PHILADELPHIA & OXFORD, England - The U.S. Food and Drug Administration (FDA) has granted accelerated approval to TECELRA® (afamitresgene autoleucel), marking a significant advancement in the treatment of adults with unresectable or metastatic synovial sarcoma who have previously undergone chemotherapy.
Manufactured by Adaptimmune Therapeutics plc (NASDAQ: NASDAQ:ADAP), this approval introduces the first engineered cell therapy for solid tumor cancers in the United States and offers the first new treatment option for synovial sarcoma in over ten years.
TECELRA® is designed for patients who are positive for specific human leukocyte antigen (HLA) types and whose tumors express the MAGE-A4 antigen, as determined by FDA-approved diagnostic tests. The approval is based on the overall response rate and duration of response observed in the SPEARHEAD-1 trial, which involved 44 patients.
The therapy achieved an overall response rate of 43%, with a median response duration of 6 months. Notably, 39% of the responding patients experienced sustained responses for 12 months or longer.
This new treatment option is a personalized immunotherapy that utilizes a patient's own immune cells to target and fight cancer cells in a one-time infusion.
Adaptimmune plans to establish a network of authorized treatment centers to administer TECELRA® and has created an integrated support program, AdaptimmuneAssist, to facilitate a seamless treatment experience.
However, TECELRA® is not without risks. It is contraindicated for adults with certain HLA types and can cause serious side effects, including cytokine release syndrome, neurotoxicity, and prolonged severe cytopenia. The most common adverse reactions reported include fever, nausea, and fatigue, among others.
The FDA's accelerated approval is contingent upon the verification of clinical benefits in a confirmatory trial. Adaptimmune remains dedicated to advancing its clinical pipeline and plans to submit a rolling Biologics License Application for the next investigational treatment in its sarcoma franchise next year.
The information in this article is based on a press release statement from Adaptimmune Therapeutics plc.
In other recent news, Adaptimmune Therapeutics has been the focus of several significant developments. Jones Trading recently increased the price target for the company to $2.50, maintaining a Buy rating.
This upgrade comes in anticipation of potential FDA approval for the company's drug candidate, afami-cel, intended for relapse/refractory synovial sarcoma patients.
On the financial front, Adaptimmune has secured significant debt financing and raised funds to support the commercial launch of afami-cel. The company's Q1 2024 financial results highlighted the regulatory progress of afami-cel and insights into its commercial launch preparations.
The company also updated its executive severance policy, enhancing the terms for its executive officers. This move reflects new severance terms for its top-tier staff, including a severance payment equal to their annual base salary for 12 months.
In terms of analyst insights, Barclays has maintained an Underweight rating on the company. Adaptimmune is also preparing for the commercial launch of their T-cell therapy for solid tumors, afami-cel, with plans to initiate the launch in 6-10 treatment centers.
Lastly, the company anticipates a decision from the FDA regarding their first T-cell receptor therapy product. Full pivotal data for Lete-cel, Adaptimmune's therapy targeting the NY-ESO-1 cancer antigen, is expected to be released in late 2024.
InvestingPro Insights
With the FDA's accelerated approval of TECELRA®, Adaptimmune Therapeutics plc (NASDAQ: ADAP) is poised to make a significant impact on the treatment of synovial sarcoma. InvestingPro data reveals some key financial metrics for Adaptimmune that could be of interest to investors monitoring the company's progress post-approval. The company's market capitalization stands at approximately $339.9 million, indicating its size in the biotechnology market. Despite a challenging revenue growth rate, with a decrease of 74.21% in the last twelve months as of Q1 2024, the company has managed to maintain a strong return on its stock price over the last six months, with a 27.88% increase.
However, potential investors should be aware of the company's financial health as they consider the implications of the new treatment's approval. An InvestingPro Tip highlights that Adaptimmune holds more cash than debt on its balance sheet, which could provide some financial stability as it ramps up the commercialization of TECELRA®. Additionally, the company's liquid assets exceed short-term obligations, suggesting that it has sufficient liquidity to meet its immediate financial needs.
Yet, challenges remain, as another InvestingPro Tip points out that the company is quickly burning through cash, which could be a concern as it invests in the rollout of its new treatment and continues its research and development efforts. Moreover, analysts do not anticipate the company will be profitable this year, which is reflected in the negative Profit/Earnings (P/E) ratio of -1.87, indicating that the company is not currently generating profits.
For those interested in deeper analysis, there are additional InvestingPro Tips available for Adaptimmune, which can provide further guidance on the company's financial and operational outlook. Visit https://www.investing.com/pro/ADAP for a comprehensive set of tips and metrics that can help inform investment decisions in the context of this latest development in cancer treatment.
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