On July 21, 2025 Cycle Pharmaceuticals (Cycle Pharma) reported it has entered into an exclusive U.S. commercialization agreement with Handa Therapeutics, LLC (Handa), for PHYRAGO, an FDA approved drug for treating two types of leukemia, Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) (Press release, Handa Oncology, JUL 21, 2025, View Source [SID1234654463]). PHYRAGO will be Cycle Pharma’s first oncology product (its ninth commercial product) and will see the company extend its expertise in caring for patients living with chronic conditions into oncology.

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PHYRAGO is a novel formulation of Sprycel (dasatinib) that allows concomitant use with proton pump inhibitors (PPIs) and H2 receptor antagonists (H2RAs),1 which can directly benefit patients on dasatinib therapy who are prescribed both medications.2

With Sprycel, the drug exposure of dasatinib can be significantly reduced by more than 40% and 60% when administered with PPIs and H2RAs, respectively.3 In contrast, with PHYRAGO, no clinically significant reduction in the bioavailability of dasatinib was observed following concomitant use with PPIs or H2RAs.1

Handa will be working closely with Cycle Pharma to launch PHYRAGO in September 2025. PHYRAGO will be launched with best-in-class patient support from Cycle Vita, providing individualized product, educational, and financial assistance* to adult patients with Ph+ CML and Ph+ ALL.

"We are excited about our second partnership with Handa, and the expansion of our patient support offerings to oncology. With PHYRAGO, Cycle Vita’s expertise in providing individualized care to patients will soon be available to patients with leukemia," says Chikai Lai – SVP & Chief Commercial Officer, Cycle Pharmaceuticals. Bill Liu, President and CEO of Handa Therapeutics, LLC, added "Handa is proud to continue its partnership with Cycle Pharmaceuticals in the commercialization of PHYRAGO, the first and only dasatinib product that can be taken concomitantly with PPIs and H2RAs. Handa is committed to bringing high quality oncology treatments such as PHYRAGO to patients."

Indications

PHYRAGO is a kinase inhibitor indicated for the treatment of:

Newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.
Adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance / intolerance to prior therapy including imatinib.
Adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph + ALL) with resistance / intolerance to prior therapy.
Important Safety Information

Warnings and Precautions:

Myelosuppression and Bleeding Events: Severe thrombocytopenia, neutropenia and anemia may occur. Use caution if used concomitantly with medication that inhibits platelet function or anticoagulants. Monitor blood counts. Transfuse and interrupt PHYRAGO when indicated.

Fluid Retention: Fluid retention, including pleural effusions. Manage with supportive care and/or dose modification.

Cardiovascular Toxicity: Monitor for signs or symptoms and treat appropriately.

Pulmonary Arterial Hypertension (PAH): PHYRAGO may increase the risk of developing PAH which may be reversible on discontinuation. Consider baseline risk and evaluate patients for signs and symptoms of PAH during treatment. Stop PHYRAGO if PAH is confirmed.

QT Prolongation: Use PHYRAGO with caution in patients who have / may develop prolongation of the QT interval.

Severe Dermatologic Reactions: Cases of severe mucocutaneous dermatologic reactions have been reported.

Tumor Lysis Syndrome: Tumor lysis syndrome has been reported. Maintain hydration and correct uric acid levels prior to initiating treatment.

Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of reproductive potential, of potential risk to fetus and to use effective contraception.

Effects on Growth and Development in Pediatric Patients: Epiphyses delayed fusion, osteopenia, growth retardation, and gynecomastia have been reported. Monitor bone growth and development in pediatric patients.

Hepatotoxicity: Assess liver function before initiation of treatment, monthly thereafter or as clinically indicated. Monitor liver function when combined with chemotherapy.

Adverse Reactions:

Common adverse reactions (≥15%) include myelosuppression, fluid retention events, diarrhea, headache, skin rash, hemorrhage, dyspnea, fatigue, nausea, and musculoskeletal pain.

Postmarketing Experience:

Post approval adverse reactions:

Hepatitis B virus reactivation, atrial fibrillation/atrial flutter, interstitial lung disease, chylothorax, Stevens-Johnson syndrome, nephrotic syndrome, thrombotic microangiopathy, hepatotoxicity.

Drug Interactions:

Strong CYP3A4 Inhibitors: Dose reduction may be necessary.

Strong CYP3A4 Inducers: Dose increase may be necessary.

Antacids: Avoid concomitant use.

Use in Specific Populations:

Pregnancy: PHYRAGO can cause fetal harm. Advise a pregnant woman of the potential risk to a fetus.

Contraception: Should be used during treatment and for 30 days after the last dose.

Lactation: Breastfeeding is not recommended during treatment and for 2 weeks after the last dose.

Pediatric Use: Monitor bone growth and development in pediatric patients.

Due to Bristol-Myers Squibb Company’s marketing exclusivity rights, this drug product is not labeled with pediatric information.

Geriatric Use: Patients over 65 and older are more likely to experience: fatigue, pleural effusion, diarrhea, dyspnea, cough, lower gastrointestinal hemorrhage, appetite disturbance, abdominal distention, dizziness, pericardial effusion, congestive heart failure, hypertension, pulmonary Cinzia, and weight decrease. Monitor closely.

For more detailed information, please refer to the full Prescribing Information at www.phyrago.com/PI/.

To report SUSPECTED ADVERSE REACTIONS, contact Cycle Pharmaceuticals at

1-844-784-1807, or the FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch.

US-DAS-2500002 (June 2025)

On July 21, 2025 Vicebio Ltd ("Vicebio" or the "Company"), a biopharmaceutical company developing novel vaccines against life-threatening respiratory viral infections, reported to have entered an exclusive, definitive agreement to be acquired by Sanofi (Press release, Sanofi, JUL 21, 2025, View Source [SID1234654462]). Under the terms of the agreement, subject to customary conditions, Vicebio shareholders will receive up to a total of US$1.6 billion, including an upfront payment of US$1.15 billion as well as development and regulatory milestones payments of US$450 million.

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Vicebio was created by Medicxi to develop next-generation vaccines for respiratory viruses utilising its proprietary Molecular Clamp technology, discovered at The University of Queensland. This technology uniquely stabilises viral glycoproteins to elicit strong protective immune responses and enables high-yield production for ready-to-use liquid multivalent formulations. The Molecular Clamp technology is applicable to a wide range of viruses including Respiratory Syncytial Virus (RSV), Human Metapneumovirus (hMPV), Parainfluenza viruses, Influenza and Coronaviruses. In September 2024 Vicebio announced a Series B financing, led by TCGX with investment from Life Sciences at Goldman Sachs Alternatives, Avoro Ventures, venBio Partners, and with participation from UniQuest and founding investor Medicxi, which enabled Vicebio to accelerate clinical development of VXB-241 and next generation products.

Vicebio is currently running an exploratory Phase 1 clinical trial with lead asset VXB-241, a bivalent vaccine targeting both RSV and hMPV viruses, pathogens that are a significant burden in the elderly and those with a weakened immune system. Interim analysis of the exploratory Phase 1 study showed a favourable safety and tolerability profile in adults aged 60 and above.

Dr. Giovanni Mariggi, Chairman of Vicebio and Partner at Medicxi, said: "Our aim in creating Vicebio was to back a clear product vision to develop a best-in-class vaccine against respiratory viruses. We are extremely proud of what we have accomplished in the last few years thanks to a team effort by the Company, University of Queensland, our investors and the Board. We are excited to partner with Sanofi which will further accelerate VXB-241’s development to ensure it ultimately benefits those in need."

Cariad Chester, Managing Partner at TCGX said: "Vicebio has successfully developed best-in-class multivalent vaccines targeting leading causes of respiratory disease. These vaccines have the potential to protect millions of patients from life-threatening viral infections and we are thrilled to partner with Sanofi to accelerate their development. We look forward to working with Sanofi and combining our innovative technology with Sanofi’s global clinical development capability."

Dr. Emmanuel Hanon, Chief Executive Officer of Vicebio, added: "Vicebio and its incredibly passionate team have been driven by the ambition to develop next-generation vaccines aimed at targeting multiple life-threatening respiratory viruses simultaneously. This acquisition validates our ability to combine innovation and deep scientific expertise towards a common goal of advancing public health prevention, and we’re excited to enter the next chapter to accelerate the global impact of our work."

On July 21, 2025 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported its participation in the upcoming investor relations event (Press release, Ideaya Biosciences, JUL 21, 2025, View Source [SID1234654461]).

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2025 BTIG Virtual Biotechnology Conference
Tuesday, July 29th, 2025 at 4:40 PM ET

Fireside chat with Yujiro S. Hata, President and Chief Executive Officer, hosted by Justin Zelin, Director, Biotechnology Research Analyst
A live audio webcast of the conference event, as permitted by the conference host, will be available at the "Investors/Events" section of the IDEAYA website at View Source and/or through the conference host. A replay of available webcasts will be accessible for 30 days following the live event.

On July 21, 2025 DualityBio (HKEX Stock Code: 9606.HK) reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to its next-generation HER3-targeting antibody-drug conjugate (ADC) DB-1310 (Press release, DualityBio, JUL 21, 2025, View Source [SID1234654460]). This designation is for the treatment of adult patients with advanced, unresectable or metastatic nonsquamous non-small cell lung cancer (nsqNSCLC) with an EGFR exon 19 deletion or L858R mutation with disease progression on or after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy.

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DB-1310 is a novel ADC targeting HER3 developed using DualityBio’s proprietary DITAC platform. In June 2025, Dr. Aaron E. Lisberg from the University of California, Los Angeles (UCLA) presented the first-in-human Phase I/IIa clinical trial data (NCT05785741) of DB-1310 in an oral session at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The results demonstrated encouraging efficacy and a manageable safety profile in patients with advanced solid tumors who had failed standard therapies.

Dr. Hua Mu, Global Chief Medical Officer of DualityBio, stated: "DB-1310 demonstrated encouraging clinical efficacy and manageable safety in patients with EGFRm nsqNSCLC and multiple solid tumors. It is noteworthy that preclinical investigations of DB-1310 in combination with EGFR TKIs and other anticancer agents have also demonstrated robust synergistic tumor suppression activity. We will spare no effort to accelerate the clinical development of DB-1310 and look forward to its potential, as a next-generation HER3 ADC, to become a novel therapeutic option for a broad population of cancer patients."

On July 21, 2025 ImCheck Therapeutics reported that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to its lead program, ICT01, a humanized anti-butyrophilin 3A (BTN3A) monoclonal antibody designed to selectively activate γ9δ2 T cells, for the treatment of acute myeloid leukemia (AML) (Press release, ImCheck Therapeutics, JUL 21, 2025, View Source [SID1234654459]). The designation in the EU follows the recently granted U.S. FDA ODD and provides additional validation of the therapeutic potential of ICT01 in AML, a disease with high unmet medical need and limited treatment options for older or unfit patients who are not eligible for intensive chemotherapy.

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"Securing orphan drug designation from both the EMA and the FDA in close succession is a major regulatory milestone for ImCheck,"said Pierre d’Epenoux, Chief Executive Officer of ImCheck Therapeutics."It reflects growing international recognition of ICT01’s potential and supports our objective to accelerate clinical development in both the U.S. and Europe. The EMA ODD’s broad market exclusivity for ICT01 once approved provides additional value as we consider our development strategy."

"The EMA’s rapid decision reinforces the highly encouraging clinical data supporting ICT01 and its differentiated mechanism of action," added Stephan Braun, MD, PhD, Chief Medical Officer of ImCheck Therapeutics. "By selectively activating γ9δ2 T cells, a powerful component of the immune system, ICT01 offers a novel therapeutic pathway in AML. This momentum brings us closer to our goal of delivering new therapeutic options to AML patients who currently have limited treatment options."

The EMA’s orphan drug designation is granted to medicines intended for the treatment of life-threatening or chronically debilitating rare conditions affecting fewer than 5 in 10,000 people in the EU. Benefits of the designation include protocol assistance, reduced regulatory fees, and ten years of market exclusivity in Europe following approval.