EO-3021 / CSPC Pharma, Elevation Oncology - LARVOL DELTA

Elevation Oncology to Discontinue Development of EO-3021… (PRNewswire) - P1 | N=120 | NCT05980416 | Sponsor: Elevation Oncology | "Elevation Oncology...announced that it has elected to discontinue development of EO-3021. EO-3021 is a Claudin 18.2 antibody-drug conjugate (ADC), which Elevation Oncology was developing for the treatment of advanced, unresectable or metastatic gastric and gastroesophageal junction (GEJ) cancers....The decision to discontinue clinical development of EO-3021 was based on data from the dose escalation and expansion stages of Elevation Oncology's Phase 1 trial, in which treatment with EO-3021 as a monotherapy demonstrated an objective response rate (ORR) of 22.2% (95% CI: 10, 39; 1 confirmed complete response and 7 confirmed partial responses) and a disease control rate (DCR) of 72.2% (95% CI: 55, 86) among 36 evaluable patients with gastric or GEJ cancer and Claudin 18.2 in ≥20% of tumor cells at IHC 2+/3+."

Discontinued • P1 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

Elevation Oncology Reports Fourth Quarter and Full Year 2024 Financial Results and Highlights Recent Business Achievements (PRNewswire) - "Expected Upcoming Milestones - EO-3021: (i) Report additional safety and efficacy data from the ongoing Phase 1 clinical trial of monotherapy EO-3021, including from the dose escalation and expansion cohorts, in the second quarter of 2025; (ii) Report initial data from the combination cohorts of the Phase 1 clinical trial of EO-3021 in the fourth quarter of 2025 or the first quarter of 2026."

P1 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Pancreatic Cancer

Combination potential of EO-3021, a CLDN18.2 vc-MMAE ADC, with VEGFR2 or PD1 inhibition in preclinical models of CLDN18.2-expressing cancers (ESMO-IO 2024) - P1 | "The current treatment landscape of gastric/GEJ cancer includes the combination of a fluoropyrimidine and platinum-based chemotherapy with an anti-PD1 inhibitor in the first line and paclitaxel with the VEGFR2 inhibitor ramucirumab in second line metastatic setting...We conducted preclinical studies to evaluate the anti-tumor activity of EO-3021 with an anti-PD1 or VEGFR2 inhibitor.Methods Mice bearing NUGC4-hCLDN18.2 gastric tumors (CrownBio) were treated with a ramucirumab surrogate, DC101 (BioXCell; 20 mg/kg twice-weekly), EO-3021 (2 mg/kg once-weekly), or the combination...An update on durability of CRs, details on the immune infiltrate in mice from the EO-3021 + anti-PD1 study, and comparisons to the ADCC/CDC-inducing CLDN18.2 mAb, zolbetuximab, will be presented.Conclusions Each of the combinations provided a more robust anti-tumor response compared to the single agents. Results from preclinical studies support the planned clinical evaluation of EO-3021 in..."

Preclinical • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CLDN18

Elevation Oncology Presents Preclinical Proof-of-Concept Data Supporting Combination Potential of EO-3021 with VEGFR2 or PD-1 Inhibitors at ESMO Immuno-Oncology Annual Congress 2024 (PRNewswire) - "Treatment with EO-3021 and DC101, a surrogate of the VEGFR2 inhibitor ramucirumab, exhibited statistically superior tumor growth inhibition (TGI) compared to treatment with either EO-3021 or DC101 alone (TGI: 88.2% for EO-3021 in combination with DC101, compared to 20.1% for EO-3021 and 59.2% for DC101 alone). Treatment with EO-3021 and a PD-1 inhibitor exhibited statistically superior TGI compared to treatment with either EO-3021 or a PD-1 inhibitor alone (TGI: 79.9% for EO-3021 in combination with a PD-1 inhibitor, compared to 33.8% for EO-3021 and 25.0% for a PD-1 inhibitor alone)....Elevation Oncology expects to initiate dosing in the combination portion of its ongoing Phase 1 clinical trial of EO-3021 in the fourth quarter of 2024....Additionally, Elevation Oncology continues to enroll patients in the monotherapy dose expansion portion of its ongoing Phase 1 clinical trial and expects to report additional monotherapy data in the first half of 2025."

P1 data • Preclinical • Trial status • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer

CSPC initiates Phase Ib/III clinical trial of CLDN18.2 ADC for gastric cancer [Google translation] (163.com) - "On November 13, the Drug Clinical Trial Registration and Information Disclosure Platform showed that Shijiao registered a randomized, multicenter, Phase Ib/III study to evaluate the efficacy and safety of SYSA1801 combined with capecitabine versus oxaliplatin combined with capecitabine (CAPOX regimen) as first-line treatment for CLDN18.2-positive, PD-L1 CPS <5, unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma."

Trial status • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

Elevation Oncology Reports Third Quarter 2024 Financial Results and Highlights Recent Business Achievements (PRNewswire) - "EO-3021: Present preclinical data on the combination potential of EO-3021 with VEGFR2 or PD-1 inhibitors at ESMO-IO 2024 in December 2024. Initiate dosing in combination portion of the ongoing Phase 1 clinical trial of EO-3021 in the fourth quarter of 2024; combination cohorts will explore EO-3021 in combination with ramucirumab, a VEGFR2 inhibitor, in the second-line setting and in combination with dostarlimab, a PD-1 inhibitor, in the front-line setting. Report additional data from the ongoing Phase 1 clinical trial of monotherapy EO-3021, including from the dose expansion cohort, in the first half of 2025."

P1 data • Preclinical • Trial status • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

Elevation Oncology Receives Fast Track Designation from the FDA for EO-3021 for the Treatment of Adult Patients with Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer Expressing Claudin 18.2 (PRNewswire) - "Elevation Oncology, Inc...today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) to EO-3021, a differentiated antibody drug conjugate (ADC), for the treatment of patients with advanced or metastatic gastric and gastroesophageal junction (GC/GEJ) cancer expressing Claudin 18.2 that has progressed on or after prior therapy.....This designation is based on nonclinical and initial clinical data from our ongoing Phase 1 clinical trial. "

Evidence highlight • Fast track • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • CLDN18

Elevation Oncology Reports Second Quarter 2024 Financial Results and Highlights Recent Business Achievements (PRNewswire) - "Elevation Oncology...announced financial results for the second quarter ended June 30, 2024, and highlighted recent business achievements...Nominate development candidate from HER3-ADC program in the second half of 2024...Research and development (R&D) expenses for the second quarter of 2024 were $6.6 million, compared to $6.0 million for the second quarter of 2023. The increase in R&D expenses in the second quarter of 2024 was primarily due to increased EO-3021 clinical trial expenses....Elevation Oncology will host a live conference call and webcast at 8:30 a.m. ET today to discuss the initial EO-3021 safety and efficacy data announced today."

Commercial • New molecule • P1 data • Esophageal Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Elevation Oncology Announces Promising Initial Data from Phase 1 Clinical Trial Evaluating EO-3021 in Patients with Advanced Unresectable or Metastatic Solid Tumors Likely to Express Claudin 18.2 (PRNewswire) - P1 | N=120 | NCT05980416 | Sponsor: Elevation Oncology | "Elevation Oncology, Inc...announced promising initial data from the dose escalation portion of the ongoing Phase 1 clinical trial of EO-3021 in patients with advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2, including gastric, gastroesophageal junction (GEJ), pancreatic or esophageal cancers....In seven patients with Claudin 18.2 in ≥20% of tumor cells at IHC 2+/3+, the objective response rate (ORR) was 42.8% (three confirmed partial responses, one of which was confirmed following the June 10, 2024, data cutoff) and the disease control rate (DCR) was 71.4%, including two patients with stable disease (SD). In eight patients with Claudin 18.2 in <20% of tumor cells at IHC 2+/3+, the ORR was 0% and the DCR was 50%, including four patients with SD.... Elevation Oncology expects to share additional data from the Phase 1 trial, including from the dose expansion cohort, in the first half of 2025."

P1 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Elevation Oncology Announces Planned Combination Strategy for EO-3021 in Patients with Gastric or Gastroesophageal Junction Cancer (PRNewswire) - "Elevation Oncology...announced plans to expand its ongoing Phase 1 clinical trial to include two combination cohorts evaluating EO-3021 for the treatment of advanced gastric or gastroesophageal junction cancer. Following recently signed clinical supply agreements with Eli Lilly and Company (Lilly) and GSK, respectively, Elevation Oncology will evaluate EO-3021 in combination with ramucirumab, a VEGFR2 inhibitor, in second-line patients and in combination with dostarlimab, a PD-1 inhibitor, in the front-line setting. The Company expects to initiate dosing in the combination portion of the Phase 1 trial by year-end 2024....Elevation Oncology continues to enroll patients in the monotherapy cohort of its ongoing Phase 1 clinical trial (NCT05980416) and remains on track to share initial safety and efficacy data by mid-third quarter 2024, with additional data in the first half of 2025."

P1 data • Trial status • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

Elevation Oncology Reports First Quarter 2024 Financial Results and Highlights Recent Business Achievements (PRNewswire) - "EO-3021: Share details on planned Phase 1 combination study evaluating EO-3021 in the first half of 2024. Provide update from ongoing Phase 1 clinical trial of EO-3021 at a corporate event by mid-third quarter 2024, including initial safety and efficacy data from at least three dose cohorts. Additional data expected in the first half of 2025. HER3-ADC: Nominate development candidate from HER3-ADC program in the second half of 2024....Research and development (R&D) expenses for the first quarter of 2024 were $6.0 million, compared to $7.3 million for the first quarter 2023. The decrease in R&D expenses in the first quarter of 2024 was primarily due to decreased clinical trial expenses associated with Elevation Oncology's former lead program, partially offset by increased clinical trial expenses associated with the ongoing EO-3021 Phase 1 trial."

Commercial • New molecule • New P1 trial • P1 data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Elevation Oncology Expands Ongoing Phase 1 Clinical Trial of EO-3021 Globally, Dosing First Patient in Japan (PRNewswire) - "Elevation Oncology, Inc...today announced that it has expanded its ongoing Phase 1 clinical trial of EO-3021 outside the United States, dosing the first patient in Japan. This trial is evaluating the safety, tolerability and preliminary anti-tumor activity of EO-3021 in patients with advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2, including gastric, gastroesophageal junction, pancreatic or esophageal cancers...Elevation Oncology's Phase 1 clinical trial (NCT05980416) is an open-label, multi-center dose escalation and expansion study to evaluate the safety, tolerability and preliminary anti-tumor activity of EO-3021....Elevation Oncology expects to provide an update from the trial in mid-2024, with additional data expected in the first half of 2025."

P1 data • Trial status • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

MODULE 3: Emerging Role of Therapy Targeting CLDN18.2 in Advanced Gastric/GEJ Adenocarcinoma (ASCO-GI 2024) - "This activity is supported by educational grants from Astellas, BeiGene Ltd, Bristol Myers Squibb, and Lilly. Biological rationale for targeting CLDN18.2 for gastric/GEJ cancers; mechanism of antitumor activity of zolbetuximab Designs, eligibility criteria and key efficacy and safety results of the Phase III SPOTLIGHT and GLOW trials evaluating zolbetuximab in combination with chemotherapy as first-line treatment for patients with CLDN18.2-positive advanced gastric/GEJ adenocarcinoma Potential role of zolbetuximab in clinical practice and implications for biomarker assessment Rationale for and ongoing trials, such as ILUSTRO, combining zolbetuximab with anti-PD-1/PD-L1 antibodies for advanced gastric/GEJ cancers Mechanism of antitumor activity and structural components of the CLDN18.2-targeted antibody-drug conjugate EO-3021 Early efficacy and safety results with and ongoing evaluation of EO-3021"

IO biomarker • Metastases • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • CLDN18

A phase I study of EO-3021 in adult patients with solid tumors likely to express CLDN18.2. (ASCO-GI 2024) - P1 | "41, 2023. Clinical trial information: NCT05980416."

Clinical • P1 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18

Elevation Oncology Announces Program Updates and Upcoming 2024 Milestones (PRNewswire) - "Elevation Oncology plans to expand its clinical development program to evaluate EO-3021 in combination. The Company believes a combination approach has the potential to offer optimal outcomes to patients, particularly in the gastric cancer setting, and plans to explore combination strategies with both immunotherapy and targeted agents. Elevation Oncology expects to share details on its planned Phase 1 combination study in the first half of 2024...Elevation Oncology's second program is a differentiated HER3-targeting ADC....Elevation Oncology is currently evaluating its HER3-ADC program and plans to nominate a development candidate in 2024."

New molecule • New P1 trial • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Elevation Oncology Reports Third Quarter 2023 Financial Results and Highlights Recent Business Achievements (PRNewswire) - "Enrollment is ongoing in the Phase 1 clinical trial evaluating EO-3021 in patients with advanced solid tumors likely to express Claudin 18.2; preliminary safety and anti-tumor activity data expected in 1H 2025."

Enrollment status • P1 data • Gastric Cancer • Gastroesophageal Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Dose Escalation and Expansion Study of CPO102, an Anti-claudin 18.2 ADC in Patients With Advanced Cancers (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Conjupro Biotherapeutics, Inc. | N=72 ➔ 0 | Trial completion date: Mar 2025 ➔ Nov 2022 | Not yet recruiting ➔ Withdrawn | Trial primary completion date: Feb 2025 ➔ Nov 2022

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18

Study of EO-3021 in Adult Patients With Solid Tumors Likely to Express CLDN18.2 (clinicaltrials.gov) - P1 | N=120 | Recruiting | Sponsor: Elevation Oncology | Not yet recruiting ➔ Recruiting

Enrollment open • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18

Elevation Oncology Announces First Patient Dosed in the Phase 1 Clinical Trial Evaluating EO-3021 (PRNewswire) - "Elevation Oncology, Inc...announced that the first patient has been dosed in the Phase 1 clinical trial evaluating EO-3021 in patients with advanced unresectable or metastatic solid tumors likely to express Claudin 18.2 including gastric, gastroesophageal junction, pancreatic or esophageal cancers....Elevation Oncology's Phase 1 clinical trial (NCT05980416) is an open-label, multi-center dose escalation and expansion study that is expected to enroll up to approximately 120 patients to evaluate the safety, tolerability, and preliminary anti-tumor activity of EO-3021 in advanced solid tumors likely to express Claudin 18.2....Elevation Oncology expects to report preliminary safety and anti-tumor data from its Phase 1 study during the first half of 2025."

P1 data • Trial status • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Study of EO-3021 in Adult Patients With Solid Tumors Likely to Express CLDN18.2 (clinicaltrials.gov) - P1 | N=120 | Not yet recruiting | Sponsor: Elevation Oncology

New P1 trial • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18

Elevation Oncology Reports Second Quarter 2023 Financial Results and Highlights Recent Business Achievements (PRNewswire) - "Expected Upcoming Milestones and Operational Objectives...Initiate Phase 1 clinical trial of EO-3021 in the United States in the second half of 2023; Ongoing target evaluation for future pipeline expansion"

New P1 trial • Oncology • Solid Tumor

First-in-human dose escalation and expansion study of SYSA1801, an antibody-drug conjugate targeting claudin 18.2 in patients with resistant/refractory solid tumors. (ASCO 2023) - P1 | "SYSA1801 shows promising early signs of efficacy with a well-tolerated safety profile in pts with CLDN18.2-expressing resistant/refractory solid tumors, especially GC. Part 1 of the study is ongoing with part 2 to start when the optimized dose is determined in China; studies outside of Greater China including in the United States are being planned by Elevation Oncology. Clinical trial information: NCT05009966."

Clinical • P1 data • Anemia • Dry Eye Disease • Gastric Cancer • Gastrointestinal Cancer • Hematological Disorders • Hepatology • Oncology • Ophthalmology • Pancreatic Cancer • Solid Tumor • CLDN18

Elevation Oncology Highlights First-in-Human Phase 1 SYSA1801 (EO-3021) Clinical Data to be Presented by Partner CSPC Pharmaceutical Group Limited at ASCO 2023 (PRNewswire) - P1 | N=272 | NCT05009966 | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | "Elevation Oncology...together with CSPC Pharmaceutical Group Limited...announced promising initial clinical data for SYSA1801 (EO-3021) from the ongoing Phase 1 dose escalation and expansion study in China. These data will be presented at the American Society of Clinical Oncology (ASCO) 2023 Annual Meeting....As of the data cutoff date of November 5, 2022, 33 patients with resistant/refractory solid tumors that expressed Claudin 18.2 were enrolled....21 patients (gastric cancer n=17; pancreatic cancer n=4) were evaluable for efficacy per RECIST v1.1. In gastric cancer, the objective response rate (ORR) was 47.1% (8 PRs, including 4 confirmed PRs) and the disease control rate (DCR) was 64.7%, including three patients with stable disease (SD); The overall ORR was 38.1% (8 PRs, including 4 confirmed PRs) and DCR was 57.1% (including 4 SDs)."

P1 data • Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Elevation Oncology Reports First Quarter 2023 Financial Results and Highlights Recent Business Achievements (PRNewswire) - "Expected Upcoming Milestones and Operational Objectives: Initiate Phase 1 clinical trial of EO-3021 in the US in the second half of 2023; Ongoing target evaluation for future pipeline expansion....Research and development expenses for the first quarter 2023 were $7.3 million, compared to $13.6 million for the first quarter 2022. The decrease in R&D expense in the first quarter of 2023 was primarily related to the decrease in costs related to manufacturing clinical supply of seribantumab for use in the CRESTONE clinical trial. The Company prioritized its pipeline and realigned resources to advance its EO-3021 product candidate."

Commercial • New P1 trial • Pipeline update • Oncology • Solid Tumor

Elevation Oncology Highlights Clinical Data for SYSA1801 (EO-3021) to be Presented by Partner CSPC Pharmaceutical Group Limited at ASCO 2023 (PRNewswire) - "Elevation Oncology...announced that an abstract featuring SYSA1801 (EO-3021) Phase 1 clinical data has been selected for a poster presentation and poster discussion at the upcoming American Society of Clinical Oncology (ASCO) 2023 Annual Meeting, being held June 2-6, 2023 in Chicago, IL. The ongoing Phase 1 dose escalation and dose expansion study is evaluating SYSA1801 in patients with Claudin 18.2-positive advanced solid tumors and is being conducted in China by Elevation Oncology's partner, CSPC Pharmaceutical Group Limited (CSPC; HKEX: 01093). Elevation Oncology remains on track to initiate a Phase 1 clinical trial in the U.S. evaluating EO-3021 in the second half of 2023."

New P1 trial • P1 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor