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First Site Activated in EU-Funded DE-ESCALATE Clinical Trial on Advance Metastatic Prostate Cancer

On June 10, 2025 The European Organisation for Research and Treatment of Cancer (EORTC) and Syreon Research Institute reported the official start of DE-ESCALATE, a pragmatic Phase III clinical trial focusing on metastatic prostate cancer (Press release, EORTC, JUN 10, 2025, View Source [SID1234653791]).

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DE-ESCALATE is one of three research projects coordinated by EORTC, alongside LEGATO and STREXIT-2, which are also funded by the Horizon Europe Programme.

About metastatic prostate cancer
Prostate cancer is the most frequently occurring cancer in men and the third leading cause of cancer death in men.¹ Despite dramatic improvements in early diagnosis and local treatment, one out of five prostate cancer patients will die from their disease.² While data about the rates of metastasis are limited, about 22% of prostate cancer cases metastasize.3 Advanced metastatic prostate cancer is a heterogeneous disease, for which androgen deprivation therapy combined with an androgen receptor pathway inhibitor (ARPI) is the mainstay of treatment.

Metastatic prostate cancer patients suffer from low quality of life and very burdensome symptoms, including treatment-related side effects.

About DE-ESCALATE
The study will evaluate whether intermittent intensified androgen deprivation treatment (iADT) in metastatic prostate cancer is not inferior to continuous treatment in terms of oncological benefit, while minimizing side effects and resource utilization and improving patient quality of life. It is also designed to detect early if iADT has a negative impact on overall survival compared to continuous therapy.

Up to 1,600 patients are expected to be enrolled in this study across Europe. The clinical trial will be opened in 80 sites in the following 8 countries within the EORTC network (Belgium, Croatia, Czechia, Denmark, Italy, Portugal, Romania, Slovenia) and 30 sites across national networks in Ireland, France, and Spain.4
The study is designed with a strong focus on patient centricity, employing a patient-developed health questionnaire to better assess quality of life improvements.

DE-ESCALATE is managed by a multidisciplinary and multistakeholder consortium involving clinical oncologists, surgeons, health economists, and patient representatives.

To compare the effectiveness of the health interventions tested within the study, Syreon Research Institute will deliver a cost-effectiveness analysis and will also oversee the health policy aspects of the dissemination of the study findings.

The DE-ESCALATE study may lead to improved patient survival and quality of life while also improve health system sustainability.

Azitra, Inc. Announces Presentation at the 2025 BIO International Convention

On June 10, 2025 Azitra, Inc. (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, reported that the company will present at the BIO International Convention being held June 16-19, 2025, in Boston, Massachusetts (Press release, Azitra, JUN 10, 2025, View Source [SID1234653787]).

The presentation will highlight recent updates and progress in Azitra’s pipeline, including ATR-12, currently in a Phase 1b clinical trial in adult patients with Netherton syndrome and ATR-04, in development for the treatment of moderate to severe EGFRi-associated dermal toxicity in adults.

Details of the presentation are as follows:

Event:

2025 BIO International Convention

Date and Time:

Tuesday, June 17 at 12:00 PM, ET

Location:

Boston Convention & Exhibition Center, Room 154

Presenter:

Travis Whitfill PhD MPH, Cofounder and Chief Operating Officer

During the conference, Dr. Whitfill will conduct one-on-one meetings with registered investors and potential partners, showcasing the company’s business and clinical development strategy, recent corporate achievements, and anticipated milestones.

SNT-5505 awarded US FDA Fast Track designation

On June 10, 2025 Syntara Limited (ASX: SNT), a clinical-stage biotechnology company focused on developing first-in-class treatments in blood cancers and other fibrotic diseases, reported that its lead candidate, SNT-5505, has been granted Fast Track designation by the US Food and Drug Administration (FDA) for the treatment of myelofibrosis in patients with an inadequate response to JAK inhibitor therapy (Press release, Syntara, JUN 10, 2025, https://mcusercontent.com/add2e2fa70ec3d0eeaf2a93cc/files/f4d68ff6-99ad-efa0-d705-81378f04fdc1/02955002.pdf [SID1234653779]).

Fast Track designation can be awarded by the FDA after its review of data demonstrating potential benefit, a mechanistic rationale for efficacy and early clinical evidence. With the published and peer reviewed pre-clinical and clinical data, as well as presentations at preeminent hematology meetings, there is a growing body of evidence supporting SNT-5505.

Fast Track designation aims to expedite the review and development of therapies that address serious conditions and unmet medical needs, facilitating earlier drug approval and patient access. Benefits include:

More frequent meetings and communication with the FDA.

Eligibility for Accelerated Approval and Priority Review, subject to meeting relevant criteria.

Potential for Rolling Review in support of a New Drug Application (NDA).

Gary Phillips, Chief Executive Officer of Syntara, stated:

"To have the FDA recognise the quality of the pre-clinical and clinical results generated to date, as well as the therapeutic promise of SNT-5505 through this Fast Track designation, is an outstanding development for Syntara. This supports our efforts to rapidly advance SNT-5505 as a potential new standard of care for patients with myelofibrosis, addressing the noticeable gaps left by existing treatments."

AMB303, Research Collaboration and License Option Agreement signed with SK Plasma

On June 6, 2025 SK Plasma reported it has entered into a licensing and joint development agreement with AimedBio to in-license AMB303, a late-stage preclinical antibody-drug conjugate (ADC) targeting ROR1. The agreement grants SK Plasma exclusive rights for development and commercialization, with the two companies set to collaborate from preclinical through clinical and commercial stages. IND submissions in both Korea and the U.S. are planned for 2026.

AMB303 was developed using AimedBio’s proprietary platforms for target discovery, antibody generation, and linker-payload engineering. It is one of the company’s advanced ADC candidates, designed to selectively target solid tumors expressing ROR1.

AimedBio, founded in 2018 as a spin-off from Samsung Medical Center, is led by Dr. Do-Hyun Nam, a globally recognized leader in neuro-oncology. The company has a proven track record in ADC innovation, having recently licensed another program to U.S.-based Biohaven.

"We’re pleased to partner with SK Plasma, whose clinical and commercial capabilities make them an ideal collaborator for advancing AMB303 globally," said Dr. Nam-Gu Her, CEO of AimedBio. "This agreement reflects growing global recognition of AimedBio’s ADC pipeline and platform."

The financial terms of the deal remain undisclosed. For SK Plasma, this marks a strategic entry into the ADC field as part of its broader push into biologics and treatments for rare and intractable diseases.

(Press release, AimedBio, JUN 9, 2025, View Source;s_keyword=&s_where=&start=0 [SID1234656916])

Defence Therapeutics Receives Uspto Allowance For Patent Application Covering Next-Gen Adc Technology

On June 9, 2025 Defence Therapeutics Inc. ("Defence" or the "Company"), (CSE: DTC, OTCQB: DTCFF, FSE: DTC) a leading biotechnology company specializing in drug delivery technologies, reported that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for its U.S. patent application covering one of its next-generation antibody-drug conjugate (ADC) technologies (Press release, Defence Therapeutics, JUN 9, 2025, View Source;utm_medium=rss&utm_campaign=defence-therapeutics-receives-uspto-allowance-for-patent-application-covering-next-gen-adc-technology [SID1234653788]). The allowance of U.S. patent application no. 18/351,291 (‘291) includes valuable composition-of-matter claims broadly covering therapeutically active ADCs – not limited to individual diseases or therapeutic targets – as well as claims covering the use of ADCs for treating or diagnosing diseases such as cancer.

Defence’s Accum-based ADCs have demonstrated enhanced intracellular delivery and cytotoxic activity in multiple preclinical cancer models compared to conventional ADCs. Upon grant, the ‘291 patent application will provide the Company with potential market exclusivity until 2043 for its proprietary second-generation Accum-based ADCs, which include antibodies conjugated to innovative new constructs featuring a bile acid conjugated to a nuclear localization signal (NLS) derived from the ribosomal protein eS17 (RPS17).

This milestone builds on Defence’s established patent portfolio for its foundational Accum technology, which includes granted patents in the United States (US 11,352,437), Japan (JP 7,126,956), Australia (AU 2017233725), and Israel (IL 261765), with applications currently pending in Canada and Europe.

"Second-generation Accum-based ADCs represent a significant advancement in both oncotherapy and targeted drug delivery," said Sébastien Plouffe, CEO and Founder of Defence Therapeutics. "This recent allowance underscores the innovation and versatility embedded in our ADC platform technology and reflects our commitment to developing novel, effective cancer treatments that push the boundaries of current ADC technologies."

This newly allowed U.S. patent application is poised to become the eighth granted U.S. patent in Defence’s expanding portfolio, which now comprises seven published patent families.