7 Hills Pharma Surpasses $25MM Milestone in Nondilutive Funding

HOUSTON, May 22, 2023 (GLOBE NEWSWIRE) — 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.

Forward-Looking Statements

Certain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events or 7HP’s future financial or operating performance. In some cases, you can identify forward-looking statements by terminology such as “may,” “should,” “expect,” “intend,” “will,” “estimate,” “anticipate,” “believe,” “predict,” “potential” or “continue,” or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by 7HP and its management, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Factors that may cause actual results to differ materially from current expectations include, but are not limited to, various factors beyond management’s control including general economic conditions and other risks, uncertainties and factors. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. 7HP does not undertake any duty to update these forward-looking statements.

CONTACT: 7 Hills Pharma Media Contact: Rob Bent rob@7hillspharma.com

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