Autolus Therapeutics receives Medicines and Healthcare products Regulatory Agency (MHRA) certification for Nucleus commercial manufacturing site

Rhea-AI Summary

Autolus Therapeutics plc (AUTL) has received Manufacturer’s Importation Authorisation for its Nucleus manufacturing facility, allowing global commercial and clinical product supply. The MHRA issued licenses with no major observations, enhancing Autolus' capabilities for autologous cell therapies.

Market Research Analyst

The Manufacturer’s Importation Authorisation (MIA) and Good Manufacturing Practice (GMP) certificate obtained by Autolus Therapeutics for its Nucleus manufacturing facility is a significant development for the company and its stakeholders. This authorization will allow Autolus to expand its manufacturing capabilities, potentially accelerating the production and distribution of its programmed T cell therapies. The ability to manufacture for both clinical and commercial supply globally enhances the company's operational flexibility and could be a catalyst for growth.

From a market perspective, the certifications may be viewed positively by investors as they reflect the company's adherence to strict regulatory standards, which is crucial in the biopharmaceutical industry. This could lead to increased investor confidence, possibly impacting the company's stock value. Moreover, the readiness of the facility to produce autologous cell therapies could shorten the time to market for Autolus' products, thereby potentially increasing revenue streams sooner than previously anticipated.

Medical Research Analyst

The progress of obe-cel, Autolus Therapeutics' therapy for adult relapsed or refractory B-cell Acute Lymphoblastic Leukemia (r/r B-ALL), is of particular interest. The therapy's designation as an Orphan Drug and its RMAT and PRIME status highlight its potential to address an unmet medical need. These designations often come with benefits such as tax credits, grant funding and potentially faster regulatory review times, which could positively influence the company's R&D efficiency and financial health.

Furthermore, the company's ability to manufacture obe-cel at the newly authorized facility may streamline the supply chain and improve the scalability of treatment production. This is crucial for personalized therapies like obe-cel, where production and logistics can be complex and time-sensitive. The MHRA's approval without major or critical observations underscores the company's commitment to quality and safety, which is paramount in gaining the trust of both regulators and patients.

Financial Analyst

Autolus Therapeutics' achievement in securing the MIA and GMP certificate for its Nucleus manufacturing facility can have significant financial implications. These certifications are essential for commercial production and can reduce the risk profile of the company's operations. Investors often scrutinize such milestones as they can lead to reduced regulatory risks and pave the way for potential revenue generation from new therapies.

Given the high costs associated with the development and manufacturing of biopharmaceutical products, the ability to manufacture in-house at a certified facility could result in cost savings and improved profit margins. This operational leverage is particularly important for clinical-stage companies that are transitioning to commercial-scale operations. The impact on the company's financials will also depend on the commercial success of therapies like obe-cel, which could be significantly influenced by the facility's operational effectiveness and regulatory compliance.

LONDON, March 12, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces that following the most recent GMP inspection by the MHRA in February 2024, Autolus’ Nucleus manufacturing facility in Stevenage has obtained a Manufacturer’s Importation Authorisation (MIA) together with the accompanying GMP certificate. This authorisation enables Autolus to manufacture for global commercial and clinical product supply from the Nucleus effective as of March 18, 2024.

Following a full site inspection in February 2024, Autolus’s Nucleus site has recently received the formal certification from the MHRA. The MHRA issued two new licenses to cover both clinical and commercial manufacture from the site and found no major or critical observations in their summary report.

“We are really proud of our brand-new facility for autologous cell therapies. Our manufacturing team did an outstanding job qualifying, validating and taking into operation the Nucleus in record time and establishing the foundation for high quality product supply,” commented Dave Brochu, Chief Technology Officer of Autolus. “We look forward to continuing to work with the MHRA, EMA and FDA throughout the evaluation process of obe-cel for patients with ALL and thank the internal team at Autolus for their hard work."

Obe-cel has been granted Orphan Drug Designation by the FDA, Orphan Medical Product Designation by the EMA, Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA and PRIority MEdicines (PRIME) designation by the EMA for adult r/r B-ALL.

About Autolus Therapeutics plc
Autolus is a clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer and autoimmune disease. Using a broad suite of proprietary and modular T cell programming technologies, the Company is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognize target cells, break down their defense mechanisms and eliminate these cells. Autolus has a pipeline of product candidates in development for the treatment of hematological malignancies, solid tumors and autoimmune diseases. For more information, please visit www.autolus.com.

About obe-cel (AUTO1)
Obe-cel is a CD19 CAR T cell investigational therapy designed to overcome the limitations in clinical activity and safety compared to current CD19 CAR T cell therapies. Obe-cel is designed with a fast target binding off-rate to minimize excessive activation of the programmed T cells. Clinical trials of obe-cel have demonstrated that this “fast off-rate” profile reduces toxicity and T cell exhaustion, resulting in improved persistence and leading to high levels of durable remissions in r/r Adult ALL patients. The results of the FELIX trial, a pivotal trial for adult ALL, have been submitted and accepted by the FDA with a PDUFA action date of November 16, 2024 and a regulatory submission with the EMA is being prepared. In collaboration with Autolus’ academic partner, UCL, obe-cel is currently being evaluated in a Phase 1 clinical trials for B-NHL.

About obe-cel FELIX clinical trial
Autolus’ Phase Ib/II clinical trial of obe-cel enrolled adult patients with relapsed / refractory B-precursor ALL. The trial had a Phase Ib component prior to proceeding to the single arm, Phase II clinical trial. The primary endpoint is overall response rate, and the secondary endpoints include duration of response, MRD negative CR rate and safety. The trial enrolled over 100 patients across 30 of the leading academic and non-academic centers in the United States, United Kingdom and Europe. [NCT04404660]

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by terms such as "may," "will," "could," "expects," "plans," "anticipates," and "believes." These statements include, but are not limited to, statements regarding Autolus’ development of its product candidates. Any forward-looking statements are based on management's current views and assumptions and involve risks and uncertainties that could cause actual results, performance, or events to differ materially from those expressed or implied in such statements. These risks and uncertainties include, but are not limited to, the risks that Autolus’ preclinical or clinical programs do not advance or result in approved products on a timely or cost effective basis or at all; the results of early clinical trials are not always being predictive of future results; the cost, timing and results of clinical trials; that many product candidates do not become approved drugs on a timely or cost effective basis or at all; the ability to enroll patients in clinical trials; and possible safety and efficacy concerns. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Autolus’ actual results to differ from those contained in the forward-looking statements, see the section titled "Risk Factors" in Autolus' Annual Report on Form 20-F filed with the Securities and Exchange Commission, or the SEC, on March 7, 2023 and in Autolus' Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 9, 2023, as well as discussions of potential risks, uncertainties, and other important factors in Autolus' subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Autolus undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law. You should, therefore, not rely on these forward-looking statements as representing Autolus’ views as of any date subsequent to the date of this press release.

Contact:

Olivia Manser
+44 (0) 7780 471568
o.manser@autolus.com

Julia Wilson
+44 (0) 7818 430877
j.wilson@autolus.com

Susan A. Noonan
S.A. Noonan Communications
+1-917-513-5303
susan@sanoonan.com

What authorization did Autolus Therapeutics plc receive for its Nucleus manufacturing facility?

Autolus received Manufacturer’s Importation Authorisation (MIA) for its Nucleus facility.

When is Autolus Therapeutics plc allowed to manufacture for global commercial and clinical product supply from the Nucleus?

Autolus is permitted to manufacture from the Nucleus effective as of March 18, 2024.

What designations has Obe-cel received from regulatory bodies?

Obe-cel has been granted Orphan Drug Designation by the FDA, Orphan Medical Product Designation by the EMA, RMAT designation by the FDA, and PRIME designation by the EMA for adult r/r B-ALL.