On October 22, 2026 Rgenta Therapeutics, a clinical-stage biotechnology company pioneering the development of a new class of oral small molecules targeting RNA and RNA regulation for oncology and neurological disorders, reported the completion of a successful end-of-Phase 2 meeting with the Food and Drug Administration (FDA) regarding the advancement of RGT-61159, the company’s oral small molecule targeting the MYB oncogene, into pivotal Phase 3 development in patients with adenoid cystic carcinoma (ACC).

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"Gaining alignment with the FDA on advancing RGT-61159 directly into a Phase 3 trial is a significant milestone for Rgenta and the patients we intend to serve," said Simon Xi, Ph.D., co-founder and chief executive officer of Rgenta. "This milestone is particularly rewarding following positive preliminary data from our Phase 1a/b clinical trial of RGT-61159 and a testament to the strength of the safety and efficacy data generated thus far. We believe RGT-61159 represents a promising and innovative potential therapy for patients with ACC, which is a rare, aggressive, malignancy for which no effective targeted therapies are available for patients with recurrent and/or metastatic disease."

Simon added, "We’d like to thank the patients and physicians who have supported our development of RGT-61159 as well as our dedicated team, whose science has translated into an encouraging therapeutic candidate and applaud their continued focus on the promise and potential our therapy may bring to patients."

"The Phase 3 clinical trial of RGT-61159 is expected to be the first study of its kind in ACC, marking an important step toward developing new treatment options for these patients," said Alan L. Ho, M.D., Chief of the Head and Neck Oncology Service at Memorial Sloan Kettering Cancer Center. "Early clinical data have demonstrated anti-tumor activity and a tolerable safety profile with once-daily oral dosing. We look forward to evaluating RGT-61159 in this Phase 3 trial and advancing research into new treatments for this rare, difficult-to-treat cancer."

Rgenta previously announced preliminary results from its ongoing Phase 1a/b clinical trial of RGT-61159, which is a multi-center, open-label dose escalation and expansion study (NCT06462183) in patients with advanced relapsed or refractory ACC or colorectal cancer (CRC). Preliminary data from the initial patients in the trial showed clinically meaningful disease control of 84.6% in 39 evaluable patients, with 3 patients achieving partial response according to RECIST criteria. Responses continued to deepen with longer treatment duration. Patients with partial responses have remained on study for a mean of 8.2 months, while all ongoing patients across the trial have a mean on-study duration of 7.3 months. RGT-61159 was well tolerated with the most common adverse events being fatigue, anemia, diarrhea, and nausea.

Highlights of the Planned Phase 3 Trial
The planned Phase 3 trial is a double-blind, placebo-controlled trial in approximately 150 patients with biomarker selected, locally advanced, incurable, recurrent or metastatic ACC. Patients will be randomized 2:2:1 to receive once daily oral RGT-61159 84 mg, RGT-61159 60 mg, or placebo. All patients will receive best supportive care. The primary endpoint is progression free survival (PFS). Key secondary endpoints include overall survival (OS), safety, and tolerability. The trial is expected to include sites in North America and Europe.

About RGT-61159
RGT-61159 is an orally available small molecule designed to specifically modulate splicing of the transcription factor MYB resulting in the inhibition of oncogenic MYB protein production, which has the potential to inhibit proliferation or induce cell death of cancer cells that overexpress MYB protein. MYB acts as a master regulator of cell proliferation, self-renewal, and differentiation processes and its aberrant expression has been demonstrated in multiple forms of human cancer including adenoid cystic carcinoma (ACC), acute myeloid leukemias (AML), T-cell acute lymphoblastic leukemias (T-ALL), colorectal cancer (CRC), small cell lung cancer (SCLC) and breast cancer.

About Adenoid Cystic Carcinoma (ACC)
It is estimated that approximately 200,000 people are living with ACC throughout the world, including 11,000 in the U.S. While it is a rare cancer, ACC is the second most common cancer type arising in the salivary gland and is an aggressive malignancy with a tendency to infiltrate surrounding nerves and metastasize to distant sites. Overactivation of the MYB oncogene has been described as a hallmark of ACC and is noted in over 90% of ACC. Treatment for ACC is extremely challenging and may include surgery and/or radiation, which often fails to control local tumor recurrence and distant metastases. There are no effective targeted therapies available for patients with recurrent and/or metastatic disease. There is thus an unmet medical need for new therapeutic targets and treatment strategies for patients with this fatal cancer.

(Press release, Rgenta Therapeutics, OCT 22, 2026, View Source [SID1234673693])

On October 22, 2026 Ernexa Therapeutics (Nasdaq: ERNA), an industry innovator developing novel cell therapies for the treatment of advanced cancers, reported the release of a new Virtual Investor "What This Means" segment highlighting the Company’s progress advancing ERNA-101 toward the clinic and the scientific foundation supporting its broader cell therapy platform.

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The discussion brings together Sanjeev Luther, President and Chief Executive Officer; Dr. Christopher Rohde, a member of Ernexa’s Scientific Advisory Board and developer of the technology underlying the Company’s platform; and Dr. Robert Pierce, Chief Scientific Officer, to discuss three key areas central to Ernexa’s next phase of development: regulatory alignment, scientific differentiation and progress toward first-in-human clinical evaluation.

At the center of the conversation is Ernexa’s pre-IND interaction with the U.S. Food and Drug Administration and what that milestone means for ERNA-101’s advancement in ovarian cancer. Mr. Luther discusses the strategic importance of the meeting, while Dr. Pierce provides additional perspective on the FDA feedback and its implications for the scientific and clinical development program.

"ERNA-101 is moving through a critical transition from preclinical development toward the clinic, and our focus is on executing each step with discipline," said Sanjeev Luther, President and Chief Executive Officer of Ernexa Therapeutics. "The progress we are making across regulatory planning, IND-enabling development and clinical preparation is bringing us closer to the point where we can begin evaluating this technology in patients."

The segment also provides a deeper look at the technology underlying Ernexa’s platform. Dr. Rohde discusses why induced mesenchymal stromal cells were selected as the foundation of the platform, the potential advantages of an allogeneic, off-the-shelf approach and the rationale for engineering ERNA-101 to express IL-7 and IL-15 within the tumor microenvironment.

"Our goal from the beginning was to build a cell therapy platform that could combine the flexibility of cellular engineering with an approach designed for practical, off-the-shelf use," said Dr. Rohde. "ERNA-101 reflects that strategy by pairing an engineered cell platform with immune-modulating biology intended to act where it matters most, within the tumor microenvironment."

Dr. Pierce further discusses how this underlying biology translates into Ernexa’s preclinical findings, including the program’s potential to recruit immune cells, alter the tumor microenvironment and enhance checkpoint blockade. The conversation also addresses findings from IND-enabling studies related to safety, biodistribution and tumor-homing characteristics as the Company prepares ERNA-101 for clinical development.

"The importance of the platform is not simply what it is engineered to do, but whether the biology translates into meaningful and reproducible activity," said Dr. Robert Pierce, Chief Scientific Officer of Ernexa Therapeutics. "Our preclinical work is helping us understand that biology in greater depth and build the scientific package needed to support ERNA-101’s advancement into the clinic."

Looking ahead, the segment outlines what investors can expect between Ernexa’s FDA interaction and initiation of a first-in-human clinical study. The discussion also explores how the underlying technology could potentially be adapted beyond the lead ovarian cancer program across additional solid tumors and therapeutic approaches.

"We believe ERNA-101 represents more than a single development program," added Mr. Luther. "Our immediate priority is to advance the asset into the clinic, but the broader opportunity lies in demonstrating what this platform can potentially enable across oncology. That is the value we are working to unlock."

(Press release, Ernexa Therapeutics, OCT 22, 2026, View Source [SID1234673692])

On October 22, 2026 Myriad Genetics, Inc., (NASDAQ: MYGN), a leader in molecular diagnostic testing and precision medicine, reported new data from the ongoing MONSTAR-SCREEN-3 study demonstrating the potential of its whole-genome sequencing (WGS)-based Precise MRD platform to support ultra-sensitive molecular residual disease (MRD) detection in patients with resectable colorectal and pancreatic cancers.

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The findings, which will be presented as part of the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026, reinforce the role of highly sensitive MRD testing after curative-intent surgery in tumor types where earlier insight into recurrence risk may help inform monitoring and treatment decisions.

"These data reinforce the potential of Precise MRD to bring more sensitive, personalized monitoring to cancers where recurrence can be difficult to identify until disease burden is higher," said Dale Muzzey, Ph.D., Chief Scientific Officer, Myriad Genetics. "By leveraging whole-genome sequencing to build individualized panels capable of detecting ctDNA at very low levels, Precise MRD may help clinicians identify recurrence risk earlier and make more informed decisions about patient management following surgery."

New MONSTAR-SCREEN-3 Data Support Utility of Ultra-Sensitive MRD Detection Across Colorectal and Pancreatic Cancers

The MONSTAR-SCREEN-3 data highlight the performance of Myriad’s WGS-based Precise MRD platform in two high-need settings: resectable colorectal cancer and resectable pancreatic cancer. The study evaluated whether personalized, ultra-sensitive MRD testing could identify patients at higher risk of recurrence following surgery and provide earlier molecular insight than conventional clinical surveillance.

In patients with resectable colorectal cancer, ctDNA detected one month after surgery was strongly associated with disease progression. ctDNA was detected prior to clinical recurrence in all observed recurrence events, with a median lead time of four months. More than half of post-surgical ctDNA-positive patients were identified at ultra-sensitive levels, i.e., below 100 parts per million.

Researchers also reported initial findings in patients with resectable pancreatic cancer, a low-shedding tumor type in which ctDNA detection has historically been challenging. Personalized panel creation was successful for all evaluable patients, with half achieving the maximum 1,000-variant panel. Patients with MRD detected one month after surgery had significantly worse recurrence-free survival than those without detectable MRD, supporting further evaluation of WGS-based MRD testing in this high-need setting.

"Together, these findings add to a growing body of evidence supporting ultra-sensitive MRD detection as a tool to improve post-surgical risk stratification and disease monitoring," said Takayuki Yoshino, MD, PhD, National Cancer Center Hospital East and principal investigator of the MONSTAR-SCREEN-3 study. "The consistent association between post-operative ctDNA detection and patient outcomes, coupled with the ability to identify recurrence months before conventional methods, highlights the potential clinical value of ultra-sensitive MRD assessment for guiding follow-up strategies in patients with resectable cancers."

The MONSTAR-SCREEN-3 findings will be featured in the following ESMO (Free ESMO Whitepaper) presentations:

Clinical Significance of Ultrasensitive ctDNA Detection for Molecular Residual Disease Assessment in Resectable Colorectal Cancer in MONSTAR-SCREEN-3

Session: Proffered Paper 1: Basic Science and Translational Research
Room: Burgos Auditorium – Hall 3
Date: Sunday, October 25, 2026
Time 2:45 -4:15pm

Molecular Residual Disease Detection for Resectable Pancreatic Cancer Using a Whole-Genome Sequencing-Based ctDNA Assay: Initial Findings from MONSTAR-SCREEN-3
Poster Number: 3138P
Date: Sunday, October 25, 2026
Time 12:00 -12:45pm

(Press release, Myriad Genetics, OCT 22, 2026, View Source [SID1234673691])

On October 22, 2026 AdvanCell, a clinical-stage radiopharmaceutical company developing innovative targeted alpha therapies for cancer, reported updated results from the TheraPb Phase 1 clinical trial (NCT05720130), evaluating ADVC001, an investigational Lead-212 PSMA-targeted alpha therapy, in patients with mAPMR prostate cancer (formerly referred to as mCRPC). The findings were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026 in Madrid, Spain.

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The study evaluated escalating doses of 60–200 MBq ADVC001 administered at pre-specified intervals every 6, 4, 2 or 1 week(s), for up to 6 cycles, enabling RP2D selection of dose and schedule. Expanding upon the initial results reported at ESMO (Free ESMO Whitepaper) 2025, the updated TheraPb Phase 1 data presented in Madrid provides an additional 12 months of safety and efficacy follow-up.

"The longer follow-up data presented at ESMO (Free ESMO Whitepaper) underscore the potential for ADVC001 to deliver durable clinical benefit while maintaining a favorable safety profile," said Christopher Sweeney, MBBS, Director of the South Australian immunoGENomics Cancer Institute. "These findings support further clinical development of this targeted alpha therapy to address the significant unmet needs of patients with metastatic prostate cancer."

The results presented include follow-up from the 22 patients enrolled across seven dose-schedule cohorts, with a median follow-up of 14.1 months as of the 5 October 2026 data cut-off (open database). Treatment was well tolerated with most patients having completed all 6 planned doses per protocol. At RP2D 160 and 200 MBq, an 80% PSA50 response rate was seen corresponding with decreases in PSMA avid tumor volume on PSMA PET and 100% ORR (5/5 confirmed responses) by BICR in patients with RECIST-measurable target lesions. Median rPFS was 11.2 months at the RP2D, as of data cut-off.

"The updated Phase 1 results from the TheraPb trial demonstrate a favorable safety and tolerability profile for ADVC001, with no new safety signals emerging after an additional 12 months of follow-up," said Aaron R. Hansen, MBBS, Principal Investigator at Princess Alexandra Hospital. "Encouraging and sustained anti-tumor activity was observed at the RP2D. These findings support the continued Phase 2 evaluation of ADVC001, incorporating an optimized induction and maintenance dosing strategy aimed at enhancing the depth and durability of clinical benefit for patients with metastatic prostate cancer."

"We thank the patients and their families, investigators, site staff, and collaborators for their commitment, partnership and contributions to this study," said Anna Karmann, MD PhD, Chief Medical Officer, AdvanCell. "These data support the continued development of ADVC001 as a potential treatment option for men with prostate cancer, and we look forward to further evaluating its therapeutic potential in ongoing and future studies."

ADVC001 continued to show a favorable safety profile and signs of sustained anti-tumor activity. The updated findings reinforce the promising therapeutic profile of ADVC001 and support further investigation and dosage optimization. Phase 2 enrollment is ongoing to evaluate the RP2D of 160 MBq and 200 MBq in mAPMS and mAPMR prostate cancer and incorporates a novel induction, maintenance and response-adapted ADVC001 dosing strategy with up to 12 doses aiming to enhance and prolong clinical benefit.

The poster presentation is available on AdvanCell’s website at: AdvanCell ESMO (Free ESMO Whitepaper) 2026 Poster

About ADVC001
ADVC001 is a proprietary and patented PSMA-targeting radiopharmaceutical therapy with optimized physicochemical properties labelled with Lead-212, an alpha-emitting payload with a high dose rate, 10.6 hours half-life and simple decay scheme. ADVC001 is designed to deliver radiation at a cellular level to effectively kill prostate cancer cells while minimizing toxicity.

About the TheraPb trial
The TheraPb trial (NCT05720130) is a prospective, open-label Phase 1/2 dose escalation and expansion study designed to determine the safety and tolerability of escalating doses and treatment schedules of ADVC001 during the dose-finding Phase 1. The Phase 2 expansion evaluates the efficacy and safety of ADVC001 at the recommended Phase 2 doses 160 and 200 MBq. The trial utilizes dosage optimization strategies to enhance outcomes in PSMA-positive mAPMR and in mAPMS.

(Press release, Advancell, OCT 22, 2026, View Source [SID1234673690])

On October 22, 2026 Summit Therapeutics Inc. (NASDAQ: SMMT) reported that ivonescimab data will be featured in numerous presentations at the European Society for Medical Oncology 2026 Congress (ESMO 2026), taking place October 23-27, 2026, in Madrid, Spain.

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Across 10 presentations at ESMO (Free ESMO Whitepaper) 2026, ivonescimab data will span a broad range of tumor types, led by positive overall survival findings from Akeso Inc.’s Phase III HARMONi-GI1 study of ivonescimab plus chemotherapy compared to durvalumab plus chemotherapy in first-line advanced biliary tract cancer, which is selected as a Late-Breaking Abstract for the Presidential Symposium. HARMONi-GI1 is a multi-center, Phase III study conducted in China and sponsored by Akeso, with all relevant data exclusively generated, managed, and analyzed by Akeso. On October 21, Summit and ECOG-ACRIN Cancer Research Group announced the initiation of the open-label Phase II/III EA2251 study, which plans to enroll patients in the U.S. who will be randomized to receive ivonescimab in combination with gemcitabine and cisplatin, or pembrolizumab or durvalumab in combination with gemcitabine and cisplatin as the established standard-of-care comparator regimen. Activation of clinical trial sites is expected to begin in the fourth quarter of 2026.

Additional data include findings from investigator-sponsored trials (ISTs). A rapid oral presentation and a proffered paper will feature ivonescimab-based regimens in first-line recurrent/metastatic thymic carcinoma and advanced renal cell carcinoma, respectively. The program also highlights emerging endometrial cancer (EC) data, alongside continued development in gastrointestinal cancers such as esophageal, gastric/GEJ, and pancreatic cancers; glioblastoma; and head and neck squamous cell carcinoma.

In a Phase II study in EC conducted at Memorial Sloan Kettering Cancer Center in New York, NY, ivonescimab monotherapy met the study’s primary endpoint for objective response rate with a manageable safety profile without new safety signals in previously treated patients with second-line and later EC. The strength of these results supported expansion of the IST led by Drs. Maria Rubinstein, MD, and Vicky Makker, MD, and provided a meaningful signal to inform opportunities for further development of ivonescimab in EC.

"The breadth of the ivonescimab data at ESMO (Free ESMO Whitepaper) underscores the expanding body of clinical evidence across a diverse range of tumor types and treatment settings," said Dr. Maky Zanganeh, President and Co-Chief Executive Officer of Summit Therapeutics. "Our ambition for ivonescimab extends beyond any single indication. We are focused on advancing a rigorous clinical development program to determine where this novel IO bispecific antibody could make a meaningful difference for patients. We look forward to engaging with the global oncology community on these data at ESMO (Free ESMO Whitepaper) 2026."

The ESMO (Free ESMO Whitepaper) 2026 ivonescimab presentations are listed below by tumor type:

Biliary Tract Cancer

Presidential Symposium Presentation: Ivonescimab plus chemotherapy versus durvalumab plus chemotherapy as first-line treatment for advanced biliary tract cancer: a randomized, controlled, double-blinded, phase 3 trial (HARMONi-GI1)

Presidential Symposium II, Oct 25, 5:42-5:54 pm CET, Abstract #LBA8

Endometrial Cancer

Poster: A phase 2 study of ivonescimab (PD1/VEGF bispecific antibody) for the treatment of endometrial cancer (EC)

Abstract #1266P

Esophageal Squamous Cell Carcinoma

Poster: Ivonescimab (AK112) plus chemotherapy as first-line treatment for advanced or metastatic esophageal squamous cell carcinoma: A phase 2 single-arm study

Abstract #2908P

Gastric and GEJ Adenocarcinoma

Poster: AK112 (PD-1/VEGF bispecific antibody) combined with low-dose radiotherapy and nab-paclitaxel as second-line therapy for advanced gastric or gastroesophageal junction adenocarcinoma: A prospective, multicenter, phase II study

Abstract #2898P

Glioblastoma

Poster: Ivonescimab combined with dose-dense temozolomide in recurrent glioblastoma: Preliminary results of efficacy and safety from a single-arm, phase Ib/II trial

Abstract #706P

Head and Neck Squamous Cell Carcinoma

Poster: Ivonescimab combined with chemotherapy as first-line treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma: A prospective, open-label, single-arm phase II study

Abstract #1676eTiP

Pancreatic Cancer

Poster: Neoadjuvant ivonescimab plus gemcitabine/nab-paclitaxel for borderline resectable pancreatic cancer: A prospective single-arm phase II trial

Abstract #3161P

Renal Cell Carcinoma

Oral Presentation: Efficacy and safety of AK112 (Ivonescimab), a PD-1/VEGF bispecific antibody, as first-line treatment for patients with IMDC favorable-risk advanced renal cell carcinoma (aRCC): Results from a phase Ib/II study

Proffered Paper 2 Session: Genitourinary Tumours, Renal and Urothelial; Oct 25, 9:32-9:42 am CET, Abstract #3592O

Thymic Carcinoma

Rapid Oral Presentation: Ivonescimab plus chemotherapy as first-line treatment in recurrent/metastatic thymic carcinoma: Results from the iTHYM phase II study

Rapid Oral Session: Non-metastatic NSCLC and Other Thoracic Malignancies; Oct 26, 11:07-11:12 am CET, Abstract #4156RO

Poster: Ivonescimab plus chemotherapy as first-line treatment for advanced thymic carcinoma: Preliminary results from a phase II study with dynamic biomarker exploration

Abstract #2020eP

Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was initially approved for marketing authorization in China in May 2024.

About Ivonescimab

Ivonescimab, known as SMT112 in Summit’s license territories, North America, South America, Europe, the Middle East, Africa, and Japan, and as AK112 outside of Summit’s license territories, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. By design, ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity to PD-1 when in the presence of VEGF.

This design is intended to differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. Summit believes ivonescimab’s specifically engineered tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the TME (Zhong, et al, iScience, 2025). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of ivonescimab’s design, together with a half-life of 6 to 7 days after the first dose (Zhong, et al, iScience, 2025) increasing to approximately 10 days at steady state dosing, is to improve upon previously established efficacy thresholds, side effects, and safety profiles associated with prior approved drugs to these targets.

Ivonescimab was invented by Akeso Inc. (HKEX Code: 9926.HK) and is currently utilized in multiple Phase III clinical trials. Over 5,000 patients have been treated with ivonescimab in clinical studies globally and over 100,000 patients when considering those treated in a commercial setting in China, as noted by Akeso.

There are currently 17 Phase III clinical studies that are either announced, ongoing, or have been completed studying ivonescimab, five of which are Summit-sponsored global studies, two of which are studies sponsored by cooperative groups, and 10 of which are being or have been conducted in China by Akeso. Summit began its clinical development of ivonescimab in NSCLC and expanded its sponsored Phase III clinical development program into colorectal cancer (CRC) and urothelial carcinoma (bladder cancer).

(Press release, Summit Therapeutics, OCT 22, 2026, View Source [SID1234673689])