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Oncoinvent Reports Positive Final Data from Phase 1 Trial of Radspherin® to Treat Ovarian Cancer

On October 8, 2025 Oncoinvent reported new data highlight continued potential of Radspherin to prevent disease progression Oncoinvent ASA, a clinical-stage radiopharmaceutical company developing innovative treatments for solid cancers, announced positive final 24-month follow-up results from its Phase 1 clinical trial (RAD-18-001) evaluating Radspherin in patients with platinum-sensitive recurrent ovarian cancer and peritoneal carcinomatosis (Press release, Oncoinvent, OCT 8, 2025, https://www.oncoinvent.com/press-release/oncoinvent-reports-positive-final-data-from-phase-1-trial-of-radspherin-to-treat-ovarian-cancer/?utm_source=mailpoet&utm_medium=email&utm_source_platform=mailpoet [SID1234656487]). Radspherin, direct intraperitoneal targeting with the alpha-emitter radium-224, aims to eliminate post-surgery micro-metastases and thereby prevent or delay peritoneal recurrence.

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In this Phase 1 trial, 10 out of 21 patients received the highest and recommended intraperitoneal dose of 7 MBq Radspherin after dose escalation (1, 2, 4 and 7 MBq). The final 24-month data still reports that only 1 of these 10 patients had peritoneal recurrence, and peritoneal recurrence rate remains at 10%. Two additional patients were reported with lymph node metastases outside of the peritoneum, giving an overall recurrence rate of 30%. In similar populations, approximately 55-60% of patients receiving best standard of care would expect disease recurrence at this time point[1],[2],[3].

"These highly encouraging results conclude our Phase 1 program for Radspherin and fuel our determination to advance Radspherin as an innovative treatment for patients with peritoneal metastases as quickly as possible," said Oystein Soug, CEO of Oncoinvent. "We are profoundly grateful to the patients, investigators, and the team for their invaluable contributions and look forward to interim results from our Phase 2 study next year."

"Peritoneal metastases remain a defining challenge in ovarian cancer, often driving recurrence," said Dr. Luis Chiva, Principal Investigator and Director of Department of Obstetrics and Gynecology, Clinica Universidad de Navarra, Spain. "These final results are truly encouraging, suggesting that Radspherin could help delay disease progression and offer patients hope for longer, healthier lives. It is particularly promising to see that the new recurrences were limited to lymph nodes, which are typically associated with longer survival compared to peritoneal relapses.

About RAD-18-001

RAD-18-001 was an open label Phase 1 trial conducted in patients with peritoneal metastases in platinum-sensitive recurrent ovarian cancer. The trial was designed to evaluate dosing, safety and tolerability, and signal of efficacy of intraperitoneally administered Radspherin following complete surgical resection. A total of 21 patients were enrolled across sites in Norway, Belgium and Spain.

AbCellera to Participate at Upcoming Investor Conferences in November and December 2025

On October 7, 2025 AbCellera (Nasdaq: ABCL) reported that the Company will participate in the following investor conferences (Press release, AbCellera, OCT 7, 2025, View Source [SID1234656501]):

Truist Securities BioPharma Symposium, November 6, 2025
Stifel Healthcare Conference, November 11-13, 2025
Jefferies Global Healthcare Conference, November 18-20, 2025
Piper Sandler 37th Annual Healthcare Conference, December 2-4, 2025

Kernal Bio Awarded up to $48 Million from ARPA-H to Develop Lower Cost in vivo CAR T-cell Therapies for Hematological Cancers and Autoimmune Disease

On October 7, 2025 Kernal Biologics, Inc., a venture-backed TechBio company pioneering novel therapeutics to program human cells directly inside the body, reported that it has been awarded up to $48 million in funding by the Advanced Research Projects Agency for Health (ARPA-H) (Press release, Kernal Biologics, OCT 7, 2025, View Source [SID1234656500]). This project is to be funded by ARPA-H’s EMBODY program, which focuses on the engineering of immune cells inside the body. EMBODY is led by ARPA-H Program Manager Daria Fedyukina, Ph.D.

The funds will be used to support the clinical development of Kernal Bio’s in vivo mRNA-encoded CAR T-cell program, KR-402, which targets multiple sclerosis and B-cell malignancies, including acute lymphoblastic leukemia, large B-cell lymphoma and chronic lymphocytic leukemia. As part of this project, Kernal Bio will collaborate with sub-awardees – Stanford University School of Medicine, Dana-Farber Cancer Institute, and The Jackson Laboratory – to engineer targeted, mRNA-encoded CARs, as well as develop novel manufacturing strategies and preclinical models for testing these therapies.

"We’re honored to join the elite cohort of ARPA-H awardees," said Yusuf Erkul, M.D., MBA., cofounder and chief executive officer of Kernal Bio. "Current CAR-T therapies heralded a true revolution in cancer treatment. Yet, they have their limitations, including a three-week vein-to-vein turnaround time, tumor resistance leading to relapse, and side effects such as cytokine release syndrome or secondary T-cell malignancies. At Kernal Bio, we believe that we have the tools to evolve the CAR-T modality towards in vivo therapies."

KR-402 is a next-generation CAR-T therapy program developed using Kernal Bio’s mRNA 2.0 platform. This platform achieves exceptional precision using a unique two-pronged strategy. First, it uses a highly selective mRNA that only translates in specific cells — intelligently designed by analyzing thousands of multi-omics datapoints across various cell types. Second, this RNA is delivered by a targeted lipid nanoparticle (LNP) delivery vehicle decorated with antibodies that allow it to home in directly on target T cells.

By reprogramming T cells inside the body with this approach, KR-402 is positioned to be a differentiated in vivo CAR-T therapy that minimizes the risk of genomic integration, while offering tremendous cost efficiencies over traditional ex vivo therapies. Furthermore, the in vivo CAR-T approach may also improve patients’ treatment journey by eliminating the need for additional toxic procedures, such as lymphodepletion agents.

"Manufacturing ex vivo CAR-T therapies is a complex and expensive process. However, with our proprietary platform, there is a potential of reducing the cost of manufacturing in vivo CAR T-cell therapies by as much as 100-fold," commented Burak Yilmaz, president of Kernal Bio. "In addition, chemotherapy drugs used for lymphodepletion prior to CAR-T therapies carry significant toxicity, making these therapies viable for just a small group of patients. We believe that with our technology and the support of our partners and ARPA-H, we can greatly transform access to this category of therapies."

Kincell Bio Announces Collaboration to Advance Moonlight Bio’s Lead Cell Therapy Candidate to Clinical Study

On October 7, 2025 Kincell Bio, a leading US cell therapy CDMO, reported a partnership with Moonlight Bio, Inc., a Seattle-based biotech company pioneering advanced T cell therapies for solid tumors (Press release, Moonlight Bio, OCT 7, 2025, View Source [SID1234656499]). In this partnership, Kincell provides CMC development and GMP manufacturing services to advance Moonlight’s lead T cell therapy program into clinic trials.

Under the agreement, Kincell is providing process and analytical transfer and GMP manufacturing services to support the scale-up and clinical supply of Moonlight’s lead T cell therapy product. The collaboration between Moonlight and Kincell is designed to accelerate clinical supply and meet the needs of patients, advancing Kincell’s mission to support innovators in the rapidly growing cell therapy sector.

"At Moonlight, we are dedicated to delivering T cell therapies that address barriers obstructing successful outcomes in solid tumors – the vast majority of the global cancer disease burden," said Jordan Jarjour, PhD, Moonlight’s CSO. "We are very excited to collaborate with Kincell to advance our lead program into the clinic."

"I am excited to partner with the team at Moonlight as they develop an innovative cell therapy that has the potential to make a significant impact on patient disease burden. Kincell has a strong and agile team that thrives on finding technical solutions to deliver for our clients and their patients," said Bruce Thompson, PhD.

"We are thrilled to partner with Moonlight, a technology leading cell therapy innovator," said Mark Bamforth. "Kincell excels at finding solutions for CMC development and clinical supply for product innovators, and we are demonstrating these capabilities for Moonlight’s clinical trial."

Kincell provides industry-leading process and analytical development, and early clinical and late-stage clinical and commercial cGMP manufacturing capabilities that are serving the needs of biotech and pharmaceutical companies and is committed to advancing the field of cell therapy with tailored solutions that empower innovators to bring their therapies to market efficiently and effectively.

Eradivir Secures $10 Million in Private Financing

On October 7, 2025 Eradivir Inc., a clinical-stage biotechnology company that harnesses the power of the immune system to target and treat disease, reported the recent closing of a $10 million private financing round (Press release, Eradivir, OCT 7, 2025, View Source [SID1234656498]). The investment will support continued clinical development of the company’s lead antiviral therapeutic for influenza, EV25, and advancement of a second molecule, EV148, for the treatment of respiratory syncytial virus (RSV).

A significant amount of the $10 million raised came from previous investors, reflecting their continued confidence in Eradivir’s platform and vision.

"The funding marks a pivotal moment for Eradivir as we prepare to share EV25 Phase 2a results and underscores the confidence investors have in our ability to build out our toolkit of small molecule immunotherapies," said Martin Low, Chief Executive Officer of Eradivir. "We’ve minimized dilution by raising our first $30 million in milestone-based tranches. This disciplined financing strategy has preserved shareholder value while driving meaningful progress in our lead programs."

The funds have been used to complete the EV25 Phase 2a influenza challenge study and will also support IND-enabling studies of Eradivir’s RSV development candidate, EV148. The results from the EV25 Phase 2a challenge study will be publicly released in the coming weeks.

EV25 and EV148 were built on Eradivir’s BAiT (Bispecific Antigenic immuno-Therapy) platform that combines the simplicity of small molecules with the efficacy of antibodies. The simplicity of the platform’s technology provides the opportunity to address multiple diseases, including additional viruses and cancer, by switching the targeting ligand to another that binds specifically to a pathological cell.