Latest news with #HER2
Yahoo
a day ago
- Business
- Yahoo
Radiopharm Theranostics Doses First Patient in Phase 1 ‘HEAT' Trial of 177Lu-RAD202 for Treatment of Advanced HER2-Positive Solid Tumors
Phase 11 First-In-Human study designed to assess safety, tolerability, right dose for Phase 2 and early signs of efficacy of 177Lu-RAD202 in individuals with advanced HER2-positive solid tumors Previous clinical proof-of concept data2 for targeting HER-2 demonstrated the safety and biodistribution of 99mTc-RAD202 in humans SYDNEY, June 04, 2025 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX:RAD, 'Radiopharm' or the 'Company'), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announced the dosing of the first patient in its Phase 1 'HEAT' clinical trial of RAD202, a proprietary nanobody that targets Human Epidermal Growth Factor Receptor 2 (HER2)-positive expression in a wide array of advanced solid tumors. The open-label Phase 1 'HEAT' clinical trial is a dose escalation trial of 177Lu-RAD202 that is designed to determine the recommended Phase 2 dose and to evaluate the safety and preliminary clinical activity of this novel radiotherapeutic in individuals with HER2-expressing advanced cancers. The study is currently being conducted at clinical centers across Australia. 'Dosing patients in the HEAT clinical trial marks an important milestone in our transition to a clinical-stage company,' said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. 'Despite progressive improvements in the management of metastatic HER2-positive disease, the majority of patients experience disease progression on current standard of care and require further therapeutic options. The dosing of the first patient in the 'HEAT' trial represents a significant step toward achieving RAD202's potential to address an unmet need for HER2-positive metastatic patients who are progressing or unable to tolerate current treatment options. With RAD202, we hope to provide an option that can meaningfully improve clinical outcomes for HER2-positive patients, while preserving their quality of life.' HER2 is overexpressed in breast cancer as well as several other solid tumors and represents a validated target in oncology. RAD202 is a proprietary single domain antibody that targets HER2. Ten HER2-positive breast cancer patients previously dosed in a Phase 1 diagnostic study of RAD202 demonstrated clinical proof-of concept as well as the safety and biodistribution of RAD202, validating its potential for the treatment of advanced HER2-expressing cancers2. Preclinical findings3 examining the therapeutic effect in HER2-positive xenografts were also recently reported with 177Lu-RAD202. Collectively, these data further justify first in humans dose finding studies. 'It is a privilege to be the first centre to administer 177Lu-RAD202, targeting HER2-positive tumors in this Phase 1 clinical trial (HEAT).' said Dr Aviral Singh, Clinical Head of Theranostics and Nuclear Medicine at St John of God Murdoch Hospital. 'This opens the possibility of novel therapeutic avenues for patients with aggressive tumor types, including breast, ovarian, gastric, pancreatic, bladder, and several other cancers. With the trust put in us by Radiopharm, we look forward to a successful trial with beneficial outcomes for our patients.' About Radiopharm Theranostics Radiopharm Theranostics is a clinical stage radiotherapeutics company developing a world-class platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in areas of high unmet medical need. Radiopharm is listed on ASX (RAD) and on NASDAQ (RADX). The company has a pipeline of distinct and highly differentiated platform technologies spanning peptides, small molecules and monoclonal antibodies for use in cancer. The clinical program includes one Phase 2 and three Phase 1 trials in a variety of solid tumor cancers including lung, breast, and brain metastases. Learn more at Authorised on behalf of the Radiopharm Theranostics board of directors by Chairman Paul Hopper. For more information: Riccardo Canevari CEO & Managing Director P: +1 862 309 0293 E: rc@ Anne Marie FieldsPrecision AQ (Formerly Stern IR)E: Paul Hopper Executive Chairman P: +61 406 671 515 E: paulhopper@ MediaMatt Wright NWR Communications P: +61 451 896 420 E: matt@ ________________________________ 1 Zhao et al, Molecular Pharmaceutics 2021 18 (9), 3616-36223 Altunay B. et al, EP-0136, Eur J Nucl Med Mol Imaging (2024) 51 (Suppl 1): S1–S1026. DOI: 10.1007/s00259-024-06838-zSign in to access your portfolio
Daily Tribune
2 days ago
- Business
- Daily Tribune
New hope for patients with less common breast cancer
A new treatment nearly halves the risk of disease progression or death from a less common form of breast cancer that hasn't seen major drug advances in over a decade, researchers reported Monday. Results from the study, presented at the annual meeting of the American Society for Clinical Oncology, are expected to be submitted to regulators and could soon establish a new firstline therapy for people with HER2-positive metastatic breast cancer -- the advanced stage of a form that comprises 15–20% of all breast cancer cases. HER2-positive cancers are fueled by an overactive HER2 gene, which makes too much of a protein called human epidermal growth factor receptor 2 that helps cancer cells grow and spread. Patients with HER2-positive breast cancer that has spread to other parts of the body live around five years. 'Seeing such a striking improvement was really impressive to us -- we were taking a standard and almost doubling how long patients could have their cancer controlled for,' oncologist Sara Tolaney, chief of the breast oncology division at Dana-Farber Cancer Institute, told AFP. The current standard of care, known as THP, combines chemotherapy with two antibodies that block growth signals from the HER2 protein. The new approach uses a drug called trastuzumab deruxtecan (T-DXd), an antibody attached to a chemotherapy drug. 'Smart bomb' This 'smart bomb' strategy allows the drug to target cancer cells directly. 'You can bind to the cancer cell and dump all that chemo right into the cancer cells,' explained Tolaney. 'Some people call them smart bombs because they're delivering chemo in a targeted fashion -- which is how I think we're able to really increase efficacy so much.' Common side effects included nausea, diarrhea and a low white blood cell count, with a less common effect involving lung scarring. T-DXd is already approved as a 'second-line' option -- used when first-line treatments stop working. But in the new trial, it was given earlier, paired with another antibody, pertuzumab. In a global trial led by Tolaney, just under 400 patients were randomly assigned to receive T-DXd in combination with pertuzumab, thought to enhance its effects. A similar number received the standard THP regimen. A third group, who received T-DXd without pertuzumab, was also enrolled -- but those results haven't yet been reported. 44 percent risk reduction At a follow-up of 2.5 years, the T-DXd and pertuzumab combination reduced the risk of disease progression or death by 44% compared to standard care. Fifteen percent of patients in the T-DXd group saw their cancer disappear entirely, compared to 8.5% in the THP group. Because this was an interim analysis, the median progression-free survival -- meaning the point at which half the patients had seen their cancer return or worsen -- was 40.7 months with the new treatment, compared to 26.9 months with the standard, and could rise further as more data come in. Tolaney said the results would be submitted to regulators around the world, including the US Food and Drug Administration, and that future work would focus on optimizing how long patients remain on the treatment, particularly those showing complete remission. 'This represents a new firstline standard treatment option for HER2-positive metastatic breast cancer,' said Dr. Rebecca Dent, a breast cancer specialist at the National Cancer Center Singapore who was not involved in the study.
Yahoo
2 days ago
- Entertainment
- Yahoo
'Bachelorette' alum Katie Thurston reveals memory loss amid breast cancer battle
Katie Thurston, former star of "The Bachelorette," is opening up about a challenging side effect she's experiencing amid her breast cancer treatment. In an emotional Instagram video shared Sunday, Thurston, 34, revealed she's been struggling with memory loss after completing her second month of breast cancer treatment. 'Bachelorette' alum Katie Thurston marries comedian Jeff Arcuri following breast cancer diagnosis Back in March, she shared on "Good Morning America" that she had been diagnosed with Stage 3 triple-positive ductal carcinoma, a type of cancer where tumor cells have estrogen receptors, progesterone receptors, and HER2 receptors on their surface, according to the U.S. National Cancer Institute. In her latest update, Thurston noted that her breast cancer had spread to her liver, making it Stage 4. "After finishing two months of my medication, my hair is coming out in an unnatural amount of clumps… I'm losing my memory," she said. "Going through customs and them being like, 'where are you coming from?' And I looked at them, I was like, 'I don't remember.'" Thurston, who tied the knot with comedian Jeff Arcuri in March, said the memory lapse even sparked a minor disagreement with her husband. "I think this has happened before. He's like, 'when?' I was like, 'I don't know, but I know it has,'" she recalled, adding that they have been able to find light in the situation. "We're able to laugh about it now," she continued. "Cancer is s---. Sometimes I'm like, 'Stop feeling bad for yourself.' Other times I'm like, 'You're allowed to feel bad for yourself. Cancer f------ sucks.'" Thurston also shared that her current medication, a hormonal therapy known as Zoladex, didn't effectively suppress her ovarian hormones production, which led to an unexpected period. As a result, her doctors are switching her to Lupron. "And if that doesn't work, I have to get my ovaries taken out," she said. She said she remains "optimistic about medical advancements in the future," even though she said her treatment may be required long-term, if not lifelong given that her breast cancer is now stage 4. "But anyway, it's National Cancer Survivors Day," she added. "And you know, every day that I'm alive, I'm a survivor, so go me. I guess." During the interview with "GMA" earlier this year, Thurston shared that she initially dismissed a small lump on her breast, assuming it was related to her menstrual cycle but when she eventually sought medical care, she was ultimately diagnosed with cancer. Thurston said she hopes that by sharing her story, she can inspire others to prioritize their breast health including routine cancer screening. "I think that's the biggest takeaway, is telling people like, 'Don't wait,' you know, 'Be proactive, get checked out,'" she said at the time. "You could be doing yourself a favor in the future." 'Bachelorette' alum Katie Thurston reveals memory loss amid breast cancer battle originally appeared on
3 days ago
- Entertainment
'Bachelorette' alum Katie Thurston reveals memory loss amid breast cancer battle
Katie Thurston, former star of " The Bachelorette," is opening up about a challenging side effect she's experiencing amid her breast cancer treatment. In an emotional Instagram video shared Sunday, Thurston, 34, revealed she's been struggling with memory loss after completing her second month of breast cancer treatment. Back in March, she shared on " Good Morning America" that she had been diagnosed with Stage 3 triple-positive ductal carcinoma, a type of cancer where tumor cells have estrogen receptors, progesterone receptors, and HER2 receptors on their surface, according to the U.S. National Cancer Institute. In her latest update, Thurston noted that her breast cancer had spread to her liver, making it Stage 4. "After finishing two months of my medication, my hair is coming out in an unnatural amount of clumps… I'm losing my memory," she said. "Going through customs and them being like, 'where are you coming from?' And I looked at them, I was like, 'I don't remember.'" Thurston, who tied the knot with comedian Jeff Arcuri in March, said the memory lapse even sparked a minor disagreement with her husband. "I think this has happened before. He's like, 'when?' I was like, 'I don't know, but I know it has,'" she recalled, adding that they have been able to find light in the situation. "We're able to laugh about it now," she continued. "Cancer is s---. Sometimes I'm like, 'Stop feeling bad for yourself.' Other times I'm like, 'You're allowed to feel bad for yourself. Cancer f------ sucks.'" Thurston also shared that her current medication, a hormonal therapy known as Zoladex, didn't effectively suppress her ovarian hormones production, which led to an unexpected period. As a result, her doctors are switching her to Lupron. "And if that doesn't work, I have to get my ovaries taken out," she said. She said she remains "optimistic about medical advancements in the future," even though she said her treatment may be required long-term, if not lifelong given that her breast cancer is now stage 4. "But anyway, it's National Cancer Survivors Day," she added. "And you know, every day that I'm alive, I'm a survivor, so go me. I guess." During the interview with "GMA" earlier this year, Thurston shared that she initially dismissed a small lump on her breast, assuming it was related to her menstrual cycle but when she eventually sought medical care, she was ultimately diagnosed with cancer. Thurston said she hopes that by sharing her story, she can inspire others to prioritize their breast health including routine cancer screening. "I think that's the biggest takeaway, is telling people like, 'Don't wait,' you know, 'Be proactive, get checked out,'" she said at the time. "You could be doing yourself a favor in the future."
New Straits Times
3 days ago
- Health
- New Straits Times
New hope for patients with less common breast cancer
WASHINGTON: A new treatment nearly halves the risk of disease progression or death from a less common form of breast cancer that hasn't seen major drug advances in over a decade, researchers reported Monday. Results from the study, presented at the annual meeting of the American Society for Clinical Oncology, are expected to be submitted to regulators and could soon establish a new first-line therapy for people with HER2-positive metastatic breast cancer – the advanced stage of a form that comprises 15–20 per cent of all breast cancer cases. HER2-positive cancers are fuelled by an overactive HER2 gene, which makes too much of a protein called human epidermal growth factor receptor 2 that helps cancer cells grow and spread. Patients with HER2-positive breast cancer that has spread to other parts of the body live around five years. "Seeing such a striking improvement was really impressive to us – we were taking a standard and almost doubling how long patients could have their cancer controlled for," said oncologist Sara Tolaney, chief of the breast oncology division at Dana-Farber Cancer Institute, speaking to AFP. The current standard of care, known as THP, combines chemotherapy with two antibodies that block growth signals from the HER2 protein. The new approach uses a drug called trastuzumab deruxtecan (T-DXd), an antibody attached to a chemotherapy drug. This "smart bomb" strategy allows the drug to target cancer cells directly. "You can bind to the cancer cell and dump all that chemo right into the cancer cells," explained Tolaney. "Some people call them smart bombs because they're delivering chemo in a targeted fashion – which is how I think we're able to really increase efficacy so much." Common side effects included nausea, diarrhoea and a low white blood cell count, with a less common effect involving lung scarring. T-DXd is already approved as a "second-line" option – used when first-line treatments stop working. But in the new trial, it was given earlier, paired with another antibody, pertuzumab. In a global trial led by Tolaney, just under 400 patients were randomly assigned to receive T-DXd in combination with pertuzumab, thought to enhance its effects. A similar number received the standard THP regimen. A third group, who received T-DXd without pertuzumab, was also enrolled – but those results haven't yet been reported. At a follow-up of 2.5 years, the T-DXd and pertuzumab combination reduced the risk of disease progression or death by 44 per cent compared to standard care. Fifteen per cent of patients in the T-DXd group saw their cancer disappear entirely, compared to 8.5 per cent in the THP group. Because this was an interim analysis, the median progression-free survival – meaning the point at which half the patients had seen their cancer return or worsen – was 40.7 months with the new treatment, compared to 26.9 months with the standard, and could rise further as more data come in. Tolaney said the results would be submitted to regulators around the world, including the US Food and Drug Administration, and that future work would focus on optimising how long patients remain on the treatment, particularly those showing complete remission. "This represents a new first-line standard treatment option for HER2-positive metastatic breast cancer," said Dr Rebecca Dent, a breast cancer specialist at the National Cancer Center Singapore who was not involved in the study.
