On June 1, 2026 Oncolytics Biotech Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage company developing pelareorep, reported initial data from a preclinical study evaluating pelareorep in combination with RAS inhibitor modalities in a solid tumor model, which demonstrate evidence of greater anti-tumor activity in combination than with the individual approaches alone. Pelareorep is an investigational, systemically active immunotherapy that promotes potentially protective immune responses, including the upregulation of key inflammatory cytokines resulting in the formation of tertiary lymphoid structures and the expansion of tumor-infiltrating lymphocytes.

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Based on these findings, the Company is planning additional studies in models of pancreatic ductal adenocarcinoma ("PDAC") and colorectal cancer ("CRC") designed to further evaluate the combinations’ effects on immune activation, tumor response durability, and time-to-resistance. The ongoing work includes evaluations of pelareorep in combination with KRAS G12C inhibitors, pan-RAS inhibitors, and additional next-generation RAS pathway-targeting agents in RAS-mutated tumor models.

"We believe these initial findings further support pelareorep’s potential to serve as an immune-priming backbone for next-generation targeted therapies," said Jared Kelly, Chief Executive Officer of Oncolytics. "RAS-mutated tumors, particularly pancreatic and colorectal cancers, remain among the most difficult cancers to treat due to intrinsic immune resistance and the emergence of therapeutic resistance over time. These preclinical results support further study of the combinations’ anti-tumor and immune effects, including in models designed to assess durability and time-to-resistance."

Mr. Kelly continued, "Importantly, we believe this strategy may ultimately represent a potentially important area for further investigation in pancreatic cancer, where nearly all tumors harbor RAS pathway alterations and where patients continue to face extremely limited treatment options. The potential synergy observed in previous PDAC clinical studies and preclinical RAS-targeted modalities reinforces our belief that pelareorep may play an important role in future combination strategies designed to improve the durability of targeted therapies."

Full results from the initial preclinical studies are expected to be presented in the fall or winter of 2026.

(Press release, Oncolytics Biotech, JUN 1, 2026, View Source [SID1234666316])

On June 1, 2026 SystImmune, Inc., a clinical-stage biotechnology company, reported the oral presentation of Phase 1 data for BL-M14D1 in patients with small-cell lung cancer (SCLC), neuroendocrine carcinoma (NEC), and other solid tumors (BL-M14D1-101, NCT06505824) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2026 Annual Meeting in Chicago. BL-M14D1 is a DLL3 targeting antibody drug conjugate being developed globally by SystImmune, a subsidiary of Biokin.

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This study evaluated the safety and efficacy of BL-M14D1 in Chinese patients with advanced SCLC, NEC, and other solid tumors. As of the November 30, 2025 data cut-off, BL-M14D1 demonstrated:

Promising antitumor activity in heavily pre-treated patients across multiple tumor types, including SCLC and other NECs
Manageable safety profile, with hematologic adverse events managed with standard supportive care
A total of 127 patients with advanced solid tumors were treated, including 87 with SCLC and 40 with NEC. Most patients were heavily pre-treated. The most common adverse events were hematologic, including neutropenia, which were generally manageable and infrequently led to dose reductions or serious complications. The safety profile is consistent with other brengitecan based topo1 ADCs. One case of grade 3 interstitial lung disease was seen, and one treatment related death was reported.

Among patients with SCLC treated at 4.0 mg/kg D1Q3W, the confirmed objective response rate was 62% (21 of 34 patients), with a median progression-free survival of 7.2 months. Based on these results, SystImmune plans to initiate a global registrational study in first-line extensive-stage SCLC.

"These initial Phase 1 results for BL-M14D1 demonstrate compelling anti-tumor activity, including a 62% confirmed response rate and encouraging durability, in heavily pre-treated patients with small-cell lung cancer," said Jonathan Cheng, M.D., Chief Medical Officer of SystImmune. "Given the significant unmet need in this population, we believe these data support the potential for BL-M14D1 to become an important new treatment option, and we are rapidly advancing the program into global registrational studies in the first-line setting."

About the BL-M14D1-101 Phase I clinical trial

BL-M14D1-101 (NCT06505824) is a multi-center, Phase I study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-M14D1 in locally advanced or metastatic solid tumors. The study is being conducted in three parts (dose escalation, dose finding, and dose expansion) with patients being dosed on Day 1 of a continuous 21-day treatment cycle (D1Q3W). In the dose escalation and dose expansion phase, patients were treated with BL-M14D1 at 0.66, 2.0, 3.5, 4.0, 4.5, 5.0, and 6.0 mg/kg. In the dose expansion phase, SCLC and NEC patients were treated at 4.0 and 4.5mg/kg D1Q3W. The primary endpoint includes safety. Secondary endpoints include objective response rate (ORR) by RECIST 1.1 criteria, duration of response (DoR), disease control rate (DCR), and PK analysis.

About BL-M14D1

SystImmune is advancing a portfolio of next-generation antibody-drug conjugates (ADCs) built on its proprietary brengitecan platform, which utilizes a potent topoisomerase I inhibitor payload designed for targeted delivery to tumor cells. The clinical progress of izalontamab brengitecan (iza-bren) provides initial validation of this platform’s potential to deliver meaningful anti-tumor activity across multiple cancer types.

BL-M14D1 targets DLL3, which is highly expressed in small-cell lung cancer and neuroendocrine tumors, facilitating selective delivery of the brengitecan payload to DLL3-positive tumor cells.

(Press release, SystImmune, JUN 1, 2026, View Source [SID1234666332])

On June 1, 2026 Elicio Therapeutics, Inc. (Nasdaq: ELTX, "Elicio" or the "Company"), a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer, reported the publication of a peer-reviewed manuscript in Science Advances, published by the American Association for the Advancement of Science, describing a series of novel AMP-DNA adjuvant candidates built from the lymph node-targeting Amphiphile ("AMP") platform technology.

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The manuscript, titled "Lymph node targeted DNA engages TBK1/IFN-I driven innate immunity to induce potent T cell responses and durable memory in mice and NHPs," highlights the ability of these preclinical novel AMP-DNA adjuvants to drive robust, durable immune responses through targeted delivery to lymph nodes and activation of innate immune pathways. This work further builds on the development of the TLR-9-specific AMP-CpG (ELI-004), providing an expanded portfolio of potent lymph node-targeted AMP immunomodulators.

"We are excited to see this work published in the prestigious peer-reviewed journal, Science Advances, as we believe it reinforces the breadth and versatility of our AMP platform beyond our initial clinical programs. These data highlight our ability to precisely direct immune activation to the lymph nodes and unlock powerful, durable T cell responses through novel mechanisms, such as TBK1 and type I interferon (IFN-I) signaling. We believe these new AMP-DNA immuno-activators represent a meaningful step toward expanding the AMP toolkit of next-generation immunotherapies across oncology and infectious disease," said Peter DeMuth, Ph.D., Chief Scientific Officer of Elicio.

The findings further expand the scientific foundation of Elicio’s AMP platform, which is designed to enhance immune responses by directing therapeutics to the lymph nodes—where immune responses are initiated and coordinated—while minimizing systemic toxicity.

Key Study Highlights

Superior Efficacy: Preclinically, AMP-DNA outperformed current clinical and commercial benchmark adjuvants in head-to-head comparisons, inducing substantially more robust cellular immunity

Potent T Cell Activation: AMP-DNA elicited high frequencies of antigen-specific, polyfunctional CD8+ and CD4+ T cell responses across tissues

Long-Term Immunity: Durable immune memory was observed for at least nine months, with rapid and robust recall responses upon antigen re-exposure

Validated in Primates: Findings were replicated in non-human primates, demonstrating strong cellular and humoral immune responses in a translationally relevant model

Lymph Node Precision: AMP-DNA targets lymph nodes to create a localized, highly immunostimulatory environment

Distinct Mechanistic Pathway: Immune activation is driven through TBK1/IFN-I signaling pathways, supporting a differentiated mechanism compared to AMP-CpG which activates TLR-9

Preclinical results demonstrated that AMP-DNA adjuvants significantly enhanced both cellular and humoral immune responses compared to unmodified DNA and clinically relevant adjuvant benchmarks. The technology enabled efficient lymph node delivery and induction of a pro-inflammatory cytokine environment critical for adaptive immunity. In non-human primates, AMP-DNA induced strong T cell responses and high titers of neutralizing antibodies, supporting its potential translational relevance for human applications.

(Press release, Elicio Therapeutics, JUN 1, 2026, View Source [SID1234666348])

On June 1, 2026 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, reported that efficacy results from a subset of patients treated with iopofosine I 131 immediately post-Bruton Tyrosine Kinase inhibitor (BTKi) therapy in the Company’s Phase 2 CLOVER WaM clinical trial of iopofosine I 131 to treat relapsed or refractory (r/r) Waldenström macroglobulinemia (WM) will be highlighted today in a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper) taking place May 29-June 2, 2026 in Chicago, Illinois.

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"We are highly encouraged by these results from the CLOVER WaM study, which demonstrate compelling efficacy and durable responses with iopofosine I 131 in the particularly challenging patient population that has progressed following BTKi therapy. I look forward to highlighting these positive outcomes at this year’s ASCO (Free ASCO Whitepaper)," said Jarrod Longcor, chief operating officer of Cellectar Biosciences. "Patients with immediate post-BTKi disease represent a distinct clinical population within WM that is characterized by limited responses and rapid disease progression after BTKi discontinuation. In addition, there is no FDA-approved treatment that reliably provides durable disease control in this setting. These outcomes give us even greater confidence in the potential of iopofosine to be effective in an earlier line setting as will be evaluated in the planned Phase 3 confirmatory study."

In the CLOVER WaM Phase 2 clinical trial, eligible WM patients received greater than two prior therapies and had symptomatic disease requiring therapy. Treatment consisted of two cycles of iopofosine I 131 administered at 15 mCi/m2 on days 1 and 15 of each 57-day cycle. The primary efficacy endpoint was major response rate (MRR). This subset analysis assessed a modified intent-to-treat (mITT) population (all patients who received ≥60 mCi total administered dose of iopofosine I 131), and whose immediately prior treatment was a BTKi. Data cut off for this analysis was January 16, 2026.

Highlights of the Data:

Iopofosine I 131 demonstrated significant efficacy (n=24):
100% clinical benefit rate
87.5% overall response rate
79.2% major response rate, partial response or better
Median duration of response (DOR) of 16 months (range: 7.3 – 25.4 months)
20% of patients exceeded 30 months DOR
The treatment was well-tolerated with a manageable toxicity profile with cytopenias as the only Grade 3 or greater adverse event.
"These new data further reinforce the compelling clinical profile of iopofosine I 131, demonstrating meaningful efficacy in a subset of WM patients following BTKi treatment," said James Caruso, president and chief executive officer. "The strength and consistency of response observed in this post-BTKi population underscore iopofosine’s potential to address a critical unmet need in the second line setting and beyond. Based on these findings, we plan to pursue accelerated approval in the U.S. and initiate a confirmatory Phase 3 study in the fourth quarter of 2026. We remain committed to bringing iopofosine to the thousands of patients who may benefit from this therapy."

Details of the poster presentation are as follows:

Title: "Iopofosine I-131 after BTK inhibitors in Waldenström macroglobulinemia: CLOVER-WaM subgroup efficacy and safety"
Poster: 592
Date/Time: June 1, 2026, 9:00am – 12:00pm CDT
Presenter: Jarrod Longcor

(Press release, Cellectar Biosciences, JUN 1, 2026, https://www.cellectar.com/investors/news-events/press-releases/detail/393/cellectar-biosciences-to-highlight-compelling-new-efficacy-data-from-phase-2b-clover-wam-study-of-iopofosine-i-131-in-rr-waldenstrm-macroglobulinemia-at-the-american-society-of-clinical-oncology-annual-meeting [SID1234666301])

On June 1, 2026 PharmaMar (MSE: PHM), reported that the European Commission (EC) has approved the combination of Zepzelca (lurbinectedin) with atezolizumab (Tecentriq) as a first-line maintenance treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC), whose disease has not progressed following standard induction therapy. This approval follows the positive opinion issued on March 27th by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) concerning this treatment.

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Luis Mora, Managing Director of PharmaMar, points out that "it is great news that European patients and doctors now have access to a new treatment for this type of cancer. We believe it has the potential to change the paradigm of treatment for this disease, so we are looking forward to it being available soon in hospitals across Europe."

The approval is based on data from the Phase 3 IMforte trial, sponsored by Roche in collaboration with Jazz Pharmaceuticals, in which the combination of lurbinectedin and atezolizumab as maintenance treatment in first-line ES-SCLC was associated with a 46% reduction in the risk of disease progression or death and a 27% reduction in the risk of death compared with atezolizumab monotherapy.

In addition, lurbinectedin has been approved as an orphan drug, a designation granted by the EMA to medicines intended for the treatment of rare or uncommon diseases affecting fewer than 5 people per 10,000 inhabitants in the European Union.

Each year, around 62,000 new cases of SCLC are diagnosed in Europe, with most patients presenting advanced disease at the time of diagnosis .

Lurbinectedin in combination with atezolizumab has already been approved in 13 other countries, including the United States, for first-line maintenance treatment of this disease.

(Press release, PharmaMar, JUN 1, 2026, View Source [SID1234666317])