Palleon Pharmaceuticals Presents First-in-Class B7-H3 Targeted Sialidase at the 2026 AACR Annual Meeting

On April 20, 2026 Palleon Pharmaceuticals reported preclinical data and announced the initiation of a human clinical trial for E-688/HLX316, a first-in-class B7-H3 targeted sialidase, in an oral presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting "New Drugs on the Horizon" session. The presentation, titled "E-688/HLX316: A First-in-Class B7-H3 Targeted Sialidase for Boosting Innate and Adaptive Anti-Tumor Immunity" introduces the first ever tumor-targeted enzymatic desialylation agent to enter the clinic.

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Tumor hypersialylation — the upregulation of sialic acid-containing glycans on the surface of cancer cells — activates several sialic acid-dependent immune regulatory pathways that suppress anti-tumor immunity. This axis of immune evasion is present across the majority of solid tumors and correlates with poor clinical outcomes in dozens of published studies. Conventional antibodies and small molecules cannot effectively disrupt this redundant glycan-mediated immunosuppression. Palleon’s engineered human sialidase overcomes this challenge by enzymatically removing sialic acid from the tumor surface, broadly neutralizing sialic acid-mediated immune suppression.

Palleon’s first-generation sialidase, E-602, established human proof-of-mechanism and a favorable tolerability profile in a previous clinical trial and is now in Phase 2 development in autoimmunity. This early clinical experience helped define the additional design requirements needed for the oncology clinical setting: durable tumor-localized desialylation and direct tumor cell killing. E-688/HLX316 was engineered to satisfy both conditions, and preclinical data confirm that it extends tumor surface desialylation to more than seven days in vivo and outperforms anti-PD-1 as a single agent in humanized tumor models, enhancing both innate and adaptive anti-tumor immunity.

"Tumor hypersialylation is now an addressable axis of immune evasion that is independent of PD-1/L1 biology," said Jim Broderick, M.D., CEO and Founder of Palleon Pharmaceuticals. "Our first-generation clinical experience identified the attributes of an effective oncology sialidase and informed the design of E-688/HLX316. The preclinical package confirms the approach works as intended."

E-688/HLX316 is being evaluated in a first-in-human monotherapy trial in platinum-resistant ovarian cancer in China led by Palleon’s strategic collaborator Henlius. Palleon’s clinical roadmap includes a systematic expansion into other large cancer populations characterized by high B7-H3 expression and hypersialylation, including lung and prostate cancer.

(Press release, Palleon Pharmaceuticals, APR 20, 2026, View Source [SID1234664578])

Nykode Therapeutics Presents Additional Immunogenicity Data from VB-C-03 Trial at the 2026 American Association for Cancer Research (AACR) Annual Meeting

On April 20, 2026 Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported the poster presentation of additional immunogenicity data from the VB-C-03 clinical trial at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.

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The data build on results initially presented at the 10th International Congress on Innovative Approaches in Head & Neck Oncology (ICHNO) in March 2026, which demonstrated a confirmed objective response rate of 38.5% and strong immunogenicity signals. The current results support an even more robust immunogenicity, with now 11 evaluable patients, where all 10 patients (100%) in the 6 and 9 mg dose groups showed HPV16-specific vaccine-induced immune responses. The responses were both rapid and durable, with a demonstrated persistence into the last analyzed timepoint at the completed end-of-treatment.

"The consistency and strength of the T-cell responses we are observing across patients underscore that abi-suva has the makings of a best-in-class vaccine for HPV16-positive cancers. For patients with recurrent or metastatic head and neck cancer, where current treatments offer a response rate of only around 19%, a therapy that can generate this quality of immune response alongside meaningful clinical activity could represent a real step forward. We enter the Abili-T trial with a well-defined dose, a strong immune response profile, and a competitive data package that sets abi-suva apart from other approaches in this indication and we are deeply motivated by the opportunity to make a difference for these patients," said Agnete Fredriksen, CSO and Co-founder of Nykode Therapeutics.

The poster will be available after the session at the Company’s Webpage: View Source

(Press release, Nykode Therapeutics, APR 20, 2026, View Source [SID1234664545])

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.

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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])

Junshi Biosciences Presents Results from JS207 (PD-1/VEGF BsAb) Phase 2 Combo Studies and JS212 (EGFR/HER3 ADC) FIH Phase 1/2 Study at AACR 2026

On April 20, 2026 Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, reported that early clinical results from four studies across its innovative pipeline were presented at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, featuring: the recombinant humanized anti-EGFR/HER3 bispecific antibody-drug conjugate (ADC) JS212, the anti-PD-1/VEGF bispecific antibody JS207, and the anti-CTLA-4 monoclonal antibody JS007.

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Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences, said, "At this year’s AACR (Free AACR Whitepaper) Annual Meeting, we reported not only two combination therapy datasets for our bispecific antibody, JS207, but also first-in-human results for the bispecific ADC, JS212. Their results demonstrated highly encouraging clinical profiles. As cornerstone assets under our Immuno-Oncology 2.0 (IO 2.0) strategy, these novel therapies have exceptional development potential. Their enhanced efficacy, activity against treatment-resistant populations, and broad-spectrum antitumor coverage position them as our next-generation flagship products. We are accelerating proof-of-concept clinical studies to identify optimal indications and deliver superior treatment options to patients."

#CT159: Preliminary results from a phase 2 study evaluating JS207 in combination with JS007 as first-line treatment for advanced hepatocellular carcinoma (HCC)

The Phase 2 study (NCT06954467) aiming to evaluate the safety and efficacy of JS207 in combination with JS007 included a safety run-in period and a randomized expansion phase, which enrolled patients with unresectable or metastatic HCC who had not previously received any systemic anticancer therapy.

As of March 20, 2026, a total of 26 patients had received JS207 plus JS007, including 7 patients in the safety run-in period and 19 patients in the randomized expansion phase.

Among the 22 evaluable patients, the objective response rate (ORR) reached 45.5% while the disease control rate (DCR) was 86.4%.
JS207 plus JS007 was well-tolerated, with no dose-limiting toxicities (DLT) observed during the safety run-in period.

Preliminary findings from the study demonstrate that JS207 combined with JS007 exhibits encouraging synergistic efficacy and favorable tolerability as first-line treatment for advanced HCC. Patient enrollment continues to progress smoothly, potentially offering a novel therapeutic approach for advanced HCC patients.

#CT152: Preliminary results from a phase 2 study evaluating JS207 in combination with chemotherapy as first-line treatment of metastatic colorectal cancer (mCRC)

This Phase 2 study (NCT06885385) evaluates the preliminary safety and efficacy of JS207 in combination with XELOX (capecitabine + oxaliplatin) as first-line therapy for mCRC. The study enrolled patients with mCRC who had not previously received systemic antitumor therapy for metastatic disease, or whose disease recurred/progressed at least 12 months after their last neoadjuvant/adjuvant therapy.

Patients received JS207 at 10 mg/kg combined with the XELOX regimen (oxaliplatin 130 mg/m² IV, d1 + capecitabine 1000 mg/m², BID, d1-14) every 3 weeks until disease progression or intolerable toxicity.

As of January 13, 2026, 32 patients had been enrolled and received JS207 plus XELOX, including 9 in the safety run-in phase and 23 in the dose-expansion phase.

Among the 31 efficacy-evaluable patients, 22 achieved a partial response (PR) and 8 achieved stable disease (SD), resulting in an ORR of 71.0% and a DCR of 96.8%.
Due to the relatively short follow-up duration, median progression-free survival (PFS) and median duration of response (DoR) have not yet been reached, and the longest duration of response remained ongoing at 8 months.
JS207 was well-tolerated overall, with no DLTs observed during the safety run-in period.

The study demonstrates that JS207 combined with chemotherapy exhibits promising antitumor activity and a favorable safety profile as first-line treatment for mCRC. These findings suggest that dual-target immunotherapy (anti-PD-1/VEGF) plus chemotherapy holds significant potential in immunologically cold tumors, providing critical clinical evidence for immuno-combination therapy as first-line treatment of mCRC.

#1715: Preclinical evaluation of JS212

Preclinical studies of JS212 (EGFR/HER3 bsAb) demonstrate high binding affinity to tumor cells expressing EGFR and/or HER3, exhibiting superior broad-spectrum antitumor activity, favorable tolerability, and optimal pharmacokinetic profiles. In multiple cell-derived xenograft (CDX) models, JS212 showed enhanced antitumor efficacy compared to the benchmark agent. Notably, it demonstrated efficacy in osimertinib-resistant, patritumab deruxtecan-resistant, and BL-B01D1-resistant CDX models.

#CT128: Preliminary results from JS212’s first-in-human (FIH) phase 1/2 study in advanced solid tumors

This FIH phase 1/2 study (NCT06888830) was designed to assess the safety, tolerability, PK, and preliminary efficacy of JS212 in patients with advanced solid tumors. It comprised dose escalation and expansion and clinical expansion. As of March 26, 2026, a total of 63 patients have been enrolled.

JS212 was administered every three weeks. The treatment was well-tolerated, and the maximum tolerated dose (MTD) was not reached.
Responses were observed at the 1.8 mg/kg cohort and above.
In the 4.2 mg/kg and 4.6 mg/kg dose cohorts, ORR reached 44.4% and 50.0% respectively, with a DCR of 100.0% in both groups. The median DoR has not yet been reached.
An ORR of 50.0% was observed in HER2-negative breast cancer and 38.9% in esophageal squamous cell carcinoma.

JS212 monotherapy exhibits encouraging efficacy across a range of dose levels (as low as 1.8 mg/kg) with favorable tolerability in advanced solid tumors, indicating promising development potential. Further exploration of JS212 in multiple indications and combination strategies are ongoing.

About JS207

JS207, a recombinant humanized anti-PD-1/VEGF bispecific antibody, was independently developed by Junshi Biosciences for the treatment of advanced malignant tumors. To date, JS207 has been approved for conducting phase 2/3 clinical study, and it has 11 ongoing phase 2 clinical studies, exploring its use in combination with chemotherapy, monoclonal antibodies, ADCs and other drugs in NSCLC, colorectal cancer, triple-negative breast cancer, liver cancer and other tumor types. Preclinical results of JS207 have been published in Frontiers in Immunology, while early-stage clinical data were first presented in a poster session at ESMO (Free ESMO Whitepaper) ASIA 2025.

JS207 can simultaneously bind to PD-1 and VEGFA with high affinity, effectively blocking the binding of PD-1 to PD-L1 and PD-L2 while also inhibiting the binding of VEGF to its receptor. JS207 has the efficacy of both immunotherapeutic drugs and anti-angiogenic drugs. Through the neutralization of VEGF, JS207 inhibits the proliferation of vascular endothelial cells, improves the tumor microenvironment, and increases the infiltration of cytotoxic T lymphocytes in the tumor microenvironment, thereby achieving better anti-neoplasm activity.

JS207’s design is based on the high-affinity, clinically proven and differentiated anti-PD-1 drug, toripalimab as the backbone. The anti-PD-1 moiety of JS207 adopts a Fab structure to maintain binding affinity to PD-1, thereby attaining better enrichment in the tumor microenvironment. The anti-VEGF moiety has a binding affinity for human vascular endothelial growth factor that is comparable to that of bevacizumab. In non-clinical in vitro cytological tests, compared with the combination of an anti-PD-1/PD-L1 monoclonal antibody and a VEGF monoclonal antibody, a bispecific antibody simultaneously targeting PD-1/PD-L1 and VEGF demonstrated significantly enhanced PD-1 antigen binding and internalization, as well as synergistic enhancement of the NFAT signaling pathway, thereby better activating immune cells in the tumor microenvironment.

About JS007

JS007 is a recombinant humanized anti-CTLA-4 monoclonal antibody developed independently by Junshi Biosciences that is mainly aimed at treating advanced cancer.

Cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) is an important receptor on the T cell surface that modulates immune response. Studies show that JS007 is able to specifically bind to CTLA-4 and effectively block the interaction between CTLA-4 and its ligand B7 (CD80 or CD86), thereby activating the T-lymphocyte and inhibiting tumor growth.

About JS212

JS212 is a recombinant humanized EGFR and HER3 bispecific ADC that is mainly used for the treatment of advanced malignant solid tumors. EGFR and HER3 are highly expressed in a variety of cancers, such as lung cancer, breast cancer and head and neck cancer etc. There is interaction in the signaling pathways between EGFR and HER3, and they jointly facilitate the proliferation, survival, migration and angiogenesis of tumor cells. In addition, HER3 is involved in the drug-resistance mechanisms of various anti-tumor drugs (including EGFR-targeted drugs, chemotherapy, etc.). Compared to single-target ADC drugs, JS212 can suppress tumors by binding to both EGFR and HER3, and may be effective on a wider range of tumors and overcome drug resistance.

According to preclinical studies, JS212’s high affinity and specific binding to EGFR and HER3 resulted in a significant anti-tumor effect in various animal models. JS212 also maintained a favorable and acceptable safety profile.

To date, an open-label, dose-escalation and dose-expansion phase 1/2 clinical trial of JS212 is underway in Chinese Mainland. The study is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of JS212 in patients with advanced solid tumors. In addition, the clinical trial application for JS212 as a multi-cohort combined drug was approved by the National Medical Products Administration of China (NMPA) in November 2025. The phase 2 clinical trial evaluating JS207 in combination with JS212 is underway. In December 2025, the investigational new drug (IND) application for JS212 for the treatment of advanced solid tumors was approved by the U.S. Food and Drug Administration (FDA).

(Press release, Shanghai Junshi Bioscience, APR 20, 2026, View Source [SID1234664579])

Adcendo ApS Provides Updates on Pipeline Progress and Recent Achievements for Its First- and Best-in-Class Antibody-Drug Conjugates

On April 20, 2026 Adcendo ApS ("Adcendo"), a biotech company focused on the development of first- and best-in-class antibody-drug conjugates (ADCs) for the treatment of cancers with high unmet medical need, reported multiple clinical and regulatory updates for the Company’s pipeline of first- and best-in-class ADCs.

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ADCE-T02 has advanced into cohort expansion portion of Tiffany-01 study. ADCE-T02 is a potential best-in-class Topo-I inhibitor-based ADC targeting tissue factor (TF), a clinically validated target overexpressed in a broad range of solid tumors (i.e., head and neck squamous cell carcinoma, pancreatic ductaladenocarcinoma, non-small cell lung cancer and colorectal cancer, among others), with limited expression in normal tissues.

ADCE-T02 is currently being evaluated as a monotherapy in the Phase I Tiffany-01 (NCT06597721) clinical trial in patients with advanced solid tumors. The first patients have now been enrolled in the cohort expansion portion of Tiffany-01 across multiple solid tumor indications. The expansion cohorts are designed to evaluate two go-forward dose levels in a randomized setting, supporting dose optimization and enabling additional assessments of safety, anti-tumor activity, and durability of response. These data are expected to further clinical proof of concept and better inform the potential therapeutic profile of ADCE-T02 across multiple solid tumor indications.

An abstract highlighting new preclinical findings underpinning ADCE-T02 clinical development plans was selected for poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2026 Annual Meeting. The abstract is available now in AACR (Free AACR Whitepaper)’s online itinerary planner. The poster, titled "ADCE-T02 – A clinical stage antibody drug conjugate targeting tissue factor demonstrates strong efficacy in preclinical models of head and neck squamous cell carcinoma" (Poulsen, et al) will be presented on April 22, 2026, from 9:00am to 12:00pm PT.

A manuscript highlighting additional ADCE-T02 preclinical data was selected for publication in the AACR (Free AACR Whitepaper) journal Molecular Cancer Therapeutics. The manuscript, titled "ADCE-T02 – A Next Generation Antibody Drug Conjugate Targeting Tissue Factor Demonstrates Superior Preclinical Efficacy and Tolerability" (Poulsen, et al) is now available online here. The published manuscript highlights the unique design of ADCE-T02 facilitating a strong in vivo efficacy in a range of preclinical models and good tolerability in non-human primates, showing no evidence of ocular, skin and lung toxicity, peripheral nerve damage, or bleedings. These data further support the clinical development of ADCE-T02 as a novel TF-targeting ADC with a potentially superior therapeutic window.

ADCE-D01 granted Orphan Drug Designation by U.S. FDA. ADCE-D01 is a first-in-class ADC targeting uPARAP conjugated to the Topo- I inhibitor payload P1021. uPARAP is a novel endocytic receptor ADC target that is overexpressed in tumors of mesenchymal origin, such as sarcomas. ADCE-D01 recently received Orphan Drug Designation (ODD) from the U.S. FDA for the treatment of soft tissue sarcoma. This ODD follows the receipt of Fast Track Designation from the FDA which was received in Oct 2025. ADCE-D01 is currently being evaluated as a monotherapy in the Phase I ADCElerate1 (NCT06797999) clinical trial in patients with metastatic and/or unresectable soft tissue sarcoma (STS).

First patient dosed in the First-in-human Phase 1 trial of ADCE-B05 in the US. ADCE-B05 is a first-in-class ADC directed against a novel, undisclosed ADC target overexpressed in multiple tumors of squamous origin. ADCE-B05 is being evaluated as monotherapy in a first-in-human Phase I (NCT07362888) clinical trial enrolling patients across US and Australian sites.

Dr. Lone Ottesen MD, PhD, Chief Medical Officer of Adcendo, said: "We are extremely pleased about the significant progress made across all programs of our unique first- and best-in class ADC pipeline. Together with world leading clinical centers, we are enrolling patients with high unmet need cancers in three separate Phase 1 trials. With the proceeds from our recent Series C financing round, we will further accelerate our clinical programs, thereby getting closer to our vision to deliver new treatments to cancer patients with limited options."

(Press release, ADCendo, APR 20, 2026, View Source [SID1234664530])