Issued on behalf of Oncolytics Biotech Inc.
VANCOUVER – USA News Group – In the oncology world, there’s been plenty to celebrate recently, with cancer deaths falling by 33% in the last 30 years. However, there’s still a lot of work to do in the war on cancer, with the 2024 World Cancer Congress in Geneva highlighting several issues, such as artificial intelligence (AI), conflict zones and crisis care taking center stage at the gathering. Plenty of support for research continues to roll in, with philanthropists recently giving a historic $150 million for pancreatic cancer research to City of Hope, while Stanford experts are calling for more massive federal funding increases to cancer research. At the research level, several players are making significant progress in oncology, with recent developments coming from Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Novartis AG (NYSE: NVS), Lantheus Holdings, Inc. (NASDAQ: LNTH), Sutro Biopharma, Inc. (NASDAQ: STRO), and Zymeworks Inc. (NASDAQ: ZYME).
Backed by favorable results in its BRACELET-1 breast cancer study, Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) has recently reported important strides towards a registration-enabling study for its flagship asset pelareorep. The recently completed BRACELET-1 randomized phase 2 study ended with favorable optimism in its evaluation of pelareorep’s ability to benefit patients with HR+/HER2- advanced or metastatic breast cancer.
Within the latest update on pelareorep’s latest breast cancer study were plenty of reasons to build optimism, corroborating results of its previous randomized IND-213 breast cancer study that led to an FDA Fast Track Designation in 2017.
One important piece of data revealed was the promising fact that the median overall survival (OS) for pelareorep combined with paclitaxel was not reached, meaning more than half the patients in that arm remained alive at the end of the study.
“The fact that the median overall survival was not reached because more than half the patients were still alive at the end of the study is a remarkable achievement for us,” said Wayne Pisano, Interim CEO and Chair of Oncolytics’ Board of Directors. “It shows just how promising pelareorep treatment can be for extending the lives of breast cancer patients. This is further exemplified by the near doubling of the 2-year survival rate for patients who received pelareorep combination therapy.”
According to Oncolytics, had the study continued beyond two years, and patients survived only until the next planned visit (in 4 months), the median OS for patients in the pelareorep + paclitaxel arm would be 32.1 months, with a recorded hazard ratio of 0.48 vs the monotherapy. In accordance with these results, the two-year survival rate for patients in this arm was 64% compared to 33% for paclitaxel monotherapy patients. Additionally, the final median progression-free survival (PFS) for BRACELET-1 was 12.1 months in the pelareorep + paclitaxel arm vs 6.4 months in the paclitaxel monotherapy arm, representing an extra 5.7-month benefit with a hazard ratio of 0.39.
The confirmed overall response rate (ORR) for the pelareorep + paclitaxel combo was 37.5%, whereas paclitaxel alone was 13.3%. Also, as previously reported, ORRs at week 16 (the trial’s primary endpoint) in the combo was 31%, whereas the monotherapy was 20%. Now, Oncolytics is setting its sights on the next stage of pelareorep’s journey towards a potential FDA approval, with a newly reinforced path to funding a registration-enabling study.
“Taken together, the BRACELET-1 results provide compelling support for the potential of pelareorep-based combination therapy to benefit patients with advanced or metastatic HR+/HER2- breast cancer,” said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. “Having recently discussed with the FDA key design elements for our next breast cancer study, in combination with the strong survival data from the BRACELET-1 and IND-213 studies, we are confident in our plan to conduct a registration-enabling study to assess pelareorep-based combination therapy in patients with advanced HR+/HER2- breast cancer.”
For patients with metastatic HR+/HER2- early-stage breast cancer, the FDA recently expanded its approval of drugmaker Novartis AG’s (NYSE: NVS) Kisqali, which is currently under regulatory review worldwide, including in the EU for the early breast cancer indication. This latest approval is based on results from the pivotal Phase III NATALEE trial, which showed a significant and clinically meaningful 25.1% reduction in risk of disease recurrence.
“The FDA approval of Kisqali for this early breast cancer population, including those with N0 disease, is a pivotal moment in improving our approach to care,” said Dennis J. Slamon, M.D., Director of Clinical/Translational Research, UCLA Jonsson Comprehensive Cancer Center and Chairman of the Board of Translational Research In Oncology (TRIO) and NATALEE trial lead investigator. “Today’s approval allows us to offer treatment with a CDK4/6 inhibitor to a significantly broader group of people as a powerful tool that, combined with endocrine therapy, can help further minimize their risk of cancer returning.”
In Barcelona, Spain, leading radiopharmaceutical-focused company Lantheus Holdings, Inc. (NASDAQ: LNTH) recently presented data from the primary analysis of its Phase 3 pivotal SPLASH trial in PSMA-positive metastatic castration-resistant prostate cancer during the European Society of Medical Oncology (ESMO) Congress 2024. As per the results, Lantheus announced that its study met its primary endpoint, evaluating the efficacy of 177Lu-PNT2002, a prostate-specific membrane antigen (PSMA)-targeted radioligand therapy (RLT), demonstrating significant improvement in radiographic PFS, with an ORR of 38.1% vs 12% for the ARPI switch arm, and also reported 9.3% complete responses (CR). Overall survival data continued to mature, with an update expected once data are available for 75% of protocol-specified target OS events.
“We are encouraged by the initial results from the SPLASH trial, with 177Lu-PNT2002 demonstrating improvement compared to ARPI change in radiographic progression-free survival, positive interim crossover-adjusted overall survival hazard ratios, as well as improved quality of life,” said Oliver Sartor, M.D., Director of Radiopharmaceutical Trials and Professor of Medical Oncology at the Mayo Clinic in Rochester, Minnesota. “These initial data underscore the importance of PSMA-targeted RLTs, including 177Lu-PNT2002, as potential treatment options for patients who have limited choices after progressing on ARPI therapy.”
Sutro Biopharma, Inc. (NASDAQ: STRO) also presented at ESMO 2024, sharing updated data through a poster presentation from its Phase 1b study of its antibody-drug conjugate Luvelta, in combination with bevacizumab for patients with epithelial ovarian cancer (EOC). In the study, the combination demonstrated encouraging antitumor activity in patients with late-stage ovarian cancer irrespective of Folate Receptor-α (FRα) expression, including patients with no FRα expression, and prior bevacizumab treatment, with an overall response rate of 35%.
“We are encouraged by these results achieved with luvelta in combination with bevacizumab, which may offer the opportunity to benefit ovarian cancer patients regardless of FRα expression,” said Jane Chung, President and Chief Operating Officer of Sutro. “We have already seen promising antitumor activity with luvelta as a monotherapy treatment and we believe these combination data support our goal to deliver effective therapies to more patients living with cancer. We look forward to sharing initial results from our expansion phase in the first half of 2025.”
Also in Barcelona, but in October, Zymeworks Inc. (NASDAQ: ZYME) is preparing to present preclinical data on its antibody-drug conjugate programs at the European Organisation for Research and Treatment of Cancer-National Cancer Institute-American Association for Cancer Research (EORTC-NCI-AACR) Conference being held October 23-25, 2024. The clinical-stage biotech company is developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat cancers and other diseases, and plans to host two presentations highlighting results from recent preclinical research for Zymeworks’ antibody-drug conjugate candidates ZW220 and ZW251.
"We are excited to share results from our preclinical studies, which highlight the activity of ZW220 in models of non-small cell lung, ovarian, and uterine cancers, as well as ZW251 in hepatocellular carcinoma models, both of which leverage our novel proprietary payload, ZD06519," said Paul Moore, Ph.D., Chief Scientific Officer at Zymeworks. "We are encouraged by the progress of these next-generation ADC programs, which remain on track for IND filings in 2025, following the recent advancement of ZW171 and ZW191, which are currently recruiting for Phase 1 studies.”
Article Source: https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/
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