Monthly Archives: June 2021

The Labor Departments report that the economy added 559,000 jobs in May, an acceleration from April, buoyed Democrats and the Biden administration on Friday, adding new fuel to the presidents claims that vaccinations and his economic program are beginning to get the economy back on track after a halting recovery from pandemic recession.

This is historic progress, Mr. Biden said in remarks from Rehoboth Beach, Del. Progress thats pulling our economy out of the worst crisis its been in in 100 years.

He went on to claim credit for that progress, both from his administrations campaign to ramp up Americas vaccine production and distribution and from the $1.9 trillion economic aid legislation he signed into law in March.

None of this success is an accident, it isnt, Mr. Biden said, hailing the cooperation, the American people in responding to my effort to get covered under control, wearing masks conditioning and getting vaccinated. And its no small part of the bold action we took by passing the American rescue plan.

But the report, which fell short of analyst expectations for the second straight month and showed a slight shrinkage in the labor force, also provided fodder for Republican critics of the president. They say enhanced unemployment benefits which were extended by Mr. Bidens aid legislation in March are discouraging workers from returning to jobs and holding back what could be an even faster recovery.

Long-term unemployment is higher than when the pandemic started, and labor force participation mirrors the stagnant 1970s, Representative Kevin Brady, the top Republican on the Ways and Means Committee, said in a news release. Its time for President Biden to abandon his attack on American jobs, his tax increases, his anti-growth regulations and his obsession with more emergency spending and endless government checks.

After the April report fell substantially short of expectations, Republican governors across the country moved to prematurely end the $300-per-week supplemental unemployment benefits that began under President Donald J. Trump and are scheduled to continue through September under Mr. Bidens aid package.

Mr. Biden said Friday those benefits had helped Americans weather the crisis but noted they expire in 90 days. That makes sense, he said, it expires in 90 days.

White House economists said last month there was not yet evidence in the numbers that the supplement was discouraging work, pointing instead to constraints like school closures and child care issues keeping women with children from returning to work, along with a large number of working-age Americans who had not been fully vaccinated. Administration economists doubled down on that reading on Friday.

It is too soon to conclude that labor supply issues are holding back the long-term path of the recovery, the chair of the White House Council of Economic Advisers, Cecilia Rouse, wrote in a blog post on Friday morning.

Democratic leaders in Congress continued to push for the unemployment benefits to continue as scheduled, and for lawmakers to move to enact the rest of Mr. Bidens $4 trillion economic agenda.

The American people need all the support they can get, especially Black and Hispanic communities that were among the hardest hit by the pandemic, Representative Don Beyer of Virginia, the chairman of the Joint Economic Committee, said in a news release. Lawmakers must step up. That includes continuing enhanced UI to support workers seeking jobs and Congress passing President Bidens Jobs and Families Plans.

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Biden Touts Job Gains as 'Historic Progress' - The New York Times

As we enter Pride Month, its a good time to reflect on where we are. President Biden recently announced a renewed push for full legal equality for LGBTQ individuals, but that takes place against a background of continuing bias, including a new legal focus in many states on rolling back civil rights protections. There are battles that are being fought in the statehouses and halls of Congress, in peoples hearts and minds, and that is where theres been a great deal of evolution in the past few years. Looking at the levels of social and interpersonal bias, we are now in a much different situation than we were when this blog started 10 years ago.

To be sure, there is still bias against those whose sexuality differs from the norm, and that bias still matters in the courtroom: LGBTQ individuals may be accorded less credibility or trust, may be seen as more likely to have engaged in some crimes, and could be seen as subtly less worthy of money damages. In this post, I want to share a few conclusions on what we know about anti-gay bias especially, as it might impact evaluations of a party in a civil or criminal case

Society Has Come a Long Way

Anti-gay bias has been falling sharply. In a past post, I wrote about the sea change in attitudes leading up to and continuing from the Obergefell Supreme Court decision allowing gay marriages across the country. As entertainment culture adapted with more gay characters, and as our friends, neighbors, and family members became more comfortable living their lives openly, we saw a dramatic falloff in opposition to equal civil rights and social participation. Interesting, that change influenced both explicit and implicit biases, and the broad shift continues to serve as a novel and timely social science test case on the ways that even hardened social attitudes can change in a relatively short time.

Society Still Has a Long Way to Go

In controlled experimental settings, varying the sexuality of a party in litigation still impacts the results. In part, that occurs when mock jurors apply stereotypes (e.g., the myth that gay individuals are more likely than straight individuals to engage in child sexual abuse). Results are also impacted even when the case has nothing to do with those stereotypes. Even this year, a study (Mirabito & Lecci, 2021) demonstrated that anti-gay bias predicted convictions for gay defendants in both stereotype-consistent and stereotype-inconsistent scenarios.

Anti-gay bias is an attitude that can be measured as part of jury selection and is also a characteristic that tracks closely with a more generalized personality dimension that Ive written about before: authoritarianism. The psychological tendency to support conventional beliefs and strong social rules and order also tracks with a bias against those perceived to be outside these norms. Given a tendency to deny explicit bias against individuals when asked about them in a courtroom context, it may be more productive for litigants seeking to uncover anti-gay bias, as well as bias against other perceived outsiders, to ask about attitudes on psychological authoritarianism instead.

While society has made some steps forward, there is also a pendulum effect to it, and perceived progress motivates a backlash. So when it could impact your case, anti-gay bias is still something you want to look out for.

____________________

Mirabito, L. A., & Lecci, L. (2020). The impact of anti-gay bias on verdicts and sentencing with gay defendants. Journal of Gay & Lesbian Social Services, 1-24.

Read more:

Note the Progress and the Challenge in Courtroom Attitudes Toward Gay Litigants - JD Supra

Posted on Jun 3, 2021 in Latest News, Newsroom

HONOLULU The Hawaii Department of Health is unveiling its newest tool to help encourage more Hawaii residents to get vaccinated: COVID-19 vaccination progress maps.

Based on vaccination data collected to date, the Hawaii Department of Healths Disease Outbreak Control Division has developed a new set of heat maps that show vaccination rates by ZIP code for each island. The maps will be used to identify potential vaccine deserts areas where access to vaccine may be limited. The goal is to increase access through innovative community-based strategies.

The vaccine is our best tool to move forward together as a state. These maps will allow us to work with partners to strategically schedule new vaccination clinics around the state, said Dr. Sarah Kemble, state epidemiologist with the health department. With this geographic information, we can deploy resources where they are needed most and bring the vaccine to where people live, work, and play.

According to vaccination data on June 3, over half (52%) of Hawaiis total population has been fully vaccinated and 59% have received at least one dose of the COVID-19 vaccine. While the state has made tremendous progress in the past six months and restrictions are beginning to loosen, there are still hundreds of thousands of unvaccinated people and vaccination rates are higher in some areas than others.

We want this data to promote health equity by identifying areas where people might be experiencing increased barriers to vaccination, said Joshua Quint, MPH, PhD, an epidemiologist with the Disease Outbreak Control Division, who spearheaded the mapping project. We encourage people to monitor these maps and use them to encourage their neighbors to get vaccinated. Areas with lower vaccination rates represent opportunities to try new strategies that make it more convenient for people to get vaccinated. We are in a critical period where there is still ongoing community transmission. If more and more people continue to get vaccinated, we will prevent future outbreaks from causing unnecessary illness, hospitalizations, and deaths. The COVID-19 vaccines are safe, effective and represent the best way to protect yourself and your loved ones and speed up our recovery process.

To view the new progress maps go to https://health.hawaii.gov/coronavirusdisease2019/what-you-should-know/current-situation-in-hawaii/#vaccine, scroll down to the Hawaii COVID-19 Vaccine Summary, and select the MAP button.

For a brief explanation, watch the Weekly Dose on Facebook.

# # #

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DOH NEWS RELEASE: VACCINATION PROGRESS MAPS IDENTIFY AREAS WHERE IMRPOVED VACCINATION ACCESS IS CRITICAL TO AVOID VACCINE DESERTS - David Y. Ige |...

In remarks on Friday, President Biden touted the country's financial recovery, saying, America is on the move again, but he cautioned that progress is not assured.

PRESIDENT JOE BIDEN: America is finally on the move again. As we continue this recovery, we're going to hit some bumps along the way. Of course, that'll happen. We can't reboot the world's largest economy like flipping on a light switch. There's going to be ups and downs in jobs and economic reports. But we're going to be a supply chain issues and price pressures on the way back to stability and steady growth.

In the coming weeks, my administration is going to take steps to combat these supply constraints, building on the work we're doing on the computer chips. That is, we're providing more computer chips to be manufactured here in the United States, so it doesn't slow up the manufacturing of automobiles, for example.

Everyone needs to get their shots though. Now's the time to accelerate the process we've been making. Now's the time to build on the foundation we've laid. Because while our progress is undeniable, it is not assured.

That's why I proposed the American Jobs Plan and the Americans Family Plan for generational investments. We need today. We need to make those investments today to be able to continue to succeed tomorrow. We have a chance to seize on the economic momentum of the first months of my administration, not just to build back, but to build back better.

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Biden touts progress on economic recovery, but warns it is not guaranteed - Yahoo News

- INNATE trial to include proof-of-concept expansion cohorts in lung, renal, head and neck, triple negative breast, cutaneous squamous cell, and ovarian cancers and soft tissue sarcomas -

- SELECT TISvopra positivity rate for patient selection in-line with projections, clinical data on-track for 2022 -

CAMBRIDGE, Mass., June 04, 2021 (GLOBE NEWSWIRE) -- Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, today presented two trial in progress posters, on the Phase 1 INNATE clinical trial and the Phase 2 SELECT clinical trial, at the American Society of Clinical Oncology (ASCO) Virtual Annual Meeting. INNATE, a proof-of-concept (POC) trial, is evaluating Jounces lead macrophage program JTX-8064 (anti-LILRB2/ILT4 inhibitor) as a monotherapy and in combination with pimivalimab (anti-PD-1 inhibitor, formerly known as JTX-4014) in patients with a variety of advanced solid tumors. SELECT, Jounces second POC trial, is evaluating pimivalimab as a monotherapy and in combination with vopratelimab (ICOS agonist) in a novel biomarker selection paradigm in PD-(L)1 nave non-small cell lung cancer patients.

Our INNATE trial is rapidly progressing through dose escalation and we are on-track to begin indication-specific, POC, monotherapy and pimivalimab combination expansion cohorts in the second half of this year, said Elizabeth Trehu, M.D., chief medical officer of Jounce Therapeutics. Furthermore, we are excited to announce the expansion cohort indications for INNATE, which were selected using our translational data-driven approach, linking JTX-8064s mechanism to tumor types in three groups of patients including: PD-(L)1 inhibitor experienced and resistant, PD-(L)1 inhibitor nave and historically resistant, and PD-(L)1 inhibitor and historically more sensitive. JTX-8064 is one of only two clinical-stage LILRB2 programs in development and we expect it to be the first program to initiate expansion cohorts in four of our chosen tumor types. We are also pleased to see TISvopra positivity rates tracking with expectations in our biomarker selection trial, SELECT, and we remain on-track to report data next year.

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Poster Presentation Details:

Poster Title: Phase 1, First-in-Human trial of JTX-8064, an anti-LILRB2/ILT4 monoclonal antibody, as monotherapy and in combination with anti-PD-1 in adult patients with advanced solid (INNATE)Presenter: Kyriakos P. Papadopoulos, MD, South Texas Accelerated Research Therapeutics (START), San Antonio, TXSession Title: Developmental Therapeutics ImmunotherapyAbstract Number: TPS2672Date and Time: Friday, June 4, 2021; 9:00am ET Highlights from the trial in progress poster include the selection criteria for expansion cohorts in the ongoing Phase 1 INNATE trial and an outline the future biomarker plan:

Expansion cohort selection was informed using human histoculture and gene signature analysis from Jounces Translational Science Platform and includes PD-(L)1 nave and experienced patients as well as PD-(L)1 sensitive and resistant tumor types.

The INNATE trial is divided into 4 stages with indication-specific expansion cohorts intended to establish proof-of-concept for JTX-8064:

JTX-8064 monotherapy dose escalation in relapsed / refractory solid tumors

JTX-8064 plus pimivalimab dose escalation in relapsed / refractory solid tumors

JTX-8064 monotherapy expansion in PD-(L)1i nave platinum resistant ovarian cancer

JTX-8064 plus pimivalimab expansions in:

PD-(L)1i nave platinum resistant ovarian cancer

PD-(L)1i nave head and neck squamous cell carcinoma (HNSCC)

PD-(L)1i nave undifferentiated pleomorphic sarcoma (UPS) and liposarcoma (LPS)

PD-(L)1i experienced non-small cell lung cancer (NSCLC)

PD-(L)1i experienced clear cell renal cell carcinoma (ccRCC)

PD-(L)1i experienced triple negative breast cancer (TNBC)

PD-(L)1i experienced cutaneous squamous cell carcinoma (cSCC).

The dose for expansion cohorts will be selected based on safety, pharmacokinetic and receptor occupancy data from the monotherapy dose escalation stage of INNATE.

Archival and pre-treatment tumor biopsies as well as pre- and post-treatment blood samples will be collected to evaluate a number of potential predictive and pharmacodynamic biomarkers using Jounces Translational Science Platform.

Poster Title: Phase 2 Study of PD-1 Inhibitor JTX-4014 (Pimivalimab) Alone and in Combination with Vopratelimab, an ICOS Agonist, in Biomarker-selected Subjects with Metastatic NSCLC After One Prior Platinum-containing Regimen (SELECT)Presenter: Oleh Kobziev, MD, Regional Center of Oncology, Kharkiv, 61070, UkraineSession Title: Lung Cancer Non-Small Cell MetastaticAbstract Number: TPS9137Date and Time: Friday, June 4, 2021; 9:00am ET

The SELECT trial is currently enrolling approximately 75 immunotherapy nave NSCLC patients who have been pre-selected with the TISvopra predictive biomarker

TISvopra may serve as a unique biomarker for potential increased benefit for both pimivalimab monotherapy as well as pimivalimab in combination with vopratelimab.

Data from Jounce and a third-party ICOS agonist program support an ICOS-focused biomarker selection strategy to identify patients that may benefit from ICOS agonism.

Early screening data from SELECT support Jounces estimate that approximately 20% of PD-(L)1i nave non-small cell lung cancer patients tested for TISvopra in the study would meet the TISvopra positivity threshold.

SELECT is on-track to report clinical data in 2022.

Both posters will be available on the Our Pipeline section of the Jounce Therapeutics website under Publications at http://www.jouncetx.com.

About JTX-8064

JTX-8064 is a humanized IgG4 monoclonal antibody designed to specifically bind to Leukocyte Immunoglobulin Like Receptor B2 (LILRB2/ILT4) and block interactions with its ligands. JTX-8064 is the first tumor-associated macrophage candidate developed from Jounces Translational Science Platform. Preclinical data presented at the 2020 Society for Immunotherapy of Cancers Annual Meeting and the 2019 and 2021 American Association for Cancer Research Annual Meetings support the development of JTX-8064 as a novel immunotherapy to reprogram immune-suppressive macrophages and enhance anti-tumor immunity. A Phase 1 clinical trial named INNATE (NCT04669899) of JTX-8064 as a monotherapy and in combination with Jounces internal anti-PD-1 inhibitor, pimivalimab (formerly JTX-4014) is currently enrolling patients with advanced solid tumors.

About Pimivalimab

Pimivalimab (formerly JTX-4014) is a well-characterized fully human IgG4 monoclonal antibody designed to block binding to PD-L1 and PD-L2. Pimivalimab demonstrated a 17% durable overall response rate in a Phase 1 trial of 18 heavily pre-treated PD-(L)1 inhibitor nave patients, which excluded all tumor types for which PD-(L)1 inhibitors were approved. In this Phase 1 trial, pimivalimab was shown to have an acceptable safety profile. Pimivalimab is currently being assessed in the INNATE Phase 1 trial (NCT04669899) in combination with JTX-8064, a LILRB2 (ILT4) inhibitor. Pimivalimab is also being assessed in the SELECT Phase 2 clinical trial (NCT04549025) in combination with vopratelimab, a clinical-stage monoclonal antibody that binds to and activates ICOS, the Inducible T cell CO-Stimulator, a protein on the surface of certain T cells commonly found in many solid tumors.

About Vopratelimab

Vopratelimab is a clinical-stage monoclonal antibody that binds to and activates ICOS, the Inducible T cell CO-Stimulator, a protein on the surface of certain T cells commonly found in many solid tumors. Vopratelimab is currently being assessed in the SELECT Phase 2 clinical trial (NCT04549025) in combination with Jounces internal investigational PD-1 inhibitor, pimivalimab (formerly JTX-4014), compared to pimivalimab alone. The SELECT trial is currently enrolling approximately 75 immunotherapy nave NSCLC patients who have been pre-selected with the TISvopra predictive biomarker, an 18 gene RNA tumor inflammation signature which predicted the emergence of ICOS hi CD4 T cells and clinical benefit in the ICONIC trial of vopratelimab alone and in combination with a PD-1 inhibitor. SELECT is powered to demonstrate the statistical superiority of the combination of vopratelimab plus pimivalimab compared to pimivalimab.

About Jounce Therapeutics:

Jounce Therapeutics, Inc. is a clinical-stage immunotherapy company dedicated to transforming the treatment of cancer by developing therapies that enable the immune system to attack tumors and provide long-lasting benefits to patients through a biomarker-driven approach. Jounce currently has multiple development stage programs ongoing while simultaneously advancing additional early-stage assets from its robust discovery engine based on its Translational Science Platform. Jounces highest priority program, JTX-8064, is a LILRB2 (ILT4) receptor antagonist shown to reprogram immune-suppressive tumor associated macrophages to an anti-tumor state in preclinical studies. Jounces most advanced product candidate, vopratelimab, is a monoclonal antibody that binds to and activates ICOS, and is currently being studied in the SELECT Phase 2 trial. Pimivalimab is a PD-1 inhibitor intended for combination use in the INNATE and SELECT trials and with Jounces broader pipeline. Additionally, Jounce exclusively licensed worldwide rights to JTX-1811, a monoclonal antibody targeting CCR8 and designed to selectively deplete T regulatory cells in the tumor microenvironment, to Gilead Sciences, Inc. For more information, please visit http://www.jouncetx.com.

Cautionary Note Regarding Forward-Looking Statements:

Various statements in this release concerning Jounces future expectations, plans and prospects, including without limitation, Jounces expectations regarding the timing, progress, results and release of data for clinical trials of vopratelimab, pimivalimab and JTX-8064, identification, selection and enrollment of patients for Jounces clinical trials, and the use of pimivalimab in combination with Jounces other product candidates, may constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws and are subject to substantial risks, uncertainties and assumptions. You should not place reliance on these forward-looking statements, which often include words such as expect, goal, plan, on track, will or similar terms, variations of such terms or the negative of those terms. Although Jounce believes that the expectations reflected in the forward-looking statements are reasonable, Jounce cannot guarantee such outcomes. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, Jounces ability to successfully demonstrate the efficacy and safety of its product candidates and future product candidates; the preclinical and clinical results for its product candidates, which may not support further development and marketing approval; the potential advantages of Jounces product candidates; Jounces ability to successfully manage its clinical trials; the development plans of its product candidates and any companion or complementary diagnostics; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials of Jounces product candidates; and those risks more fully discussed in the section entitled Risk Factors in Jounces most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission as well as discussions of potential risks, uncertainties, and other important factors in Jounces subsequent filings with the Securities and Exchange Commission. All such statements speak only as of the date made, and Jounce undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor and Media Contacts:Mark YoreJounce Therapeutics, Inc.+1-857-200-1255 myore@jouncetx.com

Julie SeidelStern Investor Relations+1-212-362-1200Julie.Seidel@sternir.com

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Jounce Therapeutics Presents Trial in Progress Posters on the INNATE and SELECT Clinical Trials at the 2021 American Society of Clinical Oncology...

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."

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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

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Contacts

Investor Contact: Alex KellyChief Financial OfficerAlex.Kelly@precisionbiosciences.com

Media Contact: Maurissa MessierSenior Director, Corporate CommunicationsMaurissa.Messier@precisionbiosciences.com

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Precision BioSciences Reports Progress on Two Strategies Designed to Optimize Durability of Allogeneic CAR T Therapy in R/R Non-Hodgkin Lymphoma -...

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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KRULL COLUMN: Pride and progress | Opinion | newsandtribune.com - Evening News and Tribune

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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Kenton Nelsons Works in Progress - The New Yorker