Watch Live: Fauci Grilled By House Over COVID-19

 Update (1000ET): Here it is - Fauci appears before the House Select Subcommittee to answer questions regarding the COVID-19 pandemic.

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by Roger Marshall via The Epoch Times,

A million Americans died from COVID-19, marking one of the darkest chapters in our nation’s history. Four years later, more than 10 million Americans are still suffering from long COVID. We continue to fight for accountability.

Dr. Anthony Fauci, in his role as chief medical adviser to the president, insisted upon mask and vaccine mandates, lockdowns, and overstated vaccine efficacy, often disregarding the public’s and private medical professional’s ability to assess the facts.

Many lessons must be learned from Dr. Fauci’s tenure, highlighting the need for supervision and ethical leadership. As a physician, I believe in informing patients of the truth and collaborating on plans.

This week, he will testify before the House of Representatives. We must demand answers for the numerous unresolved issues related to his potential role in the origins of COVID-19, and the subsequent alleged cover-up. Here are several questions I hope are asked:

Dr. Fauci has advocated for and funded risky gain of function (GOF) research for more than 30 years. He was undoubtedly aware of the history of the engineering and structural problems, along with sloppy procedural issues, at the labs in Wuhan, China.

Risky GOF Research: After learning of the possibility of a lab leak from respected scientists, did Dr. Fauci consult the appropriate government agencies at the National Biosurveillance Integration Center, National Center for Medical Intelligence, and Countering Weapons of Mass Destruction Office, all stacked with experts about the risky research at the unsafe Wuhan Institute of Virology? Evidence indicates he consulted private sector scientists with significant conflicts of interest, as they depended on his research funds. Dr. Fauci has never conceded to seeking advice from the correct government channels, why?

He knew the Chinese military was involved in all research at Wuhan laboratories, including that China’s military ran a bioweapons program at the Wuhan Institute of Virology labs. Yet, Dr. Fauci continued to use taxpayer money to fund the research projects in Wuhan, China.

Caught in a Lie: Dr. Fauci previously testified before Congress that the National Institutes of Health (NIH) wasn’t funding GOF research. Based on current information, Dr. Fauci has been caught in a lie and should answer for it. Not only has the NIH admitted to funding GOF research, they then changed the definition of GOF research to allow continued foreign research funding. What was Dr. Fauci’s role in changing this definition to secure additional funding?

Continuing Deadly Research at U.S. Taxpayers Expense: China locked us out of Wuhan after the novel coronavirus emerged and refused to share the DNA sequence of SARS-CoV-2 and other valuable information. Dr. Fauci must explain how America benefited from these grants to EcoHealth Alliance and other U.S.-funded GOF research conducted in foreign nations.

Oversight Within NIH Grant Process: Dr. Fauci must also be held accountable for overseeing the NIH grant process. We uncovered and sounded the alarm back in October of 2021 that EcoHealth Alliance was out of compliance with NIH grant policies and had not submitted its year-five report. Why did it continue to receive funding?

When confronted about this, Dr. Fauci claimed ignorance, although it was his responsibility to ensure compliance with these grants. This lack of oversight highlights the immediate need for increased accountability at the National Institute of Allergy and Infectious Diseases (NIAID) and the necessity for its own inspector general.

When following the evidence, Dr. Fauci often sought counsel from questionable advisers and scientists with clear conflicts of interest.

The Federal Advisory Committee Act mandates that advice given to the federal government by advisory committees be objective, transparent, and publicly accessible. However, email records show that Dr. Fauci consulted his close network of private scientists, some of whom financially benefited from the NIH grants that Dr. Fauci oversees, and some in that group were waiting on a grant approval worth up to $9 million.

The Federal Advisory Committee Act: Why in February 2020 did Dr. Fauci hold closed advisory committee meetings with scientists who are dependent on his NIH funding, violating the Federal Advisers Committee Act’s requirements for transparency and balanced viewpoints?

Importantly, after that meeting, the Fauci-led group published the “Proximal Origins” theory, concluding that SARS-CoV-2 emerged as a ”natural virus.” Once published, Dr. Fauci seemingly embarked on a mass media cover-up and touted that opinion piece that he orchestrated as scientific fact, even referencing it from the White House podium.

Proximal Origins Theory: Dr. Fauci should be asked why he presumably used his power to manipulate science and publish factually incorrect articles to downplay the lab leak theory. Why was Dr. Fauci directing articles in science journals and pushing his debunked proximal origins theory narrative? Was his involvement so deep that he was manufacturing and rewriting history to evade the responsibility and the role he had in this virus outbreak?

Blocking FOIA Requests: It’s also curious that after Dr. Fauci was questioned by our Senate HELP committee in May 2021, the Department of Health and Human Services shut down all Freedom of Information Act requests. Was Dr. Fauci involved in any discussions for this decision? Why was that decision made?

Many people also don’t know that Dr. Fauci received two government salaries simultaneously, making him the highest-paid federal employee ever. He was both the director of the NIAID and the director of civilian biodefense, which was operating with a $6 billion budget.

Highest-Paid Federal Employee in History: Dr. Fauci should be asked to explain how the attribution of potential intentional pathogen deployment (which he was tasked to oversee and manage) is assessed and how the action plan is developed and implemented. If he can’t adequately answer these questions when asked, he should return the salary and related pension immediately.

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https://www.zerohedge.com/political/under-oath-fauci-must-answer-these-questions

Zantac-Rout Returns, Sends GSK Shares Tumbling After Delaware Judge's Ruling On Jury Trials

 GSK shares in London tumbled the most in nearly two years after a Delaware judge allowed jury trials to proceed in cases concerning the discontinued heartburn drug Zantac, which is allegedly linked to cancer.

On Friday, Judge Vivian Medinilla of the Delaware Superior Court in Wilmington agreed that plaintiffs' scientific evidence could be heard in jury trials.  

"It would be improper to simply dismiss these experts as 'poseurs or witnesses for hire,'" Medinilla said, adding that each side's arguments should be decided by juries. 

She continued, "Delaware courts are loath to step into the heart of the technical debate between opposing scientists." 

On Saturday, Brent Wisner, one of the plaintiffs' lead lawyers, was quoted by Reuters as saying, "This moves us one step closer to justice for our clients." 

Sanofi has said it faces about 25,000 lawsuits in Delaware, much lower than GSK's 70,000 lawsuits over Zantac.

In response to Medinilla's court ruling, GSK said it will appeal the decision. 

"Following the 16 epidemiological studies looking at human data regarding the use of ranitidine, the scientific consensus is that there is no consistent or reliable evidence that ranitidine increases the risk of any cancer," GSK said. 

GSK shares plunged 10% in London, the most since Aug. 11, 2022, when the fears of Zantac litigation spooked Wall Street.

Most of the year's gains have been wiped out. 

Citi analyst Peter Verdult told clients that GSK's settlement would cost around $3 billion. JPMorgan analysts see $2 billion to $3 billion. 

https://www.zerohedge.com/markets/zantac-rout-returns-sends-gsk-shares-tumbling-after-delaware-judges-ruling-jury-trials

Caribou cut to In-Line from Outperform by Evercore

 Target $3 from $13

https://finviz.com/quote.ashx?t=CRBU&p=d

Molecular Partners: Positive Phase 1 Data at ASCO

 

• Mechanism of action supported by observed MP0317 localization and immune cell activation in the tumor microenvironment
• Favorable and manageable safety profile observed at all tested dose levels
• Weekly and three-weekly dosing schedules established, supported by pharmacokinetics and pharmacodynamics
• Data support further clinical evaluation of MP0317 in combination settings

https://www.globenewswire.com/news-release/2024/06/01/2891809/0/en/Molecular-Partners-Presents-Positive-Data-From-Completed-Phase-1-Trial-Of-MP0317-FAP-X-CD40-DARPin-Monotherapy-In-Patients-With-Advanced-Solid-Tumors-At-ASCO-2024.html

Micribot: FDA OKs trial of Endovascular Robotic Surgical System to support future 510(k) submission

 Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Endovascular Robotic Surgical System, today announces that it has received the U.S. Food and Drug Administration’s (“FDA”) approval to proceed with its pivotal human clinical trial as part of its Investigational Device Exemption (“IDE”) application for its LIBERTY® Endovascular Robotic Surgical System.

The study will be conducted in the U.S., and the Company has already signed a clinical trial service agreement with a leading academic medical center. The Company is also in the process of engaging additional leading centers to participate in the trial.

In parallel to commencing the pivotal human clinical trial, the Company is completing its biocompatibility tests as required by its IDE application.

https://www.globenewswire.com/news-release/2024/06/03/2892236/0/en/Microbot-Medical-Has-Received-FDA-Approval-to-Proceed-with-its-Pivotal-Human-Clinical-Trial.html

Bio-Path Data from Ongoing Phase in Treatment of Acute Myeloid Leukemia

 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize® liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, presented interim results from the Company’s Phase 2 study of prexigebersen (BP1001) in combination with decitabine and venetoclax for the treatment of acute myeloid leukemia (AML) in an oral presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting, on June 1, 2024 in Chicago, IL.

https://www.globenewswire.com/news-release/2024/06/03/2892094/0/en/Bio-Path-Holdings-Presents-Data-from-Ongoing-Phase-2-Combination-Study-of-Prexigebersen-for-Treatment-of-Acute-Myeloid-Leukemia-at-American-Society-of-Clinical-Oncology-ASCO-Annual.html

Can NK Cell Therapy Avoid CAR-T’s Shortcomings?

 When the first CAR T cell therapy was approved by the FDA in 2017, it was heralded as a breakthrough in cancer treatment. The approach allowed for a targeted attack on cancer cells using a patient’s own immune cells, as compared with the broad-strokes assault levied by traditional treatments such as chemotherapy and radiation.

While a total of six CAR-Ts have been approved to date, the approach works only for a subset of patients, has shown promise mainly for blood cancers and has notable side effects. To overcome these shortcomings, many researchers and biotech companies have turned their attention to natural killer (NK) cells, which are a part of the innate immune response—the body’s first line of defense against any infection.

Historically, NK cells have been notoriously difficult to culture, leading them to be overlooked, said Alicja Copik, associate professor of medicine and core scientist at the University of Central Florida.

“Better understanding of how to grow [NK cells] in the laboratory has led to an immense research interest in these cells,” she told BioSpace. “A decade ago, just one company was looking at NK cells. Now, several groups are exploring different ways to use them as cell therapies.” 

Overcoming CAR-T’s Challenges

CAR-T therapies involve reengineering T cells, typically derived from the patient. Once isolated, these cells are genetically modified to express chimeric antigen receptors (CARs) on their surface, arming them to better recognize and attack cancer cells.

However, CAR-Ts have been shown to cause several side effects, including cytokine release syndrome, neurotoxicity and blood disorders such as anemia and thrombocytopenia. In terms of allogeneic CAR-Ts, where donor T cells are used, there is the risk of graft-versus-host disease, a strong immune reaction that leads to a rejection of the transplanted cells.

“T cells with CARs can go crazy and grow uncontrollably, which leads to some of the major side effects,” said Sumiti Jain, chief scientific officer of ImmuneBridge, a San Francisco–based biotech startup that raised $12 million in seed funding in 2023 to develop NK cells from the umbilical cord. NK cell–based therapies do not cause cytokine release syndrome and neurotoxicity because “they don’t grow as robustly,” Jain said.

CAR-Ts have also been associated with secondary malignancies such as leukemias, skin cancers and T cell non-Hodgkin lymphomas. Noting this potential side effect, the FDA recently announced that it will require an update to the boxed warnings of CAR T cell therapies, alerting patients and prescribers to a heightened risk of secondary T cell malignancies.

Furthermore, David Shook, chief medical officer of Nkarta, which is developing allogeneic CAR-NK cells, told BioSpace that CAR T cell therapies, despite their benefits, have remained largely inaccessible to patients due partly to a “cumbersome” manufacturing process. The process of isolating and engineering a patient’s T cells takes over two weeks before the cells can be infused back into the patient.

“There are patients who are eligible for CAR-Ts and are on the waitlist but are not able to access them because of manufacturing constraints,” Shook said.

Advantages of NK Cell Therapy

Ann Cheung, chief scientific officer and head of R&D at Dragonfly Therapeutics, which is developing NK cell–stimulating antibodies, noted that, unlike CAR-T therapies, NK cell therapies do not require patients to undergo lymphodepletion chemotherapy with toxic agents such as fludarabine and cyclophosphamide. “Not every patient is eligible for these chemotherapies,” she told BioSpace, because of other immune conditions or a susceptibility to infections. “In that sense, the safety profile of NK cell therapies is much better.” Moreover, she said, NK cells work by recognizing multiple antigens, making them strong contenders to destroy cancer cells.

NK cell therapies have also shown promise for treating solid cancers, an area where CAR-Ts have largely failed to show benefits, Jain said. “CAR-Ts are amazing for blood cancers, but put them in solid tumors, and they seem to freeze.” NK cells seem to have the ability to migrate into solid tumors better than CAR-Ts, she explained.

These characteristics have inspired several biotech and research groups to explore the potential of turning NK cells into therapies. Nkarta is developing CAR-NK cells from a donor-derived pool of NK cells. But after seeing initial success with one candidate, NKX101, an interim evaluation of Phase I data in 14 acute myeloid leukemia patients showed a “meaningfully lower” response rate than in the first six reported patients, causing the company to deprioritize the program.

Other companies are moving forward with CAR NK cell therapy candidates. Fate is in Phase I trials with FT522 for B cell lymphoma, and Century has a CD19-targeting therapy, CNTY-101, in Phase I for B cell malignancies.

And while some are focused on genetically modifying NK cells to enhance their cancer-fighting abilities, others are harnessing the inherent qualities of NK cells. For example, San Diego–based Artiva Biotherapeutics, in partnership with Merck, is developing a non–genetically modified NK cell therapy that enhances antibody responses to specific cancers and autoimmune diseases. Meanwhile, NKGen Biotech just released interim Phase I data for its allogeneic non–genetically modified NK cell therapy, SNK02, showing that it was well tolerated—all patients completed the eight treatment cycles—and showed signs of clinical activity against pretreated solid tumors. And ImmuneBridge wants to harness the pool of NK cells from hematopoietic stem cells derived from umbilical cords, which Jain said are most likely to show anti-tumor activities against specific cancers.

The Road Ahead

Despite recent advancements, experts suggest the road ahead for upscaling NK cell therapies may not be straightforward.

“NK cells don’t live for very long,” Shook said, so patients may require a high dose and multiple rounds of injections.

Jain added that differentiating NK cells derived from donors can exhaust the cells and mellow their potential to be effective cancer killers. “We need durable cell NK therapies,” she said.

According to a study of clinical trial data recently published in Nature, the clinical benefits from NK cell–based therapies often lasted only a few months before relapse, likely due to resistance or low NK cell persistence. “NK cell persistence typically ranges from a few days to 4 months, with an average of 7 days,” the authors noted, adding that cryopreservation of NK cells further impacts their ability to grow.

While there are currently no FDA-approved NK cell therapies for cancer, Copik is hopeful that some of these therapies will make it to market. “More studies are showing us that the NK cell therapies are effective and have better safety profiles compared to CAR-Ts,” she said.

Jain holds a similar view. “Patients are battling every day. Having a new therapy that is readily accessible will be a huge advancement.”

https://www.biospace.com/article/can-nk-cell-therapy-avoid-car-t-s-shortcomings-/