Pelareorep

FDA Grants Fast Track Designation to Padeliporfin ImPACT for Steba biotech

Sunday, January 17, 2021 - 10:00am

Barak Palatchi, CEO of Steba,said: "Momentum is building towards unlocking the significant potential of padeliporfin ImPACT in a range of solid tumors first with the IND green light and now Fast Track designation.

Key Points: 
  • Barak Palatchi, CEO of Steba,said: "Momentum is building towards unlocking the significant potential of padeliporfin ImPACT in a range of solid tumors first with the IND green light and now Fast Track designation.
  • Additionally, another potential benefit of Fast Track designation is priority review, which reduces the standard 10 months NDA review to six months.
  • Steba biotech is a Luxembourg based biotech organization founded in 2002 with operations in the EU, Israel and the US.
  • Steba biotech is focused on the development of a novel oncology platform to treat a range of solid tumors with padeliporfin ImPACT (Immune Photo Activated Cancer Therapy).

ERYTECH Announces First Patient Enrolled in a Phase 1 Investigator Sponsored Trial of Eryaspase in First-Line Pancreatic Cancer

Thursday, January 14, 2021 - 9:30pm

The trial will enroll approximately 18 patients who have received no prior chemotherapy for the treatment of locally advanced or metastatic pancreatic cancer.

Key Points: 
  • The trial will enroll approximately 18 patients who have received no prior chemotherapy for the treatment of locally advanced or metastatic pancreatic cancer.
  • FOLFIRINOX is one of the most commonly utilized first-line chemotherapy regimens for the treatment of pancreatic cancer.
  • Pancreatic cancer is a disease in which malignant (cancer) cells are found in the tissues of the pancreas.
  • Eryaspase is in Phase 3 clinical development for the treatment of second-line pancreatic cancer and in Phase 2 for the treatment of triple-negative breast cancer.

NantKwest, ImmunityBio Announce Positive Interim Data on Survival Rates in Metastatic Pancreatic Cancer Trials

Wednesday, January 13, 2021 - 11:01pm

The early collaborative Cancer Moonshot trials involved the combination of cell therapy and immunotherapeutics from multiple biotech and pharmaceutical companies, including NantKwest, ImmunityBio, Celgene, and Pfizer.

Key Points: 
  • The early collaborative Cancer Moonshot trials involved the combination of cell therapy and immunotherapeutics from multiple biotech and pharmaceutical companies, including NantKwest, ImmunityBio, Celgene, and Pfizer.
  • Based on the data from these trials, ImmunityBio is conducting a pivotal, three-cohort pivotal trial (QUILT 88) in metastatic pancreatic cancer.
  • A randomized Phase 2 study (QUILT 88, Cohorts A and B) for first- and second-line metastatic pancreatic cancer is actively enrolling at three sites.
  • On the basis of our initial studies, we initiated our QUILT 88 randomized trials in metastatic pancreatic cancer and are pleased to present today those findings, including Cohort C survival rates.

Arcus Biosciences to Present Preliminary Data from Phase 1 Portion of ARC-8 Study for AB680 in Metastatic Pancreatic Cancer at ASCO-GI Symposium

Monday, January 11, 2021 - 10:03pm

every two weeks has been selected for this portion of the study.

Key Points: 
  • every two weeks has been selected for this portion of the study.
  • 1,5
    ARC-8 is a Phase 1/1b study to evaluate safety and tolerability of AB680 + zimberelimab (AB122) + chemotherapy in patients with treatment-naive metastatic pancreatic adenocarcinoma.
  • AB680 is currently in a Phase 1/1b study for the treatment of first-line metastatic pancreatic cancer.
  • AB680, the first small-molecule CD73 inhibitor to enter the clinic, is in Phase 1/1b development for first-line treatment of metastatic pancreatic cancer in combination with zimberelimab and gemcitabine/nab-paclitaxel.

ERYTECH Completes Enrollment in TRYbeCA-1 Phase 3 Trial in Second-Line Pancreatic Cancer

Monday, December 14, 2020 - 9:30pm

TRYbeCA-1, the pivotal Phase 3 clinical trial evaluating ERYTECHs lead product candidate, eryaspase, in second-line metastatic pancreatic cancer, has completed patient enrollment.

Key Points: 
  • TRYbeCA-1, the pivotal Phase 3 clinical trial evaluating ERYTECHs lead product candidate, eryaspase, in second-line metastatic pancreatic cancer, has completed patient enrollment.
  • TRYbeCA-1 is a randomized controlled Phase 3 clinical trial evaluating ERYTECHs lead product candidate, eryaspase, in second-line metastatic pancreatic cancer.
  • Pancreatic cancer is a disease in which malignant (cancer) cells are found in the tissues of the pancreas.
  • Eryaspase is in Phase 3 clinical development for the treatment of second-line pancreatic cancer and in Phase 2 for the treatment of triple-negative breast cancer.

Pelareorep Along With Checkpoint Inhibitors Proving Critically Important for Early Stage Breast Cancer

Wednesday, December 9, 2020 - 2:45pm

WHO had signified that breast cancer affects about 2.1 million women every year and is the primary cause of deaths associated with malignancy.

Key Points: 
  • WHO had signified that breast cancer affects about 2.1 million women every year and is the primary cause of deaths associated with malignancy.
  • Early detection of breast cancer is a key to effective management of the disease.
  • "Early detection can lead to desired outcomes including increased survival rate, number of treatment options, and improved quality of life.
  • Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) BREAKING NEWS: Oncolytics and SOLTI Report Clinical Synergy of Pelareorep with Checkpoint Inhibitors at the 2020 San Antonio Breast Cancer Symposium - Oncolytics Biotech and SOLTI-Innovative Breast Cancer Research today published an electronic poster at the 2020 San Antonio Breast Cancer Symposium (SABCS) with data from the AWARE-1 window-of-opportunity study in patients with early-stage breast cancer showing pelareorep delivers a significant boost known to increase the effectiveness of checkpoint inhibitors.

Pelareorep Along With Checkpoint Inhibitors Proving Critically Important for Early Stage Breast Cancer

Wednesday, December 9, 2020 - 2:45pm

WHO had signified that breast cancer affects about 2.1 million women every year and is the primary cause of deaths associated with malignancy.

Key Points: 
  • WHO had signified that breast cancer affects about 2.1 million women every year and is the primary cause of deaths associated with malignancy.
  • Early detection of breast cancer is a key to effective management of the disease.
  • "Early detection can lead to desired outcomes including increased survival rate, number of treatment options, and improved quality of life.
  • Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) BREAKING NEWS: Oncolytics and SOLTI Report Clinical Synergy of Pelareorep with Checkpoint Inhibitors at the 2020 San Antonio Breast Cancer Symposium - Oncolytics Biotech and SOLTI-Innovative Breast Cancer Research today published an electronic poster at the 2020 San Antonio Breast Cancer Symposium (SABCS) with data from the AWARE-1 window-of-opportunity study in patients with early-stage breast cancer showing pelareorep delivers a significant boost known to increase the effectiveness of checkpoint inhibitors.

Bolt Biotherapeutics Presents Ongoing Clinical Trial Poster at San Antonio Breast Cancer Symposium 2020 Virtual Meeting

Wednesday, December 9, 2020 - 2:00pm

REDWOOD CITY, Calif., Dec. 9, 2020 /PRNewswire/ -- Bolt Biotherapeutics, a clinical-stage immuno-oncology company developing tumor-targeted therapies that leverage the power of the innate and adaptive immune systems, today announced the presentation of a poster detailing the design of its ongoing Phase 1/2 clinical trial for BDC-1001 in patients with HER2-expressing solid tumors at the San Antonio Breast Cancer Symposium (SABCS) 2020 Virtual Meeting, being held Dec. 8-11, 2020.

Key Points: 
  • REDWOOD CITY, Calif., Dec. 9, 2020 /PRNewswire/ -- Bolt Biotherapeutics, a clinical-stage immuno-oncology company developing tumor-targeted therapies that leverage the power of the innate and adaptive immune systems, today announced the presentation of a poster detailing the design of its ongoing Phase 1/2 clinical trial for BDC-1001 in patients with HER2-expressing solid tumors at the San Antonio Breast Cancer Symposium (SABCS) 2020 Virtual Meeting, being held Dec. 8-11, 2020.
  • Based on initial clinical observations to date, there have been no dose-limiting toxicities and no drug-related severe adverse events.
  • We continue to see strong interest in participation in our trial from both investigators and potential patients based on our compelling preclinical data and ongoing clinical observations."
  • Bolt Biotherapeutics, based in the San Francisco Bay Area, is a clinical-stage immuno-oncology company developing tumor-targeted therapies that leverage the power of the innate and adaptive immune systems.

Athenex Presents Updated Phase 3 Data on Survival and Tolerability Associated with Oral Paclitaxel and Encequidar in Patients with Metastatic Breast Cancer

Wednesday, December 9, 2020 - 1:38pm

In the prespecified modified intent-to-treat (mITT) population, oral paclitaxel showed a benefit on both PFS and OS versus IVP.

Key Points: 
  • In the prespecified modified intent-to-treat (mITT) population, oral paclitaxel showed a benefit on both PFS and OS versus IVP.
  • These data were presented today during a spotlight poster presentation at the 2020 San Antonio Breast Cancer Symposium (SABCS).
  • The updated Phase 3 PFS and OS data further support the clinical rationale for oral paclitaxel as an efficacious and tolerable treatment option for people living with metastatic breast cancer.
  • Athenexs oral paclitaxel and encequidar (oral paclitaxel) is the first oral formulation ofpaclitaxelin late-stage development for the treatment of metastatic breast cancer (MBC), and is also in earlier stages of development for other malignancies.

Evelo Biosciences Announces New Clinical Candidate in Oncology and Presents Additional Interim Data from Phase 1/2 Clinical Trial of EDP1503 in Patients with Triple-Negative Breast Cancer

Wednesday, December 9, 2020 - 2:00pm

The Company will halt patient recruitment in the Phase 1/2 clinical trial of EDP1503 and will wind down the study.

Key Points: 
  • The Company will halt patient recruitment in the Phase 1/2 clinical trial of EDP1503 and will wind down the study.
  • The Company also announced that additional interim clinical data from its Phase 1/2 open-label study evaluating EDP1503 in combination with pembrolizumab in patients with triple-negative breast cancer (TNBC) were presented today in a poster session at the San Antonio Breast Cancer Symposium (SABCS) 2020 Virtual Meeting.
  • EVs may offer oncology patients better outcomes and serve as the foundation of a new class of potentially safe, effective, and affordable immuno-oncology medicines.
  • We are now scaling up manufacturing in order to advance EDP1908 into the clinic in the first half of 2022.