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Sunday, August 2, 2020

Cancer docs: Don’t discontinue, delay treatment impacting on overall survival

An ESMO interdisciplinary expert consensus paper on how to manage cancer patients during the COVID-19 pandemic has been published today in Annals of Oncology, encouraging medical oncologists worldwide not to discontinue or delay any type of anti-cancer treatment that may potentially impact on overall survival. The experts also urge to stop labelling all cancer patients as vulnerable to coronavirus infection since this may lead to inappropriate care and potential negative outcomes.
Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirus in humans (SARS-CoV-2) for which there is no proven therapy yet. Since its outbreak in December 2019, over 16 million cases have been reported worldwide, including more than 600,000 deaths.
The COVID-19 emergency is still challenging oncology experts to continue delivering quality cancer care while protecting patients from the risk of being exposed to the coronavirus. Earlier this year, ESMO developed adapted guidelines for prioritising the various aspects of cancer care across different tumour types, with the aim to mitigate the negative effects of the pandemic on the management of .
An was established by ESMO to discuss current clinical evidence from cohort studies and to provide expert advice on significant clinical open questions, from diagnosis to surgery related to cancer management in the COVID-19 era. The interdisciplinary expert panel, consisting of 64 experts and one voting patient advocate, agreed on 28 statements.
“The general advice is that whenever an anti-cancer treatment can impact overall survival of the patient it should not be discontinued or delayed,” explains first author of the consensus paper Prof. Giuseppe Curigliano, European Institute of Oncology (IEO), Milan, Italy, commenting on the recommendations about safety and risks of delivering cancer care in the pandemic era. The recommendation relies on the lack of convincing evidence that using immune checkpoint inhibitors, non-cytotoxic targeted therapies and some types of adjuvant or neoadjuvant systemic therapies is detrimental or, in principle, associated to a higher risk of complications or mortality. “Of course, case-by-case discussions run by multidisciplinary teams remain pivotal to balance the risk of being infected against tumour control, as stated in our previous work,” says Curigliano.
In the consensus paper, the interdisciplinary expert panel also warns against labelling all cancer patients as vulnerable to COVID-19 irrespectively of age, gender, tumour (sub)-type and stage. In fact, despite the fact that during the early days of the pandemic (5-7) cancer patients were reported to be at increased risk of contracting the and developing a more severe disease, evidences collected up to today suggest that many patients with solid tumours are not more vulnerable to COVID-19 severe outcomes than the . (8,9)
“Although it was reasonable to adopt over-protective measures for our patients at the outbreak of a novel infective disease which was not previously observed in humans, we now need to step away from the assumption that all cancer patients are vulnerable to COVID-19,” continues Curigliano. “The implications have been important, because for some patients treatment was delayed or interrupted over the last few months, and I believe that we will see the impact of this over-precautionary approach in the next future.”
Responding to the critical question about who are cancer patients really at high risk related to the COVID-19 virus and its consequences, Curigliano concludes: “Based on current evidence, only patients who are elderly, with multiple comorbidities and receiving chemotherapy are vulnerable to the infection. In this population, before starting any treatment, we recommend to test patients for COVID-19 with a real-time RT-PCR (reverse transcription polymerase chain reaction), the current gold standard for diagnosis, in order to exclude that the patient is infected by the coronavirus.”
The set of statements published in the ESMO’s flagship journal has been designed to serve as a dynamic knowledge repository that will be better informed by accumulating further data on the SARS CoV-2 biology, the pandemic characteristics, the risk of cancer patients for COVID-19 and its modulating factors and, finally, on optimal care in the presence of the virus.


Biotech week ahead, Aug. 3

Biotech stocks came under pressure in the week ended July 31 amid mixed earnings from the sector and some adverse clinical readouts.
COVID-19 news flow continued to pour in, with big pharma tie-ups flaunting positive tidings. In the biggest ever coronavirus funding deal, the Sanofi SA SNY 0.1% GlaxoSmithKline plc GSK 0.17% won a joint $2.1 billion U.S. federal funding award.
Here’re the key catalysts for the unfolding week:
Conferences
72nd National Hemophilia Foundation’s Annual Bleeding Disorders Meeting 2020 (virtual meeting): Aug. 1-8
PDUFA Dates
FDA is scheduled to rule on DBV TECHNOLOGIE/S’ ADR DBVT 6.75% Viaskin peanut allergy patch Wednesday. However, cancellation of the Adcom meeting scheduled May 15 has poured cold water on the prospects of an approval coming through.
Trevena Inc TRVN 4.04% has a tryst with the FDA Friday, with respect to the NDA for its pain drug oleceridine, which was once rejected by the agency on the premise of inadequacy of clinical data.
FDA is also due to rule on Eagle Pharmaceuticals Inc’s EGRX 2.81% exertional heat stroke drug ryanodex Saturday. The original PDUFA date was pushed back a month as the FDA finds it hard to keep up with scheduling commitments due to COVID-19.
Clinical Readouts
BioSig Technologies Inc’s BSGM 0.33% CEO Kenneth Londoner, will present at the Proactive Investors One2One Virtual Event Tuesday an update on Phase 2 clinical study of merimepodib in combination with remdesivir in adult patients with advanced COVID-19.
Novavax, Inc. NVAX 2.4% is scheduled to announce in the first week of August preliminary Phase 1 data for NVX-CoV2373, its investigational vaccine against SARS-CoV-2.
Earnings
Monday
Ligand Pharmaceuticals Inc. LGND 7.53% (before the market open)
Minerva Neurosciences Inc NERV 3.73% (before the market open)
Pacific Biosciences of California Inc PACB 1.06% (after the close)
SI-Bone Inc SIBN 0.29% (after the close)
Neurocrine Biosciences, Inc. NBIX 1.12% (after the close)
DURECT Corporation DRRX 1.03% (after the close)
Penumbra Inc PEN 1.25% (after the close)
Revance Therapeutics Inc RVNC 2.73% (after the close)
Tuesday
Haemonetics Corporation HAE 0.51% (before the market open)
Incyte Corporation INCY 1.74% (before the market open)
Karyopharm Therapeutics Inc KPTI 2.96% (before the market open)
Intersect ENT Inc XENT 2.61% (before the market open)
Oxford Immunotec Global PLC OXFD 3.18% (before the market open)
Epizyme Inc EPZM 1.21% (before the market open)
Neuronetics Inc STIM 1.52% (before the market open)
Mallinckrodt PLC MNK 5.27% (before the market open)
Evofem Biosciences Inc EVFM 1.64% (before the market open)
Zimmer Biomet Holdings Inc ZBH 2.49% (before the market open)
Strongbridge Biopharma plc SBBP 4.26% (before the market open)
BIO-TECHNE Corp TECH 0.62% (before the market open)
Avanos Medical Inc AVNS 3.86% (before the market open)
Amarin Corporation plc AMRN 1.67% (before the market open)
Aquestive Therapeutics Inc AQST 1.5% (after the close)
Akcea Therapeutics Inc AKCA 6.47% (after the close)
Acorda Therapeutics Inc ACOR 0.96% (after the close) (after the close)
BioMarin Pharmaceutical Inc. BMRN 1.57% (after the close)
Corcept Therapeutics Incorporated CORT 7.03% (after the close)
Xencor Inc XNCR 4.9% (after the close)
Vapotherm Inc VAPO 1.86% (after the close)
Rigel Pharmaceuticals, Inc. RIGL 4.96% (after the close)
NuVasive, Inc. NUVA 3.8% (after the close)
Qiagen NV QGEN 1.83% (after the close)
Jazz Pharmaceuticals PLC JAZZ 4.85% (after the close)
Fulgent Genetics Inc FLGT 0.88% (after the close)
Enanta Pharmaceuticals Inc ENTA 2.43% (after the close)
Otonomy Inc OTIC 3.57% (after the close)
Inspire Medical Systems Inc INSP 0.46% (after the close)
Myokardia Inc MYOK 4.85% (after the close)
Curis, Inc. CRIS 4.88% (after the close)
CareDx Inc CDNA 0.21% (after the close)
Cardiovascular Systems Inc CSII 1.9% (after the close)
Cytosorbents Corp CTSO 1.49% (after the close)
GenMark Diagnostics, Inc GNMK 0.33% (after the close)
Deciphera Pharmaceuticals Inc DCPH 0.9% (after the close)
Cerus Corporation CERS 0.83% (after the close)
Inspire Medical Systems Inc INSP 0.46% (after the close)
See also: Attention Biotech Investors: Mark Your Calendar For August PDUFA Dates
Wednesday
Constellation Pharmaceuticals Inc CNST 0.64% (before the market open)
Vericel Corp VCEL 1.38% (before the market open)
Oyster Point Pharma Inc OYST 4.48% (before the market open)
Eyepoint Pharmaceuticals Inc EYPT 2.74% (before the market open)
PPD Inc PPD 0.55% (before the market open)
Horizon Therapeutics PLC HZNP 1.35% (before the market open)
Moderna Inc MRNA 4.55% (before the market open)
Ionis Pharmaceuticals Inc IONS 2.47% (before the market open)
Regeneron Pharmaceuticals Inc REGN 0.1% (before the market open)
Harvard Bioscience, Inc. HBIO 2.2% (before the market open)
IVERIC bio Inc ISEE 5.42% (before the market open)
Brainstorm Cell Therapeutics Inc BCLI 4.78% (before the market open)
BioDelivery Sciences International, Inc. BDSI 0.48% (before the market open)
Allogene Therapeutics Inc (NASDAQ: ALLO (before the market open)
Arena Pharmaceuticals, Inc. (NASDAQ: ARNA (after the close)
ADMA Biologics Inc ADMA 4.55% (after the close)
ACADIA Pharmaceuticals Inc. ACAD 2.17% (after the close)
AxoGen, Inc Common Stock AXGN 0.26% (after the close)
Arrowhead Pharmaceuticals Inc ARWR 5.24% (after the close)
Global Blood Therapeutics Inc GBT 2.91% (after the close)
Transenterix Inc TRXC 4.18% (after the close)
Kindred Biosciences Inc KIN 2.08% (after the close)
ResMed Inc. RMD 0.87% (after the close)
Silk Road Medical Inc SILK 2% (after the close)
Tricida Inc TCDA 0.83% (after the close)
SurModics, Inc. SRDX 2.94% (after the close)
Immunomedics, Inc. IMMU 2.56% (after the close)
PTC Therapeutics, Inc. PTCT 1.95% (after the close)
Sangamo Therapeutics Inc SGMO 4.5% (after the close)
TRACON Pharmaceuticals Inc TCON 6.25% (after the close)
Lyra Therapeutics Inc LYRA 1.4% (after the close)
Miragen Therapeutics Inc MGEN 1.83% (after the close)
Zogenix, Inc. ZGNX 2.3% (after the close)
Sarepta Therapeutics Inc SRPT 0.37% (after the close)
Natera Inc NTRA 0.99% (after the close)
OraSure Technologies, Inc. OSUR 3.1% (after the close)
Orthopediatrics Corp KIDS 1.43% (after the close)
G1 Therapeutics Inc GTHX 7.27% (after the close)
Globus Medical Inc GMED 3.53% (after the close)
TransMedics Group Inc TMDX 1.15% (after the close)
Nevro Corp NVRO 0.55% (after the close)
Collegium Pharmaceutical Inc COLL 2.77% (after the close)
Endo International PLC ENDP 1.75% (after the close)
Thursday
Polarityte Inc PTE 1.94% (before the market open)
Mylan NV MYL 1.35% (before the market open)
Menlo Therapeutics Inc MNLO 1.83% (before the market open)
Mediwound Ltd MDWD 0.25% (before the market open)
Synlogic Inc SYBX 1.31% (before the market open)
Zoetis Inc ZTS 1.85% (before the market open)
TherapeuticsMD Inc TXMD 5.13% (before the market open)
Ironwood Pharmaceuticals, Inc. IRWD 2.65% (before the market open)
Syneos Health Inc SYNH 0.46% (before the market open)
Orthofix Medical Inc OFIX 1.7% (before the market open)
Eloxx Pharmaceuticals Inc ELOX 1.76% (before the market open)
Dicerna Pharmaceuticals Inc DRNA 3.89% (before the market open)
Alnylam Pharmaceuticals, Inc. ALNY 3.54% (before the market open)
Athenex Inc ATNX 2.66% (before the market open)
Amneal Pharmaceuticals Inc AMRX 0.57% (before the market open)
Bristol-Myers Squibb Co BMY 0.37% (before the market open)
Agenus Inc AGEN 3.18% (before the market open)
ABIOMED, Inc. ABMD 0.34% (before the market open)
BioCryst Pharmaceuticals, Inc. BCRX 3.55% (before the market open)
AMAG Pharmaceuticals, Inc. AMAG 3.19% (before the market open)
Galmed Pharmaceuticals Ltd GLMD 0.41% (before the market open)
PDL BioPharma Inc PDLI 0.63% (after the close)
Syndax Pharmaceuticals Inc SNDX 2.01% (after the close)Regenxbio Inc
Dynavax Technologies Corporation DVAX 3.34% (after the close)
Accelerate Diagnostics Inc AXDX 3% (after the close)
Adamas Pharmaceuticals Inc ADMS 3.13% (after the close)
Achieve Life Sciences Inc ACHV 2171.67% (after the close)
Acceleron Pharma Inc XLRN 1.63% (after the close)
Coherus Biosciences Inc CHRS 3.09% (after the close)
Puma Biotechnology Inc PBYI 1.81% (after the close)
Axonics Modulation Technologies Inc AXNX 0.02% (after the close)
Theravance Biopharma Inc TBPH 3.81% (after the close)
Iovance Biotherapeutics Inc IOVA 0.76% (after the close)
Glaukos Corp GKOS 0.18% (after the close)
CytomX Therapeutics Inc CTMX 5.78% (after the close)
Cytokinetics, Inc. CYTK 4.63% (after the close)
Insulet Corporation PODD 0.96% (after the close)
Chembio Diagnostics Inc CEMI 3.17% (after the close)
Exelixis, Inc. EXEL 2.9% (after the close)
Editas Medicine Inc EDIT 4.15% (after the close)
FibroGen, Inc. FGEN 2.18% (after the close)
Guardant Health Inc GH 0.99% (after the close)
GW Pharmaceuticals PLC- ADR GWPH 1.6% (after the close)
PRA Health Sciences Inc PRAH 0.18% (after the close)
Illumina, Inc. ILMN 0.16% (after the close)
Insmed Incorporated INSM 3.4% (after the close)
Pfenex Inc PFNX 3.02% (after the close)
ZIOPHARM Oncology Inc. ZIOP 3.26% (after the close)
Spero Therapeutics Inc SPRO 4.1% (after the close)
NovaBay Pharmaceuticals, Inc. NBY 6.81% (after the close)
Opiant Pharmaceuticals Inc OPNT 0.43% (after the close)
Nektar Therapeutics NKTR 4.77% (after the close)
Friday
Arbutus Biopharma Corp ABUS 11.4% (before the market open)
Meridian Bioscience, Inc. VIVO 1.84% (before the market open)
Ocular Therapeutix Inc OCUL 3.33% (before the market open)
IPO Quiet Period Expiry
Poseida Therapeutics, Inc. PSTX 2.63%
Nkarta Inc NKTX 5.4%
https://www.benzinga.com/general/biotech/20/08/16888527/the-week-ahead-in-biotech-novavax-coronavirus-vaccine-readout-fda-decisions-and-more-earnings

China sends team to Hong Kong for widespread coronavirus testing

The initiative marks the first time mainland health officials have assisted Hong Kong in its battle to control the epidemic.
The city has reported around 3,500 coronavirus cases and 34 deaths since January, far lower than many other global metropolitan centres. But the daily number of new infections has been in three digits for the past 12 days.
Members of the testing team, co-ordinated by the Chinese government, are mostly from public hospitals in Guangdong province, China’s National Health Commission said.
A group of local Hong Kong councillors said on Sunday that some local residents fear China may use their presence as an opportunity to collect DNA samples for surveillance purposes.
The territory’s government denied the claims, saying virus testing would only be conducted in the city and samples would not be transported to the mainland.
In June, to widespread criticism in the West, Beijing imposed a security law on the territory to tackle what China defines as secession, subversion and collusion with foreign forces, punishable by up to life in prison.
Hong Kong’s autonomy was guaranteed under a “one country, two systems” formula when Britain returned the city to Chinese control in 1997.
Hong Kong government leader Carrie Lam said on Saturday it had asked for help from Beijing due to the resurgence in cases. She said the government was studying whether everyone in Hong Kong could be tested, local broadcaster RTHK reported.
Following a surge in locally transmitted coronavirus cases in July, the territory introduced curbs including restricting gatherings to two people and mandating face masks in all outdoor public spaces.

U.S. Congress in position to spend big on coronavirus relief – Fed official

The U.S. Congress is in position to spend big on coronavirus relief efforts because the nation’s budget gap can be financed without relying on foreign borrowing, given how much Americans are saving, a top Federal Reserve official said on Sunday.
“Those of us who are fortunate enough to still have our jobs, we’re saving a lot more money because we’re not going to restaurants or movie theaters or vacations,” Neel Kashkari, president of the Minneapolis Federal Reserve Bank, told CBS’ “Face the Nation.”
“That actually means that we have a lot more resources as a country to support those who have been laid off,” he said.
The Democratic-led U.S. House of Representatives approved a $3 trillion relief bill in May, while Senate Republicans, many of whom have expressed concerns about mounting debt, countered by proposing a $1 trillion aid package last week.
“Those of us who are fortunate enough to still have our jobs, we’re saving a lot more money because we’re not going to restaurants or movie theaters or vacations,” Neel Kashkari, president of the Minneapolis Federal Reserve Bank, told CBS’ “Face the Nation.”
“That actually means that we have a lot more resources as a country to support those who have been laid off,” he said.
The Democratic-led U.S. House of Representatives approved a $3 trillion relief bill in May, while Senate Republicans, many of whom have expressed concerns about mounting debt, countered by proposing a $1 trillion aid package last week.
“I’m not worried about it,” he said. “Congress should use this opportunity to support the American people and the American economy.”
“If we get the economy growing, we will be able to pay off the debt.”

Pelosi says she has no confidence in White House coronavirus adviser Birx

U.S. House Speaker Nancy Pelosi said on Sunday she does not have confidence in White House coronavirus task force coordinator Dr. Deborah Birx, linking her to disinformation about the virus spread by President Donald Trump.
“I think the president has been spreading disinformation about the virus and she is his appointee so, I don’t have confidence there, no,” Speaker Pelosi told ABC’s “This Week” when asked if she has confidence in Birx.
Birx, asked about Pelosi’s comment during an interview with CNN’s “State of the Union,” said she had great respect for Pelosi and attributed the criticism to a New York Times article on the White House pandemic response that described Birx as having embraced overly optimistic assessments on the virus.
“This was not a pollyannish view. I’ve never been called pollyannish, or non-scientific, or non-data driven,” Birx said. “I will stake my 40-year career on those fundamental principles of using data to implement better programs and save lives.”
Pelosi did not elaborate about Birx, a lead member of the coronavirus task force along with Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.
According to a report in Politico, Pelosi attacked Birx’s credibility during a meeting last week with Treasury Secretary Steve Mnuchin and White House Chief of Staff Mark Meadows. She accused Birx of spreading disinformation about the coronavirus pandemic, while praising Fauci as “a hero,” Politico said.
“Deborah Birx is the worst. Wow, what horrible hands you’re in,” Pelosi told them, according to Politico.

Manufacturers to phase out sales of food packaging containing ‘forever’ chemical

Three food manufacturers whose packaging contains a type of PFAS chemical will phase it out from their packaging over the next few years, the Food and Drug Administration (FDA) announced Friday.
PFAS is a class of cancer-linked chemicals found in a variety of products. They are sometimes called “forever” chemicals because of their persistence in nature and the human body.
The voluntary phaseout of the chemical called 6:2 FTOH will start next year and last for three years; however, the manufacturers will take up to an additional 18 months to sell the remaining products whose packaging contains the chemicals, meaning it could remain on store shelves until sometime in 2025.
Three of the four manufacturers — Archroma, AGC Chemicals Americas and Daikin America — that hold authorizations for the use of 6:2 FTOH will participate in the phaseout.
The fourth manufacturer, Chemours, told the FDA in 2019 they stopped selling packaging containing the substance.
The FDA said it will monitor the progress of the phaseout through annual updates done by the manufacturers. The companies will also give the agency samples of the packaging “in case future analysis is needed.”
Some states have already banned the use of food packaging made with PFAS chemicals, citing research that shows they can transfer to food items.
The agency said the move follows an analysis of rodent studies finding “biopersistence” of the specific PFAS including 6:2 FTOH.
“While the findings were in rodents, the data point to the potential that 6:2 FTOH may also persist in humans following dietary exposure,” the FDA said in a statement. “Further scientific studies are needed to better understand the potential human health risks from dietary exposure resulting from authorized food contact substances for short-chain PFAS that contain 6:2 FTOH.”
Last year, a different FDA study that was leaked to The Hill and other news outlets showed that PFAS had been found in milk, meat, produce and store-made chocolate cakes.
Researchers found PFAS in 14 of the 91 samples tested, but the samples of meat and chocolate cake had particularly high levels.
That study focused on how food might be impacted after nearby water and soil is contaminated with PFAS.
Following news reports on the study last year, the FDA released a statement saying it did “not have any indication that these substances are a human health concern … at the levels found in this limited sampling.”
However, critics said at the time that the agency was underestimating the risks posed by the chemicals.

Birx says COVID-19 outbreak not under control because ‘people are on the move’

Deborah Birx said Sunday that the COVID-19 outbreak is not under control in the U.S. because Americans “are on the move.”
When asked about why the U.S. has not been able to stop the coronavirus spread, Birx said on CNN’s ‘State of the Union” that she’s learned through studying epidemics that health officials need a “tailored” message “on the ground.”
The White House coronavirus task force coordinator said she’s seen through recent travel to 14 states that Americans “are on the move.”
“Across America right now, people are on the move,” she said. “And so all of our discussions about social distancing and decreasing gatherings to under 10 — as I traveled around the country, I saw all of America moving.”
The public health official also said people who vacationed in “hot spots” should assume they are infected.
Birx added that the U.S. is in a “new phase” of the pandemic and called on all Americans to wear masks and to practice social distancing and proper personal hygiene.
“What we’re seeing today is different from March and April,” she said. “It is extraordinarily widespread. It’s into the rural as equal urban areas. And to everybody who lives in a rural area, you are not immune or protected from this virus.”