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 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, reported the treatment of the first participant with their first dose of 8 GBq of 67Cu-SAR-bisPSMA in the Cohort Expansion Phase of the SECuRE trial (NCT04868604) (Press release, Clarity Pharmaceuticals, APR 15, 2025, View Source [SID1234651939]).

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The dosing of this participant follows the recent successful completion of the Dose Escalation Phase (Phase I) of the trial and subsequent SRC recommendation to progress to the Cohort Expansion Phase (Phase II) at the 8 GBq dose level, with an increase in the total number of cycles from up to 4 to up to 6. This recommendation is based on the favourable safety profile and efficacy of 67Cu-SAR-bisPSMA observed to date.

This participant will be receiving the combination of 8 GBq of 67Cu-SAR-bisPSMA and enzalutamide (ARPI), allowed by a recent protocol amendment. This amendment incorporated an increase in the number of participants in this cohort from 14 to 24, in which a subset of participants will receive this combination therapy. These changes are aligned with the positive results from the Enza-p trial3 and the ongoing discussions with and advice from key global medical experts in the field of prostate cancer, including the Company’s Clinical Advisory Board members, Prof Louise Emmett and Prof Oliver Sartor, as well as the SRC.

The recently amended SECuRE trial protocol will also focus on the evaluation of metastatic castration-resistant prostate cancer (mCRPC) participants in the pre-chemotherapy setting. This aligns with Clarity’s strategy of bringing 67Cu-SAR-bisPSMA to earlier stages of the disease and is based on its promising safety and efficacy data, especially in pre-chemotherapy participants treated in the SECuRE trial to date. In the Dose Escalation Phase, preliminary data showed that 92% of pre-chemotherapy participants (12/13) demonstrated prostate-specific antigen (PSA) drops greater than 35%, PSA reductions greater than 50% were reached in 61.5% (8/13) of participants, and reductions of 80% or more were achieved in 46.2% (6/13) of participants. These outstanding results were achieved despite many of the 13 pre-chemotherapy participants having considerable disease burden, being heavily pre-treated, and the majority of them only receiving a single dose of 67Cu-SAR-bisPSMA2.

In preparation for the Cohort Expansion Phase, Clarity rolled out its improved 67Cu-SAR-bisPSMA product formulation. The enhanced formulation allows for room temperature stability, supply and scalability, which are essential for late-stage clinical trials and streamlined commercial-scale manufacture.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "We are incredibly excited about the progress we’ve achieved in the SECuRE trial to date and look forward to continuing to generate promising data in the Cohort Expansion Phase.

"With the latest protocol amendments ensuring that we are utilising the most recent advances and knowledge in the radiopharmaceutical space, we continue to be driven by the highest standards of clinical trial management and research. At Clarity, we are committed to working with various key opinion leaders in the field and incorporating the most recent findings into our study design to maximise the probability of clinical trial success and positive patient outcomes. As a result, we are focused on bringing 67Cu-SAR-bisPSMA to earlier lines of prostate cancer therapy, especially in the pre-chemotherapy setting, where we have seen very promising safety and efficacy to date. We are also investigating the benefits of combination therapy, where SECuRE participants are being treated with 67Cu-SAR-bisPSMA and enzalutamide based on the results from Prof Emmett’s Enza-p trial and in consultation with global thought leaders in the prostate cancer space.

"We are committed to continuously improving our product and took the opportunity to advance our 67Cu-SAR-bisPSMA formulation prior to dosing our first patients in the Cohort Expansion Phase of the trial. The improvements also help us prepare for the large-scale manufacture in a potential Phase III trial and during commercialisation, allowing for room temperature stability with considerable advantages for supply and scalability. The ability to manufacture 67Cu-SAR-bisPSMA under room temperature reduces the likelihood of batch failures which lead to common supply issues and subsequent product shipment delays. Through the improvements in formulation, we hope that no patient is left waiting for their 67Cu-SAR-bisPSMA treatments.

"We thank our community, our team, Principal Investigators, members of the SRC, and especially the participants who have contributed to the SECuRE study so far. Armed with favourable safety and efficacy data from the Dose Escalation cohorts and with 3 US Food and Drug Administration (FDA) Fast Track Designations for the SAR-bisPSMA molecule, 1 for therapy and 2 for diagnostics, we are closer than ever to delivering on our ultimate goal of improving treatment outcomes for people with cancer."

About the SECuRE trial
The SECuRE trial (NCT04868604)1 is a Phase I/IIa theranostic trial for identification and treatment of participants with PSMA-expressing mCRPC using 64Cu/67Cu-SAR-bisPSMA. 64Cu-SAR-bisPSMA is used to visualise PSMA-expressing lesions and select candidates for subsequent 67Cu-SAR-bisPSMA therapy. The trial is a multi-centre, single arm, dose escalation study with a cohort expansion involving approximately 54 participants in the US and Australia. The overall aim of the trial is to determine the safety and efficacy of 67Cu-SAR-bisPSMA for the treatment of prostate cancer.

About SAR-bisPSMA
SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two PSMA-targeting agents to Clarity’s proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.

On April 15, 2025 Avistone Biotechnology Co., Ltd ("Avistone"), an innovative biotechnology company focused on precision oncology therapeutics, reported that the preclinical data for ANS03, its novel, orally bioavailable Type II ROS1/NTRK tyrosine kinase inhibitor (TKI), will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025 (Press release, Avistone Pharmaceuticals, APR 15, 2025, View Source [SID1234651953]).

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The details of the poster presentation are provided below:

Poster title: ANS03, a novel, orally bioavailable small-molecule type II ROS1/NTRK inhibitor, effectively overcomes clinically relevant ROS1/NTRK resistance mutations and exhibits potent antitumor activity in preclinical tumor models
Abstract Number: 828
Session: Targeted Therapies and Combinations 1 (Clinical Research)
Location: Poster section 34, Board 16
Session Date/Time: April 27, 2025 | 2:00-5:00 PM CDT

The battle against ROS1 and NTRK fusion-positive cancers has seen major advances with next-generation tyrosine kinase inhibitors (TKIs) like repotrectinib, taletrectinib, which effectively suppress the recurrent resistance mutations such as G2032R (ROS1 SF mutation). However, the emergence of new resistance mechanisms, such as ROS1 L2086F (Cβ6) mutation, presents a growing clinical challenge and unmet need.

Non-clinical studies of ANS03 showed it was a potent, orally bioavailable Type II ROS1/NTRK inhibitor with remarkable activity against various pathogenetic ROS1/NTRK alterations (including ROS1: G2032R, D2033N, L2086F; NTRK: G667C, G595R-G667C) and with favorable absorption, distribution, pharmacokinetics, efficacy, and tolerability profiles.

"These findings suggest ANS03 could become the preferred therapeutic option for patients developing resistance to current ROS1/NTRK inhibitors," said Dr. Hepeng Shi, CEO of Avistone. "Its distinct Type II binding mode provides comprehensive coverage of clinically-relevant mutations while maintaining good CNS activity, which offers the potential to be explored as frontline therapy."

ANS03 is currently being evaluated in a global phase I study (NCT06716138) in adult patients with locally advanced or metastatic solid tumors harboring with ROS1 alterations, and in adult and pediatric patients (aged≥12 years) with NTRK alterations.

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.