SIGA Updates on Progress In Smallpox Drug Trials For Potential Use Against Monkeypox

 

• SIGA Technologies Inc 
  SIGA+1.05%+ Free Alerts
   provided an update on the status of multiple clinical trials now underway to assess the safety and efficacy of TPOXX to treat monkeypox.
• In recent weeks, the company initiated trials in the U.S., the U.K., and Congo to further assess the safety and efficacy of TPOXX in participants with monkeypox. 
• These randomized clinical trials are now enrolling patients.
  • Study of Tecovirimat for Human Monkeypox Virus (STOMP; A5418) is a U.S.-based clinical trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID). Study investigators aim to enroll more than 500 participants, including children.
  • PLATINUM is a U.K.-based clinical trial commissioned and funded by the National Institute for Health Care and Research (NIHR), intending to recruit at least 500 participants.
  • PALM 007 is a Congo-based clinical trial sponsored by NIAID and Institute National de Recherche Biomédicale (INRB). Study investigators aim to enroll more than 450 participants, including children weighing ≥3 kg and those who are pregnant or breastfeeding.
• In 2018, the FDA approved oral TPOXX for smallpox.
• SIGA disclosed that as of mid-September, it received approximately $76 million of international orders for oral TPOXX from twelve international customers.

https://www.benzinga.com/general/biotech/22/10/29252925/siga-updates-on-progress-its-smallpox-drug-trials-for-potential-use-against-monkeypox

Aveo: Patent OKd for FOTIVDA for Treatment of Refractory Advanced Renal Cell Carcinoma

 AVEO Oncology (Nasdaq: AVEO), a commercial stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer, announced today that, as disclosed on uspto.gov, the United States Patent and Trademark Office (“USPTO”) has allowed U.S. Patent Application No. 17/720,619, titled “Use of Tivozanib to Treat Subjects with Refractory Cancer” (the “Application”). AVEO expects to receive a Notice of Allowance for this Application. This Application will potentially issue as a patent in 2022 and will provide patent protection in the United States for the claimed methods of use of FOTIVDA into 2039.

A Notice of Allowance is issued after the USPTO decides that a patent can be granted from a patent application. The majority of patent applications that receive a Notice of Allowance will issue as a U.S. patent once the issue fee is paid. However, a Notice of Allowance is not a guarantee of patent issuance.

https://finance.yahoo.com/news/u-patent-trademark-office-allows-200500537.html

Cassava Starts Open-label Extension Study in Alzheimer's

 

• Alzheimer’s Patients Who Complete Participation in a Phase 3 Study of Simufilam are Eligible to Enroll

• 52-week Study of Simufilam 100 mg

• Up to 1,600 Patients Are Expected to Enroll

Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company focused on Alzheimer’s disease, today announced the initiation of an open-label extension study. This study is designed to provide no-cost access to simufilam, an investigational drug, to patients with Alzheimer’s disease who complete either one of Cassava Sciences’ on-going Phase 3 studies, which are double-blind, placebo-controlled trials.

“We believe this open-label study is the right thing to do,” said Remi Barbier, President & CEO. “Alzheimer’s patients who complete one of our Phase 3 studies are eligible to enroll, knowing there is no placebo and no blinding in our open-label extension study.”

Open-label Extension Study Design
This multi-center, multi-national, open-label extension study is expected to generate long-term safety and tolerability data for (oral) simufilam 100 mg twice daily over 52 weeks. Each clinical investigational site must choose whether to participate in this open-label extension study. Patient enrollment for this study is expected to begin early November 2022.

For more information about the open-label-extension study, please visit ClinicalTrials.gov: https://www.clinicaltrials.gov/ct2/show/NCT05575076?term=simufilam&draw=2&rank=1

Overview of On-going Phase 3 Clinical Program
Our Phase 3 program consists of two double-blind, randomized, placebo-controlled studies of simufilam, with an enrollment target of approximately 1,750 patients with mild-to-moderate Alzheimer’s disease. Both Phase 3 studies have Special Protocol Assessments (SPA) from the U.S. Food and Drug Administration. For more information about our Phase 3 studies, please visit ClinicalTrials.gov: https://www.clinicaltrials.gov/ct2/show/NCT04994483?term=simufilam&draw=2&rank=3
https://www.clinicaltrials.gov/ct2/show/NCT05026177?term=simufilam&draw=2&rank=4

https://finance.yahoo.com/news/cassava-sciences-announces-initiation-open-131500478.html

Progressive activists dominated CDC director’s lone ‘parent’ meeting

 The small group of parents that the head of the CDC consulted before unveiling the government’s COVID-19 school reopening plan last year mostly consisted mostly of progressive activists, including the head of a transgender student advocacy group.

Days before recommending a phased reopening for US schools in February 2021, Centers for Disease Control and Prevention director Dr. Rochelle Walensky held a roundtable with only five parents, according to an email obtained by Washington, DC watchdogs Americans for Public Trust and published by Fox News Digital.

Among the small group in the brief virtual roundtable discussion was Roz Keith, the founder and executive director of Stand With Trans, which lobbies for equal LGBTQ protections in schools, according to the report.

Kristin Rowe-Finkbeiner and Angelica Gonzalez, two members of MomsRising, a group that lobbies for “critical issues facing women, mothers, and families” and is financed by Democratic heavyweight donors, were also invited Walensky’s lone parental outreach event, the document reportedly said.

The closed press panel was rounded out by the Elena Hung, the president of student disability advocacy group Little Lobbyists, and Rachel Kobrin, a rabbi. Hung also co-chairs the political action group Health Care Voter, which is funded by the Sixteen Thirty Fund and has been described by Politico as a “left-leaning, secret-money group.”

Despite holding just one meeting with “parents” connected to the left side of the aisle, Walensky and the head of a powerful national teacher’s union had frequently touted her parental outreach in conjunction with the CDC’s advice to get kids back in the classroom.

As she introduced the CDC’s school opening plan on Feb. 12 2021, Walensky said she and her team had worked “to hear firsthand from parents” and had considered their “lived experiences, challenges, and perspectives.”

American Federation of Teachers president Randi Weingarten even tweeted a screenshot of the meeting’s memo several months later in response to The Post’s exclusive May report that revealed her union heavily influenced the agency’s reopening plan.

“Fox, WSJ, NY Post, and The 74 are probably never going to let their readers know that the CDC met with parents too. But everyone should know that they did, and that the NYPost knew they did when they wrote their hit piece. This is how the CDC gets stakeholder feedback,” the former New York City teacher’s union head wrote following the Post’s exclusive.

Walensky’s press secretary Jason McDonald told Fox News Digital that CDC leaders “attended dozen of engagements with a diverse range of groups and advocacy organizations ahead of the release of the COVID-19 schools guidance.”

“CDC experts met with parents at three, national PTA-hosted events on August 7, 2020, January 4, 2021, and February 12, 2021, where parents could ask CDC experts questions about the guidance and how to keep their children safe at school,” he said, adding that their experts fielded “17,276 calls and email messages from Americans asking about COVID-19 and schools between March 1, 2020, and February 11, 2021.”

Caitlin Sutherland, the executive director of Americans for Public Trust, said the roundtable discussion was evidence that the President Biden appointee, “prioritized everything but following the science.”

“First, she colluded with the teachers unions to keep our schools closed, and now we learn that her ‘parent’ meeting was nothing more than placating the demands of liberal activists from dark money groups,” Sutherland told the outlet. “Maybe if the CDC spent less time appeasing activists and unions, kids could have returned to school faster and wouldn’t be facing devastating losses in learning.”

The Post reported last year that language “suggestions” offered by the American Federation of Teachers were adopted almost verbatim by the CDC in its reopening plan, despite the agency’s insistence that its plan to adopt hybrid attendance models in schools was solely based on science.

https://nypost.com/2022/10/13/progressives-dominated-cdc-directors-lone-parent-meeting/

IDWeek preview – GSK beats Pfizer

 GSK had already described the efficacy of its adult RSV vaccine candidate RSVPreF3 OA as “exceptional”, and the headline numbers from an IDWeek abstract have lived up to this billing, with an impressive 83% efficacy. This looks better than Pfizer’s RSVpreF, although cross-trial comparisons are tricky, as usual. It is unclear how GSK defined lower-respiratory tract disease to calculate vaccine efficacy; for severe disease the company looked for two or more symptoms, in line with Pfizer’s definition for standard vaccine efficacy. But, if anything, this paints GSK’s candidate in an even better light. The available data also seem to contradict Pfizer’s claims that including both RSV-A and B antigens could improve efficacy: GSK’s asset only contains the RSV-A antigen, but still looked good against RSV-B. Presentation of full results on both vaccines is set for October 20. One thing to keep an eye on will be the agents’ tolerability profiles; the GSK project is adjuvanted, while Pfizer’s is not. With both jabs looking approvable, the focus will shift towards commercial execution. And more competition could be coming, with Johnson & Johnson and Moderna also set to release pivotal data with their adult candidates this winter, followed by Bavarian Nordic in mid-2023.

Duelling RSV vaccines in ≥60 year olds
	GSK	Pfizer
Candidate vaccine	RSVPreF3 OA (GSK3844766A)	RSVpreF (PF-06928316)
Pivotal study	Aresvi 006	Renoir
Vaccine efficacy	82.6%*	66.7%**
Vaccine efficacy in severe disease	94.1%**	85.7%^
Efficacy against RSV-A	84.6%	?
Efficacy against RSV-B	80.9%	?
Efficacy by age
60-69	81.0%	?
70-79	93.8%	?
≥80	33.8%	?
*Definition unclear; **≥2 symptoms; ^≥3 symptoms. Source: Company releases. https://www.evaluate.com/vantage/articles/events/conferences-snippets/idweek-preview-gsk-beats-pfizer

Beigene gets a Brukinsa boost, but is Calquence the one to beat?

 Beigene has long argued that Brukinsa is the best BTK inhibitor, and the final analysis of the phase 3 Alpine trial might help support this claim. The study, in relapsed or refractory chronic lymphocytic leukaemia, found Brukinsa to yield longer progression-free survival than Johnson & Johnson/Abbvie’s Imbruvica, though the exact numbers remain under wraps for now. The trial had already shown superiority on overall response rate, the primary endpoint. CLL is a huge setting for the BTK inhibitors, though poor tolerability is Imbruvica’s Achilles’ heel. Beigene describes Brukinsa as having maximised receptor occupancy and minimal off-target binding, lessening toxicities, a claim backed up by data presented at EHA last year. Still, this is the same argument that Astrazeneca is making for its BTK inhibitor Calquence, which is already approved and taking share from Imbruvica on this basis. Calquence’s CLL trial Elevate-RR only showed non-inferiority to Imbruvica, however, albeit with better toxicity. This makes Calquence the one that Brukinsa has to beat, though Beigene investors were sufficiently cheered to send the company’s stock up 21% yesterday. At the very least, a green light at Brukinsa’s January 2023 Pdufa in CLL now looks assured.