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.

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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])

On May 28, 2026 CRISPR Therapeutics (Nasdaq: CRSP) reported that members of its senior management team are scheduled to participate in the following investor conferences in June.

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Jefferies Global Healthcare Conference
Date: Wednesday, June 3, 2026
Time: 9:55 a.m. ET

William Blair’s 46th Annual Growth Stock Conference
Date: Wednesday, June 3, 2026
Time: 4:40 p.m. CT

Goldman Sach’s 47th Annual Global Healthcare Conference
Date: Tuesday, June 9, 2026
Time: 2:40 p.m. ET

A live webcast will be available on the "Events & Presentations" page in the Investors section of the Company’s website at View Source A replay of the webcasts will be archived on the Company’s website for 14 days following the presentation.

(Press release, CRISPR Therapeutics, MAY 28, 2026, View Source [SID1234666143])

On May 28, 2026 Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, reported updated positive Phase 2 results of spevatamig (PT886) in combination with chemotherapy in frontline (1L) treatment of metastatic pancreatic ductal adenocarcinoma (PDAC) for the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2026 . The full poster presentation will be held on Saturday, May 30 between 9am-12pm CDT during the Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary Session (Abstract #4192, Poster #175).

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The data show spevatamig, an anti-CLDN18.2/CD47 bsAb, in combination with chemotherapy, has the potential to be an effective 1L treatment in patients with metastatic PDAC (mPDAC).

The design of spevatamig with an optimized anti-CD47 arm mitigates hematological toxicity and improves GI tolerability, as evidenced by the results of the spevatamig monotherapy and combination therapy studies where >190 patients have been dosed globally.

Spevatamig + GnP combination is well tolerated in 1L patients with mPDAC, with no significant additive toxicity to GnP.

2 mg/kg QW spevatamig + GnP showed promising efficacy (52.4% ORR, 90.5% DCR) when compared with the GnP arm in pivotal trials in 1L mPDAC; importantly, more than 90% of patients at this dose level had de novo metastatic disease, consistent with the baseline characteristics of the patient populations in pivotal Phase 3 trials.

Median progression-free survival (mPFS) was 7.3 months, and median overall survival (mOS) was 14.7 months in US patients, where the median follow up time is 14.7 months.

The efficacy data for 3 mg/kg spevatamig + GnP is still maturing. 3 mg/kg has the potential to be the dose level for a Phase 3 registrational study.

Overall, the data support further development of spevatamig + GnP in a randomized Phase 3 trial in patients with 1L mPDAC.
Spevatamig is an innate immunity enhancer (I2E), an emerging class of immuno-oncology (IO) agents. Unlike immune checkpoint inhibitors (ICIs) (also known as anti-PD1/anti-PD-L1 drugs) which activate T cells to kill cancer cells, I2Es activate macrophages and dendritic cells to recognize and destroy cancer cells, providing an alternative mechanism to leverage the immune system to attack tumors, especially the so-called "cold tumors" that do not respond to ICIs.

"We are pleased to see the positive results at the first dose level of spevatamig in the 1L PDAC study. This result is significant because PDAC is considered a ‘cold tumor’ to ICIs. Now we have the opportunity to target PDAC with a new class of immunotherapy," said Ming Wang, PhD, MBA, Founder and CEO of Phanes. "The enrollment at the 3 mg/kg dose level is progressing rapidly and we hope to see efficacy data in the second half of 2026. We could be Phase 3 ready shortly after that. Our goal is to advance this exciting I2E aggressively and deliver an innovative immunotherapy for patients with mPDAC."

ABOUT SPEVATAMIG

Spevatamig is a first-in-class native IgG-like bispecific antibody (bsAb) targeting claudin 18.2 and CD47. It was granted orphan drug designation (ODD) for the treatment of pancreatic cancer by the FDA in 2022 and was granted Fast Track designation for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma in 2024. In 2023, Phanes entered into a clinical collaboration agreement with Merck (known as MSD outside the US and Canada) to study spevatamig in combination with pembrolizumab.

Phanes is conducting clinical trials with spevatamig in multiple cancer indications, including a Phase 2 study evaluating the efficacy of spevatamig in combination with chemotherapy in first-line PDAC patients. Spevatamig is a novel immunotherapy which has the potential to become the first innate immunity enhancer (I2E) for a solid tumor indication and is combinable with various anti-cancer therapies.

(Press release, Phanes Therapeutics, MAY 28, 2026, View Source [SID1234666159])

On May 28, 2026 Molecular Targeting Technologies, Inc. (MTTI) reported the clinical findings of the Next-Generation PRRT, ¹⁷⁷Lu-DOTA-EB-TATE to treat GEP-NET Patients. The Phase 1 dose-escalation and dosimetry study will be presented at the 2026 Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting, taking place May 29–June 3, 2026, in Los Angeles, California.

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Neuroendocrine tumors (NETs) are often detected late, limiting curative treatments and requiring systemic therapies like Peptide Receptor Radionuclide Therapy (PRRT). While 177Lu-DOTATATE has demonstrated efficacy, its rapid clearance limits tumor radiation delivery and may increase renal toxicity risk.

"Our Clinical findings suggest that EBTATE may achieve meaningful clinical responses after only two treatment cycles while delivering approximately 12.5% of the cumulative radioactivity required for standard PRRT," said Chris Pak, Chairman and Chief Executive Officer of MTTI. "If validated in larger studies, EBTATE could represent a transformative advance in radiopharmaceutical therapy, shortening treatment duration, reducing radiation exposure, and enabling physicians to evaluate efficacy much earlier than is possible today."

"EBTATE achieved substantially higher tumor uptake and prolonged retention than conventional ¹⁷⁷Lu-DOTATATE while maintaining a favorable safety profile, with no kidney toxicity observed for one year follow-up," said Lisa Bodei, MD, PhD, a nuclear medicine physician at Memorial Sloan Kettering Cancer Center. "The ability to deliver greater tumor radiation with significantly less administered radioactivity positions EBTATE as a potentially transformative PRRT. These data also support the possibility of a streamlined two-cycle regimen, enabling earlier evaluation of treatment efficacy."

The presentation entitled, "Next-Generation PRRT" by Dr. Bodei (poster # 261874). The poster has also been selected for a 10-minute oral presentation during the 2026 Patient Education Day NETS Program Schedule (View Source), on 5/31/26 during the SNMMI meeting.

MTTI will present its proprietary Evans Blue (EB) albumin-binding technology platform at Booth #1758 during the SNMMI Annual Meeting, featuring clinical data from 81 GEP-NET patients and compelling preclinical results.

MTTI’s EB technology enhances tumor targeting through reversible albumin binding, delivering up to 26-fold greater tumor retention in preclinical models and approximately eight-fold higher tumor uptake in patients compared with conventional DOTA-TATE. These findings position the platform as a potentially transformative approach for next-generation radiopharmaceuticals, with the potential to improve efficacy, expand therapeutic opportunities, and create significant strategic value.

(Press release, Molecular Targeting Technologies, MAY 28, 2026, View Source [SID1234666175])

On May 28, 2026 Enterome SA, a clinical-stage company pioneering OncoMimics, a new class of off-the-shelf, multi-targeted in vivo immune therapies, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to EO2463 for the treatment of patients with indolent non-Hodgkin lymphoma (iNHL) in the low-tumor-burden, "watch-and-wait" setting. The U.S. FDA Fast Track designation was also granted in October 2025 to EO2463 for follicular lymphoma in the watch-and-wait setting, further underscoring its potential and the unmet medical need.

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The US FDA orphan drug designation (ODD) confers several substantial financial, regulatory, and strategic advantages to sponsors developing therapies for rare diseases affecting fewer than 200,000 people in the United States. For example, upon marketing approval, orphan-designated products receive 7 years of market exclusivity in the US.

"Receiving FDA Orphan Drug Designation is an important regulatory milestone for EO2463 and re-affirms our strong commercial potential. Today, the only option for non-symptomatic low tumor burden "watch-and-wait" iNHL patients is to go without treatment and be observed until the cancer progresses. We believe this places undue stress on patients and their families and is unacceptable; it is gratifying to see the U.S. regulatory agency recognizes that ‘watch-and-wait’ patients deserve a real treatment option like EO2463," said Pierre Belichard, Chief Executive Officer of Enterome. "Together with the Fast Track designation granted late last year, FDA’s ODD further facilitates and validates our efforts to advance EO2463 toward registrational development in the watch-and-wait population. We are actively engaging with potential partners and investors to find the best path forward to rapidly advance EO2463 development in this indication."

Data from SIDNEY, which have been reported at multiple peer-reviewed medical conferences, demonstrate that EO2463 is particularly well suited for watch-and-wait iNHL patients because it has been well tolerated in clinical testing and has shown potentially disease modifying monotherapy activity in patients who generally are not eligible to receive anti-lymphoma treatment under current practice until their disease progresses. Data also suggest that EO2463 may be highly complementary when used in combination with marketed cancer therapeutics, offering potential additional disease modifying effects.

In the low-tumor-burden watch-and-wait population of SIDNEY Cohort 2, Enterome reported that EO2463 monotherapy produced a 52.6% objective response rate in 19 evaluable patients with follicular lymphoma and a 47.6% objective response rate in the overall group of 21 evaluable patients with follicular lymphoma or marginal zone lymphoma, including 14.3% complete responses and 33.3% partial responses.

Separately, Enterome reported that EO2463 rapidly induced extensive in vivo expansion of B-cell-target-specific CD8 T cells and established a correlation between EO2463-induced and B-cell-target-specific CD8 T-cell expansion and Lugano objective response, suggesting this immune readout may serve as a predictive biomarker in indolent NHL, something that would further serve to alleviate anxiety in watch-and-wait patients and help physicians decide which patients to monitor more closely.

And in addition to the impact in watch-and-wait patients, Enterome reported that EO2463 combined with lenalidomide and rituximab achieved a 60% complete response rate in 20 patients with relapsed/refractory follicular and marginal zone lymphoma, was well tolerated, and showed CD8 T-cell expansion correlating with the probability of complete remission, findings the company described as complementary to the monotherapy signal seen in watch-and-wait patients and show that EO2463 may also be complementary when used in combination with rituximab and other cancer therapeutics.

SIDNEY is an ongoing open-label Phase 1/2 study evaluating the safety, tolerability, immunogenicity and preliminary efficacy of EO2463 as monotherapy and in combination regimens in up to 55 patients with follicular lymphoma and marginal zone lymphoma. The trial includes a dedicated watch-and-wait monotherapy cohort, a first-line low-tumor-burden combination cohort with rituximab, and relapsed/refractory cohorts treated with EO2463 plus lenalidomide and rituximab.

EO2463 is an off-the-shelf OncoMimics active immunotherapy composed of four synthetic microbial-derived peptides designed to mimic the B-cell lineage markers CD20, CD22, CD37 and CD268 (BAFF receptor), plus the helper peptide UCP2. According to Enterome, this multi-target approach is intended to expand pre-existing memory CD8 T cells, selectively target malignant B cells, broaden target coverage and reduce the risk of antigen escape.

OncoMimics consist of bacteria-derived peptide antigens that closely mimic tumor-associated antigens (TAAs) of solid tumors, or cell linage markers (e.g. as observed in B cell lymphomas). These antigens induce a fast and potent in vivo expansion of cytotoxic memory CD8 T-cells, primed by gut bacteria, and cross-reactive with TAAs/B cell markers. Because the peptides are "non-self", OncoMimics avoid the self-tolerance that limits many cancer immunotherapies to enable rapid, potent, and durable responses to tumors. The synthetically produced peptides are designed in silico, mining Enterome’s proprietary database of 23 million commensal bacteria genes. Each product combines multiple high-affinity peptides to broaden target coverage and mitigate tumor heterogeneity.

(Press release, Enterome, MAY 28, 2026, View Source [SID1234666144])