USA News Group News Commentary
Issued on behalf of Oncolytics Biotech Inc.
VANCOUVER – USA News GroupNews Commentary – As many biotech companies within the oncology space begin to roll out their end-of-quarter results, the American Medical Association is pointing out the alarming trend of rising cancer rates, especially with younger people. According to data released from the National Cancer Institute (NCI), a division of the National Institutes of Health (NIH), a map shared byNewsweek showed that the prevalence of cancer varies significantly from state to state. Thankfully, there are plenty of new breakthroughs in the fight against cancer that the World Economic Forum recently highlighted, which are giving hope. Behind the scenes, biotech companies are making strides, with several touting their recent wins in their Q3 2024 financial results, including developments from Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), ImmunityBio, Inc. (NASDAQ: IBRX), Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), Syndax Pharmaceuticals, Inc. (NASDAQ: SNDX), and SpringWorks Therapeutics, Inc. (NASDAQ: SWTX).
The article continued: As reported by The Guardian, a new study is raising hopes of treating aggressive cancers by zapping rogue DNA that helps tumors thrive and become resistant to chemotherapy. Showing the shifting market, researchers at Statista recently released a report showing the Top 5 Oncology Products Worldwide by Market Share in 2017 and 2024.
Oncolytics Biotech® Reports Third Quarter 2024 Financial Results and Operational Highlights
Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, recently reported their Q3 2024 financial results and operational highlights. Among these highlights included impressive overall survival benefit results from BRACELET-1 data in HR+/HER2- metastatic breast cancer affirming its pelareorep + paclitaxel combination should be evaluated in a registrational study.
"With positive BRACELET-1 results, we have two randomized phase two studies confirming pelareorep's potential in HR+/HER2- metastatic breast cancer,” said Wayne Pisano, Chair of Oncolytics' Board of Directors and Interim CEO of Oncolytics. “After discussions with regulators and key opinion leaders and based on an estimated overall survival benefit of more than a year provided by pelareorep-based therapy, a registration-enabling study that is designed to support an accelerated approval is the next logical step for the development of pelareorep.”
In the BRACELET-1 study, pelareorep combined with paclitaxel significantly improved outcomes for patients with advanced HR+/HER2- breast cancer. Patients receiving this treatment lived without cancer progression for an average of 12.1 months, compared to just 6.4 months with paclitaxel alone—showing a benefit of nearly six months. Additionally, 64% of patients treated with pelareorep and paclitaxel lived for at least two years, compared to only 33% for paclitaxel alone. Median overall survival could not be calculated because over half of the patients on pelareorep were still alive at the study's end, but if they only lived to their next follow-up, their survival would average 32.1 months, notably higher than the 18.2 months for paclitaxel alone.
Oncolytics also highlighted upcoming milestones in its GOBLET study to include efficacy data from the anal cancer cohort and safety run-in data from the modified FOLFIRINOX pancreatic cancer cohort.
"We continue to develop our gastrointestinal cancer program and look forward to presenting updated efficacy data from our anal cancer cohort and safety data from our new modified FOLFIRNOX pancreatic cancer cohort,” continued Pisano. “Both of these indications represent a significant unmet medical need, and we have shown pelareorep provides the potential to meaningfully improve patient outcomes. This coming year will be critical for pelareorep, as well as for Oncolytics, and I've never been more confident in the potential pelareorep can deliver to cancer patients in need."
Also, as of September 30, 2024, Oncolytics had a cash position of $19.6 million, providing a cash runway through key milestones and into 2025.
Looking ahead, in H1 2025, Oncolytics is set to finalize the master protocol for the adaptive registration-enabling trial for pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab in first-line pancreatic ductal adenocarcinoma (PDAC) with the Global Coalition for Adaptive Research (GCAR) and submit it to the FDA.
Oncolytics also expects in H1 2025: safety run-in data from cohort 5 of the GOBLET study, investigating pelareorep and modified FOLFIRNOX (mFOLFIRINOX) with or without atezolizumab in newly diagnosed pancreatic cancer; and updated efficacy data from cohort 4 of the GOBLET study, investigating pelareorep and atezolizumab in second-line or later anal cancer.
As well, mid 2025 should see the first patient enrolled in registration-enabling study evaluating pelareorep and paclitaxel in metastatic HR+/HER2- breast cancer, and H2 2025 should see initial efficacy results from cohort 5 of the GOBLET study, investigating pelareorep and mFOLFIRINOX with or without atezolizumab in newly diagnosed pancreatic cancer.
CONTINUED… Read this and more news for Oncolytics Biotech at:https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/
In other industry developments and happenings in the market this week include:
ImmunityBio, Inc. (NASDAQ: IBRX), an immunotherapy innovator, recently reported its Q3 2024 financial results, which included highlights such as its ANKTIVA® receiving a J-code (HCPCS Level II Code) effective January 1, 2025, and becoming widely accessible to patients through commercial and government insurance programs (VA, DoD, Medicare), leading ImmunityBio to secure coverage for over 200 million medical lives through medical reimbursement policies.
"The U.S. launch of ANKTIVA for [non-muscle invasive bladder cancer with carcinoma in situ] (NMIBC CIS) continues to gain momentum, and we are pleased to see the clinical impact for patients," said Richard Adcock, President and CEO of ImmunityBio. "Our permanent J-code has been issued by Centers for Medicare and Medicaid Services and will be effective January 1, 2025. Our submission of ANKTIVA for NMIBC CIS to the MHRA in the UK for potential approval demonstrates our plans for global expansion. Further, we anticipate an EU submission this quarter."
The financial results came just weeks after ImmunityBio announced that the first patients had been dosed in an initial trial studying the potential of the company’s CAR-NK cell therapy targeting CD-19 in the treatment of non-Hodgkin’s lymphoma (NHL).
Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, recently reported its Q3 2024 financial results and corporate updates. Among the highlights were the reporting that significant demand for Amtagvi™ (Lifileucel) continues with $58.6M in Total 3Q24 Product Revenue and Iovance reaffirming guidance of $160-$165 million for FY 2024 and $450-$475 million for FY 2025 of total product revenue.
“Iovance is executing a successful U.S. commercial launch of Amtagvi™ for patients with previously treated advanced melanoma,” said Frederick Vogt, Ph.D., J.D., Interim President and CEO of Iovance. “Robust demand for Amtagvi and Proleukin® continues to grow as our expanding network of authorized treatment centers (ATCs) and outreach to community oncologists broaden the utilization of Amtagvi, driving a higher volume of patient referrals. Demand trends are expected to accelerate growth throughout the remainder of the year and over the following years. As a fully integrated company, Iovance is well positioned to remain the global leader in innovating, developing, and delivering current and future generations of TIL cell therapy for patients with cancer.”
Syndax Pharmaceuticals, Inc. (NASDAQ: SNDX), a commercial-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, recently reported its Q3 2024 financial results and business update. Within the highlights were the mention that new revumenib and Niktimvo™ clinical data will be highlighted at the 66th ASH Annual Meeting and that mNPM1 AML topline data from AUGMENT-101 is expected in Q4 2024, with a potential sNDA filing in H1 2025.
"This has been a historic period for Syndax as we transitioned to a commercial-stage company with the approval of Niktimvo," said Michael A. Metzger, CEO of Syndax. “We have a very exciting quarter ahead with the anticipated FDA approval and U.S. launch of revumenib for adults and pediatrics with R/R KMT2Ar acute leukemia, as well as the expected readout of topline pivotal data from patients with R/R mNPM1 AML. Our commercial organization is well-prepared to launch revumenib and leverage our first-to-market position to drive long-term value creation."
SpringWorks Therapeutics, Inc. (NASDAQ: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, recently reported their Q3 2024 financial results and provided an update on recent company developments that included achieving $49.3 million in OGSIVEO® (nirogacestat) net product revenue in the quarter, and being granted FDA Priority Review on NDA and received validation of EU Marketing Authorization Application for mirdametinib for the treatment of adults and children with NF1-PN.
"As we approach nearly one full year on market, we are very encouraged by the metrics we are seeing regarding the breadth of physician prescribing, the number of patients on OGSIVEO, and the number of patients identified who may stand to benefit in the future from our medicine," said Saqib Islam, CEO of SpringWorks. “Our focus for the remainder of the year is to continue building on OGSIVEO’s momentum in the U.S. while working to also bring it to patients in Europe, to advance our commercial preparations for mirdametinib in anticipation of serving patients with NF1-PN in the U.S. and Europe, and to progress our emerging portfolio."
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