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AMGEN ANNOUNCES POSITIVE TOPLINE PHASE 3 RESULTS FOR BEMARITUZUMAB IN FIBROBLAST GROWTH FACTOR RECEPTOR 2b (FGFR2b) POSITIVE FIRST-LINE GASTRIC CANCER

On June 30, 2025 Amgen (NASDAQ:AMGN) reported the Phase 3 FORTITUDE-101 clinical trial evaluating first-line bemarituzumab plus chemotherapy (mFOLFOX6) met its primary endpoint of overall survival (OS) at a pre-specified interim analysis (Press release, Amgen, JUN 30, 2025, View Source [SID1234654171]).

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Bemarituzumab plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in OS as compared to placebo plus chemotherapy in people living with unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) cancer with FGFR2b overexpression and who are non-HER2 positive. FGFR2b overexpression was defined as 2+/3+ staining in ≥10% of tumor cells by centrally performed immunohistochemistry (IHC) testing.

Gastric cancer is the fifth leading cause of cancer-related death worldwide, with nearly one million new cases and over 650,000 deaths globally each year 1, highlighting a critical unmet medical need.

"Most patients with gastric cancer are diagnosed at an advanced stage, with poor prognosis, low survival rates and limited therapeutic options," said Jay Bradner, M.D., executive vice president of Research and Development at Amgen. "These first positive top-line results of an FGFR2b targeted monoclonal antibody from our Phase 3 FORTITUDE-101 study mark a meaningful advance in the development of effective targeted therapy for gastric cancer."

The most common treatment-emergent adverse events (>25%) in patients treated with bemarituzumab plus chemotherapy were reduced visual acuity, punctate keratitis, anaemia, neutropenia, nausea, corneal epithelium defect and dry eye. While ocular events were consistent with the Phase 2 experience and observed in both arms, they occurred with greater frequency and severity in the Phase 3 bemarituzumab arm.

Detailed results from the trial will be shared at a future medical meeting.

FORTITUDE-101 was conducted with the support of Zai Lab. Zai Lab holds co-development and commercialization rights for bemarituzumab for mainland China, Hong Kong, Macau, and Taiwan.

A Phase 3 study of bemarituzumab plus chemotherapy and nivolumab is also ongoing in patients with first-line gastric cancer, with a data readout anticipated in H2 2025.

About FGFR2b
The FGFR2b protein (also known as fibroblast growth factor receptor 2b) is an emerging biomarker which, when overexpressed, promotes aberrant signaling leading to tumor cell proliferation.2

The FGFR2b protein is overexpressed by G/GEJ tumor cells in approximately 38% of patients with advanced G/GEJ cancer. FGFR2b protein overexpression is defined as 2+/3+ staining intensity on tumor cell membrane, as detected by immunohistochemistry (IHC) testing. In approximately 16% of patients with advanced G/GEJ cancer, FGFR2b protein overexpression is observed on ≥10% of tumor cells by IHC.3

About FORTITUDE-101
FORTITUDE-101 is a randomized, multi-center, double-blind, placebo-controlled Phase 3 study of bemarituzumab plus mFOLFOX6 versus placebo plus mFOLFOX6 as first-line therapy in advanced G/GEJ cancer with FGFR2b overexpression. The FORTITUDE-101 trial spanned 300 sites across 37 countries, with 547 patients enrolled.

The primary outcome measure of the trial is overall survival in patients with FGFR2b ≥10% 2+/3+ tumor cell staining. Key secondary outcome measures include progression-free survival and overall response rate. Candidates were excluded from the trial if they were known to be human epidermal growth factor receptor 2 (HER2) positive. FORTITUDE-101 included more comprehensive ocular-related monitoring than previous studies of bemarituzumab.

Revolution Medicines and Summit Therapeutics Enter into Clinical Collaboration to Evaluate Combinations of Three RAS(ON) Inhibitors with Ivonescimab in RAS Mutant Tumors

On June 30, 2025 Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers and Summit Therapeutics, Inc. (Nasdaq: SMMT), a biopharmaceutical oncology company focused on patient-friendly medicinal therapies intended to improve quality of life, increase potential duration of life, and resolve serious unmet medical needs, reported the companies have entered into a clinical collaboration in multiple solid tumor settings to evaluate the safety and efficacy of each of Revolution Medicines’ clinical-stage RAS(ON) inhibitors, including the multi-selective inhibitor daraxonrasib (RMC-6236), G12D-selective inhibitor zoldonrasib (RMC-9805) and G12C-selective inhibitor elironrasib (RMC-6291), in combination with Summit Therapeutics’ ivonescimab, a PD-1 / VEGF bispecific antibody (Press release, Revolution Medicines, JUN 30, 2025, View Source [SID1234654170]).

"We’ve disclosed promising initial evidence that each of daraxonrasib and elironrasib can deliver additive antitumor activity safely when combined with a PD-1 antibody in first-line treatment of patients with RAS mutant non-small cell lung cancer," said Mark A. Goldsmith, M.D., Ph.D., chairman and chief executive officer of Revolution Medicines. "Combinations with novel PD-1 bispecific inhibitors could unlock further therapeutic potential. We are eager to evaluate combinations of investigational drugs from our RAS(ON) inhibitor portfolio with ivonescimab, an advanced PD-1 / VEGF bispecific inhibitor with a differentiated profile, in a range of common RAS mutant cancers."

The clinical collaboration aims to evaluate these combinations across three priority tumor types including RAS mutant non-small cell lung cancer (NSCLC), pancreatic ductal adenocarcinoma (PDAC) and colorectal cancer (CRC). Under the terms of the agreement, Summit Therapeutics will supply ivonescimab for clinical research and Revolution Medicines will be the study sponsor. Each company will retain commercial rights to their respective compounds, and the agreement is mutually non-exclusive.

"We’re thrilled to partner with Revolution Medicines to evaluate in a clinical setting how our highly promising ivonescimab combined with their compelling RAS(ON) inhibitors could potentially improve outcomes for patients with lung and gastrointestinal cancers," said Robert W. Duggan, Chairman and Co-Chief Executive Officer and Dr. Maky Zanganeh, President and Co-Chief Executive Officer of Summit Therapeutics. "As we continue to rapidly advance the development of ivonescimab across non-small cell lung cancer and other solid tumors, we believe that it is critically important to combine ivonescimab with some of the most promising medicines and drug candidates as we seek to provide innovative therapy options to patients facing high unmet needs."

NeoRegen Biotech and Circio advance circular RNA delivery collaboration into in vivo stage

On June 30, 2025 Circio Holding ASA (OSE: CRNA) and NeoRegen Biotech, reported the signing of a second Material Transfer Agreement (MTA) to advance their ongoing collaboration for the delivery of circular RNA (circRNA) expression-based therapeutics (Press release, Circio, JUN 30, 2025, View Source [SID1234654169]). The collaboration now is progressing to the in vivo preclinical stage. This milestone follows the successful proof-of-concept (POC) results from in vitro studies conducted under their initial MTA, signed in 2023. The collaboration was formed to provide solutions to the critical challenges in the delivery of nucleic acid medicines.

Circio is the world-leader in circular RNA-based expression systems for next generation gene and cell therapy. Its unique circVec expression platform has demonstrated the potential to significantly enhance the durability and expression level of both viral and non-viral therapeutics. NeoRegen Biotech, known for its next-generation intracellular delivery solutions, contributes its NICT platform, which has shown superior performance in cellular penetration and endosomal escape compared to conventional delivery systems.

The in vivo studies aim to further validate the therapeutic potential of circRNA expression vectors through the integration of Circio’s proprietary circVec platform with NeoRegen’s NICT (Neoregen Intra-Cellular delivery Technology). Together, the two companies are addressing one of the most critical challenges in nucleic acid drug development: achieving safe, efficient, targeted and durable intracellular delivery.

"The successful transition into in vivo studies marks a pivotal step in our co-development of circular RNA vector therapeutics," said Dr. Jeongmin Seo, CEO of NeoRegen Biotech. "Combining NeoRegen’s NICT platform with Circio’s circVec technology has the potential to overcome key nucleic acid delivery barriers to fully realize the promise of gene and cell therapies."

"It is a very important milestone in the partnership that NeoRegen Biotech has decided to progress to in vivo testing of their unique NICT platform with circVec DNA vectors," said Dr. Thomas Hansen, CTO of Circio. "The NICT delivery technology has shown strong promise to enable efficient delivery of DNA-format therapeutics to specific tissues. The planned in vivo studies will generate essential data to identify target disease indications and progress circVec-NICT candidates towards future clinical studies."

This second MTA reaffirms the mutual commitment of both companies to advancing circVec-NICT therapies with potential applications in cell and gene therapy, oncology, and beyond. As the program progresses through the preclinical phase and establishes in vivo proof-of-concept, Circio and NeoRegen plan to select specific targets for development and accelerate their joint R&D efforts toward clinical readiness.

Innovent Biologics Showcases "Dual Innovations" at Oncology R&D Day, Pioneering the Future of Cancer Treatment with Next-Generation IO and ADC Platforms

On June 30, 2025 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures, and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology, and other major diseases, reported to have held its Oncology R&D Day, unveiling its forward-looking strategy centered on dual innovation in next-generation immuno-oncology (IO) and antibody-drug conjugate (ADC) technologies (Press release, Innovent Biologics, JUN 30, 2025, View Source [SID1234654168]). This strategic focus aims to redefine the standards of cancer treatment and propel Innovent toward becoming a global, premier biopharmaceutical leader. The event drew over 500 participants, including leading oncology key opinion leaders (KOLs), principal investigators, analysts, and global investors, signaling strong engagement with Innovent’s transformative vision for the future of oncology.

"Over the past decade, Innovent has been at the forefront of China’s biopharmaceutical evolution—pioneering the PD-1 immunotherapy era and building China’s leading oncology brand, with over 3 million cancer patients treated with our therapies," said Dr. Michael Yu, Founder, Chairman of the Board and CEO of Innovent. "We are entering a new chapter focused on global innovation, powered by a robust pipeline and dual innovation of next-generation IO and next-generation ADC. Our recent presence at the 2025 ASCO (Free ASCO Whitepaper) with eight oral presentations highlights the strength and global competitiveness of our R&D. But this is only the beginning. With a clear vision to advance at least five pipeline assets into MRCT Phase 3 by 2030, we are committed to delivering innovative, high-quality, and accessible cancer treatments to patients worldwide."

Dual Innovation to Unlock the Future of Oncology: Next-gen IO + Next-gen ADC

At the core of Innovent’s oncology strategy lies the dual engines of next-generation immunotherapy (IO) and next-generation antibody-drug conjugates (ADC), supported by deep insights in cancer biology and differentiated technology platforms.

"We are harnessing deep cancer biology insights, advanced antibody and protein engineering, and differentiated ADC linker-payload technologies to develop broader-spectrum, more potent, and less toxic therapies aimed at transforming the oncology treatment paradigm," said Dr. Zhou Hui, SVP of Innovent Oncology R&D. "Our strategy is designed to target some of the toughest challenges in cancer care, including drug resistance, cold tumors, and improve the efficacy of current IO treatment, while bringing new hope to patients worldwide."

Global R&D Roadmap: a Clear, Stepwise Development Strategy

Innovent’s pipeline is guided by a rational, phased IO+ADC combination strategy designed to address tumor heterogeneity and immune escape, evolving through three stages:

Next-gen IO + Chemotherapy: to redefine the IO cornerstone
Next-gen IO + mAb-ADC / bispecific ADC: to cover expansive tumor types and treatment lines
Next-gen IO + Dual-Payload ADC (dpADC): to unlock full potential of IO+ ADC synergy, and reshape cancer treatment
Currently its oncology pipeline features nearly 10 next-generation molecules in global development, with multi-regional trials actively underway in the U.S., EU, and Asia. The company also continues to invest in global R&D infrastructure, supported by R&D hubs in Shanghai and San Francisco and antibody and ADC manufacturing capacity exceeding 140,000L.

Innovent is rapidly expanding its global innovation footprint, with a 2030 goal to advance at least five pipeline assets into global MRCT Phase 3 trials. Key potential candidates includes:

IBI343: innovative CLDN18.2 ADC with site-specific conjugation and a TOPO1 inhibitor payload, demonstrating significant survival benefits in both GC and PDAC
IBI363: PD-1/IL-2α-bias fusion protein as next-gen IO to redefine cancer treatment and expand the boundaries of IO responsiveness
IBI3009: DLL3 ADC in collaboration with Roche
IBI3003: tri-specific T-cell engager targeting BCMA/GPRC5D/CD3 for multiple myeloma
IBI3001: EGFR/B7H3 ADC with two synergetic targets covering multiple potential indications
IBI3020: CEACAM5 dual-payload ADC as globally the first to enter clinical phase
IBI363: Next-Gen IO Redefining Cancer Immunotherapy

IBI363 is a global first-in-class PD-1/IL-2α-bias fusion protein, featuring a differentiated molecular design and a dual immune activation mechanism. Emerging clinical data strongly support its mechanism of action in reinvigorating and expanding tumor-specific T cells (TSTs).

At ASCO (Free ASCO Whitepaper) 2025, IBI363 demonstrated breakthrough potential in three hard-to-treat tumor types, with a long tailing effect in prolonged survival benefits:

Immune-resistant NSCLC (squamous & Adeno): boosted response rate and extended PFS reflects strong immune activation; median overall survival (mOS) up to 17.5 months in 1.5 mg dose cohorts, 12-month OS rate exceeding 70% for 3 mg dose cohorts, and benefit observed even in PD-L1 low expressers
Later-line CRC (3L+): mOS of 16.1 months in monotherapy and only 17.8% OS events occurred in combination with bevacizumab with 9.4 months follow-up, outperforming historical benchmarks
Immune-resistant melanoma (mucosal/acral subtypes): confirmed overall response rate (cORR) 23%, median duration of response (mDoR) 14 months, and median OS 14.7 months, showing unprecedented positive response and a long-lasting immunologic tailing effect
With two Breakthrough Therapy Designations from the NMPA CDE, two Fast Track Designations from the FDA, IBI363 is advancing rapidly toward registrational development. The first head-to-head trial vs. pembrolizumab in mucosal and acral melanoma was initiated. Meanwhile, IBI363 is in preparation for registrational trails in IO-treated squamous NSCLC, and third-line MSS colorectal cancer. Additional trails for first-line and other solid tumors also under exploration in ongoing PoC studies.

High-Potency, Low-toxicity ADC Platforms Synergizing with IO for Broad Indication Coverage

Innovent is rapidly advancing its next-gen ADC pipeline, including:

IBI343 (CLDN18.2 ADC): first in PDAC to demonstrate long-term survival benefits (mOS 12.1 months in 2L)
IBI3001 (EGFR/B7H3 ADC): dual-targeted ADC with broad potential in solid tumors
IBI3020 (CEACAM5 dual payload ADC): designed for high efficacy and low toxicity in treatment-resistant tumors
These programs leverage proprietary payloads and linkers, optimized for lower toxicity and high potency, and are poised to synergize with Innovent’s IO agents to address broader and deeper indications.

Innovent Academy: R&D Engine to Drive Global Innovation

Innovent Academy is the company’s discovery engine for driving global innovation. The Academy continues to expand its platforms in IO, ADC, T-cell engagers, and cytokines, firmly establishing its leadership in next-gen oncology discovery and translational science to generate 6–8 novel molecules per year.

Specifically, for next-gen IO and next-gen ADC dual upgradation, Innovent Academy focuses on:

diversified antitumor mechanisms to integrate TME modulation and optimize IO efficacy;
dual targeting approaches to overcome tumor heterogeneity and drug resistance.
This framework allows Innovent to systematically escalate efficacy and broaden tumor applicability, laying the foundation for first-in-class and best-in-class combination regimens for cancer treatments.

Catalyzing China’s Role in Global Oncology Innovation

Leading oncology KOLs and principal investigators (PIs) delivered keynote speeches, reflecting on a pivotal moment for China’s biotech industry. They emphasized that China’s innovation, which is driven by rising translational capabilities, expanding global talent pools, and patient-centric trial execution, has entered a "Deepseek" moment, one where Chinese-discovered drugs can lead global standards, not just follow them.

"What we’re witnessing is a profound shift," said one keynote speaker. "Innovent’s next-generation IO programs like IBI363, with a clear global-first design, and ADC platforms targeting previously untreatable populations, show that Chinese biotech is poised to influence—not just participate in—the next global oncology paradigm."

The enthusiastic response from investors and KOLs underscores growing confidence in China-originated oncology innovation and reaffirms Innovent’s position as it enters a new era of global innovation with a vision to become a global premier biopharmaceutical leader.

Entry into a Material Definitive Agreement

On June 27, 2025, Kura Oncology, Inc. (the "Company") and Kyowa Kirin, Inc. ("Kyowa Kirin US") reported to have entered into a Co-Promotion and Medical Affairs Agreement (the "Co-Promotion Agreement") to co-promote the Company’s product candidate, ziftomenib, a potent, selective oral menin inhibitor, for the treatment of patients with acute myeloid leukemia and other hematologic malignancies in the United States and perform medical affairs activities with respect thereto (Filing, Kura Oncology, JUN 27, 2025, View Source [SID1234654194]). The Co-Promotion Agreement was entered into under and pursuant to the terms and conditions of that certain Collaboration and License Agreement by and among the Company, Kyowa Kirin US and Kyowa Kirin Co., Ltd. (together with Kyowa Kirin US, "Kyowa Kirin"), dated as of November 20, 2024 (the "Collaboration Agreement").

United States Co-Promotion. Under the terms of the Co-Promotion Agreement, Kyowa Kirin US will have the right and responsibility to co-promote ziftomenib for up to a certain percentage of the details in the United States, and will be obligated to meet minimum detailing requirements using sales representatives that meet specific qualifications. The parties will perform such co-promotion activities, and share equally in all costs and expenses therefor, in accordance with the Collaboration Agreement.

United States Medical Affairs. Under the terms of the Co-Promotion Agreement, the Company will lead all medical affairs activities for ziftomenib in the United States, while collaborating with and receiving input and coordination from Kyowa Kirin US. Further, the parties will jointly develop the health economics and outcomes research strategy for ziftomenib in the United States. The parties will perform such medical affairs activities, and share equally in all costs and expenses therefor, in accordance with the Collaboration Agreement.

Termination. The Co-Promotion Agreement will remain in effect until the earlier of the parties’ mutual agreement to cease commercialization of ziftomenib in the United States or the expiration of the United States term under the Collaboration Agreement (which expires on the latest of expiration of all valid claims of the Company’s patent rights licensed to Kyowa Kirin in the United States, expiration of the last-to-expire regulatory exclusivity in the United States or ten years after first commercial sale in the United States). The Co-Promotion Agreement will automatically terminate upon termination of the Collaboration Agreement. Either party may terminate the Co-Promotion Agreement for uncured material breach by the other party.

The foregoing description of the material terms of the Co-Promotion Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Co-Promotion Agreement, a copy of which the Company intends to file, with confidential terms redacted, with the Securities and Exchange Commission as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2025.