SOUTH SAN FRANCISCO, Calif. and LONDON, Jan. 06, 2026 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, and Cellares Corp, the first Integrated Development and Manufacturing Organization (IDMO), today announced that Autolus will assess the feasibility of Cellares’ Cell Shuttle platform to complement its commercial manufacturing operations at the Nucleus facility in St ...

CRISPR Therapeutics AG (NASDAQ:CRSP) on Monday provided updates on zugocaptagene geleucel (zugo-cel, formerly CTX112), its investigational allogeneic CAR T targeting CD19, in development for autoimmune disease and hematologic malignancies.Autoimmune DiseaseZugo-cel, targeting CD19, is in an ongoing Phase 1 basket trial in autoimmune rheumatologic diseases.Preliminary clinical data from the Phase 1 study have been encouraging, and zugo-cel has been well-tolerated to date.Also Read: CRISPR Therapeutics’ Inves ...

-Four autoimmune patients treated to date demonstrate deep B-cell depletion sustained for at least 28 days; initial efficacy data suggest significant clinical improvement in patients dosed at the 100 million cell dose, with the first systemic lupus erythematosus (SLE) patient achieving Definitions of Remission in SLE (DORIS) remission through Month 6- -An additional Phase 1 basket trial has been initiated for zugo-cel in refractory primary immune thrombocytopenic purpura (ITP) and warm autoimmune hemolytic ...

Core Insights - Bristol Myers Squibb (BMY) has received FDA approval for the label expansion of Breyanzi (lisocabtagene maraleucel) to treat adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have undergone at least two prior lines of systemic therapy [1][11] Group 1: Product Approval and Market Position - Breyanzi is a CD19-directed CAR T cell therapy already approved for relapsed or refractory large B-cell lymphoma (LBCL) and has received accelerated approval for chronic lymphocytic leukemia and follicular lymphoma [2] - The latest FDA approval makes Breyanzi the only CAR T cell therapy approved for five different cancer types [3][11] - Breyanzi has also been approved in the EU for treating adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy [3] Group 2: Sales Performance - Breyanzi sales surged 100% to $966 million in the first nine months of 2025, driven by strong growth in LBCL and new indications [4][11] - Sales in the U.S. are bolstered by the expansion into new approved indications, while international sales benefit from strong demand in existing and newly launched markets [4] Group 3: Competitive Landscape - Breyanzi faces competition from Gilead Sciences' Yescarta, which is also a CD19-directed CAR T cell therapy approved for similar indications [6][7] - Other competitors include Novartis' Kymriah, which has seen a 12% decline in sales to $296 million in the first nine months of 2025 [8] Group 4: Financial Performance and Valuation - BMY's shares have decreased by 8.2% year to date, contrasting with the industry's growth of 19.9% [10] - BMY is currently trading at a price/earnings ratio of 8.63x forward earnings, which is lower than the large-cap pharma industry's average of 16.95x [13]

Core Insights - Bristol Myers Squibb (BMY) received European Commission (EC) approval for Breyanzi (lisocabtagene maraleucel), expanding its label to include treatment for adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor [2][10] - This marks the fourth approval for Breyanzi in Europe, which is already approved for several other lymphoma types [3][4] Approval Details - The latest EC approval is based on the MCL cohort results from the TRANSCEND NHL 001 trial, where 82.7% of patients responded to Breyanzi, and 71.6% achieved a complete response [5][10] - Sustained clinical benefits were observed, with 50.8% of patients remaining in response at 24 months [5][10] Pipeline Expansion - Bristol Myers is actively seeking to expand its pipeline due to the negative impact of generics on its legacy products like Revlimid, Pomalyst, Sprycel, and Abraxane [6] - The approval of new drugs and label expansions for existing drugs is expected to diversify its portfolio [6] Market Reaction - Shares of BMY increased by 3.3% following positive news from Bayer regarding its cardiovascular candidate asundexian, which met primary efficacy and safety endpoints in a late-stage study [7][9] - The success of Bayer's study has raised investor optimism for BMY's cardiovascular candidate, milvexian, in secondary stroke prevention [9] Study Discontinuation - Bristol Myers and Johnson & Johnson announced the discontinuation of the late-stage Librexia study for milvexian after an interim analysis indicated it was unlikely to meet primary efficacy endpoints [11] - However, two other late-stage studies for milvexian are set to continue, with top-line data expected in 2026 [12]

Core Insights - The U.K.'s NICE has recommended Autolus Therapeutics' Aucatzyl for use in the NHS for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia [1][2] - Aucatzyl will be available through routine commissioning by the NHS, with plans for launch in England and Wales [2] - The MHRA granted conditional marketing authorization for Aucatzyl based on the FELIX study results [3] Company Developments - Autolus Therapeutics is preparing to launch Aucatzyl imminently in England and Wales and is pursuing access through the Scottish Medical Consortium [2] - The stock price of Autolus Therapeutics was reported at $1.38, with a notable increase of 10.48% to $1.37 at the time of publication [5][7] Product Information - Aucatzyl (obecabtagene autoleucel) is an autologous CD19 CAR T cell therapy designed for treating specific types of leukemia [3] - The therapy targets adult patients (≥26 years) suffering from relapsed or refractory B-cell precursor acute lymphoblastic leukemia [1][3]

Core Insights - Autolus Therapeutics plc has received draft guidance from NICE recommending AUCATZYL (obecabtagene autoleucel) for use in the NHS in England and Wales for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL) [1][2] - AUCATZYL is expected to be launched imminently in England and Wales, with plans to pursue access through the Scottish Medical Consortium [1][2] - The therapy has received conditional marketing authorization from the UK MHRA based on the results of the FELIX study, which demonstrated its efficacy [2][4] Company Overview - Autolus Therapeutics plc is an early commercial-stage biopharmaceutical company focused on developing next-generation T cell therapies for cancer and autoimmune diseases [3] - The company utilizes proprietary T cell programming technologies to create targeted and controlled therapies [3] Product Details - AUCATZYL is a CD19 CAR T cell therapy designed to improve clinical activity and safety compared to existing therapies [4] - It was approved by the FDA in November 2024 and received conditional marketing authorization from the MHRA and EMA in 2025 [4]

Core Insights - Autolus Therapeutics plc reported operational and financial results for Q3 2025, highlighting progress in the launch of AUCATZYL and plans for future growth in various therapeutic areas [1][2][5] Financial Performance - The company achieved net product revenue of $21.1 million for Q3 2025, with a deferred revenue balance of $7.6 million as of September 30, 2025 [4][12] - Cost of sales for the quarter totaled $28.6 million, while research and development expenses decreased from $40.3 million to $27.9 million compared to the same period in 2024 [13][14] - Selling, general and administrative expenses increased from $27.3 million to $36.3 million, primarily due to higher employment-related costs [15] - The net loss for Q3 2025 was $79.1 million, a slight improvement from a net loss of $82.1 million in Q3 2024 [17] Product and Pipeline Updates - AUCATZYL is gaining traction in the market, with over 60 treatment centers activated in the U.S. and coverage for more than 90% of U.S. medical lives [5][6] - Data from the ROCCA Consortium will be presented at the ASH Annual Meeting, showcasing real-world outcomes for AUCATZYL in adult patients with relapsed/refractory acute lymphoblastic leukemia [5][6] - The company is advancing obe-cel into pivotal studies for pediatric ALL and severe lupus nephritis, with promising early data [4][9] Leadership and Operational Changes - Autolus has strengthened its leadership team to support the next phase of growth, appointing Cintia Piccina as U.S. Chief Commercial Officer and Miranda Neville as Chief Technical Officer [8][16] - The company aims to optimize business operations and enhance market growth through strategic planning and operational excellence [11][16] Future Outlook - Autolus is well-capitalized with cash and cash equivalents totaling $367.4 million as of September 30, 2025, to support the commercialization of obe-cel and ongoing clinical trials [18][19] - The company anticipates significant data presentations at upcoming conferences, including initial clinical data from the CATULUS trial and longer-term follow-up from the CARLYSLE trial [11][12]

Summary of Lyell Immunopharma Conference Call Company Overview - **Company**: Lyell Immunopharma (NasdaqGS:LYEL) - **Focus**: Development of next-generation CAR T cell therapies for cancer, including hematologic malignancies and solid tumors [6][7] Key Industry Insights - **Acquisition**: Lyell has acquired exclusive global rights to a novel CAR T cell product candidate, LYLE-273, in clinical development for metastatic colorectal cancer [3][7] - **Market Potential**: Colorectal cancer is the second leading cause of cancer death globally, with a market projected to grow from $6 billion to $12 billion by 2032 [12] - **Clinical Need**: Current therapies for metastatic colorectal cancer have poor outcomes, with overall response rates of less than 6% and median overall survival of less than 12 months [13][20] Clinical Data Highlights - **Phase One Trial Results**: - LYLE-273 showed a 67% overall response rate and an 83% disease control rate in patients with refractory metastatic colorectal cancer [10][20] - The median overall survival was 17 months at dose level one, with data not yet reached at dose level two [31] - The trial included patients who had received 2-6 prior lines of therapy, indicating a high-risk population [25][26] Mechanism of Action - **Target**: Guanylyl cyclase C (GCC) is expressed in 95% of colorectal cancers, making it a promising target for CAR T cell therapy [11][22] - **Enhancements**: LYLE-273 is designed with CD19 CAR expression and controlled cytokine release to improve T cell expansion and infiltration into tumors [22][39] - **Safety Profile**: The therapy has a manageable safety profile, with adverse events primarily including grade one or two cytokine release syndrome (CRS) and diarrhea [27][30] Strategic Rationale - **Pipeline Expansion**: The acquisition of LYLE-273 strengthens Lyell's pipeline in oncology, particularly in solid tumors, which represent over 90% of all cancers [7][47] - **Future Development**: There is potential to explore LYLE-273 in earlier lines of therapy and other GCC-expressing tumors, such as pancreatic cancer [62][76] Financial Terms of Acquisition - **Payment Structure**: ICT received $40 million and 1.9 million shares of Lyell stock, with additional payments based on clinical, regulatory, and commercial milestones [11][47] Future Outlook - **Clinical Trials**: Enrollment in the phase one trial of LYLE-273 continues, with further data expected in 2026 [36][52] - **Manufacturing Capacity**: Lyell operates a manufacturing facility capable of producing over 1,200 doses annually, supporting both clinical and early commercial needs [52] Conclusion - **Optimism for Impact**: The promising initial clinical data for LYLE-273 positions Lyell favorably in the competitive landscape of colorectal cancer therapies, with a focus on delivering significant clinical benefits to patients [52][70]

Core Insights - Cabaletta Bio, Inc. is advancing its investigational CAR T cell therapy, rese-cel, showing promising drug-free clinical responses in autoimmune diseases with a favorable safety profile [1][4][9] - The company plans to submit a Biologics License Application (BLA) for rese-cel in 2027, based on data from a 14-patient registrational cohort in the RESET-Myositis trial [1][5] - Recent operational highlights include rapid enrollment in clinical trials and positive data presentations across multiple autoimmune diseases, including myositis, systemic sclerosis, lupus, and myasthenia gravis [2][4] Clinical Development - Rese-cel is designed to transiently deplete CD19-positive cells to reset the immune system, aiming for durable clinical responses without chronic therapy [3][4] - Positive clinical data from 32 patients across four autoimmune trials were presented, indicating the potential for transformative, drug-free responses [4] - Initial data from the RESET-PV trial showed complete B cell depletion in 2 of 3 patients treated with a low dose of rese-cel without preconditioning, leading to plans for expanded enrollment [4][5] Regulatory Updates - The European Medicines Agency (EMA) granted PRIME access for rese-cel for myositis, while the FDA awarded RMAT and Fast Track designations for systemic lupus erythematosus and generalized myasthenia gravis [9] - The company anticipates alignment with the FDA on registrational cohort designs for RESET-SSc and RESET-SLE trials by the end of 2025 [9] Financial Performance - For Q3 2025, research and development expenses were $39.8 million, up from $26.3 million in Q3 2024, while general and administrative expenses remained stable at $6.8 million [10][16] - The net loss for Q3 2025 was $44.9 million, compared to a net loss of $30.6 million in Q3 2024 [10][16] - As of September 30, 2025, the company had cash and equivalents of $159.9 million, expected to fund operations into the second half of 2026 [10][18] Corporate Updates - Steve Gavel was appointed Chief Commercial Officer in October 2025, bringing experience from Legend Biotech to lead global commercial strategy for rese-cel [7]