- Karyopharm Therapeutics (NASDAQ:KPTI) presents data from a Phase 2 clinical study evaluating low dose oral selinexor in hospitalized patients with severe COVID-19 at the International Society for Influenza and Other Respiratory Virus Diseases Antiviral Group Virtual Conference on Therapeutics for COVID-19 taking place from October 6 - 8, 2020.
- While an interim analysis indicated that the trial was unlikely to meet its pre-specified primary endpoint, and has since been discontinued, the results demonstrated encouraging anti-viral and anti-inflammatory activity in an important subset of treated patients.
- The placebo-controlled Phase 2 study was designed to assess the activity and safety of 20mg of selinexor given orally three times a week for two weeks, a dosing level lower than the FDA approved dose of selinexor, marketed as XPOVIO, to treat patients with relapsed or refractory multiple myeloma or relapsed or refractory diffuse large B-cell lymphoma.
- A post-hoc analysis of 66 patients with either baseline serum lactate dehydrogenase (LDH) ≤370 U/L or D-dimer ≤600 mcg/L FEU (Low LDH/DD) showed that treatment with selinexor (n=38) compared to placebo (n=28) was associated with a significantly higher percentage of patients discharged by Day 14 (78.9% vs 57.1%; p=0.029) with a trend towards superior ≥2-point improvement in the Ordinal Scale (OSI-2) on Day 14 (78.9% vs 64.3%; p=0.095).
- Additionally, a positive trend was observed in patients treated with selinexor to convert to a negative COVID-19 PCR test as compared to placebo (42.1% vs 28.6%; p=0.13).
- A significant reduction in inflammation was also seen within eight days of selinexor treatment (p<0.05).
- Adverse events occurred in 63.2% of patients treated with selinexor and 51.9% of patients with placebo in the subset, with similar occurrences of deaths across the treatment arms (2 vs. 1).
- Blood levels of LDH and D-dimer are important prognostic markers for in-hospital mortality in patients admitted for COVID-19.
- XPOVIO is an oral Selective Inhibitor of Nuclear Export compound. It functions by selectively binding to and inhibiting the nuclear export protein exportin 1.
- https://seekingalpha.com/news/3620100-karyopharms-selinexor-shows-promising-results-in-covidminus-19-and-low-ldh-dd
Tuesday, October 6, 2020
Karyopharm's selinexor shows promising results in COVID-19 and Low LDH/DD
Biocept up 3% on demand for COVID-19 test
Neurotrope initiates long-term Alzheimer's study with bryostatin
- Neurotrope (NTRP) has dosed the first patient in Phase 2 study of Bryostatin-1 for the treatment of Alzheimer's disease (AD). The study will be conducted in collaboration with the National Institutes of Health (NIH) under $2.7M grant to Neurotrope.
- The 100-subject study will evaluate Bryostatin-1 in the absence of Allergan/Abbvie's Namenda (memantine) for a six-month period, which will include two 11-week dosing cycles.
- The study will focus on assessing sustained cognitive benefit as measured by the Severe Impairment Battery (SIB) score.
- Previously completed Phase 2 study (NTRP101-202) showed Bryostatin-1 was well tolerated and showed early signals of cognitive benefit, including improvement of 5.0 points in SIB score compared to baseline in moderately severe cohort in the non-Namenda group. Second pilot trial (NTRP101-203) using the same treatment protocol showed a similar SIB improvement compared to baseline in moderately severe cohort.
- https://seekingalpha.com/news/3620132-neurotrope-initiates-long-term-alzheimers-study-bryostatin
Walmart's health insurance initiative to launch this month
- Walmart (WMT +0.4%) says its new insurance services will be able to offer medicare insurance plans to consumers during this year's enrollment period that starts on October 15.
- "At launch, Walmart Insurance Services will provide Medicare plans (Part D, Medicare Advantage and Medicare Supplement plans) offered by Humana, UnitedHealthcare, Anthem Blue Cross Blue Shield, Amerigroup, Simply Health, Wellcare (Centene), Clover Health and Arkansas Blue Cross and Blue Shield. More carriers may be added in the future. We are licensed in all 50 states, plus Washington D.C., and we have built a team of licensed insurance agents who can help people find the right insurance plan for them."
- Walmart's plans to build a health insurance business were revealed earlier this year.
- See all the growth metrics on Walmart as they stand now
- https://seekingalpha.com/news/3620157-walmarts-health-insurance-initiative-to-launch-this-month
Biogen teams up with Scribe Therapeutics to develop gene therapy for ALS
- Just-launched gene editor Scribe Therapeutics will collaborate with Biogen (BIIB -0.5%) to develop and commercialize CRISPR-based therapies for the potential treatment of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease.
- Under the terms of the agreement, the parties will create therapies for genetically driven ALS with an option to pursue an additional neurological disease target with high unmet need. Scribe will receive $15M upfront, up to $400M in milestones between the two targets and tiered high single-digit-to-sub-teen royalties on net sales.
- Scribe was founded by former members of CRISPR pioneer Jennifer Doudna's lab at UC Berkeley, including Dr. Doudna herself. VC shop Andreessen Horowitz is an investor.
- https://seekingalpha.com/news/3620162-biogen-teams-up-scribe-therapeutics-to-develop-gene-therapy-for-als
Rapid COVID-19 testing coming to JFK and Newark airports
- XpresSpa Group (NASDAQ:XSPA) says it will begin rapid testing for COVID-19 at both JFK International Airport and Newark Liberty International Airport tomorrow with its XpresCheck product.
- The company says rapid testing represents an expansion of XpresCheck’s COVID-19 testing options which already include the Polymerase Chain Reaction Test and Blood Antibody Test.
- Rapid testing will also be available at all future XpresCheck locations after opening.
- “We believe rapid COVID-19 testing at airports can play a major role in slowing the virus spread and decreasing the risk of new community outbreaks linked to travel as cases continue to rise throughout many states," notes CEO Doug Satzman.
- "Having a rapid test inside the airport immediately upon travel could also eliminate the need for a full 14-day quarantine in states where that applies," he adds.
- The development could be significant for JetBlue (NASDAQ:JBLU), Southwest Airlines (NYSE:LUV), American Airlines (NASDAQ:AAL), Delta Air Lines (NYSE:DAL) and United Airlines (NASDAQ:UAL) if it raises the comfort level with traveling.
- https://seekingalpha.com/news/3620096-rapid-covidminus-19-testing-coming-to-jfk-and-newark-airports
FDA Ad Com this month to clarify COVID-19 vaccine authorization requirements
- The FDA's Vaccines and Related Biological Products Advisory Committee will meet on Thursday, October 22, to discuss pre- and post-licensure clinical trials needed to further evaluate the immunogenicity and duration of effectiveness of COVID-19 vaccines.
- The committee will also be asked to discuss the need for post-marketing studies following full approval of a COVID-19 vaccine and the requirements for active safety follow-up after emergency use authorization (EUA).
- Briefing materials (link at bottom)
- Selected tickers: Moderna (NASDAQ:MRNA), Pfizer (NYSE:PFE), BioNTech SE (NASDAQ:BNTX), Johnson & Johnson (NYSE:JNJ), AstraZeneca (NASDAQ:AZN), Sanofi (NASDAQ:SNY), GlaxoSmithKline (NYSE:GSK), Merck (NYSE:MRK), Dynavax (NASDAQ:DVAX), Novavax (NASDAQ:NVAX)
- https://seekingalpha.com/news/3620151-fda-ad-com-this-month-to-clarify-covidminus-19-vaccine-authorization-requirements
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