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Thursday, September 16, 2021

Silverback Therapeutics Presents Interim Clinical Results in Tumor Study

  Proof-of-mechanism established with activation of myeloid and T/NK cells, and evidence of SBT6050 payload localization in the tumor microenvironment –

– SBT6050 demonstrated a manageable safety profile with adverse events consistent with on-mechanism immune activation, both as a monotherapy or in combination with pembrolizumab –

– Early signals of anti-tumor activity observed in a heavily pre-treated, heterogeneous population –

– Management to host conference call today at 6:30 AM ET –

Conference Call and Webcast on Thursday, September 16, 2021, at 6:30 AM ET

Silverback’s management team will host a conference call today at 6:30 AM ET. A live webcast, including slides, can be accessed through the Events section of the Company’s website at https://ir.silverbacktx.com/news-events/events. An archived replay will be available shortly after the conclusion of the event.

https://www.businesswire.com/news/home/20210916005163/en/Silverback-Therapeutics-Presents-Interim-Clinical-Results-from-the-Ongoing-Phase-11b-Study-of-SBT6050-Alone-or-In-Combination-with-Pembrolizumab-in-Patients-with-Advanced-or-Metastatic-HER2-Expressing-Solid-Tumors

Biogen: Mixed results in mid-stage pain study

 Biogen Inc. (Nasdaq: BIIB) today announced positive topline results from its Phase 2 CONVEY study of vixotrigine (BIIB074), a non-opioid investigational oral pain drug being evaluated for the treatment of small fiber neuropathy (SFN).

The CONVEY study 200 mg twice daily arm met its primary endpoint of change from baseline to week 12 of the double-blind period in mean average daily pain (ADP) score. In this study, all participants who enrolled received the higher dose (350 mg twice daily) in an open-label portion which preceded the double-blind portion of the study. While the 350 mg twice daily arm did not meet the primary endpoint, it met statistical significance in the Patient Global Impression of Change (PGIC) at week 12, an important self-reported measure of a patient’s overall improvement since with the start of the study. The totality of data from the vixotrigine program will inform potential doses for study in future Phase 3 clinical trials. There is a significant unmet need for non-opioid treatments for people suffering from chronic neuropathic pain.

https://financialpost.com/globe-newswire/biogen-announces-positive-topline-results-from-phase-2-convey-study-in-small-fiber-neuropathy-vixotrigine-a-non-opioid-investigational-pain-drug-has-the-potential-to-address-significant-un

Intellia: FDA accepts application for leukemia med

 

  • NTLA-5001 is Intellia’s first ex vivo candidate using its proprietary cell engineering process for the treatment of cancer to enter clinical study

  • NTLA-5001 targets Wilms’ Tumor 1 (WT1), an overexpressed intracellular antigen on many hematologic malignancies and solid tumors

  • Initiation of patient screening in Phase 1/2a study of NTLA-5001 expected by year-end

Gilead Trodelvy® Significantly Improved Quality of Life Over Standard of Care

 Gilead Sciences, Inc. (Nasdaq: GILD) today announced new data from the Phase 3 ASCENT study of Trodelvy® (sacituzumab govitecan-hziy) in patients with relapsed or refractory metastatic triple-negative breast cancer (TNBC) who received two or more prior systemic therapies, at least one of them for metastatic disease. In addition to the previously reported overall survival benefit observed with Trodelvy compared with chemotherapy chosen by patients’ physicians (11.8 months vs. 6.9 months; HR: 0.51; 95% CI: 0.41-0.62; p<0.0001), this new sub-analysis demonstrated significant and clinically meaningful improvements in health-related quality of life (HRQoL) with Trodelvy. The results were presented at the European Society of Medical Oncology (ESMO) Congress 2021 from September 16-21, 2021 (Poster #257P).

https://www.businesswire.com/news/home/20210916005029/en/Trodelvy%C2%AE-Significantly-Improved-Quality-of-Life-Over-Standard-of-Care-in-2L-Metastatic-Triple-Negative-Breast-Cancer-in-Phase-3-ASCENT-Study

Moderna says new data supports need for booster shot

 People who received a dose of Moderna’s COVID-19 vaccine 13 months ago have higher rates of infections than those that got inoculated at the beginning of the year, new data shows.

The new stats from Moderna’s large vaccine trial indicated that the effectiveness of its doses decline over time, and support the case for booster doses, the company said Wednesday.

The new analysis revealed a weakness in the Moderna vaccine’s staying power — after a recent study suggested that it may be more effective over time than the Pfizer-BioNTech dose, due longer intervals between the first and second shots and higher levers of mRNA.

The drug maker compared the success of the vaccine in the 14,000 volunteers vaccinated last summer and fall to the 11,000 volunteers who took the shot between December and March. Eighty-eight people in the more recent group got COVID-19 compared to 162 cases among the former. However, only 19 of those cases were severe, and the rate of harsh illnesses was lower among the second test group.

Vials containing Moderna vaccines are pictured during the administration of a third shot of coronavirus disease (COVID-19) vaccine,
Moderna is developing a booster shot that protects against COVID-19 and the seasonal flu.
REUTERS/Raneen Sawafta

Moderna said the study adds to evidence that a booster shot is needed, especially to protect against severe cases of COVID-19. It shared two studies to back up the findings, including a CDC review that found Moderna’s vaccine was much more effective at preventing hospitalization than Pfizer or Johnson & Johnson’s.

Moderna is developing a booster shot that protects against COVID-19 and the seasonal flu, as the FDA continued to weigh the need for a third Pfizer shot ahead of a Friday meeting.

In documents released Wednesday, the agency said “data indicate that currently US-licensed or authorized COVID-19 vaccines still afford protection against severe COVID-19 disease and death in the United States.”

https://nypost.com/2021/09/15/moderna-says-new-data-supports-need-for-booster-shot/

Wednesday, September 15, 2021

Judge schedules Oct. 1 hearing on DOJ request to halt Texas abortion law

 A federal judge has scheduled an Oct. 1 hearing to consider the Department of Justice’s request to temporarily block a recently enacted Texas law that effectively bans abortions after about six weeks of pregnancy, The Texas Tribune reported.

Earlier this month, the Supreme Court declined to block the Texas abortion law, which prohibits the medical procedure after a “fetal heartbeat” is detected, which can often occur before a woman knows she is pregnant. 

The law is unique in that it allows private citizens to file a lawsuit against people suspected of performing or helping a woman receiving the procedure. Those individuals can be awarded $10,000 for each time they successfully sue.

Late Tuesday night, the Justice Department filed an emergency motion to stop the law from being enforced in the state, arguing that it prevented “women from exercising their constitutional rights.”  

Rather than act on the Biden administration’s request to freeze the law, U.S. District Judge Robert L. Pitman will instead hear arguments prior to issuing a decision at the request of the state, the Tribune reported. 

Texas has until Sept. 29 to make its case opposing the DOJ request, and then the department may respond before Oct. 1. 

The decision to hear arguments means the law will have been in force for at least one month — and will remain in place at least until the judge issues his decision on the DOJ's request.

In response to questions last week from reporters, Gov. Greg Abbott (R), who signed the law in May, defended the legislation, saying that victims of rape were covered under the legislation and that Texas was intent on eliminating rapists from the state. Victims of rape would be able to have an abortion within six weeks of becoming pregnant under the legislation.

“Let’s be clear: rape is a crime,” Abbott said, according to KXAN. “And Texas will work tirelessly to make sure that we eliminate all rapists from the streets of Texas by aggressively going out and arresting them and prosecuting them and getting them off the streets.” 

The Hill has reached out to the Justice Department and Abbott’s office for comment.

https://thehill.com/homenews/state-watch/572526-judge-schedules-hearing-on-doj-request-to-halt-texas-abortion-law

Democrats suffer blow on drug pricing as 3 moderates buck party

 Democrats' signature legislation to lower drug prices was defeated in a House committee on Wednesday as three moderate Democrats voted against their party.

Reps. Kurt Schrader (D-Ore.), Scott Peters (D-Calif.), and Kathleen Rice (D-N.Y.) voted against the measure to allow the secretary of Health and Human Services to negotiate lower drug prices, a long-held goal of Democrats.

The vote is a striking setback for Democrats' $3.5 trillion package. Drug pricing is intended to be a key way to pay for the package. Leadership can still add a version of the provision back later in the process, but the move shows the depth of some moderate concerns.

The three moderates said they worried the measure would harm innovation from drug companies and pushed a scaled-back rival measure. The pharmaceutical industry has also attacked Democratic leaders' measure, known as H.R. 3, as harming innovation.

The three lawmakers had long signaled their concerns with the drug pricing measure, but actually voting it down in the House Energy and Commerce Committee is an escalation.

A separate committee, the House Ways and Means Committee, did advance the drug pricing measures on Wednesday, keeping the provisions in play for later in the process.

Energy and Commerce Committee Chairman Frank Pallone Jr. (D-N.J.) had implored the three lawmakers to vote in favor of the measure to at least keep the process going. 

"Vote to move forward today," he said to the moderates in his party. "Vote to continue the conversation."

Still, Pallone said he is confident that some form of measure to lower drug prices will make it into the final package. The House legislation was already expected to change before the final version, given moderate Democratic concerns in the Senate as well. Senate Democrats are working on their own bill, which is not yet finalized but is expected to be less far-reaching. 

"I know it is going to have drug pricing reform," Pallone said of the final bill, noting that negotiations with the Senate would continue over the coming weeks. 

Still, the move on Wednesday is a show of force from the moderates. 

Henry Connelly, a spokesman for Speaker Nancy Pelosi (D-Calif.), said Democrats were not giving up on including drug pricing measures. 

“Polling consistently shows immense bipartisan support for Democrats’ drug price negotiation legislation, including overwhelming majorities of Republicans and independents who are fed up with Big Pharma charging Americans so much more than they charge for the same medicines overseas," he said in a statement after the vote. "Delivering lower drug costs is a top priority of the American people and will remain a cornerstone of the Build Back Better Act as work continues between the House, Senate and White House on the final bill.”

Peters and Schrader both cited concerns about harming drug companies' ability to develop new drugs, citing the industry's record during the COVID-19 crisis.

Peters warned that "government-dictated prices" under the bill would cause harm to the "private investment" that backs drug development.

Schrader said the bill would mean "killing jobs and innovation that drives cures for these rare diseases."

Advocates said the lawmakers were simply beholden to the pharmaceutical industry.

"Reps. Peters, Rice, and Schrader are prioritizing drug company profits over lower drug prices for the American people, particularly for patients with chronic conditions such as diabetes and multiple sclerosis," said Patrick Gaspard, president of the left-leaning Center for American Progress. "To the contrary of what they contend, their opposition to the drugs proposal threatens the entirety of President Joe Biden’s Build Back Better agenda, which Democrats have campaigned on for years and that they previously voted for."

Savings from the drug pricing provisions are a key way of paying for other health care priorities in the $3.5 trillion package, including expanding Medicaid in the 12 GOP-led states that have so far refused, expanding financial assistance under ObamaCare, and adding dental, vision, and hearing benefits to Medicare.

The Congressional Budget Office found that H.R. 3 would save about $500 billion over 10 years. Depending on what Senate Democrats can find agreement on, the final drug pricing legislation is expected to be less far-reaching, meaning it will result in fewer savings, though how much less is unclear.

The Senate bill would still allow Medicare to negotiate lower drug prices, but it is expected not to include another provision that would cap drug prices based on the lower prices paid in other wealthy countries. That provision has drawn particular pushback from some moderate Democrats.

Allowing Medicare to negotiate drug prices is extremely popular with voters, with almost 90 percent support in a Kaiser Family Foundation poll earlier this year. Many vulnerable House Democrats support the idea.

https://thehill.com/policy/healthcare/572447-democrats-suffer-blow-on-drug-pricing-as-3-moderates-buck-party