STAR-121 Update

On April 20, 2026, Arcus Biosciences, Inc. (the "Company") reported the discontinuation of the Phase 3 STAR-121 study, which is being conducted in collaboration with Gilead Sciences, Inc. ("Gilead"), due to futility. STAR-121 evaluated the anti-TIGIT antibody domvanalimab plus anti-PD-1 antibody zimberelimab and chemotherapy versus pembrolizumab plus chemotherapy as a first-line treatment for metastatic non-small cell lung cancer. The decision is based on the recommendation from the Independent Data Monitoring Committee ("IDMC"), following its review of data from a pre-planned futility analysis. Safety was not assessed at this futility analysis; however, no new safety issues have been identified during regular reviews by the IDMC.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The STAR-121 study also evaluated zimberelimab and chemotherapy as an exploratory endpoint. Zimberelimab plus chemotherapy performed consistently with respect to overall survival as compared to pembrolizumab plus chemotherapy.

STAR-121, along with the Phase 2 EDGE-Lung study, will be discontinued. Gilead is communicating with investigators to determine appropriate next steps for patients in these studies.

Gilead Collaboration Update.

On April 20, 2026, the Company announced that the period for Gilead’s option rights under the Option, License and Collaboration Agreement entered into between the Company and Gilead in 2020, as amended, will end on July 14, 2026, following Gilead’s decision to not make the option continuation payment to the Company. Accordingly, Gilead will not have option rights to additional programs in the Company’s early-stage pipeline, including the CCR6, CD89 and CD40L programs, but will maintain its existing time-limited options to programs including AB801 (an investigational small molecule AXL inhibitor), AB598 (an investigational anti-CD39 monoclonal antibody), AB102 (an investigational MRGPRX2 antagonist), and an investigational TNF small molecule inhibitor.

The Company has full rights to casdatifan and the casdatifan development program, other than those rights licensed to Taiho in Japan and certain other Asian territories (not including China).

(Press release, Arcus Biosciences, APR 20, 2026, View Source [SID1234664534])

Allogene Therapeutics Showcases Momentum with Clinical and Platform Advancements in Allogeneic CAR T at AACR 2026

On April 20, 2026 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products, reported upcoming presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, April 17-22, 2026, in San Diego, Calif.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Allogene’s presentations at AACR (Free AACR Whitepaper) highlight the potential of allogeneic CAR T to expand access, simplify delivery, and enable broader application of cell therapy across diseases when its inherent advantages are fully leveraged. The Company will participate in several AACR (Free AACR Whitepaper) 2026 scientific forums, including:

Poster: Preclinical Evaluation of Allogeneic BCMA/CD70 Dual CAR T Cells for High-Risk Multiple Myeloma
Presenter: Mark K. O’Dair, PhD, Allogene
Session Title: CAR T Cell Targets and TME Reprogramming
Poster Number: 1535
Location: Poster Section 7, Board 17
Session Date and Time: Monday, April 20, 9:00am-12:00pm PT

Based on its foundational work in oncology, Allogene is extending its Dagger technology into autoimmune disease, applying its gene-edited, dual-targeting CAR T approach to target both BCMA and CD70 on malignant plasma cells as well as selectively eliminate alloreactive immune cells to promote durable persistence with reduced need for chemotherapy-based lymphodepletion. This strategy builds on the Company’s expertise in allogeneic cell therapy in advanced renal cell carcinoma and is designed to deliver a readily available, off-the-shelf treatment with the potential to transform how both cancer and autoimmune diseases are treated.

Major Symposium: Off-the-Shelf Cell Therapies for Cancer and Beyond
Presenter: David Chang, M.D., Ph.D., President, CEO and Co-Founder, Allogene Therapeutics
Title: Allogeneic CAR-T: Science at Scale (SY13-03)
Location: Room 28 – Upper Level – Convention Center
Session Date and Time: Tuesday, April 21, 12:30-2:00pm PT

The future of CAR T will be defined by its ability to reach more patients, more reliably and earlier in the course of disease. Allogene’s allogeneic approach is designed to unlock this potential across five key dimensions: speed, with on-demand availability; safety, manageable across care settings; simplicity, as a one-time outpatient treatment; scalability, enabling broad patient access; and survival, with the potential to deliver meaningful clinical outcomes. Together, these attributes represent a path toward making CAR T a more practical and widely accessible therapy.

Forum: Cell Therapy at a Crossroads: Exploring the Evolving Landscape between Autologous, Allogeneic, and In Vivo Engineering (Session: FO06)
Presenter: Zachary Roberts, M.D., Ph.D., EVP, Research and Development, CMO, Allogene Therapeutics
Location: Ballroom 20 AB – Upper Level – Convention Center
Session Date and Time: Tuesday, April 21, 5:00pm-6:30pm PT

Allogeneic CAR T therapy represents a major step forward in the evolution from autologous products. With extensive experience across both hematologic and solid tumors, Allogene has been a singular leader since the earliest days of allogeneic cell therapy and has defined a path through many of the scientific challenges the field has faced. As key trials advance Allogene is positioning allogeneic CAR T as a bridge to biologic-like manufacturing scale necessary to address an ever-growing patient demand for these life-saving products.

(Press release, Allogene, APR 20, 2026, View Source [SID1234664533])

New data from investigator‑initiated study evaluating Alligator Bioscience’s mitazalimab to be presented at AACR Annual Meeting 2026

On April 20, 2026 Alligator Bioscience (Nasdaq Stockholm: ATORX), a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs, reported that new data from a Phase 1 investigator‑initiated trial evaluating intratumoral mitazalimab administered in conjunction with irreversible electroporation (IRE) in locally advanced pancreatic ductal adenocarcinoma (PDAC) will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026. The meeting takes place between 17-22 April 2026, in San Diego, California.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The abstract reports updated immunological findings from the ongoing Phase 1 dose‑escalation study (NCT06205849). The study assesses mitazalimab when injected directly into the tumor at the time of surgical IRE in patients with locally advanced PDAC after standard-of-care chemotherapy.

The abstract highlights that all six patients with completed pre‑ and post‑treatment analyses demonstrated T‑cell reactivity to patient‑specific neoantigens. Overall, neoantigen reactivity increased significantly following treatment, indicating that mitazalimab + IRE results in an expansion of tumor specific T cells.

"Scientific interest in mitazalimab continues to grow, not least through the momentum we see in our investigator-initiated trials," said Søren Bregenholt, CEO of Alligator Bioscience. "The data presented at AACR (Free AACR Whitepaper) provide further evidence of the mechanistic potential of CD40 agonism to enhance antitumor immunity, even in difficult-to-treat cancers such as pancreatic cancer. We greatly value the engagement from leading academic centers who are exploring mitazalimab in innovative clinical settings, reflecting the continued confidence in its therapeutic promise."
Abstract details
Title: Irreversible electroporation (IRE) with intratumoral CD40 antibody increases T cell reactivity to personalized neoantigens in locally advanced pancreatic cancer
Time: Monday, 20 April 2026, 09:00 am – 12:00 pm PDT
Session: PO.CTP01.01 – Phase I Clinical Trials in Progress, Section 51
Presenter: Dr. Rebekah R. White, UC San Diego School of Medicine, La Jolla, CA

The accepted abstract is available at aacr.org.

(Press release, Alligator Bioscience, APR 20, 2026, View Source [SID1234664532])

Akari Therapeutics Reports Positive Preclinical Data for AKTX-101 Demonstrating Differentiated Cytotoxicity for First-in-Class TROP2 ADC Payload Targeting RNA Splicing

On April 20, 2026 Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing antibody drug conjugates (ADCs) with a novel RNA splicing modulator payload, reported the presentation of positive preclinical data for its lead TROP2-targeting ADC, AKTX-101, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026. Access the poster here.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Unlike current TROP2-targeting ADCs that use Topoisomerase I Inhibitor (Inh.) payloads, AKTX-101 has the potential to address resistance to Topoisomerase I Inh. ADCs and contribute to durable anti-tumor efficacy due to the payload’s unique cytotoxic and immune-activating mechanisms of action.

The preclinical data compares the performance of AKTX-101 versus TROP2 ADCs with Topoisomerase I Inh. payloads in the killing of different cancer types driven by different cancer genes (oncogenes). AKTX-101’s ability to kill cancer cells at lower concentrations vs. TROP2 ADCs using Topoisomerase I Inh. payloads suggests that AKTX-101 is a more potent drug.

The preclinical data was published recently as an abstract in Cancer Research, an AACR (Free AACR Whitepaper) journal.

Here, AKTX-101 demonstrated greater potency and/or greater maximum cancer cell killing relative to TROP2 ADC Topoisomerase I Inh. payloads in cancers of the bladder, lung and breast. AKTX-101 demonstrated sub-nanomolar potency in all bladder cancer lines tested, a key tumor in which first-in-human clinical trials for AKTX-101 are planned.

AKTX-101 also demonstrated sub-nanomolar potency in several non-small cell lung cancer cell lines driven by EGFR, BRAF, and SMARCA4, as well as potent cell killing in HER2 breast cancer cell lines with inherent resistance to Topoisomerase I Inh. ADCs such as trastuzumab deruxtecan (ENHERTU).

"These data represent a significant step forward for our lead program, AKTX-101, and reinforce our belief that a differentiated ADC payload with multiple mechanisms of action has the potential to meaningfully improve outcomes for patients with TROP2-expressing cancers," commented Satyajit K. Mitra, Ph.D., Head of Oncology Research and Development at Akari Therapeutics. "We are seeing preclinical superior AKTX-101 potency and activity as compared to TROP2 ADCs using Topoisomerase I inhibitor payloads in bladder, lung, and breast cancer models. Together, these findings show that AKTX-101 has strong potential for targeting a broad range of cancer tumors and sub-types with superior cytotoxicity than current TROP2 ADCs that use Topoisomerase I Inhibitor payloads."

The TROP2 ADC class continues to emerge in terms of its potential, with revenue projections expected to reach ~$12B or greater by 2033 based on current and future entrants. Akari believes that AKTX-101, with its novel RNA splicing modulator payload, can grow this class further by addressing multiple solid tumors where TROP2 is overexpressed including bladder, lung, breast, pancreatic, head and neck, and others.

Key AKTX-101 Data Presented at AACR (Free AACR Whitepaper) Highlights:

AKTX-101 demonstrated strong, single-agent anti-tumor activity across multiple models across bladder, lung, and breast cancers.
AKTX-101 demonstrated greater potency and cell killing compared to current TROP2 ADCs, including Topoisomerase I inhibitor-resistant tumor models, as well as standard-of-care chemotherapies and targeted therapies. Combination of AKTX-101 with anti-PD-1 therapy resulted in synergistic anti-tumor efficacy and tumor regressions within in vivo models, supporting future combinations with checkpoint inhibition to maximize tumor remissions rates.
Broad in vitro cytotoxicitywas observed across a diverse panel of tumor models, including those with clinically oncogenic driver mutations including FGFR3, BRAF, EGFR, and SMARCA4.
Abizer Gaslightwala, CEO of Akari Therapeutics, added, "This data continues to add to the conviction and differentiation we have in our novel ADC payload PH1 targeting RNA splicing. We are focused on rapidly advancing AKTX-101 into the clinic, with IND-enabling studies underway and plans to submit an IND in the fourth quarter of 2026, followed by initiation of a Phase 1 study in the first quarter of 2027. Our team is executing against a clear development plan designed to efficiently translate these encouraging preclinical findings into clinical proof of concept."

These data were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026. Access the poster here.

(Press release, Akari Therapeutics, APR 20, 2026, View Source [SID1234664531])

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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])