Forlong Biotechology to Present Preclinical Data from FL115, a novel interleukin-15 (IL-15) superagonist, and FL116, a PD-1/interleukin-18 (IL-18) bispecific antibody, at the 2026 AACR Annual Meeting

On March 17, 2026 Forlong Biotechnology, a clinical-stage biotech company focusing on developing transformative cytokine therapies for patients with severe unmet needs, reported that preclinical data from its IL-15 and IL-18 programs will be presented at the 2026 AACR (Free AACR Whitepaper) Annual Meeting held April 17-22, 2026 in San Diego, California.

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IL-15 Programs: FL115 is an engineered IL-15/IL15Rα-Fbody fusion protein and has demonstrated best-in-class (BIC) profile as monotherapy in heavily pre-treated patients with late stage solid tumors, of which 3 patients (~10%) remain on treatment and progression-free currently at 9, 11 and 20 months respectively. Poster 7932 further elucidated mechanism of action underlying FL115 BIC profile, with Cryo-EM analysis of FL115/FcRn/β2M complex. In vivo, RNA-Seq and single-cell transcriptomics revealed FL115 reshaped the tumor microenvironment by enhancing NK and T cells infiltration without not triggering activation of neutrophils and macrophage. Poster 6459 showed significant potential of FL115 subcutaneous formulation. Compared to IV injection, subcutaneous injection of FL115 resulted in drastic lowering of Cmax (up to 26.7×) with bioavailability at ~60% as well as good linearity in PK file. FL115 at approximately 9 mg per injection site in rabbits showed no significant gross skin irritation.

IL-18 Programs: using structural modeling with our AI-driven Intelligent Biomolecular Discovery Platform, we developed a series of engineered IL-18 variants (IL-18v) that fully escape IL-18BP neutralization while providing tunable IL-18R1 affinity, enabling customizable cytokine potency, as described in Poster 7779. Based on one such IL-18v, we developed FL116, a PD-1/interleukin-18 (IL-18) bispecific antibody.
Poster 1777 showed FL116 achieved potent anti-tumor activities and rechallenge-confirmed immune memory while maintaining systemic immune homeostasis in multiple tumor models, and re-ignited intratumoral cytotoxic immunity while reshaping the TME toward a highly inflamed, effector-dominant state.

"Forlong’s pipeline strategy is to modulate the immune system with precision via stimulation of specific immune cell subpopulation through engineered cytokines, providing new options for patients," said Dong Wei, Ph.D., Chief Executive Officer of Forlong Biotechnology, "IL-15 and IL-18 have long been believed to be attractive cytokines for cancer immunotherapy, and we appreciate the opportunity to present initial data of FL115 and FL116 programs to leading immuno-oncology experts in this prestigious forum."

Poster Details:

Title: A tunable interleukin-18 (IL-18) platform engineered for complete escape from the decoy receptor IL-18 binding protein (IL-18BP)
Poster Number: 7779
Date & Time: 4/22/2026

Title: FL116, a PD-1/IL-18 bispecific antibody, enables cis-activation of PD-1⁺ T cells and reshapes the suppressive tumor microenvironment (TME)
Poster Number: 1777
Date & Time: 4/20/2026

Title: FL115, a novel IL-15 superagonist rationally designed to minimize safety risks for cancer immunotherapy
Poster Number: 7932
Date & Time: 4/22/2026

Title: Development of FL115, a novel IL-15 superagonist, as subcutaneous injection for cancer immunotherapy
Poster Number: 6459
Date & Time: 4/21/2026

About FL-115

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, MAR 17, 2026, View Source [SID1234663652])

Akamis Bio to Present Initial Data from the Phase 1b FORTRESS Study of NG-350A in Mismatch Repair-Proficient Locally Advanced Rectal Cancer at AACR 2026

On March 17, 2026 Akamis Bio, a clinical-stage oncology company working to advance the standard of care in colorectal cancer, reported an upcoming poster presentation of initial clinical data from the FORTRESS study of NG-350A, an oncolytic immunotherapy for the treatment of mismatch repair-proficient (pMMR) locally advanced rectal cancer (LARC), at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, taking place April 17-22 in San Diego.

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The ongoing Phase 1b FORTRESS study (NCT06459869) is assessing the anti-tumor effects of NG-350A plus chemoradiotherapy (CRT) following a 12-week active treatment period to establish whether NG-350A can improve response rates relative to expected outcomes from CRT alone. The trial is enrolling adult patients with pMMR LARC and at least one risk factor for local or distant recurrence.

NG-350A is an intravenously delivered oncolytic immunotherapy designed to drive intratumoral expression of a CD40 agonist monoclonal antibody triggering the activation of antigen-presenting cells (APCs) resident in solid tumors and their draining lymph nodes. Once activated, APCs recruit T cells into the vicinity of the tumor to deliver a potent anti-tumor immune response.

Poster Presentation Details

Title: Phase 1b trial of NG-350A, a CD40 agonist antibody expressing adenoviral vector, in combination with chemoradiotherapy (CRT), in patients with mismatch repair-proficient (pMMR) locally advanced rectal cancer (LARC): Initial results from the FORTRESS study
Session Title: Phase II and Phase III Clinical Trials
Date and Time: April 20, 2:00PM – 5:00PM PST
Location: Poster Section 52
Poster Number: 19

About NG-350A
NG-350A is a clinical-stage, intravenously delivered Tumor-Specific Immuno-Gene (T-SIGn) therapeutic designed to drive intratumoral expression of a CD40 agonist monoclonal antibody triggering the activation of antigen-presenting cells (APCs) resident in solid tumors and their draining lymph nodes. Once activated, APCs recruit T cells into the vicinity of the tumor to deliver a potent anti-tumor immune response. Akamis Bio has evaluated NG-350A’s safety, tolerability, and preliminary efficacy as a monotherapy (FORTITUDE study) and in combination with pembrolizumab (FORTIFY study) in patients with metastatic or advanced epithelial tumors. Across these studies, NG-350A has demonstrated a consistent safety and tolerability profile, as well as strong evidence of tumor-selective delivery, replication and transgene expression.

About the FORTRESS Study
The Phase 1b FORTRESS study (NCT06459869) is an open-label, single-arm, and multicenter trial of NG-350A in combination with chemoradiotherapy (CRT) in adult patients with mismatch repair-proficient (pMMR) locally advanced rectal cancer (LARC) and at least one risk factor for local or distant recurrence or with oligometastatic disease. The FORTRESS study builds upon the Akamis Bio-supported, CEDAR study, which showed a significantly greater response rate in LARC patients treated with a combination of Akamis Bio’s first generation oncolytic immunotherapy and chemoradiotherapy (CRT), relative to expected outcomes using standard-of-care CRT alone. The FORTRESS study is planning to enroll approximately 30 patients aged eighteen and older with histologically confirmed adenocarcinoma of the rectum which is locally advanced (clinical stage II-III based on pelvic MRI). During the 12-week active treatment period, patients will receive NG-350A plus CRT (oral capecitabine plus long-course intensity-modulated radiotherapy). The primary endpoint for the study is the proportion of patients achieving a response (complete clinical response [cCR] or near complete clinical response [ncCR]) at week 12. Key secondary endpoints include the incidence and severity of adverse events, characterization of the anti-tumor effects of NG-350A in combination with CRT (including clinical response outcome and magnetic resonance tumor reduction grade [mrTRG]), and measurement of levels of circulating tumor DNA (ctDNA) clearance. Patients recently diagnosed with pMMR LARC interested in learning more about the FORTRESS trial can visit www.FortressStudy.org.

About Locally Advanced Rectal Cancer (LARC)
Colorectal cancer (CRC) is the second leading cause of cancer-related death in the United States (US), and it has recently emerged as the leading cause of cancer-related death in patients under 50 years of age. There are 159,000 people newly diagnosed with CRC in the US each year, with approximately 30,000 of these people diagnosed specifically with LARC. In patients with LARC, tumors have either grown through muscle and into the outermost layers of the rectum, or in more severe cases, through the wall of the rectum where they may attach to other organs and/or into the lymph nodes. Approximately 95% of LARC patients have mismatch repair-proficient (pMMR) tumors indicating that their tumor cells have a functional DNA repair system.

(Press release, Akamis Bio, MAR 17, 2026, View Source [SID1234663651])

Frontier Medicines to Present Findings on PI3Kα-RAS Breaker FMC-242 and AI-Powered Frontier™ Platform at AACR Annual Meeting 2026

On March 17, 2026 Frontier Medicines Corporation, a clinical-stage precision medicines company unlocking the proteome to develop small molecule oncology and immunology drugs against previously undruggable disease-causing targets, reported that it will present preclinical data on its FMC-242 program, as well as advances from its AI-powered Frontier Platform, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, taking place April 17-22, 2026, in San Diego. FMC-242 is Frontier’s first-in-class allosteric breaker of the PI3Kα-RAS interaction that is in preclinical development for the treatment of solid tumors driven by RTK activation, RAS mutations and PI3Kα mutations, as both a single agent and in combination with other therapies including KRAS inhibitors.

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"We look forward to presenting new preclinical data at AACR (Free AACR Whitepaper) demonstrating that FMC-242 drives robust anti-tumor activity both as a monotherapy and in combination with targeted agents, while maintaining a favorable tolerability profile," said Kevin Webster, Ph.D., Chief Scientific Officer of Frontier Medicines. "These findings highlight the potential of selectively disrupting the PI3Kα-RAS interaction to address tumors driven by RTK activation and RAS mutations. Together with new data showcasing our AI-powered Frontier Platform, this work underscores how systematically mapping the proteome for covalent binding sites enables us to expand the range of high-value cancer targets we can drug and advance precision medicines for patients."

Summary of the findings to be presented and poster presentation details are as follows:

Title: FMC-242, a highly potent and selective covalent inhibitor of the PI3Kα-RAS interaction, demonstrates robust anti-tumor activity as monotherapy and in combination with targeted therapies
Poster Number: 5762
Session Title: Multi-Axis Antineoplastic Agents
Session Date & Time: April 21, 2026, 2:00 – 5:00 p.m. PT
Location: Poster Section 14, San Diego Convention Center
Summary of Findings: FMC-242 is a first-in-class, potent, selective, orally bioavailable covalent allosteric breaker of the PI3Kα-RAS interaction. In cell line- and patient-derived xenograft models with HER2 amplification and/or KRAS mutations, FMC-242 demonstrated potent anti-tumor activity with favorable tolerability and no effect on insulin signaling or blood glucose. In combination with EGFR inhibitors, KRASG12C inhibitors (including FMC-376), and pan-RAS/KRAS agents, FMC-242 further enhanced anti-tumor activity, supporting its potential as a differentiated monotherapy and combination approach.

Title: Finding Goldilocks: How AI-powered covalent drug discovery removes the "un" from "undruggable"
Poster Number: 4183
Session Title: Integrative Computational Approaches 2
Session Date & Time: April 21, 2026, 9:00 a.m. – 12:00 p.m. PT
Location: Poster Section 4, San Diego Convention Center
Summary of Findings: Application of the Frontier Platform, which integrates chemoproteomics, covalent chemistry, and machine learning, has enabled identification of selective covalent small-molecule leads across high-value cancer targets, including historically difficult drivers such as KEAP1, ADAR, DHX9, PTPN11, and MYC. The platform maps covalent binding sites across the proteome and applies AI-guided predictive modeling and optimized covalent fragment libraries to accelerate compound design, expanding the range of tractable oncogenic targets previously considered undruggable.

About FMC-242

FMC-242 is a first-in-class allosteric breaker of the PI3Kα-RAS interaction that breaks the interaction between PI3Kα and RAS to inhibit downstream signaling in tumors without impacting normal functions such as glucose homeostasis. The mechanism of action inhibits RAS driven PI3Kα-AKT signaling in tumors while minimizing the off-target effects and toxicities commonly associated with the broader class of kinase inhibitors. In preclinical models, FMC-242 has shown potent anti-tumor activity demonstrating the potential to impact patients with lung, colorectal, breast and other cancers that are driven by RTK activation, RAS mutation and PI3Kα mutations either as a single agent or in combination with other therapies including KRAS inhibitors. PI3Kα is the second most commonly mutated oncogene and plays an essential role in both KRAS- and RTK-driven cancers, such as colorectal, lung, and breast cancers, among others.

(Press release, Frontier Medicines, MAR 17, 2026, View Source [SID1234663650])

Pheast Therapeutics to Present Initial Phase 1a Clinical Data and Two New Preclinical Studies of PHST001, a Novel Anti-CD24 Antibody, at AACR 2026

On March 17, 2026 Pheast Therapeutics, a clinical-stage biotechnology company advancing macrophage-directed immunotherapies for cancer, reported that it will present three abstracts at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, taking place April 17–22 in San Diego.

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The presentations include initial data from the ongoing Phase 1 study of PHST001, an IgG4 anti-CD24 macrophage checkpoint inhibitor, in patients with advanced or metastatic solid tumors. Two additional preclinical abstracts evaluate PHST001 in combination with multiple classes of standard-of-care chemotherapy to enhance macrophage-mediated tumor cell clearance, and in metastatic tumor models assessing activity, Fc receptor contribution, and the impact of endogenous IgG competition.

"These presentations reflect the breadth of our work, from first-in-human evaluation to mechanistic and preclinical combination studies," said Roy Maute, Ph.D., Co-founder and Chief Executive Officer of Pheast Therapeutics. "Together, they provide important context as we advance PHST001 and develop a broad pipeline of macrophage-directed therapies for solid tumors."

"PHST001 was intentionally designed to balance effective CD24 blockade with controlled immune engagement," said Raphaël Rousseau, M.D., Ph.D., Chief Medical Officer of Pheast Therapeutics. "At AACR (Free AACR Whitepaper), we will present preliminary Phase 1a clinical data and supporting preclinical studies, as we evaluate PHST001 as a monotherapy and advance to combination settings."

AACR 2026 Presentation Details for PHST001

Initial Results from a Phase 1 Study of PHST001, a Macrophage Activating anti-CD24 Antibody, in Patients with Advanced/Metastatic Solid Tumors
Session Title: Phase 0 and First-in-Human Phase I Clinical Trials
Date & Time: Monday, April 20, 2PM–5PM PT
Location: Poster Section 51
Poster Board Number: 22
Abstract Presentation Number: CT130

PHST001 combination with standard-of-care chemotherapy enhances macrophage-mediated elimination of tumor cells
Session Title: Combination Immunotherapies
Date & Time: Monday, April 20, 9AM–12PM PT
Location: Poster Section 8
Poster Board Number: 11
Poster Number: 1557

PHST001, a humanized anti-CD24 hIgG4 antibody, is effective against metastatic tumors and retains its anti-tumor activity in the presence of competing IgG
Session Title: Monoclonal Antibodies and Antibody-Cytokine Platforms
Date & Time: Tuesday, April 21, 9AM–12PM PT
Location: Poster Section 9
Poster Board Number: 24
Poster Number: 4353

About CD24

CD24 is a cell surface protein that plays a key role in tumor immune evasion by engaging Siglec-10, an inhibitory receptor on macrophages. This interaction suppresses macrophage-mediated clearance of cancer cells, allowing tumors to escape destruction by the innate immune system. CD24 was identified as a novel macrophage checkpoint through foundational work by Dr. Amira Barkal, principal founder of Pheast. Along with other co-founders, Drs. Irving Weissman, Ravi Majeti, and Roy Maute, Pheast’s research opened the door to therapeutic strategies targeting CD24 to drive innate immune responses against cancer.

About PHST001

PHST001 is an anti-CD24 macrophage checkpoint inhibitor designed to overcome immune suppression in the tumor microenvironment. CD24 is highly expressed by many human cancers and high expression of CD24 is a negative prognostic factor in multiple cancer indications. Pheast has engineered PHST001 to be a potential best-in-class antibody designed to induce macrophages to phagocytose cancer cells and initiate a powerful immune response. PHST001-101 is an open-label, multicenter Phase 1 study in patients with advanced solid tumors (ClinicalTrials.gov Identifier: NCT06840886). Primary objectives include safety, tolerability, and dose optimization, with secondary objectives evaluating pharmacokinetics and preliminary anti-tumor activity.

(Press release, Pheast Therapeutics, MAR 17, 2026, View Source [SID1234663649])

Onchilles Pharma to Present New Preclinical Data on Systemically Delivered NEU-002 Program at AACR 2026

On March 17, 2026 Onchilles Pharma, a private biotech company advancing therapeutics targeting the ELANE pathway, reported that new preclinical data supporting its systemically delivered NEU-002 program will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, taking place April 17-22 in San Diego. The presentation will highlight the translational development of NEU-002, an engineered therapeutic elastase specifically designed for systemic administration, demonstrating anti-tumor activity via both intravenous and intraperitoneal delivery in solid tumors.

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"With our clinical-stage lead program, N17350, establishing the foundational proof-of-concept for the ELANE pathway, NEU-002 represents our second program and extends this approach into systemic delivery for solid tumors," said Court Turner, Co-Founder and Chief Executive Officer of Onchilles Pharma. "The data to be presented reflect our progress in engineering a systemically deliverable therapeutic that maintains anti-tumor activity and supports the advancement of NEU-002 toward development candidate selection and clinical translation."

Presentation Details

Title: Translational Development of NEU-002: Engineered Therapeutic Elastases Demonstrate Systemic Anti-Tumor Activity via Intraperitoneal and Intravenous Administration
Session Category: Experimental and Molecular Therapeutics
Session Title: Innovative Therapeutic Modalities and Translational Platforms
Day & Time: Saturday, April 19, from 2pm to 5pm PDT
Location: Poster Section 13
Poster Board Number: 28
Poster Number: 310

About Onchilles Therapeutic Programs Targeting the ELANE Pathway

At the core of this approach is the ELANE pathway, a unique cancer-selective killing mechanism that leverages a vulnerability shared by many cancer cell types: elevated histone H1 levels. Our pipeline is led by N17350, our first-in-class, clinical-stage program, followed by NEU-002, the second program that extends this approach with systemic delivery. By targeting the ELANE pathway and inducing immunogenic cancer cell death, N17350 and NEU-002 are designed to rapidly eliminate tumors while mobilizing an adaptive immune response, offering the potential for sustained anti-tumor immunity. N17350 and NEU-002 offer a unique approach to treating cancer regardless of their genetic makeup, anatomical origin, or immune status, positioning them as potential gamechangers in cancer therapy.

(Press release, Onchilles Pharma, MAR 17, 2026, View Source [SID1234663648])