On December 3, 2025 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) reported the first patient has been dosed in the Phase 1/2 study evaluating CRN09682 in patients with metastatic or locally advanced somatostatin receptor type 2 (SST2)-positive neuroendocrine tumors and other SST2-expressing solid tumors. CRN09682 is the lead candidate from Crinetics’ proprietary nonpeptide drug conjugate (NDC) platform, which leverages the company’s expertise in GPCR drug discovery and small molecule design to develop a pipeline of modular targeted therapies for endocrine and endocrine-related tumors.

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"We developed CRN09682 to address the need for a more efficacious, safer, and convenient targeted therapy for patients with SST2-expressing tumors," said Stephen Betz, Ph.D., Chief Scientific Officer and Co-Founder of Crinetics. "Dosing the first patient in the Phase 1/2 study marks a major milestone for CRN09682 and our NDC platform as a whole. CRN09682 is the first clinical exploration of this new modality, which we believe has the potential to unlock a new generation of receptor-targeted therapies to treat tumors with precision."

CRN09682 was designed to bind selectively and with high potency to SST2-expressing tumor cells, promoting rapid receptor internalization and linker cleavage to release a potent cytotoxic payload directly within the tumor. This targeted approach is intended to concentrate treatment at the tumor site, by optimizing tumor penetration and limiting systemic exposure and related toxicities. NDCs are manufactured by traditional chemical synthesis methods, eliminating manufacturing constraints and specialized handling required by most antibody drug conjugates and radiopharmaceuticals.

The Phase 1/2 BRAVESST2 trial is a first-in-human, open-label, dose-escalation study with a dose expansion phase designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of CRN09682. The Phase 1 portion will enroll patients in escalating dose cohorts to determine the maximum tolerated dose and recommended dose for the expansion phase. Phase 2 will further evaluate and characterize CRN09682 in selected SST2-expressing tumor types. Up to 150 participants are expected to be enrolled across both phases. Eligible patients must have metastatic or locally advanced disease progression following standard therapies and SST2-expressing tumors confirmed by somatostatin receptor imaging.

For more information about the BRAVESST2 trial, visit https://bit.ly/4hMl8qc

ABOUT CRN09682

CRN09682 is an investigational, first-in-class, non-radioactive, nonpeptide drug conjugate (NDC) linking a somatostatin receptor 2 (SST2) agonist with the cytotoxic drug monomethyl auristatin E (MMAE) via a spacer and a cleavable linker for the treatment of neuroendocrine tumors and other solid tumors that express SST2. The ligand on the CRN09682 binds to SST2 on the tumor cell surface and is internalized into the cell whereby enzymes cleave the MMAE and release it within the cell. MMAE is known to cause microtubule disruption leading to cell arrest and death. The NDC approach is intended to enhance tumor penetration and intracellularly release a potent anti-tumor agent, while minimizing systemic exposure and associated toxicities. Additionally, NDCs are manufactured by traditional chemical synthesis methods, avoiding the limitations of fermentation, bioconjugation, and heterogeneous manufacturing methods required by most antibody drug conjugates. NETs are generally incurable when metastatic, regardless of tumor grade. Overall survival rates vary significantly by stage, grade, age at diagnosis, primary site, and time period of diagnosis.

(Press release, Crinetics Pharmaceuticals, DEC 3, 2025, View Source [SID1234661097])

On December 3, 2025 ImpriMed, a precision oncology CRO specializing in ex vivo drug sensitivity testing for hematologic malignancies, reported that it has been selected to present two significant research studies at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in Orlando, Florida, taking place December 6-10.

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"Being featured at ASH (Free ASH Whitepaper) is an important validation of our xCellSense platform for both pharma partners and clinicians," said Sungwon Lim, Chief Executive Officer of ImpriMed. "Our data demonstrates that ex vivo functional testing, combined with genomic profiling, can effectively predict which acute myeloid leukemia (AML) patients will respond to specific therapies. This powerful combination equips drug developers and physicians with the critical evidence needed to select the most effective treatments, design innovative clinical trials, and ultimately improve patient outcomes."

ImpriMed will present data from a prospective study integrating NGS-based genomic profiling with ex vivo drug sensitivity testing across a panel of 21 drugs in AML patients treated with standard-of-care regimens. The data demonstrate that ex vivo drug-sensitivity testing successfully stratified survival risk in AML patients and identified clinically meaningful genotype-drug associations. These results validate the platform’s utility for drug development applications, including lead candidate selection, patient enrichment strategies, and the development of companion diagnostics.

Additionally, the company will share findings on a quantitative ex vivo drug synergy analysis methodology using primary samples from AML patients. This innovative system enables pharmaceutical companies to identify synergistic drug combinations and accurately identify the patient subgroups most likely to benefit from combination therapy.

Oral Presentation Details:

Session: 803. Emerging Tools, Techniques, and Artificial Intelligence in Hematology
Date/Time: December 8, 2025, 3:15 PM – 3:30 PM
Publication Number: 939
Title: "Ex vivo drug sensitivity testing in Korean AML patients: Integration of functional and genomic profiles for predicting clinical response and survival"
Poster Presentation Details:

Session: 803. Emerging Tools, Techniques, and Artificial Intelligence in Hematology: Poster III
Date/Time: December 8, 2025, 6:00 PM – 8:00 PM
Publication Number: 6137
Title: "Quantitative ex vivo synergy profiling uncovers heterogeneous combination responses in AML primary samples"

(Press release, ImpriMed, DEC 3, 2025, View Source [SID1234661115])

On December 3, 2025 Delcath Systems, Inc. (Nasdaq: DCTH), ("Delcath" or the "Company") an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported the publication of a retrospective study by leading interventional radiologists and oncologists from Asklepios Hospital Barmbek in Hamburg, Germany. The study, titled "Survival Outcome After Percutaneous Hepatic Perfusion with High-Dose Melphalan for Liver-Dominant Metastatic Uveal Melanoma: A 10-Year Single-Center Experience," was published in the journal Cancers and reports outcomes from 38 consecutive patients with liver-dominant metastatic uveal melanoma (mUM) who underwent 99 procedures using Delcath’s CHEMOSAT Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (PHP). The article highlights the procedure’s safety and efficacy, demonstrating a median overall survival (OS) of 29.1 months from the first PHP treatment, with improved outcomes associated with additional treatment cycles.

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"The publication of this 10-year experience in Cancers underscores the significant clinical evidence supporting the use of PHP as an effective liver-directed therapy for patients with liver-dominant metastatic uveal melanoma," said Gerard Michel, Chief Executive Officer of Delcath Systems. "These results from a high-volume specialized center show a median OS approaching 2.5 years, surpassing prior reports and reinforcing the potential survival benefits of treatment with repeated PHP cycles. We are pleased to see this data add to the collection of research supporting HEPZATO KIT and CHEMOSAT, which aligns with our commitment to advancing treatment options in interventional oncology."

The retrospective study synthesizes data from consecutive patients treated between April 2014 and March 2024, demonstrating safety and efficacy of CHEMOSAT in a real-world setting. Key highlights include:

Median OS of 29.1 months (95% CI: 18.4–38.9 months) from the first PHP treatment, with 1-, 2-, and 3-year OS rates of 79.5%, 53.2%, and 28.5%, respectively
Numerically improved median OS with ≥3 PHP cycles (29.8 months) versus ≤2 cycles (21.4 months; p=0.058), with each additional cycle associated with a ~40% reduction in risk of death (HR=0.414)
No treatment-related deaths, with procedure-related adverse events graded ≥2 occurring in 10.5% of patients
Patient population with ECOG-PS 0-1, ≤70% liver involvement, and limited extrahepatic disease, reflecting appropriate selection for PHP
Support for institutional experience and volume as factors in optimizing outcomes, providing a reference for novel mUM management strategies
The article is available here: View Source

(Press release, Delcath Systems, DEC 3, 2025, View Source [SID1234661098])

On December 3, 2025 Quadriga BioSciences, a clinical-stage oncology company developing QBS72S (formerly QBS10072S) for the targeted treatment of cancer, reported positive Phase IIa interim clinical data presented at the 7th Quadrennial World Federation of Neuro-Oncology Societies and 30th Annual Meeting of the Society for Neuro-Oncology (WFNOS–SNO), held November 19–23, 2025, at the Hawaii Convention Center in Honolulu, Hawaii. In an oral session, data were presented from a single-arm, open-label study conducted by the Department of Neurosurgery at the Stanford University School of Medicine that evaluated the safety and efficacy of QBS72S, a novel chemotherapeutic designed to cross the blood–brain barrier via the L-type amino acid transporter 1 (LAT1). The results showed that QBS72S produced both radiographic and symptomatic improvement in breast cancer patients with leptomeningeal disease (LMD).

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"The Phase IIa results provide important early clinical signals that reinforce the potential of QBS72S to meaningfully impact outcomes for patients with LMD," said Gordon Ringold, Ph.D., CEO of Quadriga BioSciences. "Seeing radiographic stability alongside improvements in neurologic and physical symptoms, as well as survival beyond 12 months in 4 out of 10 patients, is very encouraging. These findings underscore the promise of our therapeutic approach and strengthen our commitment to advancing QBS72S as a treatment option for patients with LMD, for which there are no approved treatment alternatives."

LMD is a serious complication of advanced breast cancer in which cancer cells spread to the membranes surrounding the brain and spinal cord, leading to significant neurologic symptoms, rapid clinical decline, and a poor prognosis.

"Breast cancer is one of the most common solid tumors to spread to the brain, and LMD represents a serious and challenging complication for patients," said Ron Weitzman, M.D., CMO of Quadriga BioSciences "Available treatment options remain limited, in part due to challenges with drug delivery across the blood-brain barrier. The clinical findings presented at WFNOS–SNO suggest that QBS72S reaches the cancer cells and may offer meaningful benefit for patients with advanced metastatic disease. These data support continued evaluation of QBS72S as a targeted therapeutic candidate for LMD, an area of significant unmet need."

These results reinforce Quadriga Biosciences’ commitment to advancing QBS72S toward a potential therapeutic option for patients with leptomeningeal disease and other central nervous system manifestations of metastatic breast cancer.

Reference: Abstract ID: CTNI-71, Oral Presentation

Title: Interim analysis of a phase IIa trial of LAT1-targeted QBS72S in breast cancer leptomeningeal disease
Authors: Brandon Carlson-Clarke, Sahara Rout, Meaghan Roy-O’Reilly, Rukayat Taiwo, Paul M. Harary, Monica Granucci, Sophia B. Chernikova, Thy T.H. Trinh, Sophie Bertrand, Kate Therkelsen, Summer Han, Bo Gu, Gordon Ringold, Jaymes Holland, Ron Weitzman, Seema Nagpal, Melanie Hayden Gephart

About QBS72S
QBS72S is a novel, first-in-class chemotherapeutic agent that mimics an aromatic amino acid for cellular uptake by the amino acid transporter LAT1 (L-type amino acid transporter 1) thereby enabling the drug to cross the blood brain barrier (BBB) as well as to selectively target numerous types of rapidly growing cancer cells. Once inside the cell QBS72S causes double-stranded DNA breaks resulting in cell death. Most aggressive cancers express high LAT1, which is commonly associated with poor prognoses.1

About the Study
The Phase 2 open-label clinical trial is designed to assess the safety, tolerability and efficacy of QBS72S in patients with brain metastases from breast cancer. The study will recruit up to 35 patients with the primary objective of determining preliminary efficacy through overall response rate. Secondary endpoints include measurement of progression free survival, overall survival, duration of response, and adverse events.

Please refer to www.clinicaltrials.gov [NCT05305365] for additional clinical trial details.

(Press release, Quadriga BioSciences, DEC 3, 2025, View Source [SID1234661116])

On December 3, 2025 Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, reported that the final analysis of its Phase 3 CARES-310 study was published in The Lancet Oncology. The study assessed the efficacy and safety of the combination of Elevar’s drug candidate rivoceranib, an oral TKI, and camrelizumab, a PD-1 inhibitor, as a first-line therapy for unresectable hepatocellular carcinoma (uHCC).

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In the randomized, open-label, international trial (NCT03764293), which included 543 patients at 95 study sites across 13 countries/regions, camrelizumab plus rivoceranib continued to show clinically meaningful survival improvement versus sorafenib (median overall survival of 23.8 vs. 15.2 months), a standard first-line treatment for uHCC, and a manageable safety profile.

Elevar plans resubmission of a New Drug Application to the U.S. Food and Drug Administration for the combination therapy of camrelizumab and rivoceranib in January 2026.

"Having our Phase 3 study final analysis published in a prestigious journal such as The Lancet Oncology is momentous for Elevar Therapeutics and, even more so, for the global liver cancer patient community," said Bryan Kim, chief executive officer of Elevar. "The data clearly showed the potential of our combination treatment of camrelizumab and rivoceranib, as it significantly improved survival compared to the standard treatment option. This is evidence that our hard work developing better therapies for patients with few options is paying off. We’re proud of everyone on our team and our partners for hitting this milestone, and we’re focused on getting this promising treatment to patients everywhere as soon as possible."

Findings:

Between June 28, 2019, and March 24, 2021, 543 patients (457 [84%] males; 450 [83%] were Asian) were randomly assigned to receive camrelizumab-rivoceranib (n=272) or sorafenib (n=271). At final analysis on June 14, 2023, the median follow-up was 22.1 months (IQR 11.9-30.3) in the camrelizumab-rivoceranib group and 14.9 months (7.2-28.3) in the sorafenib group. Median overall survival was 23.8 months (95% CI 20.6-27.2) with camrelizumab-rivoceranib and 15.2 months (13.2-18.5) with sorafenib (hazard ratio [HR] 0.64 [95% CI 0.52-0.79]; one-sided p<0.0001). Median progression-free survival was 5.6 months (95% CI 5.5-7.4) with camrelizumab-rivoceranib and 3.7 months (95% CI 3.1-3.7) with sorafenib (HR 0.54 [95% CI 0.44-0.67]; one-sided p<0.0001).

The most common grade 3 or 4 treatment-related adverse events were hypertension (104 [39%] of 272 patients in the camrelizumab-rivoceranib group vs. 40 [15%] of 269 patients in the sorafenib group), palmar-plantar erythrodysesthesia syndrome (33 [12%] vs. 42 [16%]), increased aspartate aminotransferase (47 [17%] vs. 14 [5%]), and increased alanine aminotransferase (38 [14%] vs. 8 [3%]). Treatment-related serious adverse events were reported in 69 (25%) patients in the camrelizumab-rivoceranib group and 18 (7%) patients in the sorafenib group. Treatment-related deaths occurred in one patient each in the camrelizumab-rivoceranib group (multiple organ dysfunction syndrome) and sorafenib group (respiratory failure and circulatory collapse).

About Hepatocellular Carcinoma

Hepatocellular Carcinoma (HCC) is the most common type of liver cancer and most frequently develops in people with chronic underlying liver inflammation, which may be from viral and non-viral causes. HCC typically has a poor prognosis with limited treatment options and continues to be a diagnosis with an ongoing urgent medical need. More than 800,000 people worldwide are diagnosed with liver cancer each year and it is also a leading cause of cancer deaths, accounting for more than 700,000 annually, according to the American Cancer Society.

About Rivoceranib

Rivoceranib, a small-molecule tyrosine kinase inhibitor (TKI), is a highly potent inhibitor of vascular endothelial growth factor receptor (VEGFR), a primary pathway for tumor angiogenesis. VEGFR inhibition is a clinically validated target to limit tumor growth and disease progression. Rivoceranib is currently being studied as a monotherapy and in combination with chemotherapy and immunotherapy in various solid tumor indications. Ongoing clinical studies include uHCC (in combination with camrelizumab), gastric cancer (as a monotherapy and in combination with paclitaxel), adenoid cystic carcinoma (as a monotherapy) and colorectal cancer (in combination with Lonsurf). Rivoceranib was the first TKI approved in gastric cancer in China (November 2014). It is also approved in China in combination with camrelizumab as a first-line treatment for uHCC (January 2023). The drug has been studied in more than 6,000 patients worldwide and was well tolerated in clinical trials with a comparable safety profile to other TKIs and VEGF inhibitors. Orphan drug designations have been granted in gastric cancer (U.S., EU and South Korea), in adenoid cystic carcinoma (U.S.) and in uHCC (U.S. and EU). Elevar Therapeutics, Inc. holds the global rights (excluding China) to rivoceranib and has partnered for its development and marketing with HLB-LS in South Korea. Rivoceranib, under the name apatinib, is also approved in China for advanced gastric cancer and in second-line advanced HCC by the Chinese-territory license-holder, Jiangsu Hengrui Pharmaceuticals Company Ltd., (Hengrui Pharma), under the brand name Aitan.

About Camrelizumab

Camrelizumab (SHR-1210) is a humanized monoclonal antibody that binds to the programmed death-1 (PD-1) receptor. Blockade of the PD-1/PD-L1 signaling pathway is a therapeutic strategy showing success in a wide variety of solid and hematological cancers. Camrelizumab is developed by Hengrui Pharma and has been studied in more than 5,000 patients. Currently, 50 clinical trials are underway in a broad range of tumors (including liver cancer, lung cancer, gastric cancer and breast cancer, etc.) and treatment settings. Camrelizumab, under the brand name AiRuiKa, is currently approved for eight indications in China, including monotherapy for the treatment of HCC (second-line), in combination with rivoceranib as a treatment for uHCC (first-line), relapsed/refractory classic Hodgkin’s lymphoma (third-line), esophageal squamous cell carcinoma (second-line) and nasopharyngeal carcinoma (third-line or further) and in combination with chemotherapy for the treatment of non-small cell lung cancer (non-squamous and squamous), esophageal squamous cell carcinoma and nasopharyngeal carcinoma in the first-line setting. The U.S. Food and Drug Administration granted Orphan Drug Designation to camrelizumab for advanced HCC in April 2021 and by the EMA in August 2024.

In October 2023, Elevar licensed camrelizumab, an anti-PD-1 antibody, for commercialization from Hengrui Pharma worldwide excluding Greater China and Korea.

(Press release, Elevar Therapeutics, DEC 3, 2025, View Source [SID1234661099])