Adaptimmune Therapeutics Plc (ADAP:NASDAQ) is getting ownership from GSK of two T-cell receptor (TCR) T-cell programs: PRAME and NY-ESO reported ROTH Capital Partners analyst Dr. Tony Butler in an October 25, 2022 research note. Terms of the deal are being negotiated.
The United Kingdom-headquartered biopharma intends to advance both programs, noted Butler.
As for the PRAME program, Butler indicated it is expected Adaptimmune will submit to the U.S. Food and Drug Administration an investigational new drug application for a therapy targeting the TCR, potentially in H2/23.
"There can be a greater opportunity in a single therapeutic area," Butler added.
Regarding the NY-ESO program, Adaptimmune will likely file a biologics license application (BLA) with the FDA for lete-cel, if the clinical data from GSK's Phase 2 sarcoma trial are positive, noted Butler. These results, expected in H2/23, should encompass synovial sarcoma and myxoid-round cell liposarcoma.
If the FDA approves the BLA, Butler added, Adaptimmune would potentially launch lete-cel in both of these applications, making it the company's second cell therapy program in synovial sarcoma. The first is its TCR T-cell therapy targeting MAGE-A4, still the company's development priority. It is anticipated Adaptimmune will submit a related investigational new drug application, for afamitresgene autoleucel (afami-cel), also in H2/23.
Butler explained the rationale behind advancing a second program in synovial sarcoma. In this case, Adaptimmune could capture two populations of patients it otherwise would not, those with myxoid/round cell liposarcoma and those positive for NY-ESO but negative for MAGE A4 markers.
"There can be a greater opportunity in a single therapeutic area," Butler added.
ROTH has a Buy rating and a $10 per share target price on Adaptimmune, the current share price of which is about $1.39.
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Disclosures For ROTH Capital Partners, Adaptimmune Therapeutics Plc., October 25, 2022
Regulation Analyst Certification ("Reg AC"): The research analyst primarily responsible for the content of this report certifies the following under Reg AC: I hereby certify that all views expressed in this report accurately reflect my personal views about the subject company or companies and its or their securities. I also certify that no part of my compensation was, is or will be, directly or indirectly, related to the specific recommendations or views expressed in this report.
Disclosures: ROTH makes a market in shares of Adaptimmune Therapeutics PLC and as such, buys and sells from customers on a principal basis. Shares of Adaptimmune Therapeutics PLC may be subject to the Securities and Exchange Commission's Penny Stock Rules, which may set forth sales practice requirements for certain low-priced securities.
ROTH Capital Partners, LLC expects to receive or intends to seek compensation for investment banking or other business relationships with the covered companies mentioned in this report in the next three months. The material, information and facts discussed in this report other than the information regarding ROTH Capital Partners, LLC and its affiliates, are from sources believed to be reliable, but are in no way guaranteed to be complete or accurate. This report should not be used as a complete analysis of the company, industry or security discussed in the report. Additional information is available upon request. This is not, however, an offer or solicitation of the securities discussed. Any opinions or estimates in this report are subject to change without notice. An investment in the stock may involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Additionally, an investment in the stock may involve a high degree of risk and may not be suitable for all investors. No part of this report may be reproduced in any form without the express written permission of ROTH.
