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Lyell Immunopharma to Present Positive Updated Ronde-Cel Data in More than 80 Patients at ASH 2026 from PiNACLE Pivotal Trial in 3L+ and from Phase 1/2 2L Cohort in Patients with Relapsed/Refractory Large B-Cell Lymphoma

On November 4, 2026 Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with cancer, reported that two abstracts featuring positive updated clinical data for rondecabtagene autoleucel (ronde-cel) have been accepted for presentation at the 68th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, taking place December 12–15, 2026, in New Orleans (ASH 2026).

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The abstracts highlight results in patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) in the third- or later-line (3L+) setting in an oral presentation, and in the second-line (2L) setting in a poster presentation. Ronde-cel is a dual-targeting CD19/CD20 autologous CAR T-cell product candidate currently being evaluated in two pivotal trials: PiNACLE, a single-arm trial in the 3L+ LBCL setting intended to support an initial BLA submission for regular marketing approval, and PiNACLE-H2H, a Phase 3 randomized controlled trial comparing ronde-cel to investigator’s choice of an approved CD19-directed CAR T-cell therapy in the 2L setting. Ronde-cel has received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the U.S. Food and Drug Administration (FDA) for R/R diffuse LBCL in the 3L+ setting, as well as RMAT designation for LBCL in the 2L setting.

"We believe the high complete response rates and durability of remissions observed with ronde-cel in both the second-line and third- or later-line settings, including in patients with high-risk disease, are impressive," said Jarrad Aguirre, M.D., Chief Medical Officer of Lyell. "The potential to deliver deep, lasting remissions for patients with large B-cell lymphoma is particularly compelling and reinforces our confidence in ronde-cel’s ability to meaningfully improve patient outcomes. We look forward to presenting updated results at ASH (Free ASH Whitepaper), including additional patients and longer follow-up, as we advance ronde-cel toward potential registration."

Third- or Later-Line (3L+) LBCL Oral Abstract and Clinical Highlights

Overall, 58 patients received ronde-cel as of the June 18, 2026 data cutoff date. The median age was 64 years, approximately 50% of treated patients had primary refractory disease, and 64% were refractory to their last therapy. Of 44 patients response-evaluable at Day 84, the overall response rate was 91% (40/44) and the complete response rate was 77% (34/44). Median duration of complete response was not reached. Among patients with a complete response, 92% remained in complete response at six months and 75% at 12 months. The median progression-free survival (PFS) was not reached, with estimated PFS rates of 76%, 63% and 54% at six, 12 and 24 months, respectively; median PFS follow-up was 12 months.

No Grade ≥ 3 cytokine release syndrome (CRS) was observed among all treated patients (N = 58). Grade 1 CRS occurred in 48% of patients and Grade 2 in 22% of patients. Grade ≥ 3 immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in 9% of patients.

Updated results, including additional patients and longer follow-up, are expected to be presented at ASH (Free ASH Whitepaper) 2026.

Second-Line (2L) LBCL Poster Abstract and Clinical Highlights

In the fully enrolled Phase 1/2 second-line cohort, 43 patients received ronde-cel, including 86% (37/43) with primary refractory disease. Among 37 patients response-evaluable at Day 84, the overall response rate was 95% (35/37) and complete response rate was 76% (28/37). Median duration of complete response was not reached. Among patients with a complete response, 92% remained in complete response at six months and 67% at 12 months. Median PFS was not reached, with estimated PFS rates of 75% at six months and 55% at 12 months; median PFS follow-up was nine months.

No Grade ≥ 3 CRS was observed among all treated patients (N = 43). Grade 1 CRS occurred in 49% of patients and Grade 2 in 19% of patients. Grade ≥ 3 ICANS occurred in 9% of patients.

Updated results, including longer follow-up, are expected to be presented at ASH (Free ASH Whitepaper) 2026. Ronde-cel is also being evaluated in PiNACLE-H2H, an ongoing randomized Phase 3 trial in the 2L setting.

Abstract Details:

Oral Abstract 1028: Durable progression-free survival and high complete response rates with rondecabtagene autoleucel, a CD19/CD20 CAR T-cell candidate, in patients with 3L+ relapsed/refractory large B-cell lymphoma: results from the ongoing pivotal PiNACLE trial

Presenting author: Sarah M. Larson, M.D., Associate Professor in the Division of Hematology-Oncology, David Geffen School of Medicine, UCLA

Session: Monday, December 14, 2026, 4:45 CST

Poster Abstract 2402: Durable progression-free survival and high complete response rates with rondecabtagene autoleucel, a CD19/CD20 CAR T-cell candidate, in patients with predominantly primary refractory, second-line relapsed/refractory large B-cell lymphoma

Presenting author: Akil Merchant, M.D., Associate Professor and Co-Director of the Lymphoma Program, Samuel Oschin Cancer Center, Cedars-Sinai Medical Center

Session: Saturday, December 12, 2026, 5:30 CST

About Ronde-Cel

Rondecabtagene autoleucel (ronde-cel) is a next-generation, dual-targeting CD19/CD20 autologous CAR T-cell product candidate designed to increase complete response rates and prolong the duration of response compared to approved CD19-targeted CAR T-cell therapies for R/R LBCL. Ronde-cel targets B cells expressing either CD19 or CD20 and is manufactured using a process that enriches for CD62L-positive cells designed to generate more naïve and central memory CAR T cells to improve the durability of responses by promoting in vivo persistence and the antitumor activity of CAR T cells.

Ronde-cel is being evaluated in two pivotal trials in R/R LBCL: PiNACLE is a multi-center single-arm pivotal trial in the 3L+ setting. Full pivotal data from this trial are expected in mid-2027 with BLA submission expected to follow in the second half of 2027. PiNACLE-H2H is a Phase 3 randomized controlled head-to-head CAR T-cell trial in the 2L setting. Patients with R/R LBCL following one prior line of therapy are randomized to receive ronde-cel or investigator’s choice of one of two approved CD19 CAR T-cell therapies. The FDA has granted ronde-cel Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations in the 3L+ setting and RMAT designation in the 2L setting.

(Press release, Lyell Immunopharma, NOV 4, 2026, View Source [SID1234674206])

Corvus Pharmaceuticals Announces Initial Data from Soquelitinib Clinical Trial in Patients with Autoimmune Lymphoproliferative Syndrome (ALPS) will be Presented at the 68ᵗʰ American Society for Hematology Annual Meeting & Exposition

On November 4, 2026 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported that initial data from a Phase 2 clinical trial of soquelitinib for the treatment of patients with autoimmune lymphoproliferative syndrome (ALPS), a rare genetic disease, will be presented in a poster session at the 68th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition, which is taking place December 12-15, 2026 in New Orleans, LA.

The Phase 2 ALPS trial was initiated by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and led by V. Koneti Rao, MD, FRCPA, Senior Research Physician, Primary Immune Deficiency Clinic (ALPS Clinic) at NIH Clinical Center. There currently is no cure or approved treatment for ALPS and the disorder is managed by a variety of empirical methods aimed at addressing pathological changes caused by the disease, such low blood-cell counts (cytopenias), excessive lymphocyte production (lymphoproliferation), enlarged spleen or lymph nodes, and lymphoma. Treatments may include corticosteroids such as prednisone and other immunosuppressive medications to modulate the immune system, or cancer therapies to address lymphoma.

As of August 3, 2026, three ALPS patients were enrolled in the Phase 2 trial and completed one year of treatment with a 200 mg twice per day dose of soquelitinib. The treatment was well tolerated, with no grade 3 or 4 adverse events and no interruptions in therapy. All three patients were able to discontinue background medications including steroids and reported improvement in ALPS related systemic symptoms. Corvus believes the data supports continued enrollment in the trial and based on the results to-date, we plan to explore longer treatment durations and enroll younger pediatric patients.

Details regarding the poster presentation are as follows:

Session Name: 203. Lymphocytes and Acquired or Congenital Immunodeficiency Disorders: Poster III
Session Date: December 14, 2026
Session & Presentation Time: 6:00 – 8:00 PM
Publication Number: 4743
Title: Clinical assessment of soquelitinib, an interleukin-2-inducible T cell kinase (ITK) inhibitor, for treatment of autoimmune lymphoproliferative syndrome (ALPS)-FAS

The abstract accepted for presentation can be viewed online at the ASH (Free ASH Whitepaper) abstracts site here, and will appear in the November supplemental issue of Blood.

(Press release, Corvus Pharmaceuticals, NOV 4, 2026, View Source [SID1234674205])

Caribou Biosciences Announces Presentations at the 2026 American Society of Hematology (ASH) Annual Meeting

On November 4, 2026 Caribou Biosciences, Inc. (Nasdaq: CRBU) reported that vispa-cel and CB-011 clinical abstracts have been accepted for two oral presentations and one poster presentation at the 2026 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which will be held December 12-15, 2026 in New Orleans, Louisiana.

The accepted abstracts were submitted prior to Caribou’s announcement of plans to explore strategic alternatives and discontinue further development activities for its two allogeneic CAR-T cell therapy programs, vispa-cel for the treatment of relapsed or refractory (r/r) B cell non-Hodgkin lymphoma and CB-011 for the treatment of r/r multiple myeloma, due to the current financing environment for allogeneic CAR-T cell therapies. Investigators will present data from both programs to share important clinical findings with the medical and scientific community.

Details of the oral presentations are as follows:

Title: Multi-year complete remissions achieved with vispa-cel, an off-the-shelf CAR-T cell therapy, in patients with relapsed/refractory B cell non-Hodgkin lymphoma: an analysis of patients who are progression-free at ≥12 months (ANTLER trial)
Presenter: Mehdi Hamadani, MD, professor of medicine, section chief of hematologic malignancies at Medical College of Wisconsin, and investigator on the ANTLER trial
Date and time: Monday, December 14, 2026, 5:00 pm CST
Session: Aggressive Lymphomas Cellular Therapies: Novel CAR-T constructs, durability and long-term outcomes
Location: Ernest N. Morial Convention Center – New Orleans Theater A
Publication number: 1029

Title: Deep and durable responses achieved with CB-011, an off-the-shelf CAR-T cell therapy, for heavily pretreated patients with relapsed/refractory multiple myeloma (CaMMouflage trial)
Presenter: Adriana Rossi, MD, director of CAR-T and stem cell transplant clinical program at the center of excellence for multiple myeloma at Mt Sinai, and investigator on the CaMMouflage trial
Date and time: Saturday, December 12, 2026, 10:15 am CST
Session: Multiple Myeloma: Cellular Therapies: CART in Myeloma: Racing Towards a Cure
Location: Ernest N. Morial Convention Center – Hall E
Publication number: 118

Details of the poster presentation are as follows:

Title: Vispa-cel, an off-the-shelf CAR-T cell therapy, in patients with large B cell lymphoma who relapsed after prior CD19-directed treatment (ANTLER trial)
Presenter: Mohamad Cherry, MD, medical director of hematology at Atlantic Health, and investigator on the ANTLER trial
Date and time: Sunday, December 13, 2026, 6:00-8:00 pm CST
Session: Aggressive Lymphomas Cellular Therapies: Poster II
Location: Ernest N. Morial Convention Center – Hall F
Publication number: 3681

Abstracts will be available on the 2026 ASH (Free ASH Whitepaper) Annual Meeting website on November 4, 2026 at 9:00 am EST.

About vispacabtagene regedleucel
Vispacabtagene regedleucel (vispa-cel; formerly known as CB-010) is an allogeneic anti-CD19 CAR-T cell therapy evaluated in patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL). To Caribou’s knowledge, vispa-cel is the first allogeneic CAR-T cell therapy in the clinic with a PD-1 knockout, a genome-editing strategy designed to enhance CAR-T cell activity by limiting premature CAR-T cell exhaustion. Vispa-cel is pivotal trial-ready, with FDA alignment already reached on the phase 3 clinical trial design. To Caribou’s knowledge, vispa-cel is the first allogeneic CAR-T cell therapy to demonstrate safety, efficacy, and durability on par with autologous CAR-T cell therapies. The FDA granted vispa-cel Regenerative Medicine Advanced Therapy (RMAT), Fast Track, and Orphan Drug designations for B-NHL.

About CB-011
CB-011 is an allogeneic anti-BCMA CAR-T cell therapy evaluated in patients with relapsed or refractory multiple myeloma (r/r MM). To Caribou’s knowledge, CB-011 is the first allogeneic CAR-T cell therapy in the clinic that is engineered to enable activity through an immune cloaking strategy with a B2M knockout and insertion of a B2M–HLA-E-peptide fusion protein to blunt immune-mediated rejection. Clinical data from the CB-011 CaMMouflage phase 1 trial has demonstrated the potential for deep, durable responses in patients with r/r MM. The FDA granted CB-011 RMAT, Fast Track, and Orphan Drug designations for r/r MM.

(Press release, Caribou Biosciences, NOV 4, 2026, View Source [SID1234674204])

Sumitomo Pharma America to Present New Clinical Data on Enzomenib and Nuvisertib at the 2026 American Society of Hematology Annual Meeting

On November 4, 2026 Sumitomo Pharma America, Inc. (SMPA) reported two oral presentations and two poster presentations at the 68th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition, taking place December 12-15, 2026, in New Orleans, Louisiana. The presentations will feature new clinical data on enzomenib, an investigational oral small molecule menin inhibitor being studied in genetic subtypes of relapsed or refractory (R/R) acute leukemia (AL), and nuvisertib, an investigational oral small molecule highly selective PIM1 kinase inhibitor with added ACVR1 inhibition being evaluated in combination with momelotinib (MMB) in patients with R/R myelofibrosis (MF).

"There remains a high unmet medical need for patients with R/R acute myeloid leukemia with KMT2Ar or NPM1m for targeted therapies that yield robust response rates and durable response that are well tolerated," said Jatin Shah, M.D., Chief Medical Officer, Oncology, SMPA. "In addition, new classes of therapeutics and combination strategies to potentially improve upon the activity of JAK inhibitors are important in MF. With this in mind, we look forward to sharing encouraging new data that further support the therapeutic potential and development of our late-stage oncology pipeline at ASH (Free ASH Whitepaper)."

For enzomenib, the oral presentation will report efficacy and safety data from the pivotal Phase 2 arm of the Horizen-1 study in patients with R/R KMT2A rearrangements (KMT2Ar) AL. The data will highlight the therapeutic potential of enzomenib as a targeted treatment option for patients with this high-risk subset of AL.

Additionally, a poster presentation will include clinical findings from the completed dose optimization study of enzomenib that informed the recommended Phase 2 dose (RP2D) in patients with R/R AL with NPM1 mutation (NPM1m). The data demonstrated that both 200 mg twice a day (BID) and 300 mg BID of enzomenib were generally well tolerated with measurable clinical activity. Objective response rates (ORRs) were 54% and 57% in patients receiving 200 and 300 mg BID, respectively, while the complete remission and complete remission with partial hematologic recovery (CR+CRh) rates were 35% at 200 mg BID and 43% at 300 mg BID.

For nuvisertib, the oral presentation will report preliminary findings from the ongoing global Phase 1 dose escalation study evaluating nuvisertib and MMB in patients with MF previously treated with a JAK inhibitor show the combination appeared to be well tolerated in the dose levels evaluated. Promising clinical activity included symptom and spleen responses, anemia improvement, and cytokine modulation. These emerging clinical data support the Phase 3 clinical development of nuvisertib in combination with MMB for patients with MF and anemia.

Presentation Details

Title

Details

Presenting Author

Investigational PIM1 kinase inhibitor nuvisertib in combination with momelotinib showed promising clinical activity in patients with myelofibrosis and anemia: Preliminary data from an ongoing Phase 1/2 study

Oral Presentation

Session: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Combining Forces Against Myelofibrosis

Sunday, December 13, 2026

9:30—11 a.m. CST

Presentation Time: 9:45—10 a.m. CST

Room: R02-R05 (New Orleans Ernest N. Morial Convention Center)

Lindsay A.M. Rein, M.D.

Selective PIM1 inhibition with nuvisertib promotes megakaryocyte maturation and platelet production in myelofibrosis patients

Poster Presentation

Session: 631. Myeloproliferative Syndromes and Chronic Myeloid Leukemia: Basic and Translational: Poster I

Saturday, December 12, 2026

5:30—7:30 p.m. CST

Room: Hall F (New Orleans Ernest N. Morial Convention Center)

Lilian Varricchio, Ph.D.

Initial report of the Phase 2 pivotal data in patients with relapsed or refractory KMT2Ar acute leukemia from the phase 1/2 trial of the investigational menin inhibitor enzomenib (DSP-5336)

Oral Presentation

Session: 616. Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies – Novel Combinations with Menin, FLT3 and BCL2 Inhibitors

Sunday, December 13, 2026

4:30—6 p.m. CST

Presentation Time: 5—5:15 p.m. CST

Room: Hall B (New Orleans Ernest N. Morial Convention Center)

Harry P. Erba, M.D., Ph.D.

Enzomenib dose optimization and determination of the recommended Phase 2 dose in patients (pts) with relapsed or refractory NPM1m acute leukemia

Poster Presentation

Session: 616. Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Poster III

Monday, December 14, 2026

6—8 p.m. CST

Presentation Time: 6—8 p.m. CST

Room: Hall F (New Orleans Ernest N. Morial Convention Center)

Cristina Papayannidis, M.D., Ph.D.

About Enzomenib (DSP-5336)
Enzomenib is an investigational, oral, small molecule inhibitor of the menin and lysine (K)-specific methyltransferase 2A (KMT2A) protein interaction, a key interaction in acute leukemia and other tumor cell proliferation and growth.1 Menin is a scaffold nuclear protein that plays key roles in gene expression and protein interactions involved in many biological pathways, including cell growth, cell cycle, genomic stability, and hematopoiesis.2,3 In preclinical studies, enzomenib has shown selective growth inhibition in human acute leukemia cell lines with KMT2A rearrangements or NPM1 mutations.4 Enzomenib reduced the expression of the leukemia-associated genes HOXA9 and MEIS1 and increased the expression of the differentiation gene CD11b in human acute leukemia cell lines with KMT2A rearrangements or NPM1 mutations.1,4 The safety and efficacy of enzomenib are currently being clinically evaluated in a Phase 1/2 dose-escalation/dose-expansion study in patients with relapsed or refractory acute leukemia (NCT04988555) and the registrational Phase 2 Horizen-1 R/R mono AML/ALL (KMT2Ar + NPM1m) study. The FDA granted Orphan Drug Designation for enzomenib for the indication of acute myeloid leukemia in June 2022 and the indication of acute lymphoblastic leukemia in July 2026. The FDA granted Fast Track Designation for enzomenib for the indication of relapsed or refractory acute myeloid leukemia with KMT2Ar or NPM1m in June 2024 and Breakthrough Therapy Designation for the treatment of patients with relapsed/refractory acute leukemia with KMT2Ar in October 2026. Japan’s Ministry of Health, Labour and Welfare (MHLW) granted Orphan Drug Designation for enzomenib for the indication of relapsed or refractory acute myeloid leukemia with KMT2Ar or NPM1m in September 2024.

About Nuvisertib (TP-3654)
Nuvisertib is an oral investigational selective inhibitor of PIM1 kinase with added ACVR1 inhibition, which has shown potential antitumor and antifibrotic activity through multiple pathways, including induction of apoptosis in preclinical models.5-7 Nuvisertib was observed to inhibit proliferation and increase apoptosis in murine and human hematopoietic cells expressing the clinically relevant JAK2 V617F mutation.6 Nuvisertib alone and in combination with ruxolitinib showed reduction of spleen size and bone marrow fibrosis in JAK2 V617F and MPLW515L murine models of myelofibrosis.6 In addition to its primary activity against PIM1, nuvisertib has been shown to bind and inhibit ACVR1 in preclinical studies, which may contribute to hemoglobin responses in patients with myelofibrosis.7 The safety and efficacy of nuvisertib monotherapy or in combination with a JAK inhibitor are currently being clinically evaluated in a Phase 1/2 study in patients with intermediate- and high-risk myelofibrosis (NCT04176198). The FDA granted Orphan Drug Designation to nuvisertib for the indication of myelofibrosis in May 2022. The Japan Ministry of Health, Labour and Welfare (MHLW) granted Orphan Drug Designation to nuvisertib for the treatment of myelofibrosis in November 2024. The European Medicines Agency (EMA) granted Orphan Drug Designation to nuvisertib for the treatment of myelofibrosis in July 2025. The FDA granted Fast Track Designation to nuvisertib for the indication of myelofibrosis in June 2025.

(Press release, Sumitomo Dainippon Pharma, NOV 4, 2026, View Source [SID1234674203])

Elicio Therapeutics to Host Virtual KOL Event on November 11, 2026: ELI-002 7P for Metastatic and Neoadjuvant PDAC

On November 4, 2026 Elicio Therapeutics, Inc. (Nasdaq: ELTX) ("Elicio" or the "Company"), a clinical-stage biotechnology company developing next-generation immunotherapies for KRAS-driven cancers, reported that it will host a virtual key opinion leader ("KOL") event on Wednesday, November 11, 2026, at 2:30 PM ET. To register, click here.

The event will feature expert oncologists Eileen M. O’Reilly, MD, FASCO and Kevin C. Soares, MD, both of Memorial Sloan Kettering Cancer Center ("MSKCC"), who will join the Company’s management to discuss:

The unmet need and current treatment landscape for metastatic pancreatic ductal adenocarcinoma ("PDAC")
Camupepimut (ELI-002 7P), Elicio’s investigational Amphiphile ("AMP")-powered immunotherapy targeting common KRAS mutations
Key Phase 2 findings informing camupepimut’s late-stage development strategy
Opportunities to expand camupepimut into neoadjuvant PDAC, including the design and progress of the ongoing MSKCC-led Phase 1 trial funded by The Lustgarten Foundation and Break Through Cancer
A live question and answer session will follow the formal presentations.

About Eileen M. O’Reilly, MD, FASCO
Eileen M. O’Reilly holds the Winthrop Rockefeller Endowed Chair in Medical Oncology at MSKCC. She serves as the Section Head for Hepatopancreaticobiliary/Neuroendocrine Cancers, Gastrointestinal Oncology Service, Co-Director Medical at the David M. Rubenstein Center for Pancreatic Cancer and is an Attending Physician and Member at MSKCC and Professor of Medicine at Weill Cornell Medical College.

Dr. O’Reilly is a clinical scientist whose research focus involves integration of molecular, genetic-based (RAS, BRCA, other) and immunotherapy for pancreas cancer along with development of adjuvant and neoadjuvant treatments and identification of biomarkers for therapy selection. Dr. O’Reilly teaches and mentors junior faculty, oncology fellows, residents and medical/other students. Dr. O’Reilly is the Principal Investigator of multiple phase I, II, III trials in pancreas cancer. She is a Clarivate highly cited author in clinical medicine. She serves as an Associate Editor for the Journal of Clinical Oncology and Senior Editor for several AACR (Free AACR Whitepaper) journals and has served on multiple grant review panels including, for the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO"), American Association forCancer Research ("AACR"), National Institutes of Health ("NIH"), Department of Defense ("DOD"), and various international entities. She is Principal Investigator of the MSK P50 Pancreas Specialized Program of Research Excellence ("SPORE"), a National Cancer Institute ("NCI") funded team science grant. Dr. O’Reilly is the recipient of named lectureships and numerous awards including the Burkitt Medal (Trinity College Dublin) in 2022, Giants of Cancer Care (GI Oncology) in 2023 and the Whitman Award for Clinical Excellence in 2025, Exceptional Women in Medicine (2019- present) and Castle Connolly Top Doctors (2005- present).

Dr. O’Reilly’s other roles include Chair of the Human Research Protection Program and Institutional Review & Privacy Board ("IRB"). Nationally, Dr. O’Reilly is Co-Chair of the NCI Alliance Co-Operative Group Gastrointestinal Cancers Committee and serves in leadership roles in several advocacy organizations including the National Pancreas Foundation, Hirshberg Foundation, PanKind and Pancreatic Cancer Action Network.

About Kevin C. Soares, MD
Dr. Kevin C. Soares obtained his undergraduate degree at Brandeis University and MD from the University of Massachusetts Medical School. He completed general surgery residency at The Johns Hopkins University School of Medicine. He completed a three-year research fellowship in cancer immunology in the Jaffee Laboratory at the Sidney Kimmel Comprehensive Cancer Center atThe Johns Hopkins University School of Medicine. After finishing residency, he completed a two-year dual fellowship in complex surgical oncology and hepatopancreatobiliary ("HPB") surgery at MSKCC. He was then appointed to the faculty of the HPB Service at MSKCC and completed a Master of Science in clinical and translational cancer research at the Louis V. Gerstner Jr. Graduate School of Biomedical Sciences,MSKCC.

Dr. Soares is a surgical oncologist and physician scientist who specializes in caring for patients with HPB malignancies. His primary research interest is combinatorial immunotherapy approaches in HPB malignancies with a particular focus on vaccine-based therapies.

About the AMPLIFY-7P Phase 2 Study

AMPLIFY-7P is a randomized Phase 2 study evaluating camupepimut (ELI-002 7P) versus observation in patients with mKRAS-driven PDAC following completion of standard therapy. The study enrolled 144 patients across 24 U.S. clinical sites.

While the study did not meet its pre-specified primary disease-free survival ("DFS") endpoint in the intent-to-treat population, subsequent analyses have provided important insights into the clinical and biological activity of camupepimut and informed the Company’s continued evaluation of the program.

At ESMO (Free ESMO Whitepaper) Congress 2026, Elicio will present new pre-specified analyses from AMPLIFY-7P that provide additional insights into the potential clinical benefit ofcamupepimut and are expected to further inform the Company’s refined Phase 3 development strategy in adjuvant pancreatic cancer.

About camupepimut (ELI-002 7P)

Camupepimut is an investigational, off-the-shelf immunotherapy designed to generate immune responses against seven of the most common KRAS mutations. Camupepimut utilizes Elicio’s proprietary AMP technology to target mutant KRAS peptide antigens and an immune-stimulatory adjuvant directly to the lymph nodes, where adaptive immune responses are orchestrated.

(Press release, Elicio Therapeutics, NOV 4, 2026, View Source [SID1234674202])