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Medscape
03-07-2025
- Health
- Medscape
Evolving Approaches in Melanoma Treatment
This transcript has been edited for clarity. Hello, everybody. I am Teresa Amaral, head of the Skin Cancer Clinical Trials Center at Tübingen University Hospital in Germany. I'm here directly from ASCO 2025 to discuss with you a couple of works that have been presented here and I think are important for you to know about and discuss. We are already in June, but last month was Melanoma and Skin Cancer Awareness Month. I think it's interesting that one of the posters and one of the works that was selected to be discussed here was associated with strategies and interventions to prevent melanoma and other skin cancers — namely, works and interventions that have been done in kids and young adults in order to prevent ultraviolet exposure. This is something that you don't see often. It's talked about frequently, but these kinds of interventions are not very common. It's very interesting to see that this has been selected to be discussed here. Well, that was part of the prevention, and now we go to early-stage melanoma. As you can imagine, and as you probably know, the majority of the patients that are diagnosed with melanoma are actually diagnosed at an early stage. This means stage I and stage II. Being the majority of the population that is diagnosed with melanoma, it's also the population for which we don't have any approved therapy, especially until stage IIA. What can we do for these patients? There have been a couple of works presented here at ASCO using artificial intelligence to look at slides from patients and from primary tumors of patients diagnosed with early-stage melanoma. Actually, these have been pretty promising for predicting the risk for recurrence of these early-stage patients. In this transcript to accompany the video, we've linked the posters and you can get more information if you want to look into more detail at the data that have been presented. Another work that I would like to call your attention to, for which I definitely have some bias because it's the poster that I presented here, is a gene expression profile also using the primary tumor of patients diagnosed with early-stage melanoma — so stage I and stage II. The majority of the patients had stage IA disease. We looked into the primary tumors and tried to identify the patients that are at higher risk of developing a recurrence without having the information of the sentinel lymph node biopsy. Looking into those who have high risk is one of the ways to look into this population, but also looking into those who have low risk and can safely forgo other evaluations or other interventions such as further follow-up, skin checks, ultrasounds, blood tests, and so on. Then moving into the adjuvant setting, where we already have some therapy that is reimbursed. For stage II, we have immunotherapy. For stage III, we have immunotherapy and targeted therapy for the patients with BRAF mutation. Some of the data that has been presented here are looking into different ways of not only clinical data, but also gene expression profile, next-generation sequencing, and other assays such as circulating tumor DNA, and combining all this information to try to understand who are the patients that will have a recurrence, and if we can see it from the very beginning in those patients who received adjuvant therapy. There were a couple of posters looking into this, showing that in principle, and based on these data, we might not have only one biomarker that can tell us which patients are those who, despite therapy, will recur, or which patients who, under therapy, will have a benefit. Interestingly enough, we also have other trials being presented on Tuesday, and we'll have another session looking into detail at trial data on targeted therapy in the adjuvant setting — the COLUMBUS-AD study— and also a negative trial, the Bristol Myers Squibb trial RELATIVITY-098, which looked into programmed cell death protein 1 (PD-1) vs PD-1 plus lymphocyte activation gene 3 in patients in stage III. I think this is a very important trial, and it's important that these negative trials are also presented and are discussed so that we can understand which patients really don't benefit and what we can use from these trials to move the investigation forward. Another interesting poster that was presented here is looking into patients receiving adjuvant therapy with immunotherapy or targeted therapy if they have a BRAF mutation. Why is this poster interesting? I would say that there are some conflicting data on what type of therapy you should use in the adjuvant setting if the patients have a BRAF mutation. There are some retrospective data showing that targeted therapy upfront might be better. The poster presented here shows that immunotherapy actually seems to do better, although the majority of the patients were indeed treated with immunotherapy, not targeted therapy. I think real-world data and retrospective data are more important every day because I don't expect to have any trial in the future looking into adjuvant targeted therapy or immunotherapy for patients with stage III melanoma. Besides the BRAF mutation, we will definitely need other biomarkers that will help to guide our decisions for patients who have BRAF -mutated stage III melanoma. Moving into the advanced setting, the most important questions that we want to get answered are not what we should use in first-line therapy because this is, I would say, pretty clear for the majority of patients. We have data from the SECOMBIT trial. We have data from the DREAMseq trial saying that patients will probably benefit more from immunotherapy upfront, even when they have a BRAF mutation. Very particular patients will be candidates for having targeted therapy upfront, as the majority of them will receive immunotherapy. This is exactly what is going to be presented on Tuesday from the DREAMseq study. The data will show that after 5 years, there is almost twice as high overall survival rate in patients that started with immunotherapy and three times better progression-free survival for patients that started with immunotherapy as compared to targeted therapy alone. There are some nuances from this trial because not all the patients that started with immunotherapy or targeted therapy did the crossover; many had brain metastases, which was one of the exclusion criteria for the crossover. Still, it shows that for the majority of the patients, you should start, if possible, with immunotherapy in the first line. It will be interesting to understand what to do for patients for whom we don't have a benefit using PD-1 therapy. There come the second-line therapies and more, I would say, experimental data on other strategies that include cell therapy and tumor-infiltrating lymphocyte (TIL) therapy. There have been some data presented in a poster, showing that patients who received TIL therapy have a good long-term outcome 5 years after this therapy. This might be a therapy that could possibly be given to a specific subgroup of patients in a very selected population. Also interesting would be to look into the same strategy without using the lympho depletion that is normally associated with this type of therapy and the interleukin-2 that is also given because this is, first, one of the limitations to select the patients that will get this therapy, and second, these two therapies are responsible for the majority of the toxicity that we see with this therapy. These are really interesting data to see how we can bring this therapy to our patients, but also how we can do it with reducing toxicity. Finally, one of our other treatments that has been discussed here and will also probably come in our future discussions are treatment-directed therapies — so local therapies such as injection therapies and viral therapies. These have been coming on the scene again, with new data from a different type of viral therapy but also with a combination of PD-1 therapy, which I think is quite interesting because they are looking into patients that really didn't benefit from PD-1 therapy. For the future, these would be my two or three populations where I think we need more data and we should definitely invest more in future trials. First, for early-stage trials, and again, looking into trials that are biomarker-selected. I don't think we can go on doing adjuvant trials in all the populations of patients with stage II and stage III. Second, for patients who did not benefit from PD-1 therapy in the advanced setting, but also those who received PD-1 in the adjuvant setting and did not benefit from that. And third, for patients with brain metastasis, which is obviously a difficult-to-treat population for which we don't have many options. Finally, there were some posters also analyzing treatment for patients with acral melanoma and mucosal melanoma, which again are populations that normally are excluded. It's nice to see that some companies are still investing in that. Also, there are some retrospective data showing that, despite the fact that patients do not benefit as much as those with normal cutaneous melanoma, there is still plenty of space to investigate new treatment avenues for this population that normally is excluded from clinical trials. This was my summary from what we know so far from ASCO 2025. I'll get back to you with a second take on this interesting meeting when we have the late-breaking abstracts presented in the rapid oral communications, and also in the oral communications, which I think might also come in handy when you want to decide what to do with your patients in the clinics next week. I hope you enjoyed the meeting, and I'm looking forward to seeing you again soon. Thank you.
New York Times
02-07-2025
- Science
- New York Times
454 Hints That a Chatbot Wrote Part of a Biomedical Researcher's Paper
Scientists know it is happening, even if they don't do it themselves. Some of their peers are using chatbots, like ChatGPT, to write all or part of their papers. In a paper published Wednesday in the journal Science Advances, Dmitry Kobak of the University of Tübingen and his colleagues report that they found a way to track how often researchers are using artificial intelligence chatbots to write the abstracts of their papers. The A.I. tools, they say, tend to use certain words — like 'delves,' 'crucial,' 'potential,' 'significant' and 'important' — far more often than human authors do. The group analyzed word use in the abstracts of more than 15 million biomedical abstracts published between 2010 and 2024, enabling them to spot the rising frequency of certain words in abstracts. The findings tap into a debate in the sciences over when it is and is not appropriate to use A.I. helpers for writing papers. When ChatGPT was introduced in November 2022, a collection of words started showing up with unusual frequency. Those words, the investigators report, were not used so often before the release of ChatGPT. They infer that the change in word usage is a telltale sign of A.I. In 2024, there were a total of 454 words used excessively by chatbots, the researchers report. Based on the frequency of the A.I.-favored words, Dr. Kobak and his team calculate that at least 13.5 percent of all biomedical abstracts appeared to have been written with the help of chatbots. And as many as 40 percent of abstracts by authors from some countries writing in a few less selective journals were A.I.-generated. Want all of The Times? Subscribe.
Associated Press
20-05-2025
- Business
- Associated Press
CureVac Announces Financial Results for the First Quarter of 2025 and Provides Business Updates
TÜBINGEN, GERMANY and BOSTON, MA / ACCESS Newswire / May 20, 2025 / CureVac N.V. (Nasdaq:CVAC), a pioneering multinational biotech company developing a new class of transformative medicines based on messenger RNA (mRNA), today announced financial results for the first quarter of 2025 and provided a business update. 'We entered 2025 with a strong momentum and robust balance sheet, driven by progress across our oncology and infectious disease programs, as well as successful execution of our strategic realignment,' said Dr. Alexander Zehnder, Chief Executive Officer of CureVac. 'With the FDA's clearance of the IND for our lung cancer program and our glioblastoma study fully enrolled, we are steadily advancing an oncology pipeline that addresses high-unmet-need tumors. At the same time, we believe the European Patent Office's recent rulings upholding two of our patents in amended form confirm the strength of our mRNA intellectual property estate. Backed by €438 million in cash, we are well positioned to unlock multiple pipeline catalysts later this year and continue to expand and execute on our next generation mRNA portfolio.' Selected Business Updates Oncology CureVac is strengthening its oncology pipeline following two complementary approaches: off-the-shelf precision immunotherapies targeting tumor antigens shared across different patient populations and/or tumor types as well as fully personalized precision immunotherapies based on a patient's individual tumor genomic profile. Prophylactic Vaccines Protection of Intellectual Property Rights Financial Update for the First Quarter of 2025 Cash Position Cash and cash equivalents amounted to €438.3 million at the end of March 2025, decreasing from €481.7 million at the end of December 2024. In the first three months of 2025, cash used in operations was mainly allocated to ongoing research and development (R&D) activities to advance candidates in oncology precision immunotherapies and prophylactic vaccines and to further develop CureVac's mRNA technology. As a result of the strategic restructuring initiated in July 2024, the cash outflow for the first quarter of 2025 decreased compared to the first quarter of 2024. CureVac completed the intended workforce reduction as part of the strategic restructuring resulting in decreased personnel expenses, while implementing further cost reductions and increasing cost discipline through the organization. The company reaffirms its expected cash runway into 2028. Revenues Revenues amounted to €0.9 million for the first quarter of 2025, representing a decrease of €11.5 million from €12.4 million for the same period in 2024. The year-on-year decrease was primarily driven by lower revenues from GSK following the restructuring of the partnership in July 2024 from a Collaboration into a Licence Agreement as well as lower sales to CRISPR Therapeutics. For the three months ending March 31, 2025, total revenues of €0.3 million and €0.6 million were recognized with GSK and CRISPR Therapeutics, respectively, compared to €8.9 million and €3.5 million in the prior year period. Operating Result Operating loss amounted to €54.7 million for the first quarter of 2025, representing a decrease of €18.6 million from €73.3 million for the same period in 2024. The decrease year-over-year is primary attributable to the implemented cost reductions initiated with the strategic restructuring in July 2024: Financial Result (Finance Income and Expenses) Net financial result for the first quarter of 2025 amounted to €3.0 million, representing a decrease of €0.4 million from €3.4 million for the same period in 2024. Pre-Tax Loss Pre-tax loss was €51.7 million for the first quarter of 2025, compared to €69.9 million in the same period of 2024. About CureVac CureVac (Nasdaq:CVAC) is a pioneering multinational biotech company founded in 2000 to advance the field of messenger RNA (mRNA) technology for application in human medicine. In more than two decades of developing, optimizing, and manufacturing this versatile biological molecule for medical purposes, CureVac has introduced and refined key underlying technologies that were essential to the production of mRNA vaccines against COVID-19, and is currently laying the groundwork for application of mRNA in new therapeutic areas of major unmet need. CureVac is leveraging mRNA technology, combined with advanced omics and computational tools, to design and develop off-the-shelf and personalized precision immunotherapy candidates to treat cancer. It also develops programs in prophylactic vaccines and in treatments that enable the human body to produce its own therapeutic proteins. Headquartered in Tübingen, Germany, CureVac also operates sites in the Netherlands, Belgium, Switzerland, and the U.S. Further information can be found at CureVac Media and Investor Relations Contact CureVac, Tübingen, Germany T: +49 7071 9883-0 [email protected] Forward-Looking Statements of CureVac This press release contains statements that constitute 'forward looking statements' as that term is defined in the United States Private Securities Litigation Reform Act of 1995, including statements that express the opinions, expectations, beliefs, plans, objectives, assumptions or projections of CureVac N.V. and/or its wholly owned subsidiaries CureVac SE, CureVac Manufacturing GmbH, CureVac Inc., CureVac Swiss AG, CureVac Corporate Services GmbH, CureVac Belgium SA and CureVac Netherlands B.V. (the 'company') regarding future events or future results, in contrast with statements that reflect historical facts. Examples include discussion of the potential efficacy of the company's vaccine and treatment candidates and the company's strategies, financing plans, cash runway expectations, timing of various milestones, the impact of restructuring, growth opportunities and market growth. In some cases, you can identify such forward-looking statements by terminology such as 'anticipate,' 'intend,' 'believe,' 'estimate,' 'plan,' 'seek,' 'project,' 'expect,' 'may,' 'will,' 'would,' 'could,' 'potential,' 'intend,' or 'should,' the negative of these terms or similar expressions. Forward-looking statements are based on management's current beliefs and assumptions and on information currently available to the company. However, these forward-looking statements are not a guarantee of the company's performance, and you should not place undue reliance on such statements. Forward-looking statements are subject to many risks, uncertainties and other variable circumstances, including negative worldwide economic conditions and ongoing instability and volatility in the worldwide financial markets, ability to obtain funding, ability to conduct current and future preclinical studies and clinical trials, the timing, expense and uncertainty of regulatory approval, reliance on third parties and collaboration partners, ability to commercialize products, ability to manufacture any products, ability to implement our pipeline strategy, possible changes in current and proposed legislation, regulations and governmental policies, pressures from increasing competition and consolidation in the company's industry, the effects of the COVID-19 pandemic on the company's business and results of operations, ability to manage growth, ability to implement, maintain and improve effective internal controls, reliance on key personnel, reliance on intellectual property protection and the company's and the company's collaborators' ability to obtain, maintain, defend and enforce such intellectual property, scope of intellectual property protection, ability to provide for patient safety, fluctuations of operating results due to the effect of exchange rates, delays in litigation proceedings, different judicial outcomes and other important factors discussed under the caption 'Risk Factors' in the company's annual report on Form 20-F filed with the U.S. Securities and Exchange Commission (the 'SEC') on April 11, 2025, as such factors may be updated form time to time in its other filings with the SEC. Such risks and uncertainties may cause the statements to be inaccurate and readers are cautioned not to place undue reliance on such statements. Many of these risks are outside of the company's control and could cause its actual results to differ materially from those it thought would occur. The forward-looking statements included in this press release are made only as of the date hereof. The company does not undertake, and specifically declines, any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments, except as required by law. For further information, please reference the company's reports and documents filed with the SEC. You may get these documents by visiting EDGAR on the SEC website at Cash and Condensed Consolidated Profit and Loss Data SOURCE: CureVac press release
