May 2019 STRH 5 th Annual Life Sciences Summit 1
Disclaimer This presentation contains “for ward-looking statemen ts,” as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as “b elieve ,” “ma y ,” “ w ill,” “ estima te,” “c ontinue ,” “a nticipa te,” “int end ,” “e x pect” and other words of similar meaning. 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; our ability to submit an IND and successfully advance our technology platform to improve the safety and effectiveness of our existing TCR therapeutic candidates; the rate and degree of market acceptance of T-cell therapy generally and of our TCR therapeutic candidates; government regulation and approval, including, but not limited to, the expected regulatory approval timelines for TCR therapeutic candidates; and our ability to protect our proprietary technology and enforce our intellectual property rights; amongst others. 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 Securities and Exchange Commission (SEC) on May 6, 2019 and our other SEC filings. We urge you to consider these factors carefully in evaluating the forward-looking statements herein and you are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. The forward-looking statements contained in this presentation speak only as of the date the statements were made and we do not undertake any obligation to update such forward-looking statements to reflect subsequent events or circumstances. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA. 2
Adaptimmune - The Leader in TCR T-cell Therapy • Compelling data with ADP-A2M4 in synovial sarcoma – Partial responses in 4 out of 5 synovial sarcoma patients treated with ~10 billion cells – Tumor shrinkage in nearly all assessed synovial sarcoma patients • Initiating SPEARHEAD-1 trial in synovial sarcoma and MRCLS with ADP-A2M4 • Aim to launch first TCR T-cell therapy in 2022 • Tumor shrinkage in other solid tumors with ADP-A2M4, ADP-A2M10 & ADP-A2AFP • Initiating SURPASS study for ADP-A2M4CD8 next generation SPEAR T-cells – Aim to transform activity in epithelial tumors into durable responses • Strong momentum with stem cell derived T-cells in allogeneic program • $168 million total liquidity taking us into Q3 2020* 3 *Represents updated guidance. Total liquidity is the total of cash and cash equivalents, and marketable securities
Our evolving pipeline in multiple solid tumor indications Initiating late stage development with SPEARHEAD-1 (ADP-A2M4 in sarcomas) Pilot studies Study Indications Dose Escalation Expansion Phase 2/3 Multiple solid ADP-A2M4 tumors** ADP-A2M4 Multiple solid MAGE-A4 2H 2019 Radiation sub-study* tumors** SPEARHEAD-1 Sarcomas Not applicable 2H 2019 2H 2019 SURPASS Multiple solid (ADP-A2M4CD8) tumors** IND APRIL 2019 MAGE-A10 NSCLC Bladder ADP-A2M10 Melanoma Head & neck AFP Hepatocellular ADP-A2AFP carcinoma Strong momentum with stem cell derived T- cells in allogeneic (“off -the- shelf”) program Range of other targets and candidates in preclinical stage *Site specific protocol amendment with MD Anderson Cancer Center 4 ** Bladder, Melanoma, Head & Neck, Ovarian, NSCLC, Esophageal, Gastric, Synovial sarcoma, MRCLS
ADP-A2M4 in synovial sarcoma 5
Responses in synovial sarcoma ADP-A2M4 Cohort 3 and Expansion Tumor shrinkage in nearly all assessed synovial sarcoma patients MAGE-A4 expression (%) Patient # Maximum change (Gender; Age [y]) Baseline SLD (mm) 1+ 2+ 3+ Peak Persistence a Dose b Best response c in SLD (%) d 1 (M, 53) 240 0 0 100 220 9.9 cPR -86 (Wk 12) 2 (M, 59) 35 0 0 100 101 10.0 cPR -54 (Wk 10) 3 (M, 42) 204 10 35 50 238 9.9 cPR -44 (Wk 11) 4 (F, 54) 32 5 15 65 325 9.7 ucPR -31 (Wk 6) 5 (M, 46) 60 0 0 100 27 4.5 SD -27 (Wk 12) 6 (F, 57) 60 0 10 90 284 9.7 SD -15 (Wk 6) 7 (M, 31) 66 10 20 10 45 6.0 SD +12 (Wk12) 8 (M, 49) 118 10 20 60 19 5.1 PD +24 (Wk 6) 9 (F, 34) 110 0 0 100 Pending 10.0 Pending Pending 10 (F, 76) 174 0 15 85 Pending 8.4 Pending Pending SLD=sum of lesion(s) diameter(s) in target lesions (a) (Vector copies per µg/DNA) x 10 3 (b) Dose (10 9 transduced cells) (c) cPR=confirmed partial response; ucPR=unconfirmed partial response; SD=stable disease; PD=progressive disease (d) Maximum (%) change in target lesions (SLD) by week of scan (to date); numbers rounded to nearest whole number 6 Data cut off 30 Apr 2019
ADP-A2M4 synovial sarcoma Partial responses in 4 out of 5 synovial sarcoma patients treated with ~10 billion cells Change from Baseline in SLD Maximum Change from Baseline in SLD through Progression or Prior to Surgical Resection through Progression or Prior to Surgical Resection 60 40 Change from Baseline (%) Change from Baseline (%) 20 8 7 0 -20 6 5 4 -40 3 2 -60 -80 1 -100 8 7 6 5 4 3 2 1 Patient number Time from SPEAR T-cell infusion (weeks) PR=partial response (confirmed); SD=stable disease; PD=progressive disease 7 Data cut off 30 Apr 2019
ADP-A2M4 synovial sarcoma Patient #1 Confirmed PR with significant tumor burden reduction (-86% max. change in 24 cm SLD) Lung Pleura Pleura Baseline Week 6 8 Max.=maximum; SLD=sum of lesion(s) diameter(s)
ADP-A2M4 synovial sarcoma Patient #3 Confirmed PR with bulky tumor almost completely resolved (-44% max. change in 20 cm SLD) Baseline Week 6 Week 12 9 Max.=maximum; SLD=sum of lesion(s) diameter(s)
SPEARHEAD-1 study starting in 2H 2019 (ADP-A2M4) Well positioned to execute based on years of engagement with sarcoma community • Single-arm, Phase 2 study in more than 20 centers (North America & EU) • Sample size of 60 treated subjects with: – Advanced (metastatic or inoperable) synovial sarcoma or MRCLS, who have received prior chemotherapy – HLA-A*02 & MAGE-A4 antigen positive – MAGE-A4 expression 30% (2 + , 3 + ) • Primary endpoint – Overall Response Rate by RECIST v1.1 by independent review – Interim futility: 3+ responses in first 15 subjects for study continuation (1H/2020) • Safety endpoints with Independent Data Safety Monitoring Board • Exploratory endpoints: translational and patient-reported outcomes • Treatment – Lymphodepletion: Flu: (30 mg/m 2 /day) x 4 days; Cy (1800 mg/m 2 /day) x 2 days – Dose: up to 10 billion transduced SPEAR T-cells 10 MRCLS=myxoid/round cell liposarcoma
ADP-A2M4 potential to be first & best in class - with 2022 launch plan Significant commercial opportunity for Adaptimmune’s first therapy Synovial Sarcoma MRCLS US incidence (patients annually) Up to 1400 Up to 1000 Median age of diagnosis c.30 35 - 50 ~ 50 – 60% ~ 30 – 50% 5 year survival MAGE-A4 expression ~ 70% ~ 50% 40 – 50% 40 – 50% HLA A-2 • Similar population profile in EU • Limited options for metastatic/unresectable disease – Localized disease initially treated by resection (surgery) – Preferred therapy for metastatic/unresectable disease is chemotherapy › Almost all patients progress over time – Second line therapy options are limited › Low response rates › Unsuccessful converting unresectable tumors into resectable ones * Data from primary and secondary market research 11 MRCLS=myxoid/round cell liposarcoma
Tumor shrinkage in other solid tumors with: - ADP-A2M4 - ADP-A2M10 - ADP-A2AFP 12
ADP-A2M4 melanoma Patient #11 with high MAGE-A4 expression Decrease in target lesion (-40% max. change in 6 cm SLD) with PD due to new lesions Baseline Week 10 13 * Patient #11 had a -40% maximum change in SLD; best overall response is PD due to new lesions
ADP-A2M10 NSCLC Patient #1 with high MAGE-A10 expression Stable disease with decrease in target lesion and disappearance of non-target lesion Supraclavicular Lymph Node Right lower lobe Lung Left upper lobe Lung Baseline Nov 2018 ~5 months Apr 2019 14 Patient #1 received second infusion at Week 16; post-baseline scans presented are after second infusion
ADP-A2AFP first patient treated in Cohort 2 with 1 billion cells Tumor shrinkage at first scan and strong transient decrease in serum AFP Baseline Week 4 CTX Cells FDB aCTLA-4 + aPD-L1 FGFR4 inh sorafenib 15
Recommend
More recommend
