Exxon Mobil Corp is working on developing technology for direct air capture (DAC) of carbon dioxide, and sees a clear place for it in a net-zero future, an Exxon executive said on Tuesday, but the largest U.S. oil company has no plans to invest in building electric vehicle charging stations.
The company could become a major player in the nascent DAC industry if high costs come down and the technology gets to a point where it can work efficiently at scale, Matthew Crocker, senior vice president of product, strategy and new assets in Exxon's low carbon solutions business, said in an interview.
Direct air capture involves extracting carbon directly from the atmosphere. It is considered essential to limiting global warming, according to the United Nations Intergovernmental Panel on Climate Change (IPCC), but costs are extremely high and currently range from $600 to $1,000 per ton of carbon removed.
The technology could be developed on the back of Exxon's carbon capture and storage (CCS) business which will also involve trapping emissions underground, Crocker said.
Exxon last year extended a joint research agreement with DAC developer Global Thermostat, intended to accelerate development of the technology for full-scale deployment. But the investment falls shy of U.S. oil producer Occidental, which has made a final investment decision on what it says could be the first of about 100 DAC plants throughout the country.
DAC "would link very closely to our CCS business where we are going to have large geologic storage and the capability to capture CO2," Crocker said. "That's one component of reducing the cost of direct air capture."
Exxon's energy transition strategy is focused on reducing carbon emissions from its business and CCS, rather than investing in renewable energy sources like solar and wind. It is also investing in hydrogen and biofuels.
The Food and Drug Administration (FDA) has "gone rogue," according to virologist Dr. Robert Malone, who accused the federal agency of sacrificing its own rules and regulations with its decision to recommend the latest batch of COVID-19 boosters, which only have limited clinical trial data attesting to their efficacy and safety.
Dr. Malone made the remarks in an interview with EpochTV's "Crossroads" program on Sept. 11, the day that the FDA cleared new COVID-19 vaccines in a bid to counter the waning effectiveness of the currently available shots.
"It's difficult to conclude anything other than the FDA is no longer feeling bound by their own rules and regulations," Dr. Malone said. "The term is—they've gone rogue."
Dr. Malone said the lack of human clinical trial data demonstrating effectiveness and safety of the updated vaccines should have precluded their approval by the FDA.
He said that, essentially, the FDA authorized the new vaccines on the premise that “neutralizing antibodies as detected in mice and their cross-reactivity are correlative protection,” which he said “is a lie, there are no established correlates of protection for SARS-CoV-2."
FDA officials didn't respond by press time to a request by The Epoch Times for comment.
The agency cleared Moderna's and Pfizer's newest mRNA vaccines on Sept. 11 without analyzing data from any human trials.
In a statement announcing its approval, the FDA said that the decision was supported by its evaluation of "manufacturing data" from vaccine producers and "non-clinical immune response data on the updated formulations including the XBB.1.5 component."
The benefit-risk profile of earlier versions of the vaccines is "well understood," the FDA claimed, adding that the similar manufacturing process for the updated vaccines "suggests that the vaccines are a good match for protecting against the currently circulating COVID-19 variants."
The Centers for Disease Control and Prevention (CDC) followed with its own recommendation on Sept. 12, urging nearly all Americans to get the new vaccines. The shots will be available to children as young as 6 months old this month.
The new vaccines target XBB.1.5, a sub-type of the Omicron variant of the SARS-CoV-2 virus, which causes the disease COVID-19. However, the XBB.1.5. subvariant has already largely been displaced by newer strains of the quickly evolving virus, including EG.5, according to the CDC.
While FDA documents show the agency did not include any trial data in its review of the new shots, data from a Moderna trial was considered by the CDC before it issued its recommendation. The trial featured just 50 people receiving a new shot, and found the vaccine induced levels of neutralizing antibodies that authorities said would protect against COVID-19. One of the 50 people suffered a vaccine-related adverse reaction.
Florida Surgeon General Dr. Joseph Ladapo in Tampa, Fla., on Oct. 15, 2022. (York Du/The Epoch Times)
'Lot of Red Flags'
"There's essentially no data," Florida Surgeon General Dr. Joseph Ladapo said at a recent news conference, where he suggested that people might be better off passing on the new round of shots.
"Not only that, but there are a lot of red flags," Dr. Ladapo added, while pointing to studiesfinding that the effectiveness of the vaccines turns negative over time.
“There's been no clinical trial done in human beings showing that it benefits people, there's been no clinical trial showing that it is a safe product for people."
He also noted that studies have linked previous versions of the COVID-19 vaccine to cardiac problems such as heart inflammation.
"It's truly irresponsible for FDA, CDC, and others to be championing something ... when we don't know the implications of it," Dr. Ladapo said.
Asked to comment on Dr. Ladopo's remarks, Dr. Malone pointed to a growing body of studies that show negative vaccine effectiveness, which he said suggests that, in the risk-benefit analysis, "there's no discernible benefit, or there's negative benefit, but there's clearly risk."
'Most Americans Take Them'
While acknowledging the current vaccines' waning effectiveness, CDC Director Mandy Cohen penned an op-ed in The New York Times on Sept. 13, in which she called the updated COVID-19 vaccines "one of the most effective tools in combating the virus."
"Covid-19 vaccines are the best way to give the body the ability to keep the virus from causing significant harm. Extensive studies and real-world experience have shown that they are safe and they work," she wrote. "And most Americans take them."
Dr. Cohen said the vaccines were put through extensive clinical trials before they were introduced in 2021 and "since then, their safety has been intensely monitored."
She didn't address criticism, such as the little trial data that's been made available.
Atara Biotherapeutics, Inc.(Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today reported important progress related to the regulatory pathway for tabelecleucel (tab-cel®) in the U.S.
Following productive discussions between Atara and the U.S. Food and Drug Administration (FDA), the FDA and Atara are now aligned on analytical comparability between manufacturing process versions. This alignment supports Atara's ability to pool the pivotal clinical trial data from different process versions in the Biologics License Application (BLA) submission.
Atara expects to submit the tab-cel BLA in Q2 2024, which will enable Atara to incorporate the latest tab-cel pivotal trial data from the ALLELE study into the BLA filing package.
Following Type C meeting feedback from the U.S. FDA, Taysha is discontinuing development of TSHA-120 in GAN due to challenges with study design feasibility for potentialBiologics License Application (BLA) submission
Taysha will pursue external strategic options for the TSHA-120 program to potentially enable further program development
Strategic program prioritization will reduce operating expenses and is anticipated to extend cash runway into the fourth quarter of 2025 to support the continued development of TSHA-102 in evaluation for Rett syndrome
60 Degrees Pharmaceuticals Inc'sSXTPsubsidiary, 60P Australia Pty Ltd, has withdrawn its investigational new drug (IND) application for ACLR8-LR, a Phase 2B study of the use of tafenoquine in treating COVID-19.
The company's decision to withdraw the IND is in response to recent comments from the FDA.
60P plans to submit a new IND to the FDA in the fourth quarter, pending an assessment of whether it is feasible to revise the trial design to meet the agency's expectations while also allowing for confirmation of the acceleration in recovery from COVID-19 symptoms suggested by an earlier study.
In the interim, pending additional interaction with the FDA, 60P has paused further start-up activities for its Phase 2B trial (ACLR8-LR), decreasing the company's burn rate and improving its cash position in the short term.
Should the outcome of further interactions with the FDA be positive, and depending on market conditions, the company will decide whether to continue its original strategy of self-funding its Phase 2B study or seek a strategic partner to continue development.
In parallel, 60P plans to continue preparing a Phase 2A study of tafenoquine in hospitalized babesiosis patients to request a pre-IND meeting with the FDA before the end of 2023.
60P plans to continue its commercialization efforts related to Arakoda (tafenoquine), an antimalarial for prophylaxis of malaria in adult patients, approved by the FDA in 2018. In Q2 2023, sales of Arakoda increased by 150% Y/Y.
Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, today announced the results of a phase 1/2 study showing that a booster dose of a novel, self-amplifying messenger RNA (sa-mRNA) vaccine against COVID-19 induces a robust, broadly cross-reactive, and durable immune response in adults that remains elevated through 12 months after vaccination. Three sa-mRNA vaccines were used in the study, which was presented as a poster at the European Scientific Working Group on Influenza's 9thESWI Influenza Conference in Valencia, Spain.
Messenger RNA (mRNA) vaccine technology protects against infectious diseases by instructing cells in the body to make a specific protein, stimulating the immune response, and leaving a blueprint to recognize and fight future infection. However, sa-mRNA also provides the body with instruction to make copies of the mRNA, amplifying the amount of protein made. This advanced technology has shown the potential to offer longer duration of immune response at considerably lower doses compared to conventional mRNA vaccines.
“Current mRNA technologies provide effective initial immunogenicity against COVID-19, but the results of this study show that our sa-mRNA vaccine platform can offer improvements in duration and breadth of protection against new and emerging variants,” said Igor Smolenov, Chief Development Officer, Arcturus. “We are proud of the role Arcturus has played, collaborating with CSL, in advancing sa-mRNA vaccine development.”
CSL’s vaccine business, CSL Seqirus, is Arcturus’ global exclusive partner for the development of novel mRNA vaccines against SARS-CoV-2 (COVID-19), influenza and pandemic preparedness. CSL has a dynamic portfolio of lifesaving medicines, including those that treat hemophilia, hereditary angioedema (HAE) and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology.
Newly granted patents expand the use of the DeltEx Drug Resistant Immunotherapy (DRI) platform to encompass Chimeric Antigen Receptor T-cell (CAR-T) and checkpoint inhibitors (CPIs).
Broadens IN8bio’s foundational intellectual property (IP) for its proprietary DeltEx DRI platform which covers the use of any genetic modification that conveys chemotherapy resistance in gamma-delta T cells, as well as natural killer (NK) cells.
IN8bio now holds 19 total granted U.S. and international patents, and numerous pending patent applications.
