Preclinical protein degrader biotech Kymera Therapeutics files for $100M IPO

Kymera Therapeutics, a preclinical biotech developing small molecule protein degrader therapies for immunology-inflammation and oncology, filed on Friday with the SEC to raise up to $100 million in an initial public offering.

The company uses its proprietary targeted protein degradation platform, Pegasus, to discover highly selective small molecule protein degraders with potent activity against disease-causing proteins throughout the body. Kymera expects to file an IND for KT-474, an orally bioavailable IRAK4 degrader, in the 1H 2021. If approved, the company will initiate a Phase 1 trial in adult healthy volunteers and hidradenitis suppurativa (HS) and atopic dermatitis (AD) patients.

The Watertown, MA-based company was founded in 2015 and booked $9 million in collaboration revenue for the 12 months ended June 30, 2020. It plans to list on the Nasdaq but has not selected symbol. Kymera Therapeutics filed confidentially on June 22, 2020. Morgan Stanley, BofA Securities, Cowen and Guggenheim Securities are the joint bookrunners on the deal. No pricing terms were disclosed.

Relevant Profile: KYTX.RC

https://www.renaissancecapital.com/IPO-Center/News/70005/Preclinical-protein-degrader-biotech-Kymera-Therapeutics-files-for-a-$100-m

Relief, NeuroRx say emergency treatment helps critically ill Covid patients

Critically ill COVID-19 patients recovered rapidly from respiratory failure after three days of treatment with RLF-100, a therapy granted fast-track designation in the United States, two drug companies said on Sunday.

Geneva-based Relief Therapeutics Holdings AG RFLB.S has a patent for RLF-100, or aviptadil, a synthetic form of a natural peptide that protects the lung. U.S.-Israeli NeuroRx Inc partnered with Relief to develop the drug in the United States.

In June the U.S. Food and Drug Administration granted fast-track designation to RLF-100 for treatment of respiratory distress in COVID-19.

While a Phase 2/3 clinical trial with 70 patients is ongoing, RLF-100 is being administered on an emergency basis to some patients who are too ill to be admitted to the trial.

The first report of rapid recovery under emergency use was posted by doctors from Houston Methodist Hospital, the companies said in a joint statement.

It said a 54-year-old man who developed COVID-19 while being treated for rejection of a double lung transplant came off a ventilator within four days of treatment with RLF-100.

Similar results were subsequently seen in more than 15 patients treated under emergency use, the companies said.

The two companies also said independent researchers in a biocontainment laboratory in Brazil reported that aviptadil blocked replication of the SARS coronavirus in human lung cells and immune cells.

“No other antiviral agent has demonstrated rapid recovery from viral infection and demonstrated laboratory inhibition of viral replication,” NeuroRx CEO Jonathan Javitt said.

The clinical trials are looking at whether similar observations will be confirmed for less ill patients with COVID-19-related respiratory failure.

An independent data monitoring committee will be conducting an interim analysis of these data later this month, Javitt told Reuters.

https://www.reuters.com/article/us-health-coronavirus-relief-hldg-neuror/relief-neurorx-say-emergency-treatment-with-rlf-100-helps-critically-ill-covid-patients-idUSKBN24Y0OR

Prescription drug marketplace GoodRx files for IPO

U.S. online prescription drug price marketplace GoodRx Inc has submitted paperwork with the U.S. Securities and Exchange Commission for a potential initial public offering, according to people familiar with the matter.

GoodRx, which was valued at $2.8 billion in 2018 when private equity firm Silver Lake invested in the company, is in the process of hiring advisers for the IPO, the sources said, requesting anonymity because the preparations are confidential.

The listing could come later this year or early in 2021, one of the sources added, noting that the plans were subject to market conditions.

GoodRx did not immediately respond to a request for comment.

Founded by Doug Hirsch and Trevor Bezdek in 2011, GoodRx gathers information for more than 70,000 U.S. pharmacies to track drug prices and offer coupons to consumers for discounts. It makes money by charging fees to partnering pharmacy benefits managers.

The Santa Monica, California-based company’s website is used by more than 10 million Americans every month, according to GoodRx. Last year, it expanded into telemedicine by acquiring HeyDoctor LLC.

In June, GoodRx appointed Karsten Voermann as chief financial officer and Bansi Nagji as president for healthcare.

Besides Silver Lake, other investors in GoodRx include buyout firms Francisco Partners and Spectrum Equity. Its competitors include prescription drug savings app SingleCare and online coupon provider RetailMeNot Inc’s RxSaver.

https://www.reuters.com/article/us-goodrx-ipo-exclusive/exclusive-prescription-drug-marketplace-goodrx-files-for-ipo-sources-idUSKBN24Y0N6

Fed’s Kashkari: 4-6 week shutdown; Congress can spend big on Covid relief

The U.S. economy could benefit if the nation were to “lock down really hard” for four to six weeks, a top Federal Reserve official said on Sunday, adding that Congress can well afford large sums for coronavirus relief efforts.

The economy, which in the second quarter suffered its biggest blow since the Great Depression, would be able to mount a robust recovery, but only if the virus were brought under control, Neel Kashkari, president of the Minneapolis Federal Reserve Bank, told CBS’ “Face the Nation.”

“If we don’t do that and we just have this raging virus spreading throughout the country with flare-ups and local lockdowns for the next year or two, which is entirely possible, we’re going to see many, many more business bankruptcies,” Kashkari said.

“That’s going to be a much slower recovery for all of us.”

He said Congress is positioned 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.

“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,” Kashkari said.

“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.

Efforts to craft a compromise appear stalled.

In an interview with ABC’s “This Week” on Sunday, Treasury Secretary Steven Mnuchin said President Donald Trump would spend what was needed, but that the deficit was a factor.

“There’s obviously a need to support workers and support the economy,” he said. “On the other hand, we have to be careful about not piling on enormous amount of debts for future generations.”

Kashkari took a different view, stressing both the high level of domestic saving and historically low interest rates.

“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,” Kashkari added.

https://www.marketscreener.com/UNITED-PARCEL-SERVICE-14758/news/Fed-s-Kashkari-suggests-four-to-six-week-shutdown-says-U-S-Congress-can-spend-big-on-coronavirus-r-31042130/?countview=0

U.S. coronavirus ‘extraordinarily widespread’, say White House experts

The United States is in a new phase of the novel coronavirus outbreak with infections “extraordinarily widespread” in rural areas as well as cities, White House coronavirus experts said on Sunday.

Coronavirus cases continue to surge in some parts of the country and the public health officials are trying to work with governors to tailor responses for each state.

“We are in a new phase,” said Dr. Deborah Birx. “What we are seeing today is different from March and April. It is extraordinarily widespread” in rural as well as urban areas.

“To everybody who lives in a rural area: You are not immune or protected from this virus,” Birx said on CNN’s “State of the Union.”

Birx, the White House task force coordinator, said people living in multigenerational households in an area that is experiencing an outbreak should wear masks inside the home to protect the elderly or those with underlying conditions.

Admiral Brett Giroir, an assistant Health and Human Services secretary, continued to stress the importance of wearing masks.

“If we don’t do that, and if we don’t limit the indoor crowded spaces, the virus will continue to run,” he said on NBC’s “Meet the Press.”

“We are very concerned and this is a very serious point.”

The coronavirus, which first appeared in China, has infected 4.6 million people in the United States and killed more than 155,000 Americans, according to a Reuters tally.

Birx said federal officials have been working on individual reports for each state examining community trends and hospital records. “Each of these responses have to be dramatically tailored,” she said.

She said what she witnessed as she visited 14 states over the last three weeks gave her cause for concern.

“As I traveled around the country, I saw all of America moving,” Birx said. “If you have chosen to go on vacation into a hot spot, you really need to come back and protect those with comorbidities and assume you’re infected.”

If people wear masks and avoid crowds, Giroir said, it gives the same outcome as a complete shutdown.

“That’s why we’re going to all the states, we’re on local radio, we give specific instructions to every governor by county, what they need to do when we start – when those counties start tipping yellow, because that’s the time when you have to stamp it down,” he said.

https://www.marketscreener.com/ADMIRAL-GROUP-PLC-9677065/news/U-S-coronavirus-extraordinarily-widespread-say-White-House-experts-31042225/?countview=0

Xencor earns $25M milestone payment on FDA nod for lymphoma treatment

The FDA approval of MorphoSys’ Monjuvi (tafasitamab-cxix) for treatment-resistant diffuse large B cell lymphoma (DLBCL) triggered a $25 million milestone payment and royalties, expected to be high single-digit-to-low double-digits, on net sales to licensor Xencor (NASDAQ:XNCR), the company announced.

Xencor out-licensed exclusive global rights to the humanized Fc-modified cytolytic anti-CD19 monoclonal antibody, which incorporates its engineered Fc domain, to MorphoSys in 2010.

MorphoSys (NASDAQ:MOR) and licensee Incyte (NASDAQ:INCY) will co-commercialize the product in the U.S.

Xencor reported trailing twelve months revenue of $77M. Learn more about XNCR’s financial situation here.

https://seekingalpha.com/news/3598739-xencor-earns-25m-milestone-payment-on-fda-nod-for-lymphoma-treatment

National Academies guide to help public officials make sense of COVID-19 data

As the COVID-19 pandemic continues, officials across the country have had to make decisions about opening and closing schools, businesses and community facilities. They have relied in large part on information about the pandemic—from hospitalization statistics to test results—to inform these decisions. But different facts and figures about COVID-19 can paint different pictures of the pandemic, according to Adrian Raftery, a professor of statistics and sociology at the University of Washington.

“The COVID-19 pandemic is generating many different types of data about this disease in communities—¬things like the number of confirmed cases or the number of deaths in a particular area,” said Raftery. “None of these data sources on their own are perfect in terms of capturing a complete and accurate summary of the prevalence of COVID-19 and the risks of doing certain things like opening businesses or schools. All have their own strengths and weaknesses.”

Raftery is lead author of a new guide published June 11 by the National Academies of Sciences, Engineering and Medicine that is intended to help officials nationwide make sense of these different COVID-19 data sources when making public health decisions.

Officials looking for COVID-19 statistics have plenty to choose from: confirmed cases, deaths, hospitalizations, intensive care unit occupancy, emergency room visits, antibody tests, nasal-swab tests and the ratio of positive test results—to name a few of the more common data points collected and distributed by hospitals and public health agencies. But officials don’t necessarily have all of these statistics on hand when making decisions, or have enough information to interpret them.

“We intend for this guide to help these decision-makers and their advisors interpret the data on COVID-19 and understand the upsides and downsides of each data source,” said Raftery.

For example, the number of positive test results for the novel coronavirus is likely an underestimate of its true prevalence in a community. Many people who have the virus are asymptomatic and aren’t likely to seek out a test, and even people with symptoms may not have access to tests and medical care, according to Raftery. As another example, the number of COVID-19 deaths in a region does not reflect the disease’s current prevalence because the number of deaths lag behind the number of cases by several weeks. In addition, some deaths may be misattributed to COVID-19, Raftery said.

The guide highlights some criteria for officials to take into account when assessing the usefulness of particular COVID-19 data points, including:

• Assessing how representative the data are for a community or region
• Whether there may be systemic biases in some data sources
• Thinking about the types of uncertainties in data sources, due to factors like sample size, how data were collected and the population surveyed
• Whether there’s a time lag due to delays in reporting data, the course of the disease and other factors

“There are no perfect data sources, but all of these data sources are still useful for making decisions that directly impact public health,” said Raftery.

Raftery has worked extensively on statistical methods to measure and estimate the prevalence of other viruses, including HIV in Africa. Though HIV and the novel coronavirus cause different types of diseases, there are similarities in how the two viruses spread among susceptible populations, as well as how types of social distancing—condom use for HIV and physical distancing and mask usage for the novel coronavirus—can decrease transmission. COVID-19 is also generating the same types of data sources, with the same limitations, as HIV/AIDS, such as test results, hospitalization rates and deaths.

Over time, it may be possible to collect more revealing data about COVID-19 from what are known as “representative random samples” within a population. In representative sampling, people are surveyed at random for a disease, and certain populations can be more heavily sampled than others based on what scientists and officials have learned about a disease’s prevalence and susceptibility. Representative sampling avoids biases and can more accurately estimate the disease’s prevalence in a region, according to Raftery.

“As we learn more about COVID-19, how it spreads, how different populations are more or less susceptible, we may be able to move more in the direction of representative sampling,” said Raftery. “The State of Indiana has already done a survey of this kind, and others should follow suit. But there is also a lot that officials can do with the statistics and data sources that hospitals and agencies are providing right now—provided that officials can be made aware of the strengths and weaknesses of each piece of data.”

The guide is the first completed by the National Academies’ Societal Experts Action Network—or SEAN—an eight-member committee tasked by the National Academies to provide rapid expert assistance on issues related to the social and behavioral sciences during the pandemic. Raftery is a member of the SEAN and spearheaded this inaugural project.

https://medicalxpress.com/news/2020-07-national-academies-publishes-covid-.html