On October 14, 2025 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that its research collaborators will present positive preclinical data at the upcoming 2025 AACR (Free AACR Whitepaper)-NCI-EROTC 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. The collaborators will present positive preclinical data from a study of Genprex’s lead drug candidate, Reqorsa Gene Therapy (quaratusugene ozeplasmid), for the treatment of ALK-EML4 positive non-small cell lung cancer (NSCLC).

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"We are thrilled that our collaborators have once again been selected to present positive preclinical data on the use of REQORSA and its ability to induce apoptosis in ALK positive lung cancer, a subset of NSCLC that impacts mostly young, non-smoking individuals," said Ryan Confer, President and Chief Executive Officer at Genprex. "These preclinical data further validate REQORSA as a potential treatment for many types of cancer, including another subset of lung cancer, and we look forward to continuing our studies of REQORSA in combination with ALK inhibitors."

The featured Genprex-supported poster to be presented at the 2025 EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics:

Title: "Quaratusugene ozeplasmid mediated TUSC2 upregulation in EML4-ALK bearing non-small cell lung carcinoma induces apoptosis and is highly effective in preclinical studies"

Collaborator: The University of Michigan Rogel Cancer Center

Session: Poster Session C

Session Date and Time: Saturday, October 25, 2025 from 12:30 – 4:00 p.m. ET

Genprex entered into a Sponsored Research Agreement (SRA) with the University of Michigan Rogel Cancer Center in October 2024 to study TUSC2, the tumor suppressor gene used in REQORSA, in combination with ALK-inhibitors in ALK-EML4 positive translocated lung cancer. Also in October 2024, Genprex announced its collaboration with ALK Positive, a non-profit patient-driven research organization dedicated to improving the life expectancy and quality of life for ALK-positive lung cancer patients, which shares in sponsoring this preclinical study.

TUSC2 is the tumor suppressor gene used in REQORSA. REQORSA consists of a TUSC2 gene expressing plasmid encapsulated in non-viral lipid-based nanoparticles in a lipoplex form (the Company’s Oncoprex Delivery System), which has a positive charge. REQORSA is injected intravenously and specifically targets cancer cells. REQORSA is designed to deliver the functioning TUSC2 gene to negatively charged cancer cells while minimizing uptake by normal tissue. Laboratory studies show that the uptake of TUSC2 in tumor cells in vitro after REQORSA treatment was 10 to 33 times the uptake in normal cells.

(Press release, Genprex, OCT 14, 2025, View Source [SID1234656639])

On October 14, 2025 Caris Life Sciences (NASDAQ: CAI), a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer, reported it will unveil six studies at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, in Berlin, Germany from October 17-21, 2025. These presentations highlight the transformative power of multiomics, a scientific approach that integrates data from multiple biological layers to achieve a comprehensive understanding of biological systems and disease. The research spans nine tumor types, and results showcase how integrated profiling, subtyping, and biomarker discovery are driving more informed treatment decisions and improving patient outcomes.

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The six studies were conducted in collaboration with more than 25 leading cancer centers across the U.S., Europe, and Japan, including members of the Caris Precision Oncology Alliance. The research will be featured across multiple formats, including one oral "Proffered Paper," one mini-oral and four poster presentations. The studies highlight Caris’ continued leadership in applying next-generation sequencing (WES and WTS), immunohistochemistry (IHC) and real-world clinico-genomic data to uncover actionable insights. Tumor types represented include colorectal, gastric, breast, pancreatic, head & neck, prostate, urothelial, renal, and biliary tract cancers.

"By integrating real-world data, advanced sequencing and biomarker discovery, we’re refining cancer subtyping and treatment decisions to improve patient outcomes across numerous cancer types,’ said Milan Radovich, PhD, Senior Vice President and Chief Scientific Officer at Caris. "ESMO provides an international stage to share these insights and accelerate the future of personalized cancer care."

Oral ‘Proffered Paper’ includes:

The Mechanism of Mismatch Repair Deficiency (MMRd) Informs Survival Outcomes Derived from Immune Checkpoint Blockade (ICB) Across MMRd Solid Tumors (Presentation Number: 1110)
Saturday, Oct 18, 2025
Mini-oral includes:

Comprehensive Multi-Omics Analysis of Early-Onset Cancer: Insights from the MONSTAR-SCREEN-2 Experience (Presentation Number: 115MO)
Saturday, Oct 18, 2025
Posters include:

Impact of Androgen Deprivation Therapy (ADT) on KLK2 mRNA Expression and Immunologic Correlates Across Prostate Cancer Disease States (Presentation Number: 2437P)
Saturday, Oct 18, 2025
Optimizing Immunotherapy in Mismatch Repair-Deficient Colorectal Cancer Through Tailored, Subtype-Specific Treatment Approaches (Presentation Number: 795P)
Sunday, Oct 19, 2025
Transcriptomic-Based Prediction of Therapeutic Response in Metastatic RAS-Mutant Colorectal Cancer (Presentation Number: 829P)
Sunday, Oct 19, 2025
NOTCH: A Dynamic Pathway in Head and Neck Squamous Cell Carcinoma (Presentation Number: 1409P)
Monday, Oct 20, 2025
The full abstracts will be available on the Caris website at the event’s conclusion.

The Caris Precision Oncology Alliance (POA) consists of 97 cancer centers, academic institutions, research consortia and healthcare systems, including 45 NCI-designated cancer centers, all collaborating to advance precision oncology and biomarker-driven research. Caris and POA members collaborate to establish and optimize standards of care for molecular testing through innovative research focused on predictive and prognostic markers, aiming to improve clinical outcomes for cancer patients.

(Press release, Caris Life Sciences, OCT 14, 2025, View Source [SID1234656655])

On October 13, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX), a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs, reported the upcoming presentation of data from the Phase 1 REACtiVe-2 trial (NCT05650918) at the ESMO (Free ESMO Whitepaper) Congress 2025, showcasing the immunologic and clinical effects of mitazalimab in combination with dendritic cell therapy in patients with metastatic pancreatic cancer (Press release, Alligator Bioscience, OCT 13, 2025, View Source [SID1234656575]).

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The investigator-sponsored trial, conducted at Erasmus MC Cancer Institute, demonstrated that the combination of mitazalimab and Amphera’s dendritic cell vaccine MesoPher was safe and well-tolerated, with enhanced systemic and local immune responses. Half of the patients achieved stable disease after three administrations, with post-treatment biopsies revealing increased tumor-infiltrating T cells and reduced collagen deposition.

Title: REACtiVe-2: Phase I Evaluation of Dendritic Cell Vaccination and Agonistic CD40 Therapy Following (m)FOLFIRINOX in Metastatic Pancreatic Cancer
Presentation number: 2218P
Date and time: Sunday, 19 October, 12 p.m.-12:45 p.m. CEST.

"These clinical data clearly demonstrate the immune-stimulatory capacity of mitazalimab in patients with pancreatic cancer. They provide important mechanistic support for mitazalimab’s mode of action as a tumor-directed CD40 agonist," said Søren Bregenholt, CEO of Alligator Bioscience. "As we actively pursue out-licensing opportunities, results such as these reinforce mitazalimab’s value proposition in immuno-oncology and its potential in novel combination therapies."

On October 13, 2025 BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for sonrotoclax, a next-generation and potentially best-in-class investigational BCL2 inhibitor, for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL) (Press release, BeOne Medicines, OCT 13, 2025, View Source [SID1234656592]). Additionally, the FDA has accepted BeOne’s request for participation in Project Orbis, an initiative that provides a framework for concurrent submission and review of oncology products among participating global health authorities.

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"Breakthrough Therapy Designation is reserved for medicines with the potential to transform outcomes for patients with serious diseases. This recognition affirms the strength of the emerging data for sonrotoclax and its potential to become a new standard of care for people with relapsed or refractory mantle cell lymphoma," said Julie Lepin, Senior Vice President, Chief Regulatory Affairs Officer at BeOne. "Additionally, by participating in Project Orbis, we may be able to accelerate access to sonrotoclax, potentially helping patients faster than previously imagined."

The decision by the FDA to grant sonrotoclax BTD and participation in Project Orbis was based on data from the BGB-11417-201 study, a Phase 1/2 study evaluating sonrotoclax in adult patients with R/R MCL, following treatment with a Bruton’s tyrosine kinase inhibitor (BTKi) and anti-CD20 therapy. The recently announced positive topline results for sonrotoclax underscore its potential to deliver deep and durable responses, giving it the potential to be the first and only BCL2 inhibitor approved for use in R/R MCL in the U.S. BeOne plans to present the full data at an upcoming medical meeting. The Phase 3 confirmatory CELESTIAL-RRMCL study (BGB-11417-302; NCT06742996) is underway.

The FDA grants BTD to medicines with early data suggesting they may offer significant advances for patients with serious diseases. Project Orbis, established by the FDA Oncology Center of Excellence in 2019, facilitates collaboration across regulatory bodies on the review of oncology medicines with the goal of making promising cancer therapies available to patients more quickly across participating countries.

This is the first BTD for sonrotoclax and the second for BeOne’s hematology program. The FDA has also granted sonrotoclax Fast Track Designation for MCL and Waldenström macroglobulinemia (WM), as well as Orphan Drug Designation for the treatment of adult patients with MCL, WM, multiple myeloma (MM), and acute myeloid leukemia (AML). These designations help reinforce sonrotoclax’s position as the next major advancement in BeOne’s commitment to redefining care in B-cell malignancies.

About Mantle Cell Lymphoma

Mantle cell lymphoma (MCL) is a rare subtype of aggressive B-cell non-Hodgkin lymphoma (NHL)1 that develops in B-cells located in the mantle zone of the lymph nodes. MCL accounts for approximately 5% of all NHL cases globally2, affecting an estimated 28,000 people3. MCL is often diagnosed at advanced stages4 and nearly all MCL patients will eventually develop refractory or relapsed (R/R) disease.5 The five-year survival rate for MCL is approximately 50%, reflecting the urgent need for new therapeutic options.6

About BGB-11417-201 Study

The BGB-11417-201 (NCT05471843) study is a global, multicenter, single-arm, open-label, Phase 1/2 study, which enrolled 125 adult patients with R/R MCL post-treatment with anti-CD20 therapy and a BTK inhibitor. In Part 1, 22 patients received daily treatment with either 160 mg or 320 mg of sonrotoclax to assess the safety and tolerability of sonrotoclax and identify the recommended dose for Part 2. In Part 2, 103 patients were enrolled to receive the recommended daily dose of sonrotoclax (320 mg), following ramp-up, to assess the efficacy of sonrotoclax. The primary endpoint is overall response rate (ORR), as assessed by an independent review committee (IRC). Secondary endpoints include complete response (CR) rate, duration of response (DOR) and progression-free survival (PFS).

About Sonrotoclax (BGB-11417)

Sonrotoclax is a next-generation and potentially best-in-class investigational inhibitor of B-cell lymphoma 2 (BCL2), which is one of several proteins that help cancer cells survive. It is part of a group of drugs called BH3 mimetics, which mimic natural cell death signals. Studies in the lab and during early drug development have shown that sonrotoclax is a highly potent and specific inhibitor of BCL2 with a short half-life and no drug accumulation. Sonrotoclax has shown promising clinical activity across a range of B-cell malignancies, and nearly 2,000 patients have been enrolled to date across the broad global development program.

On October 13, 2025 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a late-stage immunotherapy company targeting cancer and autoimmune diseases, reported that positive and straightforward feedback has been received from the US Food and Drug Administration ("FDA") regarding the successful completion of Project Optimus requirements and agreement on 30mg as the optimal biological dose for eftilagimod alfa (efti).

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Immutep’s Chief Development Officer, Christian Mueller, said, "We are very thankful for the FDA’s positive feedback and productive discussions over the past few years. The alignment on efti’s optimal biologic dose has strategic relevance to our efti oncology programs and is a major de-risking event and building block towards future BLA filings. We are excited to successfully conclude this chapter of efti’s clinical development and are intently focused on bringing this novel immunotherapy to market to help address the needs of cancer patients worldwide."

The agreement with the FDA on efti’s optimal biological dosing carries strategic importance in the ongoing and future clinical development of this first-in-class immunotherapy, including the global TACTI-004 (KEYNOTE-F91) Phase III trial evaluating efti in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA (pembrolizumab), and chemotherapy as first-line treatment for advanced or metastatic non-small cell lung cancer (1L NSCLC), regardless of PD-L1 expression. With the conclusion of Project Optimus, this registrational study is now in process of opening sites in the United States.

About Eftilagimod Alfa (Efti)

Efti is a novel immunotherapy that directly activates antigen-presenting cells or APCs (e.g. dendritic cells, monocytes) via the MHC Class II pathway to fight cancer. As an MHC Class II agonist, its activation of APCs engages the adaptive and innate immune system to initiate a broad anti-cancer immune response. This includes priming and activating cytotoxic T cells as well as generating important co-stimulatory signals & cytokines that further boost the immune system’s ability to combat cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC) in a pivotal Phase III trial called TACTI-004 (KEYNOTE-F91), as well as head and neck squamous cell carcinoma (HNSCC), soft tissue sarcoma, and breast cancer. Its favourable safety profile enables various combinations like with anti-PD-[L]1 immunotherapy, radiotherapy, and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA).

(Press release, Immutep, OCT 13, 2025, View Source [SID1234656640])