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Yahoo
10-07-2025
- Business
- Yahoo
Harmony Biosciences Preclinical Data for Narcolepsy Drug BP1.15205 Shows Promise
Harmony Biosciences Holdings Inc. (NASDAQ:HRMY) is one of the most undervalued small-cap stocks to buy according to analysts. On June 11, Harmony Biosciences Holdings presented promising preclinical pharmacological data for BP1.15205, which is an investigational orexin 2 receptor (OX2R) agonist, at the 39th Annual Meeting of the Associated Professional Sleep Societies/APSS 'SLEEP' in Seattle. The data showed significant wake-promoting and cataplexy-suppressing effects in a standard transgenic mouse model of narcolepsy type 1. Narcolepsy is a chronic neurological disease affecting ~170,000 Americans, primarily characterized by excessive daytime sleepiness/EDS and cataplexy, along with other manifestations of REM sleep dysregulation. A close-up of a pharmaceutical drug bottle, showcasing the potential of the company's innovative therapies. The disease is often caused by the loss of hypocretin/orexin, a neuropeptide crucial for sleep-wake stability. BP1.15205 features a new and unique chemical scaffold optimized for high potency, which showed statistically significant wake-promoting effects at very low oral doses in the transgenic mouse model. These findings support dosing flexibility to potentially treat all 3 central disorders of hypersomnolence at low doses, which could offer an optimized benefit-risk profile. Harmony Biosciences Holdings Inc. (NASDAQ:HRMY) is a commercial-stage pharmaceutical company that develops & commercializes therapies for patients with rare & other neurological diseases in the US. While we acknowledge the potential of HRMY 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 . READ NEXT: and . Disclosure: None. This article is originally published at Insider Monkey.
Yahoo
14-04-2025
- Business
- Yahoo
Aulos Bioscience Doses First Patient in Phase 2 Cohort Evaluating AU-007 in Combination With Nivolumab for Second-Line Treatment of Melanoma
LARKSPUR, Calif., April 14, 2025--(BUSINESS WIRE)--Aulos™ Bioscience, an immuno-oncology company working to revolutionize cancer care through development of immune-activating antibody therapeutics, today announced dosing of its first patient with a combination of AU-007, the anti-PD-1 antibody nivolumab and low-dose, subcutaneous aldesleukin in a Phase 2 expansion cohort focused on second-line treatment of melanoma. This new cohort is part of Aulos' Phase 1/2 clinical trial of AU-007 in patients with unresectable locally advanced or metastatic cancer. Preliminary Phase 2 data presented in November at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting showed that a combination of AU-007 and low-dose, subcutaneous aldesleukin is clinically active in patients with melanoma, with durable objective responses achieved. The additional Phase 2 cohort in melanoma now allows the nivolumab combination portion of this study to progress. "We are excited that the first patient is receiving treatment in this new Phase 2 cohort evaluating AU-007 in combination with nivolumab," said Aron Knickerbocker, Aulos Bioscience's president and chief executive officer. "Given its unique mechanism of action and the positive data presented to date on AU-007 and low-dose, subcutaneous aldesleukin, we believe that AU-007 holds real promise as a novel immuno-oncology treatment in combination with checkpoint inhibitors in multiple cancer types. These include non-small cell lung cancer, for which we initiated a Phase 2 cohort with the anti-PD-L1 antibody avelumab in November, and now melanoma." AU-007 is the first human monoclonal antibody designed with the assistance of artificial intelligence to enter a human clinical trial. The antibody harnesses the power of interleukin-2 (IL-2) by binding precisely to the portion of IL-2 that binds to CD25, which prevents IL-2 from binding to high-affinity IL-2 receptors on Tregs, vasculature, pulmonary tissue and eosinophils. This redirects IL-2 to medium-affinity receptors on effector T cells (Teffs) and natural killer (NK) cells, which expand and kill tumor cells. Aulos anticipates presenting preliminary data from the Phase 2 cohort evaluating AU-007, nivolumab and low-dose, subcutaneous aldesleukin as a second-line treatment for melanoma in the second half of 2025. The company will present new Phase 2 data for AU-007 and low-dose, subcutaneous aldesleukin without a checkpoint inhibitor as a second-line treatment for melanoma at the American Association for Cancer Research (AACR) Annual Meeting later this month. To learn more about the AU-007 clinical trial program, please visit (identifier: NCT05267626). For patients and providers in the U.S., please visit For patients and health professionals in Australia, please visit About AU-007 AU-007 is a human IgG1 monoclonal antibody designed by leveraging artificial intelligence that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, AU-007 redirects IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2, either exogenous or secreted by effector T cells, from binding to trimeric receptors on regulatory T cells while still allowing IL-2 to bind and expand effector T cells and NK cells. This prevents the negative feedback loop caused by other IL-2-based treatments and biases the immune system toward activation over suppression. AU-007 also prevents IL-2 from binding to CD25-containing receptors on eosinophils, as well as vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy. About Aulos Aulos Bioscience is an immuno-oncology company working to revolutionize cancer patient care through immune-activating antibody therapeutics that direct patients' immune systems toward killing tumor cells. Matching world-class machine learning from co-founder Biolojic Design with an in-depth understanding of the immune system, Aulos' initial clinical candidate, AU-007, is a human antibody designed by leveraging artificial intelligence that harnesses the power of IL-2 to induce tumor killing while limiting the immunosuppression and toxicities typically associated with this validated pathway. The company was founded by Biolojic Design and Apple Tree Partners (ATP) and is led by pioneers in the fields of artificial intelligence, antibody development and cancer immunotherapies. For more information, visit X (@AulosBioscience) and LinkedIn. View source version on Contacts info@ Media inquiries: Mike Beyer, Sam Brown LLC / 312-961-2502 / mikebeyer@ Sign in to access your portfolio
Associated Press
14-04-2025
- Business
- Associated Press
Aulos Bioscience Doses First Patient in Phase 2 Cohort Evaluating AU-007 in Combination With Nivolumab for Second-Line Treatment of Melanoma
LARKSPUR, Calif.--(BUSINESS WIRE)--Apr 14, 2025-- Aulos™ Bioscience, an immuno-oncology company working to revolutionize cancer care through development of immune-activating antibody therapeutics, today announced dosing of its first patient with a combination of AU-007, the anti-PD-1 antibody nivolumab and low-dose, subcutaneous aldesleukin in a Phase 2 expansion cohort focused on second-line treatment of melanoma. This new cohort is part of Aulos' Phase 1/2 clinical trial of AU-007 in patients with unresectable locally advanced or metastatic cancer. Preliminary Phase 2 data presented in November at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting showed that a combination of AU-007 and low-dose, subcutaneous aldesleukin is clinically active in patients with melanoma, with durable objective responses achieved. The additional Phase 2 cohort in melanoma now allows the nivolumab combination portion of this study to progress. 'We are excited that the first patient is receiving treatment in this new Phase 2 cohort evaluating AU-007 in combination with nivolumab,' said Aron Knickerbocker, Aulos Bioscience's president and chief executive officer. 'Given its unique mechanism of action and the positive data presented to date on AU-007 and low-dose, subcutaneous aldesleukin, we believe that AU-007 holds real promise as a novel immuno-oncology treatment in combination with checkpoint inhibitors in multiple cancer types. These include non-small cell lung cancer, for which we initiated a Phase 2 cohort with the anti-PD-L1 antibody avelumab in November, and now melanoma.' AU-007 is the first human monoclonal antibody designed with the assistance of artificial intelligence to enter a human clinical trial. The antibody harnesses the power of interleukin-2 (IL-2) by binding precisely to the portion of IL-2 that binds to CD25, which prevents IL-2 from binding to high-affinity IL-2 receptors on Tregs, vasculature, pulmonary tissue and eosinophils. This redirects IL-2 to medium-affinity receptors on effector T cells (Teffs) and natural killer (NK) cells, which expand and kill tumor cells. Aulos anticipates presenting preliminary data from the Phase 2 cohort evaluating AU-007, nivolumab and low-dose, subcutaneous aldesleukin as a second-line treatment for melanoma in the second half of 2025. The company will present new Phase 2 data for AU-007 and low-dose, subcutaneous aldesleukin without a checkpoint inhibitor as a second-line treatment for melanoma at the American Association for Cancer Research (AACR) Annual Meeting later this month. To learn more about the AU-007 clinical trial program, please visit (identifier: NCT05267626 ). For patients and providers in the U.S., please visit For patients and health professionals in Australia, please visit About AU-007 AU-007 is a human IgG1 monoclonal antibody designed by leveraging artificial intelligence that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, AU-007 redirects IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2, either exogenous or secreted by effector T cells, from binding to trimeric receptors on regulatory T cells while still allowing IL-2 to bind and expand effector T cells and NK cells. This prevents the negative feedback loop caused by other IL-2-based treatments and biases the immune system toward activation over suppression. AU-007 also prevents IL-2 from binding to CD25-containing receptors on eosinophils, as well as vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy. About Aulos Aulos Bioscience is an immuno-oncology company working to revolutionize cancer patient care through immune-activating antibody therapeutics that direct patients' immune systems toward killing tumor cells. Matching world-class machine learning from co-founder Biolojic Design with an in-depth understanding of the immune system, Aulos' initial clinical candidate, AU-007, is a human antibody designed by leveraging artificial intelligence that harnesses the power of IL-2 to induce tumor killing while limiting the immunosuppression and toxicities typically associated with this validated pathway. The company was founded by Biolojic Design and Apple Tree Partners ( ATP ) and is led by pioneers in the fields of artificial intelligence, antibody development and cancer immunotherapies. For more information, visit X ( @AulosBioscience ) and LinkedIn. View source version on CONTACT: [email protected] Media inquiries:Mike Beyer, Sam Brown LLC / 312-961-2502 /[email protected] KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA INDUSTRY KEYWORD: ONCOLOGY HEALTH TECHNOLOGY CLINICAL TRIALS ARTIFICIAL INTELLIGENCE PHARMACEUTICAL BIOTECHNOLOGY SOURCE: Aulos Bioscience Copyright Business Wire 2025. PUB: 04/14/2025 08:05 AM/DISC: 04/14/2025 08:06 AM
