On May 19, 2025 FUJIFILM Corporation reported the successful validation of the cancer cell-targeting potential of its peptide-oligonucleotide conjugates (Press release, Fujifilm, MAY 19, 2025, View Source [SID1234653238]). This validation resulted from combining oligonucleotides with cyclic peptides developed from Fujifilm’s proprietary peptide library, which contains trillions of variants. This research achievement will be presented at TIDES USA, an exhibition to be held from May 19 to 22, 2025, in San Diego (poster number: 35).

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Cyclic peptides, including those containing unnatural amino acids, are emerging as a promising new modality in drug discovery due to their unique and favorable properties, including high binding affinity and specificity, improved tissue permeability, and synthetic versatility. Peptide-oligonucleotide conjugation addresses delivery challenges associated with oligonucleotide-based therapies by utilizing the excellent delivery properties of peptides and have been actively researched.

Leveraging its large peptide library constructed with mRNA display technology, and structural optimization techniques, Fujifilm has developed a proprietary cyclic peptide that binds strongly to integrins overexpressed on the surface of cancer cells, with a low dissociation constant (KD) of 1.6 nM. Utilizing chemical modification methods Fujifilm can successfully synthesize the peptide-oligonucleotide conjugate at high yield. Uptake of these peptide-oligonucleotide conjugates by cancer cells is higher compared to uptake of the non-conjugated oligonucleotide, demonstrating the peptide-oligonucleotide conjugate’s ability to selectively accumulate in cancer cells.

Fujifilm is expanding its drug discovery services for peptide therapeutics globally, providing a wide range of contract research services focusing on peptide discovery, high-throughput screening, and structural optimization. Fujifilm’s one-stop comprehensive service includes peptide chemical synthesis and target protein expression and purification to meet diverse research demands. Fujifilm is committed to driving research and development that fosters technological innovation in the healthcare field, leveraging the ability of cyclic peptides to regulate cellular functions and their specific molecular recognition capabilities, contributing to the advancement of pharmaceutical development of peptide therapeutics.

On May 19, 2025 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ZL-1310, the Company’s potential first-in-class Delta-like ligand (DLL3) antibody-drug conjugate (ADC), for the treatment of extensive-stage small cell lung cancer (ES-SCLC) (Press release, Zai Laboratory, MAY 19, 2025, View Source [SID1234653237]). ZL-1310, which is being evaluated in an ongoing global Phase 1a/1b clinical trial (NCT06179069), previously received an Orphan Drug designation for SCLC from the FDA. The company will present updated data at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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"The FDA’s decision to grant Fast Track designation to ZL-1310 highlights the significant need for expanded treatment options for patients with SCLC and represents an important step in our efforts to advance a novel therapeutic option as quickly as possible," said Rafael G. Amado, M.D., President, Head of Global Research and Development, Zai Lab. "This designation reinforces the clinical progress we have achieved for ZL-1310 to-date, and we remain on track to initiate a pivotal study in small cell lung cancer later this year, positioning us for a potential accelerated approval in 2027."

Fast Track designation facilitates the expedited development and review of new drugs to address an unmet medical need or treat serious or life-threatening diseases. Benefits of this designation include more frequent engagements with the FDA to discuss the drug’s clinical development plan and eligibility for Accelerated Approval and Priority Review if relevant criteria are met. More information on the Fast Track process is available here.

Zai Lab will hold an investor conference call and webcast to highlight updated ZL-1310 data at ASCO (Free ASCO Whitepaper) and outline the next steps in clinical development.

Details regarding upcoming ZL-1310 webcast and conference call are as follows:

Date/Time: Monday, June 2, 2025, at 7:00 a.m. CT / 8:00 a.m. ET / 8:00 p.m. HKT., please register at:
Webcast presentation (preferred): View Source;
Dial-in: View Source
Presenter: Rafael G. Amado, M.D., President, Head of Global Research and Development, Zai Lab

About Small Cell Lung Cancer and ZL-1310

SCLC is one of the most aggressive and lethal solid tumors, accounting for approximately 5% of the approximately 2.5 million patients diagnosed with lung cancer worldwide each year. 1,2 Additionally, two-thirds of all SCLC patients are diagnosed at extensive stage. 3

DLL3 is an antigen overexpressed in many neuroendocrine tumors, such as SCLC, and is often associated with poor clinical outcomes. ZL-1310 comprises a humanized anti-DLL3 monoclonal antibody connected via a cleavable linker to a novel camptothecin derivative (a topoisomerase 1 inhibitor) as its payload. The compound was designed with a novel ADC technology platform called TMALIN, which leverages the tumor microenvironment to overcome challenges associated with first-generation ADC therapies.

On May 19, 2025 Pfizer Inc. (NYSE: PFE) reported it has entered into an exclusive global, ex-China, licensing agreement with 3SBio, Inc. (01530.HK), a leading Chinese biopharmaceutical company, for the development, manufacturing and commercialization of SSGJ-707, a bispecific antibody targeting PD-1 and VEGF, currently undergoing several clinical trials in China for non-small cell lung cancer, metastatic colorectal cancer, and gynecological tumors (Press release, Pfizer, MAY 19, 2025, View Source [SID1234653236]). SSGJ-707 has shown initial efficacy and safety data in a promising class of cancer medicines. 3SBio plans to initiate the first Phase 3 study in China in 2025.

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Under the terms of the agreement, 3SBio and its subsidiaries Shenyang Sunshine Pharmaceutical Co., Ltd. and 3S Guojian Pharmaceutical (Shanghai) Co., Ltd. will grant Pfizer an exclusive global license to develop, manufacture and commercialize SSGJ-707 worldwide, excluding China. The agreement also provides Pfizer the option of commercialization rights in China. 3SBio will receive an upfront payment of $1.25 billion and is eligible to receive milestone payments associated with certain development, regulatory and commercial milestones up to $4.8 billion as well as tiered double-digit royalties on sales of SSGJ-707, if approved.

The transaction is expected to close in the third quarter subject to fulfillment of customary closing conditions, including receipt of required regulatory approvals and 3SBio shareholder approval. Upon close, Pfizer will make a $100 million equity investment in 3SBio subject to an agreed upon securities subscription agreement between the parties. Pfizer plans to manufacture drug substance for SSGJ-707 in Sanford, North Carolina, and drug product in McPherson, Kansas.

On May 19, 2025 Porton Advanced, a leading contract development and manufacturing organization (CDMO) specializing in advanced therapy medicinal products (ATMPs), reported its partnership with Hualong Biological, an innovator in novel cancer therapeutics (Press release, Henan Hualong Biotechnology, MAY 19, 2025, View Source [SID1234653235]). Porton Advanced will provide end-to-end CDMO services for Hualong’s Multi-Activated T Cell (MATC) therapy, from process optimization to regulatory submission, accelerating its development progress.

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Hualong Biological ‘s research team has established a strong clinical foundation for its MATC platform through multiple investigator-initiated trials (IITs), demonstrating significant therapeutic benefits across various solid tumor indications. Porton Advanced will leverage its industry-leading process development platforms, GMP manufacturing capabilities, and proven regulatory expertise to optimize the MATC therapy’s CMC strategy and facilitate its transition from research to clinical development.

Mingguang Huang, Chairman of Hualong Biological, commented: "We are delighted to partner with Porton Advanced. Their comprehensive CDMO technical expertise and regulatory experience in cell therapy will significantly enhance our MATC program’s development efficiency and IND preparation timeline. Together, we’re committed to advancing this innovative therapy into clinical trials to benefit patients worldwide."

Andrew Chen, CFO of Porton Advanced, stated: "Collaborating with Hualong Biological marks a strategic expansion of our CDMO services in cell therapy. We are honored to provide regulatory-compliant, high-quality MATC CMC services to support their IND application. Porton Advanced is committed to supporting partners through our integrated technology platform and regulatory experience to bring cutting-edge therapies to patients faster."

On May 19, 2025 AstraZeneca reported the successful completion of the acquisition of EsoBiotec, a biotechnology company pioneering in vivo cell therapies that has demonstrated promising early clinical activity (Press release, AstraZeneca, MAY 19, 2025, View Source [SID1234653234]). The EsoBiotec Engineered NanoBody Lentiviral (ENaBL) platform empowers the immune system to attack cancers and could offer many more patients access to transformative cell therapy treatments delivered in just minutes rather than the current process which takes weeks.

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ENaBL uses highly targeted lentiviruses to deliver genetic instructions to specific immune cells, such as T cells, which programme them to recognise and destroy tumour cells for cancer treatment or autoreactive cells for potential use in immune-mediated diseases. This approach enables cell therapies to be administered through a simple IV injection and without the need for immune cell depletion.

As a result of this acquisition, EsoBiotec has become a wholly owned subsidiary of AstraZeneca, with operations in Belgium.

Financial considerations
AstraZeneca has acquired all outstanding equity of EsoBiotec for a total consideration of up to $1bn, on a cash and debt free basis. This includes an initial payment of $425m, and up to $575m in contingent consideration based on development and regulatory milestones.

The transaction does not impact AstraZeneca’s financial guidance for 2025.