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]).

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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.

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]).

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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."

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.

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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.

On June 9, 2025 Axio BioPharma Inc., a next-generation biomanufacturing company using AI to transform mammalian protein production, and Likarda Inc., a leader in advanced drug delivery and formulation technologies, reported a strategic partnership to accelerate innovation in biologic drug development (Press release, Likarda, JUN 9, 2025, View Source [SID1234653786]). This collaboration will integrate Likarda’s proprietary delivery technologies with Axio’s manufacturing capabilities, creating a more efficient and scalable path to clinical manufacturing for clients across the biopharmaceutical sector.

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Through this collaboration, Axio BioPharma will incorporate Likarda’s proprietary delivery platforms— including its Core-Shell Spherification (CSS) hydrogel technology for encapsulation, stability, and controlled release —into its service offering, enhancing workflows for monoclonal antibodies (mAbs), bispecifics, and Fc-fusions. Likarda will also offer Axio’s discovery-to-GMP manufacturing capabilities to its client base, supporting programs in need of high-quality protein production and scalable manufacturing solutions.

"This partnership brings delivery innovation directly into the development process, helping our clients move faster and make better decisions," said Justin Byers, CEO of Axio BioPharma. "By aligning earlier on both delivery and manufacturing, we reduce friction, shorten timelines, and provide integrated solutions that truly support our clients’ goals."

"At Likarda, we believe that delivery should never be an afterthought—it should be part of the development strategy from day one," said Dr. Stella Vnook, CEO of Likarda Inc. "Partnering with Axio allows us to integrate our encapsulation and formulation technologies earlier in the drug development process, where they can have the greatest impact on stability, efficacy, and patient experience. Importantly, it provides seamless integration to scaled manufacturing for our clients. Together, we’re creating a smarter, more connected path from discovery to clinic."

This collaboration strengthens Axio’s mission of transforming biologic manufacturing through predictive science and digital-first process development. At the same time, it enables Likarda to apply its proprietary delivery technologies earlier in the development cycle, giving clients new efficiencies and expanded therapeutic applications.

On June 9, 2025 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported results from the LIBERATE study published in ESMO (Free ESMO Whitepaper) Open (Press release, Guardant Health, JUN 9, 2025, View Source [SID1234653785]). The results in the peer-reviewed manuscript demonstrate the clinical validity and high performance of Guardant Reveal, the company’s minimal residual disease (MRD) blood test, in predicting recurrence in patients with early-stage breast cancer. Guardant Reveal uses epigenomic (methylation) analysis to detect circulating tumor DNA (ctDNA) in a patient’s blood without the need for a tissue sample.

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The LIBERATE study retrospectively analyzed 290 blood samples from 95 patients who were diagnosed with early-stage ER+/HER2- or triple negative breast cancer undergoing chemotherapy prior to surgery, half of whom had localized disease with no lymph node involvement. Nearly 40% had minimal or no residual tumor by pathologic assessment following neoadjuvant chemotherapy.

Key findings include:

High Sensitivity and Specificity: Guardant Reveal demonstrated 100% sensitivity for distant recurrence in patients with ER+/HER2- breast cancer (which represents about 70% of all breast cancers), and 71% overall, with 100% specificity and 100% positive predictive value for relapse.
Significant Prognostic Power: Detection of ctDNA post-operatively was significantly prognostic for event-free survival (EFS), with median lead time of 152 days (range: 15-748 days) ahead of clinical recurrence (P < 0.0001).
Nearly 100% of All Samples Evaluable: All patients with post-operative blood samples had MRD results available from Reveal, highlighting the power of a tissue-free MRD test among patients receiving neoadjuvant therapy, particularly the large percentage who have minimal to no tumor found at surgery.
"This study underscores the clinical validity, robust prognostic value and high specificity of Guardant Reveal in identifying breast cancer patients at elevated risk of recurrence without the need for a tissue sample," said Craig Eagle, M.D., Guardant Health chief medical officer. "These findings reinforce the critical role Reveal can achieve in clinical decision-making, potentially transforming neoadjuvant and post-treatment surveillance strategies and improving patient outcomes."

This publication adds to the growing body of evidence of Reveal’s strong performance in early-stage breast cancer. Earlier this year, a peer-reviewed publication in Clinical Cancer Research focused on stage II and III triple negative breast cancer demonstrated 83% sensitivity for metastatic recurrence and 99.5% sample-level specificity. Post-surgical ctDNA detection was prognostic for shorter recurrence-free interval (P < 0.0001). Additionally, ctDNA detection at the post-neoadjuvant, presurgical time point was associated with a shorter recurrence-free interval in patients with residual disease at surgery (P < 0.0001).