alintegimod (7HP349) / 7 Hills Pharma - LARVOL DELTA

7 Hills Pharma Safely Doses First Patient in Phase 1b/2a Clinical Trial Testing Alintegimod Against aPD-1-resistant Solid Tumors (GlobeNewswire) - "7 Hills Pharma...announced today that their first cancer patient has been safely dosed with alintegimod, an integrin-targeted agonist that may augment T cell activation and trafficking in patients who are resistant to immune checkpoint inhibitors. This multicenter Phase 1b/2a study (NCT06362369) is supported by a $13.4 million award from the Cancer Prevention and Research Institute of Texas (DP230062) and a $2.0 million award from the National Cancer Institute (R44CA285207)."

Financing • Trial status • Solid Tumor

A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy (clinicaltrials.gov) - P1/2 | N=126 | Recruiting | Sponsor: 7 Hills Pharma, LLC | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Monotherapy • Colorectal Cancer • Gastrointestinal Cancer • Genetic Disorders • Genito-urinary Cancer • Hepatocellular Cancer • Hepatology • Kidney Cancer • Liver Cancer • Lung Cancer • Malignant Pleural Mesothelioma • Melanoma • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Skin Cancer • Solid Tumor

A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy (clinicaltrials.gov) - P1/2 | N=126 | Not yet recruiting | Sponsor: 7 Hills Pharma, LLC

Combination therapy • Metastases • Monotherapy • New P1/2 trial • Colorectal Cancer • Gastrointestinal Cancer • Genetic Disorders • Genito-urinary Cancer • Hepatocellular Cancer • Hepatology • Kidney Cancer • Liver Cancer • Lung Cancer • Malignant Pleural Mesothelioma • Melanoma • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Skin Cancer • Solid Tumor

A randomized, placebo-controlled, first in human phase I single ascending dose (SAD) and multiple ascending dose (MAD) study in healthy male volunteers of the immunostimulant 7HP349 (SITC 2022) - "7HP349 mean terminal T 1/2 ranged from 20.6-34.6 h, with no accumulation and non-linear PK at the highest doses. Planned studies combining 7HP349 dosed at 100 mg and 300 mg/day x 5 (at a monotherapy safety margin of >10x) have the potential to augment immune checkpoint blockade without additional toxicity."

Clinical • P1 data • Oncology

New Study Demonstrates Integrin Activation Can Bring the Heat to Cold Melanoma Tumors (GlobeNewswire) - "7 Hills Pharma LLC...together with The University of Texas MD Anderson Cancer Center ('MD Anderson') and Texas Heart Institute ('THI'), released a new study in The Journal of Clinical Investigation, describing the use of 7HP’s novel integrin activator 7HP349 to convert 'cold' or non-immunogenic tumor microenvironments to a 'hot,' T cell-enriched state, improving the effectiveness of immune checkpoint blockade. The article...was published by a team at MD Anderson led by Yared Hailemichael, Ph.D., assistant professor of Melanoma Medical Oncology, with co-authors from 7 Hills and THI."

Preclinical • Melanoma • Oncology • Skin Cancer • Solid Tumor

LFA-1 activation enriches tumor-specific T cells in a cold tumor model and synergizes with CTLA-4 blockade. (PubMed, J Clin Invest) - "Here we show that 7HP349, a small molecule activator of Lymphocyte function-associated antigen-1 (LFA-1) and very late activation antigen-4 (VLA-4) integrin-cell-adhesion receptors, facilitated the preferential localization of tumor-specific T cells to the tumor and improve antitumor response...We identified baseline CXCL12 gene expression may improve response likelihood to anti-CTLA-4 therapies. Our results provided a proof-of-principle demonstration that LFA-1 activation could convert a T cell-exclusionary TME to a T-cell enriched TME through mechanisms involving cooperation with innate immune cells."

IO biomarker • Journal • Preclinical • Melanoma • Oncology • Solid Tumor • CD8 • CXCL12

7 Hills Pharma’s Clinical-stage Novel Immunostimulant 7HP349 Granted FDA Fast Track Designation for Anti-PD-1-resistant Metastatic Melanoma (GlobeNewswire) - "7 Hills Pharma LLC...announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to 7HP349, 7HP’s lead clinical-stage immunostimulant, in combination with a CTLA-4 inhibitor for the treatment of patients with unresectable or metastatic malignant melanoma following treatment failure with a PD-1 inhibitor."

Fast track designation • Melanoma • Oncology • Skin Cancer • Solid Tumor

A Phase 1 SAD and MAD Study of the Safety, Tolerability and PK of 7HP349 in Normal Healthy Male Subjects (clinicaltrials.gov) - P1; N=60; Completed; Sponsor: 7 Hills Pharma, LLC; Recruiting ➔ Completed; Trial completion date: Jun 2021 ➔ Oct 2021; Trial primary completion date: Jun 2021 ➔ Oct 2021

Clinical • Trial completion • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Use of a small molecule integrin activator as a systemically administered vaccine adjuvant in controlling Chagas disease. (PubMed, NPJ Vaccines) - "This demonstrates that 7HP349 can serve as a systemically administered adjuvant to enhance T cell-mediated immune responses to vaccines. This approach could be applied to numerous vaccines with no reformulation of existing stockpiles."

Clinical • Journal • Fibrosis • Immunology • Infectious Disease • CD4 • CD8 • IFNG

7 Hills Pharma Announces First Healthy Volunteers Dosed in Landmark Phase 1 Trial of Immunostimulant to Improve Immuno-Oncology Drugs, COVID-19 and Influenza Vaccines (GlobeNewswire) - "7 Hills Pharma...announced today the first healthy volunteers have been dosed in a Phase 1 trial of 7HP349, the company’s first-in-concept immunostimulant to improve the effectiveness of immunotherapies."

Trial status • Oncology • Solid Tumor

A Phase 1 SAD and MAD Study of the Safety, Tolerability and PK of 7HP349 in Normal Healthy Male Subjects (clinicaltrials.gov) - P1; N=68; Recruiting; Sponsor: 7 Hills Pharma, LLC; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Oncology • Solid Tumor

7 Hills Pharma Receives $2M SBIR Grant from NCI to Launch Phase 1 Trials of Lead Immunostimulant to Augment Immuno-Oncology Drugs, COVID-19 and Flu Vaccines (GlobeNewswire) - "7 Hills Pharma...has been awarded a two-year, $2 million Small Business Innovation Research (SBIR) grant from the National Cancer Institute (NCI) of the U.S. National Institutes of Health....The SBIR funding will be used to support Phase 1 clinical trials of 7HP349, an oral, first in concept small molecule immunostimulant, which is designed to improve the effectiveness of immunotherapies, such as immuno-oncology drugs and infectious disease vaccines."

Grant • New P1 trial • Oncology • Solid Tumor

A Phase 1 SAD and MAD Study of the Safety, Tolerability and PK of 7HP349 in Normal Healthy Male Subjects (clinicaltrials.gov) - P1; N=68; Not yet recruiting; Sponsor: 7 Hills Pharma, LLC

Clinical • New P1 trial • Oncology • Solid Tumor

[VIRTUAL] 7 Hills Pharma (BIO 2020) - "7HP349 improves the effectiveness of immune checkpoint inhibitors for cancer, as well as vaccines for influenza, and COVID-19. 7HP349 is the only systemically safe adjuvant that can activate both cellular and humoral immunity."

Oncology

Newly added product (GlobeNewswire) - Preclinical, Oncology

Pipeline update