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ImmunoScape Presents Data on Significant, Selective In-Vivo Expansion of Cell Therapy Product at AACR Annual Meeting

On April 21, 2026 ImmunoScape Pte. Ltd., a spin-out of A*STAR backed by Amgen Ventures and EDBI that is developing next-generation TCR-based cancer immunotherapies, reported the presentation of compelling new preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026. The poster, titled "A novel ‘Seed-and-Boost’ immunotherapy drives potent TCR-T cell expansion, tumor infiltration, and durable tumor control," was presented on Monday, April 20, 2026 by Michael Fehlings, PhD, Co-Founder and CEO of ImmunoScape.

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The data presented at AACR (Free AACR Whitepaper) details the extensive preclinical studies of the company’s proprietary Seed and Boost platform. This groundbreaking platform combines low-dose tumor-specific T cells (the Seed) with the clinically-validated CUE-100 series molecule (the Boost) that triggers dramatic but highly selective in vivo expansion of the infused T cells. The Seed and Boost platform is designed to enable T cell therapies to effectively target solid tumors, including some of the most difficult-to-treat cancers.

The first Seed and Boost program focuses on tumors expressing the Wilms’ Tumor 1 (WT1) antigen, including cancers such as mesothelioma, glioblastoma, ovarian, pancreatic, gastric, and colorectal cancers. Ranked by the National Cancer Institute as one of the most important cancer antigens, WT1 is an intracellular oncoprotein broadly overexpressed across multiple cancer types and is targetable with TCR-based immunotherapy.

Key Data Highlights

Robust in vivo expansion and anti-tumor effect: In an animal model, Seed and Boost combination therapy drove significant TCR-T cell expansion and anti-tumor effect at both standard and low cell doses—suggesting the potential to dramatically reduce cell therapy manufacturing cost while simultaneously enhancing anti-tumor effect.

100% survival in a high tumor burden ovarian cancer model: In an animal model, the Seed and Boost combination achieved 100% survival, compared to significant mortality in the monotherapy arms.

Pancreatic tumor infiltration: In an animal model, the Seed and Boost combination resulted in significant infiltration of tumor-specific T cells into pancreatic tumors.

Evidence of sustained T-cell fitness and preferential CD8+ T-cell expansion: Analysis of tumor-infiltrating lymphocytes confirmed that the Seed and Boost upregulates markers associated with a tumor reactive T-cell phenotype.

"The data we are presenting at AACR (Free AACR Whitepaper) represent the strongest preclinical case yet for the Seed and Boost platform," said Michael Fehlings, PhD, Co-Founder and CEO of ImmunoScape. "We show selective in vivo T cell expansion, robust tumor infiltration, and a durable survival benefit—achieved without additional cell engineering or systemic IL-2 administration. These results support our upcoming first-in-human IIT at a major US NCI Cancer Center, which will dose its first patients in Autumn 2026."

"WT1 is a compelling target—broadly overexpressed in tumor types with the highest unmet need," said Adrian Bot, MD, PhD, Board Member of ImmunoScape and former Chief Scientific Officer of Kite Pharma and Capstan Therapeutics. "What excites me about Seed and Boost is that it may solve multiple problems of cell therapy: high costs, lack of T-cell persistence, and lack of tunability. This platform provides a unique clinically tunable ‘Boost’ signal to expand and maintain T-cell fitness in the patient. The in vivo expansion data presented here, combined with the depth of tumor infiltration we are seeing, represents an exciting step forward for the field. I believe this could transform TCR-T cell therapy into a durable, broadly accessible treatment for patients with solid tumor cancers. Moreover, the "Boost" technology shows promise in enhancing existing CAR-T and TIL therapies as well."

"The preclinical evidence presented at AACR (Free AACR Whitepaper) is both mechanistically compelling and translationally meaningful," said Evan Newell, PhD, Co-Founder of ImmunoScape and Chair of the Scientific Advisory Board, who attended the poster presentation. "The specificity of CUE-102 ("Boost")-driven T cell expansion, the depth of tumor infiltration, and the sustaining of T-cell effector function in vivo give us strong scientific rationale to advance this combination into patients. Cancer patients facing solid tumor cancers need new options, and this program is designed to deliver them."

The AACR (Free AACR Whitepaper) presentation marks a key milestone as ImmunoScape advances toward its first-in-human investigator-initiated trial (IIT) at a premier US NCI Cancer Center, renowned globally for its pioneering history in cellular immunotherapy. The IIT is designed to evaluate the Seed and Boost combination in WT1-expressing solid tumors including mesothelioma, ovarian cancer, gastric cancer, and colorectal cancer in HLA-A*02:01-positive patients.

First patient dosing is targeted for Autumn 2026, with preliminary human data anticipated in early 2027. The IIT is supported by the company’s current convertible note financing round and non-dilutive funding from Enterprise Singapore.

AACR Poster Details

Title: "A novel ‘Seed-and-Boost’ immunotherapy drives potent TCR-T cell expansion, tumor infiltration, and durable tumor control"

Conference: American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, San Diego, CA

Presenter: Michael Fehlings, PhD, Co-Founder and CEO, ImmunoScape Pte. Ltd.

Poster/Abstract Number: Poster Section 43 | Board 27 | Presentation 3812

(Press release, immunoSCAPE, APR 21, 2026, View Source [SID1234664652])

Synthekine Presents Updated Clinical and Translational Data Demonstrating Strong Activity for STK‑012 in First‑Line Non‑Squamous NSCLC in Oral Presentation at AACR 2026

On April 21, 2026 Synthekine, Inc., a clinical‑stage biotechnology company developing precision cytokine therapeutics, reported updated clinical and translational data for STK‑012 in combination with pembrolizumab, pemetrexed, and carboplatin (PCT) in first‑line PD‑L1-negative, non‑squamous (NSQ) non‑small cell lung cancer (NSCLC). The data were presented by Salman Punekar, M.D. (NYU Langone Health), in an oral presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026 in San Diego, CA.

STK‑012 is a first‑in‑class α/β IL‑2 receptor‑biased partial agonist designed to selectively stimulate antigen‑activated T cells, which are linked to anti‑tumor activity, while minimizing broad activation of other lymphocytes, such as natural killer cells, which are associated with IL‑2‑related toxicities. These updated results, from 36 efficacy‑evaluable patients, build on clinical data first presented at SITC (Free SITC Whitepaper) 2025 and include longer follow‑up, new translational analyses, and the first detailed look at durability in the STK11/KEAP1 co‑mutated subgroup.

"These data underscore the potential for STK-012 to improve outcomes for some of the hardest-to-treat patients with lung cancer," said Naiyer A. Rizvi, M.D., Chief Medical Officer of Synthekine. "Chemoimmunotherapy remains the first‑line standard of care in non‑squamous NSCLC, but many patients derive limited benefit. These tumors are often PD‑L1-negative and/or enriched for STK11, KEAP1, and SMARCA4 loss-of-function alterations, all of which contribute to an immune-cold tumor microenvironment. The response rates and early durability signals we are seeing, together with compelling translational evidence of targeted T‑cell activation, establish a strong case that STK-012 can overcome the immune resistance that has historically limited outcomes in this population."

Efficacy and Safety in Immune Resistant Biology

STK-012 plus pembrolizumab and chemotherapy (PCT) demonstrated robust activity in patient subsets typically associated with resistance to chemoimmunotherapy:

Nearly all patients in the study were PD‑L1-negative (n=32/36), a population in which standard-of-care chemoimmunotherapy has historically produced objective response rates of 23% to 32%. In contrast, STK-012 plus PCT achieved a 50% objective response rate and 97% disease control rate in the overall efficacy-evaluable population.
In patients with STK11, KEAP1, and/or SMARCA4 loss-of-function alterations (n=18/36)—where standard-of-care response rates have been reported in the 7% to 33% range—STK-012 plus PCT delivered a 61% objective response rate and 100% disease control rate.
In the STK11/KEAP1 co‑mutated subgroup (n=8/36), STK-012 plus PCT achieved a 50% objective response rate. Median progression-free survival was 5.5 months, with two patients still on treatment, and median overall survival was not reached at a median follow-up of 6.8 months (6-month OS rate 88%). These results compare favorably to published standard-of-care benchmarks of 7%–15% ORR, ~3 months median PFS, and 5.4–7.0 months median OS in this subgroup. STK11/KEAP1 co‑mutated patients represent approximately 10% of first-line NSQ NSCLC.
Across 39 safety-evaluable patients, STK-012 plus PCT was generally well tolerated, with no dose-limiting toxicities and no STK-012–related discontinuations. The most common treatment-related adverse events were rash/dermatitis (51%), nausea (51%), and fatigue (46%), which were manageable and reversible.

Translational Data Show Selective and Durable Immune Activation

New translational data presented at AACR (Free AACR Whitepaper) provide strong biological support for the clinical findings:

Sustained exposure: STK‑012 half‑life of 5.7 days supports continuous pharmacodynamic activity across the 3‑week dosing cycle
Targeted cytokine induction: robust IFN‑γ and IP‑10 induction with minimal IL‑6 and TNF‑α, consistent with selective T‑cell‑driven activity rather than broad immune activation
Robust expansion of activated T cells: strong proliferation of 4‑1BB+ CD8+ T cells, with limited expansion of NK cells or regulatory T cells
Clonal T cell expansion: 3.5% of circulating T cells were derived from newly expanded clonotypes after a single cycle, and greater clonal expansion was associated with clinical response
Immune reactivation in STK11/KEAP1 co‑mutated subgroup: STK‑012 restored proliferation of the activated T‑cell population (4‑1BB+ CD8+), reinvigorated exhausted T cells (PD‑1+ CD8+ T cells), and drove robust clonal T cell expansion—even in tumors with the most suppressive microenvironment
"Although STK11/KEAP1 co-mutated tumors have a high neoantigen burden, the immunologically dysfunctional tumor microenvironment renders immune checkpoint inhibitors largely ineffective in this setting," said Martin Oft, M.D., Chief Scientific Officer of Synthekine. "Our translational data suggest that STK-012 can work synergistically with immune checkpoint inhibitors to help re-engage antitumor immunity and enable functional T-cell responses in these tumors."

The AACR (Free AACR Whitepaper) presentation is available on Synthekine’s website.

About the SYNERGY-101 Randomized Phase 2 Clinical Trial

Development of STK-012 is ongoing in SYNERGY-101, a global, randomized Phase 2 study evaluating STK-012 plus pembrolizumab and chemotherapy versus pembrolizumab and chemotherapy alone in first‑line, PD‑L1-negative non‑squamous NSCLC. The study is currently enrolling with the first patient dosed in November 2025. Synthekine has entered into a clinical trial collaboration and supply agreement with Merck, under which Merck provides Keytruda (pembrolizumab) for use in the trial. Synthekine retains all commercial rights to STK-012.

For additional information about the SYNERGY-101 trial, please visit www.clinicaltrials.gov and use the identifier NCT05098132.

(Press release, Synthekine, APR 21, 2026, View Source [SID1234664651])

Personalis Highlights Clinical Impact of Ultrasensitive ctDNA Monitoring and New Therapy Resistance Tracking at AACR 2026

On April 21, 2026 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported the successful presentation of clinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The data, spanning one oral podium presentation and three posters, underscore the use of the NeXT Personal ultrasensitive ctDNA assay in monitoring treatment response, identifying early recurrence, and tracking the emergence of therapy resistance.

Neoadjuvant Monitoring in Colorectal Cancer. A highlight was the oral podium presentation of the NEOPRISM-CRC trial, delivered by Dr. Jiang from the University College London, which utilized NeXT Personal to monitor patients with high-risk stage II-III dMMR/MSI-H colorectal cancer (CRC) receiving neoadjuvant pembrolizumab. In addition to 100% sensitivity for disease at baseline, the study identified three distinct groups of patient response to neoadjuvant treatment: super molecular responders, dynamic molecular responders, and poor molecular responders. Notably, 100% of "super molecular responders"—those who cleared ctDNA by the second cycle of treatment—also achieved pathological complete response (pCR). Conversely, of "poor molecular responders"—patients with relatively stable ctDNA levels during neoadjuvant treatment—100% did not achieve pCR. These findings could provide clinicians with a critical window to adjust treatment strategies prior to surgery. Post-surgery, the test achieved a 100% negative predictive value (NPV) and 100% specificity for disease relapse.

"The data presented at AACR (Free AACR Whitepaper) confirm ultrasensitive ctDNA detection with NeXT Personal as a promising therapy monitoring tool in neoadjuvant colorectal cancer treatment," said Dr. Richard Chen, President and Chief Medical Officer at Personalis. "By measuring molecular response with high resolution, we are providing the tools needed to explore ctDNA-guided management of colorectal cancer patients receiving neoadjuvant therapy."

Ultrasensitivity in Real-World Data. In a large-scale analysis of nearly 25,000 plasma samples from 10,000 real-world patients, NeXT Personal demonstrated consistent ultrasensitive performance with a median limit of detection of 1.92 PPM. The study also revealed that 39% of all positive MRD detections occurred in the ultrasensitive range below 100 PPM, with 14.6% below 10 PPM—detections that could be missed with less sensitive assays. This study also highlights the robust ultrasensitive performance of the NeXT Personal assay in real-world testing conditions across more than 14 cancer types, stage I-IV disease, and a variety of challenging sample types.

Innovation in Therapy Resistance Tracking. Personalis also debuted analytical validation and real-world data for a new opt-in feature of its NeXT Personal MRD test: Real-Time Variant Tracker. This feature allows for the simultaneous monitoring of MRD and the longitudinal tracking of specific resistance-associated mutations, such as ESR1. With a specificity of >99.9%, resistance and other clinical mutations were identified in 38% of MRD-positive patients across the real-world cohort, offering a new tool for tracking treatment resistance as it emerges.

Monitoring Immunotherapy Response in NSCLC. The DARWIN 2 study results in metastatic non-small cell lung cancer (NSCLC) demonstrated NeXT Personal’s ability to stratify risk in patients receiving immunotherapy. Patients who achieved a durable molecular complete response (dmCR) remained 100% progression-free at three years, whereas patients who failed to achieve molecular clearance were five times more likely to experience disease progression.

Together, these studies illustrate Personalis’ commitment to improving cancer management through ultrasensitive MRD testing throughout the patient journey.

(Press release, Personalis, APR 21, 2026, View Source [SID1234664650])

Foundation Medicine Expands Existing Collaboration with Bristol Myers Squibb to Develop a Next-Generation Sequencing Companion Diagnostic to Identify Patients with Homozygous MTAP Deletion

On April 21, 2026 Foundation Medicine, Inc., a global precision medicine company, reported an expansion to its collaboration with Bristol Myers Squibb (NYSE: BMY) to develop FoundationOneCDx as a next-generation sequencing-based companion diagnostic to identify patients with homozygous MTAP deletion in multiple indications for an investigational targeted therapy. The expansion broadens Foundation Medicine’s longstanding relationship in advancing biomarker-driven therapies with Bristol Myers Squibb.

Homozygous deletion is a major cause of MTAP deficiency.1 Copy number calling can have low signal-to-noise ratio, making the alterations challenging to accurately identify. FoundationOne CDx is a tissue-based next-generation sequencing test approved by the FDA to detect copy number loss. Accurate reporting of homozygous deletion can help identify eligible patients for targeted therapies.

"Homozygous MTAP deletion is a critical biomarker, yet one that can be difficult to detect without an assay that unveils blind spots others interpret as noise," said Troy Schurr, chief commercial officer at Foundation Medicine. "Foundation Medicine has approved companion diagnostic indications across all four major classes of genomic alterations and works with biopharmaceutical companies to support biomarker-driven therapy development. We look forward to collaborating with partners to help more patients benefit from advancements in precision oncology."

(Press release, Foundation Medicine, APR 21, 2026, View Source [SID1234664649])

Forlong Biotechnology to Present Clinical Data from the First-in-human Study for FL115 (IL-15 Superagonist) in US Patients with Advanced Solid Tumors at 2026 ASCO Annual Meeting

On April 21, 2026 Forlong Biotechnology, a clinical-stage biotech company focusing on developing transformative cytokine therapies for patients with severe unmet needs, reported a poster presentation at the upcoming 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which is being held from May 29 to June 2, 2026, at the McCormick Place in Chicago, IL.

The presentation will detail safety, pharmacokinetics, pharmacodynamics and antitumor activities of FL115 from the first-in-human FL115-101 study conducted at 3 investigational sites in US. First patient was dosed in December 2023, and the study was completed in September 2025 with total of 11 patients treated. One patient received the 1st dose in Jul 2024, remained progression-free at the study completion, and afterwards has continued to receive FL115 treatment under a Single Patient IND Protocol/Treatment Plan.

Details of the poster presentation are as follows:

Poster Board: 291
Poster Title: Safety, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activities of FL115, a novel IL-15 superagonist, from the first-in-human study in patients with locally advanced/metastatic solid tumors.
Session Type/Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Date and Time: May 30, 2026, 1:30 PM-4:30 PM CDT
About FL115

FL115 is an engineered IL-15/IL15Rα-Fbody fusion protein, aiming to enhance anti-tumor immunity via IL-15-mediated signaling on NK and CD8+ T cells while minimizing complexity from Fc. FL115 has demonstrated significant anti-tumor activities as a monotherapy or as part of combination therapy in vivo, and can be manufactured by a robust and efficient process with excellent product stability. Clinically, FL115 has demonstrated favorable safety profile and preliminary clinical responses as a monotherapy, and has the best-in-class potential to synergize with current and emerging T cell-targeting immunotherapies through combination therapy to significantly improve the treatment outcome for patients. It is currently being investigated in combination with Bacillus Calmette-Guérin (BCG) in a Phase 2 clinical trial to evaluate safety and preliminary efficacy in patients with nonmuscle invasive bladder cancer (NMIBC) and in combination with an anti-PD1 monoclonal antibody in a Phase 1b/2 clinical trial to evaluate safety and preliminary efficacy in patients with advanced solid tumors.

(Press release, Forlong Biotechnology, APR 21, 2026, View Source [SID1234664648])