FDA Approves First T Cell Receptor Therapy From Immunocore For Eye Cancer

 The FDA has approved Immunocore Holdings plc (NASDAQ: IMCR) (tebentafusp-tebn) for HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM).

• Marketed as Kimmtrak, approval highlighting a series of firsts:

  • First TCR therapeutic to receive FDA approval,

  • First bispecific T cell engager to receive FDA approval to treat a solid tumor.

  • The first and only therapy for unresectable or metastatic uveal melanoma to be approved by the FDA.

• The approval is based on Phase 3 IMCgp100-202 trial results.

• Data showed that Kimmtrak demonstrated unprecedented median OS benefit as a first-line treatment. The OS Hazard Ratio (HR) in the intent-to-treat population favored Kimmtrak, HR=0.51, over investigator's choice (82% pembrolizumab; 13% ipilimumab; 6% dacarbazine).

https://finance.yahoo.com/news/fda-approves-first-t-cell-141140083.html

Allergy Therapeutics Cleared to Investigate Peanut Allergy Vaccine by FDA

 Allergy Therapeutics PLC said that it has received clearance for an investigational new drug application from the U.S. Food & Drug Administration for its peanut allergy vaccine.

The commercial biotechnology company specializing in allergy vaccines said this clearance paves the way for the first phase Protect trial, to be launched in the U.S.

The trial will begin later this year, Chief Executive Manuel Llobet said.

https://www.marketscreener.com/quote/stock/ALLERGY-THERAPEUTICS-PLC-4004878/news/Allergy-Therapeutics-Cleared-to-Investigate-Peanut-Allergy-Vaccine-by-FDA-37643117/

FDA labels Philips' expanded ventilator recall as most serious

 The U.S. Food and Drug Administration (FDA) on Wednesday classified Philips' expanded recall of certain ventilators late last year as Class 1, or the most serious type of recall, saying they could lead to injuries or death.

The Dutch medical equipment company initiated the recall of 215 Trilogy Evo ventilators and 51 repair kits in the United States in December due to potential health risks from a type of foam used in the devices.

So far, there have been no reported injuries or deaths from the products, which were distributed in the United States and Korea, the FDA said.

This is the latest recall by Philips to be labeled Class 1 after it pulled back up to 4 million breathing-aid machines last year amid concerns that a polyurethane foam used in the devices could degrade and become toxic.

Earlier this month, the company raised that estimate by 1 million.

Philips was not immediately available for comment.

A Philips supplier had incorrectly used the polyurethane foam, which is intended to reduce sound and vibration, in one of the parts of the Trilogy Evo ventilators - an issue that was identified during lab testing, according to the regulator.

The foam could break down and potentially enter the device's air pathway, leading to the user inhaling chemicals or other harmful materials, the FDA said.

https://www.marketscreener.com/quote/stock/PHILIPS-NV-6289/news/U-S-FDA-labels-Philips-expanded-ventilator-recall-as-most-serious-37651482/

Most omicron cases are reinfections, research in England suggests

 Most omicron cases in England are among those who have previously been infected with the coronavirus, research suggests.

Imperial College London’s React continual study throughout the pandemic found 64.6 percent of cases from Jan. 5 to Jan. 20 were among those who said they previously had COVID-19.

The researchers caution it is unclear which cases are reinfections and which cases are just recent infections that the PCR COVID-19 test picked up again despite the patient having already recovered from it.

The study said the individuals self-reported if they had a previous COVID-19 infection.

Analyzing the genetic history of some of the cases, the group found 99 percent of the cases in that time frame were from the omicron variant and only 1 percent were made up of the delta variant.

“We observed unprecedented levels of infection with SARS-CoV-2 in England in January 2022 and almost complete replacement of Delta by Omicron,” the researchers wrote. 

React has been analyzing COVID-19 numbers monthly since May 2020 and found 4.41 percent of the 100,500 swab coronavirus tests were positive in January.

It is the highest recorded positivity since the study began and three times higher than in December.

The high number of cases comes as omicron is known to be more infectious than previous variants, but causes less severe illness than the delta variant. 

https://thehill.com/policy/healthcare/591483-most-omicron-cases-are-reinfections-research-in-england-suggests

Moderna upped to Hold from Sell by Deutsche Bank

 Target $175

https://finviz.com/quote.ashx?t=MRNA&ty=c&ta=1&p=d

Akari Advances Lung Program with Inhaled Nomacopan

 Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where complement (C5) and/or leukotriene (LTB4) systems are implicated, today announced further development of a program for the inhaled delivery of nomacopan to the lung, working with Inhalation Sciences AB to refine dosing and pharmacokinetics of nomacopan for both dry powder and nebulized delivery.

Clive Richardson, Chief Executive Officer of Akari Therapeutics, said, “Accumulating data with nomacopan indicate that the innate immune response driven by complement and leukotriene pathways could be critical in determining the severity of the inflammatory response across a range of diseases including in the lung. Gaining control of the dysregulation in innate responses by inhibiting C5 and LTB4 with an inhaled form of nomacopan could provide relief from often life-threatening exacerbations in lung illnesses such as COPD and severe asthma. We are therefore delighted to be working with Inhalation Biosciences AB to further develop an inhaled drug delivery system for nomacopan.”

Data from Akari-sponsored observational studies in exacerbating chronic obstructive pulmonary disease (COPD) (n=24) and COVID-pneumonia (n= 72) indicated complement C5 and LTB4 levels were elevated and the severity of exacerbations in COPD patients was associated with the initial levels of C5. This points to the potential for nomacopan, a potent inhibitor of both C5 and LTB4, as a focused treatment for disease exacerbations across multiple severe lung disorders, including severe asthma, COPD and COVID-pneumonia.

Importantly, given both the acute nature of exacerbations which typically last 2-4 weeks and evidence from the COPD observational studies that much of the excess C5 and LTB4 is generated in the lung, a fast-acting inhaled delivery system is likely to be the preferred delivery route for exacerbating patients. Therefore, to optimize the potential clinical utility of nomacopan, Akari is now in development of an inhaled formulation of nomacopan with Inhalation Sciences AB.

https://finance.yahoo.com/news/akari-advances-lung-program-inhaled-133000566.html

iBio Advances Its Vaccine Program for Multi-Variant COVID-19 Disease

 iBio Inc (NYSE: IBIO) received the FDA response to its pre-investigational new drug (IND) package for IBIO-202, the Company's lead COVID-19 vaccine program.

• In light of the feedback received, the Company is moving forward with IND-enabling challenge studies for its second-generation vaccine candidate targeting the nucleocapsid (N) protein.

• It plans to file an IND application before the end of calendar 2022.

• The Company previously reported completing extensive preclinical studies and identifying an antigen-adjuvant pairing with a favorable Th1 skew.

• The cytokine response observed with this pairing indicated a primary immune response, differentiation of mature T cells, and reactivation of memory T-cells.

• In September 2021, iBio submitted a pre-IND package for IBIO-202 to the FDA.

• In November 2021, the Company entered a collaboration agreement with a provider of microarray patch systems to evaluate the feasibility of intradermal delivery of a COVID-19 vaccine antigen.

https://finance.yahoo.com/news/ibio-advances-vaccine-program-multi-162147476.html