Estrogen receptor-negative breast cancer

Today, a brief rundown of news from Belharra Therapeutics, AstraZeneca, Regenxbio and Tasyha Gene Therapies.Sanofi will work with biotechnology startup Belharra Therapeutics to develop small molecule drugs for inflammatory diseases, the companies announced Tuesday. Belharra will get $40 million in upfront and near-term payments to start the deal, through which it will use what it describes as next-generation chemoproteomics to identify immune drug prospects. The alliance is the second for Belharra, which launched last year with $130 million in funding and a research pact in place with Genentech. Ben FidlerAstraZenecas bid to expand use of its new breast cancer drug Truqap has fallen short. In the Capitello-290 trial in triple negative breast cancer, Truqap plus chemotherapy didnt help people live longer than did a placebo and chemotherapy. The drug is approved to treat people with hormone-receptor positive, HER2-negative breast cancer if they have certain genetic alterations, a setting where it recorded $50 million in sales in the first quarter of 2024. The U.K.-based drugmaker expects data from a trial in prostate cancer later this year. Jonathan Gardner A gene therapy from Taysha Gene Therapieshelped improve motor function in four people with the rare neurodevelopmental disorder Rett syndrome, the biotechnology company said Tuesday. The data are from two adult and two pediatric patients enrolled in a Phase 1/2 trial of Tayshas therapy, called TSHA-102. One of the treated adults sat up unassisted for the first time in over a decade, while researchers observed symptom benefits in the other participants. Taysha plans to next test higher doses of its therapy. Ned PagliaruloRegenxbio got agreement from the Food and Drug Administration on details of an accelerated approval application for a gene therapy the company is developing for the neurodegenerative disease Hunter syndrome. According to Regenxbio, the agency endorses the companys plans to use a neurological protein as a surrogate marker reasonably likely to predict clinical benefit. Its also discussed with Regenxbio the design of a confirmatory trial that would start next year. The biotech plans to start submitting its application in the third quarter. Dubbed RGX-121, the therapy would be its first wholly owned treatment to reach market. Ben FidlerThe FDA has partially halted testing of an antibody-drug conjugate BioNTech licensed last year from China-based biotech MediLink Therapeutics. The FDA is concerned that higher doses of the drug, which is being evaluated against breast and lung tumors, may lead to unreasonable and significant risk of illness and injuries,according to a regulatory filing from BioNTech. MediLink has stopped enrolling new patients in a Phase 1 trial in the U.S. while it addresses the FDAs concerns. Ben Fidler '

TUESDAY, Jan. 30, 2024 -- A surge in breast cancers for women younger than 50 has puzzled medical experts, but a new study provides some new information that could help halt this trend. The steady increase in diagnoses during the past two decades has largely been driven by breast cancers fueled by the female hormone estrogen, formally known as estrogen-receptor positive tumors, researchers report Jan. 26 in the journal JAMA Network Open . In addition, some decreases have occurred in specific tumor types and among specific groups of women -- observations that could offer clues to possible prevention strategies. “This research offers a way to begin identifying the factors driving these increasing rates, with the goal of finding ways to slow or reverse them,” said senior study author Dr. Adetunji Toriola , a professor of surgery with the Washington University School of Medicine in St. Louis. “It also could help identify young women who are at high risk of developing early-onset breast cancer , so that we can design interventions to evaluate in clinical trials to see if we can lower that risk,” Toriola added in a university news release. For the study, researchers analyzed data on more than 217,000 U.S. women diagnosed with breast cancer between 2000 and 2019. In 2000, the breast cancer rate among women ages 20 to 49 was about 64 cases of breast cancer for every 100,000 people, researchers said. During the next 16 years, that rate increased at a slow trudge of about 0.24% per year, reaching 66 cases per 100,000 by 2016, the data show. But after 2016, the breast cancer trend line took a steep uphill turn, increasing at 3.76% per year. Only three years later, in 2019, the breast cancer rate among young women had reached 74 cases per 100,000 women. “For most women, regular breast cancer screening does not begin until at least age 40, so younger women diagnosed with breast cancer tend to have later-stage tumors, when the disease is more advanced and more difficult to treat,” Toriola noted. Researchers found that estrogen-receptor positive tumors made up nearly the entire increase in breast cancer cases. In fact, breast cancers that didn’t involve the estrogen receptor actually declined during the two decades of study. “We need to understand what is driving the specific increase in estrogen-receptor positive tumors,” Toriola said. “We also hope to learn from the decrease in estrogen-receptor negative tumors. If we can understand what is driving that rate down, perhaps we can apply it in efforts to reduce or prevent other breast tumor types.” Black women had higher rates of breast cancer, especially those ages 20 to 29, results show. Black females in that age group had a 53% increased risk of breast cancer, compared to white women the same age, researchers said. Black women ages 30 to 39 also have a higher risk, but it’s just 15% greater compared to white women in the same age range, researchers said. Then from ages 40 to 49, the rate for Black women actually dropped below that of white women, results show. Hispanic women had the lowest rate of breast cancer of any group, researchers noted. Toriola said the research team is evaluating breast tumor tissue from cancer patients of different ages and races to try and figure out why young Black women are at increased risk. In other results, researchers found an increase in cancers diagnosed at stage 1 and stage 4, and a decrease in diagnoses at stages 2 and 3. This suggests that improvements in breast cancer screening and better awareness of genetic cancer risks have led to many tumors being caught early, Toriola said. However, it also suggests that when early-stage tumors are missed in younger women, they don’t tend to be detected until they’ve become advanced, he said. When a woman was born also played a role in breast cancer risk, researchers added. There was a greater than 20% increased risk of breast cancer among women born in 1990, compared to those born in 1955, results show. “We are hopeful this study will offer clues to prevention strategies that will be effective in younger women, especially younger Black women, who are at particularly high risk of developing breast cancer before age 40,” Toriola said. Sources Washington University, news release, Jan. 26, 2024 Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions. Posted January 2024 More news resources FDA Medwatch Drug Alerts Daily MedNews News for Health Professionals New Drug Approvals New Drug Applications Drug Shortages Clinical Trial Results Generic Drug Approvals Subscribe to our newsletter Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Translational data demonstrate synergistic activity of RVU120 and MEK inhibitors in hormone receptor-negative breast cancer KRAKOW, Poland, Dec. 07, 2023 (GLOBE NEWSWIRE) -- Ryvu Therapeutics [WSE: RVU], a clinical-stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology, today announced promising translational data on RVU120 in combination with MEK inhibitors at the San Antonio Breast Cancer Symposium (SABCS) 2023 being held on December 5–9, 2023, in San Antonio, Texas. “Translational studies showed single agent activity of RVU120 in breast cancer mammosphere models in different subtypes. Importantly, synergistic activity was observed in combination with MEK inhibitors, especially in models with demonstrated EGFR amplification and RAS pathway activation,” said Hendrik Nogai, M.D., Chief Medical Officer of Ryvu Therapeutics. “These findings provide insight into the synergistic potential of the combination in hormone-negative breast cancers – a subtype particularly challenging to treat. While RVU120 is entering Phase II clinical development in hematological malignancies, these early results in breast cancer are especially encouraging and reflect the potential of targeting CDK8/19 across various cancers. Simultaneously, RVU120 is currently being evaluated in nonclinical studies in additional solid tumors.” The abstract is available on the SABCS 2023 website. A copy of the poster can be found on the Ryvu corporate website. Details on the poster presentations are as follows: Abstract Title: “Synergistic Activity of CDK8/19 Inhibitor RVU120 and MEK Inhibitors in Hormone-Negative Breast Cancer: Implications for Targeted Therapy”Session Name: Poster Session 4Session date and time: Thursday, December 7, 2023, 5:00 PM - 7:00 PM CTPoster Number: PO4-14-01 In the study, the responsiveness of RVU120, a highly selective and potent CDK8/CDK19 inhibitor, was evaluated in combination with MEK inhibitors in hormone-negative breast cancer. The cell lines where the synergy between CDK8/CDK19 inhibitors and MEK inhibitors was observed exhibited EGFR amplification and markers of an activated RAS pathway. This pattern of response was consistent across different MEK and MEK/RAF inhibitors, including selumetinib, trametinib, and avutometinib. In addition, sustained activation of both AKT and mTORC1 signaling was identified as a candidate resistance marker predicting synergistic activity of a RVU120/MEKi combination. These findings highlight the synergistic potential of combining RVU120 with MEK inhibitors in hormone-negative BC, particularly in triple negative breast cancer (TNBC) with EGFR amplification and an active RAS pathway. About Ryvu Therapeutics   Ryvu Therapeutics is a clinical-stage drug discovery and development company focused on novel small-molecule therapies that address emerging targets in oncology. Internally discovered pipeline candidates use diverse therapeutic mechanisms driven by emerging knowledge of cancer biology, including small molecules directed at kinase, synthetic lethality, and immuno-oncology targets. Ryvu’s most advanced programs are RVU120 — a selective CDK8/CDK19 kinase inhibitor with potential for the treatment of hematological malignancies and solid tumors, currently in phase Ib clinical development for the treatment of acute myeloid leukemia and myelodysplastic syndromes, and phase I/II for the treatment of r/r metastatic or advanced solid tumors — and SEL24 (MEN1703), a dual PIM/FLT3 kinase inhibitor licensed to the Menarini Group. Ryvu Therapeutics has signed multiple partnering and licensing deals with global companies, including BioNTech, Exelixis, Menarini, and Merck. The Company was founded in 2007 and is headquartered in Kraków, Poland. Ryvu is listed on the Warsaw Stock Exchange and is a component of the mWIG40 index. For more information, please see www.ryvu.com. Contacts: InvestorsCorporateJohn FrauncesNatalia BaranowskaLifeSci AdvisorsRyvu Therapeutics+1 917-355-2395+48 784 069 418jfraunces@lifesciadvisors.com natalia.baranowska@ryvu.com