FDA OKs Biopharma to Trial New Cell Therapy
Source: Mitchell Kapoor
August 31, 2022 (Investorideas.com Newswire) Now with clearance, the firm plans to commence a Phase 1 study of its lead candidate in patients with lymphoma by the end of this year, noted an H.C. Wainwright & Co. report.
Century Therapeutics Inc. (IPSC:NASDAQ) was just greenlighted by the U.S. Food and Drug Administration (FDA) to evaluate CNTY-101 in patients with relapsed or refractory CD19 positive B-cell malignancies, and the company plans to start a Phase 1 trial of this lead cell therapy candidate this year," reported H.C. Wainwright & Co. analyst Mitchell Kapoor in an August 26, 2022 research note.
CNTY-101 is one of Century's iPSC-derived natural killer cell therapies with four complementary functions, including tumor targeting.
"This represents a major milestone for Century, as this is the first investigational new drug clearance of a product candidate that utilizes Century's common iPSC progenitor, which is to be used across the pipeline," Kapoor wrote.
As such, the analyst pointed out, the successful development of CNTY-101 would establish proof of concept for the biopharma's platform and its Allo-Evasion technology.
"Allo-Evasion edits differentiate [the company's] natural killer and T-cell therapy approaches by allowing evasion of and elimination by the host immune system, which should enhance pharmacokinetics and eventually duration, in our view," noted Kapoor.
The impending Phase 1 trial, called ELiPSE-1, is designed to assess the safety, tolerability, pharmacokinetics, and efficacy of CNTY-101 in patients with relapsed or refractory, CD19 positive, aggressive lymphoma, or indolent lymphoma after receiving two or more lines of treatment including CAR-T cell therapy, Kapoor described. Initial data from the study could be available by late 2023.
Along with the commencement of ELiPSE-1, upcoming catalysts for Century, according to Kapoor, include the company:
1) Holding a research and development day to discuss preclinical data from its gamma delta solid tumor platform (in the fall)
2) Releasing preclinical data from its gamma delta T-cell platform (in Q4/22)
3) Unveiling a solid tumor candidate program (in Q4/22)
4) Choosing a candidate based on its iPSC-derived natural killer cell therapy platform (by year-end)
H.C. Wainwright has a Buy rating and a target price of $27 per share on Century Therapeutics, the current share price of which is around $10.18.
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Disclosures For H.C.Wainwright & Co., Century Therapeutics Inc., Aug. 26, 2022
H.C. Wainwright & Co, LLC (the "Firm") is a member of FINRA and SIPC and a registered U.S. Broker-Dealer.
I, Mitchell S. Kapoor and Raghuram Selvaraju, Ph.D. , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.
None of the research analysts or the research analyst's household has a financial interest in the securities of Century Therapeutics, Inc. (including, without limitation, any option, right, warrant, future, long or short position). As of July 31, 2022 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Century Therapeutics, Inc..
Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report.
The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services.
The firm or its affiliates received compensation from Century Therapeutics, Inc. for non-investment banking services in the previous 12 months. The Firm or its affiliates did not receive compensation from Century Therapeutics, Inc. for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report.
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