RE:RE:RE:Regarding the transcript…lots of good & great stuffRelevant excerpt of ONCY's Earnings Call opening remarks on May 05, 2023:
Matt Coffey
Thanks, Jon. It's my pleasure to provide an overview of our recent highlights and outlook for the coming months. I will start with the exciting news that came out just last week when we announced the results from our randomized BRACELET-1 trial in HR-positive/HER2-negative metastatic breast cancer will be shared in an oral presentation at the upcoming ASCO Annual Meeting.
ASCO is one of the world's most well-regarded oncology conferences and will provide an excellent venue to discuss our results with potential partners and the broader breast cancer community. With BRACELET’s ASCO abstract set to be published later this month, we are weeks away from a crucial milestone to pelareorep or Pela, as I'll often refer to it.
As I have mentioned on previous calls BRACELET-1 represents Pela's last major step on the path to a pivotal study in HR-positive/HER2-negative metastatic breast cancer. Key goals for the trial are to inform and design a subsequent licensure-enabling study and to validate prior randomized Phase 2 data that showed Pela driving a statistically significant near doubling of median overall survival when combined with paclitaxel in this indication. Given BRACELET is important to Pela's value proposition, setting the stage for its upcoming readout will be the primary focus of today's call.
As we look ahead to BRACELET-1 upcoming readout and beyond, we believe we are well positioned for growth with a pipeline that includes two core pillars, namely our HR-positive/HER2-negative breast cancer and pancreatic cancer programs. Both of these programs represent meaningful registration opportunities supported by compelling proof-of-concept clinical data and FDA Fast Track designations. We expect to have additional guidance on the optimal registration-enabling pathway for these programs later this year, highlighting just how excited these times are for Oncolytics.
Thomas Heineman
Additional data supporting our HR-positive/HER2-negative breast cancer program include Phase 1 results demonstrating Pela's single agent activity in this syndication as well as results of AWARE-1 a window-of-opportunity study that evaluated Pela-based treatment combinations in early-stage breast cancer patients.
On Saturday June 3, BRACELET-1’s oral presentation will be delivered by Dr. Amy Clark during one of ASCO's Clinical Science Symposium.
With the prior [IND213] results, providing a robust foundational data set for our HR-positive/HER2-negative breast cancer program, the goals of BRACELET-1 are to substantiate the positive results of IND.213 and inform the design of a licensure-enabling study. To accomplish these goals, we and our collaborators at Pfizer and Merck KGaA, designed BRACELET to enroll 48 patients randomized across three cohorts, a control arm, consisting of standard of care Paclitaxel monotherapy, an arm evaluating Paclitaxel combined with Pela and a third arm in which the checkpoint inhibitor of avelumab was added to Paclitaxel plus Pela. The first two arms mirror, the IND.213 study groups, while the third arm was included to evaluate whether the additional of avelumab to Paclitaxel plus Pela provides additional benefit.
Following this presentation, we plan to host the Key Opinion Leader Webinar on Monday, June 5 at 8:00 AM Eastern Time, to provide expert perspective on the results and what they mean for our HR-positive/HER2-negative breast cancer program’s next steps.
In addition to the oral presentation on BRACELET, the ASCO Conference will include a poster on preclinical studies evaluating Pela’s potential [indiscernible] technology for CAR T-cell therapy in solid tumors. These studies were conducted in collaboration with Dr. Richard Vile's group at the Mayo Clinic and followed the publication of a paper on this topic in Science Translational Medicine last year.