BeiGene application for tislelizumab accepted in China for lung cancer

The China National Medical Products Administration has accepted BeiGene’s (NASDAQ:BGNE) supplemental new drug application (sNDA) for anti-PD-1 antibody tislelizumab in combination with chemotherapy for first-line treatment of patients with advanced non-squamous non-small cell lung cancer (NSCLC).

Tislelizumab is approved in China as a treatment for patients with classical Hodgkin’s lymphoma and with locally advanced or metastatic urothelial carcinoma.

Tislelizumab is not approved for use outside of China.

https://seekingalpha.com/news/3584426-beigene-application-for-tislelizumab-accepted-in-china-for-lung-cancer

Dosing underway in study of COVID-19 vaccine with Dynavax adjuvant

The first participants have been dosed in a Phase 1 clinical trial evaluating Clover Biopharmaceuticals’ S-Trimer COVID-19 vaccine candidate, SCB-2019, that contains Dynavax’s (NASDAQ:DVAX) CpG 1018 adjuvant.

The study will assess safety, reactogenicity and immunogenicity of SCB-2019 alone, in combination with the CpG 1018 adjuvant combined with alum and in combination with a different adjuvant at multiple dose levels in 150 adult healthy and elderly participants.

Based on preclinical results demonstrating the ability of CpG 1018-adjuvanted SCB-2019 to elicit neutralizing antibodies in multiple animal species, the collaboration, announced on March 24, has been expanded to include clinical supply of CpG 1018 to Clover.

Preliminary safety and immunogenicity results are expected in August 2020.

https://seekingalpha.com/news/3584434-dosing-underway-in-study-of-covidminus-19-vaccine-dynavax-adjuvant

Roche’s ipatasertib shows mixed results in late-stage prostate cancer study

Roche (OTCQX:RHHBY) unit Genentech announces somewhat positive results from a Phase 3 clinical trial, IPATential150, evaluating ipatasertib, combined with Johnson & Johnson’s Zytiga (abiraterone) and prednisone/prednisolone in patients with metastatic castration-resistant prostate cancer (mCRPC).

The study met one co-primary endpoint demonstrating a statistically significant improvement in radiographic progression-free survival (rPFS) in patients with phosphate and tensin homolog (PTEN)-loss tumors compared to abiraterone and prednisone/prednisolone plus placebo.

The other primary co-primary endpoint, rPFS in the overall intent-to-treat population, was not met.

Overall survival and additional secondary endpoints are not yet mature.

No new safety signals were observed.

The trial will continue until the next planned analysis. The data will be shared with health authorities.

Results will be presented at an upcoming medical conference.

The company says that ipatasertib binds to all three isoforms of a proto-oncogene called AKT (protein kinase B), blocking a signaling pathway called PI3K/AKT which is believed to play a key role in resistance to chemo and hormonal therapies in a range of cancers, including breast and prostate.

https://seekingalpha.com/news/3584440-roches-ipatasertib-shows-mixed-results-in-late-stage-prostate-cancer-study

Dr. Reddy’s launches generic abiraterone acetate tablets in U.S.

Dr. Reddy’s Laboratories (NYSE:RDY) announces the launch of Abiraterone Acetate Tablets USP, 250 mg, a generic version of Johnson & Johnson’s (NYSE:JNJ) Zytiga.

The Zytiga brand and generic market had U.S. sales of ~$454M for the year ended March 2020 according to IQVIA Health.

https://seekingalpha.com/news/3584444-dr-reddys-launches-generic-abiraterone-acetate-tablets-in-u-s

Shopify, BlackBerry developing COVID-19 tracing app

As COVID-19 cases hit 100,000 in Canada, Shopify (NYSE:SHOP) and BlackBerry (NYSE:BB) announced a coronavirus contact tracing app – developed with provincial and federal governments – expected to launch in July.

The app, called COVID Alert, will use Bluetooth connections to swap randomly generated codes with users in a geographic vicinity.

It may pay off for Canada. The U.K. yesterday switched to the Apple and Google model for its COVID-19 test-and-trace app after a locally developed system did not work well on the iPhone.

https://seekingalpha.com/news/3584413-shopify-blackberry-developing-covidminus-19-tracing-app

Crowded homes, poor neighborhoods linked to COVID-19

A study of nearly 400 pregnant women in New York City is among the first to show that lower neighborhood socioeconomic status and greater household crowding increase the risk of becoming infected with SARS-CoV-2, the virus that causes COVID-19.
“Our study shows that neighborhood socioeconomic status and household crowding are strongly associated with risk of infection. This may explain why Black and Hispanic people living in these neighborhoods are disproportionately at risk for contracting the virus,” says the study’s leader Alexander Melamed, MD, MPH, assistant professor of obstetrics & gynecology at Columbia University Vagelos College of Physicians and Surgeons and a gynecologic oncologist at NewYork-Presbyterian/Columbia University Irving Medical Center.
What the Study Examined
The researchers examined the relationships between SARS-CoV-2 infection and neighborhood characteristics in 396 women who gave birth at NewYork-Presbyterian/Columbia University Irving Medical Center or NewYork-Presbyterian Allen Hospital during the peak of the COVID-19 outbreak in New York City.
Since March 22, all women admitted to the hospitals for delivery have been tested for the virus, which gave the researchers the opportunity to detect all infections — including infections with no symptoms — in a defined population.
Household Density Strongest COVID-19 Predictor
The strongest predictor of COVID-19 infection among these women was residence in a neighborhood where households with many people are common.
Women who lived in a neighborhood with high household membership were 3 times more likely to be infected with the virus.
Neighborhood poverty also appeared to be a factor: women were twice as likely to get COVID-19 if they lived in neighborhoods with a high poverty rate, although that relationship was not statistically significant due to the small sample size.
There was no association between infection and population density.
“New York City has the highest population density of any city in the United States, but our study found that the risks are related more to density in people’s domestic environments rather than density in the city or within neighborhoods,” says co-author Cynthia Gyamfi-Bannerman, MD, the Ellen Jacobson Levine and Eugene Jacobson Professor of Women’s Health in Columbia’s Department of Obstetrics and Gynecology and a maternal-fetal medicine specialist at NewYork-Presbyterian/Columbia University Irving Medical Center.
Public Health Implications
The study reveals information important for public health officials.
“One may think that because New York City is so dense, there’s little that can slow the spread of the virus, but our study suggests the risk of infection is related to household, rather than urban, density,” Gyamfi-Bannerman says.
“For our pregnant patients, that may mean counseling women about the risk of infection if they are considering bringing in other family members to help during pregnancy or postpartum,” she says.
“The knowledge that SARS-CoV-2 infection rates are higher in disadvantaged neighborhoods and among people who live in crowded households,” Melamed adds, “could help public health officials target preventive measures, like distributing masks or culturally competent educational information to these populations.”

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More information
“Associations Between Built Environment, Neighborhood Socioeconomic Status, and SARS-CoV-2 Infection Among Pregnant Women in New York City,” was published online June 18 in the Journal of the American Medical Association.
Other authors: Ukachi N. Emeruwa, Samsiya Ona, Jeffrey L. Shaman, Amy Turitz, Jason D. Wright (from Columbia University Irving Medical Center and NewYork-Presbyterian).
This study was supported by the National Institutes of Health (grants KL2TR001874, 1U01GM110748, 2R01HL098554, 5UG1HD040485); National Science Foundation (DMS-2027369); Society for Maternal-Fetal Medicine; and the Morris-Singer Foundation.
J. Shaman and Columbia University reported partial ownership of SK Analytics. J. Shaman reported receiving personal fees from Business Networking International and Merck. C. Gyamfi-Bannerman reported receiving personal fees from Sera. J. Wright reported receiving grants from Merck and receiving personal fees from Clovis Oncology. No other disclosures were reported.
https://www.eurekalert.org/pub_releases/2020-06/cuim-chp061820.php

Mayo finds convalescent plasma safe for diverse patients with COVID-19

Mayo Clinic researchers and collaborators have found investigational convalescent plasma to be safe following transfusion in a diverse group of 20,000 patients. The findings — from the U.S. Food and Drug Administration’s Expanded Access Program for COVID-19 — are reported in Mayo Clinic Proceedings.
The safety report assessed the seven days following transfusion for hospitalized patients between April 3 and June 11 who were deemed at risk of progressing to a severe or life-threatening condition. Nearly 40% of the patients were women; 20% African Americans; nearly 35% Hispanic and 5% Asian. Seven-day mortality rates declined to 8.6 % compared to 12% in a previous safety study of the first 5,000 transfused patients. Serious adverse events continued to be less than one percent.
“Our efforts to understand convalescent plasma continue,” says Michael Joyner, M.D., principal investigator of the EAP at Mayo Clinic and lead author of the article. “We’re optimistic but must remain objective as we assess increasing amounts of data.”
This expanded safety report reveals a decline in mortality which appears contemporary with the more rapid availability of plasma for use, but the authors caution that this alone does not provide any evidence on effectiveness of convalescent plasma for treating COVID-19. Given the accelerating use of the therapy, research is now broadening its focus to determine indicators of efficacy. At this time, convalescent plasma therapy is the only antibody-based therapy for COVID-19.
“The 7000-plus physicians who are part of the program have done an exceptional job of offering convalescent plasma to a diverse group of patients, enrolling women as forty percent of the participants as well as significant numbers of patients who are of African American, Asian or Hispanic ethnicity,” says researcher DeLisa Fairweather, Ph.D. “We hope recruitment of minority subjects continues to increase given the disproportionate burden these communities have faced with COVID-19.”
The researchers say that while the mortality rate has decreased, the patients in the latter part of this study were less critically ill. They also say the decrease may be in part due to improved medical care based on increased knowledge during the pandemic and that more of the patients received the plasma earlier in their hospital treatment. They note that there was no system in place for delivering convalescent plasma in March and now there is sufficient donation to meet most of the demand. Also, as donors came forward more rapidly, it was more likely their plasma contained neutralizing antibodies.

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Physicians at any institution in the United States who are treating hospitalized patients with COVID-19 can register their patients’ information at uscovidplasma.org.
Patients who have recovered from COVID-19 and are seeking to donate plasma should contact the national resource sharing network for a nearby blood donation center location. Mayo Clinic, groups like Vitalant, America’s Blood Centers and many others within the larger commercial and non-commercial blood-banking community are working with physicians to collect and distribute donor plasma to hospitalized patients with severe or life-threatening COVID-19.
The study was supported by a contract with the U.S. Health and Human Services, Biomedical Advanced Research and Development Authority; multiple grants from the National Institutes of Health; Natural Sciences and Engineering Research Council of Canada; the Schwab Charitable Fund; United Health Group; the National Basketball Association; Millennium Pharmaceuticals; Octapharma USA, Inc.; and Mayo Clinic.
The convalescent plasma program at Mayo Clinic grew from a national initiative of physicians and investigators from 10 institutions that self-organized to investigate the use of convalescent plasma during the COVID-19 pandemic. These institutions include Mayo Clinic, Johns Hopkins University, Washington University, Einstein Medical Center, Icahn School of Medicine at Mount Sinai, Michigan State University, and many other academic medical centers and government agencies seeking to establish a national program to modify the course of the disease.
https://www.eurekalert.org/pub_releases/2020-06/mc-mfc061820.php