On October 12, 2026 Oncolytics Biotech Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, reported an update on its intellectual property strategy, outlining progress on new method of use patents and plans to expand its portfolio with composition of matter protection for a modified "next generation" pelareorep. These initiatives build on the Company’s existing manufacturing patent protection through 2044 and are intended to extend protection for specified therapeutic uses and future innovations into the late 2040s, subject to patent issuance and applicable patent terms.

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A new method of use patent covering pelareorep as an immunotherapy for the treatment of cancer has been issued in several countries, and the Company expects the corresponding U.S. patent to issue in the near term. This patent is part of Oncolytics’ strategy to protect pelareorep’s therapeutic applications alongside the proprietary processes used to manufacture it.

Oncolytics has three patent application families pending, including multiple method of use patents. The expanding portfolio addresses certain combination therapies, including pelareorep in connection with immunotherapies and targeted therapies, reflecting the Company’s strategy to develop pelareorep across complementary cancer treatment approaches.

This quarter, the Company expects to convert one of these pending applications into a U.S. application submitted with a request for Track One prioritized examination. This application is directed to the use of pelareorep as a therapy that induces immunologic responses. The U.S. Patent and Trademark Office’s Track One program provides prioritized examination with a goal of reaching a final disposition within approximately 12 months after prioritized status is granted. The program can accelerate examination and provide earlier clarity on the scope of potential patent protection, supporting clinical development and partnering decisions. Prioritized examination does not guarantee patent allowance.

In parallel, Oncolytics is working with an academic partner on a modified form of pelareorep that the Company refers to as "next generation" pelareorep. The Company expects this work to support the addition of a new composition of matter patent to its portfolio, with the potential for up to 20 years of patent protection measured from the applicable filing date. The modified pelareorep is being developed with the expectation that it could provide enhanced efficacy, which will require confirmation through further studies.

"We are expanding our patent portfolio to protect how pelareorep is manufactured, how it is used to treat cancer, and the innovations that could define its next generation," said Jared Kelly, Chief Executive Officer of Oncolytics. "Our existing manufacturing protection through 2044 provides a strong foundation. The additional method of use patents and potential new composition of matter protection are intended to extend that foundation into the late 2040s and support the long-term development and commercial potential of pelareorep."

The Company expects the new method of use patents, once issued, to provide protection for their covered therapeutic applications into the late 2040s. The scope and duration of protection will depend on the claims ultimately granted, applicable filing dates and jurisdiction-specific patent rules. The anticipated composition of matter patent would provide a separate layer of protection for the modified pelareorep.

About Pelareorep
Pelareorep is an intravenously delivered, systemically active, investigational immunotherapy with a dual mechanism of action that selectively replicates in tumor cells while activating both innate and adaptive anti-tumor immune responses, including the upregulation of key inflammatory cytokines resulting in the formation of tertiary lymphoid structures and the expansion of tumor-infiltrating lymphocytes. It has been administered to over 1,200 patients, and clinical studies have demonstrated pelareorep’s potential to enhance the activity of checkpoint inhibitors and other anti-cancer therapies across multiple solid tumor types.

(Press release, Oncolytics Biotech, OCT 12, 2026, View Source [SID1234673326])

On October 12, 2026 Bristol Myers Squibb (NYSE: BMY) reported positive topline results from the planned interim analysis of the ACTION-1 trial (NCT05477576) conducted by RayzeBio, Inc., a Bristol Myers Squibb company. The study met the primary endpoint with a statistically significant and clinically meaningful improvement in progression-free survival by blinded independent central review, and safety results consistent with the known RYZ101 safety profile. ACTION-1 is a randomized Phase 3 clinical trial evaluating RYZ101 (225Ac-DOTATATE) versus investigator’s choice of standard of care (high-dose or high-frequency long-acting somatostatin analogues, everolimus, or sunitinib) in patients with somatostatin receptor-positive (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs) who have progressed following Lutetium-177 (Lu177)-based therapy.

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"The improvement in progression-free survival is a defining moment for RYZ101 and for the patients we built this program around — people with advanced GEP-NETs whose cancer has progressed after Lu177-based therapy and who have few remaining options," said Amreen Husain, MD, chief medical officer of RayzeBio. "This is the kind of impact we set out to deliver with actinium-based radiopharmaceuticals, and it is an important milestone supporting the pipeline we are building across our RPT platform. These are the first results from a Phase 3 trial of an alpha-isotope based targeted RPT (225Ac) in any indication, and we are moving with urgency to bring these data to the FDA and, ultimately, provide a novel option for patients."

The FDA granted RYZ101 Orphan Drug Designation for the treatment of GEP-NETs in August 2026 based on the significant unmet need facing patients with this disease. That designation, combined with the results of this interim analysis, supports RayzeBio’s continued development efforts and plans to engage with the FDA to discuss next steps toward a regulatory submission. Detailed results are expected to be presented at a future medical meeting.

"Lu177-based therapy is widely used in GEP-NETs, but unfortunately the vast majority of patients will eventually progress. Determining the optimal treatment after Lu177 has been an important question for my patients, and until now there has been no randomized Phase 3 evidence to guide it," said Simron Singh, MD, medical oncologist in the Odette Cancer Centre, Sunnybrook Health Sciences Centre, Professor of Medicine at the University of Toronto, and principal investigator of the ACTION-1 study. "ACTION-1 provides the first Phase 3 results for an alpha-based targeted RPT, and a clinically meaningful improvement in progression-free survival is a crucial development in improving the care of patients with GEP-NETs."

Individuals currently enrolled will continue to receive care consistent with the study protocol, and participants will be followed for overall survival.

About Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)
GEP-NETs are rare tumors, with an estimated incidence of approximately 18,000 patients diagnosed annually in the United States and a prevalence of fewer than 200,000 patients. Somatostatin receptor type 2 (SSTR2) is expressed in 80–90% of GEP-NET tumors, and metastatic disease is present at diagnosis in the vast majority of cases. Lu177-based radiopharmaceutical therapy has shown significant clinical benefit and is approved for adult patients with SSTR-positive GEP-NETs, but most patients invariably progress following treatment, with few effective treatment options available.

About RYZ101
RYZ101 is an investigational, targeted radiopharmaceutical therapy comprised of DOTATATE bound to Actinium-225 (225Ac), a highly potent alpha-emitting radioisotope.225Ac emits a high-energy, short-range alpha particle that can cause double-stranded DNA damage in cancer cells, potentially resulting in higher chance of cancer cell death. In a Phase 1b trial of 17 previously Lu177-treated patients with disease progression, RYZ101 was well tolerated, with no treatment-related serious adverse events or dose discontinuations due to any adverse event. RYZ101 is also being evaluated in earlier-stage trials in hormone receptor-positive (HR+) metastatic breast cancer.

(Press release, Bristol-Myers Squibb, OCT 12, 2026, View Source [SID1234673325])

On October 12, 2026 Abbott reported new real-world evidence showing that completion of multitarget stool DNA (mt-sDNA) screening was associated with approximately 54% lower colorectal cancer incidence and 45% lower odds of death following a colorectal cancer diagnosis. The findings are among 13 abstracts highlighting new colorectal cancer screening research being presented at the American College of Gastroenterology (ACG) 2026 Annual Scientific Meeting, taking place Oct. 9-14 in Nashville.

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New real-world evidence examines colorectal cancer incidence and mortality following Cologuard screening

Among the research presented at ACG are two large real-world studies that provide novel data regarding associations between completion of multitarget stool DNA (mt-sDNA) screening and important long-term colorectal cancer outcomes.

In a nationwide cohort of more than 2.5 million average-risk adults, researchers found that completing mt-sDNA screening was associated with an approximately 54% lower adjusted incidence rate of colorectal cancer compared with not completing the test. The association remained consistent across sensitivity analyses.

A separate population-based case-control study of 5,745 people diagnosed with colorectal cancer found that completing mt-sDNA screening within the five years before diagnosis was associated with 45% lower odds of death after diagnosis compared to those who did not complete an mt-sDNA test during that period. The association was observed across all racial and ethnic groups examined.

Together, the findings add to the growing body of real-world evidence examining longer-term outcomes associated with mt-sDNA screening, which has been used to screen for colorectal cancer more than 23 million times since the Cologuard test launched in 2014.1

"In order to achieve real public health benefits, colorectal cancer screening tests must demonstrate both high accuracy and adherence," said Paul Limburg, M.D., chief medical officer for screening, Abbott Cancer Diagnostics. "The research being presented at ACG helps us better understand what happens beyond the performance of an individual test — including whether people remain up to date with screening and how different strategies may ultimately affect colorectal cancer incidence and mortality. These insights can help us continue improving the screening experience and reach more people with the highest performing option that works for them."

Additional research emphasizes the value of mt-sDNA screening

The total research presence includes two oral presentations and 11 poster presentations spanning real-world clinical outcomes, sustained screening adherence, comparative effectiveness, test performance, health economics and patient costs. The findings add to the evidence supporting multitarget stool DNA (mt-sDNA) screening with Cologuard and Cologuard Plus and provide new insights into how colorectal cancer screening strategies perform in real-world populations.

The abstracts at ACG are as follows:

Sunday, October 11, 2026, from 3:30 to 7:00 PM

Modeling the Serrated Pathway Alters Projected Benefits of Colorectal Cancer Screening Strategies
Bayesian Analysis of CRC Sensitivity and Specificity Point Estimates for Molecularly-Based Stool Screening Tests: Influence of Data Precision on Projected Outcomes
Estimated Budget, Resource Use, and Clinical Impact of Increased Proportional Use of Next-Generation Multi-Target Stool DNA Test for CRC Screening: A US Payer Perspective
Impact of FIT Performance Variability on Long-Term Colorectal Cancer Screening Outcomes: A CRC-AIM Microsimulation Analysis
Sustained Adherence to Stool-Based Colorectal Cancer Screening: mt-sDNA vs. FIT Using Proportion of Time Up to Date
Colorectal Cancer Screening with Multitarget Stool DNA Testing: Real-World Adherence and Follow-up Colonoscopy in a Large Urban Academic Health System
Association Between mt-sDNA Completion and Reduced Colorectal Cancer Incidence: A Real-World Cohort Study
Monday, October 12, 2026, from 10:30 AM to 4:15 PM

A Longitudinal Adherence Trajectory Model for Realistic Colorectal Cancer Screening Simulation
Association of Multitarget Stool DNA Screening Completion With Reduced Odds of Death After Colorectal Cancer Diagnosis
System-Level Drivers of Incomplete At-Home Colorectal Cancer Screening: Un-Processable mt-sDNA Kits in 2025
Tuesday, October 13, 2026, from 10:30 AM to 4:00 PM

Adherence to Colorectal Cancer Screening with Screening Colonoscopy with and without Intervention: A Systematic Review and Meta-Analysis
Tuesday, October 13, 2026, Plenary Session 2A, 8:30 to 8:50 AM

Performance Characteristics of Fecal Immunochemical Tests in Males and/or Females: Should the Threshold Vary? — Oral presentation
Impact of Federal Policy Change on Patient Out-of-Pocket Costs for Follow-up Colonoscopy After Positive Stool-Based Tests— Oral presentation
For more information about Abbott’s presence at ACG 2026, click here.

About the Cologuard Plus Test

Developed in collaboration with Mayo Clinic, the FDA-approved Cologuard Plus test is a noninvasive colorectal cancer (CRC) screening option for adults aged 45 or older who are at average risk for the disease. The use-at-home test detects novel DNA biomarkers and blood in stool associated with colorectal cancer and advanced precancerous lesions, requiring no special preparation or time off to take the test. Cologuard tests have been used to screen for colon cancer millions of times.

Featuring novel biomarkers, improved laboratory processes and enhanced sample stability, the Cologuard Plus test is FDA-approved for both colon cancer and advanced precancerous lesion detection. By relying exclusively on molecular data from the patient sample, it helps support accurate results and reflects Abbott’s commitment to expanding access to colorectal cancer screening.

(Press release, Abbott, OCT 12, 2026, View Source [SID1234673324])

On October 11, 2026 Freenome, Inc. (Nasdaq: FRNM), an early cancer detection company developing blood-based tests, reported the company will present late-breaking data on an updated version of its SimpleScreen CRC blood-based screening test at the American College of Gastroenterology (ACG) 2026 Annual Meeting in Nashville.

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Freenome conducted a pivotal clinical validation study to assess the performance of assay and algorithm improvements for the updated version of SimpleScreen CRC. The FDA approved the first-generation version of SimpleScreen CRC in July 2026, and the test was commercially launched in late September in the United States by Freenome’s partner Abbott Cancer Diagnostics.

The updated test demonstrated 18.2% sensitivity for detecting advanced precancerous lesions (APLs), a significant improvement compared to the 13.7% sensitivity in the original PREEMPT CRC study.1 Sensitivity for APLs with high-grade dysplasia (HGD) improved to 41.9% in the updated test, compared to 30.5% reported previously. The sensitivity results for APLs and APLs with HGD demonstrated in this study are the highest reported to date for any non-invasive screening blood test in a prospective registrational pivotal clinical study.

Sensitivity was also improved for all APL subtypes, including villous or tubulovillous; adenomas ≥ 10 mm; sessile serrated lesions/polyps ≥ 10 mm; and traditional serrated adenomas.

Overall, 80.4% sensitivity was demonstrated for detecting CRC. The results were adjusted to the age and sex distribution of the U.S. Census to better reflect the intended use population, and specificity for no findings on colonoscopy was 90%.

"These results suggest that our blood-based screening test may detect precancerous lesions with clinically meaningful sensitivity," said Aaron Elliott, Ph.D., CEO of Freenome. "The ability to continually improve performance through refinements to our assay and algorithm, as seen with these results, is a fundamental part of our up-versioning strategy. We believe this iterative methodology not only improves CRC APL performance but is also applicable across our multi-cancer pipeline. Combined with our personalized cancer detection approach, this is how we continue to expand blood-based screening into an accessible option for the millions of Americans who remain unscreened."

Aasma Shaukat, M.D., M.P.H., professor of medicine at NYU Grossman School of Medicine and a co-lead principal investigator on the PREEMPT CRC study, will present the detailed results.

Presentation title: Improved Sensitivity for Advanced Precancerous Lesions (APLs) Demonstrated in Clinical Validation of an Updated Colorectal Cancer (CRC) Screening Blood Test in an Average-Risk Population.

Date: Wednesday, Oct. 14
Time: 9:10-9:20 am
Session: Plenary Session 4B: Liver, Esophagus, CRC, IBD

(Press release, Freenome, OCT 11, 2026, View Source [SID1234673319])

On October 11, 2026 Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company," Stock Code: 9887.HK) reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its core product opamtistomig (LBL-024), a PD-L1/4-1BB bispecific antibody, for the first-line treatment of advanced or metastatic biliary tract cancer (BTC).

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This is the second FDA Fast Track Designation for opamtistomig, following its previous designation in extrapulmonary neuroendocrine carcinoma (EP-NEC). The BTC designation was granted just nine days after submission, reflecting the urgency of addressing unmet medical needs in this patient population and the potential clinical value of the program. The FDA has also recommended that the Company promptly initiate discussions regarding the U.S. registration plans for opamtistomig in combination with chemotherapy for BTC. These developments provide important regulatory momentum for the program and may help streamline its development and registration pathway in the United States.

FDA Fast Track Designation: Supporting Development in an Area of High Unmet Medical Need

Fast Track Designation is an FDA program designed to facilitate the development and expedite the review of drugs and biologics intended to treat serious or life-threatening conditions and to address unmet medical needs. The designation provides opportunities for more frequent communication with the FDA and guidance on key development considerations, including clinical trial design and data requirements. If applicable regulatory criteria are met, Fast Track-designated products may also qualify for rolling review of their marketing applications, allowing completed sections to be submitted for review before the entire application is finalized. These mechanisms can facilitate development planning and potentially expedite the regulatory review process. For opamtistomig, the designation represents an important step in advancing a differentiated immunotherapy approach for first-line advanced BTC, a disease characterized by poor prognosis and limited effective treatment options.

Opamtistomig: A Differentiated Approach to Immunologically Cold Tumors

Opamtistomig is a PD-L1/4-1BB bispecific antibody designed to conditionally activate 4-1BB-mediated T-cell stimulation in the tumor microenvironment. By combining PD-L1 blockade with localized immune costimulation, opamtistomig is designed to relieve tumor-associated immune suppression while enhancing antitumor T-cell activity. This differentiated mechanism may offer particular potential in immunologically cold tumors, where existing immunotherapies often provide limited benefit.

In the Company’s Phase I/IIa basket study of opamtistomig monotherapy, initiated in 2022, 175 patients with advanced solid tumors were enrolled. Preliminary clinical findings across several difficult-to-treat tumor types—including BTC, platinum-resistant ovarian cancer, PD-1-refractory advanced hepatocellular carcinoma (HCC), and previously treated EP-NEC—have shown encouraging signals of potential survival benefit. These findings that are expected to be published in an international journal support further investigation of opamtistomig as a potential treatment option for patients with high unmet medical needs.

First-Line BTC Program Advances Toward Further Clinical Development

Leads Biolabs’ first-line advanced BTC program has continued to progress. In April 2026, following encouraging safety and efficacy findings, the Phase II study of opamtistomig in combination with chemotherapy advanced into the expansion phase. The Company subsequently completed enrollment across the study, marking an important milestone in evaluating this combination regimen.

The FDA’s Fast Track Designation, together with the agency’s recommendation to initiate discussions on the U.S. registration strategy, provides further impetus for the program’s continued development. The Company plans to engage proactively with the FDA to align on the clinical evidence and development strategy needed to support potential registration.

Executive Commentary

Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, stated:

"The FDA’s decision to grant Fast Track Designation just nine days after submission is an encouraging milestone for opamtistomig and our first-line BTC program. We appreciate the FDA’s engagement and its recommendation to initiate discussions on the U.S. registration strategy for opamtistomig in combination with chemotherapy.

BTC represents a significant unmet medical need, and immunologically cold tumors remain a major challenge for cancer immunotherapy. Opamtistomig’s differentiated PD-L1/4-1BB mechanism is designed to address this challenge by combining immune checkpoint blockade with conditional T-cell costimulation. Across multiple difficult-to-treat tumor types, we have observed encouraging clinical signals that support further exploration of its potential. We will continue to advance our clinical programs with scientific rigor and executional focus, working closely with regulatory authorities to accelerate development and bring potentially meaningful new treatment options to patients worldwide."

About Biliary Tract Cancer

Biliary tract malignancies mainly include gallbladder cancer and intrahepatic/extrahepatic cholangiocarcinoma, with approximately 419,100 new cases globally in 2024. These malignancies are predominantly adenocarcinomas with high invasiveness, and most cases are diagnosed at advanced stages, leading to poor prognosis (5-year survival rate <5%). Currently, the global incidence of biliary tract malignancies is rising, with the highest prevalence observed in Asian countries. Although PD-1/L1 inhibitors combined with chemotherapy have been approved as first-line treatment for advanced biliary tract malignancies, clinical benefits remain limited: the median overall survival improves only modestly (from ~11.5 to 12.8 months) and the objective response rate (ORR) remains below 30%. These gaps highlight a clear unmet medical need.

About Opamtistomig

Opamtistomig (LBL-024) is emerging as a next-generation pan-cancer backbone therapy with potential overall survival (OS) benefit that simultaneously targets PD-L1 and the co-stimulatory receptor 4-1BB. Currently, opamtistomig is being evaluated in 14 indications, including one pivotal single-arm registrational study, one confirmatory Phase III study, and nine proof-of-concept studies, covering major indications such as NSCLC and multiple cold tumors. To date, opamtistomig has demonstrated robust antitumor activity across seven tumor types—extrapulmonary neuroendocrine carcinoma (EP-NEC), non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), biliary tract cancer (BTC), hepatocellular carcinoma (HCC), esophageal squamous cell carcinoma (ESCC), and ovarian cancer (OC)—highlighting its clinical value and broad therapeutic promise.

Developed using Leads Biolabs’ proprietary X-body bispecific platform, opamtistomig is designed to simultaneously block PD-1/PD-L1 immune suppression and conditionally activate 4-1BB, an agonist pathway, resulting in a potent and synergistic anti-tumor immune response. It has a safety profile comparable to PD-1/PD-L1 inhibitors and demonstrates broader-spectrum anti-cancer potential. Mechanistically, 4-1BB agonism can reactivate exhausted T cells and promote robust T-cell proliferation, offering significant promise for PD-1/PD-L1–resistant or immunologically "cold" tumors and potentially offering durable survival benefits.

Recognizing its clinical potential, opamtistomig received Breakthrough Therapy Designation from China’s National Medical Products Administration (NMPA) in October 2024, and Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) in November 2024. Additionally, in January 2026, opamtistomig was granted Fast Track Designation by the FDA and ODD by the European Commission, and in September 2026, ODD from Japan’s Ministry of Health, Labour and Welfare (MHLW), further underscoring its potential to address unmet medical needs in this patient population. In July 2026, its New Drug Application (NDA) was granted priority review designation by the NMPA, followed by NDA acceptance in August 2026, positioning opamtistomig as a potential world’s first approved 4-1BB-targeting antibody, the first approved agonist antibody, and the first approved treatment for EP-NEC.

(Press release, Nanjing Leads Biolabs, OCT 11, 2026, View Source [SID1234673318])