Avelumab

FDA Approves BAVENCIO as First-Line Maintenance Treatment for Patients with Locally Advanced or Metastatic Urothelial Carcinoma

Tuesday, June 30, 2020 - 11:45pm

For patients that do not progress on platinum-containing chemotherapy, BAVENCIO is administered as a first-line maintenance treatment until disease progression or unacceptable toxicity.

Key Points: 
  • For patients that do not progress on platinum-containing chemotherapy, BAVENCIO is administered as a first-line maintenance treatment until disease progression or unacceptable toxicity.
  • BAVENCIO (avelumab) is indicated in the US for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy.
  • In the US, the FDA granted accelerated approval for BAVENCIO for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC).
  • A fatal adverse reaction (sepsis) occurred in one (0.3%) patient with locally advanced or metastatic urothelial carcinoma (UC) receiving BAVENCIOplus best supportive care (BSC) as first-line maintenance treatment.

Oncolytics Biotech® Doses First Patient in Phase 2 BRACELET-1 Study Evaluating Pelareorep-Based Combination Therapies in Metastatic Breast Cancer

Tuesday, June 23, 2020 - 12:00pm

SAN DIEGO and CALGARY, Alberta, June 23, 2020 /PRNewswire/ -- Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), today announced the first patient has been dosed in the Company's phase 2 study of pelareorep-based combination therapies in HR+/HER2- metastatic breast cancer (mBC).

Key Points: 
  • SAN DIEGO and CALGARY, Alberta, June 23, 2020 /PRNewswire/ -- Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), today announced the first patient has been dosed in the Company's phase 2 study of pelareorep-based combination therapies in HR+/HER2- metastatic breast cancer (mBC).
  • The ability of pelareorep-induced immune responses to enhance anti- PD-L1 therapy will also be evaluated through the inclusion of the paclitaxel-pelareorep-avelumab combination therapy cohort.
  • The BRACELET-1(BReast cAnCEr with the Oncolytic Reovirus PeLareorEp in CombinaTion with anti- PD-L1 and Paclitaxel) study is an open-label, phase 2, randomized study in patients with HR+/HER2-, endocrine-refractory metastatic breast cancer being conducted under a co-development agreement with Merck KGaA, Darmstadt, Germany and Pfizer.
  • Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer.

Oncolytics Biotech® Doses First Patient in Phase 2 BRACELET-1 Study Evaluating Pelareorep-Based Combination Therapies in Metastatic Breast Cancer

Tuesday, June 23, 2020 - 12:00pm

Participants in the study receive paclitaxel, pelareorep in combination with paclitaxel alone, or pelareorep in combination with paclitaxel and Merck KGaA, Darmstadt, Germany and Pfizer's anti-PD-L1 checkpoint inhibitor, avelumab (Bavencio).

Key Points: 
  • Participants in the study receive paclitaxel, pelareorep in combination with paclitaxel alone, or pelareorep in combination with paclitaxel and Merck KGaA, Darmstadt, Germany and Pfizer's anti-PD-L1 checkpoint inhibitor, avelumab (Bavencio).
  • The ability of pelareorep-induced immune responses to enhance anti- PD-L1 therapy will also be evaluated through the inclusion of the paclitaxel-pelareorep-avelumab combination therapy cohort.
  • The BRACELET-1(BReast cAnCEr with the Oncolytic Reovirus PeLareorEp in CombinaTion with anti- PD-L1 and Paclitaxel) study is an open-label, phase 2, randomized study in patients with HR+/HER2-, endocrine-refractory metastatic breast cancer being conducted under a co-development agreement with Merck KGaA, Darmstadt, Germany and Pfizer.
  • Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer.

50% Complete Response Rate Observed in YourVaccx™ Study for Patients with Metastatic Prostate Cancer was Presented at the AACR Virtual Annual Meeting II

Monday, June 22, 2020 - 2:00pm

The patients were assessed after the completion of therapy, which varied from between 1 and 3 cycles of treatment.

Key Points: 
  • The patients were assessed after the completion of therapy, which varied from between 1 and 3 cycles of treatment.
  • All responses to therapy were assessed by RECIST v. 1.1 and metastatic prostate cancer patients were also assessed by serum PSA levels.
  • For all evaluable patients, the PoC study data showed a 38% (9/24) complete response rate (CR) and a 4% (1/24) partial response rate (PR), for an objective response rate (ORR) of 42% (10/24).
  • is now available at the American Association for Cancer Research (AACR) 2020 Virtual Annual Meeting II.

Immutep Reports First Results from INSIGHT-004 Study

Monday, June 1, 2020 - 12:30am

The study is a phase I trial evaluating the combination of Immuteps lead product candidate, eftilagimod alpha (IMP321 or efti) with avelumab, a human anti-PD-L1 antibody, in 12 patients with solid cancers.

Key Points: 
  • The study is a phase I trial evaluating the combination of Immuteps lead product candidate, eftilagimod alpha (IMP321 or efti) with avelumab, a human anti-PD-L1 antibody, in 12 patients with solid cancers.
  • Avelumab is co-developed and co-commercialized by Merck KGaA, Darmstadt, Germany and Pfizer Inc.
  • INSIGHT-004 reached full recruitment in April 2020 and has recruited patients in different solid tumors, primarily with gastrointestinal indications.
  • INSIGHT-004 is progressing well and we are pleased that efti continues to be safe and well tolerated by patients.

Vaccinex Reports First Quarter 2020 Financial Results and Provides Corporate Update

Thursday, May 14, 2020 - 1:45pm

ROCHESTER, N.Y., May 14, 2020 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering novel investigational antibody therapies in cancer and Huntingtons disease, today announced financial results for the first quarter ended March 31, 2020 and provided a corporate update.

Key Points: 
  • ROCHESTER, N.Y., May 14, 2020 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering novel investigational antibody therapies in cancer and Huntingtons disease, today announced financial results for the first quarter ended March 31, 2020 and provided a corporate update.
  • Raised gross proceeds of approximately $7.5 million through a private placement of 1,468,563 shares of the companys common stock in January 2020.
  • The companys ongoing CLASSICAL-Lung study is evaluating pepinemab in combination with avelumab for the treatment of advanced (stage IIIB/IV) NSCLC.
  • Vaccinex has been invited to present near topline data at the virtual ASCO conference in late May 2020.

DGAP-News: VAXIMM Announces First Results from Phase I/II Trial in Progressive Glioblastoma with Oral T-cell Immunotherapy VXM01 in Combination with PD-L1 Inhibitor Avelumab to be Presented at ASCO20 Virtual

Thursday, May 14, 2020 - 9:02am

The presentation, entitled, "Oral DNA vaccination targeting VEGFR2 combined with anti-PD-L1 avelumab in patients with progressive glioblastoma: Safety run-in results-NCT03750071," will be given as part of the Developmental Therapeutics - Immunotherapy Oral Session.

Key Points: 
  • The presentation, entitled, "Oral DNA vaccination targeting VEGFR2 combined with anti-PD-L1 avelumab in patients with progressive glioblastoma: Safety run-in results-NCT03750071," will be given as part of the Developmental Therapeutics - Immunotherapy Oral Session.
  • Secondary endpoints include objective response rate (ORR), clinical response using immune-response assessment in neuro-oncology (iRANO) criteria and immunological assays.
  • Nine patients treated with VXM01 and avelumab in 2 dose groups had completed the safety run-in phase.
  • Three partial responses according to iRANO criteria with tumor reductions of 58, 81 and 95% to baseline were reported.

Breakthrough Innovation in Cancer Care From EMD Serono Pipeline to Be Presented at ASCO 2020

Thursday, May 14, 2020 - 12:40am

Additionally, patient-reported outcomes (PROs) of health-related quality of life (HRQoL) for the VISION study will be presented at the meeting (Abstract# 9575).

Key Points: 
  • Additionally, patient-reported outcomes (PROs) of health-related quality of life (HRQoL) for the VISION study will be presented at the meeting (Abstract# 9575).
  • These data continue to show manageable safety with durable responses and encouraging long-term survival, especially in patients with high PD-L1 expression (80%).
  • The Company's broad portfolio of investigational DNA damage response (DDR) inhibitors represents multiple development paths, including combinations with other agents and modalities.
  • There is no guarantee that BAVENCIO will be approved for first-line maintenance treatment of advanced UC by any health authority worldwide.

Vaccinex to Present Updated Results from CLASSICAL-Lung, Phase 1b/2 Study of Pepinemab (VX15/2503) in Combination with Avelumab (BAVENCIO®) in Non-Small Cell Lung Cancer at the American Society of Clinical Oncology (ASCO) 2020 Annual Meeting

Wednesday, May 13, 2020 - 10:02pm

It is a multi-center, open-label study designed to evaluate the safety and potential efficacy of the combination of pepinemab and avelumab in subjects with advanced NSCLC.

Key Points: 
  • It is a multi-center, open-label study designed to evaluate the safety and potential efficacy of the combination of pepinemab and avelumab in subjects with advanced NSCLC.
  • The combination of pepinemab and avelumab has been demonstrated to be well-tolerated at all dose levels tested.
  • Beyond neurology, Vaccinex has determined that, in combination with checkpoint inhibitors, pepinemab has potential to increase objective responses in oncology.
  • Vaccinex is focused on the development of pepinemab for the treatment of cancer and neurodegenerative diseases including Huntingtons disease.

New Data from 18 Approved and Investigational Pfizer Medicines to be Showcased at ASCO20 Virtual Scientific Program

Tuesday, May 12, 2020 - 5:00pm

Pfizer Inc. (NYSE: PFE) today announced that new data from clinical trials of 18 approved and investigational medicines will be presented virtually at the ASCO20 Virtual Scientific Program, from May 29-May 31.

Key Points: 
  • Pfizer Inc. (NYSE: PFE) today announced that new data from clinical trials of 18 approved and investigational medicines will be presented virtually at the ASCO20 Virtual Scientific Program, from May 29-May 31.
  • These data will support our rapidly expanding efforts in bladder cancer and add to the growing body of clinical evidence generated with XTANDI in prostate cancer.
  • Key presentations featuring Pfizer medicines in the ASCO20 Virtual Scientific Program include:
    Maintenance avelumab + best supportive care (BSC) versus BSC alone after platinum-based first-line (1L) chemotherapy in advanced urothelial carcinoma (UC): JAVELIN Bladder 100 phase 3 interim analysis.
  • At Pfizer Oncology, we are committed to advancing medicines wherever we believe we can make a meaningful difference in the lives of patients.