On October 14, 2025 Forlong Biotechnology, a clinical-stage biotech company focusing on developing transformative cytokine therapies for patients with severe unmet needs, reported that it has received the first milestone payment under its licensing and collaboration agreements with Shell BioTech and a third party.

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

                  Schedule Your 30 min Free Demo!

In 2020 Forlong and Shell BioTech, a CDMO in China, entered a technology development collaboration to leverage Forlong’s proprietary Fbody Technology Platform to develop long half-life peptide therapy for a third party. In 2025, Forlong and Shell BioTech entered into a licensing agreement with the third party for selected protein therapy candidates incorporating Fbody, and amended the initial collaboration agreement to restructure terms including upfront and milestones payments as well as royalty on future product sales. Following the upfront payment in 2025, this is the first milestone payment, triggered by IND submission for the Fbody-fusion protein therapy by the third party to China National Medical Products Administration.

Fbody Long-acting Technology is one of synthetic immunology platforms of Forlong. It is a single-chain Fc engineered to maintain FcRn affinity while eliminating binding of FcγRs and complement systems, aiming to optimize protein half-life and biodistribution. Forlong’s lead clinical candidate FL115 is an interleukin-15 (IL-15) superagonist incorporating Fbody. It is in multiple clinical studies in China and the United States, showing favorable safety profile and preliminary clinical responses in patients with advanced solid tumors, and is currently being advanced to combo therapy with PD-(L)1 antibodies in Phase I for patients with advanced solid tumors and combo therapy with Bacillus Calmette-Guérin (BCG) in Phase II for patients with nonmuscle invasive bladder cancer (NMIBC).

"We are excited to see another Fbody fusion protein therapy advancing into clinic, a significant milestone for our synthetic immunology platforms," said Dong Wei, Ph.D., Chief Executive Officer of Forlong Biotechnology, "FL115’s best-in-class potential in the challenging IL-15 superagonist class first showcased unique properties of Fbody, and this milestone further validates its ability to enhance profiles for variety of proteins beyond cytokines, and success of our out-licensing strategy and its ability to drive real-world impact through partnerships."

(Press release, Forlong Biotechnology, OCT 14, 2025, View Source [SID1234656666])

On October 14, 2025 Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, reported that clinical research results of its novel B7-H3-targeting ADC (R&D code: 7MW3711) for multiple advanced solid tumors, will be presented as a poster at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025.

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

                  Schedule Your 30 min Free Demo!

As of Sep. 15, 2025, 74 patients with advanced solid tumor were enrolled and treated with 7MW3711 in the phase I/II study. Among 54 patients treated at 4.0 mg/kg or above and reaching tumor assessment, 19 partial responses (PRs) or complete responses (CRs) were observed. 7 patients with esophageal cancer (EC) were enrolled at 4.0 mg/kg or above and achieved an objective response rate (ORR) of 42.9% and a disease control rate (DCR) of 100%. Among lung cancer patients treated at the 4.0 mg/kg Q2W and reaching tumor assessment, the ORR for small cell lung cancer (SCLC) and squamous non-small cell lung cancer (Sq-NSCLC) were 50.0% and 38.5% respectively, with DCR of 90.0% and 92.3% respectively.

No dose-limiting toxicities (DLTs) were observed in the dose escalation phase, and the maximum tolerated dose (MTD) has not yet been reached. The most common Grade ≥3 TEAEs were white blood cell (WBC) count decreased, neutrophil count decreased, anemia, lymphocyte count decreased, platelet count decreased.

The study results suggest encouraging efficacy of 7MW3711 in advanced solid tumors, especially in esophageal and lung cancer.

About 7MW3711

7MW3711 is a novel B7-H3-targeting ADC independently developed by Mabwell. Given the expression profile and distribution of B7-H3, ADCs targeting B7-H3 hold promising therapeutic potential for cancers with significant unmet medical needs, including lung cancer, sarcoma, prostate cancer, head and neck cancer, and esophageal carcinoma, indicating broad market prospects.

7MW3711 is pharmaceutical characterized as stable structure, homogeneous composition, high purity, and it is suitable for industrial scale-up. Compared with ADCs in the same class worldwide, 7MW3711 has shown better tumor killing effects in multiple animal tumor models. 7MW3711 utilizes a novel camptothecin payload, which demonstrates stronger antitumor activity than DXd payloads in preclinical studies. Developed with site-specific conjugation technology, 7MW3711 is a homogeneous ADC with a drug-antibody ratio of 4, ensuring optimal stability and batch-to-batch consistency. Its payload is released through tumor tissue protease hydrolysis, further enhancing systemic stability in humans. In the safety evaluation model of animals including cynomolgus monkeys, 7MW3711 demonstrated good safety profile and pharmacokinetic properties.

(Press release, Mabwell Biotech, OCT 14, 2025, View Source [SID1234656651])

On October 14, 2025 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, reported that Jarrod Longcor, chief operating officer of Cellectar, presented positive preclinical data in a poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference on Pancreatic Cancer Research that took place from September 28 through October 1, 2025, in Boston, Massachusetts. The poster highlighted preclinical data from CLR 121225 (CLR 225), the Company’s novel actinium-based radio conjugate alpha-emitter for treatment in pancreatic ductal adenocarcinoma (PDAC). CLR 225 has completed Investigational New Drug (IND)-enabling studies, and the company maintains the option to advance into a Phase 1 study.

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

                  Schedule Your 30 min Free Demo!

"We were honored to present these preclinical data before a distinguished audience of oncology professionals. The novel mechanism of action of our phospholipid ethers may enable us to more effectively target and eradicate diverse tumor cell populations and, importantly, penetrate the dense, collagen-rich extracellular matrix that characterizes pancreatic cancer. By overcoming this major barrier to therapeutic delivery, we hope to address one of the fundamental reasons pancreatic tumors remain so refractory to standard treatments and ultimately improve patient outcomes," said Jarrod Longcor, chief operating officer of Cellectar. "These results showcase the robust anti-tumor activity, selective biodistribution, and impressive uptake of CLR 225 in multiple pancreatic cancer tumor models. The data strongly support the therapeutic potential of CLR 225."

A series of studies evaluated three separate pancreatic cancer xenograft models (PANC-1, MIA PaCa-2 human pancreatic carcinoma cells and BxPC-3 tumor fragments) treated with CLR 225 at multiple doses. CLR 225 was deemed safe and well-tolerated at all dosing levels with no changes in body weight or loss of animals. Notably, all three xenograft models treated with CLR 225 demonstrated either meaningful inhibition of tumor growth or reduction in tumor volume, depending on the dose, with potential survival benefit following treatment as tumor growth post treatment was significantly diminished.

Additional pharmacokinetic studies showed excellent biodistribution of CLR 225, indicating predictable behavior with dose linearity, which can assist with future estimation of a likely efficacious dose. Furthermore, in preparation for Phase 1 first-in-human studies, the poster presented data on CLR 225 in various GLP toxicity studies where no toxicities to the compound were noted.

The poster can be accessed on the Company’s website here.

About Pancreatic Ductal Adenocarcinoma
Advanced pancreatic ductal adenocarcinoma (PDAC) is a devastating disease, with less than 10% survival after five years. There are an estimated 67,500 new pancreatic cancer cases in the U.S. each year and PDAC accounts for approximately 90% of these cases, or ~60,700 new PDAC cases annually. Most patients are diagnosed at an advanced stage, which means that between 80%-90% of PDAC patients (~48,000-54,000 patients annually, per the Surveillance, Epidemiology, and End Results (SEER) database) are likely to have advanced disease at diagnosis.

PDACs exhibit a hypoxic environment, resulting in tumor cells employing lipid rafts to transport lipids into the cells. CLR 225 is designed to target lipid rafts and deliver treatment to the tumor cell.

(Press release, Cellectar Biosciences, OCT 14, 2025, View Source [SID1234661195])

On October 14, 2025 iOnctura, a clinical-stage precision oncology company focused on neglected and hard-to-treat cancers, reported the Phase Ib study investigating oral autotaxin (ATX) inhibitor, cambritaxestat (IOA-289), has met the primary endpoint: demonstrating safety, tolerability and anti-tumor responses, in combination with standard-of-care chemotherapy, in patients with previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC). These data are being presented as a poster at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in Berlin, Germany.1

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

                  Schedule Your 30 min Free Demo!

Lead investigator, Davide Melisi, M.D., Ph.D, Associate Professor of Medical Oncology, and Director of the Digestive Molecular and Clinical Oncology Research Unit, University of Verona, and Investigational Cancer Therapeutics Clinical Unit at the University Hospital of Verona, Verona, Italy said, "These early findings with cambritaxestat are encouraging. Clinical activity alongside a manageable safety profile is particularly meaningful in a disease as aggressive and fibrotic as metastatic pancreatic cancer. These findings warrant continued scientific exploration in autotaxin inhibition."

The Phase Ib dose escalation study, AION-02 (NCT05586516) evaluated cambritaxestat in combination with standard-of-care chemotherapy GnP in patients with previously untreated mPDAC. Sixteen patients received cambritaxestat orally, twice daily at doses of 100 mg (n=4), 200 mg (n=4), 400 mg (n=5) and 800 mg (n=3). GnP was administered by IV infusion, weekly for three weeks of a four-week cycle.

The results show no dose-limiting toxicities, and no treatment-emergent adverse events (TEAE) leading to drug discontinuation or dose modification. Pharmacodynamic analysis showed a dose dependent reduction in the ATX-dependent plasma lipid LPA C18:2 over 24 hours supporting cambritaxestat’s on-target effects. Patients in the higher-dose cohorts had consistent and durable reductions of the tumor marker CA19-9. These changes were associated with radiographic responses and survival.

Dr. Michael Lahn, Chief Medical Officer at iOnctura said, "These data reinforce the therapeutic promise of targeting the autotaxin pathway to address the complex biology of pancreatic cancer, and potentially other tumors with high expression of autotaxin and its associated signaling. As we advance development, we remain focused on unlocking the potential of cambritaxestat to improve outcomes for patients facing some of the most challenging and hard-to-treat cancers."

Cambritaxestat is the first autotaxin inhibitor to be investigated in cancer patients and is being developed as a first-in-class therapy across multiple cancer indications.

This study was co-funded by the European Union and recruited patients in Italy and the United Kingdom.

(Press release, iOnctura, OCT 14, 2025, View Source [SID1234656653])

On October 14, 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 3,672 million in the third quarter of 2025. Net trade sales were USD 2,088 million in the U.S. and USD 1,584 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.

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

                  Schedule Your 30 min Free Demo!

(Press release, Genmab, OCT 14, 2025, View Source [SID1234656638])