On April 15, 2025 TJ Biopharma ("TJ Bio" or "Company"), a fully integrated biotech company focusing on discovery, development, manufacturing and commercialization of innovative biologics in the areas of autoimmune diseases, oncology and metabolic disorders, reported completion of patient enrollment in the Phase 2 stage of its ongoing Phase 2/3 clinical study evaluating uliledlimab, a differentiated CD73 antibody, in combination with toripalimab (doublet study) as first-line treatment for non-small cell lung cancer (NSCLC) (Press release, TJ Bio, APR 15, 2025, View Source [SID1234654002]). The Company anticipates topline data readout in the first half of 2025 and intends to initiate a Phase 3 registrational study of the doublet study as planned.

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"Despite multiple challenges, our team successfully managed to complete the patient enrollment on track, demonstrating TJ Bio’s exceptional clinical operations capabilities," said Dr. Jingwu Zang, Founder and Chairman of TJ Bio. "The development of uliledlimab, a cornerstone of our staged pipeline, is accelerating steadily. We’re confident in the clinical value of this therapy and look forward to upcoming data analysis results as we prepare for the Phase 3 study launch, aiming to provide more effective and innovative treatment options for lung cancer patients."

Earlier this year, TJ Bio initiated and dosed the first patient in another Phase 2 clinical study evaluating uliledlimab in combination with sintilimab and chemotherapy (triplet study) as first-line treatment for NSCLC. The Company is actively advancing both studies in China as planned.

About Uliledlimab
Uliledlimab (also known as TJD5) is a differentiated, humanized antibody against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine. Adenosine, in turn, binds to adenosine receptors on relevant immune cells and inhibits anti-tumor immune responses in the tumor microenvironment. Uliledlimab is expected to offer clinical benefits by suppressing tumor growth in concert with checkpoint therapies such as PD-(L)1 antibodies. Uliledlimab is effective in anti-tumor activities through a unique intra-dimer binding, leading to differentiated and favorable functional properties, as evident in preclinical and clinical studies.

Positive results from the Phase 1b/2 clinical study (NCT04322006) of uliledlimab in combination with toripalimab as first-line treatment for advanced non-small cell lung cancer (NSCLC) were presented at ASCO (Free ASCO Whitepaper) 2023: The combination therapy showed a 31% response rate in treatment-naïve NSCLC patients; notably, in patients with high CD73 expression and PD-L1 positivity, the response rate reached 63%. Biomarker analysis revealed a strong correlation between high tumor CD73 expression and treatment response, further supporting the potential of CD73 expression as a predictive biomarker. In September 2024, TJ Bio and Sanofi entered into strategic partnership for the development, manufacturing and commercialization of uliledlimab in Greater China.

On April 15, 2025 Flamingo Therapeutics ("Flamingo") reported that an abstract has been accepted for presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting being held in Chicago, IL from April 25-30, 2025 (Press release, Flamingo Therapeutics, APR 15, 2025, View Source;utm_medium=rss&utm_campaign=flamingo-therapeutics-announces-poster-presentation-on-the-immune-modulatory-effects-of-danvatirsen-at-the-american-association-for-cancer-research-aacr-annual-meeting [SID1234651940]).

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Poster presentation details are as follows:

Poster Title: "ASO-mediated STAT3 knockdown relieves immunosuppression sensitizing tumors to immunotherapies"

Session Category/Title: Immunology/Modulation of Tumor Microenvironment: Enhancing Immunogenicity and Counteracting Suppression

Session Time: 4/28/2025 9:00:00 AM – 12:00:00 PM

Location: Poster Section 38

Published Abstract Number: 2244

For more information, please visit the AACR (Free AACR Whitepaper) Annual Meeting 2025 website.

On April 15, 2025 Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company dedicated to developing novel treatments for liver, cardiometabolic, and gastrointestinal oncology indications, reported the unveiling of novel pharmacodynamic (PD) blood markers for its lead compound, Aramchol, the industry’s most clinically advanced SCD1 inhibitor (Press release, Galmed Pharmaceuticals, APR 15, 2025, View Source,-the-Most-Clinically-Advanced-SCD1-Inhibitor [SID1234652231]). These newly identified biomarkers shed fresh light on Aramchol’s potential far beyond its role in NASH (MASH) therapy—offering a deeper understanding of the drug candidate’s biochemical impact and presenting an exciting opportunity to enhance clinical decision-making and expand into additional disease areas.

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In collaboration with Proteas Health, a leader in innovative protein biomarker and targeted assay development, Galmed has pinpointed plasma markers that track Aramchol’s therapeutic impact through cutting-edge proteomics and AI technologies. Specifically, a panel of 70 proteins expressed at Week 12 of Aramchol treatment (compared with baseline) was captured in the Company’s Phase 3 ARMOR MASH study. This panel forms an actionable, single blood-based pharmacodynamic signature to monitor and potentially predict patient response, encompassing both systemic and local (liver) effects.

Galmed’s analysis revealed that this signature aligns with reduced chronic systemic inflammation, oxidative stress, and atherosclerotic plaque pathogenesis—key drivers in cardiometabolic diseases. Significantly, the data also demonstrate a marked reduction in ANP (Atrial Natriuretic Peptide), widely recognized as an established clinical biomarker for heart failure and left ventricular dysfunction. Moreover, the findings indicate a stimulated expression of KDM4C, a protein known to play a role in repressing liver fibrosis. Altogether, these insights underscore Aramchol’s broad therapeutic relevance and create valuable opportunities for Galmed to expand its clinical pipeline and address additional cardiometabolic and potentially oncological indications.

Allen Baharaff, CEO of Galmed Pharmaceuticals commented: "The newly discovered markers showed significant expression in untreated patients at baseline and were reversed following treatment with Aramchol. These PD markers could serve as a liquid biopsy as an early indicator of Aramchol’s efficacy in clinical settings. Additionally, the observed significant effects on cardiometabolic biomarkers open future research avenues for Aramchol in CVD and related conditions".

The collaboration with Proteas Health aims to translate these discoveries into a streamlined, cost-efficient, high-throughput assay that directly measures Aramchol’s unique PD signature. Such an assay, once validated, could bolster Galmed’s forthcoming clinical trials by further de-risking development and allowing clinicians to evaluate drug response in real time.

"Through this collaboration, Proteas Health and Galmed aim to develop a cost-effective, high-throughput assay targeting Aramchol’s unique pharmacodynamic signature. This assay could play a pivotal role in Galmed’s future clinical trials, accelerating the efforts to bring Aramchol to market" said Dr. Antigoni Manousopoulou, MD, PhD, Co-Founder and Chief Scientific Officer at Proteas Health. "By focusing on targeted pharmacodynamic biomarkers, Proteas Health is not just enhancing drug development Proteas Health ensuring therapies are tailored to achieve maximum benefit with minimal risk."

These promising data underscore Galmed’s growing momentum: by combining innovative biomarker strategies with Aramchol’s safety and efficacy profile, the Company believes it is well-positioned to broaden its market reach and deliver significant value to patients and stakeholders alike. Given the global burden of cardiometabolic and fibro-inflammatory conditions, the ability to demonstrate and monitor Aramchol’s impact through a single blood test has the potential to transform future clinical development and create new horizons for commercialization.

On April 15, 2025 Genmab A/S (Nasdaq: GMAB) reported that worldwide net trade sales of DARZALEX (daratumumab), including sales of the subcutaneous (SC) product (daratumumab and hyaluronidase-fihj, sold under the tradename DARZALEX FASPRO in the U.S.), as reported by J&J were USD 3,237 million in the first quarter of 2025 (Press release, Genmab, APR 15, 2025, View Source [SID1234651941]). Net trade sales were USD 1,829 million in the U.S. and USD 1,409 million in the rest of the world. Genmab receives royalties on the worldwide net sales of DARZALEX, both the intravenous and SC products, under the exclusive worldwide license to J&J to develop, manufacture and commercialize daratumumab.

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On April 14, 2025 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported that data on investigational drug UGN-102 (mitomycin) for intravesical solution, JELMYTO (mitomycin) for pyelocalyceal solution and UGN-301 (zalifrelimab) will be presented at the American Urological Association (AUA) 2025 Annual Meeting being held in Las Vegas, Nevada from April 26-29 (Press release, UroGen Pharma, APR 14, 2025, View Source [SID1234651908]).

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"We are thrilled to present the 18-month DOR data on UGN-102, along with additional data on JELMYTO and our investigational drug UGN-301 (zalifrelimab) an anti-CTL4 antibody in development for the treatment of recurrent non-muscle invasive bladder cancer, at the AUA Annual Meeting," said Mark Schoenberg, Chief Medical Officer, UroGen. "These data highlight the potential of our portfolio to offer significant advancements in the treatment of urothelial cancers."

Key details of UGN-102, JELMYTO and UGN-301 abstracts accepted by AUA:

UGN-102

Abstract Title

Presentation Details

Presenter

Treatment of recurrent low-grade intermediate-risk non-muscle invasive bladder cancer with UGN-102: ongoing results from a single-arm, open-label, phase 3 trial (ENVISION)

Podium Oral Presentation:

Abstract ID: PD12 – Galileo 1001

Saturday, April 26, 2025

3:30 PM – 5:30 PM

Dr. Sandip Prasad

Patient-reported side-effect burden for patients with low-grade intermediate-risk non-muscle invasive bladder cancer receiving treatment with UGN-102 (UGN-102 Integrated PROs)

Moderated Poster – MP15

Marco Polo 703

Sunday, April 27, 2025

9:30 AM – 11:30 AM

Dr. Charles Peyton

Treatment of low-grade intermediate-risk non-muscle invasive bladder cancer with UGN-102: long-term outcomes of the (OPTIMA II LT study)

Moderated Poster – MP15 –

Marco Polo 703

Sunday, April 27, 2025

9:30 AM – 11:30 AM

Dr. Neal Shore

JELMYTO

Long-term outcomes of treatment of recurrent or new-onset low-grade upper tract urothelial carcinoma with UGN-101, a mitomycin reverse thermal gel (OLYMPUS LT)

Interactive poster – IP12 – Casanova 501

Sunday, April 27, 2025

1:00 PM – 3:00 PM (IP12)

Dr. Brian Hu

UGN-301

Treatment of recurrent non-muscle invasive bladder cancer with UGN-301 (zalifrelimab): results of a phase 1 dose-escalation study (UGN-301-MONO)

Interactive Poster – IP02 – Marco Polo 701

Saturday, April 26, 2025

7:00 AM – 9:00 AM

Dr. Jay Raman

UroGen is a Founders’ Circle Sponsor of the AUA Innovation Nexus Conference
UroGen’s President and Chief Executive Officer, Liz Barrett, will participate in a Showcase Panel discussion on April 25, alongside exciting urology startups that span the globe and are developing products—devices, artificial intelligence platforms, diagnostic tests, etc.—covering a variety of urologic issues such as prostate and bladder cancer, kidney injuries, fertility testing, nocturnal enuresis, overactive bladder, and interstitial cystitis. Liz will also take part in the Founders’ Circle Awards Presentation.

The AUA Innovation Nexus is a powerful forum to advance urologic discovery to solutions that improve patient care and save lives. Register here: View Source

About UGN-102
UGN-102 (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin, currently in Phase 3 development for the treatment of recurrent LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel technology, a sustained release, hydrogel-based formulation, UGN-102 is designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. UGN-102 is delivered to patients using a standard urinary catheter in an outpatient setting by a trained healthcare professional. UroGen completed the submission of the rolling new drug application (NDA) for UGN-102 in August 2024, ahead of schedule. The FDA accepted the NDA for UGN-102 and assigned a Prescription Drug User Free Act (PDUFA) goal date of June 13, 2025.

About Non-Muscle Invasive Bladder Cancer (NMIBC)
In the U.S., bladder cancer is the second most common urologic cancer in men. LG-IR-NMIBC represents approximately 23,000 newly diagnosed bladder cancer patients each year and an estimated 59,000 recurrences annually among patients diagnosed in previous years. 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.

About JELMYTO
JELMYTO (mitomycin) for pyelocalyceal solution is a mitomycin-containing reverse thermal gel containing 4 mg mitomycin per mL gel indicated for the treatment of adult patients with LG-UTUC. It is recommended for primary treatment of biopsy-proven LG-UTUC in patients deemed appropriate candidates for renal-sparing therapy. JELMYTO is a viscous liquid when cooled and becomes a semi-solid gel at body temperature. The drug slowly dissolves over four to six hours after instillation and is removed from the urinary tract by normal urine flow and voiding. It is approved for administration in a retrograde manner via ureteral catheter or antegrade through nephrostomy tube. The delivery system allows the initial liquid to coat and conform to the upper urinary tract anatomy. The eventual semisolid gel allows for chemoablative therapy to remain in the collecting system for four to six hours without immediately being diluted or washed away by urine flow.

About UGN-301
UGN-301 is our investigational, in-licensed, anti-CTLA-4 monoclonal antibody (zalifrelimab), prepared with reverse-thermal hydrogel for intravesical administration into the bladder. Intravesical administration of UGN-301 is designed to increase drug concentrations in the bladder without significant systemic exposure, potentially diminishing the systemic toxicity associated with CTLA-4 blockade.

UroGen is evaluating UGN-301 as a monotherapy and as combination therapy for the intravesical treatment of high-grade NMIBC. UroGen is evaluating UGN-301, in a multi-arm Phase 1 study of UGN-301 as monotherapy and in combination with other agents.