On November 4, 2021 Adaptimmune Therapeutics plc (Nasdaq: ADAP), a leader in cell therapy to treat cancer, reported financial results for the third quarter ended September 30, 2021, and provided a business update (Press release, Adaptimmune, NOV 4, 2021, View Source [SID1234594487]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We made excellent progress in Q3. The SURPASS data presented at ESMO (Free ESMO Whitepaper), the start of our first Phase 2 trial with ADP-A2M4CD8 next-gen SPEAR T-cells, and the announcement of our strategic collaboration with Genentech all support our 2-2-5-2 strategy," said Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer. "Looking ahead, the SPEARHEAD-1 data that we will present at the CTOS meeting will support a BLA for afami-cel in 2022. Next year, we will initiate a Phase 2 trial with ADP-A2M4CD8 for patients with ovarian cancer and evaluate the combination of this next-generation therapy with checkpoint inhibitors. All these activities will strengthen our leadership position with our MAGE-A4 franchise."
Upcoming data updates and corporate events
Connective Tissue Oncology Society (CTOS) Virtual Annual Meeting (November 10-13)
Abstract Title: SPEARHEAD-1: A Phase 2 trial of afamitresgene autoleucel (formerly ADP-A2M4) in patients with advanced synovial sarcoma or myxoid/ round cell liposarcoma (Abstract #1080870)
Oral presentation: November 12, 2021, in the Immunotherapy & Immune Microenvironment Session starting at 10:00 a.m. EST, Presenter: Dr. Brian Van Tine, Associate Professor of Medicine at Washington University School of Medicine
Abstract Title: SPEARHEAD-1 preliminary translational insights from a Phase 2 trial of afamitresgene autoleucel (formerly ADP-A2M4) in patients with advanced synovial sarcoma or myxoid/round cell liposarcoma (Abstract #1080366)
Poster Presentation: November 12, 2021, 2:30 p.m. – 3:15 p.m. EST during the Immunology & Immunotherapy Session. Presenter: Dr. Sandra P. D’Angelo, Clinical Oncologist at the Memorial Sloan Kettering Cancer Center
The Company will issue a full data press release at the time of embargo lift at 9:00 a.m. EST on November 11th
Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting (November 10-14); Walter E. Washington Convention Center in Washington D.C. or Virtual
Abstract Title: Enhancement of TCR-engineered T-cells targeting MAGE-A4 antigen by co-expression of CD8α and inhibition of AKT signaling during ex vivo T-cell expansion (Abstract #373)
Poster presentation: November 12-14, 2021, 7:00 a.m. – 5:00 p.m. EST. Presenter: Alex Tipping, Adaptimmune
Abstract Title: Radiation sub-study to characterize safety and tolerability of low-dose radiation in combination with afami-cel in patients with advanced cancers. (Abstract #376)1
Poster Presentation: November 12-14, 2021, 7:00 a.m. – 5:00 p.m. EST. Presenter: Dr. James W. Welsh, Professor, Department of Radiation Oncology, Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center
The Company will issue a full data press release at the time of embargo lift at 7:00 a.m. EST on November 12th
Highlights from clinical data updates in Q3
SURPASS Phase 1 trial at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) virtual meeting (August 2, 2021 data cut-off)
Initial efficacy and durability data were encouraging with responses across five different solid tumors (ovarian, head and neck, esophagogastric junction, bladder, and synovial sarcoma); refer to the press release for more detail
The overall response rate was 36% and the disease control rate was 86%, per Investigator Review
There was a complete response reported in a patient with ovarian cancer, which remains ongoing at 6 months post-infusion
Eleven patients remain on study. Of the 8 responders, 5 remain in response with some remaining progression free >24 weeks
The safety profile of the next-generation ADP-A2M4CD8 cell therapy was acceptable
Data confirm preclinical observations that the enhanced TCR interaction with next-generation ADP-A2M4CD8 SPEAR T-cells results in a more potent product
Safety and efficacy, will continue to be evaluated in the ongoing SURPASS trial, which is enrolling eligible patients with gastroesophageal, head and neck, lung, bladder, and ovarian cancers
Further indications for late-stage clinical development
Initiated a Phase 2 trial, SURPASS-2, for patients with esophageal and EGJ cancers
Next year, the Company will initiate SURPASS-3, a Phase 2 trial with ADP-A2M4CD8 for people with ovarian cancer based on the initial responses seen in the SURPASS Phase 1 trial (presented at ESMO (Free ESMO Whitepaper) 2021)
The Company is planning to evaluate ADP-A2M4CD8 in combination with a checkpoint inhibitor.
The SPEARHEAD-2 trial has now closed to enrollment
ADP-A2AFP Phase 1 trial in liver cancer at the International Liver Cancer Association (ILCA) meeting
As of the April 5, 2021 data cut-off, antitumor activity, with one complete response, sustained decreases in serum AFP, and best overall response of stable disease observed in 6 patients with liver cancer, indicating that ADP-A2AFP is an active product in hepatocellular carcinoma (HCC); refer to the press release for more detail
ADP-A2AFP has been associated with an acceptable safety profile with doses up to 10 billion transduced cells
The trial is approaching 25 patients treated, which is anticipated to be sufficient to assess the trial objectives
The Company will close screening by the end of 2021, and focus on other preclinical programs for liver cancer
Preclinical pipeline updates
Allogeneic platform
Adaptimmune intends to file its first IND for an allogeneic therapy targeting MAGE-A4 (wholly owned) in 2023
The Company announced a strategic collaboration with Genentech to research, develop, and commercialize allogeneic T-cell therapies. The Agreement became effective following expiry of all applicable waiting periods under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976, with Adaptimmune set to receive the $150 million upfront payment
This strategic collaboration builds on Adaptimmune’s cell therapy expertise and progress with its allogeneic platform, which was highlighted during a live virtual event held in September
The collaboration covers the research and development of "off-the-shelf" cell therapies for up to five shared cancer targets and the development of a novel allogeneic personalized cell therapy platform
Corporate
The Company plans to open a new facility at Milton Park, Oxfordshire, UK, by the end of 2022, where allogeneic products for clinical trials will be manufactured
Financial Results for the three and nine months ended September 30, 2021
Financial Results for the three and nine months ended September 30, 2021
Cash / liquidity position: As of September 30, 2021, Adaptimmune had cash and cash equivalents of $42.9 million and Total Liquidity2 of $240.1 million. In addition, under the terms of the Genentech agreement, Adaptimmune is entitled to receive $150 million as an upfront payment, which is anticipated to be received in the fourth quarter of 2021.
Revenue: Revenue for the three and nine months ended September 30, 2021 was $1.2 million and $4.7 million, respectively, compared to $1.2 million and $2.5 million for the same periods in 2020. Revenue has increased primarily due to an increase in development activities under our collaboration arrangements.
Research and development (R&D) expenses: R&D expenses for the three and nine months ended September 30, 2021 were $28.2 million and $81.6 million, respectively, compared to $24.1 million and $65.8 million for the same periods in 2020. R&D expenses increased due to an increase in the number of employees engaged in research and development, increases in costs related to the development of a companion diagnostic assay, and expansion of our clinical trials. These increases were partially offset by an increase in reimbursements receivable for research and development tax and expenditure credits.
General and administrative (G&A) expenses: G&A expenses for the three and nine months ended September 30, 2021 were $15.1 million and $42.5 million, respectively, compared to $13.0 million and $32.6 million for the same periods in 2020 due to increases in employee-related costs, share-based compensation expense, and professional fees.
Net loss: Net loss attributable to holders of the Company’s ordinary shares for the three and nine months ended September 30, 2021 was $42.4 million and $119.3 million respectively ($(0.05) and $(0.11) per ordinary share), compared to $35.4 million and $93.5 million ($(0.04) and $(0.13) per ordinary share) for the same periods in 2020.
Financial Guidance
The Company believes that its existing cash, cash equivalents and marketable securities, together with the upfront and exclusivity payments under the Strategic Collaboration and License Agreement with Genentech, will fund the Company’s current operations into early 2024, as further detailed in the Company’s Quarterly Report on Form 10-Q for the three and nine months ended September 30, 2021, to be filed with the Securities and Exchange Commission following this earnings release.
Conference Call Information
The Company will host a live teleconference and webcast to provide additional details at 8:00 a.m. EDT (12:00 p.m. GMT) today. A live webcast of the conference call and replay can be accessed at https://bit.ly/3utRMny. An archive will be available after the call at the same address. To participate in the live conference call, if preferred, please dial (833) 652-5917 (US or Canada) or +1 (430) 775-1624 (International). After placing the call, please ask to be joined into the Adaptimmune conference call and provide the confirmation code (4557667).