On October 14, 2025 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical-stage biopharmaceutical company developing innovative treatments that exploit specific cancer cell vulnerabilities while minimizing damage to healthy cells, reported that two abstracts on its clinical programs, APR-1051 amd ATRN-119, have been accepted for poster presentation at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), taking place October 22 – 26, 2025 at the Hynes Convention Center in Boston, Massachusetts.

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Poster Details

Title: Early safety and efficacy of APR-1051, a novel WEE1 inhibitor, in patients with cancer-associated gene alterations: Updated data from ACESOT-1051 phase 1 trial
Lead author: Anthony Tolcher MD, FRCPC
Presenter: Philippe Pultar, MD
Session: Poster Session B
Session date/ time: Friday, October 24th, 12:30 – 16:00 ET
Location: Exhibit Hall D, Hynes Convention Center

Title: Updated data from ABOYA-119: A phase 1/2a trial of ATRN-119, a novel macrocyclic ATR inhibitor, in patients with advanced solid tumors harboring DNA damage
Lead author: Amit Mahipal MD
Presenter: Oren Gilad, PhD
Session: Poster Session B
Session date/ time: Friday, October 24th, 12:30 – 16:00 ET
Location: Exhibit Hall D, Hynes Convention Center

Copies of the posters will be available on the "Investor Resources" page of the Aprea corporate website on the day of the presentations.

(Press release, Aprea, OCT 14, 2025, View Source [SID1234656630])

On October 14, 2025 TransCode Therapeutics, Inc. (NASDAQ: RNAZ) reported completion of Phase 1a clinical trial with TTX-MC138, an investigational inhibitor of microRNA-10b, or miR-10b. By meeting its primary safety endpoint and defining a recommended Phase 2 dose, TTX-MC138 is moving forward into the next stage of clinical evaluation to assess its efficacy across selected metastatic diseases and for multiple indications.

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Primary objectives of the trial focused on safety, tolerability, pharmacokinetics ("PK") and establishment of a Phase 2 dose (RP2D). A total of sixteen patients were treated across four escalating dose levels. No significant treatment-related safety events or dose limiting toxicities were observed.

TTX-MC138 was administered to 16 patients (77 total doses to date) with positive pharmacodynamic effects over all four administered dose range levels. Currently three patients remain on trial receiving TTX-MC138. The median treatment duration was four months. Importantly, the duration of treatment for all patients ranged from two to 12 cycles, indicative of tolerability and disease control. Forty-four per cent or seven out of sixteen patients were classified as having stable disease lasting 4 months or longer. Preliminary data in 16 patients showed positive pharmacodynamic effects over a wide dose range, consistent with preclinical models and TransCode’s Phase 0 clinical trial. Of note, one patient diagnosed with thyroid cancer and historic evidence of an increase in thyroglobulin levels, demonstrated a reversal of the trend during treatment and presented at the most recent measurement with undetectable thyroglobulin levels.

Study investigator William McKean, MD, PhD (The START Center for Cancer Research) stated, "The clinical benefit we are observing in patients treated with TTX-MC138 is compelling given the pre-clinical data and length of time the drug remains in the tumor cells".

Data analysis and monitoring are ongoing. A final clinical study report, scientific presentations and publications are planned.

(Press release, TransCode Therapeutics, OCT 14, 2025, View Source [SID1234656647])

On October 14, 2025 NeoGenomics, Inc. (NASDAQ: NEO), a leading provider of oncology diagnostic solutions that enable precision medicine, reported the presentation of assay-relevant data, including interventional therapy trials in progress, to showcase how its molecular residual disease (MRD) assay may benefit pharmaceutical partners at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, October 17–21, in Berlin, Germany. RaDaR ST, the company’s circulating tumor DNA (ctDNA) assay, is designed to accelerate and optimize oncology drug development.

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Building on NeoGenomics’ established molecular capabilities, the RaDaR ST assay uses whole-exome sequencing data from tumor samples and advanced bioinformatics to create patient-specific MRD panels. By leveraging high-depth sequencing and personalized panel design, the assay delivers highly sensitive and specific detection of ctDNA from plasma samples, providing real-time insights into tumor dynamics and treatment response.

"We stand by our commitment to clinical validation and interventional studies utilizing NeoGenomics’ MRD technology, as reflected in three new posters from our European collaborators presented at this year’s ESMO (Free ESMO Whitepaper) congress," said Tony Zook, Chief Executive Officer. "We are excited to continue our long-standing support of drug development and interventional clinical trials, now with our RaDaR ST assay. Pharmaceutical sponsors are seeking partners who can deliver both innovation and operational excellence across every stage of oncology trials. NeoGenomics meets that need with RaDaR ST, providing patient-specific insights in real time to help drive faster, more informed decisions and advance cancer research more effectively."

As MRD gains traction as a preferred solution to monitor responses to next-generation therapies, NeoGenomics’ launch of RaDaR ST strengthens its position as a partner to biopharma organizations seeking to advance precision oncology. The company will feature RaDaR ST and its broader oncology testing and research capabilities at booth #4012.

(Press release, NeoGenomics Laboratories, OCT 14, 2025, View Source [SID1234656662])

On October 14, 2025 Biogen Inc. (Biogen) reported that its GAAP and non-GAAP results for the third quarter of 2025 will include acquired in-process research and development, upfront and milestone expense of approximately $2 million on a pre-tax basis (Press release, Biogen, OCT 14, 2025, View Source [SID1234656631]). The estimated charge is expected to impact GAAP and non-GAAP net income per diluted share for the third quarter 2025 by approximately ($0.01) per share.

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During the first quarter of 2025 we began presenting acquired in-process research and development, upfront and milestone expense as a separate line item in our condensed consolidated statements of income. Acquired in-process research and development, upfront and milestone expense includes costs incurred in connection with collaboration and license agreements such as upfront and milestone payments and, when applicable, premiums on equity securities and asset acquisitions of acquired in-process research and development. Biogen does not forecast such acquired in-process research and development, upfront and milestone expense due to the uncertainty of the future occurrence, magnitude and timing of these transactions in any given period.

Results for the quarter ended September 30, 2025, have not been finalized and are subject to our financial statement closing procedures. There can be no assurance that our final results will not differ from the preliminary unaudited estimates described herein.

On October 14, 2025 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of cancer and autoimmune diseases, reported the upcoming presentation of initial results from the ongoing Phase 1 dose-escalation study of XmAb819, a bispecific ENPP3 x CD3 T-cell engaging bispecific antibody, in patients with clear cell renal cell carcinoma (ccRCC) in a poster at the AACR (Free AACR Whitepaper)-NCI-EORTC Conference on Molecular Targets and Cancer Therapeutics, being held October 22-26, 2025 in Boston, Massachusetts.

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Today, Xencor management also became aware that an investment bank published takeaways from the abstract accepted for presentation at the conference, which is not publicly available via the conference website or app. Full abstracts are scheduled to be released by the conference next Wednesday, October 22 at 12 p.m. ET.

Xencor submitted a placeholder abstract with limited detail based on a previous data-cut from the ongoing dose-escalation study of XmAb819 (Clinicaltrials.gov Identifier: NCT05433142). The abstract contained a high-level safety summary across all dosing cohorts with no additional information regarding efficacy beyond what had been previously disclosed during a public webcast in September 2024.

Presentation of a dataset from an updated data-cut at the conference will include a detailed safety analysis along with efficacy results from the target dose range when the embargo lifts. Management will also host a webcast and conference call to discuss the results and will provide access credentials for the event on a later date.

Presentation Details

Title: Preliminary Phase 1 safety and antitumor activity of XmAb819, a first-in-class ENPP3 x CD3 bispecific antibody, in patients with advanced clear cell renal cell carcinoma (ccRCC)
Session: Poster Session B
Date and Time: Friday, October 24, 2025 from 12:30-4:00 p.m. ET
About XmAb819

XmAb819 is a first-in-class, tumor-targeted, T-cell engaging XmAb 2+1 bispecific antibody in development for patients with clear cell renal cell carcinoma (ccRCC). XmAb819 engages the immune system and activates T cells for highly potent and targeted lysis of tumor cells expressing ENPP3, an antigen highly expressed on kidney cancers. ENPP3 is a differentially expressed target, with high level expression in renal cell carcinoma (RCC) and low-level expression on normal tissues. With two tumor-antigen binding domains and one T-cell binding domain, Xencor’s XmAb 2+1 format enables antibodies to bind more avidly and selectively kill tumor cells with higher antigen density, potentially sparing normal cells. Xencor is conducting a Phase 1 study to evaluate XmAb819 in patients with advanced ccRCC.

(Press release, Xencor, OCT 14, 2025, View Source [SID1234656648])