On October 14, 2025 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, reported it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for relacorilant to treat patients with platinum-resistant ovarian cancer.

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Corcept’s MAA submission is based on positive data from its pivotal Phase 3 ROSELLA and Phase 2 trials. In these trials, patients who received relacorilant plus nab-paclitaxel experienced improved progression-free and overall survival compared to patients who received nab-paclitaxel monotherapy, with no need for biomarker selection. Relacorilant was well-tolerated, consistent with its known safety profile. Importantly, the type, frequency and severity of adverse events in the combination arms were comparable to those in the nab-paclitaxel monotherapy arms. Relacorilant conferred its benefit without increasing the safety burden of the patients who received it.

The U.S. Food and Drug Administration (FDA) is reviewing Corcept’s application to market relacorilant in the United States to treat patients with platinum-resistant ovarian cancer. The FDA’s Prescription Drug User Fee Act (PDUFA) target action date is July 11, 2026.

"Our MAA submission brings us a step closer to our goal of delivering relacorilant to patients with platinum-resistant ovarian cancer," said Joseph Belanoff, M.D., Corcept’s Chief Executive Officer. "Better treatment options are urgently needed. Relacorilant has the potential to redefine how platinum-resistant ovarian cancer is treated."

About Relacorilant

Relacorilant, an oral therapy, is a selective glucocorticoid receptor (GR) antagonist that modulates cortisol activity by binding to the GR but not to the body’s other hormone receptors. Corcept is developing relacorilant in ovarian cancer and a variety of other serious disorders, including endogenous hypercortisolism and prostate cancer. Relacorilant is proprietary to Corcept and is protected by composition of matter, method of use and other patents. It has been designated an orphan drug by the FDA and the European Commission (EC) for the treatment of hypercortisolism and by the EC for the treatment of ovarian cancer. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of December 30, 2025 for relacorilant as a treatment for patients with hypercortisolism, and a PDUFA date of July 11, 2026 for relacorilant as a treatment for patients with platinum-resistant ovarian cancer.

About Cortisol’s Role in Oncology

Cortisol plays a role in tumor growth through several mechanisms. It helps solid tumors resist chemotherapy by inhibiting cellular apoptosis — the tumor-killing effect chemotherapy is meant to stimulate. In some cancers, cortisol promotes tumor growth by activating oncogenes in the cells to which it binds. Cortisol also suppresses the body’s immune response, which weakens its ability to fight all diseases, including cancer.

About Platinum-Resistant Ovarian Cancer

Ovarian cancer is the fifth most common cause of cancer death in women. Patients whose disease returns less than six months after receiving platinum-containing therapy have "platinum-resistant" disease. There are few treatment options for these women. Median overall survival following recurrence is approximately 12 months with single-agent chemotherapy. Approximately 20,000 women with platinum-resistant disease are candidates to start a new therapy each year in the United States, with at least an equal number in Europe.

(Press release, Corcept Therapeutics, OCT 14, 2025, https://ir.corcept.com/news-releases/news-release-details/corcept-submits-marketing-authorization-application-european [SID1234656635])

On October 14, 2025 Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), an oncology company developing innovative, full-length multispecific antibodies and antibody drug conjugates (Biclonics, Triclonics and ADClonics), reported initial interim clinical data as of an April 28, 2025 data cutoff from the ongoing phase 2 trial of the bispecific antibody petosemtamab in combination with standard of care FOLFOX/FOLFIRI in 1L, 2L metastatic CRC (mCRC) and petosemtamab monotherapy in 3L+ mCRC. Updated data will be presented in a plenary session oral presentation by Dr. Moh’d Khushman M.D., Washington University School of Medicine, St. Louis, MO at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) on Friday, October 24 at 10:20 a.m. ET.

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"We are encouraged by these early data indicating the promise of petosemtamab to combine safely with chemotherapy, and its potential to benefit a wide range of cancer patients that have metastatic colorectal cancer," said Bill Lundberg, M.D., President, Chief Executive Officer of Merus. "We look forward to providing a more mature clinical update of a larger cohort of patients from a later cutoff date in our plenary session oral presentation."

Petosemtamab (MCLA-158: EGFR x LGR5 Biclonics):

Presentation title: Petosemtamab (MCLA-158) monotherapy or with chemotherapy in metastatic colorectal cancer: Preliminary antitumor activity and safety data from a phase 2 trial

Observations in the abstract include:

As of an April 28, 2025 data cutoff date:

36 patients (pts) with left- and/or right-sided, KRAS, NRAS, and BRAF wildtype microsatellite stable mCRC received petosemtamab 1500 mg Q2W, in combination with FOLFOX/FOLFIRI or as monotherapy
Pts treated in 1L or 2L had no prior anti-EGFR therapy
Pts treated in 2L received 1 prior chemotherapy regimen in the metastatic setting
Pts treated in 3L+ received at least 2 prior regimens in the metastatic setting, including a prior anti-EGFR therapy
1L petosemtamab with FOLFOX/FOLFIRI
7 pts were treated in 1L (6 FOLFOX and 1 FOLFIRI), with 6 ongoing
3 pts were efficacy evaluable, with median follow up of 2.6 months
1 unconfirmed complete response and 2 partial responses (PR; 1 unconfirmed) observed
2L petosemtamab with FOLFOX/FOLFIRI
10 pts were treated in 2L (1 FOLFOX and 9 FOLFIRI), with 8 ongoing
8 were efficacy evaluable, with median follow up of 3.4 months
4 PRs (2 unconfirmed), 3 stable diseases (SD; all ongoing) and 1 clinical deterioration prior to first scan
All unconfirmed responses in 1L and 2L were continuing on therapy without disease progression
3L+ petosemtamab monotherapy:
19 pts were treated, with 12 pts ongoing
14 were efficacy evaluable, with median follow up 2.5 months,
1 unconfirmed PR ongoing without disease progression, 6 SDs (all ongoing), 6 progressive diseases and 1 death unrelated to treatment prior to first scan observed
Petosemtamab safety:
No fatal treatment-related TEAEs observed in each cohort
Petosemtamab plus FOLFOX:
Most frequent treatment-emergent adverse events (TEAEs) regardless of causality (all Grades [G]/G3) were dermatitis acneiform (71%/0%), constipation (43%/0%), fatigue (43%/0%), and peripheral neuropathy (43%/0%)
Petosemtamab plus FOLFIRI:
Most frequent TEAEs regardless of causality (all G/G3) were diarrhea (70%/0%), mucosal inflammation (50%/10%), and fatigue (40%/0%)
Petosemtamab monotherapy:
Most frequent TEAEs regardless of causality (all G/G3) were rash (58%/0%), and nausea (26%/0%)
Presentations:
Title: Petosemtamab (MCLA-158) monotherapy or with chemotherapy in metastatic colorectal cancer: Preliminary antitumor activity and safety data from a phase 2 trial
Session Title: Plenary Session 4: Clinical Trials Plenary Session
Date and Time: Friday, October 24, 10:20 a.m. ET
The same data will also be available in a poster:
Session Title: Poster Session B
Session Date and Time: Friday, October 24, 12:30-4:00 p.m. ET The full presentations are planned to be available on the Merus website at the start of each session.

(Press release, Merus, OCT 14, 2025, View Source [SID1234656650])

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.

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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.

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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.

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"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])