Checkpoint inhibitor

Ultimovacs Publishes Positive Long-term UV1 Data from Phase I Malignant Melanoma Combination Study in Frontiers in Immunology

Retrieved on: 
Tuesday, May 11, 2021

The INITIUM trial is an Ultimovacs-sponsored clinical trial recruiting 154 patients with metastatic malignant melanoma to evaluate UV1 in combination with ipilimumab and nivolumab as first-line treatment.

Key Points: 
  • The INITIUM trial is an Ultimovacs-sponsored clinical trial recruiting 154 patients with metastatic malignant melanoma to evaluate UV1 in combination with ipilimumab and nivolumab as first-line treatment.
  • The NIPU study is testing UV1 in combination with checkpoint inhibitors ipilimumab and nivolumab as second-line treatment in 118 patients with advanced malignant pleural mesothelioma, a rare lung cancer.
  • The study is sponsored by Oslo University Hospital and Bristol-Myers Squibb is providing the checkpoint inhibitors for this study.
  • Ultimovacs\xe2\x80\x99 strategy is to clinically demonstrate UV1\xe2\x80\x99s impact in many cancer types and in combination with other immunotherapies.

Sesen Bio Reports First Quarter 2021 Financial Results and Commercial Launch Readiness Update in the US for Vicineum™

Retrieved on: 
Monday, May 10, 2021

\xe2\x80\x9cIn the US, we continue to work with the FDA as we approach our target PDUFA date, and we are making substantial progress toward launch readiness.

Key Points: 
  • \xe2\x80\x9cIn the US, we continue to work with the FDA as we approach our target PDUFA date, and we are making substantial progress toward launch readiness.
  • The Company believes Vysyneum is a brand name with strong marketing potential given its identical pronunciation to the US proprietary brand name Vicineum.
  • Sesen Bio is currently in the follow-up stage of a Phase 3 registration trial in the US for the treatment of BCG-unresponsive NMIBC.
  • Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors.

Infinity Announces the Date of Its First Quarter 2021 Financial Results Conference Call and Webcast

Retrieved on: 
Thursday, May 6, 2021

MARIO-275 is a randomized, controlled combination study of eganelisib combined with Opdivo\xc2\xae in I/O na\xc3\xafve urothelial cancer.

Key Points: 
  • MARIO-275 is a randomized, controlled combination study of eganelisib combined with Opdivo\xc2\xae in I/O na\xc3\xafve urothelial cancer.
  • MARIO-3 is the first eganelisib combination study in front-line advanced cancer patients and is evaluating eganelisib in combination with Tecentriq\xc2\xae and Abraxane\xc2\xae in front-line TNBC and in combination with Tecentriq and Avastin\xc2\xae in front-line RCC.
  • In collaboration with Arcus Biosciences, Infinity is evaluating a checkpoint inhibitor-free, novel combination regimen of eganelisib plus etrumadenant (AB928, a dual adenosine receptor antagonist) plus Doxil\xc2\xae in advanced TNBC patients.
  • With these studies Infinity is evaluating eganelisib in the anti-PD-1 refractory, I/O-na\xc3\xafve, and front-line settings.

Infinity to Present at New York Academy of Sciences’ Frontiers in Cancer Immunotherapy 2021

Retrieved on: 
Wednesday, May 5, 2021

MARIO-275 is a randomized, controlled combination study of eganelisib combined with Opdivo\xc2\xae in I/O na\xc3\xafve urothelial cancer.

Key Points: 
  • MARIO-275 is a randomized, controlled combination study of eganelisib combined with Opdivo\xc2\xae in I/O na\xc3\xafve urothelial cancer.
  • MARIO-3 is the first eganelisib combination study in front-line advanced cancer patients and is evaluating eganelisib in combination with Tecentriq\xc2\xae and Abraxane\xc2\xae in front-line TNBC and in combination with Tecentriq and Avastin\xc2\xae in front-line RCC.
  • In collaboration with Arcus Biosciences, Infinity is evaluating a checkpoint inhibitor-free, novel combination regimen of eganelisib plus etrumadenant (AB928, a dual adenosine receptor antagonist) plus Doxil\xc2\xae in advanced TNBC patients.
  • With these studies Infinity is evaluating eganelisib in the anti-PD-1 refractory, I/O-na\xc3\xafve, and front-line settings.

PDS Biotech Announces Oral Presentation of PDS0101 Data by the National Cancer Institute at 2021 American Society of Clinical Oncology Annual Meeting

Retrieved on: 
Thursday, April 29, 2021

The trial subsequently expanded enrollment to both checkpoint inhibitor na\xc3\xafve patients and patients who have failed prior therapy with checkpoint inhibitors.

Key Points: 
  • The trial subsequently expanded enrollment to both checkpoint inhibitor na\xc3\xafve patients and patients who have failed prior therapy with checkpoint inhibitors.
  • \xe2\x80\x9cWe are encouraged by the data and look forward to the presentation of initial findings from the study,\xe2\x80\x9d said Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech.
  • The company\xe2\x80\x99s lead investigational cancer immunotherapy product PDS0101 is currently in Phase 2 clinical studies in multiple indications.
  • Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance.

Alpine Immune Sciences to Present ALPN-202 Clinical Data at the 2021 ASCO Virtual Annual Meeting

Retrieved on: 
Wednesday, April 28, 2021

Preclinical studies of ALPN-202 have successfully demonstrated superior efficacy in tumor models compared to checkpoint inhibition alone.

Key Points: 
  • Preclinical studies of ALPN-202 have successfully demonstrated superior efficacy in tumor models compared to checkpoint inhibition alone.
  • NEON-1 (NCT04186637), a Phase 1 study of ALPN-202 in patients with advanced malignancies, is currently enrolling.
  • Alpine also plans the initiation of NEON-2, a combination study of ALPN-202 and a PD-1 inhibitor, later this year.\nAlpine Immune Sciences, Inc. is committed to leading a new wave of immune therapeutics.
  • Alpine has entered into strategic collaborations with leading global biopharmaceutical companies and has a diverse pipeline of clinical and preclinical candidates in development.

Replimune to Host Virtual Investor Event on June 3, 2021

Retrieved on: 
Wednesday, April 28, 2021

The webcast and slides will be accessible live under \xe2\x80\x9cEvents & Presentations\xe2\x80\x9d on the Investors page of the Company\xe2\x80\x99s website at www.replimune.com or by clicking here .

Key Points: 
  • The webcast and slides will be accessible live under \xe2\x80\x9cEvents & Presentations\xe2\x80\x9d on the Investors page of the Company\xe2\x80\x99s website at www.replimune.com or by clicking here .
  • Replimune is developing novel, proprietary therapeutics intended to improve the direct cancer-killing effects of selective virus replication and the potency of the immune response to the tumor antigens released.
  • The approach is expected to be highly synergistic with immune checkpoint blockade and other approaches to cancer treatment.
  • Replimune intends to progress these therapies rapidly through clinical development in combination with other immuno-oncology products with complementary mechanisms of action.\xc2\xa0For more information, please visit www.replimune.com .\n'

Compugen Publishes Preclinical Data Demonstrating Therapeutic Potential of COM902 in Cancer Immunology, Immunotherapy

Retrieved on: 
Tuesday, April 27, 2021

"These published data answer fundamental questions regarding TIGIT\'s biology and demonstrate potential synergies with other immune checkpoints.

Key Points: 
  • "These published data answer fundamental questions regarding TIGIT\'s biology and demonstrate potential synergies with other immune checkpoints.
  • Furthermore, these data provide additional support that COM902 has the potential to improve outcomes for patients with advanced malignancies, expanding the reach of checkpoint inhibitors.
  • The trial, which was initiated in 2020, is on track to report initial data in Q4 2021.
  • Compugen does not assume any obligation to update any forward-looking statements unless required by law.\n'

Vaccinex Announces Publication of Results from CLASSICAL-Lung Phase 1b/2 Clinical Trial in Non-Small Cell Lung Cancer in the Peer-Reviewed Journal Clinical Cancer Research

Retrieved on: 
Wednesday, April 21, 2021

Notably, the objective response rate (ORR) with the combination therapy was higher than previously reported for single agent avelumab in the PD-L1 negative / low population.

Key Points: 
  • Notably, the objective response rate (ORR) with the combination therapy was higher than previously reported for single agent avelumab in the PD-L1 negative / low population.
  • Finally, exploratory biomarker analysis from biopsies demonstrated improved penetration of killer CD8+ T cells into the tumor.\nDr.
  • This appears to enhance the efficacy of checkpoint inhibition, even in some patients who did not respond to prior anti-PD-1/L1 therapies.
  • Except as required by law, we assume no obligation to update these forward-looking statements.

Candel Therapeutics Completes Enrollment in Phase 1 Clinical Trial of CAN-2409 in Combination with Opdivo® (nivolumab) for the Treatment of High-Grade Gliomas

Retrieved on: 
Thursday, April 22, 2021

\xe2\x80\x9cWith a significant number of patients affected each year and limited treatment options available, there remains a critical need for effective therapies in high-grade glioma.

Key Points: 
  • \xe2\x80\x9cWith a significant number of patients affected each year and limited treatment options available, there remains a critical need for effective therapies in high-grade glioma.
  • HSV-tk is an enzyme that locally converts orally administered valacyclovir into a toxic metabolite that kills nearby cancer cells.
  • Combination activity with standard of care radiation therapy, surgery, immune checkpoint inhibitors\n(ICI) and chemotherapy has already been shown in several preclinical and clinical settings.
  • Our approach combines an in-depth knowledge of viral immunotherapy with extensive clinical experience across a wide range of indications.