Autolus Therapeutics plc reports news on its commercial-stage biopharmaceutical business developing, manufacturing and delivering next-generation programmed T cell therapies. Updates center on AUCATZYL (obecabtagene autoleucel, or obe-cel), product revenue, manufacturing capacity, gross margin plans and the company’s acute lymphoblastic leukemia business.
Company announcements also cover clinical programs using obe-cel and related T cell therapy candidates in pediatric relapsed/refractory acute lymphoblastic leukemia, lupus nephritis and progressive multiple sclerosis. Other recurring items include financial results, operational efficiency actions, investor presentations, Nasdaq inducement equity grants and ADR-related public-company disclosures.
Autolus Therapeutics (AUTL) provided updates on its CAR T therapy, obe-cel, at the ASH 2021 Annual Meeting. The ALLCAR19 study reported a morphological event-free survival (EFS) of 46% at 24 months. Obe-cel achieved a metabolic complete response in 100% of patients with follicular lymphoma, mantle cell lymphoma, and diffuse large B-cell lymphoma, showing favorable safety with no high-grade cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) reported. The company anticipates further clinical data in 2022.
Autolus Therapeutics (Nasdaq: AUTL) will hold a conference call on December 13, 2021, at 8:00 am ET to discuss data presented at the 63rd American Society of Hematology (ASH) Annual Meeting, taking place December 11-14. This call reflects a timing change from the previous announcement. The call will include a webcast with accompanying slides available on the company's website. A replay of the call will be accessible for one week after.
Autolus Therapeutics plc (Nasdaq: AUTL) announced the appointment of Dr. William D. Young as a non-executive director, effective immediately. This decision follows a recent investment by Blackstone Life Sciences. Dr. Young brings over 50 years of experience in the life sciences sector, previously serving as COO of Genentech and CEO of Monogram Biosciences. His expertise is expected to enhance the commercial strategy of the company’s investigational therapy, Obe-cel, which aims to improve outcomes for adult patients with acute lymphoblastic leukemia and other cancers.
Autolus Therapeutics has published a significant article in Nature Scientific Reports detailing its controllable CAR T cell system, named TetCAR. This innovative approach allows for reversible dampening of programmed T cell activity using widely available antibiotics, tetracycline and minocycline. Such control mechanisms are crucial for managing severe adverse side effects in patients undergoing CAR T cell therapy. The company emphasizes that this method is based on established pharmacological agents, enhancing its practical application in clinical settings.
Autolus Therapeutics has announced a strategic collaboration with Blackstone Life Sciences, securing up to $250 million in financing to advance its investigational therapy, obe-cel, for adult acute lymphoblastic leukemia (ALL). The investment includes $150 million in product financing, with $50 million available at closing. Blackstone will also acquire $100 million in Autolus' American Depositary Shares. This funding aims to support clinical development and initial commercialization activities for obe-cel, which has shown potential as a curative treatment in a last-line setting.
Autolus Therapeutics plc (Nasdaq: AUTL) announced progress in its CAR T cell therapies, specifically obe-cel (AUTO1), at the 63rd ASH Annual Meeting in December 2021. The company will present an oral session on the industrialization of its Miltenyi Prodigy-Based manufacturing process and poster presentations on its AUTO1 programs for adult and pediatric Acute Lymphocytic Leukemia. A conference call is scheduled for December 14, 2021, to discuss ASH data. Autolus aims to enhance safety and efficacy through its innovative therapies designed to target cancer cells effectively.
Autolus Therapeutics (Nasdaq: AUTL) reported operational and financial results for Q3 2021, highlighting continued progress in clinical evaluations, particularly for obe-cel in the FELIX study. The expected delivery of primary endpoint data is slated for mid-2022. Cash at the end of Q3 totaled $173.1 million, down from $216.4 million in Q2 2021. The net loss attributable to ordinary shareholders was $34.0 million, an improvement from $37.3 million in 2020. The company anticipates key data presentations at the 63rd ASH Meeting in December 2021.
Autolus Therapeutics plc (Nasdaq: AUTL) announced its plan to release third quarter 2021 financial results on November 3, 2021, before U.S. markets open. The company’s management will host a conference call at 8:30 am ET to discuss the financial results and provide a business update. Interested parties can access the webcast through the company’s events section on its website. The call can also be dialed in using provided numbers for U.S. and international callers with a reference conference ID of 6984737.
Autolus Therapeutics has received planning approval to construct a new manufacturing facility in Stevenage, UK, aimed at enhancing global commercial launch capacity for obe-cel (AUTO1). The 70,000 square foot facility will allow for GMP production of approximately 2,000 batches annually, with potential for expansion. The company anticipates pivotal data from the FELIX study in 2022 for treating adult patients with acute lymphoblastic leukemia (ALL). This new facility positions Autolus to secure its place in Europe's growing biotechnology sector.
Autolus Therapeutics (Nasdaq: AUTL) announced the appointment of John H. Johnson as non-executive chairman of its Board of Directors, effective September 15, 2021. Johnson, with over 30 years in the life sciences sector, previously held executive roles at Strongbridge Biopharma and major firms like Eli Lilly and Pfizer. The company is preparing for pivotal data on obe-cel, a CD19 CAR T cell therapy aimed at treating adult acute lymphoblastic leukemia, expected in 2022. This leadership change is seen as pivotal for advancing Autolus' clinical programs.