Engitix Licenses Lonza’s Technology to Advance ADC Therapies

Lonza and Engitix signed a licensing agreement to advance the development of antibody-drug conjugates (ADCs) as therapies for patients with chronic diseases.

Engitix will access Lonza’s ADC technology platform through a single-target license, including the use of SYNtecan E™ linker-payload and complementary GlycoConnect® and HydraSpace®. These technologies are intended to support Engitix’s goal to develop and commercialize therapies.

Lonza, through one of its affiliated companies, is eligible to receive upfront, clinical, regulatory, and commercial milestone payments, plus royalties on net sales of resulting products. Lonza is responsible for manufacturing components that are related to its proprietary technologies, and Engitix will work on the R&D, manufacturing, and commercialization of the ADCs.

Engitix has developed a proprietary human extracellular matrix (ECM) platform that allows the study of disease biology directly in human tissue, according to a company official, who adds that this approach focuses on targets within the ECM itself, offering a differentiated pathway compared to traditional methods that focus on cell surface targets. 

The collaboration enables Engitix to leverage Lonza’s established ADC technology platform to develop differentiated therapeutic candidates designed to selectively deliver potent payloads to tumor-selective targets identified through Engitix’s proprietary human ECM discovery platform, explains Giuseppe Mazza, MD, PhD, CEO and co-founder of Engitix.

‘We are committed to translating our unique understanding of the disease microenvironment into transformative therapies for patients with high unmet medical need,” he continues. “Licensing Lonza’s clinically validated conjugation and linker-payload technologies provides us with a powerful toolkit to develop next-generation ECM-targeted therapeutics with the potential for enhanced efficacy, reduced toxicity and improved therapeutic index.” 

“We are pleased to collaborate with Engitix on this innovative program,” says Jan Vertommen, vice president of commercial development, advanced synthesis, Lonza. “By combining our ADC development and  manufacturing expertise with Engitix’s unique ECM-based discovery platform, we aim to advance next-generation ADCs and unlock new possibilities in targeted therapies for patients.” 

The post Engitix Licenses Lonza’s Technology to Advance ADC Therapies appeared first on GEN – Genetic Engineering and Biotechnology News.

Job dissatisfaction and health care access uncertainty grows in the U.S., new study finds

Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox.

Good morning. I admit that I didn’t finish rereading “The Odyssey” before I saw the movie last weekend, but it’s never too late. For now, scroll down to read a related First Opinion essay and to sign up for office hours with Bob Herman, STAT’s own Homeric chronicler of the business of health care.

Read the rest…

STAT+: ‘Cochlear implant for blindness’ debuts in Europe, could launch in U.S. in 2027

Europeans can now receive a device that can partially restore their vision loss. Americans may not have to wait long to get it, either.

Science Corporation announced Wednesday that European regulators had approved the commercial sale of the startup’s retinal implant that improves eyesight for patients with age-related macular degeneration in their central vision, enough to read books and road signs more clearly. 

“We have a cochlear implant for vision now,” said Science founder and CEO Max Hodak.

Continue to STAT+ to read the full story…

Shape-shifting mirrors on NASA’s new space telescope could unveil Jupiters like our own

When NASA’s Nancy Grace Roman Space Telescope launches, as early as the end of next month, it will attempt one of astronomy’s most precise disappearing acts to date. The telescope will carry the first space-bound “active” coronagraph, an instrument that effectively erases most of the light from a star during photography.

It will allow astronomers to take the first pictures of planets orbiting other stars that are similar to those in our solar system. Ultimately, it could pave the way for a future mission that could snap the first photos of Earth-like worlds.

“I hope it’s remembered for it being that critical stepping stone for … finding Earth 2.0,” says Brandon Creager, the instrument’s lead mechanical engineer at NASA’s Jet Propulsion Laboratory (JPL).

Named after Nancy Grace Roman, NASA’s first chief of astronomy, this new telescope will carry a roughly 300-megapixel wide-field camera that will enable it to capture images about 100 times larger than the Hubble Space Telescope’s widest exposures at a similar resolution.

These capabilities will help astronomers unpack the mysterious identities of dark matter and dark energy—and to detect around 100,000 new exoplanets, planets outside our solar system, whose presence can be inferred from the way they distort the starlight of more distant stars. Javier Viaña, a research scientist at Harvard who has had two projects selected for Roman’s highly competitive first year of observing, compares the leap to moving from “interviewing a handful of people” to “conducting a global census.”

Another camera will use the coronagraph, blocking out a star’s light as it observes one stellar system at a time. The instrument will allow astronomers an unprecedented look at the space around stars, enabling them to see smaller, dimmer, and more close-in exoplanets. “It’s giving us the ability to see planets that we haven’t been able to physically see before,” says Creager.

The anatomy of a vanishing trick

Coronagraphs in space aren’t new. But earlier incarnations, such as those currently aboard Hubble and the James Webb Space Telescope, use a stationary system to block a star’s blinding light. The approach does help, but it’s a bit like putting your thumb over a flashlight while searching a dark room for a firefly. Though the bulb vanishes, stray glare can still escape and overwhelm the light of the insect. Inside a telescope, that glare can come from light leaking around the edges of machinery or from minuscule imperfections in mirrors and coatings that can scatter starlight into speckles. All this can hide, or even impersonate, a planet.

Roman’s coronagraph, however, will attempt something completely unseen in space telescopes until this year: Before each observation, it will measure that leftover light and try to suppress it, a technique known as active wavefront control.

The telescope is able to do this because it contains two deformable mirrors. Each has a 48-by-48 checkerboard of actuators (tiny pistons) beneath a thin, deformable sheet of glass. Applying a small amount of voltage makes the actuators contract and tug their patches of mirror slightly backward, like thousands of microscopic fingers delicately sculpting a surface.

The effect is very subtle: Each patch of mirror can deform by up to 0.5 micrometers, or about one-fourth the size of an E. coli bacterium, and in increments as small as approximately 10 picometers. That’s about a tenth the diameter of a hydrogen atom, says Ilya Poberezhskiy, the instrument’s project systems engineer at JPL.

The actuators allow the mirrors to create an “active wavefront,” where each component is moved to the perfect position to cancel out incoming waves of unwanted light—a bit like a pair of noise-canceling headphones, but for light instead of sound. The “canceled-out” light creates a “doughnut-shaped region around the star where we suppress starlight and where we’re hoping to see exoplanets,” says Poberezhskiy.

Compared with current space-based coronagraphs, the system is expected to improve sensitivity to exoplanets against the glare of their host stars by a factor of up to 1,000, revealing planets that would have been far too faint to detect before.

Like Hubble and JWST, Roman also uses masks, patterned plates placed in the path of the light that are designed to block the photons that run into them. One tool in Roman’s mask arsenal is “silicon grass,” a thicket of microscopic spikes on some masks that can be used in certain configurations to absorb photons so they don’t bounce around the telescope and accidentally reach a detector.

Light entering the forest bounces deeper and deeper between the blades and gets trapped instead of reflecting back toward the camera. “Once the light gets into there, it never gets out,” Poberezhskiy says. The mirrors and masks form a succession of gates and hedges to guide as much of the preserved planetary light as possible toward the final detector.

Alien Jupiters

This elaborate setup could open a new chapter in the direct imaging of exoplanets. Nearly all exoplanets photographed so far are oversize youngsters that are nothing like the residents of our solar system: several times the mass of Jupiter, still glowing with the heat left over from their birth, and orbiting tens or hundreds of times farther from their star than the Earth is from the sun. This is because they are relatively easy to see. Their size, warmth, and distance from their parent star makes them shine brightly in infrared light, far away from the worst of the stellar glare.

Roman, however, could directly image a true Jupiter analogue—a planet similar to Jupiter in mass and circling a sunlike star a few times farther out than Earth is from our sun. Unlike the hot Jupiters we can see now, this one would be a much more mature gas giant like ours, primarily reflecting its parent star’s light after billions of years of cooling instead of heavily emitting its own.

Astronomers have been able to infer the existence of such planets from the gravitational wobble they impart to the star. Roman instead will collect starlight reflected from the planet itself. “We’re not looking at the star. We’re not looking at the effect of the planet on the star,” says Meredith MacGregor, a professor of astronomy at Johns Hopkins who has also secured an observing program. “We are actually looking at the planet, and that is super powerful.”

Once this instrument becomes available, it will become the scientists’ turn to do their jobs. “I’m honestly a little terrified about how we’re all going to deal with it, because I think it’s just so much data,” MacGregor says. “I think people will legitimately still be working on Roman data for decades.”

But don’t expect to see a 4K photo of an alien Jupiter in the coming months. Roman will not be able to resolve such a planet into a solid globe—at best, it will likely resemble a smattering of pixels. Still, that will be enough, MacGregor says, as Roman can then use the coronagraph to get information on the various wavelengths of light from the planet, which can tell astronomers about its atmospheric chemistry.

“You’re taking something that’s a point of light and turning it into an actual world,” she says, “because if you know that about its atmosphere, now you know something about the surface of the planet and the possibility of life being on that planet, right? So that’s a big step.”

During its first observations, scientists and engineers will see whether they can hold a star at the very center of the coronagraph’s masks, shape the mirrors, “dig” the dark doughnut (as Poberezhskiy describes it), and then maintain everything as the spacecraft moves through space and actively changes temperature.

The results will inform NASA’s proposed Habitable Worlds Observatory, the daydream of many an exoplanet astronomer, which will in theory be able to separate the light of an Earthlike planet from that of a sunlike star, over 10 billion times brighter.

Creager, who has worked on the instrument since 2018, is proud of the achievement: “Not too many people get to say, ‘I built something and it’s taking a picture of a planet that’s at a star that’s 50 light-years away or 100 light-years away.’” He imagines the moment he and his team will be able to look at the first image as it arrives: “Yes, we did that.” While the planet may show up only as a tiny dot, Roman’s achievement will be the darkness engineered around it.

STAT+: Federal health quality research grants worth $109 million ended early

Dozens of researchers funded by the federal Agency for Healthcare Research and Quality received notices last week that they would not receive future installments of funding for their ongoing research grants. While frustrating, the development was largely not a surprise to these researchers, many of whom had been waiting months for renewed funding or been unable to get explanations as to why the funding spigots had run dry from staffers at the agency. 

The notices punctuated nearly a year of uncertainty for health services researchers funded by AHRQ and left those who lost funding concerned about the future of their field. AcademyHealth, a professional organization representing health services researchers, has confirmed at least 78 grants worth $200 million have been affected. In all, those grants had $109.2 million in funding remaining, it  estimated.

Grant recipients were told in a letter of “non-award” that “AHRQ is adjusting its discretionary health services research award portfolio in order to better prioritize agency resources towards the above-mentioned priorities to best serve the interests of the Federal Government,” according to one such letter reviewed by STAT. The letter states the agency is prioritizing research on patient safety, antibiotic resistance, AI, long Covid, nutrition, and understanding autism, among others. 

Continue to STAT+ to read the full story…

Opinion: STAT+: Hospitals’ AI may be drifting. Who’s watching?

Walk into almost any U.S. hospital today and you will find AI doing some of the important work of medicine: drafting clinical notes, flagging sepsis, screening imaging, conducting prior authorizations, and answering patient messages. Adoption is moving fast, and the benefits are real.

But there’s a problem. Most health systems are monitoring the safety and performance of these tools the same way they govern a new MRI scanner in 2010: a subcommittee, a checklist, a quarterly meeting, an approval or a rejection. The process could take six months or longer.

That approach was already strained for older digital tools. For AI, it is dangerously inadequate, and the responsibility for fixing it rests not with IT, but with senior leadership.

Continue to STAT+ to read the full story…

Opinion: STAT+: I’m a cardiologist. I’m not sure the new cholesterol drug enlicitide is a game-changer

A long-awaited moment in preventive cardiology arrived last week, when enlicitide (which Merck is selling under the name Lipfendra) was approved by the FDA to lower blood cholesterol levels.

As the first oral PCSK9 inhibitor — powerful cholesterol-lowering medications, that, until now, have only been injectable — enlicitide itself is an impressive achievement. It punctuates a story of pharmaceutical innovation that has glided from the stories of families enrolled in the Dallas Heart Study at the bedside, to drug targets discovered at the lab bench, all ultimately transforming care back at the bedside.

It also comes at an opportune time. With new clinical guidelines supporting a more aggressive approach to lowering cholesterol levels, enlicitide may be particularly useful for people with either established or at high risk for cardiovascular disease. For the millions of Americans who fit into these groups, it has already been hailed as a game changer. But the story here — of whom it would actually help, and what it implies about prevention today — is more complicated.

Continue to STAT+ to read the full story…