On June 12, 2025 Scenic Biotech reported the extension of its research collaboration with Bristol Myers Squibb (Press release, Scenic Biotech, JUN 12, 2025, View Source [SID1234653832]). The growth of this partnership highlights the unique power of our Cell-Seq platform, which unlocks the underlying genetic interactions of cellular pathways for novel drug targets.

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Together, we are working to identify target biology for indication selection, and expansion, driving progress towards novel treatments for severe diseases. It’s a testament to the productive collaboration and shared vision between our teams.

In parallel to advancing our proprietary pipeline in neuro- and metabolic diseases, we remain committed to supporting our partners in shaping the future of medicine and improving patient outcomes. We look forward to the continued progress we’ll make together!

On June 12, 2025 FivepHusion, an advanced clinical-stage biotechnology company, reported the successful completion of the phase 1 (Part A) component of the phase 1/2 Deflexifol at Relapse Trial (DART) proudly supported by the Kids with Cancer Foundation, an Australian-led study of a new brain cancer treatment for children (Press release, FivepHusion, JUN 12, 2025, View Source [SID1234653831]).

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The phase 1/2 DART study is an Australian investigator-initiated trial, led by Principal Investigators Professor David Ziegler and Dr Marion Mateos and sponsored by the Australian and New Zealand Children’s Haematology / Oncology Group (ANZCHOG) in collaboration with FivepHusion. The trial is designed to investigate Deflexifol monotherapy as a treatment for paediatric ependymoma and other childhood brain cancers. All major paediatric oncology centres in Australia are participating in the trial, and major trial funding has been provided by the Kids with Cancer Foundation, through Sydney Children’s Hospitals Foundation, and the Robert Connor Dawes Foundation. An abstract summarising the results of the Phase 1 component has been submitted to the Society of Neuro-Oncology for consideration of presentation at their international meeting in November.

Dr Christian Toouli, CEO and Managing Director of FivepHusion commented, "Completion of Part A of the DART study, and confirmation of a safe and tolerable phase 2 dose, are major milestones in our plans to develop Deflexifol as a potential treatment for paediatric ependymoma and other brain cancers. We thank the patients and their families for their participation in this trial, and our collaborators and partners for conducting this important study."

Deflexifol is an advanced clinical-stage, next-generation co-formulation of 5-fluorouracil (5-FU) and leucovorin (LV), a drug that significantly enhances 5-FU activity. Deflexifol has previously been evaluated in two successfully completed clinical trials in adults with a variety of solid tumours; the DART study is the first clinical evaluation of Deflexifol in paediatric patients. FivepHusion is harnessing the proven cytotoxic activity of 5-FU together with the unique, optimised attributes of the Deflexifol co-formulation to pursue Deflexifol development in a range of strategic solid tumour indications presenting with significant unmet medical needs, including paediatric ependymoma.

Ependymomas are rare central nervous system tumours (annual incidence of ~4 patients per million) that are more common in young children 0-4 years of age. The current standard treatment for ependymoma is surgery and radiotherapy, though relapse occurs in one third of all paediatric patients and is associated with a poor prognosis. Currently, there are no drugs approved for the treatment of ependymoma, presenting a significant unmet medical need for the development of safe and efficacious new treatments for this disease.

Previously, 5-FU has been reported as a promising drug candidate for the treatment of paediatric ependymoma by independent research groups1,2, and in a clinical trial conducted at the St Jude Children’s Research Hospital (Memphis, Tennessee, USA)3. Recently, independent studies have gained further insights into understanding the susceptibility of paediatric ependymoma to 5-FU4. Research by FivepHusion collaborators indicates that Deflexifol, as an optimised co-formulation of 5-FU and LV, may be efficacious against paediatric ependymoma and other brain cancers. Due to its improved safety, tolerability, and potentially superior anti-tumour efficacy, Deflexifol offers the exciting opportunity of addressing the limitations of current 5-FU formulations to enable development as potentially the first approved drug for ependymoma and possibly other brain tumours.

On June 11, 2025 Lantheus Holdings, Inc. (the Company) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, reported the presentation of new data highlighting two oncology radiodiagnostic agents will be presented at the upcoming 2025 Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting, taking place June 21-24, 2025, in New Orleans, LA.

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Presentation details are as follows:

Oral Presentations

Date & Time: Tuesday, June 24, 2025; 2:30 – 3:35 PM CT
Session Number: SS39
Session Title: Advancing Radiopharmaceutical Production, Quality Control, and Translational Readiness
Title: Optimized Production and Quality Control of the FAP imaging Agent [64Cu]LNTH-1363S
Presenter: Gengyang Yuan, Lantheus

Poster Presentations

Date & Time: Sunday, June 22, 2025; 5:30 – 6:15 PM CT
Session Number: MTA03
Session Title: Oncology: Clinical Diagnosis & Therapy Meet the Author Session, part 1
Title: 18F-Piflufolastat PET/CT in Patients with Biochemically Recurrent Prostate Cancer: a CONDOR Sub-analysis of Positive Predictive Value in the Prostate/Prostatic Bed Stratified by PSA
Presenter: Amir Iravani, University of Washington

Date & Time: Monday, June 23, 2025; 10:30 – 11:15 AM CT
Session Number: MTA06
Session Title: Oncology: Discovery & Translational Meet the Author Session
Title: First Clinical Evaluation of 68Ga-LNTH-1363S, a Novel FAP-Targeting Radiopharmaceutical for PET Imaging: Physiological Biodistribution and Tumor Uptake in Cancer Patients
Presenter: Ida Sonni, University of California, Los Angeles

Date & Time: Tuesday, June 24, 2025; 8:00 – 9:15 AM CT
Session Number: SS27
Session Title: Emerging Role of Fibroblast Activation in Cardiovascular Imaging
Title: Preclinical assessment of 64Cu-LNTH-1363S for FAP PET imaging in mouse models of myocardial infarction
Presenter: Gyu Seong Heo, Department of Radiology, Washington University

About PYLARIFY (piflufolastat F 18) Injection
PYLARIFY (piflufolastat F 18) injection (also known as 18F-DCFPyL or PyL) is a fluorinated small molecule PSMA-targeted PET imaging agent that enables visualization of lymph nodes, bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer. For men with prostate cancer, PYLARIFY PET combines the accuracy of PET imaging, the precision of PSMA targeting and the clarity of an F 18 radioisotope for superior diagnostic performance. The recommended PYLARIFY dose is 333 MBq (9 mCi) with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10 mCi), administered as a bolus intravenous injection.1-6

PYLARIFY has made a profound impact on the lives of patients battling prostate cancer. It is the number one ordered PSMA PET imaging agent in the U.S., and is a proven diagnostic backed by real-world experience, including in over 500,000 scans across 48 states.

PYLARIFY (piflufolastat F 18) Injection

Indication

PYLARIFY (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:

with suspected metastasis who are candidates for initial definitive therapy.
with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
Important Safety Information

Contraindications

None.

Warnings and Precautions

Risk of Image Misinterpretation
Imaging interpretation errors can occur with PYLARIFY imaging. A negative image does not rule out the presence of prostate cancer, and a positive image does not confirm the presence of prostate cancer. The performance of PYLARIFY for imaging of patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. The performance of PYLARIFY for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by risk factors such as Gleason score and tumor stage. PYLARIFY uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes and in normal tissues. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.

Hypersensitivity Reactions
Monitor patients for hypersensitivity reactions, particularly patients with a history of allergy to other drugs and foods. Reactions may be delayed. Always have trained staff and resuscitation equipment available.

Radiation Risks
Diagnostic radiopharmaceuticals, including PYLARIFY, expose patients to radiation. Radiation exposure is associated with a dose-dependent increased risk of cancer. Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration.

Adverse Reactions
The most frequently reported adverse reactions were headaches, dysgeusia and fatigue, occurring at rate of ≤2% during clinical studies with PYLARIFY. In addition, a delayed hypersensitivity reaction was reported in one patient (0.2%) with a history of allergic reactions.

Drug interactions

Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of PYLARIFY in prostate cancer. The effect of these therapies on performance of PYLARIFY PET has not been established.

To report suspected adverse reactions for PYLARIFY, call 1-800-362-2668 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please read the accompanying full Prescribing Information also available at PYLARIFY.com.

(Press release, Lantheus, JUN 11, 2025, View Source [SID1234662960])

On June 16, 2025 LaNova Medicines reported that the investigational new drug (IND) of LM-168, a next-generation anti-CTLA-4 antibody, has been approved by China NMPA (Press release, LaNova Medicines, JUN 11, 2025, View Source [SID1234656024]).

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On June 11, 2025 Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, reported that it intends to offer and sell $650 million of shares of its common stock in an underwritten public offering (Press release, Insmed, JUN 11, 2025, View Source [SID1234653878]). In addition, Insmed intends to grant the underwriters a 30-day option to purchase up to an additional $97.5 million of shares of common stock. All of the shares to be sold in the offering are to be sold by Insmed. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Goldman Sachs & Co. LLC and Leerink Partners are acting as joint book-running managers for the offering.

The public offering of common stock described above is being made pursuant to Insmed’s shelf registration statement on Form S-3 (File No. 333-272088) that was previously filed with the Securities and Exchange Commission (SEC) and became automatically effective on May 19, 2023. A preliminary prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, from Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, facsimile: 212-902-9316 or by emailing [email protected] or Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.