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Avenzo Therapeutics Announces First Patient Dosed in Combination Cohort Evaluating CDK4 Selective Inhibitor (AVZO-023) with CDK2 Selective Inhibitor (AVZO-021) In Ongoing Phase 1/2 ORION-1 Study

On May 28, 2026 Avenzo Therapeutics, Inc. ("Avenzo"), a clinical-stage biotechnology company developing next-generation oncology therapies, reported that the first patient has been dosed in the combination cohort evaluating AVZO-023, its potentially differentiated cyclin-dependent kinase 4 (CDK4) selective inhibitor, in combination with AVZO-021, its potentially differentiated cyclin-dependent kinase 2 (CDK2) selective inhibitor, with fulvestrant in patients with advanced or metastatic hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer in the ongoing Phase 1 portion of the ORION-1 Phase 1/2 clinical study.

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The Phase 1/2 first-in-human, open-label ORION-1 clinical study is designed to assess the safety, tolerability, and preliminary clinical activity of AVZO-023 with endocrine therapy as well as the combination of AVZO-023 and AVZO-021 with endocrine therapy. The combination cohort will evaluate AVZO-023 and AVZO-021 with fulvestrant in patients with HR+/HER2- advanced or metastatic breast cancer. AVZO-021 is currently being studied in a separate Phase 1/2 clinical study in HR+/HER2- advanced or metastatic breast cancer and other advanced solid tumors, and the company plans to present updated safety and efficacy results from the Phase 1 portion of the ongoing study at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

"We are proud to have dosed the first patient in this combination cohort," said Mohammad Hirmand, M.D., Co-founder and Chief Medical Officer of Avenzo Therapeutics. "We believe this novel combination of AVZO-023 and AVZO-021 with fulvestrant may provide a differentiated treatment approach, and we look forward to continuing to evaluate its potential to meaningfully improve outcomes for patients with HR+/HER2- breast cancer."

(Press release, Avenzo Therapeutics, MAY 28, 2026, View Source [SID1234666141])

New JNM publication strengthens the scientific foundation for AKIR001

On May 28, 2026 Akiram Therapeutics, a Swedish biotech company specializing in molecular radiotherapy, reported that new preclinical data on its lead candidate AKIR001 have been published in The Journal of Nuclear Medicine. The results demonstrate selective tumor uptake, clear antitumor effects, and favorable tolerability in preclinical pancreatic cancer models, further strengthening the scientific foundation for AKIR001.

The article [177Lu]Lu-AKIR001 for CD44v6-Positive Pancreatic Cancer: Preclinical Efficacy and Combination Strategies presents new preclinical data for AKIR001 in models of pancreatic cancer, one of the most aggressive cancer types with a significant unmet medical need. The findings demonstrate dose-dependent tumor growth inhibition and support the effective targeting of CD44v6 with molecular radiotherapy in CD44v6-positive tumors.

The lead candidate is currently undergoing Phase I clinical evaluation at Karolinska University Hospital.

The publication has also been highlighted by the Society of Nuclear Medicine and Molecular Imaging (SNMMI) through its official channels. The recognition reflects the growing interest in targeted radiopharmaceuticals and CD44v6 as a therapeutic target in difficult-to-treat cancers.

"The study provides additional scientific support for AKIR001 and reinforces the preclinical foundation of our CD44v6-targeted strategy in molecular radiotherapy. The recognition by SNMMI also reflects the growing interest in targeted radiopharmaceuticals and CD44v6 as a therapeutic target," says Marika Nestor, CEO of Akiram Therapeutics.

About the Phase I trial
The ongoing Phase I clinical trial at Karolinska University Hospital enrolls patients with CD44v6-positive solid tumors who currently lack available treatment options. The trial evaluates safety, tolerability, and pharmacokinetics.
The trial is registered at ClinicalTrials.gov: NCT06639191.

About AKIR001
177Lu-AKIR001 is a CD44v6-targeted drug candidate for molecular radiotherapy developed by Akiram Therapeutics. Preclinical studies have demonstrated high tumor specificity, favorable tolerability, and clear antitumor effects in CD44v6-positive tumor models.

(Press release, Akiram Therapeutics, MAY 28, 2026, View Source [SID1234666140])

Akari Therapeutics Discusses Breakthrough Potential of AKTX-101 and Novel Spliceosome-Modulating ADC Platform in Virtual Investor “What This Means” Segment Following ASCO Abstract Acceptance

On May 28, 2026 Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing antibody drug conjugates (ADCs) with novel RNA splicing modulator payloads, reported that its CEO participated in a Virtual Investor "What This Means" interview focused on the Company’s recently accepted abstract at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

During the interview, Mr. Gaslightwala highlighted the significance of Akari’s first ASCO (Free ASCO Whitepaper) abstract acceptance and discussed newly presented preclinical data demonstrating combination synergy between Akari’s differentiated spliceosome-modulating ADC platform and a KRAS inhibitor in KRAS-mutated pancreatic cancer models. The data further supports the potential of Akari’s proprietary PH1 payload platform to address the most difficult-to-treat cancers with significant unmet met, such as KRAS-driven tumors.

"The acceptance of our data at ASCO (Free ASCO Whitepaper) represents an important validation milestone for Akari and reinforces the growing excitement surrounding our differentiated ADC platform," said Abizer Gaslightwala, President and Chief Executive Officer of Akari Therapeutics. "We believe AKTX-101 and our novel spliceosome-modulating payload approach have the potential to redefine how difficult-to-treat KRAS-driven cancers are targeted, particularly in patient populations where current therapeutic options remain limited."

The discussion also explored the key findings from the accepted abstract and what management believes differentiates Akari’s approach within the rapidly evolving ADC landscape, including the Company’s novel RNA splicing modulation mechanism designed to enhance anti-tumor activity and broaden therapeutic applicability across multiple solid tumor indications.

In addition, Mr. Gaslightwala outlined several anticipated milestones investors should monitor, including continued advancement of Akari’s PH1 spliceosome-modulating payload platform and the Company’s targeted initiation of a Phase 1 first-in-human clinical trial by mid-2027.

The Virtual Investor "What This Means" segment featuring Akari Therapeutics is now available here.

(Press release, Akari Therapeutics, MAY 28, 2026, View Source [SID1234666139])

Imugene Doses First Patient in BTK Inhibitor Combination Cohort of azer-cel Phase 1b Study

On May 28, 2026 Imugene Limited (ASX: IMU) a clinical-stage immunooncology company, reported the enrolment of first patient into the BTK inhibitor combination cohort of its ongoing Phase 1b basket study of azer-cel. Azer-cel is an offthe-shelf, allogeneic CAR T cell therapy being evaluated across multiple advanced blood cancers with significant unmet medical need.

Patients in this third cohort will be treated with azer-cel in combination with a BTKi with the objective of evaluating safety and preliminary efficacy. These patients have previously failed BTKi therapy, an established standard of care therapy across multiple B-cell malignancies. including follicular lymphoma (FL), chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL). Enrolment is ongoing across ten US and five Australian sites.

Despite their efficacy as front-line and subsequent treatments, many patients ultimately develop resistance or intolerance to BTKi therapy, representing a significant area of unmet medical need. The combination of azer-cel with a BTKi aims to explore whether concurrent dosing may enhance the activity of azer-cel and BTKi in this setting.

The addition of the BTKi combination cohort expands the clinical scope of the azer-cel program and may support further partnering and collaboration opportunities. By broadening the range of eligible B-cell malignancies in the Phase 1b study, the Company is better positioned to prioritise indications where azer-cel demonstrates the strongest clinical potential, supporting a disciplined and capital-efficient development strategy. The global BTKi market was valued at approximately US$12.0 billion in 2025.

Chief Executive Officer Leslie Chong said "The enrolment of first patients into the BTKi combination cohort is a meaningful step in expanding the clinical scope of the azer-cel program. BTKi-relapsed patients represent a significant population with limited options, and we believe the concurrent combination approach has the potential to address this unmet need.

We look forward to reporting safety and preliminary efficacy data as patients become evaluable, and to continuing to build the evidence base for azer-cel across B-cell malignancies."

Further updates will be provided as patients become evaluable and data matures.

About the Phase 1b azer-cel trial

The azer-cel allogeneic CAR T trial is an ongoing, open-label, multi-centre Phase 1b clinical trial in the U.S. and Australia, for CAR T relapsed patients and CAR T naïve patients diagnosed with a broad range of Non-Hodgkins lymphomas including follicular lymphoma (FL), chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), marginal zone lymphoma (MZL), Waldenstrom macroglobulinemia (WM), and mantle cell lymphoma (MCL). The trial has recently expanded into a BTKi combination cohort, for patients with a range of B-cell malignancies who have previously failed BTKi therapy. Treatment with azer-cel, lymphodepletion (LD) and IL-2 is showing promising results with evidence of meaningful clinical activity, and durability of response. Additionally, the safety profile is manageable and generally well tolerated.

(Press release, Imugene, MAY 28, 2026, View Source [SID1234666111])

Systemic immune activation with eftilagimod alfa associated with statistically significant increased overall survival in late-stage cancer patients

On May 28, 2026 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company targeting cancer and autoimmune diseases, reported results from a systematic evaluation of 5 clinical trials of eftilagimod alfa ("efti") an antigen-presenting cell (APC) activator in combination with standard-of-care (SOC) therapies in late-stage cancer patients.

In these trials, treatment with 30 mg subcutaneous (SC) efti plus SOC resulted in a significant increase in circulating absolute lymphocyte count (ALC), a blood-based measure of immune activity, compared to SOC alone where this effect was not seen. More importantly, increased ALC was significantly associated with improved clinical outcomes in the E+SOC group. A clinically meaningful and significant median overall survival (OS) improvement (median +7.7 months; p=0.00171) was seen in ALC responders compared to ALC non-responders in the efti + SOC group (figure on the left). No corresponding association between ALC response and OS was observed in the SOC alone group (figure on the right).

The analysis included 5922 patients across five independent clinical studies (TACTI-mel, TACTI-002, TACTI-003, AIPAC, AIPAC-003) spanning four cancer indications (NSCLC, HNSCC, MBC, melanoma), correlating the pharmacological effects of efti in combination with SOC treatments with clinical efficacy.

Overall survival of late-stage cancer patients treated with SOC + efti (left) and SOC alone (right), ALC responders vs ALC non-responders.

Effects were observed across the different tumor types and were independent of the combination partner i.e., chemotherapy or immunotherapy such as PD-1 antagonists.

"These findings link the immune-activating effect of efti measured in patients´ blood with meaningful and significant survival improvements observed in previous clinical trials. Importantly, this highlights a key connection between efti´s mechanism of action and clinical efficacy," said Frederic Triebel, Chief Scientific Officer of Immutep.

In addition, treatment with efti plus SOC was associated with a rapid and significant increase in circulating TH1-related biomarkers, which correlated with clinical response. Gene expression profiling further demonstrated enhanced T-cell function scores in responding patients.

Collectively, these data suggest that efti induced broad immune activation, including circulating immune cells, cytokine responses and gene expression, and that this activation was associated with improved clinical benefit in late-stage cancer patients across multiple tumor types.

The data will be presented in a poster at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

ASCO 2026 Poster Presentation Details
Title: Eftilagimod alfa, an APC activator via MHC class II, induced lymphocyte activation linked to improved survival in metastatic cancer patients
Poster Session: Developmental Therapeutics—Immunotherapy
Date and Time: 30 May 2026, 1:30 PM-4:30 PM CDT
Poster Board: 359
Abstract #: 2569

The poster will be available on the Posters & Publications section of Immutep’s website following the presentation.

TACTI Program Context
Efti has been tested in multiple clinical trials, including the TACTI program (TACTI-mel, TACTI-002, TACTI-003 and TACTI-004).

In March 2026, following a planned interim futility analysis, Immutep discontinued the TACTI-004 Phase III trial in first-line non-small cell lung cancer based on a recommendation from the Independent Data Monitoring Committee, and Immutep continues to review available data to understand factors behind the futility outcome and to evaluate implications for the broader eftilagimod alfa development program.

The data presented in this explorative analysis does not include data from the TACTI-004 study, as immune data collection for that trial had not been completed at the time of the analysis. All data presented were generated from earlier clinical trials.

(Press release, Immutep, MAY 28, 2026, View Source [SID1234666106])