On November 24, 2025 Lineage Cell Therapeutics, Inc. reported it had achieved the first milestone available under its worldwide collaboration with Roche and Genentech, a member of the Roche Group, for OpRegen (RG6501), a suspension of human allogeneic retinal pigment epithelial (RPE) cells, currently in development for the treatment of geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD). The milestone was achieved based on manufacturing and clinical advancements related to the OpRegen cell therapy program.

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"We are excited to have achieved the first of the $620 million of milestone payments available under our collaboration with Roche and Genentech. The achievement of this milestone is rooted in our manufacturing expertise, which we deployed with the OpRegen cell therapy program, and reflects years of investment to optimize our in-house production processes and highlights the importance of having in-house control of complex manufacturing processes," stated Brian M. Culley, Lineage CEO. "Roche and Genentech are established leaders in ophthalmology, with a demonstrated and longstanding commitment to patients, innovative research, and successful product development, and we are proud to have reached this manufacturing milestone to support the Genentech team’s clinical efforts."

"Long-term clinical outcomes following a single administration of OpRegen cell therapy is challenging the view that GA causes irreversible damage. Clinical data reported at 12-, 24-, and 36-months for Cohort 4 of the Phase 1/2a study (12 patients) continues to demonstrate a consistent and durable treatment effect, with OpRegen-treated eyes exhibiting mean BCVA scores above baseline at each of these timepoints in these patients with less advanced disease. Notably, five patients who received significant coverage of OpRegen cell therapy across their GA lesion are demonstrating long-term outcomes consistent with meaningful disease stabilization and even improvement," added Mr. Culley.

RG6501 (OpRegen) is a suspension of human allogeneic retinal pigment epithelial (RPE) cells currently in development for the treatment of GA secondary to AMD. Subretinal delivery of OpRegen cell therapy has the potential to counteract RPE cell loss in areas of GA lesions by supporting retinal cell health and improving retinal structure and function. It is being developed under an exclusive worldwide collaboration between Lineage, Roche, and Genentech, a member of the Roche Group, and is currently being evaluated in a Phase 2a clinical study, GAlette, in patients with GA secondary to AMD (ClinicalTrials.gov Identifier: NCT05626114).

(Press release, Lineage Cell Therapeutics, NOV 24, 2025, View Source [SID1234660899])

On November 24, 2025 IN8bio, Inc. (the "Company") reported consolidated data, a summary of which is located below, from its investigator-sponsored Phase 1 single-center clinical trial of INB-200 and its Company-sponsored Phase 2 multi-center clinical trial of INB-400 for the treatment of patients with newly diagnosed glioblastoma ("GBM") in poster and oral presentations at the 2025 Society for Neuro-Oncology ("SNO") Annual Meeting on November 21 and 22, 2025.

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Summary of Clinical Update from Phase 1 Trial of INB-200 and Phase 2 Trial of INB-400

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Across the two trials, 17 patients were treated with the Company’s DeltExTM Drug Resistant Immunotherapy ("DeltEx DRI") gamma-delta T cells, with 14 patients receiving repeated (3 up to 6) doses. 10 additional patients were consented contemporaneously but received only the standard-of-care Stupp protocol ("SOC") and were monitored for progression and survival.

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Patients treated with repeated doses of DeltEx DRI cells achieved a median progression-free survival ("mPFS") of 13.0 months (n=14), compared to the mPFS of 6.6 months for patients receiving only SOC (n=10).

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Patients receiving repeated doses of DeltEx DRI cells have not yet reached median overall survival ("mOS"), which continues to climb at 16.4+ months as of October 31, 2025, while SOC patients attained a mOS of 11.0 months.

(Press release, In8bio, NOV 24, 2025, View Source [SID1234660898])

On November 24, 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 the publication of data from its Acclaim-1 Phase 1 clinical trial of Reqorsa Gene Therapy (quaratusugene ozeplasmid) in combination with Tagrisso (osimertinib) in patients with advanced non-small cell lung cancer (NSCLC) in the peer-reviewed journal Clinical Lung Cancer.

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"We believe REQORSA is an innovative gene therapy that may benefit many lung cancer patients, and we are pleased to see these data for REQORSA published and shared with the scientific community," said Ryan Confer, President and Chief Executive Officer at Genprex. "Genprex is thankful to the patients who participated in this study, along with the investigators who made the completion of the study possible. We believe this new mechanism and novel approach targeting lung cancer, which comes with a strong safety profile and early signs of efficacy, is paving new ground in the fight against lung cancer."

The Acclaim-1 clinical trial is an open-label, multi-center Phase 1/2 clinical trial evaluating REQORSA in combination with osimertinib in patients with late-stage NSCLC with activating epidermal growth factor receptor (EGFR) mutations whose disease progressed after treatment with osimertinib (osimertinib monotherapy or osimertinib combination therapy).

The Phase 1 dose escalation portion of the trial was designed primarily to assess safety, however, the Company believes promising efficacy results were also observed. The reported results showed no Dose Limiting Toxicities (DLTs), established a Recommended Phase 2 Dose (RP2D) of 0.12 mg/kg (the highest dose level administered in the trial) and provided data showing early efficacy of REQORSA in combination with osimertinib.

Of the 12 patients treated with escalating doses of REQORSA and standard doses of osimertinib, all of whom had progressed on osimertinib containing regimens, three patients had experienced prolonged time to progression, including one with continuing partial response.

Specifically, one patient at the 0.06 mg/kg dose level, previously treated with carboplatin, pemetrexed and osimertinib, had a partial remission by investigator evaluation, and as of the data from April 2025 used in the published manuscript had continued to receive study treatment for 47 cycles over 32 months. The patient continues to receive REQORSA and osimertinib treatment in the trial more than three years after enrolling.A second patient at the 0.12 mg/kg dose level who was previously treated with cisplatin, pemetrexed, carboplatin and osimertinib had stable disease and received REQORSA for 32 cycles, or approximately 24 months, until disease progression occurred.

A third patient who was at the 0.09 mg/kg dose level, previously treated with osimertinib, had stable disease and received 14 cycles over approximately 10 months before disease progression occurred.

The extended Progression Free Survival (PFS) of each of these patients is consistent with long-term PFS seen in several patients in prior early-stage clinical trials of REQORSA and is not expected with treatment with osimertinib alone after progression on osimertinib.

REQORSA administration was generally well tolerated and there were no DLTs. The administration was associated with a delayed infusion-related reaction of muscle aches, fever and chills in some patients, which we believe is similar to reactions seen with the administration of antibodies routinely used in oncology treatment. This was managed with prophylactic steroids, acetaminophen and diphenhydramine, and symptoms decreased with repeat cycles.

(Press release, Genprex, NOV 24, 2025, View Source [SID1234660897])

On November 24, 2025 Genmab A/S (Nasdaq: GMAB) reported that its Chief Financial Officer Anthony Pagano will participate in a fireside chat at the Citi Global Healthcare Conference in Miami at 9:45 AM EST (3:45 PM CET) on December 4, 2025. A webcast of the fireside chat will be available on Genmab’s website at View Source

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(Press release, Genmab, NOV 24, 2025, View Source [SID1234660896])

On November 24, 2025 Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, reported it will present 10 abstracts across its Precision Oncology portfolio at the 2025 San Antonio Breast Cancer Symposium (SABCS), taking place from December 9-12 in San Antonio, Texas.

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The data to be presented builds upon Exact Sciences’ long-standing commitment to backing innovation with strong clinical evidence and commitment to equitable breast cancer care. This commitment includes equipping clinicians with innovative solutions that provide actionable insights to support patient needs throughout every stage of cancer care.

"Oncotype DX has long set a global standard as a predictive and prognostic test in breast cancer, helping clinicians confidently guide therapy decisions that improve outcomes and reduce disparities," said Dr. Rick Baehner, Chief Medical Officer, Precision Oncology, Exact Sciences. "The data presented at this year’s SABCS reaffirms our leadership in breast cancer prediction and prognosis and expands our evidence base for Oncodetect—our molecular residual disease test—as a powerful recurrence predictor and tool for personalizing surveillance in high-risk patients."

Data presentations across Exact Sciences’ Precision Oncology portfolio include:

The Oncodetect Test

Title: Evaluation of a Whole-Exome Sequencing Tumor-informed Circulating Tumor DNA MRD Assay in Patients with Early Triple-Negative Breast Cancer (TNBC) receiving Neoadjuvant Chemotherapy (NAC) with or without Atezolizumab: A Prospective Sub-study of the NSABP-B59/GBG-96-GeparDouze Trial

In partnership with the National Surgical Adjuvant Breast and Bowel Project (NSABP), this sub-study evaluated MRD in patients with triple-negative breast cancer (TNBC) and demonstrated the strong predictive performance of the Oncodetect test using prospectively collected samples from a Phase III randomized trial.

Session: RF4-03, Thursday, December 11, 2025; 4:30-5:30 PM

Title: Prospective Breast Cancer Clinical Validation Study of an Ultrasensitive, Tumor Informed, Whole Genome, Circulating Tumor DNA Assay to Detect Molecular Residual Disease and Predict Recurrence of High-Risk Early Breast Cancer Treated with Standard (Neo)adjuvant Therapy; NSABP B-64/EXActDNA-003NCT06401421

Conducted in collaboration with the NSABP, this large-scale, ongoing trial is enrolling more than 1,800 participants across all breast cancer subtypes. Tracking patients from diagnosis through treatment and post-therapy surveillance, the study will deliver multiple readouts beginning in 2027 that will further expand the clinical evidence supporting the Oncodetect test.

Session: PS5-08-21, Friday December 12, 2025; 12:30-2:00 PM

Title: Early Adoption of Molecular Residual Disease Testing in Breast Cancer Patients using Real World Data

This real-world data analysis of MRD adoption trends in breast cancer highlights the increasing use and integration of these tests into clinical practice.

Session: PS2-04-01, Thursday, December 11, 2025; 5:00-6:30 PM

The Oncotype DX Breast Recurrence Score Test

Title: Clinical and economic impact of the 21-gene assay for guiding treatment in patients with HR+/HER2- early breast cancer across racial and ethnic subgroups in the US

Study confirms that utilization of the Oncotype DX Breast Recurrence Score test to guide adjuvant therapy decision-making can lead to improved outcomes and reduce costs across diverse racial and ethnic subgroups, highlighting the potential of the assay to support more equitable care and reduce outcome disparities.

Session: PS4-09-24, Thursday, December 11, 2025; 5:00-6:30 PM

Title: Real-world utilization of the 21-gene assay for guiding treatment decisions in patients with HR+/HER2- early breast cancer in the US

Analysis demonstrates that the Oncotype DX Breast Recurrence Score test reliably guides adjuvant chemotherapy with utilization rising appropriately with higher scores and applied consistently across racial and ethnic groups, confirming equitable, guideline‑concordant treatment patterns highlighting the test’s impact in standardizing care decisions.

Session: PS2-06-21, Wednesday, December 10, 2025, 5:00-6:30 PM

Title: Real-world evidence on the use of a 21-gene recurrence score assay in patients with HR+/HER2− early breast cancer in Japan: a nationwide claims database analysis

First large-scale study of the Oncotype DX test in Japan confirmed that patients are treated at cancer-specialized or large medical centers and staging/treatment patterns show appropriate application of the Oncotype DX test in HR+/HER2 early breast cancer, consistent with current guidelines.

Session: PS3-08-28, Thursday, December 11, 2025; 12:30-2:00 PM

Title: Decision-Making on Adjuvant Chemotherapy in Early HR+ Breast Cancer: A Prospective Evaluation of Oncotype DX Utility Among Swiss Breast Cancer Experts

Study found that the Oncotype DX test significantly influenced adjuvant treatment decisions—primarily driving chemotherapy de‑escalation—and improved decision consistency among breast cancer specialists, underscoring the test’s utility in the Swiss healthcare system.

Session: PS3-10-10, Thursday, December 11, 2025; 12:30-2:00 PM

Title: The Societal Cost Impact of Oncotype DX Testing in an Irish Healthcare Setting

Use of the Oncotype DX test to identify node-positive patients that could avoid chemotherapy across 5 of Ireland’s oncology centers over an 11-year period has led to an estimated cost-savings of more than 60 million euros associated with chemotherapy use.

Session: PS3-09-03, Thursday, December 11, 2025; 12:30-2:00 PM

Title: Defining postpartum breast cancer based on 21-gene recurrence score

Breast cancer diagnosed within 5 years postpartum shows significantly higher Oncotype DX Recurrence Score results and higher histologic grade than in nulliparous peers—independent of nodal status. By stratifying risk by time since childbirth, the study refines the temporal definition of postpartum breast cancer and may inform risk stratification and treatment escalation.

Session: Poster PS3-07-11, Thursday, December 11; 2025; 12:30-2:00 PM

Title: Postpartum breast cancer as a potential driver of increased 21-gene recurrence score (RS) and RS category for node-positive HR+/HER2- breast cancer

In premenopausal, node-positive HR+/HER2− breast cancer, postpartum cases show higher Oncotype DX Recurrence Score results than nulliparous or non-postpartum cases. The study examines whether this impacts outcomes (e.g., invasive disease-free survival) to refine Recurrence Score result interpretation and better identify patients who might safely forgo chemotherapy, noting that larger studies with longer follow-up are needed.

Session: PS3-08-09, Thursday, December 11, 2025; 12:30-2:00 PM

(Press release, Exact Sciences, NOV 24, 2025, View Source [SID1234660895])