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 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company working to develop a new class of drugs based on targeted protein degradation, reported that management will participate in a fireside chat at the Jefferies Global Healthcare Conference on Thursday, June 5 at 2:35 p.m. ET in New York City (Press release, Arvinas, MAY 30, 2025, View Source [SID1234653511]).

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A live audio webcast of the presentation will be available here and under "Events and Presentations" on the Investors and Media section of the Company’s website.

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 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a development stage biopharmaceutical company pursuing life-changing therapies in oncology and rare disease, reported that a poster including new data from the single-arm pilot phase of the investigator-initiated, randomized CheMo4METPANC Phase 2 combination clinical trial will be presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 30-June 3, 2025 in Chicago, Illinois (Press release, BioLineRx, MAY 30, 2025, View Source [SID1234653512]).

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The CheMo4METPANC trial is evaluating the company’s CXCR4 inhibitor motixafortide, the PD-1 inhibitor cemiplimab, and standard-of-care chemotherapies gemcitabine and nab-paclitaxel, versus gemcitabine and nab-paclitaxel alone, in first-line pancreatic cancer (PDAC).

Updated results from the pilot phase indicate that four of eleven patients remained progression free after more than one year. Two patients underwent definitive treatment for mPDAC: one had complete resolution of all radiologically detected liver lesions and underwent definitive radiation to the primary pancreatic tumor, and one had a sustained partial response and underwent pancreaticoduodenectomy with pathology demonstrating a complete response. An analysis of pre- and on-treatment biopsies and peripheral blood mononuclear cells (PBMCs) also revealed that CD8+ T-cell tumor infiltration increased across all eleven patients treated with the motixafortide combination. In addition, patients achieving a partial response were found to have higher pre-treatment proportions of CXCL12-producing cancer associated fibroblasts, a potential marker of response.

"The data that continue to emerge from the pilot phase of the CheMo4METPANC Phase 2 study are extremely encouraging, with four of eleven patients remaining progression free after more than one year, as well as two patients that underwent definitive treatment, in what has historically been among the most challenging tumor types to treat," stated Philip Serlin, Chief Executive Officer of BioLineRx Ltd. "Notably, these results further suggest that the combination of motixafortide, cemiplimab and standard-of-care chemotherapy can overcome the immunosuppressive mechanisms of the tumor microenvironment (TME) and increase intratumoral CD8+ T-cell infiltration, resulting in improved patient outcomes. We look forward to results from the ongoing randomized portion of this important study."

The pilot clinical trial of motixafortide, cemiplimab, gemcitabine and nab-paclitaxel (N=11) demonstrated an overall response rate (ORR) of 64% (7/11) and a disease control rate (DCR) of 91% (10/11), compared to historical ORR and DCR of 23% and 48%, respectively, with gemcitabine and nab-paclitaxel. Based on these encouraging results, the CheMo4METPANC Phase 2 trial was amended to become a randomized study, with planned enrollment increasing from 30 to 108 patients. The trial is the first large, multi-center, randomized study evaluating motixafortide with a PD-1 inhibitor and first-line PDAC chemotherapies. The trial is planned to be fully enrolled in 2027, and a prespecified interim analysis is planned for when 40% of PFS events are observed.

Poster Presentation at ASCO (Free ASCO Whitepaper) 2025
McCormick Place, Chicago, Illinois

Poster Session Details

Primary Track: Gastrointestinal Cancer—Gastroesophageal, Pancreatic and Hepatobiliary

Title: CheMo4METPANC: Combination Chemotherapy (Gemcitabine and Nab-Paclitaxel), Chemokine (C-X-C) Motif Receptor 4 Inhibitor (Motixafortide), and Immune Checkpoint Blockade (Cemiplimab) in Metastatic Treatment-Naïve Pancreatic Adenocarcinoma

Presenter: Gulam Abbas Manji, MD, PhD, Columbia University Herbert Irving Comprehensive Cancer Center
Abstract: 4167
Poster Bd #: 457
Date: May 31, 2025
Time: 9:00am CDT
Location: Hall A

About CheMo4METPANC Phase 2 Clinical Trial
The multi-center CheMo4METPANC Phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT04543071) is a randomized, investigator-initiated clinical trial in first line metastatic pancreatic cancer. Sponsored by Columbia University, and supported equally by BioLineRx and Regeneron, the study is evaluating the combination of CXCR4 inhibitor motixafortide, PD-1 inhibitor cemiplimab, and standard of care chemotherapies gemcitabine and nab-paclitaxel, versus gemcitabine and nab-paclitaxel alone, in 108 patients. The trial’s primary endpoint is progression free survival (PFS). Secondary objectives include safety, response rate, disease control rate, duration of clinical benefit and overall survival.

About Pancreatic Cancer
Pancreatic cancer has a low rate of early diagnosis and a poor prognosis. In the United States in 2024, an estimated 66,000 adults will be diagnosed with the disease, which accounts for approximately 3% of all cancers in the U.S. and about 7% of all cancer deaths.1 Worldwide, an estimated 496,000 people were diagnosed with the disease in 2020. In the U.S., if the cancer is detected at an early stage when surgical removal of the tumor is possible, the 5-year relative survival rate is 44%. About 12% of people are initially diagnosed at this stage. If the cancer has spread to surrounding tissues or organs, the 5-year relative survival rate is 15%. For the 52% of patients who are initially diagnosed with metastatic cancer, the 5-year relative survival rate is 3%.2 In particular, hepatic (liver) metastases are a critical risk factor driving poor prognoses for patients with metastatic PDAC. These data highlight the need for the development of new therapeutic options.

About Motixafortide in Cancer Immunotherapy
Motixafortide inhibits CXCR4, a chemokine receptor and a well validated therapeutic target that is over-expressed in many human cancers including pancreatic ductal adenocarcinoma (PDAC). Motixafortide leverages the expression of the CXCR4 receptor on different immune cells and potentiates the immune system against the tumor. Among CXCR4-expressing immune cells, some exhibit anti-tumoral activity, such as effector T cells and some exhibit pro-tumoral activity and support tumor growth. By blocking the CXCR4 receptor, motixafortide was shown in a Phase 2 study in pancreatic cancer patients to enhance anti-tumoral activity and to ameliorate the pro-tumoral activities by modulating the effector/suppressor cell ratio towards a proinflammatory profile.

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