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Q1 2026 Results

On April 29, 2026 AstraZeneca reported first quarter 2026 results.

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(Presentation, AstraZeneca, APR 29, 2026, View Source [SID1234665031])

Imviva Biotech to Present Clinical Data from Ongoing Phase 1/2 Study of CTA313 at the American Society of Gene & Cell Therapy’s Annual Meeting

On April 29, 2026 Imviva Biotech, a clinical-stage biotechnology company developing next-generation allogeneic CAR-T cell therapies, reported that it will present clinical data from its ongoing open-label Phase 1/2 study of CTA313, a CD19/BCMA dual-targeted allogeneic CAR-T cell therapy, at the American Society of Gene & Cell Therapy’s Annual Meeting (ASGCT 2026). The conference is taking place May 11-15, 2026, in Boston, Massachusetts. The study evaluates CTA313 in patients with systemic lupus erythematosus (SLE).

Ben Capoccia, Director of Translational Medicine and Clinical Research at Imviva Biotech, will present results from a study of SLE patients treated with a single administration of CTA313, demonstrating rapid and profound B-cell depletion, followed by an immunologic profile consistent with an immune-reset mechanism.

Presentation details:

Title: CTA313, CD19/BCMA dual targeted allo-CAR-T ANS cell, Induces Deep B-Cell depletion, Supporting an Immune-Reset Mechanism for Durable Remission in Autoantibody-Mediated Diseases

Session Title: Engineering high-performance CAR T cells to overcome resistance and improve potency

Session Type: Oral Abstract Sessions

Session Location: Thomas Michael Menino Convention & Exhibition Center, MCEC Room 258ABC (Level 2)

Presentation Date & Time: Tuesday, May 12, 8:30 AM – 8:45 AM ET

Abstract Number: 425

Presentation ID: 28

Abstracts are currently available to the public at: View Source

For more information, visit www.imvivabio.com.

About CTA313

CTA313 is an investigational dual-targeting CD19/BCMA allogeneic CAR-T cell therapy derived from healthy donors and designed for B-cell-mediated autoimmune diseases. The product incorporates Imviva’s proprietary ANSWER inhibitory ligands and genetic edits to enhance resistance to host immune rejection and enable therapeutic durability. CTA313 can be manufactured in advance and stored for multiple patients, providing an off-the-shelf solution for patients in need of CAR-T cell therapy. The therapy has been evaluated in an open-label Phase 1/2 study across multiple autoimmune indications in China, including systemic lupus erythematosus, lupus nephritis, systemic sclerosis, anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis, and idiopathic inflammatory myopathy.

(Press release, Imviva Biotech, APR 29, 2026, View Source [SID1234664926])

Syncromune®, Inc. Presents Innovative SYNC-T™ Combination Immunotherapy Approach at Major European Interventional Oncology Conference

On April 29, 2026 Syncromune, Inc., a clinical-stage biopharmaceutical company advancing SYNC-T, an investigational platform combination immunotherapy for metastatic solid tumor cancers, reported an oral presentation at the 2026 European Conference on Interventional Oncology (ECIO) in Basel, Switzerland. The oral presentation reflects continued clinical and scientific interest in the SYNC-T platform as development progresses.

The presentation, titled "Abscopal effects of an Image-Guided Percutaneous Combination Device/Drug Immunotherapy Approach to Metastatic Prostate Cancer," was delivered by Stephen Kee, M.D., EVP, Clinical Medical & Business Operations, EMEA, at Syncromune. Dr. Kee described the minimally invasive outpatient SYNC-T combination drug/device immunotherapy procedure, noting that a single needle/infusion sheath device is placed percutaneously under image guidance into the center of a target tumor, either primary or metastatic. A cycle of partial cryolysis is then performed to disrupt tumor cell membranes and release tumor-derived antigens into the tumor microenvironment (TME), facilitating immune recognition. Immediately following lysis, a fixed dose of the multi-target drug SV-102 is infused through the same device into the zone of lysis where it co-locates with tumor antigens in the TME.

The infusion volume is designed to promote the flow of tumor antigens and SV-102 into regional lymphatics, where they synchronize location with immune cells. This synchronization approach is intended to create conditions for T cell activation and a systemic anti-tumor response, also known as an abscopal effect. SYNC-T’s intratumoral delivery enables effective high dose local drug concentrations while limiting systemic exposure, which may reduce immune-related toxicity.

"ECIO brings together experts who understand the clinical implications of innovative cancer therapies like SYNC-T," said Stephen Kee, M.D., presenter of the ECIO oral presentation and EVP, Clinical Medical & Business Operations, EMEA at Syncromune. "Today’s presentation highlights the distinct procedural logic of SYNC-T: combining partial cryolysis and intratumoral infusion through a single device using an image-guided percutaneous method. This novel approach has the potential to drive systemic anti-tumor responses, including regression of metastatic lesions, while maintaining a favorable tolerability profile."

Charles Link, M.D., Executive Chairman and Chief Innovation Officer of Syncromune added: "SYNC-T is designed to integrate cryolysis with a precisely coordinated immunomodulatory biologic, through a streamlined minimally invasive procedure intended to generate systemic anti-tumor effects. The Phase 1 clinical findings reviewed today continue to support the potential of the SYNC-T platform as we advance our ongoing Phase 2 LEGION-100 trial in patients with metastatic castration-resistant prostate cancer and support the broader potential of the platform across metastatic solid tumors."

The presentation also reviewed previously reported preliminary Phase 1 findings supporting the clinical rationale for the approach. In a single-arm study of 15 patients with metastatic prostate cancer, SYNC-T Therapy SV-102 demonstrated an overall response rate of 87%, including complete responses in 53% of patients. Among the 13 patients with bone metastases at baseline, all bone metastases resolved in seven patients (54%), as confirmed by imaging. Median time to response was 2.9 months, median duration of response was 12.1 months, and median overall survival had not been reached at 17.2 months of follow-up.

Previously reported safety findings were also reviewed. A total of 41 treatment-emergent adverse events were observed in 13 patients, with 95% graded 1 or 2. The most common events were hematuria and fever. Two Grade 2 immune-related adverse events and two Grade 3 treatment-emergent adverse events were reported, with no Grade 4 or 5 events observed.

Syncromune is advancing SYNC-T Therapy SV-102 in the ongoing Phase 2 LEGION-100 study (NCT06533644), which is actively enrolling across multiple sites in the U.S. Please visit www.legion100trial.com to learn more.

(Press release, Syncromune, APR 29, 2026, https://www.globenewswire.com/news-release/2026/04/29/3283931/0/en/syncromune-inc-presents-innovative-sync-t-combination-immunotherapy-approach-at-major-european-interventional-oncology-conference.html [SID1234664925])

Candel Therapeutics Announces Commercialization Agreement with EVERSANA to Support Potential U.S. Launch of Aglatimagene Besadenovec in Localized Prostate Cancer

On April 29, 2026 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal immunotherapies to help patients with cancer, reported that it entered into a product commercialization agreement (the "Agreement") with EVERSANA, a leading provider of global commercialization services to the life sciences industry, to support the potential U.S. commercial launch of aglatimagene besadenovec (aglatimagene or CAN-2409) for the treatment of intermediate- to high-risk, localized prostate cancer.

Under the terms of the agreement, EVERSANA will provide Candel with a broad suite of integrated commercialization services including data and analytics, medical affairs, market access and field operations. EVERSANA joins IDEA Pharma, a division of SAI MedPartners (IDEA), which has been providing path-to-market strategies and strategic positioning for aglatimagene. Candel has worked in close collaboration with both EVERSANA and IDEA on key pre-commercial workstreams as previously announced during Candel’s virtual Research and Development Day in December 2025.

This collaboration reflects Candel’s deliberate approach to building a world class commercial organization with global reach, designed from the ground up and leveraging a team of highly experienced professionals poised to support the potential commercial launch of aglatimagene for the treatment of intermediate- to high-risk, localized prostate cancer, subject to regulatory approval. This operating model gives Candel access to leading commercial capabilities while maintaining financial flexibility, capital efficiency, and scientific focus that has driven Candel’s progress to date.

"From the beginning, we designed Candel’s commercial strategy around a partner-led model that allows us to stay focused on advancing the science and navigating the regulatory pathway, while having access to world-class commercial capabilities on demand," said Paul Peter Tak, M.D., Ph.D., FMedSci, President and Chief Executive Officer of Candel. "With the addition of EVERSANA, that model is fully in place, and with the progress we’ve already made across our pre-commercialization workstreams, we have confidence in our readiness for the potential commercial launch of aglatimagene for the treatment of intermediate- to high-risk, localized prostate cancer. We look forward to working with EVERSANA and IDEA Pharma in providing a novel and potentially invaluable therapeutic for localized prostate cancer patients."

"We are proud to support Candel as it advances what could be a new and potentially transformative treatment option for patients with localized prostate cancer," said Gregory Skalicky, President of EVERSANA. "Candel’s unique approach to commercialization, building a dedicated and flexible platform with specialized partners, rather than a fixed pharmaceutical infrastructure, is exactly the type of model EVERSANA was designed to support. We have already integrated our resources alongside the Candel team, with key commercial workstreams actively underway, and we look forward to helping ensure that aglatimagene reaches patients efficiently and effectively upon potential approval."

(Press release, Candel Therapeutics, APR 29, 2026, View Source [SID1234664924])

Tacalyx Secures €11 Million to Advance Lead TACA-Targeting ADC Programme Toward the Clinic

On April 29, 2026 Tacalyx, a leader in the discovery and development of cancer therapies directed at Tumour Associated Carbohydrate Antigens (TACAs), reported the selection of its first clinical candidate, TCX-201, which is being advanced toward clinical development with the goal of filing a clinical trial application (CTA) in 2027. In support of this progress, the company has secured €11 million in a first closing of its seed extension round from its existing international investor syndicate, including Boehringer Ingelheim Venture Fund (BIVF), Kurma Partners, High-Tech Gründerfonds (HTGF), Eurazeo, Creathor Ventures, and Thuja Capital. The company intends to expand the round with additional investors in a subsequent closing. The proceeds will be used to see TCX-201 through preclinical development while advancing the company’s broader pipeline.

TCX-201 is an antibody drug conjugate (ADC) against an undisclosed TACA, developed using the company’s proprietary platform for the treatment of gastrointestinal malignancies and other solid tumours. TACAs represent a largely untapped class of targets found on tumour cell surface structures that may enable the development of highly selective therapies for patients with hard-to-treat tumours. In parallel, the newly secured capital will allow Tacalyx to continue to progress and expand its rich portfolio of first-in-class and best-in-class programmes designed to address multiple solid tumour indications with a high unmet medical need. The selection of the next clinical candidate is planned for the end of 2026.

"We are deeply grateful to our investors for their unwavering commitment in our mission to develop novel and effective treatments against solid tumours", said Jean Engela, CEO of Tacalyx. "Over the past years, we have built a powerful platform capable of reliably discovering and developing high-affinity antibodies against TACAs, sugar structures specifically found on tumour cells. Heralding a new stage for the company, Tacalyx has selected a clinical candidate for its TCX-201 programme and is now progressing preclinical activities to prepare for the CTA submission. With that, we are now redoubling our laser focus on translating the cutting-edge science on which the company was founded into transformative cancer therapies. Cancer patients cannot wait."

Klaus Schollmeier, Chairman of the Board of Tacalyx, said: "Tacalyx has delivered on its promise to unlock the therapeutic potential of TACAs, a frontier in oncology that has long been considered undruggable. With the selection of its first clinical candidate and significant advances with its earlier pipeline, the company is now rapidly transitioning from discovery research to a clinical-stage biotech. I am proud of the team’s achievements."

TACAs are distinctive glycan structures that are uniquely expressed or overexpressed on tumour cells and often play critical roles in tumour progression, including cell adhesion, immune evasion and metastasis. Because TACAs are found across a range of diverse cancer types, they represent promising targets for the development of pan-cancer therapeutics. Importantly, TACAs remain consistently expressed even in tumours lacking actionable genomic alterations or after standard therapies fail, positioning them as a differentiated and largely untapped class of cancer-specific targets with the potential to address treatment resistance. However, these novel targets have historically been difficult to address with antibodies, leaving much of this therapeutic space largely unexplored. Tacalyx is a pioneer in the discovery and development of therapies targeting TACAs. The company has built a proprietary discovery platform capable of reliably identifying and generating high-affinity antibodies against TACAs, enabling these previously inaccessible targets to become druggable. These antibodies can be further developed into novel antibody-based therapeutics tailored to specific clinical needs, including ADCs, TCEs and multi-specifics.

(Press release, Tacalyx, APR 29, 2026, View Source [SID1234664923])