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])

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 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 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, reported topline data from its Phase 2 trial of silevertinib in frontline (1L) non-small cell lung cancer (NSCLC) patients with non-classical epidermal growth factor receptor (EGFR) mutations (NCMs) and outlined plans for a randomized Phase 2 trial of silevertinib in patients with newly diagnosed glioblastoma (ND GBM).

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"We are pleased to share these initial data in frontline NSCLC patients showing silevertinib’s activity against a broad spectrum of 35 distinct non-classical EGFR mutations," said Mark Velleca, M.D., Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. "We are particularly encouraged by the CNS activity of silevertinib in treating NSCLC patients with brain metastases, as published data clearly demonstrate that CNS metastases are a key factor in early disease progression for NCM NSCLC patients treated with second- and third-generation EGFR-TKIs. We also believe that silevertinib is uniquely positioned as a potential treatment for patients with newly diagnosed EGFR-altered GBM, and plan to initiate a randomized Phase 2 trial in the first half of 2026, while PFS data matures in our Phase 2 NSCLC study and we continue our partnering discussions."

Silevertinib Phase 2 1L NSCLC Initial Clinical Results and Program Update

43 frontline NSCLC patients harboring a broad spectrum of 35 distinct non-classical EGFR mutations were enrolled, including 16 patients with brain metastases (7 of whom had measurable CNS target lesions). All patients were enrolled at a 200mg oral daily dose of silevertinib. Efficacy and safety were assessed with a November 3, 2025 data cutoff; median follow-up time as of this date was 7.2 months and the study remains ongoing.

Key data highlights include:

For the 43 patients enrolled, preliminary efficacy data is as follows:

25 confirmed partial responses, 1 confirmed complete response
60% Objective Response Rate (ORR by RECIST 1.1)
86% CNS ORR (by RANO-BM)
91% disease control rate (DCR)

Initial duration of treatment data:

29 patients remain on therapy (5/29 after progression), longest ongoing for >19 months

Summary of safety data:

No new safety signals observed
Adverse events (AEs) experienced by a majority of patients include rash, stomatitis, diarrhea and paronychia
AEs were managed with standard supportive care and dose interruptions/reductions without compromising response depth or durability to date

The Company expects to present updated results from the Phase 2 NSCLC trial, including Duration of Response (DOR) and Progression-free Survival (PFS) data in both the recurrent (83 patients) and frontline (43 patients) settings, at a medical meeting in the second quarter of 2026. Black Diamond continues to explore potential partnerships to advance silevertinib into pivotal development.

"These highly encouraging data speak to the potential of silevertinib to be the treatment of choice for frontline NSCLC patients with the full spectrum of non-classical EGFR mutations" said Sergey Yurasov, M.D., Ph.D., Black Diamond’s Chief Medical Officer. "We are struck by the compelling CNS response rate, which may translate to prolonged durability of response for patients with CNS metastases. Based on these data, and promising Phase 0/1 and Phase 1 GBM results, we are preparing to initiate a randomized Phase 2 trial of silevertinib in newly diagnosed GBM patients, one of the highest unmet needs in oncology."

GBM Program Update and Phase 2 Plans
Approximately 50% of patients with glioblastoma (GBM) present with an oncogenic EGFR alteration that can be targeted by silevertinib; each year approximately 7,000 patients in the U.S. are diagnosed with GBM harboring these EGFR alterations.

"Prior attempts to treat EGFR-altered GBM patients have been limited by poor brain penetrance of targeted therapies and/or lack of potency of these therapies on the full spectrum of EGFR alterations" said Elizabeth Buck, Ph.D., Chief Scientific Officer of Black Diamond. "Based on encouraging CNS activity demonstrated by silevertinib across multiple trials, and its preclinical potency on all EGFR alterations found in GBM, we believe that silevertinib has the potential to be the first targeted therapy for these patients."

Black Diamond plans to initiate a randomized Phase 2 trial in newly diagnosed GBM patients in the first half of 2026, with preliminary data expected in 2028.

Key trial highlights include:

Expected to enroll approximately 150 newly diagnosed patients, randomized to receive TMZ (control arm) or silevertinib + TMZ (experimental arm)
Initial focus will be on EGFRvIII-positive patients (approximately 30% of GBM) who are MGMT-negative (unmethylated)
Randomization and treatment will begin after patients have had their surgical resection and radiation
Primary endpoint is PFS (RANO by Blinded Independent Committee Review), with an interim analysis; secondary endpoint is overall survival (OS)
Trial will be governed by an Independent Data Monitoring Committee (IDMC)

Updated Financial Guidance

Black Diamond previously reported cash, cash equivalents and investments of approximately $135.5 million as of September 30, 2025, which the Company now believes is sufficient to fund its anticipated operating expenses and capital expenditure requirements into the second half of 2028.
Financial guidance assumes Black Diamond funds the Phase 2 trial of silevertinib in ND GBM and a potential partner funds pivotal development in NSCLC. Financial guidance does not assume receipt of potential development milestones from the Company’s partnership with Servier Pharmaceuticals LLC for BDTX-4933 (now S241656).

Conference Call Information

Black Diamond will host a conference call and webcast on Wednesday, December 3, 2025, at 8:00 AM ET to discuss the preliminary Phase 2 data for silevertinib in 1L NSCLC and plans for a Phase 2 trial of silevertinib in GBM. The webcast may be accessed online here or by visiting the Events page in the Investors section of the Company’s website at www.blackdiamondtherapeutics.com.

A replay of the webcast will be available for 30 days on the Investors section of Black Diamond’s website.

(Press release, Black Diamond Therapeutics, DEC 3, 2025, View Source [SID1234661096])

On December 3, 2025 BioNTech SE (Nasdaq: BNTX, "BioNTech") reported that 184,071,410 shares of CureVac N.V. (Nasdaq: CVAC, "CureVac"), representing approximately 81.74% of CureVac’s issued and outstanding shares, were validly tendered and not properly withdrawn prior to the expiration of the initial offering period at 9:00 a.m. Eastern Time on December 3, 2025. As a result, the minimum condition for the exchange offer (the "Offer") has been satisfied, and all validly tendered shares have been accepted. All closing conditions related to the completion of the post-offer reorganization have now been satisfied. BioNTech will now proceed to deliver BioNTech American Depositary Shares ("ADSs") (and/or cash in lieu of fractional BioNTech ADSs) to the holders of CureVac shares who have tendered their shares, to close the transaction, as set out in more detail in the offer documents (as referred to below).

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BioNTech also announced that the subsequent offering period has commenced. CureVac shareholders who have not yet tendered their shares may still tender during the subsequent offering period, which will expire at 12:01 a.m. Eastern Time on Thursday, December 18, 2025. No guaranteed delivery procedures apply.

The parties will initiate the post-offer reorganization as promptly as practicable following the expiration of the subsequent offering period. The post-offer reorganization will result in non-tendering holders of CureVac shares receiving BioNTech ADSs (and/or cash in lieu of fractional BioNTech ADSs) pursuant to the post-offer reorganization (rather than the Offer). Non-tendering holders of CureVac shares who receive BioNTech ADSs (and/or cash in lieu of fractional BioNTech ADSs) pursuant to the post-offer reorganization generally will be subject to a 15% Dutch dividend withholding tax.

Promptly after the completion of the post-offer reorganization, shares held by non-tendering CureVac shareholders will cease to be tradable on any national stock exchange and may be subject to additional transfer restrictions.

Please refer to the Exchange Offer Prospectus, the EU Prospectus, or the UK exemption document (each as referred below) for more information and a full description of the summaries above.

(Press release, BioNTech, DEC 3, 2025, View Source [SID1234661095])