On April 13, 2022 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, reported 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") (Press release, Lineage Cell Therapeutics, APR 13, 2022, View Source [SID1234612151]). 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.
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"We are pleased that Cancer Research UK has successfully completed patient enrollment in the VAC2 Phase 1 clinical study and overcame substantial challenges stemming from the COVID pandemic. We look forward to initial clinical results from this study being available later this year," stated Brian M. Culley, Lineage CEO. "Clinical data previously collected by Cancer Research UK demonstrated peripheral immunogenicity in patients with NSCLC treated with VAC2, providing support to the underlying mechanism of using allogeneic dendritic cells to present tumor-associated antigens to the body’s immune system. Simultaneous with Cancer Research UK efforts to complete enrollment in the current study, the focus at Lineage has been on making improvements and modernizations to the VAC manufacturing process, an approach which we similarly employed in the development of OpRegen. We believe our focus on manufacturing will help prepare VAC2 for additional clinical trials and provide a competitive advantage for any future VAC programs which we advance, either alone or through alliances. With Cancer Research UK having completed enrollment of the current study, 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."
Dr. Nigel Blackburn, Director of Cancer Research UK’s Centre for Drug Development, added: "We are delighted to see that this innovative VAC2 program has reached such an important milestone in its development and are extremely proud to have played an important role in establishing its tolerability in lung cancer patients. We look forward to seeing Lineage advance VAC2 under their leadership in the future."
About VAC2
VAC2 is an allogeneic, or non-patient specific "off-the-shelf," cancer vaccine product candidate designed to stimulate patient immune responses to an antigen commonly expressed in cancerous cells but not in normal adult cells. VAC2, which is produced from a pluripotent cell technology using a directed differentiation method, is comprised of a population of nonproliferating mature dendritic cells. As the most potent type of antigen presenting cell in the body, dendritic cells instruct the body’s immune system to attack and eliminate harmful pathogens and unwanted cells. Because the tumor antigen is loaded exogenously into the dendritic cells prior to administration, VAC2 is a platform technology that could be modified to carry selected antigens, including patient-specific tumor neo-antigens or viral antigens. VAC2 is currently being tested in a Phase 1 study in adult patients with NSCLC in the advanced and adjuvant settings (NCT03371485), conducted by Cancer Research UK.
About Cancer Research UK’s Centre for Drug Development
Cancer Research UK has an impressive record of developing novel treatments for cancer. The Cancer Research UK Centre for Drug Development has been pioneering the development of new cancer treatments for 25 years, taking over 140 potential new anti-cancer agents into clinical trials in patients. It currently has a portfolio of 21 new anti-cancer agents in preclinical development, Phase I or early Phase II clinical trials. Six of these new agents have made it to market including temozolomide for brain cancer, abiraterone for prostate cancer and rucaparib for ovarian cancer. Two other drugs are in late development Phase III trials.
About Cancer Research UK’s Commercial Partnerships Team
Cancer Research UK is the world’s leading cancer charity dedicated to saving lives through research. Cancer Research UK’s specialist Commercial Partnerships Team works closely with leading international cancer scientists and their institutes to protect intellectual property arising from their research and to establish links with commercial partners. Cancer Research UK’s commercial activity operates through Cancer Research Technology Ltd., a wholly owned subsidiary of Cancer Research UK. It is the legal entity which pursues drug discovery research in themed alliance partnerships and delivers varied commercial partnering arrangements.