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Thursday, December 2, 2021

T-cell test bronze goes to Qiagen

 Qiagen today became the third company to launch a T-cell-based test for prior Covid-19 infection and also to assess individuals’ response to vaccination. The Quantiferon Sars-Cov-2 assay, which detects CD4+ and CD8+ T-cell responses elicited by the virus, is now available in Europe, joining Perkinelmer’s T-Spot Discovery Sars-CoV-2 product. Neither of these is yet available in the US, however, where the only T-cell test with FDA emergency authorisation is Adaptive Biotechnologies’ T-Detect Covid assay. Qiagen says its blood test, which has grown out of the Dutch group’s year-old collaboration with Tscan Therapeutics, is differentiated from the competition as it does not require a purification step for the lymphocytes. Testing for Covid-19-reactive T-cells is believed to be a useful adjunct to antibody testing since the response declines more slowly than antibody response, but also appears beforehand, since CD4+ T-cells help B cells generate anti-Covid antibodies. Quantiferon Sars-Cov-2 could indicate how severe the course of a Covid infection will be, according to Qiagen, as well as how long immunity might last. But there is as yet no definitive evidence linking T-cell readings to resistance to subsequent infection with Covid-19. 

Marketed Covid-19 T-cell tests
CompanyTestStatus 
PerkinelmerT-Spot Discovery Sars-CoV-2CE marked Mar 2021; awaiting US EUA
Adaptive BiotechnologiesT-Detect Covid US EUA granted Mar 2021
QiagenQuantiferon Sars-Cov-2CE marked Dec 2021
Source: FDA, company releases.\

https://www.evaluate.com/vantage/articles/news/policy-and-regulation-snippets/t-cell-test-bronze-goes-qiagen

Novartis gets in on alpha-synuclein

 Novartis is hardly known for novel CNS projects. But today the group took a punt on a potentially disease-modifying mechanism for Parkinson’s, via a deal with UCB. The target, alpha-synuclein, has had its fair share of setbacks, with Roche and Prothena last year reporting mixed data with their antibody, prasinezumab, and Biogen this year discontinuing BIIB054. At least Novartis has not paid top dollar: the company is giving UCB $150m up front, although it is on the hook for up to $1.5bn in milestones. In return, the Swiss company gets global co-development and co-commercialisation rights to UCB0599, an oral, brain-penetrant alpha-synuclein misfolding inhibitor, and an option on UCB7853, an anti-alpha-synuclein antibody. The two projects could complement each other, UCB noted. As well as Roche and Prothena, which are pressing on with prasinezumab, other companies looking at this target include include AC Immune, which struck its own deal here in July. Annovis Bio’s ANVS401, meanwhile, inhibits amyloid-beta and tau as well as alpha-synuclein – that group is planning phase 3 trials in both Parkinson’s and Alzheimer’s, but phase 2 data have been far from convincing.

Alpha-synuclein-targeting projects in clinical development
ProjectCompanyDescriptionTrial details
Phase 2
ANVS401Annovis BioSmall molecule amyloid precursor protein, alpha-synuclein & Tau inhibitorPh2 PD data reported Oct 2021, ph3 planned
Prasinezumab (PRX002/RO7046015)Prothena/RocheAnti-alpha-synuclein MabPD: Ph2 Pasadena failed, Ph2b Padova began May 2021
ENT-01EnterinSmall molecule alpha-synuclein aggregation inhibitorPh2 Karmet in PD-related constipation completed Jul 2021; Ph2 planned in PD+psychosis & PD+dementia
Lu AF82422Lundbeck/GenmabAnti-alpha-synuclein MabAmulet in multiple system atrophy completes May 2023
UCB0599Novartis/UCB (licensed from Neuropore Therapies)Small molecule alpha-synuclein misfolding inhibitorPh2 in PD completes Jul 2024
Phase 1
ACI-7104 (PD01 )AC Immune (via Affiris)Anti-alpha-synuclein vaccinePh1 completed, ph2 to start "shortly"
MEDI341 (TAK-341)Astrazeneca/TakedaAnti-alpha-synuclein MabMAD trial in PD completes Jul 2022
ION464 (BIIB101)Biogen/IonisAlpha-synuclein antisenseHorizon in multiple system atrophy completes Jul 2022
UB-312VaxxinityAnti-alpha-synuclein vaccinePh1 in healthy volunteers & PD pts completes Dec 2022
UCB7853 UCB (Novartis has option)Anti-alpha-synuclein MabPh1 in healthy volunteers & PD pts completes Jun 2023
ABBV-0805Abbvie/BioarcticAnti-alpha-synuclein MabPh1 withdrawn for "strategic reasons", project still listed on pipeline
Source: Evaluate Pharma & clinicaltrials.gov.

https://www.evaluate.com/vantage/articles/news/deals-snippets/novartis-gets-alpha-synuclein

Vor started at Outperform by Oppenheimer

 Target $30

https://finviz.com/quote.ashx?t=vor

First omicron cases detected in India

 India on Thursday confirmed its first cases of the omicron COVID-19 variant in two men who returned from international travel. 

The men, 66 and 46, tested positive for the variant in the southern Indian state of Karnataka and are under observation, according to The Associated Press. It is not known which country they traveled to or whether or not they were vaccinated. 

All contacts of the men have reportedly been traced and tested for the virus. 

Balram Bhargava, head of the Indian Council of Medical Research, the country's top medical research organization, urged people to get vaccinated as soon as possible. 

“Increased vaccine uptake is the need of the hour. Don’t delay in getting fully vaccinated,” he said, according to the AP.

Several countries have already been classified by officials in India as "at risk" in response to the variant, which the World Health Organization said poses a “very high” risk of infection. Travelers from the "at risk" countries are reportedly tested upon arrival to India. In addition, 2 percent of international travelers are also randomly selected for COVID-19 testing.

Health policy expert Dr. Chandrakant Lahariya told the AP that the focus should be on making sure unvaccinated residents receive the jab.

“Some of the hesitancy may disappear on the news of the new variant," he said. "But this can’t be taken for granted."

Some states in India have also enforced strict restrictions on international arrivals, including mandatory COVID-19 tests for travelers from South Africa, Botswana and Hong Kong, the news service noted.

More than 57 percent of Indians have received at least one dose of a COVID-19 vaccine, with 33 percent fully vaccinated and 24 percent having received a single jab, according to Our World In Data. 

https://thehill.com/policy/international/583965-first-omicron-cases-detected-in-india

  

Biden to announce insurance reimbursements for at-home COVID-19 tests

 Biden will announce Thursday that Americans with private insurance will be able to receive reimbursements for at-home COVID-19 diagnostic tests as part of a broader plan to combat the omicron and delta variants.

The White House said that departments of Health and Human Services, Labor and the Treasury will issue guidance by mid-January clarifying that Americans with private insurance will be able to seek reimbursement for the costs of the at-home tests during the public health emergency.

A senior administration official said that the new policy would impact some 150 million Americans who have private insurance. The reimbursement is not expected to be retroactive, but officials are still working out the specifics of the policy.

Additionally, Biden will announce plans to expand access to free at-home tests in underserved communities in the U.S. The administration plans to distribute 25 million more free tests to community sites, on top of the 25 million Biden already committed. The administration is also adding rural clinics to the list of sites that will receive the free tests.

Health experts say that increased COVID-19 testing, in addition to the push for vaccines, will be key to confronting the virus and its more transmissible variants.

Biden is scheduled to lay out the White House’s multi-step plan in a speech at the National Institutes of Health Thursday afternoon. He will also announce other steps, like stricter testing rules for international travelers entering the U.S. and an extension of the TSA’s mask mandate for domestic transit.

The first known case of the omicron variant in the U.S. was detected Wednesday in California. Officials are rushing to understand more about the variant, including its transmissibility, severity and the degree to which the COVID-19 vaccines protect against it. U.S. officials expect the vaccines to provide at least some protection and are urging Americans who have not done so to get vaccinated against COVID-19 or receive booster shots.

https://thehill.com/homenews/administration/583958-biden-to-announce-insurance-reimbursements-for-at-home-covid-19-tests

Roberts and Roe: Supreme Court considers narrow question on abortion

 Think big, go small. That seems to be Chief Justice John Roberts’s approach to Dobbs v. Jackson Women’s Health, the Supreme Court’s most consequential abortion case in a generation.

Mississippi’s regulation prohibits most abortions after the 15th week of pregnancy. Though that is well past the point where a woman is aware of her pregnancy, it is significantly earlier than fetal viability — the stage at which an unborn child can potentially live outside the mother’s womb. Current medical consensus is that viability occurs at 24 weeks of pregnancy. But note that critical word: current. Medical technology constantly improves, so viability will always be a capricious standard — not an objective moment of human gestation between conception and birth, but a constantly-changing metric of scientific proficiency.

Why does that matter? Because viability is the straw at which the Supreme Court grasped in Roe v. Wade (1973) to establish when the state begins to have a cognizable interest in the life of the unborn child. Only then may it intrude on the woman’s right to terminate the pregnancy, the putative right the Roe court manufactured in an act of imperious judicial legislating. Because a 15-week restriction would necessarily forbid abortions that would be permitted under the viability standard that Roe purported to divine from the Constitution, it stands to reason that the court must invalidate Roe to uphold Mississippi’s law.

Let’s not forget, moreover, that Roe was substantially overhauled by Planned Parenthood v. Casey (1992). Put aside Roe’s illiteracy as jurisprudence. By the time Casey was decided nearly 20 years later, Roe’s fatal flaws as policy were patent — in particular, its facile “trimester” architecture for balancing the competing interests of the pregnant woman and the unborn child. 

Rather than abort Roe, as fidelity to constitutional law would have dictated, the Casey court went political. That is the story of the court’s doleful half-century in the abortion thicket. Casey undertook to scrap the trimester formulation while continuing to hang Roe’s hat on viability, notwithstanding its manifest instability as a legal standard. The justices opaquely elaborated that, post-viability, states were at liberty to enact restrictions as long as they did not “unduly burden” a woman’s right to abortion. 

As we’ve noted, Mississippi’s ban on pre-viability abortions violates RoeA fortiori, it poses an “undue burden” under Casey. One would think that both precedents must go.

One of the most fascinating developments in Wednesday’s oral arguments was Chief Justice John Roberts’s demolition of viability as the linchpin of the Roe right — and with it, his powerful illustration of the overarching folly of judicial legislating. Digging through the published papers of Roe’s author, the late Justice Harry A. Blackmun, the chief justice spotlighted the concession that viability was an afterthought: It was not argued as a major issue in the case, and it was dicta in Blackmun’s opinion — i.e., not central to the court’s holding.

Yet, by the time Casey rolled around, the afterthought had become foundational, even as the rest of the Roe edifice was swept away. Viability is what the Biden administration and the rest of the pro-abortion opposition to Mississippi’s law contend is the framework of the liberty interest the court has erected. Roberts exposed it as an illusion.

Logic would make that Roe’s death knell, but this isn’t necessarily about logic. Roberts is clearly struggling to minimize the ramifications of eviscerating Roe’s underpinnings, fearful of the public reaction — meaning, the hysteria of the media-Democrat complex — if the court were to make the obvious explicit: Roe is such bad constitutional law that no one dares defend it as such (the arguments for preserving it are odes to stare decisis — the doctrine of respect for even wrongly decided precedent), but rest assured that a court renunciation of Roe and Casey would not ban abortion, it would leave the matter to the states and the democratic process.

The chief justice can’t do anything about Roe’s fatal flaws, but he might be able to constrict the lens through which the court assesses them. On Wednesday, he took pains to point out that the question the court agreed to review is a narrow one: Whether all pre-viability prohibitions on abortion are unconstitutional.

Interesting thing about that. Mississippi’s petition asked for three questions to be reviewed. Besides the one the court accepted, another asked for a searching analysis of Casey’s undue burden standard in light of Whole Woman’s Health v. Hellerstedt, which materially revised it in 2016 — effectively raising the bar for justifying state abortion restrictions. A third question would have probed third-party standing — i.e., whether abortion providers should be heard to complain about restrictions on a right that belongs not to them but to the woman seeking an abortion. As Justice Clarence Thomas pointed out in dissent at the time, the Hellerstedt majority permitted such claims, against the weight of court precedent.

The court did not agree to consider those two questions. Why did Roberts stress that fact? Probably because he hopes to sidestep a wholesale review and rejection of Roe and Casey, despite their infirmities. He may calculate that Roe need not be swept aside entirely to hold in Dobbs that the Constitution does not prohibit all pre-viability restrictions on abortion. That is, the only question before the court is whether a prohibition after 15 weeks is permissible. Answering that question in the affirmative would not necessarily require invalidating Roe if the court agrees to put blinders on and ignore the ultimate logic of that answer.

Okay, but what about 13 weeks … or seven … or none? Are there five votes on the Supreme Court for a go-slow strangulation of Roe that will keep it barely breathing, and keep both sides of this most divisive national debate fulminating, for years to come?

Former federal prosecutor Andrew C. McCarthy is a senior fellow at National Review Institute, a contributing editor at National Review, a Fox News contributor and the author of several books, including “Willful Blindness: A Memoir of the Jihad.” 

https://thehill.com/opinion/judiciary/583927-roberts-and-roe-the-supreme-court-considers-a-narrow-question-on-abortion

Codiak Engineered Exosomes Promote T Cell, Antibody Responses to SARS-CoV-2 in vivo

 Codiak BioSciences, Inc. (Nasdaq: CDAK), a clinical-stage biopharmaceutical company focused on pioneering the development of exosome-based therapeutics as a new class of medicines, today announced new preclinical data from its exoVACC™ exosome-based vaccine platform. The data describe for the first time the potential of Codiak’s novel vaccine candidate for SARS-CoV-2, the virus that causes COVID-19, to generate a comprehensive immune response conferring both antibody and T cell-mediated immunity. The study reported the generation of a neutralizing antibody response that showed evidence of activity against multiple SARS-CoV-2 variants. In addition, the ability of exoVACC to generate antigen-specific T cell responses against structurally conserved regions of multiple coronavirus variants provides evidence of a broad immune response to the candidate. The results are being presented today at the World Vaccine & Immunotherapy Congress (WVIC) 2021 in San Diego.

https://finance.yahoo.com/news/codiak-engineered-exosomes-promote-t-133000155.html