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.
Novaremed AG has acquired Metys Pharmaceuticals AG in an all-share transaction, expanding its pipeline of non-opioid treatments for chronic pain. The acquisition includes two new development projects, allowing Novaremed to target neuropathic pain, including chemotherapy-induced peripheral neuropathy (CIPN). This move aligns with Novaremed's strategy to lead in non-opioid pain management. Additionally, Andrew J. Oakley has been appointed to the Board of Directors, enhancing the leadership team. Key objectives include advancing clinical studies and seeking further capital for development.
Autolus Therapeutics plc (Nasdaq: AUTL) has announced its participation in three upcoming virtual investor conferences. These events include the Goldman Sachs Eleventh Annual Biotech Symposium on September 7, the Wells Fargo Healthcare Conference on September 10 at 7:30 am ET, and the H.C. Wainwright & Co 23rd Annual Global Investment Conference on September 13 at 7:00 am ET. Audiences can access live audio webcasts of the presentations through the company's website, with archived versions available for a limited time.
Autolus is focused on developing innovative T cell therapies to treat various cancers.
Autolus Therapeutics has reported promising results from the Phase 1 ALLCAR19 clinical trial of its CD19 CAR-T therapy, obe-cel, published in the Journal of Clinical Oncology. The therapy is designed to minimize toxicity while enhancing patient response rates in relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL). Notably, 85% of participants achieved minimal residual disease negative complete responses at one month, and no patients experienced severe cytokine release syndrome. The company plans to advance obe-cel into the pivotal FELIX study to further evaluate its efficacy.
Autolus Therapeutics (Nasdaq: AUTL) announced that its CAR T cell therapy, obe-cel, has received Promising Innovative Medicine (PIM) designation from the UK Medicines and Healthcare products Regulatory Agency (MHRA). This designation acknowledges obe-cel's potential to significantly benefit adult patients with relapsed/refractory B-cell Acute Lymphocytic Leukemia (ALL). The ongoing FELIX Phase 1b/2 study is exploring its efficacy and safety, with promising implications for early access to treatment for patients with high unmet medical needs.
Autolus Therapeutics (Nasdaq: AUTL) reported its Q2 2021 financial results, revealing a net loss of $33.2 million, or $(0.47) per share, an improvement from $(0.62) per share in the prior year. Cash reserves totaled $216.4 million, projected to fund operations into H1 2023. Promising updates on the obe-cel therapy highlighted a 50% event-free survival rate in adult acute lymphoblastic leukemia patients after 24 months and successful outcomes in B-cell non-Hodgkin lymphoma trials. The company anticipates pivotal data from ongoing trials in 2022.
Autolus Therapeutics has entered an exclusive licensing agreement with Moderna for up to four immuno-oncology targets, permitting Moderna to develop and commercialize mRNA therapeutics utilizing Autolus' proprietary binders.
Autolus will receive upfront payments for each licensed target, along with milestone payments for successful commercialization, plus royalties on net sales. This partnership underscores Autolus' innovative positioning in the biopharmaceutical field, particularly in cancer treatment technologies.
Autolus Therapeutics (AUTL) announced the appointment of Dr. Edgar Braendle as Chief Development Officer, effective immediately. His expertise in oncology development is expected to propel the company's lead program, obe-cel, through its pivotal study aimed at treating relapsed/refractory adult Acute Lymphoblastic Leukemia (ALL). Dr. Braendle previously held leadership roles at Sumitomo Dainippon Pharma Oncology and Boston Biomedical. His experience includes managing global oncology programs and a strong background in clinical affairs. Autolus aims to advance its proprietary CAR T cell therapies.
Autolus Therapeutics plc (Nasdaq: AUTL) will release its second quarter 2021 financial results and operational highlights on August 5, 2021, before U.S. market open. A conference call will follow at 8:30 AM EDT to discuss these results. CEO Christian Itin will also participate in a panel discussion on July 14, 2021, at the William Blair Biotech Focus Conference 2021. Autolus specializes in developing advanced programmed T cell therapies for cancer treatment, leveraging proprietary programming technologies for improved efficacy against malignancies.
Autolus Therapeutics (Nasdaq: AUTL) announced that its CAR T cell therapy, AUTO1 (obe-cel), has received innovative licensing and access pathway (ILAP) designation from the UK MHRA. This designation is part of the regulatory body’s initiative to expedite the development of promising medicines.
CEO Dr. Christian Itin highlighted that this is a crucial step in accelerating the review process for obe-cel, which is currently under investigation for relapsed/refractory adult B-cell Acute Lymphocytic Leukemia (ALL) in a Phase 1b/2 study.
Autolus Therapeutics (AUTL) reported a 100% complete remission rate in patients with indolent B Cell Non-Hodgkin lymphoma, alongside robust CAR T engraftment. No severe Cytokine Release Syndrome (CRS) or Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) occurred. In adult Acute Lymphoblastic Leukemia (ALL), 85% achieved minimal residual disease-negative complete remission. The event-free survival rate at 12 months is 50.2%, indicating potential for obe-cel as a transformative therapy. A conference call on findings will be held on June 11.