Antares Therapeutics Enters Agreement with Novartis to Discover, Develop and Commercialize First-in-Class Cancer Therapies

On June 24, 2026 Antares Therapeutics, Inc. ("Antares"), a biotechnology company developing first-in-class precision medicines for cancer and other serious diseases, reported a strategic collaboration with Novartis to discover, develop and commercialize small molecule therapies against promising but historically undruggable oncology targets. The agreement underscores the productivity and breadth of Antares’ discovery capabilities, which have repeatedly delivered development candidates against targets long considered intractable.

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Under the terms of the agreement, Antares will receive a $105 million upfront payment and is eligible to receive up to $1.8 billion in additional payments across programs, inclusive of option exercise, development, regulatory, and commercial milestones, as well as tiered royalties on global net sales up to the low double-digit range. Antares will lead all research and apply its proprietary discovery engine to a limited number of historically undruggable targets until option exercise. In parallel, Antares will continue to advance its wholly owned and partnered portfolio of precision medicines for cancer and other serious diseases.

"From the outset, our goal has been to build a discovery engine that systematically unlocks high-value, challenging targets and delivers first-in-class precision medicines," said Adam Friedman, M.D., Ph.D., Chief Executive Officer of Antares. "This collaboration lets us scale that engine alongside Novartis’ world-class development capabilities and global reach, so we can translate our science into transformative therapies for patients faster than either of us could alone. It builds on the work of a team that has consistently produced highly selective medicines against some of the hardest targets in drug discovery."

The collaboration pairs Antares’ covalent drug discovery expertise – proprietary screening libraries, chemical proteomics capabilities, structure-driven computational chemistry and a machine-learning suite purpose-built for compelling first-in-class targets – with Novartis’ world-class R&D and global resources.

"Novartis is committed to advancing innovative approaches to cancer drug discovery and expanding the boundaries of what’s possible in oncology treatment," said Fiona Marshall, President of Biomedical Research at Novartis. "Many of the most compelling targets today in oncology have historically been considered undruggable. We believe this collaboration has the potential to unlock a new wave of targeted therapies and bring meaningful advances to patients."

(Press release, Antares Therapeutics, JUN 24, 2026, View Source [SID1234668933])

AIM ImmunoTech Accelerates Toward Potential Pivotal Pancreatic Cancer Program as Ampligen Continues to Advance Through Key Clinical Milestones

On June 24, 2026 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported the significant progress achieved across its pancreatic cancer development program and outlined a series of anticipated milestones that position the Company for what management believes could be a pivotal period in its evolution as a clinical-stage oncology company.

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At the center of AIM’s strategy is Ampligen (rintatolimod), the Company’s proprietary TLR3 agonist immunotherapy, which is being evaluated in the ongoing Phase 2 DURIPANC study in combination with AstraZeneca’s PD-L1 inhibitor Imfinzi (durvalumab) for the treatment of metastatic pancreatic cancer.

Pancreatic cancer remains one of the deadliest forms of cancer worldwide, with limited treatment options and an urgent need for innovative therapies capable of extending survival and improving quality of life. AIM believes Ampligen’s unique mechanism of action and encouraging clinical observations to date position the program as a potentially differentiated immunotherapy approach in this difficult-to-treat disease.

Execution Continues to Drive Momentum

Over the past several months, AIM has delivered a series of meaningful achievements that have advanced Ampligen toward potential late-stage development:

Completed Phase 2 DURIPANC enrollment ahead of schedule
Achieved the important clinical milestone of dosing the final patient in the study
Reported positive interim clinical updates from the ongoing trial
Continued to demonstrate a favorable safety profile with no significant toxicity reported in study updates
Advanced the program under a collaboration involving AstraZeneca and Erasmus Medical Center
Expanded and strengthened global intellectual property protection surrounding Ampligen and checkpoint inhibitor combinations
Maintained orphan drug designation for pancreatic cancer in major markets
Regained compliance with NYSE American continued listing standards
Strengthened the balance sheet through multiple financing transactions designed to support strategic clinical priorities
These accomplishments represent important de-risking events that management believes support the advancement of Ampligen toward a potential registration-directed development pathway.

Growing Clinical Foundation Supports Advancement

Ampligen’s pancreatic cancer program is supported by a growing body of clinical evidence. The ongoing DURIPANC Phase 2 study builds upon prior clinical experience in late-stage pancreatic cancer, including a Dutch government approved named patient program where Ampligen-treated patients demonstrated encouraging survival outcomes and quality-of-life observations compared with historical expectations.

Recent interim updates from DURIPANC have continued to support management’s confidence in the program, reinforcing the rationale for advancing Ampligen as a potential immunotherapy platform capable of activating innate immunity while potentially enhancing the effectiveness of checkpoint inhibition.

Importantly, the combination of Ampligen and durvalumab has thus far demonstrated encouraging tolerability, a critical consideration in patients who have already undergone intensive chemotherapy treatment.

Multiple Near-Term Catalysts Ahead

With enrollment completed and all subjects now receiving treatment, AIM is entering what management believes may be the most catalyst-rich period in the Company’s recent history.

Key anticipated milestones include:

Additional clinical updates from the ongoing DURIPANC study
Primary Endpoint analysis anticipated to begin in December 2026, with topline results expected in the first quarter of 2027
Progression-free survival, overall survival and other secondary endpoint assessments expected to begin in June 2027
Continued immune monitoring and biomarker analyses
Regulatory interactions supporting future development planning
Further expansion of the Company’s global intellectual property portfolio
Advancement of Phase 3 planning activities
Potential design and initiation activities associated with a registration-focused pivotal study
Management believes each of these milestones has the potential to further validate Ampligen’s clinical profile and strengthen the Company’s strategic position.

A Clear Focus on Shareholder Value Creation

AIM has increasingly concentrated its resources on pancreatic cancer, which management believes represents the most significant opportunity to create long-term shareholder value.

The Company has consistently communicated that advancing Ampligen toward a pivotal clinical program and ultimately a potential regulatory approval pathway remains its highest priority.

As the biotechnology sector continues to place significant value on late-stage oncology assets, AIM believes successful execution of its pancreatic cancer strategy could substantially enhance the value of the Ampligen franchise.

With positive interim clinical progress, completed enrollment, orphan drug designations, strengthened intellectual property protection, strategic collaborations, and potential Phase 3 development, AIM believes it is entering a critical value-inflection period.

"We have built meaningful momentum across every aspect of the Ampligen pancreatic cancer program," said Thomas K. Equels, Chief Executive Officer of AIM ImmunoTech. "Our focus remains clear: facilitate the DURIPANC study, continue generating meaningful clinical data, advance regulatory planning, and position Ampligen for a potential pivotal development pathway. We believe these efforts have the potential to unlock significant value for patients, partners and our stockholders."

As AIM advances through the remainder of 2026 and prepares for potential pivotal-stage development activities, management believes the Company is increasingly positioned as a unique oncology opportunity centered on one of the largest unmet needs in cancer treatment today.

(Press release, AIM ImmunoTech, JUN 24, 2026, View Source [SID1234668932])

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])