On October 6, 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 that the Company will host a virtual key opinion leader (KOL) event featuring Jonathan M. Hernandez, M.D, an Investigator with Surgical Oncology Program at the National Cancer Institute’s Center for Cancer Research. Dr. Hernandez will join company management to discuss clinical outcomes from the PDS0301 Phase 2 trials for the treatment of advanced liver-associated cancers, with a focus on the metastatic colorectal cancer (mCRC) cohort. The event will provide an overview of the PDS0301 trial in patients with second and third line unresectable microsatellite stable (MSS) or mismatch repair-proficient (pMMR) colorectal liver metastases. These MSS patients constitute the majority of mCRC, a population in which immunotherapy has been mostly ineffective.

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PDS0301 is an investigational IL-12 immunocytokine designed using an antibody that binds to necrotic DNA that is found within tumors. PDS0301 specifically targets and delivers the IL-12 into the tumor to promote T cell and natural killer (NK) cell infiltration into the tumor, as well as localized anti-tumor activation of both T cells and NK cells.

A live question and answer session will follow the formal presentations.

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Date:
Thursday, October 15, 2026
Time:
8:00 AM ET
Registration:
Click Here

Jonathan M. Hernandez, M.D., Investigator, Surgical Oncology Program, NCI/CCR

Dr. Hernandez graduated from medical school with honors from the University of Florida and completed general surgery training at the University of South Florida. During his residency, Dr. Hernandez spent two years at the Moffitt Cancer Center and Research Institute interrogating molecular diagnostics for liver metastases and miRNA-mediated mechanisms of metastatic spread. Following residency, Dr. Hernandez completed fellowship training in both surgical oncology and hepatopancreatobiliary surgery at Memorial Sloan Kettering Cancer Center. During his fellowships, Dr. Hernandez spent an additional two years in dedicated basic research studying metastatic colonization as a scholar in the Cell Biology Program of the Sloan Kettering Institute and as a visiting investigator in the Cell and Developmental Biology Department of Weill Medical College of Cornell University. The Hernandez lab studies hepatic metastases and has been the home to twenty surgical residents since its establishment at the NIH in 2016. Dr. Hernandez has authored over 175 peer-reviewed publications and has contributed book chapters in numerous authoritative surgical texts.

(Press release, PDS Biotechnology, OCT 6, 2026, View Source [SID1234673217])

On October 6, 2026 NUCLIDIUM AG, a clinical-stage radiopharmaceutical company, reported that the first patient has been successfully imaged in a Phase 2 clinical trial evaluating the diagnostic accuracy and safety of the Company’s 61Cu-NU101 radiotracer in patients with metastatic prostate cancer. 61Cu-NU101 is a positron emission tomography (PET) imaging agent that effectively combines high-radiopure Copper-61 with a targeting peptide to specifically bind to Prostate-Specific Membrane Antigen (PSMA), an established biomarker for prostate cancer. 61Cu-NU101 is the diagnostic component of NUCLIDIUM’s NU101 theranostic program for metastatic prostate cancer, paired with the 67Cu-NU101 therapeutic.

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"PSMA-targeted PET is currently the best method of imaging metastatic prostate cancer, and we are always striving to do better. In a phase 1 trial, we showed that 61Cu-NU101 was safe and able to detect additional lesions in 50% of patients compared to the currently most sensitive imaging agents", said Dr. Gary Ulaner, MD, PhD, Chair of Molecular Imaging and Therapy at the Hoag Family Cancer Institute and Professor of Radiology at the University of Southern California. "These data supported the opening of our phase 2 trial, which is statistically powered to compare against currently available imaging agents and uses pathology as the reference standard of truth."

The investigator-initiated, non-randomized Phase 2 trial will enroll approximately 34 patients with biopsy-confirmed metastatic prostate cancer at clinical sites in the United States. Patients will receive a single intravenous dose of 61Cu-NU101, followed by PET/CT imaging at 1 and 4 hours post-dose. The primary endpoint will evaluate the sensitivity of tumor lesion detection of 61Cu-NU101 compared to an 18F-based, FDA-approved PSMA-targeting radiotracer. Secondary endpoints include a sensitivity comparison to CT and bone scans, and safety evaluation.

"The supportive Phase 1 diagnostic data and differentiated clinical profile reinforce our belief in the best-in-class potential of NU101 as a next-generation copper-based radiotheranostic for prostate cancer. Importantly, progress in our diagnostic program will inform and strengthen our therapeutic development strategy, enabling our true radiotheranostic approach of direct diagnosis to treatment conversion. The initiation of this Phase 2 trial represents an important step in executing our broad and robust development plan, with multiple clinical trials expected over the coming months and expansion into new cancer patient populations," said Thomas Reiner, PhD, CSO of NUCLIDIUM.

NUCLIDIUM’s 61Cu-NU101 program can be manufactured in 5 minutes at room-temperature, allowing for on-demand preparation and seamless integration into existing hospital infrastructure. These manufacturing advantages, coupled with the longer half-life, delayed imaging capability and beneficial tumor-to-background ratio, further underscore the benefits of this copper-based approach compared with alternative radioligands. Phase 1 data previously presented at the Society of Nuclear Medicine & Molecular Imaging (SNMMI) 2025 Annual Meeting highlight the favorable clinical profile of 61Cu-NU101.

(Press release, NUCLIDIUM, OCT 6, 2026, View Source [SID1234673216])

On October 6, 2026 Northwest Biotherapeutics (OTCQB:NWBO) (the "Company" or "NWBio"), a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, reported that Dr. Marnix Bosch, the Company’s Chief Technical Officer, will be making an invited keynote presentation entitled "Harnessing Immunity: A Personalised, Multi-Target Approach to Cancer" at the annual UK National Health Service (NHS) CancerCare Oncology Conference on Tuesday, October 6, at 11:30 a.m. UK time.

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The CancerCare Conference brings together NHS leaders and clinicians, cancer alliances and other healthcare professionals from across the UK to discuss developments in cancer care, innovation and emerging treatments.

Dr. Bosch will discuss the new era of cancer vaccines, the need for personalized treatments, the unique capabilities of dendritic cell (DC) based cancer vaccines such as DCVax, clinical trial results, potential combination treatments and related matters. The slide deck will be posted on the Northwest Biotherapeutics website after the NHS conference.

(Press release, Northwest Biotherapeutics, OCT 6, 2026, View Source [SID1234673215])

On October 6, 2026 Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company addressing drug resistance in cancer, reported positive interim efficacy data from its ongoing Phase 2 clinical trial evaluating ENV-105 (carotuximab) in combination with apalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC). The interim analysis demonstrated a statistically significant difference in progression-free survival (PFS) between all patients in the trial treated with ENV-105 plus apalutamide and those treated with apalutamide alone. Median PFS was 17.7 months with the combination compared with 2 months with apalutamide alone (P=0.0008).

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With the interim efficacy signal, Kairos Pharma has modified the Phase 2 protocol to enroll patients earlier in the course of disease progression. Rather than treating patients after one or two anti-androgen agents, the modified protocol will enroll patients who experience a PSA increase following upfront treatment with an androgen signaling inhibitor. Patients will be randomized to enzalutamide alone or enzalutamide in combination with ENV-105. The protocol modification is intended to expand the eligible patient population and facilitate enrollment, with Kairos Pharma targeting completion of the Phase 2 trial in or before the fourth quarter of 2027.

"These interim results provide an important clinical signal for ENV-105 and support our strategy of targeting the mechanisms underlying drug resistance," said Chief Executive Officer of Kairos Pharma, Dr. John Yu. "The protocol modification will allow more patients to be eligible for the potential benefits of ENV-105 treatment while evaluating the therapy earlier in disease progression."

The findings further support Kairos Pharma’s strategy of targeting mechanisms associated with cancer drug resistance. ENV-105 targets CD105, a protein identified as a key driver of resistance and disease relapse in response to standard therapy, providing the rationale for evaluating ENV-105 in combination with standard cancer therapies. The Phase 2 trial is designed to evaluate ENV-105, a first-in-class CD105 antibody, in men with metastatic prostate cancer resistant to standard hormone therapy, in combination with standard of care, apalutamide. Patients have been enrolled at Cedars-Sinai Medical Center, City of Hope and Huntsman Cancer Institute at the University of Utah.

(Press release, Kairos Pharma, OCT 6, 2026, View Source [SID1234673214])

On October 6, 2026 CatalYm reported that updated clinical results from its Phase 2 GDFATHER-NEO trial will be presented in a rapid oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026, taking place October 23-27, 2026, in Madrid, Spain.

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The oral presentation will feature updated findings from the Phase 2 GDFATHER-NEO trial (NCT06059547) and will include final pathological and radiological outcomes as well as event-free survival from the stratified, blinded trial evaluating visugromab versus placebo in combination with nivolumab as neoadjuvant treatment for patients with muscle-invasive bladder cancer (MIBC). These updated findings will provide further insights into the potential of GDF-15 inhibition in combination with immune checkpoint blockade.

In addition, two Trial in Progress presentations will provide an overview of the ongoing GDFATHER-NSCLC-02 (NCT07246863) and GDFATHER-HCC-01 (NCT07219459) Phase 2b trials, which are evaluating visugromab in second-line metastatic non-squamous non-small cell lung cancer (NSCLC) and hepatocellular carcinoma (HCC), respectively. Together, these studies reflect CatalYm’s continued advancement of visugromab across multiple solid tumor indications.

Presentation Details

Rapid Oral Presentation – GDFATHER-NEO

Abstract #9061

Title: Final pathological and radiological outcomes and initial EFS from a blinded, exploratory Phase 2 trial of nivolumab ± visugromab in MIBC (GDFATHER-NEO)

Session: Rapid oral 1: Genitourinary tumours, renal and urothelial
Presentation Date and Time: October 24, 2026; 10:15 – 11:45 am CEST
Presenter: Andrea Necchi
Location: Bilbao Auditorium – Hall 3

Trials in Progress Poster Presentation – GDFATHER-NSCLC-02

Abstract #4316

Title: Phase 2b randomized, blinded, placebo-controlled trial investigating the efficacy and safety of visugromab plus nivolumab with or without docetaxel in second line metastatic non-squamous NSCLC: GDFATHER-NSCLC-02

Presentation Date and Time: October 26, 2026; 12:00 – 12:45 pm CET
Presenter: Martin Reck
Presentation Number: 2725TiP

Trials in Progress e-Poster Presentation – GDFATHER-HCC-01

Abstract #7627

Title: Phase 2b randomized, blinded trial to investigate the efficacy and safety of visugromab in combination with nivolumab and lenvatinib in unresectable or metastatic hepatocellular carcinoma after failure of first-line treatment including an anti-PD-(L)1 compound: GDFATHER-HCC-01

Presenter: Richard S. Finn

Presentation Number: 1761eTiP

About Visugromab

Visugromab is a monoclonal antibody that neutralizes Growth Differentiation Factor-15 (GDF-15), a locally acting immunosuppressant produced by tumors which fosters immunotherapy resistance and drives cachexia in people with cancer. Neutralizing GDF-15 with visugromab reverses key cancer resistance mechanisms to reinstate an efficient anti-tumor response by re-enabling immune cell activation, proliferation, and induction of interferon-γ. In addition, visugromab also mitigates cancer cachexia, a severe condition affecting a significant number of advanced cancer patients by inhibiting the activation of the GFRAL pathway in the brainstem, a key driver of weight loss and appetite suppression in cancer patients.

(Press release, Catalym, OCT 6, 2026, View Source [SID1234673213])