Pharma Focus Asia

7 Hills Pharma Secures $4.7 Million Grant to Advance First-of-Its-Kind Cell/Gene Therapy Technology into Clinical Trials

Tuesday, June 04, 2024

7 Hills Pharma Inc. (referred to as "7 Hills" or "7HP"), a clinical-stage pharmaceutical company, has been granted $4.7 million by the Cancer Prevention and Research Institute of Texas (CPRIT) to bolster its cell/gene therapy (CGT) development program. This funding will facilitate the advancement of 7HP935, the company’s primary first-in-class small molecule designed to enhance CGT, through a Phase I clinical trial. Notably, 7 Hills' CGT program has previously received over $3.2 million through various awards from the National Heart, Lung, and Blood Institute, including STTR grants R41HL129612 and R42HL129612, as well as the Catalyze grant R33HL161778.

Numerous CGT strategies, such as CRISPR-based therapies and treatments for blood cancers, involve incorporating CGT into hematopoietic stem cell transplantation (HSCT), more commonly known as a “bone marrow transplant.” Bone marrow is crucial for generating red blood cells, platelets, and the white blood cells that constitute the immune system. During HSCT, a patient's bone marrow undergoes chemotherapy or radiation to create space for the infusion of healthy CD34+ stem cells intravenously. These healthy stem cells migrate to the bone marrow niche, engraft, and commence repopulating the patient's entire blood and immune system.

In the interim between treating a patient's bone marrow and the engraftment of new stem cells, the patient is susceptible to severe infections, often necessitating prolonged hospital stays. Additionally, up to 10% of HSCT patients encounter a complication termed 'graft failure,' which requires urgent intervention, including a second CD34+ stem cell graft.

In a preclinical mouse model of HSCT, 7HP935 in combination with umbilical cord blood (UCB)-derived CD34+ stem cell transplant notably reduced the time required for hematopoietic and immune reconstitution post-transplantation. This combination holds promise for potentially reducing infection rates, hospitalization duration, and overall treatment costs in clinical applications. The immediate availability and immunological adaptability of UCB, coupled with the enhanced stem cell engraftment facilitated by 7HP935, present a promising solution for patients experiencing delayed engraftment or, worse, graft failure, as well as for patients from ethnic minorities who often struggle to find a suitable tissue-matched stem cell donor.

Dr. Mary Laughlin, Founder and Medical Director of the Cleveland Cord Blood Center (CCBC), expressed optimism about the innovative approach, stating, “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." Dr. Peter Vanderslice, Director of Molecular Cardiology Research at The Texas Heart Institute (THI), echoed this sentiment, emphasizing the collaborative efforts with 7 Hills and the technology's potential to address racial disparities in HSCT.

7HP935, the lead integrin activator developed by 7 Hills, aims to enhance hematopoietic stem cell transplant. This first-in-class small molecule selectively activates the integrin VLA-4 to augment the homing and engraftment of transplanted stem cells into the bone marrow niche. In preclinical HSCT models, 7HP935 has demonstrated a reduction in the time required for immune reconstitution post-transplantation, hinting at potential improvements in HSCT safety, efficacy, cost-effectiveness, and patient accessibility across various dimensions.



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