'We are building the cell therapy company of the future for people with cancer. With our '2-2-5-2' by 2025 strategic plan, we will deliver value with marketed SPEAR T-cell products starting with ADP-A2M4 for people with synovial sarcoma,' said
Planned 2021 data updates1
SPEARHEAD-1 trial with ADP-A2M4 for people with synovial sarcoma
June: preliminary data at
November: full update at
SURPASS Phase 1 trial with ADP-A2M4CD8 (next-generation product targeting MAGE-A4)
September: update at
Additional clinical updates
September: update at
October: update at
November: ADP-A2M4 translational data update at
'2-2-5-2' by 2025 strategic plan
At an Investor Day held in
Estimated potential addressable population in tumor types with significant MAGE-A4 expression, factored for HLA-A23, is 39,000 patients per year in the US and EU
Durable responses in synovial sarcoma - on track to file a Biologics License Application (BLA) for ADP-A2M4 in 2022
The first commercial opportunity for SPEAR T-cells targeting MAGE-A4 will be in synovial sarcoma with plans to file a BLA in the US in 2022
In 2020, the Company received positive endorsements from regulatory authorities with Regenerative Medicine Advanced Therapy (RMAT) designation and Orphan Drug Designation (ODD) in the US, and access to PRIority MEdicines (PRIME) regulatory support and ODD in the EU
Data from the Phase 1 trial with ADP-A2M4 (presented at CTOS 2020)
In 16 patients with synovial sarcoma, there was an Overall Response Rate of 44% and a Disease Control Rate of 94%
Responses were durable with a median duration of response of 28 weeks with ongoing responses beyond 72 weeks in two patients (median overall survival had not been reached)
These data are considerably superior4 to response rates observed with available second line therapies in synovial sarcoma
SURPASS-2 in esophageal and esophagogastric junction (EGJ) cancers in 1H 2021
The Company will initiate a Phase 2 trial, SURPASS-2, with ADP-A2M4CD8 (next-generation SPEAR T-cells targeting MAGE-A4 that co-express CD8 intended to increase potency) for patients with esophageal or EGJ cancers in 1H 2021
SURPASS-2 is supported by encouraging data from the Phase 1 SURPASS trial (presented at SITC 2020) with one confirmed partial response (PR) in a patient with EGJ cancer and tumor reductions in two additional patients (1 with esophageal and 1 with EGJ cancer)
The trial will be conducted at multiple centers in
The Company also presented preclinical data at SITC 2020 indicating that AKT inhibition during the manufacture of SPEAR T-cells results in a more consistent expansion and phenotype of the final product. This process is currently being used for the Phase 1 SURPASS trial.
'2' - Two additional BLAs for SPEAR T-cell products
In 2020,
The Phase 1 trial with ADP-A2AFP for people with liver cancer is ongoing. As presented at ILC 2020, nine patients were treated as of the data cut-off and best responses were: One patient with a complete response, one with stable disease (SD), and two with progressive disease (PD) among the four patients who received 5 billion or more SPEAR T-cells
Five patients with SD who received doses of 100 million and 1 billion SPEAR T-cells in the first two dose cohorts
'5' - Five new autologous products in the clinic
These include multiple possibilities for next-generation autologous SPEAR T-cells such as: DP-A2AFP SPEAR T-cells co-expressing CD8
ADP-A2M4 SPEAR T-cells co-expressing IL-7, IL-15, dnTGF, and/ or PDE7
Enhancing SPEAR T-cells with IL-7 for proliferation and survival and CCL19 for migration into tumor in collaboration with
Enhancing SPEAR T-cells using transmembrane and surface immunoregulatory mechanisms with
The Company is also developing new products, including: Expanding into HLAs beyond HLA-A2 to increase the addressable patient population
HLA-independent TCR (HiT) candidates for multiple targets including GPC3
A new program for next-generation TILs co-expressing IL-7 in melanoma in collaboration with leading TIL therapy center (CCIT,
'2' - Two allogeneic products in the clinic
In
The first target nominated is a HiT targeting mesothelin
At ASGCT 2020,
Corporate updates from 2020
Despite the impact of the COVID-19 pandemic on the biotechnology industry,
In Q1, the Company received an upfront payment of
Underwritten public offering in Q1 generated net proceeds of approximately
Underwritten public offering in Q2 generated net proceeds of approximately
About
Forward-Looking Statements
This release contains 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA). These forward-looking statements involve certain risks and uncertainties. Such risks and uncertainties could cause our actual results to differ materially from those indicated by such forward-looking statements, and include, without limitation: the success, cost and timing of our product development activities and clinical trials and our ability to successfully advance our TCR therapeutic candidates through the regulatory and commercialization processes. For a further description of the risks and uncertainties that could cause our actual results to differ materially from those expressed in these forward-looking statements, as well as risks relating to our business in general, we refer you to our Quarterly Report on Form 10-Q filed with the
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Contact:
Tel: +44 1235 430 583
Email: Sebastien.Desprez@adaptimmune.com
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