On April 24, 2025 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported a strategic collaboration with Pfizer, Inc. (NYSE: PFE), to support the development and commercialization of Pfizer’s oncology portfolio using the Guardant Infinity smart liquid biopsy platform (Press release, Guardant Health, APR 24, 2025, View Source [SID1234652120]).

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Under the multi-year collaboration agreement, Guardant and Pfizer aim to:

Utilize Guardant’s portfolio of liquid biopsy tests in Pfizer’s global clinical studies
Evaluate the clinical utility of (a) circulating tumor DNA (ctDNA) level as a surrogate endpoint to monitor therapy response and (b) related blood-based epigenomic analyses
The collaboration will also provide Pfizer with access to Guardant’s liquid biopsy tests in China for their global clinical trials that include China cohorts. In July 2022, Guardant announced a strategic partnership with Adicon Holdings Limited, a leading independent clinical laboratory company based in China, to offer Guardant tests to biopharmaceutical companies conducting clinical trials in China. Cancer is the leading cause of death in China, with over three million cancer-related deaths in 2020.

On April 24, 2025 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that the U.S. Food and Drug Administration (FDA) has approved its differentiated PD-1 monoclonal antibody, penpulimab-kcqx, in combination with cisplatin or carboplatin and gemcitabine for the first-line treatment of adult recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC) (Press release, Akeso Biopharma, APR 24, 2025, View Source [SID1234652118]). FDA also approved penpulimab-kcqx as a single agent for adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and with least one other prior line of therapy. Penpulimab-kcqx was developed independently by Akeso, with further development and commercialization managed through a joint venture with Chia Tai-Tianqing Pharmaceutical Group.

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This milestone marks penpulimab-kcqx as Akeso’s first internally developed innovative biologic to receive FDA approval. The approval underscores the robust clinical research behind penpulimab-kcqx and marks Akeso’s successful entry into the United States regulatory system for the first time. This achievement highlights the company’s innovative drug development capabilities and its commitment to adhering to the highest international standards in pharmaceutical quality management.

The FDA’s approval of penpulimab-kcqx validates Akeso’s international drug development strategy and expansion capabilities. This approval lays a strong foundation for Akeso’s continued clinical development efforts in the global therapeutics markets.

Penpulimab-kcqx has been approved in China for two indications: 1. first-line treatment of advanced NPC, and 2. second or later line treatment of advanced NPC. The recent FDA approval of penpulimab-kcqx offers a new, immunotherapy option for advanced NPC patients in the US.

The FDA approval is based on the international Phase III clinical trial AK105-304 and the pivotal AK105-202 study, which supported the two Biologics License Application (BLA) for penpulimab-kcqx. These studies demonstrated the drug’s clinical benefits and favorable safety profile across two stages of treatment for metastatic NPC. AK105-304 is a randomized, double-blind, international Phase III trial that enrolled NPC patients of diverse ethnicities. The data will be presented at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. Previously, the FDA granted penpulimab-kcqx Breakthrough Therapy Designation (BTD), Orphan Drug Designation (ODD), and Fast Track Designation (FTD) for NPC treatment, highlighting the critical unmet need for this therapy.

According to the WHO 2020 Global Cancer Statistics, over 133,000 new NPC cases are diagnosed annually worldwide, with more than 70% of the patients presented with locally advanced disease. Recurrent or metastatic NPC has a poor prognosis and limited survival. Penpulimab-kcqx’s FDA approval will expand the number of NPC patients that can benefit from its treatment.

Prof. Chaosu Hu, Principal Investigator of penpulimab-kcqx from Fudan University Shanghai Cancer Center, commented: "This milestone enhances international treatment guidelines for advanced NPC and extends the benefits of China’s innovations to global patients, ultimately reshaping the treatment landscape for metastatic NPC worldwide."

Prof. Xiaozhong Chen, Investigator of penpulimab-kcqx from Zhejiang Cancer Hospital, added: "The FDA approval of penpulimab-kcqx confirms its high efficacy and low toxicity, positioning China’s innovative drug development in alignment with international standards."

Dr. Yu Xia, Founder, Chairwoman, President & CEO of Akeso, expressed: "We are very excited by the approval of penpulimab-kcqx’s approval in the US FDA for first line and later line NPC. Beyond reaching our first international regulatory milestone, this approval also provides an important immunotherapy treatment option for patients with NPC in the United States. The FDA approval of penpulimab-kcqx not only highlights the quality of our innovation but also underscores Akeso’s focus on delivering treatments for difficult to treat cancers for patients around the world. We are deeply grateful to all the researchers, participants, and patients who have contributed to this success. Akeso will continue to advance first and best in class therapies, including bispecific antibodies and CD47 inhibitors, challenge global standards of care and unlocking the full potential of our pipeline for cancer patients everywhere."

On April 24, 2025 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (6990.HK) reported that it will present results from six Kelun-led clinical studies at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, held in Chicago from May 30 to June 3 (Press release, Kelun, APR 24, 2025, View Source [SID1234652117]). Results include data from its TROP2 antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT), anti-PD-L1 mAb tagitanlimab, and RET inhibitor KL590586 (A400/EP0031). The abstracts for these studies will be published on the ASCO (Free ASCO Whitepaper)’s official website on May 22, 2025, local time.

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Detailed information on the studies selected for ASCO (Free ASCO Whitepaper) 2025 are as follows:

Title: Sacituzumab tirumotecan (sac-TMT) in patients (pts) with previously treated advanced EGFR-mutated non-small cell lung cancer (NSCLC): Results from the randomized OptiTROP-Lung03 study.
Presentation Type: Oral
Abstract Number: 8507
Session Date and Time: 6/1/2025 8:00 AM-11:00 AM CDT

Title: Tagitanlimab versus placebo in combination with gemcitabine and cisplatin as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (R/M NPC): Results from a randomized, double-blind, phase 3 study.
Presentation Type: Oral
Abstract Number: 6004
Session Date and Time: 5/31/2025 1:15 PM-4:15 PM CDT

Title: Sacituzumab tirumotecan (sac-TMT) as first-line treatment for unresectable locally advanced/metastatic triple-negative breast cancer (a/m TNBC): Initial results from the Phase II OptiTROP-Breast05 study.
Presentation Type: Rapid oral
Abstract Number: 1019
Session Date and Time: 5/30/2025 2:45 PM-4:15 PM CDT

Title: Sacituzumab tirumotecan (sac-TMT) in combination with tagitanlimab (anti-PD-L1) in first-line (1L) advanced non-small-cell lung cancer (NSCLC): Non-squamous cohort from the phase II OptiTROP-Lung01 study.
Presentation Type: Poster
Abstract Number: 8529
Session Date and Time: 5/31/2025 1:30 PM-4:30 PM CDT

Title: Sacituzumab Tirumotecan (sac-TMT) in patients (pts) with previously treated locally advanced or metastatic (LA/M) non-small cell lung cancer (NSCLC) harboring uncommon EGFR mutations: Preliminary results from a phase 2 study.
Presentation Type: Poster
Abstract Number: 8615
Session Date and Time: 5/31/2025 1:30 PM-4:30 PM CDT

Title: Results from a phase I study of KL590586 in patients with advanced RET-mutant medullary thyroid cancer.
Presentation Type: Poster
Abstract Number: 6098
Session Date and Time: 6/2/2025 9:00 AM-12:00 PM CDT

About Sac-TMT

Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as Non-small Cell Lung Cancer (NSCLC), breast cancer (BC), gastric cancer (GC), gynecological tumors, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.

In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc., Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (includes Mainland China, Hong Kong, Macau, and Taiwan).

To date, two indications for sac-TMT have been approved and marketed in China for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting) and EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy. Sac-TMT became the first domestic ADC with global intellectual property rights to be fully approved for marketing. It is also the world’s first TROP2 ADC to be approved for marketing in a lung cancer indication. In addition, the NDA application for sac-TMT for the treatment of adult patients with EGFR-mutant locally advanced or metastatic NSCLC who progressed after treatment with EGFR-TKI therapy was accepted by the National Medical Products Administration (NMPA), and was included in the priority review and approval process. As of today, Kelun-Biotech has initiated 8 registrational clinical studies in China. MSD has initiated 12 ongoing Phase 3 global clinical studies of sac-TMT as a monotherapy or with pembrolizumab or other agents for several types of cancer. These studies are sponsored and led by MSD.

About Tagitanlimab

Tagitanlimab is the first PD-L1 monoclonal antibody (mAb) globally to receive authorization for the first-line treatment of NPC. Previously, the National Medical Products Administration (NMPA) has approved the marketing in China of tagitanlimab used in combination with cisplatin and gemcitabine for the first-line treatment of patients with R/M NPC and monotherapy for the treatment of patients with recurrent or metastatic NPC who have failed after prior 2L+ chemotherapy, respectively.

About KL590586 (A400/EP0031)

A400, a novel next-generation selective RET inhibitor for NSCLC, MTC and other solid tumors with a high prevalence of RET alterations. We are currently conducting pivotal clinical study for both 1L and 2L+ advanced RET+ NSCLC as well as a phase 1b/2 clinical study for RET+ MTC and solid tumor in China.

In March 2021, we granted Ellipses Pharma, a U.K.-based international oncology drug development company, an exclusive license to develop, manufacture and commercialize this agent outside Greater China and certain Asian countries under the code EP0031.

In March 2024, it was announced that EP0031/A400 was granted Fast Track designation by the FDA for the treatment of RET-fusion positive NSCLC. In April 2024, EP0031/A400 was cleared by the FDA to progress into Phase 2 clinical development and is now open in the US, UK, EU and UAE.

On April 24, 2025 Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, reported that the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting will feature the latest study results from the company’s investigational drugs DZD8586 and DZD6008 in B-cell non-Hodgkin lymphomas (B-NHLs) and non-small cell lung cancer (NSCLC) (Press release, Dizal Pharma, APR 24, 2025, View Source [SID1234652116]).

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The oral presentation includes results in B-NHLs from a pooled safety and efficacy analysis of two phase I/Ⅱ studies of DZD8586 in chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients with prior treatment of covalent and/or non-covalent BTK Inhibitors as well as BTK degraders.

While early clinical data showed encouraging anti-tumor activities from BTK degraders in CLL/SLL patients, resistance mutations to both BTK inhibitors and degraders have already been reported, and degrader-related toxicities may affect long-term clinical application. Data from Phase I/II studies of DZD8586 in CLL/SLL, presented at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, showed that 94.4% of patients achieved tumor shrinkage at ≥50 mg QD. Significant tumor responses were also observed in other B-NHLs, including diffuse large B-cell lymphoma (DLBCL). Preliminary results from the ongoing phase Ⅱ study of DZD8586 monotherapy in patients with relapsed/refractory DLBCL will be presented at this ASCO (Free ASCO Whitepaper) meeting.

Dizal will also present Phase I/II data of DZD6008, a 4th generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) with full blood–brain barrier (BBB) penetration, in advanced EGFR mutation positive (EGFRm) NSCLC patients who failed prior 3rd generation EGFR TKI treatment. Lung cancer is a leading cause of brain metastases (BMs), with 10-20% of patients with NSCLC presenting with BMs at diagnosis and 25-50% developing them over the course of their disease. NSCLC patients whose disease progressed after 3rd generation EGFR TKI treatment often develop CNS metastasis and exhibit acquired EGFR resistance mutations. Preclinical data shows that DZD6008 demonstrates good safety and efficacy in NSCLC patients with brain metastases who had failed 3rd generation EGFR TKI therapy or multiple lines of pre-treatments.

"We are honored that our study results have been selected for oral presentations at ASCO (Free ASCO Whitepaper) for three consecutive years. Our presence at this congress highlights our commitment to addressing global unmet medical needs in hematological malignancies and lung cancer," said Xiaolin Zhang, PhD, CEO of Dizal. "We look forward to sharing positive clinical data of our novel medicines, which have the potential to bring clinical benefit to patients with limited treatment options."

Dizal presentation details during ASCO (Free ASCO Whitepaper) 2025：

Lead Author

Abstract Title

Presentation Details

Prof. Jianyong Li

Phase 1/2 Studies of DZD8586 in
CLL/SLL Patients after Covalent or
Non-covalent BTK Inhibitors and BTK
Degraders

Abstract #7010

Rapid Oral Abstract Session

May 31, 2025, 8:00-9:30 (CDT)

Prof. Mengzhao Wang

Phase 1/2 Study of DZD6008, a 4th-
Generation EGFR TKI with Full BBB
Penetration, in EGFR-mutant NSCLC

Abstract #8616

Poster Session

May 31, 2025, 13:30-16:30 (CDT)

Prof. Lugui Qiu

Phase 2 Study of DZD8586, a Non-
Covalent BBB Penetrant LYN/BTK
Dual Inhibitor, as Monotherapy in
Relapsed/Refractory Diffuse Large B-
Cell Lymphoma (r/r DLBCL) (TAI-
SHAN9)

Abstract #e19050

Online Publication

May 22, 2025, 17:00 (EDT)

About DZD8586
DZD8586 is a first-in-class, non-covalent, LYN/BTK dual inhibitor with full blood-brain barrier (BBB) penetration, designed as a potential treatment option for B-cell non-Hodgkin lymphoma (B-NHL).

While Bruton’s Tyrosine Kinase (BTK) inhibitors have been approved for the treatment of B-NHL, resistance can arise through two major mechanisms: the BTK C481X mutation and BTK-independent BCR signaling pathway activation. Currently, there is no targeted therapy available to address both resistance mechanisms, posing an urgent clinical challenge. Although BTK degraders have shown encouraging efficacy in early clinical studies, mutation-related resistance has been reported, and degrader-related toxicities may affect long-term clinical application.

DZD8586 has high selectivity against other TEC family kinases (TEC, ITK, TXK and BMX). By targeting BTK and LYN, it blocks both BTK-dependent and -independent BCR-signaling pathways, effectively inhibiting tumor growth of B-NHLs in cell lines and in animal models. Phase I clinical trial suggests that DZD8586 exhibits favorable PK properties, good central nervous system (CNS) permeability, complete blockade of BCR signaling, and encouraging anti-tumor efficacy with good safety and tolerability in patients with B-NHL.

About DZD6008
DZD6008 is a novel, highly selective, full-BBB penetrant EGFR TKI, designed as a potential treatment option for advanced EGFR mutation positive (EGFRm) NSCLC.

Non-small cell lung cancer is the leading cause of cancer death in the world. Epidermal growth factor receptor (EGFR) gene is one of the most common driver genes for NSCLC. Multiple agents can be used to treat patients with EGFR mutated NSCLC who develop resistance to EGFR tyrosine kinase inhibitors (TKIs), but the clinical outcome was not satisfactory. Brain metastases (BM) are a leading cause of death and disease progression for NSCLC. Approximately 23%-30% of NSCLC patients are synchronous BM at their initial diagnosis. Previous studies reported that the 3-year cumulative rate of BMs ranges from 29.4% to 60.3% in patients with mutated EGFR.

Currently, the clinical benefits of existing treatments for third-generation EGFR TKI-resistant NSCLC are limited and DZD6008 is expected to fill the unmet medical needs. DZD6008 effectively inhibits EGFR-mutated tumor growth in cell lines and in animal models. Previous clinical studies have validated the design concept of the molecule and suggest that DZD6008 demonstrates good safety and efficacy in NSCLC patients with brain metastases who had failed third-generation EGFR TKI therapy or multiple lines of pre-treatments.

On April 24, 2025 Verismo Therapeutics, a clinical-stage CAR T company pioneering the KIR-CAR platform, reported a Trials in Progress poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), being held from May 30 – June 3, 2025 in Chicago, IL (Press release, Verismo Therapeutics, APR 24, 2025, View Source [SID1234652115]). Poster details are below.

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Poster Details:
Abstract Number: TPS5630
Abstract Title: SynKIR-CAR T Cell Advanced Research (STAR)-101 phase 1 clinical trial for patients with advanced mesothelin-expressing ovarian cancer, mesothelioma, or cholangiocarcinoma.
Presenting Author: Janos L. Tanyi, M.D., Ph.D., Perelman School of Medicine at the University of Pennsylvania
Session Title: Gynecologic Cancer
Session Date: June 1, 2025, 9:00 AM-12:00 PM CDT

About the KIR-CAR Platform

The KIR-CAR platform is a multi-chain CAR T cell therapy and has been shown in preclinical animal models to be capable of maintaining antitumor T cell activity even in challenging tumor microenvironments. Using NK cell derived KIR and DAP12 split signaling provides a novel combined activation and co-stimulation separate from the usual T cell stimulation pathways. It also enables sustained chimeric receptor expression and improves KIR-CAR T cell long term function. This results in prolonged T cell functional persistence and leads to tumor regression in preclinical models that are resistant to traditional CAR T cell therapies. As a result of decreased T cell exhaustion, KIR-CAR also enables targeting of solid tumors in addition to blood cancers.