HiberCell, Inc.

HiberCell, Inc. is a clinical-stage biopharmaceutical company based in New York, United States, focused on the discovery and development of cancer therapies that target adaptive cellular stress pathways. According to its official website, the company is "pioneering the development of differentiated treatment approaches that target the ISR to help patients live longer, cancer-free lives." Its scientific premise is that tumors which resist treatment, relapse, or metastasize commonly rely on adaptive stress pathways such as the integrated stress response (ISR) and the unfolded protein response (UPR). The company's pipeline centers on two first-in-human small-molecule kinase inhibitors. HC-7366 is an activator of GCN2, a kinase in the ISR family that senses amino acid deprivation and metabolic stress; it is under investigation in a Phase 1b trial as monotherapy and in combination with a HIF-2α inhibitor for clear cell renal cell carcinoma (ccRCC), and in a separate Phase 1b study as monotherapy and in combination with venetoclax and azacitidine for acute myeloid leukemia (AML). HC-7366 has received FDA Fast Track Designation in AML. HC-5404 is a first-in-human PERK inhibitor targeting the UPR; it completed a Phase 1a monotherapy trial in advanced solid tumors enriched for renal cell carcinoma (RCC) and gastric cancer, and a Phase 1b/2 study is planned in combination with a VEGFR tyrosine kinase inhibitor. HiberCell operates as a private company and collaborates with larger pharmaceutical partners. In November 2025, AVEO Oncology, an LG Chem company, and HiberCell announced an exclusive development and option agreement to develop HC-5404 alone and in combination with AVEO's FOTIVDA (tivozanib) for RCC, with AVEO responsible for initial-stage clinical development and holding an option to an exclusive worldwide license for development, manufacturing, and commercialization of HC-5404. The company positions itself at the intersection of cancer stress biology and precision oncology, aiming to exploit stress-driven vulnerabilities in cancer cells. Its public communications emphasize the role of the ISR and UPR in enabling tumor survival under hypoxia, nutrient deprivation, and oxidative stress, and the potential of targeting these pathways to produce anti-tumor responses.

HiberCell, Inc. is a clinical-stage biopharmaceutical company headquartered in New York, United States. The company was founded to pursue a therapeutic hypothesis centered on tumor stress biology: that cancer cells which survive treatment, relapse, or metastasize frequently depend on adaptive stress pathways, particularly the integrated stress response (ISR) and the unfolded protein response (UPR). HiberCell's public materials state that it is "pioneering the development of differentiated treatment approaches that target the ISR to help patients live longer, cancer-free lives." The company's scientific approach focuses on two stress-response kinases. GCN2 (General Controlled Nonderepressible 2) is an ISR kinase that responds to amino acid deprivation and acts as a key metabolic stress sensor. HiberCell's HC-7366 activates GCN2, which phosphorylates eIF2α, inhibits global translation, and enhances ATF4 translation, producing a context-dependent pro-tumor survival or anti-tumor response. The company reports that activation of GCN2 by HC-7366 results in a broad, lethal anti-tumor stress response, with preclinical activity demonstrated in several tumor histologies. HC-7366 has advanced into clinical development: a Phase 1b trial is investigating it as monotherapy and in combination with a HIF-2α inhibitor for clear cell renal cell carcinoma (ccRCC), and a separate Phase 1b study is investigating it as monotherapy and in combination with venetoclax and azacitidine for acute myeloid leukemia (AML). The FDA has granted Fast Track Designation for HC-7366 in AML. The second program, HC-5404, is a first-in-human PERK (protein kinase R–like endoplasmic reticulum kinase) inhibitor. PERK is an ER-resident transmembrane kinase in the UPR pathway that signals through eIF2α to block ER-dependent protein synthesis and maintain homeostasis under hypoxia and other stress conditions. HiberCell reports that inhibition of PERK by HC-5404 results in significant antitumor efficacy in combination with standard-of-care anti-angiogenic agents in multiple solid tumor models, including renal cell carcinoma and gastric cancer. HC-5404 completed a Phase 1a trial as a monotherapy for advanced solid tumors enriched for patients with RCC and gastric cancer, and a Phase 1b/2 study is planned for HC-5404 in combination with a VEGFR TKI. A significant corporate development occurred in November 2025, when AVEO Oncology, an LG Chem company, and HiberCell announced an exclusive development and option agreement for HC-5404. Under the agreement, the first-in-human PERK inhibitor is to be developed alone and in combination with AVEO's FOTIVDA (tivozanib), an anti-angiogenic agent approved by the U.S. FDA in March 2021 for adult patients with relapsed or refractory renal cell carcinoma following two or more prior systemic therapies. AVEO is responsible for conducting initial-stage clinical development, and during the Phase 2 clinical trial AVEO will have the option to obtain an exclusive license for the development, manufacturing, and commercialization of HC-5404 in all therapeutic indications worldwide for an undisclosed option fee. If AVEO exercises its option, HiberCell will be eligible to receive additional payments as described in the announcement. HiberCell operates as a private company and, as of the available evidence, is based in New York. Its pipeline remains in clinical-stage development, with no approved products of its own; its strategy combines internal development with partnerships with larger oncology-focused companies.

• AVEO Oncology, an LG Chem company, and HiberCell announced an exclusive development and option agreement for HC-5404, to be developed alone and in combination with FOTIVDA (tivozanib) for renal cell carcinoma.

Clinical-stage biopharmaceutical company targeting the integrated stress response (ISR) and unfolded protein response (UPR) to overcome cancer treatment resistance, relapse, and metastasis.

• HC-7366

  A GCN2 activator under investigation in a Phase 1b trial as monotherapy and in combination with a HIF-2α inhibitor for clear cell renal cell carcinoma (ccRCC), and in a Phase 1b study as monotherapy and in combination with venetoclax and azacitidine for acute myeloid leukemia (AML). FDA Fast Track Designation granted in AML.

• HC-5404

  A first-in-human PERK inhibitor that completed a Phase 1a monotherapy trial in advanced solid tumors enriched for renal cell carcinoma (RCC) and gastric cancer; a Phase 1b/2 study is planned in combination with a VEGFR TKI. In November 2025, AVEO Oncology obtained an exclusive development and option agreement for HC-5404.

• Unconfirmed

  Reported2021.08.17

  HiberCell acquires Genuity Science[6]HiberCell收购Genuity Sciencesiliconrepublic.com

  HiberCell acquired Genuity Science; Genuity and its Irish and Icelandic operations will operate as a wholly owned subsidiary of HiberCell.

Read more

1. 1Home - HiberCellhibercell.com
2. 2HC-7366 - HiberCellhibercell.com
3. 3HC-5404 - HiberCellhibercell.com
4. 4AVEO Oncology, an LG Chem company, and HiberCell Enter Into an Exclusive Development and Option Agreement for First-in-Human Compound - HiberCellhibercell.com
5. 5HiberCell, Inc. (United States) - Wikidatawikidata.org
6. 6HiberCell收购Genuity Sciencesiliconrepublic.com