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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.

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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])

Laguna Announces FDA Clearance of IND Application for LGNA-100, a Novel γδ T Cell Activator for High-Risk Pediatric Leukemias

On April 29, 2026 Laguna Biotherapeutics, Inc. (Laguna), a clinical-stage biotechnology company focused on novel live bacterial therapeutics, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application, granting a "safe to proceed" for its lead clinical candidate from the QUAIL platform, LGNA-100.

LGNA-100 is a first-in-class, attenuated live bacterial immunotherapy designed to safely harness our immune system’s evolved response to Listeria; robustly and durably expanding and activating endogenous γδ T cells that can directly kill cancer cells while also improving existing immunotherapies. The Phase 1 first-in-human study will validate the QUAIL platform and evaluate LGNA-100 in patients with high-risk leukemia following hematopoietic stem cell transplantation (HSCT) to prevent leukemic relapse.

"The IND clearance of our first clinical study is a defining moment and transformative milestone for Laguna as we transition into a clinical-stage company," said Jonathan Kotula, Ph.D., CEO of Laguna. "Our goal is to create systems-level therapies for complex diseases. With LGNA-100, and the QUAIL platform we are taking a fundamentally new approach to selectively stimulate innate T cells to improve long-term outcomes for pediatric patients with high-risk leukemia."

The clinical rationale for the QUAIL platform builds directly upon decades of research into the human γδ T cell response to Listeria, and the protective role of γδ T cells against leukemia recurrence following HSCT. A presentation covering our clinical rationale will be presented at the ISCT 2026 Annual Meeting on May 6 in Dublin, Ireland.

"In the setting of αβ-depleted HSCT, γδ T cells are critical effectors that provide potent graft-versus-leukemia activity without driving graft-versus-host disease," said Dr. Alice Bertaina, MD, PhD, Co-Director of the Bass Center for Childhood Cancer and Blood Diseases, Lucile Packard Children’s Hospital at Stanford University and lead Clinical Advisor for Laguna. "While early pharmacologic activators like zoledronic acid (ZOL) showed the clinical potential of this approach, intense ZOL stimulation pushes these cells into a more mature, terminally differentiated and exhausted state. Our comprehensive preclinical evaluations demonstrate that LGNA-100 drives a distinct, multifunctional γδ T cell response with improved kinetic, phenotypic, and functional features compared to ZOL, supporting more durable activation without hyperactivation or early exhaustion. I am very excited to see this translated into the clinic for these high-risk leukemia patients."

"Pediatric AML remains one of the most challenging frontiers in oncology, demanding novel modalities that can detect and kill the disease without compounding toxicities," said Bill Newell, former CEO of Sutro Biopharma and Strategic Advisor to Laguna. "Having spent years evaluating platforms to tackle these exact malignancies, I believe Laguna’s approach using γδ T cells to potentially solve the problems associated with high-risk leukemia is a massive leap forward. Securing this IND is a testament to the rigor of their science and positions LGNA-100 as a highly differentiated asset in the cancer immunotherapy space."

The Phase 1 clinical study is a company-sponsored open-label, first-in-human, single ascending dose study designed to assess safety and tolerability, and support the proof of LGNA-100’s mechanism of action. The study will evaluate LGNA-100 administered via intravenous (IV) infusion in pediatric and young adult participants with high-risk acute leukemias and MDS who have received an αβ-depleted HSCT.

About LGNA-100

LGNA-100 also known as QUAIL-100 is an investigational cancer immunotherapeutic agent derived from Listeria monocytogenes (Lm), developed from the QUAIL platform, designed to activate and expand a patient’s endogenous γδ T cells.

(Press release, Laguna Bio, APR 29, 2026, View Source [SID1234664922])

Spherix Advances Oncology Leadership with Novel PD-1 Findings and Inaugural Presence at American Society of Clinical Oncology (ASCO) Annual Meeting 2026

On April 29, 2026 Spherix reported breadth of physician-driven research underscores emerging trends in oncology as three abstracts are accepted at ASCO (Free ASCO Whitepaper) 2026:

Operational and clinical drivers of subcutaneous PD-1/PD-L1 inhibitor adoption: A mixed-methods analysis of U.S. oncology practice patterns.
Tumor-specific drivers of PD-1/PD-L1 inhibitor brand preference in NSCLC, melanoma, and renal cell carcinoma: A U.S. oncologist perspective.
Treatment decision-making after CAR-T and bispecific antibody therapy in relapsed/refractory multiple myeloma: Real-world perspectives from U.S. hematologist/oncologists.
Spherix Global Insights continues to expand its presence in oncology market intelligence with the release of new findings from its RealTime Dynamix service focused on PD-1 inhibition in solid tumors, alongside the company’s acceptance of three abstracts at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, including one poster presentation, coauthored with Dr. Kimberly Ku of Illinois CancerCare. Together, these milestones underscore both the breadth of Spherix’s oncology research portfolio and the growing impact of its physician-derived insights on the broader oncology community.

The latest RealTime Dynamix research, based on a survey of more than 100 U.S. oncologists, highlights a rapidly evolving PD-1 landscape marked by increasing overall utilization, meaningful shifts in route of administration, and emerging complexities in real-world treatment decision-making.

Across tumor types, oncologists report that use of PD-1 inhibitor regimens is expected to grow over the next six months, reinforcing the class’s continued central role in solid tumor management. At the same time, the data reveal a notable transition from traditional intravenous administration toward subcutaneous options. While intravenous regimens remain foundational – often serving as the preferred starting point – physicians increasingly signal a willingness to adopt subcutaneous alternatives, particularly in maintenance settings where convenience and efficiency are more highly valued.

Importantly, this shift is not without friction. Spherix findings suggest that while uptake of subcutaneous PD-1 inhibitors is accelerating, particularly in monotherapy settings, utilization may be more limited in combination regimens due to logistical challenges and access considerations encountered in real-world practice. These dynamics highlight a nuanced adoption curve, where clinical enthusiasm is tempered by operational realities.

The competitive landscape remains highly differentiated by tumor type. Pembrolizumab (Keytruda, Merck) continues to lead across multiple non-small cell lung cancer (NSCLC) segments and renal cell carcinoma (RCC), while nivolumab (Opdivo, Bristol Myers Squibb) maintains a strong position in melanoma. However, the introduction of subcutaneous formulations is reshaping share dynamics within brands, with meaningful internal shifts from intravenous to subcutaneous use projected across key indications in the coming months.

Beyond branded therapies, Spherix research points to a growing awareness of PD-1 biosimilars in development, though physician visibility into actual product selection remains limited. Oncologists largely recognize the value of biosimilars – particularly in high-volume settings such as NSCLC – yet report that treatment decisions are often dictated at the institutional or payer level, reducing direct physician control over brand choice.

Collectively, these findings illustrate a market in transition, where innovation in formulation, evolving treatment strategies, and cost considerations are converging to shape the next phase of PD-1 utilization.

Spherix’s upcoming presence at ASCO (Free ASCO Whitepaper) 2026 builds on this momentum. The company’s three accepted abstracts, including a poster presentation, reflect the depth and rigor of its oncology research and mark a significant milestone as Spherix brings its real-world evidence and physician insights to one of the field’s most prominent global stages for the first time.

The accepted research spans key areas of oncology, further reinforcing Spherix’s commitment to delivering timely, actionable insights that inform strategic decision-making across the healthcare ecosystem. By pairing robust primary research with deep therapeutic expertise, Spherix continues to provide a uniquely comprehensive view of rapidly evolving markets.

As the oncology landscape grows increasingly complex, Spherix remains focused on illuminating the intersection of clinical innovation and real-world practice – equipping stakeholders with the clarity needed to navigate change and anticipate what comes next.

About RealTime Dynamix

RealTime Dynamix is an independent service providing strategic guidance through quarterly or semiannual reports, which include market trending and a fresh infusion of event-driven and variable content with each wave. The reports provide an unbiased view of the competitive landscape within rapidly evolving specialty markets, fueled by robust HCP primary research and our in-house team of experts.

(Press release, Spherix, APR 29, 2026, View Source [SID1234664921])

OPTIMAL-PSMA Trial of TLX597-Tx Next Generation RLT Presented at IPCS 2026 Highlighting Therapeutic Potential in Prostate Cancer

On April 29, 2026 Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") reported dosimetry results from the randomized Phase 2 OPTIMAL-PSMA trial of TLX597-Tx in metastatic castration-resistant prostate cancer (mCRPC), presented at the 2026 International Prostate Cancer Symposium (IPCS 2026) held in Lugano, Switzerland. These findings support TLX597-Tx’s potential to deliver a treatment that overcomes quality-of-life challenges that currently limit the clinical utility of existing RLTs in earlier-stage metastatic prostate cancer.

TLX597-Tx (177Lu-DOTA-HYNIC-panPSMA) is a novel PSMA-targeting small molecule RLT candidate with a highly favorable dosimetry profile. Significantly reduced radiation exposure to healthy organs, including the salivary glands and kidneys5, may lower the incidence of xerostomia (dry mouth) and renal toxicity and support better tolerability for patients. This dosimetry profile combined with higher tumor uptake compared to existing PSMA RLTs may deliver a wider therapeutic window and enable dose intensification to maximize tumor control while preserving patient quality-of-life.

OPTIMAL-PSMA is an open-label, multi-center, randomized, Phase 2 investigator-initiated trial (IIT) led by Professor Louise Emmett at St Vincent’s Hospital in Sydney, Australia. The study is evaluating the safety, dosimetry, and efficacy of an intensified dosing regimen of TLX597-Tx compared with a standard dose schedule in 120 men with advanced mCRPC, randomized on a 2:1 basis. The novel dose-intensification regimen delivers higher activity per cycle (8.5 GBq), delivered on day 1, day 3 and day 15, followed by 10-weekly dosing for three further cycles. The study aims to confirm that a dose intensified TLX597-Tx regimen will maximize the radiation dose to cancerous lesions when they are most vulnerable to damage and therefore improve overall response to treatment.

Telix believes these dosimetry data support further evaluation of TLX597-Tx in earlier-stage disease and is initiating OPTIMAL-E, a Phase 2 study in androgen pathway-sensitive prostate cancer (mHSPC).

Principal Investigator for OPTIMAL-PSMA, Professor Louise Emmett, commented, "The goal of OPTIMAL-PSMA is to identify a dose regimen for TLX597-Tx that leads to deeper and longer responses without increasing toxicity for men with metastatic prostate cancer. We look forward to starting the Phase 2 OPTIMAL-E trial soon."

Dr. David N. Cade, Group Chief Medical Officer at Telix, added, "These encouraging dosimetry results from OPTIMAL-PSMA, combined with earlier exploratory work6, are very promising and highlight TLX597-Tx’s potential to substantially increase the tumor dose while minimizing radiation to sensitive organs. For people living with earlier-stage metastatic disease, preserving quality-of-life alongside effective cancer control is mandatory. These findings support further study in mHSPC and reinforce Telix’s strategy to develop differentiated PSMA-targeting therapies, so clinicians may be able to tailor treatment choice to the patient’s disease stage and individual condition."

TLX597-Tx is being developed alongside TLX591-Tx (lutetium-177 (177Lu) rosopatamab tetraxetan), Telix’s lead antibody-based prostate cancer therapy candidate, currently the subject of the Phase 3 ProstACT Global7 trial in mCRPC, which is actively dosing patients in jurisdictions with regulatory approval and recently reported data from a safety and dosimetry lead-in8. TLX591-Tx and TLX597-Tx exhibit complementary modes-of-action, suggesting the potential for distinct applications in mCRPC and mHSPC settings as part of Telix’s portfolio approach to treating prostate cancer. TLX591-Tx and TLX597-Tx have not received marketing authorization in any jurisdiction.

(Press release, Telix Pharmaceuticals, APR 29, 2026, View Source [SID1234664920])