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Alloy Therapeutics and Kansai Startup Academia Coalition (KSAC) Announce Strategic Collaboration to Accelerate Global Growth of Japanese Life Science Startups

On July 22, 2025 Alloy Therapeutics Co. Ltd. ("Alloy Japan") reported the signing of a Memorandum of Understanding (MOU) with the Kansai Startup Academia Coalition ("KSAC"), represented by Kyoto University, to foster the global expansion of university-affiliated life science startups across Japan (Press release, Alloy Therapeutics, JUL 22, 2025, View Source [SID1234654446]). This strategic collaboration is designed to accelerate research and development (R&D) activities by providing critical support and connecting academic innovations with the global biopharmaceutical industry.

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KSAC is a coalition of more than 90 academic institutions located in western Japan, formed under the leadership of Kyoto University and with support from Japan’s Ministry of Education, Culture, Sports, Science and Technology (MEXT). KSAC’s mission is to bridge academia and industry by managing GAP funds for research, delivering entrepreneurship education, supporting digital workshop networks, and showcasing early-stage technologies through events and exhibitions both domestically and internationally.

Alloy Therapeutics Inc. ("Alloy") is a Boston-based biotechnology ecosystem company that democratizes access to foundational biologics discovery technologies. Through its suite of platform technologies and discovery services as well as its venture studio, 82VS, Alloy enables scientists and entrepreneurs around the world to accelerate the discovery of medicines. Alloy recently launched its Japan subsidiary, Alloy Japan, which is focused on iPS cell therapy development and is continuing to broaden its offerings by supporting ecosystem growth throughout Japan and greater Asia.

Through this MOU, Alloy Japan and KSAC will collaborate to connect promising academic seeds from Japan to global Biopharma markets, while also bringing valuable insights from the global community back to strengthen Japan’s startup ecosystem. Together, they aim to enrich critical capabilities across Japan’s academic and entrepreneurial communities to foster the development of globally competitive life science startups.

"Alloy’s capabilities and global network bring a highly complementary strength to our mission of empowering academic startups to compete internationally. Alloy Japan offers a highly distinct and complementary contribution to our activities with Global Incubators and Venture Capital firms," said Koji Murota, Director-General of the Office of Institutional Advancement and Communications at Kyoto University, representing KSAC. "By collaborating with ecosystem builders like Alloy Japan, we can provide our researchers and entrepreneurs with access to additional scientific resources, global Biopharma insights, and opportunities to scale their innovations beyond Japan."

As a first step, Alloy Japan will support KSAC’s GAP Fund program, which provides funding to selected academic projects within the KSAC network. Over the three-year term of the MOU, the collaboration is expected to expand to additional KSAC initiatives aimed at building a globally integrated and innovation-driven biotech community.

"Our collaboration with KSAC builds on Alloy Japan’s commitment to deep, sovereign partnerships that nurture innovation at the academic and early translational stages," said Victor Stone (Yoshihide Ishii), CEO of Alloy Japan. "By working alongside KSAC and its network of universities, we aim to strengthen the bridge between Japanese academic excellence and the Biopharma ecosystem, accelerating the global growth of life science startups."

UroGen Announces Five-Year Long-Term Extension Study of the OPTIMA II Trial Demonstrates Long-Term Durability of Response to ZUSDURI™ in Patients with Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

On July 21, 2025 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions for urothelial and specialty cancers, reported the publication of results of a five-year long-term extension study of the Phase 2b OPTIMA II trial evaluating ZUSDURI (mitomycin) for intravesical solution in patients with low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) demonstrating durable, long-term complete responses (CRs) in patients who initially achieved a CR following treatment with ZUSDURI (Press release, UroGen Pharma, JUL 21, 2025, View Source [SID1234654465]). The publication, titled "Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer With UGN-102: Outcomes From the 5-year Long-Term Extension Study of the Single-Arm, Phase 2b OPTIMA II Study", is now available online at View Source

"Low-grade intermediate-risk bladder cancer is a chronic, recurring disease that often requires repeated surgical intervention," said Neal D. Shore, MD, FACS Medical Director for the START Carolinas/Carolina Urologic Research Center and lead author of the study. "The long-term data from the extension study of OPTIMA II highlight ZUSDURI’s ability to deliver sustained responses in an outpatient setting, which may be especially valuable for recurrent patients and thus for physicians who prefer a different, non-surgical treatment option."

Among the 41 patients who achieved CR at three months post-treatment with ZUSDURI in the OPTIMA II trial, 25 remained in CR at 12 months and 17 entered the long-term follow-up study. For the 41 patients achieving CR at three months, the median Kaplan-Meier estimate of duration of response (DOR) was 24.2 months (95% CI 9.7, 42.1) with a median follow-up of 35.8 months. For the 17 patients in the long-term follow-up study, the median DOR was 42.1 months by Kaplan-Meier estimate (95% CI: 24.2, NE), with a median follow-up of 50.4 months. These results build upon previously published 12-month DOR data, showing ZUSDURI’s potential to deliver meaningful, lasting event-free periods.

"These results reflect our continued commitment to bringing forward innovative treatments that give patients and physicians more options," said Mark Schoenberg, MD, Chief Medical Officer, UroGen. "For recurrent patients facing repeated surgeries, it offers a non-surgical approach that can empower patients and providers to choose a path that best fits individual needs and preferences."

Safety data were not collected during the long-term follow-up trial. The most commonly reported treatment emergent adverse events (>10% of patients) from the parent OPTIMA II study were dysuria in 26 (41% of patients); pollakiuria in 13 (21%); hematuria in 10 (16%); urgency to urinate or urinary tract infection, both occurring in 9 (14%); and fatigue in 7 (11%).

The OPTIMA II trial included both newly diagnosed and recurrent adult patients with LG-IR-NMIBC. Of the 17 patients that entered long-term follow up, 16 (94%) were recurrent and 1 (6%) was newly diagnosed. This cohort of patients had a median DOR of 3.5 years by Kaplan-Meier estimate. ZUSDURI is indicated only for the treatment of adults with recurrent LG-IR-NMIBC.

About ZUSDURI

ZUSDURI (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin, approved for the treatment of adults with recurrent LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel technology, a sustained release, hydrogel-based formulation, ZUSDURI is delivered directly into the bladder in an out-patient procedure by a trained healthcare professional using a urinary catheter to enable the treatment of tumors by non-surgical means. Visit ZUSDURI.com for more information.

About Non-Muscle Invasive Bladder Cancer (NMIBC)

LG-IR-NMIBC affects around 82,000 people in the U.S. every year and of those, an estimated 59,000 are recurrent. Bladder cancer primarily affects older populations with increased risk of comorbidities, with the median age of diagnosis being 73 years. Guideline recommendations for the management of NMIBC include trans-urethral resection of bladder tumor (TURBT) as the standard of care. Up to 70 percent of NMIBC patients experience at least one recurrence, and LG-IR-NMIBC patients are even more likely to recur and face repeated TURBT procedures. Learn more about non-muscle invasive bladder cancer at www.BladderCancerAnswers.com.

About OPTIMA II

OPTIMA II (OPTimized Instillation of Mitomycin for Bladder Cancer Treatment) was an open-label, single-arm, multi-center Phase 2b clinical trial of ZUSDURI to evaluate its safety and efficacy in patients with LG-IR-NMIBC.

Learn more about the Phase 2b OPTIMA II trial at www.clintrials.gov (NCT03558503).

Lantern Pharma Secures EU Patent Allowance for LP-284, Bolstering Global IP Position for AI-Developed Cancer Therapy

On July 21, 2025 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical-stage oncology company leveraging its proprietary RADR artificial intelligence (AI) platform to accelerate drug discovery, reported that the European Patent Office (EPO) has issued a notice of allowance for a composition of matter patent covering its drug candidate LP-284 (Press release, Lantern Pharma, JUL 21, 2025, View Source [SID1234654464]). This patent, expected to be granted in the coming months with exclusivity through early 2039, strengthens Lantern’s global intellectual property (IP) portfolio and supports the development and commercialization path for LP-284, a novel therapy in development for relapsed or refractory non-Hodgkin’s lymphoma (NHL), including mantle cell lymphoma (MCL) and high-grade B-cell lymphomas (HGBL).

LP-284, a next-generation acylfulvene, was optimized using Lantern’s RADR platform, which identified its synthetically lethal mechanism targeting cancer cells with DNA damage repair deficiencies. Currently in a Phase 1 clinical trial (NCT06132503), LP-284 has demonstrated preclinical potential in addressing aggressive NHL subtypes, including MCL and double-hit lymphoma (DHL). The drug candidate has earned Orphan Drug Designations from the U.S. FDA for both MCL and HGBL, highlighting its role in tackling rare cancers with significant unmet needs.

Expanding Global Patent Protection

The EU patent complements a composition of matter patent granted in Japan (June 2024) and the U.S. (April 2023), with additional patent allowances grants in India and Mexico, and applications pending in China, Australia, Canada, and Korea. This expanding international IP portfolio positions LP-284 for global commercialization and strategic partnerships.

"The EU patent allowance for LP-284 is a critical milestone that enhances our ability to deliver this AI-advanced therapy to patients globally," said Panna Sharma, President and CEO of Lantern Pharma. "Our RADR platform enabled us to rapidly advance LP-284’s unique mechanism, achieving clinical trial readiness in under three years at a cost of approximately $1.5 to $2.0 million. This patent reinforces our commitment to precision oncology and creates opportunities for strategic collaborations with biotech partners."

Addressing Significant Market Need

LP-284 targets a global market estimated at $4 billion annually for blood cancers, driven by the rising incidence of NHL globally. Nearly all patients diagnosed with aggressive NHL subtypes like MCL will relapse after treatment, creating an urgent need for novel therapeutic approaches.

Lantern’s RADR platform, powered by over 200 billion oncology-focused data points and 200+ machine learning algorithms, has streamlined LP-284’s development, reducing timelines and costs compared to traditional drug discovery. This efficiency and capability positions Lantern to attract investment and partnerships with biotech and pharma companies seeking innovative oncology solutions.

About LP-284

LP-284 is an investigational next-generation acylfulvene designed to exploit synthetic lethal interactions in cancer cells with DNA damage repair deficiencies. Developed with guidance from Lantern’s AI platform RADR, LP-284 represents a novel therapeutic approach for treating relapsed or refractory non-Hodgkin’s lymphoma and other hematologic malignancies. The compound is currently being evaluated in a Phase 1 clinical trial (NCT06132503) to determine its safety profile, optimal dosing, and preliminary efficacy in patients with aggressive NHL subtypes who have failed standard therapies.

LP-284 has received multiple Orphan Drug Designations from the U.S. FDA, including designations for mantle cell lymphoma and high-grade B-cell lymphomas, recognizing its potential to address significant unmet medical needs in rare cancer populations.

Cycle Pharmaceuticals Signs Exclusive U.S. Sales License for PHYRAGO™ (dasatinib) Tablets

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.

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)

Vicebio, next-generation vaccine biotech, to be acquired by Sanofi for US$1.6 billion

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.

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."