Germany leads pandemic recovery in Europe

JPMorgan says while the trade-off between virus-containment and near-term growth is present everywhere, the tension is diminished across much of Europe due to the success in reducing the outbreak and limiting its reemergence.

“In the Euro area, mobility indicators have been rising rapidly for nearly six weeks, and are now reflected in official activity data… Consumer spending is bouncing, with German retail sales jumping to well above the pre-COVID-19 level in May.”

The firm notes that other countries are lagging Germany because they reopened shops later in May, but it expects the Euro area to post a 16% M/M May retail sales gain next week and see other regions catch up to Germany later in the summer.

Absent concerns that the virus makes a comeback, the lingering risk called out by JP is that as wage subsidies fade, businesses will want to protect earnings and begin layoffs.

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https://seekingalpha.com/news/3588548-germany-leads-pandemic-recovery-in-europe

New Virus-Fighting Technologies That Could Soon Become Standard In Public

As the push for some to head back to the office continues, despite being the midst of the ongoing pandemic, a focus has shifted to what kinds of technologies are going to be used in order to make sure that public areas, like office environments and airports, are virus-free.

Aside from the usual hand sanitizers and face masks, FT published a report this week highlighting some of the other technologies that businesses are choosing to employ in order to surfaces and spaces clean.

Shaun Fitzgerald, visiting professor at the University of Cambridge, said: “Pandemics like this can provide fertile ground for creative minds to think about how to do things differently.”

One option that’s being looked at is self-cleaning surfaces. While the virus can stay alive for up to 72 hours on plastics and steel, silver and copper have a track record of killing viruses and bacteria within four hours. Felicity de Cogan, research fellow at the University of Birmingham and founder of NitroPep, said that timeframe needs to get down to “seconds to minutes” and it needs to be “built into the material”.

Her company is working on developing layers of materials with spike particles on them that puncture and kill viruses within minutes. Her company’s antimicrobial agents can be added to already existing desks, walls and other surfaces and rupture “anything with a membrane”.

“It doesn’t require a change in behaviour, it just sits there and kills whatever lands on it,” de Cogan said. In a pilot run of the technology for a Royal Navy ship, it killed more than 95% of bacteria like E. Coli and MRSA. de Cogan aims to implement it in public transport and for self-cleaning equipment, if it proven to be able to kill coronavirus.

Another option is UV irradiation. The idea of “germicidal ultraviolet” has been known for years but is now getting another look. UV beams are used to kill micro-organisms by targeting the RNA in viruses and DNA in bacteria and fungi. UV lamps have been found in the past to be effective in stopping drug-resistant tuberculosis in large rooms.

The technology is good for large rooms and crowded and poorly ventilated environments. Covid has accelerated demand for UV charging robots that emit UV light that leaves bacteria and viruses too damaged to function. They robots cost about 60,000 Euro each and can be found in places like hospitals and hotels.

A third technology being used is environmental monitors that “check the pulse” of a building that already exists to assess things like CO2 levels. In Switzerland, researchers are trying to develop sensors that detect the virus itself. The Swiss Federal Institute of Technology (ETH Zurich) and Swiss Federal Laboratories for Materials Science and Technology (Empa) have together developed a sensor inside of a chamber that emits light if it finds the viruses RNA. Real-world testing is set to start soon.

Finally, ventilation is in focus. HVAC systems play a huge role in the accumulation of aerosol droplets and improving the amount of fresh air a person gets per second can help slow the viruses movement. This can be especially true in confined spaces like elevators and airplanes.

Gardner Allen, assistant professor at the Harvard TH Chan School of Public Health said: “You always want the air to move from clean to dirty and then out. In the bathroom, you want it to move from indoor, to bathroom and then out through the exhaust.”

One thing is for certain: the world is changing and evolving to try and deal with the pandemic threat in ways that 6 months ago, we would have never thought possible. Surely this will lead to a whole host of new Silicon Valley startups that will focus not only on combating the virus, but also likely on burning cash at ungodly WeWork-style levels.

Keep your eyes out for those “exciting” IPO opportunities to probably start hitting the market around late 2021. 

https://www.zerohedge.com/technology/meet-four-new-virus-fighting-technologies-could-soon-become-standard-public-areas

Preclinical oncology biotech Nkarta sets terms for $150 million IPO

Nkarta, a preclinical developer of off-the-shelf cancer therapies based on natural killer cells, announced terms for its IPO on Thursday.

The South San Francisco, CA-based company plans to raise $150 million by offering 10 million shares at a price range of $14 to $16. At the midpoint of the proposed range, Nkarta would command a fully diluted market value of $426 million.

Nkarta was founded in 2015 and plans to list on the Nasdaq under the symbol NKTX. Cowen, Evercore ISI, Stifel, and Mizuho Securities are the joint bookrunners on the deal.

Relevant Profile: NKTX

https://www.renaissancecapital.com/IPO-Center/News/69262/Preclinical-oncology-biotech-Nkarta-sets-terms-for-$150-million-IPO

CytoDyn in Deal for Distribution, Supply of Covid-19 Treatment in U.S.

This Agreement will allow for immediate distribution of leronlimab to patients for the treatment of COVID-19 upon successful completion of CytoDyn’s ongoing clinical trials and FDA approval

CytoDyn Inc. (OTC.QB: CYDY), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today it has signed an exclusive Distribution and Supply Agreement with American Regent, Inc. (“American Regent”) for the  distribution of leronlimab for the treatment of COVID-19 in the United States.

Under the terms of the agreement, CytoDyn will supply leronlimab for the treatment of COVID-19 for distribution by American Regent and receive quarterly payments based on a profit-sharing arrangement.

“Having this distribution agreement in place ahead of the readout from CytoDyn’s COVID-19 clinical trials further emphasizes CytoDyn’s commitment to making leronlimab immediately available to patients based on the successful completion of its ongoing clinical trials,” said Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn.  “We are particularly happy to be partnering with a company with the proven expertise, unparalleled commercial reach and stellar reputation of American Regent.”

“American Regent is looking forward to partnering with CytoDyn to provide COVID-19 patients rapid and efficient access to a potentially life-saving drug,” said Mr. Harsher Singh, American Regent’s Vice President and Chief Commercial Officer.

CytoDyn is currently enrolling a Phase 2b/3 clinical trial for 390 severe and critically ill COVID-19 patients, which is a randomized, placebo-controlled with 2:1 ratio (active drug to placebo ratio). The Company has also completed its enrollment of a Phase 2 randomized clinical trial with 75 patients in the mild-to-moderate COVID-19 population.  CytoDyn has been granted more than sixty emergency Investigational New Drug (eIND) authorizations by the U.S. Food and Drug Administration (FDA) and plans to provide clinical updates for this patient population in the coming weeks.

American Regent, Inc., a Daiichi Sankyo Group company, is a top-10 injectable manufacturer.

https://www.marketscreener.com/CYTODYN-INC-163210/news/CytoDyn-Announces-Execution-of-Exclusive-Agreement-with-American-Regent-for-Distribution-and-Suppl-30868323/

Gilead Data Supports Potential 6-Month Dosing for Investigational HIV-1 Therapy

Gilead Sciences, Inc. (Nasdaq: GILD) today announced data from an ongoing Phase 1 study, which showed that a sustained-delivery subcutaneous formulation of the company’s investigational, novel inhibitor of HIV-1 capsid function, lenacapavir (GS-6207), sustained predicted therapeutic concentrations for at least six months following a single 900 mg dose. In the study, lenacapavir was generally well-tolerated, and no serious adverse events were reported. These data were presented at the 23rd International AIDS Conference (AIDS 2020: Virtual).

“Long-acting antiretroviral therapy may help address challenges with treatment adherence and treatment fatigue, providing additional options to people living with HIV,” said Eric S. Daar, MD, Chief of the Division of HIV Medicine at the Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center and Professor of Medicine at the David Geffen School of Medicine at UCLA. “The promising safety and pharmacokinetic profiles of lenacapavir support continued evaluation of an every six-month dosing interval and further demonstrate the potential for a single subcutaneous injection of lenacapavir to be part of a long-acting HIV treatment regimen.”

Lenacapavir is an investigational agent that is being developed as a component of a long-acting regimen in combination with other antiretroviral agents. Lenacapavir disrupts HIV capsid, a multimeric shell that is essential to viral replication, at multiple stages throughout the viral life cycle. In May 2019, the FDA granted Breakthrough Therapy Designation for the development of lenacapavir for the treatment of HIV-1 infection in heavily treatment-experienced patients with multi-drug resistance in combination with other antiretroviral drugs.

“There is a compelling unmet need for interventions that can potentially improve treatment adherence to chronic HIV therapy, including the development of long-acting formulations, which can be administered less frequently,” said Diana Brainard, MD, Senior Vice President and Virology Therapeutic Area Head, Gilead Sciences. “We hope to make HIV a more manageable part of people’s lives through continued treatment innovations, including the exploration of dosing intervals that coincide with regularly scheduled visits with healthcare providers.”

The safety, efficacy and dosing of lenacapavir are being evaluated in multiple ongoing clinical studies, and have not yet been established. Initial data from Phase 1 studies that assessed the antiviral activity of lenacapavir were presented at the 17th European AIDS Conference (EACS) in Basel, Switzerland in 2019 and presented at the Conference on Retroviruses and Opportunistic Infections (CROI) 2020 in Boston, Mass.

Data presented on lenacapavir at AIDS 2020: Virtual:

Virtual Poster PEB0265: GS-6207 Sustained Delivery Formulation Supports 6-Month Dosing Interval

In this ongoing, randomized, blinded, placebo-controlled, single-ascending dose (SAD) Phase 1 study, 30 participants were randomized (4:1) to receive 300 mg/mL of subcutaneous lenacapavir (n=eight per cohort) or placebo (n=two per cohort), at 300 mg (1 x 1.0 mL) or 900 mg (3 x 1.0 mL or 2 x 1.5 mL). All study participants completed dosing, and pharmacokinetic and safety data were collected through approximately 64 weeks post-dose.

A slow initial release of lenacapavir was observed, and therapeutic plasma concentrations were sustained for at least six months following a single 900 mg dose, administered as 3 x 1.0 mL injections. Similar results were observed following a 900 mg dose administered as 2 x 1.5 mL injections. Lenacapavir exposures increased in a generally dose-proportional manner from 300 mg to 900 mg, with maximum concentrations achieved 11 to 14 weeks post-dose and an apparent half-life of roughly 15 weeks.

Lenacapavir was generally well-tolerated; no serious or grade 3 or 4 adverse events (AEs) related to study drug or leading to study discontinuation occurred. The most common AEs were injection site induration (87 percent), pain (63 percent) and erythema (70 percent), all of which were mild. There were no clinically relevant laboratory abnormalities of grade 3 or higher.

https://www.marketscreener.com/GILEAD-SCIENCES-INC-4876/news/Gilead-Sciences-Presents-Data-Supporting-a-Potential-Six-Month-Dosing-Interval-for-Investigational-30878888/

Live in a COVID-19 hotspot? Harvard created a simple map that will tell you

How likely are you to contract COVID-19? That’s a complicated question with a lot of variables. Trying to get insight into your personal risk involves parsing state and county data on rates of infection, hospitalizations, and deaths.

But now there’s a tool that can help you cut through all the noise. Researchers at the Harvard Global Health Institute, in collaboration with a team of scientists, have launched a new interactive map and dashboard that allows you to quickly identify your risk level by state and county. It uses a four-color system, where green represents the lowest level of risk and red represents the highest.

The dashboard is the work of more than a dozen researchers from eight organizations, including Harvard’s Edmond J. Sacra Center for Ethics, CovidActNow, and the Rockefeller Foundation. Tsai says it was important to have a breadth of experiences represented, but also to have a clear, unified approach. “Science by definition is messy,” Tsai says. “There can be a diversity of opinion even among scientists. But what we could agree on is that we need a common language to help guide policymakers.”

Explore the interactive map here. [Screenshot: globalepidemics.org]

While other organizations have developed maps and dashboards to help understand the spread of the virus, what’s notable about this one is that it uses a single metric, which is the number of daily new cases per 100,000 people. This standardizes the numbers and makes it easier to understand the specific risk level in your area. Tsai and his colleagues believe this is more helpful than hearing about the absolute number of new cases in a state or a county. “A thousand new cases in New York is very different from a thousand new cases in Idaho,” says Tsai. “We wanted to create a common metric across the population.” 

The researchers have also chosen to represent this information using a visual language—colors—that people will instinctively understand. “There are amber alerts for all kinds of risks, from terrorism to air pollution,” Tsai says. “For COVID, what was lacking was a clear communication around the prevalence of the disease in a particular area.” My colleague Mark Wilson recently pointed out that using colors, rather than text and figures, allows people to process information more easily and can make it easier to remember the information as well.

At the beginning of the pandemic, when the virus first made its way to the United States, it made sense to think about COVID-19 at a national level. But as time has passed, different states have had very different responses and have consequently seen different levels of outbreak. “There’s been a lack of a concerted federal effort against the disease,” Tsai says. “As a result, we’ve seen a patchwork response play out.”

It is now important to assess risk based on your state and county, then respond accordingly. It’s equally important to note how the virus is spreading in adjacent counties. Tsai warns that people living in green or yellow zones shouldn’t feel complacent, because the disease can quickly spread across state and county lines. “If you live in a green area, it doesn’t mean you shouldn’t wear a mask or go back to large gatherings,” he says. “The virus doesn’t respect any boundaries. ”

https://www.fastcompany.com/90523542/do-you-live-in-a-covid-19-hotspot-harvard-created-a-simple-map-that-will-tell-you

Goldfinch Raises $100M for Kidney Drug Studies Now, Perhaps an IPO Later

Goldfinch Bio, a biotech company employing genetic analysis to develop new medicines for kidney diseases, has raised $100 million to bring its lead drug candidate into mid-stage clinical trials.

The Series B round of financing was led by Eventide Asset Management.

Cambridge, MA-based Goldfinch is taking a big data approach to kidney disease drug discovery and development. The heart of its research is a database of anonymized patient data, called the Kidney Genome Atlas. This database has genomic, proteomic and transcriptomic data that the biotech uses to identify genetic targets that are relevant to kidney disease. As drug candidates progress to clinical testing, Goldfinch says its technology can also help it select the patients most likely to respond to a particular therapy.

Goldfinch plans to apply its new cash toward the clinical testing of its two lead drug candidates. The most advanced compound, GFB-887, is a potential treatment for focal segmental glomerulosclerosis (FSGS), a rare kidney disorder in which scar tissue forms on renal glomeruli, the parts of the organ that filter waste from the blood. The disease can lead to permanent kidney damage or even kidney failure. The company is also testing the compound as a treatment for diabetic nephropathy.

The Goldfinch drug is designed to block transient receptor potential canonical channel 5, an ion channel whose overactivation is associated with the development of FSGS and diabetic nephropathy. Goldfinch says its drug is intended to stop these diseases from progressing to kidney failure. A Phase 2 study of GFB-887 in FSGS and diabetic nephropathy is expected to start in the middle of this year.

A second Goldfinch compound, GFB-024, is designed to block cannabinoid receptor 1, a receptor found in research to be associated with diabetic nephropathy. That compound is being readied for a clinical trial expected to begin next year.

In addition to its in-house programs, Goldfinch has a research partnership with Gilead Sciences (NASDAQ: GILD). Last year, the Foster City, CA-based company paid $50 million in cash and made a $5 million equity investment to kick off the alliance, which aims to discover and develop drugs for diabetic kidney disease and rare kidney disorders. Depending on the progress of the research, Goldfinch could earn up to $1.95 billion in milestone payments.

Goldfinch’s latest round of funding added new investors Wellington Management Company, Ally Bridge Group, and funds and accounts managed by investment management firm BlackRock (NYSE: BLK), Casdin Capital, and Irving Investors. The new Goldfinch investors invest in both private and public companies. Such “crossover” investments are seen as a signal that a company is preparing for an IPO.

The Series B round also included earlier investors Gilead Sciences, Yonjin Capital, and Schroder Adveq. In connection with the financing, Eventide’s Jay Ghosh is joining Goldfinch’s board of directors.

Here’s more on the origins of Goldfinch, which spun out of venture capital firm Third Rock Ventures.

https://xconomy.com/boston/2020/06/30/goldfinch-raises-100m-for-kidney-drug-studies-now-perhaps-an-ipo-later/