On February 26, 2025 Oncoinvent, a clinical-stage radiopharmaceutical company developing innovative treatments for solid cancers, reported the successful enrollment of the sixth patient into the safety lead-in cohort of its ongoing Phase 2 trial evaluating Radspherin for the treatment of peritoneal carcinomatosis from ovarian cancer (Press release, Oncoinvent, FEB 26, 2025, https://www.oncoinvent.com/press-release/oncoinvent-asa-reports-completed-inclusion-in-the-initial-safety-lead-in-cohort-of-the-phase-2-trial-of-radspherin-in-ovarian-cancer-patients/?utm_source=mailpoet&utm_medium=email&utm_source_platform=mailpoet [SID1234650649]).

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Radspherin is a novel alpha-radiation therapy designed for targeted, direct treatment of cancers that have spread to body cavities. The Phase 2 is a randomised, open label, multicentre trial (NCT06504147) assessing the efficacy and safety of Radspherin in patients with peritoneal metastases from ovarian cancer following complete surgical resection and pre-operative chemotherapy.

The initial safety lead-in is designed to evaluate the safety and tolerability of Radspherin at the recommended dose of 7 MBq in the trial population before expanding to enrollment in the randomized part of the trial.

"The completion of patient recruitment in the safety lead-in marks an important milestone in the advancement of our Phase 2 trial," said Oystein Soug, CEO of Oncoinvent. "We are encouraged by being able to recruit patients and ship Radspherin to centers in the US, UK, EU as well as Norway in this trial. We will now analyze the safety data, announce the findings during March and we subsequently expect to move ahead with full trial enrollment. This milestone further reinforces our commitment to developing Radspherin as a promising treatment option for patients with peritoneal carcinomatosis."

On February 26, 2025 Adcendo, a biotech company pioneering the development of first and best-in-class ADCs for cancers with a high unmet medical need, reported that the U.S. Food & Drug Administration (FDA) has provided clearance of the IND application for a Phase I study evaluating ADCE-T02 in patients with advanced solid tumors (Press release, ADCendo, FEB 26, 2025, View Source [SID1234650619]).

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Tiffany-01 is an ongoing first-in-human Phase I multicenter, open-label, dose escalation study of ADCET02 as a monotherapy in patients with advanced solid tumors. The primary objectives of the study are to determine the maximum tolerated dose and recommended Phase II dose and schedule of ADCET02 monotherapy in addition to assessing ADCE-T02 safety and tolerability. The secondary objectives are to characterize the pharmacokinetics and to evaluate the preliminary efficacy of ADCE-T02. The study is currently recruiting in Australia and will start recruiting in the U.S. in the next few months.

"Tissue factor (TF) is a validated ADC target with overexpression in many high unmet need solid tumor indications, however, the currently approved TF targeting ADC has severe limitations due to a suboptimal side effect profile and a limited therapeutic window. The highly differentiated profile of ADCE-T02, based on the use of an improved monoclonal antibody and a next generation Topoisomerase I inhibitor linker/payload technology, could overcome those limitations and offer an enhanced therapeutic window and improved side effect profile, which may lead to better clinical outcomes for patients," said Dr. Lone Ottesen, Chief Medical Officer of Adcendo. "The U.S. IND clearance of ADCE-T02 is an important milestone for our program and our company, and we look forward to initiating patient enrollment in the U.S. and working closely with all of our investigators to evaluate the therapeutic utility of this drug in multiple advanced solid tumor indications."

Prof. Vinod Ganju. Managing Director of Peninsula and Southeast Oncology (PASO), Melbourne, Australia and Principal Investigator of Tiffany-01, commented: "ADCs have in the past years shown highly encouraging results and have already become Standard of Care in quite a number of solid tumor indications. ADCE-T02 represents an attractive new option to explore in advanced solid tumors with high unmet need. I am pleased to be working with Adcendo to develop ADCE-T02, potentially offering a broader therapeutic window and a better safety profile for our patients."

About ADCE-T02

Tissue Factor is a clinically validated ADC target with strong overexpression in multiple tumor indications with high unmet medical need including Cervical Cancer, Head and Neck Cancer, Colorectal Cancer, Non-Small Cell Lung Cancer, and Pancreatic Ductal Adenocarcinoma. ADCE-T02 is a highly differentiated anti-TF ADC, and the first ADC with a Topoisomerase I inhibitor-based linker/payload, clinically developed in Australia and the U.S. Its unique antibody design minimizes the impact on the coagulation pathway, while the T1000-exatecan linker-payload technology platform has been shown to amplify the bystander effect, improve linker stability, and has the potential to overcome emerging resistance mechanisms. These differentiated features are expected to translate into a superior therapeutic window, a better safety profile, enhanced response rates and longer duration of response.

On February 26, 2025 Microbiotica, a clinical-stage biopharma company developing a pipeline of oral precision microbiome medicines called live biotherapeutic products (LBPs), reported that it has presented new data on the mechanism of action of MB097 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) AACR (Free AACR Whitepaper) IO meeting held in Los Angeles, February 23-26 (Press release, Microbiotica, FEB 26, 2025, View Source [SID1234650634]). MB097 is an LBP in development as an adjunct to immune-oncology treatments such as MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab).

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Dr Mat Robinson, Microbiotica’s Senior Vice-President of Research, presented data from new pre-clinical studies in a poster entitled "Clinical response to immune checkpoint inhibitors in melanoma is associated with distinct gut bacterial species that promote anti-tumor immunity by different mechanisms". The poster can be accessed here (View Source)

The bacteria comprising MB097 were found to be associated with response to immune-oncology treatments, such as KEYTRUDA (pembrolizumab), in multiple cohorts of melanoma patients. These new data demonstrate that the bacterial strains within MB097 can interact directly with dendritic cells to potently activate cytotoxic T lymphocytes (CTL). In addition, certain MB097 bacteria also produced metabolites that enhanced the tumor cell-killing potential of CTLs. One strain released metabolites that reversed the inhibitory effects of tumor-associated macrophages.

Mat Robinson, Microbiotica’s Senior VP of Research, said, "These data begin to identify the different mechanisms by which gut commensal bacteria drive immunotherapy response."

MB097 is being tested in an international Phase Ib clinical study, in combination with KEYTRUDA (pembrolizumab), MSD’s anti-PD-1 therapy, in patients with cutaneous melanoma who have failed to respond to immunotherapies. Data readout expected by the end of 2025.

On February 26, 2025 Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, reported results generated in a joint research collaboration, combining Compugen’s AI/ML powered predictive computational discovery platform, Unigen, with high throughput single cell sequencing on Ultima’s UG 100 to uncover new insights on gene structure for immuno-oncology (Press release, Compugen, FEB 26, 2025, View Source [SID1234650650]).

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"We are excited to collaborate with Ultima Genomics, a pioneer in next generation gene sequencing, to enhance our proprietary gene sequencing database, which is part of our Unigen platform," said Eran Ophir, Ph.D., Chief Scientific Officer at Compugen. "We developed algorithms to study gene splicing in single cell resolution and applied it to analyze patient tumor samples to uncover new potential regulatory mechanisms in immuno-oncology. Some of the findings were presented at the AGBT conference. Compugen plans to further harness Ultima’s technology to develop its proprietary single cell atlases for accelerated discovery of new immunotherapies."

"We are excited to support Compugen’s capabilities in predictive computational discovery of new drug targets and development of new cancer immunotherapies," said Gilad Almogy, Founder and CEO of Ultima Genomics. "We built our innovative sequencing architecture and our UG 100 sequencing platform to enable researchers to unlock new applications and insights through lower cost sequencing and more omics data. The successful outcome of our collaboration with Compugen is a great example of an application that is data-starved due to the constraints of conventional sequencing technology and can be transformed through large scale data and AI/ML techniques. Single cell sequencing is also an excellent fit for our technology which is now compatible with the leading library prep technologies."

Dr. Roy Granit, Head of Computational Discovery at Compugen is the lead author on a poster presented by Ultima Genomics at the Advances in Genome Biology and Technology (AGBT) 2025 general meeting on February 25, 2025, in Marco Island, Florida.

Poster presentation details:

Title: Using 3′ Single Cell Sequencing to Study Patient-Derived Tumor Cells Reveals Enhanced Potential to Study Differential Splicing at the Cell Type Level
Poster number: 224
Date and time: Tuesday, February 25, 4:45 p.m. – 6:10 p.m. ET
Leading author: Roy Granit, Ph.D., Director, Head of Computational Discovery, Compugen, Israel
Presenter: Zohar Shipony, Ph.D. Ultima Genomics, United States

Key Findings:

Comparative analysis using tumor samples from cancer patients, found high consistency in single-cell expression levels across Ultima Genomics’ UG 100 and Illumina’s Novaseq 6000 sequencing platforms.
UG 100 offers clearer demarcation of 3′ mRNA transcript end and provides a unique opportunity to study gene structure, which can potentially be harnessed to better understand tumor biology and immune regulation.
Gene structure information identified in this approach is contributing to the predictive models of Unigen.
The poster is available on the publications section of Compugen’s website, www.cgen.com.

About Unigen

Compugen has been at the forefront of decoding cancer biology, with its AI/ML powered predictive computational discovery platform, recently branded as Unigen. Unigen is Compugen’s code-to-cure, flexible-loop platform for the computational prediction of novel drug target discovery and development of cancer immunotherapy. Unigen combines Compugen’s deep scientific knowledge, AI/ML predictive algorithms and a cloud-based, technology-agnostic platform integrating a variety of biological data such as multi-omics, single-cell RNA sequencing and spatial omics data. The outcomes from Compugen’s preclinical and clinical trials enrich the proprietary knowledgebase to discover additional novel drug targets and further understand complex biology. To date, Unigen has yielded multiple novel immuno-oncology drug targets, potential first- or best-in-class clinical stage immuno-oncology programs, validating partnerships with multiple pharmaceutical companies and undisclosed programs in its early-stage pipeline.

On February 26, 2025 Mabqi reported the company secures a €5 million non-dilutive financing from the France 2030 public investment plan to advance preclinical development of it’s lead antibody candidate MQI-201 in oncology (Press release, Mabqi, FEB 26, 2025, View Source [SID1234651774]).

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We are thrilled to announce a €5 million funding as part of the "Innovations in Biotherapies and Bioproduction" call for projects under the France 2030 public investment plan program, managed by BpiFrance.

This non-dilutive funding will accelerate the development of a patented first-in-class antibody for the treatment of metastatic prostate cancer, one of the most common cancers in the world.

Mabqi develops a first-in-class MQI-201 antibody specifically targeting the TRPV6 ion channel, an innovative therapeutic target in oncology. This funding will enable Mabqi to launch the bioproduction of this antibody, regulatory IND-enabling studies and FIH trial. We target a Phase I clinical study early 2027.

MQI-201 antibody candidate is the result of a close collaboration with SATT Nord and INSERM teams in Lille. It has already shown excellent tolerance and high efficacy in vivo prostate cancer models and could, in the long term, be used in combination with standard prostate cancer treatments.

Mabqi aims at discovering 2 antibodies candidates per year thanks to its proprietary human antibody library combined to an AI-powered phage & yeast display platform.