Issued on behalf of Oncolytics Biotech Inc.
VANCOUVER – Baystreet.ca News Commentary – Cancer treatment is experiencing unprecedented momentum as the FDA approved breakthrough therapies for aggressive cancers, including Modeyso for deadly brain tumors, while breakthrough designations surge for next-generation therapies targeting previously resistant cancers. The momentum extends beyond individual approvals as a wave of July breakthrough designations and regulatory milestones spans multiple cancer types. This accelerating regulatory environment is creating significant opportunities for companies with innovative oncology platforms to capitalize on streamlined approval pathways, including Oncolytics Biotech Inc. (NASDAQ: ONCY), Immuneering Corporation (NASDAQ: IMRX), Eli Lilly and Company (NYSE: LLY), ALX Oncology Holdings Inc. (NASDAQ: ALXO), and NovoCure Limited (NASDAQ: NVCR).
Analysts at Precedence Research project the cancer immunotherapy market to reach $338.40 billion by 2034, growing at a 10.65% CAGR, as Coherent Market Insights projects the cellular immunotherapy market to surge toward $20.45 billion by 2032 amid rising cancer prevalence. The regulatory environment is creating unprecedented opportunities as FDA Fast Track and Breakthrough designations accelerate promising therapies through streamlined approval pathways, enabling companies with innovative platforms to capture significant market share before major pharmaceutical competitors enter these specialized segments.
Oncolytics Biotech Inc. (NASDAQ: ONCY) has provided updated safety data that could strengthen its regulatory position as the company advances toward potential registration-enabling trials. The company recently announced comprehensive safety information spanning over 1,200 patients, including more than 300 gastrointestinal cancer patients across 8 clinical studies, with management describing pelareorep as among "the most de-risked immunotherapies" not yet approved in gastrointestinal tumors.
The expanded safety database comes as Oncolytics works toward registration-enabling trials for its investigational immunotherapy, pelareorep, in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC). According to CEO Jared Kelly, this safety data should serve as "a positive characteristic for regulators and potential partners."
The safety profile appears consistent across multiple treatment combinations and tumor types. The most frequently reported adverse events remain Grade 1 and 2 flu-like symptoms, with data suggesting pelareorep does not appear to modify the safety profile of established chemotherapy regimens.
Previously, the company confirmed ongoing discussions with the U.S. Food and Drug Administration (FDA) to finalize pivotal study parameters, with Oncolytics targeting potential initiation of trial activities by Q4 2025. This regulatory engagement represents a transition from proof-of-concept research toward potential regulatory-stage development.
The focus on mPDAC builds on survival data in an area of significant unmet medical need. Pelareorep is a systemically delivered oncolytic virus intended to transform immunologically "cold" tumors into "hot" targets that may become more responsive to immune-based treatments. Clinical data show pelareorep combinations achieved a 21.9% two-year overall survival rate in first-line pancreatic cancer patients, compared to the 9.2% historical benchmark reported for standard chemotherapy protocols.
Pelareorep demonstrated a 62% objective response rate when combined with chemotherapy and a checkpoint inhibitor. This may be particularly relevant since checkpoint inhibitors currently lack approval for pancreatic cancer treatment, suggesting pelareorep might help unlock immunotherapy effectiveness in historically resistant tumors.
"We have turned the corner from proof-of-concept studies and will be sprinting toward regulatory clarity for the remainder of the year," said Jared Kelly, CEO of Oncolytics. "As we shore up our intellectual property, get a clear registration path for pelareorep, and allow our GOBLET data to mature, we will establish our position as the only platform immunotherapy in gastrointestinal tumors."
These observations, combined with survival data from over 1,200 patients across multiple clinical programs, have guided management's focus on pancreatic cancer as the lead indication for regulatory advancement. The expanded safety database may provide additional confidence for regulatory discussions across the broader gastrointestinal platform.
Recent leadership changes reflect an execution-focused approach. CEO Jared Kelly and Chief Business Officer Andrew Aromando both contributed to Ambrx Biopharma's US$2 billion acquisition by Johnson & Johnson. The company has eliminated its At-the-Market and Equity Line facilities, which management suggests reflects confidence in current cash resources to reach key development milestones.
Pelareorep currently holds both Fast Track and Orphan Drug designations from the FDA specifically for pancreatic cancer, which may facilitate expedited review processes and could enhance partnership discussions with major pharmaceutical companies.
Current FDA discussions reportedly focus on study design parameters that could support regulatory submission for potential commercial approval. Oncolytics expects to share updated clinical development timelines during Q3 2025, with trial initiation activities potentially commencing by Q4 2025. With safety data spanning over 1,200 patients, survival data from multiple studies, and experienced leadership, the company appears positioned to advance pelareorep through what management considers its most critical development phase.
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 recent industry developments and happenings in the market include:
ALX Oncology Holdings Inc. (NASDAQ: ALXO) has dosed the first patient in its Phase 1 dose-escalation trial evaluating ALX2004, a potential best- and first-in-class EGFR-targeted antibody-drug conjugate for EGFR-expressing solid tumors. The first-in-human trial builds upon positive preclinical data demonstrating dose-dependent anti-tumor activity and a favorable safety profile across multiple tumor types and EGFR expression levels. ALX2004 is uniquely designed with every component optimized to maximize the therapeutic window by reducing toxicity, including an affinity-tuned EGFR antibody and proprietary topoisomerase I inhibitor payload.
"Dosing of the first patient in the Phase 1 trial is an important milestone in ALX Oncology's mission to develop a pipeline of best-in-class drugs; ALX2004 is our first ADC and treating our first patient with this drug is a significant step forward in fulfilling the potential of EGFR-targeted ADCs," said Jason Lettmann, CEO of ALX Oncology. "Our preclinical data supports our conviction that ALX2004, with its optimized antibody, linker and payload, has the potential to overcome the toxicity challenges that have limited earlier generation EGFR-targeted ADCs."
The company expects to report initial safety data from this combination trial in the first half of 2026. ALX Oncology's lead therapeutic candidate, evorpacept, continues advancing across multiple ongoing clinical trials in various cancer indications, while ALX2004 represents the second pipeline candidate to enter clinical development.
Immuneering Corporation (NASDAQ: IMRX) has entered a clinical supply agreement with Eli Lilly and Company (NYSE: LLY) to evaluate atebimetinib in combination with Lilly's second-generation KRAS G12C inhibitor olomorasib in advanced non-small cell lung cancer (NSCLC) patients. The planned Phase 2 trial will target patients with locally advanced or metastatic KRAS G12C-mutant NSCLC who have progressed on prior therapy, representing Immuneering's second major collaboration this year following a February agreement with Regeneron Pharmaceuticals to evaluate atebimetinib with Libtayo.
"This agreement with Lilly marks the second such collaboration we have announced this year as we seek to evaluate the potential of atebimetinib in combination with synergistic anti-cancer mechanisms," said E.B. Brakewood, Chief Business Officer of Immuneering. “A pan-MAPK solution is of particular interest in challenging tumor types such as NSCLC.”
"The combination of atebimetinib and olomorasib has the potential to provide a vertical blockade of the RAS-MAPK pathway, which is supported by preclinical studies of this combination in which enhanced tumor regression, delayed emergence of tumor resistance and prolonged survival relative to monotherapy was observed," said Igor Matushansky, MD, PhD, Chief Medical Officer of Immuneering. “This dual targeted approach has the potential to improve outcomes in a population with limited effective treatment options.”
Immuneering will maintain global development and commercialization rights to atebimetinib while advancing its lead Deep Cyclic Inhibitor through multiple combination strategies targeting MAPK pathway-driven tumors.
NovoCure Limited (NASDAQ: NVCR) has received coverage from Spain's Ministry of Health for Tumor Treating Fields (TTFields) therapy through the Spanish National Health System for adult patients with newly diagnosed glioblastoma. Eligible patients can now access TTFields therapy through qualified hospitals and health centers, expanding availability of the innovative electric field cancer treatment in one of Europe's largest economies. The coverage decision adds Spain to NovoCure's growing list of reimbursed markets, which now includes Austria, France, Germany, Israel, Japan, Sweden, Switzerland and the United States.
"Glioblastoma is one of the most common and aggressive forms of primary brain cancer with few treatment options. We are very pleased Tumor Treating Fields therapy is now available through the Spanish public health system for eligible patients with newly diagnosed glioblastoma," said Alvaro Nunez, General Manager, NovoCure Spain. "The expanded coverage will help more patients benefit from TTFields therapy."
The company's wearable medical device technology has now treated more than 35,000 patients globally across multiple cancer indications. NovoCure continues advancing clinical trials exploring TTFields applications in glioblastoma, non-small cell lung cancer and pancreatic cancer while expanding international market access.
Source: https://usanewsgroup.com/2024/09/21/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/
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