Atara Biotherapeutics
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- Public
- Established
- 2012-01-01
- Employees
- 225
- Market Cap
- $33.6M
- Website
- http://www.atarabio.com
- Introduction
Atara Biotherapeutics, Inc. is an allogeneic T-cell immunotherapy company, which engages in the development of transformative therapies for patients with serious diseases including solid tumors, hematologic cancers, and autoimmune diseases. It also delivers off-the-shelf treatments to patients with high unmet medical need. Its product pipeline includes Tab-cel, ATA188, ATA2271/ATA3271, and ATA3219. The company was founded by Isaac E. Ciechanover on August 22, 2012 and is headquartered in Thousand Oaks, CA.
FDA Rejects ImmunityBio's Expanded Anktiva Application While Lifting Hold on Atara's Ebvallo Trials
• ImmunityBio received an FDA "refusal to file" letter for its application to expand Anktiva's use in bladder cancer patients, causing a 25% stock plunge and prompting calls for agency clarification.
• The rejection comes despite Anktiva's approval last year for a related subset of bladder cancer patients, with ImmunityBio's founder Patrick Soon-Shiong citing "confounding inconsistency" in the FDA's decision-making process.
• In contrast, Atara Biotherapeutics received positive news as the FDA lifted its clinical hold on blood cancer drug Ebvallo and scheduled discussions for resubmission, driving a 6% stock increase.
Atara Biotherapeutics Secures $16 Million Funding to Advance Tab-cel BLA Approval
• Atara Biotherapeutics has priced a $16 million offering of common stock and pre-funded warrants to institutional investors including Adiumentum Capital Management and EcoR1 Capital.
• The proceeds will primarily fund ongoing activities required to achieve biologics license application (BLA) approval for tab-cel, a T-cell immunotherapy leveraging Atara's allogeneic EBV T-cell platform.
• The offering, expected to close around May 16, 2025, includes 834,237 shares at $6.61 per share and pre-funded warrants for 1,587,108 shares at $6.6099 per warrant.
CAR-T Cell Therapy Funding Surges to $141.2 Billion as Industry Expands Globally
• The CAR-T cell therapy industry has raised over $141.2 billion through various financing mechanisms, with estimates suggesting total industry funding could reach $281.7 billion when including undisclosed deals.
• More than 170 companies worldwide are developing CAR-T products with 1,944 therapies in development, while 13 CAR-T cell therapies have received regulatory approval globally since 2017.
• Despite a slowdown in IPOs and M&A activity in 2024, venture capital funding remains strong with 89 CAR-T companies securing $7.7 billion since 2014, supporting advancement in both blood cancer and solid tumor applications.
Leap Therapeutics Halves Workforce and Refocuses Cancer Drug Development Amid Market Challenges
• Leap Therapeutics has announced a significant restructuring, reducing its workforce by approximately 50% and narrowing the development focus of its lead cancer drug candidate in response to challenging market conditions.
• The strategic pivot aims to extend the company's cash runway while concentrating resources on the most promising clinical applications of its lead oncology asset, potentially improving its chances for regulatory success.
• This move follows similar restructuring trends across the biotech sector, with companies like Arcturus, NGM Bio, and Erasca all recently announcing staff reductions and pipeline reprioritizations to navigate the difficult funding environment.
B-Cell Lymphoma Pipeline Expands with 300+ Therapies in Development for 2025
• DelveInsight's latest report reveals a robust B-cell lymphoma pipeline with over 295 companies developing 300+ therapies, highlighting significant industry investment in this area.
• Several major pharmaceutical companies including BeiGene, Celgene, Hoffmann-La Roche, and Allogene Therapeutics have initiated pivotal late-stage clinical trials for novel B-cell lymphoma treatments in March 2025.
• Emerging therapies include CAR-T cell approaches, bispecific antibodies, and novel targeted agents, with many incorporating dual-targeting mechanisms to overcome resistance seen with single-target therapies.
Scholar Rock's Phase III Trial Advances Apitegromab Development for Spinal Muscular Atrophy
• Scholar Rock's Phase III clinical trial demonstrates promising results for apitegromab in treating spinal muscular atrophy, marking a significant advancement in neuromuscular disease therapeutics.
• The company's strategic initiatives and positive trial outcomes have attracted favorable analyst attention, leading to optimistic market projections and strengthened investor confidence.
• The development represents a potential breakthrough for SMA patients, offering a novel therapeutic approach that complements existing treatment options.
Azitra Advances Clinical Programs for Netherton Syndrome and EGFR Inhibitor-Associated Rash
• Azitra has initiated a Phase 1b trial for ATR-12 in Netherton syndrome patients, with initial safety data expected in H1 2025 and topline results by year-end 2025.
• The company received FDA clearance and Fast Track designation for ATR-04, targeting EGFR inhibitor-associated skin rash, with Phase 1/2 trial initiation planned for first half of 2025.
• Preclinical data showed ATR-12 significantly reduced protease activity in Netherton syndrome skin samples, while ATR-04 demonstrated inhibition of key disease drivers IL-36g and S. aureus.
Cell and Gene Therapy CDMO Market Set to Reach $74 Billion by 2034, Growing at 28% CAGR
• The global cell and gene therapy CDMO market is projected to grow from $8.07 billion in 2025 to $74.03 billion by 2034, expanding at a robust CAGR of 27.92% as demand for advanced therapies increases.
• North America currently dominates the market with 67% share, while Asia Pacific is expected to grow fastest at a 29.03% CAGR due to strategic expansions and government support for regulatory frameworks.
• Technological advancements including AI integration, automation, and decentralized manufacturing are transforming the CDMO landscape, with oncology applications representing 50% of the current market.
Alumis and Acelyrin Announce Merger to Create $737M Clinical-Stage Biopharma Company
• Alumis and Acelyrin have agreed to merge in an all-stock transaction, creating a combined entity with $737 million in cash runway extending into 2027.
• The merged company will retain the Alumis name and prioritize development of two TYK2 inhibitors targeting conditions including psoriasis, lupus, and multiple sclerosis.
• Acelyrin's thyroid eye disease drug lonigutamab is included in the deal but will undergo strategic review to assess its market differentiation potential.
FDA Issues Warning to Sanofi for API CGMP Deviations; Clinical Hold Placed on Atara Biotherapeutics
• The FDA issued a warning letter to Sanofi, citing significant deviations from CGMP standards at its Genzyme facility, potentially leading to regulatory actions.
• Atara Biotherapeutics faces a clinical hold on its IND applications, including Ebvallo and ATA3219, due to GMP compliance issues at a third-party manufacturing site.
• Atara Biotherapeutics is collaborating with the FDA to address the issues and aims to submit the necessary data for the release of the clinical hold, prioritizing patient safety.
• Sanofi's partnership with Scribe Therapeutics reached a milestone, potentially earning Scribe over $1.2 billion, while Atara's Ebvallo received EMA clearance for testing at a FUJIFILM facility.
Atara Biotherapeutics Navigates Regulatory Hurdles and Financial Uncertainty
• Atara Biotherapeutics faces an FDA clinical hold on ATA3219 and EBVALLO due to manufacturing issues, delaying product sales and increasing perceived risk.
• The company's need for additional financing to support its key programs is crucial, but uncertainties around resolving the clinical hold complicate matters.
• Recent workforce reductions, affecting about half of its employees, reflect ongoing challenges following the FDA's Complete Response Letter for EBVALLO.
• Atara is exploring strategic options, including potential mergers or acquisitions, to secure funding amidst regulatory and manufacturing challenges.
FDA Places Clinical Hold on Atara Biotherapeutics' Cell Therapy Programs Due to Manufacturing Concerns
• The FDA has placed a clinical hold on Atara Biotherapeutics' EBVALLO (tabelecleucel) program and ATA3219, pausing new patient enrollment.
• The hold is linked to GMP compliance issues at a third-party manufacturing facility, as identified in the Complete Response Letter for EBVALLO.
• Existing patients who may benefit clinically can continue treatment, while Atara collaborates with the FDA to resolve the manufacturing issues.
• Atara is working with the FDA to address the issues and aims to resubmit the BLA for EBVALLO, potentially securing approval within six months of resubmission.
Atara Biotherapeutics' Ebvallo Nears EU Approval for Transplant Complication Therapy
Atara Biotherapeutics' cell therapy, Ebvallo, is on the verge of becoming the first allogeneic T-cell therapy approved globally, targeting Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD). The EMA's human medicines committee has recommended its approval as a second-line therapy, showing promising results in clinical trials with a 50% overall response rate and a significant improvement in one-year survival rates among responders.
Biopharma Industry Faces Continued Layoffs in 2025 Amid Strategic Realignments
• Biopharma companies continue to announce layoffs in 2025, driven by strategic realignments, pipeline reprioritizations, and challenging financial conditions.
• Several companies, including Intellia Therapeutics and IGM Biosciences, are cutting a significant portion of their workforce to focus on key programs and extend cash runways.
• These workforce reductions are often accompanied by discontinuation of certain drug development programs and a shift in strategic focus towards core assets.
• The layoffs reflect a broader trend in the industry as companies adapt to evolving market dynamics and prioritize efficiency and long-term sustainability.
CAR T-Cell Therapy Shows Promise in Treating Autoimmune Diseases: Clinical Trials and Future Directions
• UChicago Medicine launched a Phase 2 clinical trial to explore CAR T-cell therapy for systemic lupus erythematosus, inflammatory myositis, and systemic sclerosis.
• CAR T-cell therapy, initially for blood cancers, is being adapted to autoimmune diseases, potentially offering a new solution for resistant cases.
• BMS reported promising Phase 1 trial results using CD19 CAR T-cells for severe autoimmune diseases, showing significant disease activity reduction.
• Researchers are optimistic about CAR T-cell therapy's potential to 'reset' the immune system, but emphasize the need for long-term data and safety monitoring.
Advancements in Gene and Cell Therapies Target Diverse Diseases
• Ultragenyx seeks accelerated FDA approval for UX111, a gene therapy for MPSIII, based on Phase 1/2/3 trial data.
• Arbor Biotechnologies' CRISPR-based therapy ABO-101 receives clearance for US trial in Primary Hyperoxaluria Type 1.
• Allogene Therapeutics' ALLO-329 cleared by FDA for Phase 1 trial in rheumatology indications including lupus.
• uniQure progresses in trial for SOD1-ALS gene therapy AMT-162, advancing to the second cohort enrollment.
Cell Therapy and Targeted Therapies Dominate Oncology Advances in Early 2025
• The FDA issued a CRL for Atara Biotherapeutics' tabelecleucel due to third-party manufacturing issues, not efficacy or safety data, delaying potential approval for EBV+ PTLD.
• EsoBiotec dosed the first patient in a trial for ESO-T01, an in vivo BCMA-directed CAR-T therapy for multiple myeloma, aiming for lower costs and simplified administration.
• Obecabtagene autoleucel (obe-cel) gained FDA approval for relapsed/refractory B-cell precursor ALL, offering a less toxic CD19-directed CAR T-cell therapy option.
• Arlocabtagene autoleucel (arlo-cel) shows promise in heavily pretreated relapsed/refractory multiple myeloma, eliciting a 48% complete response rate in phase 1 studies.
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