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 Starpharma (ASX: SPL, US OTC: SPHRY), an innovative biotechnology company with two decades of experience in advancing dendrimer technology from the lab to the patient, reported its Interim Report and Half-Year Financial Results for the period ended 31 December 2024 (H1 FY25) (Press release, Starpharma, FEB 26, 2025, View Source;mc_eid=bf52dd3418 [SID1234650550]).

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Starpharma’s Chief Executive Officer, Cheryl Maley, commented:

"In the first half of FY25, Starpharma has made good progress in executing our strategy, aimed at maximising the value of our DEP assets, accelerating early asset development, and building long-term sustainability. I know our internal progress may not always be evident externally, but I can vouch for the dedication and hard work of everyone at Starpharma as we work towards achieving our strategic objectives.

"We have made important progress in advancing our DEP clinical assets, particularly DEP SN38, which has shown promising clinical outcomes in patients with high unmet need. A key regulatory milestone during the period was the recent meeting with the US Food and Drug Administration (FDA) regarding DEP SN38. The FDA provided feedback on the path to market for DEP SN38, confirming that the 505(b)(2) regulatory approval pathway is appropriate for DEP SN38 and the potential for Fast Track designation and accelerated approval. The positive response from the US regulator increases our confidence in the potential of DEP SN38 for treating platinum-resistant ovarian cancer. During the six months to December, our partner engagement through ongoing meetings and conference participation highlighted the importance of FDA feedback to potential partners for the commercialisation of DEP SN38.

"We are advancing our early-stage DEP programs, particularly in the area of radiopharmaceuticals, with the aim of initiating a first-in-patient clinical trial this calendar year. We are also expanding our research pipeline, positioning us well for future collaborations and long-term growth. Commercially, we anticipate the launch of VivaGel BV in key markets in the Middle East and continue to support sales of Viraleze online through digital marketing initiatives, which have resulted in a ~30% increase in revenue from the e-commerce channels compared to the prior corresponding period.

"We have focused on building a sustainable organisation and have sufficient capital to support our medium-term objectives, with a cash balance of $20.3 million as at 31 December 2024. The completion of multiple clinical programs in FY24 has led to a reduction in our research and development expenses, extending our cash runway. Over the past 12 to 18 months, we have implemented a number of cost-saving initiatives that are positively impacting our cash balance. Notably, our Corporate and Administration costs in this half-year period have decreased by $0.5 million compared to the prior corresponding period.

"Starpharma is committed to driving revenue growth, advancing our pipeline, and managing costs effectively to deliver improved and long-term value for our shareholders. We are focused on prioritising resources for our high-impact DEP programs, pursuing partnerships to advance our assets toward commercialisation, and increasing revenue through collaborations, licensing and product sales."

On February 26, 2025 Imugene Limited (ASX: IMU), a clinical-stage immuno-oncology company, reported receipt of a Notice of Allowance from the Chinese Patent Office, for City of Hope’s patent application number 201880064280.9 which protects the CD19-expressing oncolytic virus, onCARlytics (Press release, Imugene, FEB 26, 2025, View Source [SID1234650549]).

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The patent, titled "ONCOLYTIC VIRUS EXPRESSING A CAR T CELL TARGET AND USES THEREOF" protects the method of composition and method of use of onCARlytics through to 2038.

Exclusively licensed to Imugene, OnCARlytics is a CD19-expressing oncolytic virus that enters solid tumour cells and forces them to express the CD19 protein on the cell surface, presenting a target for CD19 targeting therapies.

Imugene’s OASIS dose escalation trial of onCARlytics is being conducted at up to ten sites in the United States, with up to approximately 40 patients proposed to take part in the trial.

Imugene MD & CEO Leslie Chong said: "Intellectual property has remained a priority for our innovative range of immuno-oncology assets, and to have onCARlytics protected in a major market like China is an integral part of this strategy."

On February 26, 2025 Neogap Therapeutics AB, a Swedish clinical-stage biotechnology company, reported that it has been awarded a USD 125,000 ScaleReady G-Rex Grant to optimise the development and manufacturing of its innovative personalised cancer immunotherapy, pTTL (Press release, Neogap Therapeutics, FEB 26, 2025, View Source;g-rex-grant-to-advance-personalised-cancer-immunotherapy,c4110383 [SID1234650547]). The funding supports Neogap’s efforts to further advance the manufacturing of their cell therapy product by developing a bioreactor process able to support large-scale manufacturing.

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The G-Rex Grant is part of ScaleReady’s USD 20 million programme aimed at advancing Cell and Gene Therapy (CGT) development and manufacturing. With this funding, Neogap Therapeutics will optimise manufacturing for pTTL (personalised Tumour Trained Lymphocytes), an ATMP (Advanced Therapy Medicinal Product) that combines EpiTCer technology with the PIOR AI platform.

Designed to target neoantigens with precision, pTTL uses the patient’s immune cells to generate tumour-specific T cells. It is currently being evaluated in a Phase I/IIa clinical trial in patients with advanced colorectal cancer.

"We are very excited to have been selected for this significant grant from ScaleReady and look forward to incorporating the G-Rex platform into our pTTL manufacturing process," says Kristine Bylund, Head of Cell Therapy Production and Development at Neogap Therapeutics. "Our development team has already completed preliminary experiments, and this grant will allow us to continue the development of a robust and cost-effective bioreactor process required to meet our quality and safety standards for clinical production, bringing us closer to our goal of delivering personalised medicine to patients in need."

"We are fortunate to have the opportunity to help Neogap develop a cost-effective G-Rex centric manufacturing process to create personalised Tumour Trained Lymphocytes. Neogap’s novel approach has the potential to make a highly favorable impact on clinical outcomes for patients with advanced colorectal cancer and are grateful for the opportunity to participate," says John Wilson, CEO of Wilson Wolf and co-inventor of G-Rex. ​

About Neogap’s immunotherapy, pTTL
pTTL (personalised Tumour Trained Lymphocytes) is a cell-based immunotherapy that enhances the patient’s own T cells to fight cancer. The therapy combines advanced DNA analysis with T-cell expansion in a precision treatment for solid tumours. It is based on Neogap’s patented technologies, PIOR and EpiTCer. The goal is to provide patients with a tailored and innovative therapy that meets their specific needs.

On February 25, SinocellTech reported that its independently developed recombinant humanized anti- PD-1 IgG4 monoclonal antibody, fenolimab (Anyouping , SCT – I10A ), combined with the recombinant humanized anti -VEGF monoclonal antibody bevacizumab, received official approval from the China National Medical Products Administration ( NMPA ) for the first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma ( HCC ) who have not received prior systemic therapy (Press release, Sinocelltech, FEB 25, 2025, View Source [SID1234656253]). Following its approval as a first-line treatment for recurrent/metastatic head and neck squamous cell carcinoma, SinocellTech secured its second indication in the PD-1 arena .

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