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HUTCHMED Completes Patient Enrollment of SANOVO Phase III Trial of ORPATHYS® and TAGRISSO® Combination as a First-Line Therapy for Certain Lung Cancer Patients in China

On August 20, 2025 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) reported the completion of patient enrollment of SANOVO, a China Phase III study of ORPATHYS (savolitinib) and TAGRISSO (osimertinib) as a first-line treatment in certain non-small cell lung cancer ("NSCLC") patients whose tumors harbor epidermal growth factor receptor ("EGFR") mutation and MET overexpression (Press release, Hutchison China MediTech, AUG 20, 2025, https://www.hutch-med.com/sanovo-phiii-enrollment-completion/ [SID1234655371]). The last patient was enrolled on August 18, 2025.

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This Phase III trial is a blinded, randomized, controlled study in previously untreated patients with locally advanced or metastatic NSCLC with activating EGFR mutations and MET overexpression. The study will evaluate the efficacy and safety of TAGRISSO in combination with ORPATHYS comparing to TAGRISSO alone, a standard-of-care treatment option for these patients. The primary endpoint of the study is progression free survival ("PFS") as assessed by investigators. Other endpoints include PFS assessed by an independent review committee, overall survival (OS), objective response rate ("ORR"), duration of response (DoR), disease control rate (DCR), time to response (TTR), and safety. Additional details may be found at clinicaltrials.gov, using identifier NCT05009836.

Topline results from the SANOVO study are estimated to be reported in the second half of 2026, followed by submission of results for presentation at an appropriate medical congress. If favorable, the results would enable a supplementary New Drug Application submission to China’s National Medical Products Administration ("NMPA").

ORPATHYS is an oral, potent and highly selective MET tyrosine kinase inhibitor ("TKI") being jointly developed by AstraZeneca and HUTCHMED and commercialized by AstraZeneca. TAGRISSO is a third-generation, irreversible EGFR TKI.

About NSCLC and MET aberrations
Lung cancer is the leading cause of cancer death, accounting for about one-fifth of all cancer deaths.[1] Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% classified as NSCLC.[2] The majority of NSCLC patients (approximately 75%) are diagnosed with advanced disease, and approximately 10-15% of NSCLC patients in the US and Europe and up to 40-50% of patients in Asia have EGFR-mutated ("EGFRm") NSCLC.[3],[4],[5],[6],[7]

MET is a tyrosine kinase receptor that has an essential role in normal cell development. MET overexpression and/or amplification can lead to tumor growth and the metastatic progression of cancer cells, and is one of the mechanisms of de novo or acquired resistance to EGFR TKI for metastatic EGFRm NSCLC.[8],[9]

About ORPATHYS
ORPATHYS (savolitinib) is an oral, potent and highly selective MET TKI that has demonstrated clinical activity in advanced solid tumors. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations), gene amplification or protein overexpression.

ORPATHYS is approved in China and is marketed by AstraZeneca for the treatment of adult patients with locally advanced or metastatic NSCLC with MET exon 14 skipping alteration, representing the first selective MET inhibitor approved in China. ORPATHYS is also approved in China for the treatment of patients with locally advanced or metastatic EGFRm-positive non-squamous NSCLC with MET amplification after disease progression on EGFR tyrosine kinase inhibitor therapy, in combination with TAGRISSO.

It is currently under clinical development for multiple tumor types, including lung, kidney, and gastric cancers as a single treatment and in combination with other medicines.

About TAGRISSO
TAGRISSO (osimertinib) is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system (CNS) metastases. TAGRISSO (40mg and 80mg once-daily oral tablets) has been used to treat more than one million patients across its indications worldwide and AstraZeneca continues to explore TAGRISSO as a treatment for patients across multiple stages of EGFRm NSCLC.

There is an extensive body of evidence supporting the use of TAGRISSO in EGFRm NSCLC, and it is the only targeted therapy shown to improve patient outcomes across all stages of the disease.

In late-stage disease, TAGRISSO demonstrated improved outcomes as monotherapy in the FLAURA Phase III trial and in combination with chemotherapy in the FLAURA2 Phase III trial. TAGRISSO is also being investigated in this setting in combination with ORPATHYS (savolitinib) in the SAFFRON Phase III trial and in combination with DATROWAY (datopotamab deruxtecan or Dato-DXd) in the TROPION-Lung14 and TROPION-Lung15 Phase III trials.

TAGRISSO also showed improved outcomes in early-stage disease in the NeoADAURA and ADAURA Phase III trials and in locally advanced stages in the LAURA Phase III trial. As part of AstraZeneca’s ongoing commitment to treating patients as early as possible in lung cancer, TAGRISSO is also being investigated in the early-stage adjuvant resectable setting in the ADAURA2 Phase III trial.

About ORPATHYS and TAGRISSO Combination Development in EGFR-mutated NSCLC
Among patients who experience disease progression following treatment with a third-generation EGFR TKI, approximately 15-50% present with MET aberration, depending on the sample type, detection method and assay cut-off used. TAGRISSO is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system metastases. Treatment with ORPATHYS in combination with TAGRISSO has been studied extensively in these patients in the TATTON (NCT02143466) and SAVANNAH (NCT03778229) studies. The encouraging results led to the initiation of several Phase III trials in this setting including the SACHI trial in China (NCT05015608) and the global SAFFRON trial (NCT05261399), as well as the SANOVO trial in China (NCT05009836).

This combination represents a promising chemotherapy-free oral treatment strategy to address mechanisms of resistance in this advanced setting. Positive data from the SACHI randomized Phase III trial led to the filing of a third NDA in China. Strong data from the SAVANNAH single-arm Phase II study was recently presented at the European Lung Cancer Congress (ELCC) in March 2025 demonstrated high, clinically meaningful and durable ORR, with consistent safety results. The SAFFRON randomized Phase III trial is progressing. Following AstraZeneca’s consultation with the US Food and Drug Administration ("FDA"), we look forward to completing the SAFFRON trial as soon as possible to support potential US and other global registration filings.

SACHI: The SACHI China Phase III study evaluated the combination of ORPATHYS and TAGRISSO for the treatment of patients with EGFRm, MET-amplified locally advanced or metastatic NSCLC after progression on EGFR TKI compared to platinum-based doublet chemotherapy. Results were presented at the ASCO (Free ASCO Whitepaper) Annual Meeting in June 2025. Based on the data from the SACHI study, the combination of ORPATHYS and TAGRISSO received approval from the China NMPA for the treatment of patients with locally advanced or metastatic EGFR mutation-positive non-squamous NSCLC with MET amplification after disease progression on EGFR TKI therapy in June 2025.

SAFFRON: In 2023, ORPATHYS and TAGRISSO received Fast Track Designation from the US FDA in this setting. The global SAFFRON Phase III trial is currently ongoing to assess the ORPATHYS plus TAGRISSO combination versus platinum-based doublet chemotherapy in patients with EGFRm, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC following progression on treatment with TAGRISSO. Patients are being prospectively selected using the high MET level cut-off identified in SAVANNAH.

ARC Therapies Advances Gut Microbiome Research with YB328 Toward Clinical Application

On August 19, 2025 ARC Therapies Inc. (Head Office: Shinjuku, Tokyo; President & CEO: Rami Suzuki), a certified startup from the National Cancer Center Japan, reported it has initiated research of YB328, a newly identified gut microbe, toward clinical application (Press release, ARC Therapies, AUG 19, 2025, View Source [SID1234655418]). Utilizing its proprietary intellectual property, the company has designated the YB328 strain as ARC0812 (RUX: "Lux") and will proceed with preclinical and human clinical trials to evaluate its administration methods and therapeutic efficacy for potential real-world application.

YB328 was identified by a research group led by Dr. Hiroyoshi Nishikawa, Chief of the Division of Cancer Immunology at the National Cancer Center Research Institute. This specific bacterial strain was found to be prevalent in the gut microbiota of cancer patients who responded favorably to immune checkpoint inhibitors. In murine models, the presence of YB328 was also associated with activation of anti-tumor immune responses.

Building on these findings, ARC Therapies is now exploring the potential of ARC0812 (RUX) to serve as an immune adjuvant in human cancer immunotherapy. Further studies are underway with a view toward eventual commercialization.

About Immune Adjuvants
Immune adjuvants are agents that enhance the body’s immune response to a specific antigen. When administered alongside an antigen-targeting agent that alone may not provoke a sufficient immune reaction, adjuvants help stimulate immune cells and facilitate the formation of immune memory.

Xspray Pharma Submits XS003 to the FDA – The Company’s Second Product Candidate from the HyNap Platform

On August 19, 2025 Xspray Pharma (Nasdaq Stockholm: XSPRAY) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its product candidate XS003 (nilotinib) for the treatment of chronic myeloid leukemia (CML) (Press release, Xspray, AUG 19, 2025, View Source [SID1234655396]). The application is based on successful studies demonstrating bioequivalence with the reference product Tasigna. XS003 demonstrates the lowest documented food interaction within the nilotinib class and improved dose linearity, which gives physicians greater predictability when adjusting the dose, enabling more consistent exposure and potentially reducing the risk of side effects. Due to XS003’s improved food interaction profile, the warning about three hours of fasting, currently included in the reference product’s so-called boxed warning, is not expected to apply to XS003. This may simplify treatment and improve adherence.

XS003 is an improved formulation of nilotinib (Tasigna) and developed using the company’s proprietary HyNap technology.

"Patients with chronic leukemia live not only with their disease—but also with side effects from medications, often related to food interaction and concomitant treatments. Our proprietary HyNap technology addresses these challenges and may help improve treatment outcomes and quality of life for this patient group. Our goal is to develop and commercialize a portfolio of next-generation Protein Kinase Inhibitor products with stable absorption, low variability, and minimal food interaction. With XS003, we now have two product candidates under FDA review with strong clinical potential, addressing a total U.S. market worth USD 2.7 billion," says Per Andersson, CEO of Xspray Pharma.

Data from registration studies demonstrate bioequivalence with the reference product, despite XS003 being administered at less than half the dose of the reference product. In addition, the studies confirm clearly improved dose linearity, which may provide physicians with better predictability when adjusting doses, and thereby a greater ability to achieve improved treatment outcomes. The uptake of XS003 is only slightly affected when taken with food, while the reference product is significantly affected as reflected in their label (28% vs. 82%). This may indicate improved control and a lower risk of side effects when taken with food.

Xspray expects the FDA to initiate its review within 60 days, with a regulatory decision anticipated approximately eight months thereafter.

Global 2024 nilotinib sales reached USD 1.67 billion in 2024, of which USD 850 million came from the U.S.

CorriXR Therapeutics Secures $1M Investment from State of Delaware

On August 19, 2025 CorriXR Therapeutics, Inc., a pioneering oncology-focused biotherapeutics company, reported a significant milestone with a $1M investment from the State of Delaware (Press release, CorriXR Therapeutics, AUG 19, 2025, View Source [SID1234655390]). This funding will be instrumental in advancing CorriXR’s lead program aimed at developing next-generation treatments for solid tumors, with particular focus on head and neck, and lung cancers. This investment not only underscores the potential of CorriXR’s cutting-edge therapies but also highlights Delaware’s commitment to supporting innovative early-stage companies.

"We’re excited to have the State of Delaware participate in our Series A financing round as we advance toward our first-in-human clinical trial," said Eric Kmiec, Ph.D., founder & CEO of CorriXR. "This investment will be critical as we complete preclinical studies, scale-up manufacturing, and prepare our investigational new drug (IND) submission."

The State of Delaware’s investment in CorriXR is the first $1M investment from the Delaware Accelerator & Seed Capital Program (DASCP), one of four programs awarded under the State Small Business Credit Initiative (SSBCI) federal program from the U.S. Treasury Department. The Division of Small Business is administering Delaware’s $60.9 million SSBCI award aimed at providing access to capital for start-up and early-stage businesses.

"Our first $1 million investment is proof that Delaware’s path to becoming the Mid-Atlantic hub for Innovation is well underway," said Delaware Division of Small Business Director CJ Bell. "Supporting companies like CorriXR to scale isn’t just good business – it’s the blueprint for turning that vision into reality."

"This is how Delaware wins the future, with CorriXR demonstrating the power of turning research into real solutions," said Delaware Governor Matt Meyer. "By working closely with experts at the Gene Editing Institute, CorriXR is making promising CRISPR therapies a reality for patients faster than ever. This is exactly why the SSBCI program exists—because supporting innovation today means better treatments, stronger businesses, and a brighter future for Delaware."

Kelonia Therapeutics Doses First Patient in Phase 1 inMMyCAR Study Evaluating in vivo CAR T-Cell Therapy for Relapsed and Refractory Multiple Myeloma

On August 19, 2025 Kelonia Therapeutics, Inc., a biotech company revolutionizing in vivo gene delivery, reported that the first patient has been dosed in the inMMyCAR study, a Phase 1 clinical trial evaluating KLN-1010, a novel in vivo gene therapy that generates anti-BCMA CAR-T cells, in patients with relapsed and refractory multiple myeloma (Press release, Kelonia Therapeutics, AUG 19, 2025, View Source [SID1234655389]).

"KLN-1010 offers hope to multiple myeloma patients who can’t access today’s CAR-T cell therapies," said Kevin Friedman, Ph.D., Chief Executive Officer and Founder of Kelonia. "This first-in-human dosing marks a major milestone toward a future where CAR-T benefits can be delivered without preparative chemotherapy or bespoke manufacturing delays, and at virtually any hospital around the world. Beginning our Phase 1 inMMyCAR study is not only pivotal for patients, but for the entire field. It’s the starting point for transforming CAR-T cell therapies with our in vivo Gene Placement System (iGPS) technology."

Professor Simon Harrison, MBBS, MRCP(UK), FRCPath(UK), FRACP, Ph.D., Director of the Centre of Excellence in Cellular Immunotherapy at the Peter MacCallum Cancer Centre, Melbourne, Australia and inMMyCAR Lead Investigator, added, "Multiple myeloma can be a challenging disease to treat as most patients experience relapse after initial treatment, and many become resistant to currently available therapies. In vivo CAR-T cell therapies would be transformative for these patients, providing rapid access to potentially life-saving treatments. We’re at a pivotal moment, in which we’re taking important steps to make such therapies a reality in Australia through highly novel clinical trials, and I’m proud to play a role in ushering in these innovative therapies."

inMMyCAR is a multi-center Phase 1, open-label, dose-escalation clinical trial designed to assess the safety and preliminary efficacy of a single dose of KLN-1010. The first patient was dosed at Royal Prince Alfred Hospital, Sydney, Australia, by inMMyCAR Investigator, Professor Joy Ho, MB.BS. (Hons), D.Phil (Oxon), FRACP, FRCPA, FFSc (RCPA).

"Dosing the first patient in the inMMyCAR Phase 1 study is a tremendous milestone and marks significant advancement towards bringing KLN-1010 to patients who need it most," said Professor Ho. "I and my team are proud to have achieved this proficiently. As an in vivo CAR-T cell therapeutic candidate, KLN-1010 has the potential to deliver the full promise of CAR-T cell therapies without the complex manufacturing requirements, lengthy production timelines and toxic lymphodepleting chemotherapy that ex vivo CAR-T cell therapies require. We believe it has the potential to revolutionize CAR-T therapy in myeloma."

About inMMyCAR

inMMyCAR is a Phase 1, open-label, dose-escalation clinical trial designed to assess the safety, tolerability, pharmacology and preliminary efficacy of a single dose of KLN-1010 in up to 40 patients. The primary endpoints are incidence and severity of treatment-emergent adverse events (TEAEs), including dose limiting toxicities (DLTs), and to establish the recommended Phase 2 dose of KLN-1010. KLN-1010 has been granted Human Research Ethics Committee (HREC) approval and Clinical Trial Notification (CTN) clearance by the Australian Therapeutic Goods Administration (TGA). This Phase 1 clinical trial marks the first time KLN‑1010 will be evaluated in humans. Additional information and study site information may be found on clinicaltrials.gov (NCT07075185).

About Relapsed and Refractory Multiple Myeloma

Multiple myeloma is a hematologic malignancy characterized by the proliferation of plasma cells in the bone marrow, leading to bone destruction, anemia, renal dysfunction, and immunosuppression. It is driven by complex genetic and epigenetic alterations that promote malignant cell survival and resistance to apoptosis. Relapsed and refractory multiple myeloma is characterized by clonal evolution, drug resistance, and increased disease heterogeneity, heightening the need for accessible, personalized therapeutic strategies.

About KLN-1010

KLN‑1010 is an investigational in vivo gene therapy that generates anti-BCMA CAR-T cells, targeting a protein expressed on the surface of multiple myeloma cells. Unlike traditional CAR‑T treatments, KLN‑1010 is administered to patients via direct transfusion and is designed to generate durable CAR‑T cells inside the body after a single dose, potentially eliminating the need for long wait times to receive treatment. This may overcome several limitations faced by current CAR-T approaches, including limited access to treatment and preconditioning chemotherapy.