Bio-Path up on advancement of prexigebersen leukemia study

The first participant has been dosed in the amended second stage of a Phase 2 clinical trial evaluating Bio-Path Holdings’ (NASDAQ:BPTH) prexigebersen (BP1001), added to first-line venetoclax and decitabine, in acute myeloid leukemia (AML) patients.

Open-label Stage 1 assessed prexigebersen and low-dose cytarabine but oncologists favored decitabine.

Stage 2 has three cohorts, the first-untreated AML patients, the second-relapsed/refractory AML and the third- relapsed/refractory patients resistant to or intolerant of prexigebersen and decitabine. The first two cohorts will receive the triplet therapy.

The primary endpoint is the number of patients achieving complete remission.

If preliminary data are positive, the company plans to convert the study into a registration trial to support a U.S. application for accelerated approval.

https://seekingalpha.com/news/3605165-bio-path-up-10-on-advancement-prexigebersen-study-in-aml

Encouraging COVID-19 vaccine data lifts Heat Biologics

Micro cap Heat Biologics (NASDAQ:HTBX) jumps 24% premarket on increased volume on the heels of encouraging preclinical data on its gp96-based COVID-19 vaccine candidate.

The results, generated at the University of Miami Miller School of Medicine, showed a robust T cell-mediated immune response against the SARS-CoV-2 spike protein. Specifically, the vaccine induced responses in both “killer” CD8+ T cells and “helper” CD4+ T cells.

The results from the animal studies will be published in the coming weeks.

https://seekingalpha.com/news/3605115-encouraging-covidminus-19-vaccine-data-lifts-heat-biologics-up-24

Thermo Fisher walks away from Qiagen after deal deadline passes

Thermo Fisher Scientific (NYSE:TMO) announces that its revised €43.00 per share offer for diagnostic test maker Qiagen (NYSE:QGEN) is no longer valid.

The deadline for a deal was Monday, August 10, contingent on at least 66.67% of QGEN shares tendered. According the settlement agents, only 47.02% of QGEN shares were.

TMO has terminated the acquisition agreement and will receive a $95M payment from QGEN per contract terms.

Thermo Fisher first announced a €39/share offer for QGEN in March, then upped its bid after institutional investors rebelled over, what they considered, an inadequate price considering the sharp spike in demand for QGEN’s COVID-19 tests. Certain shareholders were advocating a price of €48 to €52 per share.

https://seekingalpha.com/news/3605097-thermo-fisher-walks-away-from-qiagen-after-deal-deadline-passes

Apple plans Services bundles with fitness app; Peloton shares drop August 13, 2020

Bloomberg sources say Apple (NASDAQ:AAPL) will offer different tiers, starting with a basic package containing Apple Music and Apple TV+ and topping out at a bundle that adds Arcade, News+, and extra iCloud storage.

The tech giant is offering the discounted bundles, dubbed “Apple One” internally, to keep device owners in the ecosystem. Apple One could launch as early as October along with the new iPhone models.

Another bundle will reportedly add virtual fitness class subscriptions that can be accessed through an app for the iPhone, iPad, and Apple TV. The classes would rival those offered by Peloton (NASDAQ:PTON) and Nike.

Separately, Apple is planning software and hardware bundles that would include giving Apple TV owners a free year of Apple Arcade.

Apple shares are up 0.4% pre-market to $453.80. Peloton drops 4.1%.

Related: In FQ3, Services revenue accounted for $13.2B of Apple’s $59.7B in revenue.

https://seekingalpha.com/news/3605094-apple-plans-services-bundles-fitness-app-peloton-shares-drop

Janus Kinase-Inhibitor and Type I Interferon Ability to Produce Favorable Clinical Outcomes in COVID-19

Lucas Walz, Avi J. Cohen, Andre P. Rebaza, James Vanchieri, Martin D. Slade, Charles S. Dela Cruz, Lokesh Sharma

doi: https://doi.org/10.1101/2020.08.10.20172189

This article is a preprint and has not been certified by peer review [what does this mean?]. It reports new medical research that has yet to be evaluated and so should not be used to guide clinical practice.

PDF: https://www.medrxiv.org/content/10.1101/2020.08.10.20172189v1.full.pdf

Abstract

Background Novel coronavirus (SARS-CoV-2) has infected over 17 million. Novel therapies are urgently needed. Janus-kinase (JAK) inhibitors and Type I interferons have emerged as potential antiviral candidates for COVID-19 patients for their proven efficacy against diseases with excessive cytokine release and by their ability to promote viral clearance in past coronaviruses, respectively. We conducted a systemic review and meta-analysis to evaluate role of these therapies in COVID-19 patients. Methods MEDLINE and MedRxiv were searched until July 30th, 2020, including studies that compared treatment outcomes of humans treated with JAK-inhibitor or Type I interferon against controls. Inclusion necessitated data with clear risk estimates or those that permitted back-calculation. Results We searched 733 studies, ultimately including four randomized and eleven non-randomized clinical trials. JAK-inhibitor recipients had significantly reduced odds of mortality (OR, 0.12; 95%CI, 0.03-0.39, p=0.0005) and ICU admission (OR, 0.05; 95%CI, 0.01-0.26, p=0.0005), and had significantly increased odds of hospital discharge (OR, 22.76; 95%CI, 10.68-48.54, p<0.00001), when compared to standard treatment group. Type I interferon recipients had significantly reduced odds of mortality (OR, 0.19; 95%CI, 0.04-0.85, p=0.03), and increased odds of discharge bordering significance (OR, 1.89; 95%CI, 1.00-3.59, p=0.05). Conclusions JAK-inhibitor treatment is significantly associated with positive clinical outcomes regarding mortality, ICU admission, and discharge. Type I interferon treatment is associated with positive clinical outcomes regarding mortality and discharge. While these data show promise, additional randomized clinical trials are needed to further elucidate the efficacy of JAK-inhibitors and Type I interferons and clinical outcomes in COVID-19.

Competing Interest Statement

The authors have declared no competing interest.

Funding Statement

Lokesh Sharma is supported by Parker B Francis Fellowship. Charles Dela Cruz is supported by Veterans affairs Merit Grant (BX004661), Department of Defense grant (PR181442), and a U19 supplement for this work (AI089992-09S2).

https://www.medrxiv.org/content/10.1101/2020.08.10.20172189v1

Sputnik V Clinical Trials

Before the start, of clinical trials the vaccine had gone through all stages of pre-clinical trials with experiments on different types of animals, including 2 types of primates.

Phase 1 and 2 clinical trials of the vaccine have been completed on August 1, 2020. All the volunteers are feeling well, no unforeseen or unwanted side effects were observed. The vaccine induced strong antibody and cellular immune response. Not a single participant of the current clinical trials got infected with COVID-19 after being administered with the vaccine. The high efficacy of the vaccine was confirmed by high precision tests for antibodies in the blood serum of volunteers (including an analysis for antibodies that neutralize the coronavirus), as well as the ability of the immune cells of the volunteers to activate in response to the spike S protein of the coronavirus, which indicates the formation of both antibody and cellular immune vaccine response.

Phase 3 clinical trial involving more than 2,000 people in Russia, a number of Middle Eastern (UAE and Saudi Arabia), and Latin American countries (Brazil and Mexico) will start on August 12. The vaccine has received a registration certificate from the Russian Ministry of Health on August 11 and under emergency rules adopted during the COVID-19 pandemic can be used to vaccinate the population in Russia. Mass production of the vaccine is expected to start in September 2020.

The unique substance of the Sputnik V and method of using it has a patent protection in Russia, obtained by Gamaleya National Research Institute of Epidemiology and Microbiology.

Sputnik V clinical trialsAn Open Study of the Safety, Tolerability and Immunogenicity of “Gam-COVID-Vac Lyo” Vaccine Against COVID-19An Open Study of the Safety, Tolerability and Immunogenicity of the Drug “Gam-COVID-Vac” Vaccine Against COVID-19

https://sputnikvaccine.com/about-vaccine/clinical-trials/

Obesity and Mortality Among Patients Diagnosed With COVID-19

Sara Y. Tartof, PhD, MPH, Lei Qian, PhD, MS, Vennis Hong, MPH, Rong Wei, MA, … View all authors

https://doi.org/10.7326/M20-3742

PDF: https://www.acpjournals.org/doi/pdf/10.7326/M20-3742

Abstract

Background:

Obesity, race/ethnicity, and other correlated characteristics have emerged as high-profile risk factors for adverse coronavirus disease 2019 (COVID-19)–associated outcomes, yet studies have not adequately disentangled their effects.

Objective:

To determine the adjusted effect of body mass index (BMI), associated comorbidities, time, neighborhood-level sociodemographic factors, and other factors on risk for death due to COVID-19.

Design:

Retrospective cohort study.

Setting:

Kaiser Permanente Southern California, a large integrated health care organization.

Patients:

Kaiser Permanente Southern California members diagnosed with COVID-19 from 13 February to 2 May 2020.

Measurements:

Multivariable Poisson regression estimated the adjusted effect of BMI and other factors on risk for death at 21 days; models were also stratified by age and sex.

Results:

Among 6916 patients with COVID-19, there was a J-shaped association between BMI and risk for death, even after adjustment for obesity-related comorbidities. Compared with patients with a BMI of 18.5 to 24 kg/m², those with BMIs of 40 to 44 kg/m² and greater than 45 kg/m² had relative risks of 2.68 (95% CI, 1.43 to 5.04) and 4.18 (CI, 2.12 to 8.26), respectively. This risk was most striking among those aged 60 years or younger and men. Increased risk for death associated with Black or Latino race/ethnicity or other sociodemographic characteristics was not detected.

Limitation:

Deaths occurring outside a health care setting and not captured in membership files may have been missed.

Conclusion:

Obesity plays a profound role in risk for death from COVID-19, particularly in male patients and younger populations. Our capitated system with more equalized health care access may explain the absence of effect of racial/ethnic and socioeconomic disparities on death. Our data highlight the leading role of severe obesity over correlated risk factors, providing a target for early intervention.

Primary Funding Source:

Roche–Genentech.

https://www.acpjournals.org/doi/10.7326/M20-3742#f1-M203742