VCB-1102 / Vaxcell-Bio Therap - LARVOL DELTA

Autologous Vax-NK/HCC Consolidation Therapy in ES-SCLC (IASLC-WCLC 2025) - "Abstract is embargoed at this time."

Hepatocellular Cancer • Lung Cancer • Small Cell Lung Cancer • Solid Tumor

Vaxcell Bio, NK cell source patent for liver cancer treatment registered [Google translation] (HIT News) - "Vaxcell Bio has secured a domestic original patent for NK cell manufacturing technology used in the development of advanced liver cancer treatment. It is expected that this will further accelerate the technological independence and commercialization speed of the company's core pipeline, autologous NK cell treatment 'VCB-1102'."

Patent • Liver Cancer

NK cell therapy opens new ways for treating advanced pancreatic cancer (Korea Biomedical Review) - "Chonnam National University Hwasun Hospital and anticancer immunotherapy company VaxCell Biotherapeutics have received approval for a clinical study on advanced regenerative medicine for advanced pancreatic cancer using NK cell-based therapy, VCB-1102. According to the hospital on Monday, the Ministry of Health and Welfare recently held this year’s first meeting of the Committee for Advanced Regenerative Medicine and Advanced Biopharmaceuticals, approving the hospital’s research on advanced pancreatic cancer patients in collaboration with its corporate partner....Chonnam National University Hwasun Hospital and VaxCell Bio will conduct a study on 22 patients by combining VCB-1102 with the existing standard of care chemotherapy (mFOLFIRINOX). The aim is to confirm the potential of VCB-1102, which has shown a high objective response rate of 68.75 percent in liver cancer clinical trials, to treat pancreatic cancer."

New trial • Pancreatic Cancer

Anti-tumor Activity and Safety of Autologous Vax-NK/HCC Consolidation Therapy Following First-line Chemoimmunotherapy in Patients with Extensive-Stage Small Cell Lung Cancer (KATRDIC 2024) - "Puropose The addition of atezolizumab to platinum-based chemotherapy (ACE regimen) in the first-line treatment of extensive-stage small-cell lung cancer (ES-SCLC) resulted in significantly longer progression-free survival (PFS) and overall survival (OS) than chemotherapy alone. Conclusion Autologous natural killer cell consolidation therapy for ES-SCLC was feasible with manageable toxicity. The antitumor activity with survival data has not yet been mature and we need to follow up."

Clinical • Constipation • Gastroenterology • Gastrointestinal Disorder • Hepatocellular Cancer • Herpes Zoster • Immunology • Infectious Disease • Lung Cancer • Musculoskeletal Pain • Myositis • Oncology • Pain • Small Cell Lung Cancer • Solid Tumor • Varicella Zoster

VaxCell-Bio partners with ProBio to accelerate CAR-related therapies development (Korea Biomedical Review) - "VaxCell-Bio...said it signed a memorandum of understanding (MOU) with ProBio, a global contract development and manufacturing organization (CDMO), to accelerate the development of its chimeric antigen receptor (CAR)-related therapies...Under this agreement, the two companies will collaborate on the development, manufacturing, and clinical processes of CAR therapies in compliance with good manufacturing practices (GMP), with a focus on antibody drug development, gene and cell therapy-based drug discovery, and the creation of advanced pharmaceutical manufacturing processes....VaxCell-Bio is optimistic that its partnership with ProBio, a company with extensive experience in cell therapy development and commercialization, will provide a solid foundation for its ongoing projects, including dual-target CAR-T, CAR-MILs, and CAR-NK platform therapies."

Licensing / partnership • Gastric Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Hematological Malignancies • Hepatocellular Cancer • Multiple Myeloma • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor

Why did Paxel Bio expand its production facilities?… “Expecting sales” [Google translation] (Nate) - "As Vaxcell Bio...expands its research and production facilities...'The recent expansion of production facilities is related to the research and development of the advanced liver cancer treatment ‘Vax-NK/HCC’ that recently completed phase 2a.'...According to the study design, a total of 10 Vax-NK/HCC administrations were performed per patient...Since the existing Vaxcell Bio had an annual production capacity of 162 batches, it was a simple calculation that it would take a full year to produce even if the factory was operated at 100%...If Phase 2b is conducted according to the standards required by Vaxcell Bio and the regulatory authorities, it is expected that approximately 500 NK cell treatments will be produced....Vax-NK/HCC is expected to meet the demand through this facility expansion as it will be used more actively in the medical field due to the revision of the Advanced Therapeutics Act scheduled to be implemented from February next year."

Commercial • Trial status • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

Vaxcell Bio announces final results of phase 2a of ‘hepatocellular cancer treatment’ at BioUSA [Google translation] (HIT News) - P2a | N=17 | NCT05040438 | Sponsor: Vaxcell Bio, Co., Ltd. | "Vaxcell Bio...participated in the '2024 Bio International Convention...In the case of Vax-NK/HCC, a treatment for hepatocellular carcinoma, an objective response rate of 68.75% was recorded in the final report of phase 2a clinical trial as a result of combination therapy with standard treatment HAIC. This figure is more than twice as high as the existing standard treatment, atezolizumab and bevacizumab combination therapy at 30%, sorafenib at 11%, and HAIC alone at 30%....PD-L1·EphA2 dual-target CAR-T solid cancer treatment targeting solid cancers such as ovarian cancer, stomach cancer, and pancreatic cancer has attracted attention from related industries as it is effective in blocking gastric evasion of cancer cells with two target cancer markers instead of one. Vaxcell Bio applied for a patent for PD-L1·EphA2 dual-target CAR-T solid tumor treatment in November last year..."

P2a data • Patent • Preclinical • Gastric Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Hepatocellular Cancer • Liver Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor

Lee Je-joong, CEO of Vaxcell Bio, “Conditional approval for Vax-NK/HCC is possible…there are no problems with side effects.” [Google translation] (Nate) - "Vaxel Bio...is pursuing ‘conditional product approval’ that allows for commercialization before phase 3 clinical trials based on excellent phase 2a clinical data for Vax-NK/HCC, a treatment for advanced liver cancer. Vaxcell Bio plans to soon apply for ‘expedited approval’ for conditional approval...On the 27th, Lee Je-joong, CEO of Vaxcell Bio, said in a written interview with Edaily, 'We plan to discuss expedited approval with the Ministry of Food and Drug Safety based on Vax-NK/HCC phase 2a clinical data, and we are seeking approval for advanced regenerative treatment under the Advanced Regenerative Medicine Act, which will be implemented next year. 'We will actively review the application,'...Vaxel Bio is pursuing commercialization based on this Vax-NK/HCC phase 2a data and has established a two-track strategy at home and abroad."

Korea approval • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

VaxCell-Bio sees chances for homegrown hepatocellular carcinoma treatment (Korea Biomedical Review) - P2a | N=17 | NCT05040438 | Sponsor: Vaxcell Bio, Co., Ltd. | "VaxCell-Bio has completed a phase 2a clinical trial study of 'Vax-NK,' a natural killer (NK) cell therapy for advanced hepatocellular carcinoma (HCC)...In a public notice issued on Wednesday, VaxCell-Bio unveiled the results of the phase 2a study today...The objective response rate (ORR) for the primary endpoint, BICR, was 68.75 percent, meaning that 11 of the 16 patients had a complete response (CR) or partial response (PR)....Specifically, 18.75 percent (three patients) had a complete response (CR), and 50 percent (eight patients) had a partial response (PR). The 95 percent confidence interval ranged from 41.34 to 88.98, which, according to VaxCell-Bio, can be interpreted as a statistically significant result."

P2a data • Trial completion • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

Vaxcell Bio forms a scientific advisory group and launches an integrated R&D center [Google translation] (HIT News) - "Vaxcell Bio...launched a new scientific advisory group and integrated and expanded its research and development (R&D) organization...Vaxcell Bio signed a one-year advisory contract with new scientific advisory committee members, including Dr. Byeong-wook Ryu, who has led the research and development of CAR-T treatments in the United States, and Professor Seung-hwan Lee, a professor at the University of Ottawa in Canada, who is considered an authority on immune cell therapy research and development. It was announced on the 14th that it was done....'With the joining of the two scientists, the research and development of CAR-T, CAR-NK, and CAR-MILs, the Vax-CAR platform built by Vaxcell Bio, will accelerate and will have the effect of being recognized externally.'"

Licensing / partnership • Gastrointestinal Cancer • Hematological Malignancies • Hepatocellular Cancer • Oncology • Solid Tumor

Natural Killer (NK) Cell Therapy in Locally Advanced HCC (clinicaltrials.gov) - P2 | N=17 | Completed | Sponsor: Vaxcell Bio, Co., Ltd. | Recruiting ➔ Completed | Phase classification: P2a ➔ P2 | Trial completion date: May 2024 ➔ Sep 2023

Metastases • Phase classification • Trial completion • Trial completion date • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

Vaxcell Bio applies for patent for treatment of advanced hepatocellular carcinoma [Google translation] (News1 Korea) - "Vaxcell Bio...announced on the 24th that it has applied for a patent for a second-generation NK (Natural killer cell) treatment targeting advanced hepatocellular carcinoma...Following the completion of Phase 2a clinical trials for advanced liver cancer treatment Vax-NK/HCC (Vax-NK/HCC), a final report will soon be submitted to the Ministry of Food and Drug Safety, and the application process for designation as a subject for expedited processing for conditional approval of the treatment will also be underway."

Patent • Trial status • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

[Bio Zoom Person] Lee Je-joong, CEO of Vaxell Bio, “I am close to applying for conditional approval for Vax-NK liver cancer phase 2a” [Google translation] (Sisa Journal e) - "Vaxel Bio is signaling imminent commercialization of its anti-cancer NK cell therapy 'Vax-NK/HCC' for advanced liver cancer. Last year, the phase 2a clinical trial of Vax-NK/HCC for advanced liver cancer was completed and the process of securing result data has begun...Vaxcell Bio plans to apply for conditional approval from the Ministry of Food and Drug Safety (hereinafter referred to as the Ministry of Food and Drug Safety) in the first half of this year....Phase 2b is also being considered to make up for the shortcomings in Vax-NK/HCC phase 2a."

Non-US regulatory • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

Vaxcell Bio suspends its supply of clinical drugs arbitrarily changed without approval [Google translation] (HIT News) - "Vaxcell Bio...was suspended from business for 1.5 months for supplying clinical trial drugs whose use (validity) period was arbitrarily changed without approval from regulatory agencies...According to the industry, on the 1st, the Ministry of Food and Drug Safety placed Vaxel Bio on administrative suspension. From the 1st of this month to the 15th of next month, work on the phase 2a clinical study of the combined treatment of natural killer cells and hepatic artery infusion chemotherapy in patients with advanced hepatocellular carcinoma cannot be carried out for 1.5 months. The reason for the disposition is violation of the Pharmaceutical Affairs Act....'There will be no damage from this 1.5-month clinical trial suspension. We are preparing to change the expiration date based on the long-term safety results for Vax-NK/HCC that have already been obtained.'"

Trial suspension • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

A PHASE II STUDY OF AUTOLOGOUS NATURAL KILLER CELLS WITH HEPATIC ARTERIAL INFUSION CHEMOTHERAPY IN PATIENTS WITH LOCALLY ADVANCED HEPATOCELLULAR CARCINOMA (AASLD 2023) - "Patients who had achieved SD or better after 2nd cycle of HAIC with 5-fluorouracil and cisplatin received Vax-NK/HCC therapy for 5 consecutive days every 4 weeks for up to 2 cycles (dose: 1×109 NK cells/injection) through hepatic arterial infusion following 2 additional cycles of HAIC. Although this phase II study is still in progress, its preliminary data suggest that the locoregional infusion of NK cells with cytotoxic chemotherapy is safe and feasible for locally advanced HCC refractory to the standard treatment. This result warrants further development of this novel treatment to establish its efficacy in this type of disease."

Clinical • Metastases • P2 data • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

Vaxcell Bio confirms liver cancer treatment potential with immune cell therapy ‘Vax-NK/HCC’ [Google translation] (Pinpoint News) - P2a | N=20 | NCT05040438 | Sponsor: Vaxcell Bio, Co., Ltd. | "Vaxell Bio...announced the status of the phase 2a clinical trial of Vax-NK/HCC for advanced liver cancer at the National Immunotherapy Innovation Center Symposium...'Of the 16 patients who received treatment for Vax-NK/HCC, 6 (nearly 40%) were judged to have a complete response (CR) with no cancer observed,'....'There were 4 patients with partial response (PR), and 6 patients with stable disease (SD), where the size of the cancer decreased slightly or stopped growing,' he said. This figure represents a 100% disease control rate during the survey period."

P2a data • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

Professor Woo Gyun of Chonnam National University Hwasun Hospital received the Oral Award from the Korean Society of Medical Oncology. (Sports Chosun) - P2a | N=20 | NCT05040438 | Sponsor: Vaxcell Bio, Co., Ltd. | "Professor Bae said that through the interim analysis results of phase 2a of 'Vax-NK/HCC' and hepatic arterial chemotherapy (HAIC) combination therapy, the disease symptoms of all liver cancer patients completely or partially disappeared or were stable during the trial period revealed. The results of this phase 2a clinical trial are awaiting verification by an independent review committee."

P2a data • Trial status • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

Vaxel Bio ’Vax-NK liver cancer clinical trial will end soon’…Development and technology export ‘two-track’ [Google translation] (eDaily) - P2a | N=20 | NCT05040438 | Sponsor: Vaxcell Bio, Co., Ltd. | "Vaxel Bio...is expected to soon secure clinical data for liver cancer indications for its representative pipeline 'Vax-NK'. The final clinical result report (CSR) is scheduled to be received in the first half of next year, and Vaxcell Bio plans to implement a two-track strategy of self-development and technology export (licensing out) in line with the current situation...According to Vaxcell Bio on the 28th, the phase 2a clinical study of 'Vax-NK/HCC' targeting advanced liver cancer will be completed within September...Looking at the interim results of the Vax-NK/HCC phase 2a clinical trial, complete response (CR) and partial response (PR) were confirmed in 4 out of 12 patients. The objective response rate (ORR) was calculated to be 66.7%. The disease control rate (DCR) is 100%."

P2a data • Trial completion date • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

K-Bio Conquers Cancer, Takes to the World Stage… Increased attention on clinical performance in the second half of the year [Google translation] (Nate) - "In addition, Vaxcell Bio will disclose the final research results for the completion of phase 2a clinical trial for advanced liver cancer treatment as a poster at the American Association of the Liver Association's international conference."

P2a data

VaxCell-Bio back on track with positive liver cancer clinical progress, capital increase (Korea Biomedical Review) - P2a | N=20 | NCT05040438 | Sponsor: Vaxcell Bio, Co., Ltd. | "VaxCell Biotherapeutics said it reported an impressive disease control rate (DCR) of '100 percent' for combination therapy using VAX-NK, its hepatocellular carcinoma (HCC) treatment candidate, and hepatic arterial infusion chemotherapy (HAIC), from its phase 2a trial....Speaking at a press conference at the Federation of Korean Industries (FKI) Tower in Seoul on Tuesday, VaxCell-Bio CEO Lee Je-jung said that out of 16 liver cancer patients treated with combination drug, six showed a complete response, four exhibited a partial response, and six remained in a stable disease condition....'However, VaxCell-Bio's objective response rate stands notably higher at 62.5 percent, with 10 out of the 16 patients showing a partial or better response,' Lee said."

P2a data • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

VaxCell-Bio back on track with positive liver cancer clinical progress, capital increase (Korea Biomedical Review) - "As per the Financial Supervisory Service's electronic disclosure system last Sunday, VaxCell-Bio plans to raise about 100 billion won ($75.4 million) through an issuance of 3,938,000 new shares, priced at 25,550 won per share, slated for Sep. 21....In detail, 13.9 billion won will be invested in phase 2b and 3 clinical studies of Vax-NK/HCC, 3.9 billion won in the clinical trial of Vax-NK/PDAC, a pancreatic cancer treatment, and 2.1 billion won in the clinical trial of Vax-NK/SCLC, a small cell lung cancer treatment."

Financing • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Lung Cancer • Oncology • Pancreatic Cancer • Small Cell Lung Cancer • Solid Tumor

Vaxel Bio 'Vax-NK liver cancer clinical trial will end soon'…Development and technology export ‘two-track’ [Google translation] (eDaily) - "Vaxcell Bio will present the results of this study orally at the Korean Society of Medical Oncology International Conference (KSMO 2023), which will be held for two days from September 7th to 8th. Subsequently, the research results will be revealed through a poster at the American Association for the Study of the Liver Association (AASLD 2023), which will be held from November 10th to 14th."

P2a data • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

Vaxel Bio 'Vax-NK liver cancer clinical trial will end soon'…Development and technology export ‘two-track’ [Google translation] (eDaily) - "Vaxcell Bio decided to conduct a paid-in capital increase through a general public offering of forfeited shares after allocating KRW 100.6 billion to shareholders early this month, and plans to invest KRW 13.9 billion of this into Phase 2b and 3 clinical trials for Vax-NK/HCC....Vaxcell Bio plans to seek conditional approval in Korea next year when the results of phase 2a clinical trials are obtained for plan 1. If additional clinical trials are conducted, the plan is to seek conditional approval in 2026 after conducting phase 2b. Accordingly, it is expected that commercialization of Vax-NK/HCC will be possible as early as 2025."

Commercial • Non-US regulatory • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

Vaxcell Bio, presented the results of research on NK and CAR treatments at the Chinese Society of Hematology [Google translation] (Health Korea News) - P2a | N=20 | NCT05040438 | Sponsor: Vaxcell Bio, Co., Ltd. | "Baxel Bio announced on the 3rd that it has announced the results of cell therapy research at the 'Lu Daopei Hemotology Forum' hosted by Lu Daopei Medical Group in China...Baxel Bio is directly leading the development of NK cell therapy and CAR therapy. Vax-NK/HCC, which conducted phase 2a clinical studies for advanced liver cancer, has already shown superior treatment results compared to existing treatments through phase 1 results papers and preliminary phase 2a study results. CAR treatments under research and development also drew attention by disclosing full-time results at various international conferences."

P2a data • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

Natural Killer (NK) Cell Therapy in Locally Advanced HCC (clinicaltrials.gov) - P2a | N=20 | Recruiting | Sponsor: Vaxcell Bio, Co., Ltd. | Trial completion date: Aug 2022 ➔ May 2024 | Trial primary completion date: Jan 2022 ➔ Sep 2023

Metastases • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatocellular Cancer • Immune Modulation • Oncology • Solid Tumor • CD4 • IL10 • NCAM1