ADC Therapeutics Announces Strategic Reorganization to Support ZYNLONTA® Growth Opportunities and Regulatory Priorities

On June 24, 2026 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), reported a strategic reorganization to focus resources behind key value-driving initiatives in support of the ZYNLONTA (loncastuximab tesirine-lpyl) franchise.

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As part of the reorganization, ADC Therapeutics plans to reduce its workforce globally by approximately 17 percent. The reduction is driven by the expected completion of the LOTIS-5 and LOTIS-7 trials this year, as well as operational efficiencies. With these changes, the Company is resourced to deliver on its key clinical, regulatory and manufacturing activities while maintaining the full externally facing medical affairs and commercial footprint to support ZYNLONTA.

"As we further assess the Phase 3 LOTIS-5 trial outcomes, including feedback from key medical experts, we continue to believe in the favorable overall benefit-risk profile and look forward to our pre-sBLA meeting with the U.S. Food and Drug Administration in August," said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. "This strategic reorganization will enable us to increase our financial flexibility as we prepare for upcoming LOTIS-5 regulatory milestones and continue building on the broader opportunity for ZYNLONTA through LOTIS-7 and support for the indolent lymphoma investigator-Initiated trials. We are grateful to all of our employees for their efforts to help make a meaningful impact for patients and thank them for their important contributions to our company."

The Company is preparing for a scheduled pre-sBLA meeting with the FDA in August 2026 to discuss the potential regulatory path forward for ZYNLONTA in combination with rituximab to treat relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) following the recent topline data results from the Phase 3 LOTIS-5 trial. ADC Therapeutics expects to submit an sBLA in the fourth quarter of 2026.

In addition, the Company continues to advance the ZYNLONTA franchise through the ongoing Phase 1b LOTIS-7 trial evaluating ZYNLONTA in combination with glofitamab in 2L+ DLBCL, with data anticipated by the end of 2026, as well as through support for Phase 2 IITs exploring ZYNLONTA across indolent lymphomas.

ADC Therapeutics expects the reorganization to generate annualized estimated cost savings of approximately $10 million. ADC Therapeutics estimates that it will incur one-time pre-tax charges of approximately $3 million for employee severance, benefits and related termination costs, the majority of which will be recognized in the 2nd quarter of 2026. The Company has an expected cash runway at least into 2028.

About ZYNLONTA

ZYNLONTA is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death.

The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval and in the European Union under conditional approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Please see full prescribing information including important safety information about ZYNLONTA at www.ZYNLONTA.com.

ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.

(Press release, ADC Therapeutics, JUN 24, 2026, View Source [SID1234668931])

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.

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"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.

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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).

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"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])