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 Vaccinex reported its annual report for the year 2024 (Filing, 3 mnth, DEC 31, Vaccinex, 2024, APR 15, 2025, View Source [SID1234652129]).

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On April 15, 2025 Baylink Biosciences reported that new preclinical data from its portfolio will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting from April 25-30, 2025, in Chicago, IL (Press release, Baylink Biosciences, APR 15, 2025, https://www.baylinkbio.com/post/lorem-ipsum-dolor-sit-amet-consectetur-adipiscing-elit [SID1234652049]). These data provide insights into the potential of Baylink’s innovative Antibody Drug Conjugate platform in treatment of cancers with high unmet medical need. Scientists at Baylink have invented a platform technology that enables the delivery of a variety of payloads including hydrophobic chemotherapy and protein degrader drugs at a high drug to antibody ratio while preserving stability and pharmacokinetic characteristics to enable application in ADC format. The innovative linker panel combined with Baylink’s proprietary payloads create a deep well of products, including dual payload ADC designs, and Degrader Antibody Conjugates (DAC) with potential application in cancer treatment.

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Preclinical data from Baylink’s most advanced candidate (BLB-101) will be presented. BLB-101 is an antibody drug conjugate designed to target Claudin 6/9 and deliver the topoisomerase 1 inhibitor, exatecan in a highly efficient manner with a drug to antibody ratio of 8. Claudin 6 (CLDN6) is a tight junction protein that is highly expressed in various human cancers, including ovarian cancer, endometrial cancer, and non-small cell lung cancer (NSCLC), but is absent in normal adult tissues. Claudin 9 (CLDN9), which shares high homology with CLDN6, exhibits a similar expression pattern—being nearly undetectable in normal tissues but upregulated in ovarian and endometrial cancers.

Data generated to support the rationale for Baylink’s innovative linker platform will also be presented. Baylink’s linker platform is designed to reduce non-specific uptake into healthy tissues and cells while enhancing potency by improving ADC’s homogeneity, stability, PK, and efficacy. The platform also has the ability to deliver ADCs with multiple payload classes.

"We are very pleased to share these results from Baylink’s innovative antibody drug conjugate platform. The data presented at this year’s AACR (Free AACR Whitepaper) meeting demonstrate the potential for Baylink’s technology to overcome critical challenges in the ADC field," said Alice Chen, PhD, Chief Scientific Officer and Founder of Baylink. "In addition to sharing details on our platform technology, we are presenting data for one of our lead products, BLB-101, a novel antibody targeting CLDN6/9, conjugated to our linker BL001 delivering exatecan. We believe BLB-101 offers the potential for best in class performance for CLDN6/9+ tumors such as ovarian, endometrial, and lung cancer."

A linker platform for antibody drug conjugates (ADCs): expanding the therapeutic window

Poster number：7463

Session Date and Time: April 30, 2025, 9:00 AM – 12:00 PM

Preclinical evaluation of BLB-101, a topoisomerase-inhibitor-based anti-CLDN6/9 antibody-drug conjugate featuring a proprietary hydrophilic linker

Poster number：1578

Session Date and Time: April 28, 2025, 9:00 AM – 12:00 PM

On April 15, 2025 Baylink Biosciences reported that new preclinical data from its portfolio will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting from April 25-30, 2025, in Chicago, IL (Press release, Baylink Biosciences, APR 15, 2025, https://www.baylinkbio.com/post/lorem-ipsum-dolor-sit-amet-consectetur-adipiscing-elit [SID1234652037]). These data provide insights into the potential of Baylink’s innovative Antibody Drug Conjugate platform in treatment of cancers with high unmet medical need. Scientists at Baylink have invented a platform technology that enables the delivery of a variety of payloads including hydrophobic chemotherapy and protein degrader drugs at a high drug to antibody ratio while preserving stability and pharmacokinetic characteristics to enable application in ADC format. The innovative linker panel combined with Baylink’s proprietary payloads create a deep well of products, including dual payload ADC designs, and Degrader Antibody Conjugates (DAC) with potential application in cancer treatment.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Preclinical data from Baylink’s most advanced candidate (BLB-101) will be presented. BLB-101 is an antibody drug conjugate designed to target Claudin 6/9 and deliver the topoisomerase 1 inhibitor, exatecan in a highly efficient manner with a drug to antibody ratio of 8. Claudin 6 (CLDN6) is a tight junction protein that is highly expressed in various human cancers, including ovarian cancer, endometrial cancer, and non-small cell lung cancer (NSCLC), but is absent in normal adult tissues. Claudin 9 (CLDN9), which shares high homology with CLDN6, exhibits a similar expression pattern—being nearly undetectable in normal tissues but upregulated in ovarian and endometrial cancers.

Data generated to support the rationale for Baylink’s innovative linker platform will also be presented. Baylink’s linker platform is designed to reduce non-specific uptake into healthy tissues and cells while enhancing potency by improving ADC’s homogeneity, stability, PK, and efficacy. The platform also has the ability to deliver ADCs with multiple payload classes.

"We are very pleased to share these results from Baylink’s innovative antibody drug conjugate platform. The data presented at this year’s AACR (Free AACR Whitepaper) meeting demonstrate the potential for Baylink’s technology to overcome critical challenges in the ADC field," said Alice Chen, PhD, Chief Scientific Officer and Founder of Baylink. "In addition to sharing details on our platform technology, we are presenting data for one of our lead products, BLB-101, a novel antibody targeting CLDN6/9, conjugated to our linker BL001 delivering exatecan. We believe BLB-101 offers the potential for best in class performance for CLDN6/9+ tumors such as ovarian, endometrial, and lung cancer."

A linker platform for antibody drug conjugates (ADCs): expanding the therapeutic window

Poster number：7463

Session Date and Time: April 30, 2025, 9:00 AM – 12:00 PM

Preclinical evaluation of BLB-101, a topoisomerase-inhibitor-based anti-CLDN6/9 antibody-drug conjugate featuring a proprietary hydrophilic linker

Poster number：1578

Session Date and Time: April 28, 2025, 9:00 AM – 12:00 PM

About Baylink Biosciences innovative linker technology

Baylink’s linker technology was designed to overcome key challenges in the antibody drug conjugate field such as tumor resistance, lack of payload diversity, and narrow therapeutic window. Using proprietary, innovative linker designs, Baylink scientists created a panel of linkers enabling delivery of challenging drug payloads. Drugs that are hydrophobic in nature are problematic for delivery using traditional ADC linker technology. Baylink scientists incorporated design features into the linker technology that allows conjugation of these hydrophobic payloads with high DAR. Additionally, the linker technology effectively reduces non-tumor-antigen-specific uptake into healthy tissues and cells reducing potential for adverse events. The overall resulting ADCs have potential for better efficacy and safety. The platform is also enabling delivery of multiple payloads, so called dual payload ADCs.

On April 15, 2025 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, reported the online availability of new data on its lead compound REYOBIQ (rhenium Re186 obisbemeda) in an abstract for both an oral presentation and a poster to be presented at the Nuclear Medicine and Neurooncology conference to be held May 9-10, 2025 in Vienna, Austria (Press release, Plus Therapeutics, APR 15, 2025, View Source [SID1234651962]).

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The abstract, titled, "Rhenium Obisbemeda (REYOBIQ) in Leptomeningeal Metastases," highlights additional data from the Company’s completed Phase 1 ReSPECT-LM dose escalation trial demonstrating a dose dependent increase in the average absorbed dose to the cranial and spinal subarachnoid space reaching 253Gy in Cohort 5. Neuroimaging response data was available for 16 patients as of the data cutoff with five of those (31%) showing a partial response. An additional seven patients showed stable disease by neuroimaging through day 112 for a Clinical Benefit Rate (complete response + partial response + stable disease) of 75%. Additionally, a clinical response based on the physician evaluation showed a decrease in disease findings in two of 14 evaluable patients (14%) and 10 patients showed stable findings through day 112 for an 86% Clinical Benefit Rate. Furthermore, there was no dose limiting toxicity (DLT) observed in the first four cohorts, with a grade 4 DLT (thrombocytopenia), one in each of Cohorts 5 and 6.

Finally, RNA sequencing of LM cells showed early induction of apoptosis, with an innate immune response followed by an increase in T cells and an adaptive immune response by Day 28. Further details can be found here; the Company will provide additional data and explanation following the meeting.

"This newly-presented ReSPECT-LM data further reinforces our confidence in the potential utility of REYOBIQ in these critically ill patients with the devastating diagnosis of Leptomeningeal Metastases," said Marc H. Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer. "Reyobiq can be delivered at very high doses of radiation to the cancer at the recommended phase 2 dose and shows promising response data across multiple parameters while simultaneously being well tolerated by normal organs and tissues."

About Leptomeningeal Metastases (LM)
LM is a rare complication of cancer in which the primary cancer spreads to the cerebrospinal fluid (CSF) and leptomeninges surrounding the brain and spinal cord. All malignancies originating from solid tumors, primary brain tumors, or hematological malignancies have this LM complication potential with breast cancer as the most common cancer linked to LM, with 3-5% of breast cancer patients developing LM. Additionally, lung cancer, GI cancers and melanoma can also spread to the CSF and result in LM. LM occurs in approximately 5% of people with cancer and is usually terminal with 1-year and 2-year survival of just 7% and 3%, respectively. The incidence of LM is on the rise, partly because cancer patients are living longer and partly because many standard chemotherapies cannot reach sufficient concentrations in the spinal fluid to kill the tumor cells, yet there are no FDA-approved therapies specifically for LM patients, who often succumb to this complication within weeks to several months, if untreated.

About REYOBIQ (rhenium Re186 obisbemeda)
REYOBIQ (rhenium Re186 obisbemeda) is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. REYOBIQ has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. REYOBIQ is being evaluated for the treatment of recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT).