NRF2

C4X Discovery Holdings plc: Half-year results for the six months ended 31 January 2023

Retrieved on: 
Wednesday, April 26, 2023

Up to $402 million AstraZeneca deal for NRF2 Activator programme; Third global out-licensing deal executed

Key Points: 
  • Up to $402 million AstraZeneca deal for NRF2 Activator programme; Third global out-licensing deal executed
    MANCHESTER, United Kingdom, April 26, 2023 (GLOBE NEWSWIRE) -- C4X Discovery Holdings plc (AIM: C4XD), a pioneering Drug Discovery company, today announces its half-year results for the six months ended 31 January 2023.
  • "I'm excited that following a review of our expertise and previous successes, our strategy is now focused on treatments for immuno-inflammatory diseases.
  • Indivior's Phase 1 multiple ascending dose clinical trial of C4XD's oral Orexin-1 receptor antagonist, C4X_3256 (INDV-2000), for substance use disorder is ongoing.
  • C4XD signed an exclusive worldwide licensing agreement with AstraZeneca in November 2022, worth up to $402 million, for its NRF2 Activator programme.

Pan-Biome Pharmaceuticals, a startup focused on age-related diseases and increasing human healthspan, reports positive results in a preclinical trial of colitis

Retrieved on: 
Tuesday, April 25, 2023

We have found that the compound demonstrates selective antimicrobial activity and has the ability to modulate the gut microbiome in mice.

Key Points: 
  • We have found that the compound demonstrates selective antimicrobial activity and has the ability to modulate the gut microbiome in mice.
  • Most age-related diseases are accompanied by chronic low-grade inflammation (Inflammaging), resulting in higher levels of pro-inflammatory cytokines in the bloodstream.
  • Pan-Biome’s lead compound activates anti-inflammatory cytokine IL-10 and inhibits the major pro-inflammatory cytokines TNF-a, IL-1b, and IL-6.
  • Pan-Biome CSO Dr. Poul Sorensen: “While we are still working out the mechanism, our compound most likely optimizes mitochondrial functionality.

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.

C4X Discovery Holdings plc: C4XD signs exclusive global licence worth up to $402 million¹ with AstraZeneca for the development and commercialisation of NRF2 Activator programme

Retrieved on: 
Monday, November 28, 2022

MANCHESTER, United Kingdom, Nov. 28, 2022 (GLOBE NEWSWIRE) -- C4X Discovery Holdings plc (AIM: C4XD), a pioneering Drug Discovery company, has signed an exclusive worldwide licensing agreement with AstraZeneca worth up to $402 million1, for its NRF2 Activator programme. AstraZeneca will develop and commercialise an oral therapy for the treatment of inflammatory and respiratory diseases with a lead focus on chronic obstructive pulmonary disease (COPD).

Key Points: 
  • AstraZeneca will develop and commercialise an oral therapy for the treatment of inflammatory and respiratory diseases with a lead focus onchronic obstructive pulmonary disease (COPD).
  • Under the terms of the agreement, C4XD will receive pre-clinical milestone payments worth up to $16 million ahead of the first clinical trial, including $2 million upfront.
  • In addition, C4XDis eligible toreceive a further potential $385.8 million in clinical development and commercial milestones and tiered mid-single digit royalties upon commercialisation.
  • Lead molecules from C4XD's oral NRF2 Activator programme have been found to significantly activate NRF2 following oral dosing, providing anti-inflammatory and antioxidant activity.

Calithera Receives FDA Fast Track Designation for Sapanisertib for the Treatment of NRF2-mutated Squamous Lung Cancer

Retrieved on: 
Monday, October 3, 2022

While there have been significant advances in targeted treatments for lung cancer, little progress has been made specifically for patients with squamous lung cancer.

Key Points: 
  • While there have been significant advances in targeted treatments for lung cancer, little progress has been made specifically for patients with squamous lung cancer.
  • This Fast Track designation allows for a variety of benefits, including the possibility of priority review of sapanisertib as we seek to provide a first-in-class treatment option that may help address the major unmet need in this patient population."
  • NRF2 mutations are found across multiple solid tumor types, with these mutations occurring in approximately 15% of sqNSCLC patients.
  • Calithera Biosciences is a clinical-stage, precision oncology biopharmaceutical company developing targeted therapies to redefine treatment for biomarker-specific patient populations.

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.

Calithera Biosciences Announces First Patient Enrolled in Phase 2 Clinical Trial of Sapanisertib in Relapsed/Refractory NRF2 (NFE2L2)-Mutated Squamous Non-Small Cell Lung Cancer

Retrieved on: 
Wednesday, July 6, 2022

SOUTH SAN FRANCISCO, Calif., July 06, 2022 (GLOBE NEWSWIRE) -- Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage, precision-oncology biopharmaceutical company, today announced that it has enrolled the first patient in a phase 2 clinical trial of sapanisertib (CB-228) in patients with relapsed/refractory NRF2 (NFE2L2)-mutated squamous non-small cell lung cancer (sqNSCLC).

Key Points: 
  • Sapanisertib is a potent and selective, dual mTORC 1/2 inhibitor that targets a key survival mechanism in tumors harboring these mutations.
  • Our experience enrolling biomarker-driven clinical trials has allowed us to quickly advance sapanisertib since acquiring it from Takeda in the fourth quarter of last year.
  • Sapanisertib has the potential to be a first-in-class treatment for patients with NRF2-mutated squamous lung cancer, a patient population with poor prognosis and high unmet need.
  • Calithera Biosciences is a clinical-stage, precision oncology biopharmaceutical company developing targeted therapies to redefine treatment for biomarker-specific patient populations.

Calithera Biosciences Reports First Quarter 2022 Financial Results and Recent Highlights

Retrieved on: 
Tuesday, May 10, 2022

SOUTH SAN FRANCISCO, Calif., May 10, 2022 (GLOBE NEWSWIRE) -- Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage, precision-oncology biopharmaceutical company, today announced its financial results for the first quarter ended March 31, 2022.

Key Points: 
  • ET on Tuesday, May 10, 2022 --
    SOUTH SAN FRANCISCO, Calif., May 10, 2022 (GLOBE NEWSWIRE) -- Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage, precision-oncology biopharmaceutical company, today announced its financial results for the first quarter ended March 31, 2022.
  • We made significant headway in the transfer of mivavotinib and sapanisertib materials to Calithera during the first quarter and are well into site start-up activities.
  • Calithera anticipates the first patient enrolled in the second quarter of 2022.
  • Calithera anticipates the first patient enrolled in this study in the second quarter of 2022.

Calithera Biosciences Reports Fourth Quarter and Full Year 2021 Financial Results and Recent Highlights

Retrieved on: 
Thursday, March 31, 2022

SOUTH SAN FRANCISCO, Calif., March 31, 2022 (GLOBE NEWSWIRE) -- Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage, precision-oncology biopharmaceutical company, today announced its financial results for the fourth quarter and year ended December 31, 2021.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., March 31, 2022 (GLOBE NEWSWIRE) -- Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage, precision-oncology biopharmaceutical company, today announced its financial results for the fourth quarter and year ended December 31, 2021.
  • Research and development expenses for the fourth quarter of 2021 were $13.7 million, compared to $17.1 million for the same period last year.
  • General and administrative expenses for the fourth quarter of 2021 were $4.6 million, compared to $5.6 million for the same period last year.
  • Interest and other income, net for the fourth quarter of 2021 was none, compared to $0.1 million for the fourth quarter of 2020.