Item 5.02 Departure of Directors or Certain Officers; Election of Directors;
Appointment of Certain Officers; Compensatory Arrangements of Certain
Officers.
On
Prior to the Effective Date, the Company expects to enter into amended
employment agreements and related benefits and compensatory arrangements with
each of
Item 8.01 Other Events.
In connection with announcing the executive transitions described in Item 5.02 above, the Company provided the following update regarding certain of its development programs:
P-PSMA-101 Autologous CAR-T for Prostate Cancer
A Phase 1 trial evaluating P-PSMA-101, the Company's autologous CAR-T candidate
for the treatment of metastatic castrate resistant prostate cancer (mCRPC) is
ongoing. Initial clinical data was presented in late
P-BCMA-ALLO1 Allogeneic CAR-T for R/R Multiple Myeloma
The Phase 1 trial of P-BCMA-ALLO1, an allogeneic CAR-T product candidate for the
treatment of relapsed refractory multiple myeloma, is currently initiating with
a clinical data update expected later in the year. In addition to the continued
product manufacturing at the current contract manufacturing organization, the
Company is exploring a parallel path to enable manufacturing of P-BCMA-ALLO1 at
its in-house GMP manufacturing pilot plant in
P-MUC1C-ALLO1 Allogeneic CAR-T for Solid Tumors
The Company announced on
Dual P-CD19CD20-ALLO1 Allogeneic Car T for B-cell Malignancies
Due to the prioritization of the lead allogeneic programs and the focus on achieving associated milestones in 2022, the Company is shifting expectations for an IND filing of its first dual CAR-T program from the end of 2022 into 2023.
P-OTC-101 In Vivo Liver Directed Gene Therapy for OTC
The Company's leading internal gene therapy program, P-OTC-101, an in vivo liver-directed gene therapy for ornithine transcarbamylase (OTC) deficiency, continues with IND enabling activities and evaluation of both a fully nanoparticle delivery approach as well as a hybrid nanoparticle/AAV approach. A decision of whether to pursue the fully nanoparticle or hybrid approach going forward is expected by mid-year.
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Forward-Looking Statements
Statements contained in this report regarding matters that are not historical
facts are "forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. Such forward-looking statements
include statements regarding, among other things, the potential benefits of the
Company's technology platforms and product candidates, the Company's plans and
strategy with respect to developing its technologies and product candidates, and
anticipated timelines and milestones with respect to the Company's development
programs and manufacturing activities. Because such statements are subject to
risks and uncertainties, actual results may differ materially from those
expressed or implied by such forward-looking statements. These forward-looking
statements are based upon the Company's current expectations and involve
assumptions that may never materialize or may prove to be incorrect. Actual
results could differ materially from those anticipated in such forward-looking
statements as a result of various risks and uncertainties, which include,
without limitation, risks and uncertainties associated with development and
regulatory approval of novel product candidates in the biopharmaceutical
industry and the other risks described in the Company's filings with the
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