Biden officials require insurers to cover eight at-home tests per month

 The Biden administration on Monday issued rules requiring private health insurers to cover the cost of at-home COVID-19 tests starting Jan. 15 amid pressure to make testing more available.

Under the policy, insurers will be required to cover the cost of eight at-home COVID-19 tests per person each month.

The broad outlines of the policy were first announced by President Biden in early December, but the new rules provide details — such as the number of tests that will be covered — for the first time.

The steps come as the Biden administration has faced intense pressure to do more to increase availability amid reports of long lines for PCR tests and pharmacies selling out of rapid at-home tests.

Experts criticized the announcement when Biden made it last month for relying on consumers to pay for the tests upfront at a pharmacy or other retailer and then get a reimbursement from their insurer after the fact, a cumbersome process that could discourage people from seeking tests.

The administration took some steps to try to address that issue in Monday’s rules by incentivizing insurers to cover the cost of tests upfront. If insurers establish a network of preferred pharmacies or retailers where they pay upfront for the tests, then they could cap their costs at $12 per test at pharmacies outside that network.

“The Biden Administration's testing guidance protects insurers against price gouging by unscrupulous retailers, but only if the insurance company provides a way for consumers to get at-home tests for free at pharmacies with no upfront payment,” tweeted Larry Levitt, a health policy expert at the Kaiser Family Foundation. 

Despite the new rules, there is still the issue of whether at-home rapid tests will be in stock and on store shelves for people to buy in the first place given that finding the tests has often been difficult amid the omicron wave. 

“The success of the Biden Administration's requirement that insurers pay for at-home COVID tests will depend, of course, on being able to snag those valuable tests to begin with,” Levitt added.

The rules also do not apply to people who get insurance through Medicare or who are uninsured.

https://thehill.com/policy/healthcare/589069-biden-officials-require-insurers-to-cover-eight-at-home-tests-per-month

Selective and cross-reactive SARS-CoV-2 T cell epitopes in unexposed humans

 Jose Mateus 1, Alba Grifoni 1, Alison Tarke 1, John Sidney 1, Sydney I Ramirez 1 2, Jennifer M Dan 1 2, Zoe C Burger 2, Stephen A Rawlings 2, Davey M Smith 2, Elizabeth Phillips 3, Simon Mallal 3, Marshall Lammers 1, Paul Rubiro 1, Lorenzo Quiambao 1, Aaron Sutherland 1, Esther Dawen Yu 1, Ricardo da Silva Antunes 1, Jason Greenbaum 1, April Frazier 1, Alena J Markmann 4, Lakshmanane Premkumar 5, Aravinda de Silva 5, Bjoern Peters 1 2, Shane Crotty 1 2, Alessandro Sette # 6 2, Daniela Weiskopf # 6

• DOI: 10.1126/science.abd3871

PDF: https://www.ncbi.nlm.nih.gov/pmc/articles/pmid/32753554/

Abstract

Many unknowns exist about human immune responses to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus. SARS-CoV-2-reactive CD4+ T cells have been reported in unexposed individuals, suggesting preexisting cross-reactive T cell memory in 20 to 50% of people. However, the source of those T cells has been speculative. Using human blood samples derived before the SARS-CoV-2 virus was discovered in 2019, we mapped 142 T cell epitopes across the SARS-CoV-2 genome to facilitate precise interrogation of the SARS-CoV-2-specific CD4+ T cell repertoire. We demonstrate a range of preexisting memory CD4+ T cells that are cross-reactive with comparable affinity to SARS-CoV-2 and the common cold coronaviruses human coronavirus (HCoV)-OC43, HCoV-229E, HCoV-NL63, and HCoV-HKU1. Thus, variegated T cell memory to coronaviruses that cause the common cold may underlie at least some of the extensive heterogeneity observed in coronavirus disease 2019 (COVID-19) disease.

https://pubmed.ncbi.nlm.nih.gov/32753554/

Cross-reactive memory T cells associate with protection against SARS-CoV-2 infection in COVID-19 contacts

 

Rhia Kundu, 

Janakan Sam Narean, 

Lulu Wang, 

Joseph Fenn, 

Timesh Pillay, 

Nieves Derqui Fernandez, 

Emily Conibear, 

Aleksandra Koycheva, 

Megan Davies, 

Mica Tolosa-Wright, 

Seran Hakki, 

Robert Varro, 

Eimear McDermott, 

Sarah Hammett, 

Jessica Cutajar, 

Ryan S. Thwaites, 

Eleanor Parker, 

Carolina Rosadas, 

Myra McClure, 

Richard Tedder, 

Graham P. Taylor, 

Jake Dunning & 

Ajit Lalvani 

• DOI  https://doi.org/10.1038/s41467-021-27674-x

• PDF: https://www.nature.com/articles/s41467-021-27674-x.pdf

• Abstract

  Cross-reactive immune responses to SARS-CoV-2 have been observed in pre-pandemic cohorts and proposed to contribute to host protection. Here we assess 52 COVID-19 household contacts to capture immune responses at the earliest timepoints after SARS-CoV-2 exposure. Using a dual cytokine FLISpot assay on peripheral blood mononuclear cells, we enumerate the frequency of T cells specific for spike, nucleocapsid, membrane, envelope and ORF1 SARS-CoV-2 epitopes that cross-react with human endemic coronaviruses. We observe higher frequencies of cross-reactive (p = 0.0139), and nucleocapsid-specific (p = 0.0355) IL-2-secreting memory T cells in contacts who remained PCR-negative despite exposure (n = 26), when compared with those who convert to PCR-positive (n = 26); no significant difference in the frequency of responses to spike is observed, hinting at a limited protective function of spike-cross-reactive T cells. Our results are thus consistent with pre-existing non-spike cross-reactive memory T cells protecting SARS-CoV-2-naïve contacts from infection, thereby supporting the inclusion of non-spike antigens in second-generation vaccines.

• https://www.nature.com/articles/s41467-021-27674-x

Century Therapeutics Shares Rise After Bristol Myers Deal

 Century Therapeutics Inc. shares were up 12% to $14.79 in premarket trading Monday after the company said it was in a research collaboration and license agreement with Bristol Myers Squibb Co.

The company said the agreement is to develop and commercialize up to four induced pluripotent stem cell derived, engineered natural killer cell and/or T cell programs for hematologic malignancies and solid tumors.

The first two programs include a program in acute myeloid leukemia and a program in multiple myeloma, which could incorporate either the iNK or a gamma delta iT platform. Bristol Myers has the option to add two additional programs which can be nominated subject to certain conditions agreed with Century in the agreement.

Century said that it will be responsible for development candidate discovery and preclinical development activities. Thereafter, Bristol Myers Squibb will be responsible for clinical development and commercialization activities subject to Century's co-promotion rights on certain programs.

Under the terms of the agreement, Century will receive a $100 million upfront payment and Bristol Myers Squibb will make a $50 million equity investment in Century Therapeutics' common stock at a price of $23.14 a share.

Century said that it will receive reimbursement of certain preclinical development costs for development candidates licensed by Bristol Myers Squibb, and is eligible for additional payments for future program initiations and development, regulatory, and commercial milestone payments totaling more than $3 billion across the four potential programs. Century will also receive tiered royalties as a percentage of global net sales in the high-single to low-double digits.

https://www.marketscreener.com/quote/stock/CENTURY-THERAPEUTICS-INC-123820661/news/Century-Therapeutics-Shares-Rise-12-Premarket-After-Bristol-Myers-Deal-37507096/

Fate Therapeutics Says FDA Clears Application for Solid Tumor Treatment

 Fate Therapeutics Inc. said the U.S. Food and Drug Administration cleared its Investigational New Drug application for FT536 for the treatment of solid tumors.

The proprietary antigen binding domain of FT536 has been shown to overcome MICA/B shedding, a common mechanism of tumor cell escape broadly observed across solid tumors, Fate Therapeutics said.

The cancer-focused clinical-stage biopharmaceutical company said the Phase 1 clinical protocol allows for administration of FT536 initially in up to two 30-day cycles, with each cycle consisting of three days of conditioning chemotherapy and three weekly doses of FT536.

Patients with clinical benefit may be re-treated with up to two additional cycles. For patients that achieve initial clinical response, additional treatment with FT536 may be administered following disease progression. The off-the-shelf treatment regimen is designed to be administered in the outpatient setting.

https://www.marketscreener.com/quote/stock/FATE-THERAPEUTICS-INC-14297698/news/Fate-Therapeutics-Says-FDA-Clears-Application-for-Solid-Tumor-Treatment-37507953/

Atara Biotherapeutics Sees Tabelecleucel FDA Meeting in 1Q

 Atara Biotherapeutics Inc. said its Tabelecleucel tab-cel for Post-Transplant Lymphoproliferative Disease is having continued progress with the U.S. Food and Drug Administration, including productive engagement with CBER and a Type B CMC meeting scheduled for the first quarter of 2022.

The company said it plans to complete the Biologics License Application submission for patients with EBV+ PTLD in the second quarter of 2022, and U.S. approval of BLA for patients with EBV+ PTLD anticipated in the first half of 2023.

Atara submitted a Marketing Authorization Application for tab-cel in patients with EBV+ PTLD, the first ever for an allogeneic, off-the-shelf T-cell therapy, in November. With the granting of Accelerated Assessment, the company is looking for a decision regarding EU approval in the fourth quarter.

The company also said the FDA has granted Fast Track designation for ATA188 in non-active primary progressive multiple sclerosis and non-active secondary progressive multiple sclerosis.

Atara said it is continuing to make good progress enrolling the Phase 2 study evaluating the efficacy and safety of ATA188 in patients with progressive MS. The company plans to conduct Phase 3 studies at the conclusion of the Phase 2 study and is actively exploring partnership opportunities.

Atara said it is continuing to advance its CAR T programs in liquid and solid tumors, which include a differentiated approach to allogeneic cell therapy, with no gene editing of the T-cell receptor and next generation CAR technologies to enhance expansion and persistence of functional T cells.

https://www.marketscreener.com/quote/stock/ATARA-BIOTHERAPEUTICS-IN-16917577/news/Atara-Biotherapeutics-Sees-Tabelecleucel-FDA-Meeting-in-1Q-37508417/

Adamis Shares Rally After Fast-Track Application for Covid Drug

 Adamis Pharmaceuticals Corp. shares rose more than 30% on Monday after the biopharmaceutical company said it had filed for U.S. Food and Drug Administration fast-track designation for Tempol for the treatment and prevention of Covid-19.

The San Diego company, which is currently conducting a Phase 2/3 study of Tempol in adults with confirmed Covid-19 infection, said the drug has been shown to have antiviral, anti-inflammatory and antioxidant activity.

The FDA's fast-track program is designed to facilitate the development and expedite the review of treatments for serious or potentially life-threatening illnesses with high unmet medical needs.

Adamis said that while the FDA has recently approved oral antiviral Covid-19 drugs, including pills from Pfizer Inc. and the team of Merck & Co. and Ridgeback Biotherapeutics, the company believes Tempol would qualify for the designation because of its unique mechanism of action and safety profile.

https://www.marketscreener.com/quote/stock/ADAMIS-PHARMACEUTICALS-CO-15227729/news/Adamis-Shares-Rally-After-Fast-Track-Application-for-Covid-Drug-37509237/