Y-mAbs Therapeutics announces presentation of PK data of CD38-SADA
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Forbes
6 days ago
- Forbes
Doctors Use Large Neuro Model To Decode Brain Activity
While Dimitris Fotis Sakellariou and Kris Pahuja both shared a passion for playing music, what ultimately brought them together was an opportunity to use artificial intelligence to advance the field of brain science. Sakellariou's medical research and deep technical skills coupled with Pahuja's AI strategy and product credentials were the perfect mix and in 2023 they became cofounders of Piramidal. As a graduate startup of Y Combinator, what has made Piramidal particularly compelling is that they have built a large foundation model that instead of learning from a corpus of text, uses data produced by electrical activity in the human brain. In this way, their AI is trained to understand and detect patterns of brain language potentially transforming neurological diagnostics. It's the first step in many that they hope will lead them to their ultimate goal of building a fully AI-enabled neurologist. Building The First Large Neuro Model In November 2022, ChatGPT was released to the public. It enabled anyone to type a plain English question into a text box and get a natural sounding, informed response. ChatGPT was most people's first encounter with a large language model, a type of AI. In simple terms, an LLM works by being trained on a massive amount of text data that is derived from websites, databases, articles, and more. Through this process, the LLM learns language patterns and is then able to apply them in response to input from a user. Sakellariou, who holds a PhD in neuroscience and AI, had a breakthrough idea to build a specialized LLM, which his team now calls a large neuro model, that would use data, specifically neural language from the brain, from an electroencephalogram also known as an EEG. EEG devices, found in a clinical setting, conduct tests that record and display brainwave patterns, and are used to detect and investigate epilepsy, and other problems such as dementia, brain tumors, sleep disorders, and head injuries. What Problems Can A Large Neuro Model Solve? In a typical hospital context an EEG is hooked up to a patient through electrodes that are placed on the scalp. Brainwaves are displayed on a monitor or printed on paper. Doctors, nurses, and other medical technicians check on EEG results from many patients periodically during the day. As a practical matter, it's not possible for medical staff to continuously monitor and interpret EEG output. As an example, if a doctor checks an EEG in the morning and then before lunch the patient has a brain dysfunction, the doctor may not know about it until they check the EEG again in the evening, when appropriate intervention may be too late. New York-based Piramidal's LNM solves this problem by constantly consuming the EEG data, enabling it to produce accurate patient time series reports, in seconds. The LNM's on-going monitoring means it can analyze, identify, flag, and alert medical staff about abnormalities in real-time. Treatment close to or as the medical event is occurring can literally save the patient's life. Their model also eliminates the manual time-consuming work required to study EEG results, which often takes hours of effort, and it is particularly valuable in situations such as emergencies, when high quality data can support better real-time medical decisions and interventions. The result? Improved healthcare outcomes. Cleveland Clinic Makes A Bet On Piramidal Cleveland Clinic, opened in 1921, is a medical center with 23 hospitals and 280 outpatient facilities globally. In 2024 it served close to 16 million patients, and it is considered one of the world's top centers for neurology. As a large provider, the Clinic has around 100 EEG devices in ICUs serving patients at any time. Monitoring, reporting, and managing each EEG is a highly time-consuming task relying on scarce time availability from medical professionals. In addition, the current absence of real-time brainwave time-series analysis, interpretation, and alerts means inefficiencies can exist in being able to reduce brain injury and even death in the event of an ICU emergency. It makes sense then that Clinic leaders would have a keen interest in Sakellariou and Pahuja's innovation and consequently, a strategic collaboration is now underway. Over a period of several months, Piramidal's LNM will be deployed across many of the Clinic's ICUs. The center will work to co-develop a custom version through testing and refinement that meets their specific needs. Sakellariou believes the solution that emerges from this collaboration will also inform the development of a more widely available commercial version for medical networks across the world. A Challenging But Bright Future For AI In Healthcare AI is ushering in a new era of healthcare innovation. Today, breakthroughs using AI in multiple areas of medicine are happening with greater frequency. Examples include greater accuracy in imaging and diagnosis, acceleration of drug discovery and development, robots assisting with surgery, and precision medicine enabling treatments to be tailored for each patient. There's a lot happening to be encouraged and excited about in the medical field. That said, it will take more than just advances in technology to realize the benefits of innovation in healthcare. Pahuja sees many non-technical hurdles in the way, particularly in the US. Despite the availability of solutions, slow technological adoption is still a characteristic of healthcare systems for many complex reasons including the process in which reimbursements are made. In addition, the current healthcare regulatory environment can quickly become a roadblock for adoption of AI. Despite these hurdles, both Sakellariou and Pahuja are convinced that healthcare innovation driven by AI is about to flourish, and they are well positioned to ride what will likely be a long wave. They acknowledge that it's going to require a lot more investment, after all, training a large neuro model doesn't come cheap. With AI, perhaps many of our worst healthcare fears, from cancer to neurological diseases, will be soon be overcome. That future can't come fast enough.
Business Wire
08-08-2025
- Business Wire
Bicycle Therapeutics Reports Recent Business Progress and Second Quarter 2025 Financial Results
CAMBRIDGE, England & BOSTON--(BUSINESS WIRE)--Bicycle Therapeutics plc (NASDAQ: BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle ®) technology, today reported financial results for the second quarter ended June 30, 2025, and provided recent corporate updates. 'We continue to execute on our strategy, which is grounded in scientific rigor and focused on fulfilling our mission to develop next-generation precision-guided therapeutics that have the potential to help patients live longer and live well,' said Bicycle Therapeutics CEO Kevin Lee, Ph.D. 'We are energized by the progress we are making across our pipeline, and with this momentum, we are pleased to welcome our new Research and Innovation Advisory Board members, as well as new Board member Charles Swanton, to further our innovation and strategic growth.' Dr. Lee continued: 'As we advance our various pipeline programs that hold strong potential for changing the treatment paradigm for patients with cancer and creating value for shareholders, Bicycle remains committed to disciplined capital allocation. Today we announced organizational streamlining efforts that provide us with operational flexibility to deliver potentially value-generating datasets while strengthening our financial position in uncertain market conditions. Saying goodbye to talented team members is very difficult, and we sincerely thank them for their dedication to our company. We believe Bicycle is strongly positioned to realize our strategic priorities and milestones and look forward to providing key program updates over the second half of this year.' Second Quarter 2025 and Recent Events Presented additional human imaging data for an early Bicycle Radioconjugate ® (BRC ®) molecule targeting MT1-MMP at the American Association for Cancer Research (AACR) Annual Meeting 2025. A poster presentation included new data from a second patient who underwent MT1-MMP-PET/CT imaging that build on previously announced data. Altogether, the data continue to validate the potential of MT1-MMP as a novel cancer target and demonstrate the positive properties of BRC molecules for radiopharmaceutical imaging. Imaging data from these two patients are representative of the data generated to date in 12 out of 14 patients with various solid tumors. Bicycle Therapeutics continues to advance its emerging BRC pipeline, with initial EphA2 human imaging data expected in 2H 2025 and company-sponsored clinical trials planned for 2026. Presented two abstracts highlighting the development of Bicycle ® Drug Conjugate (BDC ®) zelenectide pevedotin for metastatic urothelial cancer (mUC) at the 2025 American Society for Clinical Oncology (ASCO) Annual Meeting. The abstracts outlined previously disclosed topline combination data for zelenectide pevedotin plus pembrolizumab in first-line mUC from the Phase 1/2 Duravelo-1 trial and provided an overview of the ongoing Phase 2/3 Duravelo-2 registrational trial for zelenectide pevedotin in mUC. Bicycle Therapeutics is on track to provide an update on dose selection from the Duravelo-2 trial and the accelerated approval pathway for zelenectide pevedotin in mUC following a meeting with the U.S. Food and Drug Administration planned for 4Q 2025. Phase 1/2 Duravelo-4 trial for zelenectide pevedotin in NECTIN4-amplified non-small cell lung cancer (NSCLC) open and actively recruiting patients. Duravelo-4 is Bicycle Therapeutics' second trial to leverage NECTIN4 gene amplification as a biomarker for patient selection and to expand the development of zelenectide pevedotin for additional solid tumors. With several trials underway assessing the potential for zelenectide pevedotin to treat mUC, breast cancer and lung cancer, the company has decided to pause the previously announced Phase 1/2 Duravelo-5 trial in multiple tumors. Expanded Board of Directors with the addition of Charles Swanton, M.D., Ph.D., FRS, FMedSci, FRCP, current chair of Bicycle Therapeutics' Clinical Advisory Board. Dr. Swanton leads the Cancer Evolution and Genome Instability Laboratory at the Francis Crick Institute. His research focuses on how tumors evolve over space and time, developing an understanding of branching evolutionary histories of solid tumors, processes that drive cancer cell-to-cell variation and the impact of cancer diversity on effective immune surveillance and clinical outcomes. Dr. Swanton is a fellow of the Royal Society, a fellow of the Royal College of Physicians and a fellow of the Academy of Medical Sciences. He completed his M.D. and Ph.D. training at the Imperial Cancer Research Fund Laboratories. Formed Research and Innovation Advisory Board (RAB) to support scientific advancement and strategic growth across preclinical programs. The RAB replaces Bicycle's Scientific Advisory Board. Inaugural RAB members include: Jose-Carlos Gutierrez-Ramos, Ph.D., is a director on the Bicycle Therapeutics Board of Directors. He also serves as the chief science officer at Danaher Corporation, leading the Danaher Innovation Centers and the Danaher Scientific Advisory Board. Previously, Dr. Gutierrez-Ramos was head of global drug discovery at AbbVie Inc., group senior vice president of biotherapeutics research and development (R&D) at Pfizer Inc., and senior vice president and CEDD head of immuno-inflammation at GlaxoSmithKline plc. He was also the founding CEO and president of Repertoire Immune Medicine, where he built and led a team focused on decoding the human immunome. Prior to that, he served as president and CEO of Synlogic, Inc. Dr. Gutierrez-Ramos earned a Ph.D. from the immunology department of the Center for Molecular Biology at the Universidad Autonoma de Madrid, and a B.S., summa cum laude, in chemistry with a minor in biochemistry from the Universidad Complutense de Madrid. Jason Lewis, Ph.D., is the Emily Tow Chair at Memorial Sloan Kettering Cancer Center (MSKCC) and currently serves as the deputy director at the Sloan Kettering Institute, overseeing the Office of Scientific Education and Training. He is also the scientific director of the Radiochemistry and Molecular Imaging Probe Core Facility at MSKCC. Dr. Lewis is a laboratory head in Sloan-Kettering Institute's molecular pharmacology program and serves as a professor at the Gerstner Sloan-Kettering Graduate School of Biomedical Sciences and at Weill-Cornell Medical College. He earned a Ph.D. in biochemistry from the University of Kent and an M.S. and B.S. in chemistry from the University of Essex. Robert Lutz, Ph.D., is a consultant/advisor to biotech and pharma with more than 30 years of experience with a significant focus on the development of antibody-drug conjugates (ADCs). He currently serves as chief scientific officer of Iksuda Therapeutics and is a board member and chief development officer of Synthis Therapeutics. Prior to his consulting practice, Dr. Lutz was vice president of translational research and development at ImmunoGen, where he was responsible for the advancement of multiple ADC programs, including KADCYLA ® (ado-trastuzumab emtansine), the first ADC to be approved for solid tumor indications, and ELAHERE ® (mirvetuximab soravtansine). He earned a Ph.D. in biochemistry from Brandeis University and a B.S. in biochemistry from the University of New Hampshire. Michael Hofman, MBBS, FRACP, FAANMS, FICIS, GAICD, is a nuclear medicine physician and professor at the Sir Peter MacCallum Department of Oncology at the University of Melbourne in Australia. His research has been instrumental in advancing PSMA PET imaging and PSMA radioligand therapy, helping to revolutionize the diagnosis and treatment of prostate cancer. He was named Australia's top researcher in nuclear medicine, radiotherapy and molecular imaging in both 2024 and 2025. Professor Hofman leads the PET/CT program and the Prostate Cancer Theranostics and Imaging Centre of Excellence at Peter MacCallum Cancer Centre. He earned a degree in medicine and surgery from Monash University in Australia and undertook a PET/CT fellowship at St. Thomas' Hospital in London. Welcomed Michael Method, M.D., as senior vice president of clinical development. Dr. Method is an academic and clinical gynecologic oncologist with extensive drug development experience. He most recently served as a senior vice president of clinical development at Karyopharm Therapeutics, Inc., after his time as an executive medical director at ImmunoGen, Inc. where he led global clinical development for gynecologic and female malignancies. Previously, Dr. Method was a senior medical advisor for global medical affairs at Eli Lilly, focused on breast cancer. He earned his M.D. and MPH from Northwestern University, and his B.S. in biochemistry and MBA from the University of Notre Dame. Participation in Upcoming Investor Conferences Bicycle Therapeutics management will participate in the following investor conferences in September: Cantor Global Healthcare Conference on Thursday, Sept. 4; fireside chat at 3:55 p.m. ET Morgan Stanley 23 rd Annual Global Healthcare Conference on Tuesday, Sept. 9; fireside chat at 7:45 a.m. ET Live webcasts of the fireside chats will be accessible in the Investor section of the company's website at Archived replays of the webcasts will be available following the fireside chat dates. Second Quarter 2025 Financial Results Cash and cash equivalents were $721.5 million as of June 30, 2025, compared to $879.5 million as of December 31, 2024. The decrease in cash and cash equivalents is primarily due to cash used in operations, including increased cash payments for clinical program activities. R&D expenses were $71.0 million for the three months ended June 30, 2025, compared to $40.1 million for the three months ended June 30, 2024. The increase in expense of $30.9 million was primarily due to increased clinical program expenses for zelenectide pevedotin development, increased discovery, platform and other expenses, and increased personnel-related costs, offset by decreased clinical program expenses for Bicycle Tumor-Targeted Immune Cell Agonist ® (Bicycle TICA ®) molecules as well as higher U.K. R&D tax credits period over period. General and administrative expenses were $18.5 million for the three months ended June 30, 2025, compared to $15.9 million for the three months ended June 30, 2024. The increase in expense of $2.6 million was primarily due to increased personnel-related costs, as well as increased professional and consulting fees. Net loss was $79.0 million, or $(1.14) basic and diluted net loss per share, for the three months ended June 30, 2025, compared to net loss of $39.8 million, or $(0.77) basic and diluted net loss per share, for three months ended June 30, 2024. In recognition of the evolving macroeconomic environment and the importance of preserving capital, Bicycle Therapeutics is implementing a workforce reduction and taking other steps to optimize its operations and extend the company's expected financial runway. These strategic cost realignment efforts are being implemented to prioritize potentially high-impact, value-generating programs, which include the advancement of zelenectide pevedotin, BT5528, next-generation Bicycle ® Drug Conjugates and the company's wholly owned pipeline of Bicycle ® Radioconjugates. Bicycle Therapeutics anticipates total operational savings of approximately 30% over the course of the financial runway period. These actions are expected to extend the financial runway into 2028 and strengthen the company's ability to weather continued market uncertainty as it advances clinical programs through key milestones. About Bicycle Therapeutics Bicycle Therapeutics is a clinical-stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle ® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycle molecules attractive candidates for drug development. The company is evaluating zelenectide pevedotin (formerly BT8009), a Bicycle ® Drug Conjugate (BDC ®) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BDC molecule targeting EphA2, a historically undruggable target; and BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist ® (Bicycle TICA ®) targeting Nectin-4 and agonizing CD137, in company-sponsored clinical trials. Additionally, the company is developing Bicycle ® Radioconjugates (BRC ®) for radiopharmaceutical use and, through various partnerships, is exploring the use of Bicycle ® technology to develop therapies for diseases beyond oncology. Bicycle Therapeutics is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Cambridge, Mass. For more information, visit Forward Looking Statements This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as 'aims,' 'anticipates,' 'believes,' 'could,' 'estimates,' 'expects,' 'forecasts,' 'goal,' 'intends,' 'may,' 'plans,' 'possible,' 'potential,' 'seeks,' 'will' and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding the validation of MT1-MMP as a cancer target and BRC molecules having positive properties for radiopharmaceutical imaging; the initiation of new clinical trials, the progress of Bicycle's ongoing clinical trials and the timing of EphA2 human imaging data and updates on dose selection in the Duravelo-2 clinical trial and accelerated approval pathway; the outcome of Bicycle's strategic cost realignment efforts and Bicycle's expected financial runway; and the use of Bicycle Therapeutics' technology through various partnerships to develop therapies for diseases beyond oncology. Bicycle Therapeutics may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: uncertainties inherent in research and development and in the initiation, progress and completion of clinical trials and clinical development of Bicycle Therapeutics' product candidates; the risk that Bicycle Therapeutics may not realize the intended benefits of its cost realignment efforts; the risk that Bicycle's projections regarding its expected cash runway are inaccurate or that its conduct of its business requires more cash than anticipated; and other important factors, any of which could cause Bicycle Therapeutics' actual results to differ from those contained in the forward-looking statements, are described in greater detail in the section entitled 'Risk Factors' in Bicycle Therapeutics' Annual Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 1, 2025, as well as in other filings Bicycle Therapeutics may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Bicycle Therapeutics expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. Balance Sheets Data (In thousands) (Unaudited) June 30, December 31, 2025 2024 Cash and cash equivalents $ 721,451 $ 879,520 Working capital 726,840 861,375 Total assets 832,184 956,868 Total shareholders' equity 668,915 793,060 Expand
Yahoo
03-08-2025
- Yahoo
Meet Charlotte, a canine first responder bringing pawsitivity to a Quebec community
Equipped with her customized vest, Charlotte the golden doodle keeps a busy schedule. For the past four years, she's been responding to emergency calls with a paramedic team in Mont-Laurier, Que. The five-year-old therapy dog and her handler Marc Paquette with Les Ambulances Y. Bouchard et Fils have followed ambulances to help deliver death notices, offered support for people with suicidal thoughts and intervened in cases involving autistic patients. Her skill is providing comfort and support, says Paquette. "It often starts with eye contact," he said. "She looks like a big stuffed animal, very harmless, and she's trained to be calm." He says Charlotte's presence has become integral in the Laurentians town of 14,000, and her unique role has allowed the first responders to not only gain trust among patients but also improve crisis management in the field. "Charlotte is an integral part of the pre-hospital care system," said Paquette. "We're available every day, evening or night, to assist the public." In her four years of service with the team, Charlotte's presence in the community has turned her into a quasi celebrity, joked Paquette. She's recently been asked to help provide support in court, to provincial police and residents in care homes. "She's well known and has become part of the fabric of Mont-Laurier," he said. "It's not rare that when I'm walking, people ask me 'Where's Charlotte?'" De-escalating situations Initially, Charlotte started her training with Paquette when she was three months old with the goal of becoming a service dog to support first responders. But Paquette decided to take it further. "To really bring it into the community and to respond to interventions in the field," he said. "We enter people's homes. We defuse crises." Paquette says he knows of other support service dogs working with paramedics in the province, but he isn't sure they're as integral to their team as Charlotte is to his. The main benefit of this program is how she has improved crisis management, says Paquette. When Charlotte approaches an individual in crisis, Paquette says 90 per cent of the time, the individual starts opening up. He says her presence sometimes prevents paramedics from having to bring people into the hospital network because of the dog's ability to de-escalate situations. "Once the crisis has been defused ... we are able to refer them through 811 to other psychosocial resources," said Paquette. "Before, the only place [to] transport was the emergency room." A complex training program Charlotte was trained at Mélanie Boucher's dog school in Sainte-Thérèse, Que., L'AcadémieChien. President and founder of the school, Boucher says the dog's success is not Charlotte's alone, but speaks to the commitment of her handler, who also put in hours of training. The duo had to go through three levels of obedience school and Charlotte had to complete between 160 to 180 hours of training, she says. Charlotte was the first dog the school trained for a team of paramedics. Since then, about 20 have gone through the program to serve with other professionals. The school has trained about 100 dogs for a variety of needs since 2018, she says. It's quite a complicated training process to train dogs to serve in a professional setting. It takes about a year, considering the school is preparing dogs to meet a variety of individuals in less-than-ideal circumstances, says Boucher. "Unlike assistance dogs that we train for individuals ... [Charlotte] has to be able to approach people" she said. "We teach the dogs to go and apply pressure points to bring comfort to people … let's say to lean on them, on their knee, on their chest, wherever the person needs it." Dedicated to the dog's training, Paquette would make the commute from his Laurentians town to the school just outside of Montreal regularly, says Boucher. "I'm proud of Charlotte, but I'm just as proud of Marc [Paquette]," said Boucher.
