Monthly Archives: January 2022

CAMBRIDGE, England, & BOSTON--(BUSINESS WIRE)--Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, today announced continued progress in its ongoing Phase I/II clinical trials of BT8009, BT5528 and BT7480.

Last quarter, we reported interim clinical results from ongoing trials of two of our Bicycle toxin conjugates, BT8009 and BT5528, demonstrating preliminary anti-tumor activity in two tumor types, and announced the first patient dosed in the Phase I clinical trial of BT7480, our first tumor-targeted immune cell agonist to enter the clinic. In our trial of BT8009, we are pleased to confirm the preliminary activity and see that these patients remain on trial. We look forward to presenting interim BT8009 Phase I results at a medical meeting and initiating the BT5528 expansion cohorts this year, said Kevin Lee, Ph.D., Chief Executive Officer. We are also pleased with our progress advancing BT7480 in the ongoing Phase I clinical trial and look forward to sharing additional details regarding the potential for Bicycles beyond our toxin conjugates as we strive to become a leader in the development of targeted oncology therapeutics.

Bicycle Toxin Conjugates (BTCs) BT8009 and BT5528

In the ongoing Phase I portion of the Phase I/II clinical trial of BT8009, a second-generation BTC targeting Nectin-4, four out of 11 patients were previously reported to have a partial response under Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, including one out of four (25%) in the 2.5mg/m2 dose and three out of seven (43%) at the 5.0 mg/m2 cohorts. All four patients previously reported as responders have since received at least one subsequent scan, and all have been confirmed as ongoing RECIST 1.1 responses. One patient in the 5.0 mg/m2 cohort, who previously was reported to have a partial response with an 89% tumor reduction, has now received two subsequent scans, which each showed that total tumor volume has been reduced by 100%, constituting a confirmed complete response. All four patients previously reported to have a RECIST 1.1 clinical response remain on therapy. The tolerability profile of the 2.5mg/m2 and 5.0 mg/m2 cohorts remains consistent with that previously reported.

Dose escalation in the BT8009 Phase I trial remains ongoing, with patients currently being dosed at 7.5mg/m2 weekly or every-other-week. Bicycle intends to present interim Phase I results from the ongoing clinical trial at a medical meeting this year.

The Phase I/II trial of BT5528, Bicycles second-generation BTC targeting EphA2, is also ongoing, with plans remaining on track to initiate the expansion cohorts this year, with an expected recommended Phase II dose of 6.5mg/m2 every-other-week.

Bicycle tumor-targeted immune cell agonist (Bicycle TICA) BT7480

Bicycle also initiated a Phase I clinical trial of BT7480, a novel, fully synthetic Bicycle TICA targeting Nectin-4 and agonizing CD137, in the fourth quarter of 2021, and dose escalation in that trial remains ongoing. BT7480 and other Bicycle TICAs, including a novel NK-cell-engaging molecule, were the subjects of four posters at SITC in November 2021.

Management Team Updates

Bicycle is also announcing the expansion of and transition in its management team. Michael Skynner, Ph.D., the companys Chief Operating Officer (COO), has been appointed to the newly created position of Chief Technology Officer, effective January 3, 2022, to focus on leading and overseeing the growth of Bicycles proprietary phage display discovery platform in oncology, as well as on creating innovative opportunities for the platform outside of oncology. Dr. Skynner joined the company in January 2016 as Vice President, Operations and Discovery and had served as COO since March 2018. Alistair Milnes, who has served as the companys Vice President, Human Resources and Communications since January 2021, has assumed the COO role. Mr. Milnes previously led human resources and communications at multinational energy and mineral companies. Both Dr. Skynner and Mr. Milnes are based in the United Kingdom.

We are delighted to announce our recent management team appointments, with Mike Skynner becoming our new CTO and Alistair Milnes moving to the COO role. Mike has been an invaluable contributor to Bicycles success to date and has led our platform discovery efforts since joining in early 2016. Following recent promising clinical progress, we believe it is time to focus on accelerating the growth of our proprietary oncology pipeline and on identifying innovative ways to potentially capitalize on our unique technology beyond our current therapeutic focus. I am confident that Mike can help us achieve these objectives. Dr. Lee added, I am similarly enthusiastic about Alistairs appointment as COO and believe his operational experience and track record of successfully identifying, recruiting, and retaining key talent at large, multinational companies will be instrumental in helping guide Bicycle through our next phase of growth.

About Bicycle Therapeutics

Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycles, for diseases that are underserved by existing therapeutics. Bicycles are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycles attractive candidates for drug development. Bicycle is evaluating BT5528, a second-generation Bicycle Toxin Conjugate (BTC) targeting EphA2; BT8009, a second-generation BTC targeting Nectin-4, a well-validated tumor antigen; and BT7480, a Bicycle TICA targeting Nectin-4 and agonizing CD137, in company-sponsored Phase I/II trials. In addition, BT1718, a BTC that targets MT1-MMP, is being investigated in an ongoing Phase I/IIa clinical trial sponsored by the Cancer Research UK Centre for Drug Development. Bicycle is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Lexington, MA. For more information, visit bicycletherapeutics.com.

Forward Looking Statements

This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as aims, anticipates, believes, could, estimates, expects, forecasts, goal, intends, may, plans, possible, potential, seeks, will and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding the discovery, development and potential commercialization of potential product candidates using Bicycles technology; Bicycles anticipated advancement of its product candidates, including BT5528, BT8009 and BT7480; the advancement of Bicycles product candidate pipeline; anticipated design of, initiation of expansion cohorts in and progression of Bicycles clinical trials; the availability of data from clinical trials; the therapeutic potential for Bicycles in oncology and other applications; and Bicycles ability to accelerate its product pipeline and identify potentially innovative applications of its technology beyond oncology. Bicycle may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: risks to clinical trial site initiation, patient enrollment and follow-up, as well as to Bicycles abilities to meet other anticipated deadlines and milestones, presented by the ongoing COVID-19 pandemic; uncertainties inherent in the initiation and completion of clinical trials and clinical development of Bicycles product candidates; the risk that Bicycle may not realize the intended benefits of its technology; availability and timing of results from clinical trials; whether the outcomes of preclinical studies will be predictive of clinical trial results; whether initial or interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; the risk that trials may be delayed and may not have satisfactory outcomes; potential adverse effects arising from the testing or use of Bicycles product candidates; the risk that Bicycle may not be able to identify additional product candidates or additional applications of its technology; and other important factors, any of which could cause Bicycles actual results to differ from those contained in the forward-looking statements, are described in greater detail in the section entitled Risk Factors in Bicycles Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 4, 2021, as well as in other filings Bicycle may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Bicycle expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

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Bicycle Therapeutics Announces Continued Clinical Progress and Updates to Management Team - Business Wire

Legislative topic today is education. Bottom line: progress slight over last two decades. - Arkansas Times

On

The Arkansas House and Senate Education Committees are hearing this morning from the Bureau of Legislative Research on a study of the states effort in education, including what progress has been made since the landmark Lake View ruling in 2002 that the state was failing the constitutional requirement of equal and adequate education.

A mountain of information was prepared for todays meeting, to wit:

The state has made some progress in financial support for schools since Lakeview (though teacher pay has essentially flat-lined against national growth in recent years.) But the rubber meets the road on student performance. You can find an extensive look at measurements in the starting slate presentation.

Spoiler alert, the concluding slides:

The report comments:

The first decade or so after the Lake View reforms were instituted, many of the indicators Kilgore cited saw improvement. Progress on most, however, has stalled or, in some cases, declined since around 2013. When current data is compared with other states, Arkansas often ranks among the lower performing states.

Arkansas spending has improved since Lake View but hasnt kept pace with national changes. A couple of illustrations.

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Legislative topic today is education. Bottom line: progress slight over last two decades. - Arkansas Times

By CHARLENE PAUL

The Progress

Charlene Paul

As I reflected over the past 365 days of 2021, it seems impossible that they passed so quickly. So quickly! After the chaos that was 2020, I had so many plans for 2021, and I set about writing New Years resolutions to my feet firmly planted and my mind keenly focused.

I wish I could report that I accomplished each of those resolutions made on that first day of 2021 that Im in tip-top shape, that I scanned all of my photos and papers, that I published my first book, that I am in control of my emotions, that I no longer procrastinate, that I sleep eight hours every night, that my laundry is under control, and that I check everything off my to-do list every day. But the truth is, I am still a work in progress.

In the past, that would have affected me in one of two ways: 1) I would have been a mess of depression, or 2) I would have made a list of resolutions that was twice as long as last years.

But New Year 2022 was different. I didnt beat myself up because of my inability to get everything done. It was a year of ups and downs, challenges and cheers, joys and sorrows. I know. What an understatement.

Being the mother of adult children and in-law children has taught me lessons in dealing with trials I have no control over. Watching our kids go through their challenges kept me on my knees in fervent prayer. But, unfortunately, that wasnt on my list.

Spending time in conversation with a newly-widowed friend wasnt on my list. Talking to friends and neighbors about everything under the sun also didnt make my list. Taking time to watch a sunset and enjoy the all-too-infrequent rain wasnt on my list. Spending time with grandchildren wasnt on my list. Daydreaming and scheming, crocheting and crafting werent on my list.

My husbands job as a middle school principal was stressful last year. Sometimes when he got home, he wanted to walk and talk. That wasnt on my list.

No matter what my New Years Resolutions were, life happened. And that had to be okay. Dont get me wrong, resolutions are good, and to-do lists keep me centered. But somewhere in those resolutions and lists, I need empty spaces for wiggle room when life happens.

Life is precious and unpredictable, and I dont want to miss any more of it than I already have. On my last day on earth, I hope to look back over my lists of resolutions and find I have made a difference in the lives of those I came in contact with. I want those I love to know that they are more important than anything on a to-do list.

So, heres to empty spaces in 2022.

Charlene Paul and her husband Ken raised their family in Moapa Valley. She loves reading, writing, baking, crochet, and talking. She is the owner of Look on the WRITE Side, a freelance writing and proofreading company.

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'PAUL' IT ALL TOGETHER: Resolutions And Empty Spaces - mvprogress

Six months after the formation of the Supply Chain Disruptions Task Force, its members and President Joe Biden convened for a final time in 2021, on Dec. 22.

At the meeting, supply chain executives and cabinet members touted progress in relieving port congestion, stocking store shelves and boosting the workforce.

"The much-predicted crisis didnt occur," Biden said, referring to dire warnings in the fall that inventory may not make it to store shelves in time for the holidays. "Packages are moving. Gifts are being delivered. Shelves are not empty."

The president and the task force members relayed several facts and figures to illustrate the strides made so far in alleviating supply chain snarls.

Sean Gallup via Getty Images

By the numbers

90%

On-shelf availability in retail stores, nearly the same as pre-pandemic levels of 91%, Biden said.

adamkaz via Getty Images

By the numbers

Nearly 50%

The reduction in containers dwelling at the ports of Los Angeles and Long Beach for more than eight days, according to John Porcari, Port Envoy to the White House Supply Chain Disruptions Task Force. "This is striking progress since November," Biden said.

5 days

Average dwell time for containers at the Port of Long Beach, down from 12 days in mid-October, Porcari said.

4 days

Average dwell time for containers at the Port of Los Angeles, down from nine days in mid-October.

25%

Justin Sullivan via Getty Images

By the numbers

100 million

The number of packages FedEx moved in the first weekend of peak season after Thanksgiving, CEO Fred Smith said.

14.4 million

The number of square feet of sortation capacity FedEx added in 2021. "I think this is also true of UPS and the Postal Service, who have done a good job in opening up capacity," Smith said.

Urupong via Getty Images

By the numbers

2 days

How long it takes companies to set up registered apprenticeships for truck drivers. Previously, it took two months, the president said. "These apprenticeships are going to help new drivers get trained better and faster, and help companies retain drivers in a field that has a lot of turnover," Biden said.

111,000

The number of employment applications FedEx processed "over the last few weeks," Smith said Dec. 22.

300,000

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By the numbers: Biden reviews supply chain progress with task force - Supply Chain Dive

KINGSTON, N.Y. Mayor Steve Noble said Kingston has been courageous, resilient, and compassionate over the past two years while facing the ongoing COVID-19 pandemic and other challenges.

And as Kingston continues to move forward and build on its recent accomplishments, residents were urged once again to put aside prejudices and personal interests and work with a singleness of purpose, Noble said Tuesday during his annual State of the City address. Lets move forward and heal as a community. Lets push ourselves and our city to be all that we know it can be.

The city is making progress and wont stop now, Noble added.

The mayor gave his speech during the Common Council meeting at City Hall, which was also shown live online.

Noble said the city faces many challenges now, just as it did when it was formed in 1872. Those now include building safe and accessible roadways, rebuilding the 150-year-old sewer system, taking a close look at policing practices, and repairing the central fire station. The city also needs to continue to address the ongoing pandemic and its severe housing crisis, while also working to repair the painful division in the nation, state, and local community, he said.

In order to accomplish our goals of rebuilding our roads and vital infrastructure, ensuring every member of our community is fed and housed, and making meaningful change to our policing methods, it will take a coordinated and collective effort, Noble said. Together we can heal the divides because we can only move forward if we are working with one another, helping each other along.

Moving forward, Noble said Kingston is undertaking a city-wide rezoning initiative that will overhaul its outdated code. He said the rezoning will introduce form-based code that encourages revitalization, promotes affordable housing, spurs small businesses, promotes walkability, and will help preserve what makes Kingston unique.

Also on the housing front, Noble said he hopes, together with the Common Council, to pass Good Cause Eviction legislation to protect tenants from rising rental costs and unfair eviction. He said the city has also identified two vacant lots where it will build tiny homes in a partnership with Family of Woodstock. Those lots are located at 81 Cedar St. and 78 Franklin St., Noble said.

I am committed to ensuring that all residents have adequate, safe housing, and my administration will be pursuing all avenues to realize this effort, the mayor said.

Noble also pointed to approximately $17 million in federal funding the city will receive through the American Rescue Plan Act. He said the city expects to soon have a plan ready to present to the public as to how the funding will be spent over the next five years. The goal is to build on the citys existing resources, opportunities, and past planning efforts, and to provide funding in areas for sustained future growth that will bolster Kingstons economy, Noble said.

In terms of policing, Noble said the city is working with the Peaceful Guardians Project to create a concrete plan for applying recommendations created by the Re-envision Public Safety Task Force. He said the public would be presented with a two-pronged approach that will include a one-year plan for immediate implementation and a five-year plan for loftier goals.

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Resilient Kingston making progress while facing COVID, other challenges, mayor says in State of the City address - The Daily Freeman

By CHARLENE PAUL

The Progress

An old steam engine rail car sits on the slopes of the Virgin range. It was brought several miles from the valley floor near Bunkerville as a way to provide water for livestock and wildlife. PHOTO BY CHARLENE PAUL/The Progress

Farming and ranching in the desert of Southern Nevada isnt easy. And the men and women who choose to grow crops and run livestock in this unforgiving landscape cant rely solely on Mother Nature to solve the problem of how to supply much-needed water.

Back in the late 1960s and early 1970s, Bunkerville resident Melburn Jensen looked over a bunch of old mining equipment and junk that had been brought in for the Key West Mine. When he saw the old train car that had been sitting on a lot across from the cement plant, he got an idea. The train car consisted of a firebox for the coal to keep the fire burning and a tank that supplied water for the steam. It was just what he needed to bring water down from Hen Spring high up on Bunkerville Mountain.

The problem was how to get this huge steel behemoth from the valley floor near Bunkerville where it sat, up the mountain to the spring.

He contacted his friend Paul Leavitt in Moapa, and the two of them began planning.Dad and Paul decided to use Pauls big Caterpillar D8 dozer, explained Virgin Valley resident Andrew Jensen. I think they put the train car on poles and then drug it up the road and then up the wash. I cant remember how long it took, but I know it was more than a couple of days.

Once they got it to the spot where it sits today, they went about the task of bringing the water from the mother spring further up the mountain. Since the terrain was so rugged from the mouth of the spring, black plastic pipe was laid on top of the ground to the place where it was buried and ran to the tank car several miles further down.

The whole line runs about four to five miles, Jensen said. Dad maintained and used the tank car for our cattle for about thirty years. Cliven Bundy also used it for his cattle.

The old tank is still set up for use today.We put a couple of old scraper tires under the tank, said Cliven Bundy. The spring water fills the tank, and the water siphons out the bottom into the tires. The tires become a trough for cattle and wildlife. The problem is that someone burned up the tires, so we have to get that fixed.

These water improvements provide water not only for cattle but also for desert bighorn sheep, deer, quail, dove, and other wildlife in the area.Its so interesting that when you bring water down from the mother spring, how quickly you have a couple of hundred head of quail, said Bundy. Its good range improvements like these that help the livestock and wildlife thrive in harsh desert conditions.

People like Melburn Jensen and Paul Leavitt didnt wait for government engineers and official orders to solve problems. Instead, they looked at a pile of junk rusting in the desert, and figured out how to recycle an old steam train car. And then they set about getting it up the mountain.

Good old cowboy ingenuity got the job done. And it will continue to get the job done in half the time with a fraction of the cost.

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Cowboy Ingenuity And A Steam Engine - The Progress - mvprogress

NEWPORT, N.C. (WNCT) As 2021 came to an end, the NC Coastal Federation looked back at its progress to help conserve the coast over the past year and get ready for its upcoming projects in 2022.

In 2021, the NC Coastal Federation partnered with the Division of Coastal Management to do a large-scale marine cleanup for hurricane debris, as well as abandoned vessel removal. Thus far, they have removed about 80 abandoned vessels and will continue to do so throughout the spring of 2022. They were also able to remove over 800,000 pounds of debris from marshes and waterways.

Going into 2022, the NC Coastal Federation has received funding through the North Carolina General Assembly to continue its marine debris cleanup projects and start a lost fishing gear recovery project.The lost fishing gear recovery project will pull out derelict crab pots, which are bad for the environment and can catch marine animals and wildlife.

Sarah Bodin with the NC Coastal Federation said its important to have crews out cleaning up debris along the shorelines to help improve the quality for the future.

Were definitely seeing an improvement. Its important to have these crews out in the environment removing this marine debris, theyre navigational hazards. If we have people boating out, and theres wood floating around, its dangerous for boaters. Its dangerous for wildlife, said Bodin.

Bodin said she is excited to get started on the 2022 projects.

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NC Coastal Federation recaps its progress, looks forward to 2022 - WNCT

J Thomas Taylor| Columbia Daily Tribune

Tolton girls basketball sought some momentum entering the new year.

The Trailblazers got it last Wednesday, defeating Harrisburg 46-35 on the road to record their first victory of the 2021-22 season.

That might be the best game that I have watched this team play, said coach Sam Sexauer, who notched his first win as head coach. I wasn't the coach last year, but I watched this team play, and this game was the best defensive performance that they've had in probably two years. Moving the ball, moving well defensively.

I wish we moved a little bit better offensively sometimes, but ultimately, we played really great defense.

Senior Sophie Angel agreed with her coach on her teams play.

Our defense is what made us stand out. I think we rotated well and caused a lot of turnovers for them, Angel said. We got steals and pushed the ball up the floor. We have some bigs down low who do some work for us. Everyone plays their part.

Angel led all scorers with 15 points, including three makes from3-point range, and hit key baskets on a bum ankle in the third quarter to keep Toltons lead.

Angel rolled her ankle about halfway through the quarter but fought through the pain.

The first thing (Angel) brings is leadership. She leads by example. She's got the personality trait; that's one of the reasons she's going to be a collegiate athlete, Sexauer said. She has toughness. … She didn't want to come out of that game. She's just tough as nails. She's a great leader.

Once Tolton secured enough of a cushion, Sexauer pulled Angel to rest her ankle, but Harrisburg fought back and Sexauer relied on Angel to finish off the Bulldogs, hitting free throws in the final minutes to clinch the win.

Brooklyn Coolley and Ellie Reynolds added to the scoring with 12 and eight points, respectively.

I thought Brooklyn had her best game, Sexauer said. If Ellie played strong in the post, she was going to have some pretty good opportunities, and she played strong. She was probably the best defensive player that we had tonight.

Harrisburg junior Carli Ellis led the Bulldogs in scoring with 12 points, while Emma Fischer added eight in the losing effort.

Harrisburg fell to 5-5 on the season.

We knew their No. 1 (Ellis) was one of their better players and that she plays a pretty good post, Sexauer said. But we have to be strong and straight up on defense on the backside, and Ellie was that backside most of the night. She did a phenomenal job.

The win moved Tolton to 1-6 this season. Sexauer knows there remains plenty of room for improvement to navigate a tough schedule in January.

If we can get into an offense, we run it really well. I see it in practice all the time. Sexauer said. We have a young team. We have four seniors that play a lot, but also three freshmen that get ample playing time, a couple of sophomores and a junior, so just trying to build their confidence up.

I think this will help a ton, help to build the confidence and know that they can compete.

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Tolton girls basketball shows signs of progress in first win of the season - Columbia Daily Tribune

The Big Apple saw an increase in almost every category of major crime in 2021 returning to levels not seen in five years, NYPD data shows.

The tally for major crime murder, rape, robbery, felony assault, burglary, grand larceny and grand larceny auto topped 100,000 incidents for the first time since 2016.

Felony assaults surpassed 22,000 incidents for the first time since 2001, according to police data that also showed a 9.8 percent jump from 2020.

Another pandemic crime trend, stolen cars, was up 15 percent from 2020 and reached levels not seen since 2010.

And for the first time in a decade, murders neared 500 last year which closed out with 486 slayings, compared to 468 the year prior.

Burglary was the only category of the seven major crimes that saw a decrease 18 percent from 2020 to 2021, but it was still up 17 percent compared to pre-pandemic figures from 2019, according to the data.

Misdemeanor assaults were also down by nearly 14 percent compared to 2019.

Reversing the troubling crime trend remains one of the main challenges for Mayor Eric Adams, who has said he wants his police administration, led by new top cop Keechant Sewell, to create a blueprint for policing in other major cities.

Homicides steadily decreased in the Big Apple before spiking during the pandemic, primarily driven by the two-year pattern of surging gun violence.

In 2021, the NYPD recorded 1,562 incidents of gun violence with 1,877 victims, a 101 percent and 103 percent increase from 2019.

Robberies were up slightly from 2020 and 2019, 5.1 percent and 2.8 percent, respectively.

Grand larcenies were also up but still remained lower than pre-pandemic levels.

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NYC wiped out five years of policing progress in 2021 - New York Post

ELKHART The Daylite Inn has been staying on top of its code violations cited last month, city officials said, but it still must fix plumbing and electrical deficiencies.

The hotel at 2820 Cassopolis St. was cited as unsafe for human occupancy by city inspectors after the Elkhart Fire Department saw several smoke detectors not working during a routine inspection, which prompted a further inspection from city code enforcement officers.

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City: Daylite Inn making progress on code violations - The Elkhart Truth