On May 1, 2025 Foresight Diagnostics, Inc. ("Foresight"), a leading diagnostics company specializing in the development of ultra-sensitive minimal residual disease (MRD) detection, reported that new data in newly diagnosed diffuse large B-cell lymphoma (DLBCL) will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place from May 30 – June 3, 2025, in Chicago, Illinois (Press release, Foresight Diagnostics, MAY 1, 2025, View Source [SID1234652460]).

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The company will deliver an oral presentation in collaboration with Amsterdam University Medical Centers (Amsterdam UMC), highlighting new validation results using Foresight CLARITY MRD, along with a trial-in-progress poster on the SHORTEN-ctDNA clinical trial in partnership with Columbia University. Foresight CLARITY’s ultra-sensitive MRD detection is powered by Foresight’s proprietary PhasED-Seq technology, which delivers an analytical sensitivity of less than 1 part per million in B-cell lymphoma.1

"These presentations mark important clinical validation milestones for our Foresight CLARITY platform," said Dr. David Kurtz, Chief Medical Officer at Foresight Diagnostics. "The presentations demonstrate that our ultra-sensitive MRD detection at the end of first-line therapy identifies DLBCL patients at significantly higher risk of relapse. Meanwhile, the SHORTEN-ctDNA study is exploring how MRD testing can inform de-escalation strategies in newly diagnosed patients. Our goal is to provide oncologists with actionable data that meaningfully improves treatment decisions and patient outcomes."

Further information about the presentations is below:

Oral Presentation Details:

Title: Prospective validation of end of treatment ctDNA-MRD by PhasED-Seq in DLBCL patients from a national trial
Presenter: Steven Wang, MD, PhD (Amsterdam UMC)
Session: Oral Abstract Session – Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Time: Friday, May 30 | 2:45 – 5:45 p.m. CDT
Location: Room S100a or live stream for virtual attendees
Abstract number: 7000
Poster Presentation Details:

Title: Sequencing-guided Chemotherapy Optimization Using Real-Time Evaluation in Newly Diagnosed DLBCL With Circulating Tumor DNA: SHORTEN-ctDNA (NCT06693830)
Presenter: Stephanie Meek, PhD (Foresight Diagnostics)
Session: Poster Session – Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Time: Sunday, June 1 | 9:00 a.m. – 12:00 p.m. CDT
Abstract number: TPS7096
Poster Board number: 272a
In addition, the Foresight Diagnostics booth is located in the Innovation Hub #3. To learn more about Foresight’s activities at ASCO (Free ASCO Whitepaper), please visit the ASCO (Free ASCO Whitepaper) event page on our website.

On May 1, 2025 TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to more effectively treating cancer using RNA therapeutics, reported further progress in its Phase 1a clinical trial of TTX-MC138 in patients with metastatic cancer (Press release, TransCode Therapeutics, MAY 1, 2025, View Source [SID1234652459]). TTX-MC138 is a first-in-class therapeutic candidate designed to inhibit microRNA-10b, or miR-10b, a microRNA widely believed to be critical to the emergence and progression of many metastatic cancers. To date, 13 patients have received at least one dose of TTX-MC138 at 4 separate dose levels ranging from 0.8 mg/kg to 4.8 mg/kg. Two patients have been treated in the expanded enrollment.

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Eight patients remain on study for continued treatment, receiving an additional dose of TTX-MC138 during each 28 day treatment cycle and may remain on study absent any significant safety observations or disease progression. To date, the two patients who have remained on study the longest have received seven doses of TTX-MC138 over the course of approximately seven months and have demonstrated stable disease. No significant safety or dose limiting toxicities have been reported to date in any of the trial’s 13 patients. Ongoing analyses of PK activity from Cohorts 1, 2 and 3 suggest that TTX-MC138 demonstrates a PK/PD profile consistent with preclinical results and results from TransCode’s Phase 0 clinical trial. Specifically, the preliminary PK data follow a predictable dose-response relationship. Analysis of PD activity from cycle 1 treatments in Cohorts 1 and 2, treated with a dose of 0.8 mg/kg and 1.6 mg/kg respectively, demonstrates miR-10b target engagement at 24 hours post-infusion in 5 out of the 6 patients analyzed to date.

The observed tolerability profile and the available PK/PD results thus far supports advancement of the clinical trial to further evaluate safety and potential anti-tumor activity of TTX-MC138 in the planned dose expansion (Phase 1b) portion of the trial. At the highest dose administered, TTX-MC138 was well tolerated with no significant toxicities noted.

About TTX-MC138

TTX-MC138 is a first-in-class therapeutic candidate designed to inhibit microRNA-10b, or miR-10b, a microRNA widely believed to be critical to the emergence and progression of many metastatic cancers. TransCode’s 2023 Phase 0 clinical trial produced evidence of delivery of a radiolabeled version of TTX-MC138 to metastatic lesions and pharmacodynamic activity, even at a microdose of the drug candidate, suggesting a broad therapeutic window for TTX-MC138.

About the Trial

TransCode’s Phase 1 clinical trial is a multicenter, open-label, dose-escalation and dose-expansion study designed to generate critical data to support evaluation of the safety and tolerability of TTX-MC138 in patients with a variety of metastatic solid cancers. While not an endpoint, the trial may provide early evidence of clinical activity of TTX-MC138. The trial comprises an initial dose-escalation stage followed by a dose-expansion stage. The primary objective of the dose-escalation stage is to evaluate the safety and tolerability of escalating dose levels of TTX-MC138. In the dose-expansion stage, the safety, tolerability and anti-tumor activity of TTX-MC138 will be further evaluated in certain tumor types selected based on preliminary results from the dose-escalation phase.

Further information is available at www.clinicaltrials.gov NCT Identifier: (NCT06260774).

On May 1, 2025 SK Life Science Labs, a subsidiary of SK Biopharmaceuticals Co., Ltd., a global biotech focused on the research, development, and commercialization of treatments for cancer and disorders of the central nervous system (CNS), reported the publication of its research in the journal, Nature Communications, detailing the discovery of PVTX-405, a best-in-class IKZF2 molecular glue degrader (Press release, SK Life Science, MAY 1, 2025, View Source [SID1234652458]).

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"This novel agent represents a significant step toward improved oncology treatments, establishing PVTX-405 as a potent IKZF2 molecular glue degrader that supercharges the body’s immune response against cancer," said Ryan Kruger, Ph.D., Chief Scientific Officer at SK Life Science Labs. "By targeting IKZF2, PVTX-405 dramatically reduces immune suppression, allowing the patient’s own immune system to more effectively fight cancer."

Regulatory T-cells, also known as Tregs, are a major roadblock in cancer treatment, suppressing the immune system and allowing tumors to thrive. IKZF2 is a critical factor in maintaining Tregs stability within the tumor environment. By selectively degrading IKZF2, PVTX-405 weakens Tregs, boosting the activity of tumor-fighting effector T-cells and amplifying the immune response against cancer.

The findings of this research show that PVTX-405 offers superior selectivity, potency and safety over previous IKZF2 molecular glue degraders. It is designed to degrade IKZF2 more efficiently while reducing the risk of unintended immune or blood cell-related toxicities. Most importantly, once-daily oral administration of PVTX-405 demonstrates exceptional anti-tumor efficacy, substantially slowing tumor growth and enhancing the impact of immune checkpoint inhibitors. This combined effect results in greater tumor regression and prolonged survival in preclinical trials.

"These exciting results reinforce our enthusiasm for partnering with biopharma, research institutions, and investors to fast-track the clinical development of this groundbreaking immunotherapy, with the goal of improving and extending the lives of cancer patients," said Dr. Kruger. "This research not only showcases the potential of molecular glue degraders as powerful therapeutic agents but also highlights SK Life Science Labs’ dedication to advancing life-saving treatments."

On May 1, 2025 Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), an oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), reported that management will participate in two upcoming investor conferences (Press release, Sutro Biopharma, MAY 1, 2025, View Source;utm_medium=rss&utm_campaign=sutro-biopharma-to-participate-in-upcoming-investor-conferences-6 [SID1234652454]).

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Conference Details:

The Citizens Life Sciences Conference
Date: May 7-8, 2025
Location: New York, NY

BofA Securities 2025 Health Care Conference
Date: May 13-15, 2025
Location: Las Vegas, NV

Webcasts of the presentations will be accessible through the News & Events page of the Investor Relations section of the Company’s website at www.sutrobio.com. Archived replays will be available for at least 30 days after the event.

On May 1, 2025 Repare Therapeutics Inc. ("Repare") (Nasdaq: RPTX), a leading clinical-stage precision oncology company, reported that it has out-licensed its discovery platforms, including certain platform and program intellectual property, to DCx Biotherapeutics Corporation ("DCx"), a newly-launched Canadian biotechnology company developing next generation precision drug conjugates and supported by Amplitude Ventures (Press release, Repare Therapeutics, MAY 1, 2025, View Source [SID1234652453]). Additionally, DCx will retain certain preclinical research personnel, acquire lease rights to certain laboratory facilities in Montreal and acquire certain laboratory equipment.

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"We have taken careful steps to evaluate all aspects of our business to ensure continued value generation, and this out-licensing agreement with DCx for our discovery platforms enables us to further focus on our clinical portfolio and drive cost reductions while maintaining an economic interest in the platform technologies we have developed." said Steve Forte, President, Chief Executive Officer and Chief Financial Officer of Repare. "We look forward to reporting initial data from our two ongoing Phase 1 clinical trials in the second half of 2025, and continue to evaluate partnering and strategic alternatives across our portfolio assets."

Under the terms of the out-licensing agreement, Repare will receive upfront and near-term payments totaling $4 million, as well as a 9.99% common equity position in DCx (including certain dilution protection rights) and is eligible to receive potential future out-licensing, clinical and commercial milestone payments, as well as low-single digit tiered sales royalites for the development of certain products by DCx. Additionally, DCx will retain approximately 20 of Repare’s preclinical research employees. Repare has the right to appoint one nominee to the board of directors of DCx. In connection with the transaction, Repare out-licensed its clinically-validated SNIPRx platform and its early discovery-stage SNIPRx-surf and STEP2 platforms, along with other intellectual property. The SNIPRx-surf platform identifies cell surface targets based on gene expression and protein features in tumors or cancer models, including by clinically relevant biomarkers and machine learning algorithm. The STEP2 platform is a chemogenomic discovery platform, which uses CRISPR-enabled genetic screens with small molecule inhibitors to identify clinically relevant genetic lesions that are sensitive to small molecule inhibitors.