CBP501 / CanBas - LARVOL DELTA

Notice of receipt of orphan drug designation for CBP501 from European authorities [Google translation] (CanBas) - "Today, we announced the European Medicines Agency (EMA) regarding CBP501, an in-house developed anti-cancer drug candidate compound that is undergoing clinical trials. We have received notification of orphan drug designation for pancreatic cancer from the European Medicines Agency...Orphan designation number: EU/3/24/2974....With this designation, we will provide clinical trial protocol creation support (scientific support) for the future development of CBP501 in Europe. You can receive advice and advice. Additionally, if CBP501 is approved for sale, it will be granted 10 years of market exclusivity."

Orphan drug • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

CANBAS - The stock has risen sharply for the fourth consecutive day and hits the daily limit. Although the operating loss forecast for the fiscal year ending June 2024 is expected to increase, selling factors have been exhausted, and preparations for clinical trials are favorable. [Google translation] (Yahoo Finance) - "A sharp fourth consecutive day of gains, hitting the daily limit. The company has announced a forecast operating loss of 1.363 billion yen for the term ending June 2024 (a loss of 965 million yen in the previous term). Research and development expenses increased due to preparations for US Phase 2b clinical trials of the anti-cancer drug candidate CBP501, as well as progress in preparations for European Phase 3 clinical trials. The loss is expected to widen compared to the previous term, but there is a growing feeling that selling factors have been exhausted, and the progress in clinical trial preparations is being well received, which is attracting buying."

Commercial • Oncology • Solid Tumor

Announcement of commencement of discussions with EMA for initiation of CBP501 European Phase 3 clinical trial [Google translation] (CanBas) - "We have recently started the application process to start a clinical trial with the European regulatory authority EMA (European Medicines Agency), and our company will conduct the process...We would like to inform you that we have begun discussions regarding the specific details of the Phase 3 clinical trial that we are hoping to conduct...The Company will proceed with discussions with the EMA in order to realize the early start of the Phase 3 CBP501 clinical trial in Europe...Regarding the Phase 3 clinical trial in Europe, if any matters that should be disclosed in the future arise or are determined, we will promptly disclose them....Including this, the progress of preparations for the CBP501 clinical trial and trends in alliance acquisition activities, etc will affect business earnings and business results for the fiscal year ending June 2024."

New P3 trial • Oncology • Solid Tumor

A multicenter, randomized phase 2 study to establish combinations of CBP501, cisplatin and nivolumab for ≥3rd-line treatment of patients with advanced pancreatic adenocarcinoma. (PubMed, Eur J Cancer) - P2 | "The combination CBP(25)/(16)/CDDP/nivo demonstrated promising signs of efficacy and a manageable safety profile for the treatment of advanced PDAC."

Journal • Metastases • P2 data • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer

CanBas’ Strengths: Pipeline strategy focused on cancer immunity [Google translation] (logmi) - "We would like to provide you with a transcript of the explanation of CanBas Co., Ltd.'s financial results for the second quarter of the fiscal year ending June 2024...The immune igniter 'CBP501'...'We are currently planning a Phase 3 clinical trial in Europe with the goal of approval and market launch in 2027, and our team is currently busy working on this'...'The application to start the Phase 3 clinical trial is scheduled for the end of this month. If the Phase 3 trial in Europe is successful, based on the results, we aim to apply for approval in the United States without additional trials.'"

European regulatory • Launch Europe • New P3 trial • Oncology • Solid Tumor

A multicenter, randomized phase 2 study to establish combinations of CBP501, cisplatin and nivolumab for ≥3rd-line treatment of patients with advanced pancreatic adenocarcinoma (Eur J Cancer) - P2 | N=36 | NCT04953962 | Sponsor: CanBas Co. Ltd. | "Among 36 patients, 3MPFS was 44.4% in arms 1 and 2, 11.1% in arm 3 and 33.3% in arm 4. Two patients achieved a partial response in arm 1 (ORR 22.2%; none in other arms). Median PFS and OS were 2.4, 2.1, 1.5 and 1.5 months and 6.3, 5.3, 3.7 and 4.9 months, respectively. Overall, all treatment combinations were well tolerated. Most treatment-related adverse events were grade 1-2."

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

Canvas and CBP501 scheduled for next phase clinical trials in the United States and preparations for phase 3 clinical trials in Europe [Google translation] (Nikkei) - "At the extraordinary board of directors meeting held today, the Company announced that...the next phase clinical trial in the United States will be a phase 2B clinical trial, and for the time being preparations will be made to begin the first stage of the trial; the trial will begin in Europe....We would like to inform you that we will continue to prepare for the Phase 3 clinical trial, and if this is achieved, we will suspend or cancel the next phase clinical trial in the United States and prioritize development in Europe."

New P2b trial • New P3 trial • Oncology • Solid Tumor

Canvas presents poster presentation of CBP501 clinical phase 2 trial results at ESMO Annual Meeting [Google translation] (Nikkei) - "A poster will be presented at the European Society of Medical Oncology (ESMO) Annual Meeting to be held in Madrid, Spain from October 20th to 24th, 2023 regarding the Phase 2 clinical trial data of our anticancer drug candidate CBP501. We would like to inform you that it has been done."

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

Multicenter, randomized, parallel group, phase II study to establish the efficacy and safety of CBP501, cisplatin, and nivolumab for ≥ third-line treatment of patients with exocrine pancreatic cancer and WBC <10,000/mm3 (ESMO 2023) - P2 | "SAE acute renal failure (arm 3, after 1 cycle) was assessed as possibly related to CBP501 and definitely related to cisplatin. Conclusions Preliminary results indicate clinically meaningful improvement and tolerable safety of CBP501, cisplatin and nivolumab as 3rd line treatment for metastatic PDAC."

Clinical • P2 data • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

Canvas financial results, CBP501 is being developed in-house and is preparing for Phase 3 clinical trials (Nikkei) - "On August 22, 2023, Canvas held a financial results briefing for the full year ending June 2023. Regarding CBP501, which is being developed for pancreatic cancer, he explained the plan for the Phase 3 clinical trial, aiming to obtain approval through in-house development."

New P3 trial • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Study of CBP501/Cisplatin/Nivolumab Combinations in Advanced Pancreatic Cancer (clinicaltrials.gov) - P2 | N=36 | Completed | Sponsor: CanBas Co. Ltd. | Active, not recruiting ➔ Completed

Metastases • Trial completion • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

Canvas to Present CBP501 Phase 2 Data at ESMO Annual Meeting [Google translation] (Nikkei) - "We are pleased to announce that the Phase 2 clinical trial data of our anticancer drug candidate CBP501 will be presented at the European Society for Clinical Oncology (ESMO) Annual Meeting to be held from October 20 to 24, 2023 in Madrid, Spain."

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

CANVAS Receives US FDA Orphan Drug Designation for CBP501 [Google translation] (Nikkei) - "...The U.S. Food and Drug Administration (FDA) approved CBP501, an anti-cancer drug candidate compound created in-house for which we are conducting clinical trials in the U.S., as an orphan drug for pancreatic cancer."

Orphan drug • Gastrointestinal Cancer • Oncology • Pancreatic Cancer

Study of CBP501/Cisplatin/Nivolumab Combinations in Advanced Pancreatic Cancer (clinicaltrials.gov) - P2 | N=36 | Active, not recruiting | Sponsor: CanBas Co. Ltd. | Trial completion date: Dec 2022 ➔ Apr 2023 | Trial primary completion date: Dec 2022 ➔ Mar 2023

Metastases • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

Canvas bounces back, completes prescribed dosing in all treatment groups in Phase 2 clinical trial of “CBP501“ [Google translation] (Yahoo Finance) - "After the close of the 29th, in all administration groups of the Phase 2 clinical trial of 'CBP501' for the third-line treatment of pancreatic cancer currently underway in the United States (decided to end early in Stage 1), it was announced that the administration was completed, and it was considered as material....In the future, the company will continue to monitor the progress of living patients and follow up on the survival of subjects whose status has not been confirmed after withdrawal from clinical trials. After that, when the necessary information such as overall survival period is collected, a cut-off (declaration to discontinue the data collection of the clinical trial) will be made and the clinical trial will be completed."

Trial status • Gastrointestinal Cancer • Oncology • Pancreatic Cancer

CANBAS---Primary endpoint achieved in phase 2 clinical trial for 3rd line pancreatic cancer [Google translation] (Reuters) - P2 | N=36 | NCT04953962 | Sponsor: CanBas Co. Ltd. | "It has been announced that the primary endpoint was achieved in two of the three-drug combination administration groups in the Phase 2 clinical trial stage 1 of CBP501 for the third-line treatment of pancreatic cancer. Three-month progression-free survival was also confirmed in the 4th patient in the treatment group in which the achievement of the primary endpoint was confirmed and in the 3-drug combination treatment group (CBP501, cisplatin, nivolumab) with different CBP501 dosages. Currently, we are considering the handling of two-drug administration groups that do not correspond to either early effective discontinuation or early ineffective discontinuation."

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

Study of CBP501/Cisplatin/Nivolumab Combinations in Advanced Pancreatic Cancer (clinicaltrials.gov) - P2 | N=36 | Active, not recruiting | Sponsor: CanBas Co. Ltd. | Recruiting ➔ Active, not recruiting | N=92 ➔ 36

Enrollment change • Enrollment closed • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

Study of CBP501/Cisplatin/Nivolumab Combinations in Advanced Pancreatic Cancer (clinicaltrials.gov) - P2; N=92; Recruiting; Sponsor: CanBas Co. Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

Study of CBP501/Cisplatin/Nivolumab Combinations in Advanced Pancreatic Cancer (clinicaltrials.gov) - P2; N=92; Not yet recruiting; Sponsor: CanBas Co. Ltd.; Trial completion date: Aug 2022 ➔ Dec 2022; Trial primary completion date: Aug 2022 ➔ Dec 2022

Clinical • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

Phase Ib clinical study of CBP501, cisplatin and nivolumab administered every 3 weeks in patients with advanced refractory tumors. Dose escalation cohort (AACR 2019) - P1b; "The triple-drug combination is tolerable and an RP2D has been determined. Pancreatic and MSS colorectal cancers were selected for expansion cohorts. Pre- and on-treatment biopsies will be obtained to assess modulation of the immune microenvironment by combination treatment."

Clinical • P1 data

[VIRTUAL] Phase Ib clinical study of CBP501, cisplatin, and nivolumab administered every three weeks in patients with advanced refractory tumors: Efficacy in dose-escalation and expansion cohorts. (ASCO 2020) - P1b | "The triple-drug combination is reasonably tolerable with preliminary signs of efficacy in refractory solid tumors, including those in which cisplatin and nivolumab have limited single-agent activity. Research Funding: CanBas Co., Ltd."

Clinical • P1 data • Biliary Cancer • Cholangiocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Hematological Disorders • Oncology • Pancreatic Cancer • Urticaria

Phase 2 Study of CBP501, Cisplatin, and Nivolumab for ≥3rd Line Treatment of Patients With Exocrine Pancreatic Cancer (clinicaltrials.gov) - P2; N=92; Not yet recruiting; Sponsor: CanBas Co. Ltd.

Clinical • New P2 trial • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

CBP501, Cisplatin and Nivolumab in Advanced Refractory Tumors (clinicaltrials.gov) - P1b; N=47; Completed; Sponsor: CanBas Co. Ltd.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Cholangiocarcinoma • Colorectal Cancer • Gallbladder Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Sarcoma • Solid Tumor

CBP501, Cisplatin and Nivolumab in Advanced Refractory Tumors (clinicaltrials.gov) - P1b; N=48; Active, not recruiting; Sponsor: CanBas Co. Ltd.; Recruiting ➔ Active, not recruiting; Trial completion date: Mar 2020 ➔ Apr 2021; Trial primary completion date: Jan 2020 ➔ Mar 2021

Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Cholangiocarcinoma • Colorectal Cancer • Gallbladder Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Sarcoma • Solid Tumor

CBP501, Cisplatin and Nivolumab in Advanced Refractory Tumors (clinicaltrials.gov) - P1b; N=48; Recruiting; Sponsor: CanBas Co. Ltd.; Trial completion date: Mar 2019 ➔ Mar 2020; Trial primary completion date: Dec 2018 ➔ Jan 2020

Clinical • Trial completion date • Trial primary completion date