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Tuesday, August 24, 2021

Immunocore Gets Speedy U.S., Europe Review of Tebentafusp

Immunocore Holdings PLC on Tuesday said U.S. and European regulators will review on an expedited basis the biotechnology company's tebentafusp for the treatment of HLA-A*02:01-positive adults with metastatic uveal melanoma.

The Oxfordshire, U.K., company said the U.S. Food and Drug Administration granted priority review to its application, with a target action date of Feb. 23.

The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period.

Immunocore said the European Medicines Agency's Committee for Medicinal Products for Human Use has agreed to the company's request for accelerated assessment of its application.

Immunocore said its applications are based on a Phase 3 study in which tebentafusp showed a clinically and statistically significant superior overall-survival benefit as a monotherapy in previously untreated metastatic uveal melanoma, the most common primary intraocular cancer in adults.

https://www.marketscreener.com/quote/stock/IMMUNOCORE-HOLDINGS-PLC-118621679/news/Immunocore-Gets-Speedy-U-S-Europe-Review-of-Tebentafusp-36233595/

PolarityTE Study Placed on Clinical Hold After FDA Feedback

 PolarityTE Inc. said its study has been placed on clinical hold after it received feedback from the U.S. Food and Drug Administration related to its investigational new drug application for a product for chronic cutaneous ulcers.

The company on Tuesday said the FDA provided feedback that certain chemistry, manufacturing and control items need to be addressed before proceeding with the study.

PolarityTE said the FDA told the company it would issue a clinical hold letter with details on the basis for the hold by Sept. 21.

"We are actively working to address the issues identified by the FDA and our team plans to respond to the agency's feedback as expeditiously as possible, and we are hopeful that we will be able to resolve any open items," Chief Executive David Seaburg said.

https://www.marketscreener.com/quote/stock/POLARITYTE-INC-33339222/news/PolarityTE-Study-Placed-on-Clinical-Hold-After-FDA-Feedback-36234105/

Tonix Shares Up After Minutes From FDA Meeting on Long Covid

 Tonix Pharmaceuticals Holding Corp. shares were higher in premarket trading after the company received the minutes from a pre-investigational new drug application meeting with the U.S. Food and Drug Administration.

The meeting was for TNX-102 SL as a potential treatment for Long Covid Syndrome. Tonix said it believes the minutes provide a path to an agreement on the design of a Phase 2 study and the overall clinical development plan for TNX-102 SL in a subset of patients affected by Long Covid.

Shares were up 16% to 80 cents premarket.

The company said it is planning to submit the IND in the fourth quarter to support a Phase 2 study for the management of a subset of Long Covid patients whose symptoms overlap with fibromyalgia.

Although most people recover from Covid-19 within weeks of the acute illness, a substantial portion develop a chronic syndrome called Long Covid, the company said. These individuals experience symptoms long past the time of recovery, which can include fatigue, sleep disorders, pain, fevers, shortness of breath, cognitive impairment described as "brain fog" or memory disturbance, gastrointestinal symptoms, anxiety, and depression.

"Based on our positive fibromyalgia Phase 3 RELIEF study in which TNX-102 SL showed activity in addressing persistent pain, sleep disturbance, memory, fatigue and energy, we are hopeful that TNX-102 SL might provide a unique treatment opportunity for the symptoms of Long Covid in patients whose symptoms overlap with those of fibromyalgia," said Chief Medical Officer Gregory Sullivan.

TNX-102 SL is in mid-Phase 3 development for the treatment of fibromyalgia.

https://www.marketscreener.com/quote/stock/TONIX-PHARMACEUTICALS-HOL-47362663/news/Tonix-Shares-Up-After-Minutes-From-FDA-Meeting-on-Long-Covid-36234201/

Cassava Sciences Reaches Agreement With FDA for Alzheimer's Studies

 Cassava Sciences Inc. it has reached agreement with the U.S. Food and Drug Administration under a special protocol assessment for both of its pivotal Phase 3 studies of oral simufilam for the treatment of patients with Alzheimer's disease.

The company said these SPA agreements document that the FDA has reviewed and agreed upon the key design features of Cassava Sciences' Phase 3 study protocols of simufilam for the treatment of patients with Alzheimer's disease.

Cassava Sciences also reaffirmed prior guidance to advance simufilam into a Phase 3 pivotal program in Alzheimer's disease in fall 2021.

https://www.marketscreener.com/quote/stock/CASSAVA-SCIENCES-INC-56537199/news/Cassava-Sciences-Reaches-Agreement-With-FDA-for-Alzheimer-s-Studies-36235044/

U.S. Review of COVID's China Origin Unlikely to Solve Vexing Questions

 President Joe Biden is set to be briefed on the U.S. intelligence community's investigation into how COVID-19 started, with the report likely to disappoint in delivering clear answers about the deadly pandemic's origin in China.

Biden in May ordered aides to work to resolve disputes among intelligence agencies examining rival theories about how the novel coronavirus started, including a once-dismissed theory about the possibility of a laboratory accident in China, as well as that the virus originated naturally with animals, such as bats or birds.

A 90-day intelligence review the president ordered is due on Tuesday, according to White House press secretary Jen Psaki, with the release of unclassified portions likely to take a few days longer.

Yet three U.S. government officials and a fourth person familiar with the scope of the investigation said they did not expect the review to lead to firm conclusions after China stymied earlier international efforts to gather key information on the ground.

Instead, one official said the report would likely point to additional lines of inquiry that officials could pursue, including demands of China that are likely to further ratchet up tensions with Beijing at a time when the country's ties with Washington are at their lowest point in decades.

"It's basically impossible to have a proper investigation if one of the main parties doesn't want to cooperate," said Thomas Wright, Brookings Institution senior fellow and co-author of "Aftershocks," a book about the pandemic with Biden's Under Secretary of Defense Colin Kahl. "We need to proceed as if both hypotheses are true."

The report also comes as the U.S. intelligence agencies have come under pressure from within the administration and Congress over issues related to the handling of Afghanistan after the fall of Kabul to the Taliban came faster than many U.S. intelligence, defense and diplomatic analysts predicted.

COVID-19 has killed 4.6 million people worldwide, according to a Reuters tally https://graphics.reuters.com/world-coronavirus-tracker-and-maps, but its precise origins remain shrouded in mystery.

The first known cases emerged in the central Chinese city of Wuhan in December 2019 and U.S. agencies started looking into the origins shortly afterwards.

U.S. spy agencies initially strongly favored the explanation that the virus originated in nature.

A team led by the World Health Organization (WHO) that spent four weeks in and around Wuhan in January and February said the virus had probably been transmitted from bats to humans through another animal.

But their March report https://www.who.int/health-topics/coronavirus/origins-of-the-virus, which was written jointly with Chinese scientists and concluded that the lab theory was "extremely unlikely," did not satisfy Washington.

People familiar with intelligence reporting have said that there has been little corroboration over recent months that the virus had spread widely and naturally amongst wild animals.

Meanwhile, China has refused to give U.S. researchers the kind of access to the Wuhan lab and officials there that the U.S. believes it would need to definitively try to determine the virus' origins.

The WHO's director-general, Tedros Adhanom Ghebreyesus, has said the group has not ruled out any hypothesis. The Geneva-based organization is set to impanel a new group to further examine the origins of the virus causing COVID-19.

For its part, China has ridiculed a theory that COVID-19 escaped from the state virology lab in Wuhan and pushed fringe theories including that the virus slipped out of a lab in Fort Detrick, Maryland, in 2019.

https://www.usnews.com/news/world/articles/2021-08-24/us-review-of-covids-china-origin-unlikely-to-solve-vexing-questions

Health Care Down As Traders Hedge On Growth Outlook

 Health-care companies fell as traders hedged their bets on the outlook for the sector.

A new assessment by U.S. spy agencies of the origins of Covid-19 scheduled to be delivered Tuesday to the White House is likely to highlight the Biden administration's challenges wresting more information from Beijing that would shed light on how the global pandemic began.

https://www.marketscreener.com/news/latest/Health-Care-Down-As-Traders-Hedge-On-Growth-Outlook-Health-Care-Roundup--36239526/

FTC Urges Judge to Unwind $7.1 Billion Illumina-Grail Merger

 The U.S. Federal Trade Commission on Tuesday said it seeks to unwind life science company Illumina Inc's $7.1 billion acquisition of Grail Inc, alleging it would harm innovation and boost prices.

FTC senior counsel Susan Musser said in her opening statement at a trial in Washington that cancer test-detection company Grail and its competitors rely on San Diego, California-based Illumina's DNA sequencing technology. She argued that Illumina's purchase of Grail would give the company the "incentive and ability to foreclose downstream rivals."

Antitrust lawyers are closely tracking https://www.reuters.com/legal/litigation/illumina-grail-deal-heads-ftc-trial-eu-weighs-penalty-2021-08-23 the FTC trial as a rare enforcement action against a "vertical" merger in which two companies are not direct competitors. The FTC's witnesses are expected to include representatives from other companies competing with Grail.

"Evidence will show that the war on cancer, if it is to be won, will be won by competition, not by this acquisition," Musser said. Grail is in an "innovation race" to develop and market its early-detection test, she added, and Illumina would have the power to "anoint" Grail the winner if the deal is not canceled.

Illumina, founded in 1998, owned Grail but spun it off in 2016 while retaining a 12% ownership stake.

Illumina and Grail closed their merger last week, saying no legal barrier blocked the deal. European antitrust regulators said https://www.reuters.com/business/healthcare-pharmaceuticals/illumina-eu-antitrust-sights-over-premature-8-bln-grail-deal-2021-08-20 on Friday they "deeply regret" the closure prior to regulatory approval.

Illumina's attorney, David Marriott of Cravath, Swaine & Moore, said in his opening statement that the "reunion" of Illumina and Grail would accelerate the development and adoption of an early cancer-detection product.

"The FTC's theory asks the court to forego the life-saving benefits of this transaction to avoid the potential harm that could not possibly occur for years - that could only occur, we submit, if other tests actually in fact ultimately are developed," Marriott said. He said the FTC theory "needlessly gambles with human lives."

A lawyer for Grail said at trial that the company's merger with Illumina will provide the fastest way toward "widespread commercial acceptance" of its multi-cancer early detection test, which relies on a blood draw.

https://money.usnews.com/investing/news/articles/2021-08-24/ftc-urges-judge-to-unwind-71-billion-illumina-grail-merger