SOT102 / Sotio, Boehringer Ingelheim - LARVOL DELTA

CLAUDIO-01: Clinical Trial of SOT102 Antibody Drug Conjugate in Patients With Advanced Gastric and Pancreatic Adenocarcinoma (clinicaltrials.gov) - P1/2 | N=44 | Terminated | Sponsor: SOTIO Biotech a.s. | N=160 ➔ 44 | Trial completion date: Jun 2028 ➔ Dec 2024 | Recruiting ➔ Terminated | Trial primary completion date: Dec 2027 ➔ Dec 2024; Trial terminated by Sponsor based on benefit- risk reassessment

Enrollment change • Monotherapy • Trial completion date • Trial primary completion date • Trial termination • Gastric Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • CLDN18

CLAUDIO-01: Clinical Trial of SOT102 Antibody Drug Conjugate in Patients With Advanced Gastric and Pancreatic Adenocarcinoma (clinicaltrials.gov) - P1/2 | N=160 | Recruiting | Sponsor: SOTIO Biotech a.s. | Suspended ➔ Recruiting | N=269 ➔ 160 | Trial completion date: Jun 2025 ➔ Jun 2028 | Trial primary completion date: Dec 2023 ➔ Dec 2027

Combination therapy • Enrollment change • Enrollment open • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Gastric Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • CLDN18

CLAUDIO-01: Clinical Trial of SOT102 Antibody Drug Conjugate in Patients With Advanced Gastric and Pancreatic Adenocarcinoma (clinicaltrials.gov) - P1/2 | N=269 | Suspended | Sponsor: Sotio Biotech Inc. | Recruiting ➔ Suspended

Combination therapy • Metastases • Monotherapy • Trial suspension • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • CLDN18

CLAUDIO-01: A multicentric phase I/II trial to evaluate the safety and efficacy of SOT102 as monotherapy and in combination with standard of care (SoC) in patients with gastric, gastroesophageal junction(GEJ), and pancreatic adenocarcinoma (ESMO 2023) - P1/2 | "The trial consists of the following modules: • Part A: First-in-human, CLDN18.2 agnostic, single-agent dose escalation trial of SOT102 in advanced or metastatic gastric/GEJ or pancreatic cancer patients • Part B gastric, GEJ cohort/pancreatic cohort: CLDN18.2 agnostic dose escalation trial of SOT102 in combination with SoC for first-line treatment of patients with advanced or metastatic gastric/GEJ cancer (SoC: mFOLFOX with nivolumab) or pancreatic cancer (SoC: nab-paclitaxel/gemcitabine), which will start once monotherapy SOT102 dose level 3 in Part A is deemed safe The following expansion cohorts are planned upon identification of the recommended phase 2 dose (RP2D): • Part C gastric, GEJ/pancreatic cohort: Single-agent SOT102 in CLDN18.2 positive gastric/GEJ cancer patients after two or more prior systemic therapies and in pancreatic cancer after one or more prior systemic therapies. Enrollment to dose level 4 of Part A and to dose level 1 in both cohorts of..."

Clinical • Combination therapy • Monotherapy • P1/2 data • Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • CLDN18

SOT102, A Novel CLDN18.2- Targeting Antibody-Drug Conjugate for Gastric & Pancreatic Cancer with Wide Range of Target Expression (ADC-USA 2023) - "Outlining the engineering of a Claudin18.2 targeting antibody; Outlining the preclinical development of SOT102, a novel PNU-based antibody– drug conjugate targeting Claudin18.2 -expressing cancers; Exploring combinations with immunotherapy"

IO biomarker • Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18

SOTIO Announces First Patients Dosed in Two Combination Arms of CLAUDIO-01 Study Evaluating SOT102 in First-Line Gastric and Pancreatic Cancer (Businesswire) - "SOTIO Biotech...announced today that it has dosed the first patients in the combination therapy arms of its Phase 1/2 CLAUDIO-01 trial. CLAUDIO-01 is evaluating SOTIO’s potent antibody-drug conjugate SOT102 in patients with gastric and pancreatic cancer. The combination arms will be the first clinical evaluation of SOT102’s potential as a first-line cancer treatment in combination with current standard of care. In the gastric cancer arm, SOT102 will be combined with mFOLFOX plus nivolumab. In the pancreatic cancer arm, SOT102 will be combined with Nab-paclitaxel plus gemcitabine....CLAUDIO-01 (EudraCT number: 2021-005873-25) is a Phase 1/2 first-in-human, open-label, multicenter trial to assess the safety and preliminary efficacy of SOT102."

Trial status • Gastric Cancer • Pancreatic Cancer

SOT102, a novel CLDN18.2-targeting antibody-drug conjugate for gastric and pancreatic cancer with a wide range of the tumor target expression (ESMO-TAT 2023) - P1/2 | "Conclusions SOT102 represents a novel potent ADC with the potential to treat Claudin 18.2 expressing tumors irrespective of the intensity of expression. The first in human dose escalation trial has been initiated in patients with gastric and pancreatic cancer."

Colon Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • CLDN18

Introducing SOT102, a Claudin 18.2 Targeting PNU-based ADC into Clinical Development (ADC-USA 2022) - "Outlining the design of ongoing first-in-human trials Sharing preliminary interim data of first-inhuman trials Overviewing the next step into broader clinical development"

Clinical • CLDN18

SOTIO Initiates CLAUDIO-01 Trial with Antibody-Drug Conjugate SOT102 in Patients with Gastric and Pancreatic Cancer (Yahoo Finance) - "Josep Tabernero, M.D., Ph.D...added, 'CLDN18.2 is a promising target in gastric and pancreatic cancer due to its prevalent expression in cancers of the gastrointestinal tract. Based on its preclinical data SOT102 represents a potentially safer and more effective treatment option for targeting the CLDN18.2 protein in gastric and pancreatic cancers. The initiation of this clinical trial is major milestone in studying its potential benefit for these patients.'"

Media quote

"And another Claudin18.2 asset: Sotio's SOT102 (an ADC) enters phase 1 https://t.co/MnPqwColDA" (@JacobPlieth)

CLDN18 • CLDN8

SOTIO Initiates CLAUDIO-01 Trial with Antibody-Drug Conjugate SOT102 in Patients with Gastric and Pancreatic Cancer (GlobeNewswire) - "SOTIO Biotech...announced today that it has dosed the first patient in its Phase 1/2 CLAUDIO-01 trial of SOT102 in patients with gastric and pancreatic cancer. SOT102 is the lead program of SOTIO’s growing ADC pipeline built on multiple platforms....The phase 1/2 CLAUDIO-01 trial (EudraCT number: 2021-005873-25) is a first in human, open label, multicenter clinical trial to assess the safety and preliminary efficacy of SOT102 in monotherapy and in combination with established standard of care therapies (SoC). The trial will enroll up to 109 patients with gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction (GEJ) and pancreatic adenocarcinoma..."

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

SOTIO Secures €280m of Funding to Expand and Advance Clinical Pipeline (GlobeNewswire) - "The funding will be used to advance SOT101 through two multi-indication phase 2 clinical trials: The phase 2 AURELIO-03 study tests SOT101 as monotherapy in patients with melanoma, squamous skin carcinoma and kidney cancer, and a planned phase 2 AURELIO-04 study will evaluate the combination of SOT101 with a checkpoint inhibitor...This funding will also be used to advance three novel programs through phase 1: BOXR1030 is the company’s lead CAR-T program for the treatment of various solid tumors expressing GPC3...The study is scheduled to start early 2022; SOT102...A phase 1 dose escalation in patients with gastric and pancreatic cancer shall start in March 2022; SOTIO plans to initiate a phase 1 study with our first IL-15 based immunocytokine using a PD-1 inhibitor as the targeting arm by the end of 2022."

Commercial • New P1 trial • New P2 trial • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Hepatocellular Cancer • Kidney Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Renal Cell Carcinoma • Skin Cancer • Squamous Cell Skin Cancer

SOTIO Expands its Antibody-Drug Conjugate Pipeline with Exclusive Collaboration and License Agreement with LegoChem Biosciences (GlobeNewswire) - "SOTIO will obtain rights to deploy LCB’s ADC technology for up to five therapeutic programs targeting distinct tumor-associated antigens.....'At SOTIO we are building an innovative pipeline of ADC programs and plan IND filing for our lead program SOT102 by the end of 2021.'"

IND • Licensing / partnership • Oncology

[VIRTUAL] SO-N102, a novel CLDN18.2-targeting antibody-drug conjugate with strong anti-tumor effect in various solid tumors expressing low target levels (AACR 2021) - "Stability of SO-N102 without any significant loss of the payload was demonstrated in vitro and in animals. Further toxicology studies in rats and cynomolgus monkeys were initiated, paralleled by process development and manufacturing activities with the plan to initiate the first clinical study with SO-N102 in patients in the first half of 2022."

Gastric Cancer • Gastrointestinal Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18

SOTIO Demonstrates Strong Potential of SOT102 (ADC Targeting Claudin 18.2) for Treatment of Solid Tumors in Preclinical Studies (GlobeNewswire) - "SOT102 is a CLDN18.2 targeting antibody-drug conjugate based on a proprietary, highly specific monoclonal antibody conjugated to a potent cytotoxic drug molecule and is being developed in collaboration with NBE-Therapeutics. IND-enabling studies of SOT102 are currently ongoing with an IND filing planned for the fourth quarter of 2021, followed by a first-in-human clinical study in patients with gastric and pancreatic cancer planned for the first half of 2022."

IND • New trial • Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer

SOTIO Demonstrates Strong Potential of SOT102 (ADC Targeting Claudin 18.2) for Treatment of Solid Tumors in Preclinical Studies (GlobeNewswire) - "SOTIO...announced new preclinical data of its antibody-drug conjugate (ADC), SOT102 (formerly SO-N102), for the treatment of solid tumors in a virtual poster presentation at the 2021 American Association of Cancer Research (AACR) Annual Meeting. The data, which demonstrate that SOT102 has strong potential to eliminate CLDN18.2-expressing tumor cells in a target-specific manner, provide proof of concept for SOT102 as well as SOTIO’s proprietary ADC platform...Complete responses were observed in all 10 patient-derived mouse xenograft models, including those for gastric, pancreatic, liver, colon and lung adenocarcinomas, independent of CLDN18.2 expression levels"

Preclinical • Oncology

SOTIO to Present Preclinical Results Describing SOT102 as Treatment of Solid Tumors at the American Association of Cancer Research Annual Meeting (GlobeNewswire) - "SOTIO...announced the presentation of a virtual poster at the 2021 American Association of Cancer Research Annual Meeting. The presentation focuses on preclinical data describing SOT102 which is intended for the treatment of CLDN18.2-expressing solid tumors...SOT102 was studied in models of various CLDN18.2-positive solid tumors, mainly of gastric and pancreatic origin....Title: SOT102, a novel CLDN18.2-targeting antibody-drug conjugate with strong anti-tumor effect in various solid tumors expressing low target levels"

Preclinical • Oncology