Small Cell Carcinoma

HEIDELBERG, Germany, April 15, 2025 /PRNewswire/ -- NEC Laboratories Europe and Data-Driven.AI are working together to enhance medical laboratory diagnosis and increase the effectiveness of preventive health measures and early clinical intervention to improve the well-being of patients. If detected early, many illnesses and diseases can be managed or resolved without serious complications. However, by the time recognizable symptoms present themselves, conditions may already be advanced. In addition, doctors may miss symptoms that call for a specific range of tests to confirm a diagnosis. Giampaolo Pileggi, Project Manager in Biomedical AI at NEC Laboratories Europe, explains, "The human body is incredibly complex, its organ systems working in harmony to keep us healthy. Over time, a minor issue with one system can quickly become serious and affect others." He adds, "Doctors can greatly benefit from AI systems that can uncover hidden correlations in medical data, detecting even the slightest anomalies that may indicate an imbalance in the body. These advanced tools can help physicians to intervene promptly, improving diagnosis and patient care." In regions such as Europe, where age-related illnesses are common, prevention and early-stage intervention are critical to help maintain healthy living and control health services costs. Standard blood tests identify low or elevated levels that may be cause for concern, thus providing clear hints to problematic anomalies, but diagnosing an underlying cause often requires further investigation. NEC Laboratories Europe and Data-Driven.AI are using machine learning to identify unique patterns in blood results that may call for further investigation. Using embedding propagation, NEC technology combines blood analysis information with other patient information to build a condensed representation of their health, which can be used to help predict future patient conditions through additional recommended testing. Diego Facchini, CEO and founder of Data-Driven.AI, says, "As humans, we exhibit characteristic responses to infections, illnesses or imbalances within our bodies, which can be detected through patterns in normal blood values or specific markers found in laboratory diagnostics." He further explains, "The continuous training and refinement of AI models have the potential to revolutionize early disease detection by identifying subtle deviations in a person's health that might be overlooked by traditional methods. By leveraging machine learning algorithms and vast datasets, AI can enhance diagnostic accuracy and improve predictive capabilities, which represent a significant breakthrough in the field of disease detection and prevention." NEC technology's ability to detect subtle nuances in a patient's well-being or current health status has a wide range of potential applications, such as predicting unexpected events in intensive care units and helping diagnose long COVID and the early onset of neurodegenerative diseases such as Parkinson's. About NEC Laboratories Europe NEC Laboratories Europe research and develop cutting-edge technology to create innovative social solutions. Located in Heidelberg, Germany, major research areas of NEC Laboratories Europe include artificial intelligence, blockchain security, 5G and 6G networks, and IoT platforms. These technologies promote NEC Group solutions for a better society in the fields of digital health, safer cities, public services and communication infrastructure. For more information visit . About Data-Driven.AI Data-Driven.AI is a technology company specializing in artificial intelligence and software development, creating innovative solutions that transform data into actionable insights. By leveraging advanced machine learning algorithms, predictive analytics and automation, the company designs and develops AI-driven software applications that optimize business processes, enhance decision-making and unlock new opportunities across industries. With a strong focus on innovation, Data-Driven.AI empowers organizations to harness the full potential of their data, improving efficiency, accuracy and scalability in an increasingly digital world. For more information visit . SOURCE NEC Laboratories Europe GmbH WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Monte Rosa Therapeutics reported Phase 1 data Thursday morning for a Novartis-partnered program that the companies believe could change the treatment paradigm for some immune-mediated diseases. Though the data come from healthy volunteers, observers are keen to see whether the program known as MRT-6160 can affect certain immunological biomarkers while remaining safe. Other drug classes targeting the immune system, particularly JAK and interleukin inhibitors, can sometimes cause taxing side effects for patients. In the Phase 1 study, researchers tested MRT-6160 in 70 individuals across five single-ascending doses and three multiple-ascending doses. The program degraded a protein called VAV1 by greater than 90% in individuals’ peripheral T cells in all but the lowest dose cohorts, according to SEC documents. The results were also dose-dependent. Monte Rosa also measured VAV1 degradation in peripheral B cells, with MRT-6160 inducing “similar” results to the T cell data — although the company did not report specific figures. On an investor call Thursday morning, Monte Rosa executives were asked how the results might translate to patients, given that the Phase 1 came from ex vivo stimulation of healthy volunteers’ blood cells. CEO Markus Warmuth said it would depend on the disease but the company is confident in how MRT-6160 hit its biomarkers. Following the Phase 1 trials, Novartis is expected to take over development and decide which diseases to test Phase 2. Preparation for Phase 2 studies is ongoing. Warmuth said the final decision on which diseases to test MRT-6160 in Phase 2 has not been made, but hinted at where Monte Rosa and Novartis see the most potential. “We had a very strong preclinical data in [ulcerative colitis], very interesting data in rheumatoid arthritis,” Warmuth said. “There’s related diseases you could think about.” MRT-6160 is designed to target VAV1, which works downstream of T cell and B cell receptors, according to Monte Rosa. The idea is to reduce cytokine proteins that fuel autoimmune conditions when modulated. The data also provide an early snapshot into the potential of molecular glues. The space has grown significantly in the last 18 months, with at least 10 licensing deals signed between biotech and pharma partners. Novartis paid Monte Rosa $150 million upfront for full rights to MRT-6160 in the largest upfront payment for a molecular glue deal in that time frame . Jefferies analyst Kelly Shi previewed the data in a Sunday note, saying the expectation heading into Thursday was VAV1 degradation of about 80%, as well as reducing certain biomarker expression by at least 70%. Such a profile, Shi wrote, could “support its early potential” in both rheumatoid arthritis and inflammatory bowel disease. The four main biomarkers Shi highlighted were CD69, IL-2, IL-6, and IL-17, with the latter three implicated in AbbVie’s JAK inhibitor Rinvoq. IL-17 in particular plays an important role in ulcerative colitis. Another experimental drug, Merck and Prometheus’ anti-TL1A program MK-7240, showed a 50% reduction in IL-17 for IBD patients in a Phase 2 study. Results from the trial showed that in CD69, MRT-6160 suppressed regulation by greater than 90% in certain doses, Monte Rosa said. The program also inhibited IL-2, IFN-γ and IL-17A “by up to 99%.” IL-6 levels were between 60% and 90%. Safety data indicated all side effects were mild or moderate. Monte Rosa’s stock price $GLUE was volatile premarket, going up about 6% and then falling as much as 16% Thursday morning. After the market opened, shares were up about 8%. Separately, Monte Rosa released new Phase 2 data for an oncology program called MRT-2359, which it is developing in-house. This molecular glue aims to degrade the GSPT1 protein in the hopes of improving outcomes for cancer patients with tumors driven by what are known as MYC transcription factors. So far, researchers tested the program in 59 patients with MYC-related malignancies. They found that, among 37 evaluable patients, MRT-2359 induced one partial response in a patient with MYC biomarkers. There was also one unconfirmed partial response in an individual who was biomarker negative. Monte Rosa is opting to deprioritize most indications. Warmuth noted on the call that the partial response occurred in a patient with neuroendocrine bladder cancer. The patient had “extremely high expression” of MYC biomarkers. The lead indication for MRT-2359 will now be castration-resistant prostate cancer, and all lung cancer work will be shelved. Monte Rosa will still enroll patients with HR+ breast cancer. Additional data will be available for both prostate and breast cancer in the second half of the year. Monte Rosa does not yet have data from prostate cancer patients, Warmuth said, because it hasn’t received clear biopsies. When the company reports data later this year, Warmuth said he hopes there will be results from 20 to 30 prostate cancer patients. Monte Rosa also reported its full-year and fourth-quarter earnings Thursday morning, saying its cash runway will extend into 2028. Editor’s note: This article was updated to include additional information from Monte Rosa’s investor call on Thursday morning.

SAN DIEGO, Feb. 19, 2025 /PRNewswire/ -- Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, announced today that the first patient has been dosed in the clinical study of peluntamig (PT217) in combination with chemotherapy. Peluntamig (PT217), a first-in-class native IgG-like bispecific antibody (bsAb) targeting DLL3 and CD47, is being developed for the treatment of patients with small cell lung cancer (SCLC) and neuroendocrine carcinoma (NEC), including neuroendocrine prostate cancer (NEPC). Peluntamig (PT217) was granted two orphan drug designations (ODD) for the treatment of SCLC and NEC, respectively, by the US Food and Drug Administration (FDA). It was also granted two Fast Track designations for extensive-stage small cell lung cancer (ES-SCLC) with disease progression following platinum chemotherapy with or without a checkpoint inhibitor, and metastatic de novo or treatment-emergent neuroendocrine prostate cancer (NEPC), respectively, by the agency. Last year, Phanes entered into a clinical supply agreement with Roche to study peluntamig (PT217) in combination with Roche's anti-PD-L1 therapy, atezolizumab. The multi-center Phase I/II clinical trial of peluntamig (PT217) (NCT05652686), known as the SKYBRIDGE study, is currently evaluating the safety, tolerability, pharmacokinetics and preliminary efficacy of peluntamig (PT217) in patients with advanced or refractory cancers expressing DLL3. A Phase I clinical trial of peluntamig (PT217) is also ongoing in China (CTR20242720). ABOUT PHANES THERAPEUTICS Phanes Therapeutics, Inc. is a clinical stage biotech company focused on innovative drug discovery and development in oncology. Currently, it is conducting three Phase I/II clinical trials, including the MORNINGSTAR study with its best-in-class monoclonal antibody (mAb) program, mavrostobart (PT199), the TWINPEAK study with spevatamig (PT886) and the SKYBRIDGE study with peluntamig (PT217). Both spevatamig and peluntamig are first-in-class bispecific antibodies and have been granted orphan drug designations as well as Fast Track designations by the FDA. The company has built a strong pipeline by leveraging its proprietary technology platforms: PACbody®, SPECpair® and ATACCbody® to develop novel biologics that address high unmet medical needs in cancer. For more information about Phanes Therapeutics, please visit For business development or media inquiries, please contact [email protected] or [email protected], respectively. SOURCE Phanes Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED