STK11

BerGenBio Announces Initiation of Phase 2a in First Line Non-Small Lung Cancer Patients with a STK11 mutation

Retrieved on: 
Wednesday, March 20, 2024
AXL, Survival, NSCLC, STK11, Bemcentinib, Patient, Cancer, Safety, DSMB, Pharmaceutical industry

BERGEN, Norway, March 20, 2024 /PRNewswire/ -- BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, announced today it has initiated the Phase 2a portion of the BGBC016 clinical study of its selective AXL inhibitor bemcentinib in combination with standard of care therapy in first-line Non Small Cell Lung Cancer (NSCLC) patients harboring a STK11 mutation (STK11m).

Key Points: 
  • The initiation of Phase 2a follows a positive recommendation by the independent Drug Safety Monitoring Board (DSMB) which evaluated the safety of the combination of bemcentinib with pembrolizumab (Keytruda®) and doublet chemotherapy in first-line (1L) NSCLC patients enrolled in the Phase 1b portion of the study.
  • Patients with STK11m NSCLC have a significantly poorer response to current therapies, including immune checkpoint inhibitors, when compared with patients with wild-type (non-mutated) STK11.
  • There are currently no targeted therapies available for the STK11m NSCLC patient population, which represents up to 20% of 1L NSCLC patients.
  • Martin Olin, Chief Executive Officer of BerGenBio added, "The high unmet medical need in 1L STK11m NSCLC patients is widely recognized.

BerGenBio Announces Initiation of Phase 2a in First Line Non-Small Lung Cancer Patients with a STK11 mutation

Retrieved on: 
Wednesday, March 20, 2024
AXL, Survival, NSCLC, STK11, Bemcentinib, Patient, Cancer, Safety, DSMB, Pharmaceutical industry

BERGEN, Norway, March 20, 2024 /PRNewswire/ -- BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, announced today it has initiated the Phase 2a portion of the BGBC016 clinical study of its selective AXL inhibitor bemcentinib in combination with standard of care therapy in first-line Non Small Cell Lung Cancer (NSCLC) patients harboring a STK11 mutation (STK11m).

Key Points: 
  • The initiation of Phase 2a follows a positive recommendation by the independent Drug Safety Monitoring Board (DSMB) which evaluated the safety of the combination of bemcentinib with pembrolizumab (Keytruda®) and doublet chemotherapy in first-line (1L) NSCLC patients enrolled in the Phase 1b portion of the study.
  • Patients with STK11m NSCLC have a significantly poorer response to current therapies, including immune checkpoint inhibitors, when compared with patients with wild-type (non-mutated) STK11.
  • There are currently no targeted therapies available for the STK11m NSCLC patient population, which represents up to 20% of 1L NSCLC patients.
  • Martin Olin, Chief Executive Officer of BerGenBio added, "The high unmet medical need in 1L STK11m NSCLC patients is widely recognized.

Panbela Announces Publication of Abstract Titled: Evaluation of Myeloma Cell Lines Viability Following Administration of SBP-101 and DFMO Polyamine Inhibitors

Retrieved on: 
Monday, December 4, 2023
Immune system, Research, Apoptosis, Polyamine, PBLA, Multiple myeloma, MD Anderson Cancer Center, MSN, Doctor of Philosophy, Cell proliferation, Literature, Therapy, Eflornithine, DFMO, STK11, Patient, University

Data published in the November supplemental issue of the Journal Blood investigated the effects of polyamine inhibition by ivospemin and CPP-1X on myeloma cell lines growth and viability in vitro.

Key Points: 
  • Data published in the November supplemental issue of the Journal Blood investigated the effects of polyamine inhibition by ivospemin and CPP-1X on myeloma cell lines growth and viability in vitro.
  • Results showed that ivospemin and CPP-1X treatment significantly decreased cell proliferation and induced apoptosis in a panel of multiple myeloma cell lines.
  • When ivospemin and CPP-1X were combined an almost complete abolition of cell growth occurred.
  • “We are excited to have initiated the studies evaluating our polyamine inhibitors ivospemin and CPP-1X in models of multiple myeloma.

Tango Therapeutics Reports Third Quarter 2023 Financial Results and Provides Business Highlights

Retrieved on: 
Wednesday, November 8, 2023
Research, Breast, PRMT5, NSCLC, GBM, Cancer, Pembrolizumab, Georgetown University, Safety, SITC, Preclinical development, Head, Annual general meeting, University of California, San Diego Performance-Based Skills Assessment, USP1, Biotechnology, Genta (company), Lead, University, Therapy, Patient, Society for Immunotherapy of Cancer, Neuro-oncology, MTA, SNO, Conference, RCOR1, Immunotherapy, Clinical trial, MTAP, Nervous tissue, FDA, IND, Prostate cancer, Fast Track, Pharmacokinetics, STK11, Third Rock Ventures, Drug discovery, Collaboration, Carcinoma, Jannik Madum Andersen, Glioblastoma, FTD, Mutation, PARP, Pharmaceutical industry, Vaccine, Birth control, Petroleum, Arms industry, Biology

For TNG462, we dosed the first patient in the phase 1/2 trial in July 2023.

Key Points: 
  • For TNG462, we dosed the first patient in the phase 1/2 trial in July 2023.
  • Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting, November 1-5, 2023, San Diego, CA
    In November 2023, Tango scientists presented preclinical data highlighting the potential of TNG260 in STK11-mutant cancers.
  • AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, October 11-15, 2023, Boston, MA
    In October 2023, Tango scientists presented five posters highlighting preclinical data from the precision oncology pipeline and synthetic lethality discovery platform.
  • The year-to-date increase is the result of out-licensing a program to Gilead for $5.0 million during the second quarter of 2023.

BerGenBio Announces Data from Biomarker Analyses in 2L NSCLC

Retrieved on: 
Monday, November 6, 2023
MSD, OSE, Asian literature, ESMO, Pembrolizumab, Data, KEAP1, Merck, Non-small-cell lung cancer, Immunotherapy, STK11, Merck Sharp & Dohme Federal Credit Union, Patient, AXL, Merck & Co., Pharmaceutical industry, NSCLC

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
MSD, OSE, Asian literature, ESMO, Pembrolizumab, Data, KEAP1, Merck, Non-small-cell lung cancer, Immunotherapy, STK11, Merck Sharp & Dohme Federal Credit Union, Patient, AXL, Merck & Co., Pharmaceutical industry, NSCLC

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

New Data on BerGenBio's Selective AXL Inhibitor Bemcentinib Released Today at 2023 ESMO Meeting

Retrieved on: 
Monday, October 23, 2023
OSE, Data analysis, ESMO, Publication, Pembrolizumab, Assistant professor, Non-small-cell lung cancer, STK11, Haukeland University Hospital, Melanoma, European Society for Medical Oncology, Patient, AXL, Pharmaceutical industry, Medical device, NSCLC

In addition, the combination of bemcentinib with pembrolizumab was well tolerated with no new safety signals identified.

Key Points: 
  • In addition, the combination of bemcentinib with pembrolizumab was well tolerated with no new safety signals identified.
  • These data provide a strong foundation for further clinical investigations of bemcentinib in NSCLC patients with high unmet needs, including those with STK11 mutations."
  • Dr. Oliva continued, "During the meeting, our collaborator, Dr. Oddbjorn Straume, also presented data on the combination of bemcentinib with standard of care therapies in first line and second line melanoma patients.
  • In totality, these new data substantiate BerGenBio's focused strategy on the treatment of first line NSCLC patients with STK11m patients in our on-going BGBC016 study."

New Data on BerGenBio's Selective AXL Inhibitor Bemcentinib Released Today at 2023 ESMO Meeting

Retrieved on: 
Monday, October 23, 2023
OSE, Data analysis, ESMO, Publication, Pembrolizumab, Assistant professor, Non-small-cell lung cancer, STK11, Haukeland University Hospital, Melanoma, European Society for Medical Oncology, Patient, AXL, Pharmaceutical industry, Medical device, NSCLC

In addition, the combination of bemcentinib with pembrolizumab was well tolerated with no new safety signals identified.

Key Points: 
  • In addition, the combination of bemcentinib with pembrolizumab was well tolerated with no new safety signals identified.
  • These data provide a strong foundation for further clinical investigations of bemcentinib in NSCLC patients with high unmet needs, including those with STK11 mutations."
  • Dr. Oliva continued, "During the meeting, our collaborator, Dr. Oddbjorn Straume, also presented data on the combination of bemcentinib with standard of care therapies in first line and second line melanoma patients.
  • In totality, these new data substantiate BerGenBio's focused strategy on the treatment of first line NSCLC patients with STK11m patients in our on-going BGBC016 study."

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

Retrieved on: 
Sunday, September 10, 2023
Docetaxel, KRAS, Hepatotoxicity, TP53, Progression-free survival, IO, Health care, DOR, European Medicines Agency, Survival, International Association, Lung cancer, Hope, Mutation, Medication, Research, NSCLC, Female, CNS, PFS, STK11, EMA, MD, Patient, KEAP1, FDA, Conference, ORR, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, MHRA, Pharmaceutical industry

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.

Panbela Provides Business Update and Reports Q2 2023 Financial Results

Retrieved on: 
Thursday, August 10, 2023
Pancreatic cancer, Abstract, JDRF, AACR, Therapy, DSMB, MSN, Diabetes, Eflornithine, Clinical trial, Advanced Materials and Processes Research Institute, American Association for Cancer Research, PBLA, FAP, Research, NSCLC, Doctor of Philosophy, IDS, MD Anderson Cancer Center, Data monitoring committee, CPP, Acquisition, Patent, Patient, Colorectal cancer, University, DFMO, Endocrine Society, Immunology, H. Lee Moffitt Cancer Center & Research Institute, Ovarian cancer, Safety, Johns Hopkins School of Medicine, Pharmaceutical industry, Life insurance, STK11

MINNEAPOLIS , Aug. 10, 2023 (GLOBE NEWSWIRE) -- Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, today provides a business update and reports financial results for the quarter ended June 30, 2023.

Key Points: 
  • MINNEAPOLIS , Aug. 10, 2023 (GLOBE NEWSWIRE) -- Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, today provides a business update and reports financial results for the quarter ended June 30, 2023.
  • Poster presentation highlighting the results for CPP-1X in recent onset type 1 diabetes at the Endocrine Society meeting in June 2023.
  • Research and development expenses were $4.2 million in the second quarter of 2023, compared to $20.0 million in the second quarter of 2022.
  • Notes payable, plus accrued interest, on the balance sheet, the result of the acquisition of CPP, totaled approximately $5.3 million.