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Vancouver, BC – March 24, 2023 – USA News Group – Treatments for various forms of breast cancer continue to evolve, with several new breakthroughs being labeled as landmark in nature and giving hope to families dealing with a fateful diagnosis. According to the American Cancer Society in 2022, the 5-year relative survival rate for localized breast cancer, cancer that has not spread outside the breast, is 99%, and for those whose cancer has spread outside the breast to nearby structures or lymph nodes, the survival rate is 86%. Over the last year, the biotech sector has increased its efforts and delivered very optimistic data from such groups as Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), CytomX Therapeutics, Inc. (NASDAQ:CTMX), BriaCell Therapeutics (NASDAQ:BCTX, BCTXW) (TSX:BCT), Relay Therapeutics (NASDAQ:RLAY), and Hologic, Inc. (NASDAQ:HOLX).
Further demonstrating the anti-cancer activity of its flagship asset pelareorep in combination with chemotherapy paclitaxel (Taxol), Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) announced back in December 2022 that its Chinese development partner Adlai Nortye delivered new interim results from a clinical trial in Chinese patients with advanced/metastatic HR+/HER2- breast cancer.
Within the results, thirteen of fourteen (93%) evaluable patients achieved disease control, with twelve (86%) showing tumor shrinkage, and no reported serious adverse effects (SAEs). Half of the evaluable patients achieved partial response (PR), three of the patients (20%) achieved a confirmed PR, while another two patients are awaiting potential confirmatory scans.
“These impressive results have us well-positioned to leverage Oncolytics’ prior positive data and join pelareorep’s global development program,” said Lars Birgerson, M.D., Ph.D., Adlai Nortye President and Chief Medical Officer. “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. There are also promising signs of pelareorep-paclitaxel combination therapy driving durable clinical benefit, with one patient notably still on study for nearly a year while maintaining a PR. We look forward to further characterizing the efficacy and durability of the studied combination as data from the trial mature and to continuing our collaboration with Oncolytics.”
Data from the bridging trial are expected to accelerate Adlai Nortye’s development of pelareorep in China by allowing future regulatory submissions to include data from Oncolytics’ North American metastatic breast cancer trials, IND-213 and BRACELET-1. Oncolytics expects to report overall response rate, progression-free survival (PFS), and evolving overall survival data from BRACELET-1 at a major medical meeting in the first half of 2023.
“BRACELET-1’s upcoming readout represents a crucial catalyst for Oncolytics, as data from the trial are expected to pave the way for pelareorep’s advancement to a registrational breast cancer study,” said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. “We believe Adlai Nortye’s latest data significantly de-risk this upcoming readout as they validate IND-213’s positive results by confirming the ability of pelareorep plus paclitaxel to drive durable clinical responses in HR+/HER2- breast cancer patients.”
The news of the positive results from the Adlai Nortye trial comes one week after Oncolytics Biotech announced it had received FDA Fast Track Designation for the treatment of advanced/metastatic pancreatic cancer, representing the company’s second FDA Fast Track win to date.
The data from Oncolytics and Adlai Nortye came at the same San Antonio Breast Cancer Symposium (SABCS) where CytomX Therapeutics, Inc. (NASDAQ:CTMX) presented its Phase 2 data for praluzatamab ravtansine (CX-2009) in patients with advanced breast cancer.
Back in July 2022, CytomX delivered Phase 2 results showing the study had met its primary endpoint of objective response rate (ORR) in HR+/HER2-non-amplified breast cancer, as well as secondary endpoints including clinical benefit rate of 24 weeks and median PFS of 40% and 2.6 months, respectively.
“These results from our Phase 2 evaluation of praluzatamab ravtansine support single-agent activity of this novel drug candidate in hormone receptor-positive breast cancer where significant unmet need remains,” said Sean McCarthy, D.Phil., CEO and Chairman at CytomX Therapeutics.
Already so far in 2023, BriaCell Therapeutics (NASDAQ:BCTX, BCTXW) (TSX:BCT) announced it had received agreement and feedback from its End of Phase II meeting with the FDA for lead clinical candidate, Bria-IMT
in combination with a checkpoint inhibitor, in advanced metastatic breast cancer.
Both BriaCell and the FDA have agreed on the primary end point, the essential elements of the study design, and the type of patients to be enrolled in BriaCell’s upcoming pivotal clinical study. This pivotal registration study will be enrolling advanced metastatic breast cancer patients for whom no approved treatment options exist.
“The importance of this milestone speaks for itself and is yet another major step towards our goal to become one of the leading immuno-oncology companies,” stated Dr. William V. Williams, BriaCell’s President and CEO. “Jumping directly into a pivotal study shortly after receiving Fast Track status has greatly advanced our lead clinical program timetable with the ultimate goal of commercializing our novel immunotherapy approach for women with no approved treatment options.”
In 2022, Relay Therapeutics (NASDAQ:RLAY) continued evaluating RLY-2608 in combination with fulvestrant for patients with HR+, HER2–, PI3Kα-mutated, locally advanced or metastatic breast cancer.
“…Building on the foundation of our PI3Kα franchise, we will outline a broad commitment to developing comprehensive treatment options for breast cancer patients.,” said Sanjiv Patel, M.D., Relay Therapeutics’ President and CEO. “We believe our platform and approach have the potential to address some of the hardest-to-treat diseases and are excited to do just that in the coming years.”
Relay has previously disclosed three new programs from a growing breast cancer franchise including a selective CDK2 inhibitor, a rationally designed ERα degrader, and a chemically distinct pan-mutant selective PI3Kα inhibitor (RLY-5836).
Back at the beginning of October 2022, pioneers of 3D mammogram technology Hologic, Inc. (NASDAQ:HOLX) rang the opening bell for the Nasdaq to kick off Breast Cancer Awareness Month. The company went into the SABCS in December 2022 presenting data that revealed the predictive value of the Breast Cancer Index Text for ovarian function suppression in premenopausal women with HR+ breast cancer.
“Multiple clinical studies and national oncology guidelines affirm the predictive ability of the Breast Cancer Index test for extended endocrine therapy,” said Kevin Thornal, Group President, Global Diagnostic Solutions at Hologic. “These new data further establish the Breast Cancer Index test as a significant endocrine response biomarker and reveal additional predictive capabilities of the test. As we explore its predictive power earlier in a patient’s journey, we aim to uncover broader potential clinical utility in more women with early-stage, HR+ breast cancer.”
Hologic’s data showed that the Breast Cancer Index test identified which premenopausal patients with early-stage HR+ breast cancer benefited from the addition of ovarian function suppression (OFS) to primary adjuvant endocrine therapy. The Breast Cancer Index test is the first biomarker to be evaluated in a cohort from the landmark Suppression of Ovarian Function Trial (SOFT).
The landmark SOFT trial was an international, three-arm, non-blinded, randomized clinical trial of 3,066 premenopausal women with HR+ breast cancer, and demonstrated that the addition of OFS to five years of primary adjuvant endocrine therapy (either tamoxifen or exemestane) reduced the risk of recurrence compared to adjuvant tamoxifen alone.
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