Alintegimod

HOUSTON, June 03, 2024 (GLOBE NEWSWIRE) -- 7 Hills Pharma Inc. (“7 Hills” or “7HP”), a clinical-stage pharma company leveraging a novel mechanism of action to safely enhance the effectiveness of cancer immunotherapies, was awarded $4.7 million from the Cancer Prevention and Research Institute of Texas (CPRIT) to support its cell/gene therapy (CGT) development program. This grant will allow 7 Hills to advance 7HP935, the Company’s lead first-in-class small molecule to augment CGT, through a Phase I clinical trial. 7HP’s CGT program has previously been awarded over $3.2 million via multiple awards from the National Heart, Lung, and Blood Institute, including STTR grants R41HL129612 and R42HL129612, and Catalyze grant R33HL161778. CCBC laboratory staff members prepare the Center’s 800th umbilical cord blood unit for shipment. 7 Hills Pharma aims to increase clinical utilization of cord blood resources and improve patient access to life-saving HSCT. Many CGT approaches, including CRISPR-based therapies and treatments for blood cancers, include integration of CGT within hematopoietic stem cell transplantation (HSCT), popularly known as a “bone marrow transplant”. Bone marrow is the tissue that generates red blood cells, platelets, and the white blood cells that comprise the immune system. During HSCT, a patient’s bone marrow is first treated with chemotherapy or radiation to ‘make space’ for engraftment of healthy CD34+ stem cells infused intravenously. These healthy stem cells traffic or ‘home’ to the bone marrow niche, engraft, and begin to repopulate the patient’s entire blood and immune system. During the period after a patient’s bone marrow has been treated but before the new stem cells have engrafted, the patient is at risk for serious infection and its management often requires prolonged hospitalization. Importantly, up to 10% of HSCT patients experience a complication where the healthy CD34+ HSC do not engraft. This is termed ‘graft failure’ and it necessitates urgent management including treatment with a second CD34+ stem cell graft. In a preclinical mouse model of HSCT, 7HP935 in combination with an umbilical cord blood (UCB)-derived CD34+ stem cell transplant significantly reduced the time from transplant to hematopoietic and immune reconstitution, offering the potential in clinical application to decrease the rate of infection, time in hospital, and total treatment costs. The immediate availability and immunologic flexibility of UCB, combined with the enhanced stem cell engraftment enabled by 7HP935, provides a potential new and better solution for patients with delayed engraftment or worse - graft failure, as well as for patients from ethnic minorities who often are unable to find a suitably tissue matched stem cell donor. “I believe in the potential of this novel approach to improve outcomes after HSCT and increase patient access to these life-saving treatments for hematologic malignancies and genetic disorders. Umbilical cord blood is a uniquely flexible stem cell source, and we are excited that 7HP935 may finally solve the problem of slow stem cell engraftment that has held back UCB from greater clinical utilization,” said Dr. Mary Laughlin, Founder and Medical Director of the Cleveland Cord Blood Center (CCBC). Dr. Peter Vanderslice is a co-founder of 7 Hills Pharma and a pioneer of small molecule integrin activation. “We are proud to continue our collaboration with 7 Hills and inspired by this technology being successfully applied across multiple indications,” said Dr. Peter Vanderslice, Director of Molecular Cardiology Research at The Texas Heart Institute (THI). “7HP935 is the second molecule discovered at THI that will enter clinical trials with 7 Hills following 7HP349, also known as alintegimod. I am particularly gratified that CPRIT appreciated how the 7 Hills approach could help address racial disparities in HSCT, as Black and Hispanic patients with AML and ALL suffer from a high risk of not finding a matched donor.” About 7 Hills Pharma Inc. 7 Hills Pharma is a clinical-stage immunotherapy company developing a platform of novel small molecules for the treatment of cancer and prevention of infectious diseases. Our compounds are first-in-concept allosteric integrin activators that leverage a unique mechanism of action to stabilize the cell-cell interactions required to effectively mount an immune response and more quickly engraft transplanted hematopoietic stem cells. For more information, visit http://www.7hillspharma.com. About 7HP935 7HP935 is 7HP’s lead integrin activator to improve hematopoietic stem cell transplant. It is a first-in-class small molecule that safely and selectively activates the integrin VLA-4 to augment the homing and engraftment of transplanted stem cells into the bone marrow niche. In a preclinical model of HSCT, 7HP935 decreased the time from transplant to immune reconstitution, setting the stage to potentially improve HSCT across a variety of dimensions, including safety, efficacy, cost, and patient access. About Texas Heart Institute Texas Heart Institute (THI), founded by world-renowned cardiovascular surgeon Dr. Denton A. Cooley in 1962, is a nonprofit organization dedicated to delivering the future of cardiovascular health through exceptional patient care, discovery, and a commitment to learning. Participating in research programs in cardiology, cardiovascular surgery, stem cell, and gene therapy, and regenerative medicine, THI’s scientists and physicians are spearheading some of the most innovative research in the medical field. Through its translational basic and clinical research programs, Texas Heart Institute is learning more every day about the underlying causes of heart disease and the ways to better treat and even prevent it. With initiatives ranging from postdoctoral and continued medical education to public outreach and scientific publications, THI is dedicated to spreading awareness and sharing updates on ways to prevent, treat, and defeat cardiovascular disease. As a global leader in patient care for nearly six decades, Texas Heart Institute has been ranked among the top cardiovascular centers in the United States by U.S. News & World Report for the past 30 years. With over 12 million visitors coming to its website from around the world every year, www.texasheart.org is just one of the ways THI is helping to educate people on the importance of heart health. For more information, please visit https://www.texasheart.org. @Texas_Heart 7 Hills Pharma Media Contact: Rob Bent rob@7hillspharma.com Photos accompanying this announcement are available at: https://www.globenewswire.com/NewsRoom/AttachmentNg/d3c4bdbf-5225-4124-8ead-3626c13367ba https://www.globenewswire.com/NewsRoom/AttachmentNg/5c7bf66a-433a-4caa-9668-4217846bd7b5

7 Hills Pharma LLC (“7 Hills” or “7HP”) announced today that it has been awarded $13.5MM in nondilutive grant funds from the Cancer Prevention & Research Institute of Texas (CPRIT) to advance 7HP349, its first-in-class oral selective integrin activator into a Phase 1b/2a clinical trial in patients who are resistant to PD-1-based therapies. The new CPRIT funds follow over $13MM in federal grant awards, in collaboration with world-class institutions such as The Texas Heart Institute, the University of Texas MD Anderson Cancer Center, the University of Texas Health Science Center, and the Icahn School of Medicine, that supported the development of the platform technology from 7 Hills and fully funded a Phase 1 clinical trial of 7HP349. Immune checkpoint inhibitors, such as KEYTRUDA® (pembrolizumab) and OPDIVO® (nivolumab), command global sales of over $30 billion per annum due to their curative potential. However, up to 90% of patients with solid tumors were found not to respond, leaving these patients with limited treatment options. Alintegimod, also known as 7HP349, has the potential to offer a novel mechanism to safely overcome resistance to a broad range of immunotherapies, including anti-tumor immune checkpoint inhibitors and infectious disease vaccines. The CPRIT-funded clinical trial will test the ability of 7HP349 to augment T-cell activation in patients with checkpoint blockade-resistant tumors, a novel approach that may offer patients a compelling treatment option with no additional toxicities. “Developing first-in-class therapeutics, especially in Houston, is a challenging task,” said Dr. Michael S. Perry, chairman of the 7 Hills Board of Managers. “CPRIT’s support of early-stage Texas talent and technology is critical to enabling next-generation innovations like alintegimod to thrive in our underserved regional venture capital ecosystem and to attract follow-on investment and strategic partnering.” 7 Hills Chief Medical Officer Lionel Lewis, MB BCh., MD, added, “We are grateful for CPRIT’s support as we bring our revolutionary technology and novel mechanism of action to patients with advanced solid tumors for the first time. 7 Hills is inspired to finally deliver the full promise of immunotherapy and we are excited to demonstrate alintegimod’s distinctive benefits when combined with checkpoint blockade.” About 7 Hills Pharma LLC 7 Hills Pharma is a clinical-stage immunotherapy company developing a platform of novel, oral small molecules for the treatment of cancer and prevention of infectious diseases. Our compounds are first-in-concept allosteric integrin activators that leverage a unique mechanism of action to stabilize the cell-cell interactions required to mount an effective immune response. Our lead clinical candidate, 7HP349 (also known as alintegimod), is the only reported systemically safe immune stimulant that can activate both cellular and humoral immunity. For more information, visit 7hillspharma.com About Alintegimod Alintegimod, also designated 7HP349, is the lead, clinical-stage integrin agonist from 7 Hills Pharma. It is a first-in-class, orally delivered small molecule that safely and selectively activates the integrins LFA-1 and VLA-4 to augment antigen-specific immune responses. In preclinical models, alintegimod has been shown to improve the effectiveness of a broad range of immune checkpoint inhibitors and a wide variety of infectious disease vaccines. In a Phase 1 clinical trial, alintegimod demonstrated oral bioavailability and a clean safety profile at exposures well exceeding therapeutic levels. The content above comes from the network. if any infringement, please contact us to modify.