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Sapience Therapeutics Presents First Clinical Results from Phase 2 Study of ST316, First-in-Class β-catenin Antagonist, in Second-Line Colorectal Cancer at the American Association for Cancer Research (AACR) Annual Meeting 2026

On April 20, 2026 Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address oncogenic and immune dysregulation that drive cancer, reported the presentation of new data on its clinical and pipeline programs at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, taking place April 17-22, 2026, in San Diego, California. The posters will include the first public disclosure of clinical data from the Phase 2 dose expansion study of ST316, the company’s first in class β-catenin antagonist, in metastatic colorectal cancer (mCRC).

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Colorectal cancer is the third most commonly diagnosed cancer in both men and women and the second leading cause of cancer-related death in the United States.1 The Wnt/β-catenin pathway drives more than 80% of these cases,2 making it one of the highest-value targets in oncology. Despite decades of industry investment, no Wnt-targeted therapy has reached approval, as prior approaches were consistently constrained by systemic toxicity.

In Sapience’s ongoing Phase 2 expansion study of ST316, 15 patients with 2L CRC have been enrolled and treated with a combination of ST316 and standard-of-care, FOLFIRI + bevacizumab. As of an April 13, 2026 cutoff date:

The confirmed objective response rate (ORR) per RECIST 1.1 was 47%, with 7 of 15 patients having a confirmed Partial Response (PR). This ORR compares favorably to historical studies evaluating the combination of anti-VEGF and chemotherapy in 2L CRC (ORR range: 5 – 23%).3
The disease control rate (DCR) was 93%, with 14 patients classified as having Stable Disease (SD) or PR.
Responses were seen in RAS-mutated and RAS-wild type patients, patients with liver metastases, and patients treated with prior bevacizumab.
In the ST316 Phase 1 monotherapy dose escalation study, trial objectives were achieved, which demonstrated:

Potent on-target pharmacodynamic effects, including significant and consistent knock down of Wnt-related signatures in tumor cells but not in adjacent normal cell types, recapitulation of a β-catenin/BCL9 genetic knock-out signature, reduced expression of Wnt target genes, and loss of cancer stem cell features.
Dose-proportional pharmacokinetics that achieve predicted efficacious exposures.
A well-tolerated safety profile, with no dose-limiting toxicities (DLTs) or related serious adverse events (SAEs) observed.
"We are extremely encouraged by the ST316 data we are presenting at AACR (Free AACR Whitepaper) 2026. Metastatic colorectal cancer patients continue to face poor survival outcomes with currently available therapies, and our results highlight ST316’s potential to address a wide segment of this underserved population," said Barry Kappel, Ph.D., Sapience’s Chief Executive Officer. "The efficacy observed in combination with standard-of-care provides a strong foundation for advancing ST316 both within and beyond CRC, and we look forward to initiating additional clinical studies to unlock these opportunities. We are preparing a monotherapy Phase 1b study in familial adenomatous polyposis (FAP), a precancerous Wnt-driven syndrome marked by the development of hundreds of intestinal polyps that typically develops into CRC. With no approved treatments for FAP, ST316 presents a compelling opportunity to meet this critical unmet need."

In addition to the ST316 clinical data, Sapience will also present non-clinical data at AACR (Free AACR Whitepaper) demonstrating that ST316 suppresses and reprograms immunosuppressive myeloid cells that are driven by β-catenin, and on its FraAP program, a first-in-class antagonist of the activator protein 1 (AP-1) complex, showing potent anti-tumor activity in head and neck squamous cell carcinoma (HNSCC) models.

Details of the presentations are as follows:

Title: "ST316, a first in class β-catenin antagonist, demonstrates safety and efficacy in metastatic colorectal cancer (mCRC)"
Session Title: Phase II and Phase III Clinical Trials
Location: Poster Section 52, Poster Board Number 20
Abstract Number: CT156
Date and Time: Monday, April 20, 2026, 2:00PM – 5:00PM PST

Title: "Antagonism of β-catenin/BCL9 interaction suppresses polymorphonuclear myeloid-derived suppressor cell generation and maintenance"
Session Title: Oncogenic Pathways and Cancer Immunity
Location: Poster Section 7, Poster Board Number 5
Abstract Number: 5562
Date and Time: Tuesday, April 21, 2026, 2:00PM – 5:00PM PST

Title: "Targeted antagonism of the activator protein 1 transcription factor complex results in potent anti-tumor activity in HNSCC models"
Session Title: Oncogenic Transcription Factors and Cancer Programs
Location: Poster Section 24, Poster Board Number 17
Abstract Number: 4767
Date and Time: Tuesday, April 21, 2026, 9:00AM – 12:00PM PST

More information can be found on the AACR (Free AACR Whitepaper) Annual Meeting 2026 website.

About the Phase 1/2 Trial of ST316
ST316-101 (NCT05848739) is a first-in-human, open-label, Phase 1/2 dose escalation and expansion study designed to determine the safety, tolerability, PK, PD and early efficacy of ST316. The Phase 1 dose escalation portion of the study tested various dose levels of ST316 in patients with selected advanced solid tumors that are known to harbor abnormalities of the Wnt/β-catenin signaling pathway, including colorectal cancer (CRC). ST316 is currently being evaluated in the Phase 2 dose expansion portion of the study in CRC patients in combination with relevant standards of care and in multiple lines of treatment. The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to ST316 for the treatment of familial adenomatous polyposis (FAP).

About ST316
ST316 is a first-in-class antagonist of the interaction between β-catenin and its co-activator, BCL9, a complex responsible for driving oncogene expression and immune exclusion in multiple cancers where aberrant Wnt/β-catenin pathway signaling is observed. Aberrant activation of the Wnt/β-catenin pathway is a critical driver of tumor progression and immune evasion in tumors including colorectal cancer (CRC). Targeting this pathway is challenging for multiple reasons including its role in normal tissue physiology. BCL9 is a co-activator essential for oncogenic β-catenin activity, but not its physiologic functions, highlighting the β-catenin/BCL9 interaction as a therapeutic target. ST316 was designed to selectively disrupt the β-catenin and BCL9/9L interaction, resulting in disruption of oncogenic Wnt/β-catenin transcriptional activity and potent antitumor activity, with no negative impact on intestinal or bone physiology.

(Press release, Sapience Therapeutics, APR 20, 2026, View Source;catenin-antagonist-in-second-line-colorectal-cancer-at-the-american-association-for-cancer-research-aacr-annual-meeting-2026-302746755.html [SID1234664563])

AACR 2026 Oral Presentation: Abogen Presents Preliminary Results of ABO2203 (mRNA-Encoded CD3×CD19 TCE) from First-in-Human Clinical Study in R/R B-NHL

On April 20, 2026 Abogen, a clinical-stage biotechnology company focused on RNA innovation, reported preliminary clinical results from the first-in-human (FIH) study of ABO2203 in patients with relapsed/refractory B-cell non-Hodgkin lymphoma (R/R B-NHL). The data were presented in an oral session delivered at the AACR (Free AACR Whitepaper) Annual Meeting 2026 in San Diego by Professor Li Wang of Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine.

ABO2203 is a lipid nanoparticle (LNP)-formulated mRNA drug candidate encoding a CD3×CD19 bispecific T-cell engager (TCE). By enabling in vivo TCE expression via mRNA, ABO2203 is designed to mitigate cytokine release syndrome (CRS) while maintaining robust clinical efficacy.

The Key to TCE Therapies: Overcoming CRS Toxicity

Nearly all marketed protein-based TCEs carry black-box warnings for CRS, which remains a primary safety challenge in the development of such therapies. While step-up dosing strategies are commonly used to reduce CRS risk, their effectiveness remains limited: Grade 2 CRS still occurs on average in 13%-22% of patients, with some cases requiring hospitalization or even ICU admission. In addition, from the standpoint of drug development, 2-3 years are typically required for dose-finding to determine an appropriate step-up dosing regimen.

These challenges are further amplified when extending TCE therapies beyond oncology into autoimmune diseases. Patients with autoimmune conditions often exhibit heightened immune responsiveness and lower tolerance for adverse events, further raising the safety threshold. Moreover, given the chronic and generally non-life-threatening nature of these diseases, CRS-related risks present significant clinical barriers, particularly in outpatient settings. In autoimmune diseases where long-term disease stability depends on treatment safety, a favorable safety profile may represent a more meaningful competitive advantage than efficacy alone.

Initial Clinical Data: Proof of Concept Validated, with Unlimited Potential

The first‑in‑human trial of ABO2203 in R/R B‑NHL is a dose‑escalation and expansion study. The presentation included data from nine patients in the dose- escalation stage. Patients had received a median of four prior lines of therapy, and all had failed prior CD20‑targeted therapy. ABO2203 was administered subcutaneously across dose levels ranging from 3 μg to 1,920 μg. The maximum tolerated dose (MTD) has not yet been reached.

Exceptional Safety Profile: ABO2203 was well tolerated across all evaluated dose levels. No dose‑limiting toxicities (DLTs), CRS, or ICANS were observed. Elevations in liver enzyme elevations were limited to Grade 1 and occurred at low incidence. The most common adverse event was Grade 1–2 pyrexia, without clinically significant changes in oxygen saturation or blood pressure. Grade 3/4 events were infrequent and primarily hematologic, with no unexpected safety signals beyond those associated with the TCE class or NHL.

Favorable Pharmacokinetics and Pharmacodynamics: TCE expression was detected across all three dose cohorts. The time to peak concentration was gradual after each administration (Tmax = 5.5 days), with a half‑life of 7.9 days. These findings support an initial once-weekly dosing regimen, with the potential to extend dosing intervals to every two weeks following response, and possibly every three to four weeks thereafter.

In contrast to the "pulse‑like" pharmacokinetic profile of protein‑based TCEs, the mRNA‑expressed TCE demonstrated a flatter and more sustained exposure profile. Compared with a protein TCE of identical amino acid sequence (P4107), which reached peak levels and was eliminated rapidly, ABO2203 exhibited a delayed peak TCE concentration and prolonged half-life. The lower peak concentration (Cmax) may help mitigate cytokine release, while sustained mRNA expression may contribute to more durable anti-tumor efficacy than P4107.

Encouraging Efficacy Signals: Based on Lugano 2014 criteria, objective response rates (ORR) were dose-dependent across cohorts, reaching 33%, 67%, and 100% in the low-, medium-, and high-dose groups, respectively. Complete metabolic responses (CMRs) were observed in both the medium- and high-dose cohorts, with a 100% complete response (CR) rate achieved in the high-dose cohort as updated by Professor Li Wang. Responses were seen across both aggressive (DLBCL) and indolent (FL, MCL, MZL) lymphomas, with a 100% ORR in follicular lymphoma.

Compelling Clinical Significance and Commercial Potential

These findings provide initial clinical proof of concept (PoC) for mRNA-encoded TCE therapeutics, demonstrating a superior safety profile, favorable pharmacodynamics, and encouraging efficacy in B-NHL. The data also suggest potential applications in autoimmune diseases. ABO2203’s ability to effectively deplete B cells within lymph nodes may address a well-recognized limitation of conventional CD19/CD20 monoclonal antibodies and existing TCEs in these indications.

The results come amid growing momentum in the TCE field. Since late 2024, the sector has seen increased deal activity, including Merck’s USD 1.3 billion acquisition of CN201 (CD3/CD19) and GSK’s USD 300 million upfront licensing of Chimagen’s trispecific TCE. More recently, Gilead announced a USD 1.675 billion upfront acquisition of Ouro Medicines and its CD3/BCMA bispecific asset, CM336/OM336 this March. With the global TCE market projected to reach USD 121 billion by 2035 (Frost & Sullivan), ABO2203 represents a promising asset in this rapidly expanding category.

(Press release, Abogen Biosciences, APR 20, 2026, View Source [SID1234664562])

Inhibrx To Host Webcast Presentation to Provide Clinical Update on Ozekibart (INBRX-109) in Late Line Colorectal Cancer

On April 20, 2026 Inhibrx Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapeutics for oncology and rare diseases, reported that it will host a live webcast presentation on Tuesday, April 21, 2026 at 1:30 p.m. Pacific Time to provide a clinical update from its Phase 1/2 study evaluating ozekibart (INBRX-109) in combination with FOLFIRI in patients with locally advanced or metastatic, unresectable colorectal cancer (CRC).

Investors may join via the web: View Source or may listen to the call by dialing (1-888-880-3330). Please refer to Inhibrx Biosciences, Inc. or the conference ID 9536529 when calling in. Following the webcast, the presentation may be accessed through a link on the "Events and Presentations" section of Inhibrx’s website. The webcast will be available for 60 days following the event. Following the presentation, Inhibrx will also update its corporate presentation within the "Investors" section of its website at www.inhibrx.com.

About ozekibart (INBRX-109)
Ozekibart is a precision-engineered, tetravalent death receptor 5 (DR5) agonist antibody designed to exploit the tumor-biased cell death induced by DR5 activation. In January 2021, the FDA granted Fast Track designation to ozekibart for the treatment of patients with metastatic or unresectable conventional chondrosarcoma, and, in November 2021, the FDA granted orphan drug designation to ozekibart for chondrosarcoma.

In June 2021, Inhibrx initiated a randomized, blinded, placebo-controlled, registrational trial of ozekibart in metastatic, unresectable conventional chondrosarcoma. The trial enrolled a total of 206 patients across 67 different sites worldwide. In October 2025, Inhibrx announced the ChonDRAgon study met its primary endpoint of a statistically significant and clinically meaningful median progression-free survival (PFS) for patients with advanced or metastatic chondrosarcoma treated with ozekibart compared to placebo. Ozekibart achieved a 52% reduction in the risk of disease progression or death compared to placebo (stratified Hazard Ratio [HR] 0.479; 95% CI: 0.33, 0.68); P<0.0001), more than doubling median PFS to 5.52 months versus 2.66 months for placebo. Importantly, ozekibart is the first investigational therapy to demonstrate a significant PFS benefit in a randomized trial for chondrosarcoma, a disease with no approved systemic options.

Additionally, in Phase 1/2 trials, Inhibrx is investigating ozekibart in colorectal cancer in combination with FOLFIRI and Ewing sarcoma in combination with irinotecan/temozolomide, as well as other tumor types.

(Press release, Inhibrx, APR 20, 2026, View Source [SID1234664561])

Rznomics Reports Interim Clinical Data for RZ-001 in Hepatocellular Carcinoma at AACR 2026 Demonstrating Encouraging Efficacy and Favorable Safety Profile

On April 20, 2026 Rznomics reported that it presented interim clinical data from its ongoing study of RZ-001, an RNA editing-based investigational anticancer therapy, in patients with hepatocellular carcinoma (HCC) during an oral presentation at the AACR (Free AACR Whitepaper) 2026 (American Association for Cancer Research Annual Meeting), held on April 19, 2026, in San Diego, California.

The presentation was delivered by Professor Yoon-Jun Kim of the Department of Gastroenterology at Seoul National University Hospital.

The study includes patients with HCC who are refractory to or ineligible for transarterial chemoembolization (TACE) and have not received prior systemic therapy.

According to the data presented, combination treatment of RZ-001 with atezolizumab and bevacizumab demonstrated an objective response rate (ORR) of 38.5% (confirmed) and 46.2% (unconfirmed) based on RECIST v1.1 criteria.

Under mRECIST criteria, the ORR reached 61.5%, with a complete response (CR) rate of 23%, suggesting deep tumor responses. Given that mRECIST reflects tumor necrosis, these findings may indicate meaningful therapeutic impact in HCC.

At interim analysis, responses are typically categorized as "confirmed" or "unconfirmed." Confirmed responses are those validated through subsequent assessments, while unconfirmed responses represent initial observations. In this study, patients classified as having "unconfirmed PR" under RECIST criteria had achieved an initial tumor size reduction of at least 30%.

In terms of safety, a total of five Grade 3 or higher adverse events were reported as related to combination agents, including hypertension (2 cases), proteinuria, hyperglycemia, and gastrointestinal bleeding. Notably, no Grade 3 or higher adverse events were attributed to RZ-001.

The company believes these results demonstrate a favorable safety profile for RZ-001, with no treatment-related safety concerns identified to date, along with encouraging signals of antitumor activity in terms of both response depth and overall response rate in combination with standard immunotherapy.

"This oral presentation at AACR (Free AACR Whitepaper) represents an important milestone for our lead program RZ-001," said Seong-Wook Lee, Chief Executive Officer of Rznomics. "We are encouraged by the early efficacy and safety signals observed, and we believe these data support the potential of RZ-001 as a novel therapeutic approach for HCC."

He added, "Beyond the RZ-001 program, these findings could further support the clinical applicability of our RNA trans-splicing ribozyme platform technology."

Hepatocellular Carcinoma (HCC)

Hepatocellular Carcinoma (HCC) is the most common type of primary liver cancer, accounting for the vast majority of liver cancer cases worldwide. It originates in the hepatocytes, the main cells of the liver, and is often associated with chronic liver diseases such as cirrhosis or viral hepatitis (B or C). HCC is known for its aggressive nature and high recurrence rates, presenting a significant global health challenge. Because it is often diagnosed at advanced stages, there is a critical unmet medical need for innovative therapies that can provide deeper and more durable responses than current systemic treatments.

Transarterial Chemoembolization (TACE)

Transarterial Chemoembolization (TACE) is a minimally invasive, localized procedure frequently used to treat patients with intermediate-stage liver cancer. The procedure involves delivering a concentrated dose of chemotherapy directly to the tumor through the hepatic artery, while simultaneously blocking (embolizing) the blood vessels that supply the tumor with oxygen and nutrients. While TACE can be effective for localized control, patients are considered "TACE refractory" when the tumor continues to progress or recurs despite multiple sessions, at which point systemic therapy is typically required.

RECIST v1.1 (Response Evaluation Criteria in Solid Tumors)

RECIST v1.1 is the standardized international guideline used to evaluate how solid tumors respond to treatment based on anatomical changes in tumor size. It primarily focuses on the sum of the longest diameters of target lesions, where a significant reduction in physical dimensions is categorized as a "response." While it remains the gold standard for most oncology trials, it mainly tracks physical shrinkage and may not fully capture the immediate biological impact of therapies that induce cell death without an immediate change in the overall tumor mass.

mRECIST (modified RECIST)

mRECIST is a specialized assessment tool developed specifically for Hepatocellular Carcinoma (HCC) to provide a more accurate evaluation of therapeutic efficacy. Unlike traditional criteria that measure the total size of a tumor, mRECIST focuses on the "viable" or living portion by measuring arterial enhancement—the area with active blood flow as seen on imaging. This is particularly critical in HCC because effective targeted or local treatments often cause internal tumor necrosis (cell death). In such cases, the tumor’s overall size may remain the same even though the cancer cells are dead, a successful response that mRECIST is uniquely designed to capture.

(Press release, Rznomics, APR 20, 2026, View Source [SID1234664560])

Cadonilimab Combination Demonstrates Promising Survival Benefit in Locally Advanced Pancreatic Cancer: Phase II COMPASSION-26 Data Presented at AACR 2026

On April 20, 2026 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that positive Phase II results from the COMPASSION-26 study evaluating cadonilimab, its first-in-class PD-1/CTLA-4 bispecific antibody, in combination with chemotherapy as first-line treatment for advanced pancreatic ductal adenocarcinoma (PDAC), were presented at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.

As of the October 20, 2025 data cutoff, with a median follow-up of more than two years, the cadonilimab plus chemotherapy combination continued to deliver robust and durable survival benefits. Results were particularly strong in patients with locally advanced disease, where the median PFS reached 11.1 months and the median OS exceeded 23 months. Landmark survival rates in this group included a 12-month OS rate of 91.7% and a 24-month OS rate of 44.1%.

The cadonilimab regimen also provided strong tumor control across the overall study population. Of the patients evaluable for efficacy (95% had at least one post-baseline tumor assessment), the objective response rate (ORR) was 33.9% and the disease control rate (DCR) reached 96.4%. Response rates were similar between patients with locally advanced and metastatic disease, indicating consistent benefit across both subgroups.

No new safety signals were identified, and the overall safety profile of the cadonilimab combination remained favorable and manageable.

Cadonilimab is the world’s first approved bispecific antibody for cancer immunotherapy, having received marketing approval in 2022. In extensive real-world clinical practice and multiple Phase III studies, it has demonstrated clinically meaningful benefit across all patient populations regardless of PD-L1 expression status, addressing a significant unmet medical need and earning broad recognition from physicians and patients.

As a cornerstone therapy in the era of tumor immunotherapy 2.0, cadonilimab not only offers the significant advantage of clinical benefit across broad patient populations, but has also demonstrated important breakthrough potential in difficult-to-treat settings, including immunotherapy-refractory disease and immunologically "cold" tumors. Akeso is fully leveraging its global leadership in bispecific antibody development for oncology to continue addressing major unmet clinical needs and advancing transformative treatment options for patients with challenging cancers.

(Press release, Akeso Biopharma, APR 20, 2026, View Source [SID1234664559])