AdvanCell Strengthens Executive Leadership to Accelerate U.S. Expansion and Scale its Global Targeted Alpha Therapy Platform

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])

Johnson & Johnson to Acquire Firefly Bio, Inc. to Expand Oncology Pipeline with Novel Degrader Antibody Conjugate Platform

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])

BostonGene to Present High-Impact AI Models and Biomarker-Driven Frameworks at EHA2026 Congress

On June 8, 2026 BostonGene, developer of the leading AI model for tumor and immune biology, reported that six abstracts have been accepted for presentation at European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress, taking place June 11 – 14 in Stockholm, Sweden. As Europe’s premier congress for hematology, the annual EHA (Free EHA Whitepaper) meeting brings together world-leading clinicians and researchers to share medical breakthroughs in the diagnosis, treatment, and clinical management of blood disorders.

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The presentations showcase how BostonGene’s platforms integrate clinical, genomic, and immune data to uncover critical disease mechanisms. Conducted in collaboration with leading institutions, including Memorial Sloan Kettering Cancer Center, Weill Cornell Medicine, the University of Miami, and UT MD Anderson, this research demonstrates how integrated multiomics, predictive modeling, and high-dimensional blood immune system profiling can define resistance phenotypes to CAR-T therapies, identify unique immune states, and uncover deep remission pathways. These findings deliver actionable data that enable smarter patient selection, optimize frontline treatment decision-making, and enhance clinical trial design for blood cancers.

Details about the abstracts selected for presentation can be found below:

Oral presentation
Abstract: S283
Title: Integrated Multi-Omic Profiling Identifies Genomic Subtypes Associated with Differential Outcomes after CAR-T Therapy in Large B-Cell Lymphoma
Date & time: Saturday, June 13 | 18:00 – 18:15 CEST
Speaker: Silvia Escribano Serrat, MD, Memorial Sloan Kettering Cancer Center

Researchers at Memorial Sloan Kettering Cancer Center leveraged BostonGene’s multimodal computational pipeline, integrating molecular classifiers with gene signatures, to characterize mechanisms of CAR-T resistance in large B-cell lymphoma. Using the BostonGene Lymphly classifier, the BN2 subtype emerged as a high-risk group associated with significantly inferior survival and reduced response rates. Compared with existing frameworks, Lymphly provided improved stratification and clearer discrimination of outcome-relevant subgroups, underscoring the value of integrated molecular profiling for refining risk assessment following CAR-T.

Research conducted in collaboration with Memorial Sloan Kettering Cancer Center

Poster presentations

Abstract: PS2188
Title: Overlaying TP53 Loss and Aneuploidy with Distinct Diffuse Large B-Cell Lymphoma Subtypes Refines Tumor Classification and Enhances Risk Stratification
Date & time: Saturday, June 13 | 18:45 – 19:45 CEST
Speaker: Pavel Zemskiy, MS, BostonGene

BostonGene integrated two dimensions of genomic instability, TP53 loss‑of‑function alterations and quantitative aneuploidy, into Lymphly, a classification framework for diffuse large B‑cell lymphoma. This approach explicitly separates TP53 loss from aneuploidy, clarifying their independent and combined effects on tumor biology. By defining these mechanisms, the framework enables drug developers to anticipate and bypass resistance pathways, identify biomarker‑driven patient groups, and design trials aligned with genomic instability profiles.

Research conducted in collaboration with Center for Cancer Research

Abstract: PS1829
Title: Risk-Stratified Patient Selection in Multiple Myeloma for Frontline Treatment Decision-Making Based on a Transcriptomic Classifier
Date & time: Saturday, June 13 | 18:45 – 19:45 CEST
Speaker: Evgenia Alekseeva, PhD, BostonGene

BostonGene developed a transcriptomic-based risk stratification model to identify newly diagnosed multiple myeloma patients who may benefit from risk-adapted frontline treatment strategies, including aggressive regimens with bispecific T-cell engager (BiTE) and CAR T-cell therapies. This model outperformed conventional tools by isolating high-, intermediate-, and low-risk groups, while exposing high-risk cases with established resistance to proteasome inhibitors. Together, these findings define a biologically distinct high-risk state that may help prioritize patients for novel, more intensive treatment approaches earlier in the disease course.

Abstract: PS1854
Title: Peripheral Blood Immunoprofiling Defines Three Distinct Immune States Associated with Clinical and Molecular Axes in Multiple Myeloma
Date & time: Saturday, June 13 | 18:45 – 19:45 CEST
Speaker: Anastasia Radko, MS, BostonGene

BostonGene applied high‑dimensional flow cytometry to characterize peripheral blood immune architecture in multiple myeloma. Three coordinated immune states emerged, each aligned with cytogenetic risk, therapy exposure, and disease subtype. By defining these mechanisms, spanning T‑cell differentiation, checkpoint enrichment, and monocyte expansion, the framework enables drug developers to anticipate resistance, identify biomarker‑driven patient groups, and design trials that integrate circulating immune states into active therapeutic strategies.

Research conducted in collaboration with University of Miami

Abstract: PS2344
Title: Tazemetostat-Mediated Immune Remodeling in B-Cell Lymphomas Receiving CAR-T
Date & time: Saturday, June 13 | 18:45 – 19:45 CEST
Speaker: Samuel Yamshom, MD, Weill Cornell Medicine

BostonGene applied its multimodal molecular profiling platform to characterize the systemic immune remodeling driven by tazemetostat priming in patients with B-cell lymphomas receiving CART therapy. By integrating high-parameter flow cytometry, RNA sequencing, immune cell deconvolution, and functional gene signature analysis, BostonGene’s analysis revealed systemic immune remodeling associated with enhanced antigen presentation, T-cell activation, and reduced immunosuppressive signaling, validating the use of EZH2 inhibition for improved CART efficacy and durability.

Research conducted in collaboration with Weill Cornell Medicine

Abstract: PS1673
Title: Integrated Transcriptomic and Immune Profiling Identifies Determinants of Deep Remission with Ibrutinib–Venetoclax in Chronic Lymphocytic Leukemia
Date & time: Saturday, June 13 | 18:45 – 19:45 CEST
Speaker: Varsha Gandhi, PhD, UT MD Anderson

Leveraging BostonGene’s blood immunoprofiling platform and KassandraTM cell deconvolution, researchers at UT MD Anderson investigated the impact of ibrutinib–venetoclax combination therapy in patients with chronic lymphocytic leukemia. The findings revealed immune cell populations and gene expression patterns consistent with a common treatment resistance mechanism among patients who did not achieve remission. This study highlights BostonGene’s ability to harmonize clinical, genomic, transcriptomic, and immune data for reliable insights that drive smarter patient selection and optimized treatment decisions.

(Press release, BostonGene, JUN 8, 2026, View Source [SID1234666494])

Zai Lab Receives China NMPA Approval of TIVDAK® (tisotumab vedotin for injection) for the Treatment of Adult Patients with Recurrent or Metastatic Cervical Cancer

On June 8, 2026 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported that China’s National Medical Products Administration (NMPA) has approved the Biologics License Application (BLA) for TIVDAK (tisotumab vedotin for injection) for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. This approval is based on results from the global, randomized, Phase 3 innovaTV 301 clinical trial, which met its primary endpoint, demonstrating overall survival (OS) benefit in adult patients with previously treated recurrent or metastatic cervical cancer treated with TIVDAK compared to chemotherapy, including in an exploratory subpopulation of patients in China.

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The NMPA approval follows regulatory approvals in the United States, Japan, European Union, United Kingdom, Macau (China), and Hong Kong (China), underscoring the broad global clinical evidence supporting TIVDAK availability in China. The indication statement for TIVDAK differs slightly by region.

"Cervical cancer remains one of the leading causes of cancer death in women in China. Antibody-drug conjugates have proven to be novel and effective treatments for many types of cancer, and we are pleased to bring this innovative therapeutic class to patients in China with cervical cancer," said Rafael G. Amado, M.D., President and Head of Global Research and Development at Zai Lab. "Coupled with the previous global approvals of TIVDAK for this disease, the China BLA approval further validates the robust global evidence of clinical benefit for this population of advanced patients with limited therapeutic options."

Results from the Phase 3 innovaTV 301 clinical trial, including data from the China subpopulation of this study that Zai Lab conducted, supported global approval of TIVDAK:

In the global study, the trial met its primary endpoint of OS in the intention-to-treat (ITT) population of the global study (HR=0.70; 95% CI: 0.54–0.89; two-sided p=0.0038). The China subpopulation showed consistent results, with a clinically meaningful improvement in OS (HR: 0.55, 95% CI: 0.27- 1.15), corresponding to a 45% reduction in the risk of death compared to chemotherapy.1
54.1% of the China subpopulation received prior anti-PD(L)1 therapy, the current standard of care for second-line treatment of cervical cancer. TIVDAK showed consistent OS benefit trends irrespective of prior immunotherapy exposure.2
There were no new safety signals identified among patients in the China subpopulation who received TIVDAK. The most common Grade ≥3 treatment-emergent adverse events (TEAEs) in the global study were anemia (8.4%), urinary tract infection (4.4%), and abdominal pain (4.0%).1 The most common Grade ≥3 TEAEs in the China subpopulation were anemia (11.4%), cough (5.7%), and malaise (5.7%).2
"Treatment options are very limited for cervical cancer patients once recurrence or metastasis occurs," said Dr. Lingying Wu, Ph.D., China Leading Principal Investigator of the innovaTV 301 Study and Professor of the Department of Gynecologic Oncology of National Cancer Center / Cancer Hospital Chinese Academy of Medical Sciences. "Consistent with findings from the global innovaTV 301 trial, the China subpopulation data demonstrate that TIVDAK offers significant clinical benefits to these patients, irrespective of prior PD-(L)1 inhibitor therapy."

Zai Lab will leverage the company’s extensive experience and expanding presence in the Chinese gynecologic oncology community, as well as commercial synergies with its ZEJULA team, to bring TIVDAK to patients in China.

About Cervical Cancer in China

An estimated 150,000 new cases of cervical cancer occur annually in China3. Current treatment options are limited for patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy. TIVDAK is well positioned to provide a new option for previously treated advanced cervical cancer patients.

About Tisotumab Vedotin

Tisotumab vedotin (approved under the brand name TIVDAK in the EU, U.K., U.S. and Japan) is an antibody-drug conjugate (ADC) composed of Genmab’s human monoclonal antibody directed to tissue factor (TF) and Pfizer’s ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody. Nonclinical data suggest that the anticancer activity of tisotumab vedotin is due to the binding of the ADC to TF-expressing cancer cells, followed by internalization of the ADC-TF complex and release of MMAE via proteolytic cleavage. MMAE disrupts the microtubule network of actively dividing cells, leading to cell cycle arrest and apoptotic cell death. In vitro, tisotumab vedotin also mediates antibody-dependent cellular phagocytosis and antibody-dependent cellular cytotoxicity.

TIVDAK received full approval from the U.S. Food and Drug Administration in April 2024, and U.S. approval was first secured in September 2021 under the accelerated approval pathway for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Approval has also been received in Japan, European Union, Macau (China), and Hong Kong (China) for the same indication.

Zai Lab has an exclusive license from Seagen Inc., a company later acquired by Pfizer, for TIVDAK in Greater China (mainland China, Hong Kong, Macau, and Taiwan, collectively). Zai Lab is solely responsible for the development, supply, and commercialization of TIVDAK in Greater China.

(Press release, Zai Laboratory, JUN 8, 2026, View Source [SID1234666493])

Compugen to Participate in Jones Trading Fireside Chat Series with Leaders in AI/ML-based Drug Development

On June 8, 2026 Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery powered by AI/ML, reported that management will participate in Jones Trading’s Mapping the Path from Target to Patient: Fireside Chat Series with Leaders in AI/ ML-based Drug Development on Monday, June 15, 2026, from 10:30-11:00 AM ET.

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A live webcast will be accessible on the Investor Relations section of the Compugen website at www.cgen.com. A replay will also be available following the live event.

(Press release, Compugen, JUN 8, 2026, View Source [SID1234666492])