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Saturday, April 9, 2022

SC Senate passes bill banning COVID-19 vaccine requirments

 The South Carolina Senate has passed a bill that would ban businesses from refusing to serve people who haven’t gotten the COVID-19 vaccine and prevent public employers from requiring the shots.

The Senate approved the bill 29-12 on Wednesday. Senators made changes to a House bill which that chamber passed in December, meaning the proposal returns to the House to see if it accepts those changes.

Senators initially put in a large unemployment tax penalty for private businesses that fired unvaccinated workers. But instead they compromised to allow fired workers to collect unemployment benefits, retroactive to the last nine months.

Opponents of the Republican-backed bill questioned why a group that typically says government shouldn’t tell businesses what to do is taking up this fight.

Supporters of the bill said they were trying to protect the choice of people who don’t want to take the COVID-19 vaccine.

The proposal bans state and local governments and public schools from requiring vaccines for their employers, contractors or students and also says first responders can’t be fired for refusing a COVID-19 shot.

The House can either agree to the Senate’s changes, sending the bill to Gov. Henry McMaster’s desk, or insist on its version of the bill, meaning a small group of House members and senators will have to work on a compromise between the two versions.

https://apnews.com/article/covid-health-business-south-carolina-6e8052e24d6addaaa76f4f4a2d810f85

Treatment for opioid addiction often brings discrimination

 Danielle Russell was in the emergency department at an Arizona hospital last fall, sick with COVID-19, when she made the mistake of answering completely when she was asked what medications she was on.

“I said yes, I was taking methadone,” said Russell, a doctoral student who also was in recovery from heroin use. “The smart thing to do, if I wanted to be treated like a human, would be to say no.”

Even though her primary doctor had sent her to the ER, she said she was discharged swiftly without being treated and given a stack of papers about the hospital’s policies for prescribing pain medications — drugs she was not asking for.

“It becomes so absurd and the stigma against methadone especially is so strong,” she said, noting that other people in recovery have had it worse. “You’re getting blocked out from housing resources, employment.”

It’s a problem people in the addiction recovery community have dealt with for decades: On top of the stigma surrounding addiction, people who are in medical treatment for substance abuse can face additional discrimination — including in medical and legal settings that are supposed to help.

This week, the U.S. Department of Justice published new guidelines aimed at dealing with the problem: They assert that it’s illegal under the Americans with Disabilities Act to discriminate against people because they are using prescribed methadone or other medications to treat opioid use disorder.

The guidelines don’t change federal government policy, but they do offer clarification and signal that authorities are watching for discrimination in a wide range of settings. The Justice Department’s actions this year also show it’s taken an interest in the issue, reaching multiple legal settlements, filing a lawsuit and sending a warning letter alleging other violations.

One of the government’s recent settlements was with a Colorado program that helps house and employ people who are homeless. A potential client filed a complaint claiming she was denied admission because she uses buprenorphine to treat her addiction. As part of the settlement, Ready to Work is paying the woman $7,500. Stan Garnett, a lawyer for the organization, said Thursday that the organization’s staff is being trained to comply with the law.

“It’s terrifying to be told by some authority — whether it’s a judge, or a child welfare official, or a skilled nursing facility — someone who has something you need is telling you you have to get off the medication that is saving your life,” said Sally Friedman, senior vice president of legal advocacy at the Legal Action Center, which uses legal challenges to try to end punitive measures for people with health conditions, including addiction.

Friedman said advocates and lawyers will cite the new guidelines when they’re making discrimination claims.

Dan Haight, president of The LCADA Way, which runs addiction treatment programs in the Cleveland area, said a suburb where they wanted to put a clinic at one point nixed the idea because of a moratorium in place on new drug counseling centers.

“We’re not looked at as another medical facility or counseling office,” Haight said. “We’re looked at because we do addiction.”

The new guidelines suggest that such broad denials could be violations of the ADA.

Overdoses from all opioids, including prescription drugs containing oxycodone, heroin and illicit laboratory-made varieties including fentanyl, have killed more than 500,000 Americans in the last two decades, and the problem has been growing only worse. That has frustrated advocates, treatment providers and public health experts who see the deaths as preventable with treatment.

Even as the crisis has deepened, there have been glimmers of hope. Drugmakers, distribution companies and pharmacy chains have announced settlements since last year to pay government entities about $35 billion over time plus provide drugs to treat addictions and reverse overdoses. Most of the money is required to be used to fight the epidemic.

It’s still to be determined how the money will be deployed, but one priority for many public health experts is expanding access to medication-based treatments, which are seen as essential to helping people recover.

But there’s still a stigma associated with the treatment programs, which use the medication naltrexone or drugs that themselves are opioids, such as methadone and buprenorphine.

Marcus Buchanan used methadone from 2016 through 2018 to help end a decadelong heroin habit. During that time, he was looking for work near his home in Chouteau, Oklahoma — mostly at factories — and could never land one.

“I can nail an interview. It would be the drug-screen process” when he’d explain why the results showed he was using methadone, said Buchanan, who is now an outreach coordinator for an opioid prevention program. “Every job, more than 20 probably, during those two years, was a door shut in the face.”

Dr. Susan Bissett, president of the nonprofit West Virginia Drug Intervention Institute, said people who are in treatment programs often hide it out of fear that they could lose their jobs.

She said she wants to reach out to business leaders and encourage them to hire and retain people who are using the medications.

“The next step is helping employers understand this is a disease instead of a moral failing,” Bissett said. “We don’t think about substance abuse disorder the way we think about diabetes, for example.”

One of the places where medication-assisted treatment is sometimes restricted or banned is in state drug diversion court programs, which are intended to get people help for addiction rather than incarcerate them.

Fewer than half the states have specific language that prohibits judges from excluding people who are taking the medications from participating in diversion programs or requires that they allow its use as part of the programs. That finding is based on an Associated Press review of legislation, administrative court orders and drug court handbooks that guide state drug diversion court programs.

Some states allow individual courts to make their own rules, while others only include language saying people can’t be excluded. Judges in some states still require defendants to taper off the medications and allow the diversion programs to decide whether the medications are appropriate for each person enrolled.

The Center for Court Innovation is trying to steer the drug courts into creating policies and programs that support people taking those medications instead of incentivizing them to stop.

“It can be frustrating, because nobody needs to tell a judge they need to allow someone to take blood pressure medication,” said Sheila McCarthy, a senior program manager for the Center for Court Innovation. “But for some, there is just a disconnect about the real effect these medications have on a person’s daily life.”

Veronica Pacheco has been off methadone for nearly a year after being on it for more than six years to treat an addiction to pain pills.

She said some people in the medical field — a physician, a dentist, a pharmacist — seemed to treat her differently after they learned she was on methadone treatment. They sometimes assume she was going to ask for new prescriptions for pain medications.

“I felt like I had a sign on my forehead saying, ‘I am a methadone person.’ The minute someone has your medical record, everything changes,” said Pacheco, who lives in the Minneapolis suburb of Dayton. “Now that I’ve been off it, I can see the night-and-day difference.”

https://apnews.com/article/covid-business-health-opioids-discrimination-5462560a707d7c27b71ed4773d9ba82c

GENFIT Recovers Post-Pandemic with Key Studies On ACLF and Cholestatic Diseases

 GENFIT, the late-stage biopharmaceutical firm, delivered on its promise to improve its financial situation in the year to December 31, 2021, posting an income of $40.8 million USD from a loss of $20.3 million in the year prior. As of the year's end, the company saw its cash and cash equivalents rise from $185.5 million in the previous year to $280.7 million.

Much of its recovery is attributable to the $130 million initial payment it received from its licensing deal with Ipsen in December, plus a $30.37 million equity investment. The company was also approved for two state-guaranteed loans and other loans subsidies amounting to a total of $16.5 million.

In the last year, GENFIT was also able to get a CIR reimbursement worth $8.6 million and gain $51.5 million for the partial repurchase of Oceane convertible bonds.

But what was particularly interesting about GENFIT's bounce-back year was the apparent success in its attempt to change its direction in research and development to focus on cholestatic diseases and acute on chronic liver failure (ACLF) programs.

"We are pleased to have delivered on our key commitments which were to improve our financial situation, pursue our Phase 3 trial and strengthen our pipeline. We start 2022 having made great progress regarding ELATIVE, and our improved financial visibility will enable us to grow our pipeline and accelerate our existing programs, as we continue to seek therapeutic and diagnostic solutions that can improve the health and quality of life of patients affected by severe chronic liver diseases," commented Pascal Prigent, CEO of GENFIT, in a statement.

The company is preparing to start its Phase I study of NTZ in patients with renal impairment by the fourth quarter of 2022 as part of its ACLF project. This initiative presents a potentially huge milestone for GENFIT. If successful and positive, it could lead to the launch of a proof-of-concept trial in patients with ACLF and acute decompensated cirrhosis.

Another highlight was an update on GENFIT's Phase III ELATIVE clinical trial of elafibranor in patients diagnosed with primary biliary cholangitis (PBC) and an incomplete response to ursodeoxycholic acid (UDCA). Despite the COVID-19 restrictions and some disruptions to the company's operations, participant enrollment progressed steadily, allowing GENFIT to still meet its timelines.

In addition, Elifibranor was able to meet the primary endpoint based on primary and composite biochemical evaluation guidelines, paving the way for possible accelerated approval. The company is expected to share topline data as scheduled by the second quarter of 2023.

"GENFIT will continue to grow and diversify its pipeline in 2022 by leveraging its expertise in bringing early-stage assets to late-development stages. To achieve this goal, we follow a dual-track approach based on repurposing of molecules approved in other indications and in-licensing of molecules developed by other companies," said the announcement.

Details were shared in a conference call dated April 8, 2022. 

https://www.biospace.com/article/genfit-recovers-post-pandemic-key-studies-on-aclf-cholestatic-diseases-on-track/

GeoVax’s Novel Vaccine Platform Induces Both Antibody and T Cell Responses

 Two major challenges in viral vector technologies are coding capacity – how much material can fit inside the vector – and manufacturing capabilities. GeoVax’s viral vector platform potentially overcomes both of those issues, enabling a broader immune system response and a manufacturing system able to quickly produce at scale and deliver vaccines successfully worldwide.

To illustrate the problem, “Think about the malaria vaccine, for example. It’s about 30% effective and requires four doses. As a vaccine, it’s inadequate, needing improved efficacy and simpler administration,” David Dodd, chairman and CEO of GeoVax, told BioSpace. “A better way to develop an acceptable malaria vaccine might be to encode elements from the genetic structure at different stages of malaria to induce a broader immune response, but limitations in coding capacity for most vaccine platforms don’t allow that.”

GeoVax’s platform directs the in vivo production of multiple viral proteins using a modified Vaccinia Ankara (MVA) delivery vector. “The MVA can encode multiple viral proteins resulting in the induction of strong and broadly specific immune responses with both antibody and T-cell effector function,” Dodd said. In contrast, other vaccine platforms, such as mRNA or adenovirus vectors can encode only a single viral protein. 

“In the case of COVID-19 vaccines, the mRNA and adenovirus platform vaccines (Pfizer/BioNTech and Moderna for mRNA; J&J and AstraZeneca for adenovirus viruses) only incorporate the spike (S) protein, which induces neutralizing antibodies and limited cellular immunity. In contrast, the GeoVax MVA-based COVID-19 vaccine, GEO-CM04S1, encodes the S-protein and the nucleocapsid (N) protein, which induces both strong antibody and strong T-cell responses,” Dodd said, explaining that T-cell responses are critical to establishing functional responses with long-term durability and immunological memory.

The GeoVax MVA manufacturing process is also being developed to overcome manufacturing capacity issues by using continuous cell line manufacturing rather than the traditional chicken embryo fibroblasts that have been used historically for MVA vaccines. This enables significantly more vaccine to be produced in less time, which allows a faster response to high volume requirements associated with infectious disease outbreaks and epidemics.

The MVA-based vaccines also can be lyophilized – freeze-dried – to bypass the cold-chain or frozen-state requirements of many other vaccines. “As such, our focus is on developing vaccines that can be delivered and administered to those in need, regardless of where in the world they are located (e.g., tropical, rural or far-away areas),” Dodd said. With a BARDA-funded partner, GeoVax is working to transfer its vaccine into a microneedle format so it can be self-administered.

GeoVax is conducting two Phase II COVID-19 vaccine clinical trials with its GEO-CMO4S1 vaccine. One of the trials is among immunocompromised patients who have been treated with CAR T therapy or have undergone bone marrow transplants. As a result of such cancer therapy, those patients have had their immune systems severely abated.

Overall, immunocompromised patients constitute approximately 3% of the U.S. population – essentially, 10-12 million people. “Such patients are not being adequately served by the current authorized COVID-19 vaccines,” Dodd said. He said he believes this is the first trial of a COVID-19 vaccine in an immunocompromised population with a direct comparison of GEO-CM04S1 to the Pfizer/BioNTech vaccine. Application to immunocompromised populations “is our major point of differentiation. Phase I data of this multi-antigen vaccine showed strong neutralizing antibody and T cell responses,” he added.

This Phase II trial is being conducted at the City of Hope in Los Angeles, which developed the GEO-CM04S1vaccine that GeoVax licensed. This trial is currently in active recruitment and enrollment.

“The second Phase II trial evaluates GEO-CM04S1 as a booster in healthy people who have received a primary mRNA vaccine,” he said. With those vaccines, “there appears to be a rapid waning of immune response, resulting in the need for third and fourth shots. In general, a heterologous booster ought to provide a more robust and more durable immune response than simply adding another mRNA booster, especially if the booster results in both antibody and cellular immunity. This trial is currently recruiting and enrolling patients.” He said he expects to follow these trial participants for at least one year to gauge durability of response.

Additionally, Dodd said, “We have developed a single-dose pan-coronavirus vaccine candidate (GEO-CM02) that is progressing to an investigational new drug (IND) filing. It includes the spike protein (S) to induce the antibody immune response, and membrane (M) and envelope (E) proteins to induce T-cell immune responses.” Dodd explained that incorporating those three proteins – hopefully – will enable the vaccine to work effectively against future coronavirus variants without the need for reformulation. “We’re essentially targeting variants before they arise, rather than chasing after them.”

Data for that pan-coronavirus vaccine was presented at the World Vaccine & Immunotherapy Congress last December. As Dodd recounted, “We presented animal data that demonstrated 100% protection in a single dose in a lethal challenge model. Such results are unprecedented and are the basis of our current IND-enabling COVID-19 pan-coronavirus program.”

GeoVax also is developing therapeutic vaccines for oncology indications. “We believe therapeutic vaccines will provide the opportunity to enhance the utility of standard of care treatments and specifically, immune checkpoint inhibitors,” Dodd said. To that end, GeoVax is conducting IND-enabling work for a cancer vaccine using an MVA-VLP-MUC1 cancer immunotherapy to target solid tumors. This vaccine stimulates the immune system and heightens its response. Then, by combining it with an immune checkpoint inhibitor, it enables a significantly greater response.

In the future, Dodd said he envisions incorporating additional tumor-associated antigens beyond MUC1, such as cyclin B1, into the company’s immuno-oncology platform and development programs.

Additionally, GeoVax recently in-licensed Gedeptin, a Phase II stage cancer immunotherapy which is in an active, expanding multi-site trial addressing advanced head and neck cancers.  This vaccine has also been granted orphan drug status and the clinical trial is partially funded by the FDA Orphan Drugs Clinical trial program.  Since acquiring the worldwide rights to Gedeptin and the respective technology, GeoVax has expanded the trial sites and assigned CRO oversight to accelerate the completion of the patient enrollment and evaluation of this Phase II program.

Vaccines, whether therapeutic or for infectious diseases, are becoming more capable as the field advances beyond the current generation of products and treatment options. Longer durability and pan-coronavirus applications, therefore, will be expected. GeoVax plans to meet those expectations.

https://www.biospace.com/article/geovax-s-novel-vaccine-platform-induces-both-antibody-and-t-cell-responses-/

Kinnate Biopharma Highlights Data from Lead RAF Candidate, Clinico-Genomics Studies at AACR

 Kinnate Biopharma Inc. announced that it will present data from the company’s lead RAF kinase inhibitor program, KIN-2787, and its clinico-genomics study investigating the occurrence of BRAF Class II and Class III alterations across solid tumors. The three separate poster presentations will be delivered at the American Association for Cancer Research (AACR) Annual Meeting in New Orleans, Louisiana taking place April 8-13, 2022. This presentation will highlight analyses conducted utilizing the GuardantINFORM platform and suggest that the prevalence of BRAF Class II and Class III alterations across patients with advanced and metastatic solid tumors screened via liquid biopsy-based comprehensive genomic profiling may be higher than previously understood. Among the nearly 6,000 patients who were identified as having BRAF alteration-positive cancers, approximately 55% were found to be harboring Class II and Class III alterations across all tumor types. When looking across common tumor types – Non-Small Cell Lung Cancer (NSCLC), Colorectal Cancer and Melanoma – approximately 65%, 30% and 20% of oncogenic BRAF alterations, respectively, are BRAF Class II and Class III. NSCLC and melanoma patients with BRAF Class II and Class III alterations experienced inferior clinical outcomes and represent populations that could benefit from novel targeted therapies.

https://www.marketscreener.com/quote/stock/KINNATE-BIOPHARMA-INC-115958458/news/Kinnate-Biopharma-Inc-Highlights-Data-from-its-Lead-RAF-Candidate-KIN-2787-and-RAF-Clinico-Genomi-40008319/

Cellectis S.A. Releases Preclinical Data on Candidate UCART20x22 At AACR

 Cellectis released preclinical data on its product candidate UCART20x22 at the American Association for Cancer Research (AACR) Annual Meeting. The data showed robust pre-clinical proof of concept with the potential to overcome common mechanisms of resistance to CAR T-cell therapies in relapsed or refractory Non-Hodgkin Lymphoma (r/r NHL), such as single-antigen escape or tumor heterogeneity. UCART20x22 is Cellectis’ first allogeneic dual CAR T-cell product candidate being developed for patients with r/r NHL. It features TALEN®-mediated disruptions of the TRAC gene (to reduce the risk of graft-versus-host disease) and of the CD52 gene (to permit use of a CD52-directed monoclonal antibody in patients’ preconditioning) to enhance CAR T engraftment, expansion and persistence. Dual targeting of CD20 and CD22, both validated targets in B-cell malignancies, is designed to enhanced tumor cell killing and to prevent immune escape due to single-antigen targeting. UCART20x22 has the potential to offer an alternative to CD19-directed therapies and CD19 negative relapses. The poster presentation at AACR highlighted the following preclinical data: UCART20x22 showed strong activity against tumor cell lines expressing either a single antigen, CD20 or CD22, or both simultaneously. In vivo pre-clinical models demonstrate that UCART20x22 efficiently eradicates tumors expressing both or either antigen, and sustained presence of UCART20x22 cells was observed in the bone marrow after tumor clearance. In vitro assays against primary cells from Non-Hodgkin Lymphoma patients with diverse CD22 and CD20 antigen levels demonstrate that UCART20x22 has potent and specific cytotoxic activity. UCART20x22 is expected to be Cellectis’ first product candidate fully designed, developed and manufactured in-house, showcasing the Company’s transformation into an end-to-end cell and gene therapy platform from discovery, product development, GMP manufacturing, to clinical development. An Investigational New Drug application (IND) for UCART20x22 is expected to be filed this year.

https://www.marketscreener.com/quote/stock/CELLECTIS-S-A-42457/news/Cellectis-S-A-Releases-Preclinical-Data-on-Its-Product-Candidate-UCART20x22-At-the-American-Associa-40008320/

Friday, April 8, 2022

US hospitals that give the most free care to patients

 Becker's determined which U.S. hospitals provide the most free health services to patients as a share of their total patients.

The 2019 data released April 5 is from the coverage, cost and value team at the National Academy for State Health Policy in collaboration with Houston-based Rice University's Baker Institute for Public Policy.

Hospitals with the highest percentage of charity in their payer mix:

(1) Minnie Hamilton Health Care Center — 76 percent

Location: Grantsville, W.Va.

Beds: 25 

System: independent

Ownership type: nonprofit

 

(2) Harris Health System — 55 percent

Location: Houston

Beds: 615

System: Harris Health

Ownership type: public

 

(3) Westside Medical Center — 49 percent

Location: Hillsboro, Ore. 

Beds: 122

System: Kaiser Permanente

Ownership type: nonprofit

 

(4) Robert Wood Johnson University Hospital — 48 percent

Location: Hamilton, N.J.

Beds: 152 beds

System: RWJBarnabas Health

Ownership type: nonprofit

 

(5) Moanalua Medical Center — 43 percent

Location: Honolulu

Beds: 295 beds

System: Kaiser Permanente

Ownership type: nonprofit

 

(6) Western Regional Medical Center — 41 percent

Location: Goodyear, Ariz. 

Beds: 38

System: independent

Ownership type: for-profit

 

(7) John H. Stronger Jr. Hospital of Cook County — 36 percent

Location: Chicago

Beds: 448

System: Cook County Health and Hospital System

Ownership type: public

 

(8) Dallas County Hospital District — 35 percent

Location: Dallas

Beds: 777 beds

System: Parkland Health and Hospital System

Ownership type: public

 

(9 — tie) Dorminy Medical Center — 31 percent

Location: Fitzgerald, Ga. 

Beds: 48 beds

System: Phoebe Putney Health Systems

Ownership type: public

 

(9 — tie) Dell Seton Medical Center — 31 percent

Location: Austin, Texas

Beds: 226

System: Ascension Health

Ownership type: public

https://www.beckershospitalreview.com/finance/us-hospitals-that-give-the-most-free-care-to-patients.html