Strategic Collaboration between Adaptimmune and Genentech to Research, Develop, and Commercialize Cancer-targeted Allogeneic T-cell Therapies Terminated
Company remains focused on launching afami-cel later this year with a PDUFA date of August 4th and developing its broader sarcoma franchiseUpdate on afami-cel launch plans to be provided at the April 18th Investor DayPhiladelphia, Pennsylvania and Oxford, United Kindgom--(Newsfile Corp. - April 12, 2024) - Adaptimmune Therapeutics plc (NASDAQ: ADAP), a company redefining the treatment of solid tumor cancers with cell therapy, today announced that its strategic collaboration with Genentech entered in 2021, has been terminated. Adrian Rawcliffe, Adaptimmune's...
2024-04-12 8:00 AM EDT
Results of Adaptimmune's SPEARHEAD-1 Trial with Afami-cel in Advanced Sarcomas Published in the Lancet
Philadelphia, Pennsylvania and Oxford, United Kindgom--(Newsfile Corp. - March 27, 2024) - Adaptimmune Therapeutics plc (NASDAQ: ADAP), a company redefining the treatment of solid tumor cancers with cell therapy, today announced that The Lancet published the company's pivotal Phase 2 data with afami-cel. The article, titled "SPEARHEAD-1: a single-arm phase 2 trial of afamitresgene autoleucel (afami-cel) in advanced synovial sarcoma and myxoid/round cell liposarcoma," details clinical and translational results from afami-cel's SPEARHEAD-1 trial (NCT04044768). Dennis Williams, PharmD., Senior Vice President,...
2024-03-27 7:30 PM EDT
Adaptimmune Reports Q4/Full Year 2023 Financial Results and Business Updates
U.S. FDA accepted BLA for afami-cel for the treatment of advanced synovial sarcoma with priority review and a PDUFA date of August 4th, 2024Confirmatory evidence for afami-cel full approval agreed with FDA; will use data from Cohort 2 of pivotal SPEARHEAD-1 trial, which is fully enrolled Company is targeting launch of afami-cel upon receipt of FDA approval with commercial, manufacturing, and supply chain teams preparing for product delivery Lete-cel program transitioned back to Adaptimmune and the Company is planning for...
2024-03-06 7:00 AM EST
Adaptimmune Hires Chief Commercial Officer in Advance of Q3 2024 PDUFA Date for Afami-cel, a Late-stage Product in the Company's Sarcoma Franchise
Philadelphia, Pennsylvania and Oxford, United Kingdom--(Newsfile Corp. - February 27, 2024) - Adaptimmune Therapeutics plc (NASDAQ: ADAP), a company redefining the treatment of solid tumor cancers with cell therapy, today announced the reappointment of Cintia Piccina as Chief Commercial Officer effective March 18, 2024. Cintia served in this role from January 2022 to March 2023. Cintia will lead a rapidly expanding commercial team as it prepares for the launch of afami-cel for the treatment of advanced synovial sarcoma which, on...
2024-02-27 8:00 AM EST
Adaptimmune to Report Q4 and Full Year 2023 Financial and Business Updates on Wednesday, March 6, 2024
Philadelphia, Pennsylvania and Oxford, United Kingdom--(Newsfile Corp. - February 21, 2024) - Adaptimmune Therapeutics plc (NASDAQ: ADAP), a company redefining the treatment of solid tumor cancers with cell therapy, will report financial results and provide business updates for the fourth quarter and full year ended December 31, 2023, before the US markets open on Wednesday, March 6, 2024. Following the announcement, the Company will host a live webcast at 8:00 a.m. EST (1:00 p.m. GMT) that same day.The press release...
2024-02-21 4:00 PM EST
Adaptimmune Announces U.S. FDA Acceptance of Biologics License Application for Afami-cel for the Treatment of Advanced Synovial Sarcoma with Priority Review
If approved, afami-cel will be the first engineered T-cell therapy for solid tumors and the first effective treatment option for synovial sarcoma in more than a decade Philadelphia, Pennsylvania and Oxford, United Kingdom--(Newsfile Corp. - January 31, 2024) - Adaptimmune Therapeutics plc (NASDAQ: ADAP), a company redefining the treatment of solid tumor cancers with cell therapy, today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review its Biologics License Application (BLA) for afami-cel, an...
2024-01-31 4:44 PM EST
Adaptimmune Projects Sarcoma Franchise to Deliver US Peak Year Sales up to $400 Million - Presentation at JP Morgan Healthcare Conference
Sarcoma franchise of afami-cel and lete-cel leverages same development and commercial footprint with US peak year sales projected to be up to $400 million BLA submitted in 2023 for afami-cel; projected acceptance by US FDA in Q1 2024 Company preparing for US launch of afami-cel in 2H 2024 upon expected approvalPivotal trial for lete-cel met its primary endpoint for efficacy; full data set in Q3 2024 Company working toward approval of lete-cel; planning for US commercial launch in 2026Company funded...
2024-01-04 7:37 AM EST
Adaptimmune Completes Submission of Rolling Biologics License Application (BLA) to U.S. FDA for Afami-cel for the Treatment of Advanced Synovial Sarcoma
First BLA for an engineered T-cell therapy for solid tumors submitted to U.S. Food and Drug AdministrationAfami-cel data demonstrate better outcomes for people with synovial sarcoma compared to historical control data; pivotal trial has met primary endpoint for efficacyPhiladelphia, Pennsylvania and Oxford, United Kingdom--(Newsfile Corp. - December 6, 2023) - Adaptimmune Therapeutics plc (NASDAQ: ADAP), a leader in cell therapy to treat cancer, today announced the completion of the submission of its rolling Biologics License Application (BLA) to the U.S....
2023-12-06 7:00 AM EST
Adaptimmune Receives Transfer of IND for Lete-cel Program
Interim analysis of pivotal IGNYTE-ESO trial demonstrates 40% response rate in people with synovial sarcoma or myxoid/ round cell liposarcoma Company will lay out plans for its cell therapy sarcoma franchise including afami-cel and lete-cel in January 2024Philadelphia, Pennsylvania. and Oxford, United Kingdom--(Newsfile Corp. - November 29, 2023) - Adaptimmune Therapeutics plc (NASDAQ: ADAP), a leader in cell therapy to treat cancer, announces the transfer of the IND for letetresgene autoluecel (lete-cel) from GSK to Adaptimmune for the pivotal IGNYTE-ESO...
2023-11-29 8:00 AM EST
Adaptimmune Reports Third Quarter Financial Results and Business Update
Afami-cel: overall survival for people with synovial sarcoma who received afami-cel is superior to historic controls (CTOS 2023); BLA submission on track to complete in Q4 this yearSURPASS Phase 1 trial: 75% response rate in ovarian, urothelial, and head & neck cancers in patients with ≤ 3 prior lines of therapy (ESMO 2023)SURPASS trial plans: Phase 1 trial focused on head & neck and bladder cancers in earlier line treatment settings; Phase 2 SURPASS-3 trial initiated for platinum resistant ovarian...
2023-11-08 7:30 AM EST
Adaptimmune Selects ADP-600 as Clinical Candidate for Best-in Class PRAME Strategy
Candidate is 10x more sensitive to target peptide than competitor candidatesEntry into the clinic in 2024Selection of approaches from next-gen toolbox in developmentPhiladelphia, Pennsylvania and Oxford, United Kingdom--(Newsfile Corp. - November 8, 2023) - Adaptimmune Therapeutics plc (NASDAQ: ADAP), a leader in cell therapy to treat cancer, provides a progress update on its PRAME program (ADP-600). Jo Brewer Adaptimmune Chief Scientific Officer: "We have taken everything we know about design and development of TCRs to make a potent engineered TCR...
2023-11-08 7:05 AM EST
Adaptimmune Reports Better Outcomes for People with Synovial Sarcoma who Received Afami-cel Compared to Historical Control
~39% of patients who received afami-cel in the pivotal SPEARHEAD-1 trial had clinical responses with a median duration of response of ~12 months (CTOS 2022)Median overall survival (mOS) was ~17 months in SPEARHEAD-1 compared to historical mOS of <12 months for people with synovial sarcoma who received two or more prior lines of therapy[1]70% of people with advanced synovial sarcoma who respond to afami-cel are alive two years post-treatmentPhiladelphia, Pennsylvania and Oxford, United Kingdom--(Newsfile Corp. - October 31, 2023) -...
2023-10-31 8:00 AM EDT
Adaptimmune Reports Positive Data with Lete-cel[1] from an Interim Analysis of the Pivotal IGNYTE-ESO Trial for People with Synovial Sarcoma or MRCLS
40% (18/45) of people with synovial sarcoma or MRCLS and who have received ≥ 2 prior lines of therapy had clinical responses with lete-cel, by independent review[2]; primary efficacy endpoint requires 16/60 patients have responsesMedian duration of response was ~11 months, data are immature and still evolving80% (4/5) response rate by investigator assessment with lete-cel in a small substudy of treatment-naïve synovial sarcoma patients with all responses ongoing at the time of this analysis (CTOS 2023)[3]Philadelphia, Pennsylvania and Oxford, United...
2023-10-31 8:00 AM EDT
Adaptimmune to Report Q3 2023 Financial and Business Updates on Wednesday, November 8, 2023
Philadelphia, Pennsylvania and Oxfordshire, United Kingdom--(Newsfile Corp. - October 25, 2023) - Adaptimmune Therapeutics plc (Nasdaq: ADAP), a leader in cell therapy to treat cancer, will report financial results and provide business updates for the third quarter ended September 30, 2023, before the US markets open on Wednesday, November 8, 2023. Following the announcement, the Company will host a live teleconference and webcast at 8:00 a.m. EST (1:00 p.m. GMT) that same day.The press release will be available in the...
2023-10-25 8:06 AM EDT
Next-Generation TCR T-cell Therapy (ADP-A2M4CD8) Demonstrates Strong Efficacy in a Broad Range of Solid Tumors; Adaptimmune Presents Data Update from its SURPASS trial at ESMO
35% response rate in the ADP-A2M4CD8 monotherapy cohort with ~5 months median duration of response in heavily pre-treated patients across a broad range of solid tumors 50% response rate in 26 patients with ovarian, urothelial, and head & neck cancers75% response rate in ovarian, urothelial, and head & neck cancers in patients who received three or fewer prior lines of therapyAcceptable benefit-to-risk profile with ADP-A2M4CD8 next-generation monotherapy and in combination with the checkpoint inhibitor nivolumab across multiple solid tumor indicationsPhase...
2023-10-23 4:15 AM EDT
Dr. Karen Chagin Joins Adaptimmune as Senior Vice President of Early-Stage Development
Philadelphia, Pennsylvania and Oxford, United Kingdom--(Newsfile Corp. - September 11, 2023) - Adaptimmune Therapeutics plc (NASDAQ: ADAP), a leader in cell therapy to treat cancer, today announces that Karen Chagin, MD has joined the Company as its Senior Vice President of Early-Stage Development. Dr. Chagin will oversee the Company's early-stage pipeline activities from pre-IND and IND activities through Phase 1 clinical trials. Karen joins Adaptimmune from Tmunity where she served as Chief Medical Officer and previously as Head of Clinical Development...
2023-09-11 8:00 AM EDT
Adaptimmune Reports Second Quarter Financial Results and Business Update
Substantial progress on the afami-cel BLA including FDA agreement on plan for confirmatory evidence and favorable feedback on commercial T-cell potency assay - submission now targeted for Q4 2023Transition of lete-cel from GSK and data from the completed pivotal trial in synovial sarcoma and MRCLS expected in late 2023Initiated Phase 2 SURPASS-3 trial in ovarian cancer, which has the potential to be registrational and is supported by RMAT designation Completed strategic combination with TCR2 to form a pre-eminent cell therapy...
2023-08-09 7:29 AM EDT
Adaptimmune to Report Q2 2023 Financial and Business Updates on Wednesday, August 9, 2023
Philadelphia, Pennsylvania and Oxford, United Kingdom--(Newsfile Corp. - August 3, 2023) - Adaptimmune Therapeutics plc (NASDAQ: ADAP), a leader in cell therapy to treat cancer, will report financial results and provide business updates for the second quarter ended June 30, 2023, before the US markets open on Wednesday, August 9, 2023. Following the announcement, the Company will host a live conference call at 8:00 a.m. EDT (1:00 p.m. BST) that same day.The press release will be available in the...
2023-08-03 1:24 PM EDT
Adaptimmune Announces Completion of Strategic Combination with TCR2 Therapeutics Creating a Preeminent Solid Tumor Cell Therapy Company
First marketed engineered T-cell therapy for a solid tumor; BLA for afami-cel on track to complete submission in mid-2023Compelling clinical data with late-stage programs targeting MAGE-A4 and mesothelinPreclinical programs targeting PRAME and CD70 in IND-enabling studiesAdaptimmune funded into early 2026 with multiple value creating catalystsWebcast to be held tomorrow, June 2nd at 8 a.m. EDT: https://www.gowebcasting.com/12589Philadelphia, Pennsylvania and Oxford, United Kingdom--(Newsfile Corp. - June 1, 2023) - Adaptimmune Therapeutics pl
2023-06-01 3:29 PM EDT
Adaptimmune Announces 70% of People with Advanced Synovial Sarcoma Who Respond to Afami-cel are Alive Two Years Post-Treatment; Data from Cohort 1 of SPEARHEAD-1 to be Presented at ASCO
Approximately 39% of patients had clinical responses after a single dose of afami-cel in Cohort 1 of the pivotal SPEARHEAD-1 trial and the median duration of response was ~12 months (CTOS 2022)Median overall survival (mOS) was ~17 months Patients with a RECIST response have a 12-month OS probability of 90% and 24-month OS probability of 70%, and the mOS for responders has not yet been reachedHistorical outcomes are poor for advanced synovial sarcoma with a mOS of <12 months in...
2023-05-25 5:00 PM EDT