Sapienza University of Rome

BLINCYTO Added to Multiphase Consolidation Chemotherapy Significantly Reduced the Risk of Death Versus Chemotherapy Alone THOUSAND OAKS, CA, USA I January 29, 2025 I Amgen (NASDAQ: AMGN ) today announced that the European Commission (EC) has approved BLINCYTO ® (blinatumomab) monotherapy as part of consolidation therapy for the treatment of adult patients with newly diagnosed Philadelphia chromosome-negative CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL). “This approval represents a significant advancement, offering patients the opportunity to receive BLINCYTO earlier in their treatment pathway, with the potential to improve outcomes,” said Jean-Charles Soria, senior vice president of Global Oncology Development at Amgen. “The E1910 data that served as the basis of this approval adds to the growing body of evidence of the meaningful survival impact of BLINCYTO.” The Phase 3 E1910 clinical trial led by ECOG-ACRIN Cancer Research Group studied patients with newly diagnosed Philadelphia chromosome-negative B-ALL receiving postinduction consolidation treatment, which aims to deepen remission to achieve durable responses. Study results demonstrated that BLINCYTO added to multiphase consolidation chemotherapy showed superior overall survival (OS) versus chemotherapy alone. With a median follow-up of 4.5 years, the 5-year OS was 82.4% in the BLINCYTO plus chemotherapy arm (n=112) and 62.5% in the chemotherapy arm (n=112). “While there has been some treatment progress, many patients with newly diagnosed Philadelphia chromosome-negative B-ALL remain at high risk of relapse,” said Robin Foà, M.D., emeritus professor of hematology, Sapienza University of Rome. “The E1910 study results highlight that BLINCYTO has the potential to advance frontline consolidation treatment, including patients who are minimal residual disease (MRD)-negative, offering a crucial new option to achieve deeper remissions and improve long-term survival.” The E1910 study was designed and conducted independently from industry. ECOG-ACRIN led the trial with public funding and sponsorship provided by the National Cancer Institute (NCI), part of the National Institutes of Health (NIH). Other NCI-funded network groups took part in the study. In addition, Amgen provided BLINCYTO and support through an NCI Cooperative Research and Development Agreement. About Acute Lymphoblastic Leukemia (ALL) ALL, also known as acute lymphoblastic leukemia, is a fast-growing type of blood cancer that develops in the bone marrow and can sometimes spread to other parts of the body, including the lymph nodes, liver, spleen and central nervous system. In Europe, ALL has an estimated prevalence of 1.28 persons per 100,000 people. 1 Among both children and adults, the most common subtype of ALL is B-ALL. 1 B-ALL begins in immature cells that would normally develop into B-cell lymphocytes, which are white blood cells that grow in bone marrow. 2,3 B-ALL is the most common type of ALL, constituting approximately 75% of cases in adults. 4 About BLINCYTO ® (blinatumomab) BLINCYTO is the first globally approved Bispecific T-cell Engager (BiTE ® ) immuno-oncology therapy that targets CD19 surface antigens on B cells. BiTE ® molecules fight cancer by helping the body’s immune system detect and target malignant cells by engaging T cells (a type of white blood cell capable of killing other cells perceived as threats) to cancer cells. By bringing T cells near cancer cells, the T cells can inject toxins and trigger cancer cell death (apoptosis). BiTE ® immuno-oncology therapies are currently being investigated for their potential to treat a wide variety of cancers. In the European Union (EU), BLINCYTO is indicated as monotherapy for the treatment of: BLINCYTO was granted breakthrough therapy and Priority Review designations by the U.S. FDA and is approved in the U.S. for the treatment of: EU SAFETY INFORMATION FOR BLINCYTO ® The safety profile of BLINCYTO in the Phase 3 E1910 study was consistent with the known safety profile for BLINCYTO. See BLINCYTO ® full Summary of Product Characteristics (SmPC) at www.ema.europa.eu About BiTE ® Technology Bispecific T-cell Engager (BiTE ® ) technology is a targeted immuno-oncology platform that is designed to engage patient’s own T cells to any tumor-specific antigen, activating the cytotoxic potential of T cells to eliminate detectable cancer. The BiTE ® immuno-oncology platform has the potential to treat different tumor types through tumor-specific antigens. The BiTE ® platform has a goal of leading to off-the-shelf solutions, which have the potential to make innovative T cell treatment available to all providers when their patients need it. Amgen is advancing multiple BiTE ® molecules across a broad range of hematologic malignancies and solid tumors, further investigating BiTE ® technology with the goal of enhancing patient experience and therapeutic potential. To learn more about BiTE ® technology, visit https://www.amgenoncology.com/bite-platform.html . About Amgen Amgen discovers, develops, manufactures and delivers innovative medicines to help millions of patients in their fight against some of the world’s toughest diseases. More than 40 years ago, Amgen helped to establish the biotechnology industry and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases. In 2024, Amgen was named one of the “World’s Most Innovative Companies” by Fast Company and one of “America’s Best Large Employers” by Forbes, among other external recognitions . Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average ® , and it is also part of the Nasdaq-100 Index ® , which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization. For more information, visit Amgen.com and follow Amgen on X , LinkedIn , Instagram , YouTube and Threads . SOURCE: Amgen

Some say the next step in human evolution will be the integration of technology with flesh. Now, researchers have used virtual reality to test whether humans can feel embodiment -- the sense that something is part of one's body -- toward prosthetic 'hands' that resemble a pair of tweezers. They report that participants felt an equal degree of embodiment for the tweezer-hands and were also faster and more accurate in completing motor tasks in virtual reality than when they were equipped with a virtual human hand. Some say the next step in human evolution will be the integration of technology with flesh. Now, researchers have used virtual reality to test whether humans can feel embodiment -- the sense that something is part of one's body -- toward prosthetic "hands" that resemble a pair of tweezers. They report June 6 in the journal iScience that participants felt an equal degree of embodiment for the tweezer-hands and were also faster and more accurate in completing motor tasks in virtual reality than when they were equipped with a virtual human hand. "For our biology to merge seamlessly with tools, we need to feel that the tools are part of our body," says first author and cognitive neuroscientist Ottavia Maddaluno, who conducted the work at the Sapienza University of Rome and the Santa Lucia Foundation IRCCS with Viviana Betti. "Our findings demonstrate that humans can experience a grafted tool as an integral part of their own body." Previous studies have shown that tool use induces plastic changes in the human brain, as does the use of anthropomorphic prosthetic limbs. However, an open scientific question is whether humans can embody bionic tools or prostheses that don't resemble human anatomy. To investigate this possibility, the researchers used virtual reality to conduct a series of experiments on healthy participants. In the virtual reality environment, participants had either a human-like hand or "bionic tool" resembling a large pair of tweezers grafted onto the end of their wrist. To test their motor ability and dexterity, participants were asked to pop bubbles of a specific color (by pinching them with their tweezers or between their index finger and thumb). For this simple task, the researchers found that participants were faster and more accurate at popping virtual bubbles when they had tweezer-hands. Next, the team used a test called the "cross-modal congruency task" to compare implicit or unconscious embodiment for the virtual hand and bionic tool. During this test, the researchers applied small vibrations to the participants' fingertips and asked them to identify which fingers were stimulated. At the same time, a flickering light was displayed on the virtual reality screen, either on the same finger as the tactile stimulus or on a different finger. By comparing the participants' accuracy and reaction times during trials with matched and mismatched stimuli, the researchers were able to assess how distracted they were by the visual stimulus. "This is an index of how much of a mismatch there is in your brain between what you feel and what you see," says Maddaluno. "But this mismatch could only happen if your brain thinks that what you see is part of your own body; if I don't feel that the bionic tool that I'm seeing through virtual reality is part of my own body, the visual stimulus should not give any interference." In both cases, participants were faster and more accurate at identifying which of their real fingers were stimulated during trials with matched tactile and visual stimuli, indicating that participants felt a sense of embodiment toward both the virtual human hand and the tweezer-hands. However, there was a bigger difference between matched and mismatched trials when participants had tweezer- rather than human hands, indicating that the non-anthropomorphic prosthesis resulted in an even greater sense of embodiment. The researchers speculate that this is due to the tweezer-hands' relative simplicity compared to a human-like hand, which might make it easy for the brain to compute and accept. "In terms of the pinching task, the tweezers are functionally similar to a human hand, but simpler, and simple is also better computationally for the brain." says Maddaluno. They note that it could also relate to the "uncanny valley" hypothesis, since the virtual human hands might have been too eerily similar yet distinct for perfect embodiment. In addition to the tweezer-hands, the researchers also tested a wrench-shaped bionic tool and a virtual human hand holding a pair of tweezers. They found evidence of embodiment in all cases, but the participants had higher embodiment and were more dexterous when the tweezers were grafted directly onto their virtual wrists than when they held them in their virtual hand. Participants also displayed a higher sense of embodiment for the bionic tools when they had the opportunity to explore the virtual reality environment before undertaking the cross-modal congruency test. "During the cross-modal congruency task participants had to stay still, whereas during the motor task, they actively interacted with the virtual environment, and these interactions in the virtual environment induce a sense of agency," says Maddaluno. Ultimately, the researchers say that this study could inform robotics and prosthetic limb design. "The next step is to study if these bionic tools could be embodied in patients that have lost limbs," says Maddaluno. "And we also want to investigate the plastic changes that this kind of bionic tool can induce in the brains of both healthy participants and amputees."

The potential of quantum technology is huge but is today largely limited to the extremely cold environments of laboratories. Now, researchers have succeeded in demonstrating for the very first time how laser light can induce quantum behavior at room temperature -- and make non-magnetic materials magnetic. The breakthrough is expected to pave the way for faster and more energy-efficient computers, information transfer and data storage. The potential of quantum technology is huge but is today largely limited to the extremely cold environments of laboratories. Now, researchers at Stockholm University, at the Nordic Institute for Theoretical Physics and at the Ca' Foscari University of Venice have succeeded in demonstrating for the very first time how laser light can induce quantum behavior at room temperature -- and make non-magnetic materials magnetic. The breakthrough is expected to pave the way for faster and more energy-efficient computers, information transfer and data storage. Within a few decades, the advancement of quantum technology is expected to revolutionize several of society's most important areas and pave the way for completely new technological possibilities in communication and energy. Of particular interest for researchers in the field are the peculiar and bizarre properties of quantum particles -- which deviate completely from the laws of classical physics and can make materials magnetic or superconducting. By increasing the understanding of exactly how and why this type of quantum states arise, the goal is to be able to control and manipulate materials to obtain quantum mechanical properties. So far, researchers have only been able to induce quantum behaviors, such as magnetism and superconductivity, at extremely cold temperatures. Therefore, the potential of quantum research is still limited to laboratory environments. Now, a research team from Stockholm University and the Nordic Institute of Theoretical Physics (NORDITA)* in Sweden, the University of Connecticut and the SLAC National Accelerator Laboratory in USA, the National Institute for Materials Science in Tsukuba, Japan, the Elettra-Sincrotrone Trieste, the 'Sapienza' University of Rome and the Ca' Foscari University of Venice in Italy, is the first in the world to demonstrate in an experiment how laser light can induce magnetism in a non-magnetic material at room temperature. In the study, published in Nature, the researchers subjected the quantum material strontium titanate to short but intense laser beams of a peculiar wavelength and polarization, to induced magnetism. "The innovation in this method lies in the concept of letting light move atoms and electrons in this material in circular motion, so to generate currents that make it as magnetic as a refrigerator magnet. We have been able to do so by developing a new light source in the far-infrared with a polarization which has a "corkscrew" shape. This is the first time we have been able to induce and clearly see how the material becomes magnetic at room temperature in an experiment. Furthermore, our approach allows to make magnetic materials out of many insulators, when magnets are typically made of metals. In the long run, this opens for completely new applications in society," says the research leader Stefano Bonetti at Stockholm University and at the Ca' Foscari University of Venice The method is based on the theory of "dynamic multiferroicity," which predicts that when titanium atoms are "stirred up" with circularly polarized light in an oxide based on titanium and strontium, a magnetic field will be formed. But it is only now that the theory can be confirmed in practice. The breakthrough is expected to have broad applications in several information technologies. "This opens up for ultra-fast magnetic switches that can be used for faster information transfer and considerably better data storage, and for computers that are significantly faster and more energy-efficient," says Alexander Balatsky, professor of physics at NORDITA. In fact, the results of the team have already been reproduced in several other labs, and a publication in the same issue of Nature demonstrates that this approach can be used to write, and hence store, magnetic information. A new chapter in designing new materials using light has been opened.