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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.

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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.

Zai Lab Announces China National Medical Products Administration Grants Innovative Medical Device Designation for Tumor Treating Fields for Patients with Pancreatic Cancer

On August 19, 2025 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported that the China National Medical Products Administration (NMPA) has granted Innovative Medical Device Designation for Tumor Treating Fields (TTFields) for patients with pancreatic cancer based on the positive results from the Phase 3 PANOVA-3 trial (Press release, Zai Laboratory, AUG 19, 2025, View Source [SID1234655388]). The Innovative Medical Device Designation allows Zai Lab to take advantage of an expedited approval procedure for TTFields that offers opportunities for the NMPA to prioritize the allocation of review resources to expedite the regulatory review and approval process.

"We are excited that TTFields has been granted the Innovative Medical Device Designation, a status that offers expedited registration and priority review by the NMPA. This designation also allows us to submit the application in China before approval in the country of origin," said Rafael Amado, M.D., President, Head of Global Research and Development at Zai Lab. "Pancreatic cancer remains one of the most challenging cancers to treat globally, with approximately 134,000 new cases diagnosed annually in China alone. We are on track to submit for regulatory approval in China in the second half of 2025 and look forward to collaborating closely with the NMPA throughout the review process."

The Phase 3 PANOVA-3 trial evaluated the use of TTFields therapy concomitantly with gemcitabine and nab-paclitaxel as a first-line treatment for unresectable, locally advanced pancreatic adenocarcinoma compared to gemcitabine and nab-paclitaxel alone. The trial met its primary endpoint, demonstrating a statistically significant improvement in median overall survival for patients treated with TTFields. Zai Lab participated in the study in Greater China (mainland China, Hong Kong, Macau and Taiwan, collectively).

In August 2019, the NMPA granted Innovative Medical Device Designation for Optune in China for the treatment of newly diagnosed and recurrent glioblastoma (GBM). Zai Lab subsequently submitted the regulatory application in September 2019 and received approval in May 2020. Optune is a registered trademark of Novocure GmbH, and Zai Lab markets Optune under license from Novocure GmbH.

About PANOVA-3

PANOVA-3 is an international prospective, randomized, open-label, controlled Phase 3 clinical trial designed to test the efficacy and safety of TTFields therapy used concomitantly with gemcitabine and nab-paclitaxel, as a first-line treatment for locally advanced pancreatic adenocarcinoma. Patients were randomized to receive either TTFields therapy concomitant with gemcitabine and nab-paclitaxel or gemcitabine and nab-paclitaxel alone.

The primary endpoint is overall survival. Secondary endpoints include progression-free survival, local progression-free survival, objective response rate, one-year survival rate, quality of life, pain-free survival, puncture-free survival, resectability rate, and toxicity.

The PANOVA-3 trial enrolled 571 patients who were randomized 1:1 and followed for a minimum of 18 months.

About Pancreatic Cancer in China

Pancreatic cancer is one of the most common and deadliest cancers globally. In China, there were an estimated 134,374 new cases and 131,203 cancer deaths in 2022, and it is the sixth leading cause of cancer mortality in China1. Pancreatic cancer has a 5-year survival rate of less than 10%, making it the malignancy with the lowest survival rate in China 2.

The patients with locally advanced, unresectable pancreatic cancer are no longer operable, so chemotherapy with or without radiation is the only treatment option, with a median overall survival only nine to twelve months.

1 Xia C, Dong X, Li H et al. Cancer statistics in China and United States, 2022: profiles, trends, and determinants. Chin Med J (Engl) 2022; 135: 584-590.

2 Hu JX, Zhao CF, Chen WB et al. Pancreatic cancer: A review of epidemiology, trend, and risk factors. World J Gastroenterol 2021; 27: 4298-4321.

About Tumor Treating Fields

Tumor Treating Fields (TTFields) is a cancer therapy that uses electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. These multiple, distinct mechanisms work together to target and kill cancer cells. Due to these multi mechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibitors, or targeted therapies in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors.

To learn more about TTFields therapy and its multifaceted effects on cancer cells, visit tumortreatingfields.com.