On April 20, 2026 Verismo Therapeutics, a clinical-stage CAR T cell therapy company pioneering a novel multichain KIR-CAR platform technology, reported the first clinical results from its ongoing Phase 1 STAR-101 clinical trial (NCT05568680) evaluating SynKIR-110 KIR-CAR living medicine in patients with advanced mesothelin-expressing solid tumors, including ovarian cancer, mesothelioma, and cholangiocarcinoma. These late-breaking data were presented during the Clinical Trial Plenary session 3 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026 in San Diego, CA (Abstract CT 104).

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"We are excited to share Verismo’s first presentation of clinical data evaluating our multi-chain SynKIR-110 KIR-CAR candidate, showing a positive safety profile, dose-dependent efficacy signals, and no dose-limiting toxicities," said Laura Johnson, Ph.D., Chief Operating Officer and Chief Scientific Officer of Verismo Therapeutics. "These data represent an important milestone for Verismo’s KIR-CAR platform, which is designed to combine the best of natural killer and T cells to fight cancer and may provide a more durable response than current single-chain CAR T therapies that are prone to exhaustion in difficult-to-treat solid tumor microenvironments."

Janos L. Tanyi, M.D., Ph.D., Principal Investigator for STAR-101 and Professor at the Perelman School of Medicine at the University of Pennsylvania (Penn), presented the data from nine patients treated across three dose-escalation cohorts. SynKIR-110 in dose level cohorts 1 through 3 showed a favorable safety profile, with no dose-limiting toxicities, no high-grade (Gr3+) cytokine release syndrome (CRS), and no immune effector cell-associated neurotoxicity syndrome (ICANS) events observed.

The initial data showed on-target biologic activity based on KIR-CAR T cell expansion and persistence in patients and serum cytokine changes after SynKIR-110 infusion. Anti-tumor activity was observed at increased dose levels, with 1 of 3 patients at dose level 3 achieving a partial response per RECIST criteria that was ongoing after 3+ months at the interim data cut-off for this dataset, which was September 2025. The trial remains ongoing, with continued enrollment to evaluate safety and determine the recommended Phase 2 dose.

"These data are significant because patients with mesothelin-expressing solid tumors continue to face significant and urgent needs for better treatments," said Dr. Tanyi, who is an associate professor of Obstetrics and Gynecology at Penn. "The safety profile we have observed, including low grade (Gr 1-2) CRS in only 3 of 9 patients, and no neurotoxicity, combined with early signs of clinical activity, support continued investigation of this novel approach in patients with solid tumors."

About SynKIR-110 KIR-CAR and the STAR-101 Clinical Trial

SynKIR-110 KIR-CAR is an investigational autologous engineered cell therapy developed using Verismo’s KIR-CAR platform. This approach utilizes a multi-chain, split-signaling architecture derived from natural killer cells, designed to drive long-term anti-tumor T cell function without T cell exhaustion. By keeping antigen recognition separate from T cell activation, the multi-chain architecture is intended to sustain T cell activity even in challenging solid-tumor microenvironments.

The STAR-101 clinical trial is a first-in-human, multicenter, open-label Phase 1 study in the U.S., designed to evaluate the safety, feasibility, and preliminary efficacy of SynKIR-110 in patients with advanced mesothelin-expressing solid tumors, including ovarian cancer, mesothelioma, and cholangiocarcinoma. These target indications are associated with poor prognosis and remain areas of high unmet medical need. The STAR-101 trial follows a dose-escalation design with an expansion cohort at the recommended Phase 2 dose. Patient recruitment and dose escalation in the trial is ongoing.

(Press release, Verismo Therapeutics, APR 20, 2026, View Source [SID1234664570])

On April 20, 2026 Independent biopharmaceutical company Specialised Therapeutics (ST) reported the approval of ZEPZELCA (lurbinectedin), in combination with atezolizumab (Tecentriq), as a new first-line maintenance treatment option for adult patients in Australia and Singapore, who have been diagnosed with extensive-stage small cell lung cancer (ES-SCLC), an aggressive form of lung cancer.[1],[2] This follows the recent decision by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) to issue a positive opinion recommending the approval of ZEPZELCA in Europe.[10]

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In combination with atezolizumab, ZEPZELCA has been approved for use in Australia and Singapore as a maintenance treatment for extensive-stage small cell lung cancer (ES-SCLC) in adult patients whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide.[1],[2]

Both approvals for ZEPZELCA in ES-SCLC were obtained under Project Orbis — an initiative of the United States Food and Drug Administration’s (US FDA’s) Oncology Center of Excellence. These ZEPZELCA approvals represent the eighth time ST has successfully navigated the Project Orbis process since 2021.

Lung cancer remains a significant health challenge in the region, with an estimated 15,000 diagnoses and 9,000 deaths from the disease each year in Australia.[7],[8] In Singapore, lung cancer is the third most common cancer, with 9,732 new cases diagnosed between 2019-2023.[11] Small cell lung cancer (SCLC) is a highly aggressive cancer that has often already spread to other organs when first diagnosed.[6] It accounts for approximately 10-15% of all lung cancer cases and has a low 5-year survival rate of under 7%.[6]

Professor Nick Pavlakis, Medical Oncologist from Royal North Shore Hospital in Sydney, acknowledged the approval of the new combination therapy as an important step in helping to improve outcomes for patients with ES-SCLC.

"Most patients with small cell lung cancer typically present with extensive-stage disease at diagnosis, meaning they are often faced with experiencing high rates of relapse or recurrence, limited treatment options and a poor prognosis," said Professor Pavlakis.

"While outcomes for patients have improved over the past five years with the addition of immunotherapy to chemotherapy, there continues to be a significant clinical need to improve on first-line therapies used to treat extensive-stage small cell lung cancer to prolong disease control and enhance survival. Today’s announcement is welcome news for the medical and patient community."

ZEPZELCA is being made available in Australia, New Zealand, Singapore, Malaysia, Thailand and Vietnam by Specialised Therapeutics (ST), under exclusive license from European biopharmaceutical company PharmaMar, which has pioneered the development of marine-based oncology medicines.

ST Chief Executive Officer, Mr Carlo Montagner, said the approval of ZEPZELCA for ES-SCLC in the first-line setting would provide clinicians and patients with an important new therapeutic option for this difficult to treat cancer.

"We are delighted to have secured regulatory approvals for ZEPZELCA in combination with atezolizumab as a first-line maintenance therapy for adults diagnosed with ES-SCLC in Australia and Singapore," said Mr Montagner.

"Despite the improved efficacy of first-line therapies for ES-SCLC that have been available since 2019, survival outcomes remain suboptimal, with an estimated 40% of patients experiencing a relapse and requiring second-line treatment. The availability of additional first-line treatment options will enable eligible patients and their clinicians to find the therapy that is right for them, can help to improve their quality of life and importantly, give them more time to spend with their families and loved ones."

Chief Medical Officer for PharmaMar, Javier Jimenez, welcomed the regulatory approval for ZEPZELCA, saying: "We are very pleased that patients in Australia and Singapore can have access to this new therapy, as it marks an important milestone in the management of this disease, where a significant unmet medical need persists. Building on more than 40 years of commitment to research in diseases with limited treatment options, we will continue to collaborate with our partner in Australia to enable timely and equitable access to this new treatment."

ZEPZELCA belongs to a class of medicines known as alkylating agents, which work by damaging the DNA of cancer cells, helping to slow or stop their growth.[12] The regulatory approvals for ES-SCLC in Australia and Singapore were based on results from the Phase 3 IMforte clinical trial. The study enrolled 660 treatment-naïve patients with ES-SCLC across 13 countries in the induction phase. Following this, 483 patients who responded to induction treatment were randomised to receive either ZEPZELCA with atezolizumab (LU-AT) or atezolizumab monotherapy (AT) as first-line maintenance therapy.[13] The trial results supported the use of LU-AT as a new first-line maintenance treatment option over AT alone in patients with this aggressive cancer, with improvements recorded in both median progression free survival (PFS; 5.4 months vs. 2.1 months) and median overall survival (OS; 13.2 months vs.10.6 months).[13]

Significant variations in treatment-related adverse events (AEs) were noted in the two trial groups (83.5% in patients receiving LU-AT vs. 40% among patients receiving AT monotherapy).[13] Treatment with LU-AT was considered to be generally well tolerated, with no new or unexpected safety signals.[13] The most common adverse reactions (≥ 30%), including laboratory abnormalities, in patients who received ZEPZELCA with atezolizumab were decreased lymphocytes, decreased platelets, decreased haemoglobin, decreased leukocytes, decreased neutrophils, nausea, and fatigue/asthenia.

For further details on ZEPZELCA, contact your healthcare professional and refer to the approved Australian Consumer Medicine Information, available from the TGA’s website.*

PBS Information: ZEPZELCA is not listed on the Pharmaceutical Benefits Scheme (PBS).

(Press release, Specialised Therapeutics Australia, APR 20, 2026, View Source [SID1234664569])

On April 20, 2026 AlphaGen Therapeutics (AlphaGen), a biopharmaceutical company that focuses on developing next-generation targeted alpha radiotherapies, reported that it will present preclinical data on two advanced radiopharmaceutical programs at the 2026 Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), is being held in San Diego, California, from April 17–22.

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[212Pb]Pb-AG1002 is a next-generation non-agonist SSTR2-targeting alpha radiopharmaceutical. In preclinical studies, the compound demonstrated high binding affinity and a superior tumor-to-kidney (T/K) ratio compared to agonist radioligands. It showed robust tumor growth inhibition and survival benefit across multiple models with a very favorable safety profile.

[212Pb]Pb-AG1206 is a novel FAP-targeted alpha radioligand based on a macrocyclic peptide scaffold with picomolar binding affinity. The compound has rapid tumor accumulation and renal clearance, giving rise to high T/K ratio. It showed strong anti-tumor activity in multiple preclinical tumor models. Consistent with preclinical observations, patient imaging IIT showed strong tumor uptake and clean tissue background.

"We have developed a robust pipeline of novel and differentiated targeted alpha radiotherapies. We are pleased to showcase our exciting progress in two such programs at AACR (Free AACR Whitepaper) Annual Meeting 2026." said Dr. Mai-Jing Liao, CEO of AlphaGen Therapeutics. "The data to be presented underscore our commitment to advancing next-generation targeted alpha therapies and delivering significant improvements for patients with difficult-to-treat tumors."

[212Pb]Pb-AG1002，SSTR2-targeted alpha therapy

Title: Preclinical evaluation of [212Pb]Pb-AG1002, a next generation SSTR2-targeting, non-agonist radiopharmaceutical

Poster Link: Abstract 5811: Preclinical evaluation of [212Pb]Pb-AG1002, a next generation SSTR2-targeting, non-agonist radiopharmaceutical | Cancer Research | American Association for Cancer Research (AACR) (Free AACR Whitepaper)

Session: Radiopharmaceutical Platforms for Theranostic Precision Oncology

Category: Experimental and Molecular Therapeutics

Date/Time: Tuesday, April 21, 2026, 2:00 PM – 5:00 PM PDT

Poster #: 5811

[212Pb]Pb-AG1206，FAP-targeted alpha therapy

Title: [212Pb]Pb-AG1206, A novel fibroblast activation protein-targeted radioligand therapy demonstrated excellent efficacy and safety profile

Poster Link: Abstract 5810: [212Pb]Pb-AG1206, A novel fibroblast activation protein-targeted radioligand therapy demonstrated excellent efficacy and safety profile | Cancer Research | American Association for Cancer Research (AACR) (Free AACR Whitepaper)

Session: Radiopharmaceutical Platforms for Theranostic Precision Oncology

Category: Experimental and Molecular Therapeutics

Date/Time: Tuesday, April 21, 2026, 2:00 PM – 5:00 PM PDT

Poster #: 5810

(Press release, AlphaGen Therapeutics, APR 20, 2026, View Source [SID1234664568])

On April 20, 2026 Bracco Imaging reported a strategic alliance with NYU Langone Health to advance innovation in medical imaging through the signing of a multi-year Master Research Agreement (MRA). By combining resources, scientific capabilities and complementary expertise, the collaboration aims to accelerate the development and optimization of advanced imaging technologies, enhancing clinical insights and contributing to improved patient management.

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The partnership will focus on key areas of diagnostic imaging, including Magnetic Resonance Imaging (MRI), Photon-Counting Computed Tomography (PCCT), targeted ultrasound, and artificial intelligence-enabled PET/CT and MRI image analysis. Through this collaboration, both parties aim to further support the advancement of precision medicine and enable more informed and timelier clinical decision-making. The agreement is designed to foster closer interaction between research and clinical practice, facilitating the translation of scientific discoveries into real-world healthcare applications. Joint research activities will leverage NYU Langone Health’s clinical and academic excellence alongside Bracco’s longstanding expertise in contrast imaging and diagnostic solutions.

"The agreement reflects a shared commitment between the Bracco Group and NYU Langone Health to advance research and clinical innovation in medical imaging," said Fulvio Renoldi Bracco, Vice Chairman and CEO of Bracco Imaging. "NYU Langone Health is among the world’s most respected leaders in radiology, with a proven history in translational research and an exceptional ability to combine clinical practice, advanced technologies, and academic expertise. By combining our respective strengths, we aim to further enhance diagnostic performance, streamline clinical workflows and ultimately generate meaningful impact for patients and healthcare systems."

"Diagnostic imaging is advancing at a remarkable pace, and strategic collaborations are essential to progress," said Michael P. Recht, M.D., the Louis Marx Professor of Radiology and chair of the Department of Radiology at NYU Grossman School of Medicine. "We are excited to build on NYU Langone Health’s legacy of advances and to work with the Bracco Group toward breakthroughs in modalities central to precision medicine in terms of superior diagnostic accuracy and enhanced clinical decision-making."

(Press release, Bracco, APR 20, 2026, View Source [SID1234664567])

On April 20, 2026 Fapon Biopharma, a clinical-stage biotech company innovating therapeutic antibodies and fusion proteins, reported its participation in the AACR (Free AACR Whitepaper) Annual Meeting 2026, taking place April 19–22, 2026 in San Diego, California. At the meeting, the company is exhibiting at Booth No.3856 and presenting four scientific abstracts in the poster session, highlighting its scientific platform capabilities and pipeline progress.

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At AACR (Free AACR Whitepaper) 2026, Fapon Biopharma spotlights its two core technology platforms: IL-10 biased functional engineering and antibody fusion, and VHH human-monkey cross-binding T-cell engagers. These capabilities reflect the company’s focus on developing next-generation therapeutic approaches designed to deliver differentiated efficacy, improved translational potential, and broader applicability across immuno-oncology and aotoimmune diseases.

The company’s IL-10 biased functional engineering and antibody fusion platform underpins a series of novel cytokine-based fusion proteins intended to unlock more precise immune modulation. Among the most advanced programs is FP008, a global first-in-class PD1 x IL10M fusion protein and potential next-generation backbone for cancer immunotherapy, with Phase I readout anticipated in 2026. Fapon Biopharma is also advancing FP012, a global first-in-class TL1A x IL10MM fusion protein for inflammatory bowel disease and other inflammatory indications, with IND-enabling CMC/GLP toxicology planned in 2026.

Complementing this platform is Fapon Biopharma’s proprietary VHH human-monkey cross-binding T-cell engager platform, an innovative approach designed to overcome developability and flexibility challenges associated with traditional multi-specific antibodies. This technology is represented in the company’s expanding CD3/TCR VHHs, including FPE024, a potential best-in-class CD19xBCMAxCD3 tri-specific T-cell engager for autoimmune indications, and FPE021, a potential best-in-class CDH17-targeting T-cell engager with a second signal for gastrointestinal tract cancers. Both programs are expected to enter IND-enabling CMC/GLP toxicology in 2026.

Attendees are invited to visit Booth #3856 and attend Fapon Biopharma’s abstracts to learn more about the company’s technology platforms, research strategy, and pipeline programs. Fapon Biopharma is seeking strategic partners for co-development and licensing. For partnership inquiries, please contact us at [email protected] (USA, Europe and other regions) or [email protected] (Asia-Pacific)

Abstract #5582:
Tri-specific T-cell engager with second signal boosts solid tumor response efficacy, durability and safety
Tue, Apr 21, Section 8, Board 1, 2:00pm – 5:00pm

Abstract #5586:
A next-generation CD8-selective tri-specific T-cell engager targeting CDH17 with enhanced efficacy and reduced toxicity
Tue, Apr 21, Section 8, Board 5, 2:00pm – 5:00pm

Abstract #1637:
Human-cynomolgus cross-reactive CD3 nanobody-centric T-cell engager platform enhances clinical translation
Mon, Apr 20, Section 10, Board 29, 9:00am – 12:00pm

Abstract #5593:
A CD19/BCMA dual-targeting VHH format T-cell engager with novel CD3 binder for enhanced potency and safety profile
Tue, Apr 21, Section 8, Board 12, 2:00pm – 5:00pm

(Press release, Fapon Biopharma, APR 20, 2026, View Source [SID1234664566])