On June 11, 2026 Anocca AB (‘Anocca’ or the ‘Company’), a clinical-stage biotechnology company developing advanced T-cell immunotherapies, reported the successful dosing of the first patients across multiple clinical sites with ANOC-001, a novel T cell receptor-modified T cell therapy (TCR-T)[1] targeting KRAS G12V mutations in an aggressive form of pancreatic cancer.

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ANOC-001 is the first product to enter Anocca’s VIDAR-1 clinical programme, which focuses on pancreatic ductal adenocarcinoma (PDAC). The therapy is designed for patients whose tumours carry a specific mutation in the KRAS gene. The product candidate has been discovered, developed and manufactured by Anocca at its in-house facilities in Sweden. ANOC-001 is the first non-viral gene-edited T cell therapy to be evaluated in Europe, with the deployment of this technology enabling scalable product development and future commercialisation.

Pancreatic cancer remains one of the deadliest cancer types, with a five-year survival rate below 10% (1). Despite recent advances there are currently no definitive treatments for patients with progressed disease (2). KRAS mutations are one of the most common cancer mutations and are implicated in pancreatic, lung and colorectal cancers. G12V and G12D mutations in KRAS affect around 90% of pancreatic cancer patients. VIDAR-1 addresses this unmet need by engineering the immune system’s T-cells to recognise and attack cancer cells carrying the KRAS mutation.

Reagan Jarvis, co-founder and Chief Executive Officer of Anocca, said: "The dosing of patients marks an important milestone for Anocca, and demonstrates our ability to develop, manufacture and clinically deploy precision TCR-T cell therapy products. The novel ANOC-001 clinical candidate was developed with Anocca’s proprietary analytical platform that maps targets and identifies, characterises and engineers T-cell receptors. We are grateful to our team, investors and partners whose efforts and participation made this milestone possible."

Hugh Salter, Chief Scientific Officer, added: "The VIDAR-1 clinical programme is designed to evaluate multiple TCR-T product candidates targeting distinct KRAS mutations and HLA combinations [2]. ANOC-001 is the first product in this series and additional products targeting different forms of mutant KRAS will be introduced into the uniquely designed clinical programme. By using non-viral gene editing technology, we are able to scale delivery of highly precise therapies to broader patient populations. We would like to thank our clinical collaborators for their support as well as the study participants and their families."

Recruitment and manufacture are ongoing for Phase I of the multi-centre VIDAR-1 trial, which is being conducted at eight leading university hospitals across Sweden, Denmark, Germany, and The Netherlands.

(Press release, Anocca, JUN 11, 2026, View Source [SID1234666589])

On June 11, 2026 Immunome, Inc. (Nasdaq: IMNM), a biotechnology company committed to developing first-in-class and best-in-class targeted cancer therapies, reported that the first patient has been dosed in the Phase 1, first-in-human trial of IM-1617, a potential first-in-class ADC directed at an undisclosed solid tumor target and incorporating HC74, Immunome’s proprietary TOP1 inhibitor payload.

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"The first patient dosed with IM-1617 is a significant milestone for Immunome’s ADC platform and a meaningful step toward our mission of delivering targeted therapies for patients with cancer," said Clay Siegall, Ph.D., President and Chief Executive Officer of Immunome. "We are encouraged by the pace of progress across our portfolio and look forward to advancing IM-1617 while continuing to expand the clinical potential of our proprietary HC74 payload through additional ADC programs."

The Phase 1 trial is an open-label, multicenter dose escalation and expansion study designed to determine the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of IM-1617. The study is expected to include participants with advanced solid tumors, including colorectal cancer, non-small cell lung cancer, and breast cancer.

About IM-1617

IM-1617 is a clinical-stage solid tumor ADC. It targets an undisclosed receptor tyrosine kinase that promotes tumor cell survival and mediates immune cell exclusion, and it incorporates HC74, Immunome’s proprietary TOP1 inhibitor. Preclinical in vivo efficacy studies showed impressive tumor regression after a single, clinically relevant dose of IM-1617 in a variety of solid tumor models.

(Press release, Immunome, JUN 11, 2026, View Source [SID1234666588])

On June 11, 2026 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported that the U.S. Food and Drug Administration (FDA) has approved Guardant360 CDx as a companion diagnostic (CDx) for Boehringer Ingelheim’s HERNEXEOS (zongertinib tablets), the first targeted therapy for adults with HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC) as an initial treatment option.

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The approval enables Guardant360 CDx, a liquid biopsy test that analyzes circulating tumor DNA (ctDNA) from a simple blood draw, to identify patients with HER2 (ERBB2) tyrosine kinase domain activating mutations who may be eligible for treatment with HERNEXEOS.

HERNEXEOS is indicated for the treatment of adult patients with unresectable or metastatic non-squamous NSCLC whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test. This indication was approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. More information and full prescribing information can be found at HERNEXEOS.com.

"This approval highlights the growing impact of liquid biopsy across advanced cancer care and underscores the utility of Guardant360 CDx to ensuring more patients can be matched to the right therapy at the right time," said Helmy Eltoukhy, Guardant Health chairman and co-CEO. "Guardant360 CDx has been at the forefront of enabling comprehensive genomic profiling through a simple blood draw, helping clinicians identify actionable mutations in genes such as HER2 with speed and accuracy."

Guardant360 CDx was the first FDA-approved liquid biopsy that provides comprehensive genomic profiling across multiple tumor types and biomarkers. By detecting tumor-derived alterations in circulating cell-free DNA, the test helps clinicians match patients to appropriate targeted therapies and clinical trials.

"Companion diagnostics are essential to personalized lung cancer care, guiding biomarker-driven treatment decisions," added Vicky Brown, U.S. Therapeutic Area Head for Oncology and Emerging Areas, Boehringer Ingelheim. "Guardant360 CDx will help identify patients with HER2-mutant advanced non-small cell lung cancer and connect eligible patients to the appropriate targeted therapy when timely treatment decisions matter most."

NSCLC is the most common type of lung cancer, and a subset of patients harbor HER2 mutations that may be targetable with precision therapies. HER2-mutant NSCLC is an aggressive type of lung cancer that has been associated with a poor prognosis. Blood-based testing offers a faster, less invasive alternative to tissue biopsy, which can be challenging in advanced disease.

This latest FDA approval for Guardant360 CDx marks the 27th CDx indication across multiple tumor types globally, building on the platform’s increasing clinical utility and broad coverage by Medicare and commercial payers, representing more than 300 million covered lives.

For more information about Guardant360 CDx, visit www.guardanthealth.com.

About Guardant360 CDx

Guardant360 CDx is the first FDA-approved liquid biopsy for comprehensive genomic profiling. It detects multiple genomic alterations across all solid tumors and is approved as a companion diagnostic for therapies in non-small cell lung cancer, breast cancer, and colorectal cancer.

(Press release, Guardant Health, JUN 11, 2026, View Source [SID1234666587])

On June 11, 2026 PeptiDream Inc., a public Kanagawa, Japan-based biopharmaceutical company (President: Patrick C. Reid, hereinafter "PeptiDream") reported the dosing of the first patient in a first-in-human imaging study of 64Cu-PD-29875 targeting Claudin 18.2 ("CLDN18.2").

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This clinical research is a first-in-human Phase 0 imaging study*¹ of 64Cu-PD-29875. In this study, 64Cu-PD-29875 is being evaluated for the safety, pharmacokinetics, tumor uptake, and dosimetry using PET/CT imaging in patients with gastric cancer, including gastroesophageal junction cancer. PET imaging with 64Cu-PD-29875 will enable assessment of its diagnostic performance and provide insights into its potential as a paired radiotherapeutic*² agent when labeled with therapeutic radioisotopes.

CLDN18.2 is a member of the claudin family of proteins that form tight junctions in epithelial tissues. While it is primarily expressed in gastric epithelial cells in normal tissues, it has been reported to be highly expressed in a variety of solid tumors, including gastric cancer, esophageal cancer, pancreatic cancer and lung adenocarcinoma. It is regarded as an attractive molecular target for both cancer diagnosis and therapy.

PD-29875 is a macrocyclic peptide discovered using PeptiDream’s proprietary PDPS technology and further optimized through in vivo imaging*³ and efficacy studies conducted at PDRadiopharma, a wholly owned subsidiary of PeptiDream.

In this clinical research, PD-29875 is labeled with the diagnostic radioisotope 64Cu to generate PET imaging data. These data are expected to provide early insights into the diagnostic performance, inform the likelihood of therapeutic benefit when labeled with therapeutic radioisotopes, and support the design of subsequent clinical studies, thereby significantly accelerating clinical development.

Patrick C. Reid, President & CEO of PeptiDream commented: "The initiation of clinical dosing for PD-29875 marks an important step in realizing our vision of building a differentiated radiotheranostics platform. As our second wholly owned radiopharmaceutical program, PD-29875 targets CLDN18.2, a highly promising oncology target, and exemplifies the strength of our peptide discovery engine. By advancing both a 225Ac-labeled therapeutic and 64Cu-labeled diagnostic as part of our integrated radiotheranostic approach, we are accelerating our mission to deliver next-generation precision radiopharmaceuticals for patients with cancer."

PD-29875 was adopted by the Japan Agency for Medical Research and Development (AMED) as part of the "Practical Research for Innovative Cancer Control" and received funding support from AMED in 2024.

(Press release, PeptiDream, JUN 11, 2026, View Source [SID1234666586])

On June 11, 2026 Zetagen Therapeutics, a clinical‑stage biopharmaceutical company developing novel therapies for primary and metastatic breast cancer, reported preliminary topline results from its Phase 2a clinical study evaluating ZetaMet (Zeta BC 003) in subjects with metastatic breast cancer (MBC) with lytic bone lesions.

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In this open‑label study, no skeletal‑related events (SREs) or fractures were observed, no treatment‑related adverse events (AEs) or serious adverse events (SAEs) were reported, and cessation of tumor activity was noted in treated vertebral bodies. Zeta BC 003 is an investigational product that has received Breakthrough Designation from the U.S. Food and Drug Administration (FDA) and has not been approved by the FDA or any regulatory authority.

"We are encouraged by the preliminary findings from this Phase 2a study, which provide important clinical observations on the investigational use of ZetaMet in patients with metastatic breast cancer involving bone," said Joe C. Loy, President & CEO of Zetagen Therapeutics. "These results also highlight a major achievement for our team, overcoming longstanding industry challenges in intratumoral administration by developing proprietary carriers which deliver compounds that demonstrate solubility and localized bio‑adhesion."

The preliminary findings were presented by Dr. Bryan Margulies, Chief Scientific Officer, and Joe C. Loy, President & CEO, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on Monday, June 2, 2026. Abstract: View Source

Study Overview
The open‑label Phase 2a study (ZGMBC; NCT05280067), conducted at the University of British Columbia, enrolled 10 subjects with a mean age of 52, representing multiple MBC subtypes:

HR+ (n=6)
HR+/HER2+ (n=2)
HER2+/HR– (n=1)
TNBC (n=1)
Five subjects had breakthrough lytic lesions despite prior bisphosphonate therapy. One subject died due to pleural edema, unrelated to study treatment. Across the 10 subjects, 11 target lesions received a single intratumoral injection of Zeta BC 003 under sedation. Four adjacent, non‑injected lesions were also evaluated.

Study Context
Historical literature reports SRE rates of approximately 53% (Parke et al., Journal Oncologist, 2018) in metastatic breast cancer with bone involvement under conventional therapy, with SREs, particularly fractures, associated with a reduction in overall survival of approximately 4.8 months (Saad et al., Journal of the National Cancer Institute, 2004).

Observed Study Findings

No SREs or fractures reported
Cessation of tumor activity within treated vertebral bodies
Therapeutic spread observed to adjacent, untreated lesions within the same vertebral body
No treatment‑related AEs or SAEs
Mean bone defect volume decreased 65.4% at Day 84 (±20.5%; p=0.0003)
Mean bone defect volume decreased 84.1% at Day 180 (±13.1%; p<0.0001)
Pain scores (NRS) decreased by 4.16 points (p<0.05)
Opioid use (MED) decreased 33–67% among opioid‑treated subjects
Spinal stability (SINS) improved 18.5% (p<0.05)
Quality of life improved:
PCS increased 24.2%
MCS increased 12.1%
While cross‑study comparisons have inherent limitations, the absence of AEs and SREs in this Phase 2a study provides supportive information for continued investigation.

These observations are also consistent with two published Expanded Access case reports (seven lesions, 2‑year follow‑up; Palma et al., Pain Management, 2023), which similarly demonstrated absence of SREs, cessation of tumor activity, neo‑trabecular bone formation, and therapeutic spread within treated vertebral bodies.

Acknowledgment of Clinical Partners
Zetagen Therapeutics acknowledges and extends its appreciation to the University of British Columbia, Nor Consult, LLC (NorCo), and Medical Medics Incorporated for their contributions to the ZetaMet clinical study. NorCo provided comprehensive clinical operations support, and Medical Medics delivered centralized imaging services that enabled rigorous data quality and standardized imaging assessments throughout the trial.

About ZetaMet (Zeta BC 003)
ZetaMet is designed for single intratumoral administration into lytic bone lesions associated with metastatic breast cancer. Preclinical and clinical studies suggest the potential for ZetaMet to cease lytic activity, reducing pain, initiating bone healing, and prevent SREs; however, ZetaMet has not been approved by the FDA or any regulatory authority.

(Press release, Zetagen Therapeutics, JUN 11, 2026, View Source [SID1234666585])