On June 8, 2026 Adcentrx Therapeutics ("Adcentrx"), a clinical-stage biotechnology company advancing Antibody-Drug Conjugate (ADC) therapies for cancer treatment and other life-threatening diseases, reported that the China National Medical Products Administration (NMPA) has cleared Adcentrx’s Investigational New Drug (IND) application for ADRX-0405. The clearance enables the company to include China-based clinical centers to its ongoing Phase 1a/1b trial (NCT06710379) evaluating ADRX-0405 in patients with late-stage solid tumors, including metastatic castration resistant prostate cancer, gastric cancer, and non-small cell lung cancer.

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ADRX-0405 is a potential first-in-class, next-generation ADC targeting six-transmembrane epithelial antigen of the prostate 1 (STEAP1), a cell surface protein that is overexpressed in prostate cancer and certain other cancers, with limited expression in healthy tissue.

"NMPA’s clearance of the ADRX-0405 IND is another important milestone for Adcentrx," said Hui Li, Ph.D., Founder and Chief Executive Officer of Adcentrx. "This clearance expands our ability to enroll patients in both the U.S. and China, broadening geographic representation and allowing us to generate clinical data across more diverse patient populations. This enables ADRX-0405 to address important unmet needs across multiple tumor types."

The first-in-human Phase 1a/b clinical trial of ADRX-0405 is an open-label, multicenter dose escalation and dose expansion study. The study is enrolling patients with select advanced solid tumors. The primary objectives of the study are to characterize the safety and tolerability and to determine the optimal dose of ADRX-0405. The company anticipates completing the Phase 1a portion of the trial by the fourth quarter of 2026.

About ADRX-0405

ADRX-0405 is a clinical-stage ADC targeting STEAP1. The ADC is composed of a humanized IgG1 antibody coupled with a novel topoisomerase inhibitor linker-payload through Adcentrx’s innovative i-Conjugation technology platform, a core element of its ADC design. The platform utilizes a cleavable linker and stable conjugation chemistry to enhance payload delivery. This novel technology enables a highly stable ADC with a drug-antibody ratio of eight (DAR 8) to maximize payload delivery to solid tumors. ADRX-0405 preclinical studies have demonstrated its favorable pharmacokinetics, safety profile, and significant efficacy across multiple animal tumor models. ADRX-0405 is currently being evaluated in a Phase 1a/b clinical trial.

For more information about the ADRX-0405 Phase 1a/b clinical trial, please refer to the Study ID NCT06710379 on ClinicalTrials.gov.

I-CONJUGATION is a trademark registered in China.

(Press release, Adcentrx Therapeutics, JUN 8, 2026, View Source [SID1234666478])

On June 7, 2026 OriCell Therapeutics Holdings Limited ( The "Company" or "Oricell") , reported that its proprietary GPC3-targeted autologous CAR-T therapy, Ori-C101, has received clearance from China’s National Medical Products Administration (NMPA) to proceed into a confirmatory Phase II clinical trial in patients with GPC3-positive advanced hepatocellular carcinoma (HCC). The study is designed as a prospective, randomised, open-label, multi-centre registration trial evaluating the efficacy and safety of Ori-C101 in patients who have failed two or more prior lines of therapy.

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This marks the first GPC3-directed immune cell therapy anywhere in the world to enter a confirmatory trial, and the first CAR-T product for a liver cancer indication to reach a Phase II randomised controlled study — a milestone that underscores China’s potential to lead the next wave of innovation in cell therapy for solid tumours.

HCC, a disease with few options at the late line

Hepatocellular carcinoma is among the most prevalent malignancies globally, with China alone accounting for roughly 410,000 new cases and 317,000 deaths each year. For patients whose disease has progressed through both immune checkpoint inhibitors (ICI) and tyrosine kinase inhibitors (TKI), options are essentially exhausted: existing second-line agents were developed for patients intolerant of, or progressing on, first-line sorafenib, and nothing has been approved beyond that point. The unmet need is acute.

Phase I data of Ori-C101: robust efficacy and manageable safety

Results from the Phase I BEACON study were featured as an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which recently wrapped up in Chicago, drawing significant attention from the oncology community. All enrolled patients had failed at least two prior lines of therapy, including both TKI and ICI treatment.

Key results:

Objective response rate (ORR): 50% across the evaluable population; 66.7% in the recommended Phase II dose (RP2D) cohort; 100% in the highest dose cohort (DL4)

Speed of response: 89% of responders had already achieved objective response by their first post-infusion assessment, with marked tumour shrinkage

Overall survival (OS): Median OS of 21.4 months in the overall population; 12-month survival rate of 69.3% — more than double the roughly 10.6-month historical median seen with available second-line agents, heralding a potential new era of long-term survival for patients with advanced HCC

Safety: Cytokine release syndrome (CRS) was manageable; no immune effector cell-associated neurotoxicity syndrome (ICANS) or off-target toxicity was observed, and tolerability was favourable across the study population

Notable case: One patient achieved partial response at first assessment, progressed to complete response by month four, and remains in remission at 24 months

Mechanism and broader potential

GPC3 (Glypican-3) is overexpressed in more than 70% of hepatocellular carcinomas, as well as in gastric cancer, lung squamous cell carcinoma, and ovarian clear cell carcinoma — making it a highly specific and compelling target for cancer therapy. Ori-C101 is engineered to identify and eliminate GPC3-positive tumour cells with precision, drawing on two proprietary platforms: OriAb (AI-assisted antibody discovery and engineering) and OriArmoring (structure-enhanced cell platform).

Ori-C101’s profile has the potential to support use in earlier lines of treatment, and GPC3’s expression across multiple tumour types provides a strong scientific rationale for future indication expansion. As the confirmatory trial advances, the goal of treatment in advanced HCC has the potential to shift from controlling disease to achieving durable remission — or even cure.

Principal investigators

The confirmatory Phase II study is a nation-wide, multi-centre trial co-led by Professor Fan Jia (Academician of the Chinese Academy of Sciences and Honorary President of Zhongshan Hospital, Fudan University) and Professor Qin Shukui (Qiantang Scholar and Professor at Nanjing Tianyinshan Hospital, China Pharmaceutical University).

In a joint statement, the two investigators said: "In our earlier work on late-line advanced HCC, the BEACON study delivered important progress. GPC3 is specifically overexpressed in HCC and represents an ideal therapeutic target, yet GPC3-directed CAR-T approaches have historically been constrained by the immunosuppressive tumour microenvironment. BEACON was designed precisely to break through that barrier and find a new, accessible path for patients who have exhausted their options. The preliminary results from this novel ‘armoured’ GPC3 CAR-T construct — showing strong objective response rates with a manageable safety profile — not only address an evidence gap in late-line refractory HCC but offer broader lessons for innovative immune cell therapies in solid tumours. We look forward to the Phase II randomised controlled study, and to obtaining the expected results under rigorous scientific design, comprehensive management, and strict quality control."

OriCell co-founder, Chairman and Chief Executive Officer Dr. Yang Huanfeng commented: "We are deeply grateful to the NMPA Centre for Drug Evaluation and relevant government authorities for their strong support of innovative drug development, and to Academician Fan, Professor Qin and their teams for their trust and active participation. This approval validates the scientific soundness and feasibility of our technology platform and marks a new stage of growth for OriCell. With a clear regulatory pathway now in place, we will push forward with Ori-C101’s confirmatory clinical development, with the aim of bringing a genuinely new treatment option to patients as quickly as we can. We believe this progress will also underpin China’s strategy for taking innovative medicines global and competing actively in international markets."

(Press release, OriCell Therapeutics, JUN 7, 2026, View Source [SID1234666476])

On June 5, 2026 Kura Oncology, Inc. (the "Company") (Nasdaq: KURA), a biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported that on June 1, 2026, the Compensation Committee of the Company’s Board of Directors (the "Compensation Committee") granted inducement awards consisting of nonstatutory stock options to purchase 53,000 shares of common stock to four (4) new employees under the Company’s 2023 Inducement Option Plan, as amended. The Compensation Committee approved the stock options as an inducement material to such employees’ employment in accordance with Nasdaq Listing Rule 5635(c)(4).

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Each stock option has an exercise price equal to $9.04 per share, the closing price of the Company’s common stock on June 1, 2026, and will vest over four years, with 25% of the underlying shares vesting on the one-year anniversary of the applicable vesting commencement date and the balance of the underlying shares vesting monthly thereafter over 36 months, subject to the new employees’ continued service relationship with the Company through the applicable vesting dates. The stock options are subject to the terms and conditions of the Company’s 2023 Inducement Option Plan, as amended, and the terms and conditions of an applicable stock option agreement covering the grant.

(Press release, Kura Oncology, JUN 5, 2026, View Source [SID1234666473])

On June 5, 2026 Foghorn Therapeutics Inc. (Nasdaq: FHTX), a clinical-stage biotechnology company pioneering a new class of medicines that treat serious diseases by correcting abnormal gene expression, reported that management will participate in the Goldman Sachs 47th Annual Global Healthcare Conference 2026. With an initial focus in oncology, Foghorn’s Gene Traffic Control platform and resulting broad pipeline have the potential to transform the lives of people suffering from a wide spectrum of diseases.

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Goldman Sachs 47th Annual Global Healthcare Conference 2026

Fireside Chat: Tuesday, June 9, 2026, at 1:20 p.m. EDT
Presenter: Adrian Gottschalk, President and Chief Executive Officer
Registration link: Register here
Management will also participate in one-on-one meetings
A webcast of the fireside chat can be accessed under "Events & Presentations" in the Investors section of the Company’s website here and will be available for 90 days.

(Press release, Foghorn Therapeutics, JUN 5, 2026, View Source [SID1234666471])

On June 5, 2026 Owkin, the agentic AI company pioneering Biological Artificial Superintelligence to transform drug discovery and development, reported a multi-year collaboration with Sanofi to co-develop next-generation biopharma agents, to be backed by a five-year license for K Pro, Owkin’s AI Scientist.

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Owkin and Sanofi have collaborated since 2021 through a €90 million strategic partnership focused on target identification in oncology and patient subgrouping. The collaboration was later expanded to include drug positioning for Sanofi’s immunology pipeline. This new collaboration represents the next evolution in the partnership.

During the five-year collaboration, Owkin will lead the end-to-end development of novel AI-driven biopharma agents purpose-built for Sanofi. These AI agents will work like intelligent assistants, autonomously performing complex tasks in drug research and development. They will be deployed through K Pro, with the aim of complementing and reinforcing Sanofi’s existing agentic AI capabilities.

K Pro combines multimodal patient data with specialized biological, agentic AI systems to support each stage of the pharmaceutical value chain, from early discovery through clinical development, while providing competitive intelligence, enabling faster, more informed, and more precise decisions.

"Building on our collaboration with Sanofi, this marks a shift toward truly embedded AI," said Thomas Clozel, CEO and co-founder of Owkin. "Owkin believes that, with K Pro, Sanofi can further harness agentic systems within their own workflows, unlocking the full value of their data to accelerate better decisions across drug development."

"Across Sanofi, we are continually investing in frontier AI solutions with the potential to accelerate and improve decision-making throughout the drug development lifecycle," said Emmanuel Frenehard, Chief Digital Officer at Sanofi. "By implementing purpose-built agentic systems into our workflows, we aim to empower our teams to operate with greater speed, depth, and confidence as we continue to work to deliver transformative outcomes for patients."

K Pro’s development is part of Owkin’s mission to achieve Biological Artificial Superintelligence to unlock new therapeutic discoveries beyond the limits of human cognition alone. Owkin believes this technology will enable the pharmaceutical industry to address, and ultimately automate, some of the most complex challenges in R&D.

(Press release, Sanofi, JUN 5, 2026, View Source [SID1234666470])