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FDA’s speed kills Agenus’ BLA application for PD-1 inhibitor balstilimab


30/12/2021 | 4 minutes to read

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FDA approved Tecartus as first and only CAR-T for relapsed or refractory B-cell ALL

Kite and Gilead announced the FDA has granted approval for Tecartus (brexucabtagene autoleucel) for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

Following FDA Breakthrough Therapy Designation and a priority review, Tecartus is the first and only CAR-Tcell therapy approved for adults with ALL. There is a high unmet need, as half of this patient population will relapse, and median OS is only approximately eight months with current standard-of-care treatments. Patients can access Tecartus through 109 authorized treatment centers across the US.


Allogene reported FDA clinical hold of AlloCAR T trials based on single paitent case in APLHA 2 trial

Allogene reported that following a report of a chromosomal abnormality in ALLO-501A CAR T cells in a patient treated in the ALPHA2 study, FDA has placed a hold on the company’s AlloCAR T clinical trials. Allogene expects to provide additional updates in the coming weeks following consultation with the FDA. The FDA continues to actively review the end of Phase 1 materials submitted in anticipation for an ALLO-501A pivotal Phase 2 trial. The clinical hold follows the company’s notification to FDA of a chromosomal abnormality in an ALPHA2 study patient which was detected in a bone marrow biopsy undertaken to assess pancytopenia. An investigation is underway to further characterize the observed abnormality, including any clinical relevance, evidence of clonal expansion, or potential relationship to gene editing.The single case involves a patient with Stage IV transformed follicular lymphoma and c-myc rearrangement whose cancer was refractory to two prior lines of immune-chemotherapy and additional radiation therapy. The patient could not receive an autologous CD19 CAR T cell therapy due to manufacturing failure associated with inadequate expansion of autologous CAR T cells.

CRISPR Therapeutics reported positive results from its Phase 1 of CTX110 in B cell malignancies

CRISPR Therapeutics announced updated results from its ongoing Phase 1 CARBON trial evaluating the safety and efficacy of CTX110, its wholly-owned allogeneic CAR-T cell therapy targeting CD19+ B-cell malignancies. The positive data from the trial show that CTX110 could offer patients with large B-cell lymphomas an immediately available ‘off-the-shelf’ therapy with efficacy similar to autologous CAR-T and a differentiated safety profile. Based on these encouraging results, the company is planning to expand CARBON into a potentially registrational trial in the first quarter of 2022.


CBMG completed $120 million Series A funding to accelerate its CAR-T therapy pipeline

Cellular Biomedicine Group developing innovative cellular immunotherapies for the treatment of cancer and degenerative diseases announced the closing of a $120 million Series A investment, led by AstraZeneca-CICC Fund, Sequoia Capital China and Yunfeng Capital. Both new and certain existing investors, including GIC and TF Capital, subscribed to the Series A financing. This round of financing will largely be used to accelerate the clinical development of the Company’s immune-oncology platform. Specifically, C-CAR039, an anti-CD19/CD20 bispecific CAR-T therapy for the treatment of patients with relapsed or refractory non-Hodgkin lymphoma and C-CAR088, BCMA therapy for patients with late-stage relapsed/refractory multiple myeloma, as well as armored CAR-T therapies and tumor-infiltrating lymphocytes therapies targeting solid tumors.

MiNK Therapeutics completed its IPO raising $40 million

MiNK Therapeutics, a clinical-stage company focused on allogeneic, off-the-shelf, invariant natural killer T (iNKT) cell therapies to treat cancer and other immune-mediated diseases, announced the closing of its previously announced IPO of 3,333,334 shares of its common stock at a public offering price of $12 per share. The gross proceeds from the offering were $40 million. The company had hoped to sell 4 million shares at $12-$16. MiNK expects data this quarter from a Phase 1 study of lead program AGENT-797 to treat multiple myeloma, as well as a trial to treat acute respiratory distress syndrome secondary to COVID-19. Evercore ISI, William Blair, B. Riley and Baird are underwriters.

LSP and Bpifrance back T cell company Egle’s with €40 million financing

Egle Therapeutics will advance its two lead assets into the clinic and strengthen its internal drug pipeline, having raised €40 million ($46.6 million) in a series A. The financing was co-led by LSP and Bpifrance through their InnoBio 2 fund, with participation from Fund+, Bioqube Ventures and Takeda Ventures. Led by CEO and co-founder Luc Boblet, Egle is developing immunotherapies targeting immune suppressor regulatory T cells for oncology and autoimmune diseases.

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