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FDA accepts Genocea Biosciences GEN-011 IND application. 

Genocea Biosciences recently announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) Application for GEN-011, an adoptive T cell therapy targeting neoantigens and designed to improve upon the limitations of TIL and TCR therapies. 

The IND allows Genocea to initiate a Phase 1/2a clinical study of GEN-011 in patients who have failed standard-of-care checkpoint inhibitor therapy. The trial will evaluate safety, T cell proliferation and persistence as well as clinical activity.

Genocea plans to enroll up to 24 patients across several tumor types in the Phase 1/2 trial and will be divided in batches. In one batch, patients will receive multiple low doses of GEN-011 with low-dose IL-2 and without lymphodepletion. In the other batch, patients will receive a single GEN-011 dose after lymphodepletion and a high dose of IL-2.

(Source: Biospace, 2020)


FDA Grants Fast Track Designation to Precision Biosciences’ CAR T-cell Therapy.

The U.S. Food and Drug Administration (FDA) has granted fast track designation to PBCAR269A, Precision BioSciences‘ donor-derived CAR T-cell therapy for the treatment of relapsed or refractory multiple myeloma.

The grant will help facilitate the development and accelerate the review, of new medications that aim to treat serious conditions and fill an unmet medical need. It is given the potential for accelerated approval and priority review.

PBCAR269A is an allogeneic, or donor-derived CAR T-cell therapy that uses T-cells from healthy donors, allowing for the production of an “off-the-shelf” treatment that may potentially be used in numerous patients. Moreover, a donor-derived CAR T-cell therapy could reduce the costs of the treatment.

(Source: Myeloma Research News, 2020)


Pfizer and Vivet Therapeutics enter into a manufacturing deal for treatment of Wilson Disease.

Vivet Therapeutics and Pfizer recently announced that they have entered into a manufacturing agreement, under which Pfizer will provide clinical supply for a Phase 1/2 clinical trial evaluating Vivet’s proprietary, investigational gene therapy, VTX-801, for the potential treatment of Wilson disease, a rare and potentially life-threatening liver disorder.

The trial is expected to begin in early 2021 and no other terms of the agreement were disclosed.

The Phase 1/2 clinical supply for VTX-801 is reported to be manufactured in Pfizer’s facility in North Carolina.

Back in March 2019, Pfizer acquired a minority equity interest in Vivet Therapeutics and secured an exclusive option to acquire all outstanding shares. It was also reported that they would collaborate on the development of VTX-801, for which an Investigational New Drug (IND) application is planned to be sent to the U.S. Food and Drug Administration (FDA) in 2020.

(Source: Business Wire, 2020)