Tag: Biotech

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Proteins.1 Launches to Develop Single Molecule Protein Amplification Tech for Diagnostics

Finnish deep-tech startup, Proteins.1, launched with €4.7 million in pre-seed funding, led by Lifeline Ventures and Cloudberry Ventures, with in-kind support from VTT and Business Finland. Harnessing technology transferred from VTT Technical Research Centre of Finland, Proteins.1 is developing a PCR-like enzyme-free, ultra-sensitive amplification platform for the detection of proteins at the single-molecule level. The firm says it aims to transform early disease diagnostics by enabling detection of disease-related molecular warning signals long before there are clinical signs.

While polymerase chain reaction (PCR) technology has transformed modern diagnostics by allowing tiny amounts of DNA to be amplified into detectable signals, no equivalent amplification method has existed for proteins, which often signal the earliest onset of cancer, neurodegeneration, cardiovascular disease, and inflammatory conditions, the company notes. Proteins.1 aims to leverage its technology to establish a new category of ultra-sensitive protein diagnostics, combining high multiplexing, scalable chip-based detection, and significantly lower capital costs compared to existing systems.

The patented, physics-based technology introduces cyclic signal amplification for proteins, potentially enabling up to 1,000 times better sensitivity than current gold-standard platforms, Proteins.1 claims. Unlike conventional immunoassays that rely on enzymatic reactions prone to variability and noise, the Proteins.1 approach is solid-state, enzyme-free, and compatible with semiconductor-based photonic detection.

The platform replaces enzymatic signal amplification with a physics-based magnetic cycling mechanism that repeatedly reads a single captured protein molecule, accumulating signal clarity without increasing background noise. The company says this supports ultra-high sensitivity combined with high multiplexing, potentially enabling the simultaneous measurement of hundreds of biomarkers from a few drops of blood.

“For decades, diagnostics has been limited not by biology, but by what our instruments can detect,” commented Proteins.1 co-founder and CEO Prateek Singh, who is inventor of the core technology. “The body produces early warning signals long before disease becomes visible. Our mission is to make those signals measurable and actionable, years earlier than today.”

Built on research conducted at VTT and further validated through European Union breakthrough innovation funding, the technology has been granted U.S. and Finnish patents, and additional international applications are pending. Initially, the company aims to develop research-use-only applications in oncology, neurology, and immunology, before progressing toward regulated clinical diagnostics. “Early detection dramatically improves survival rates in diseases such as cancer and neurodegenerative disorders,” Singh continued. “If we can detect disease at the molecular stage rather than the symptomatic stage, we entirely change treatment possibilities.”

Proteins.1 plans to expand its engineering and product development team in Finland during 2026–2027, positioning itself as a European hub for next-generation diagnostic technology. “Proteins.1 represents the kind of deep scientific breakthrough that can redefine an entire industry,” said Jyri Engeström at Lifeline Ventures. “The team combines world-class research with proven experience in building and scaling regulated medtech businesses.” Cloudberry Ventures further highlighted the company’s strong alignment with European strengths in photonics, microfabrication, and precision engineering.

Added Rene Kromhof, at Cloudberry VC, “What sets Proteins.1 apart is a fundamentally new sensing approach. Rather than using enzymes that give you one chance to detect a protein, they use light and thin-film transistors to amplify the signal from a single protein until it rises above the noise. That dramatically improves sensitivity, and ultimately, how early disease can be caught.”

CEO Prateek Singh has previously raised venture capital for microfluidics ventures and holds multiple patent families. Co-founder and COO Harri Hallila previously built and exited a regulated medical device company. The broader team includes commercial leadership with experience in leading diagnostics platforms.

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Advances in Stem Cell‑Derived Insulin‑Producing Cells for Type 1 Diabetes

Researchers at Karolinska Institutet and KTH Royal Institute of Technology have developed an improved method for creating insulin-producing cells from human stem cells. In a newly published study, the team demonstrated that these cells effectively regulate blood sugar levels in laboratory tests and can reverse diabetes in mice.

“We have developed a method that reliably produces high-quality insulin-producing cells from multiple human stem cell lines,” said Per-Olof Berggren, PhD, professor at the Department of Molecular Medicine and Surgery, Karolinska Institutet. “This opens up opportunities for future patient-specific cell therapies, which could reduce immune rejection.” Berggren and Siqin Wu, PhD, researcher at Spiber Technologies AB (formerly at Karolinska Institutet), are co-corresponding authors of the researchers’ published paper in Stem Cell Reports, titled “An optimized protocol for efficient derivation of pancreatic islets from multiple human pluripotent stem cell lines.”

Type 1 diabetes (T1D) occurs when the immune system destroys insulin-producing cells in the pancreas, meaning the body can no longer absorb glucose from the blood and regulate blood sugar levels. “In type 1 diabetes (T1D), autoimmune destruction of β cells results in loss of glycemic control,” the authors wrote.

One possible treatment strategy is to replace these cells with new ones. However, previous methods of producing such cells from stem cells have often yielded mixed results. Stem cell therapy for type 1 diabetes is already being tested in several clinical trials. However, a challenge with previous methods is that the stem cells often develop into a combination of the desired and undesired cell types, increasing the risk of complications. Another challenge is that the insulin-producing cells created are often not mature enough to respond well to glucose.

“The success of cell therapy for type 1 diabetes (T1D) depends on reliable differentiation of stem cells into functional pancreatic islets,” the authors noted. They pointed out that previous protocols have exhibited variable efficiency across different human pluripotent stem cell (hPSC) lines. “Differentiation beyond the stage (S) 4 pancreatic progenitor (PP) stage frequently yields heterogeneous cultures containing proliferative non-endocrine cells and immature endocrine cells … increasing the risk of cyst or tumor formation,” the team further commented.

The newly optimized production process reported by Berggren and colleagues yields more mature and purer insulin-producing cells than previous methods. In a laboratory setting, the cells were able to secrete insulin and responded strongly to glucose. When the researchers transplanted these cells into streptozotocin (STZ)-induced diabetic mice, the animals gradually regained the ability to regulate their blood sugar. “By adjusting the culture steps and allowing the cells to form three-dimensional clusters themselves, many unwanted cell types are eliminated and the cells gain a better ability to respond to glucose, according to the researchers. “Single-cell analyses show that the SC-islets are free of non-endocrine cell populations before and after transplantation,” the team stated.

The transplantation was performed in the anterior chamber of the eye (ACE) which provides a transparent and accessible site for noninvasive monitoring of engrafted SC-islets through the cornea, the team pointed out. Transplantation into this compartment is also straightforward and minimally invasive.  In their paper, the team noted, “Intraperitoneal glucose tolerance tests (IPGTT) at three, four, and six months post-transplantation showed improved glucose handling over time … SC-islet transplantation reversed hyperglycemia by three months, and by five–six months blood glucose levels fell slightly below pre-STZ baselines.”

Berggren commented, “This is a technique we use to monitor the development and function of the cells over time in a minimally invasive way. We observed that the cells gradually matured after transplantation, retaining their ability to regulate blood sugar for several months, which demonstrates their potential for future treatments.”

Fredrik Lanner, PhD, professor at the Department of Clinical Science, Intervention and Technology, Karolinska Institutet, and last author of the paper, added, “This could solve several of the problems that have previously hindered the development of stem cell-based treatments for type 1 diabetes. Building on this, we will work towards clinical translation aiming at treating type 1 diabetes.” In their report the authors concluded, “Our protocol generated glucose-responsive SC-islets from all eight hPSC lines tested … demonstrating potential for autologous applications … Our efficient differentiation protocol represents a key step toward autologous cell therapy, though further work is required to realize this goal.”

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Integrated Sample Preparation System Standardizes and Streamlines Pre-Analytical Workflows

Invivoscribe launched the PrepQuant™ sample preparation platform that integrates nucleic acid extraction, concentration, and quantification with a single automated instrument. The product is designed to standardize sample preparation and simplify pre-analytical workflows to reduce costs and eliminate a primary source of inconsistency in molecular testing.

Developed in collaboration with Hitachi High-Tech Corporation, PrepQuant combines Invivoscribe’s experience in developing standardized molecular assays, providing global clinical testing services, along with Hitachi High-Tech’s technological and manufacturing capabilities

The PrepQuant system is assay agnostic, generating highly concentrated genomic DNA and cell free DNA (cfDNA) yields for next-generation sequencing (NGS), qPCR, and digital PCR (dPCR) assays. By consolidating multiple steps in a single platform, the system can lab operating costs, sample variability, and lab bench space, while optimizing tests results.

“PrepQuant represents a significant advancement in our commitment to standardize the entire testing process, starting with the pre-analytical workflow,” said Jeff Miller, CEO and CSO of Invivoscribe. “This is particularly important in the era of precision medicine, where reliability of measurable residual disease and liquid biopsy results depend markedly on the quality and consistency of the starting material.”

“The concept for the [product] was driven directly by insights from LabPMM, our global network of testing laboratories,” added Jordan Thornes, vice president, global clinical lab operations. “Our teams recognized the limitations of currently available automated instruments, particularly the labor-intensive nature and increased risk of errors associated with running three separate protocols across multiple instruments. This all-in-one system was designed to reduce costs, while addressing those challenges and significantly improving operational efficiency.”

The PrepQuant is designed and validated for use with blood, plasma, and bone marrow specimens, with ongoing development for additional specimen types. Invivoscribe will officially unveil the product at the American Association for Cancer Research (AACR) Annual Meeting in San Diego, at booth #3459 from April 19–22.

 

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STAT+: Researchers behind GLP-1 obesity drugs advance new approach: Drop GLP-1 as a target

The scientists whose work spurred the development of powerful obesity drugs like Eli Lilly’s Zepbound are now raising a provocative hypothesis: Perhaps targeting the GLP-1 hormone is actually not necessary to achieve effective weight loss.

A group of researchers led by Richard DiMarchi and Matthias Tschöp has created an experimental drug that activates receptors of the GIP and glucagon hormones. They propose — based on rodent and monkey studies — that this kind of molecule, when administered at high enough doses, may result in weight loss comparable to the weight loss seen with drugs that include GLP-1 as a target, and without the tolerability issues like nausea and vomiting that often come with the approved treatments, according to a peer-reviewed draft paper published this week.

The research, funded by a biotech called BlueWater Biosciences, would still need to be confirmed in humans; oftentimes results seen in animals don’t translate in the clinic. But the proposed approach, outlined in the journal Molecular Metabolism by some of the most well-known scientists in the field, is likely to stir controversy, as it challenges a central notion underpinning not just the development of approved obesity products but also next-generation versions. 

Continue to STAT+ to read the full story…

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Landmark Pancreatic Cancer Trial Highlights Promise of RAS-Targeting Daraxonrasib

Earlier this week, Revolution Medicines reported positive results from a global Phase III trial of its RAS‑targeting inhibitor daraxonrasib (RMC-6236) in metastatic pancreatic ductal adenocarcinoma (PDAC). In the RASolute 302 trial, patients receiving daraxonrasib achieved longer progression‑free survival (PFS) and overall survival (OS) than those on standard cytotoxic chemotherapy.

The RASolute 302 trial enrolled patients with pancreatic tumors harboring a wide range of RAS variants, including those with RAS G12 mutations (such as G12D, G12V, and G12R), as well as those without an identified RAS mutation. The primary endpoints of the trial were PFS and OS in patients with tumors harboring RAS G12 mutations. Secondary endpoints assessed PFS and OS in all enrolled patients (the intent-to-treat population), including those with tumors with and without (wild type) an identified RAS mutation.

Daraxonrasib patients achieved a median OS of 13.2 months versus 6.7 months for chemotherapy. The drug was generally well tolerated, with a manageable safety profile and with no new safety signals.

“With these unprecedented results, daraxonrasib has the potential to achieve our goal of bending the mortality curve in pancreatic cancer. Unlike chemotherapy, daraxonrasib is a RAS-targeted medicine that targets RAS in its active ‘ON’ state, shutting down a key signaling pathway that drives aggressive tumor growth. This is especially important in pancreatic cancer, which is among the most RAS-driven cancers, with more than 90% of tumors harboring a RAS mutation that is the driver of the cancer,” asserted Mark A. Goldsmith, MD, PhD, CEO and chairman of Revolution Medicines.

Pancreatic cancer carries one of the highest mortality rates of any solid tumor, a consequence of late-stage diagnosis and resistance to standard chemotherapy. In the United States, recent estimates point to roughly 60,000 new cases and nearly 50,000 deaths each year. With most PDAC tumors driven by RAS alterations, the early success of emerging RAS‑targeted strategies hints at how much more may be possible as this therapeutic space continues to expand.

RAS is the key oncogenic driver of pancreatic cancer. Nearly all RAS mutations occur at KRAS position G12, but RAS mutations in other isoforms and at KRAS positions G13 and Q61 are also observed. Daraxonrasib works by suppressing RAS signaling through inhibition of the interaction between both wild-type and mutant RAS(ON) proteins and their downstream effectors.

Pancreatic cancer is the most RAS-addicted of all major cancers, with more than 90% of patients harboring tumors driven by mutations in RAS proteins. These mutations span a range of RAS variants that fuel aggressive tumor behavior. Daraxonrasib, a multi-selective inhibitor of RAS(ON) proteins, is the first investigational agent in a novel class of RAS inhibitors designed to address a diverse and broad spectrum of oncogenic RAS drivers.

“For patients with metastatic pancreatic cancer, new treatment options are urgently needed to increase survival time and improve quality of life,” said Brian M. Wolpin, MD, MPH, professor of medicine at Harvard Medical School, director of the Hale Family Center for Pancreatic Cancer Research at Dana-Farber Cancer Institute, and principal investigator for the RASolute 302 trial. “The widely anticipated results of this study indicate that daraxonrasib provides a clear and highly meaningful step forward for patients with pancreatic cancer who have experienced progression on prior treatment, typically chemotherapy. I believe that this new approach is a very important advance for the field that I expect will be practice-changing for physicians and improve the care for patients with previously treated metastatic pancreatic cancer.”

Revolution Medicines now intends to submit the drug for approval by regulatory authorities, including the U.S. Food and Drug Administration as part of a future New Drug Application, and for presentation at the 2026 American Society of Clinical Oncology Annual Meeting. 

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An inducible base editing platform for cancer functional genomics in vivo

Nature Biotechnology, Published online: 15 April 2026; doi:10.1038/s41587-026-03079-3

We developed a functional genomics platform using a small-molecule-controllable base editor that enables gene editing with reduced cellular toxicity and minimal transcriptional perturbation. The resulting high efficiency of the method potentiates in vivo inducible genetic screening, allowing systematic identification of critical residues in cancer therapeutic targets.

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Fujifilm Biotechnologies Opens New QC Lab in Denmark

Fujifilm Biotechnologies, a CDMO, celebrated the opening of its new, 2,000‑square‑meter quality control (QC) laboratory at its Hillerød, Denmark, commercial‑scale manufacturing site. The expanded QC footprint will enable bioassay and virology operations and support the site’s planned expansion, according to the company.

The laboratory features ventilation systems, personnel, and material airlocks, and an open‑plan layout. The space supports approximately 100 quality team members to conduct viral safety testing for drug substance/product release, scale capacity for complex cell‑based potency and ELISA methods, and perform raw material and critical total organic carbon cleanability studies to accelerate future partner campaigns.

The QC laboratory also incorporates robotics and an ongoing LIMS implementation across the company’s global network of sites to enable digital harmonization and data integrity.

The company doubled its Hillerød capacity in 2024 from six to 12 x 20,000 L mammalian cell culture bioreactors, increasing the complexity and volume for QC testing. The expanded production scale required expanded QC capabilities and advanced analytical equipment to support current operations and anticipated future demand. The QC lab is housed within a new 7,600-square-meter building that also features employee amenities, office and collaboration space, utility services, and an emergency generator to ensure uninterrupted operations and timely delivery of critical test results.

Construction of the lab was completed in last month and subsequently received approval from the Danish Medicines Agency (DKMA) following an on‑site inspection. Laboratory operations will begin in May 2026.

The new QC laboratory is part of Fujifilm Biotechnologies’ kojoX modular, connected network of manufacturing facilities, where harmonized equipment, layouts, methods, and digital systems are used to enable cross‑site workflows and consistent application of quality standards across regions, explains Christian Houborg, senior vice president and Hillerød site lead.

“Today, we are opening a world-class GMP-approved QC laboratory to elevate our quality control and be ready for the upcoming expansion, thereby continuing to manufacture advanced biological treatments for patients with severe diseases, such as cancer and rare autoimmune diseases. Together, we’re making a measurable impact for patients and partners around the world,” he said.

 

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Digital Twin Process Could Slash Microbial Protein Costs

A consortium of companies has developed what they call a digital twin of a microbial process to produce protein A.

Novasign, based in Vienna, hopes its participation through the ECOnti consortium will help manufacturers slash the costs of microbial proteins by improving experimental design.

According to the company, the digital twin can reduce the number of experiments needed to understand process behavior by 70% compared to Design of Experiments (DoE).

“Generally, the biggest problem in the industry right now is it’s not very efficient,” explains Mark Duerkop, PhD, CEO of Novasign.

“We need methods to learn more efficiently from experiments, design better experiments, and adapt process trajectories if something goes wrong.”

According to Duerkop, Novasign began developing an end-to-end digital twin of the full processing chain for microbial protein production as part of the ECOnti consortium three years ago.

Novasign says it develops digital twins spanning an entire process—from upstream to downstream—with the goal of improving both process development and manufacturing efficiency.

“The digital twin supports process development by systematically recommending the next set of experiments based on model-informed insights,” he says.

Setup of the Novasign ECOnti Digital Twin Technology

“During manufacturing, it can detect deviations from the intended process trajectory and support corrective actions.”

For example, if the digital twin is used to recover a process following disturbances, such as pH shifts or feed pump failure, manufacturers could significantly reduce product losses.

However, this remains for the future, he says, as the U.S. Food and Drug Administration (FDA) requires extensive validation before approving self-optimizing or autonomous manufacturing processes.

At the recent Bioprocessing Summit Europe, Duerkop presented a showcase on using the Novasign Studio software for full process control for 30 consecutive days.

He also showed how the software can use small-scale experimental data to inform scale-up and, in biosimilar development and viral vector manufacturing, can reduce experimental effort by up to 64%.

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