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3B Pharmaceuticals and TetraKit Technologies Announce Strategic Collaboration for Joint Radioligand Therapy (RLT) Development

On April 10, 2025 3B Pharmaceuticals GmbH (3BP), a leader in the development of targeted radiopharmaceuticals, and TetraKit Technologies (TT), developing cuttingedge click chemistry radiolabeling technologies, reported a strategic collaboration in the targeted radiotherapy field (Press release, 3B Pharmaceuticals, APR 10, 2025, View Source [SID1234651866]). This partnership will leverage the unique strengths of both companies towards development of a drug candidate, which can be labeled with astatine-211, a highly promising alpha particle-emitting radionuclide to treat cancer patients.

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This collaboration has the potential to advance an emerging class of peptide radiopharmaceuticals labeled with astatine-211. "We are very excited to work with 3BP," said Andreas Jensen, CEO of TetraKit Technologies. "By combining our radiolabeling platform with the impressive drug discovery know-how and expertise of a highly reputable and established company such as 3BP, we are confident that we can advance the development of a ground-breaking novel drug that harnesses the promising properties of astatine-211 and sets the stage for further advances in the field."

Engine Biosciences and Experimental Drug Development Centre Partner to Advance Novel Therapies to Combat Cancer

On April 9, 2025 Engine Biosciences (Engine), a Singapore- and Silicon Valley-based biotechnology company pioneering precision medicine for cancer, reported a new partnership with the Experimental Drug Development Centre (EDDC), Singapore’s national platform for drug discovery and development hosted by the Agency for Science, Technology and Research (A*STAR) (Press release, Experimental Drug Development Centre, APR 9, 2025, View Source [SID1234654013]).

This first-of-its-kind collaboration unites Engine’s NetMAPPR platform and proprietary oncology intellectual property with EDDC’s drug discovery and development expertise to create first-in-class precision cancer treatments.

The first project under this partnership focuses on ENB-871, a novel pairing of a drug target and patient selection biomarkers discovered through Engine’s NetMAPPR platform. This platform combines AI, computation, biology, and chemistry to identify, validate, and prioritise drug targets with strong clinical and commercial potential, driving the development of new therapies that exploit specific vulnerabilities in tumours.

This programme shows significant promise for treating tumours with particular genetic mutations that predict sensitivity to the ENB-871 targeted therapy, including breast, liver, kidney and prostate cancers – diseases afflicting large and growing patient populations in Singapore and worldwide. In total, the potential addressable population exceeds 500,000 patients per year.

The teams will collaborate to develop small molecule degraders targeting ENB-871, including demonstration of in vivo efficacy. By bringing together Engine’s proprietary technology and deep translational insights with EDDC’s strengths in designing and developing therapies, this partnership aims to create targeted cancer treatments tailored to patients’ specific profiles, improving treatment effectiveness and outcomes. Engine and EDDC may also identify additional drug targets and research programmes for collaboration during the partnership.

"We’re excited by the synergies created by bringing together our two platforms, leveraging first-in-class Singapore research and innovation to advance transformative cancer therapies. This marks another key step in Engine’s mission to develop more effective, targeted and safer drugs for cancer patients." said Jeffrey Lu, CEO and Co-Founder of Engine Biosciences.

"The future of drug development lies in precision-driven innovation. Our partnership with Engine enables us to develop therapies tailored to specific patient populations through Engine’s biomarker-driven patient selection approaches. We are particularly excited to launch our first collaborative project around monovalent small molecule degraders, building on EDDC’s expanding capabilities in this field. Beyond this, we look forward to strengthening our partnership by advancing more precision therapies that have the potential to transform the lives of cancer patients in need," shared Damian O’Connell, CEO of EDDC.

OS Therapies Completes Acquisition of Advaxis Immunotherapies Clinical, Pre-clinical and IP Assets from Ayala Pharmaceuticals

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.

"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.

Solu Therapeutics Closes $41M Series A Financing and Announces First Patient Dosed in Phase 1 Clinical Trial of STX-0712 in Patients with CMML and Other Advanced Hematologic Malignancies

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.

"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.

Infinitopes Granted Phase I/IIa Clinical Trial Application Approval to Evaluate Precision Vaccine Targeting Early-Stage Oesophageal Cancer

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).

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)