LaNova Medicines Receives CDE Approval to Initiate Phase II Trial of LM-24C5 (Anti-CEACAM5/4-1BB BsAb)

On August 7, 2025 LaNova Medicines Ltd. reported that its internally developed CEACAM5/4-1BB bispecific antibody, LM-24C5, has received approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China to initiate a Phase II clinical trial (Press release, LaNova Medicines, AUG 7, 2025, View Source [SID1234656022]). The trial will evaluate LM-24C5 in combination with other anti-tumor agents in patients with CEACAM5-positive advanced solid tumors.

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CEACAM5 (carcinoembryonic antigen-related cell adhesion molecule 5) is highly expressed in various solid tumors—including non-small cell lung cancer, colorectal cancer, and gastric cancer—making it a promising target for cancer therapy[1]. LM-24C5 is a conditionally activated bispecific antibody engineered using LaNova’s proprietary 4-1BB agonist platform. It is designed to simultaneously bind CEACAM5 on tumor cells and 4-1BB on immune cells, thereby directing and activating immune responses within the tumor microenvironment while minimizing off-target immune activation and associated systemic toxicities.

Preclinical studies have demonstrated that LM-24C5 can induce durable anti-tumor immune memory and exhibits synergistic effects when used in combination with other immunotherapeutic agents. These results support its potential to become a first-in-class immunotherapy.

LM-24C5 is currently in Phase I/II clinical development in the United States.

Genmab Announces Financial Results for the First Half of 2025

On August 7, 2025 Genmab reported Financial Results for the First Half of 2025 (Press release, Genmab, AUG 7, 2025, View Source [SID1234655264]).

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Half-yearly financial results 2025

On August 7, 2025 Merck KGaA reported second quarter 2025 results (Presentation, Merck KGaA, AUG 7, 2025, View Source [SID1234655046]).

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Q2 2025: Merck Delivers Profitable Organic Growth Amid Strong Currency Headwinds

On August 7, 2025 Merck, a leading science and technology company, reported its organic growth (Press release, Merck KGaA, AUG 7, 2025, View Source [SID1234655045]). Despite ongoing geopolitical uncertainties, Group net sales in the second quarter of 2025 increased by 2.0% organically compared with the year-earlier quarter, while EBITDA pre rose by 4.6% organically. Process Solutions within the Life Science business sector recorded another very strong quarter, while sales of Healthcare’s blockbuster drugs Mavenclad and Erbitux saw very strong growth. In addition, the Semiconductor Materials business within Electronics continued to grow, fueled by strong demand for AI technologies.

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Strand Therapeutics Raises $153 Million Series B Financing to Further Advance Programmable mRNA Therapeutic Pipeline

On August 7, 2025 Strand Therapeutics, a leader in next-generation mRNA-based therapeutics, reported $153M Series B funding led by Kinnevik, with new investors Regeneron Ventures, ICONIQ, Amgen Ventures, Alderline Group (the family office of Alex Gorsky), JIC-VGI, LG Technology Ventures, and Gradiant Corporation, with continued participation from existing investors including FPV Ventures, Playground Global, Eli Lilly and Company, ANRI, and Potentum (Press release, Strand Therapeutics, AUG 7, 2025, View Source [SID1234655013]). To date, Strand has raised over $250M. As part of the financing, Ala Alenazi, Ph.D., of Kinnevik, will join the company’s Board of Directors.

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The funding will advance Strand’s pipeline, led by STX-001, a programmable mRNA therapy that expresses the cytokine interleukin-12 (IL-12) directly from the tumor microenvironment. The company recently announced promising initial Phase 1 clinical data for patients with advanced solid tumors at the 2025 ASCO (Free ASCO Whitepaper) annual meeting, noting multiple RECIST responses (including cases of complete response and complete metabolic response), multiple cases of prolonged disease stabilization, and a favorable safety profile in treatment-resistant patients.

Earlier this year, Strand also presented preclinical data for STX-003, a world-first systemically administrable mRNA therapy with tumor targeting that is programmed to avoid off-target payload delivery (including liver avoidance), showing the first glimpse into the massive potential of their programmable mRNA genetic circuits. Data presented at the 2025 AACR (Free AACR Whitepaper) and ASGCT (Free ASGCT Whitepaper) annual meetings demonstrated the candidate’s potential to target expression of IL-12 to tumors following systemic administration of the LNP-mRNA drug, creating an effective anti-tumor therapy that was well tolerated.

IL-12 is a potent pro-inflammatory cytokine primarily produced by antigen-presenting cells such as macrophages and dendritic cells. IL-12 holds significant promise in cancer immunotherapy due to its robust immunostimulatory effects. STX-001 encodes IL-12 which Strand has designed so that it can reprogram the tumor microenvironment and stimulate a systemic anti-tumor immune response. Unlike traditional mRNA therapies, Strand’s approach uses self-replicating mRNA, ensuring localized and durable therapeutic activity.

"We believe programmable RNA is the next frontier in therapeutics, and Strand has built the leading platform to unlock it," said Christian Scherrer, Senior Investment Director and Head of Health and Bio at Kinnevik. "Their early clinical data is outstanding, and the systemic delivery capability has the potential to reshape how we treat disease, starting with cancer, with more disease targets on the horizon. We look forward to partnering with founders Jake and Tasuku and the entire team as they move into this next phase of growth."

"With support from our investors, we’re advancing our vision of developing safe, effective, and accessible therapies through programmable genetic medicines, especially for those patients with few treatment options," said Jake Becraft, PhD, CEO and Co-founder of Strand Therapeutics. "Our initial STX-001 Phase 1 data provides early and strong clinical validation of our platform’s capabilities. We have observed systemic immune activation and anti-tumor responses, including responses in non-injected lesions, across multiple tumor types. Now is an exciting period of expansion for our existing clinical work, as well as the exciting breakthrough assets in our pipeline, all with the potential to transform the treatment of cancer and other serious diseases."

Strand’s proprietary platform for programmable and potent mRNA therapeutics is the first of its kind. Its therapies combine best-in-class engineered next-generation mRNA modalities, such as self-replicating mRNA and circular RNA, with genetically programmed logic circuits, allowing for precise, controlled therapeutic payload delivery directly into the cells/tissues themselves. The novel approach brings the potential to effectively treat cancer and other deadly chronic diseases through its targeted therapies that are scalable, accessible, and expand the treatment landscape for patients desperately in need.

About STX-001

STX-001 is an investigational multi-mechanistic, synthetic self-replicating mRNA technology that expresses an IL-12 cytokine for an extended period of time, directly administered to tumors in order to promote immune modulation and antitumor activity. The company received IND clearance from the U.S. Food and Drug Administration (FDA) in December 2023 to initiate a Phase 1/2 clinical trial for STX-001, announced its first patient dosed just before the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting, and presented the first data of the trial at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting. Additional details can be found at clinicaltrials.gov, using identifier: NCT06249048.