Vir Data from Its Ongoing Phase 2 Chronic Hepatitis B and Delta Trials

 VIR BIOTECHNOLOGY, Inc. (Nasdaq: VIR) today announced that it will be presenting new data from its Phase 2 trials evaluating the potential clinical impact that VIR-3434 and VIR-2218 could have for chronic hepatitis B (CHB) and chronic hepatitis delta (CHD) patients at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting^®, taking place in Boston, MA, from November 10-14, 2023. These include one late-breaking poster presentation and one late-breaking oral presentation.

Late-Breaking Presentations

• Title: VIR-2218 and VIR-3434 With or Without Pegylated Interferon Alfa-2A for the Treatment of Chronic HBV Infection: End of Treatment (EOT) Results After 24 Weeks of Therapy (March Study Part B) (Abstract #48500)
  Session: Late Breaking Poster Session
  Date: Monday, November 13
  Time: 1:00 p.m. ET
  Presenter: Edward Gane, M.D., Professor of Medicine at the University of Auckland, New Zealand, and Chief Hepatologist, Transplant Physician and Deputy Director of the New Zealand Liver Transplant Unit at Auckland City Hospital

• Title: The Monoclonal Antibody VIR-3434 And siRNA VIR-2218 for the Treatment of Chronic Hepatitis D Virus: Preliminary Results from the Phase 2 SOLSTICE Trial (Abstract #5004)
  Session: Oral, Late Breaking Parallel Session
  Date: Monday, November 13
  Time: 3:00 p.m. ET
  Presenter: Tarik Asselah, M.D., Ph.D., Professor of Hepatology at the Hôpital Beaujon, APHP, Clichy, France, and at the University of Paris, and Head of Viral Hepatitis at INSERM UMR1149, France

The AASLD late breaking presentation abstracts can be accessed under Events & Presentations in the Investors section of the Vir website here.

Vir will host an investor conference call to discuss the Phase 2 CHD & CHB AASLD data at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time on November 13th. A live webcast will be available on https://investors.vir.bio and will be archived on www.vir.bio for 30 days.

https://www.biospace.com/article/releases/vir-biotechnology-to-present-late-breaking-data-from-its-ongoing-phase-2-chronic-hepatitis-b-and-delta-trials-at-aasld-s-the-liver-meeting-2023/

AstraZeneca’s Imfinzi, Chemo Combo Meets Endpoint in Phase III Liver Cancer

 AstraZeneca’s cancer immunotherapy treatment Imfinzi (durvalumab) has shown encouraging survival results for hepatocellular carcinoma patients eligible for embolization in combination with Genentech’s Avastin (bevacizumab) and transarterial chemoembolization.

On Thursday, AstraZeneca announced that results from the Phase III Emerald-1 trial “demonstrated a statistically significant clinically meaningful improvement” in the primary endpoint of progression-free survival. The trial is ongoing as AstraZeneca continues to follow the secondary endpoint of overall survival.

AstraZeneca reported that the safety profile of the combination was “consistent with the known profile of each medicine,” with no new safety issues identified.

“These positive results for Imfinzi-based treatment in Emerald-1 may bring the potential of immunotherapy to patients with earlier stages of liver cancer. We look forward to discussing these data with regulatory authorities and seeing the survival data mature over time, which will be important as we aim to bring this novel treatment option to patients,” Susan Galbraith, AstraZeneca’s executive vice president of oncology R&D, said in a statement. 

While no detailed data was provided, AstraZeneca said that the complete dataset will be presented at an unspecified medical meeting and the company will share it with regulatory authorities.

“These results for durvalumab plus bevacizumab have the potential to reshape the treatment of this complex disease with a poor prognosis by showing for the first time that adding an immunotherapy combination to [transarterial chemoembolization (TACE)] significantly improves progression-free survival,” Riccardo Lencioni, the trial’s principal investigator and director of the cancer imaging program in the Department of Diagnostic and Interventional Radiology of Pisa University Hospital in Italy, said in a statement. 

Imfinzi is also being investigated in other gastrointestinal cancers, including a combination with bevacizumab in adjuvant hepatocellular carcinoma (HCC) and a combo with Imjudo, Lenvatinib and TACE in embolization-eligible HCC. 

The drug is one of the main moneymakers for AstraZeneca, bringing in over $1.1 billion in the third quarter and $3.1 billion for the first nine months of 2023. 

Imfinzi has also been showing its efficacy in other cancers. Last month, Imfinzi, in combination with chemotherapy, showed positive results in a Phase III trial for patients with resectable, early-stage and locally advanced gastric and gastroesophageal junction cancers. In April 2023, a combination of the drug and Lynparza reached its primary endpoint in a Phase III trial for patients with high-grade epithelial ovarian cancer. 

https://www.biospace.com/article/astrazeneca-s-imfinzi-chemo-combo-hits-endpoint-in-phase-iii-liver-cancer-trial/

Takeda Wins First FDA Approval for Ultra-Rare Blood Clotting Disease

 The FDA on Thursday approved Takeda’s recombinant ADAMTS13, now to be marketed as Adzynma, for the treatment of the rare blood disorder congenital thrombotic thrombocytopenic purpura—the biopharma company’s second approval in as many days.

Adzynma is indicated as an intravenous prophylactic and on-demand therapy of congenital thrombotic thrombocytopenic purpura (cTTP) in both adults and children. Afflicting two to six patients in every million people, cTTP is an ultra-rare and debilitating clotting disorder characterized by thrombocytopenia, red blood cell destruction, headaches and abdominal pain. When left unchecked, cTTP can lead to widespread organ damage and reach mortality rates of almost 90%.

According to Julie Kim, president of Takeda’s U.S. business unit, Adzynma is the “first FDA-approved therapeutic option for people with cTTP,” who often face “serious, life-threatening health challenges” and are left with no treatment options specifically designed to treat their conditions.

The disease is caused by a deficiency in ADAMTS13, an enzyme that cleaves the glycoprotein von Willebrand factor (VWF). Faulty ADAMST13 results in the accumulation of ultra-large VWF complexes in the blood, which in turn leads to the uncontrolled aggregation and adhesion of platelets.

Adzynma addresses the underlying cause of cTTP by delivering a functional human recombinant ADAMTS13 protein, restoring the body’s ability to break down the large VWF complexes and prevents the formation of clots. This mechanism of action won Adzynma the FDA’s Orphan Drug, Fast Track and Rare Pediatric Disease designations for the treatment and prevention of cTTP.

The FDA’s approval on Thursday was supported by data from a pivotal Phase III trial, as well as additional evidence from a continuation trial. In June 2023, Takeda presented findings from the Phase III trial at the 2023 Congress of the International Society on Thrombosis and Hemostasis.

Results showed that Adzynma cut the incidence of thrombocytopenia by 60% compared to a plasma-based control therapy. None of the patients receiving prophylactic Adzynma experienced an acute TTP event.

Adzynma’s data package also showed a favorable safety profile for the therapy. The most common side effects were headache, migraine, diarrhea, nausea, abdominal pain and vomiting. None of the patients treated with Adzynma developed neutralizing antibodies.

While Adzynma’s label does not carry a boxed warning, it comes with precautions against hypersensitivity reactions as well as the risk of developing antibodies against Adzynma, which might lead to a “decreased or lack of response” to the treatment.

Thursday’s approval comes just a day after Takeda also won the FDA’s greenlight for its fruquintinib, now being marketed as Fruzaqla, the “first and only selective inhibitor of all three VEGF receptor kinases” for previously treated metastatic colorectal cancer regardless of biomarker status.

https://www.biospace.com/article/takeda-wins-first-fda-approval-for-ultra-rare-blood-clotting-disease-/

Stefanik Hits "Radical Leftist" Trump Judge With Ethics Complaint

 While the jury is still out over whether the wife of Judge Arthur Engoron made anti-Trump posts on X, Rep. Elise Stefanik (R-NY) has filed an ethics complaint against judge himself, accusing him of displaying "inappropriate bias and judicial intemperance" towards the former president in his civil fraud trial taking place in New York.

"I filed an official judicial complaint against Judge Arthur Engoron for his inappropriate bias and judicial intemperance in New York’s disgraceful lawsuit against President Donald J. Trump and the Trump Organization," Stefanik told NBC News. "Americans are sick and tired of the blatant corruption by radical Leftist judges in NY. All New Yorkers must speak out against the dangerous weaponized lawfare against President Trump."

According to the complaint, Engoron has exhibited "clear judicial bias" against Trump, including telling Trump's attorney that the former president is "just a bad guy," who NY Attorney General Letitia James "should go after."

"Simply put, Judge Engoron has displayed a clear judicial bias against the defendant throughout the case, breaking several rules in the New York Code of Judicial Conduct," reads the letter.

Rep. Elise Stefanik (R-NY)

"Judge Engoron entered summary judgment against the defendant before the trial even began, without witnesses, other evidence, and cross-examination," she continued, noting that this was "despite the fact there’s disputed material evidence–and there’s no victim of the defendant’s supposed fraud. "

Stefanik also notes that Engoron and his staff are "partisan Democrat donors," and that Engoron himself, as recently as 2018, "donated to the Manhattan Democrats."

"If Judge Engoron can railroad a billionaire New York businessman, a former President of the United States, and the leading presidential candidate, just imagine what he could do to all New Yorkers," the letter continues. "Judge Engoron’s lawlessness sends an ominous and illegal warning to New York business owners: If New York judges don’t like your politics, they will destroy your business, the livelihood of your employees, and you personally. This Commission cannot let this continue."

"Section 100.2(A) states: 'A judge shall respect and comply with the law and shall act at all times in a manner that promotes public confidence in the integrity and impartiality of the judiciary.' Judge Engoron has grossly failed to do this," she wrote.

Activist wife?

On Thursday, Engoron's wife, Dawn Engoron, denied making anti-Trump posts on X, after journalist Laura Loomer claimed to have "uncovered screenshots" showing extreme bias.

Dawn Engoron denied the claims, telling Newsweek: "I do not have a Twitter account. This is not me. I have not posted any anti Trump messages."

Engoron is overseeing Trump's New York civil case, in which AG Letitia James has accused the former President and his organization of inflating their net worth by billions of dollars to obtain premium financing between 2011 and 2021. In September, Engoron ruled - sans jury, that Trump's financial statements committed fraud.

Following the denial, Loomer doubled down, noting that the suspected X account has been locked, that Newsweek "admit(s) they can’t definitively say this account doesn’t belong to Arthur Engoron’s wife," and that Engoron's son has deleted his LinkedIn account yesterday "after I exposed him getting preferential seating from his father in the trial of President Trump."

Read Stefanik's complaint below:

https://www.zerohedge.com/markets/stefanik-hits-radical-leftist-trump-judge-ethics-complaint

Pacira: Expanded EXPAREL Label to Include Two Additional Nerve Block Indications

 — EXPAREL is the only FDA-approved single-dose regional analgesic to safely demonstrate four days of superiority versus bupivacaine in two clinical studies — 

— New indications for use as an adductor canal block and sciatic nerve block in the popliteal fossa will significantly extend reach within more than 3 million lower extremity procedures —

https://www.globenewswire.com/news-release/2023/11/10/2778236/0/en/Pacira-Announces-FDA-Approval-of-Expanded-EXPAREL-Label-to-Include-Two-Additional-Nerve-Block-Indications.html

Adaptive Biotechnologies in strategic review

 

• Strategic review underway with Goldman Sachs to maximize the value of the MRD and Immune Medicine businesses.
• Revenue for the third quarter 2023 was $37.9 million, representing a 21% decrease from the third quarter 2022 driven primarily by a 61% reduction in GNE amortization and a 14% decrease in MRD pharma services and IM pharma services largely due to biopharmaceutical industry headwinds.
• clonoSEQ test volume in the third quarter 2023 grew 56% to 15,072 tests delivered versus the third quarter of prior year.
• Immune Medicine achieved a key milestone with the discovery of a novel target in multiple sclerosis, which validates our target discovery approach in autoimmune disorders.
• Operating expenses, excluding cost of revenue, for the third quarter 2023 decreased 11% versus the same period last year as a result of continued operating efficiencies efforts.

https://www.globenewswire.com/news-release/2023/11/09/2777819/0/en/Adaptive-Biotechnologies-Reports-Third-Quarter-2023-Financial-Results-and-Provides-Business-Update.html

Biolase 'BENEFITTING FROM STRATEGIC ACTIONS'

 Third Quarter Financial Summary

• Total revenue was $10.9 million, below the year-ago revenue, as the current macro-environment is impacting laser system sales
• Total consumable sales were $2.9 million, a 10% year-over-year increase as utilization of installed laser systems continues to increase
• Gross margin was 34%, a 1,400-basis expansion compared to the year-ago level due to the specific actions taken by the Company to drive toward profitability
• Continued operating improvements and efficiencies reduced operating loss by 52% year over year compared to the year-ago quarter

https://www.prnewswire.com/news-releases/biolase-reports-third-quarter-financial-results-company-benefitting-from-strategic-actions-taken-to-streamline-operations-and-gain-greater-operational-efficiencies-301983980.html