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LONDON - Autolus Therapeutics plc (NASDAQ:AUTL), a clinical-stage biopharmaceutical company, has reported encouraging data from its FELIX Phase 1b/2 study at the Society of Hematologic Oncology Annual Meeting in Houston, Texas. The study examines the efficacy of tumor burden (TB)-guided dosing with obe-cel, a novel CAR T-cell therapy, for adult patients with Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia (r/r B-ALL).
The study's findings highlight the impact of bone marrow blast percentage prior to lymphodepletion on the treatment's outcome. Obe-cel, unlike other CD19 CAR T-cell therapies, is administered in two infusions based on TB-guided dosing. This approach has shown substantial CAR T-cell expansion and a lower incidence of severe immunotoxicity.
The analysis of 127 patients who received obe-cel indicated that 94% of them received the planned two doses, with high CAR T expansion observed in both low and high TB groups. Peak expansion was noted after the second dose, suggesting the importance of both doses irrespective of TB at the time of lymphodepletion. The overall remission rate was 90% in the low TB group and 75% in the high TB group, with a manageable adverse event profile.
Dr. Christian Itin, CEO of Autolus, emphasized the differentiation of obe-cel based on its unique binding properties and TB-guided dosing approach. The therapy is designed with a fast off-rate CD19 binding domain to minimize excessive activation of programmed T cells, potentially reducing toxicity and T cell exhaustion, leading to durable remissions in patients.
The results of the FELIX trial have been submitted to the FDA with a target action date of November 16, 2024. Regulatory submissions have also been accepted in the EU and the UK. Additionally, obe-cel is being evaluated in a Phase 1 clinical trial for B-cell non-Hodgkin lymphoma in collaboration with University College London.
The promising data from the FELIX study support the TB-guided dosing approach in adult r/r B-ALL and may offer a new therapeutic option for this patient population. This news is based on a press release statement from Autolus Therapeutics plc.
In other recent news, Autolus Therapeutics has seen significant developments. The company's Annual General Meeting concluded with the approval of all nine resolutions, including the adoption of 2023 financial statements and the re-election of several directors. The shareholders also endorsed the Directors' remuneration report and re-appointed Ernst & Young LLP as the company's auditors.
In recent clinical trials, Autolus Therapeutics reported encouraging results from its FELIX study, which involves the treatment of adult B-cell Acute Lymphoblastic Leukemia (ALL) with obecabtagene autoleucel (obe-cel). The study showed that 40% of patients who responded to obe-cel are in ongoing remission without the need for subsequent stem cell transplant or other therapy. The results of the FELIX trial have been submitted to the FDA, with a target action date set for November 16, 2024.
In the realm of financial analysis, Truist Securities maintained a Buy rating on shares of Autolus Therapeutics, with minor revisions to the projected market penetration for Obe-cel. Similarly, Wells Fargo reiterated its Overweight rating on Autolus Therapeutics stock, anticipating positive developments in the second half of 2024. In its first-quarter 2024 earnings, Autolus reported a net loss per share of $0.24, wider than the consensus estimate of a $0.08 loss per share, but held $758.5 million in cash and equivalents at the end of the quarter.
InvestingPro Insights
Autolus Therapeutics plc (NASDAQ:AUTL) has shown a commitment to innovation in the field of CAR T-cell therapies, as evidenced by the recent positive data from its FELIX study. With a market capitalization of approximately $1.06 billion, the company is positioned as a notable player in the biopharmaceutical industry. Despite not being profitable in the last twelve months and a substantial gross profit margin deficit of -1206.51%, the company has managed to achieve an impressive revenue growth of 40.22% during the same period. This growth indicates a potential for future financial health and might be a sign of the company's underlying value proposition and strategic focus on research and development.
Investors should note that Autolus holds more cash than debt on its balance sheet, which could be a sign of financial stability and operational flexibility, an important aspect given the company's current stage of development. Additionally, the company's liquid assets exceed short-term obligations, providing further evidence of Autolus' ability to manage its immediate financial commitments.
However, it's important for potential investors to consider the volatility of Autolus' stock price movements, as well as the analysts' consensus that the company will not be profitable this year. With three analysts having revised their earnings downwards for the upcoming period, reflecting concerns about the company's near-term profitability, investors may want to keep a close eye on the company's financial performance and market expectations.
For those interested in a deeper analysis, there are additional InvestingPro Tips available for Autolus Therapeutics, which can be found at InvestingPro. These tips include insights on sales growth expectations, cash burn rate, and potential valuation concerns, providing a more comprehensive understanding of the company's financial health and market position.
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