7 Hills Pharma Receives $4.7MM Grant to Advance First-in-class Cell/Gene Therapy Technology into the Clinic

7 Hills Pharma Inc., 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 to support its cell/gene therapy development program.

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.

7HP935 combined with umbilical cord blood may represent a new and better option for patients in need of HSCT.

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, 7 Hills Pharma co-founder

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

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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.
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Dr. Peter Vanderslice is a co-founder of 7 Hills Pharma and a pioneer of small molecule integrin activation.
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