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 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 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 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 15, 2025 Hoth Therapeutics, Inc.(NASDAQ: HOTH), a biopharmaceutical company focused on developing innovative therapies for patients with high unmet medical needs, reported positive interim data from the open-label portion of its Phase 2a clinical trial, CLEER-001, evaluating HT-001 for the treatment of pruritus associated with skin toxicities caused by Epidermal Growth Factor Receptor (EGFR) inhibitors (Press release, Hoth Therapeutics, APR 15, 2025, View Source [SID1234651942]).

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EGFR inhibitors, widely used in oncology, are often associated with skin-related adverse effects, including intense itching, which can impair quality of life and reduce treatment compliance. HT-001 is designed to address this significant unmet need.

Key Interim Results (Day 1–21):

● Patients experienced a 50% reduction in pruritus severity, with mean scores dropping from 1.6 on Day 1 to 0.8 by Day 21.

● Rapid symptom relief was observed, with mean scores improving to 1.0 by Day 7.

● Some patients achieved complete resolution of pruritus within the 21-day period.

● HT-001 was well tolerated, with no treatment-related serious adverse events reported.

"These findings support the potential of HT-001 to deliver meaningful relief for cancer patients experiencing EGFR-related pruritus," said Robb Knie Chief Executive Officer of Hoth Therapeutics. "Cutaneous toxicities can significantly impact quality of life and may interfere with treatment. Our goal is to provide a safe and effective therapy that enhances patient comfort and continuity of care. This data along with our initial results released in January give us further belief in the promise of HT-001."

The CLEER-001 study is ongoing, with both cohorts in effect including the randomized, double-blind portion of the trial.

Hoth would like to thank Mr. Graig Springer who will be leaving our board as his professional position and family life both expand. Mr. Springer has not only been a superb board member, but he has been a great sounding board for the company and we wish Graig much success in all his endeavors.