On April 9, 2025 OS Therapies (NYSE-A: OSTX) ("OS Therapies" or "the Company"), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, reported that it has completed the acquisition of the listeria-based cancer immunotherapy assets of Advaxis Immunotherapies from Ayala Pharmaceuticals (Press release, OS Therapies, APR 9, 2025, View Source [SID1234651863]). The Company is now positioned as the world leader in listeria-based cancer immunotherapies, poised to become a new commercial category of immunotherapy in oncology upon approval of the Company’s lead asset OST-HER2 in the prevention of recurrence in fully-resected, lung metastatic osteosarcoma targeted for year-end 2025. New manufacturing-based intellectual property protects the listeria-based immunotherapy platform and cancer immunotherapy candidates into 2040.

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"We are thrilled to have now consolidated all of the intellectual property for the listeria cancer immunotherapy platform into OS Therapies, positioning us to fully expand it in the years ahead and improve the standard of care across cancer treatment in the years ahead," said Paul Romness, CEO of OS Therapies. "We now have late-stage, mid-stage and early-stage cancer immunotherapy candidates, a rich pipeline of preclinical cancer immunotherapy candidates and a long IP runway to in order to fully leverage this powerful cancer immunotherapy platform."

A video explaining how the listeria platform works is available here.

Clinical-stage Cancer Immunotherapy Programs Acquired

OST-AXAL (previously AXAL/ADXS/HPV) for Human Papilloma Virus (HPV) associated cancers completed 1st (AIM2CERV) of 2 Phase 3 trials;
OST-503 (previously ADXS-503) for Non-Small Cell Lung Cancer (NSCLC) & Glioblastoma reported positive Phase 2 data in NSCLC;
OST-PSA (previously ADXS-504/ADXS31142) for Prostate Cancer.
Pre-clinical Cancer Immunotherapy Programs Acquired

8 un-named OST-HOT Listeria constructs designed for off-the shelf treatment of common cancers with shared hotspot mutations and cancer-testes antigen targets.

"The listeria cancer immunotherapy platform holds tremendous potential to improve the outcomes for cancer patients worldwide" said Dr. Robert Petit, Chief Medical & Scientific Officer of OS Therapies. "Immune-checkpoint inhibitors have revolutionized cancer treatment in settings where tumor antigens have generated a sufficient T cell response. However, in many cancers these treatments don’t help because T cell responses against key tumor antigens have not developed. The OST Listeria platform specifically delivers relevant cancer targets directly to the immune system and generates new T cell responses that can be used to fight these cancers and help eliminate metastases. With OST-HER2 and the rest of the listeria platform, we have the potential to generate novel, more potent immune and targeted immune responses against solid tumors, metastatic disease and micro metastases from early-stage to late-stage cancers. I am thrilled to be able to guide the OST-HER2 asset through approval in osteosarcoma, and then fully explore that listeria platform’s potential to improve treatment outcomes for cancer patients."

The global cancer immunotherapy market size was valued at $126 billion in 2023 and is projected to surpass around $296 billion by 2033, according to Nova One Advisor.

On April 9, 2025 Solu Therapeutics, a biotechnology company pioneering therapies to eliminate disease-driving cells in cancer, immunology, and other therapeutic areas, reported the successful completion of a $41 million Series A financing that included participation from five new investors – Eli Lilly and Company, Biovision Ventures, Pappas Capital, Hengdian Group Capital (HgC), and The Leukemia & Lymphoma Society Therapy Acceleration Program – as well as continued support from existing Solu investors Longwood Fund, DCVC Bio, Santé Ventures, Astellas Venture Management, and Alexandria Venture Investments (Press release, Solu Therapeutics, APR 9, 2025, View Source [SID1234651862]). The company also announced initiation of treatment of the first patient in its first-in-human Phase 1 clinical trial evaluating STX-0712 in patients with resistant/refractory chronic myelomonocytic leukemia (CMML) and other hematologic malignancies.

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"In the short period since our initial seed funding, Solu Therapeutics has rapidly advanced to a clinical-stage company targeting areas of high unmet medical need for patients," said Philip J. Vickers, President and CEO at Solu Therapeutics. "With this Series A round we are grateful for the continued support from our existing investors and are excited to welcome several new investors who recognize the potential of our novel CyTAC (Cytotoxicity Targeting Chimera) and TicTAC (Therapeutic Index Control Targeting Chimera) platforms. These technologies have demonstrated an unprecedented ability to unlock high-value cell surface targets that are beyond the reach of traditional antibodies, making it possible to eliminate disease-driving cells with greater precision and efficacy."

Proceeds from the Series A financing will be used to complete dose escalation and expansion of the company’s lead CCR2-CyTAC program, STX-0712, for the treatment of CMML. Additionally, the funding will support the generation of new development candidates, including a novel, first-in-class mast cell depletor for immunological diseases, initiation of new discovery programs targeting pathogenic cells, further pipeline expansion, and exploration of new applications for the CyTAC and TicTAC platforms.

STX-0712 is designed to selectively eliminate CCR2-positive malignant monocytes in patients with advanced hematologic malignancies, with an initial focus on CMML. The Phase 1 trial of STX-0712 is an open-label, multicenter study designed in two parts. Part A will focus on dose escalation to determine the maximum tolerated dose and/or minimum effective dose, enrolling participants with resistant/refractory CMML. Part B will further evaluate safety, tolerability, recommended Phase 2 dose and preliminary antitumor activity of STX-0712.

"Our team is thrilled to initiate this first-in-human clinical trial of STX-0712, marking a significant step forward in our mission to develop innovative therapies for patients with high unmet medical needs," said Sergio Santillana MD, Chief Medical Officer. "By directly depleting the CCR2-positive malignant monocytes driving CMML, STX-0712 has the potential to offer a highly specific and targeted therapy for patients who currently have limited treatment options available. This trial represents an important milestone for Solu Therapeutics as we work to bring novel and potentially more effective targeted therapies to patients with CMML and other hematologic malignancies."

In December 2024, Solu Therapeutics presented preclinical data at the 2024 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting showing robust ex-vivo activity of STX-0712 against CCR2-positive monocytes in CMML patient samples. CMML is characterized by elevated monocyte counts and dysplastic bone marrow features with limited treatment options.

About STX-0712
STX-0712 is a CyTAC designed to target the G-Protein Coupled Receptor CCR2, a selective marker expressed at high levels on malignant monocytes that are key drivers of disease in CMML and other hematologic malignancies. By eliminating CCR2-positive cells, STX-0712 has the potential to offer a more targeted and effective treatment option with minimal effects on non-malignant cells.

On April 9, 2025 Infinitopes Ltd reported that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Clinical Trial Application (CTA) approval for the first-in-human Phase I/IIa clinical trial of ITOP1, the company’s lead ‘off-the-shelf’ cancer vaccine (Press release, Infinitopes, APR 9, 2025, View Source [SID1234651861]). ITOP1 is a precision cancer vaccine, designed to safely and accurately target tumour antigens, leveraging the company’s vector delivery system, aiming to drive strong and durable T-cell protection for patients with surgically resectable oesophageal adenocarcinoma (OAC).

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The vaccine is designed to stimulate a robust immune response, including activation of CD8+ cytotoxic T cells, to eliminate residual cancer cells expressing the target antigens, reducing the risk of disease recurrence. Tumour antigen targets for ITOP1, Infinitopes’ lead asset from its Precision Immunomics platform, are derived using the company’s bespoke AI/ML-driven immunopeptidomics approach and demonstrate high tumour-specificity and inter-patient conservation with potential clinical applicability across multiple cancer types.

The VISTA* study is a phase I/IIa double-blind, randomised, placebo-controlled trial to assess the safety, tolerability and anti-tumour activity of ITOP1 in reducing OAC recurrence rates. 60 patients will receive ITOP1 in a prime/boost regimen, in combination with the best standard of care, i.e., a priming dose following neoadjuvant and a boost dose before adjuvant FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel) chemotherapy. Infinitopes’ VISTA trial will be one of the first in the world to administer a cancer vaccine in the neoadjuvant setting while the primary tumour remains in situ, unlocking the potential for enhanced protection from epitope spreading.

The multicentre VISTA study will be conducted at specialist cancer centres in the UK under the leadership of Prof Mark Middleton, a world-renowned Chief Investigator. The VISTA* study is set to commence in Q2 2025. For further details, visit the UK Clinical Trials Registry for Integrated Research Application System (IRAS) project 1008088.

Prof Mark Middleton, Chief Investigator, Head of Oncology & Co-director, CRUK Oxford Centre, University of Oxford, and Scientific Advisory Board Member for Infinitopes, said: "Half of us will suffer cancer in our lifetimes, so we need better, affordable treatments for the disease. ITOP1 is an exciting new immunotherapy with the potential to make a difference across a wide range of cancers, bringing hope to many patients. This first trial in oesophageal cancer will evaluate ITOP1’s precision targeting, which enables anti-tumour immunity through epitope spreading to tackle residual cancer cells and prevent recurrence. We are particularly excited that, by working with the MHRA, we can test ITOP1 where we believe it will achieve the best protection, in potentially curable disease."

Dr Jonathan Kwok, Chief Executive Officer & Co-Founder at Infinitopes, commented: "We are delighted that we have advanced our lead vaccine candidate, ITOP1, from university research to a groundbreaking clinical programme in just over three years. This marks a major performance milestone for the company, bringing Infinitopes an important step closer to offering lifesaving solutions for patients with oesophageal and other aggressive cancers. This achievement is a testament to the power of our team, across immunopeptidomics, computational biology/AI/ML, immunology, oncology, advanced trial design, and our collaborations with Cancer Research UK and leading centres around the world."

Infinitopes recently strengthened its scientific and clinical team with the appointments of exceptional industry leaders, Dan Menichella and Jo Brewer, PhD, supporting the company’s ambition to advance ITOP1 through clinical development to prolong survival and improve the quality of life for patients.

Dan Menichella, Non-Executive Director at Infinitopes, noted: "Infinitopes’ Precision Immunomics approach has the potential to revolutionise cancer treatment as we know it today. I am very excited for the start of our VISTA study, to validate our ITOP1 vaccine and the fundamental enabling technologies."

*VISTA (Vaccination with ITOP1 in resectable oesophageal adenocarcinoma, to evaluate Safety, Tolerability & Anti-tumour activity)

On April 9, 2025 Diakonos Oncology, a clinical-stage biotechnology company developing innovative immunotherapies for difficult-to-treat cancers, reported the successful presentation of an abstract at the 2025 American Academy of Neurology (AAN) Annual Meeting, which took place April 5-9, 2025, in San Diego, California (Press release, Diakonos Oncology, APR 9, 2025, View Source [SID1234651860]). The abstract presentation, titled "Phase I Analysis of DOC1021, a Cell-Based Vaccination Platform for Adjuvant Therapy of Glioblastoma", featured promising data from an open-label Phase I trial evaluating the safety, immunogenicity, and early efficacy signals of DOC1021.

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"We were honored to present our latest research at the American Academy of Neurology Annual Meeting," said Jay Hartenbach, President and Chief Operating Officer of Diakonos Oncology. "Glioblastoma remains one of the most aggressive and challenging cancers to treat, and we are committed to advancing novel immunotherapy approaches that have the potential to make a meaningful impact for patients. The results of this Phase I analysis are highly encouraging and reinforce the potential of DOC1021 as a novel immunotherapy for glioblastoma."

Abstract Presentation Details:

Title: Phase I Analysis of DOC1021, a Cell-Based Vaccination Platform for Adjuvant Therapy of Glioblastoma
Authors: Zhu J-J, Esquenazi-Levy Y, Hsu S, Zvavanjanja RC, Vu M, Schumann EH, Trivedi A, Liu W, Namekar M, Hofferek CJ, Ernste K, Mossop C, Clay CM, Amin S, Ravi V, Kemnade JO, Aguilar LK, Turtz A, Tandon N, Konduri V, Georges JF, Decker WK
Session: S29 – Neuro-oncology
Date and Time: Tuesday, April 8, from 4:06-4:18 p.m. PT
Location: San Diego Convention Center, 25C
Key Highlights:

DOC1021 vaccines were administered to 16 newly diagnosed glioblastoma patients, with 94% (15/16) being MGMT unmethylated.
No adverse events greater than Grade 2 attributable to the investigational regimen and no dose-limiting toxicities (DLTs) were observed.
CD4+ (13/13) and CD8+ (11/13) central memory T-cell compartments expanded post-vaccination (p<0.002 and p<0.05, respectively), indicating robust immune activation.
CD8+CD127+ memory precursor effector cells (MPECs) expanded in 12/13 patients (p<0.001), suggesting enhanced immune memory potential.
Spatial transcriptomics analysis of three patients showed intense CD25+ foci overlapping effector memory T-cell and migratory microglial markers post-vaccination.
One-year overall survival (OS) rate in the 15/16 unmethylated cohort was 88%, compared to 53% in an age-matched control cohort (p<0.002), highlighting a potential survival benefit.
"In the Phase I trial, the dendritic vaccine injections at the lymph nodes were well tolerated, with no significant side effects observed in any participants," said Dr. Jay-Jiguang Zhu, Principal Investigator of the study and Professor and Director of Neuro-oncology at UTHealth Houston. "We are looking forward to assessing this dendritic cell-based vaccine therapy in the upcoming Phase II trial."

About DOC1021

DOC1021 is an autologous dendritic cell vaccine (DCV) that initiates a complete cytotoxic TH1 immune response against a patient’s cancer through the company’s proprietary double loading technology. The vaccines are made with a patient’s dendritic cells combined with mRNA and proteins prepared from freshly obtained patients’ tumor specimens.

This unique approach unlocks a synergistic tumor killing TH1 response driven by dual protein and RNA antigen sourcing, and it allows targeting of the complete cancer antigen pool. Moreover, the approach does not require any molecular modification of the patient’s immune cells for manufacturing, and does not require preconditioning of bone marrow or high dose IL-2 for administration.

In addition to the lead GBM study, a clinical trial of another Diakonos dendritic cell vaccine is ongoing for the treatment of pancreatic cancer. Diakonos has received Fast Track designations from the FDA for both the GBM and pancreatic cancer programs. The company has also received Orphan Drug Designation for the GBM program.

On April 9, 2025 TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (OTC: TCBPY) a clinical-stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, reported receipt of a patent, granted from the European Patent Office (EPO), for targeting microbial, oncological, and viral indications using modified gamma delta T cells (Press release, TC Biopharm, APR 9, 2025, View Source [SID1234651859]).

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The Company intends to proceed with the patent process in specific European countries, in alignment with the existing commercial strategy.

"The expanding patent portfolio secures our future development of high-value assets," said Bryan Kobel, CEO of TC BioPharm. "The potential for off-target recognition of healthy tissues limits the application of modified cell therapies. By refining the targeting of these modified cells, we can apply high-impact therapies to a broad spectrum of indications while mitigating the toxicity risks associated with modified cell therapies."