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]).

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"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."

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.

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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.

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.

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"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.

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").

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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.

On June 27, 2025 Schrödinger, Inc. (Nasdaq: SDGR) reported that SGR-1505, its clinical stage MALT1 inhibitor, was designated as a Fast Track product by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with Waldenström macroglobulinemia that have failed at least two lines of therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor (Press release, Schrodinger, JUN 27, 2025, View Source [SID1234654163]).

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"We are excited to receive Fast Track designation for SGR-1505, which underscores the significant need in patients with Waldenström macroglobulinemia," said Karen Akinsanya, Ph.D., president, head of therapeutics R&D and chief strategy officer, partnerships at Schrödinger. "Despite the continued therapeutic advances in the treatment of hematologic malignancies, treatment failure and disease progression due to BTK resistance remains a challenge for a growing number of patients. This unmet need represents an opportunity for novel mechanisms such as MALT1 as monotherapy and as part of new combination regimens."

"We believe this Fast Track designation in Waldenström macroglobulinemia, combined with our encouraging Phase 1 data across a broad range of relapsed/refractory B-cell malignancies such as chronic lymphocytic leukemia, diffuse large B-cell lymphoma, and marginal zone lymphoma, reinforce the potential of SGR-1505 as a future therapeutic option for patients," said Margaret Dugan, chief medical officer at Schrödinger. "We look forward to discussing our Phase 1 study results and recommended Phase 2 dose with the FDA later this year."

The FDA Fast Track program is designed to facilitate the development and expedite the review of drug candidates to treat serious conditions and fill an unmet medical need. A drug granted Fast Track designation is eligible for multiple benefits, including more frequent meetings and written communications with the FDA, as well as eligibility for Accelerated Approval, Priority Review or Rolling Review, if relevant criteria are met.

SGR-1505 is currently being evaluated in a Phase 1 clinical study as a treatment for patients with relapsed/refractory B-cell malignancies. Initial data were recently presented at the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress and International Conference on Malignant Lymphoma where SGR-1505 was observed to have a favorable safety profile and was well tolerated. Encouraging signs of preliminary efficacy were observed in multiple B-cell malignancy subtypes, including Waldenström macroglobulinemia patients, previously treated with a BTK inhibitor prior to starting SGR-1505.

On August 11, 2023, the FDA granted orphan drug designation to SGR-1505 for Mantle Cell Lymphoma (MCL) based on preclinical data.

About SGR-1505
SGR-1505 is an oral investigational MALT1 inhibitor being evaluated for the treatment of relapsed/refractory B-cell malignancies. MALT1 plays a central role in key signaling pathways that drive cancer cell survival and proliferation, making its location downstream of BTK in the NF-κB signaling pathway an attractive target for the development of novel therapeutics for a potentially broad range of B-cell malignancies. In preclinical studies, SGR-1505 was observed to be highly potent and selective, and has demonstrated anti-tumor activity in preclinical models both as a monotherapy and in combination with BTK and BCL-2 inhibitors. There is also emerging therapeutic rationale supporting MALT1 inhibition as a potential treatment for inflammatory and autoimmune disorders.

SGR-1505 was designed using Schrödinger’s computational platform at scale and was discovered approximately 10 months after the company started its MALT1 program. A Phase 1 study in patients with relapsed/refractory B-cell malignancies is ongoing (NCT05544019).