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ASCO 2025: Melanoma TILs, Toxicity, and Diet Insights
ASCO 2025: Melanoma TILs, Toxicity, and Diet Insights

Medscape

time6 days ago

  • Health
  • Medscape

ASCO 2025: Melanoma TILs, Toxicity, and Diet Insights

This transcript has been edited for clarity. Welcome, everybody. My name is Teresa Amaral. Today I'm here with you to follow up on my presentation on the best of ASCO 2025. Today, we'll have two different sections. The first one is dedicated to the rapid oral communications, and the second one is dedicated to the oral communications that took place on the last day of the congress. For the rapid oral communications, we'll focus on one topic that came through three presentations, tumor-infiltrating lymphocyte (TIL) therapy. Then we will look into a very interesting aspect: the reduction in toxicity associated with immunotherapy that we know is an important aspect for patients that need to receive immunotherapy. And finally, we'll look into a potential modifiable factor that might be associated with better outcomes in patients receiving immunotherapy, which is a diet rich in fiber. In the oral communications, we'll focus on the adjuvant trials — two of them that were quite important to be presented in this session. Then [I'll discuss] a trial that dealt with an unanswered question, which is how long should we treat patients in the metastatic setting. And finally, we will look into two different trials. The first one was on sequencing therapy, which was the DREAMseq trial on the final analysis, and then [there was] a specific analysis for patients that have symptomatic brain metastases, which are still a population of patients that unfortunately are excluded from the majority of clinical trials despite the fact that they do not a very good outcome. Starting with the TIL therapy, the first trial or the first presentation that I want to show you is a new way of applying TIL therapy. Basically, this is a new engineered TIL cell therapy that is intended to be given to patients that already received immune checkpoint inhibitors — so [patients] that are resistant to this therapy. But the interesting part of this type of therapy is that it doesn't require giving interleukin-2, and it also is possible to be given with a low dose of lymphodepletion. This is one of the reasons why I decided to bring this study because we know that TIL therapy might have a good outcome in the long run and these are the results that we are going to discuss in the next presentation. One of the problems is the toxicity that is associated with the pre-therapy and the after-therapy that we need to give to these patients, which includes this lymphodepleting chemotherapy and then the interleukin-2. What these very preliminary data showed is that it is indeed feasible to do this type of therapy by not giving interleukin-2 and reducing the lymphodepleting chemotherapy, and that the overall response rate was quite reassuring because we have an overall response rate that is around 67%. The median duration of response was not reached. Of course, we will need to wait for further data because this phase 1/2 trial is recruiting and we will need to confirm this data further in a broader population with more patients. But I think these results are quite reassuring and will maybe allow us to give this type of therapy to a broader spectrum of patients, as we don't need to have fitter patients to receive this therapy because we have low toxicity. The next discussion, or the next work, that was presented was indeed quite interesting because it looked into the 5-year-old outcome of another TIL product that is called lifileucel. Basically, what the authors showed was that this one-time therapy that was given was able to demonstrate durable and deepening responses in patients with advanced melanoma. It was also interesting to see the long-term toxicity is not more than what we saw before, because the toxicity is mostly associated with the interleukin-2 and lymphodepleting chemotherapy that is necessary to give with this product. So in line with what we discussed in the previous work, this is one of the reasons why most patients, or some patients, cannot receive this type of therapy. What we saw was that after 5 years, approximately 20% of the patients remained alive. Obviously, the best outcomes are seen in the patients that do respond. If the patient responds, the chances that they have a long-term outcome are significant, which is expected. So, the other side shows that this might be feasible, at least for approximately one fifth of the population. Another point that I would like to go through with you is that we saw two works looking into TILs that are definitely a potential therapeutic option for patients that received therapy in the first line, or patients that did not benefit from immunotherapy in the first line. The third work that I would like to discuss with you is the fact — and it was also presented in these rapid oral communications — that indeed not all TILs that we give to patients are the same. What the authors from this work looked into are the infusion product characteristics that are able to predict the response of patients that are treated with TILs. What they showed is the TIL persistence and also the distinctive TIL population in terms of immunophenotypic features, in terms of the proportion of CD8+ T cells, and the high surface expression of LAG3+. All of these characteristics are associated with improved TIL outcomes in patients with metastatic melanoma, meaning that not everything that we infuse that are called TILs work exactly the same and have the same influence, let's say, on the patient's response. This is obviously important because in the future, we might need to concentrate on some strategies, or on other strategies, that modulate ex vivoTIL expansion, so that we have the optimal TIL phenotype associated with better outcomes and we make sure the TILs that we are giving to our patients are the ones that will most likely produce a better outcome — a longer response, but a more durable response. I found this work quite interesting because it's always nice and important to look into these details and understand exactly what we are treating our patients with and how these treatment characteristics influence the patient's outcomes. The second point I would like to discuss with you is the toxicity that I mentioned in the very beginning. We treat a significant amount of patients with immunotherapy, but we know that one of the problems of immunotherapy is the toxicity associated with the therapy. Several strategies are being investigated to reduce the toxicity associated with immunotherapy. One of the strategies that was presented this year is looking into interleukin-6 receptor blocking with an antibody called sarilumab. This was tested in patients that received a combination of ipilimumab, nivolumab, and relatlimab — patients with resectable stage III or stage IV melanoma. Basically, what the author showed was that indeed it was possible to reduce the toxicity associated with this triple combination. Not only did this reduce the grade 3 to grade 5 immune-related adverse events to 12% when we use this interleukin-6 receptor inhibitor, but it also resulted in the best overall response rate being more than 60% — 64%, approximately. This means that it might not only be able to reduce the severe toxicity, so grade 3 and grade 4 adverse events, but also allow patients to have a long-term benefit — especially because this is one of the highest overall response rates that we saw recently in terms of combination of immunotherapy. Obviously, these data need to be confirmed by a larger trial looking into whether this triple combination with, or without, this interleukin-6 receptor inhibitor allows lower toxicity and the high response rate we saw in this smaller trial. Finally, for the rapid oral communications, I would like to show you a trial that looks into acting on some potential modulated factors, including the diet of the patients that we treat with immune checkpoint inhibitors. This was a randomized phase 2 trial that looked into a high-fiber diet intervention in patients who received immune checkpoint inhibitors. What they showed is that it is feasible to do these kinds of studies, but it's quite challenging, especially because some patients progressed earlier or abandoned the study due to other aspects that did not really have to do with the diet itself. Giving this high-fiber diet is safe and it's also well tolerated, and it seems that this high-fiber diet might lead to improved responses in patients receiving immune checkpoint inhibitors. I must say that it might lead [to these responses], only because these are very preliminary data and they need some kind of confirmation before we start prescribing high fiber diets to all patients that are receiving immune checkpoint inhibitors. I think it's very interesting that these types of factors are being analyzed and are being discussed and investigated because these might be, I would say, simple changes that we can make in order to improve the patient's outcomes to the current therapies that we offer them anyhow. Moving into oral communications, I will start by looking into the adjuvant trials. Two important adjuvant trials were discussed. The first one was RELATIVITY-098. This was a trial that investigated programmed cell death protein 1 (PD-1) monotherapy vs PD-1 plus a LAG-3 inhibitor in the adjuvant setting. Unfortunately, the trial was negative, but I think it's very important that we show these negative trials because it allows us to understand what happened and prevents other companies or other groups from looking at the same question exactly the same way, because the reasons, or the potential reasons, for the failure of the trial were not known or were not published. I think it's very important that these negative data are presented so that we can all learn and avoid repetition of the same issues. Basically, the combination did not improve relapse-free survival compared to the monotherapy, although there were no new safety data. Interestingly enough, from the biomarker analysis and the preliminary analysis that was presented, the message came out that for this combination to work, it may be necessary for some tumor cells to be present and not completely excised, as was [the case] in this setting. These comparisons were made with the same combination in the metastatic setting, where the combination was better than immunotherapy. This kind of analysis is always interesting to look into because it might give us some hints on where we can move with this combination in the future.

LG Debuts Next-Generation Precision Medical AI
LG Debuts Next-Generation Precision Medical AI

Korea Herald

time10-07-2025

  • Health
  • Korea Herald

LG Debuts Next-Generation Precision Medical AI

Joint Development Underway: World-Class Precision Medical AI Platform with Vanderbilt University Medical Center SEOUL, South Korea, July 10, 2025 /PRNewswire/ -- LG AI Research announced on July 9 the official launch of 'EXAONE Path 2.0', its next-generation precision medical AI model. Following the introduction of its 1.0 model in August of last year, LG AI Research showcased its 1.5 model last month at ASCO 2025, the world's largest oncology conference, held in Chicago, Illinois. 'EXAONE Path 2.0' represents a substantial advancement from the initial version, incorporating high-quality, real-world data. It offers accurate characterization and prediction of gene mutations and expression profiles, as well as minute morphological and structural features of human cells and tissues, all derived directly from pathology slide images. These capabilities make it an essential tool for early detection, prognosis, oncology drug development, and personalized treatment selection. 'EXAONE Path 2.0' was trained using multi-omics data, including both DNA and RNA, enabling it to interpret pathology images and underlying biological processes while integrating genetic insights vital to disease research and therapeutic development. Pathology images refer to high-resolution Whole Slide Images (WSIs) generated during the diagnostic test of patient tissue specimens. Whole Slide Images (WSIs) are large, multi-gigabyte digital files that capture detailed information on cell and tissue architecture. To facilitate analysis, these comprehensive images are typically divided into thousands of smaller sub-images or "patches." When AI models analyze only patch-level data, they are susceptible to a "feature collapse" effect, in which excessive attention to localized features leads to reduced prediction accuracy due to a lack of holistic context. LG AI Research has implemented an innovative approach in 'EXAONE Path 2.0', enabling learning from individual patches through to the full Whole Slide Image. This enhancement has increased the model's gene mutation prediction accuracy to a best-in-class 78.4%, establishing a new State-of-the-Art (SOTA) benchmark. 'EXAONE Path 2.0' was developed using over 10,000 matched datasets comprising Whole Slide Images and multi-omics data. This robust training enables it to predict gene expression patterns solely from image analysis, eliminating the need for expensive molecular testing. Yong-min Park, Head of AI Business Team at LG AI Research, stated, "EXAONE Path 2.0 enables us to reduce molecular testing time from over two weeks to under a minute—helping clinicians capture critical therapeutic windows for cancer patients. By leveraging EXAONE Path 2.0, physicians and pharmaceutical partners can rapidly analyze tissue pathology slides, identify driver mutations, and select appropriate targeted therapies." LG AI Research also introduced additional models trained for specific tumor types, including lung and colorectal cancers. These disease-specific models may support more efficient triaging and early detection of patients eligible for targeted therapeutic interventions. LG AI Research expects 'EXAONE Path 2.0' to play a significant role in clinical trial optimization by enabling real-time monitoring of patient responses and facilitating biomarker discovery for disease prediction. LG AI Research has taken a major step forward in applying AI to cancer care. In collaboration with Professor Tae-hyun Hwang of Vanderbilt University Medical Center—a premier U.S. academic medical institution in biomedical research—LG AI Research is co-developing a cutting-edge multi-modal medical AI platform. Moving away from the conventional model of building technologies prior to clinical validation, the team has adopted a problem-first approach—developing AI solutions in tandem with real-world clinical needs. Together, LG AI Research and Professor Hwang's lab aim to build a platform that supports personalized precision medicine, utilizing real tissue samples, pathology images, and clinical outcome data from cancer patients enrolled in trials. Their joint research will focus on: Professor Tae-hyun Hwang noted, " Our mission goes beyond developing AI models—we are building a platform that actively supports clinicians in the care and treatment of patients. This platform will serve not just as a diagnostic assistant but as a transformative engine for oncology drug development." Professor Hwang is a renowned Korean-American expert leading the Cancer Moonshot's gastric cancer initiative, a U.S. federal program dedicated to accelerating cancer breakthroughs. He also founded the Molecular AI Initiative at Vanderbilt, focused on advancing AI-integrated molecular medicine. "We're now focused on identifying not just what treatments work but when and how to apply them," said Seth Karp, Chair of the Section of Surgical Sciences at Vanderbilt University Medical Center. "The collaboration between LG AI Research and Professor Hwang's team marks a critical inflection point. The most meaningful aspect of this partnership is its real-world impact—we are creating a platform that will directly support patient care and improve outcomes." Beginning with oncology, the LG AI Research–Vanderbilt collaboration plans to expand into other domains including transplant immunology, autoimmune diseases, and metabolic disorders such as diabetes. LG AI Research will formally introduce 'EXAONE Path 2.0' during the upcoming LG AI Talk Concert 2025 on July 22. Separately, LG AI Research remains committed to addressing high-burden diseases. It is collaborating with The Jackson Laboratory (JAX) to identify Alzheimer's disease risk factors and advance drug discovery, and is also working with Professor Min-kyung Baek of Seoul National University on AI models for next-generation protein structure prediction. Furthermore, LG AI Research is actively engaged in global partnerships with pharmaceutical and biotech firms to drive innovation in AI-based drug development. LG Corporation Chairman and CEO Kwang-mo Koo has identified AI and biotechnology as strategic growth areas central to improving human health. Reflecting this vision, LG is accelerating efforts in AI–bio convergence through targeted open innovation initiatives aimed at delivering tangible results. About LG Group LG Group is a leading global company representing South Korea, offering innovative products and services across various industries such as electronics, chemicals, telecommunications, and energy. Established in 1947, LG Group has grown into a world-renowned brand through its activities in these diverse fields. The company is committed to continuous research and development, focusing on innovation to enhance the quality of life for its customers. Emphasizing its role as a socially responsible enterprise, LG Group is striving to strengthen its competitiveness in the global market and achieve sustainable growth through its future portfolio in areas like AI, Bio, and Cleantech. The company is dedicated to realizing its vision of being a business that provides value to customers and society, pursuing this mission with unwavering determination. For more information, visit About LG AI Research Launched in December 2020 as the artificial intelligence (AI) research hub of South Korea's LG Group, LG AI Research aims to lead the next epoch of artificial intelligence (AI) to realize a promising future by providing optimal research environments and leveraging state-of-the-art AI technologies. And LG AI Research developed its large-scale AI, EXAONE, a 300 billion parametric multimodal AI model, in 2021. EXAONE, which stands for "Expert AI for Everyone," is a multi-modal large-scale AI model that stands out from its peers due to its ability to process both language and visual data. With one of the world's largest learning data capacities, LG AI Research aims to engineer better business decisions through its state-of-the-art artificial intelligence technologies and its continuous effort on fundamental AI research. For more information, visit About Vanderbilt University Medical Center Vanderbilt University Medical Center (VUMC) is one of the nation's leading academic medical centers, dedicated to advancing healthcare through pioneering research, high-impact education, and exceptional patient care. Based in Nashville, Tennessee, VUMC provides comprehensive services across every major clinical specialty and serves as a regional and national referral center for complex conditions. VUMC is a hub for innovation in translational medicine, biomedical informatics, genomics, and AI-driven healthcare. Its close integration with Vanderbilt University enables seamless collaboration across disciplines, accelerating the development of next-generation diagnostics, therapeutics, and digital health solutions. VUMC is home to nationally recognized programs in cancer, cardiovascular disease, neurosciences, transplantation, and surgical innovation, and is committed to bringing cutting-edge discoveries from bench to bedside. For more information, visit

FF-10832 Granted FDA Orphan Drug Designation for the Treatment of Biliary Tract Cancer
FF-10832 Granted FDA Orphan Drug Designation for the Treatment of Biliary Tract Cancer

Yahoo

time07-07-2025

  • Business
  • Yahoo

FF-10832 Granted FDA Orphan Drug Designation for the Treatment of Biliary Tract Cancer

CAMBRIDGE, Mass., July 07, 2025--(BUSINESS WIRE)--FUJIFILM Pharmaceuticals U.S.A., Inc., drug development center and a leading provider of Contract Development and Manufacturing Organization (CDMO) services for drug delivery system (DDS) technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Fujifilm's FF-10832 — an investigational liposomal formulation of gemcitabine — for the treatment of biliary tract cancer (BTC). Phase 1 study (NCT03440450) results presented at ASCO 2025 suggest FF-10832 is well tolerated and has anti-tumor activity in patients with advanced BTC. FF-10832 is currently being evaluated in phase 2a studies (NCT05318573) as monotherapy or in combination with pembrolizumab for the treatment of solid tumors in the U.S. The FDA grants orphan drug designation to support the development of therapies for rare diseases that affect fewer than 200,000 people in the U.S.1 Small patient populations can limit preclinical research and slow clinical trials, stalling progress in therapeutic development for rare diseases. The designation supports research and clinical development by providing 7-years marketing exclusivity and other financial incentives. There are approximately 16,000 new cases of BTC in the U.S per year.2 Most (≥70%) patients present with unresectable or metastatic disease at diagnosis, and current treatments of surgery, chemotherapy, and radiation show limited efficacy in advanced stages. High recurrence (50–70%) and low 5-year survival rates (4–13%) highlight the urgent need for new and effective treatments. Gemcitabine has been a key component of BTC treatment since its approval in the 1990s, with all major first line regimens currently containing gemcitabine.3 FF-10832's novel liposomal formulation of gemcitabine for intravenous administration is designed to enhance anti-tumor activity by prolonging plasma half-life and improving targeted delivery to tumors. "BTCs are rare but aggressive malignancies associated with a poor prognosis and limited treatment options," said Susumu Shimoyama, president, FUJIFILM Pharmaceuticals U.S.A., Inc. "Receiving orphan drug designation highlights the significant unmet medical need that still remains and supports development of FF-10832 for patients with BTC who have few satisfactory options." FF-10832 is manufactured by FUJIFILM Toyama Chemical, providing seamless CDMO end-to-end services for full integration from formulation development to GMP manufacturing. Fujifilm's investigational drug candidates FF-10502 and FF-10850 have also been granted orphan drug designations for cholangiocarcinoma and Merkel cell carcinoma, respectively. About FUJIFILM FUJIFILM Pharmaceuticals U.S.A., Inc., based in Boston, Massachusetts, specializes in next generation drug delivery system formulation and CDMO services for precision treatment and care. In addition, the Company builds and maintains relationships with medical institutions, academic partners, and industry partners to conduct clinical trials and advance development of unique therapeutic compounds in oncology pipelines. For more information, please visit FUJIFILM Corporation is a subsidiary of FUJIFILM Holdings Corporation. FUJIFILM Holdings Corporation, headquartered in Tokyo, leverages its depth of knowledge and proprietary core technologies to deliver innovative products and services across the globe through the four key business segments of healthcare, electronics, business innovation, and imaging with over 70,000 employees. Guided and united by our Group Purpose of "giving our world more smiles," we address social challenges and create a positive impact on society through our products, services, and business operations. Under its medium-term management plan, VISION2030, which ends in FY2030, we aspire to continue our evolution into a company that creates value and smiles for various stakeholders as a collection of global leading businesses and achieve a global revenue of 4 trillion yen (29 billion USD at an exchange rate of 140 JPY/USD). For more information, please visit: For further details about our commitment to sustainability and Fujifilm's Sustainable Value Plan 2030, click here. 1 Food and Drug Administration (FDA). 2013. 21CFR Part 316 - Relevant Excerpts. Available at accessed 2025 May 10. 2 Lowe RC, Anderson CD. 2024. Epidemiology, risk factors, anatomy, and pathology of cholangiocarcinoma. UpToDate [website]. Available at: accessed 2025 April 29. 3 Rizzo A, Brandi G. 2021. Cancer Treat Res Commun 27:100335, PMID: 33592561. View source version on Contacts Media Michele DarnellFUJIFILM Holdings America CorporationE-mail: Megan AugustineFUJIFILM Holdings America CorporationE-mail: Other Contacts FUJIFILM Pharmaceuticals U.S.A.,

FF-10832 Granted FDA Orphan Drug Designation for the Treatment of Biliary Tract Cancer
FF-10832 Granted FDA Orphan Drug Designation for the Treatment of Biliary Tract Cancer

Business Wire

time07-07-2025

  • Business
  • Business Wire

FF-10832 Granted FDA Orphan Drug Designation for the Treatment of Biliary Tract Cancer

CAMBRIDGE, Mass.--(BUSINESS WIRE)--FUJIFILM Pharmaceuticals U.S.A., Inc., drug development center and a leading provider of Contract Development and Manufacturing Organization (CDMO) services for drug delivery system (DDS) technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Fujifilm's FF-10832 — an investigational liposomal formulation of gemcitabine — for the treatment of biliary tract cancer (BTC). Phase 1 study (NCT03440450) results presented at ASCO 2025 suggest FF-10832 is well tolerated and has anti-tumor activity in patients with advanced BTC. FF-10832 is currently being evaluated in phase 2a studies (NCT05318573) as monotherapy or in combination with pembrolizumab for the treatment of solid tumors in the U.S. The FDA grants orphan drug designation to support the development of therapies for rare diseases that affect fewer than 200,000 people in the U.S. 1 Small patient populations can limit preclinical research and slow clinical trials, stalling progress in therapeutic development for rare diseases. The designation supports research and clinical development by providing 7-years marketing exclusivity and other financial incentives. There are approximately 16,000 new cases of BTC in the U.S per year. 2 Most (≥70%) patients present with unresectable or metastatic disease at diagnosis, and current treatments of surgery, chemotherapy, and radiation show limited efficacy in advanced stages. High recurrence (50–70%) and low 5-year survival rates (4–13%) highlight the urgent need for new and effective treatments. Gemcitabine has been a key component of BTC treatment since its approval in the 1990s, with all major first line regimens currently containing gemcitabine. 3 FF-10832's novel liposomal formulation of gemcitabine for intravenous administration is designed to enhance anti-tumor activity by prolonging plasma half-life and improving targeted delivery to tumors. 'BTCs are rare but aggressive malignancies associated with a poor prognosis and limited treatment options,' said Susumu Shimoyama, president, FUJIFILM Pharmaceuticals U.S.A., Inc. 'Receiving orphan drug designation highlights the significant unmet medical need that still remains and supports development of FF-10832 for patients with BTC who have few satisfactory options.' FF-10832 is manufactured by FUJIFILM Toyama Chemical, providing seamless CDMO end-to-end services for full integration from formulation development to GMP manufacturing. Fujifilm's investigational drug candidates FF-10502 and FF-10850 have also been granted orphan drug designations for cholangiocarcinoma and Merkel cell carcinoma, respectively. About FUJIFILM FUJIFILM Pharmaceuticals U.S.A., Inc., based in Boston, Massachusetts, specializes in next generation drug delivery system formulation and CDMO services for precision treatment and care. In addition, the Company builds and maintains relationships with medical institutions, academic partners, and industry partners to conduct clinical trials and advance development of unique therapeutic compounds in oncology pipelines. For more information, please visit FUJIFILM Corporation is a subsidiary of FUJIFILM Holdings Corporation. FUJIFILM Holdings Corporation, headquartered in Tokyo, leverages its depth of knowledge and proprietary core technologies to deliver innovative products and services across the globe through the four key business segments of healthcare, electronics, business innovation, and imaging with over 70,000 employees. Guided and united by our Group Purpose of 'giving our world more smiles,' we address social challenges and create a positive impact on society through our products, services, and business operations. Under its medium-term management plan, VISION2030, which ends in FY2030, we aspire to continue our evolution into a company that creates value and smiles for various stakeholders as a collection of global leading businesses and achieve a global revenue of 4 trillion yen (29 billion USD at an exchange rate of 140 JPY/USD). For more information, please visit: For further details about our commitment to sustainability and Fujifilm's Sustainable Value Plan 2030, click here.

H.C. Wainwright Reaffirms Buy on BioLineRx Ltd. (BLRX) After ASCO 2025
H.C. Wainwright Reaffirms Buy on BioLineRx Ltd. (BLRX) After ASCO 2025

Yahoo

time04-07-2025

  • Business
  • Yahoo

H.C. Wainwright Reaffirms Buy on BioLineRx Ltd. (BLRX) After ASCO 2025

BioLineRx Ltd. (NASDAQ:BLRX) is among the best growth stocks to invest in for the next 5 years. H.C. Wainwright reaffirmed its Buy rating on BioLineRx Ltd. (NASDAQ:BLRX) while maintaining a price target of $26.00. This confidence follows the company's participation in ASCO 2025, where the management presented full data from the pilot phase of its CheMo4METPANC Phase 2 trial. While exhibiting superior efficacy in contrast to historical controls, the outcomes showcased an overall response rate and a disease control rate of 64% and 91%, respectively. What's even more exciting is that four out of eleven patients remained progression-free even after a year of treatment. While one patient showed a complete radiologic resolution of liver metastases and secured definitive radiation to the primary pancreatic tumor, the other one maintained a sustained partial response, and upon undergoing pancreaticoduodenectomy, a complete response was noted. A pharmacist preparing a dose of an immuno-oncology agent for research use. These results set the foundation for the company to transform the trial into a randomized Phase 2 study with 108 patients. All of these efforts are a testament to the company's strong footing in the coming years. Having said that, FTSE Russell recently announced the addition of BioLineRx Ltd. (NASDAQ:BLRX) to the Russell Microcap Index. BioLineRx Ltd. (NASDAQ:BLRX) is a commercial-stage biopharmaceutical company that develops and commercializes therapeutics targeting oncology and rare diseases. Incorporated in 2003, the company is focused on fulfilling unmet medical needs through its drug development efforts. While we acknowledge the potential of BLRX as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: The Best and Worst Dow Stocks for the Next 12 Months and 10 Unstoppable Stocks That Could Double Your Money. Disclosure: None.

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