AUTOLUS THERAPEUTICS PLC Stock Price, News & Analysis

Autolus Therapeutics published data from the FELIX study of obe-cel in The New England Journal of Medicine, showing promising results for relapsed/refractory adult B-cell Acute Lymphoblastic Leukemia treatment. The study demonstrated a 76.6% overall response rate in the pivotal cohort, with a median follow-up of 20.3 months. The treatment showed low immune-related toxicity, with Grade ≥3 CRS and ICANS observed in only 2.4% and 7.1% of patients respectively. The 12-month event-free survival rate was 49.5%. Obe-cel was recently approved by the FDA as AUCATZYL® and is under review by EU and UK regulators.

Autolus Therapeutics announces FDA approval of AUCATZYL® (obecabtagene autoleucel) for adult B-cell Acute Lymphoblastic Leukemia treatment, ahead of the target PDUFA date. The approval triggers a $30 million milestone payment from Blackstone. Q3 2024 financial results show cash position of $657.1 million, with operating expenses of $67.9 million and net loss of $82.1 million. Marketing authorizations are under review with MHRA and EMA. The company appointed Matthias Will as Chief Development Officer and expects initial data from SLE Phase 1 study in Q1 2025.

Autolus Therapeutics announces FDA approval of AUCATZYL® for treating adults with relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). The approval is based on the FELIX clinical trial, where 63% of evaluable patients achieved overall complete remission, with 42% achieving complete remission within 3 months. The median duration of remission was 14.1 months. Notably, AUCATZYL is the first CAR T therapy approved without requiring a REMS program, showing low levels of Cytokine Release Syndrome (3% Grade 3) and manageable ICANS (7% Grade ≥3). The therapy will be manufactured at Autolus' Nucleus facility in Stevenage, UK, with Cardinal Health handling U.S. distribution.

Autolus Therapeutics (AUTL) will present four abstracts at the ASH Annual Meeting 2024 in San Diego, featuring updates on obecabtagene autoleucel (obe-cel) for adult r/r B-ALL treatment. Key findings include: 84% of responders achieved MRD <10-6 leukemic cells, associated with better survival rates; bridging therapy with Inotuzumab ozogamicin (INO) effectively reduced disease burden; analysis of healthcare resource utilization for managing CRS and ICANS events; and correlation between CAR-HEMATOTOX scores and patient outcomes.

Autolus Therapeutics (Nasdaq: AUTL), a clinical-stage biopharmaceutical company focused on programmed T cell therapies, will release its third quarter 2024 financial results before US markets open on November 12, 2024. The company will host a conference call and webcast at 8:30 am EDT/1:30 pm BST, where management will discuss financial results and provide a business update. Participants must pre-register to receive dial-in details and a personal PIN for the call.

Autolus Therapeutics presented clinical data at the 2024 Lymphoma, Leukemia & Myeloma Congress, focusing on obecabtagene autoleucel (obe-cel) for relapsed/refractory B-Cell Acute Lymphoblastic Leukemia (r/r B-ALL). Key findings suggest:

1. Comparable outcomes for patients regardless of stem cell transplant (SCT) timing pre or post obe-cel, indicating no additional benefit from consolidative transplant.

2. Better outcomes when obe-cel was given as sole treatment to patients with lower tumor burden at lymphodepletion.

3. 78% of obe-cel infused patients achieved CR/CRi.

4. At median 21.5 months follow-up, 49% of responders without SCT were alive and in remission, compared to 28% of those who underwent SCT.

5. Lower tumor burden at lymphodepletion was associated with improved event-free survival in patients without SCT.

These results suggest potential for obe-cel treatment without consolidative SCT in a large subgroup of patients and highlight the importance of reducing tumor burden prior to lymphodepletion for improved outcomes.

Autolus Therapeutics plc (Nasdaq: AUTL) has appointed Dr. Matthias Will as Chief Development Officer, effective September 30, 2024. Dr. Will, joining from Dren Bio, Inc., brings extensive experience in pharmaceutical product development and regulatory milestones. CEO Dr. Christian Itin highlighted Dr. Will's track record and leadership skills as valuable assets for expanding the obe-cel opportunity in oncology and autoimmune diseases.

Dr. Will expressed excitement about joining Autolus as it prepares to commercialize obe-cel for relapsed/refractory adult B-ALL. His previous roles include leadership positions at CRISPR Therapeutics, CytomX Therapeutics, Gilead Sciences, and Novartis Oncology. Dr. Will's appointment aims to strengthen Autolus' development organization and advance its innovative portfolio in oncology.

Autolus Therapeutics (Nasdaq: AUTL) presented clinical data on obecabtagene autoleucel (obe-cel) for relapsed/refractory adult B-cell acute lymphoblastic leukemia (r/r B-ALL) at the SOHO Annual Meeting 2024. The FELIX Phase Ib/II study utilized a tumor burden (TB)-guided dosing strategy, resulting in high CAR T-cell expansion and manageable adverse events.

Key findings:

• 94% of patients received two planned doses
• Overall remission rates: 90% (low TB) and 75% (high TB)
• Peak expansion reached after Dose 2 in both groups
• 50% TB increase associated with 1.754-fold Cmax increase and 2.068-fold AUC0-28days increase

The data support the TB-guided dosing approach in adult r/r B-ALL, highlighting obe-cel's differentiation based on its unique binding properties.

Autolus Therapeutics (NASDAQ: AUTL) reported Q2 2024 financial results and provided business updates. Key highlights include:

1. On track for potential US commercial launch of obe-cel with FDA PDUFA date of November 16, 2024.

2. MAA submitted to MHRA in UK for obe-cel in r/r adult B-ALL.

3. FELIX Phase 2 data showed durable responses, with 40% of patients in ongoing remission without subsequent stem cell transplant.

4. Cash position of $705.9 million as of June 30, 2024.

5. Total operating expenses increased to $58.9 million in Q2 2024 from $44.4 million in Q2 2023.

6. Net loss of $58.3 million for Q2 2024, compared to $45.6 million in Q2 2023.

7. Basic and diluted net loss per share of $0.22 for Q2 2024.