KEAP1

BerGenBio Announces Data from Biomarker Analyses in 2L NSCLC

Retrieved on: 
Monday, November 6, 2023

BERGEN, Norway, Nov. 6, 2023 /PRNewswire/ -- BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, announced that a poster presentation detailing additional data from a Phase II trial of bemcentinib in combination with MSD's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab)  in second line Non-Small Cell Lung Cancer (NSCLC) patients was presented on November 4th at the 2023 Society of Immunotherapy of Cancer Annual Meeting.

Key Points: 
  • The pre-planned biomarker analysis of the BGBC008 study in 2L NSCLC patients adds to the clinical data recently announced at the 2023 ESMO meeting.
  • The poster presentation entitled "Bemcentinib + Pembrolizumab show promising efficacy in metastatic NSCLC patients harboring mutations associated with poor prognosis: exploratory sub-analysis from the BGBC008 Trial", is now available on BerGenBio's website under the Scientific Publications section.
  • Martin Olin, Chief Executive Officer of BerGenBio, commented "The findings add to the industry's understanding of the outcomes in 2L NSCLC patients and the potential for bemcentinib to benefit patients in combination with immune checkpoint inhibition.
  • KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA

BerGenBio Announces Data from Biomarker Analyses in 2L NSCLC

Retrieved on: 
Monday, November 6, 2023

BERGEN, Norway, Nov. 6, 2023 /PRNewswire/ -- BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, announced that a poster presentation detailing additional data from a Phase II trial of bemcentinib in combination with MSD's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab)  in second line Non-Small Cell Lung Cancer (NSCLC) patients was presented on November 4th at the 2023 Society of Immunotherapy of Cancer Annual Meeting.

Key Points: 
  • The pre-planned biomarker analysis of the BGBC008 study in 2L NSCLC patients adds to the clinical data recently announced at the 2023 ESMO meeting.
  • The poster presentation entitled "Bemcentinib + Pembrolizumab show promising efficacy in metastatic NSCLC patients harboring mutations associated with poor prognosis: exploratory sub-analysis from the BGBC008 Trial", is now available on BerGenBio's website under the Scientific Publications section.
  • Martin Olin, Chief Executive Officer of BerGenBio, commented "The findings add to the industry's understanding of the outcomes in 2L NSCLC patients and the potential for bemcentinib to benefit patients in combination with immune checkpoint inhibition.
  • KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA

KRYSTAL-1 Trial Finds that Adagrasib Demonstrates Durable Clinical Activity in Patients with KRAS G12C Mutations

Retrieved on: 
Sunday, September 10, 2023

SINGAPORE, Sept. 10, 2023 /PRNewswire-PRWeb/ -- KRAS G12C mutations occur in approximately 14% of patients with NSCLC. The KRYSTAL-1 study, a multicohort Phase 1/2 trial, evaluated adagrasib as a monotherapy or in combination for patients with KRAS G12C-mutated solid tumors. The U.S. Food and Drug Administration (FDA) granted accelerated approval of adagrasib for patients with previously treated KRAS G12C-mutated advanced/metastatic NSCLC based on data from this study in December 2022. Additionally, the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) are currently reviewing the drug.

Key Points: 
  • SINGAPORE, Sept. 10, 2023 /PRNewswire-PRWeb/ -- KRAS G12C mutations occur in approximately 14% of patients with NSCLC.
  • The KRYSTAL-1 study, a multicohort Phase 1/2 trial, evaluated adagrasib as a monotherapy or in combination for patients with KRAS G12C-mutated solid tumors.
  • The U.S. Food and Drug Administration (FDA) granted accelerated approval of adagrasib for patients with previously treated KRAS G12C-mutated advanced/metastatic NSCLC based on data from this study in December 2022.
  • The findings suggest durable clinical activity of adagrasib for KRAS G12C-mutated NSCLC.

Isolation of Circulating Tumor Cells with TellDx Platform Reveals Potential Mechanism of Resistance to Immune Checkpoint Blockade in Melanoma

Retrieved on: 
Thursday, March 16, 2023

BEVERLY, Mass., March 16, 2023 (GLOBE NEWSWIRE) -- TellBio, Inc., a development stage biotechnology company focused on revolutionizing the detection of cancer through its unique and proprietary circulating tumor cell (CTC) technology, the TellDx CTC System, announces publication of data from the scientific founders that reveal downregulation of KEAP1 in melanoma promotes resistance to immune checkpoint blockade (ICB). The paper, titled “Downregulation of KEAP1 in melanoma promotes resistance to immune checkpoint blockade,” was published on March 02, 2023, in NPJ Precision Oncology (DOI 10.1038/s41698-023-00362-3).

Key Points: 
  • The paper, titled “Downregulation of KEAP1 in melanoma promotes resistance to immune checkpoint blockade,” was published on March 02, 2023, in NPJ Precision Oncology (DOI 10.1038/s41698-023-00362-3 ).
  • While ICB has significantly improved clinical outcomes in melanoma, a subset of patients do not respond or develop resistance over time.
  • “These exciting data demonstrate that isolation of CTCs from melanoma patients with the TellDx platform and subsequent single cell RNA sequencing can reveal pathways of response and resistance to ICB.
  • Overall, these data provide valuable insights into the mechanisms behind melanoma resistance to immune checkpoint blockade therapy and highlight the potential of monitoring CTCs to improve outcomes of patients with cancer.

IMFINZI® (durvalumab) and tremelimumab with chemotherapy demonstrated sustained survival benefit in metastatic non-small cell lung cancer, nearly doubling the number of patients alive after three years vs. chemotherapy

Retrieved on: 
Sunday, September 11, 2022

Treatment-related AEs leading to death occurred in 3.3% of patients in the combination arm versus 2.4% in the chemotherapy arm.

Key Points: 
  • Treatment-related AEs leading to death occurred in 3.3% of patients in the combination arm versus 2.4% in the chemotherapy arm.
  • Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy.
  • Of the patients who received IMFINZI (475), 1.1% were fatal and 2.7% were Grade 3 adverse reactions.
  • Immune-mediated colitis occurred in 2% (37/1889) of patients receiving IMFINZI, including Grade 4 (

Calithera Biosciences Reports Second Quarter 2022 Financial Results and Recent Highlights

Retrieved on: 
Monday, August 15, 2022

SOUTH SAN FRANCISCO, Calif., Aug. 15, 2022 (GLOBE NEWSWIRE) -- Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage, precision-oncology biopharmaceutical company, today announced its financial results for the second quarter ended June 30, 2022.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., Aug. 15, 2022 (GLOBE NEWSWIRE) -- Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage, precision-oncology biopharmaceutical company, today announced its financial results for the second quarter ended June 30, 2022.
  • Calithera plans to share data from this trial by the first quarter of 2023.
  • Research and development expenses for the second quarter 2022 were $7.8 million, compared to $12.8 million in the same period prior year.
  • General and administrative expenses for the second quarter 2022 were $3.6 million, compared to $4.5 million in the same period prior year.

Calithera Biosciences Shares Progress in Sapanisertib and Mivavotinib Clinical Programs at Upcoming Lung Cancer and Lymphoma Conferences

Retrieved on: 
Wednesday, July 13, 2022

SOUTH SAN FRANCISCO, Calif., July 13, 2022 (GLOBE NEWSWIRE) -- Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage, precision-oncology biopharmaceutical company, announced that updates related to the ongoing clinical programs for sapanisertib (CB-228) and mivavotinib (CB-659) will be presented at the upcoming International Association for Lung Cancer (IASLC) 2022 World Conference on Lung Cancer (WCLC) and the 2022 Pan Pacific Lymphoma Conference, respectively.

Key Points: 
  • The phase 2 trial ( NCT05319028 ), which enrolled its first patient in June, is an open-label study of mivavotinib monotherapy in patients with relapsed/refractory non-GCB (ABC) diffuse large B-cell lymphoma (DLBCL).
  • Data from this trial could position Calithera to initiate a study with registrational intent in biomarker-specific DLBCL populations.
  • Calithera Biosciences is a clinical-stage, precision oncology biopharmaceutical company developing targeted therapies to redefine treatment for biomarker-specific patient populations.
  • The potential product candidates that Calithera develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all.

Kuria Therapeutics and SCOHIA PHARMA Announce Strategic Licensing Agreement for Ophthalmic and Dermal Rights to SCO-116, A Novel Nrf2 Activator

Retrieved on: 
Monday, June 27, 2022

The R&D team at SCOHIA has discovered SCO-116, a novel, potent, selective activator of the Nrf2 pathway with demonstrated activity in multiple animal disease models.

Key Points: 
  • The R&D team at SCOHIA has discovered SCO-116, a novel, potent, selective activator of the Nrf2 pathway with demonstrated activity in multiple animal disease models.
  • The licensing agreement announced today will allow Kuria to develop locally delivered formulations of SCO-116 in ophthalmic and dermal disease.
  • SCO-116 is a novel Nrf2 activator originated by SCOHIA which selectively inhibits the interaction of Nrf2 and KEAP1* through non-covalent binding.
  • Kuria Therapeutics, Inc. is a US-based pharmaceutical company dedicated to the development of novel therapeutics for ophthalmic and dermal disease.

Calithera Biosciences to Present Telaglenastat KEAPSAKE Trial in Progress Poster at the IASLC 2021 World Conference on Lung Cancer

Retrieved on: 
Wednesday, September 8, 2021

The trial in progress poster presentation will summarize the ongoing double-blind KEAPSAKE trial (NCT04265534).

Key Points: 
  • The trial in progress poster presentation will summarize the ongoing double-blind KEAPSAKE trial (NCT04265534).
  • KEAPSAKE is enrolling approximately 120 patients with stage IV non-squamous NSCLC with tumors that have a KEAP1 or NRF2 mutation.
  • We believe in the potential of telaglenastat to meaningfully improve outcomes for patients with NSCLC harboring KEAP1/NRF2 mutations.
  • Calithera is conducting the randomized Phase 2 KEAPSAKE trial to evaluate telaglenastat in patients with advanced non-small cell lung cancer harboring KEAP1/NRF2 mutations.

Calithera Biosciences Reports Second Quarter 2021 Financial Results and Recent Highlights

Retrieved on: 
Thursday, August 5, 2021

SOUTH SAN FRANCISCO, Calif., Aug. 05, 2021 (GLOBE NEWSWIRE) -- Calithera Biosciences, Inc. (Nasdaq: CALA), a fully-integrated clinical stage biotechnology company focused on discovering and developing novel, small molecule drugs for the treatment of cancer and other life-threatening diseases, announced today its financial results for the second quarter ended June 30, 2021.

Key Points: 
  • Calithera anticipates releasing interim data from the KEAPSAKE trial in the fourth quarter of 2021.
  • Revenue was $3.0 million for the three months ended June 30, 2021 and represents revenue recognized in the second quarter from the companys license agreement with Antengene.
  • Research and development expenses for the second quarter 2021 were $12.8million, compared to $15.6million in the same period prior year.
  • General and administrative expenses for the second quarter 2021 were $4.5million, compared to $5.1million in the same period prior year.