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Daily Archives: June 4, 2021
Precision BioSciences Reports Progress on Two Strategies Designed to Optimize Durability of Allogeneic CAR T Therapy in R/R Non-Hodgkin Lymphoma -…
Posted: June 4, 2021 at 4:00 pm
Company Reports Updated Phase 1/2a Interim Study Results for 12 R/R Non-Hodgkin Lymphoma Patients who Received PBCAR0191 CAR T Cells Following Enhanced Lymphodepletion (eLD)
- Median Interval of 1 Day from Enrollment to Start of Lymphodepletion
- Single Dose of PBCAR0191 with eLD Yielded Overall Response Rate (ORR) of 75% and Complete Response Rate (CR) of 50% at Day 28 in Heavily Pretreated Patients with a Median and Mean of ~7 Prior Lines of Therapy
- 56% (5/9) of Responding Patients Remained Progression Free; 44% (4/9) of Responding Patients Showed Ongoing Responses > 4 Months; Assessment for Durability of Response is Ongoing
Company Showcases Preclinical Data Demonstrating that PBCAR19B Evaded Rejection by T-Cells and Natural Killer Cells
- PBCAR19B Stealth Cell Phase 1 Trial Open for Enrollment
Company to Host Webcast Today at 8:00 a.m. ET to Discuss Updated Study Results
Precision BioSciences Inc. (Nasdaq: DTIL), a clinical stage biotechnology company developing allogeneic CAR T and in vivo gene correction therapies with its ARCUS genome editing platform, today announced encouraging progress on two strategies designed to optimize the durability of allogeneic CAR T therapy in patients with relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL). The Company reported updated interim results from its Phase 1/2a study of PBCAR0191, the Companys investigational, off-the-shelf, allogeneic CAR T cell therapy targeting CD19. As of May 21, 2021, 12 patients with R/R NHL were enrolled and evaluated for response to PBCAR0191 with enhanced lymphodepletion (eLD). The Company also reported preclinical data demonstrating the potential mechanism by which its investigational immune evading stealth cell, PBCAR19B, may avoid rejection by T cells and natural killer (NK) cells.
"These interim results in heavily pretreated R/R NHL patients illustrate the potential for PBCAR0191 to recognize and target CD19 positive cancer cells and suggest that enhanced lymphodepletion may be a strategy to help suppress host immune rejection. Were encouraged by the high initial response rates and look forward to monitoring the responses for evidence of long-term durability," said Alan List, MD, Chief Medical Officer of Precision BioSciences. "In addition, our PBCAR19B Phase 1 study is open for enrollment, and we believe this candidate has the potential to build on the encouraging clinical responses weve seen with PBCAR0191 to date and reduce the need for prolonged immunosuppression."
Story continues
As of May 21, 2021, 18 subjects in the Phase 1/2a study of PBCAR0191 with R/R NHL completed Day 28 evaluation and received either eLD1 (n=12) or standard lymphodepletion2 (sLD; n=6) with Dose Level 33 of PBCAR0191.
Efficacy
Use of eLD mitigated PBCAR0191 rejection and markedly increased peak cell expansion (~72x) and area under the curve (AUC) (~59x), each as compared to sLD.
A single dose of PBCAR0191 cells following eLD yielded clinical responses in the majority of patients, with overall response rates (ORR) and complete response (CR) rates of 75% and 50%, respectively at Day 28.
Five of nine responding patients (56%) who received PBCAR0191 cells following eLD remained progression-free, including 4/9 evaluable subjects with responses lasting > 4 months. Assessment of duration of response is on-going.
Median interval from confirmation of eligibility to start of LD was 1 day, reinforcing the potential feasibility for rapid delivery of off-the-shelf, allogeneic, cellular therapy for high-risk patients.
Day 28 Evaluation
All eLD Subjects(n=12)
CD19-CAR T Nave(n=8)
Prior Auto CAR(n=4)*
Overall Response Rate (ORR) n (%)
9 (75%)
6 (75%)
3 (75%)
Complete Response (CR) n (%)
6 (50%)
4 (50%)
2 (50%)
* Three of four responding patients had prior auto-SCT and auto CD19 CAR treatment.
Safety and Tolerability
As of May 21, 2021, PBCAR0191 with eLD continued to show acceptable tolerability without evidence of graft versus host disease (GvHD) and with a similar frequency of immune effector cell-associated neurotoxicity syndrome (ICANS) and cytokine release syndrome (CRS) compared to patients who received sLD. Infections occurred more frequently when PBCAR0191 was dosed following eLD.
Adverse Event Max Grade
sLD(n=6)
eLD(n=12)
CRS(Cytokine release syndrome)
Grade 1 or Grade 2
3 (50%)
7 (58%)
Grade 3 or higher
0
0
ICANS(Immune effector cell-associated neurotoxicity)
Grade 1 or Grade 2
2 (33%)
3 (25%)
Grade 3 or higher
0
1 (8%)
GvHD(Graft versus host disease)
0
0
Neutropenia
Grade 3 or higher
0
2 (17%)
Grade 3+ at Day 28
0
2 (17%)
Infection
Grade 1 or Grade 2
0
1 (8%)
Grade 3 or higher
0
3 (25%)
Three treatment emergent deaths without disease progression occurred, including two cases of infection and one case of cardiac arrest after a choking incident. Two of these patients were in ongoing complete responses at time of death. Only one death, as previously reported on December 4, 2020 was assessed by the investigator as possibly related to study treatment.
Demographics for Enrolled R/R NHL Patients (PBCAR0191 with eLD)
Over 80% of subjects had advanced and aggressive lymphomas.
75% had stage III/IV disease.
Subjects had received a median of seven lines of therapy prior to study enrollment.
33% of subjects had prior CD19-directed CAR therapy.
PBCAR19B Immune Evading Stealth Cell
PBCAR19B is designed to extend persistence of allogeneic CAR T cells by evading rejection by the immune system of the patient. In preclinical studies, the anti-CD19 PBCAR19B stealth cell exhibited substantial resistance to rejection mediated by both allo-reactive T cell and NK cells, suggesting the potential utility of this approach.
In January 2021, Precision announced that the U.S. Food and Drug Administration accepted its investigational new drug application to evaluate the safety and clinical activity of PBCAR19B in patients with R/R NHL. Initial clinical trial sites have been selected for the Phase 1 study that is now open for enrollment. PBCAR19B will be evaluated at increasing flat dose levels beginning at 2.7 x 108 cells using sLD with the ability to dose up to 8.1 x 108 cells. Of note, the first dose level is approximately equivalent to Dose Level 3 in the PBCAR0191 trial.
Company-Hosted Conference Call and Web Cast Information
Precision will host a conference call and webcast today, Friday, June 4, 2021 at 8:00 a.m. ET to discuss the most recent interim clinical data for PBCAR0191 and preclinical data for PBCAR19B. The dial-in conference call numbers for domestic and international callers are (866) 996-7202 and (270) 215-9609, respectively. The conference ID number for the call is 5647916. Participants may access the live webcast and the accompanying presentation materials on Precisions website http://www.precisionbiosciences.com in the Investors and Media section under Events and Presentations. An archived replay of the webcast will be available on Precisions website.
About PBCAR0191 and Study Design (Clinical Trials Study Identifier: NCT03666000)
PBCAR0191 is an investigational allogeneic chimeric antigen receptor T cell therapy (CAR T) in a Phase 1/2a trial for the treatment of patients with R/R NHL and R/R B-ALL. PBCAR0191 was designed using Precision BioSciences novel and proprietary ARCUS genome editing platform. It has been granted Fast Track Designation by the FDA for B-ALL. Precision also holds Orphan Drug Designation from the FDA for this program in mantle cell lymphoma, an aggressive subtype of NHL.
About PBCAR19B (Clinical Trials Study Identifier: NCT04649112)
PBCAR19B is a next-generation, stealth cell candidate for patients with CD19-positive malignancies such as R/R NHL. PBCAR19B is designed to improve the persistence of allogeneic CAR T cells following infusion by reducing rejection by T cells and NK cells. In addition to the CAR gene, the PBCAR19B stealth cell vector carries a short hairpin RNA that suppresses expression of beta-2 microglobulin, a component of Major Histocompatibility Complex (MHC) Class I molecules found on the cell surface. Reducing or knocking-down Class I MHC expression on allogeneic CAR T cells has been shown to reduce CAR T cell killing by cytotoxic allo-reactive T cells. Additionally, in an effort to attenuate NK cell-mediated elimination due to MHC class I knockdown, the PBCAR19B vector also carries an HLA-E gene designed to inactivate NK cells.
About Precision BioSciences, Inc.
Precision BioSciences, Inc. is a clinical stage biotechnology company dedicated to improving life (DTIL) with its wholly proprietary ARCUS genome editing platform. ARCUS is a highly specific and versatile genome editing platform that was designed with therapeutic safety, delivery, and control in mind. Using ARCUS, the Companys pipeline consists of multiple "off-the-shelf" CAR T immunotherapy clinical candidates and several in vivo gene correction therapy candidates to cure genetic and infectious diseases where no adequate treatments exist. For more information about Precision BioSciences, please visit http://www.precisionbiosciences.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding our clinical development pipeline and the clinical benefit of our product candidates. In some cases, you can identify forward-looking statements by terms such as "aim," "anticipate," "believe," "could," "eligible," "expect," "expected," "should," "plan," "intend," "estimate," "target," "mission," "goal," "may," "will," "would," "should," "could," "target," "potential," "potentially," "promising," "project," "predict," "contemplate," "potential," or the negative thereof and similar words and expressions.
Forward-looking statements are based on managements current expectations, beliefs and assumptions and on information currently available to us. Such statements are subject to a number of known and unknown risks, uncertainties and assumptions, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various important factors, including, but not limited to: our ability to become profitable; our ability to procure sufficient funding and requirements under our current debt instruments and effects of restrictions thereunder; risks associated with raising additional capital; our operating expenses and our ability to predict what those expenses will be; our limited operating history; the success of our programs and product candidates in which we expend our resources; our limited ability or inability to assess the safety and efficacy of our product candidates; our dependence on our ARCUS technology; the initiation, cost, timing, progress, achievement of milestones and results of research and development activities, preclinical or greenhouse studies and clinical or field trials; public perception about genome editing technology and its applications; competition in the genome editing, biopharmaceutical, biotechnology and agricultural biotechnology fields; our or our collaborators ability to identify, develop and commercialize product candidates; pending and potential liability lawsuits and penalties against us or our collaborators related to our technology and our product candidates; the U.S. and foreign regulatory landscape applicable to our and our collaborators development of product candidates; our or our collaborators ability to obtain and maintain regulatory approval of our product candidates, and any related restrictions, limitations and/or warnings in the label of an approved product candidate; our or our collaborators ability to advance product candidates into, and successfully design, implement and complete, clinical or field trials; potential manufacturing problems associated with the development or commercialization of any of our product candidates; our ability to obtain an adequate supply of T cells from qualified donors; our ability to achieve our anticipated operating efficiencies at our manufacturing facility; delays or difficulties in our and our collaborators ability to enroll patients; changes in interim "top-line" and initial data that we announce or publish; if our product candidates do not work as intended or cause undesirable side effects; risks associated with applicable healthcare, data protection, privacy and security regulations and our compliance therewith; the rate and degree of market acceptance of any of our product candidates; the success of our existing collaboration agreements, and our ability to enter into new collaboration arrangements; our current and future relationships with and reliance on third parties including suppliers and manufacturers; our ability to obtain and maintain intellectual property protection for our technology and any of our product candidates; potential litigation relating to infringement or misappropriation of intellectual property rights; our ability to effectively manage the growth of our operations; our ability to attract, retain, and motivate key executives and personnel; market and economic conditions; effects of system failures and security breaches; effects of natural and manmade disasters, public health emergencies and other natural catastrophic events effects of the outbreak of COVID-19, or any pandemic, epidemic or outbreak of an infectious disease; insurance expenses and exposure to uninsured liabilities; effects of tax rules; risks related to ownership of our common stock and other important factors discussed under the caption "Risk Factors" in our Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2021, as any such risk factors may be updated from time to time in our other filings with the SEC. These filings are accessible on the SECs website at http://www.sec.gov and the Investors & Media page of our website at investor.precisionbiosciences.com.
All forward-looking statements speak only as of the date of this press release and, except as required by applicable law, we have no obligation to update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
1 Fludarabine (30 mg/m2/day for 4 days) and cyclophosphamide (1000 mg/m2/day for 3 days)2 Fludarabine (30 mg/m2/day for 3 days) plus cyclophosphamide (500 mg/m2/day for 3 days) 3 Dose Level 3 of 3 x 106 cells/kg
View source version on businesswire.com: https://www.businesswire.com/news/home/20210604005124/en/
Contacts
Investor Contact: Alex KellyChief Financial OfficerAlex.Kelly@precisionbiosciences.com
Media Contact: Maurissa MessierSenior Director, Corporate CommunicationsMaurissa.Messier@precisionbiosciences.com
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KRULL COLUMN: Pride and progress | Opinion | newsandtribune.com – Evening News and Tribune
Posted: at 4:00 pm
The meeting was tense.
This was almost 20 years ago, when I was executive director of what was then the Indiana Civil Liberties Union. The ICLU, on behalf of several couples, had filed suit challenging Indianas ban on same-sex marriage.
The suit provoked consternation on all sides.
Social conservatives were furious. I remember one discussion with a thought leader on the right. He was so indignant at the thought of same-sex unions that he trembled while he talked. He almost looked as if he were going to pass out.
Even proponents of same-sex marriage were concerned. They worried that the timing wasnt right. That the suit would provoke a backlash. That it would make things even worse.
Thats what led to the meeting.
It was a gathering of leaders and activists advocating for LGBTQ rights. They wanted to know why the ICLU had filed the suit and they wanted to express their concerns.
I was aware that feelings were running high before I arrived at the meeting. I wasnt aware how high until I walked into the room.
After I explained why the ICLU had filed the suit in short, because we believed some citizens rights had been violated and the ACLU exists to defend peoples rights we opened things up for discussion.
Some people snapped their questions or comments. Others yelled.
One woman who sat on the floor in front of where I stood hissed at me again and again, too upset to even speak.
It was an education.
As a straight white male from middle America, I had been insulated from many of the indignities, abuses and outrages heaped upon my fellow LGBTQ citizens. I had friends who were LGBTQ, of course, but I was in my 30s before many of them started coming out.
I had little idea of all they had to resent about our society.
All they had to resist.
All they had to fear.
That night, I learned a lot.
The feelings ran so high in that room because there were so many feelings and so many of them were complicated. There was fear of continuing oppression and of betrayal. There was anger that so many people had to fight for rights that most people simply took for granted. There was worry that, somehow, someone would make a mistake that would cast away hard-fought and hard-won gains.
And there was just frustration that they ordinary, decent people had to put up with all of this. That they had to devote substantial pieces of their lives to gaining what should have been theirs at birth.
That night, after the meeting was over, I recounted what had happened to my wife. For a time, neither of us said anything.
Then I said:
Its not right. No one should have to go through that and work that hard just to be who they are.
Flash forward nearly 20 years.
The other night, my wife and I went to dinner. It was our anniversary. We chose a nice restaurant in Indianapolis, a place where we could sit outside and enjoy the evening.
Not long before our entrees arrived, two men walked in. They were holding hands. Each had a wedding band. They were smiling.
When they sat down, they ordered a nice bottle of wine. They toasted. Clearly, they were celebrating something. Id like to think it was their anniversary, but it might just have been some other happy event.
As I watched them laugh and talk over dinner, I remembered that long-ago meeting. I recalled all the high feelings the palpable anxiety in the room as I saw these two men who just seemed to be alive and together.
And I thought: Progress is possible.
This month is Pride Month. Its supposed to be a time of affirmation and self-affirmation for LGBTQ people.
Its a good thing.
I know we still have a lot of ground to cover before we live in a truly just world. We will cover that ground crawling, stumbling, walking or running because justice demands it.
And because people shouldnt have to work that hard just to be who they are.
John Krull is director of Franklin Colleges Pulliam School of Journalism and publisher of TheStatehouseFile.com, a news website powered by Franklin College journalism students.
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Kenton Nelsons Works in Progress – The New Yorker
Posted: at 4:00 pm
Theres been much debate, in the past few weeks, about whether President Bidens emphasis on infrastructure, public spending, and government support merits comparison to the New Deal. For the cover of the Money Issue, Kenton Nelson evokes one of the hallmarks of that program: the Works Progress Administration, or W.P.A., which put millions of Americans to work in a time of staggering unemployment. We recently talked to Nelson about how he was inspired by Depression-era muralists, and about his experience during the pandemic.
This painting evokes much of the art created by and for the W.P.A. Do you draw inspiration from any particular artists?
Ive always been inspired by the design of J. C. Leyendeckers Arrow Collar ads, and by Maxfield Parrishs mural works, especially Old King Cole at the St. Regis Hotel, in New York. Grant Wood and Thomas Hart Benton, with their distinct American voices, were also influential. Bentons murals at the Met are something to behold! Lastly, I couldnt help but be influenced by my great-uncle Roberto Montenegro, and by his friends Diego Rivera, Jos Clemente Orozco, and David Alfaro Siqueiros.
You often depict the formal beauty of everyday America. Do you travel in the U.S. a lot? Where do you find that small-town feeling preserved?
I was born and raised in the small provincial town of Pasadena, California, which is full of beautiful architecture and charm. But I do travel a lot, as Im intrigued by how people live. The intimacy of some of the outer boroughs in New York is fascinating. Every person has a remarkable story, which can be found in the fabric of their neighborhood.
Youve been a working artist for decades. Have you ever had another job to support yourself?
No, I started doing graphic design and illustration while I was going to college. In the early nineties, with the advent of the computer and desktop publishing, I decided to teach myself how to paint, and have been working at that ever since.
If you hadnt become an artist, what other jobs would have attracted you?
I have always been jealous of good jazz musicians, vocalists in particular.
Did COVID-19 change your work patterns much? Did you begin any new projects as a result of the shutdown?
My studio is a couple miles from my home. I missed one day of work in the last fifteen months, but that was because of a hip replacement. I love what I do, and tend to be a little compulsive.
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Gingold Theatrical Group Announces Phase 1, Plays-In-Progress Readings from Speaker’s Corner Writers Group – Broadway World
Posted: at 4:00 pm
Gingold Theatrical Group, now in its 16th Season, will continue its new play development with the Phase 1 Plays-In-Progress virtual table readings of this year's SPEAKER'S CORNER Writers Group. This season, writers Kate Douglas, Aeneas Sagar Hemphill, Divya Mangwani, Seth McNeill, Sophie Sagan-Gutherz, and Marcus Scott are developing works in response to Shaw's Arms and the Man. To learn more about these closed developmental table reads, and to register in advance to join, please visit gingoldgroup.org.
by Kate Douglas, directed by Colette RobertJune 5th at 2:30 PM ET
by Aeneas Sagar Hemphill, directed by Arpita MukherjeeJune 8th at 7 PM ET
by Sophie Sagan-Gutherz, directed by Jaye HuntJune 10th at 7 PM ET
by Seth McNeill, directed by Lico WhitfieldJune 12th at 7 PM ET
by Divya Mangwani, directed by Aneesha KudtarkarJune 15th at 7 PM ET
by Marcus Scott, directed by Christopher BurrisJune 17th at 7 PM ET
Named after the corner of London's Hyde Park where George Bernard Shaw and other political speakers have delivered speeches since 1855, GTG's SPEAKERS' CORNER brings together six to ten writers each year who will spend the year exploring a specific Shaw play and writing individual new plays in response to that text and Shaw's forward thinking humanitarian ideals.
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LGBTQ+ progress being made in Peachtree City – The Citizen.com
Posted: at 4:00 pm
One year ago, on June 1, we placed a small rainbow sticker in the front window of our Peachtree City home. Even though our then-president had for his entire term neglected to declare June as Pride Month.
Because of the pandemic, we stayed close to home; the limited shops in our community boasted no Pride merchandise that we saw. I made do with my treasured One Pulse t-shirt (commemorating the massacre at the Florida night club). It was a solemn time.
What a difference a year can make!
Last Tuesday, President Biden formally declared June, Pride Month. A White House statement asserts, after 4 years of relentless attacks on LGBTQ+ rights, the Biden-Harris Administration has taken historic actions to accelerate the march toward full LGBTQ+ equality.
Our window sticker has been replaced with a bright HAPPY PRIDE MONTH! lawn sign! We have come across celebratory Pride clothing in local stores! Just today, while picking up to-go in a small restaurant, we were greeted by two employees with rainbow hair we joyfully gushed Happy Pride! as we left. Even the cereal aisle in our grocery store made me grin, with a Kelloggs Together heart-shaped, berry flavored breakfast cereal!
I realize that change has been too long coming; and is still too slow. Much damage has been done; and many people have been terribly hurt. Members of the LGBTQ+ community are certainly at the top of that list (along with other minorities in the U.S., including persons of color and non-Christians).
But we are not hopeless.
May I say to my brothers and sisters
We are supporting you, the best that we know how. Forgive us when we get it wrong.
We are grateful to you. And for you. You add so much to our lives and our society.
We love you.
And we wish us all together a very Happy Pride Month!
Suzanne Sports
Peachtree City, Ga.
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Revving it up Progress Times – Progresstimes
Posted: at 4:00 pm
State championship winning coach retires
Hes coached soccer at Sharyland High School for over 20 years. Hes led the Rattlers to 21 playoff appearances over that span. Hes one of only a handful of Valley coaches in any sport to ever lead a team to a state championship. Hes Coach Reveriano Rev Hernandez, and with the 2020/2021 school year having concluded last week, his coaching career has now officially come to an end at the same place it all began.
Its no secret that anyone who chooses to go into coaching as a career does so knowing full well that there are no guarantees when it comes to job stability. Thats because coaching is a, What have you done for me lately? profession. In other words, todays success in no way guarantees continued employment tomorrow. A coach can have his or her team at the top of the heap one day and be gone the next.
Sharyland High head soccer coach Reveriano Hernandez celebrates the Rattlers state championship in front of thousand of fans that showed up for the welcome home rally thrown in their honor. Progress Times photo by Luciano Guerra
There are of course exceptions to this rule, but they are few and far between. Having coached his entire career at Sharyland High, Hernandez is one of the exceptions. And were it not for his decision to retire at the relatively young age of 54, theres no doubt that he wouldve extended what is now his 22 year tenure of coaching soccer at Sharyland High, even longer.
Hernandezs love for the sport of soccer began long before his coaching career began. He grew up playing soccer in his hometown of Brownsville, Texas and he was good enough to be given the opportunity to play at both the high school level and the Division 1 collegiate level.
I graduated from Brownsville Hanna in 1986, Hernandez said. I played soccer there three years. After high school I went to play for what was then Pan American University. I received a scholarship to play there. I played there four years. I graduated in 1990 with a degree in Special Ed and I went to work in 1990/1991.
Having graduated from Pan American during the month of December and not wanting to wait until the beginning of the following school year to begin his teaching career, Hernandez accepted a position in Rio Grande City. A position he only kept for two years due to receiving an offer he could not refuse to teach in Sharyland, where he was already living.
Back then the Special Ed department at Sharyland was a co-op so I was working for four districts, Valley View, Hidalgo, San Isidro and Sharyland, Hernandez said. The districts were small and the Special Ed departments were super small since they only had a few kids.
Two years later, Hernandez took his first coaching position.
I think when I started working at Sharyland, thats when they started the soccer program, Hernandez said. Demian Marroquin and Shane Hurley, both of whom were my teammates at Pan Am, were the coaches at Sharyland so I started as a volunteer. When Hurley moved on to San Antonio I started coaching the JV team. Within two years Marroquin moved on as well, and I became the head coach.
As stated previously, that was 22 years ago. And while its true that hes led the Rattlers to the playoffs in 21 of those seasons, it took a pandemic to prevent him from making it 22 playoff appearances in 22 years. Thats because despite having a 14-0 district record (26-3-2 overall) and claiming the district championship last year, COVID-19 forced the UIL cut all Texas high school soccer seasons short just as the playoffs were about to kick off.
Under Coach Rev, the Rattlers have never finished district play in any worse than second place. Thats 13 district championships and nine district runner-ups in 22 seasons. In addition, Hernandez has led his teams to 16 Bi-district championships, 13 Area championships, six Regional Quarterfinal championships, one Regional Semifinal championship, one Regional Final championship and the one ultimate championship that every high school coach across the state of Texas aspires to but only a select few ever attain, a State championship!
We went up against Morton Ranch from Katy, Texas for the state championship, Hernandez said. I know that we went ahead 1-0 but they turned the game around and we were losing 2-1. Then we scored in the last minute of the game, I think, to tie it at 2-2. Then we went into overtime but nobody scored in overtime. Then we went to shootouts and we were losing 3-1. Our first three guys missed and then on the last two we scored. They missed on their last two, so it was 3-3. Then we went to sudden death and Amahry Lozano scored the winning goal for us.
While Valley soccer teams have won more state championships over the years than Valley teams from any other sport, being a state champion in the Rio Grande Valley is still a very exclusive club.
Hidalgo won the first one (soccer state championship), Hernandez said. And then I think Brownsville Lopez won one. And then it was Brownsville Porter. And then there was us. And finally it was Brownsville Rivera, and again Brownsville Porter. Thats pretty much it.
That night the Sharyland Rattlers arrived back at Sharyland High School at around midnight. The team was greeted by thousands of fans at a rally in their honor which was held at the football stadium. When asked what it was like to be greeted by so many fans, Hernandez said, It was really something. I think the whole Upper Valley was there in the stadium waiting for us. Even at the stadium where we played over there, there were so many people from the Valley, and not only from Sharyland, cheering for us. It was something special.
The Rattlers two goals in regulation of that state championship game were scored by Daniel Garcia and Jesus Olivares. The goalkeeper was Jorge Medina. He had six saves in that game.
Over his 22 year tenure as the Rattlers head coach, Hernandez has accumulated a record of 466 wins, 108 losses and 41 ties. No matter how you look at his won-loss record and no matter how you look at all the playoff appearances, all the district championships and all the playoff championships the Rattlers have won under him, Hernandezs accomplishments are extremely impressive.
What has made him so successful? Hernandez had no problem answering that question.
Ive never looked at my 22 years as the Rattlers head soccer coach as a job, Hernandez said. Its been a calling. Its been my passion. I think thats the reason Ive been so successful.
I want to thank everybody, Hernandez added. All my former players, all my coaches, all the people that were on top of me like the ACs (athletic coordinators), the AD (athletic directors) and the principals. I thank them for giving me the opportunity to work with them and for making it possible for me to enjoy every day of my time here at Sharyland.
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Zoetis Releases 2020 Sustainability Report and Creates the Zoetis Foundation, Marking Progress in Creating a Healthier Future for Communities, Animals…
Posted: at 4:00 pm
PARSIPPANY, N.J--(BUSINESS WIRE)--Zoetis today published its 2020 Sustainability Report Our Journey Toward a Better World describing its commitment to continued disclosure on environmental, social and governance (ESG) topics and progress toward the companys Driven to Care long-term sustainability aspirations. The report highlights the companys journey to champion a healthier, more sustainable future through specific commitments to Communities, Animals and the Planet; these commitments build on Zoetis purpose and help achieve the United Nations Sustainable Development Goals (SDGs). Complementing the report is a comprehensive ESG Appendix, an update from the companys baseline disclosure published in November 2020, which shares key ESG performance indicators, including those set out by the Sustainability Accounting Standards Board (SASB) for the biotechnology and pharmaceuticals industry.
Building on its history of supporting the people who care for animals, Zoetis is proud to commit $35 million over five years through the newly established Zoetis Foundation. The signature work of the Foundation will advance opportunities for veterinarians and farmers, with grantmaking focused on enabling thriving professions and livelihoods. Initially, the Foundation will focus on scholarships and diversity initiatives to help drive a more inclusive veterinary community in the U.S. In 2022, the Foundations work will expand to support veterinary debt relief, additional diversity, equity and inclusion programming, and mental wellness for farmers and veterinarians in the U.S., as well as support farmer and veterinary livelihoods in Africa, Australia, Brazil, China and Europe.
Zoetis has a long history of addressing important challenges faced by veterinarians and farmers. Our new charitable foundation represents the next chapter in extending and driving forward these commitments, said Jeannette Ferran Astorga, Head of Sustainability at Zoetis and President of the Zoetis Foundation. Specifically, the Zoetis Foundation will look for opportunities to address lack of diversity in both professions, the need for resources that support emotional well-being, financial burdens such as veterinary student loans, and lack of access to a higher standard of animal care in underserved areas.
Caring for Communities and Colleagues
In 2020, Zoetis donated over $6 million to support animals and the people who care for them, with 9.6% of all community investments supporting COVID-19 relief efforts across the globe. As progress toward its goal to provide at least $1 million in scholarships to veterinary students annually, in 2020 the company provided over $934,000 in scholarships to support over 400 students. In the U.S., 34% of students supported by the Zoetis and Association of American Veterinary Medical Colleges Veterinary Student Scholarship Program were diverse. Zoetis also provided over $1.83 million through charitable programs and in-kind donations to care for animals impacted by disasters around the world.
The events of the past year reaffirmed our purpose to nurture the world and humankind by advancing care for animals, and strengthened our resolve to champion a healthier, more sustainable future for people, animals, and the planet we share, said Kristin Peck, Chief Executive Officer of Zoetis. The world depends on animals for nutrition, comfort and companionship, and the people who care for them play essential roles in that dynamic. That was amplified by the COVID-19 pandemic. Im incredibly proud of our colleagues who went above and beyond to safely and effectively connect with customers, keep our business operations running smoothly, and make a difference in their local communities to support the health of animals and people who care for them.
Supporting colleagues and their health, well-being and safety was the companys top priority in navigating the COVID-19 pandemic. Approximately 70% of Zoetis colleagues moved to remote working arrangements, while strict health and safety protocols were implemented at the companys essential sites. In response to a survey, 85% of colleagues reported being satisfied with the companys communication, actions and focus on well-being, and 94% of colleagues felt they were able to effectively perform their roles amidst the pandemic. In addition, Zoetis reported progress toward its aspiration to support colleagues and cultivate a safe, flexible, diverse and inclusive workplace, including specific improvements in the diverse representation of our workforce in the U.S. The report also highlights success as a leader for workplace inclusion by achieving a 100% score on the Human Rights Campaigns Corporate Equality Index. To further support colleagues, Zoetis expanded its Colleague Resource Groups (CRGs) to bring together colleagues who share similar backgrounds and experiences or interests and can help work toward the companys diversity, equity and inclusion aspirations.
Innovating for Animal Health
Based on the belief that healthier animals help make a healthier future for all, Zoetis is committing its innovation expertise to solve sustainability challenges facing animals and people. One of the companys sustainability targets is continued investment in its Center for Transboundary and Emerging Diseases (CTED). Through the CTEDs inter-connected capabilities, Zoetis will continue to combat diseases that pose the greatest risk to animals and people and develop vaccines for high impact emerging infectious diseases including Foot and Mouth Disease, African Swine Fever and COVID-19.
More than ever before, SARS-CoV-2 (the virus that causes COVID-19 in people) put a spotlight on the important connection between animal health and human health. When concerns first surfaced in February 2020 about SARS-CoV-2 in domestic animals, Zoetis initiated development activities for diagnostic tests and a vaccine that could be used in animals. Building on the companys experience with other coronavirus vaccines for animals, Zoetis completed initial studies in eight months, and the resulting vaccine has been used experimentally to help care for zoo animals at risk of being infected with SARS-CoV-2. Zoetis also developed and validated feline and canine-specific real-time Polymerase Chain Reaction (PCR) diagnostic tests for SARS-CoV-2.
Additionally, to provide products that support livestock farmers and veterinarians environmental, social and animal welfare goals, Zoetis is innovating across the continuum of care to predict, prevent, detect and treat health conditions. Promoting a preventive approach to animal health and helping to reduce the need to use antibiotics to treat disease is one way the company is innovating, including new vaccines introduced in 2020 for salmonids and poultry. Alpha ERM Salar and Poulvac E. coli both are having a direct impact on reducing antibiotics used in raising fish and poultry.
Protecting the Planet
To minimize the carbon footprint and improve environmental sustainability of the companys locations, Zoetis reported it is sourcing 8.8% renewable electricity and progressing toward its RE100 commitment to source 100% renewable energy by 2050. Additionally, eight of the companys international manufacturing sites are operating with 100% renewable electricity. To help meet its second goal to reduce energy intensity in manufacturing and research and development (R&D) by 5% by 2025, the company also shared progress of 2.2% reduction while at the same time increasing its production.
Zoetis is also committed to using resources wisely, including reducing its energy use and associated greenhouse gas emissions. The company reported reduction of energy intensity in manufacturing and R&D by 2.2% through investments in energy efficiency upgrades to manufacturing equipment, utilities including cooling towers, chillers and boilers, and LED lighting. Further, Zoetis reported progress to minimize its impact on the environment by reducing its generation of solid non-hazardous and hazardous waste by increased focus on recycling.
In rethinking product packaging to reduce the companys environmental footprint, in 2020 Zoetis formed the Packaging Council to integrate sustainability considerations into all new packaging designs. The council is a cross-functional group that develops resources and considers recyclability, use of recycled and sustainable materials, and greenhouse gas emissions along with cost, time to market and customer experience.
Zoetis will continue to share updates on its sustainability activities, including progress against its Driven to Care goals, and report annually.
About Zoetis
As the worlds leading animal health company, Zoetis is driven by a singular purpose: to nurture our world and humankind by advancing care for animals. After nearly 70 years innovating ways to predict, prevent, detect, and treat animal illness, Zoetis continues to stand by those raising and caring for animals worldwide - from livestock farmers to veterinarians and pet owners. The companys leading portfolio and pipeline of medicines, vaccines, diagnostics, and technologies make a difference in over 100 countries. In 2020, Zoetis generated revenue of $6.7 billion with ~11,300 employees. For more information, visit http://www.zoetis.com.
DISCLOSURE NOTICES
Forward-Looking Statements: This press release contains forward-looking statements, which reflect the current views of Zoetis with respect to: business plans or prospects, ESG commitments, goals and aspirations, the plans and future work of the Zoetis Foundation, and other future events. These statements are not guarantees of future performance or actions. Forward-looking statements are subject to risks and uncertainties. If one or more of these risks or uncertainties materialize, or if management's underlying assumptions prove to be incorrect, actual results may differ materially from those contemplated by a forward-looking statement. Forward-looking statements speak only as of the date on which they are made. Zoetis expressly disclaims any obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2020, including in the sections thereof captioned Forward-Looking Statements and Factors That May Affect Future Results and Item 1A. Risk Factors, in our Quarterly Reports on Form 10-Q and in our Current Reports on Form 8-K. These filings and subsequent filings are available online at http://www.sec.gov, http://www.zoetis.com, or on request from Zoetis.
All trademarks are the property of Zoetis Services LLC or a related company or a licensor unless otherwise noted.
2021 Zoetis Services LLC. All rights reserved.
ZTS-CORZTS-IR
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U.S. continue to show progress vs. Switzerland but key areas of improvement remain – ESPN
Posted: at 4:00 pm
Heading into this week's CONCACAF Nations League Finals in Denver and, more importantly, World Cup qualifying in the fall, what the United States men's national team needed more than anything was a step up in competition. Its nine-match unbeaten streak over the past 18 months was at least partially a product of the quality of the opposition, which made Sunday's match on the road against Switzerland, the No. 13-ranked team in the world, a valuable barometer for coach Gregg Berhalter.
The results were mixed. After a strong first-half performance in which Sebastian Lletget scored the opening goal, the Americans faded after halftime while playing at altitude in a 2-1 loss.
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Berhalter has said all week part of the goal for this match -- from its location to the day of the week -- was to mimic the timeline for what the team will face in the unusual upcoming three-game World Cup qualifying windows. Playing in Switzerland essentially replicates the final club game the European-based players will have before flying across the Atlantic Ocean to take on CONCACAF opposition.
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Any benefits from the scheduling exercise won't pay off until the fall, but playing against a strong Switzerland provided a decent snapshot of where the team stands, albeit without three key players: Christian Pulisic and Zack Steffen, due to their involvement in Saturday's Champions League final, and midfielder Tyler Adams, who is rehabbing a back injury.
In the first half, the U.S. was the better team on balance. They created the more dangerous scoring chances, were patient and played effectively out of the back and pressed Switzerland into some mistakes in the final third. Sergino Dest was effective pushing forward on the left side, where Brenden Aaronson -- who impressed last window and since his move to Austrian champion FC Salzburg in January -- was also an energetic presence.
Without Adams, Berhalter handed a start to Jackson Yueill, and he mostly acquitted himself well, dropping deep to serve as an option for center backs John Brooks and Mark McKenzie.
"I think it was it was an interesting game for Jackson, it seemed that he gave [Liverpool's Xherdan Shaqiri] a difficult time with this movement and he opened up and got the ball in some good positions," Berhalter said. "There are a couple times that he lost the ball, but he was feeling the game out. I think his diagonal passing could have been a little bit sharper, but overall pleased with his effort."
Yueill was replaced by Kellyn Acosta in the second half, and both players figure to be in the mix to see playing time in the Nations League with Adams' status still uncertain. Berhalter said he would receive an update on Adams' status on Monday, after the team travels to the United States.
It was a difficult game for striker Josh Sargent, who wasn't able to make much of an impact before being subbed off for Jordan Siebatcheu in the 72nd minute. Sargent has always had a reputation for being a talented player expected to come good with time, but as other options at his position have emerged over the past year, it's fair to question what the depth chart should look like at his position. Daryl Dike finished the season on fire with Barnsley, while Siebatcheu scored 15 goals in all competitions for Swiss champion Young Boys. Siebatcheu didn't necessarily improve his standing, either, on Sunday, but the idea that Sargent deserves the benefit of the doubt has become less convincing the longer he goes without being a consistent scoring threat.
Despite Sargent's minimal impact in front of goal, Berhalter praised the job he did in other aspects of the game.
"I think that he had a game where he gave everything he got. He battled," Berhalter said. "I think he played a good game save for scoring a goal, because that's what we want our forward to do. But other than that, very active, very committed."
Darryl Dike isn't on the Nations League roster, but he is with the team in this camp and is expected to play against Costa Rica on June 9. Timothy Weah has been training primarily as a winger with the team but is another option Berhalter could experiment with at the No. 9 spot, having played there some with French champion Lille.
The U.S. had some decent moments to start the second half, but it didn't take long for Switzerland to tip the scales in its favor after switching from a 3-4-1-2 to a 5-3-2 formation. By using a central midfielder behind the American's pressing No. 9, Switzerland played through the press more easily, and it led to several good chances -- with goalkeeper Ethan Horvath coming up big on a few occasions to keep the score within reach.
Switzerland's game winner came almost immediately after the U.S. took off Lletget, Yueill and center back John Brooks, with Acosta, Tim Ream and Yunus Musah coming on. A stray touch by Dest and some suspect defending in the box allowed the ball to bounce around before Steven Zuber beat Horvath.
"It's a great measuring stick," Berhalter said. "This is a team that has been playing together for a really long time. It's the same group that Switzerland has had for the last four years, five years. It's a mature group, it's older than us and our guys can look at that as what this team could be in the future."
Berhalter didn't completely tip his hand at what to expect in the starting lineup against Honduras in the Nations League semifinals on Thursday but indicated that Pulisic was firmly in the plans.
"Try to tell Christian that he's not playing on Thursday," he said. "It's gonna be a very difficult one coming off of winning the Champions League, coming in the game making an impact in that game. He's ready to go."
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SunHydrogen Reports Progress on its Nanoparticle-Based Green Hydrogen Technology – GlobeNewswire
Posted: at 4:00 pm
SANTA BARBARA, CA, June 01, 2021 (GLOBE NEWSWIRE) -- SunHydrogen, Inc. (OTC:HYSR), the developer of a breakthrough technology to produce renewable hydrogen using sunlight and water, today announced progress on the development process for the scale-up of its nanoparticle hydrogen generation technology.
Earlier this year, the company announced its cooperation with Schmid Group in Freudenstadt, Germany and InRedox in Longmont, Colorado to develop its technology to commercial scale. Schmid is developing the process and equipment for manufacturing while InRedox is focused on the electrochemical process of creating nanoporous templates on transparent substrates for growing nanoparticles.
Despite foreseen challenges in the supply chain for necessary materials and equipment, the company has made positive progress in testing and confirming the scalable potential of the transparent substrates, a critical component for fabricating nanoparticle hydrogen generators. The company has worked with various transparent substrates to determine the best-performing ones for creation of nanoporous layers, which will then serve as a template and foundation for growing the nanoparticles. The company isfurthermoving toward testing the growth of nanoparticles on the down-selected substrates at scales relevant for mass manufacturing.
The company is also making good progress in the acquisition of the equipment and chemicals for fabrication, testing and validation of large-scale devices. The devices will consist of arrays of billions of nanoparticle-based hydrogen generators, each able to split water molecules into hydrogen and oxygen. Each array will be approximately the size of a single six-inch silicon solar cell.
InRedox and Schmid have been dedicated in providing the necessary input and support for the development process. They have pushed the project hard even with the challenges in supply chains due to persisting pandemic, said Tim Young, CEO of SunHydrogen, Inc. With the team in Germany now in place, and the necessary equipment now able to be obtained, we expect to see more rapid progress very soon. Due to the delays associated with supply chain challenges, the Cooperation Agreement with Schmid has been extended to fully complete the work scope with no additional cost to the company.
About SunHydrogen, Inc.SunHydrogen is developing a breakthrough, low-cost technology to make renewable hydrogen using sunlight and any source of water, including seawater and wastewater. The only byproduct of hydrogen fuel is pure water, unlike hydrocarbon fuels such as oil, coal and natural gas that release carbon dioxide and other contaminants into the atmosphere when used. By optimizing the science of water electrolysis at the nano-level, our low-cost nanoparticles mimic photosynthesis to efficiently use sunlight to separate hydrogen from water, ultimately producing environmentally friendly renewable hydrogen. Using our low-cost method to produce renewable hydrogen, we intend to enable a world of distributed hydrogen production for renewable electricity and hydrogen fuel cell vehicles. To learn more about SunHydrogen, please visit our website at http://www.SunHydrogen.com.
Safe Harbor StatementMatters discussed in this press release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. When used in this press release, the words "anticipate," "believe," "estimate," "may," "intend," "expect" and similar expressions identify such forward-looking statements. Actual results, performance or achievements could differ materially from those contemplated, expressed or implied by the forward-looking statements contained herein, and while expected, there is no guarantee that we will attain the aforementioned anticipated developmental milestones. These forward-looking statements are based largely on the expectations of the Company and are subject to a number of risks and uncertainties. These include, but are not limited to, risks and uncertainties associated with: our ability to successfully negotiate agreements with suppliers and manufacturers of its hydrogen generation panels, our ability to procure project financing, our ability to retain the service of a qualified engineering firm to design and build a pilot plant, our ability to secure an agreement to with a partner with us for the pilot plant, the impact of economic, competitive and other factors affecting the Company and its operations, markets, product, and distributor performance, the impact on the national and local economies resulting from terrorist actions, and U.S. actions subsequently; and other factors detailed in reports filed by the Company.
Press Contact:info@sunhydrogen.com
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Bionano Stock Is Enticing on Strong Q1 Results and Saphyr’s Progress – InvestorPlace
Posted: at 4:00 pm
After Bionano (NASDAQ:BNGO) reported very strong first-quarter results and showed that its Saphyr DNA analysis tool is progressing on multiple fronts, I remain extremely bullish on BNGO stock.
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On May 13, Bionano reported that its Q1 revenue had soared 179% year-over-year to $3.2 million, while its gross margin increased to roughly 33% from 25% during the same period a year earlier.
Moreover, Bionano expects to expand the user base of its Saphyr genome analysis machines by 50% this year to 150.
Bionano CEO Erik Holmlinnoted that the company had sold record numbers of flow cells (the amount of DNA that can be analyzed) and analyzed a record number of service samples.
Since flow cells and service samples are the revenue-generating razor blades in the companys shaver and razor-blade model, those records are extremely important achievements for Bionano.
More specifically, the number of flow cells sold by Bionano jumped 275% YOY and rose 5% versus the previous quarter, reaching 2,603. In its services lab, the company analyzed 227 samples, during Q1, the CEO reported.
Importantly, Bionano acquired a number of very promising customers last quarter.
Both of the key deals it made in Q1 involved the acquisition of new Saphyr systems. One deal was with Torontos University Health Network, which has the largest hospital lab in all of Canada. That agreement leaves Bionano well-positioned to grow in Canada.
In the other noteworthy deal, one hospital and one lab that are part of the UKs national insurance system agreed to launch Saphyr systems.
I think that, in the wake of those transactions, Bionano is very well-positioned to expand not only in the UK, but in all of Europe.
In recent weeks and months, a number of important scientific achievements that are likely to increase the demand for Saphyr systems have been documented.
For example, MD Anderson Cancer Center released a study showing that Saphyr reduced the time needed to analyze the tumors of patients with myelodysplastic syndrome from several weeks to four days.
Childrens Hospital proved that Saphyr, unlike older methods of analysis, detected gene fusions in pediatric acute leukemias, Holmlin said, adding that these fusions can be treated with drugs.
Tel Aviv University showed that Saphyr can be used to analyze DNA methylation in the DNA of tumors, the CEO reported. According to the Journal of Clinical Oncology, Alterations in DNA methylation are common in a variety of tumors.
Meanwhile, in the U.S. and Europe, Bionanos customers are developing and validating new tests that can be performed with Saphyr. Among these are whole-genome analysis within constitutional genetic disorders, whole-genome analysis for neurodevelopmental disorders and blood cancers.
The company also is in the midst of comparing Saphyr with older tools when it comes to analyzing prenatal and postnatal genetics, hematological malignancies and solid tumors.
If the results of these studies are favorable, the acceptance of Saphyr will become more widespread, Holmlin said. Moreover, I believe that positive data from these studies would likely drive BNGO stock much higher.
Finally, Penn State has used Saphyr to analyze solid tumors and has published protocols on how to do so. As a result, Saphyr can expand into solid tumors in areas such as breast cancer, colon cancer, melanoma, lung cancer and many other areas of solid tumor oncology, including glioblastoma, et cetera, Holmlin said.
Clearly, adoption of Bionanos Saphyr is rapidly accelerating, while new, vital, potentially life-saving uses for it are being found.
Given these points, along with the relatively low market capitalization of BNGO stock, I remain very bullish on the name.
On the date of publication, Larry Ramerheld a long position in Bionano.The opinions expressed in this article are those of the writer, subject to the InvestorPlace.comPublishing Guidelines.
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