Clinical R&D 95 ACHILLES THERAPEUTICS ENROLLS FIRST US PATIENT IN ONGOING PHASE I/IIA STUDY IN ADVANCED NON-SMALL CELL LUNG CANCER Achilles Therapeutics plc (NASDAQ: ACHL), a clinical-stage biopharmaceutical company developing precision T cell therapies to treat solid tumors, has announced that the first patient in the United States (US) has been enrolled in the Company's ongoing Phase I/IIa CHIRON clinical trial. CHIRON is an open-label, multicenter Phase I/IIa trial evaluating the safety, tolerability, and activity of clonal neoantigen T cell (cNeT) therapy as a single dose in adult patients with advanced metastatic non-small cell lung cancer (NSCLC). cNeT are selectively expanded T cells that target a patient's own clonal neoantigens which are present on all tumor cells but absent from healthy tissue. This first US patient was enrolled at the Moffitt Cancer Center in Tampa, FL where Dr. Benjamin Creelan is the Principal Investigator. CHIRON is now open at 10 sites in the UK, EU and the US. "We are delighted to have taken our cutting-edge, cNeT platform into the US with the successful enrollment of the first patient at the Moffitt Cancer Center in our ongoing CHIRON study," said Dr Iraj Ali, CEO of Achilles Therapeutics. "With our cNeT platform we prospectively target patient-specific clonal neoantigens and are able to generate comprehensive characterization including the dose of the active cNeT component for each product. We look forward to providing an update from 10 patients across our CHIRON and THETIS studies in NSCLC and melanoma, respectively, in the fourth quarter of this year where we will present data highlighting a basis for our proposed potency assay." CHIRON is expected to recruit approximately 40 patients with advanced unresectable or metastatic NSCLC. The primary objective of the trial is to assess the safety and tolerability of cNeT. Clinical efficacy will be evaluated as a secondary measure. Additional data evaluating cNeT persistence, phenotype, and functionality will be reviewed while also exploring potential biomarkers of clinical activity and factors affecting response. This will include analysis of patient samples using a bespoke plasma ctDNA assay.
"There is still a large unmet need in NSCLC where there are very limited options for relapsed patients. We at the Moffitt are pleased to be the first US-based site for the CHIRON study to evaluate this important, precision tumor-infiltrating lymphocyte therapy," said Dr Benjamin C Creelan, Principal Investigator of the CHIRON study and thoracic oncologist at Moffitt Cancer Center. "This is the first US patient to be enrolled to receive a precision T cell therapy specifically targeting clonal neoantigens and we are pleased to be working with the team at Achilles."
ethical, legal and social implications must be taken into account; these include the perspectives of a broad range of stakeholders, such as, the child, their family, scientists, healthcare professionals, and public health professionals. Furthermore, the resources required to expand the programme should be considered at an early stage.
HIQA ADVISES ON APPROACHES FOR CONSIDERING THE EXPANSION OF THE NEWBORN BLOODSPOT
Dr Máirín Ryan, HIQA’s Deputy CEO and Director of Health Technology Assessment, said, “The current newborn screening programme is highly successful with consistently high uptake rates, estimated at around 99.9%. In considering further expansion of the programme, it is vital that the existing processes are protected and maintained and that any expansion of the programme is preceded by clearly defined and transparent decision-making to ensure ongoing trust and confidence in the programme.”
The Health Information and Quality Authority (HIQA) has published a report on approaches for considering the expansion of newborn bloodspot screening programmes. This report was provided to the National Screening Advisory Committee (NSAC) to help inform the development of their processes for the assessment of conditions being considered for inclusion in Ireland’s National Newborn Bloodspot Screening Programme (NNBSP). The NNBSP provides newborn bloodspot screening (the 'heel prick test'), within the first 72 to 120 hours of life. The current NNBSP screens for eight conditions and each year the NNBSP identifies approximately 110 babies in Ireland with one of these conditions. In 2020, the NSAC recommended the addition of a ninth condition to the programme, and, following the approval of this recommendation by the Minister for Health, the HSE has been making arrangements for its inclusion. HIQA undertook a review of nine countries recognised as having described policy-making processes in place for their newborn bloodspot screening programmes. The review of the academic literature and relevant policy documents examined how and why these countries decide on conditions to screen for. The review also included an examination of the range of conditions currently screened for, as well as the role of emerging technology in NBS programme expansion internationally.
HIQA has recommended that an explicit, structured approach to each aspect of policy-making on this topic should be prepared to ensure consistency and transparency into the future.
Dr Ryan continued: “International screening advisory groups are increasingly recognising the importance of a ‘lifecycle’ approach to making recommendations on newborn bloodspot screening. This includes taking a thorough look at the practicalities of adding a new condition to the programme, and making sure there is a longterm plan for the success of the programme, including its evaluation.” °MEQU WINS A PUBLIC TENDER TO SUPPLY °M WARMER SYSTEM – PORTABLE BLOOD AND IV WARMING DEVICE TO UK MOD It has been announced that °MEQU, in co-operation with UK
partner Fenton Pharmaceuticals, has won a public tender to provide portable blood and IV fluid warming devices (˚M Warmer System) to The Ministry of Defence (MOD) of the United Kingdom. The Ministry of Defence is the government department responsible for implementing the defence policy set by Her Majesty's Government. The UK regular forces consist of the Royal Navy, British Army, Royal Air Force, and Strategic Command. The ˚M Warmer System was chosen by the UK MOD as it has been proven to satisfy all the criteria set for their blood and IV warming needs. The system is not only small, light and robust, but also offers easy and fast setup. Most importantly, it delivers warm blood or IV fluids to patients within a few seconds. Ulrik Krogh Andersen (CEO) commented, “Fluid resuscitation before arriving at a hospital is shown to significantly reduce mortality among severely injured patients. We are glad that the UK MOD chose our ˚M Warmer System to treat their service people. With their choice, we at °MEQU keep up with our mission to improve the survival and recovery rate of patients regardless of where the injury occurs.” Graham Hill (MD Fenton Pharmaceuticals) commented, “We are very happy that the UK MOD has chosen the °M Warmer System as the blood and fluid warmer for British troops. We have for quite some time supplied the system to an increasing number of civilian HEMS units, but this confirms that the system is ideal for both civilian and military use. ˚M Warmer System is currently used both in pre-hospital and in-hospital environments, and ˚MEQU is continuously developing its technology to bring warm blood and IV fluids to more patients.”
The report notes that, when considering expansion of a screening programme, important
HOSPITALPROFESSIONALNEWS.IE | HPN • AUGUST - 2021
