On June 17, 2025 HanchorBio Inc., a pioneer of immunotherapy biologics, reported interim data for a concurrent Phase 1b dose-escalation trial (NCT05892718) for HCB101, its breakthrough checkpoint inhibitor (CPI) biologic for cancer treatment (Press release, Hanchor Bio, JUN 17, 2025, View Source [SID1234653966]). The company presented the data at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting held May 31 – June 4 in Chicago, Illinois.

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Key findings include:

Favorable safety and tolerability across escalating doses
High-level CD47 receptor occupancy in peripheral immune cells
Early clinical signs of anti-tumor activity, including confirmed partial responses in patients with head and neck cancer (HNSCC) and non-Hodgkins lymphoma
HCB101: The best-in-class next generation of CPI

CPI treatments such as HCB101 are considered particularly promising forms of immunotherapy because they activate the body’s own defenses to kill cancer cells. They work by blocking proteins like CD47 — also known colloquially as the ‘don’t eat me’ protein — that allow cancer cells to evade detection. Compared to chemotherapy, CPI has demonstrated greater long-term remission and broader efficacy across various cancers.

While previous generations of CPI treatments tended to be either safe or effective, HCB101 stands out for its potential to achieve both. Utilizing the engineered signal-regulatory protein α (SIRPα) that targets CD-47, it has demonstrated efficacy against both solid and hematologic tumors, while earlier clinical trial data from the completed Phase 1a confirmed 100% safety across all dose levels. It can also be used as both a standalone treatment and in combination with other therapies. In terms of efficacy, HCB101 demonstrated a 26.7% disease control rate in the Phase 1a data, with 16.7% of subjects maintaining disease control for over four months.

"HCB101 solves the challenge that traditional CPI-based treatments face — the trade-off between safety and efficacy," commented Scott Liu, Ph.D., Founder, Chairman, and Chief Executive Officer of HanchorBio. "As clinical trials progress, HanchorBio is laying the groundwork to expand possibilities for immunotherapy and have an immense impact on oncology."

HCB101’s ongoing multi-region Phase 2 trial

Spanning Taiwan, the United States, and China, earlier in 2025 the company reached the key milestone of conducting a Phase 2 trial for HCB101, which has enrolled an even distribution of participants from diverse populations and included multiple cancer types, such as lung, head and neck, stomach, and breast cancers. The US portion of the trial has been approved by the US Food and Drug Administration (FDA) and will be conducted through US healthcare institutions.

A streamlined pipeline powered by in-depth expertise

With HCB101, HanchorBio has established a record for a biotech company of its size — achieving investigational new drug (IND) status from inception in 2.3 years. This has helped to attract USD 80 million in funding in recent years and demonstrates how the company distinguishes itself:

A highly streamlined pipeline
End-to-end approach
Over 30 years of industry expertise
A seasoned research team
State-of-the-art R&D facilities
HanchorBio further stands out for using its proprietary Fc-Based Designer Biologics (FBDB) platform, which has successfully fostered multiple pipeline programs from discovery to clinical trials.

On June 17, 2025 Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer tests, reported the launch of its DIRECT-AI registry study (Press release, Artera, JUN 17, 2025, View Source [SID1234653965]). This study will assess how the ArteraAI Prostate Test influences treatment decision-making between clinicians and patients with localized prostate cancer. Additionally, the study will monitor participants to evaluate their long-term cancer outcomes, reinforcing Artera’s commitment to advancing personalized cancer treatment and identifying future opportunities for test optimization.

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The DIRECT-AI study centers on the award-winning ArteraAI Prostate Test—the only test included in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for localized prostate cancer that can both predict therapy benefit and prognosticate long-term outcomes.

"Harnessing the power of AI, the ArteraAI Prostate Test marks a significant advancement in the personalized treatment of localized prostate cancer. Through the DIRECT-AI registry, we are rigorously evaluating how this technology can enhance clinical decision-making and improve patient outcomes, providing clinicians and patients with the most accurate, tailored insights available," said Dr. Tim Showalter, Chief Medical Officer at Artera.

The study is structured into two phases. The initial phase captures real-world insights into how the Artera Prostate Test informs clinical decision-making, with feedback collected from participating clinicians and patients. The second phase will monitor long-term health outcomes at key intervals of 2 and 5 years, looking at endpoints such as distant metastasis, survival rates, and treatment effectiveness. This research will help Artera understand how its test impacts cancer outcomes and monitor its performance so that it can be improved for patients in the future.

Any patient receiving the commercial ArteraAI Prostate Test and whose ordering physician is associated with an enrolling clinic is eligible to participate in the study. Patients must have localized prostate cancer and must not have started or received treatment for their condition. The study is non-interventional, meaning it does not require additional procedures or tests, and there will be no changes to the care participants receive, regardless of their participation.

For clinics participating in the DIRECT-AI Registry, physicians can enroll all patients for whom they order an ArteraAI Prostate Test in the study.

On June 17, 2025 SunRock Biopharma and Escugen reported to have joined forces in a strategic partnership to co-develop SRB123, a First-in-Class antibody-drug conjugate (ADC) targeting C-C motif chemokine receptor 9 (CCR9), a tumor-associated antigen overexpressed in multiple solid tumors, including pancreatic, ovarian and lung cancer (Press release, SunRock Biopharma, JUN 17, 2025, View Source [SID1234653964]).

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The collaboration combines SunRock’s proprietary SRB1 antibody, selected for its high binding affinity and efficient tumor cell internalization, with Escugen’s EZWi-Fit linker-payload platform, a next-generation ADC technology optimized for the linker stability and selective tumor release of the potent payload. The result is a highly differentiated therapeutic candidate designed exclusively for solid tumors with high CCR9 expression and internalization rates.

Under the agreement, both companies will share development responsibilities, file joint patents, and hold reciprocal licensing option rights. The primary goal is to generate robust preclinical proof-of-concept data to support early clinical entry in the near term.

"Combining our deep antibody engineering expertise with Escugen’s innovative conjugation platform enables us to deliver a precision oncology candidate with First-in-Class potential," said Dr. Laureano Simón, CEO of SunRock. "CCR9 remains an underexploited but clinically validated target. This program addresses real unmet needs in aggressive tumors with poor prognosis."

Dr. Qing Zhou, Co-Founder and CEO of Escugen, stated, "This strategic collaboration with SunRock Biopharma aligns with our vision of developing First-in-Class precision oncology candidates through technological innovation. It further highlights the unique advantages of our EZWi-Fit platform technology in next-generation ADC development. The platform’s strong anti-tumor activity and favorable tolerability provide a solid foundation for targeting high CCR9-expressing solid tumors. We are confident that combining our expertise will accelerate SRB123’s progress and bring new hope to patients."

CCR9 has been associated with metastatic potential and chemoresistance, particularly in pancreatic and ovarian cancers. SRB1, the unconjugated antibody from SunRock, has already demonstrated strong preclinical efficacy in these models. The ADC format (SRB123) leverages this targeting while enhancing tumor cell killing via Escugen’s payload delivery system.

The partnership will be showcased during the BIO International Convention 2025, where both companies will engage with potential development and commercialization partners.

On June 17, 2025 Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, and Noetik, a leader in AI-driven spatial and multimodal biology, reported a research collaboration to develop predictive biomarkers of response to Agenus’ lead clinical stage immuno-oncology (IO) combination, botensilimab (BOT, multifunctional Fc-enhanced anti-CTLA-4) and balstilimab (BAL, anti-PD-1) (Press release, Agenus, JUN 17, 2025, View Source [SID1234653963]). The collaboration harnesses Noetik’s proprietary virtual cell foundation models and large-scale, multimodal tumor data to uncover novel insights into the biology of tumor immunology. Together, the teams will deploy Noetik’s first-in-class foundation models directly on clinical results with the aim to enrich clinical efficacy.

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Central to this collaboration is Noetik’s OCTO virtual cell model, a 1.5 billion parameter foundation model trained on one of the largest proprietary multimodal spatial datasets. This dataset brings together spatial proteomics, spatial transcriptomics, H&E pathology, DNA genotyping, and clinical metadata from nearly 200 million tumor and immune cells collected from thousands of patients with cancers such as colorectal cancer, non-small cell lung cancer, ovarian cancers, and sarcomas. By integrating these diverse data types, Noetik’s foundation models provide a systems-level view of the tumor microenvironment in real patients, unlocking novel insights into cancer biology that can drive more precise therapeutic discovery and development.

Botensilimab, alone or in combination with BAL, has been evaluated in more than 1,200 patients across nine tumor types, including colorectal cancer, NSCLC, and sarcomas. By targeting complementary immune pathways, the BOT/BAL combination has shown deep and durable clinical responses—even in tumors considered immunotherapy "cold" or resistant to prior IO treatment. The regimen has generated growing recognition within the medical community, supported by compelling data presented in both late-line and neoadjuvant settings, multiple peer-reviewed publications, and presentations at more than a dozen major medical congresses over the past three years.

The collaboration aims to uncover clear, actionable biomarkers that can help predict which patients are most likely to respond to BOT/BAL treatment. Using OCTO virtual cell models to simulate how tumors behave in the body, Noetik will analyze complex biological data from multiple cancer types. The goal is to identify patterns that can predict treatment outcomes and help classify patient groups who may benefit most. Agenus will have exclusive rights to apply these insights in its drug development and commercialization efforts.

"Enhancing clinical efficacy is the most important problem in developing new medicines, and exactly what we’ve trained our foundation models to do. We are excited to deploy Noetik’s virtual cell foundation models on Agenus’ rich clinical data to uncover biomarkers that can enrich patient therapeutic response, improve trial outcomes, and ultimately deliver more precise therapies," said Ron Alfa, M.D., Ph.D., CEO & Co-Founder, Noetik.

"At Agenus, we are committed to transforming cancer care through scientific innovation and next-generation immunotherapies. This collaboration with Noetik enables us to harness cutting-edge AI to better understand patient biology and tailor treatments more precisely," said Dr. Garo Armen, Chairman and CEO of Agenus. "By integrating Noetik’s virtual cell models with our expansive BOT/BAL clinical dataset, we have the potential to accelerate the identification of predictive biomarkers, enhance the success of our pivotal trials, and ultimately improve outcomes for patients who currently have limited or no treatment options."

This collaboration reflects a growing momentum in oncology toward model-driven trial design and AI-enabled precision medicine—an area increasingly prioritized by the FDA under the guidance of the current U.S. administration as central to advancing more equitable, effective cancer care. By applying these technologies to real patient data, the goal is to accelerate the delivery of more personalized treatments, improve outcomes, and expand access to therapies for patients who need them most.

On June 17, 2025 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that members of its executive team will participate in the upcoming investor conferences, detailed below (Press release, Innate Pharma, JUN 17, 2025, View Source [SID1234653962]).

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H.C. Wainwright 3rd Annual Immune Cell Engager Virtual Conference
Dates: June 24, 2025 | Virtual

Wolfe Research Virtual Biotech Day
Dates: June 26, 2025 | Virtual