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Breyanzi
Breyanzi

FDA approved Brayanzi for patients with relapsed or refractory follicular lymphoma

Sotio Biotech

11/7/2024 | 3 minutes to read

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BMS announced the FDA has granted accelerated approval for Breyanzi (liso-cel), a CD19-directed CAR-T cell therapy, for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

CLINICAL AND REGULATORY 

Breyanzi approved by FDA for relapsed or refractory follicular lymphoma 

The Phase 2 TRANSCEND study included the largest primary analysis set of patients with relapsed or refractory FL of a clinical trial evaluating a CAR T cell therapy in this patient population. Based on the US Prescribing Information (USPI), in patients treated with Breyanzi in the third-line plus setting and included in the primary efficacy analysis set (n=94), the ORR was 95.7% (95% CI: 89.5-98.8). ORR was defined as the percentage of patients achieving a partial or complete response per Lugano criteria as assessed by an IRC. The CR rate was 73.4% (95% CI: 63.3-82.0) and required a negative bone marrow biopsy for confirmation. Responses were rapid and durable with a median time to response of one month (range: 0.6-3.3) and median DOR not reached (95% CI: 18.04-NR), with 80.9% of responders remaining in response at 12 months, and 77.1% of responders remaining in response at 18 months. Results from the primary analysis of TRANSCEND FL presented at the 2023 International Conference on Malignant Lymphoma showed an ORR of 97% (95% CI: 91.6-99.4; one-sided p<0.0001) in efficacy evaluable patients (n=101), with 94% of patients achieving a CR (95% CI: 87.5-97.8; one-sided p<0.0001). 

DEALS AND FINANCING 

AstraZeneca completed equity investment agreement with Cellectis 

AstraZeneca announced the successful completion of an equity investment with Cellectis, a clinical-stage biotechnology company. The equity investment and a research collaboration agreement, announced in November 2023 will leverage the Cellectis proprietary gene editing technologies and manufacturing capabilities, to design up to 10 novel cell and gene therapy products for areas of high unmet need, including oncology, immunology and rare diseases. In Q4 2023, Cellectis received an initial payment of $105 million from AstraZeneca, which comprised a $25 million upfront cash payment under the terms of a research collaboration agreement and an $80 million equity investment. An additional $140 million equity investment, at $5 per share, has closed following the satisfaction of customary closing conditions including Cellectis shareholders’ approval and regulatory clearances. Post-closing of this second investment, AstraZeneca holds a total equity stake of c.44% in Cellectis. AstraZeneca expects to continue to treat its investment in Cellectis as an associate. Under the terms of the research collaboration, Cellectis is also eligible to receive an IND option fee and development, regulatory and sales-related milestone payments, ranging from $70 million up to $220 million, per each of the 10 candidate products, plus tiered royalties. AstraZeneca retains an option for a worldwide exclusive license for the candidate products developed under the research collaboration agreement, to be exercised before IND filing. 

Allogene announced pricing of $110 million offering of common stock 

Allogene Therapeutics announced the pricing of an underwritten offering of 37,931,035 shares of its common stock at a price of $2.90 per share. The gross proceeds from this offering are approximately $110 million. The offering is anchored by mutual funds and large institutional investors and includes leading healthcare specialists as well as certain members of the Allogene Board of Directors and Executive Management Team. The offering is expected to close on or about May 16, 2024, subject to customary closing conditions. Goldman Sachs was acting as sole book-running manager for the offering. 

OverT Bio raised $16 million to develop next generation cell therapies 

OverT Bio, a data-driven company working to unlock the curative potential of cell therapies in solid tumors, announced that it has raised $16 million in seed funding. The round was co-led by ARTIS Ventures and Wing VC, with participation from Fusion Fund, OMX Ventures, Alexandria Venture Investments, Gaingels, Civilization Ventures, Hawktail, and Cancer Research Institute. The funding will go toward expanding discovery platforms focused on addressing the primary barriers for cell therapy, leading to durable and curative treatments for advanced solid tumor.

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