GCN2

HiberCell Announces Recent Publication and Poster Presentations for its Novel GCN2 Activator, HC-7366

Retrieved on: 
Friday, April 5, 2024
SOC, EGFR, GCN2, NSCLC, Journal, Abstract, AACR, Publication, Therapy, Metastasis, Medicinal chemistry, Pharmaceutical industry

This publication and abstracts are now available online and on the AACR website, respectively.

Key Points: 
  • This publication and abstracts are now available online and on the AACR website, respectively.
  • Our first poster features the remarkable preclinical activity of HC-7366 as monotherapy and in combination with belzutifan in clear cell renal cell carcinoma models (ccRCC).
  • This work was foundational to our ongoing Phase 1b study in ccRCC in combination with belzutifan, which was announced earlier this year.
  • Abstract Title: HC-7366, a potent GCN2 kinase activator, augments osimertinib therapy to delay resistance in EGFR mutant NSCLC models.

Nuvectis Pharma Announces Upcoming Presentations at the 2024 American Association for Cancer Research Meeting

Retrieved on: 
Tuesday, March 19, 2024
AACR, GCN2, Clinical trial

Fort Lee, NJ, March 19, 2024 (GLOBE NEWSWIRE) -- Nuvectis Pharma, Inc. (NASDAQ: NVCT) ("Nuvectis" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, today announced upcoming presentations for NXP800 and NXP900 at the upcoming 2024 American Association for Cancer Research Meeting (2024 AACR), taking place from April 5th to April 10th in San Diego, California.

Key Points: 
  • Fort Lee, NJ, March 19, 2024 (GLOBE NEWSWIRE) -- Nuvectis Pharma, Inc. (NASDAQ: NVCT) ("Nuvectis" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, today announced upcoming presentations for NXP800 and NXP900 at the upcoming 2024 American Association for Cancer Research Meeting (2024 AACR), taking place from April 5th to April 10th in San Diego, California.
  • Presentation details are below:
    Pharmacokinetic and pharmacodynamic evaluation of NXP800, a novel GCN2 activator, in a first in human clinical trial

HiberCell Announces Presentation at ASH, Highlighting Preclinical Data for HC-7366 with Standard of Care Agents in Acute Myeloid Leukemia (AML)

Retrieved on: 
Friday, December 15, 2023
Metastasis, Conference, Exposition, AACR, ISR, CRISPR, MCL1, ASH, Azacitidine, BCL2, Venetoclax, Patient, Therapy, AML, GCN2, SOC, Explosive

“Our data also demonstrated that HC-7366 has monotherapy activity in TP53-mutant preclinical models as well as tumor regressions in models of AML as part of a triplet combination with venetoclax and azacitidine.

Key Points: 
  • “Our data also demonstrated that HC-7366 has monotherapy activity in TP53-mutant preclinical models as well as tumor regressions in models of AML as part of a triplet combination with venetoclax and azacitidine.
  • Both the TP53-mutant and relapsed/refractory, to venetoclax and azacitidine, are settings with poor prognoses for patients and represent major unmet clinical needs.
  • The triplet combination of low-dose HC-7366, venetoclax, and azacitidine is significantly more efficacious than the venetoclax/azacitidine doublet.
  • Together, these data support the treatment of AML patients with HC-7366 in combination with venetoclax and azacitidine.

HiberCell, Inc. Announces Clinical Collaboration with Merck to Evaluate HC-7366, an Activator of ISR Kinase GCN2, in Combination with WELIREG® (belzutifan) in a Phase 1b Study of Patients with Clear Cell Renal Cell Carcinoma (ccRCC)

Retrieved on: 
Tuesday, December 5, 2023
MSD, Metastasis, Principal, Merck & Co., Clinical trial, RCC, MSKCC, Patient, Safety, Therapy, GCN2, Renal cell carcinoma, Pharmaceutical industry

The Phase 1b study will evaluate the safety, tolerability, and preliminary efficacy of HC-7366 in combination with WELIREG in participants with ccRCC.

Key Points: 
  • The Phase 1b study will evaluate the safety, tolerability, and preliminary efficacy of HC-7366 in combination with WELIREG in participants with ccRCC.
  • With a focus on determining the recommended Phase 2 dose (RP2D), the study includes a dose-escalation phase followed by a dose-expansion phase and an independent HC-7366 monotherapy cohort.
  • The study is planned to open in Q1 2024 and will enroll up to 80 participants at clinical sites across the US.
  • “We are excited to collaborate with Merck to evaluate HC-7366 in combination with belzutifan,” said Jonathan Lanfear, President & CEO of HiberCell.

Deciphera Pharmaceuticals Announces First Quarter 2023 Financial Results

Retrieved on: 
Wednesday, May 3, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, GIST, KRAS, DNA, AACR, INSIGHT, Pfizer, CRC, Autophagy, TGCT, Breakthrough therapy, BRAF, Mutation, BTD, Tenosynovial giant cell tumor, MEK, Cetuximab, Sale, Binimetinib, Trial of the century, II, ASCO, KIT, Public expenditure, Journal of the National Comprehensive Cancer Network, American Society of Clinical Oncology, Patient, American Association for Cancer Research, Colorectal cancer, Annual general meeting, Neoplasm, Exon, FDA, GCN2, Regulation of tobacco by the U.S. Food and Drug Administration, IND, Society, CSF1R, III, Food, D, Pharmaceutical industry, Video game, Medical imaging, Vaccine, Reinsurance, Cancer

Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, today announced financial results for the first quarter ended March 31, 2023 and provided a corporate update.

Key Points: 
  • Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, today announced financial results for the first quarter ended March 31, 2023 and provided a corporate update.
  • In the third quarter of 2022, Deciphera completed the sale of zero cost inventories of QINLOCK that had been expensed prior to FDA approval.
  • R&D Expenses: Research and development expenses for the first quarter of 2023 were $54.8 million, compared to $47.4 million for the same period in 2022.
  • Deciphera will host a conference call and webcast to discuss this announcement today, May 3, 2023, at 8:00 AM ET.

HiberCell to Present Pre-clinical Data on its Novel GCN2 Activator and PERK Inhibitor Programs at the American Association for Cancer Research (AACR) Annual Meeting 2023

Retrieved on: 
Friday, March 24, 2023
Abstract, AACR, Therapy, CRC, Renal cell carcinoma, RCC, SITC, Oregon Health & Science University, NSCLC, OHSU, VEGFR, HNSCC, GCN2, Stomach, Metastasis, Pharmaceutical industry

The abstracts are now available on the AACR website .

Key Points: 
  • 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.
  • 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.
  • We look forward to presenting initial clinical data from these studies later this year.”

Deciphera Pharmaceuticals Announces Eight Presentations Highlighting Discovery Research Programs at the American Association for Cancer Research (AACR) Annual Meeting 2023

Retrieved on: 
Tuesday, March 14, 2023
Oncology, Health, Other Health, Clinical Trials, Pharmaceutical, Biotechnology, ULK, Cancer, Research, Integrated stress response, AACR, Abstract, Encorafenib, Cetuximab, BRAF, Gastrointestinal stromal tumor, Autophagy, III, Exon, Growth, GIST, Colorectal cancer, RAF, KIT, Preclinical SPECT, GCN2, Investigational New Drug, II, IND, Pharmaceutical industry, Vaccine, Medical imaging

Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, today announced the presentation of eight posters at the upcoming AACR Annual Meeting 2023, taking place in Orlando, Florida on April 14-19, 2023.

Key Points: 
  • Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, today announced the presentation of eight posters at the upcoming AACR Annual Meeting 2023, taking place in Orlando, Florida on April 14-19, 2023.
  • The Company will also host a virtual investor event on Tuesday, April 18 at 6:30 PM ET.
  • A webcast of the event will be available in the “Events and Presentations” page in the “Investors” section of the Company’s website at https://investors.deciphera.com/events-presentations .
  • The archived webcast will be available on the Company’s website within 24 hours after the event and will be available for 30 days following the event.

HiberCell Maps Forward Path for Novel GCN2 Activator, HC-7366 in Acute Myeloid Leukemia (AML)

Retrieved on: 
Wednesday, February 22, 2023
Tissue, Metastasis, Safety, Venetoclax, Integrated stress response, Bone marrow, Investigational New Drug, IND, Syndrome, GCN2, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, American Association for Cancer Research, Therapy, Myelodysplastic syndrome, CRISPR, Conference, AACR, AML, Food, Poster, ISR, Explosive, Pharmaceutical industry, Medical imaging

The Company also announced the recently cleared Investigational New Drug (IND) application for the initiation of clinical studies of HC-7366, the Company’s GCN2 stress response protein kinase modulator for the treatment of AML.

Key Points: 
  • The Company also announced the recently cleared Investigational New Drug (IND) application for the initiation of clinical studies of HC-7366, the Company’s GCN2 stress response protein kinase modulator for the treatment of AML.
  • Increased expression of the ISR markers confirmed HC-7366 functioned as a GCN2 activator in vivo.
  • The viability and marker effects of HC-7366 were confirmed to be on-target through GCN2 using CRISPR knockout cells.
  • In a xenotransplantable model of patient-derived AML, HC-7366 significantly reduced myeloid restricted precursor (CD34+CD33+) AML cells in all tissues, especially bone marrow as compared to venetoclax.

HiberCell to Present Preclinical Data from Novel GCN2 Activator and PERK Inhibitor Programs at The Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting

Retrieved on: 
Wednesday, November 2, 2022
ISR, ER, Unfolded protein response, SITC, GLOBE, Intelligence, UPR, Cell, Immunotherapy, Annual general meeting, Patient, Machine learning, Metastasis, Neoplasm, 2021 Essex County Council election, Therapy, Society, GCN2, Society for Immunotherapy of Cancer, Pharmaceutical industry

Full text of the abstracts will be available on the SITC website at 8:00 a.m.

Key Points: 
  • Full text of the abstracts will be available on the SITC website at 8:00 a.m.
  • PERK is part of the unfolded protein response (UPR) that is activated in cancer cells by accumulation of misfolded proteins in the ER and enables their adaptive survival mechanism.
  • HiberCell is currently conducting Phase 1 clinical trials in solid tumors for each of our therapeutic candidates HC-7366 (NCT05121948) and HC-5404 (NCT04834778).
  • HiberCell is a clinical-stage biotechnology company dedicated to the advancement of novel therapeuticagentstargeting adaptive stress pathways and immune modulation to enable patients to live longer, cancer-free lives.

HiberCell Initiates its Phase 1a/b Clinical Trial of HC-7366 in Patients with Advanced Solid Tumors

Retrieved on: 
Thursday, February 24, 2022
GLOBE, Therapy, Head, Metastasis, Neoplasm, Clinical trial, Safety, GCN2, Lymphatic system, Automatic generation control, Sarah Cannon Research Institute, IND, Colorectal cancer, Cancer, Patient, Large-cell lung carcinoma, Pharmaceutical industry

The first clinical trial site opened January 2022 with Sarah Cannon Research Institute at Tennessee Oncology in Nashville, Tennessee.

Key Points: 
  • The first clinical trial site opened January 2022 with Sarah Cannon Research Institute at Tennessee Oncology in Nashville, Tennessee.
  • We are pleased to announce that HC-7366, our first in-human GCN2 modulator, is now being tested in cancer patients with advanced solid tumors.
  • HiberCells approach utilizes AI/ML to integrate multi-omic and phenotypic profiles of tumors to generate insights that connect this information to clinical outcomes.
  • To that end, HiberCell is developing therapeutics that resolve the stress-mediated adaptive response that is essential for cancer cell survival.