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GSK delivers strong Q3 performance and upgrades 2025 guidance

On October 29, 2025 GlaxoSmithKline reported strong third quarter performance and upgrades 2025 guidance (Press release, GlaxoSmithKline, OCT 29, 2025, View Source [SID1234659533]).

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Cellipont Bioservices and Ernexa Therapeutics Enter Cell Therapy Manufacturing Partnership to Advance ERNA-101 Toward Clinical Trials in Ovarian Cancer

On October 29, 2025 Cellipont Bioservices, a leading cell therapy Contract Development and Manufacturing Organization (CDMO), reported it has entered into a collaboration with Ernexa Therapeutics (Nasdaq: ERNA), an industry innovator developing novel cell therapies for the treatment of advanced cancer and autoimmune disease. The partnership agreement will focus on Engineering, Differentiation, and Production (EDP) activities to advance ERNA-101, Ernexa’s lead cell therapy for the treatment of ovarian cancer, into clinical manufacturing and clinical trials.

"We are pleased to collaborate with Ernexa Therapeutics as they advance a bold and highly differentiated approach to treating cancer," said Darren Head, CEO of Cellipont Bioservices. "Supporting the development of synthetic, allogeneic iMSC therapies like ERNA-101 aligns with our commitment to enabling scientific innovation through collaborative, high-quality cell therapy manufacturing."

"Cellipont brings deep technical capabilities and a shared sense of urgency to help us translate the promise of ERNA-101 into a clinically viable therapy," said Sanjeev Luther, President and CEO of Ernexa Therapeutics. "This collaboration marks an important milestone in advancing our iMSC platform, which we believe has the potential to reshape the treatment landscape for patients with advanced solid tumors."

Ernexa’s core technology focuses on engineering induced pluripotent stem cells (iPSCs) and transforming them into induced mesenchymal stem cells (iMSCs). iMSC is a more specialized type of stem cell that has a unique ability to migrate toward tumors. Ernexa’s allogeneic synthetic iMSCs provide a scalable, off-the-shelf treatment, without needing patient-specific cell harvesting. ERNA-101 is Ernexa’s lead cell therapy product, designed to activate and regulate the immune system’s response to recognize and attack cancer cells.

In preclinical studies, presented at this year’s AACR (Free AACR Whitepaper) and ASCO (Free ASCO Whitepaper) annual meetings, ERNA-101 has shown the potential to reprogram immunologically "cold" tumors into "hot" ones, increasing immune cell infiltration and suppressing tumor growth. The Cellipont partnership will support the current Good Manufacturing Practice (cGMP) development and scale-up of the ERNA-101 manufacturing process in preparation for upcoming clinical trials.

(Press release, Ernexa Therapeutics, OCT 29, 2025, View Source [SID1234657121])

IASO Bio Partners with Korea’s GC Cell to Bring CAR-T Therapy to Korea

On October 29, 2025 Nanjing IASO Biotechnology ("IASO Bio"), reported that it has signed an agreement with Korea’s GC Cell to introduce the CAR-T therapy "Fucaso" (Equecabtagene Autoleucel) to the South Korean market for the treatment of multiple myeloma. This partnership aims to provide a new therapeutic option for Korean patients with multiple myeloma, and GC Cell plans to sequentially pursue domestic regulatory approval and commercialization of Fucaso.

Multiple myeloma is an incurable form of blood cancer with a high risk of relapse, most commonly affecting older adults. In South Korea, the number of multiple myeloma patients has been increasing annually due to an aging population. Many patients eventually develop resistance or refractoriness to existing treatments, limiting their effective options. While some combination therapies have recently become reimbursable — improving the initial treatment landscape — patients in fourth-line and later stages still face a critical lack of viable treatments, as advanced options like CAR-T therapies or bispecific antibodies are often prohibitively expensive and out of reach.

Fucaso is a BCMA (B Cell Maturation Antigen)-targeted CAR-T cell therapy developed by IASO Bio. It received approval in China in June 2023 and is currently being prescribed to patients there. By securing a competitive price point, this innovative therapy is expected to greatly improve accessibility for patients who need it.

To facilitate Fucaso’s introduction in Korea, GC Cell obtained Orphan Drug Designation for the therapy from the Ministry of Food and Drug Safety (MFDS) in July. In August, Fucaso was also selected as a fast-track Advanced Therapy Medicinal Product by Korean regulators, expediting its review and development process. Through a stable supply chain, GC Cell aims to ensure that patients can access this treatment in a timely and cost-effective manner.

"This contract marks a meaningful first step for GC Cell, as Korea’s leading cell therapy company, to lay the groundwork for CAR-T commercialization," said Sungyong Won, Co-CEO of GC Cell, in a statement. "We will work to stabilize the supply chain so that patients can have the opportunity to receive treatment at a more reasonable cost," he added.

"This partnership is a significant milestone in our global strategy," stated Jinhua Zhang, Founder, Chairwoman and CEO of IASO Bio. "It not only validates the international potential of Fucaso but also enables us to leverage our strengths with GC Cell’s regulatory and commercial expertise in Korea. Together, we are committed to making this innovative therapy accessible to more patients in need".

(Press release, IASO Biotherapeutics, OCT 29, 2025, View Source [SID1234657120])

InSysBio to announce its collaboration with BeOne Medicines

On October 29, 2025 InSysBio, one of the world’s pioneers of Quantitative Systems Pharmacology (QSP) modeling, reported its collaboration with BeOne Medicines, a global oncology company.

Mechanistic PK/RO modeling will be leveraged to support the selection of the optimal recommended phase 2 dose by predicting the dynamics of the various complexes formed when the BGB-B2033 binds to its targets. BGB-B2033, a GPC3 x 4-1BB bispecific antibody, is currently in early clinical development by BeOne Medicines.

"This project represents a valuable opportunity to apply our cutting-edge modeling approach since determining the optimal dose for therapies expected to exhibit a bell-shaped dose-response relationship poses a significant challenge," said Oleg Demin Jr, Scientific Director, InSysBio. "InSysBio’s QSP modeling expertise can help to address this issue. Namely, we have developed generic mechanistic PK/RO model for multispecific antibodies that accelerates project timelines and improves efficiency. Moreover, FDA’s Project Optimus encourages the application of mechanistic modeling approaches such as QSP to guide the selection of optimal dose in oncology."

(Press release, BeOne Medicines, OCT 29, 2025, View Source [SID1234657119])

Caris Data Validates TET2 Clonal Hematopoiesis as a Biomarker for Enhanced Immunotherapy Response

On October 29, 2025 Caris Life Sciences (NASDAQ: CAI), a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer, reported collaborative new research identifying TET2 clonal hematopoiesis (CH) as a promising biomarker for improved response to immune checkpoint inhibitor (ICI) therapy in patients with solid tumors. The study titled, `TET2-mutant clonal hematopoiesis enhances macrophage antigen presentation and improves immune checkpoint therapy in solid tumors,’ was led by Padmanee Sharma, M.D., Ph.D. at the James P. Allison Institute at The University of Texas MD Anderson Cancer Center and published in Cancer Cell.

The study’s purpose was to investigate how immune cells carrying CH-derived TET2 mutations influence solid tumor immunology and respond to ICI therapy. Dr. Sharma and Shelley Herbrich, Ph.D., postdoctoral fellow in Dr. Sharma’s lab, explored the underlying mechanisms using TET2-mutant laboratory models, which revealed how these mutations shape immune dynamics within the tumor microenvironment.

To validate the clinical relevance of these findings, the study leveraged Caris Life Sciences’ extensive clinico-genomic database, analyzing outcomes in a real-world cohort of nearly 36,000 patients with non-small cell lung cancer (NSCLC) and over 25,000 colorectal (CRC) cancer patients. This dual approach provided insight and large-scale evidence supporting TET2-CH as a potential biomarker for enhanced ICI response. Importantly, these findings represent a major observation that directly ties clonal hematopoiesis to therapy outcomes in solid tumors, suggesting a future role of CH for driving therapy selection.

"These findings represent a major step forward in understanding how clonal hematopoiesis influences cancer immunology," said Milan Radovich, Ph.D., Senior Vice President, Chief Scientific Officer at Caris. "It further demonstrates that we are only scratching the surface on the potential applications of CH, namely a novel function of CH as a predictive therapeutic biomarker that can be used to improve patient outcomes."

"These results are encouraging, highlighting TET2-mutated clonal hematopoiesis as a potential biomarker to select patients who are more likely to respond to immunotherapy," said Padmanee Sharma, M.D., Ph.D., professor of Immunology and Genitourinary Medical Oncology at MD Anderson and director of scientific programs for the Allison Institute.

(Press release, Caris Life Sciences, OCT 29, 2025, View Source [SID1234657118])