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A new cancer immunotherapy brings cautious hope for a field long awaiting the next big breakthrough

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.
He had texted his wife, a pediatric.

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Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

She excused herself to her hotel as fast as possible, and when she finally called back, 45 minutes later, Bob didn’t need an oncologist or a technical explanation to know what that constellation of tumors pointed to.

“She was not sobbing but close to it,” Bob said. “And up to that point, she had not showed me any part of that side.”

Then his wife, Amanda, heard a knock on the hotel door. It was another cheer mom. She saw Amanda leave and wanted to checked everything was alright. When Amanda explained her husband’s melanoma had returned and spread, the other mom said she knew someone high up at MD Anderson, the famous University of Texas cancer center. Maybe they could help.

Bob Seibert

Within a week, on Dec. 12, 2020, Bob was on a plane to Houston, where he waited in an exam room for Dr. Hussein Tawbi. Lean and confident, with a whisper of a mustache and a reassuring demeanor, Tawbi explained that a decade ago, all he could’ve told Bob was to get his affairs in order. Now there were two options: one immunotherapy that was pretty tolerable and would probably extend his life a little, or a combination of two immunotherapies that might boost survival but came with extensive side effects.

There was also door #3: a trial for a third immunotherapy that, though still experimental, might give him all the benefits of the combination but without the vomiting and liver damage. If he was one of a lucky few who are particularly responsive, Tawbi said, he might get something close to a cure. If not, a couple years wasn’t so bad, given the circumstances.

“I started the treatment eight weeks later,” the 60-year-old Seibert said, the first of what would become a monthly voyage to Texas. “And the day before my third treatment, they scanned me. And all the same spots had shrunk by 60% or more.”

A year later, Seibert appears cancer free — scans still turn up centimeter-sized lesions, but doctors assure him it’s likely leftover scar tissue — and the drug he received, an antibody called relatlimab, is on track for what some researchers say would be a landmark approval.

Hussein Tawbi

After the two so-called checkpoint inhibitors — Seibert’s door #1 and #2 — began to transform cancer care a decade ago, extending lives and sparing patients toxic chemo, companies spent billions searching for new molecules to turbocharge the immune system against cancer. Those efforts almost universally failed or proved inconclusive until last year, when Bristol Myers Squibb announced a combination of relatlimab and a commonly used PD-1 inhibitor stopped cancer progression for 10.1 months in melanoma patients, compared to 4.6 months for PD-1 alone.

Some researchers think it may do the same for other cancers, while paving the way for new targets and new combinations.

“We’ve been waiting a while for this,” Tawbi said.

But not everyone is convinced. Many oncologists and even major companies developing drugs for the same receptor, called LAG-3, think it will probably only work for a few tumors, mostly skin cancers. They note how little we know about LAG-3, or even the basic, broader interplay between tumor and immune system, almost a decade after checkpoints were approved. And they caution that to see many more cases like Seibert’s, researchers may need tools and targets only just now coming to the fore.

“Unfortunately, since PD-1 and CTLA-4, none of these agents have produced anything remarkable,” said Garo Armen, CEO of the immuno-oncology biotech Agenus. “Does that mean immuno-oncology has hit a brick wall?”

Or, he added, does that mean researchers just haven’t figured out how to match the pieces of the puzzles?

The class of drugs that have most radically altered cancer care in the last decade target T cells, the immune system’s search-and-destroy drones. T cells have “on switches” that other immune cells, called sentinels, can flick when a threat is detected. And they have “off switches” that the sentinels can flick to prevent the drones from going Rambo and destroying healthy tissue. (These various switches are called “checkpoints” because they represent various gates T cells have to clear to attack.)

To survive, many tumors learn to flick the off switches, shutting down the drones. The two approved classes of checkpoint inhibitors, CTLA-4 and PD-(L)1, jam those switches, allowing the T cells to stay active. The results have been dramatic: In 2018, Keytruda, the best-selling PD-(L)1 drug, dramatically extended the lives of metastatic lung cancer patients. It’s now approved for 18 different indications and generates $14 billion per year.

And yet still only a small percentage of US cancer patients — 11% by one 2020 conservative estimate — are actually eligible and almost all eventually relapse. So researchers started looking for other switches to hit.

Antoni Ribas

“We all thought — at least most of the field, including me — that there were other checkpoints maybe limiting the immune response in cancers that weren’t being benefited,” said Antoni Ribas, a professor of medicine at UCLA and one of the earliest proponents of checkpoint therapy.

A reasonable thought, but not, until recently, a particularly fruitful one. For years, every new checkpoint companies tested failed or produced murky results.

That’s why some researchers are so excited about the relatlimab data. Oncologists widely expect approval by April, when it will likely change how doctors treat metastatic melanoma. When combined with PD-1, the drug dramatically improves survival without all the toxicity of CTLA-4. Although doctors still want to see CTLA-4/PD-1 and LAG-3/PD1 head-to-head in a rigorous trial, LAG-3 will become the go-to option for patients who can’t or don’t want to tolerate the side effects CTLA-4 drugs bring.

Scientists who watched trials for an alphabet soup of T cell targets — TIM-3, VISTA, OX-40 — struggle in the clinic say those data have to be seen as a breakthrough. It proves combination treatments can, in principle, improve on Keytruda and other PD-1s, suggesting other duos may follow.

“That’s very significant,” Ribas said. Previously, some researchers had begun to suspect maybe PD-1 is so important and dominant “that all the other checkpoints are irrelevant,” he said. “It’s been really hard to demonstrate that you can do better with a combination.”

For Tawbi, LAG-3’s safety is what makes it “so incredible.” Because PD-1 is so tolerable, companies could throw it at thousands of trials, combining it with chemo and targeted therapy in search of the best cocktail for dozens of cancers.

They can test LAG-3 with similar abandon, he said, launching “tons of trials” to see if it can add “that extra 25%” efficacy like in melanoma.

“I have no idea whether it’s going to end up doing that,” Tawbi said. “But that’s my expectation.”

The roots of relatlimab are actually as old as the drugs that have already changed cancer.

Jim Allison — the straggly-haired, Willie Nelson-playing, Nobel Prize-winning scientist — started studying CTLA-4 around 1990, the year Frédéric Triebel, an immunologist at a cancer center just south of Paris, cloned a receptor on T cells that he called lymphocyte-activation gene 3, or LAG-3 — so-named because it was present on active, but not resting, T cells. (T cells are a type of lymphocyte.)

“It’s not a very nice name,” Triebel, who has full white hair like Allison and a thin French accent,  said in a recent interview. “But it is what it is.”

In a series of experiments over the next five years, Triebel showed LAG-3 can pick up a key signal that the scouts and foot soldiers of the immune system use to relay information to T cells. LAG-3 was another one of those off-switches. Block it, and the T cells kill at a greater clip.

Frédéric Triebel

“And of course, you can use it in cancer patients,” Triebel said. At the time, though, Allison’s groundbreaking results were still years away. Immuno-oncology had barely emerged from what one researcher has called its “dark decade.” In 2001, Triebel founded a biotech company, Immutep, to develop LAG-3 targeted drugs. Few invested.

“I’m like Steve Jobs,” he said. “Working in my garage for the last 30 years.”

Then in 2011, the FDA approved Yervoy, Allison’s CTLA-4 antibody by then licensed to Bristol Myers, after a trial showed it could halt melanoma’s progression almost twice as long on it as chemo. Not long after, the first data came in suggesting targeting PD-1 could be even more transformative in many cancers.

Samit Hirawat

LAG-3 was first on Bristol Myers’ list as it looked for the next frontier. In 2013, researchers started a relatlimab trial in melanoma, but it became clear immediately it wasn’t shrinking tumors. “Very quickly, there was a realization there was really not much activity,” said BMS CMO Samit Hirawat.

Immutep’s data from the mid-2000s similarly showed a slightly different approach to targeting LAG-3 had “minimal activity” when given alone. By then, though, researchers had already demonstrated that combining CTLA-4 and PD-1 could induce longer responses than either alone.

Two staff scientists, Fouad Namouni and Brian Lestini, decided to combine PD-1 plus LAG-3 in a trial. They picked melanoma, because it was known to be particularly susceptible to immunotherapy.

“The rest is history,” said Hirawat.

The big question now is whether LAG-3 can change treatment for other cancers, and what its early success might mean for the broader field of immunotherapy.

Bristol Myers is betting the drug has wide utility. There are 39 active trials of relatlimab (many but not all sponsored by Bristol Myers) listed on clinicaltrials.gov, testing it in combination with PD-1 in leukemia, colon cancer, lung cancer, head and neck cancer and esophageal cancer, among others.

Not everyone, though, is convinced. Regeneron has focused it’s LAG-3 antibody exclusively on melanoma and similar skin cancers.

Israel Lowy

“My understanding of what’s been at least publicly released is there’s not a slam dunk indication, where you get the same kick in activity, as melanoma,” said Israel Lowy, Regeneron’s head of oncology.

Miriam Merad, head of Mount Sinai’s Precision Immunology Institute, agreed. “I think it’s going to be very tumor specific,” she said.

The problem, in part, is LAG-3’s mechanism. Although researchers don’t fully grasp how LAG-3 works, the best way to understand its limitations is by picturing a factory control board covered with all of a T cell’s on and off switches. If a tumor wants to evade the immune system, one of the first things it will do is reach out and pull an “off” switch called PD-1. That’s a pretty powerful switch, the immunological equivalent of a big red metal lever to override nearly everything else.

PD-1 inhibitors jam the switch so tumors can’t keep pulling it. After that, a tumor has to find other ways of avoiding T cells if it wants to survive. A small handful of cancer cells might, out of all the little metal switches on the board, figure out that pulling LAG-3 will also shut down many of the T cells.

But it’s a secondary approach, after PD-1, and only a small number of tumors figure out they can use it. An antibody like relatlimab can jam the LAG-3 switch, but it’ll only help in the patients whose tumors flicked it in the first place.

(For those wanting more technicals: LAG-3 interacts with a signaling complex on the surface of cells called MHC Class II. Few cancer cells express this — really only ones, like melanoma, already heavily exposed to the immune system. Melanoma, in other words, is the lowest hanging fruit.)

The same may be true for the other checkpoints on Big Pharma’s radar, including TIGIT, the only other target to show significant efficacy and the center of a multi-billion dollar arms race involving Bristol Myers, Gilead, Roche, Novartis, Merck and GSK: Some patients’ cancers rely on it, but many more don’t.

Ribas said developers are facing the same problem that quarterbacks face as they approach the end zone.

Leena Gandhi

“The closer you get to the goal line, the harder it is to make a play,” he said. With PD-1, “we dialed up the immune response in a subset of patients and then there’s less margin for improvement with all the combinations.”

Indeed, selecting those patients has been among the most frustrating frontiers of immuno-oncology. The 2000s have seen two revolutions in oncology. In the first, targeted therapy, picking the patients most likely to respond is the high-tech equivalent of a Pre-K matching game: Sequence their tumors and see if they have the exact protein that a given drug targets. If so, there are high odds their tumors will shrink.

But a decade after the first checkpoint approval, doctors still have virtually no ability to predict who will respond to immunotherapy and who won’t. Bob Seibert appears to have been all but cured by relatlimab, but Tawbi can’t tell him why he wasn’t one of the many patients who see their cancers return after 10 months, or the patients who don’t respond at all.

At least for PD-1 drugs, data suggest patients whose tumors express higher amounts of a protein that turns on PD-1 are more likely to respond. But it’s only a very rough correlation, and MD Anderson researchers found no such relationship for LAG-3.

The struggle contributes to a trend that has long stymied immuno-oncology: Researchers run hundreds of trials, they see flash-in-the-pan responses — one patient in a dozen responding — in a few but because they can’t pre-select that patient, they can neither prove the response wasn’t a fluke, nor use the molecule effectively in the clinic.

“We need to focus in that direction,” said Leena Gandhi, director of the Center for Cancer Therapeutic Innovation at Dana-Farber. “Certainly where we’ve had the most success with any therapeutic in cancer is where we can really match the right patient to the right treatment.”

The tumor samples arrive daily to the third floor of a large brick-and-glass building on the south side of MD Anderson’s sprawling Houston campus, delivered by assistant from the nearby pathology center. About six sections come per tumor, each floating in their own personal test tube, ready to be further sliced, inspected and analyzed by a dozen different researchers and machines.

Padmanee Sharma

For much of the last half decade, Allison and Padmanee Sharma, a respected professor of immunology and oncology, have worked in the 6,000-square-foot facility to decipher the delicate interplay between immune system and tumor: How the tumor first interacts with the immune system and how that changes when a patient is exposed to PD-1 inhibitors or another checkpoint inhibitor. Recently, they started studying tumor samples from Tawbi’s LAG-3 patients.

By comparing samples from before and after immunotherapy and between responsive and non-responsive patients, Sharma and Allison — who are also married — hope to discover why certain patients respond and which types of tumors use which mechanisms to evade treatment.

In theory, that should allow them to target immune-harnessing therapies with greater precision.

This process of “reverse translation” is actually a marked departure from immuno-oncology’s focus over  the last decade, when as Tawbi puts it, companies started “thousands of clinical trials,” trying “everything on the planet-plus-PD-1.”

“We didn’t just throw drug A and drug B to come up with immune checkpoint therapy, right? That really came from basic and discovery science,” Sharma said, while stressing the deluge of recent clinical trials have been critical to try to save patients suffering today. “We need to get back to the fundamentals.”

Partly, that means an increased focus on the tumor microenvironment, the dense jungle of blood vessels and basic immune cells tumors can use to keep T cells out. The cells in this habitat, called myeloid cells, are supposed to act as sentinels, alerting and instructing T cells if there’s a problem. But tumors often figure out ways to hijack and reprogram myeloid cells, turning sentinels into saboteurs that keep T cells in the dark.

In just the last couple of years, venture capitalists have poured hundreds of millions into companies trying to change so-called cold tumors — ones that allow T cells to enter — into so-called hot tumors. Gilead spent $4.9 billion in 2020 to buy out a startup with promising early data on myeloid cells. They followed it up with $275 million for another that promises to re-program pro-tumor myeloid cells back into tumor-eating ones.

Miriam Merad

The push could find results in all cancers but, experts say, will be particularly important for tumors that have always been notoriously resistant to immunotherapy, such as pancreatic cancer and brain cancers like glioblastoma.

In many of these patients, unleashing T cells never had an effect because T cells hadn’t noticed there even was an invader or couldn’t reach it.

“I don’t know one cancer immunologist that is not” excited about this, said Merad, whose lab focuses on myeloid cells. “That was not the case 10 years ago. But even the most T cell chauvinists are good scientists. They just look at the data and realize we need to harness these instructors.”

Ironically, LAG-3 could play a role here too. Triebel and Immutep are now focused not on blocking the LAG-3 receptor on T cells, as relatlimab does, but on giving patients an IV version of the LAG-3 protein itself. They believe it can stimulate these instructor cells, and investors have given a rare bit of faith, offering $45 million to the oft-underfinanced company in June.

For now, though, these approaches remain, like most, unproven. Yet what’s newly clear is that there are ways of getting more people to benefit from checkpoints and for longer, if researchers can just get all the pieces in alignment.

Bob Seibert is a testament to that. A year after he began treatment, he isn’t feeling 100%. He wakes up daily with fatigue that’s worsened to the point that, during the holidays he took off from the job he’s held for 35 years at a local hardware chain, to make sure they could have the most able staff during the rush.

But it’s nothing, he said, in comparison to the alternatives. He can still fish for black drum and redfish off the Carolina coast once or twice a week, even if it’s for four hours instead of eight. A Christian who prides himself on self-sufficiency, he talks about a renewed faith in God, about the humbling experience of — as James commands — asking those in his community to pray for him, about the “miracle” of the chance hotel room encounter that got him to MD Anderson.

Bob Seibert and his wife, Amanda

“You know that’s too much for me to believe,” he sad. “The idea that God put that together to show us not only what to do but, you know, that he was involved.”

Now he toys with the idea of traveling with his wife when the pandemic lifts: to Greece, touring the country and its history, “not necessarily more than a couple nights in one place,” he said. “But seeing the entire country in a span of a couple weeks.”

More immediately, his youngest daughter just got into Clemson and he wants to drive through Arkansas and Texas, where much of his family lives too. He already goes there often, anyway, once every four weeks for more infusions, in hopes of keeping the T cells going as long as possible — or at least until the next breakthrough is available.

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After mass shootings like Uvalde, national gun control fails – but states often loosen gun laws

After mass shootings, politicians in Washington have failed to pass new gun control legislation, despite public pressure. But laws are being passed at…

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A girl cries outside the Willie de Leon Civic Center in Uvalde, Texas, on May 24, 2022. Allison Dinner/AFP via Getty Images

Calls for new gun legislation that previously failed to pass Congress are being raised again after the May 24, 2022, mass shooting at an elementary school in the small town of Uvalde, Texas.

An 18-year-old shooter killed at least 19 fourth grade students and two teachers at Robb Elementary School, marking the deadliest school shooting in the U.S. in a decade.

The U.S. has been here before – after shootings in Tucson, Aurora, Newtown, Charleston, Roseburg, San Bernardino, Orlando, Las Vegas, Parkland, El Paso, Boulder, and 12 days earlier at a grocery store in Buffalo, N.Y.

Gun production and sales in the U.S. remain high, following a purchasing surge during the COVID-19 pandemic. In 2021, the firearms industry sold about six guns for every 100 Americans.

Senator Chris Murphy of Connecticut was among the Democratic politicians who pleaded for action on gun control as horrifying details of the Uvalde school shooting unfolded.

“What are we doing?” Murphy asked other lawmakers, speaking from the Senate floor on the day of the shooting. “Why are you here if not to solve a problem as existential as this?”

Congress has declined to pass significant new gun legislation after dozens of shootings, including those that occurred during periods like this one, with Democrats controlling the House of Representatives, Senate and presidency.

This response may seem puzzling given that national opinion polls reveal extensive support for several gun control policies, including expanding background checks and banning assault weapons.

In October 2021, 52% of people polled by Gallup said that they thought firearm sales laws should be made more strict.

But polls do not determine policy.

I am a professor of strategy at UCLA and have researched gun policy. With my co-authors at Harvard University, I’ve studied how gun laws change following mass shootings.

Our research on this topic finds there is legislative activity following these tragedies, but it’s at the state level.

A Democratic senator and Sandy Hook parents and teachers at a press conference in the US Capitol in 2013.
U.S. Senator Richard Blumenthal (D-Conn.) speaks to the media as teachers, parents and residents from Newtown, Conn. – where the Sandy Hook school massacre happened – listen after a Capitol Hill hearing on Feb. 27, 2013, on the Assault Weapons Ban of 2013. Alex Wong/Getty Images

Restrictions loosened

Stricter gun laws at the national level are more popular among Democrats than Republicans, and major new legislation would likely need votes from at least 10 Republican senators. Many of these senators represent constituencies opposed to gun control.

Despite national polls showing majority support for an assault weapons ban, not one of the 30 states with a Republican-controlled legislature has such a policy.

U.S. Texas Senator Ted Cruz said on May 24 that more gun control laws could not have prevented the Uvalde attack, explaining “that doesn’t work, it’s not effective, it doesn’t prevent crime.”

The absence of strict control policies in Republican-controlled states shows that senators crossing party lines to support gun control would be out of step with the views of voters whose support they need to win elections.

But a lack of action from Congress doesn’t mean gun laws are stagnant after mass shootings.

To examine how policy changes, we assembled data on shootings and gun legislation in the 50 states between 1990 and 2014. Overall, we identified more than 20,000 firearm bills and nearly 3,200 enacted laws. Some of these loosened gun restrictions, others tightened them, and still others did neither or both – that is, tightened in some dimensions but loosened in others.

We then compared gun laws before and after mass shootings in states where mass shootings occurred, relative to all other states.

Contrary to the view that nothing changes, state legislatures consider 15% more firearm bills the year after a mass shooting. Deadlier shootings – which receive more media attention – have larger effects.

In fact, mass shootings have a greater influence on lawmakers than other homicides, even though they account for less than 1% of gun deaths in the United States.

As impressive as this 15% increase in gun bills may sound, gun legislation can reduce gun violence only if it becomes law. And when it comes to enacting these bills into law, our research found that mass shootings do not regularly cause lawmakers to tighten gun restrictions.

In fact, we found the opposite. Republican state legislatures pass significantly more gun laws that loosen restrictions on firearms after mass shootings.

In 2021, Texas Governor Greg Abbott signed a new law that eliminated a requirement for Texans to obtain a license or receive training to carry handguns. This came two years after a 2019 mass shooting at a Walmart in El Paso.

That’s not to say Democrats never tighten gun laws – there are prominent examples of Democratic-controlled states passing new legislation following mass shootings.

California, for example, enacted several new gun laws following a 2015 mass shooting in San Bernardino. Our research shows, however, that Democrats don’t tighten gun laws more than usual following mass shootings.

After the Buffalo shooting in early May 2022, New York Governor Kathy Hochul said that she would work to increase the age for legal gun purchasing from 18 to 21 “at a minimum.”

'Change gun laws or change Congress' reads a sign at a 2018 rally in New York City.
In August 2018, Moms Demand Action hosted a rally at New York City’s Foley Square to call upon Congress to pass gun safety laws. Erik McGregor/LightRocket via Getty Images

Ideology governs response

The contrasting response from Democrats and Republicans is indicative of different philosophies regarding the causes of gun violence and the best ways to reduce deaths.

While Democrats tend to view social factors as contributing to violence, Republicans are more likely to blame the individual shooters.

Cruz, for example, has said that stopping individuals with criminal records from committing violence could help prevent mass shootings.

Politicians favoring looser restrictions on guns following mass shootings frequently argue that more people carrying guns would allow law-abiding citizens to stop perpetrators.

In fact, gun sales often surge after mass shootings, in part because people fear being victimized.

Democrats, in contrast, typically focus more on trying to solve policy and societal problems that contribute to gun violence.

For both sides, mass shootings are an opportunity to propose bills consistent with their ideology.

Since we wrote our study of gun legislation following mass shootings, which covered the period through 2014, several additional tragedies have energized the gun control movement that emerged following the December 2012 shooting at Sandy Hook Elementary School in Connecticut. These include the May 2022 shooting at the Tops grocery store in Buffalo, as well as the Uvalde school massacre.

While President Joe Biden issued executive orders in 2021 with the goal of reducing gun violence, action in Congress remains elusive. States, meanwhile, have been more active on the issue.

Student activism following the 2018 shooting at Marjory Stoneman Douglas High School in Parkland, Florida, did not result in congressional action but led several states to pass new gun control laws.

With more funding and better organization, this new movement is better positioned than prior gun control movements to advocate for stricter gun policies following mass shootings. Public outcry and devastation over the Uvalde shootings will likely provide fuel to this advocacy work.

But with states historically more active than Congress on the issue of guns, both advocates and opponents of new restrictions should look beyond Washington for action on gun policy.

This is an updated version of an article originally published on March 21, 2021.

Christopher Poliquin does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

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Lactation Lab receives FDA Breakthrough Device designation for breast-milk-testing device that allows mothers to test for key nutritional elements in their milk

Los Angeles, May 25, 2022 –Lactation Lab, which offers the most scientifically advanced breast milk testing available, has announced today that the…

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Los Angeles, May 25, 2022 –Lactation Lab, which offers the most scientifically advanced breast milk testing available, has announced today that the U.S. Food and Drug Administration (FDA), has granted the company Breakthrough Device designation for its latest device Emily’s Care Nourish Test System that tests and provides a nutritional analysis of breast milk. 

Credit: Dr. Stephanie Canale

Los Angeles, May 25, 2022 –Lactation Lab, which offers the most scientifically advanced breast milk testing available, has announced today that the U.S. Food and Drug Administration (FDA), has granted the company Breakthrough Device designation for its latest device Emily’s Care Nourish Test System that tests and provides a nutritional analysis of breast milk. 

This first-of-its-kind breast-milk (point of care)-test allows mothers to test for key macronutrients (fat, protein, carbohydrates and adjust their nutritional intake accordingly. The test was developed for use in the NICU, hospital clinics, milk banks and home use. 

“The FDA Breakthrough Device designation for Emily’s Care Test System is a critical step in serving the most vulnerable infant population,” says Dr. Stephanie Canale, CEO of Lactation Lab. “Research in the past five years demonstrates how important key nutrients are for babies in the first five weeks of life. Nutrition is the only modifiable factor for preterm babies, and our Emily’s Care device provides potentially life-saving data, especially for those at risk of life-threatening conditions.”

The FDA Breakthrough Device designation will expedite regulatory review of Emily’s Care to provide patients and health care providers with quicker access. The designation is only awarded to breakthrough technologies that have the potential to provide effective treatment and diagnosis for life-threatening or irreversible debilitating diseases or conditions.

Founded in 2017 by CEO Dr. Stephanie Canale, Lactation Lab’s proprietary tests were developed by a team of practicing physicians, Ph.D. chemists and toxicologists. The startup company is housed at the Magnify Incubator at the California NanoSystems Institute at UCLA, which provides access to one of the most advanced research labs in the world. 

Lactation Lab is pioneering academic research in breast milk composition, also publishing findings in several prominent scientific journals, including Breastfeeding Medicine and Clinical Lactation.

Canale, a physician formerly at UCLA whose practice largely consisted of new mothers and babies, started Lactation Lab to provide parents with scientific and evidence-based insights, resources, and guidance. As a mom with an infant diagnosed with “failure to thrive,” also known as growth faltering. Canale wondered why there was no way to know what was in her own breast milk. 

“The time is now to empower moms with the kind of information and peace of mind I needed during my own breastfeeding journey. During the Covid-19 pandemic, amid the anxiety of leaving the home and going to doctor’s visits, we decided to bring Emily’s Care directly to mothers and take the guesswork out of breastfeeding,” said Canale. 

Lactation Lab’s breast-milk-test surpasses the creamatocrit breast milk test first developed in 1978. This rudimentary test is still widely used in hospitals, NICUs and support centers. Lactation Lab’s Emily’s aims to replace the existing test with Emily’s Care, which provides more accurate data than infra-red human milk analyzers. The company also just launched Emily’s Care infant supplement, which is the first infant supplement to receive Clean Label Project Certification and will support breastfeeding babies.

“We would like to continue advancements in women’s health to remove the current stigma around postpartum care and breastfeeding,” said Canale. “The data supports objective, evidence-based decision-making not only for hospitals and NICUs, but also for mothers at home. These are revolutionary steps to improve the standard of care surrounding breast milk for mom and baby.” 

Currently in the seed round of funding. Those interested in investing in Lactation Lab may reach out to scanale@lactationlab.com. To learn more, visit lactationlab.com and join the conversation @lactationlab.

About Lactation Lab

Founded by CEO Stephanie Canale, a doctor and mother of two, Lactation Lab is a first-of-its-kind breast-milk-testing kit. Lactation Lab analyzes your breast milk for basic nutritional content like calories and protein, as well as vitamins, fatty acids, and environmental toxins. Results are delivered in a user-friendly report that reads like a food label. Lactation Lab explains how results affect children, offers suggestions for enhancing the quality of milk, and offers personal consultation. Other products include mastitis screening test strips and the company will soon be launching a Clean Label certified infant supplement. Learn more at www.lactationlab.com.

About the FDA Breakthrough Device Program

The FDA Breakthrough Device program enables expedited regulatory assessment of novel technologies with the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency’s mission to protect and promote public health.

About Magnify Incubator at the California NanoSystems Institute at UCLA 

Centrally located at UCLA’s Court of Sciences, Magnify strives to enhance the vibrant culture of entrepreneurship at UCLA and the broader Los Angeles region. Magnify was built with one goal in mind: to help startups succeed by vastly accelerating their access to facilities while increasing their capital efficiency and market opportunities.

Related Links

www.lactationlab.com
magnify.cnsi.ucla.edu

Learn more about Lactation Lab from CEO Dr. Stephanie Canale
https://www.youtube.com/watch?v=3t4Q1OX05lg


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Hertz Foundation announces 2022 Hertz fellows

The Fannie and John Hertz Foundation today announced the recipients of the prestigious 2022 Hertz Fellowships in applied science, mathematics and engineering….

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The Fannie and John Hertz Foundation today announced the recipients of the prestigious 2022 Hertz Fellowships in applied science, mathematics and engineering.

Credit: Fannie and John Hertz Foundation

The Fannie and John Hertz Foundation today announced the recipients of the prestigious 2022 Hertz Fellowships in applied science, mathematics and engineering.

This year’s fellowships will fund 13 remarkable doctoral students who demonstrate extraordinary potential to become foremost leaders in their fields and tackle the most significant challenges facing the nation and the world. The fellowship will directly support researchers interested in defending the nation’s digital infrastructure against cyberthreats, developing more efficient electronics that can help reduce dependence on fossil fuels, and creating biomedical devices to aid rehabilitation and cancer diagnostics.

“To remain a global leader in science and technology, our nation requires enterprising minds capable of inventing creative solutions to real problems,” said Robbee Baker Kosak, president of the Hertz Foundation. “We’re thrilled to be able to support these promising innovators and fuel their research at such a pivotal time in their careers.”

Since 1963, the Hertz Foundation has granted fellowships empowering the nation’s most promising young minds in science and technology. Hertz Fellows receive five years of funding, valued up to $250,000, which offers flexibility from the traditional constraints of graduate training and the independence needed to pursue research that best advances our security and economic vitality.

In addition to receiving financial support, Hertz Fellows join a multigenerational, intellectual community of peers, which offers a unique engine for professional development and collaboration. Hertz Fellows have access to lifelong programming, such as mentoring, events, and networking, which has led them to form research collaborations, commercialize technology, and create and invest in early-stage companies together, among other opportunities.

Among the past recipients of the Hertz Fellowship are Nobel laureate John Mather, a NASA astrophysicist and project scientist for the James Webb Space Telescope; Kim Budil, director of Lawrence Livermore National Laboratory; Nathan Myhrvold, founder and CEO of Intellectual Ventures, founding director of Microsoft Research, and former chief technology officer at Microsoft; Kathleen Fisher, deputy office director for the Defense Advanced Research Projects Agency Information Innovation Office; and neuroscientist Ed Boyden of the Massachusetts Institute of Technology, who is developing optogenetic technologies to understand and treat brain conditions such as Parkinson’s disease. 

The Hertz Foundation is dedicated to expanding and accelerating the U.S. pipeline of scientific and technical leadership. Through a rigorous and time-tested selection process, led by Hertz Fellow Philip Welkhoff, director of the malaria program at the Bill & Melinda Gates Foundation, the fellowship selection committee sought out candidates demonstrating deep, interconnecting knowledge and the extraordinary creativity necessary to tackle problems that others can’t solve.

“John Hertz’s vision was that as new challenges arise, a vibrant and innovative cadre of researchers in the applied sciences was essential for facing and overcoming them,” said Welkhoff. “This cohort of Hertz Fellows embodies these values in so many unique and individual ways. I am delighted to welcome them into the Hertz community and to see what they achieve in the decades ahead.”

The 2022 class joins a community of fellows comprising some of the nation’s most noted science and technology leaders, whose transformative research and innovation impact our lives every day. Hertz Fellows have increased the accessibility of ultrasounds with the invention of a low-cost handheld device and helped prove the big-bang theory of the universe. They are using machine learning to investigate disparities in COVID-19 testing and develop collaborative research tools. They have saved lives with a simple test that reveals fake pharmaceuticals, are influencing companies to institute environmentally sound practices, and are developing aircraft powered by hydrogen fuel cells for energy-efficient, lower-cost transportation.

Over the foundation’s 59-year history of awarding fellowships, more than 1,200 Hertz Fellows have established a remarkable track record of accomplishments. Their ranks include two Nobel laureates; recipients of eight Breakthrough Prizes and three MacArthur Foundation “genius awards”; and winners of the Turing Award, the Fields Medal, the National Medal of Technology and the National Medal of Science. In addition, 48 are members of the National Academies of Sciences, Engineering and Medicine, and 32 are fellows of the American Association for the Advancement of Science. Hertz Fellows hold over 3,000 patents, have founded more than 375 companies, and have created hundreds of thousands of science and technology jobs.

Introducing the 2022 Hertz Fellows

Fellows are listed with their graduate university affiliations and fields of interest.

Roderick Bayliss III
University of California, Berkeley
Power Electronics

Roderick Bayliss wants to design more efficient and power-dense electronics, a step toward reducing the world’s dependence on fossil fuels. Currently a graduate student at the University of California, Berkeley, Bayliss has already carried out work developing novel types of power converters — devices that change the current, voltage or frequency of electrical energy — and inductors, which store energy. He received both his bachelor’s degree and his master’s degree in electrical engineering from MIT.

Nikhil Bhattasali
New York University
Neuroscience, Artificial Intelligence

Nikhil Bhattasali is interested in understanding biological intelligence to build better artificial intelligence. Inspired by animal nervous systems, he assembles computational models that can control embodied agents and robots. Currently a NeuroAI Scholar at Cold Spring Harbor Laboratory, Bhattasali conducts highly interdisciplinary research combining machine learning, systems neuroscience and computer science. Bhattasali received both his bachelor’s degree in symbolic systems and his master’s degree in computer science from Stanford University. He will be joining the doctorate program in computer science at New York University in fall 2022. 

Alexander Cohen
Massachusetts Institute of Technology
Mathematics

Alexander Cohen studies how waves interfere with each other — a topic of mathematics that has far-reaching implications across computer science, physics and number theory. Cohen is a first-year graduate student at MIT, and he graduated from Yale University in 2021 with a dual bachelor’s and master’s degree in mathematics. He was awarded a Goldwater Scholarship for his work and an honorable mention for the Morgan Prize — one of the highest undergraduate honors in mathematics.

Wenjie Gong
Massachusetts Institute of Technology
Physics

Wenjie Gong is interested in the intersection between quantum information and physical systems. Her goal is to develop scalable, stable and noiseless quantum devices that can push technology past the classical era. Gong is currently finishing her bachelor’s and master’s degrees at Harvard University, where she has already made significant inroads into understanding quantum phenomena in the fundamental constituents of matter. She will begin her doctorate in quantum information theory at MIT in fall 2022.

Jonah Herzog-Arbeitman
Princeton University
Physics

Jonah Herzog-Arbeitman is a condensed matter physicist working toward the discovery of new states of matter and the development of quantum materials. He hopes to tackle high-temperature superconductivity — the challenge of keeping superconductors stable at anything other than extreme cold temperatures. Herzog-Arbeitman studied physics, math and poetry as an undergraduate at Princeton University. Now a first-year graduate student at Princeton University, he is active in mentorship programs that demystify academia and the path to a career in research.

David Li 
Stanford University
Bioengineering

David Li aims to develop transformative technologies that enable new biological insights, approaches and therapies. Throughout his undergraduate career at MIT, Li worked on tools for gene editing, directed evolution and COVID-19 diagnostics. Li will spend time abroad in the U.K. as a Marshall Scholar, studying the structure of amyloid filaments at the MRC Lab of Molecular Biology through Cambridge University before pursuing a doctorate in bioengineering at Stanford University. He received a bachelor’s degree in electrical engineering and computer science from MIT in 2022.

Daniel Longenecker
Princeton University
Physics

Daniel Longenecker studies scattering amplitudes in quantum field theory and string theory at Princeton University, where he is a first-year graduate student. His goal is to contribute to the reformulation of quantum field theory by discovering new principles and mathematical structures. During his time as an undergraduate at Cornell University, where he received his bachelor’s in physics and physics education in 2021, Longenecker discovered a new connection between string theory and mathematical linguistics.

Scott Barrow Moroch
Massachusetts Institute of Technology
Physics

Scott Moroch is an experimental physicist pursuing research at the intersection of atomic, nuclear and particle physics. Using tabletop experiments, Moroch hopes to shed new light on the standard model of particle physics. He is currently a graduate student at MIT and received his undergraduate degree in physics from the University of Maryland in 2021. 

Vivek Nair
University of California, Berkeley
Computer Science

Vivek Nair develops cutting-edge cryptographic techniques to defend digital infrastructure against sophisticated cyberthreats. Currently a graduate student at the University of California, Berkeley and a researcher at Cornell’s Initiative for Cryptocurrencies and Contracts, Nair is also the founder of Multifactor.com and holds multiple patents for secure user authentication technologies. He was the youngest-ever recipient of bachelor’s and master’s degrees in computer science at the University of Illinois Urbana-Champaign.

Syamantak Payra
Stanford University
Engineering

Syamantak Payra is a scientist and engineer who is passionate about creating new biomedical devices to solve unmet health care needs. A senior at MIT, Payra has created digital fibers for electronic garments that can assist in diagnosing illnesses and has contributed to next-generation space suit prototypes that could better protect astronauts on spacewalks, among many other projects. He will begin his doctorate at Stanford University in fall 2022.

Shuvom Sadhuka
Massachusetts Institute of Technology
Computational Biology

Shuvom Sadhuka wants to apply mathematical algorithmic principles to the biological sciences to help create more efficient, private and robust tools for analyzing biological — especially genomic — data. In particular, he hopes to leverage ideas from algorithmic privacy, machine learning and data structures to create safe and efficient methods to accelerate biomedical research. He will receive his bachelor’s degree in computer science and statistics in spring 2022 from Harvard University and plans to pursue a graduate degree in computer science at MIT.

Emily Trimm
Stanford University
Biophysics, Medicine

An MD-PhD student in biophysics at Stanford University, Emily Trimm is interested in combining genomics with innovative biophysical techniques to address some of the biggest unanswered questions in human disease. Her current research uses multiomic data from high-altitude species, such as guinea pigs, alpine ibex and snow leopards, to study how the cells lining veins and arteries respond to physical force. She received her bachelor’s degree in physics and biophysics from the University of Pennsylvania in 2018.

Anonymous
Massachusetts Institute of Technology
Physics

About the Hertz Foundation

The Fannie and John Hertz Foundation identifies the nation’s most promising innovators in science and technology and empowers them to pursue solutions to our toughest challenges. Launched in 1963, the Hertz Fellowship is the most prestigious fellowship program in the U.S., fueling more than 1,200 leaders, disruptors and creators who apply their remarkable talents where they’re needed most — from our national security to the future of health care. Hertz Fellows hold 3,000+ patents, have founded 375+ companies, and have received 200+ major national and international awards, including two Nobel Prizes, eight Breakthrough Prizes, the National Medal of Technology, the Fields Medal and the Turing Award. Learn more at HertzFoundation.org.


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