Pelareorep

Oncolytics Biotech's® Chinese Development Partner Adlai Nortye Presents Interim Clinical Data Further Demonstrating the Anti-Cancer Activity of Pelareorep-Paclitaxel Combination Therapy in HR+/HER2- Metastatic Breast Cancer at the San Antonio Breast Canc

Retrieved on: 
Thursday, December 8, 2022

SAN DIEGO and CALGARY, AB, Dec. 8, 2022 /PRNewswire/ -- Oncolytics Biotech® Inc.'s (NASDAQ: ONCY) (TSX: ONC) Chinese partner Adlai Nortye today announced interim results from a multicenter, single-arm bridging clinical trial to evaluate the safety, tolerability, and preliminary efficacy of pelareorep-paclitaxel combination therapy in Chinese patients with advanced/metastatic HR+/HER2- breast cancer. The data were featured in a poster presented yesterday at the San Antonio Breast Cancer Symposium (SABCS), which is being held at the Henry B. González Convention Center in San Antonio, Texas through December 10, 2022.

Key Points: 
  • 's (NASDAQ: ONCY) (TSX: ONC) Chinese partner Adlai Nortye today announced interim results from a multicenter, single-arm bridging clinical trial to evaluate the safety, tolerability, and preliminary efficacy of pelareorep-paclitaxel combination therapy in Chinese patients with advanced/metastatic HR+/HER2- breast cancer.
  • One patient achieving a PR at week 8 has maintained the PR through week 48 and remains on study.
  • The studied combination has been well tolerated, with no dose-limiting toxicities or serious adverse events (SAEs) reported to date.
  • "With no SAEs reported, the data suggests the favorable safety and potent anti-cancer activity displayed by the studied combination in North American HR+/HER2- breast cancer patients extends to the Chinese population.

Oncolytics Biotech® Receives FDA Fast Track Designation for the Treatment of Advanced/Metastatic Pancreatic Cancer

Retrieved on: 
Thursday, December 1, 2022

SAN DIEGO, and CALGARY, AB, Dec. 1, 2022 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to pelareorep in combination with Roche's anti-PD-L1 checkpoint inhibitor atezolizumab, and the chemotherapeutic agents gemcitabine and nab-paclitaxel, for the treatment of advanced/metastatic pancreatic ductal adenocarcinoma (PDAC). This represents pelareorep's second FDA Fast Track designation.

Key Points: 
  • This represents pelareorep's second FDA Fast Track designation.
  • Fast Track designation is designed to facilitate the development and expedite the review of therapies to treat serious conditions and fill an unmet medical need.
  • For conditions where an available treatment exists, a therapy must show some advantage over the available treatment, such as superior effectiveness, to be granted a Fast Track designation.
  • In addition, clinical programs with Fast Track designation may be eligible for Accelerated Approval and Priority Review, if relevant criteria are met.

Oncolytics Biotech® Receives FDA Fast Track Designation for the Treatment of Advanced/Metastatic Pancreatic Cancer

Retrieved on: 
Thursday, December 1, 2022

SAN DIEGO, and CALGARY, AB, Dec. 1, 2022 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to pelareorep in combination with Roche's anti-PD-L1 checkpoint inhibitor atezolizumab, and the chemotherapeutic agents gemcitabine and nab-paclitaxel, for the treatment of advanced/metastatic pancreatic ductal adenocarcinoma (PDAC). This represents pelareorep's second FDA Fast Track designation.

Key Points: 
  • This represents pelareorep's second FDA Fast Track designation.
  • Fast Track designation is designed to facilitate the development and expedite the review of therapies to treat serious conditions and fill an unmet medical need.
  • For conditions where an available treatment exists, a therapy must show some advantage over the available treatment, such as superior effectiveness, to be granted a Fast Track designation.
  • In addition, clinical programs with Fast Track designation may be eligible for Accelerated Approval and Priority Review, if relevant criteria are met.

Oncolytics Biotech® Receives FDA Fast Track Designation for the Treatment of Advanced/Metastatic Pancreatic Cancer

Retrieved on: 
Thursday, December 1, 2022

SAN DIEGO, and CALGARY, AB, Dec. 1, 2022 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to pelareorep in combination with Roche's anti-PD-L1 checkpoint inhibitor atezolizumab, and the chemotherapeutic agents gemcitabine and nab-paclitaxel, for the treatment of advanced/metastatic pancreatic ductal adenocarcinoma (PDAC). This represents pelareorep's second FDA Fast Track designation.

Key Points: 
  • This represents pelareorep's second FDA Fast Track designation.
  • Fast Track designation is designed to facilitate the development and expedite the review of therapies to treat serious conditions and fill an unmet medical need.
  • For conditions where an available treatment exists, a therapy must show some advantage over the available treatment, such as superior effectiveness, to be granted a Fast Track designation.
  • In addition, clinical programs with Fast Track designation may be eligible for Accelerated Approval and Priority Review, if relevant criteria are met.

Oncolytics Biotech® Receives FDA Fast Track Designation for the Treatment of Advanced/Metastatic Pancreatic Cancer

Retrieved on: 
Thursday, December 1, 2022

SAN DIEGO, and CALGARY, AB, Dec. 1, 2022 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to pelareorep in combination with Roche's anti-PD-L1 checkpoint inhibitor atezolizumab, and the chemotherapeutic agents gemcitabine and nab-paclitaxel, for the treatment of advanced/metastatic pancreatic ductal adenocarcinoma (PDAC). This represents pelareorep's second FDA Fast Track designation.

Key Points: 
  • This represents pelareorep's second FDA Fast Track designation.
  • Fast Track designation is designed to facilitate the development and expedite the review of therapies to treat serious conditions and fill an unmet medical need.
  • For conditions where an available treatment exists, a therapy must show some advantage over the available treatment, such as superior effectiveness, to be granted a Fast Track designation.
  • In addition, clinical programs with Fast Track designation may be eligible for Accelerated Approval and Priority Review, if relevant criteria are met.

Oncolytics Biotech® Receives FDA Fast Track Designation for the Treatment of Advanced/Metastatic Pancreatic Cancer

Retrieved on: 
Thursday, December 1, 2022

SAN DIEGO, and CALGARY, AB, Dec. 1, 2022 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to pelareorep in combination with Roche's anti-PD-L1 checkpoint inhibitor atezolizumab, and the chemotherapeutic agents gemcitabine and nab-paclitaxel, for the treatment of advanced/metastatic pancreatic ductal adenocarcinoma (PDAC). This represents pelareorep's second FDA Fast Track designation.

Key Points: 
  • This represents pelareorep's second FDA Fast Track designation.
  • Fast Track designation is designed to facilitate the development and expedite the review of therapies to treat serious conditions and fill an unmet medical need.
  • For conditions where an available treatment exists, a therapy must show some advantage over the available treatment, such as superior effectiveness, to be granted a Fast Track designation.
  • In addition, clinical programs with Fast Track designation may be eligible for Accelerated Approval and Priority Review, if relevant criteria are met.

Oncolytics Biotech® Announces Presentations at the Upcoming San Antonio Breast Cancer Symposium

Retrieved on: 
Monday, November 21, 2022

(NASDAQ: ONCY) (TSX: ONC) today announced the publication of two abstracts for poster presentations at the upcoming San Antonio Breast Cancer Symposium (SABCS), to be held at the Henry B. Gonzlez Convention Center in San Antonio, Texas from December 6 10, 2022.

Key Points: 
  • (NASDAQ: ONCY) (TSX: ONC) today announced the publication of two abstracts for poster presentations at the upcoming San Antonio Breast Cancer Symposium (SABCS), to be held at the Henry B. Gonzlez Convention Center in San Antonio, Texas from December 6 10, 2022.
  • Thebridging trial is designed to accelerate Adlai Nortye's development of pelareorep in China by allowingfuture regulatory submissions to include data from Oncolytics' North American metastatic breast cancer trials, IND-213 and BRACELET-1.
  • Described in this abstract are the results of gene expression analyses from cohorts 1 and 2 of AWARE-1, a collaborative window-of-opportunity study in patients with early-stage breast cancerthat was conducted by Oncolytics Biotech and SOLTI-Innovative Cancer Research.
  • The study combined pelareorep, without or with atezolizumab, and the standard of care therapy according to breast cancer subtype.

Oncolytics Biotech® Announces Presentations at the Upcoming San Antonio Breast Cancer Symposium

Retrieved on: 
Monday, November 21, 2022

(NASDAQ: ONCY) (TSX: ONC) today announced the publication of two abstracts for poster presentations at the upcoming San Antonio Breast Cancer Symposium (SABCS), to be held at the Henry B. Gonzlez Convention Center in San Antonio, Texas from December 6 10, 2022.

Key Points: 
  • (NASDAQ: ONCY) (TSX: ONC) today announced the publication of two abstracts for poster presentations at the upcoming San Antonio Breast Cancer Symposium (SABCS), to be held at the Henry B. Gonzlez Convention Center in San Antonio, Texas from December 6 10, 2022.
  • Thebridging trial is designed to accelerate Adlai Nortye's development of pelareorep in China by allowingfuture regulatory submissions to include data from Oncolytics' North American metastatic breast cancer trials, IND-213 and BRACELET-1.
  • Described in this abstract are the results of gene expression analyses from cohorts 1 and 2 of AWARE-1, a collaborative window-of-opportunity study in patients with early-stage breast cancerthat was conducted by Oncolytics Biotech and SOLTI-Innovative Cancer Research.
  • AWARE-1 was an open-label window-of-opportunity study in early-stage breast cancer.The study combined pelareorep, without or with atezolizumab, and the standard of care therapy according to breast cancer subtype.

Biotech Sector Gaining Wins Against Pancreatic Cancer with Early Detection and New Therapies

Retrieved on: 
Monday, November 14, 2022

VANCOUVER, British Colombia, Nov. 14, 2022 /PRNewswire/ -- USA News Group  -  English actor, comedian and Monty Python alumnus Eric Idle credits early detection for his victory over pancreatic cancer, known as the world's deadliest common cancer. "The good news is that we are starting to fight back," said Idle after creating the Bright Side Fund to support research and help promote early detection. Despite US cancer death rates being down across all age groups, however mortality rates for pancreatic cancers have gone up, so there's much work to be done. Now there's developments in the fight against pancreatic cancer coming that are generating huge amounts of optimism from biotech groups such as Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Roche Holding AG (OTCQX: RHHBY), Eli Lilly and Company (NYSE: LLY), Bristol-Myers Squibb Company (NYSE: BMY), and BioNTech SE (NASDAQ: BNTX).

Key Points: 
  • One of the most promising new data sets in pancreatic cancer therapies is coming from pelareorep, developed by Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC).
  • Highlighting the impressive significance of the data, Oncolytics Biotech cites the Increased Survival in Pancreatic Cancer with nab-Paclitaxel plus Gemcitabine study published in 2013 by Dr.
  • Back in June, Oncolytics Biotech announced it had achieved success criteria for efficacy in its pancreatic cancer cohort.
  • Back in June, BioNTech presented preliminary Phase I data of its BNT122, evaluating with Genentech (a Roche subsidiary) in pancreatic cancer.

Biotech Sector Gaining Wins Against Pancreatic Cancer with Early Detection and New Therapies

Retrieved on: 
Monday, November 14, 2022

VANCOUVER, British Colombia, Nov. 14, 2022 /PRNewswire/ -- USA News Group  -  English actor, comedian and Monty Python alumnus Eric Idle credits early detection for his victory over pancreatic cancer, known as the world's deadliest common cancer. "The good news is that we are starting to fight back," said Idle after creating the Bright Side Fund to support research and help promote early detection. Despite US cancer death rates being down across all age groups, however mortality rates for pancreatic cancers have gone up, so there's much work to be done. Now there's developments in the fight against pancreatic cancer coming that are generating huge amounts of optimism from biotech groups such as Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Roche Holding AG (OTCQX: RHHBY), Eli Lilly and Company (NYSE: LLY), Bristol-Myers Squibb Company (NYSE: BMY), and BioNTech SE (NASDAQ: BNTX).

Key Points: 
  • One of the most promising new data sets in pancreatic cancer therapies is coming from pelareorep, developed by Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC).
  • Highlighting the impressive significance of the data, Oncolytics Biotech cites the Increased Survival in Pancreatic Cancer with nab-Paclitaxel plus Gemcitabine study published in 2013 by Dr.
  • Back in June, Oncolytics Biotech announced it had achieved success criteria for efficacy in its pancreatic cancer cohort.
  • Back in June, BioNTech presented preliminary Phase I data of its BNT122, evaluating with Genentech (a Roche subsidiary) in pancreatic cancer.