VAC2 / Cancer Research UK, Lineage Cell Therap - LARVOL DELTA

Lineage Cell Therapeutics and Cancer Research UK Report Topline Phase 1 Study Results With VAC2 for the Treatment of Advanced Non-small Cell Lung Cancer (Businesswire) - "Patients enrolled were diagnosed with refractory, metastatic or locally advanced, non-small cell lung cancer (NSCLC), for whom there were no other suitable treatment options; Five of eight patients treated (62.5%) had a best response of immune-related stable disease, and three (37.5%) demonstrated immune-related progressive disease; No patients had treatment emergent serious adverse events and all patients completed per protocol vaccination; Three of eight treated patients (37.5%) reached the 2-year survival endpoint....Further analyses from immunogenicity of VAC2 in the tumor, skin punch biopsies, and peripheral responses are being conducted by Cancer Research UK."

P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

CRUKD/17/003: AST-VAC2 Vaccine in Patients With Non-small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=9 | Completed | Sponsor: Cancer Research UK | Active, not recruiting ➔ Completed | Trial completion date: Feb 2027 ➔ Aug 2022 | Trial primary completion date: Feb 2027 ➔ Aug 2022

Metastases • Trial completion • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • TERT

Lineage Cell Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update (Businesswire) - "Some of the events and milestones anticipated by Lineage in 2023 include:...Clinical data update from the ongoing VAC2 Phase 1 NSCLC study, pending release from Cancer Research UK, anticipated in the second quarter."

P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

Lineage Cell Therapeutics Reports Third Quarter 2022 Financial Results and Provides Business Update (Businesswire) - "Pre-Investigational New Drug (IND) application briefing package submitted to the U.S. Food and Drug Administration (FDA) to support U.S. clinical development for immuno-oncology....Some of the key upcoming milestones and activities anticipated by Lineage include:...Response to a pre-IND regulatory submission which should provide clarity on a VAC2 CMC, nonclinical, and clinical information package to inform future U.S. clinical development, expected around year-end."

FDA event • Oncology

Lineage and Cancer Research UK Announce Completion of Patient Enrollment in Phase 1 Clinical Study of VAC2 for the Treatment of Non-small Cell Lung Cancer (Businesswire) - "Lineage Cell Therapeutics, Inc...announced today that Cancer Research UK recently completed patient enrollment in the ongoing Phase 1 clinical trial of VAC2, an allogeneic cancer vaccine product candidate, for the treatment of non-small cell lung cancer ('NSCLC'). Under the terms of an existing agreement, Cancer Research UK will complete the ongoing clinical trial and Lineage has now assumed responsibility for further clinical development of the VAC2 product candidate and any future development opportunities derived from the VAC platform...'the team at Lineage also has begun work towards the submission of an Investigational New Drug Application for clinical testing of VAC2 in the U.S., which we anticipate submitting to the FDA later this year'."

Enrollment closed • IND • Lung Cancer • Non Small Cell Lung Cancer • Oncology

AST-VAC2 Vaccine in Patients With Non-small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=8 | Active, not recruiting | Sponsor: Cancer Research UK | Recruiting ➔ Active, not recruiting | N=48 ➔ 8 | Trial completion date: Oct 2022 ➔ Feb 2027 | Trial primary completion date: Oct 2022 ➔ Feb 2027

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Lineage to Present at B. Riley Securities 2022 Virtual Oncology Conference on January 27, 2022 (Businesswire) - "Lineage Cell Therapeutics, Inc...announced that Brian M. Culley, Lineage’s Chief Executive Officer, will present at the B. Riley Securities 2022 Virtual Oncology Conference, in a fireside chat hosted by Mayank Mamtani, Managing Director, Senior Biotech Research Analyst and Group Head of Healthcare Research at B. Riley Securities....Mr. Culley will provide an update on Lineage’s cell therapy pipeline, including an outline of the clinical development plans for its OPC1 program for the treatment of spinal cord injury and VAC2 for the treatment of solid tumors."

Clinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Lineage Reports Third Quarter 2021 Financial Results and Highlights Progress From Clinical Cell Therapy Programs (Businesswire) - "Completion of enrollment by Cancer Research UK in the ongoing VAC2 Phase 1 non-small cell lung cancer study; anticipated in Q1 2022. Continued development of a dendritic cell-based therapeutic for glioblastoma with our strategic partner; ongoing throughout 2022. Evaluation of opportunities for new VAC product candidates based on internally identified or partnered tumor antigens; ongoing throughout 2022."

Clinical • Enrollment status • Glioblastoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Lineage Reports Second Quarter 2021 Financial Results and Highlights Additional Progress From Clinical Cell Therapy Programs (Businesswire) - "Some of the events and milestones to look forward to include: Completion of enrollment in the ongoing VAC2 Phase 1 non-small cell lung cancer study; Reporting results from the ongoing VAC2 Phase 1 study; Evaluation of opportunities for new VAC product candidates based on internally identified or partnered tumor antigens."

Enrollment status • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Lineage Announces Worldwide License Agreement With Immunomic Therapeutics for an Allogeneic Cell-Based Cancer Immunotherapy Based on Its VAC Platform (Businesswire) - "Lineage Cell Therapeutics, Inc...announced a worldwide license and development collaboration agreement with Immunomic Therapeutics, Inc...The collaboration will generate a novel product candidate derived from Lineage’s VAC allogeneic cancer immunotherapy platform and targeting a proprietary Tumor Associated Antigen (TAA) construct provided by ITI, for the treatment of glioblastoma multiforme...Under the terms of the agreement, Lineage will be entitled to upfront payments totaling $2 million anticipated in the first year and up to $67 million in development and commercial milestones across multiple indications and territories....VAC2 is currently being tested in a Phase 1 study in adult patients with non-small cell lung cancer (NSCLC) in the advanced and adjuvant settings."

Licensing / partnership • Glioblastoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Lineage Cell Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update (Businesswire) - "Complete VAC2 patient enrollment in the ongoing Phase 1 clinical study for the treatment of non-small cell lung cancer, anticipated in the second quarter of 2021; Report results from the ongoing Phase 1 clinical study of VAC2 for the treatment of non-small cell lung cancer, anticipated in the fourth quarter of 2021."

Enrollment status • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology

"Appreciate the inclusion of $LCTX among pioneers #BioNTech & #Moderna @biospace. #LineageCellTherapeutics #celltherapy #VAC2 #NSCLC #stockstowatch #traders @CR_UK https://t.co/OvYmtzAYSQ" (@LineageCell)

Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Lineage Posts Series of Webinars Highlighting Recent Progress With its Three Clinical-Stage Allogeneic Cell Transplant Programs (Businesswire) - "Lineage Cell Therapeutics, Inc...recently highlighted to members of the investment community its clinical and operational progress through a series of webinars hosted by FORCE Wealth with presentations by Brian M. Culley, Chief Executive Officer. The seminars covered all three of the company’s clinical-stage product development programs: OpRegen®, a retinal pigment epithelium (RPE) cell transplant for the treatment of dry age-related macular degeneration (AMD), OPC1, an oligodendrocyte progenitor cell transplant for the treatment of acute spinal cord injuries, and VAC2, a dendritic cell transplant for the treatment of cancer....VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, currently in clinical development for the treatment of non-small cell lung cancer."

Clinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Lineage Cell Therapeutics Reports Third Quarter 2020 Financial Results and Provides Business Update (Businesswire) - “We look forward to presenting updated data on OpRegen at the American Academy of Ophthalmology (AAO) Annual 2020 Meeting in mid-November, and then completing patient enrollment in our Phase 1/2a clinical study of OpRegen, anticipated by the end of the year. With respect to VAC2, we are working closely with Cancer Research UK and anticipate completing enrollment in the VAC2 Phase 1 study in non-small cell lung cancer by the end of the first quarter of 2021."

Enrollment status • P1/2 data • Age-related Macular Degeneration • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ophthalmology

Lineage Cell Therapeutics and Cancer Research UK Announce Encouraging Preliminary Phase 1 Study Results With VAC2 for the Treatment of Non-small Cell Lung Cancer (Businesswire) - P1, N=48; NCT03371485; "VAC2 demonstrated remarkably potent induction of immune responses in all patients dosed to date, with high levels of peripheral antigen-specific immunogenicity observed at multiple time points and confirmed by multimer staining....Based on review of all available data, the therapy was safe and well tolerated in all patients. While the safety profile was expected, the immunogenicity data are remarkable and highly provocative"

P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology

LINEAGE CELL THERAPEUTICS RECEIVES $24.6 MILLION PAYMENT FROM JUVENESCENCE LTD. (Lineage Cell Therapeutics Press Release) - " Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, today announced it received $24.6 million in cash from Juvenescence Ltd., representing principal and interest due under a convertible promissory note....Lineage has the following plans and objectives for the remainder of 2020:...Report initial VAC2 clinical data from patients treated in the ongoing Phase 1 trial in NSCLC (non-small cell lung cancer) run by Cancer Research UK."

Financing • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Asterias Biotherapeutics announces first patient dosed in first-in-human clinical study of immunotherapy AST-VAC2 in non-small cell lung cancer (GlobeNewswire) - P1, N=48; NCT03371485; Sponsor: Cancer Research UK; "Asterias Biotherapeutics, Inc....announced enrollment and dosing of the first subject in the first-in-human Phase 1 clinical trial of AST-VAC2 in the United Kingdom. This initial clinical trial, which is being sponsored, managed and funded by Cancer Research UK, will examine the safety and tolerability of AST-VAC2 in non-small cell lung cancer (NSCLC) as the study’s primary endpoints."

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

AST-VAC2 Vaccine in Patients With Non-small Cell Lung Cancer (clinicaltrials.gov) - P1; N=48; Recruiting; Sponsor: Cancer Research UK; Not yet recruiting ➔ Recruiting; Initiation date: Feb 2018 ➔ Jun 2018

Enrollment open • Trial initiation date • Biosimilar • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Asterias announces conference call to discuss 6-month efficacy data from AST-OPC1 SCiStar study (PRNewswire) - "The company's research partner, Cancer Research UK, plans to begin a Phase 1/2a clinical trial of AST-VAC2 in non-small cell lung cancer in the first half of 2017."

Anticipated new P1/2 trial • Non Small Cell Lung Cancer • Oncology

Lineage Cell Therapeutics reports first quarter 2020 financial results and provides business update (Businesswire) - "2020 Plans and Objectives: Present new OpRegen data from the ongoing Phase 1/2a clinical trial as available throughout the year. Complete patient enrollment in the U.S. with the Gyroscope Orbit SDS and new thaw-and-inject formulation in the ongoing Phase 1/2a clinical trial of OpRegen for the treatment of dry AMD. Meet with the U.S. Food and Drug Administration (FDA) to discuss the further clinical development of OpRegen....Report VAC2 clinical data from the initial patients treated in the ongoing Phase 1 trial in NSCLC (non-small cell lung cancer) run by Cancer Research UK."

Enrollment status • FDA event • P1 data • P1/2 data • Age-related Macular Degeneration • Lung Cancer • Macular Degeneration • Non Small Cell Lung Cancer • Oncology • Ophthalmology • Solid Tumor • Thoracic Cancer

Lineage Cell Therapeutics announces early exercise of option with Cancer Research UK for immuno-oncology cell therapy program (Businesswire) - "Lineage Cell Therapeutics, Inc...announced...that Cancer Research UK’s Commercial Partnerships has permitted Lineage to conduct an early exercise of its option to acquire data from Cancer Research UK’s ongoing Phase 1 clinical trial of VAC2 in non-small cell lung cancer (NCT03371485), and develop an allogeneic dendritic cell therapy platform ('VAC')."

Licensing / partnership • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

Lineage Cell Therapeutics provides shareholder update (Businesswire) - “Near term milestones our investors can look forward to include: Obtain VAC2 immunogenicity data from the initial patients in the ongoing Phase I study in NSCLC (non-small cell lung cancer) run by Cancer Research UK, expected around year end; Strengthen existing partnerships with the National Institutes of Health, the Israel Innovation Authority, the California Institute for Regenerative Medicine and Cancer Research UK.”

Licensing / partnership • P1 data