HCW Biologics Inc. (the “Company”) (NASDAQ: HCWB), a biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen health span by disrupting the link between inflammation and age-related diseases, today announced that the Masonic Cancer Center, University of Minnesota was cleared by the U.S. Food and Drug Administration (FDA) to proceed to evaluate the Company’s lead drug candidate, HCW9218, in a Phase 1 clinical trial in patients with advanced solid tumors with progressive disease after prior chemotherapies. HCW9218 is an injectable, bifunctional fusion protein complex designed to drive anti-tumor activity by activating desired immune responses to attack cancer cells while simultaneously blocking unwanted immunosuppressive activities.
Phase 1 trial of TSC-100 expected to initiate in the first half of 2022 –
– IND for TSC-101 on hold pending additional assessment of the risk of off-tumor reactivity –
TScan Therapeutics, Inc. (Nasdaq: TCRX), a biopharmaceutical company focused on the development of T-cell receptor (TCR) engineered T cell therapies (TCR-T) for the treatment of patients with cancer, today announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to evaluate TSC-100 for the treatment of patients with hematologic malignancies who are undergoing allogeneic hematopoietic cell transplantation (HCT). The target of TSC-100 is the minor histocompatibility antigen HA-1, which is a lineage-specific antigen found on blood cells. The Company will now submit the clinical protocol to Institutional Review Boards (IRB) for the initial study sites and expects to begin dosing patients in the first half of 2022.
Top-line Data Expected in the Third Quarter of 2022
Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), a clinical-stage biopharmaceutical company focused on respiratory diseases, today announces it has completed patient enrollment with more than 800 subjects randomized in the ENHANCE-2 trial, evaluating ensifentrine for the maintenance treatment of chronic obstructive pulmonary disease (“COPD”). Top-line data are expected in the third quarter of 2022.
“Completing enrollment in the Phase 3 ENHANCE-2 trial with more than 800 subjects is an important accomplishment for Verona Pharma,” said David Zaccardelli, Pharm. D., President and Chief Executive Officer. “We are pleased to achieve our recruitment targets during the ongoing global pandemic.”
“We expect to report top-line data from ENHANCE-2 in the third quarter of 2022 and from ENHANCE-1 around the end of 2022. We look forward to reporting these results and working with the regulatory authorities to address the urgent need for a novel treatment for COPD.”
The Phase 3 ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) program consists of two double-blind, placebo-controlled studies (ENHANCE-1 and ENHANCE-2) evaluating nebulized ensifentrine for the maintenance treatment of COPD. The 48-week subset of the ENHANCE-1 trial completed enrollment of approximately 400 subjects in December 2021, which was first reported on January 5, 2022. Enrollment in the 24-week subset of ENHANCE-1 is expected to complete in the second quarter of 2022. Data for both subsets of ENHANCE-1 are expected around the end of 2022. Conditional upon positive results, the Company intends to file a New Drug Application (“NDA”) with the US Food & Drug Administration (“FDA”) in the first half of 2023.
Ensifentrine is a first-in-class product candidate that combines bronchodilator and anti-inflammatory activities in one compound. In prior clinical studies in COPD, ensifentrine has shown significant and clinically meaningful improvements in lung function, symptoms and quality of life as a monotherapy or added onto a maintenance bronchodilator. Ensifentrine has been well tolerated in clinical trials involving more than 1,400 subjects to date.
Family members who lost loved ones in nursing homes during the COVID-19 pandemic slammed Gov. Kathy Hochul for failing to include a$4 billion victims compensation fund in her$216.3 billionstate budget.
“We believe the victims compensation fund should be included in the budget as a final admission of guilt. That will give the families closure and some sense of accountability,” said Vivian Zayas, who lost her 78-year-old mother, Ana Martinez in a Long Island nursing home in April 2020.
Initially proposed last year by state Assemblyman Ron Kim (D-Queens), the 9/11-style Nursing Home Victims Compensation Fund would earmark $4 billion to families whose relatives died amid the state’s nursing home debacle at the start of the pandemic.
Zayas lost her 78-year-old mother, Ana Martinez in a Long Island nursing home in April 2020, at the beginning of the pandemic.Stephen Yang
Kim’s bill, if passed, would serve as an alternative for families seeking accountability — with many barred from suing individual facilities thanks to a defunct state law that gave hospitals and nursing homes legal protection.
“Our family members died of no fault of their own,” said Zayas, founder of advocacy group Voices for Seniors. “They lived in the nursing homes where they put COVID-positive patients in their homes.
“If we had not been barred, we could have pursued our own accountability to sue those nursing homes, but they took that legal recourse from us. That’s why we are pursuing this fund.”
Zayas sued her mother’s nursing home, Our Lady of Consolation in West Islip, claiming the facility didn’t protect her mom from exposure to COVID-19.Stephen Yang
Kim’s legislation is in response to a provision included in ex-Gov. Andrew Cuomo’s 2020 state budget called the “Emergency or Disaster Treatment Protection Act,” which granted health care facilities and workers liability immunity from negligence suits during the early days of the pandemic.
The corporate immunity clause was supported by New York’s powerful healthcare lobbying group, the Greater New York Hospital Association – which has donated millions to Cuomo’s campaign in the past, according to reports.
Although that measure was eventually repealed in April 2021, it doesn’t allow lawsuits to be filed retroactively from the beginning of the pandemic in March 2020.
The FBI and prosecutors with the Eastern District of New York are conducting an ongoing investigation into Cuomo and his former top aides’ nursing home policies and cover up of COVID-19 deaths there.Getty Images
Following her mother’s April 1, 2020 death, Zayas sued Our Lady of Consolation nursing home in West Islip, claiming the facility didn’t protect her mom from exposure to the killer bug. Zayas also believes the state’s repeal of the immunity provision should extend to March 2020. Her case is pending in Brooklyn Supreme Court.
Zayas and other grieving relatives-turned-nursing home advocates, including Fox News meteorologist Janice Dean, had asked Hochul to prioritize the fund’s creation during an October meeting.
“There has to be accountability for what happened to our family members in nursing homes in the spring of 2020,” Dean, who lost both of her in-laws in elder care facilities in March and April 2020, told The Post. “Gov. Kathy Hochul met with us face to face in October and promised that there would be transparency when it came to the true number of deaths and why over 9,000 COVID-positive patients were admitted into their care facilities.”
Hochul apologized for Cuomo’s policies, which may have covered up the deaths of over 15,000 elderly residents, but she did not include the compensation fund in the state’s budget.Getty Images
But the creation of the fund failed to make it into her budget.
Brett Leitner, Zayas’ lawyer, blasted Hochul for not following through.
“The former governor took millions of dollars in donations from the millionaire nursing home owners, gave those friends blanket protection for their negligence which led to 15,000 deaths, and then tried to hide those deaths from the public,” said Leitner – referencing the past donations Cuomo’s campaign had received from the healthcare industry.
“In what appeared to be a change from the usual ‘pay-for-play’ tactics of the former administration, a few months ago, Gov. Hochul offered a formal apology to the victims’ families for the pain the former governor caused, and pledged in effect to do right by them.
“It appears this was an empty promise.”
Kim – who lost his uncle to COVID in a Queens nursing home – told The Post it’s “embarrassing” that New York has refused to pay even a cent to families so far, when New Jersey in December agreed to pay a nearly $53 million settlement to the families of 119 residents of the state’s military veteran facilities who died during the pandemic.
“I think it’s embarrassing because New Jersey already settled with the veteran nursing home families and we should be leading the country in making the families and nursing homes whole — especially because we had private conversations with [Hochul] last year,” he said.
Kim proposed the $4 billion victims compensation fund as an alternative to families seeking accountability.James Messerschmidt for NY Post
Kim said he’s going to work on passing his legislation this session, as well as securing companion legislation in the state Senate.
Hochul spokeswoman Hazel Crampton-Hays pointed to the governor’s work so far on combatting the pandemic — and cleaning up Cuomo’s mess.
“On her first day in office, Governor Hochul released additional nursing home data, and every day since she has worked to deliver accountability, restore trust in government, and protect vulnerable New Yorkers,” she said, noting the governor has also implemented policies to increase the vaccination and booster rate in these homes as well as the deployment of the National Guard to help with staffing issues.
Hochul has made moves to increase the vaccination and booster rate in nursing homes since taking office.Getty Images
“In the Governor’s State of the State and Executive Budget, she proposed a number of new initiatives to support older New Yorkers, including investments in nursing homes to improve quality of care for residents, establishing clear certification criteria for ‘memory care,’ supporting innovative nursing home models like the Green House model, combating social isolation and abuse of older residents, and strengthening the long-term care ombudsman program.”
Hochul’s budget includes a new $10 billion multi-year investment for New York’s healthcare industry. That includes a $1.2 billion bonus program for nurses and other healthcare workers.
“We will work with the legislature and advocates on these priorities to ensure the health and well-being of aging New Yorkers during the legislative session,” said Crampton-Hays.
Meanwhile, the FBI and prosecutors with the Eastern District of New York are conducting an ongoing investigation into Cuomo and his former top aides’ nursing home policies and cover up of COVID-19 deaths there.
Borough President Mark Levine said the MTA must overcome its longstanding reluctance to embrace platform barriers, which officials have warned would be incredibly complicated to make happen at many stations.
“The density and crowding of subways here … makes our stations more vulnerable,” Levine said in an interview Sunday. “It’s true that we have a huge number of needs and finite resources, but this would amount to a small fraction of the capital budget.”
In a letter to MTA Chair Janno Lieber, Levine and all 10 council members representing his borough said platform screen doors “must be given the priority they deserve, studied, and funded for installation.”
“Each year, hundreds of New Yorkers enter subway tracks via accidental fall, trespassing, suicide attempts, and, in rare cases, being pushed. The tragic loss of Michelle Go on January 15th is but the most recent painful example,” they wrote.
Manhattan Borough President Mark Levine claimed that Manhattan subway commutes are more vulnerable to subway shoves because of the crowded platforms at busy stations.Stefan Jeremiah
A 2019 MTA study reported by NY1 concluded that platform doors were only feasible at 128 of the subway’s 472 stations. Installing floor-to-ceiling gates at those stations would cost over $7 billion, the study found.
Lieber last week said the MTA would explore the feasibility of platform barriers among other solutions to various types of “track intrusions.”
In an interview with ABC7 New York that aired on Sunday, the newly confirmed MTA boss said the challenge of installing barriers “is not a matter of cost.”
MTA Chair Janno Lieber said that platform barriers are currently being considered.Paul MartinkaLieber claimed that installing barriers “is not a matter of cost.”Robert Mecea
“There are some physical constraints,” he said. “But we’re studying it again, and we are interested in seeing whether there are opportunities to install it, especially in some of the more, the busier stations where you get a little more crowded.”
Levine told The Post platform barriers could “transform people’s understanding of what a subway station can be.”
“This is not just about preventing people from being pushed on the tracks — which is horrific but, thank God, rare,” he said. “It’s also about preventing people from falling, from dropping their iPhones on the tracks, from suicide attempts. And it will prevent delays, because one of the main causes of delays is track fires.”
Royal Philips NV said Monday that sales and net profit for the last quarter of the year fell as it continued to experience challenges related to the supply chain and Covid-19.
The Dutch health-technology company said group sales for the fourth quarter of 2021 were 4.9 billion euros ($5.56 billion) compared with EUR6.00 billion a year earlier.
Net profit was EUR157 million compared with EUR603 million for the same period the year before.
Fourth-quarter group adjusted earnings before interest taxes and amortization--one of the company's preferred metrics, which strips out exceptional and other one-off items--were EUR647 million compared with EUR995 million in 2020.
Full-year 2021 sales were EUR17.2 billion and 2021 adjusted Ebita was EUR2.05 billion
For 2022, Philips expects growth and margin expansion, despite short-term volatility and headwinds related to Covid-19 and supply-chain challenges. It expects to start the year with a comparable sales decline, followed by a recovery and strong second half. For the full year, it targets 3%-5% comparable sales growth.
Philips declared a dividend of EUR0.85, flat on year.
Before consuming a meal, many people with diabetes need to inject themselves with insulin. This is a time-consuming process that often requires estimating the carbohydrate content of the meal, drawing blood to measure blood glucose levels, and then calculating and delivering the correct insulin dose.
Those steps, which typically must be repeated for every meal, make it difficult for many patients with diabetes to stick with their treatment regimen. A team of MIT researchers has now come up with a new approach to streamline the process and help patients maintain healthy glucose levels.
"Any intervention that makes it easier for patients to receive therapy can have an enormous impact, because there are multiple barriers that have to do with time, inconvenience, dexterity, or learning and training," says Giovanni Traverso, the Karl van Tassel Career Development Assistant Professor of Mechanical Engineering at MIT and a gastroenterologist at Brigham and Women's Hospital. "If we're able to overcome those barriers through the implementation of new engineering solutions, it will make it easier for patients to receive that therapy."
Traverso and his colleagues designed two different devices that can simplify the process of calculating and injecting the correct dose of insulin. One, which combines many of the existing steps into a single device, could be used in patients in the near future. Their second prototype incorporates flexible electronics onto the surface of a needle so that the blood measurement and insulin delivery can happen through the same needle. This could eventually make the process of managing diabetes even more streamlined.
MIT postdocs Hen-Wei Huang and Sean You, and visiting students Luca Di Tizio and Canchen Li, are the lead authors of the paper, which appeared recently in the Journal of Controlled Release.
All-in-one device
Diabetes affects 34 million people in the United States and more than 400 million people worldwide. Patients with diabetes often use two types of insulin to control their blood sugar levels: long-acting insulin, which helps control glucose levels over a 24-hour period, and short-acting insulin, which is injected at mealtimes. Patients first measure their blood glucose levels with a glucose meter, which requires pricking their finger to draw blood and placing a drop of blood onto a test strip. They must also estimate how many carbohydrates are in their meal and combine this information with their blood glucose levels to calculate and inject the proper insulin dose.
Existing technologies such as continuous blood glucose monitors and insulin pumps can help with some parts of this process. However, these devices are not widely available, so most patients must rely on finger pricks and syringes.
"Every day, many patients need to do this complicated procedure at least three times," Huang says. "The main goal of this project is to try to facilitate all of these complex procedures and also to eliminate the requirement for multiple devices. We also used a smartphone camera and deep learning to create an app that identifies and quantifies food content, which can aid in carbohydrate counting."
The research team devised two different types of "all-in-one" devices, both of which incorporate the new smartphone app. Patients first take a picture of the food, and the app can then estimate the volume of food and also the amount of carbohydrates, based on nutrient information from a USDA database.\
The first all-in-one device that the researchers designed consolidates many of the existing tools that patients use now, including a lancet for drawing blood and glucose test strips. Once the blood glucose measurement is taken, the device conveys the information to the smartphone app via Bluetooth, and the app calculates the correct insulin dose. The device also includes a needle that injects the correct amount of insulin.
"What our device is doing is automating the procedures to prick the skin, collect the blood, calculate the glucose level, and do the computation and insulin injection," Huang says. "The patient no longer needs a separate lancing device, glucose meter, and insulin pen."
Many of the components included in this device are already FDA-approved, but the device has not been tested in human patients yet. Tests in pigs showed that the system could accurately measure glucose levels and dispense insulin.
A single jab
For their second device, the researchers wanted to come up with a system that would require just one needle prick. To achieve that, they designed a novel glucose sensor that could be incorporated into the same needle that is used for insulin injection.
"The idea would be that if we can integrate the glucose sensor directly onto the surface of the insulin delivery needle, we would only need one stick for the patient, which minimizes pain and also makes the whole process easier to administer," You says.
The researchers designed a flexible electronic sensor that can be attached to the needle and measure glucose levels in the interstitial fluid, just below the surface of the skin. Once the needle penetrates the skin, it takes between five and 10 seconds to measure the glucose levels. This information is transmitted to the smartphone app, which calculates the insulin dose and delivers it through the inserted needle.
In tests in the pigs, the researchers showed that they could accurately measure glucose levels with this system, and that glucose levels dropped after insulin injection.
Because this device uses a novel type of glucose sensor, the researchers expect that it will require further development to get to a point where it could be tested in patients. They have filed for patents on both of the systems described in the new study and hope to work with companies to further develop them.
The research was funded by the MIT Department of Mechanical Engineering and Brigham and Women's Hospital.
Hen-Wei Huang, Siheng Sean You, Luca Di Tizio, Canchen Li, Erin Raftery, Claas Ehmke, Christoph Steiger, Junwei Li, Adam Wentworth, Ian Ballinger, Declan Gwynne, Kewang Nan, Jia Y. Liang, Jason Li, James D. Byrne, Joy Collins, Siddartha Tamang, Keiko Ishida, Florencia Halperin, Giovanni Traverso. An automated all-in-one system for carbohydrate tracking, glucose monitoring, and insulin delivery. Journal of Controlled Release, 2022; DOI: 10.1016/j.jconrel.2022.01.001
