Kelun-Biotech Presents First-in-human Study Data for Its Novel B7-H3 ADC SKB500 at ASCO 2026

On June 2, 2026 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", 6990.HK) reported that at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting held in Chicago, USA, the first-in-human study results of the novel B7-H3 ADC SKB500 in patients with advanced solid tumors were presented as a rapid oral report by Professor Liu Haifeng from Jilin Provincial Cancer Hospital (Abstract #3011|Molecularly Targeted Agents and Tumor Biology).

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SKB500 utilizes an antibody with high affinity, high hydrophilicity, and enhanced endocytosis, and has been engineered to silence Fc effector function in the constant region. Moreover, the antibody is conjugated to a payload with moderate toxicity via a cleavable hydrophilic AAA linker, with a drug-to-antibody ratio (DAR) of approximately 8.

The study was divided into three stages: dose escalation, dose expansion, and indication expansion, enrolling a total of 192 patients, including those with small cell lung cancer (SCLC), esophageal squamous cell carcinoma (ESCC), head and neck squamous cell carcinoma (HNSCC), colorectal cancer (CRC), neuroendocrine carcinoma (NEC), and other tumors. Patients received SKB500 at doses ranging from 2 to 18 mg/kg every three weeks (Q3W), with dose expansion and indication expansion conducted at 12 mg/kg and 16 mg/kg.

As of March 31, 2026, efficacy data showed:

Antitumor activities were observed across multiple solid tumor types, including SCLC, ESCC, HNSCC, pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), and nasopharyngeal carcinoma (NPC). Among 124 patients treated at 12 mg/kg with at least 6 weeks of follow-up, the objective response rate (ORR) was 42.7%, and the disease control rate (DCR) was 83.9%.
Among the treated SCLC patients (n=40), the ORR was 65.0% (95% CI: 48.3, 79.4), median progression-free survival (mPFS) was 7.2 months (95% CI: 4.3, NE), DCR was 95.0%, and mDOR was 5.8 months.
Among the treated ESCC patients (n=37), the ORR was 54.1%.
In terms of safety, compared to the 16 mg/kg group, the 12 mg/kg group demonstrated a more favorable safety profile, characterized by a lower incidence of grade ≥3 treatment-related adverse events (TRAEs) and treatment-related serious adverse events (TRSAEs), as well as a low rate of permanent discontinuation. In the 12 mg/kg group, the incidence of grade ≥3 TRAEs was 32.3%, most commonly hematologic events.

The study demonstrates that SKB500 exhibits broad-spectrum antitumor activity, with responses observed in multiple treated advanced solid tumors including SCLC, ESCC, HNSCC, and PDAC, with notable efficacy in SCLC patients. At the 12 mg/kg group, SKB500 showed a favorable safety profile, where there was a low incidence of permanent discontinuation and no treatment-related deaths.

Professor Liu Haifeng, Principal Investigator from Jilin Provincial Cancer Hospital, said: "The positive results from this first-in-human study of SKB500 not only preliminarily confirm its favorable efficacy and manageable safety profile as a novel B7-H3 ADC, but also suggest its therapeutic potential in multiple solid tumors—offering particular hope for SCLC, a disease that is highly aggressive and has limited later-line treatment options. These findings lay a solid foundation for further clinical development. We look forward to further validating its clinical value in subsequent trials."

About SKB500

SKB500 is a novel B7-H3-targeted ADC independently developed by the company using its OptiDC platform technology, featuring a site-specific cleavable linker and a potent topoisomerase I inhibitor. In the Phase I clinical study, SKB500 demonstrated robust efficacy and manageable safety profiles across multiple advanced solid tumors. Currently, a Phase II exploratory study of SKB500 in combination with immunotherapy with or without chemotherapy as first-line treatment for extensive-stage small cell lung cancer (ES-SCLC) is ongoing in China.

(Press release, Kelun, JUN 2, 2026, View Source [SID1234666378])

Nanobiotix Provides First Quarter 2026 Operational and Financial Update

On June 2, 2026 NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – the "Company"), a late-clinical stage biotechnology company pioneering nanotherapeutic approaches to expand treatment possibilities for patients with cancer and other major diseases, reported an update on operational progress and reported financial results for the first quarter of 2026.

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"Nanobiotix continues to advance with focus, discipline, and ambition as we work to unlock the full potential of physics-based nanotherapeutics," said Laurent Levy, chief executive officer of Nanobiotix and chairman of the executive board. "During the first quarter of 2026, we strengthened our foundation by supporting the advancement of JNJ-1900 (NBTXR3), progressing our Nanoprimer platform, and reinforcing our financial position. We remain deeply grateful to the team members, patients, investigators, collaborators and shareholders who give us their trust, commitment and support as we pursue our mission of revolutionizing treatment outcomes for millions."

Operational Highlights

Part 1 data from Phase 2 JNJ-1900 (NBTXR3) Study in Unresectable Stage 3 NSCLC (CONVERGE) presented at ELCC 2026 and updated at ESTRO 2026
Initial investigator-reported efficacy responses observed in 7 patients following the full treatment regimen of concurrent chemoradiotherapy, JNJ-1900 (NBTXR3), and consolidation with durvalumab showed:
Overall response rate ("ORR") = 85.7% (6/7 patients) reported at ESTRO 2026
In the same cohort of 7 patients, ORR observed at earlier time point and reported at ELCC 2026 was 71.4% (5/7 patients)
Complete response rate ("CRR") = 57.1% (4/7 patients) reported at ESTRO 2026
With the current standard of care, concurrent chemoradiation therapy (cCRT) ± durvalumab, depth of response remains limited in Stage 3 Inoperable NSCLC with very low rates of complete response (<5%)1
Absence of progressive disease and deepening response over time suggests potential for long-term durability
The procedure demonstrated an acceptable safety profile without serious treatment-emergent adverse events (TEAEs)
Early results suggest that intratumoral/intranodal injection of JNJ-1900 (NBTXR3) is feasible and can be performed safely in patients with stage III unresectable NSCLC
Protocol amendment to global Phase 3 JNJ-1900 (NBTXR3) Study in Cisplatin-ineligible Head and Neck Cancer (NANORAY-312)
Interim analysis eliminated and final analysis modified to be conducted sooner with fewer events than originally planned
New preclinical data presented at 2026 AACR (Free AACR Whitepaper) Meeting:
Pre-treatment with Nanoprimer followed by administration of LNP-delivered recombinant DNA ("LNP-DNA") designed for anti-tumor immunotherapy showed increased systemic bioavailability, reduced hepatic toxicity, and reduced cGAS-STING related inflammation compared to LNP-DNA administered without the Nanoprimer

First Quarter Financial Updates

Cash and Cash Equivalents: The Company believes that the net proceeds from the recent follow-on offering, together with its cash and cash equivalents of €42.1 million as of March 31, 2026, will be sufficient to meet its working capital requirements for operations into 2029, consistent with the Company’s currently contemplated cash burn rate.

About JNJ-1900 (NBTXR3)

JNJ-1900 (NBTXR3) is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. Its proof-of-concept was achieved in soft tissue sarcomas through a successful randomized Phase 2/3 study in 2018. The product candidate’s mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that JNJ-1900 (NBTXR3) could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.

Radiotherapy-activated JNJ-1900 (NBTXR3) is being evaluated across multiple solid tumor indications as a single agent or combination therapy. The program is led by NANORAY-312—a global, randomized Phase 3 study in locally advanced head and neck squamous cell cancers. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of JNJ-1900 (NBTXR3) activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the Phase 3 study.

Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and Phase 2 studies evaluating JNJ-1900 (NBTXR3) across tumor types and therapeutic combinations. In 2023, Nanobiotix announced a license agreement for the global co-development and commercialization of JNJ-1900 (NBTXR3) with Janssen Pharmaceutica NV, a Johnson & Johnson company.

(Press release, Nanobiotix, JUN 2, 2026, View Source [SID1234666394])

Can-Fite Reports Positive Clinical Observation in Phase 2a Pancreatic Cancer Study and Highlights Namodenoson’s RAS Signaling Inhibition Mechanism

On June 2, 2026 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a clinical-stage biotechnology company developing a pipeline of proprietary small molecule drugs for the treatment of cancer and inflammatory diseases, reported the differentiated mechanism of action of namodenoson in pancreatic cancer, including inhibition of the RAS signaling pathway, alongside encouraging clinical observations from its ongoing Phase 2a pancreatic cancer study.

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Recent presentations and publications emerging from the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting have reinforced the importance of targeting RAS-driven malignancies, particularly pancreatic ductal adenocarcinoma (PDAC), where KRAS mutations and downstream RAS activation are central drivers of tumor growth and therapeutic resistance. Can-Fite previously reported preclinical findings demonstrating that namodenoson exerts potent anti-tumor activity in pancreatic cancer through a multi-pathway mechanism involving deregulation of the RAS, Wnt/β-catenin, and NF-κB signaling pathways, leading to apoptosis and marked inhibition of tumor growth.

The Company also reported encouraging clinical observations from its Phase 2a study of namodenoson as a monotherapy in pancreatic cancer. Enrollment has been completed and several patients have demonstrated prolonged disease control, including one patient who has remained on therapy and follow-up for approximately 16 months.

"Growing clinical validation of RAS inhibition in pancreatic cancer supports the relevance of the pathway that namodenoson was shown to modulate in our preclinical work," said Pnina Fishman, Chairperson and CSO of Can-Fite BioPharma. "Importantly, namodenoson offers a differentiated approach through simultaneous targeting of RAS, Wnt/β-catenin and NF-κB signaling pathways together with a favorable safety profile observed across clinical programs. The durable observation in our pancreatic study further encourages continued development of namodenoson in this highly aggressive malignancy."

Pancreatic cancer remains among the most lethal malignancies, with limited treatment options and poor long-term survival. Approximately 90% of pancreatic cancers are associated with KRAS pathway activation, highlighting the importance of therapies capable of modulating this signaling network.

About Namodenoson

Namodenoson is a highly selective A3 adenosine receptor (A3AR) agonist, which has shown a compelling safety profile and demonstrated anti-tumor activity in preclinical pancreatic cancer models. The drug is also being evaluated in clinical trials for advanced liver cancer.

Namodenoson has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer.

(Press release, Can-Fite BioPharma, JUN 2, 2026, View Source [SID1234666363])

CREATV BIO AND NEOVIA ONCOLOGY ANNOUNCE STRATEGIC PARTNERSHIP TO STUDY MULTIPLE DRUG RESISTANCE (MDR) IN SOLID TUMORS

On June 2, 2026 Creatv Bio, a Division of Creatv MicroTech, Inc. ("Creatv"), a liquid biopsy company focused on innovative diagnostics for cancer, and Neovia Oncology LLC, a Delaware based pharmaceutical company dedicated to developing novel oncology therapies, reported the signing of a strategic partnership agreement to collaborate on Neovia’s upcoming studies treating patients with advanced multiple drug resistant solid tumors who are entering late lines of therapy.

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The collaboration is expected to generate translational and biomarker data designed to improve patient stratification and deepen understanding of treatment response dynamics in advanced cancers.

In addition to its development as a systemic therapy, Neovia is also evaluating the broader platform potential of NEV-801 in next-generation oncology applications, including antibody-drug conjugate (ADC) strategies.

"We selected Creatv Bio because of their strong scientific capabilities and extensive experience supporting biomarker research across multiple solid tumor types," said Trevor Blake, Founder and CEO of Neovia Oncology. "By integrating advanced liquid biopsy technologies into our clinical development program, we hope to gain deeper insights into patient response patterns and resistance biology as we advance NEV-801."

Creatv’s LifeTracDx blood test isolates Cancer Associated Macrophage-Like Cells (CAMLs) and Circulating Tumor Cells (CTCs) using Creatv’s CellSieveTM microfilters to develop companion diagnostics to monitor drug targets and provide information on patient treatment response.

Dr. Cha-Mei Tang, President and CEO of Creatv Bio added, "Our partnership with Neovia Oncology LLC has the potential to advance the future of cancer diagnosis and treatment, thus saving and improving the lives of cancer patients."

(Press release, Neovia Oncology, JUN 2, 2026, View Source [SID1234666379])

BriaCell Therapeutics Announces Closing of Offering

On June 2, 2026 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXL, BCTXZ) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, reported the closing of its best-efforts offering of 1,449,300 common shares. Each common share was sold at an offering price of $3.25 per share. All of the common shares in the offering were offered by the Company. Total gross proceeds from the offering, before deducting placement agent’s fees and other offering expenses, were approximately $4.7 million. The Company relied upon the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible interlisted issuers on a recognized exchange, such as Nasdaq.

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The Company intends to use the net proceeds from the offering for working capital requirements, general corporate purposes, and the advancement of business objectives.

ThinkEquity acted as the sole placement agent for the offering.

The securities described above were offered and sold by the Company pursuant to a shelf registration statement on Form S-3 (File No. 333-276650), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the "SEC") on January 22, 2024 and declared effective on January 31, 2024. The offering was made only by means of a written prospectus. A final prospectus supplement and accompanying prospectus relating to the offering has been filed with the SEC and can be accessed for free on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, from the offices of ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, BriaCell Therapeutics, JUN 2, 2026, View Source [SID1234666395])