On October 20, 2025 Immatics N.V. (NASDAQ: IMTX, "Immatics" or the "Company"), a clinical-stage biopharmaceutical company and the global leader in precision targeting of PRAME, reported the presentation of updated data from 16 patients with metastatic uveal melanoma treated with anzu-cel PRAME cell therapy.

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The uveal melanoma data from the ongoing Phase 1b trial will be presented today at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025 during the Presidential Symposium III by Sapna Patel, M.D., Professor of Medicine, University of Colorado Cancer Center. The slides are accessible in the ‘Events & Presentations’ section of the Investors & Media section of the Company’s website.

"Patients with metastatic uveal melanoma face a poor prognosis and represent a population in need of better outcomes, given the limited options currently available," said Sapna Patel, M.D. "I believe the results with anzu-cel presented today signal a much-needed breakthrough for patients with metastatic uveal melanoma. These findings highlight the potential of anzu-cel to redefine the treatment paradigm for uveal melanoma and bring new hope to patients who urgently need more effective options."

"Our goal is to leverage every opportunity to bring innovative PRAME therapies to patients with limited treatment options," said Cedrik Britten, M.D., Chief Medical Officer at Immatics. "The continued strong clinical data presented today reinforce our conviction in maximizing the potential of our PRAME cell therapy, anzu-cel, and expanding its development into metastatic uveal melanoma, a rare cancer with very high unmet medical need. We are excited to further execute on our PRAME franchise and bring meaningful progress to patients in need."

Presidential Symposium III Presentation Summary – Anzu-cel Phase 1b Trial

Patient Population: Difficult-to-treat patient population with metastatic uveal melanoma

As of September 24, 2025, 16 patients with metastatic uveal melanoma were administered a one-time infusion of anzu-cel at the recommended Phase 2 dose (RP2D, 1 to 10 billion total TCR T cells) as part of the anzu-cel Phase 1b dose expansion. Patients received a median infused TCR T-cell dose of ~4 billion (range 1.62 – 8.43 billion TCR T cells) and had a median of 2 lines of prior systemic treatments. Patients had a median target lesion sum of a diameter of 103 mm (ranging from 31 to 210 mm), and 81% of patients had liver and extrahepatic metastasis.

Anti-tumor Activity and Durability: Continued strong anti-tumor activity and durability of anzu-cel PRAME cell therapy

Updated data of a one-time infusion of anzu-cel PRAME cell therapy demonstrated promising benefit in a difficult-to-treat population with limited effective treatment options:

Confirmed objective response rate (cORR) of 67% (10/151)
Disease control rate (DCR) of 88% (14/16)
Median duration of response (mDOR) of 11 months (min 4.4, max 31.6 months)
Median progression-free survival (mPFS) of 8.5 months (min 1.4, max 32.9) at a mFU of 10.4 months. The PFS rate was 69% at six months and 39% at 12 months
Median overall survival (mOS) not reached (min 4.3+, max 34.2+ months) at a mFU of 14.3 months. The OS rate was 71% at 12 months

Anti-tumor activity was observed in liver and extrahepatic metastases, including lung, lymph node, abdomen/peritoneum and others. 14/16 patients had target lesions in the liver and treatment with anzu-cel led to a median shrinkage in liver target lesion size of 49.6%.

Notably, 11 out of the 16 patients received a TCR bispecific (ten gp-100-targeting, one PRAME-targeting) as prior systemic treatment line, and thereof, six achieved a confirmed partial response, one a partial response and three stable disease. These results demonstrate anti-tumor activity of anzu-cel in patients who received prior TCR-based therapies.

Safety: Favorable tolerability in uveal melanoma, generally consistent with full anzu-cel tolerability profile

The most frequent treatment-emergent adverse events (TEAs) were anticipated cytopenias associated with lymphodepletion. Expected and manageable cytokine release syndrome (CRS) was mostly Grade 1 or 2, which is consistent with the mechanism of action (Grade 1: 37.5%, Grade 2: 43.8%, Grade 3: 18.8%, Grade 4: 0%). No patients experienced long-term CRS, and most CRS was resolved by day 14. No anzu-cel-related Grade 5 events were observed.

Tolerability in the uveal melanoma subset was generally consistent with the full anzu-cel tolerability profile in the Phase 1b.

Development Path for Anzu-cel in Metastatic Uveal Melanoma

Based on the promising clinical data in patients with metastatic uveal melanoma, Immatics has initiated a Phase 2 cohort with approximately 30 uveal melanoma patients planned. The cohort is being conducted at select centers in the U.S. and Germany with deep expertise in uveal melanoma. Given the high prevalence of PRAME expression in uveal melanoma, prospective PRAME testing is no longer required for inclusion in the clinical trial.

The consistent tolerability, anti-tumor activity and pharmacokinetic profile of anzu-cel across both uveal and cutaneous melanoma provide a strong rationale for pursuing a parallel late-stage development strategy to serve both patient populations.

About PRAME
PRAME is a target expressed in more than 50 cancers. Immatics is the global leader in precision targeting of PRAME and has the broadest PRAME franchise with the most PRAME indications and modalities. The Immatics PRAME franchise currently includes three product candidates, two therapeutic modalities and a combination therapy that target PRAME: anzu-cel (IMA203) PRAME cell therapy, IMA203CD8 PRAME cell therapy (GEN2), IMA402 PRAME bispecific, anzu-cel in combination with Moderna’s PRAME cell therapy enhancer.

About Anzu-cel (IMA203) PRAME Cell Therapy
Anzu-cel (anzutresgene autoleucel; IMA203) is a PRAME-directed TCR T-cell therapy engineered to recognize an intracellular PRAME-derived peptide presented by HLA-A*02:01 on the cell surface and initiate a potent and specific anti-tumor response. Anzu-cel PRAME cell therapy is currently being evaluated in a registration-enabling randomized controlled Phase 3 trial, "SUPRAME," in patients with unresectable or metastatic cutaneous melanoma who have disease progression on or after treatment with at least one checkpoint inhibitor. In parallel, the Phase 1b clinical trial in patients with PRAME cancers is ongoing with a focus on uveal melanoma.

(Press release, Immatics, OCT 20, 2025, View Source [SID1234656815])

On October 20, 2025 GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, and the University of Oxford, reported that positive long-term results from an extended registry follow-up of the SYMPLIFY study will be presented on Oct. 21 at the Early Detection of Cancer Conference (EDCC) in Portland, Oregon.

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SYMPLIFY, a prospective observational study, is the first large-scale evaluation of a multi-cancer early detection (MCED) test in individuals who presented with symptoms to primary care and were referred for diagnostic follow-up for suspicion of cancer. In SYMPLIFY, the Galleri test was used to assess blood samples from more than 6,000 participants with symptoms of cancer who followed standard diagnostic pathways. However, as a non-interventional study, the results of the tests were unknown to physicians and did not inform the approach to diagnosis. No MCED results were returned to participants or their clinicians during the study.

"The conversion of false positive results to cancer diagnosis in this updated analysis of the SYMPLIFY study highlights the importance of proactive follow-up on positive MCED results, as one third of the apparent false positive results were actually cancers the standard-of-care diagnostic process couldn’t immediately identify," said Brian D. Nicholson, MRCGP, DPhil, Associate Professor at the Nuffield Department of Primary Care Health Sciences, University of Oxford, United Kingdom and co-lead investigator of the study. "Additionally, the results underscore the value of Galleri’s Cancer Signal Origin prediction, which aligned with the eventual diagnosis in almost all of the cases initially considered to be false positives. We are pleased to present these data at EDCC and have submitted this analysis for full publication."

Previous SYMPLIFY results showed potential of MCED testing in people with symptoms suggestive of cancer

Most people diagnosed with cancer visit primary care with symptoms before diagnosis1. Many of these people report common, non-specific symptoms such as bloating, unexplained weight loss or abdominal pain, which can be attributed to various conditions as well as cancer2.

The primary analysis of the SYMPLIFY study, previously published in The Lancet Oncology, supported the feasibility of using the Galleri test to assist clinicians with decisions regarding referral from primary care. In that analysis, which followed participants until diagnostic resolution or up to nine months, Galleri’s positive predictive value (PPV) was 75.5%. When a cancer signal was detected, the test accurately predicted the Cancer Signal Origin (CSO) in 84.8% of cases.

Updated results demonstrate importance of continued follow-up after a cancer signal is detected

Patients reported to have a false positive Galleri result were followed for 24 months in national cancer registries for England and Wales. The analysis showed that 35.4% (28 of 79 participants) were later diagnosed with cancer within 24 months of enrollment. This reduction in false positives from 79 to 51 resulted in an increase of PPV to 84.2%. In aggregate, 27 of these 28 participants had a correct CSO prediction which could have led to a faster or more efficient diagnosis. In more than half of these cases, the cancer type diagnosed was not congruent with the original diagnostic clinic to which the patient was referred by the general practitioner based on the clinical presentation:

16 of the 28 (57.1%) were diagnosed with cancer within nine months of enrollment.
Eight of the 16 (50%) were diagnosed with cancers that were correctly predicted by the Galleri test’s CSO finding, but were incongruent with the diagnostic pathway chosen by the general practitioner based on the participants’ presenting symptoms.
12 of the 28 (42.9%) were diagnosed 10-24 months after enrollment.
Seven of the 12 (58.3%) were diagnosed outside the original referral pathway; in those cases, the CSO also was correct, matching the site that was ultimately diagnosed.
"The SYMPLIFY study, focused on patients presenting with symptoms, adds to the breadth of our clinical experience in asymptomatic populations. This robust data demonstrates the potential benefit of the Galleri test as a diagnostic tool for individuals presenting with symptoms of cancer, particularly where those symptoms are non-specific. The fact that, in all but one of the additional patients diagnosed with cancer, a Galleri CSO prediction correctly identified the cancer type, including in many cases where the symptoms were non-specific, further reinforces the value of the Galleri test’s CSO capability," said Sir Harpal Kumar, President, International Business & BioPharma at GRAIL. "Furthermore, the 24-month follow-up data being presented at EDCC underscore the importance of continued follow-up to help identify cancers that may initially be missed in diagnostic evaluation. These latest results add to the body of evidence that Galleri could support clinical decision-making in primary care for referral to urgent diagnostic investigations of cancer and drive more efficient use of diagnostic capacity."

About the SYMPLIFY Study
SYMPLIFY is a prospective multicentre observational study and represents the first large-scale evaluation of an MCED test in symptomatic patients who were referred from the primary care setting due to clinical suspicion of cancer. The study enrolled 6,238 patients, aged 18 years and older, in England and Wales who were referred for urgent imaging, endoscopy or other diagnostic modalities to investigate symptoms suspicious for possible cancer. Of the total enrolled patients, there were 5,461 evaluable patients who achieved diagnostic resolution. GRAIL’s MCED test was performed in batches, blinded to clinical outcome, and results were compared with the diagnosis obtained by standard of care pathways to assess the test’s performance.

The University of Oxford sponsored the SYMPLIFY study and was responsible for data collection, analysis and interpretation. The study was funded by GRAIL with support from National Health Service (NHS) England, NHS Wales, the National Institute for Health and Care Research (NIHR) and NIHR Oxford Biomedical Research Centre.

(Press release, Grail, OCT 20, 2025, View Source [SID1234656831])

On October 20, 2025 Fulgent Genetics, Inc. (NASDAQ: FLGT) ("Fulgent" or the "Company"), a technology-based company with a well-established clinical diagnostic business and a therapeutic development business, reported preliminary clinical data as of September 25, 2025, the preliminary data cutoff from its ongoing phase 2 clinical trial investigating FID-007 in combination with cetuximab in ≤ 2nd line treatment of patients diagnosed with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC). This preliminary data will be presented on October 20, 2025, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper), held October 17th to the 21st in Berlin, Germany.

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"We believe this preliminary data reinforces our mission to build a holistic platform that delivers comprehensive solutions across the cancer care continuum — from early detection, diagnostics, and monitoring to drug discovery and development," said Ming Hsieh, Chairman and CEO of Fulgent Genetics and co-founder of Fulgent Therapeutics. "We are encouraged by the steady advancement of FID-007 in oncology indications to date, while our precision diagnostics business continues to provide strong momentum as the primary driver of revenue for Fulgent."

Poster title: "A Randomized Phase 2 Study of FID-007 Plus Cetuximab in Patients with Recurrent / Metastatic Head and Neck Squamous Cell Carcinoma"

Observations in the Poster include:

As of a September 25, 2025 preliminary data cutoff date:

39 patients with R/M HNSCC have been randomized, of which 36 have received at least one dose of study treatment (FID-007 at 75 mg/m2 or 125 mg/m2 IV on Days 1, 8, 15 Q4W and cetuximab 500 mg/m2 IV biweekly).
FID-007 combined with cetuximab demonstrated meaningful anticancer efficacy at both dose levels for the 1L – 2L treatment of R/M HNSCC. Of the 35 patients evaluable for efficacy, the objective response rate (ORR) for the 75 mg/m2 arm and the 125 mg/m2 arm were 44% and 59% respectively, and 51% overall when both arms are combined. The median progression-free survival (PFS) for the 75 mg/m2 arm and the 125 mg/m2 arm were 9.2 months and 7.8 months, respectively. The overall PFS was 7.8 months, compared to the historical 2.3 months of the standard-of-care therapies.
FID-007 exhibited a favorable safety and tolerability profile, with a 6% overall treatment-related serious adverse event (SAE) rate in the 36 patients evaluated for safety. Overall grade 3 and worse treatment-related adverse events were observed in ≥ 5% of patients and consisted of lymphocyte count decreased (19%), neutrophil count decreased (17%), anemia (8%), dermatitis acneiform (8%), white blood cell count decreased (8%), rash (6%), hypomagnesaemia (6%) and pneumonia (3%). Grade 1-2 peripheral neuropathy was reported in 31% of the patients. No grade 3 and above peripheral neuropathy has been reported to date.
An optimal dose of FID-007 will be determined after data maturation to support further development of this combination therapy.
The poster will be available on the Investor Relations section of the company’s website at: View Source

About FID-007

FID-007 is designed to improve the pharmacokinetics of paclitaxel (PTX), increase its water solubility, reduce formulation-related toxicity, and enhance therapeutic efficacy by encapsulating PTX with a clinically safe polyethyloxazoline (PEOX) polymer excipient. Importantly, the smaller size of FID-007 nanoparticles compared to solvent-based PTX micelles in plasma enables efficient penetration and reduced clearance within the tumor due to the enhanced permeability and retention effect, thus resulting in higher accumulation of FID-007 in the tumor tissue.

(Press release, Fulgent Genetics, OCT 20, 2025, View Source [SID1234656847])

On October 20, 2025 Upthera (CEO Si-Woo Choi), a company specializing in the development of innovative new drugs based on Targeted Protein Degradation (TPD) technology, reported that it has received approval from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for a Phase 1/2a clinical trial of its PLK1-targeted protein degradation-based (TPD) drug candidate ‘UP1002’ for small cell lung cancer (SCLC).

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This approval marks the first global entry into clinical trials for a new TPD-class drug targeting PLK1, and is considered an achievement that demonstrates Upthera’s proprietary protein degradation technology and global competitiveness. Next year, we plan to proceed with the IND approval process in Korea as well to expand the global clinical trials of ‘UP1002’ in earnest.

The clinical trial approved this time is a Phase 1/2a combined design that proceeds to confirm safety and tolerability through initial dose escalation, followed by evaluating efficacy indicators through an expansion cohort. Uptera aims to administer the drug to the first patient starting next year, involving 30 to 60 patients in the U.S., and plans to consider expanding to other solid tumor indications depending on future results.

Small cell lung cancer (SCLC) has been known for decades as a cancer where new drug development is significantly more difficult compared to other types of cancer, and even recently approved drugs have limited anticancer efficacy, such as extending survival.

In addition, it is an intractable cancer with a very low 5-year survival rate of less than 7% due to the rapid rate of tumor metastasis and high recurrence rate. While the development of numerous targeted anticancer drugs based on reliable biomarkers is underway for non-small cell lung cancer, the development of targeted anticancer drugs for small cell lung cancer is difficult due to the lack of accurate biomarkers.

To overcome these limitations, Upthera is developing ‘UP1002,’ a novel drug candidate that directly degrades PLK1 (Polo-like kinase 1), a key protein regulating cell division, by utilizing TPD technology. PLK1 is an essential protein (kinase) that regulates cell division during the cell cycle (G2/M phase) and is overexpressed in rapidly proliferating cells, such as cancer cells. While numerous global pharmaceutical companies, including Boehringer Ingelheim and Takeda, have developed PLK1 inhibitors (small molecule inhibitors), most have been discontinued during clinical trials due to dose-limiting toxicity (DLT). To date, there are no approved drugs with a mechanism that selectively inhibits or degrades PLK1.

UP1002 is characterized by inducing an anticancer effect even at lower concentrations than existing inhibitors by directly degrading the PLK1 protein, and by fundamentally overcoming the problem of dose-limiting toxicity (DLT). This mechanism is a novel approach that induces apoptosis by halting the cell cycle of cancer cells, and is expected to lead a paradigm shift in treatment for cancers with rapid cell proliferation, such as small cell lung cancer.

Upthera’s UP1002 (PLK1) was recognized for its innovation and technological capabilities and was selected as a project under the Korea Drug Development Fund (KDDF) ​​in 2022, receiving support. Based on the Global RA support program within the KDDF, Upthera has established a global clinical development strategy in collaboration with global clinical research institutions such as QubeST Bio and KCRN Research.

UP1002 is recognized as the first-in-class anticancer drug that degrades PLK1 and the first clinical pipeline in the TPD industry to target cell cycle-related proteins, which are difficult to develop. In addition, Upthera has filed 82 domestic and international patents related to UP1002, 19 of which have been registered. The company plans to continuously strengthen its patent portfolio and build patent barriers to effectively block the entry of latecomers in the PLK1 degradation field and solidify its position as a first mover.

"This FDA IND approval is an achievement that officially recognizes Upthera’s proprietary protein degradation technology and global development capabilities," said Choi Si-woo, CEO of Upthera. "We will present new treatment options to patients with small cell lung cancer through clinical results and strengthen our global competitiveness in the TPD field."

(Press release, Uppthera, OCT 20, 2025, View Source [SID1234664781])

On October 20, 2025 IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, reported that it will host an R&D Day for investors at the Harvard Club (35 West 44th Street) in New York City on November 10, 2025, beginning at 8:00 a.m. ET.

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The investor event will feature ovarian cancer thought leaders, principal investigators from the Company’s Phase 3 OVATION 3 Study and Phase 2 minimal residual disease (MRD) clinical trial, conducted in partnership with Break Through Cancer Foundation, statistical experts and members of IMUNON’s management team, delivering updates on new IMNN-001 data and discussing progress with the OVATION 3 Study and IMNN-001’s potential role in transforming the treatment landscape for women with advanced ovarian cancer. There will be a live Q&A session and networking opportunities with the speakers and IMUNON management team following the formal presentations.

Featured Presentations and Speakers:

Title: Advancing Ovarian Cancer Care: IMNN-001’s Potential to Transform the Microtumor Environment from Cold to Hot in Phase 3
Presenter: Premal H. Thaker, M.D., David & Lynn Mutch Distinguished Professor of Obstetrics & Gynecology, Chief of Gynecologic Oncology, Director of Gynecologic Oncology Clinical Research, Professor in Gynecologic Oncology, Washington University School of Medicine

Title: Unveiling Progress: Safety, Tolerability, and Translational Insights for IMNN-001
Presenter: Amir Jazaeri, M.D., Vice Chair for Clinical Research, Director, Gynecologic Cancer Immunotherapy Program, Department of Gynecologic Oncology and Reproductive Medicine, University of Texas MD Anderson Cancer Center
Title: OVATION 3 Probability of Success & the Statistical Properties of Phase 3 Trial Design
Presenter: Giorgio Paulon, Ph.D., Director & Senior Statistical Scientist, Berry Consultants, LLC
Title: Phase 3 OVATION 3 Trial Update
Presenter: Douglas V. Faller, M.D., Ph.D., Chief Medical Officer, IMUNON

(Press release, IMUNON, OCT 20, 2025, View Source [SID1234656816])