On June 8, 2026 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported positive progress in a mid-year update from the ongoing Phase 2 clinical study evaluating AIM’s drug Ampligen (rintatolimod) combined with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) in the treatment of metastatic pancreatic cancer patients with stable disease post-FOLFIRINOX standard of care (the "DURIPANC" study) (see: ClinicalTrials.gov NCT05927142).

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See: DURIPANC, 2026 Mid-Year Interim Clinical Progress Update

AIM recently announced enrollment of the final patient in the clinical trial, barring any disqualifying pre-treatment circumstances. The Company remains on track for a planned December 2026 evaluation of the clinical trial’s primary endpoint, Clinical Benefit Rate ("CBR"), defined as stable disease, partial response or complete response (progression-free disease) at 6 months (24 weeks) after start of combination therapy.

DURIPANC is a follow-up to a 57-subject Named Patient Program ("NPP") of Ampligen as a monotherapy in late-stage pancreatic cancer, where Ampligen was associated with median survival of 19.7 months, which is an extension of median overall survival of 8.6 months when compared to the standard of care. The EAP subjects also reported improved quality of life.

AIM Chief Executive Officer Thomas Equels stated: "There is a clear need for an approved treatment that is both more effective and less toxic than what is currently available to people suffering with pancreatic cancer. Despite advances in chemotherapy, survival for these patients is too often short and agonizing. The published NPP data and the DURIPANC interim results support our belief that Ampligen has the potential to meaningfully extend survival and provide late-stage pancreatic cancer patients with a higher quality of life. For example, in the NPP stratification of subjects with immune marker Neutrophil/Lymphocyte ratios less than 4.5, we saw overall median survival of 34.8 months compared to 12.5 months for historical controls, for an improvement of 22.3 months – and with positive measures of quality of life. We are also diligently planning the next step in Ampligen’s development, with an eye toward a pivotal Phase 3 clinical trial evaluating the experimental drug in combination with a PD-1 inhibitor in an effort to demonstrate its value across multiple endpoints, most importantly overall survival and progression-free survival. If a Phase 3 clinical trial was able to pair significant survival results with AIM’s impressive safety and tolerability profile, then it could position AIM as a leader in pancreatic cancer research potentially translational to the patient as a standard of care."

The DURIPANC study is an investigator-initiated, exploratory, open-label, single-center study expected to enroll up to 25 subjects in the Phase 2 portion. The clinical trial is a joint collaboration between AIM, AstraZeneca and Erasmus Medical Center in the Netherlands. The primary objective of the study is the clinical benefit rate of the combination therapy. The secondary/exploratory objectives include assessing overall survival (OS) and progression-free survival (PFS); exploring immune-monitoring using available tissue biopsies and peripheral immune profiling; and assessing quality of life.

(Press release, AIM ImmunoTech, JUN 8, 2026, View Source [SID1234666479])

On June 8, 2026 Johnson & Johnson (NYSE: JNJ) reported it has entered into a definitive agreement to acquire Firefly Bio, Inc., a biotechnology company advancing its proprietary Firelink degrader antibody conjugate (DAC) platform, for $1 billion in cash. The Firelink DAC platform for KRAS-driven tumors bolsters Johnson & Johnson’s oncology pipeline and ambition to develop targeted medicines for the most prevalent and hard-to-treat solid tumors with high unmet need1.

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Antibody therapeutics have revolutionized the treatment of cancer through continuous innovations from monoclonal antibodies, to bi-and multi-specifics, antibody drug conjugates, and other antibody-based approaches. The Firelink DAC platform is a novel, innovative approach to overcome limitations of existing treatments by delivering a highly selective protein degrader to tumor cells, while avoiding healthy cells.

"KRAS has notoriously been considered an undruggable target and patients with KRAS-driven cancers continue to face limited treatment options with survival measured in months, not years," said John Reed, M.D., Ph.D., Executive Vice President, Innovative Medicine, Research & Development, Johnson & Johnson. "We believe the proprietary Firelink platform will overcome the limitations of current treatments and diversify our pipeline with preclinical candidates for treating multiple types of solid tumors."

Johnson & Johnson is at the forefront of oncology therapies
For more than three decades, Johnson & Johnson has advanced innovative therapies to address some of the most complex cancers and improve outcomes for patients worldwide. Firefly Bio Inc.’s capabilities in emerging modalities complement Johnson & Johnson’s existing expertise in antibody engineering and accelerates the Company’s pioneering of more effective, durable treatments.

About the agreement
Under the terms of the agreement, Johnson & Johnson will acquire Firefly Bio, Inc. for $1 billion in cash. The closing of the transaction is expected to occur later this year, subject to applicable regulatory approvals and other customary closing conditions. The accounting treatment will be communicated on or before the close of the transaction.

(Press release, Johnson & Johnson, JUN 8, 2026, View Source [SID1234666495])

On June 8, 2026 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported on a recent update regarding patient recruitment in the ongoing Phase 3 clinical trial of HLX22, developed by Shanghai Henlius Biotech, Inc.

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According to communication shared by Henlius, the first patients have now been dosed in all regions participating in the global Phase 3 study of HLX22, including China, Japan, Korea, Latin America, Australia, the United States and Europe.

HLX22 is an innovative anti-HER2 monoclonal antibody that has been granted orphan drug designation in both the U.S. and EU for gastric cancer and is being developed by Henlius under a license from AbClon, Inc., following a discovery collaboration which grants Alligator the right to participate in potential future revenues.

"The successful dosing of the first patients across all regions marks an important milestone, signaling the continued progress in the Phase 3 study with HLX22," said Søren Bregenholt, CEO of Alligator Bioscience. "The continued advancement also suggests sustained investigator interest in evaluating HLX22 as a potential treatment option for patients with gastric cancers."
Under the terms of Alligator’s agreement with AbClon, Alligator is entitled to 35% of AbClon’s revenue from its sublicense to Henlius, including potential milestone payments and royalty revenues, which, if HLX22 is successfully developed and approved, could represent a meaningful long-term revenue opportunity for Alligator.

(Press release, Alligator Bioscience, JUN 8, 2026, View Source [SID1234666480])

On June 8, 2026 AdvanCell, a clinical-stage radiopharmaceutical company developing innovative targeted alpha therapies for cancer, reported the appointment of Justyna Kelly as Chief Technology Officer (CTO) and François Gaudet as Chief Scientific Officer (CSO), expanding the company’s executive leadership team in the U.S. as it continues to scale its U.S. capabilities, and advance its growing pipeline of innovative targeted alpha therapies.

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Justyna Kelly will lead AdvanCell’s global technical operations strategy, including CMC, GMP production and clinical supply, the company’s global manufacturing network, supply chain, and preparation for commercial readiness. Her focus will include further developing U.S. manufacturing capabilities to support the next phase of development for ADVC001. Ms. Kelly brings 16 years of radiopharmaceutical manufacturing and operations experience, most recently serving as Vice President and Site Head of Eli Lilly and Company’s Indianapolis radioligand therapy manufacturing site. She previously served as Chief Operating Officer at POINT Biopharma prior to its acquisition by Lilly and has held leadership roles of increasing responsibility, including Chief Executive Officer, at the Centre for Probe Development and Commercialization. She holds an MSc in Biochemistry from McMaster University.

"AdvanCell has built a differentiated Lead-212 platform with the potential to meaningfully impact patients with cancer," said Justyna Kelly, CTO of AdvanCell. "I am excited to join the team and help execute a holistic strategy to scale our Lead-212 manufacturing infrastructure for Phase 3 and commercial readiness, while ensuring the quality, reliability, and operational excellence needed to deliver these therapies to patients."

François Gaudet has commenced the role of CSO and will lead AdvanCell’s discovery and preclinical efforts, with a focus on accelerating the progression of new innovative Lead-212 targeted alpha therapies into clinical development. An accomplished drug hunter, Dr. Gaudet brings 25 years of experience across pharmaceutical and biotechnology companies, including leadership roles of increasing responsibility at Novartis, Johnson & Johnson, and Mnemo Therapeutics where he served as Chief Scientific Officer. He has led research teams responsible for the discovery and development of innovative therapeutic assets through commercialization, including TECVAYLI and TALVEY. He conducted his graduate work in cancer epigenetics at the Massachusetts Institute of Technology and holds a PhD in Biology from Ludwig Maximilians Universität.

"AdvanCell has built an innovative platform of Lead-212 targeted alpha therapies based on its commitment to advance new treatment options for patients in oncology. Lead-212 alpha therapy is a nascent field and ADVC001 represents a validation of the modality," said François Gaudet, CSO at AdvanCell. "I’m excited to have joined the team to continue driving forward the pipeline development and help realize the full potential of the company’s differentiated approach."

Simon Puttick has transitioned from Chief Scientific Officer to the role of Chief Isotope Development Officer. Having played a key role in establishing AdvanCell’s targeted alpha therapy platform, Dr. Puttick, in his new role, will have a dedicated mandate to advance the company’s next-generation isotope production technologies, driving radioisotope process development from concept through to scalable manufacturing, strengthening supply chain security, and further positioning AdvanCell as a leader in this strategically critical capability, supporting the company’s platform expansion. Dr. Puttick will continue to be based at the company’s Australian headquarters in Brisbane.

"These leadership appointments strengthen AdvanCell’s ability to build a category-defining targeted alpha therapy company, accelerating our U.S. expansion and scaling our targeted alpha therapy platform globally," said Philina Lee, CEO of AdvanCell. "Justyna brings deep radiopharmaceutical manufacturing and operations expertise, François brings a proven track record of discovering and advancing innovative oncology therapeutics, and Simon’s dedicated focus on innovative methods for next-generation isotope production reinforces a core strategic advantage for AdvanCell: secure, scalable isotope supply and manufacturing."

TECVAYLI and TALVEY are registered trademarks of Johnson & Johnson or its affiliated companies.

About 212Pb-ADVC001

212Pb-ADVC001 (ADVC001) is a proprietary and patented PSMA-targeting radioligand with optimized physicochemical properties and labelled with Lead-212 (212Pb), an alpha-emitting payload (radionuclide) with a high dose rate, 10.6-hour half-life and simple decay scheme. ADVC001 is designed to deliver radiation at a cellular level to effectively kill prostate cancer cells while minimizing toxicity.

About the TheraPb trial

The TheraPb trial (NCT05720130) is a prospective, open-label Phase 1/2 dose escalation and expansion study evaluating ADVC001 in metastatic prostate cancer. The completed Phase 1b dose escalation assessed the safety and tolerability of escalating doses of ADVC001 administered every 6, 4, 2 or 1 week(s) (see press release). The Phase 2 expansion is assessing the efficacy and safety of ADVC001 at two dose levels. The trial utilizes a randomized dose-response design and dose optimization elements to evaluate ADVC001 in PSMA-positive mCRPC and in mHSPC.

(Press release, Advancell, JUN 8, 2026, View Source [SID1234666496])

On June 8, 2026 Amphista Therapeutics ("the Company" or "Amphista"), a leader in the discovery and development of next generation targeted protein degradation (TPD) medicines, reported that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for AMX-883, an orally available non-cereblon degrader of BRD9, for the treatment of acute myeloid leukaemia (AML). AMX-883 is expected to enter the clinic in H2 2026.

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IND clearance allows Amphista to start its Phase 1 monotherapy dose-escalation and optimisation clinical trial of AMX-883 in patients with relapsed or refractory AML and high-risk myelodysplastic syndrome (MDS), a related bone marrow disorder that often progresses to AML. After establishing the monotherapy profile, the Company intends to explore AMX-883 in combination with venetoclax and azacitidine in early lines of therapy, where treatment resistance continues to pose a major clinical challenge.

Louise Modis, Chief Executive Officer at Amphista, said: "FDA clearance of our IND for AMX-883, our lead Targeted Glue, for acute myeloid leukaemia is a significant milestone as we transition into a clinical-stage company. AMX-883 is the only BRD9 degrader currently being developed and the compelling preclinical findings submitted to the FDA support its potential as a first-line treatment option in the earlier disease setting in one of the most aggressive blood cancers. We look forward to commencing the clinical trial in H2 2026."

Patrick Kelly, Chief Medical Officer at Amphista, added: "AML remains one of the most devastating blood cancers, with a 5-year survival rate of just 33%, and resistance to standard-of-care treatments like venetoclax a critical challenge. FDA clearance of our IND for AMX-883 supports the advancement of a differentiated therapeutic approach, with the potential to establish an important new treatment pathway for patients in urgent need of innovative therapies."

(Press release, Amphista Therapeutics, JUN 8, 2026, View Source [SID1234666481])