Tabelecleucel

FDA Rejects ImmunityBio's Expanded Anktiva Application While Lifting Hold on Atara's Ebvallo Trials

4 days ago

• 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

7 days ago

• 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.

Azitra Advances Clinical Programs for Netherton Syndrome and EGFR Inhibitor-Associated Rash

3 months ago

• 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.

FDA Issues Warning to Sanofi for API CGMP Deviations; Clinical Hold Placed on Atara Biotherapeutics

4 months ago

• 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

4 months ago

• 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.

Novo Nordisk's High-Dose Wegovy Shows Promising Weight Loss Results; FDA Approves Expanded Uses for Amgen and AstraZeneca Drugs

4 months ago

Novo Nordisk's high-dose Wegovy demonstrated significant weight loss in a Phase 3b study, with participants losing an average of 20.7% of their body weight. Meanwhile, the FDA approved AstraZeneca's Calquence for first-line treatment of mantle cell lymphoma and Amgen's Lumakras for colorectal cancer, marking significant advancements in cancer treatment.

FDA Places Clinical Hold on Atara Biotherapeutics' Cell Therapy Programs Due to Manufacturing Concerns

4 months ago

• 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.

FDA Rejects Atara Biotherapeutics' Blood Cancer Treatment, Shares Plunge

4 months ago

Atara Biotherapeutics faced a significant setback as the FDA rejected its application for a blood cancer treatment, leading to a sharp decline in its stock value. The company plans to address the FDA's concerns, primarily related to a third-party manufacturing facility, and resubmit the application, expecting approval within six months. To support its efforts, Atara has secured potential funding and is considering strategic options including a merger or acquisition.

Atara Biotherapeutics' Ebvallo Nears EU Approval for Transplant Complication Therapy

4 months ago

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.

FDA Decision on Atara Biotherapeutics' Tab-cel Expected Soon

4 months ago

Atara Biotherapeutics anticipates an FDA decision on its lead product candidate, tabelecleucel (tab-cel), for treating EBV+ PTLD, a rare blood cancer. The company also reports progress on its ATA3219 CAR T program, with significant milestones expected in 2025. A partnership with Pierre Fabre could further bolster Atara's financial position upon U.S. approval of tab-cel.

Biopharma Industry Faces Continued Layoffs in 2025 Amid Strategic Realignments

4 months ago

• 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.

FDA Gears Up for Critical Decisions on Alzheimer's, Breast Cancer, and Neurological Therapies in Early 2025

5 months ago

• The FDA is set to decide on Biogen and Eisai's Leqembi for monthly intravenous maintenance in early Alzheimer's disease, potentially improving patient convenience. • AstraZeneca and Daiichi Sankyo await a decision on Dato-DXd for metastatic HR-positive, HER2-negative breast cancer, offering a new antibody-drug conjugate approach. • Vertex's suzetrigine, a non-opioid analgesic for moderate-to-severe acute pain, anticipates FDA verdict, representing a novel drug class for pain management. • SpringWorks' mirdametinib is under priority review for neurofibromatosis type 1-associated plexiform neurofibromas, addressing a significant unmet need.

VANCE Trial: T Cell Therapy Shows Promise in Subgroup of Solid Tumor Patients

6 months ago

• The VANCE trial, the largest T cell therapy trial for solid tumors, demonstrated the feasibility of large-scale T cell production and delivery. • While the overall trial did not show a survival benefit, a subset analysis revealed improved progression-free and overall survival in patients treated with EBV-CTL therapy plus chemotherapy. • Researchers are now focused on identifying biomarkers to refine patient selection and optimize T cell therapy design for enhanced outcomes. • The study underscores the potential of personalized T cell therapies and the need for further research to improve efficacy in solid tumors.

Cell Therapy and Targeted Therapies Dominate Oncology Advances in Early 2025

7 months ago

• 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.

Intellia Therapeutics Initiates Phase 3 Trial of NTLA-2002 for Hereditary Angioedema

8 months ago

• Intellia Therapeutics has dosed the first patient in its Phase 3 HAELO trial evaluating NTLA-2002 for hereditary angioedema (HAE). • The HAELO trial is a global, randomized, double-blind, placebo-controlled study involving 60 adults with Type I or Type II HAE. • NTLA-2002, a single-dose CRISPR-based therapy, targets the _KLKB1_ gene to reduce plasma kallikrein activity and prevent HAE attacks. • Intellia anticipates completing enrollment in the second half of 2025 and plans for a potential U.S. launch in 2027, pending regulatory approval.

FDA Grants Priority Review to Tabelecleucel for EBV+ PTLD Treatment

10 months ago

• The FDA has accepted Atara Biotherapeutics' BLA for tabelecleucel, a monotherapy for Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD). • Tabelecleucel's BLA received Priority Review, setting a PDUFA target action date of January 15, 2025, highlighting the urgent need for new treatments. • The BLA is supported by data from over 430 patients, including the ALLELE study, which demonstrated a 48.8% Objective Response Rate (ORR). • Tabelecleucel has already been granted marketing authorization in Europe, the UK, and Switzerland under the brand name Ebvallo.

FDA Grants Fast Track Status to BBO-8520 for KRAS G12C-Mutated NSCLC

5 years ago

• The FDA has granted fast track designation to BBO-8520, an oral agent under investigation for treating KRAS G12C-mutated metastatic non-small cell lung cancer. • This designation aims to expedite the development and review of BBO-8520, addressing an unmet need in previously treated NSCLC patients. • The decision was based on the drug's potential to improve outcomes in this specific genetic subgroup of lung cancer, where treatment options are limited.

Drug Development Updates