On April 27, 2026 Dispatch Bio, a biotech company engineering a universal treatment across solid tumors leveraging its first-in-class Flare platform, reported the presentation of new preclinical data supporting its SEND (Synthetic Efficacy eNableD) T cell armoring strategy at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 2026 Annual Meeting, taking place May 11–15, 2026, in Boston. The data will be presented in a poster entitled, "SEND – A T cell armoring strategy that incorporates simultaneous signaling through multiple pathways for optimized safety and efficacy via novel cell state," during a poster session on Thursday, May 14, from 5:00–6:30 p.m.

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SEND is a novel T cell armoring strategy designed to overcome the limitations of supportive cytokine signals in the tumor microenvironment by utilizing a synthetic cytokine receptor to simultaneously activate multiple pathways required for optimal T cell function. Preclinical data show that SEND outperforms current benchmarks for armored T cell performance in high bar solid tumor models and has the potential to optimize safety and efficacy profiles of a multitude of immunotherapy treatments.

"Engineering T cells with a single cytokine signal often forces a tradeoff between proliferation, persistence, and effector function in engineered T cells," said Lex Johnson, Ph.D., Co-Founder and Chief Platform Officer. "SEND is designed to eliminate those compromises by coordinating multiple signaling pathways within the same cell, resulting in a fundamentally new T cell state with the potential for best-in-class performance. We look forward to sharing our findings at the upcoming ASGCT (Free ASGCT Whitepaper) conference."

"Based on these data, we believe SEND could have broad applicability across engineered T cell approaches, including autologous CAR T therapies, in vivo CAR T approaches, and TCR-based therapies, amongst others," said Barbra Sasu, Ph.D., Chief Scientific Officer. "We are advancing SEND as a foundational T cell armoring strategy, as we continue to work toward a world in which all people with cancer can be cured."

SEND-armored CAR T cells demonstrated robust anti-tumor activity in vivo, achieving tumor clearance at low doses, while remaining well tolerated at all doses tested with a 200X+ therapeutic window. Moreover, this activity was observed with or without lymphodepleting chemotherapy, which has the potential to significantly improve patient treatment options in the clinic. Single-cell RNA sequencing of tumor-infiltrating CAR T cells armored with SEND revealed, for the first time in published literature, simultaneous enrichment of effector and memory gene programs within the same cell, demonstrating robust expansion without exhaustion and contraction following tumor clearance, supporting controlled, antigen-dependent activity and a favorable safety profile.

(Press release, Dispatch Bio, APR 27, 2026, View Source [SID1234664818])

On April 27, 2026 Taiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd., and Araris Biotech AG ("Araris") reported that the U.S. Food and Drug Administration (FDA) has completed its Investigational New Drug (IND) review period for ARC-02, an antibody-drug conjugate (ADC) being developed for the treatment of non-Hodgkin lymphoma, enabling Taiho Oncology to initiate a Phase 1 dose-escalation clinical trial of ARC-02.

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Taiho Pharmaceutical acquired Araris Biotech in March 2025, expanding Taiho group’s capabilities in biologics and ADC research and development. Araris is a spin-off of the Paul Scherrer Institute and ETH in Switzerland focused on the development of antibody-drug conjugates (ADCs). Central to Araris’ approach is its proprietary AraLinQ ADC technology, which enables the creation of stable and site-specific ADCs using standard antibodies with scalable manufacturing processes. ARC-02 is a CD79b-protein-targeting ADC based on Araris’ proprietary AraLinQTM technology using monomethyl auristatin E (MMAE) as payload, designed for selective targeting and killing of B-cell malignancies.

The trial represents the first clinical trial of a product candidate developed using the AraLinQ ADC technology and marks Taiho’s expansion into the clinical development of ADCs for oncology.

"Advancing our first ADC into the clinic represents an important milestone for our pipeline and reflects the continued expansion of Taiho group’s oncology development capabilities," said Fabio Benedetti, MD, Global Chief Medical Officer, Taiho Pharmaceutical. "This initial clinical study will allow us to evaluate ARC-02 in patients and generate data to inform both the continued development of ARC-02 and our ADC platform. We look forward to advancing this program as part of our broader efforts to deliver innovative therapies to people living with cancer."

About AraLinQ

AraLinQTM is Araris’ ADC technology, which enables site-specific payload attachment to a privileged attachment site on a specific amino acid residue (Q295) within the native antibody Fc framework. Preclinical data demonstrate that when a payload is attached to this site using Araris’ proprietary linkers, the antibody maintains nearly identical performance (e.g. pharmacokinetics and effector functions) to the unconjugated, original antibody. Furthermore, the linker-payload is connected to the antibody through a very strong isopeptide bond resulting in exceptional stability. Once entering a cancer cell via antibody-mediated internalization, the linker can be easily broken to release the payload. All three of these properties are key factors to enable efficient payload delivery and maximize ADC efficacy. AraLinQTM linkers are hydrophilic, rendering them soluble and avoiding their clumping in water-based solutions like blood. In addition, this linker can have unique branching structures that make it possible to create ADCs that carry multiple payloads of different types. AraLinQ allows for the generation of ADCs in one step using "off-the-shelf," antibodies that are native or engineered. The process is fast, cost-efficient and can be easily upscaled without the need for custom antibody synthesis.

(Press release, Taiho, APR 27, 2026, View Source [SID1234664817])

On April 27, 2026 Strand Therapeutics, a clinical-stage biotechnology company pioneering programmable mRNA medicines, reported it will present preclinical data from its in vivo CAR-T program at the 2026 American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting, taking place May 11-15 in Boston.

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Ashlesha Odak, PhD, Principal Scientist of Advanced Cell Engineering, will present findings addressing a central challenge in the field: generating CAR-T cells directly in the body without ex vivo cell engineering. The data demonstrate that Strand’s programmable EverScript circular RNA (circRNA), combined with a targeted lipid nanoparticle (LNP) delivery approach, can generate functional CAR-T cells in vivo following intravenous administration, achieving robust target cell elimination across humanized mouse models and non-human primates.

Strand Signal Stack technology integrates an optimized EverScript circRNA backbone, enhanced CAR architecture, and a targeted LNP delivery approach capable of reaching T cells systemically without the manufacturing complexity of conventional ex vivo CAR-T approaches. The broader Strand Signal Stack technology also includes SignalLock, Strand’s proprietary microRNA (miRNA)-responsive regulatory sequences designed to modulate CAR protein expression in off-target cell types, thereby building safety controls directly into the construct while minimizing unintended immune activation and helping to support repeat dosing.

Together, these advances establish a programmable circRNA platform with the potential to enable scalable in vivo CAR-T therapies across cancer, autoimmune diseases, and beyond.

"Generating functional CAR-T cells inside the body has been a long-standing goal for the field, and the data show we can do it with delivery precision and programmable safety controls it requires," said Jake Becraft, PhD, Co-founder and Chief Executive Officer of Strand Therapeutics. "In vivo CAR-T is a natural extension of what we have been building, and the NHP data is exactly the kind of validation that moves this program forward."

"These results reflect years of work optimizing every layer of this platform, from the circRNA backbone and CAR architecture to the microRNA targeting system and built-in safety controls," said Tasuku Kitada, PhD, MBA, Co-founder, President, and Head of R&D of Strand Therapeutics. "What excites us is the breadth of what this unlocks. The same programmable architecture driving CAR-T activity in oncology has clear implications for autoimmune disease and beyond, and this data moves us meaningfully closer to both."

Abstract Title: Programmable circRNA-tLNP platform enables efficient in vivo CAR-T cell programming and robust activity in a NHP model
Session Type: Oral
Session Name: LNPs for in vivo CAR-T applications
Date and Time: Tuesday, May 12, 2026, at 9:00-9:15 am ET
Location: MCEC Room 210 ABC (Level 2)

Full abstract details are available on the ASGCT (Free ASGCT Whitepaper) Annual Meeting website.

(Press release, Strand Therapeutics, APR 27, 2026, View Source [SID1234664816])

On April 27, 2026 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the U.S. Food and Drug Administration (FDA) accepted for filing with Priority Review the supplemental Biologics License Application (sBLA) for Ziihera (zanidatamab-hrii) containing combinations for the first-line treatment of adult patients with HER2-positive (HER2+) unresectable locally advanced or metastatic gastric, gastroesophageal junction (GEJ), or gastroesophageal adenocarcinoma (GEA). The FDA has set a PDUFA target action date of August 25, 2026.

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The sBLA is supported by data from the pivotal HERIZON-GEA-01 trial to investigate the efficacy and safety of zanidatamab in combination with standard-of-care chemotherapy with or without the PD-1 inhibitor Tevimbra (tislelizumab) in patients with advanced or metastatic GEA, including gastric, GEJ and esophageal adenocarcinomas. The submission is under review via the Real-Time Oncology Review (RTOR) program, an initiative of FDA’s Oncology Center of Excellence designed to provide a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible.

"The HERIZON-GEA-01 trial results are practice changing, supporting the potential of zanidatamab as the HER2-targeted agent-of-choice in HER2+ first-line locally advanced or metastatic GEA. Importantly, the results demonstrated adding tislelizumab to zanidatamab plus chemotherapy further enhanced clinical benefit and marked the first immuno-oncology combination to show efficacy across both PD-L1–positive and PD-L1–negative tumors in this clinical setting," said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of R&D, and chief medical officer of Jazz Pharmaceuticals. "We look forward to continuing to work closely with FDA to obtain approval and quickly bring zanidatamab to market for GEA patients in need of new options."

The FDA granted Breakthrough Therapy designation to zanidatamab in combination with fluoropyrimidine- and platinum-containing chemotherapy, with or without tislelizumab, for the first-line treatment of patients with HER2+ unresectable locally advanced or metastatic gastric, GEJ, or esophageal adenocarcinoma. Breakthrough Therapy designation is intended to expedite the development and review of therapies that, based on preliminary clinical evidence, may offer substantial improvement over available therapies on one or more clinically significant endpoints, reflecting both the seriousness of the disease and the unmet medical need in this setting.

About the Phase 3 HERIZON-GEA-01 Trial
HERIZON-GEA-01 (NCT05152147) is a global, randomized, open-label Phase 3 trial, conducted jointly with BeOne Medicines, to evaluate and compare the efficacy and safety of zanidatamab plus chemotherapy, with or without tislelizumab, to trastuzumab plus chemotherapy as first-line treatment for adult patients with advanced/metastatic HER2+ GEA. The trial randomized 914 patients from approximately 300 trial sites in more than 30 countries. Appropriate patients for this trial had unresectable locally advanced, recurrent or metastatic HER2+ GEA (adenocarcinomas of the stomach or esophagus, including the gastroesophageal junction), defined as 3+ HER2 expression by IHC or 2+ HER2 expression by IHC with ISH positivity per central assessment. Patients were randomized to the three trial arms: zanidatamab in combination with chemotherapy and tislelizumab; zanidatamab in combination with chemotherapy; and trastuzumab plus chemotherapy. The trial is evaluating dual primary endpoints, PFS per blinded independent central review (BICR) and OS. Results from the trial were presented in January 2026 at the 2026 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium.

About Gastroesophageal Adenocarcinoma
GEA, including cancers of the stomach, gastroesophageal junction, and esophagus, is the fifth most common cancer worldwide, and approximately 20% of patients have HER2+ disease.1,2,3 HER2+ GEA has high morbidity and mortality, and patients are urgently in need of new treatment options. The overall prognosis for patients with GEA remains poor, with a global five-year survival rate of less than 30% for gastric cancer and about 19% for GEA.4

About Ziihera (zanidatamab-hrii)
Ziihera (zanidatamab-hrii) is a bispecific HER2-directed antibody that binds to two extracellular sites on HER2. Binding of zanidatamab-hrii with HER2 results in internalization leading to a reduction in HER2 expression of the receptor on the tumor cell surface. Zanidatamab-hrii induces complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC), and antibody-dependent cellular phagocytosis (ADCP). These mechanisms result in tumor growth inhibition and cell death in vitro and in vivo.5 In the United States, Ziihera is indicated for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test.1 The FDA granted accelerated approval for this indication based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).1

Zanidatamab is being developed in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Zanidatamab is being developed by Jazz Pharmaceuticals and BeOne under license agreements from Zymeworks, which first developed the molecule.

An sBLA for zanidatamab is being reviewed by the FDA under RTOR in first-line HER2+ locally advanced or metastatic GEA. The FDA granted two Breakthrough Therapy designations for zanidatamab’s development: one as a single agent for previously treated HER2 gene-amplified BTC, and one in combination with fluoropyrimidine- and platinum-containing chemotherapy, with or without tislelizumab for first-line HER2+ unresectable locally advanced or metastatic gastric, GEJ or esophageal adenocarcinoma. The FDA also granted two Fast Track designations for zanidatamab: one as a single agent for refractory BTC and one in combination with standard-of-care chemotherapy for first-line GEA. Additionally, zanidatamab has received Orphan Drug designations from the FDA for the treatment of BTC, gastric (including GEJ) cancer, and esophageal cancer, as well as Orphan Drug designations from the European Medicines Agency for the treatment of BTC, gastric/GEJ cancer and oesophageal cancer.

Important Safety Information for ZIIHERA

WARNING: EMBRYO-FETAL TOXICITY
Exposure to ZIIHERA during pregnancy can cause embryo-fetal harm. Advise patients
of the risk and need for effective contraception.

WARNINGS AND PRECAUTIONS

Embryo-Fetal Toxicity
ZIIHERA can cause fetal harm when administered to a pregnant woman. In literature reports, use of a HER2-directed antibody during pregnancy resulted in cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death.

Verify the pregnancy status of females of reproductive potential prior to the initiation of ZIIHERA. Advise pregnant women and females of reproductive potential that exposure to ZIIHERA during pregnancy or within 4 months prior to conception can result in fetal harm. Advise females of reproductive potential to use effective contraception during treatment with ZIIHERA and for 4 months following the last dose of ZIIHERA.

Left Ventricular Dysfunction
ZIIHERA can cause decreases in left ventricular ejection fraction (LVEF). LVEF declined by >10% and decreased to <50% in 4.3% of 233 patients. Left ventricular dysfunction (LVD) leading to permanent discontinuation of ZIIHERA was reported in 0.9% of patients. The median time to first occurrence of LVD was 5.6 months (range: 1.6 to 18.7). LVD resolved in 70% of patients.

Assess LVEF prior to initiation of ZIIHERA and at regular intervals during treatment. Withhold dose or permanently discontinue ZIIHERA based on severity of adverse reactions.

The safety of ZIIHERA has not been established in patients with a baseline ejection fraction that is below 50%.

Infusion-Related Reactions
ZIIHERA can cause infusion-related reactions (IRRs). An IRR was reported in 31% of 233 patients treated with ZIIHERA as a single agent in clinical studies, including Grade 3 (0.4%), and Grade 2 (25%). IRRs leading to permanent discontinuation of ZIIHERA were reported in 0.4% of patients. IRRs occurred on the first day of dosing in 28% of patients; 97% of IRRs resolved within one day.

Prior to each dose of ZIIHERA, administer premedications to prevent potential IRRs. Monitor patients for signs and symptoms of IRR during ZIIHERA administration and as clinically indicated after completion of infusion. Have medications and emergency equipment to treat IRRs available for immediate use.

If an IRR occurs, slow, or stop the infusion, and administer appropriate medical management. Monitor patients until complete resolution of signs and symptoms before resuming. Permanently discontinue ZIIHERA in patients with recurrent severe or life-threatening IRRs.

Diarrhea
ZIIHERA can cause severe diarrhea.

Diarrhea was reported in 48% of 233 patients treated in clinical studies, including Grade 3 (6%) and Grade 2 (17%). If diarrhea occurs, administer antidiarrheal treatment as clinically indicated. Perform diagnostic tests as clinically indicated to exclude other causes of diarrhea. Withhold or permanently discontinue ZIIHERA based on severity.

ADVERSE REACTIONS
Serious adverse reactions occurred in 53% of 80 patients with unresectable or metastatic HER2-positive BTC who received ZIIHERA. Serious adverse reactions in >2% of patients included biliary obstruction (15%), biliary tract infection (8%), sepsis (8%), pneumonia (5%), diarrhea (3.8%), gastric obstruction (3.8%), and fatigue (2.5%). A fatal adverse reaction of hepatic failure occurred in one patient who received ZIIHERA.

The most common adverse reactions in 80 patients with unresectable or metastatic HER2-positive BTC who received ZIIHERA (≥20%) were diarrhea (50%), infusion-related reaction (35%), abdominal pain (29%), and fatigue (24%).

USE IN SPECIFIC POPULATIONS

Pediatric Use
Safety and efficacy of ZIIHERA have not been established in pediatric patients.

Geriatric Use
Of the 80 patients who received ZIIHERA for unresectable or metastatic HER2-positive BTC, there were 39 (49%) patients 65 years of age and older. Thirty-seven (46%) were aged 65-74 years old and 2 (3%) were aged 75 years or older.

No overall differences in safety or efficacy were observed between these patients and younger adult patients.

The full U.S. Prescribing Information for ZIIHERA, including BOXED Warning, is available at: View Source

TEVIMBRA (tislelizumab) is a registered trademark of BeOne Medicines.

(Press release, Jazz Pharmaceuticals, APR 27, 2026, View Source [SID1234664814])

On April 27, 2026 Xcovery Holdings, Inc., (Xcovery) an evidence-based, innovation-driven pharmaceutical company, reported an agreement with EVERSANA, a leading provider of commercialization services to the global life sciences industry, to support and expand the U.S. commercial launch of ENSACOVE (ensartinib), the company’s novel therapy for adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).

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Ensacove (ensartinib) is a next generation ALK inhibitor jointly developed by Xcovery and Betta Pharmaceuticals, Co. Ltd. (Betta). It is indicated for the treatment of adult patients with ALK-positive locally advanced or metastatic NSCLC as detected by an FDA-approved test who have not previously received an ALK inhibitor and is now available in the United States as a treatment for these patients (www.ensacove.com).

Under the agreement, EVERSANA will provide comprehensive end‑to‑end commercialization services for Xcovery, including but not limited to agency of record, market access, commercial and medical teams to support the company’s strategy to make Ensacove available to more patients across the U.S.

"The approval of Ensartinib was a major milestone in our mission to advance precision oncology," said Giovanni Selvaggi, M.D., Chief Medical Officer of Xcovery Holdings, Inc. "As we expand the U.S. launch of ENSACOVE, we are focused on ensuring that patients and providers have the support they need. EVERSANA brings highly experienced, scalable commercialization capabilities, and we’re pleased to partner with them to broaden patient access."

"EVERSANA was built to help companies just like Xcovery implement more impactful commercial strategies which will allow more patients to benefit from therapies like Ensartinib," said Gregory Skalicky, President, EVERSANA.

About ENSACOVE

ENSACOVE (ensartinib) is a kinase inhibitor indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received an ALK inhibitor.

ENSACOVE is contraindicated in patients who have experienced a severe hypersensitivity reaction to ENSACOVE, FD&C Yellow No. 5 (tartrazine), or to any of its components.
ENSACOVE can cause the following serious adverse reactions. Withhold, reduce the dose, or permanently discontinue ENSACOVE based on severity.

Interstitial Lung Disease (ILD)/Pneumonitis occurred in 5% of patients, including 1.3% Grade 3 and 0.4% Grade 4. Monitor patients for new or worsening symptoms indicative of ILD/pneumonitis and immediately withhold ENSACOVE if suspected. Permanently discontinue in patients with ILD/pneumonitis.

Hepatotoxicity, including drug-induced liver injury can occur. 59% of patients had increased alanine aminotransferase (ALT), including 5% Grade 3. Increased aspartate aminotransferase (AST) occurred in 58% of patients, including 1.8% Grade 3. Increased bilirubin occurred in 12% of patients, including 2.3% Grade 3 and 0.2% Grade 4. There was one case of drug-induced liver injury. Monitor liver function tests at baseline and every 2 weeks during the first cycle of treatment, and then monthly or as clinically indicated.

Dermatologic Adverse Reactions can occur, including drug reaction with eosinophilia and systemic symptoms (DRESS), rash, pruritus, and photosensitivity. Dermatologic adverse reactions occurred in 80% of patients, including Grade 3 in 14% of patients. Rash occurred in 72% of patients, including Grade 3 in 12% of patients. Pruritus occurred in 32% of patients, including 2.4% Grade 3. There was one Grade 3 case (0.2%) of DRESS. Advise patients to limit direct sun exposure during treatment and for at least 1 week after discontinuation. Monitor for dermatologic adverse reactions during treatment.
Bradycardia occurred in 6% of patients. All bradycardia events were Grade 1 or 2. Monitor heart rate regularly during treatment.

Hyperglycemia. Increased blood glucose occurred in 44% of patients, including Grade 3 in 2.5% (based on laboratory data). Monitor serum glucose periodically during treatment.
Visual Disturbances occurred in 8% of patients (0.2% Grade 3) and included blurred vision, diplopia, photopsia, vitreous floaters, visual impairment, visual field defect, and reduced visual acuity. Advise patients to report visual symptoms during treatment and obtain ophthalmologic evaluation in patients with visual disturbances.

Increased Creatine Phosphokinase (CPK) occurred in 43% of patients who had CPK laboratory data available, with Grade 3 in 1.5% and 0.5% Grade 4. Advise patients to report any unexplained muscle pain, tenderness, or weakness. Monitor CPK periodically during treatment.

Hyperuricemia occurred in 6% of patients, with 0.4% Grade 3 and 0.7% Grade 4. Monitor uric acid periodically during treatment and initiate urate-lowering medications as clinically indicated.
ENSACOVE can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception during treatment and for 1 week after the last dose.

ENSACOVE contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons.

The most common adverse reactions (incidence ≥20%) were rash, musculoskeletal pain, constipation, pruritus, cough, nausea, edema, vomiting, fatigue, and pyrexia.

Drug Interactions: Avoid concomitant use of P-gp inhibitors and moderate or strong CYP3A inhibitors or inducers.

Lactation: Advise women not to breastfeed during treatment and for 1 week after the last dose.
Use in Specific Populations: Avoid use of ENSACOVE in patients with severe hepatic impairment (total bilirubin >3 times ULN and any AST).

(Press release, Xcovery, APR 27, 2026, View Source [SID1234664813])