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FDA granted Fast Track to Allogene’s ALLO-605 to treat relapsed or refractory multiple myeloma


30/9/2021 | 3 minuty čtení

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Allogene announced that FDA granted Fast Track designation to ALLO-605, the Company’s next-generation AlloCAR T therapy targeting BCMA for the treatment of relapsed or refractory multiple myeloma.

The FDA granted Fast Track designation based on the potential of ALLO-605 to address the unmet need for patients who have failed other standard multiple myeloma therapies.

The phase 1 dose escalation portion of the IGNITE trial evaluating ALLO-605 was initiated in Q2 2021. ALLO-605 is the company’s first TurboCAR clinical candidate. TurboCAR is a proprietary, next generation platform technology based upon programmable cytokine signaling designed to improve the function and potency of AlloCAR T cells. These properties may also enable CAR T therapy to succeed in solid tumors and increase efficacy in hematologic malignancies.


Caribou raised $304 million during IPO to herd off the shelf CAR-Ts into the clinic

Caribou completed upsized $304 million IPO. The company had already raised its goal for the offering - proposing first to sell 13.5 million shares, and then 17 million - before pricing 19 million shares late Thursday at $16, the top end of its $14-$16 range. The deal valued Caribou at $907.3 million. Caribou, one of a handful of companies that holds a license to the foundational CRISPR/Cas9 gene editing IP, is developing next-generation gene-edited cell therapies via its CRISPR hybrid RNA-DNA (chRDNA) platform, designed for greater specificity, efficiency and versatility than first-generation therapies.

The company expects initial clinical data next year from the Phase I ANTLER study of its first clinical candidate, CB-010, an allogeneic CAR T therapy targeting CD19 with a genome-edited knockout of PD-1.

Wugen secured $172 million in Series B to advance its CAR-T therapies

After adding memory NK cells to its cell therapy tool kit last year, Wugen has raised $172 million in a series B round led by Abingworth and Tybourne Capital to advance multiple off-the-shelf therapies for cancer. Wugen launched in 2018 to develop CAR T cell therapies but broadened its scope last year to include memory NK cells after in-licensing the technology from Washington University in St. Louis.

The company believes memory NK cells will be more effective at eliminating cancer cells, as they express more activating receptors and have fewer inhibitory signals. They also produce more cytotoxic effector molecules and cytokines to activate downstream components of the immune system, and they persist longer. Wugen’s lead program WU-NK-101 is in Phase I/II testing to treat relapsed and refractory acute myelogenous leukemia (AML). 

Fastback Bio launches with CAR-T technology from University of North Carolina

Cell and gene therapy platform company Inceptor Bio launched FastBack Bio with technology licensed from Lishan Su’s lab at the University of North Carolina at Chapel Hill to develop T cell therapies targeting difficult-to-treat solid tumors. The start-up plans to develop CAR Ts with co-stimulatory domain M83 as an alternative to CD28 and 4-1BB.

Inceptor said M83 provides CAR T cells with “enhanced expansion kinetics, a balance of effector and central memory phenotypes, and resistance to T cell exhaustion,” adding that murine models have shown that M83-based CAR T cells have enhanced tumor-killing capabilities and are superior to both CD28- and 4-1BB-based CAR-T cells. The newco will have access to Inceptor’s Advanced Manufacturing Platform.

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