BOSTON, March 24, 2023 — HiberCell, a clinical-stage biotechnology company developing novel therapeutics to address mechanisms of metastasis, treatment resistance, and cancer relapse, today announced three pre-clinical poster presentations which will be highlighted at the American Association for Cancer Research (AACR) Annual Meeting 2023, taking place April 14-19 in Orlando, Florida. The abstracts are now available on the AACR website.

“We are excited to announce promising preclinical data for our novel PERK inhibitor, HC-5404, and novel GCN2 activator, HC-7366 in multiple solid tumors,” said Jonathan Lanfear, President and Chief Executive Officer of HiberCell. “At the upcoming AACR meeting, we will be presenting data on HC-5404, which has shown remarkable activity in models of clear cell Renal Cell Carcinoma (RCC) in combination with anti-angiogenic VEGFR Tyrosine Kinase Inhibitors, an important component of standard of care in this setting. We will also present data on HC-7366, which have shown robust anti-tumor activity both as a monotherapy in and in combination with standard of care agents in several tumor types. In addition to these posters, building on the data that HiberCell presented at SITC 2022 for HC-5404 in combination with anti-PD-1 antibodies, we are excited to announce that our collaborators at Oregon Health and Science University (OHSU) will be presenting on the combination therapy of HC-5404 with PD1/PD-L1 inhibitors. These data represent a strong rationale for the continued advancement of HC-5404 and HC-7366 as monotherapy and combination therapy approaches in solid tumors.”

Mr. Lanfear continued, “HC-5404 is currently under clinical development in a Ph1a study in solid tumors including RCC, gastric cancer and other solid tumors. HC-7366 is currently under clinical development in a Ph1a study in solid tumors including Head and Neck Squamous Cell Carcinoma (HNSCC), colorectal (CRC), Non-Small Cell Lung Cancer (NSCLC), and other solid tumors.   We look forward to presenting initial clinical data from these studies later this year.”

Poster Presentations:

Abstract Title: Inhibition of PERK by HC-5404 sensitizes clear cell renal cell carcinoma tumor models to anti-angiogenic tyrosine kinase inhibitors
Abstract/Poster Number: 4010
Presentation Time: Tuesday April 18, 2023, 9:00 AM – 12:30 PM

Abstract Title: Activation of GCN2 by HC-7366 results in significant antitumor efficacy as monotherapy and in combination with multiple standard of care agents in multiple solid cancer models
Abstract/Poster Number: 6231
Presentation Time: Wednesday April 19, 2023, 9:00 AM – 12:30 PM

Abstract Title: Combination therapy using PERK and PD1/PD-L1 inhibitors reprograms tumor associated macrophages and reduces tumor burden
Poster/Abstract Number: 3247
Presentation Time: Monday April 17, 2023, 1:30 PM – 5:30 PM

About HC-5404
HC-5404 is a first-in-class, first-in-human selective and potent protein kinase RNA-like endoplasmic reticulum kinase (PERK) inhibitor. PERK is a kinase of the Unfolded Protein Response (UPR), an adaptive cellular program used by cancer cells to survive by facilitating adaptation to harsh tumor microenvironments characterized by hypoxia, nutrient deprivation and oxidative stress.  In preclinical studies, inhibition of PERK with HC-5404 has been shown to have anti-tumor and immunomodulatory activity. HC-5404 is currently under investigation in a Phase 1 clinical trial for solid tumors (NCT04834778).

About HC-7366
HC-7366 is a first-in-class, first-in-human general controlled nondepressable 2 (GCN2) activator. GCN2 is one of the kinases of the ISR family, which responds to amino acid deprivation and is a key metabolic stress sensor in cells. While cancer cells utilize the ISR for survival, prolonged or hyperactivation of GCN2 with HC-7366 has been shown to have anti-tumor and immunomodulatory activity as a monotherapy and in combination with SOC agents in both solid and liquid tumors. HC-7366 is under investigation in a Phase 1a/b clinical trial (NCT05121948) as monotherapy for the treatment of advanced solid tumors, including HNSCC, CRC, and other solid tumors.

About HiberCell
HiberCell is a clinical stage oncology company, dedicated to the advancement of first-in-class agents with the novel MOA of modulation of adaptive stress pathways and anti-tumor immunity. We believe that therapeutic modulation of these mechanisms allows us to address tumor metastasis, treatment resistance, and cancer relapse; all significant drivers of cancer-related deaths. Our product candidates HC-5404 and HC-7366, both completing Phase 1a clinical trials, target the stress response kinases PERK and GCN2, respectively, while our product candidate odetiglucan, currently in Phase 2 clinical development, modulates the anti-tumor innate immune response.

Contact:
Suzanne Messere
Stern Investor Relations, Inc.
212.698.8801
suzanne.messere@sternir.com