On July 16, 2025 SN BioScience reported that its anticancer candidate SNB-101 has been selected as a clinical-stage project under the 2025 Korea Drug Development Project, a government-initiated program led by the Korea Drug Development Fund (KDDF) (Press release, SN BioScience, JUL 16, 2025, View Source [SID1234654417]). The program includes two years of research support, aiding the company’s advancement of SNB-101 into global Phase 1b/2 trials.

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The Korea Drug Development Fund (KDDF) is a government agency funded by three ministries. It aims to actively fund and provide necessary support for drug development in academia and the pharmaceutical industry.

As Korea’s most authoritative national drug development platform, the KDDF is dedicated to advancing innovative drug development projects, spanning the entire process from early discovery to clinical stages.

SNB-101 is a polymeric nanoparticle-based nanoformulation of SN-38, the potent active metabolite of irinotecan, a topoisomerase I inhibitor in the Camptothecin class. Utilizing its proprietary dual nanomicelle platform, the drug is designed to maximize tumor-specific targeting by leveraging the Enhanced Permeability and Retention (EPR) effect, thereby enhancing therapeutic efficacy while minimizing toxicity to healthy tissues.

SNB-101 has already garnered international recognition through multiple regulatory designations as a next-generation anticancer therapy. The U.S. FDA has granted SNB-101 Orphan Drug Designation for both small cell lung cancer (SCLC) and pancreatic cancer, and has also granted Fast Track Designation for SCLC — a regulatory green light to accelerate its development timeline.

SN BioScience is set to launch a multinational Phase 1b/2 clinical trial for patients with extensive-stage small cell lung cancer (ES-SCLC), spanning key sites across South Korea, the United States, and Europe. The study will focus on dose optimization, safety, and efficacy, with particular emphasis on enrolling a racially and ethnically diverse patient population to support early commercialization efforts.

Given the aggressive nature and poor prognosis of this rare cancer, SNB-101 is gaining attention as a potential second- or third-line treatment for patients who have failed existing therapies. Furthermore, the company is exploring combination strategies with immunotherapies to position SNB-101 as a potential first- or second-line standard of care in the future.

"SNB-101 represents our commitment to overcoming the limitations of conventional cancer therapies," said Young-Hwan Park, CEO of SN BioScience. "This national grant will accelerate our global clinical development and solidify SNB-101’s position as a next-generation anticancer therapy."

On July 16, 2025 Kairos Pharma, Ltd. (NYSE American:KAPA), a clinical-stage biopharmaceutical company focused on innovative cancer therapeutics, reported participation and presentation at the H.C. Wainwright 27th Annual Global Investment Conference, taking place September 8–10, 2025, at the Lotte New York Palace Hotel in New York City (Press release, Kairos Pharma, JUL 16, 2025, View Source [SID1234654418]). Kairos Pharma will participate in on-on-one meetings and present at the meeting which will be available virtually and hosted on the kairospharma.com website.

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John Yu, MD, CEO and Chairman, will be hosting one-on-one meetings during the meeting September 8-10. To register for one-on-one meetings with management at The Lotte New York Palace Hotel in New York City.

On July 16, 2025 MAA Laboratories reported that it has received formal written scientific advice from the Federal Institute for Drugs and Medical Devices (BfArM) in Germany for its Dasatinib Nanoparticle Tablets (Press release, MAA Laboratories, JUL 16, 2025, View Source [SID1234654403]).

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The advice supports MAA’s ongoing development efforts and provides regulatory clarity for advancing the program in the European Union. Importantly, the feedback from BfArM is consistent with guidance previously received from the U.S. Food and Drug Administration (FDA), further validating the Company’s development strategy and the scientific strength of its NanoCont platform.

"We are grateful for BfArM’s constructive guidance," said Dr. Anjani Jha, CEO of MAA Laboratories. "The alignment between U.S. and EU regulators provides strong validation for our regulatory and clinical approach and reinforces our confidence in the potential of our nanoparticle-based therapies."

MAA Laboratories remains committed to delivering differentiated therapies that improve patient outcomes through enhanced drug delivery, tolerability, and systemic performance. The Company looks forward to initiating clinical studies and advancing its broader pipeline across global markets.

On July 16, 2025 Amphista Therapeutics ("the Company" or "Amphista"), a leader in the discovery of next-generation, Targeted Protein Degradation (TPD) medicines, reported the successful achievement of a discovery research milestone under its exclusive research collaboration and licence agreement with Merck (Press release, Amphista Therapeutics, JUL 16, 2025, View Source [SID1234654404]). In conjunction with the milestone achievement, Amphista receives a pre-specified financial payment. The associated target on which the milestone is triggered is currently undisclosed.

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"As we continue to build our portfolio of first- and/or best-in-class Targeted Glues, we are delighted to have reached an important milestone in our collaboration with Merck. The progress we have made together speaks to the effective partnership between scientists from both companies, enabling us to focus on advancing high-quality compounds for further development," said Antony Mattessich, Chief Executive Officer at Amphista. "This achievement reinforces the exceptional capabilities of our Eclipsys platform in the rational design of orally bioavailable protein degraders, bringing us a step closer to improving patient outcomes."

Under the agreement, Amphista is responsible for the discovery and early development of small molecule protein degraders using its Eclipsys platform. Merck is granted a global exclusive license to the resulting degrader molecules and will be responsible for further development and commercialisation activities.

On July 16, 2025 Genmab A/S (Nasdaq: GMAB) reported 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 3,539 million in the second quarter of 2025 (Press release, Genmab, JUL 16, 2025, View Source [SID1234654407]). Net trade sales were USD 2,017 million in the U.S. and USD 1,521 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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