On May 23, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported the presentation of biomarker data from its OPTIMIZE-1 clinical trial at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Alligator Bioscience, MAY 23, 2025, View Source [SID1234653353]).

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OPTIMIZE-1 is an ongoing Phase 1b/2 trial of mitazalimab in combination with mFOLFIRINOX in first-line metastatic pancreatic cancer (mPDAC). The trial has demonstrated strong clinical outcomes to date, including a ~30% survival rate at 24-months follow up.

Mitazalimab-induced biomarkers were associated with clinical benefit supporting a significant contribution of mitazalimab to clinical efficacy, including the intratumoral immune activation in responding patients. In addition, a fibrosis-related gene signature was identified as potentially predictive of improved overall survival, while ctKRAS clearance and molecular response were significantly associated with longer survival and outcomes.

These translational data strengthen the rationale for mitazalimab’s mode of action, showing that mitazalimab-induced immune activation and suppression of tumor-promoting genes contribute to the clinical benefits observed in OPTMIZE-1. With an observed median overall survival of 14.9 months and objective response rate of 54.4%, the results support further development of mitazalimab in mPDAC, including the planned randomized confirmatory trial.

Alligator’s participation at ASCO (Free ASCO Whitepaper) reflects its commitment to scientific exchange and business development. The meeting provides an important platform to highlight mitazalimab’s potential and engage in strategic partnering discussions.

Abstract information:

Title: Biomarkers associated with outcomes from OPTIMIZE-1: CD40 agonist mitazalimab with mFOLFIRINOX in patients with untreated metastatic pancreatic cancer
First Author: Philippe Cassier
Date and time: 2nd June 2025, 1.30 p.m. – 4:30 p.m CDT.
Session Title: Developmental Therapeutics—Immunotherapy
Sub Track: Tissue-Based Biomarkers
Abstract Number: 2624
Poster Board Number: 271
Abstract link

On May 22, 2025 ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (HKEX Code: 1541.HK, "ImmuneOnco") and Instil Bio, Inc. (Nasdaq: TIL, "Instil") , reported clinical trial updates of IMM2510/AXN-2510 and NSCLC clinical development strategy (Press release, ImmuneOnco Biopharma, MAY 22, 2025, View Source [SID1234655710]).

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Dr. Wenzhi Tian, CEO of ImmuneOnco said: "Our collaboration on IMM2510/AXN-2510 has achieved meaningful progress. We are actively conducting a Phase 2 clinical trial of IMM2510/AXN-2510 in combination with chemotherapy in patients with first-line NSCLC. The data generated to date underscore its best-in-class potential within the promising PD-(L)1xVEGF class. We anticipate sharing further clinical data in the second half of 2025."

Bronson Crouch, CEO of Instil said: "We are delighted with the significant clinical advancements by our collaborator, ImmuneOnco, with IMM2510/AXN-2510 for NSCLC in China. We are confident that IMM2510/AXN-2510 has the potential to emerge as a leading PD-(L)1xVEGF bispecific antibody, and we look forward to the initial results from the ongoing first-line chemotherapy combination trial in China. In parallel, we are advancing preparations to initiate U.S. clinical development later this year, and we look forward to bringing this potential important new medicine to patients globally."

Phase 2 Trial of IMM2510/AXN-2510 in Combination with Chemotherapy in Front-Line NSCLC
●ImmuneOnco expects to complete enrollment of approximately 60 patients in Q3 2025 in its Phase 2 trial of IMM2510/AXN-2510 in combination with chemotherapy in patients with NSCLC in the first-line setting in China.

● Among more than 30 NSCLC patients enrolled(including the safety run-in), more than 20 first-line NSCLC patients have been treated since the end of March.

●ImmuneOnco anticipates sharing initial safety and efficacy results from this Phase 2 trial in the second half of 2025.

IMM2510/AXN-2510 Monotherapy Data in Relapsed/Refractory NSCLC (China)

●The objective response rate(ORR)is similar to datasets from competitor PD-(L)1xVEGF bispecific antibodies at a similar stage of development in patients with previously treated NSCLC, showing ORR of 23%(efficacy evaluable n=13).

●The updated clinical safety from the full IMM2510/AXN-2510 monotherapy trial(n=106)and efficacy data in NSCLC are further detailed in a new corporate deck posted on ImmuneOnco’s investor relations webpage at :

View Source

On May 22, 2025 Taiho Pharmaceutical Co., Ltd. reported that its U.S. subsidiary, Taiho Oncology, Inc., will present the results of a Phase 1/2 clinical trial of the combination regimen of decitabine and cedazuridine plus venetoclax for acute myeloid leukemia (AML) in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held May 30 through June 3 in Chicago (Press release, Taiho, MAY 22, 2025, View Source [SID1234653716]).

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This Phase 1/2 trial evaluated the safety and efficacy of an oral administration regimen of decitabine-cedazuridine paired with venetoclax in 101 adult　AML patients who were ineligible for first-line induction chemotherapy.
Study results
Complete remission (CR), which was the primary endpoint of the study, was 46.5%, and CR with incomplete hematologic recovery rates was 63.4%. Median time to CR was 2.4 months. Median CR duration was not reached; among patients who achieved it, 80% maintained that status at 6 months and 75.3% at 12 months. Median OS was 15.5 months.

98% of patients reported treatment-emergent adverse events of grade 3 or higher*, most commonly febrile neutropenia (49.5%), anemia (38.6%) and neutropenia (35.6%). The 30- and 60-day mortality rates were 3% and 9%, respectively.
*Revsied on June 4
About acute myeloid leukemia (AML)
AML is a disease in which the proliferation of leukemia cells inhibits the normal production of blood in the bone marrow. It is the most common type of acute leukemia in adults, and its incidence increases with age. There is a need for less toxic treatment methods for elderly patients who have difficulty receiving first-line induction chemotherapy.
About decitabine-cedazuridine
This combination is the world’s first oral DNA methylation inhibitor combined with a novel metabolic inhibitor that inhibits the breakdown of decitabine when administered orally.
It was approved in the U.S. and Canada in 2020 for the indications of myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML), and in Europe in 2023 for the indication of AML.

On May 22, 2925 Evaxion A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, has dosed the first patient in its one-year extension of the ongoing phase 2 trial with its lead asset EVX-01 (Press release, Evaxion Biotech, MAY 22, 2025, View Source [SID1234653291]). Designed with Evaxion’s AI-Immunology platform, EVX-01 is a personalized cancer vaccine currently being evaluated as a treatment for advanced melanoma (skin cancer).

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The extension will further explore the full potential of EVX-01 as a possible new and innovative treatment of advanced melanoma, particularly its long-term clinical and immune benefits. The trial extension involves minimal cost as trial sites are running and the vaccine product has already been produced.

Having completed the initial two-year treatment, the first patient in the extension of the trial has now received the first additional dose of EVX-01. Patients entering the one-year extension of the trial will in total receive two additional EVX-01 doses as monotherapy.

In the first two years of the trial, EVX-01 was administered in combination with standard anti-PD-1 therapy (checkpoint inhibitors). With checkpoint inhibitor treatment restricted to a two-year duration, the extension phase provides an opportunity to evaluate the benefits of EVX-01 monotherapy. This could position EVX-01 as a potential standalone treatment for advanced melanoma.

"Extending the trial allows us to explore EVX-01’s potential beyond its combination use with checkpoint inhibitors. By studying EVX-01 as a monotherapy, we aim to assess the independent effects of EVX-01, including its induced immune response and clinical outcome. Given that checkpoint inhibitor therapy is not approved beyond two years of treatment, this additional EVX-01 treatment option could offer a meaningful option for patients", says Birgitte Rønø, Chief Scientific Officer of Evaxion.

EVX-01 is designed with Evaxion’s AI-Immunology platform and tailored to target the unique tumor profile and immune characteristics of each individual patient. It engages the patient’s immune system to fight off cancer by mounting a targeted response against tumors.

The phase 2 trial investigates EVX-01 in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in patients with advanced melanoma (skin cancer). Each patient enrolled in the trial has received a unique vaccine designed and manufactured based on their individual biology. KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Convincing one-year phase 2 data
Initially planned to run for two years, the trial remains on track to yield two-year data for presentation in the second half of 2025. Convincing interim one-year data from the trial was presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in September 2024. Data demonstrated a 69% Overall Response Rate, reduction in tumor target lesions in 15 out of 16 patients, and a positive correlation between the AI-Immunology platform predictions and immune responses induced by the individual neoantigens in the EVX-01 vaccine (p=0.00013).

Further, 80% of EVX-01’s vaccine targets triggered a targeted immune response, as presented at American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2025. This number compares very favorably to what is seen with other approaches.

About EVX-01
EVX-01 is a personalized peptide-based cancer vaccine intended for first-line treatment of multiple advanced solid cancers. It is Evaxion’s lead clinical asset.

EVX-01 is a personalized therapy designed with our AI-Immunology platform and is tailored to target the unique tumor profile and immune characteristics of each patient. It engages the patient’s immune system to fight off cancer by mounting a targeted response against tumors.

In the completed phase 1/2a clinical trial (NCT03715985), assessing EVX-01 in combination with a PD-1 inhibitor, eight of twelve metastatic melanoma patients (67%) had objective clinical responses, with two complete and six partial responses.

In addition, vaccine-induced T cells were detected in all patients and a significant correlation between clinical response and the AI-Immunology predictions was observed, underlining the predictive power of the platform.

On May 22, 2025 NeoGenomics, Inc. (NASDAQ: NEO), a leading provider of oncology testing services, reported the commercial launch of c-MET CDx for NSCLC, its c-MET companion diagnostic immunohistochemistry (IHC) assay (Press release, NeoGenomics Laboratories, MAY 22, 2025, View Source [SID1234653351]). The test is now available to oncologists and pathologists nationwide, supporting treatment selection for patients with advanced non-small cell lung cancer (NSCLC) with a 48-hour turnaround time.

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The c-MET CDx for NSCLC assay detects c-Met protein overexpression, a biomarker observed in up to 50% of patients with advanced NSCLC.¹ It is designed to help identify patients who may be eligible for newly approved targeted therapies, including EMRELIS (telisotuzumab vedotin-tllv), which was recently approved by the U.S. Food and Drug Administration (FDA).*

"Accurate and timely biomarker testing is critical in lung cancer, where targeted therapies can meaningfully change the course of a patient’s treatment," said Dr. Nathan Montgomery, Vice President of Medical Services at NeoGenomics. "The c-MET CDx for NSCLC assay adds an important tool to our testing portfolio, helping oncologists quickly identify patients who may benefit from MET-directed therapies. It also complements our PanTracer suite, enabling comprehensive biomarker profiling for NSCLC."

Key features of NeoGenomics’ assay include:

Companion Diagnostic Indication: Developed in accordance with FDA guidance and validated for use with MET-targeted therapies.
Fast Turnaround: Delivers results within 48 hours to enable timely, informed clinical decisions.
Validated Performance: Designed for use with tumor tissue samples to detect MET protein overexpression.
Integrated NSCLC Offering: Complements NeoGenomics’ broader PanTracer portfolio, including genomic and immuno-oncology markers.
The c-MET CDx for NSCLC assay is now available as part of NeoGenomics’ comprehensive NSCLC testing portfolio. Its addition supports the growing use of MET-directed therapies and reflects ongoing efforts to align diagnostic services with emerging standards in precision cancer care.

For more information or to order the test, visit www.neogenomics.com/cmetcdx.

*EMRELIS (telisotuzumab vedotin-tllv) was approved by the U.S. FDA on May 14, 2025, for adults with previously treated advanced NSCLC with high c-MET protein overexpression.