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Circio and Tcelltech jointly announce CAR-T cell therapy research collaboration

On June 24, 2026 Circio Holding ASA (OSE: CRNA), a biotechnology company developing novel circular RNA expression technology for gene and cell therapy, and Tcelltech GmbH, a biotechnology company developing non-viral, episomal DNA vector technology for the engineering of T cells, reported a research collaboration to combine Circio´s circVec circular RNA expression technology with Tcelltech´s double-stranded, non-integrating nanoSMAR vector platform for the development of next generation engineered T-cell therapies.

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Engineered T-cell therapies such as CAR-T have transformed the treatment of certain cancers. However, ex vivo manufacturing remains complex and the shift towards in vivo approaches currently relies on viral vectors that have significant safety concerns. By integrating the technologies developed by Circio and Tcelltech, the parties aim to engineer T-cells with enhanced and sustained CAR/TCR expression, without the need for viral vectors. The aim is to develop novel in vivo cell therapies that are safer and more durable than current in vivo approaches.

"The combination of Tcelltech’s non-viral, episomal nanoSMAR DNA vector platform with Circio’s circVec expression technology holds great promise for the development of in vivo gene delivery systems that are non-disruptive to target cells, maintain high expression levels, and enable straightforward, cost-effective manufacturing. Furthermore, the exceptionally large cargo capacity of nanoSMAR vectors—beyond what is achievable with viral approaches—enables the design of complex, and sophisticated constructs incorporating multiple payload genes and regulatory elements," said Dr. Richard Harbottle, Head of Vector Technology and Manufacturing at Tcelltech.

Under the collaboration, Circio and Tcelltech will combine Circio’s circVec circular RNA expression technology with Tcelltech’s non-viral, high-cargo capacity nanoSMAR vector platform and evaluate the combination in engineered T cells through a staged research program. An initial proof-of-concept phase will compare how strongly and how durably the different technology combinations drive gene expression in primary human T cells, followed by a functional phase in which CD19-directed CAR T cells are generated and tested for their ability to kill tumor cells.

"In vivo T cell therapy is one of the most exciting frontiers for our circVec technology and is a rapidly advancing approach that could make these therapies more scalable and accessible," said Dr. Victor Levitsky, Chief Scientific Officer of Circio. "Tcelltech´s universal nanoSMAR platform is a promising and differentiated delivery technology for T-cells, which we expect will act synergistically with circVec-enhanced payload expression. This collaboration fits into Circio´s broad business development strategy of testing circVec across multiple modalities and delivery systems to identify the optimal technology combination and identify the most promising therapeutic avenues."

(Press release, Circio, JUN 24, 2026, View Source [SID1234668906])

IMUNON Announces Data Monitoring Committee Recommends Continuation of Phase 3 OVATION 3 Study Without Modification

On June 23, 2026 IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, reported that the independent Data Monitoring Committee (iDMC) has recommended continuation of the pivotal Phase 3 OVATION 3 clinical trial evaluating IMNN-001 in combination with standard of care (SoC) neoadjuvant and adjuvant chemotherapy (N/ACT) in women with newly diagnosed advanced ovarian cancer.

"We are very pleased that the iDMC has recommended continuation of the landmark OVATION 3 clinical trial without modification, representing another important validation of the remarkable efficacy and safety data previously reported and further indicating the potential for IMNN-001 to represent a historic advance in the treatment of ovarian cancer," said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. "We remain ahead of our anticipated schedule in patient enrollment and this recommendation by the iDMC brings new levels of momentum to our efforts to advance this trial as rapidly as possible."

The pivotal Phase 3 OVATION 3 trial is a robustly designed clinical study with the primary endpoint of overall survival (OS). The trial design includes two planned interim analyses of the primary endpoint, designed to allow for an accelerated timeline for potential submission of a Biologics License Application (BLA) for full approval of IMNN-001 to the U.S. Food and Drug Administration (FDA) if the primary endpoint reaches statistical significance. With 27 patients enrolled to date, the trial remains on track to complete enrollment of approximately 80 patients by the end of Q1 2027. The strong benefit/risk profile, with an advantageous safety profile, has been validated in two successive randomized and controlled clinical trials.

"I want to express our gratitude to all of our investigators and to the patients who have supported this trial thus far, and also to our outstanding leadership team at IMUNON who have showed a remarkable level of dedication to advancing this trial and bringing a new option and new hope to women living with ovarian cancer," Dr. Lindborg added. "We look forward to updating on our progress in the months ahead."

About the Phase 3 OVATION 3 Study

OVATION 3 is an ongoing Phase 3 pivotal study to evaluate the dosing, safety, efficacy and biological activity of intraperitoneal administration of IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy (N/ACT) of paclitaxel and carboplatin in patients newly diagnosed with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. Treatment in the neoadjuvant period is designed to activate the patient’s immune system to recognize and eliminate tumor cells, while also shrinking the tumor as much as possible for optimal surgical removal after three cycles of chemotherapy. Following N/ACT, patients undergo interval debulking surgery, followed by three additional cycles of adjuvant chemotherapy plus IMNN-001 to further stimulate anti-tumor immunity and treat any residual tumor. This randomized controlled study will enroll 500 patients, who will be randomized 1:1 and evaluated for safety and efficacy to compare N/ACT plus IMNN-001 versus standard-of-care N/ACT. In accordance with the study protocol, patients randomized to the IMNN-001 treatment arm can receive up to 17 weekly doses of 100 mg/m2 in addition to N/ACT. The primary endpoint of the trial is overall survival. Additional endpoints include objective response rate, chemotherapy response score, surgical response score, and time to second line therapy. The trial includes two interim analyses for assessment of efficacy, which could potentially serve as opportunities for early registration. OVATION 3 is currently enrolling at multiple sites throughout the US.

About the Phase 2 OVATION 2 Study

OVATION 2 evaluated the dosing, safety, efficacy and biological activity of intraperitoneal administration of IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy (N/ACT) of paclitaxel and carboplatin in patients newly diagnosed with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. Treatment in the neoadjuvant period is designed to shrink the tumors as much as possible for optimal surgical removal after three cycles of chemotherapy. Following N/ACT, patients undergo interval debulking surgery, followed by three additional cycles of adjuvant chemotherapy to treat any residual tumor. This open-label study enrolled 112 patients who were randomized 1:1 and evaluated for safety and efficacy to compare N/ACT plus IMNN-001 versus standard-of-care N/ACT. In accordance with the study protocol, patients randomized to the IMNN-001 treatment arm could receive up to 17 weekly doses of 100 mg/m2 in addition to N/ACT. As a Phase 2 study, OVATION 2 was not powered for statistical significance. The Company reported a median 14.7-month increase in OS (45.1 vs. 30.4 months) in women in the IMNN-001 treatment arm compared to SoC alone, demonstrating continuous improvement in OS (3.6 delta). In addition, women treated with IMNN-001 and SoC chemotherapy plus poly ADP-ribose polymerase (PARP) inhibitors as part of maintenance therapy achieved a median increase in OS of 24.2 months (65.6 vs. 41.4 months) compared to SoC chemotherapy alone. With these efficacy results, IMNN-001 continued to maintain a highly favorable safety and tolerability profile. Additional endpoints included objective response rate, chemotherapy response score and surgical response.

About IMNN-001 Immunotherapy

Designed using IMUNON’s proprietary TheraPlas platform technology, IMNN-001 is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anticancer immunity acting through the induction of T-lymphocyte and natural killer cell proliferation. IMUNON previously reported positive safety and encouraging Phase 1 results with IMNN-001 administered as monotherapy or as combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer and completed a Phase 1b dose-escalation trial (the OVATION 1 Study) of IMNN-001 in combination with carboplatin and paclitaxel neoadjuvantly in patients with newly diagnosed ovarian cancer. IMUNON previously reported positive results from the recently completed Phase 2 OVATION 2 Study, which assessed IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (N/ACT) of paclitaxel and carboplatin compared to standard-of-care N/ACT alone in 112 patients with newly diagnosed advanced ovarian cancer.

About Epithelial Ovarian Cancer

Epithelial ovarian cancer is the sixth deadliest malignancy among women in the U.S. There are approximately 20,000 new cases of ovarian cancer every year and approximately 70% are diagnosed in advanced stage III/IV. Epithelial ovarian cancer is characterized by dissemination of tumors in the peritoneal cavity with a high risk of recurrence (75%, stage III/IV) after surgery and chemotherapy. Since the five-year survival rates of patients with stage III/IV disease at diagnosis are poor (41% and 20%, respectively), there remains a need for a therapy that not only reduces the recurrence rate but also improves overall survival. The peritoneal cavity of advanced ovarian cancer patients contains the primary tumor environment and is an attractive target for a regional approach to immune modulation.

(Press release, IMUNON, JUN 23, 2026, View Source [SID1234668928])

Plus Therapeutics to Provide Business Update Call on June 30, 2026

On June 23, 2026 Plus Therapeutics, Inc. (Nasdaq: PSTV) ("Plus" or the "Company"), a healthcare company focused on central nervous system ("CNS") cancers, reported that management will host a business update conference call and webcast on Tuesday, June 30, 2026, at 8:30 a.m. Eastern Time.

During the call, management will focus on the Company’s CNSide diagnostic launch and its integrated development plan for lead drug Reyobiq. Furthermore, management will provide further detail on its CNS oncology strategy and native artificial intelligence development plans.

"Our team is making substantial progress in all 3 areas of the company, specifically diagnostics, therapeutics and artificial intelligence," said Marc H. Hedrick, M.D., President and Chief Executive Officer of Plus Therapeutics. "We are excited to provide an update on our progress toward our milestones and vision for the company to enable better outcomes for CNS oncology patients and provide long-term value creation for stockholders."

Conference Call and Webcast Details

Date: Tuesday, June 30, 2026
Time: 8:30 a.m. Eastern Time
Webcast: Link
Dial-in (U.S./Canada): 1-888-349-0106
Dial-in (International): 1-412-317-6789

A replay of the webcast will be available following the event in the Investor Relations section of the Company’s website at www.plustherapeutics.com.

(Press release, Plus Therapeutics, JUN 23, 2026, View Source [SID1234668927])

Revolution Medicines Begins Treating Patients in RASolute 305, a Phase 3 Clinical Trial Evaluating Zoldonrasib in Combination with Chemotherapy as a First Line Treatment for Patients with RAS G12D Metastatic Pancreatic Cancer

On June 23, 2026 Revolution Medicines, a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported that it has begun treating patients in RASolute 305, a global, randomized Phase 3 clinical trial evaluating zoldonrasib in combination with standard of care chemotherapy as a first line treatment in patients with metastatic RAS G12D pancreatic ductal adenocarcinoma (PDAC).

"Pancreatic cancer is a RAS-driven disease, and we recently reported that daraxonrasib, our RAS(ON) multi-selective inhibitor, significantly improved overall survival, progression-free survival, response rates, and preservation of measures of quality of life versus standard of care chemotherapy in second line treatment of patients with metastatic pancreatic cancer across a range of RAS genotypes. These unprecedented findings provide important clinical validation of RAS(ON) inhibition in pancreatic cancer and support its evaluation earlier in the treatment course," said Alan Sandler, M.D., chief development officer of Revolution Medicines.

"RAS G12D, the most common RAS subtype in pancreatic cancer, is associated with particularly poor clinical outcomes. Early studies of zoldonrasib, our oral RAS(ON) G12D-selective covalent inhibitor, have demonstrated encouraging clinical activity and safety. The RASolute 305 trial is evaluating whether combining zoldonrasib with chemotherapy can improve outcomes in first line treatment for metastatic RAS G12D pancreatic cancer. Both RASolute 305 and RASolute 303, a separate ongoing Phase 3 trial evaluating daraxonrasib in first line pancreatic cancer, reflect our broad commitment to studying RAS(ON) inhibitors with differentiated profiles across a range of unmet medical needs in pancreatic cancer," added Dr. Sandler.

RASolute 305 (NCT07621718) is a global, randomized, double-blind placebo-controlled clinical trial evaluating zoldonrasib plus investigator’s choice of standard of care chemotherapy compared with placebo plus investigator’s choice of chemotherapy in patients with previously untreated metastatic RAS G12D PDAC. Investigator’s choice of chemotherapy includes modified FOLFIRINOX or gemcitabine plus nab-paclitaxel. The primary endpoints are progression-free survival and overall survival. Key secondary endpoints include additional measures of antitumor activity, safety and tolerability, and patient reported outcomes.

About Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma
Pancreatic cancer is one of the most lethal malignancies, characterized by its typically late-stage diagnosis, resistance to standard chemotherapy, and high mortality rate. In the U.S., recent estimates indicate that approximately 60,000 people are diagnosed annually with pancreatic cancer, and about 50,000 people will die from this aggressive disease.1

Pancreatic ductal adenocarcinoma, or PDAC, is the most common form of pancreatic cancer. Due to the lack of early symptoms and effective detection methods, approximately 80% of patients are diagnosed with advanced or metastatic disease. PDAC is the most commonly RAS-driven malignancy of all major cancers, with more than 90% of patients have tumors that harbor RAS mutations.2 RAS G12D is the most prevalent RAS mutation subtype in PDAC, occurring in 40% of patients, and has been associated with poorer outcomes than RAS wild-type disease and certain other RAS-mutant subgroups.2-5 Metastatic PDAC remains a leading cause of cancer-related death in the U.S., with a five-year survival rate of approximately 3%. 6,7

About Zoldonrasib
Zoldonrasib is a tri-complex inhibitor that binds to cyclophilin A, creating a complex that selectively recognizes and inhibits the active, oncogenic RAS(ON) G12D mutation. RAS G12D is the most prevalent RAS mutation, accounting for 29% of all RAS cancers.2 Across tumor types, approximately 61,000 new patients with RAS G12D cancers are estimated each year in the U.S., and no targeted therapy is currently approved for these patients.8 Zoldonrasib is currently being evaluated as a monotherapy and in combination with other therapies, including with Revolution Medicines’ RAS(ON) multi-selective inhibitor daraxonrasib (RMC-6236), as well as standard of care regimens in lung and gastrointestinal cancers.

(Press release, Revolution Medicines, JUN 23, 2026, View Source [SID1234668926])

Silexion Therapeutics Receives Approval from Germany’s BfArM to Initiate Phase 2/3 Clinical Trial of SIL204 in Locally Advanced Pancreatic Cancer

On June 23, 2026 Silexion Therapeutics Corp. (NASDAQ: SLXN) ("Silexion" or the "Company"), a clinical-stage biotechnology company pioneering RNA interference (RNAi) therapies for KRAS-driven cancers, reported that it has received formal approval from Germany’s Federal Institute for Drugs and Medical Devices (BfArM, Bundesinstitut für Arzneimittel und Medizinprodukte) to initiate its planned Phase 2/3 clinical trial of SIL204, the Company’s lead small interfering RNA (siRNA) product candidate, in patients with locally advanced pancreatic cancer (LAPC). The trial has been approved without conditions, with both Part I and Part II of the assessment determined to be justifiable, following the positive opinion of the Ethics Committee of the North Rhine Medical Association regarding the conduct of the trial in Germany.

The decision was issued under Articles 5 and 8 of EU Regulation No. 536/2014 in conjunction with the German Medicines Act (AMG), with Germany serving as the Reporting Member State (rMS) leading the scientific assessment of the trial under the EU Clinical Trials Regulation. The approval follows the Company’s April 2026 submission of its Clinical Trial Application (CTA) through the EU Clinical Trials Information System (CTIS), which was informed by the positive written Scientific Advice from BfArM received in December 2025, the previously announced completion of two-species toxicology studies confirming no systemic organ toxicity, and the Company’s broader preclinical package. The decision also builds on the March 24, 2026 approval from the Israeli Ministry of Health, which authorized initiation of the same Phase 2/3 trial in Israel. With the assessment in Germany complete, Silexion is now positioned to potentially expand its Phase 2/3 program across additional EU member states under the harmonized CTIS framework.

"With this BfArM approval, Silexion has now secured clinical trial authorizations in the two leading regulatory jurisdictions where we sought to initiate the Phase 2/3 trial of SIL204," said Ilan Hadar, Chairman and Chief Executive Officer of Silexion Therapeutics. "Germany is widely regarded as one of the most rigorous regulatory environments globally, and an unconditional approval as Reporting Member State under the EU Clinical Trials Regulation is, for us, a strong external validation of the SIL204 preclinical and safety package and a meaningful endorsement of the trial design we developed in close engagement with the agency. With Israeli and German authorizations now in hand, our focus shifts entirely to clinical execution, and we expect to dose our first patient in the coming weeks at one of the activated sites in Israel or Germany."

With both regulatory authorizations now obtained, Silexion is finalizing site activation procedures at participating medical centers in Israel and Germany, including the contracting and budget arrangements customary for multi-site international trials of this scale. The Company expects first-patient dosing to occur in the coming weeks, with the initial dosing site to be determined by the timing of site activation across the participating centers. Site activation in Israel is led by Sheba Medical Center and Tel Aviv Sourasky Medical Center, both of which previously received local ethics approvals for the trial, with leading German oncology centers being brought into the program under the EU CTIS framework.

The Phase 2/3 trial is designed to evaluate SIL204 in combination with standard-of-care chemotherapy in patients with LAPC, using Silexion’s innovative dual-route administration strategy – combining intratumoral delivery to target primary tumors with systemic administration to address metastatic disease. The study is structured as an initial safety run-in cohort of approximately 18 patients, followed by expansion into a randomized cohort of approximately 166 patients. Pancreatic cancer remains one of the most lethal malignancies, with a five-year survival rate below 13%, and more than 80% of pancreatic cancer mortality driven by metastatic disease. KRAS mutations are present in approximately 90% of pancreatic cancers, 45% of colorectal cancers, and 30–35% of lung adenocarcinomas, representing one of the largest and most persistent unmet needs in oncology.

(Press release, Silexion Therapeutics, JUN 23, 2026, View Source [SID1234668925])