ELU001 / Elucida Oncology - LARVOL DELTA

Pediatric AML: ELU001 in Pediatric Subjects Who Have Relapsed and/or Refractory CBFA2T3-GLIS2-positive AML (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Elucida Oncology | Trial completion date: Apr 2026 ➔ Jun 2024 | Trial primary completion date: Sep 2025 ➔ Jun 2024

Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • Pediatrics • CBFA2T3 • GLIS2

ELU-FRα-1: A Study to Evaluate ELU001 in Patients With Solid Tumors That Overexpress Folate Receptor Alpha (FRα) (clinicaltrials.gov) - P1/2 | N=79 | Terminated | Sponsor: Elucida Oncology | Trial completion date: Sep 2024 ➔ Jun 2024 | Active, not recruiting ➔ Terminated; Lack of Funding - no safety issue with Drug; Company Bankruptcy

Metastases • Trial completion date • Trial termination • Breast Cancer • Cholangiocarcinoma • Colorectal Cancer • Endometrial Adenocarcinoma • Endometrial Cancer • Esophageal Cancer • Fallopian Tube Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Peritoneal Cancer • Sarcoma • Solid Tumor • Triple Negative Breast Cancer • FOLR1

ELU-FRα-1: A Study to Evaluate ELU001 in Patients With Solid Tumors That Overexpress Folate Receptor Alpha (FRα) (clinicaltrials.gov) - P1/2 | N=79 | Active, not recruiting | Sponsor: Elucida Oncology | Recruiting ➔ Active, not recruiting | N=166 ➔ 79 | Trial completion date: Jun 2025 ➔ Sep 2024

Enrollment change • Enrollment closed • Metastases • Trial completion date • Breast Cancer • Cholangiocarcinoma • Colorectal Cancer • Endometrial Adenocarcinoma • Endometrial Cancer • Esophageal Cancer • Fallopian Tube Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Peritoneal Cancer • Sarcoma • Solid Tumor • Triple Negative Breast Cancer • FOLR1

Study of ELU001, a C'Dot drug conjugate (CDC) targeting folate receptor α (FRα) overexpressing solid tumors. (ASCO 2024) - P1/2 | "Oncol. (2023) 34 (suppl_2): S458-S497."

Endometrial Cancer • Oncology • Ovarian Cancer • Solid Tumor • CTSB • FOLR1

Broadening Therapeutic Indications to Cancers with Lower Target Antigen Expression with C’Dot Drug Conjugates (ADC London 2024) - "Synopsis Unveiling C’Dot Drug Conjugates (CDCs) as a platform technology that is associated with specific tumor targeting/low normal tissue exposure  Showcasing the exciting potential of CDCs in targeting and killing tumors with lower antigen expression than is normally possible with ADCs  Unpacking clinical efficacy and safety data from the safety/dose escalation study of ELU001, in addition to anti-folate receptor alpha CDC data"

Oncology • FOLR1

Pediatric AML: ELU001 in Pediatric Subjects Who Have Relapsed and/or Refractory CBFA2T3-GLIS2-positive AML (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Elucida Oncology | N=21 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • Pediatrics • CBFA2T3 • GLIS2

First-in-human study of ELU001, a targeted nanoparticle drug conjugate, in subjects with folate receptor α (FRα) overexpressing solid tumors (ESMO 2023) - P1/2 | "The Q2W regimen had a better hematological safety profile with no related discontinuations. Conclusions Safety and efficacy of ELU001 demonstrated expected, manageable safety profile based on the payload, exatecan, with promising activity in heavily pretreated patients across several cancer indications with low, moderate or high FRα expression."

Clinical • P1 data • Biliary Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CTSB • FOLR1

Elucida Oncology Presents Encouraging Clinical Data from Phase 1/2 Study of ELU001 in Solid Tumors Overexpressing Folate Receptor Alpha at ESMO Congress 2023 (GlobeNewswire) - P1/2 | N=166 | NCT05001282 | Sponsor: Elucida Oncology | "Elucida Oncology... announced today that new data have been presented from its recently completed dose escalation/safety phase of its first-in-human Phase 1/2 clinical trial evaluating ELU001, its lead C’Dot drug conjugate (CDC) clinical candidate, at the ESMO Congress 2023 being held in Madrid, Spain....Anti-tumor activity was observed in patients with low (≥25% - <50%), moderate (≥50% - <75%) and high (≥75%) FRα expression levels, across multiple tumor types including ovarian, colorectal, and endometrial cancers. For the 19 evaluable patients with ≥25% FRα expression (FRα positive), the study achieved a disease control rate (DCR) of 89%, with 1 partial response (PR) and 16 patients achieving stable disease (SD)....Two patients were still on treatment as of October 6th, 2023....Clinical data from the ongoing dose expansion study is expected in the first half of 2024."

P1/2 data • Trial status • Colorectal Cancer • Endometrial Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Solid Tumor

Clinical Translation & Initial Clinical Safety Results of ELU001, an Anti-Folate Receptor Alpha C’Dot Drug Conjugate (CDC) Delivering a Potent Exatecan Payload (ADC-USA 2023) - "Reviewing the preclinical development of ELU001 and how it guided the design of the initial clinical trial will be presented; Exploring the selection of appropriate models for the nonclinical toxicology studies of ELU001 to guide initial safety trials; Reiterating how the nonclinical toxicology studies of ELU001 and historical studies with the free exatecan payload accurately identified its clinical safety profile"

Clinical • Oncology • FOLR1

Elucida Oncology Announces Abstract Accepted for Poster Presentation at ESMO Congress 2023 (GlobeNewswire) - "Elucida Oncology...announced today an abstract featuring ELU001, its lead C’Dot Drug Conjugate (CDC) clinical candidate, has been accepted for poster presentation at the ESMO Congress 2023 being held in Madrid, Spain from October 20-24, 2023. The poster presentation will highlight updated safety, pharmacokinetic, and efficacy data from the dose escalation portion of the first-in-human Phase 1/2 study of ELU-001 in patients with advanced, recurrent, or refractory cancers overexpressing folate-receptor alpha (FRα)....The most promising is now being explored in expansion cohorts of patients with ovarian and endometrial cancers."

P1/2 data • Endometrial Cancer • Ovarian Cancer

ELU-FRα-1: A Study to Evaluate ELU001 in Patients With Solid Tumors That Overexpress Folate Receptor Alpha (FRα) (clinicaltrials.gov) - P1/2 | N=166 | Recruiting | Sponsor: Elucida Oncology | Trial completion date: Mar 2025 ➔ Jun 2025 | Trial primary completion date: Mar 2024 ➔ Jun 2024

Metastases • Trial completion date • Trial primary completion date • Biliary Cancer • Breast Cancer • Cholangiocarcinoma • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Endometrial Adenocarcinoma • Endometrial Cancer • Esophageal Cancer • Fallopian Tube Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Peritoneal Cancer • Sarcoma • Solid Tumor • Triple Negative Breast Cancer • FOLR1

Elucida Oncology Announces First Patient Dosed with ELU001 in Expansion Cohort of its Phase 1/2 Clinical Trial (GlobeNewswire) - "Elucida Oncology...announced today that the first patient has been treated with ELU001, its proprietary folate receptor alpha (FRα)-targeted C’Dot drug conjugate (CDC), in one of three Tumor Group Expansion Cohorts in its Phase 1/2 trial. These initial Tumor Group Expansion Cohorts will evaluate ELU001 for efficacy and safety in patients with advanced, recurrent, or refractory ovarian and endometrial cancer with all levels of FRα expression (low, moderate, and high)....Initial efficacy data from the Dose Escalation phase will be presented at a medical conference in the second half of 2023."

P1/2 data • Trial status • Endometrial Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor • Uterine Cancer

Phase 1 trial of a novel C’Dot drug conjugate (CDC), ELU001, in patients with solid tumors known to overexpress folate receptor alpha (FRα). (ASCO 2023) - P1/2 | "The study is enrolling in Part 1 Q2W Cohort 301 and Q3W Cohort A in the US. Clinical trial information: NCT05001282."

Clinical • P1 data • Biliary Cancer • Cholangiocarcinoma • Endometrial Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer • CTSB • FOLR1

ELU-FRα-1: a study to evaluate ELU001 in patients with solid tumors that overexpress folate receptor alpha (FRα) (AACR 2023) - P1/2 | "The study is actively enrolling in the US and currently recruiting in Q2W Cohort 201 and Q3W Cohort A. QW Cohorts 1-3 and Q2W Cohort 101 are complete. Clinical trial information: NCT05001282."

Clinical • Biliary Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CTSB • FOLR1

ELU001 - A Targeted C'Dot Drug Conjugate (CDCs) for the Treatment of Folate Receptor Alpha Expressing Tumors (PEGS 2023) - "Non-clinical toxicity studies of ELU001 revealed a lack of the common ADC-related toxicities. ELU001 is currently being evaluated in clinical trials."

Brain Cancer • Oncology • Solid Tumor • FOLR1

Preclinical development of ELU001: A folate receptor alpha (FRα)-targeted C’Dot drug conjugate (CDC) for the treatment of brain metastases (AACR 2023) - "Retreatment of these animals resulted in an additional decrease in tumor burden. These results suggest that ELU001 may have promise for the treatment of metastatic brain tumors that are difficult to treat with currently available agents."

Preclinical • Brain Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • FOLR1

Elucida Oncology Announces Positive Early Phase 1 Safety Data Along with Preclinical Data for the Treatment of Brain Metastases for ELU001, an Anti-Folate Receptor Alpha C’Dot Drug Conjugate (GlobeNewswire) - "In addition, the company presented new preclinical data in a poster...(abstract #837)....New preclinical data with ELU001 highlights its unique ability to penetrate the disrupted blood brain barrier for the treatment of brain metastases, potentially addressing a critically ill patient population. 'We were excited to present compelling preclinical data demonstrating our lead agent, ELU001, is capable of selectively localizing in, and treating, lung tumors established in the brains of mice while avoiding the healthy regions of the brain'..."

Preclinical • Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

Elucida Oncology Announces Positive Early Phase 1 Safety Data Along with Preclinical Data for the Treatment of Brain Metastases for ELU001, an Anti-Folate Receptor Alpha C’Dot Drug Conjugate (GlobeNewswire) - P1/2 | N=166 | NCT05001282 | Sponsor: Elucida Oncology | "Elucida Oncology...presented positive initial safety data from Phase 1 dose escalation trial of ELU001 (NCT05001282) in a poster...(abstract #CT255) at the American Association for Cancer Research (AACR) 2023 Annual Meeting....'Data on two different dosing schedules demonstrates an ELU001 safety profile with side-effects confined to predictable, manageable, and reversible hematologic and gastrointestinal adverse events consistent with its exatecan payload. Importantly, there has been no evidence of interstitial lung disease, peripheral neuropathy, or ocular, liver, renal or cardiac toxicities observed to date. We remain on track to complete the dose escalation study by mid-2023 and initiate expansion studies in endometrial and ovarian cancers. We look forward to presenting efficacy data from our dose escalation and expansion studies in 2023'..."

P1 data • Trial status • Endometrial Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor • Uterine Cancer

Elucida Oncology to Present New Clinical and Preclinical Data at the 2023 AACR Annual Meeting (GlobeNewswire) - "Elucida Oncology...announced today that two abstracts featuring ELU001, its lead C’Dot Drug Conjugate (CDC) clinical candidate, have been accepted for poster presentation at the American Association for Cancer Research (AACR) Annual Meeting 2023, to be held April 14-19, in Orlando, FL. The poster presentations will highlight early safety and pharmacokinetic data from the ongoing dose escalation portion of the Phase 1/2 study of ELU-001 in patients with advanced, recurrent, or refractory cancers overexpressing folate-receptor alpha (FRα), as well as pre-clinical data for the treatment of brain metastases."

P1/2 data • PK/PD data • Preclinical • Biliary Cancer • Biliary Tract Cancer • Breast Cancer • Cholangiocarcinoma • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Endometrial Cancer • Esophageal Cancer • Fallopian Tube Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Rectal Cancer • Solid Tumor • Thoracic Cancer • Triple Negative Breast Cancer • Uterine Cancer

"Back at #ADC23 with FRα: Elucida's ELU001, a "c dot" ADC. 1/14 PR, data possible at #Esmo23" (@JacobPlieth)

ELU-FRα-1: A study to evaluate ELU001 in patients with solid tumors that overexpress folate receptor alpha (FRα). (ASCO 2022) - P1/2 | "The study is actively enrolling in the US – Cohorts 1-2 have been completed without DLT. Enrollment to Cohort 3 began in December 2021."

Clinical • Biliary Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CTSB • FOLR1

Therapeutic targeting of CBFA2T3-GLIS2 infant AML with ELU001 - folate receptor alpha-directed C’Dot-drug-conjugate (AACR 2022) - P1/2 | "ELU001 was well tolerated with an apparent maximum tolerance dose of 1.50 mg/kg/mouse (0.5 mg/kg exatecan, Q3DX3). In summary, we demonstrated that ELU001 is highly effective at eliminating FOLR1 positive AML cells in vitro and in vivo, providing the preclinical data to support further assessment of ELU001 in clinical trials for pediatric patients with CBFA2T3-GLIS2 fusions overexpressing FOLR1."

Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • CBFA2T3 • FOLR1 • GLIS2

Outlining the Exciting Clinical Progress of ELU001 (ADC London 2023) - "• Learn about ELU001, a ligandconjugated nanoparticle targeting folate receptor alpha • Discussing the clinical Phase I/II results of ELU001 • Outlining the future opportunities for this novel format"

Clinical • FOLR1

A Study to Evaluate ELU001 in Patients With Solid Tumors That Overexpress Folate Receptor Alpha (FRα) (clinicaltrials.gov) - P1/2; N=166; Recruiting; Sponsor: Elucida Oncology; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Biliary Cancer • Breast Cancer • Cholangiocarcinoma • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Endometrial Adenocarcinoma • Endometrial Cancer • Esophageal Cancer • Fallopian Tube Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Peritoneal Cancer • Sarcoma • Solid Tumor • Triple Negative Breast Cancer • FOLR1

Pediatric AML: ELU001 in Pediatric Subjects Who Have Relapsed and/or Refractory CBFA2T3-GLIS2-positive AML (clinicaltrials.gov) - P1 | N=21 | Not yet recruiting | Sponsor: Elucida Oncology

New P1 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • Pediatrics • CBFA2T3 • GLIS2