MYD88

Awardees are poised to advance healthcare innovations within five years to improve patient care in oncology, gastroenterology and more AURORA, Colo., Jan. 18, 2024 /PRNewswire/ -- The University of Colorado Anschutz Medical Campus announced the grant awards for the Anschutz Acceleration Initiative, a program focused on advancing cutting-edge healthcare innovations poised to reach patients within three to five years. The initiative was made possible by a $50 million gift from The Anschutz Foundation, a longtime philanthropic campus partner focused on bringing the innovative work at CU Anschutz to the forefront of patient care. "The Anschutz Foundation has championed the people and programs that drive innovation here," said CU Anschutz Chancellor Donald M. Elliman. "As a result, we have become recognized locally, nationally and internationally as leaders in healthcare innovation." The CU Anschutz faculty, whom the Anschutz Acceleration Initiative will fund, represent a range of expertise that spans disciplines including oncology, dermatology, gastroenterology, ophthalmology, pharmacology, dental medicine, and more. They were chosen through a rigorous scientific review by an external committee of experts, which assessed the degree to which proposed projects fit the initiative's intent: to rapidly advance medical treatments and health innovations poised to impact patients directly within the next few years. The grant recipients are: Project: Immunomodulatory Therapy for Down Syndrome Principal investigator (PI): Joaquin Espinosa, PhD | Professor, Pharmacology & Executive Director, Linda Crnic Institute for Down Syndrome Espinosa and team are working to pave the way for the first immunomodulatory therapy for children with Down syndrome. Assuming positive results, their work could launch a new age of therapeutic development to improve the quality of life and extend the lifespan of millions of individuals affected by this condition. Project: Implementation of Personalized Skin Cancer Screening: Using Genetic and Clinical Risk Factors to Identify a High-Risk Subgroup PI: Maryam Asgari, MD, MPH | Professor and Chair, Dermatology Leveraging established expertise in developing skin cancer polygenic risk scores (used for stratification and prediction of disease risk), Asgari and team will test a skin cancer screening risk prediction tool that combines genetic and clinical risk factors to identify individuals at high risk for skin cancer among study participants. The results of this research are likely to impact patient care in the next five years by identifying a high-risk subgroup for which skin cancer screenings could yield clear, direct benefits, including reduction in morbidity and mortality. Project: Making Personalization the Standard Through Rapid Design, Implementation, Testing and Maintenance PIs: Dan Matlock, MD | Professor, Geriatrics & Director, Colorado Program for Patient Centered Decisions (plaid shirt) Russell Glasgow, PhD | Research Professor, Family Medicine & Director, ACCORDS Dissemination and Implementation Science Program (glasses) This comprehensive, patient-centered personalization program will develop patient-centered decision support tools across various clinical domains, with a strong emphasis on rapid and rigorous development, sustainable processes and equity in engagement. Initially, the team will embark on four distinct projects: primary care for patients with multiple chronic conditions; specialty care – carotid stenting decision aid; tertiary care – heart transplant decision aid; and late life care for patients with dementia. Project: Multimaterial 3D Print Processing of Antimicrobial and Antifungal Dental Prosthetics PI: Jeffrey Stansbury, PhD | Senior Associate Dean for Research and Professor, Craniofacial Biology Stansbury and team plan to enhance affordability of dentures for patients most in need, while significantly raising the clinical value and performance of dentures for denture wearers. Their goal is to bring together several already demonstrated materials-based technologies that, when combined and used with innovative printing processes, will significantly advance the potential application of the field of 3D printing for dentistry. Project: MyD88 Platform for Enhancing Cellular Cancer Immunotherapy PI: Eduardo Davila, PhD | Professor, Medical Oncology The Davila laboratory, in collaboration with multiple stakeholders, is developing a novel methodology to enhance all forms of cellular immunotherapy including a more universal form of cell therapy referred to as tumor-infiltrating lymphocyte (TIL) therapy. The goal is to develop good manufacturing practices, technology and methodology to reduce production times, reduce the number of cells that need to be administered, lessen costs, and generate more effective cellular immunotherapy products. Project: Oculomics as a Biomarker for Comprehensive and Non-Invasive Patient Health Assessment PI: Jayashree Kalpathy-Cramer, PhD | Professor, Ophthalmology Kalpathy-Cramer and team are developing a multidisciplinary project by bringing AI-assisted ophthalmic imaging outside of ophthalmology to improve patient health and clinical outcomes, meet quality metrics and reduce health system costs, and further advance the field of oculomics. The successful completion of this ambitious goal would make oculomics a mainstream, non-invasive and cost-effective tool for the assessment of patient health. Project: Retinal Transplant to Restore Vision in Patients with Macular Degeneration PI: Valeria Canto-Soler, PhD | Associate Professor, Ophthalmology & Director, CellSight Canto-Soler and team have developed two products to address the needs of patients with geographic atrophy (GA) – an advanced form of dry age-related macular degeneration or AMD. The potential impacts of these products are enormous, as approximately 2 million Americans with GA would be immediately eligible for experimental retinal transplantation to restore vision, thus having a profound effect on their quality of life. Project: Targeting Protein Translation Elongation to Treat Cancer Patients PI: Antonio Jimeno, MD, PhD | Professor, Medical Oncology An interdisciplinary team will target fusion proteins to treat patients with head and neck cancers. With the use of a synthetic small molecule called SVC112 that uses a new and unique mechanism of action, the team now has a clear line of sight from discovery to generate preclinical data to de-risk and ready SVC112 for the clinic. Project: Transforming Gastrointestinal Cancer Care from Inpatient Surgery to Outpatient Endoscopy by Enabling Third Space Endoscopy PI: Steven Edmundowicz, MD | Professor, Gastroenterology & Medical Director, Digestive Health Center Edmundowicz and team are developing minimally invasive, highly specialized endoscopy procedures that have the potential to supplant one-third of conventional surgical gastrointestinal (GI) interventions and transform GI cancer care. They intend to bridge the gap between conventional tools and advanced procedures by using the Ancora™ platform that leverages CU's patented Pillar balloon in an interventional overtube to reduce dependence on expert free-hand skill and enable more repeatable and predictable procedures. To read more about the initiative and the awardees, visit the Anschutz Acceleration Initiative website. About the University of Colorado Anschutz Medical Campus The University of Colorado Anschutz Medical Campus is a world-class medical destination at the forefront of transformative science, medicine, education and patient care. The campus encompasses the University of Colorado health professional schools, more than 60 centers and institutes, and two nationally ranked independent hospitals - UCHealth University of Colorado Hospital and Children's Hospital Colorado - that treat more than two million adult and pediatric patients each year. Innovative, interconnected and highly collaborative, the University of Colorado Anschutz Medical Campus delivers life-changing treatments, patient care and professional training and conducts world-renowned research fueled by over $704 million in research grants. For more information, visit . Contact: Julia Milzer, [email protected] SOURCE University of Colorado Anschutz Medical Campus

LEXINGTON, Mass., Dec. 12, 2023 /PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 inhibitor, today announced initial combination study data from its TakeAim Lymphoma trial including 5 primary CNS lymphoma (PCNSL) patients. "We are very pleased with the initial emavusertib/ibrutinib combination data from the TakeAim Lymphoma study. We are particularly excited about the activity in relapsed/refractory PCNSL and the meaningful benefit emavusertib may provide in combination with BTKi," said James Dentzer, President and Chief Executive Officer of Curis. As of October 12th, the TakeAim Lymphoma trial has enrolled and treated 19 Non-Hodgkin Lymphoma (NHL) patients, with a combination of emavusertib and ibrutinib; with emavusertib doses ranging from 100 mg to 300 mg BID. The initial data reveal encouraging efficacy, demonstrating multiple objective responses in both BTK-naïve and BTK-experienced patients. Patients with PCNSL who had a history of failed BTKi therapy showed a particularly noteworthy response: 3 out of 5 evaluable PCNSL patients achieved a Complete Response (CR), with durability ranging from 0.3 – 8.9 months. These data underscore the potential of emavusertib to re-sensitize patients to BTKi therapy, marking a significant advancement in Non-Hodgkin Lymphoma treatment. Consistent with our previous findings, the emavusertib/ibrutinib combination demonstrates a manageable and acceptable safety profile, with no observed dose-limiting toxicities (DLTs) in the 200 mg cohort and 2 reversible DLTs (stomatitis and syncope) in the 300 mg cohort. About emavusertib (CA-4948) Emavusertib is a small molecule IRAK4 inhibitor. IRAK4 plays an essential role in the toll-like receptor (TLR) and interleukin-1 receptor (IL-1R) signaling pathways, which are frequently dysregulated in patients with cancer. TLRs and the IL-1R family signal through the adaptor protein MYD88, which results in the assembly and activation of IRAK4, initiating a signaling cascade that induces cytokine and survival factor expression mediated by the NF-κB protein complex. Preclinical studies targeting IRAK1/4 in combination with FLT3 have demonstrated the ability to overcome the adaptive resistance incurred when targeting FLT3 alone. Further, emavusertib has shown anti-tumor activity across a broad range of hematologic malignancies including monotherapy activity in patient-derived xenografts and synergy with both azacitidine and venetoclax. About TakeAim Lymphoma Study TakeAim Lymphoma Study (NCT03328078) – study is open for enrollment. About Curis, Inc. Curis is a biotechnology company focused on the development of emavusertib, an orally available, small molecule IRAK4 inhibitor. Emavusertib is currently undergoing testing in the Phase 1/2 TakeAim Lymphoma study in patients with hematologic malignancies, such as non-Hodgkin's lymphoma and other B cell malignancies in combination with the BTK inhibitor ibrutinib, and as a monotherapy in the Phase 1/2 TakeAim Leukemia study in patients with acute myeloid leukemia and myelodysplastic syndrome, for which it has received Orphan Drug Designation from the U.S. Food and Drug Administration. Curis, through its 2015 collaboration with Aurigene, has the exclusive license to emavusertib (CA-4948). Curis licensed its rights to Erivedge® to Genentech, a member of the Roche Group, under which they are commercializing Erivedge® for the treatment of advanced basal cell carcinoma. For more information, visit Curis's website at . Cautionary Note Regarding Forward-Looking Statements: This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, including, without limitation, any statements with respect to the TakeAim Lymphoma study including the potential developments and benefits of emavusertib in combination with ibrutinib in relapsed/refractory primary CNS lymphoma (PCNSL) and/or the potential benefits in combination with BTKi, and the activity, safety, tolerability, manageability and efficacy of emavusertib. Forward-looking statements may contain the words "believes," "expects," "anticipates," "plans," "intends," "seeks," "estimates," "assumes," "predicts," "projects," "targets," "will," "may," "would," "could," "should," "continue," "potential," "focus," "strategy," "mission," or similar expressions. These forward-looking statements are not guarantees of future performance and involve risks, uncertainties, assumptions and other important factors that may cause actual results to be materially different from those indicated by such forward-looking statements. Curis may experience adverse results, delays and/or failures in its drug development programs and may not be able to successfully advance the development of its drug candidates in the time frames it projects, if at all. Curis's drug candidates may cause unexpected toxicities, fail to demonstrate sufficient safety and efficacy in clinical studies and/or may never achieve the requisite regulatory approvals needed for commercialization. Favorable results seen in preclinical studies and early clinical trials of Curis's drug candidates may not be replicated in later trials. There can be no guarantee that the collaboration agreement with Aurigene will continue for its full term, or the CRADA with NCI, that Curis or its collaborators will each maintain the financial and other resources necessary to continue financing its portion of the research, development and commercialization costs, or that the parties will successfully discover, develop or commercialize drug candidates under the collaboration. Regulatory authorities may determine to delay or restrict Genentech's and/or Roche's ability to continue to commercialize Erivedge in basal cell carcinoma. Competing drugs may be developed that are superior to Erivedge. In connection with its agreement with Oberland Capital, Curis faces risks relating to the transfer and encumbrance of certain royalty and royalty-related payments on commercial sales of Erivedge, including the risk that, in the event of a default by Curis or its wholly-owned subsidiary, Curis could lose all retained rights to future royalty and royalty-related payments, Curis could be required to repurchase such future royalty and royalty-related payments at a price that is a multiple of the payments it has received, and its ability to enter into future arrangements may be inhibited, all of which could have a material adverse effect on its business, financial condition and stock price. Curis will require substantial additional capital to fund its business. If it is not able to obtain sufficient funding, it will be forced to delay, reduce in scope or eliminate some of its research and development programs, including related clinical trials and operating expenses, potentially delaying the time to market for, or preventing the marketing of, any of its product candidates, which could adversely affect its business prospects and its ability to continue operations, and would have a negative impact on its financial condition and its ability to pursue its business strategies. Curis faces substantial competition. Curis and its collaborators face the risk of potential adverse decisions made by the FDA and other regulatory authorities, investigational review boards, and publication review bodies. Curis may not obtain or maintain necessary patent protection and could become involved in expensive and time-consuming patent litigation and interference proceedings. Unstable market and economic conditions, natural disasters, public health crises, political crises and other events outside of Curis's control could significantly disrupt its operations or the operations of third parties on which Curis depends and could adversely impact Curis's operating results and its ability to raise capital. Other important factors that may cause or contribute to actual results being materially different from those indicated by forward-looking statements include the factors set forth under the captions "Risk Factor Summary" and "Risk Factors" in our most recent Form 10-K and Form 10-Q, and the factors that are discussed in other filings that we periodically make with the Securities and Exchange Commission. In addition, any forward-looking statements represent the views of Curis only as of today and should not be relied upon as representing Curis's views as of any subsequent date. Curis disclaims any intention or obligation to update any of the forward-looking statements after the date of this press release whether as a result of new information, future events or otherwise, except as may be required by law. SOURCE Curis, Inc.

LEXINGTON, Mass., Dec. 11, 2023 /PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 inhibitor, last night presented clinical data from its TakeAim Leukemia Study at the 2023 ASH Conference. "We continue to be pleased with patient enrollment in the TakeAim Leukemia study and are especially pleased that the data confirm our observations to date – that emavusertib demonstrates a safe and manageable safety profile in addition to clear anti-cancer activity," said James Dentzer, President and Chief Executive Officer of Curis. Data were presented for 92 patients treated with emavusertib monotherapy at doses ranging from 200 mg to 500 mg BID. Substantial reductions in blast counts were observed across all patient groups, irrespective of dose level, mutation status, or prior treatment history. Treatment-related adverse events (TRAEs) of grade ≥ 3 were found to be both manageable and acceptable, with no dose-limiting myelosuppression detected. In the targeted population of patients with a FLT3 mutation, evidence of clear anti-cancer activity included changes in mutational profiles that suggest disease-modifying activity. These results were observed in patients including those who had progressed on a prior FLT3 inhibitor. Among relapsed/refractory patients with FLT3 mutation who received ≤ 2 prior lines of treatment and had both baseline and post-treatment marrow evaluations, administering 300 mg emavusertib BID yielded compelling results. Notably, 2 out of 3 patients achieved a Complete Response (CR) with the other achieving morphological leukemia free state, indicating strong activity in patients with FLT3 mutation. About emavusertib (CA-4948) Emavusertib is a small molecule IRAK4 inhibitor. IRAK4 plays an essential role in the toll-like receptor (TLR) and interleukin-1 receptor (IL-1R) signaling pathways, which are frequently dysregulated in patients with cancer. TLRs and the IL-1R family signal through the adaptor protein MYD88, which results in the assembly and activation of IRAK4, initiating a signaling cascade that induces cytokine and survival factor expression mediated by the NF-κB protein complex. Preclinical studies targeting IRAK1/4 in combination with FLT3 have demonstrated the ability to overcome the adaptive resistance incurred when targeting FLT3 alone. Further, emavusertib has shown anti-tumor activity across a broad range of hematologic malignancies including monotherapy activity in patient-derived xenografts and synergy with both azacitidine and venetoclax. About TakeAim Leukemia Study TakeAim Leukemia Study (NCT04278768) – study is open for enrollment. About Curis, Inc. Curis is a biotechnology company focused on the development of emavusertib, an orally available, small molecule IRAK4 inhibitor. Emavusertib is currently undergoing testing in the Phase 1/2 TakeAim Lymphoma study in patients with hematologic malignancies, such as non-Hodgkin's lymphoma and other B cell malignancies in combination with the BTK inhibitor ibrutinib, and as a monotherapy in the Phase 1/2 TakeAim Leukemia study in patients with acute myeloid leukemia and myelodysplastic syndrome, for which it has received Orphan Drug Designation from the U.S. Food and Drug Administration. Curis, through its 2015 collaboration with Aurigene, has the exclusive license to emavusertib (CA-4948). Curis licensed its rights to Erivedge® to Genentech, a member of the Roche Group, under which they are commercializing Erivedge® for the treatment of advanced basal cell carcinoma. For more information, visit Curis's website at . Cautionary Note Regarding Forward-Looking Statements: This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, including, without limitation, any statements with respect to the TakeAim Leukemia study including the activity, safety, tolerability, manageability and efficacy of emavusertib. Forward-looking statements may contain the words "believes," "expects," "anticipates," "plans," "intends," "seeks," "estimates," "assumes," "predicts," "projects," "targets," "will," "may," "would," "could," "should," "continue," "potential," "focus," "strategy," "mission," or similar expressions. These forward-looking statements are not guarantees of future performance and involve risks, uncertainties, assumptions and other important factors that may cause actual results to be materially different from those indicated by such forward-looking statements. Curis may experience adverse results, delays and/or failures in its drug development programs and may not be able to successfully advance the development of its drug candidates in the time frames it projects, if at all. Curis's drug candidates may cause unexpected toxicities, fail to demonstrate sufficient safety and efficacy in clinical studies and/or may never achieve the requisite regulatory approvals needed for commercialization. Favorable results seen in preclinical studies and early clinical trials of Curis's drug candidates may not be replicated in later trials. There can be no guarantee that the collaboration agreement with Aurigene will continue for its full term, or the CRADA with NCI, that Curis or its collaborators will each maintain the financial and other resources necessary to continue financing its portion of the research, development and commercialization costs, or that the parties will successfully discover, develop or commercialize drug candidates under the collaboration. Regulatory authorities may determine to delay or restrict Genentech's and/or Roche's ability to continue to commercialize Erivedge in basal cell carcinoma. Competing drugs may be developed that are superior to Erivedge. In connection with its agreement with Oberland Capital, Curis faces risks relating to the transfer and encumbrance of certain royalty and royalty-related payments on commercial sales of Erivedge, including the risk that, in the event of a default by Curis or its wholly-owned subsidiary, Curis could lose all retained rights to future royalty and royalty-related payments, Curis could be required to repurchase such future royalty and royalty-related payments at a price that is a multiple of the payments it has received, and its ability to enter into future arrangements may be inhibited, all of which could have a material adverse effect on its business, financial condition and stock price. Curis will require substantial additional capital to fund its business. If it is not able to obtain sufficient funding, it will be forced to delay, reduce in scope or eliminate some of its research and development programs, including related clinical trials and operating expenses, potentially delaying the time to market for, or preventing the marketing of, any of its product candidates, which could adversely affect its business prospects and its ability to continue operations, and would have a negative impact on its financial condition and its ability to pursue its business strategies. Curis faces substantial competition. Curis and its collaborators face the risk of potential adverse decisions made by the FDA and other regulatory authorities, investigational review boards, and publication review bodies. Curis may not obtain or maintain necessary patent protection and could become involved in expensive and time-consuming patent litigation and interference proceedings. Unstable market and economic conditions, natural disasters, public health crises, political crises and other events outside of Curis's control could significantly disrupt its operations or the operations of third parties on which Curis depends and could adversely impact Curis's operating results and its ability to raise capital. Other important factors that may cause or contribute to actual results being materially different from those indicated by forward-looking statements include the factors set forth under the captions "Risk Factor Summary" and "Risk Factors" in our most recent Form 10-K and Form 10-Q, and the factors that are discussed in other filings that we periodically make with the Securities and Exchange Commission. In addition, any forward-looking statements represent the views of Curis only as of today and should not be relied upon as representing Curis's views as of any subsequent date. Curis disclaims any intention or obligation to update any of the forward-looking statements after the date of this press release whether as a result of new information, future events or otherwise, except as may be required by law. SOURCE Curis, Inc.