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CEL-SCI to Launch FDA Registration-Enabling Phase 3 Confirmatory Study to Bring Multikine® to Market for Newly Diagnosed Head and Neck Cancer

On July 13, 2026 CEL-SCI Corporation (NYSE American: CVM) reported it is launching its global Confirmatory Registration Study of Multikine (Leukocyte Interleukin, Injection)* as a neoadjuvant treatment for newly diagnosed, previously untreated, resectable, locally advanced primary head and neck cancer.

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The global, multi-center study will enroll patients in the United States, Europe, Asia, and South America. Orient EuroPharma, CEL-SCI’s strategic partner in Taiwan, will oversee and fund patient enrollment within its territory. The study is highly optimized and designed with approximately 97% statistical power to detect a previously observed 0.34 hazard ratio based on overall survival (OS).

The Confirmatory Study will enroll approximately 212 patients presenting with newly diagnosed, previously untreated, resectable, locally advanced squamous cell carcinoma (head and neck cancer) whose tumors exhibit low or zero PD-L1 expression and who present with no clinical lymph node involvement at entry. This precise cohort represents the patient population that demonstrated the most profound clinical benefit in CEL-SCI’s completed 928-patient randomized controlled Phase 3 study. The patients in the confirmatory study will be required to possess the same disease characteristics as the patients who showed the excellent survival benefit in the completed Phase 3 study. By isolating this specific high-responder group of patients identified in the prior randomized controlled trial, the confirmatory study maintains robust statistical power while requiring a substantially smaller, more efficient patient enrollment target.

"Our Confirmatory Registration Study marks a definitive milestone toward establishing Multikine as the new immunotherapy standard of care for newly diagnosed head and neck cancer with low or zero levels of PD-L1," said Geert Kersten, CEO of CEL-SCI. "Enrollment will span premier clinical centers across the U.S., Europe, Asia, and South America, targeting the exact population where our previous Phase 3 trial demonstrated compelling, statistically significant improvements in overall survival, quality of life, and safety. Backed by approximately 97% statistical power to confirm this survival advantage, we believe this registration-enabling study provides an exceptional opportunity to validate our earlier Phase 3 results and bring this much-needed therapy to patients."

Clinical Rationale & Phase 3 Data Foundation

In the target cohort of CEL-SCI’s completed Phase 3 study, 114 patients who received a 3-week regimen of Multikine prior to receiving standard of care (SOC) experienced a significant reduction in the risk of death, achieving a 73% five-year overall survival rate compared to 45% for patients treated with SOC alone.

Furthermore, neoadjuvant administration of Multikine induced rapid, statistically significant pre-surgical tumor responses, including complete tumor responses confirmed by pathology, within 3 weeks of Multikine treatment. In the target population, the pre-surgical objective response rate was 13% in the Multikine arm versus 0% in the control arm. Pre-surgical downstaging was observed in 35% of Multikine-treated patients compared to 13% of controls.

Because these early, pre-surgical objective responses were demonstrated to be highly prognostic and appear to be predictive of long-term overall survival, CEL-SCI intends to utilize these early endpoints to support potential accelerated or conditional approval applications globally. Concurrently, overall survival follow-up will continue to be assessed in a blinded manner until the required event threshold is met.

About Head and Neck Cancer

Head and neck cancer remains one of the world’s most challenging oncology indications, with approximately 900,000 new diagnoses annually. Despite modern iterations of surgery and chemoradiation, long-term survival outcomes have stalled, highlighting a critical global need for non-toxic neoadjuvant immunotherapies that directly improve survival.

About Multikine

Multikine (Leukocyte Interleukin, Injection) is a novel, patented investigational cancer immunotherapy designed to be administered immediately following diagnosis, prior to surgery, radiation, or chemotherapy. By treating patients before any other treatment, while their immune systems are still intact, Multikine aims to stimulate a robust anti-tumor immune response before the immune system is compromised by conventional treatments. Multikine has been administered to over 740 patients across its clinical development program and has received Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for the neoadjuvant therapy of squamous cell carcinoma of the head and neck.

(Press release, Cel-Sci, JUL 13, 2026, View Source [SID1234669177])

Aethlon Medical Continues to Observe Directional Changes in Second Cohort of Australian Oncology Clinical Trial Evaluating Hemopurifier

On July 13, 2026 Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company developing products to treat cancer and life-threatening viral infections, reported that patients in the second cohort of its Australian oncology feasibility study demonstrated biological changes consistent with those previously observed in the first cohort following treatment with the investigational Hemopurifier. Replicating these findings in a second group of patients strengthens the scientific rationale for the Company’s ongoing clinical program and supports continued enrollment in the third and final cohort before an independent statistical analysis is conducted.

"We are encouraged to observe similar directional changes across multiple biomarkers in both the first and second patient cohorts," said James Frakes, Chief Executive Officer and Chief Financial Officer of Aethlon Medical. " Observing these directional changes in a second patient cohort builds upon our initial observations and provides additional data as we advance toward completion of the third cohort. While these are preliminary findings from an early feasibility study, they represent an important milestone as we advance toward completion of the third cohort and an independent statistical analysis to determine whether these observations represent a dose-response to Hemopurifier treatment."

The Australian feasibility study is evaluating the safety, feasibility and dosing of the Hemopurifier in patients with advanced solid tumors whose cancers have progressed despite treatment with anti-PD-1 immunotherapies.

The second cohort continued to show directional changes in several biomarkers that researchers believe are associated with tumor growth, immune suppression and response to immunotherapy, including:

Reductions in tumor-derived extracellular vesicles (EVs), platelet-derived EVs and PD-L1-positive EVs, with these changes appearing more consistently across all participants than in the first cohort and generally persisting through the eight-week follow-up period.
Reductions in two microRNAs that have been associated with tumor growth and cancer invasion.
Improvements in multiple immune-related laboratory ratios—including neutrophil-to-lymphocyte ratio (NLR), monocyte-to-lymphocyte ratio (MLR), Systemic Immune-Inflammation Index (SII), monocyte-to-albumin ratio (MAR) and Lymphocyte Albumin Index (LAI)—that have been associated in published research with improved responses to immunotherapy.
Increases in total T cells, CD4 and CD8 T-cell populations, and tumor-specific CD137-positive T cells in all three participants, with these changes generally persisting through the eight-week follow-up period.
Taken together, the first two cohorts have now shown similar directional changes across multiple biological markers following Hemopurifier treatment. Enrollment in the third cohort is underway, with the first participant having already completed three four-hour Hemopurifier treatments during a one-week period. After all three cohorts are complete, an independent statistician will analyze the combined data to determine whether these observations support a dose-response relationship.

EVs continue to be recognized as important drivers of cancer progression and resistance to checkpoint inhibitors such as Keytruda and Opdivo. The Hemopurifier is designed to remove these tumor-derived vesicles from the bloodstream, with the goal of reducing immune suppression and potentially enhancing the body’s ability to fight cancer.

"We believe the Hemopurifier has the ability to complement existing therapies rather than replace them and could be a platform technology with potential applications across multiple disease areas such as oncology, infectious diseases, and future emerging threats. We believe there exists a ‘pipeline within a single device,’" said Mr. Frakes.

Advancing a Novel Approach to Cancer Immunotherapy

Extracellular vesicles released by tumors continue to be recognized as important drivers of cancer progression, metastasis and resistance to immunotherapy. EVs expressing PD-L1 have been associated with resistance to checkpoint inhibitors, including Keytruda and Opdivo. The Hemopurifier is designed to remove tumor-derived EVs and other pathogenic particles from circulation, potentially reducing immunosuppressive signaling and improving the body’s anti-tumor immune response.

The Hemopurifier has received FDA Breakthrough Device Designation for the treatment of patients with advanced or metastatic cancer who are unresponsive or intolerant to standard-of-care therapy, as well as for the treatment of life-threatening viral infections not addressed by approved therapies.

Important Study Limitations

The Company cautions that these findings represent descriptive observations from raw data generated in an early-stage feasibility study. Formal statistical analyses have not yet been performed and will be conducted only after completion of all three study cohorts by an independent statistician.

The study was not designed to demonstrate clinical efficacy, and no conclusions can be drawn regarding the Hemopurifier’s impact on patient outcomes. Larger, adequately powered clinical trials designed with clinical efficacy endpoints will be required to determine whether the biological changes observed translate into meaningful clinical benefit.

(Press release, Aethlon Medical, JUL 13, 2026, View Source [SID1234669176])

Leads Biolabs Announces Multiple Studies Selected for ESMO 2026, Highlighting the Growing Global Competitiveness of Its Core Pipeline

On July 13, 2026 Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company," Stock Code: 9887.HK) reported that six of its latest research studies have been accepted for presentation at the 2026 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress. Among these, two have been selected as Proffered Papers—the congress’s highest-profile oral presentation format, while four will be presented as posters, covering multiple tumor types such as extrapulmonary neuroendocrine carcinoma (EP‑NEC), biliary tract cancer (BTC), and relapsed/refractory multiple myeloma (RRMM). In addition, the Company has been granted a Late‑Breaking Abstract (LBA) status and plans to submit the full LBA abstract in September.

The ESMO (Free ESMO Whitepaper) Annual Congress is one of the most influential scientific conferences in oncology. The 2026 congress will take place in Madrid, Spain, from October 23 to 27, 2026. Proffered Papers are reserved for studies considered to have the greatest clinical significance and scientific innovation, while LBA features the latest clinical findings with breakthrough potential and the ability to change clinical practice. The selection of multiple Leads Biolabs’ studies underscores the international academic community’s strong recognition of the Company’s clinical data and the value of its pipeline, further demonstrating its sustained innovation capabilities and expanding leadership in cancer immunotherapy. The full data from the selected studies will be released through the ESMO (Free ESMO Whitepaper) online abstract publication and during the congress.

Separately, the Company previously announced that Opamtistomig for first‑line non‑small cell lung cancer (1L NSCLC) has been selected for an oral presentation at the 2026 World Conference on Lung Cancer (WCLC), to be held in September 2026. The full abstract is scheduled to be published on the WCLC website on August 19.

Executive Commentary

Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, stated: "The acceptance of multiple studies at ESMO (Free ESMO Whitepaper) represents strong international recognition of Leads Biolabs’ innovative capabilities and clinical development achievements, and marks another important step in our journey toward becoming a leading global innovator in drug development. Opamtistomig continues to demonstrate encouraging depth of responses, favorable survival trends, and a well-tolerated safety profile across multiple tumor types, further reinforcing its strategic positioning as an IO 2.0 pan‑tumor backbone therapy. Meanwhile, LBL‑034 further validates the global competitiveness of our proprietary LeadsBody platform in the TCE field. Looking ahead, we remain committed to advancing global registrational clinical development and commercialization of our core assets, with the goal of bringing breakthrough therapies to more patients worldwide as quickly as possible."

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. Developed using Leads Biolabs’ proprietary X-Body bispecific platform, Opamtistomig is designed to simultaneously block PD-1/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. To date, Opamtistomig has demonstrated first- or best-in-class potential in Phase II or registrational clinical trials across four indications: non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), biliary tract cancer (BTC), and extrapulmonary neuroendocrine carcinoma (EP-NEC).

As the first 4-1BB–targeting bispecific antibody globally to advance to a single-arm pivotal trial as monotherapy, Opamtistomig has been evaluated in 13 solid tumor indications in China, including 1 pivotal registration trial and 8 proof-of-concept studies. These cover EP-NEC, NSCLC, SCLC, BTC, ovarian cancer (OC), esophageal squamous cell carcinoma (ESCC), hepatocellular carcinoma (HCC), gastric cancer (GC), triple-negative breast cancer (TNBC), malignant melanoma, and other areas with high unmet medical needs.

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. Recognizing its clinical potential, Opamtistomig received Breakthrough Therapy Designation (BTD) 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) for the treatment of neuroendocrine carcinoma in November 2024. Additionally, in January 2026, Opamtistomig was granted Fast Track Designation (FTD) by the FDA and ODD by the European Commission for the treatment of EP-NEC, further underscoring its potential to address unmet medical needs in this patient population.

About LBL-034

LBL-034 is a bispecific T-cell engager (TCE) that targets both GPRC5D and CD3, developed using the Company’s proprietary LeadsBody platform. Designed with a 2:1 binding format—two sites for GPRC5D and one for CD3—LBL-034 can selectively target GPRC5D+ cancer cells, conditionally activate T cells, reduce the risk of cytokine release, minimize the risk of systemic toxicity, and lower the risk of T cell exhaustion, thereby exerting anti-tumor effects in an efficient, low-toxic, and long-term stable manner.

LBL-034 has demonstrated promising efficacy signals in both preclinical and clinical studies. It is currently being evaluated in a Phase I/II clinical trial for RRMM and other malignant plasma cell neoplasms in China. Notably, breakthrough clinical data from LBL-034 monotherapy in RRMM were presented as the first oral presentation on the opening day of the ASH (Free ASH Whitepaper) 2025 Annual Meeting, highlighting its emerging clinical profile.

In October 2024, LBL-034 received Orphan Drug Designation from the U.S. FDA for the treatment of multiple myeloma. In January 2026, LBL-034 received Fast Track Designation from the U.S. FDA for the treatment of RRMM.

(Press release, Nanjing Leads Biolabs, JUL 13, 2026, View Source [SID1234669174])

Zelluna doses first solid tumour patient with ZI-MA4-1 in the ZIMA-101 Phase 1 trial

On July 13, 2026 Zelluna ASA (OSE: ZLNA), a company pioneering allogeneic "off-the-shelf" T Cell Receptor-based Natural Killer (TCR-NK) cell therapies for the treatment of solid cancers, reported that the first patient has been given the first dose in ZIMA-101, the Company’s first-in-human Phase 1 clinical trial evaluating ZI-MA4-1, Zelluna’s lead TCR-NK product candidate.

The first patient was treated at The Christie NHS Foundation Trust in the United Kingdom, the largest single site cancer centre in Europe and the lead clinical site for the study where Professor Fiona Thistlethwaite serves as Chief Investigator for the study.

ZIMA-101 is evaluating ZI-MA4-1, the world’s first MAGE-A4-targeting TCR-NK cell therapy to enter clinical development, in patients with advanced MAGE-A4-positive solid tumours. MAGE-A4 is present in several common cancer types, including ovarian cancer, squamous non-small cell lung cancer, synovial sarcoma and head and neck cancer, making it an attractive target for precision cell therapy.

ZIMA-101 also represents the first clinical evaluation of Zelluna’s proprietary TCR-NK platform and builds on years of scientific innovation, preclinical research and manufacturing development. The study is now active at two clinical sites in the United Kingdom: The Christie and The Royal Marsden NHS Foundation Trusts.

"This is a defining milestone for Zelluna and marks the beginning of the clinical evaluation of our proprietary TCR-NK platform," said Namir Hassan, Chief Executive Officer of Zelluna. "Dosing the first patient in ZIMA-101 is the culmination of years of scientific innovation, preclinical research and manufacturing development, and represents the transition from laboratory science to treating patients for the first time with our novel TCR-NK therapy. We are deeply grateful to the investigators and the clinical teams for making this milestone possible. We now look forward to advancing the study, generating the first clinical data from our proprietary TCR-NK platform and, ultimately, improving outcomes for patients with advanced solid tumours."

Professor Fiona Thistlethwaite, Consultant Medical Oncologist at The Christie and honorary professor at The University of Manchester and Chief Investigator for the study said: "Dosing the first patient represents an exciting moment for everyone who has worked collaboratively to bring this brand-new class of cellular therapy to the clinic. In the coming weeks and months, we will be monitoring the patient’s progress closely and gathering important data from this very innovative first-in-human early-phase trial, which will inform the next stages of patient recruitment. We are extremely grateful to the patient for agreeing to participate in this important research."

Patient identification, pre-screening and screening activities continue across all four tumour indications included in the ZIMA-101 study. Zelluna expects initial clinical data from the ZIMA-101 study to emerge from mid-2026.

About ZIMA-101

ZIMA-101 is a first-in-human, multicentre Phase 1 dose-escalation study evaluating the safety, tolerability and preliminary anti-tumour activity of ZI-MA4-1 in patients with advanced MAGE-A4-positive solid tumours. The study is being conducted at The Christie and The Royal Marsden NHS Foundation Trusts in the United Kingdom.

The study follows a dose escalation design (3+3) with three predefined dose levels and three patients per dose level. Each patient will receive three doses on Days 1, 4 and 8 of a treatment cycle. For the first patient at each dose level, an Independent Data Monitoring Committee will review the patient’s data following completion of the initial safety observation period before providing recommendations on enrolment of the remaining two patients at that dose level.

About ZI-MA4-1

ZI-MA4-1 is Zelluna’s lead allogeneic (off the shelf) TCR-NK product candidate and the world’s first MAGE-A4-targeting TCR-NK cell therapy in clinical development. The product combines the innate tumour-killing properties of NK cells with precision tumour targeting enabled by affinity engineered T cell receptors (TCRs), with the goal of addressing key limitations of existing cell therapies in solid tumours, including scalability, tumour targeting and access.

(Press release, Zelluna Immunotherapy, JUL 13, 2026, View Source [SID1234669173])

Oncolytics Biotech® Reports FDA Regulatory Milestone and Strong Clinical Progress in Randomized RAS-Mutant MSS Colorectal Cancer Trial

On July 13, 2026 Oncolytics Biotech Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage company developing pelareorep, an investigational, systemically active immunotherapy that promotes potentially protective immune responses, including the upregulation of key inflammatory cytokines resulting in the formation of tertiary lymphoid structures and the expansion of tumor-infiltrating lymphocytes, reported a clinical and regulatory update on REO 033, the Company’s randomized controlled study evaluating pelareorep in combination with folinic acid, fluorouracil and irinotecan ("FOLFIRI") and bevacizumab for the second-line treatment of patients with Rat Sarcoma ("RAS")-mutant, microsatellite stable ("MSS") metastatic colorectal cancer.

REO 033 builds upon the previously reported REO 022 study, which more than doubled historical standard-of-care benchmarks across progression-free survival, overall survival, duration of response, and objective response rate.1-4 Based on these data, pelareorep has received Fast Track designation from the U.S. Food and Drug Administration ("FDA") for this indication. The multi-part randomized REO 033 study is designed to prospectively validate these encouraging findings against a contemporary control arm while advancing pelareorep toward a potential registration pathway. The Company continues to make rapid operational progress in Part A of REO 033 (n=60 patients), with approximately half of the planned clinical sites activated by the end of July, and more than 20 patients have been pre-identified across participating centers. The remaining sites are expected to be activated by the end of August, positioning the study for accelerated enrollment during the second half of 2026. Most recently, global lead principal investigator Dr. Sanjay Goel and his team opened enrollment at Rutgers Cancer Institute of New Jersey.

"The magnitude and durability of the efficacy observed in REO 022 warrant earnest evaluation in a randomized setting," said Dr. Sanjay Goel, Global Lead Principal Investigator for REO 033 and Professor of Medicine and Director of the Phase I Program at Rutgers Cancer Institute of New Jersey. "It is encouraging to see REO 033 expanding rapidly across leading academic centers, and I believe this study has the potential to further define the role of pelareorep in RAS-mutant MSS metastatic colorectal cancer."

The Company also announced that it will hold a Type D meeting with the FDA in the first half of August 2026 to discuss the registrational design for REO 033 through the addition of Part B of the study. Building on the currently enrolling Part A of the study, this new registration-directed Part B would preserve the core design elements of REO 033 while increasing enrollment and incorporating blinded independent central review to support both a potential accelerated approval and a traditional full approval within the same study. The Company intends to align with the FDA on a registrational pathway that preserves the operational efficiencies already established through REO 033 while maintaining continuity with the existing clinical program under a prospectively agreed regulatory framework.

"Launching a global randomized study with multiple high-quality sites in a short period of time reflects the operational capabilities of our clinical organization and our investigators," said Jared Kelly, Chief Executive Officer of Oncolytics. "Just as importantly, our ongoing interactions with the FDA have enabled us to focus on efficiently transitioning REO 033 into a registration-directed program built upon the existing trial infrastructure. We believe this strategy has the potential to significantly reduce development timelines while maintaining scientific rigor as we work to bring a much-needed immunotherapeutic option to patients in a treatment landscape that desperately needs innovation."

The Company believes this approach provides the opportunity to generate early randomized efficacy data from Part A while simultaneously positioning Part B as a potential registrational study without the need to initiate a separate registrational trial. It also expects to report an initial tumor response update from patients enrolled in Part A by year-end 2026 and, subject to FDA feedback, initiate enrollment in Part B of the study during the first quarter of 2027.

About REO 033
REO 033 is a multi-part randomized controlled clinical trial evaluating pelareorep in combination with FOLFIRI and bevacizumab versus FOLFIRI and bevacizumab alone in patients with second-line RAS-mutant, microsatellite stable metastatic colorectal cancer (link to study on ClinicalTrials.gov). The study is designed to confirm the encouraging efficacy signals observed in REO 022 while generating the controlled clinical data necessary to support future regulatory interactions and potential registration.

(Press release, Oncolytics Biotech, JUL 13, 2026, View Source [SID1234669170])