FN Media Group Presents USA News Group News Commentary
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.
For more information please visit: https://usanewsgroup.com/2022/11/27/market-uncertainty-is-creating-opportunities-that-have-somehow-been-overlooked/
DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. (“MIQ”). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles.
While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.
USA News Group is Source of all content listed above. FN Media Group, LLC (FNM), is a third party publisher and news dissemination service provider, which disseminates electronic information through multiple online media channels. FNM is NOT affiliated in any manner with USA News Group or any company mentioned herein. The commentary, views and opinions expressed in this release by USA News Group are solely those of USA News Group and are not shared by and do not reflect in any manner the views or opinions of FNM. FNM is not liable for any investment decisions by its readers or subscribers. FNM and its affiliated companies are a news dissemination and financial marketing solutions provider and are NOT a registered broker/dealer/analyst/adviser, holds no investment licenses and may NOT sell, offer to sell or offer to buy any security. FNM was not compensated by any public company mentioned herein to disseminate this press release.
This release contains “forward-loking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “may”, “future”, “plan” or “planned”, “will” or “should”, “expected,” “anticipates”, “draft”, “eventually” or “projected”. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a company’s annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and FNM undertakes no obligation to update such statements.
Media Contact Information:
FN Media Group, LLC
Media Contact e-mail:
U.S. Phone: +1(954)345-0611
SOURCE USA News Group