On May 30, 2025 ImmunoGenesis, a clinical-stage biotech company developing innovative, science-driven immunotherapies, reported that a Trial in Progress poster for its first-in-human, Phase 1a/1b clinical trial of IMGS-001 will be presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held in Chicago, Illinois from May 30 to June 3, 2025 (Press release, ImmunoGenesis, MAY 30, 2025, View Source [SID1234653530]).

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This Phase 1a/1b first-in-human, open-label, multicenter study (NCT06014502) includes a dose escalation and an expansion portion to evaluate the safety, pharmacokinetics, and preliminary anti-tumor activity of IMGS-001 in adult patients with locally advanced or metastatic solid tumors refractory to standard-of-care treatment. The study will enroll approximately 25 patients in Phase 1a and up to 250 in Phase 1b. The first three of five planned dose cohorts have completed without any dose limiting toxicities (DLTs), with cohort 4 (10 mg/kg) now enrolling.

"This clinical trial is an important first step to understand how IMGS-001 may potentially remove immunosuppressive cells while improving PD-1 pathway blockade to treat otherwise immunoresistant tumors that represent a significant unmet medical need," stated Charles Schweizer, PhD, Senior Vice President of Clinical Development at ImmunoGenesis. "We are pleased to discuss the study plan and progress at this important conference as we look ahead to sharing results."

"We are encouraged by the early performance of IMGS-001 as we proceed with Phase 1 dose escalation in patients with a variety of advanced solid tumors," said James Barlow, President and CEO of ImmunoGenesis. "Initial low doses administered to date have been well-tolerated with no dose-limiting toxicities, and we are seeing promising early signs of anti-tumor activity in patients who have failed prior treatments. IMGS-001 has the potential to be a foundational therapy for immune-excluded tumors, addressing a major unmet need."

ASCO Poster Presentation

Title: A Phase 1a/1b study to evaluate the safety, tolerability, Pharmakokinetics, and anti-tumor activity of IMGS-001 in Patients with relapsed or refractory advanced solid tumors.
Abstract: TS2686 | Poster Bd #: 324a
Track: Developmental Therapeutics—Immunotherapy
Location: Hall A -Posters and Exhibits | On Demand
Time: June 2, 2025, 1:30 PM – 4:30 PM CDT

On May 30 Adela, Inc., an innovator in blood testing for molecular residual disease (MRD) monitoring and early cancer detection through a proprietary genome-wide methylome enrichment technology, reported results of two studies demonstrating the ability of its MRD test to predict progression and identify non-responders to immunotherapy at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from May 30 – June 3, 2025 (Press release, Adela, MAY 30, 2025, View Source [SID1234653529]).

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"In patients with advanced cancer receiving immunotherapy, it can be challenging to differentiate true progression from pseudoprogression during early treatment cycles based on imaging," said Lillian Siu, MD, FRCPC, Medical Oncologist and Senior Scientist, Princess Margaret Cancer Centre, University Health Network. "To better identify non-responders and guide timely treatment adjustments, more reliable response assessment tools are needed. Methylation-based circulating tumor DNA (ctDNA) technology shows promise in these regards."

The ability of Adela’s test to identify progression in patients treated with immunotherapy was demonstrated in two studies. The first study included banked samples from 64 patients with advanced head & neck, breast, ovarian, melanoma, or other solid tumors who received pembrolizumab. Blood samples were collected pre-treatment and prior to initiation of cycle 3 of treatment. A decrease in ctDNA from the pre-treatment blood draw to the pre-cycle 3 blood draw was associated with a significantly better PFS [hazard ratio (HR) of 0.28 (0.15, 0.49); p<0.0001] and OS [HR 0.42 (0.24, 0.76); p=0.003].

"These results show promise in assessing response to immunotherapy early in a patient’s course of treatment," said Enrique Sanz-Garcia, MD, Medical Oncologist and Clinician-Investigator at Princess Margaret Cancer Centre, University Health Network. "Identifying non-response earlier can support timely treatment decisions and help avoid unnecessary toxicity."

The second study included banked samples from 63 patients with stage III/IV non-small cell lung cancer treated with definitive chemoradiation followed by consolidative durvalumab (stage III) or with PD-1 inhibitors +/- chemotherapy (stage IV). Blood samples were collected pre-treatment, 2-4 weeks after treatment initiation and approximately 6-8 weeks thereafter until progression. Patients with a positive MRD test showed significantly worse PFS than those who tested negative (HR 4.8; 95% CI, 2.1-10.8; P < 0.0001).

"Together, these two studies demonstrate the potential of Adela’s tissue-agnostic test to predict outcomes and support clinical decision-making for patients receiving immunotherapy across a range of cancer types," said Dr. Anne-Renee Hartman, Chief Medical Officer at Adela. "Because tumor tissue is often unavailable in patients with advanced cancer, Adela’s blood-only, tissue-free approach offers a universally accessible solution for this population."

Adela’s MRD test based on its genome-wide methylome enrichment platform is currently available to biopharmaceutical companies and other investigators for Research Use Only (RUO), including for biomarker discovery and drug development. Adela plans to commercialize the test in 2025 for use in patients who have received curative intent treatment for head & neck cancer, regardless of HPV status, to detect recurrence earlier and help guide treatment decision-making.

Presentation Details

Abstract #8550: Identification of immunotherapy early treatment failure in non-small cell lung cancer (NSCLC) using a novel cell-free DNA (cfDNA) tissue-agnostic genome-wide methylome enrichment assay

Dr. Tuan Hoang1

Hall A, Poster Board: 30

Saturday May 31, 2025 1:30 PM-4:30 PM CDT

Abstract # 2545: Validation of an optimized tissue-agnostic genome-wide methylome enrichment assay to predict clinical outcomes in patients treated with pembrolizumab

DR. Enrique Sanz-Garcia1

Hall A, Poster Board: 192

Monday June 2, 2025 1:30 PM-4:30 PM CDT

On May 30, 2025 Myeloid Therapeutics, Inc. ("Myeloid"), a clinical-stage immunology company advancing RNA therapeutics to conquer cancer, reported it will present two posters at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago taking place from May 30 – June 3, 2025 (Press release, Myeloid Therapeutics, MAY 30, 2025, View Source [SID1234653528]). The presentations will highlight the clinical trial design for MT-303 and preliminary translational findings for MT-302 – the company’s lead in vivo mRNA CAR therapies, which together signify a key milestone in the field of RNA-based immuno-oncology.

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"Our presentations at ASCO (Free ASCO Whitepaper) demonstrate the clinical translation of our proprietary mRNA-LNP platform for in vivo immune cell engineering," said Daniel Getts, PhD, CEO and Co-founder of Myeloid Therapeutics. "With MT-302 and MT-303, we are pushing beyond the limits of traditional CAR therapies—removing the need for often complicated ex vivo manipulation while delivering potent, tumor-specific immune activation in patients with advanced solid tumors."

"These data show that we can deliver repeated doses of LNP-mRNA in patients demonstrating that CAR-programmed myeloid cells can penetrate solid tumors and alter the tumor microenvironment (TME), which opens up multiple avenues for potential clinical benefit moving forward," said Matt Maurer, MD, Chief Medical Officer of Myeloid Therapeutics. "The results offer early validation of Myeloid’s platform technologies, and could ultimately change how solid tumors are treated, offering patients a more accessible, potentially more tolerable, and highly targeted therapy option in the future without the burdens associated with traditional cell therapies."

MT-302: TROP2-Targeted mRNA CAR Therapy in Advanced Epithelial Tumors

MT-302 is the first intravenously delivered mRNA-based CAR therapy to enter clinical trials. It uses synthetic mRNA encapsulated in lipid nanoparticles (LNPs) to reprogram circulating immune cells in vivo to express a TROP2-targeted CAR.

Poster Board: 238
Title: First-in-human mRNA CAR Therapy: Correlative Biomarker analysis from the MT-302 Phase 1 Study Targeting TROP2 in Patients with Advanced Epithelial Tumors
Lead Author: Dr. Charlotte Lemach, MBBS
Session Date & Time: June 2, 2025 | 1:30 PM–4:30 PM CDT
Location: Hall A, McCormick Place, Chicago
Key MT-302 Findings Include:

Immune Activation: Single-cell RNA sequencing demonstrated selective CAR expression in myeloid cells and increased pro-inflammatory gene signatures across tumor types.
Target Engagement: Pharmacodynamic markers confirmed successful delivery and CAR expression following systemic administration.
Continued dose escalation: Dose escalation continues with an optimized liner mRNA based on preclinical demonstration of expression beyond 12 days.
MT-303: GPC3-Targeted mRNA CAR Therapy in Hepatocellular Carcinoma

MT-303 is an innovative in vivo CAR therapy specifically designed to reprogram Fc receptor gamma chain-expressing myeloid cells to recognize and destroy GPC3+ tumor cells following intravenous mRNA-LNP administration.

Poster Board: 499b
Title: A First-in-Human Study of MT-303, an Innovative In Vivo mRNA CAR Therapy Targeting GPC3 in Adults with Hepatocellular Carcinoma
Lead Author: Dr. Timothy Humphries, Linear Clinical Research
Session Date & Time: May 31, 2025 | 9:00 AM-12:00 PM CDT
Location: Hall A, McCormick Place, Chicago
MT-303 Clinical Trial Highlights:

Design: Ongoing multicenter, open-label Phase 1 trial in advanced solid tumors expressing GPC3 (including HCC) employing a Bayesian Optimal Interval (BOIN) dose escalation.
Mechanism: mRNA encodes a GPC3-targeted CAR construct driven by CD89, restricting expression to myeloid cells.
Myeloid expects to share additional clinical translational data at an upcoming medical meeting upon completion of the Phase 1 studies of MT-302 and MT-303.

About MT-302

MT-302 is a first-in-class, TROP2-FcA-LNP targeting TROP2, which is overexpressed in many epithelial tumors and corresponds with low expression in healthy tissues. MT-302 has demonstrated promising preclinical results to date, including robust expression in myeloid cells and a favorable safety profile in rodents and non-human primates. Unlike other therapies, MT-302 brings the potential advantages of eliciting a full immune response by also presenting tumor neoantigen to stimulate T cells. MT-302 is Myeloid’s first in vivo CAR clinical program that further builds on the company’s innovative approach to cancer treatment through immune cell programming.

About MT-303

MT-303 is a first-in-class, GPC3-FcA-LNP targeting glypican-3 (GPC3), which is overexpressed in most human hepatocellular carcinomas (HCCs) and exhibits limited expression in healthy tissues. MT-303 has demonstrated promising preclinical results to date, including robust expression in myeloid cells and a favorable safety profile in rodents and non-human primates. Unlike other therapies, MT-303 brings the potential advantages of eliciting a full immune response by also presenting tumor neoantigen to stimulate T cells. MT-303 is Myeloid’s second in vivo CAR clinical program that further builds on the company’s innovative approach to cancer treatment through immune cell programming.

On May 30, 2025 Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715 (together with its subsidiaries and/or associated companies, "Sun Pharma")) reported the successful completion of its acquisition of Checkpoint Therapeutics, Inc. ("Checkpoint"), an immunotherapy and targeted oncology company (Press release, Sun Pharma, MAY 30, 2025, View Source [SID1234653527]). As part of the acquisition, Sun Pharma acquires UNLOXCYT, the first and only FDA-approved anti-PD-L1 treatment for advanced cutaneous squamous cell carcinoma.

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"This acquisition exemplifies Sun Pharma’s commitment to supporting patients and growing its innovative therapies business," said Dilip Shanghvi, Chairman & Managing Director of Sun Pharma. "By adding UNLOXCYT, we will be able to leverage our leadership in the onco-derm space to help patients access an important treatment option while growing our product portfolio."

Financial Terms

Sun Pharma has acquired all outstanding shares of Checkpoint at a price of $4.10 per share in cash, without interest, plus one non-tradable contingent value right (CVR) per share representing the right to receive up to an additional $0.70 in cash, without interest, if certain specified milestones are met, as set out in the terms and conditions of the contingent value rights agreement.

On May 30, 2025 MEDSIR reported the positive results of the TUXEDO-3 trial at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2025 (Press release, MedSIR, MAY 30, 2025, View Source [SID1234653526]). This phase II study funded by Daiichi Sankyo and Merck, known as MSD outside of the United States and Canada, evaluates the efficacy and safety of patritumab deruxtecan (HER3-DXd) in patients with active brain metastases and leptomeningeal disease, serious complications associated with advanced stages of the cancer.

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The study was carried out to evaluate HER3-DXd in patients with metastatic breast cancer (mBC) and advanced non-small cell lung cancer (aNSCLC) with active brain metastases, and patients with leptomeningeal disease from solid tumors. This is an antibody-drug conjugate to target HER3, a protein receptor found on the surface of cancer cells in brain metastases. HER3-DXd is an investigational agent consisting of a fully human anti-HER3 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADC Technology payload causes tumor DNA damage, killing cancer cells within and surrounding the tumor microenvironment

The study showed promising results, which were presented today in an oral session. Results from the leptomeningeal cohort have been simultaneously published in the renowned journal Nature Medicine due to its potential benefit in patients with a high unmet medical need. In patients with breast cancer and brain metastases, intracranial responses were observed across all breast cancer subtypes, including luminal, HER2-positive, and triple-negative. Furthermore, some patients with breast cancer who had previously received antibody-drug conjugates also responded to HER3-DXd, highlighting the potential of HER3-DXd to overcome resistance and expand treatment options in refractory disease. Intracranial activity was also observed in patients with aNSCLC and brain metastases, intracranial responses were observed in patients whose tumors contained no activating driver mutations as well as patients whose tumors contained an EGFR or KRAS mutation. Overall, the data suggest that HER3-DXd may offer a novel treatment option for patients with secondary CNS involvement.

KEY HIGHLIGHTS OF THE TUXEDO-3 STUDY

The TUXEDO-3 study aimed to assess whether HER3-DXd could be an effective treatment option for patients with mBC and aNSCLC with active brain metastases, and leptomeningeal disease from solid tumors.

The study met its primary objectives, with 23.8% and 30% patients achieving intracranial responses in active brain metastases from patients with mBC and aNSCLC, respectively, and 65% patients with leptomeningeal disease alive after 3 months. Side effects were consistent with previous studies using HER3-DXd. Tests evaluating quality of life and neurocognitive functions showed that patients remained stable or improved during the treatment follow-up.

The primary objectives consisted of assessing the intracranial objective response rate in patients with active brain metastases from mBC and aNSCLC, and determining the number of patients with leptomeningeal disease alive after 3 months of starting the treatment.

A NEW HOPE FOR DIFFICULT-TO-TREAT METASTASES

"This study represents a significant advancement in our understanding of how to treat brain metastases and leptomeningeal disease, and we are hopeful that our findings will pave the way for new, effective therapies for these patients," stated Dr. Matthias Preusser, MD, Medical Oncologist and Head of the Clinical Division of Oncology, Medical University of Vienna and Principal Investigator of TUXEDO-3. Dr. Rupert Bartsch, MD, PhD, Consultant Hematology and Medical Oncology, Medical University of Vienna, added: "Brain metastases and leptomeningeal disease represent severe complications in cancer, leading to increased morbidity and mortality, and HER3-DXd could be a promising therapeutic alternative for these patients."

ABOUT UMMET CANCER NEEDS

Unmet cancer needs refer to gaps in resources, support, and treatment options that exist for cancer patients. Addressing unmet cancer needs is crucial to improving quality of life and outcomes for cancer patients. Through the collaborative work of healthcare providers, policymakers, and patient advocacy groups unmet cancer needs can be identified to help provide patients with comprehensive and quality care.

SHOWCASING PROMISING COLLABORATIVE TRIALS AT ASCO (Free ASCO Whitepaper)

In addition to the oral presentation of TUXEDO-3, MEDSIR will present both ADELA and WIN-B studies in poster format. The ADELA clinical trial is an ongoing international phase III study in collaboration with The Menarini Group, a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc., a wholly-owned subsidiary of the Menarini Group focused on bringing transformational oncology treatments to cancer patients. The study is being conducted across multiple countries which combines elacestrant with everolimus to treat advanced ER+/HER2- breast cancer with ESR1 mutations, aiming to delay disease progression.

Regarding WIN-B, is a phase Ib/II, multi-center investigator-initiated trial, evaluating the safety and preliminary efficacy of combining Debiopharm’s selective WEE1 inhibitor, Debio 0123 and Gilead’s antibodydrug conjugate Trodelvy (sacituzumab govitecan-hziy) in advanced HR+/HER2- and triple-negative breast cancers.

MEDSIR active presence at the ASCO (Free ASCO Whitepaper) Annual Meeting 2025 reinforces its leadership in excellence-driven oncology research and highlights its focus on addressing unmet needs in cancer treatment, with the aim of not leaving any patient left behind.