On April 17, 2025 Endevica Bio, a privately held company developing first-in-class peptide drug candidates, reported the dose administration for the first patient in a Phase 2 trial for its experimental drug TCMCB07 (B07) to prevent weight loss in cancer patients undergoing chemotherapy (Press release, Endevica Bio, APR 17, 2025, View Source [SID1234651979]).

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The trial, being conducted in partnership with WuXi Clinical, will include 20 sites and 100 patients who are diagnosed with stage 4 metastatic colorectal cancer.

In the trial, patients are dosed with B07 as they begin chemotherapy and during the first several rounds of chemotherapy. The primary endpoint is preventing weight loss, which can lead to a debilitating condition called cachexia, a life-threatening wasting syndrome associated with chronic diseases, including cancer.

"This marks an important milestone in our commitment in developing a potentially life changing treatment for cachexia," said Russell Potterfield, Chief Executive Officer and Executive Chair of Endevica. "Each trial brings us closer to offering a viable solution for this debilitating disease, and we remain dedicated to making a lasting impact on the lives of those affected."

"We are incredibly excited to have our first patient dosed with B07 in individuals diagnosed with metastatic colorectal cancer who are undergoing chemotherapy," said Dr. Daniel Marks, Chief Medical and Scientific Officer of Endevica Bio. "Since there is no FDA approved therapeutic for cancer cachexia, this trial is a crucial step to provide a therapy for an area of huge unmet clinical need, and we look forward to the results."

In 2024, Endevica Bio completed its Phase 1 clinical trial with preliminary findings supporting its strong safety and efficacy. Last November, the Journal of Clinical Investigation, showed that B07 improved the appetite and preserved lean mass and fat mass in rodent models of cancer and its associated combination chemotherapy. This same study showed the strong potential of B07 to alleviate chemotherapy-induced anorexia and weight loss for millions of patients worldwide.

About TCMCB07
TCMCB07 is a melanocortin‐3/4 antagonist peptide candidate in clinical development for the treatment of cachexia. It is designed to be a first-in-class peptide drug with the ability to cross the blood-brain barrier and act on previously inaccessible target receptors to modulate the body’s behavioral and metabolic response to chronic illness. Pre-clinical animal trial results show significant lean muscle mass retention (e.g., a reversal of the cachectic condition) during administration of the drug. The results are consistent in cachexia arising from many different types of chronic disease.

On April 17, 2025 nference, a company dedicated to transforming healthcare by making biomedical data computable, reported a collaboration with BeiGene, Ltd, a global oncology company that intends to change its name to BeOne Medicines Ltd., to unlock new insights in treating B-cell cancers (Press release, BeiGene, APR 17, 2025, View Source [SID1234651978]). The collaboration will leverage nference’s proprietary Agentic AI platform to deepen understanding of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) treatment patterns.

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B-cell cancers, including CLL and SLL, are a group of malignancies affecting lymphocytes, a type of white blood cell crucial to immune function. These cancers impact thousands, with CLL being the most common adult leukemia in the U.S. This retrospective descriptive analysis will review more than 700 patient charts to identify real-world treatment patterns.

"Through this collaboration with BeiGene, we aim to uncover valuable real-world insights into treatment patterns and outcomes, helping refine clinical practices," said Dr. Venky Soundararajan, Co-founder and Chief Scientific Officer at inference. "Our goal is to generate a comprehensive view of real-world outcomes that enhances clinical decisions, leading to more effective, personalized care for patients with CLL, SLL, and other B-cell malignancies."

On April 17, 2025 Hoth Therapeutics, Inc.(NASDAQ: HOTH), a clinical-stage biopharmaceutical company developing next-generation RNA-targeted precision therapies, reported it has been granted a key patent by the Japan Patent Office (JPO), expanding its global intellectual property portfolio in RNA-based cancer therapeutics (Press release, Hoth Therapeutics, APR 17, 2025, View Source;expands-global-ip-in-precision-oncology-platform-302431170.html [SID1234651977]).

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The newly issued patent secures broad claims covering antisense oligomers that target the KIT gene — a clinically validated oncogene associated with gastrointestinal stromal tumors (GIST), leukemia, mastocytosis, and other cancers. These oligomers are designed to alter pre-mRNA splicing or reduce KIT protein expression, offering a highly targeted therapeutic mechanism.

"This patent significantly strengthens Hoth’s position in the RNA therapeutics space and marks a major milestone in our global strategy," said Robb Knie, CEO of Hoth Therapeutics. "Targeting the KIT pathway with antisense technology represents a precision-driven approach that holds immense potential in oncology and beyond. This grant provides strong validation and global momentum as we continue advancing our RNA platform toward the clinic."

The patent includes coverage for:

Antisense RNA molecules comprising 10–50 nucleotides targeting KIT pre-mRNA splicing sequences
Morpholino and chemically modified antisense variants
Pharmaceutical compositions and expression vectors
Applications in both human and veterinary medicine
Why It Matters:
The KIT gene is implicated in aggressive and difficult-to-treat cancers. By leveraging antisense oligonucleotides (ASOs) to modulate KIT expression, Hoth is pioneering a novel RNA-based strategy that could bypass traditional small molecule resistance mechanisms. With this patent, Hoth now holds exclusive rights to develop, partner, and commercialize ASO-based therapies targeting KIT — a critical asset in the precision oncology space.

Key Highlights:

Patent grant accelerates Hoth’s global IP expansion in RNA-targeted therapies
Targets validated oncogene KIT, widely implicated in cancer progression and resistance
Supports pipeline momentum in oncology, immunology, and rare diseases
Creates licensing and partnership opportunities in high-growth therapeutic areas

On April 17, 2025 Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company, reported a sponsored research collaboration with Virginia Commonwealth University (VCU) to investigate Aramchol’s potential in overcoming drug resistance in gastrointestinal (GI) cancers. Under the Sponsored Project Agreement, VCU scientists will study Aramchol in preclinical models of advanced GI malignancies – focusing on colorectal and hepatocellular (liver) cancers – in combination with standard-of-care treatments (Press release, Galmed Pharmaceuticals, APR 17, 2025, View Source [SID1234651976]). The goal is to determine whether Aramchol’s novel mechanism of action can prevent or reverse resistance to therapies such as targeted kinase inhibitors and chemotherapies, thereby enhancing their efficacy against these aggressive tumors.

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This collaboration addresses a critical unmet need: GI cancers (including colon and liver cancers) are among the leading causes of cancer mortality worldwide, and treatment options are often limited by therapy resistance. By targeting Stearoyl-CoA Desaturase 1 (SCD1) – a key enzyme in fatty acid metabolism implicated in cancer progression – Aramchol offers a novel therapeutic strategy. Recent breakthrough research published in Nature Communications (View Source) has highlighted the role of lipid metabolic pathways (notably SCD1) in driving drug resistance in GI tumors. Leveraging these insights, the Galmed–VCU project will explore Aramchol’s ability to reprogram tumor metabolism and sensitize cancer cells to existing treatments, potentially delivering a breakthrough in resistance reversal for patients with few alternatives.

" A large proportion of patients with advanced HCC gain no long-term benefit from the approved 2nd line systemic therapy of tyrosine kinase inhibitors (TKIs) due to drug resistance, which keeps HCC a highly fatal disease. Most HCC patients receiving TKIs develop resistance within 6 months of treatment. Previous studies showed that SCD1 is highly expressed in some liver cancers, and its inhibition sensitizes cancer cells to TKIs" said Paul Dent, Ph.D. Professor, School of Medicine Biochemistry and Molecular Biology Virginia Commonwealth University. "The aim of the collaboration is to overcome mechanisms of drug resistance in cells exposed to Aramchol and FDA approved drugs. Based on these findings we would contemplate developing safe drug combinations that will block and circumvent drug resistance in HCC."

Strategic Expansion and Market Implications

For Galmed, the partnership with VCU is part of a strategic expansion beyond its historical focus on fibrotic liver diseases into the oncology arena. Aramchol (an oral therapy with a strong safety profile demonstrated in NASH/fibrosis trials) is the most clinically advanced SCD1 inhibitor, and its dual action on metabolic and fibrotic pathways presents a unique opportunity in cancer treatment. Allen Baharaff, President and CEO of Galmed, noted that this program aligns with the Company’s growth strategy and commitment to addressing diseases with high unmet need:

"HCC is the only major cancer for which death rates have not improved over the last 10 years. Tyrosine kinase inhibitors (TKIs) such as Sorafenib, Regorafenib and Lenvatinib are pivotal molecular targeted agents in advanced HCC.

"The clinical benefit of TKIs based systemic therapy for advanced HCC is limited due to drug resistance mediated by dysregulated lipid metabolism. Consequently, monoclonal antibodies (MABs) such as Atezolizumab & bevacizumab emerged as the first-line therapy for patients with HCC. However as 75% of patients are refractory to or intolerant to MABs and because of their high cost, the cost effectiveness is limited. Targeting lipid metabolism with Aramchol, a potent SCD1 inhibitor, is a promising emerging strategy to overcome TKIs therapy resistance in HCC and a combination of the two agents could replace MABs as a cost-effective 1st line treatment."

Through this sponsored research, Galmed and VCU seek to generate proof-of-concept data on Aramchol’s efficacy in an oncology setting. Positive findings could lay the groundwork for subsequent clinical development in cancer, expanding Galmed’s pipeline and creating value for investors and stakeholders. The Company’s extended patent runway for Aramchol (protected through 2035) further enhances the commercial prospects of any new oncological application by providing a long horizon for development and potential market exclusivity.

Galmed will provide funding and Aramchol materials, while VCU’s researchers – including experts from the VCU Massey Comprehensive Cancer Center – will conduct the studies and analyze outcomes. The collaboration leverages VCU’s deep expertise in cancer biology and drug resistance models along with Galmed’s decade-long experience with Aramchol in metabolic diseases. Both parties believe this partnership can accelerate the path toward a first-in-class therapy that tackles cancer resistance mechanisms head-on.

On April 17, 2025 Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, reported it has acquired the FDA-approved Abbreviated New Drug Application (ANDA) for trametinib tablets from Novugen (Press release, Hikma, APR 17, 2025, View Source [SID1234651975]). Hikma also announces it has entered into a commercial agreement with Novugen where Hikma will be responsible for all US sales and marketing of this product, which Novugen will manufacture and supply to Hikma.

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Trametinib is an orally administered kinase inhibitor medication used to treat certain cancers. When launched, Hikma will have 180 days of US generic market sales exclusivity for this product.

"Hikma’s Generics business is accelerating its efforts to expand its pipeline by developing and acquiring important medicines in growing therapeutic areas most needed by US patients and healthcare providers," said Dr. Hafrun Fridriksdottir, president of Hikma Generics. "Our acquisition of this cancer treatment strengthens our broad US pipeline of essential medicines and will further our ability to put better health within reach every day for millions of Americans."

"As cancer treatment remains a critical healthcare challenge, our partnership with Hikma reflects a shared commitment to ensuring the availability of effective, cost-efficient, and high-quality oncology treatments in the US," said Rahil Mahmood, Chief Executive Officer of Novugen. "This exclusive first-to-file molecule is a testament to Novugen’s innovation, regulatory excellence, and dedication to expanding access to high-barrier, niche products with limited alternatives—ensuring life-changing treatments reach more US patients. With Hikma’s strong market presence and commercial capabilities, this collaboration represents an excellent strategic synergy."

According to IQVIA, US sales of trametinib, sold under the brand name Mekinist (trametinib) Tablets, were approximately $436 million in the 12 months ending December 2024.

Hikma’s Generics business supplies a range of oral, inhalation and other generic and specialty products in the North American market, and has expertise in complex technologies, such as nasal sprays, where we are the largest supplier by volume in the US1.

1IQVIA MAT December 2024, volumes by eaches

Mekinist is a registered trademark of Novartis Pharma AG

This product has been approved for marketing in the United States by the US FDA. This product approval does not confer the right on Hikma, or any other party, to market this product outside the United States.