GEN-001 / Genome & Company, LG Chem - LARVOL DELTA

Genome & Company shifts business strategy from microbiome to ADCs (Korea Biomedical Review) - "Genome & Company, which led the development of microbiome drugs in Korea, has revised its drug development strategy to antibody-drug conjugates (ADCs) after struggling to produce significant business results, including technology transfer. The company plans to complete the phase 2 clinical trials of its existing microbiome pipeline by the end of the year and will not pursue additional microbiome drug development. In the future, Genome & Company plans to strengthen ADC drug development by discovering new target antibodies. The company has just started ADC drug development, so it is taking a technology transfer strategy through early research rather than clinical development....GEN-001, phase 2 study in gastric cancer, will report results by year-end."

P2 data • Pipeline update • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

Genome & Company halts phase 2 microbiome immunotherapy trial in bile duct cancer (Korea Biomedical Review) - "Genome & Company said it would discontinue its phase 2 clinical trial for GEN-001, a microbiome-based immunotherapy, in patients with bile duct cancer. The strategic decision reflects shifts in the treatment landscape, including recent approvals of new therapies, and aligns with the company's revised focus on antibody-drug conjugate (ADC) development...The company cited the recent approval of Keytruda in combination with chemotherapy agents gemcitabine and cisplatin as a first-line treatment for bile duct cancer as a key factor behind the decision. Given the evolving treatment landscape, Genome & Company reassessed the feasibility and commercial viability of continuing the trial and opted to shift its focus toward ADC development...Genome & Company recently completed a phase 2 trial evaluating GEN-001 with Bavencio for gastric cancer, with results expected in the first half of this year."

P2 data • Trial termination • Biliary Cancer • Gastric Cancer

Profiling of endogenous metabolites and changes in intestinal microbiota distribution after GEN-001 (Lactococcus lactis) administration. (PubMed, Korean J Physiol Pharmacol) - "Compared with predose, the relative abundance (%) of Parabacteroides and Alistipes significantly decreased, whereas that of Lactobacillus and Lactococcus increased; Lactobacillus and tryptophan levels were negatively correlated. A single administration of GEN-001 shifted the gut microbiota in healthy volunteers to a more balanced state as evidenced by an increased abundance of beneficial bacteria, including Lactobacillus, and higher levels of the metabolites that have immunogenic properties."

Journal • Gastrointestinal Disorder

Phase II study of GEN-001 in combination with avelumab in patients with PD-L1–positive locally advanced, or metastatic gastric cancer (GC) or gastroesophageal junction cancer (GEJC) who have progressed after second-line (2L) and beyond (GEN001-201 study). (ASCO-GI 2024) - P2 | "Treatment of patients with GC/GEJC with GEN-001 in combination with avelumab in the ≥ 3L setting showed promising antitumor activities with an overall manageable safety profile. The results from this trial will be updated about its effects on clinical outcome, including survival, safety, and biomarker findings. Clinical trial information: NCT05419362."

Clinical • Combination therapy • IO biomarker • Metastases • P2 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • PD-L1

Genome & Company Announces Positive Topline Results from Phase 2 Clinical Trial of Combination of GEN-001 and Bavencio for the Treatment of Gastric Cancer Poster presented at ASCO GI (PRNewswire) - P2 | N=42 | NCT05419362 | Sponsor: Genome & Company | "As a result of the efficacy evaluation of 42 patients participating in the phase 2 clinical trial, partial responses (PRs) were observed in 7 out of 42 patients. Furthermore, 3 out of 8 patients among 42 patients who were previously treated by immunotherapy experienced PRs (overall response rate, ORR 37.5%)...In addition, the topline results revealed the median progression free survival (PFS) at 1.7 months and the median overall survival (OS) at 7.9 months...'The overall response rate (ORR) of 37.5% is particularly promising among PD-L1-positive refractory patients to prior immunotherapy.'"

P2 data • Gastric Cancer

Genome & Company Announces Positive Topline Results from Phase 2 Clinical Trial of Combination of GEN-001 and Bavencio for the Treatment of Gastric Cancer Poster presented at ASCO GI (PRNewswire) - P2 | N=42 | NCT05419362 | Sponsor: Genome & Company | "As a result of the efficacy evaluation of 42 patients participating in the phase 2 clinical trial, partial responses (PRs) were observed in 7 out of 42 patients. Furthermore, 3 out of 8 patients among 42 patients who were previously treated by immunotherapy experienced PRs (overall response rate, ORR 37.5%). In addition, the topline results revealed the median progression free survival (PFS) at 1.7 months and the median overall survival (OS) at 7.9 months....Treatment-related adverse events (TRAEs) were observed in 14 patients out of 42 patients, and only 2 patients experienced grade 3 TRAEs including anemia, fatigue, and pneumonitis. Overall, this combination showed manageable safety and tolerability."

P2 data • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Genome & Company targets 3rd-line stomach cancer treatment with microbiom-based immunotherapy (Korea Biomedical Review) - P2 | N=42 | NCT05419362 | Sponsor: Genome & Company | "At an online news conference Friday, Genome & Company unveiled the phase 2 clinical trial results of its candidate, GEN-001, for gastric cancer....On Thursday (local time), Genome & Company presented a poster on GEN-001 phase 2 cutoff data at the American Society of Clinical Oncology (ASCO) Gastrointestinal (GI) Cancers Symposium in San Francisco, Calif....Clinical results showed seven partial responses (PRs), most notably in three of eight patients (objective response rate of 37.5 percent) who had received and failed prior immunotherapy. Median progression-free survival (mPFS) estimated by Kaplan-Meier analysis was 1.7 months and median overall survival (mOS) was 7.9 months."

P2 data • Gastric Cancer • Gastrointestinal Cancer • Oncology

Genome & Company approves IND change for ’GEN-001’ domestic phase 2 clinical trial for biliary tract cancer [Google translation] (The Bio) - "Genome & Company announced on the 4th that it has received approval from the Ministry of Food and Drug Safety by changing the domestic phase 2 clinical trial plan (IND) for biliary tract cancer patients for the microbiome immune anti-cancer treatment 'GEN-001'...The change is to add an explanation of the statistical analysis method, which is the primary indicator. The company announced that it uses the 'Clover Pearson analysis method' for ORR analysis....This analysis method is a method of calculating the confidence interval for the parameters of the binomial distribution when the sample size is small, allowing for more accurate analysis."

Trial status • Biliary Cancer • Biliary Tract Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Genome & Company to disclose gastric cancer phase 2 data for 'GEN-001' at next year's 'ASCO GI' [Google translation] (HIT News) - "Genome & Company...will present key data from the gastric cancer phase 2 clinical trial of the microbiome immunotherapy drug 'GEN-001' at the 'American Society of Clinical Oncology Digestive Cancer Symposium (ASCO GI 2024)' to be held in January next year....'We have completed recruitment of 42 targeted patients, and key data on safety and efficacy have been collected.'"

Enrollment closed • P2 data • Trial status • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

GEN-001 in Combination With Avelumab for Patients With PD-L1 Positive Gastric Cancer (clinicaltrials.gov) - P2 | N=42 | Active, not recruiting | Sponsor: Genome & Company | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Metastases • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • PD-L1

GEN-001 Plus Pembrolizumab for Patients With Advanced Refractory Biliary Tract Cancer (clinicaltrials.gov) - P2 | N=148 | Recruiting | Sponsor: Genome & Company | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Genome & Company begins phase 2 clinical trial of ’GEN-001’ for biliary tract cancer… First patient administered [Google translation] (Pharm News) - "Genome & Company...announced on the 19th that it has completed the administration of the first patient in the phase 2 clinical trial for biliary tract cancer with the microbiome immune anti-cancer treatment 'GEN-001'. The phase 2 clinical trial for 'GEN-001' for biliary tract cancer will be conducted in combination with MSD (Merck, USA)'s immunotherapy drug Keytruda (ingredient name: pembrolizumab), and will be conducted at 8 domestic hospitals targeting biliary tract cancer patients who did not see results from previous treatment. It takes place in We plan to prove the safety and effectiveness of combined administration through this clinical trial."

Trial status • Biliary Cancer • Biliary Tract Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Genome&Company targets 2nd-line treatment for biliary tract cancer, launches phase 2 trial (Korea Biomedical Review) - "Genome&Company recently initiated a phase 2 clinical trial for biliary tract cancer by combining MSD's immune checkpoint inhibitor Keytruda (pembrolizumab) with its immuno-oncology candidate GEN-001....According to Park, Genome&Company has begun a phase 2 trial of Keytruda-combined biliary tract cancer, screening participating patients. The company will soon enroll patients. The target number of recruits is 148....Besides, Park explained that last month, the last patient was enrolled in a phase 2 gastric cancer study combining GEN-001 with Merck's Bavencio (avelumab)."

Enrollment closed • Trial status • Biliary Cancer • Biliary Tract Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

GEN-001 Plus Pembrolizumab for Patients With Advanced Refractory Biliary Tract Cancer (clinicaltrials.gov) - P2 | N=148 | Not yet recruiting | Sponsor: Genome & Company

Combination therapy • Metastases • New P2 trial • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

GEN-001 in Combination With Avelumab for Patients With PD-L1 Positive Gastric Cancer (clinicaltrials.gov) - P2 | N=42 | Recruiting | Sponsor: Genome & Company | Trial completion date: Sep 2024 ➔ Dec 2024 | Trial primary completion date: Sep 2024 ➔ Dec 2024

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • PD-L1

GEN-001 (Live Biotherapeutic Product) and Avelumab Combination Study for Patients With Solid Tumors Who Have Progressed on Anti-PD-(L)1 Therapy (clinicaltrials.gov) - P1 | N=11 | Completed | Sponsor: Genome & Company | Recruiting ➔ Completed | N=93 ➔ 11 | Trial completion date: Jan 2024 ➔ Jan 2023 | Trial primary completion date: Jan 2024 ➔ Jan 2023

Combination therapy • Enrollment change • Metastases • Trial completion • Trial completion date • Trial primary completion date • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

Genome & Company, GEN-001 Domestic phase 2 IND application for change approval [Google translation] - "Genome & Company announced on the 21st that it has applied for approval to change the domestic phase 2 clinical trial plan (IND) for patients with gastric or gastroesophageal junction adenocarcinoma of the microbiome immunotherapeutic agent GEN-001."

New P2 trial • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology

Positive Results from Interim Analysis of ’GEN-001’ Plus avelumab (Bavencio) Phase II Trial (PRNewswire) - P2 | N=50 | NCT05419362 | Sponsor: Genome & Company | "This is a Phase II study to evaluate the safety and efficacy of GEN-001 plus Avelumab as a ≥3rd line treatment for PD-L1 positive GC/GEJ patients regardless of prior immune-oncology treatment. Following enrollment of the 21st patient, a pre-planned interim analysis was conducted and results were reviewed by an independent data monitoring committee....As the observed ORR met the pre-determined criteria together with no safety concerns, the IDMC recommended to continue with the second stage without modifications and enroll additional 21 patients. The detailed results will be presented at an Oncology conference in the second half of 2023. The top-line data of the final analysis from Phase II are expected in the second half of next year."

DSMB • P2 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

Why Genome & Co. changes p2 trial IND for bile duct cancer drug? (Korea Biomedical Review) - "Genome & Company is about to revise its strategy in developing a biliary tract cancer treatment candidate, GEN-001....In a public filing last Friday, the company said it has submitted applications for changing its investigational new drug (IND) plan for the domestic phase 2 clinical trial of GEN-001 to the Ministry of Food and Drug Safety....Through the IND change, the company plans to add one more cohort to the phase 2 clinical trial. Aside from the combo therapy with Keytruda, Genome & Co. will explore the safety and efficacy of the combined use of GEN-001, Keytruda, and mFORFOX (fluorouracil/leucovorin/oxaliplatin), anticancer chemotherapy. The company targets up to 140 subjects and conducts the trial for about three years, beginning in August and continuing through October 2060."

New P2 trial • Biliary Tract Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

Genome & Company "Phase 2 GEN-001 gastric cancer combination, announcement of interim results in the first half" [Google translation] (HIT News) - "Genome & Company is expected to speed up the phase 2 clinical trial of GEN-001, a microbiome immunotherapy for cancer of the stomach and biliary tract. Genome & Company plans to announce the interim results of the phase 2 clinical trial (co-administration of Bavencio) for gastric cancer of GEN-001 in the first half of this year....In addition, the company is in the process of conducting phase 2 clinical trials (co-administration with Keytruda) for GEN-001 for bile duct cancer. The official explained, 'We plan to administer the first patient in the first half of 2023'."

New P2 trial • P2 data • Biliary Tract Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

Genome & Company halts GEN-001’s phase-1b solid cancer trials (Korea Biomedical Review) - "Genome & Company said on Tuesday that it will drop the phase-1b clinical trials of GEN-001 in solid cancer in the US and Korea, citing too much competition in new drug development for solid cancer. Instead, the company will focus on its gastric and biliary tract indications in phase-2 combination trials, it said....Currently, this drug is linked with Pfizer's Bavencio (avelumab) in phase 1/1b clinical trials in solid tumors (non-small cell lung cancer, head, and neck cancer, urothelial cancer) in the US and South Korea. GEN-001 is also in phase 2 trials in combination with Bavencio for gastric cancer in Korea. The company plans to start a phase 2 clinical trial with MSD's Keytruda (pembrolizumab) for biliary tract cancer....Interim analysis and results will be announced early next year..."

New P2 trial • P2 data • Trial termination • Biliary Tract Cancer • Cholangiocarcinoma • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

Genome & Company approves phase 2 clinical trial plan for biliary tract cancer in combination with GEN-001 and Keytruda [Google translation] (ET news) - "Genome & Company...conducted a phase 2 clinical trial of a combination of Keytruda, an immunotherapy drug, and its immuno-oncology microbiome treatment, GEN-001, for patients with biliary tract cancer. It was announced on the 8th that the IND was approved by the Ministry of Food and Drug Safety...The approved phase 2 clinical trial for biliary tract cancer plans to evaluate the safety and effectiveness of 'GEN-001' and the immunotherapy Keytruda® combination therapy for patients with biliary tract cancer that have not been effective with existing standard treatments...Meanwhile, Genome & Company has been approved for phase 2 clinical trials for gastric cancer as a combination therapy of Bavencio® (ingredient name: avelumab) in October 2021 in relation to 'GEN-001'. It is currently undergoing clinical trials. The phase 2 clinical trial for gastric cancer is scheduled to announce interim results in the first half of 2023."

New P2 trial • P2 data • Biliary Tract Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

The Role of The Tumor Microbiome in Tumor Development and Its Treatment. (PubMed, Front Immunol) - "TM is expected to be a biomarker for tumors, and engineered tumor-targeting bacteria and anti-cancer microbial agents (GEN-001) have an important role in the treatment of tumors. This paper reviews the relevant studies on TM in recent years and describes its distribution in different tumors, its correlation with clinical features, its effect on local immunity, and the research directions of TM in tumor treatment."

Journal • Review • Breast Cancer • Oncology • Pancreatic Cancer • Solid Tumor

GEN-001 in Combination With Avelumab for Patients With PD-L1 Positive Gastric Cancer (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: Genome & Company

Combination therapy • New P2 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • PD-L1

Genome and Company announces Clinical Trial Collaboration with MSD to evaluate ’GEN-001’ in combination of KEYTRUDA (pembrolizumab) in phase 2 clinical trial in biliary tract cancer patients (PRNewswire-Asia) - "Genome and Company...announced it has entered into a first Clinical Trial Collaboration and Supply Agreement (CTCSA) with MSD....Upon the execution of the agreement, Genome and Company will conduct a phase 2 clinical trial to evaluate the safety and efficacy of its immuno-oncology microbiome therapeutic, 'GEN-001', in combination with MSD's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with biliary tract cancer. Genome and Company will be the sponsor of the clinical trial and MSD will supply KEYTRUDA."

Licensing / partnership • New P2 trial • Biliary Cancer • Biliary Tract Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor