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OSE Immunotherapeutics Announces Presentation of Combi-TED Phase 2 Topline Results of Tedopi® in Non-Small Cell Lung Cancer at the ESMO 2026 Meeting

On September 23, 2026 OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), a clinical-stage biotech company dedicated to developing first-in-class therapies in immuno-oncology and immuno-inflammation, reported that topline results from the Combi-TED Phase 2 international clinical trial of Tedopi in metastatic Non-Small Cell Lung Cancer sponsored by FoRT have been selected for an oral presentation at the 2026 Annual Meeting of the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) in Madrid, Spain (October 23-27, 2026).

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Federico Cappuzzo, MD, PhD, Director of Medical Oncology at the National Cancer Institute Regina Elena (Rome, Italy) and Lead Investigator of the trial, will present topline results from the Combi-TED trial evaluating Tedopi in second-line treatment in combination with anti-PD1 or chemotherapy in patients with metastatic Non-Small Cell Lung Cancer (NSCLC).

"Results of a multicenter, phase II, open-label, randomized trial evaluating OSE2101 plus docetaxel or OSE2101 plus nivolumab as second-line therapy in metastatic non-small-cell lung cancer (NSCLC) progressing after first-line chemo-immunotherapy"

Rapid Oral Presentation
Session: Non-Small Cell Lung Cancer, Metastatic
Abstract 2661RO
Room: Barcelona Auditorium, Hall 9
October 25, 2026, 8:30-10:00am CET
Combi-TED is an open label, randomized, three-arm Phase 2 study evaluating Tedopi in combination with the anti-PD1 immune checkpoint inhibitor Opdivo (nivolumab), with docetaxel or docetaxel alone (reference arm) as second-line treatment in 105 HLA-A2 positive patients with metastatic NSCLC and no evidence of EGFR mutations or ALK or ROS1 rearrangement, after first-line chemo-immunotherapy. The primary endpoint is 1-year survival rate. The trial is conducted in 23 sites in France, Italy and Spain.
(NCT04884282).

(Press release, OSE Immunotherapeutics, SEP 23, 2026, View Source [SID1234671012])

Marker Therapeutics Highlights Expanded Manufacturing Support of CDMO Partner Following Formation of Kincellis Advanced Therapies

On September 22, 2026 Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company developing multi-antigen recognizing (MAR)-T cell therapies for the treatment of hematologic malignancies and solid tumors, reported the expanded infrastructure, technical expertise and manufacturing capabilities supporting its lead program, MT-601 (neldaleucel), following the combination of Cellipont Bioservices and Kincell Bio to form Kincellis Advanced Therapies.

Marker previously selected Cellipont Bioservices as its manufacturing partner for MT-601 (neldaleucel) to support the continued clinical development and prepare for potential pivotal-stage and commercial manufacturing requirements.

Kincellis was formed through the combination of Cellipont Bioservices and Kincell Bio, creating a U.S.-based contract development and manufacturing organization (CDMO) focused on cell therapies and other advanced modalities. Announced on September 17, 2026, the combination created a larger advanced-therapies CDMO with approximately 140,000 square feet of development and manufacturing infrastructure and 16 operational, qualified GMP manufacturing suites across three U.S. locations. The combined organization also brings together broader scientific and technical expertise, an expanded manufacturing network and additional financial resources to support programs from clinical development through commercial supply.

Marker believes these expanded capabilities further strengthen and de-risk the manufacturing foundation for MT-601 as the program advances toward later-stage clinical development.

"We congratulate the Cellipont and Kincell teams on the formation of Kincellis Advanced Therapies," said Juan Vera, MD, President and Chief Executive Officer of Marker Therapeutics. "The combination creates a stronger manufacturing partner, and we look forward to continuing our work with the team as MT-601 advances into its next stage of clinical development."

MT-601 (neldaleucel) is currently investigated in the Company’s Phase 1 APOLLO study (clinicaltrials.gov identifier: NCT05798897) in patients with lymphoma who have relapsed after anti-CD19 chimeric antigen receptor (CAR)-T cells or are not candidates for anti-CD19 CAR-T cell therapies. Marker previously reported a favorable safety profile and encouraging clinical activity from the dose-escalation portion of the study demonstrating a 66% objective response rate among 12 patients with Non-Hodgkin Lymphoma (NHL), with 50% achieving complete remission (Press Release, August 26, 2025).

"Establishing a robust and scalable manufacturing platform is an important component of advancing MT-601 through late-stage clinical development," Dr. Vera continued. "Kincellis’ expanded U.S. footprint, advanced cell therapy expertise and capabilities spanning clinical development through potential commercial supply align well with our long-term strategy and the evolving manufacturing needs of the MT-601 program."

"We are proud to continue supporting Marker and the advancement of MT-601," said Darren Head, Chief Executive Officer of Kincellis Advanced Therapies. "Marker will continue to work with the team that understands its program, now supported by the broader expertise, resources and manufacturing network of Kincellis. This combination allows us to provide continuity today while preparing to support Marker’s evolving needs as the program advances."

About Neldaleucel (MT-601)
The Company’s lead product, MT-601, is a multi-antigen recognizing (MAR) T cell product that utilizes a non-genetically modified approach that specifically targets six different tumor antigens upregulated in lymphoma cells (Survivin, PRAME, WT-1, NY-ESO-1, SSX-2, MAGEA-4). Marker is currently investigating MT-601 in the Company-sponsored Phase 1 APOLLO trial (clinicaltrials.gov identifier: NCT05798897) for the treatment of patients with lymphoma who have relapsed after or are not candidates for anti-CD19 CAR-T cell therapies.

About APOLLO
The APOLLO trial (clinicaltrials.gov Identifier: NCT05798897) is a Phase 1, multicenter, open-label study designed to evaluate the safety and efficacy of neldaleucel (MT-601) in participants with relapsed or refractory lymphoma. The primary objective of the exploratory Phase 1 clinical trial is to evaluate the optimum dose, safety, and preliminary efficacy of neldaleucel in participants with various lymphoma subtypes. The APOLLO study is supported by the National Cancer Institute of the National Institutes of Health (Award Number R44CA291521) and the U.S. Department of War (formerly U.S. Department of Defense).

About MAR-T cells
The multi-antigen recognizing (MAR) T cell platform (formerly multiTAA-specific T cells) is a novel, non-genetically modified cell therapy approach that selectively expands tumor-specific T cells from a patient’s/donor’s blood capable of recognizing a broad range of tumor antigens. Unlike other T cell therapies, MAR-T cells allow the recognition of hundreds of different epitopes within up to six tumor-specific antigens, thereby reducing the possibility of tumor escape. Since MAR-T cells are not genetically engineered, Marker believes that its product candidates will be easier and less expensive to manufacture, with an improved safety profile compared to current engineered T cell approaches and may provide patients with meaningful clinical benefits.

(Press release, Marker Therapeutics, SEP 22, 2026, View Source [SID1234671019])

NeOnc’s Delivery may Finally Change the Equation for Brain Cancer’s Next Frontier

On September 22, 2026 NeOnc Technologies Holdings (NASDAQ: NTHI) reported that it is becoming a prominent player, as brain cancer research is entering an increasingly sophisticated era.

However, one of the field’s biggest problems remains stubbornly simple: getting effective therapy to the tumor while protecting the brain from additional damage. A July 2026 review in Science Translational Medicine described glioblastoma as remaining one of the most aggressive adult brain cancers, with survival still largely unchanged despite advances in molecular diagnostics and supportive care. At the same time, researchers are pursuing an expanding menu of approaches; targeted therapies, immunotherapy, tumor-treating fields, focused delivery technologies and molecularly selected treatments.

One of the most important developments has been the increasing use of molecular biomarkers to divide brain tumors into more precisely defined diseases. The FDA’s recent brain-tumor approvals illustrate the trend: therapies are increasingly being developed around specific molecular alterations rather than treating every tumor as biologically identical. Vorasidenib, for example, targets susceptible IDH1/IDH2-mutant tumors, while other recent approvals have focused on specific alterations in pediatric brain cancers.

That is where NeOnc enters the story with NEO100. Rather than attempting to solve the blood-brain barrier problem by forcing a conventional systemic drug through it, NEO100 uses an intranasal delivery approach designed to reach the central nervous system through the nasal/olfactory pathway. The company’s Phase 2a study specifically enrolled patients with recurrent or progressive Grade III and Grade IV glioma carrying an IDH1 mutation; a biomarker-defined population where the company is attempting to establish a targeted development path.

The August 2026 Phase 2a readout gives investors and researchers a reason to pay attention, while also demanding caution. NeOnc reported six-month progression-free survival of 48.9% versus a prespecified 20% benchmark, with a reported p-value of 0.0047. Median overall survival was 26.09 months, and five of 24 patients remained on treatment at the data cutoff. The company also reported no major toxicities across the cohort, with adverse events predominantly low-grade.

The appropriate takeaway being that NEO100 generated a clinical signal worthy of further investigation.

The broader competitive landscape underscores both the opportunity and the challenge. The National Cancer Institute currently lists numerous active glioblastoma trials involving combinations of chemotherapy, radiation, immunotherapy, targeted agents, tumor-treating fields and other experimental approaches. Meanwhile, Novocure’s Phase 3 TRIDENT study did not meet its primary endpoint for overall survival when tumor-treating fields were initiated earlier, illustrating how difficult it remains to translate promising therapeutic concepts into statistically conclusive clinical benefits.

For NeOnc, the next major question is therefore whether the NEO100 signal can be reproduced in a larger, better-controlled study. The company says it plans to seek a Type B meeting with the FDA to discuss a potential registrational pathway for recurrent IDH1-mutant high-grade glioma. That regulatory discussion could help clarify what evidence would be required for the program’s next stage.

The bigger significance of NEO100 may ultimately extend beyond a single drug. If intranasal delivery can demonstrate that therapeutically meaningful exposure to the brain can be achieved while maintaining tolerability, it could strengthen interest in the nose-to-brain delivery concept itself.

(Press release, Neonc, SEP 22, 2026, View Source [SID1234671018])

PDS Biotech Announces Publication of VERSATILE-002 Phase 2 Clinical Trial Results of PDS0101 with pembrolizumab in HPV16-Positive Recurrent and/or Metastatic (R/M) Head and Neck Cancer in JAMA Oncology

On September 22, 2026 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, reported the publication of results from a Phase 2 trial evaluating PDS0101, its HPV16-targeted immunotherapy, in combination with pembrolizumab in the September 17, 2026, issue of JAMA Oncology, a peer reviewed journal of the American Medical Association. The data were published in an article titled "VERSATILE-002 – A Phase 2 Study of PDS0101 HPV16-targeted T Cell Immunotherapy and Pembrolizumab Combination in HPV16-Positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma: A Nonrandomized Clinical Trial."

Key findings

62.3% of the ICI-naïve participants in the mITT cohort (n = 53) had low CPS of 1-19, and 37.7% had high CPS ≥ 20. In the overall CPS ≥ 1 population, the mOS was 39.3 months (95% CI, 23.9 to NE); The best published result with standard of care pembrolizumab or pembrolizumab + chemotherapy is 17.9 months 1.
Objective response rate (ORR) for CPS ≥ 1 was 36% of which 5/53 were complete responders by investigator review and 34% of which 6/53 were complete responders by central review.
The published ORR for the overall population with CPS ≥ 1 when treated with standard of care pembrolizumab is 19%2.
The treatment was well-tolerated with 13.8% Grade ≥3 treatment-related adverse events (TRAEs), 1 Grade 4 event one year after PDS0101 therapy, and no Grade 5 TRAEs.
The published safety profile for the overall population with CPS ≥ 1 when treated with standard of care pembrolizumab reports 17% Grade ≥ 3 TRAEs2.

VERSATILE-002 was an open-label, non-randomized phase 2 trial performed at twenty-six oncology centers across the US, UK and Ireland. Eighty-eight patients with histologically confirmed R/M HPV16-positive diseases were enrolled in the study; 87 received treatment and comprised the safety population; 75 were in the modified Intention-to-Treat (mITT) population used for efficacy analyses: 53 ICI-naïve with PD-L1 CPS ≥1, 22 ICI-resistant (Mean age = 64.5 years, 94.7% male, 92.0% White).

The trial was led by Dr. Jared Weiss, MD, of the Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, and was performed to determine the efficacy and safety of PDS0101, in combination with pembrolizumab in participants with HPV16-positive recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC), with separate evaluation of immune checkpoint inhibitor (ICI)-naïve and -resistant cohorts.

"We’re very pleased with the publication of the Phase 2 clinical results of the VERSATILE-002 clinical trial in a leading peer reviewed oncology journal," said Dr. Kirk Shepard, M.D., Chief Medical Officer of PDS Biotech. "These results support the durable clinical effect of PDS0101, consistent with promising survival outcomes reported in two other recently published studies, the IMMUNOCERV study, and the NCI-led study in HPV16-positive recurrent and/or metastatic cancers. We believe PDS0101 has the potential to bring new hope to the rapidly growing population of HPV16-positive head and neck cancer patients."

The Company recently announced the initial closing of a PIPE financing of up to $22.3 million led by Nant Capital, alongside an agreement granting NantWorks, LLC, an affiliate of Nant Capital, a one-year exclusive right to negotiate an exclusive license to PDS0101.

(Press release, PDS Biotechnology, SEP 22, 2026, View Source [SID1234671017])

Envisagenics and Boehringer Ingelheim Enter Multi-Target Collaboration to Develop First-in-Class Precision Therapies Based on RNA Splicing-Derived Targets for Hard-to-Treat Cancers

On September 22, 2026 Envisagenics reported a multi-year research collaboration and option agreement with Boehringer Ingelheim to validate selected tumor-specific targets for the development of first-in-class precision therapies for people living with solid tumors. Envisagenics has pioneered an artificial intelligence (AI)-powered approach that is transforming alternative RNA splicing into a new frontier for drug discovery.

Despite significant advances in cancer treatment, progress has not reached all patients equally. Many people with aggressive solid tumors still have few effective treatment options, in part because there are not enough targets that clearly distinguish cancer cells from healthy tissue. Identifying highly tumor-specific targets could create new opportunities to develop precision therapies that recognize and attack cancer cells through different mechanisms while limiting effects on healthy tissue. This could open new treatment options for cancer.

"We’re proud to partner with Boehringer Ingelheim, a recognized leader in oncology with deep expertise in advancing first-in-class precision therapies," said Maria Luisa Pineda, Ph.D., Chief Executive Officer and Co-Founder of Envisagenics. "This collaboration validates our vision that alternative RNA splicing represents one of the richest untapped sources of novel disease-specific therapeutic targets across human disease. By combining our AI-powered SpliceCore platform with Boehringer’s oncology expertise, we can accelerate the development of highly differentiated new medicines for patients."

The agreement supports Boehringer Ingelheim’s oncology strategy of pairing bold modalities with novel, highly tumor-selective targets sourced through long-term partnerships. The collaboration builds on targets previously identified through Envisagenics’ proprietary SpliceCore platform and will further validate their therapeutic potential across multiple therapeutic modalities, including antibody-drug conjugates (ADCs), T-cell engagers (TcEs) and multispecific antibodies. Upon successful completion of the research program, Boehringer Ingelheim will have the option to exclusively license selected targets for further development and commercialization.

"Growing innovation together with partners is central to how we build our oncology pipeline," said Mark Petronczki, Global Head of Oncology Research at Boehringer Ingelheim. "Alternative RNA splicing offers access to a largely unexplored target space, and Envisagenics has built a distinctive capability to investigate it. Through this collaboration, we hope to identify highly tumor-selective targets for the development of new cancer therapies to address the needs of patients who are still waiting for better treatment options."

Alternative RNA splicing is a fundamental biological process that expands proteomic diversity and is frequently dysregulated across human cancers. This generates tumor-specific protein isoforms – a rich source of disease-specific therapeutic targets that remain inaccessible to conventional, gene-centric discovery approaches.

Envisagenics’ proprietary SpliceCore platform combines artificial intelligence, large-scale transcriptomics and experimental validation to identify and prioritize these targets systematically – screening more than 14 million distinct splicing events to predict disease specificity, patient prevalence and therapeutic suitability.

(Press release, Envisagenics, SEP 22, 2026, https://www.globenewswire.com/news-release/2026/09/22/3366249/0/en/envisagenics-and-boehringer-ingelheim-enter-multi-target-collaboration-to-develop-first-in-class-precision-therapies-based-on-rna-splicing-derived-targets-for-hard-to-treat-cancers.html [SID1234671016])