On November 5, 2025 HanchorBio Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, reported that the preclinical data on HCB301, a novel tri-specific immunotherapeutic fusion protein, has been accepted for presentation at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), taking place November 5-9, 2025, in National Harbor, Maryland. Featured in a poster presentation, the data highlight HCB301’s differentiated design and multi-pronged antitumor mechanism, which engages both innate and adaptive immunity.

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HCB301 is designed to simultaneously:

Block SIRPα-CD47 interaction to enable macrophage-mediated phagocytosis
Block PD-1-PD-L1 signaling to restore exhausted T-cell function
Trap TGFβ to overcome stromal and immune exclusion in tumor microenvironment (TME)
This tripartite approach aims to overcome the limitations of existing checkpoint inhibitors by activating both arms of the immune system, especially in tumors with immunologically ‘cold’ or suppressive tumor microenvironments (TMEs) resistant to current treatments.

In addition to the HCB301 preclinical poster presented on November 5, HanchorBio will also present two late-breaking abstracts on November 7 to showcase clinical data on its SIRPα-Fc fusion protein HCB101. Together, the three posters underscore the breadth and translational strength of HanchorBio’s proprietary Fc-Based Designer Biologics (FBDB) platform across innate and adaptive immune pathways.

Scott Liu, Ph.D., Founder, Chairman, and CEO of HanchorBio, commented: "HCB301 builds directly on the foundation of HCB101, our clinical-stage SIRPα-engineered fusion protein. By integrating PD-1 blockade and TGFβ neutralization into a single molecule, HCB301 represents what we believe to be the first-in-class tri-specific fusion protein that simultaneously targets immune checkpoints, immune suppression, and macrophage dysfunction. This design reflects our commitment to building modular, next-generation immunotherapies with global translation potential. With IND clearance and first-patient dosing now achieved in both the US and China, HCB301 demonstrates the scalability of our FBDB platform and the executional readiness of our team across regions. As we advance HCB301 into the clinical stage, this milestone further positions HanchorBio as a long-term innovation partner for global co-development, particularly in cancers with high resistance to conventional immunotherapies."

Preclinical highlights of HCB301 (SITC Poster #P321)
Title: HCB301, a tri-specific fusion protein targeting SIRPα/CD47, PD-1/PD-L1, and TGFβ, promotes anti-tumor macrophage and T cell activity in preclinical models of solid tumors

Strong immune activation: HCB301 induced robust antibody-dependent cellular phagocytosis (ADCP), activated tumor-associated macrophages, and increased CD8+ T cell infiltration.
Synergistic antitumor efficacy: In CT26, MC38, and B16F10 models, HCB301 demonstrated superior tumor growth inhibition compared with single- or dual-arm comparators.
TGFβ suppression: HCB301 potently neutralized active TGFβ, reversing TME immunosuppression, and restoring T cell function.
Fc-effector tuning: Selective Fc engineering optimized immune activation while minimizing off-target toxicity.
"HCB301 was purpose-built to break through the resistance barriers that limit current PD-1 or CD47 monotherapies," remarked Wenwu Zhai, Ph.D., Chief Scientific Officer of HanchorBio. "Each of its three arms addresses a key axis of tumor immune evasion: CD47 for innate immune clearance, PD-1 for adaptive immune reactivation, and TGFβ for TME remodeling. Our preclinical data show that HCB301 delivers synergistic immune activation and tumor control, strongly supporting its advancement into the clinic."

About HCB301
Based on company analysis, HCB301 is the first clinical-stage tri-specific recombinant Fc-fusion protein that simultaneously targets SIRPα/CD47, PD-1/PD-L1, and TGFβ. It was designed using HanchorBio’s FBDB platform, which enables modular multi-arm immunotherapies with tunable Fc regions and enhanced manufacturability.

HCB301 integrates:

A high-affinity SIRPα domain that binds cancer cells’ CD47 to promote macrophage phagocytosis
A PD-1 extracellular domain that blocks PD-L1 and restores T-cell effector function
A TGFβRII domain that traps active TGFβ to alleviate immunosuppressive signals in the tumor microenvironment
The protein shows a favorable safety profile in repeat-dose toxicology studies in cynomolgus monkeys. Its differential tumor vs. RBC binding profile may reduce the risk of anemia, thrombocytopenia, or other cytopenia while maintaining potent anti-tumor activity.

HCB301 achieved IND clearance and first-patient dosing in both the US and China in 2025. The ongoing Phase 1 study (HCB301-101; NCT06487624) is a multi-regional, multi-center, open-label, dose-finding, first-in-human trial evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical efficacy of HCB301 in patients with advanced solid tumors or relapsed and refractory classical Hodgkin lymphoma.

(Press release, Hanchor Bio, NOV 5, 2025, View Source [SID1234659487])

On November 5, 2025 BioDlink (1875.HK) reported to have congratulated its partner Lepu Biopharma (2157.HK) on receiving conditional marketing approval from China’s National Medical Products Administration (NMPA) for MEIYOUHENG (Becotatug Vedotin injection). This Class 1 innovative antibody-drug conjugate (ADC) targets the epidermal growth factor receptor (EGFR) for the treatment of recurrent or metastatic nasopharyngeal carcinoma (R/M NPC). Significantly, this is the world’s first approved non-photoimmunological EGFR-targeted ADC and a first-in-class innovation. This project is BioDlink’s first commercial ADC manufacturing initiative globally, validating its robust capabilities in the commercialization of complex biologics.

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This approval builds on BioDlink’s earlier success with Lepu Biopharma’s ADC program that achieved 100% first-pass success across technology transfer, Process Performance Qualification (PPQ), and Pre-Approval Inspection (PAI).

The program, designated as a Breakthrough Therapy Project, required rapid tech transfer and full production line delivery from monoclonal-antibody Drug Substance through ADC Drug Product.

BioDlink’s performance in this project secured BLA approval on October 30, 2025, demonstrating its capacity to meet aggressive regulatory timelines and ensure commercial readiness for global markets.

ADC manufacturing is technologically demanding, requiring exceptional process capabilities and robust quality systems. BioDlink participated in the entire development and production cycle, from technology transfer, process development, and analytical method establishment to clinical sample and GMP-compliant commercial batch manufacturing. This reflects the company’s end-to-end capabilities in supporting complex biologics from R&D to market launch.

Through close coordination with Lepu Biopharma and multiple regulatory authorities, BioDlink established an integrated quality management system. This system ensures seamless coordination across the entire production chain—accelerate the timeline for pivotal clinical batch production and subsequent PPQto meet aggressive regulatory submission goals and aligns with global GMP standards, including those of China, the U.S., and the EU. BioDlink’s manufacturing facilities have obtained GMP certifications from several countries and Foreign Manufacturer Approval from Japan’s PMDA. This collaboration sets a practical model for efficient multi-party industry collaboration and resource integration in the biopharma sector.

BioDlink’s manufacturing facilities have obtained GMP certifications from China, Brazil, Argentina, Indonesia, Egypt, Colombia, Pakistan and Thailand, as well as Foreign Manufacturer Approval from Japan’s PMDA. And also passed EU-QP 5 times in these years. This achievement marks a major step forward for ADC commercialization and demonstrates a practical model for multi-party industry collaboration and efficient resource integration.

Dr. Ziye Sui, Executive Director and CEO of Lepu BioPharma, commented: "We sincerely thank the BioDlink team for their outstanding CDMO services and strong collaboration. This approval also establishes a practical pathway for multi-party collaboration, offering new hope for R/M NPC patients who have failed anti-PD-(L)1 and platinum-based therapies."

Dr. Jian Zhang, Chief Operating Officer, BioDlink, noted: "The approval of this pilot batch highlights the increasing technical and quality coordination demands placed on both the Marketing Authorization Holder (MAH) and the CDMO. Moving forward, we will continue working closely with our partners to accelerate the launch of innovative medicines to benefit patients worldwide."

About Becotatug Vedotin

MEIYOUHENG (Becotatug Vedotin injection) is an ADC comprised of an EGFR-targeted monoclonal antibody conjugated with the potent microtubulin inhibiting payload monomethyl auristatin E via a valine-citrulline linker. It is the world’s first approved EGFR-targeted ADC and a first-in-class innovation, for the treatment of recurrent or metastatic nasopharyngeal carcinoma (R/M NPC).

It binds specifically with high affinity to EGFR on the surface of tumor cells, releases the potent payload upon internalization and lysosomal protease cleavage of the linker and results in tumor cell death. EGFR is highly expressed in colorectal cancer, lung cancer, head and neck cancer and other malignant solid tumors, and is expressed in 89% advanced NPC. Therefore, EGFR is an important target for cancer treatment.

(Press release, BioDlink, NOV 5, 2025, View Source [SID1234659486])

On November 5, 2025 The Parker Institute for Cancer Immunotherapy (PICI), reported that research and expertise from across its network will be showcased at the 2025 Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) from November 5–9 in National Harbor, Maryland. PICI leaders, investigators and collaborators are contributing to 80 posters, presentations and discussions throughout the 40th anniversary program – a significant presence that highlights the organization’s commitment to accelerating the development of breakthrough immune therapies for cancer.

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Notably, PICI’s President of Research, Ira Mellman, PhD, will receive SITC (Free SITC Whitepaper)’s 2025 Richard V. Smalley Memorial Award, which is given to a recognizable luminary in the field that has significantly contributed to the advancement of cancer immunotherapy research. Dr. Mellman is a distinguished cell biologist and member of the National Academy of Sciences. His pioneering work has been critical to the development of groundbreaking cancer therapies, including Tecentriq (atezolizumab), patient-specific neo-antigen mRNA and DNA vaccines, T cell-engaging bispecific antibodies and novel immunotherapies such as tiragolumab (anti-TIGIT). Dr. Mellman will receive the award and present, "The Coming Renaissance of Cancer Immunotherapy" on Saturday, November 8th (8:05-8:55 AM ET, Potomac Ballroom).

PICI CEO Karen Knudsen, MBA, PhD, will also participate in a panel discussion, "The Momentum and Future of Cancer Research Funding" on Saturday, November 8th (12:30-1:30 PM ET, Cherry Blossom Ballroom). In the session, Dr. Knudsen will join leaders from key research funding agencies that are actively shaping the cancer research landscape to discuss sustaining momentum in cancer research and funding models to accelerate discovery and drive therapeutic breakthroughs.

"The breadth of PICI science featured at SITC (Free SITC Whitepaper) this year – reflecting everything from next-gen cell therapies to applying artificial intelligence – reflects the strength of the PICI model that unites academic excellence, industry expertise, and entrepreneurial innovation," said Dr. Knudsen. "Through our investigators and portfolio companies, we are developing and accelerating access to breakthrough cancer therapies and curating innovation from discovery to commercialization, with the vision of converting all cancers to curable diseases."

Presentation Highlights from the Network

Engineering Smarter Cell Therapies
PICI investigators are redefining how engineered immune cells can safely and effectively target tumors. Through innovations like CRISPR editing, logic-gated circuits, and synthetic control of CAR and TCR activity, researchers are driving the next generation of precision cellular immunotherapies.

Primer on Tumor Immunology and Cancer Immunotherapy Workshop – Update on CAR-T cell Therapies (Pre-Conference Workshop, Thursday, November 6)
Speaker: Carl H. June, MD, Director of the PICI Center at University of Penn

UCCT-BCMA-1: A First-in-Human, Non-Viral CRISPR-Engineered CAR T Cell Therapy Targeting BCMA in Relapsed/Refractory Multiple Myeloma (Top 150Abstract 247, Poster Presentation, Friday, November 7)
Presenting author: PICI Investigator Ke Li, PhD (University of California, San Francisco)
Co-authors: PICI Investigators David Y. Oh, MD, PhD (University of California, San Francisco); Alexander Marson, MD, PhD (Gladstone Institutes); Justin Eyquem, PhD (University of California, San Francisco); Brian Shy, MD, PhD (University of California, San Francisco)

Targeting tumor-associated macrophages with CAR-Monocytes as a first-in-class approach for cellular therapy in breast cancer (Abstract 254, Oral Presentation, Young Investigator Award, Saturday, November 8)
Co-author: PICI Investigator Rizwan Romee, MD (Dana-Farber Cancer Institute)

Engineered T cell therapy combined with PD-1, Lag-3 and Tim-3 checkpoint inhibition promotes pro-inflammatory CD4 T cell differentiation in an ovarian cancer mouse model (Abstract 339, Poster Presentation, Friday, November 7)
Co-author: PICI Investigator Philip D. Greenberg, MD (Fred Hutchinson Cancer Center)

Discovery and characterization of human T cell receptors that recognize tumor-associated antigens derived from tumor suppressors p16INK4A and p14ARF ( Abstract 345 , Poster Presentation, Friday, November 7)
Co-author: PICI Investigator Philip D. Greenberg, MD (Fred Hutchinson Cancer Center)

Tuning CAR-T cells by targeting cancer-associated glycan in pancreatic cancer; Augmenting Notch1 to enhance CD19-BBz CAR-T therapy (Abstract 262, Poster Presentation, Saturday, November 8)
Co-author: PICI Extramural Researcher Marcela Maus, MD, PhD (Massachusetts General Hospital)

AB-3028: Dual-targeting sequential AND logic gated CAR T cell for potential mCRPC therapeutic; Programmable Circuit T cells encoding multiplexed shRNAs and logic-gates for mCRPC (Abstract 303, Poster Presentation, Friday, November 7)
Presenting author: PICI Portfolio Company ArsenalBio
Artificial Intelligence and Machine Learning Driving Discovery
From tumor profiling to CAR-T optimization, AI is accelerating discovery and decision-making in immuno-oncology. PICI researchers are leveraging multimodal data and large language models to predict toxicity, design smarter therapies, and redefine how data informs innovation.

Leveraging the Power of Artificial Intelligence to Foster Progress in Immuno-oncology: Opportunities and Challenge – A Post-Data World – LLMs and the End of Data Paralysis (Pre-Conference Workshop, Thursday, November 6)
Speaker: PICI Investigator Garry P. Nolan, PhD (Stanford Medicine)

Rational CAR T cell design via attention-based multiple instance learning of infusion product scRNA-seq data (Abstract 1126, Poster Presentation, Saturday, November 8)
Co-authors: PICI Investigators Crystal L. Mackall, MD (Stanford Medicine); David Miklos, MD, PhD (Stanford Medicine); Zinaida Good, PhD (Stanford Medicine)

A Pan-Cancer Single-Cell Multimodal Atlas of Antigen-Specific T Cells and Scalable Framework for Mapping Antigen Specificity (Top 150,Abstract 1112, Oral Presentation, Young Investigator Award, Saturday, November 8)
Co-author: PICI Investigator Roberta Zappasodi, PhD (Weill Cornell Medicine)

Pre-treatment predictive modeling of immune-related adverse event risk in immune checkpoint blockade therapy: A multi-modal machine learning approach from a real-world setting – RADIOHEAD Cohort Study (Abstract 1094, Poster Presentation, Saturday, November 8)
Co-authors: PICI Chief Scientific Officer John Connolly, PhD; PICI Research Director EnJun Yang, PhD

gx1: Virtual Target Identification for Overcoming T Cell Exhaustion (Abstract 1125, Poster Presentation, Friday, November 7)
Presenting author: PICI Portfolio Company ArsenalBio

(Press release, Parker Institute for Cancer Immunotherapy, NOV 5, 2025, View Source [SID1234659485])

On November 5, 2025 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, reported that its management team is scheduled to participate and present at the following investor conferences in November:

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Guggenheim Healthcare Conference 2025: Fireside chat on Tuesday, November 11 at 1:00 pm ET
Jefferies Global Healthcare Conference in London: Fireside chat on Wednesday, November 19 at 2:30 pm GMT (9:30 am ET)
A live webcast of the fireside chats can be accessed under "Events & Presentations" in the Investor section of the Company’s website, View Source A replay of the webcasts will be archived on the website for approximately 90 days following the presentation.

(Press release, Verastem, NOV 5, 2025, View Source [SID1234659483])

On November 5, 2025 Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing novel peptide-based therapeutics for liver and cardiometabolic diseases, reported that members of the Company’s management team will participate and be available for one-on-one meetings at the following investor conferences:

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Stifel 2025 Healthcare Conference
Wednesday, November 12, 2025
Fireside Chat at 10:00 a.m. ET
Jefferies Global Healthcare Conference
Thursday, November 20, 2025
Fireside Chat at 9:30 a.m. GMT
The sessions will be webcast and can be accessed by visiting the Events section of the Altimmune website.

(Press release, Altimmune, NOV 5, 2025, View Source [SID1234659482])