers the patient’s complete repertoire of tumor antigens to the immune system, creating a dual innate and adaptive immune response, activating fighter T cells, and triggering the immune system to recognize, and seek out and destroy any cells containing the antigens and specific mutations from their tumor. 

Historically, autologous cancer vaccines have been rather onerous to develop, sometimes taking months between the tumor biopsy and administration. Elios has simplified the process so the time from resection to injection is approximately two weeks. This makes the vaccine highly feasible and will ultimately be easy for community and academic oncologists to adopt into their practices.

The TLPLDC vaccine is currently being studied as a monotherapy and in combination with standard-of-care checkpoint inhibitor therapies in a Phase IIb clinical trial for the treatment of late-stage melanoma at leading academic cancer centers in the United States.

About Elios Therapeutics, LLC
Elios Therapeutics, LLC, a wholly owned subsidiary of Perseus Holdings, LLC., is a biopharmaceutical company developing a portfolio of innovative personalized therapeutic cancer vaccines targeting unmet medical needs across a broad range of tumor types. Elios’ lead therapeutic candidate is the TLPLDC (tumor lysate, particle-loaded, dendritic cell) vaccine, a personalized therapeutic cancer vaccine that uses a proprietary particle delivery system to stimulate the body’s immune system to recognize cancer cells as foreign pathogens and fight a patient’s specific cancer. For more information, please visit www.eliostherapeutics.com.

Forward-Looking Statements
This document contains forward–looking statements relating to the Company’s strategy, objectives, business development plans and financial position. All statements other than statements of historical facts included in this document, including, without limitation, statements regarding the Company’s future financial position, strategy, anticipated investments, costs and results, status and results of clinical trials, size of patient population, plans, outcomes of product development efforts, and objectives of management for future operations, may be deemed to be forward–looking statements. You can identify forward-looking statements by words such as «anticipate,» «believe,» «could,» «estimate,» «expect,» «intend,» «may,» «plan,» «potential,» «predict,» «project,» «should,» «will,» «would,» or the negative of those terms, and similar expressions that convey uncertainty or future events or outcomes. These forward–looking statements involve known and unknown risks, uncertainties, and other factors that may cause the Company’s actual results, performance, or achievements or industry results to be materially different from those contemplated, projected, forecasted, estimated or budgeted, whether expressed or implied, by these forward–looking statements. Given these risks and uncertainties, investors should not place undue reliance on forward–looking statements as a prediction of actual results. None of these forward–looking statements constitutes a guarantee of the future occurrence of such events or of actual results. These statements are based on data, assumptions, and estimates that the Company believes are reasonable. The forward–looking statements contained in this document are made only as of the date hereof. Except as otherwise required by law, the Company expressly disclaims any obligation or undertaking to release publicly any updates of any forward-looking statements contained in this document to reflect any change in its actual results, assumptions, expectations or any change in events, factors, conditions, or circumstances on which any forward–looking statement contained in this document is based.

Contacts:

Media Relations
Vikki Christian 
Elixir Health Public Relations
+1 (424) 610-1241
vchristian@elixirhealthpr.com

¹ Siegel RL, Miller KD, Jemal A. Cancer statistics, 2018. CA Cancer J Clin 2018; 68:7–30_Accessed at: https://www.ncbi.nlm.nih.gov/pubmed/29313949

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SOURCE Elios Therapeutics, LLC; Perseus Holdings USA

SCHAUFFHAUSEN, Switzerland, Aug. 5, 2020 /PRNewswire/ — TE Connectivity (NYSE: TEL), a world leader in connectivity and sensors, today unveiled a long-term sustainability and corporate responsibility strategy to better focus on the company’s vision for the future.

TE’s One Connected World strategy details a series of goals to make the world a better place as the company serves its employees, customers and shareholders.

«At TE, we have had an ongoing and transparent record of environmental, social and governance reporting through our annual corporate responsibility report and I’m proud of our progress over the past 10 years,» said CEO Terrence Curtin. «Now, we are evolving our strategy to the next level with One Connected World, which builds on our purpose of creating a safer, sustainable, productive and connected future and provides a roadmap for us to make a measurable impact over the next decade.»

TE has set nine strategic goals to meet by 2030:

• Embed sustainability in product creation at TE
• Partner with our direct and logistics suppliers to strengthen the sustainability of our supply chain; align our new construction with the Sustainable Facility Initiative
• Zero-accident workplace
• 100% of facilities in water-scarce locations meet reduction targets
• Decrease waste disposed
• 35%+ reduction in greenhouse gas emissions
• Strengthen our workplace culture, in which all differences are valued and all opinions count
• Impact 3 million people in next-generation technology education
• Implement a global human rights program

The company will measure its progress toward these goals and report out annually in its corporate responsibility report starting with the FY2020 report. Some of the work TE already does in pursuit of its vision of One Connected World is detailed in the FY2019 report. As one example, the report showcases how TE has incorporated sustainability into its operations over the past decade. The company has met greenhouse gas and energy reduction goals in 2012, 2015 and 2018.

This report also marks the first year TE’s corporate responsibility report aligns with the Sustainability Accounting Standards Board (SASB) standards. TE reports to the SASB standard specific to its industry as identified in the Sustainable Industry Classification System® (SICS®): Resource Transformation Sector — Electrical & Electronic Equipment Sustainability Accounting Standard.

To view the full FY2019 corporate responsibility report, visit TE.com/responsibility.

ABOUT TE CONNECTIVITY

TE Connectivity (NYSE: TEL) is a $13 billion global industrial technology leader creating a safer, sustainable, productive, and connected future. Our broad range of connectivity and sensor solutions, proven in the harshest environments, enable advancements in transportation, industrial applications, medical technology, energy, data communications, and the home. With nearly 80,000 employees, including more than 8,000 engineers, working alongside customers in approximately 150 countries, TE ensures that EVERY CONNECTION COUNTS. Learn more at www.te.com and on LinkedIn, Facebook, WeChat and Twitter.

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SOURCE TE Connectivity Ltd.

EMERYVILLE, Calif., Aug. 5, 2020 /PRNewswire/ — Grocery Outlet Bargain Market, extreme-value grocery retailer, today announced its tenth annual Independence from Hunger^® Food Drive campaign raised over $3 million, and made an additional $1 million contribution to match the efforts of its participating store locations to support families in need – bringing the total donation for 2020 to $4 million. From June 24 through July 31, over 350 Grocery Outlet stores nationwide raised funds and collected monetary donations from customers, employees and Independent Operators to donate back to local food agencies. In the current state of school closures, children and their families in vulnerable and disadvantaged communities throughout the US are at risk of experiencing food insecurity.

According to the USDA’s latest analysis of Food Insecurity in America, over 11 million households undergo limited access to food sources and suffer from food insecurity ^[1]. In the COVID-19 era, Brookings estimates households with insufficient food supply was estimated between 22-38 percent ^[2]. This year, food agencies have experienced a staggering demand and growing need to provide food for children who have been prematurely released from annual school schedules and unable to attend summer school – resulting in record lows for food bank inventories across the country. Now more than ever, Grocery Outlet has strengthened its commitment that was born a decade ago with its Independence from Hunger campaign to find solutions that ensure all families have access to high-quality meals.

«We are extremely proud to support food agencies in our back yards across the nation, raising over $11 million since the campaign began is a big milestone we’ve reached,» said Eric Lindberg, CEO at Grocery Outlet Inc. «To celebrate Independence from Hunger’s 10^th year anniversary, it was important to augment the great work our Independent Operators do with local partners, as a company we’re excited to contribute $1M to match their efforts.»

Since its launch in 2011, the Independence from Hunger campaign efforts have collected over $11 million in total donations nationwide. Throughout the campaign, Grocery Outlet customers and employees were encouraged to contribute to the campaign through:

• Purchase of a pre-made food bags filled with an assortment of nonperishable items
• Give $5, Get $5 at the register. Donate $5 or more in a single transaction and receive a $5 coupon
• Contribution of a monetary donation through in-store and online platforms

Each of Grocery Outlet’s 350-plus stores identified local food agencies in their respective locations to partner with throughout the campaign. Grocery Outlet’s San Francisco Bay Area partner, Alameda County Community Food Bank, will receive all donations completed online at GroceryOutlet.com/Donate. In addition, Grocery Outlet has partnered with regional area partners such as, Central Pennsylvania Food Bank, Los Angeles Regional Food Bank and Oregon Food Bank, who will also receive generous donations from long-time supplier partners Campbell’s, ConAgra, Frito-Lay, Gamesa-Quaker, Harris Ranch, Kellogg’s, MW Polar Foods, PepsiCo, Tyson Foods, Sanderson Farms, Thomas Foods and United Salad (Del Monte).

No administration or collateral fees are deducted from the funds collected by Grocery Outlet.

For more information on the Independence from Hunger campaign and Grocery Outlet, visit GroceryOutlet.com.

About Grocery Outlet
Extreme-value grocery retailer Grocery Outlet, based in Emeryville, California, offers big savings on brand name products every day, at more than 350 locations in California, Idaho, Nevada, Oregon, Pennsylvania, and Washington. Grocery Outlet carries a full range of products from fresh produce, meat, deli and dairy to a wide assortment of natural and organic choices. They also offer a large selection of beer and wine, health and beauty care, as well as seasonal items. A third-generation, family-led company founded in 1946, Grocery Outlet exists to provide customers an exciting place to find WOW deals on name brands they trust. Grocery Outlet stores are run by an Independent Operator in the local community.

For more information about Grocery Outlet, please visit www.GroceryOutlet.com

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SOURCE Grocery Outlet

LAVAL, QC, Aug. 5, 2020 /PRNewswire/ — Bausch Health Companies Inc. (NYSE/TSX: BHC) («Bausch Health» or the «Company»), today announced that the parties in the Canadian securities class action (Cattuci et al. v. Valeant Pharmaceuticals International Inc. et. al., Court File No.: 500-06-000783-163)) (the «Action») have agreed to resolve the Action for $94 million CAD (approximately $69 million USD), plus an additional amount for settlement administration costs, subject to court approval. The Action, filed in the Quebec Superior Court in 2015, alleged violations of Canadian securities laws regarding substantively the same matters as in the U.S. securities class action, which the Company also successfully settled. Once approved by the court, the settlement will resolve and discharge all class claims against the Company and the other defendants in the Action (the «Settlement»).

«This Settlement, together with our U.S. securities class action settlement and recent successful resolution of the legacy SEC investigation, puts an end to several of the more significant legal matters from the Valeant era and enables us to continue to focus our attention on Bausch Health today and our future,» said Joseph C. Papa, chairman and CEO of Bausch Health.

As part of the Settlement, the Company and the other defendants admit no liability and deny all allegations of wrongdoing whatsoever.

About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global company whose mission is to improve people’s lives with our health care products. We develop, manufacture and market a range of pharmaceutical, medical device and over-the-counter products, primarily in the therapeutic areas of eye health, gastroenterology and dermatology. We are delivering on our commitments as we build an innovative company dedicated to advancing global health. More information can be found at www.bauschhealth.com.

Forward-looking Statements
This news release may contain forward-looking statements, which may generally be identified by the use of the words «anticipates,» «expects,» «intends,» «plans,» «should,» «could,» «would,» «may,» «believes,» «estimates,» «potential,» «target,» or «continue» and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in the Bausch Health’s most recent annual report on Form 10-K and detailed from time to time in Bausch Health’s other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. They also include, but are not limited to, risks and uncertainties caused by or relating to the evolving COVID-19 pandemic, and the fear of that pandemic and its potential effects, the severity, duration and future impact of which are highly uncertain and cannot be predicted, and which may have a material adverse impact on Bausch Health, including but not limited to its project development timelines, and costs (which may increase). Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. Bausch Health undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.

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SOURCE Bausch Health Companies Inc.