Nivolumab

Onconova Therapeutics Announces Encouraging Clinical Data Supporting the Anti-Cancer Activity of Rigosertib-Nivolumab Combination in Advanced KRAS+ Non-Small Cell Lung Cancer

Wednesday, September 22, 2021 - 1:00pm

NEWTOWN, Pa., Sept. 22, 2021 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced preliminary safety and efficacy data from an investigator-initiated Phase 1/2a trial of oral rigosertib plus the immune checkpoint inhibitor nivolumab in advanced KRAS mutated (KRAS+) non-small cell lung cancer (NSCLC). The data, which are being featured in a presentation at the 3rd Annual RAS Targeted Drug Development Summit, support the potential anti-cancer activity of rigosertib-nivolumab combination therapy in this indication and show that the doublet has been well tolerated to-date. Three quarters of patients enrolled in the trial have failed two or more lines of prior therapy and all have failed immune checkpoint inhibitors in various combinations.

Key Points: 
  • Radiographic responses were seen across multiple KRAS variants, which potentially differentiates rigosertib from other RAS pathway modulators that target particular KRAS mutations.
  • These responses were observed at the primary tumor site as well as metastatic sites such as the pleura and bone.
  • Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer.
  • The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.

CG Oncology and Roche to Collaborate on Clinical Trial of Oncolytic Immunotherapy CG0070 as Part of Novel Combination for Various Solid Tumor Indications

Wednesday, September 22, 2021 - 1:00pm

CG Oncology, Inc. announced today that it has entered into a clinical trial collaboration agreement to evaluate the combination of CG Oncologys investigational oncolytic immunotherapy CG0070, with Roches atezolizumab, an anti-PD-L1 (programmed death-ligand 1) therapy.

Key Points: 
  • CG Oncology, Inc. announced today that it has entered into a clinical trial collaboration agreement to evaluate the combination of CG Oncologys investigational oncolytic immunotherapy CG0070, with Roches atezolizumab, an anti-PD-L1 (programmed death-ligand 1) therapy.
  • The Phase 1/2 clinical trial will evaluate the safety and efficacy of this novel immunotherapy combination in patients with various advanced solid tumors yet to be disclosed.
  • We are pleased to enter into this collaboration agreement with Roche, said Arthur Kuan, CEO of CG Oncology.
  • CG Oncology is a clinical-stage biotechnology company focused on developing the next evolution of oncolytic immunotherapy for patients with advanced cancer.

Zenith Epigenetics and Newsoara Announce Initiation of a Randomized Phase 2b Metastatic Castration-Resistant Prostate Cancer (mCRPC) Study

Tuesday, September 21, 2021 - 1:00pm

The study will evaluate the efficacy of ZEN-3694 + enzalutamide vs. single agent enzalutamide as measured by its primary endpoint, radiographic free progression.

Key Points: 
  • The study will evaluate the efficacy of ZEN-3694 + enzalutamide vs. single agent enzalutamide as measured by its primary endpoint, radiographic free progression.
  • Abiraterone, also an ARSI, is frequently prescribed as a first line therapy for patients with metastatic prostate cancer.
  • Prostate cancer is the second-most commonly diagnosed cancer among men and the fifth most common cause of male cancer death worldwide.
  • Ovarian cancer in combination with immune-checkpoint inhibitors, nivolumab and ipilimumab in collaboration with the National Cancer Institute.

Tempest Announces First Patient Dosed in Randomized Study Evaluating TPST-1120 in First-Line Regimen for Hepatocellular Carcinoma in Clinical Collaboration with Roche

Monday, September 20, 2021 - 1:00pm

The trial is being conducted under a clinical collaboration with F. Hoffman La-Roche (Roche).

Key Points: 
  • The trial is being conducted under a clinical collaboration with F. Hoffman La-Roche (Roche).
  • The initiation of this randomized TPST-1120 study in collaboration with Roche marks significant progress in the advancement of the Tempest clinical pipeline, said Sam Whiting, MD, Ph.D., chief medical officer of Tempest.
  • The Tempest team looks forward to further evaluation of TPST-1120 in this randomized combination in the first-line treatment of patients with HCC.
  • Under the terms of the collaboration agreement, Roche will manage the study operations for this global, multicenter trial.

Onconova Therapeutics Announces Upcoming Presentation at the 3rd Annual RAS Targeted Drug Development Summit

Monday, September 20, 2021 - 1:00pm

Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer.

Key Points: 
  • Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer.
  • The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.
  • Onconovas novel, proprietary multi-kinase inhibitor ON 123300 is being evaluated in two separate and complementary Phase 1 dose-escalation and expansion studies.
  • These statements relate to Onconovas expectations regarding the timing of Onconovas and investigator-initiated clinical development and data presentation plans, and the mechanisms and indications for Onconovas product candidates.

Mirati Therapeutics Announces Positive Phase 2 Topline Results for Investigational Adagrasib in Patients with KRAS G12C-Mutated Advanced Non-Small Cell Lung Cancer

Monday, September 20, 2021 - 12:30pm

The safety and tolerability profile was consistent with previously reported findings for adagrasib in patients with advanced NSCLC.

Key Points: 
  • The safety and tolerability profile was consistent with previously reported findings for adagrasib in patients with advanced NSCLC.
  • In addition to these topline Phase 2 results, the Company reported updated findings from the Phase 1/1b KRYSTAL-1 study evaluating adagrasib 600mg BID in all 19 patients enrolled with KRASG12C-mutated advanced NSCLC as of the June 15, 2021 data cutoff.
  • Lung cancer consists of non-small cell lung cancer (NSCLC) in approximately 85 percent of cases and small cell lung cancer (SCLC) in approximately 15 percent of cases.
  • Mirati is also advancing its differentiated preclinical portfolio, including MRTX1133, an investigational KRASG12D inhibitor, MRTX1719, an investigational PRMT5 inhibitor, and other oncology discovery programs.

OSE Immunotherapeutics To Present Positive Results of Tedopi® Phase 3 Clinical Trial in Non-Small Cell Lung Cancer Patients in Secondary Resistance to Immune Checkpoint Inhibitors At the European Society for Medical Oncology (ESMO) Virtual Congress 2021

Monday, September 20, 2021 - 6:30am

The companys immunology research and development platform is focused on three areas: T-cell-based vaccination, Immuno-Oncology (focus on myeloid targets), Auto-immunity & Inflammation.

Key Points: 
  • The companys immunology research and development platform is focused on three areas: T-cell-based vaccination, Immuno-Oncology (focus on myeloid targets), Auto-immunity & Inflammation.
  • Its balanced first-in-class clinical and preclinical portfolio has a diversified risk profile:
    Tedopi (innovative combination of neoepitopes): the companys most advanced product; positive final results of the Phase 3 trial (Atalante 1) in Non-Small Cell Lung Cancer patients post-ICI failure.
  • In Phase 2 in non-small cell lung cancer in combination with nivolumab, sponsor Italian foundation FoRT.
  • OSE-230 (ChemR23 agonist mAb): first-in-class therapeutic agent with the potential to resolve chronic inflammation by driving affected tissues to tissue integrity.

Mirati Therapeutics Presents Positive Clinical Data with Investigational Adagrasib as Monotherapy and in Combination with Cetuximab in Patients with KRAS G12C-Mutated Colorectal Cancer

Sunday, September 19, 2021 - 2:47pm

Results showed that adagrasib alone and with cetuximab demonstrated significant clinical activity and broad disease control in these patients.

Key Points: 
  • Results showed that adagrasib alone and with cetuximab demonstrated significant clinical activity and broad disease control in these patients.
  • "The positive results presented today show that adagrasib alone or in combination with cetuximab may improve clinical outcomes in patients with colorectal cancer harboring a KRASG12C mutation."
  • Adagrasib monotherapy and in combination with cetuximab was well-tolerated in this study, with a manageable safety profile.
  • Treatment related adverse events led to treatment discontinuation in 6% of patients who received combination therapy and in none (0%) of those who received adagrasib monotherapy.

Gritstone Announces Dosing of First Solid Tumor Patient with Optimized SLATE “Off-the-Shelf” Mutant KRAS-directed Neoantigen Immunotherapy in Phase 2 Clinical Trial

Friday, September 17, 2021 - 12:02pm

The data from SLATE v1 will be reviewed during the companys previously announced investor event taking place today at 1:30pm ET.

Key Points: 
  • The data from SLATE v1 will be reviewed during the companys previously announced investor event taking place today at 1:30pm ET.
  • SLATE v1 demonstrated the greatest activity in 6 NSCLC patients with the KRASmut G12C presented by the HLA protein A*02:01.
  • SLATE is being evaluated in combination with immune checkpoint blockade in the Phase 2 portion of its clinical study( NCT03953235 ).
  • The companys lead oncology programs include an individualized neoantigen-based immunotherapy, GRANITE, and an off-the-shelf shared neoantigen-based immunotherapy, SLATE, which are being evaluated in clinical studies.

Boehringer Ingelheim and OSE Immunotherapeutics Present Phase 1 Results with First-in-Class SIRPα Inhibitor BI 765063 in Advanced Solid Tumors at ESMO 2021

Thursday, September 16, 2021 - 5:00pm

BI 765063, a first-in-class SIRP inhibitor in the SIRP/CD47 Dont eat me pathway, is being developed under collaborative agreement between OSE Immunotherapeutics and Boehringer Ingelheim.

Key Points: 
  • BI 765063, a first-in-class SIRP inhibitor in the SIRP/CD47 Dont eat me pathway, is being developed under collaborative agreement between OSE Immunotherapeutics and Boehringer Ingelheim.
  • The dose escalation part (Step 1) of the Phase 1 trial evaluating BI 765063 alone and in combination with BI 754091 (ezabenlimab) in advanced solid tumors has been completed.
  • The study is being conducted by OSE Immunotherapeutics as part of a collaboration and license agreement under which Boehringer Ingelheim obtained exclusive rights to BI 765063.
  • BI 765063 (OSE-172, anti-SIRP mAb in CD47/SIRP pathway): developed in partnership with Boehringer Ingelheim in advanced solid tumors; positive Phase 1 results in monotherapy and BI 765063 dose escalation study ongoing in combination with Ezabenlimab (PD-1 antagonist).