Adaptimmune Therapeutics PLC (ADAP)

[Vader69]

AdaptImmune Therapeutics (ADAP)


MARKET PULSE:
Consensus 8/8 BUY rating with median target $12 and low/high targets of $6-$17 respectively.
Current Share Price: $3.99
52 week range: $1.15 to $13.40
-Interesting volume on 12/11/20 with 4million (almost 3.5x average volume of 1.4)
-Added to NASDAQ Biotechnology Index on 12/12/20
-Reditt user SaraJewel posted she has synovial sarcoma and indicated an initial 42% response followed by a later scan showed “no disease remaining.”
Source:

$ADAP Looks like this PR from Synovial Sarcoma study is now a CR and will be reflected in next update pic.twitter.com/pyQWkWpQIz

— AbuOlive (@AbuOlive) November 23, 2020

SHAREHOLDERS & INSTITUTIONS:
89 institutions are holding. 84.35% institutional holdings, .07% insider holding
#1 institutional holder: Matrix Capital Management at 4.99%
#2 institutional holder: NEA Management at 2.19%
Other notable investors: ARKg, Baker Brothers at .81%, RA Capital at 1.45%, Avoro Capital at 1.41% and Citadel Advisors at .63%
**Notably: ADAP is included in the holdings of ARKG. In April of 2020, they had a .51% position but increased their position in Q3. ARKG holds 1,129,039 63 shares representing 1.09% of the fund as of 12/11/20.
https://ark-funds.com/wp-content/fundsiteliterature/holdings/ARK_GENOMIC_REVOLUTION_MULTISECTOR_ETF_ARKG_HOLDINGS.pdf


FINANCIALS: (from 11/20/20 investor day update)
-Total liquidity position of 400million as of 11/30/20
-Cash Runway is covered until early 2023
-Balance of common stock as of 1/1/20: 631,003,568

CATALYSTS:
Q4 2020 – SPEARHEAD1 enrollment completion (ahead of schedule despite COVID)
January 14th 2021 – Primary Study Completion of SURPASS trial
1H 2021- SURPASS Phase 2 for GE Junction tumors
June 2021 - AFP Hepatocellular Phase 1 Results
April 2022 – Primary Study Completion of SPEARHEAD2 trial
2022 – BLA for MAGE-A4 Synovial indication
2024 – BLA for MAGE-A4 GE carcinoma indication

FOUR Key Value Drivers:
1. 2 products (MAGE-A4) target for GE tumors and synovial carcinoma
Launch expected 2022 for synovial and 2024 for GE cancers
2. BLAs for SPEAR T cell products for MAGE A4 and ADP-A2AFP
3. 5 programs in the autologous sector (HiT, next gen TILS, new targets broader HLA coverage
4. 2 allogenic products with Spear T cell products targeting MAGE -A4, HiT mesothelin partnered with Astrellas (HLA independent = HiT). Co-commercialization with Astellas

PIPELINE:
1. MAGE A4 Program: Engineered T cell therapy for solid tumor indications
ADP-A2M4 – SPEARHEAD 1 & 2 Trials
ADP-A2M4CD8 – SURPASS Trial 1 & 2 (Phase 1)

2. AFP program
ADP-A2AFP – Phase 1 trail for hepatocellular carcinoma

3. Allogenic/HiT
-Spear T cells – attack a range of solid tumors, especially in advanced disease
-Engineered T cell therapy for a solid tumor indication (synovial sarcoma)
-Off the shelf allogenic therapies

FOUR Key Value Drivers:
5. 2 products (MAGE-A4) target for GE tumors and synovial carcoma
Launch expected 2022 for synovial and 2024 for GE cancers
6. BLAs for SPEAR T cell products for MAGE A4 and ADP-A2AFP
7. 5 programs in the autologous sector (HiT, next gen TILS, new targets broader HLA coverage
8. 2 allogenic products with Spear T cell producting targeting MAGE -A4, HiT mesothelin partnered with Astrellas (HLA independent = HiT). Co-commercialization with Astellas

SPEARHEAD1 (Clinical Trials# NCT04044768, phase 2 for ADP-A2M4)
Enrollment: 45 patients with Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma
Start Date: 7/24/19
Primary completion Date: 1/2022
Study Completion: 11/1/34

SPEARHEAD2 (Clinical Trials# NCT04408898, phase 2 for ADP-A2M4 in combination with pembrolizumab)
Enrollment: 10 participants with recurrent or metastatic head and neck cancer
Start Date: 7/2/20
Primary Completion: April 2022
Study completion October 2036

SURPASS (Clinical Trials# NCT04044859, A Phase 1 Dose Escalation Study To Assess Safety And Efficacy Of ADP-A2M4CD8 In HLA-A2+ Subjects With MAGE-A4 Positive Tumors
(synovial sarcoma, MRCLS, melanoma, ureothelial carcinoma, H&N, ovarian, gastric cancer, EGJ disorder, squamous cell lung, esophageal cancer)
Enrollment: 30 patients
Study Start: 4/30/18
Primary Completion Jan 14, 2021
Study Completion: Jan 14, 2036
*Prelim Data reported 11/9/20 with data cut off 10/1/2020: heavily pre-treated patients with advanced cancers (n=6), three were treated with target doses of 1 billion SPEAR T-cells, and three with target doses of 5 billion. H&N had -63% tumor reduction, EGJ -51% tumor reduction, EGJ -34%, ovarian -16%, esophageal -13%, MRCLS =1.35% growth


MAGE-A4?¹º³²T for Multi-Tumor (Clinical Trials#NCT03132922, Autologous genetically modified MAGE-A4c1032T cells combined with autologous and low dose radiation subset arms)
Enrollment: 52 patients
Study Start: 5/15/17
Primary Completion: Sept 2032
Study Completion: Sept 2025

AFP?³³²T in Advanced HCC (Clinical Trials# NCT03132792, Phase 1 for hepatocellular cancer and AFP Expressing Tumors)
Enrollment: 45 participants
Study Start: 5/8/17
Primary Completion: June 2021
Study Completion: June 2026

2 Studies No Longer Recruiting:
MAGE-A10?7?6T for Urothelial Cancer, Melanoma or Head and Neck Cancers (Clinical Trials# NCT02989064)
Enrollment: 10 participants
Start Date: 10/2016
Primary Completion date: 12/18/19
Study Completion Date: Nov 2034

Autologous Genetically modified T cells, MAGEA10?7?6T (Clinical Trials# NCT02592577)
Enrollment: 28 participants
Start Date: 11/2015
Primary Completion Date: 3/11/20
Study Completion date: Dec 2034


Data for Synovial Sarcoma as of 9/2020:
-Seven out of 16 patients (44%) had confirmed partial responses (PR) per RECIST criteria, with disease control in 15 patients (94%)
-There was a median duration of response of 28 weeks (range: 12-72+ weeks) with two PRs that were ongoing beyond 72 weeks at the time of data cut-off
-Eleven out of 16 patients were alive at data cut-off and median overall survival had not been reached
-Translational data indicate that induction of the IFNy-related pathway by serum analyses is an emerging biomarker of response. MAGE-A4 expression and transduced cell dose correlate with tumor reduction
-Most adverse events were consistent with those typically experienced by cancer patients undergoing lymphodepletion chemotherapy and cellular therapy including low blood counts and cytokine release syndrome

Future Value:
-MAGE-A4 – 300k in the US and EU are diagnosed with tumors that express MAGE-A4.
-If successful, ADAP will have the first product on the market against this target.
-300k patients annually express MAGE-A4 in the EU and USA. (similar opportunity to BRAF and FGFR markets)
-39k possible patients who express MAGE-A4 with HLA2+
-773 patients per year for sarcoma treatment but 8000 patients annually for GE tumors
-5 autologous products and 2 allogenic products: Targeting Curative and Mainstream