PRECISION BIOSCIENCES, INC. Item 7.01.Regulation FD Disclosure.
On
As described in the accompanying press release, the Company will host a
conference call and webcast today,
The information contained in this Item 7.01 (including Exhibit 99.1) is being furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that Section, nor shall it deemed to be incorporated by reference in any filing of the Company under the Securities Act or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 8.01.Other Events.
On
As of
Efficacy
• Use of eLD mitigated PBCAR0191 rejection and markedly increased peak cell
expansion (~72x) and area under the curve (~59x), each as compared to sLD.
• A single dose of PBCAR0191 cells following eLD yielded clinical responses in
the majority of patients, with overall response rates ("ORR") and complete
response ("CR") rates of 75% and 50%, respectively, at Day ? 28.
• Five of nine responding patients (56%) who received PBCAR0191 cells following
eLD remained progression-free, including four of nine evaluable subjects with
responses lasting greater than 4 months. Assessment of duration of response
is on-going.
• Median interval from confirmation of eligibility to start of LD was 1 day,
reinforcing the potential feasibility for rapid delivery of off-the-shelf,
allogeneic, cellular therapy for high-risk patients.
Day ? 28 Evaluation All eLD Subjects CD19-CAR T Naïve Prior Auto CAR
(n=12) (n=8) (n=4)*
Overall Response Rate n (%) 9 (75%) 6 (75%) 3 (75%)
Complete Response n (%) 6 (50%) 4 (50%) 2 (50%)
* Three of four responding patients had prior auto-SCT and auto CD19 CAR treatment.
11 Fludarabine (30 mg/m2/day for 4 days) and cyclophosphamide (1000 mg/m2/day
for 3 days)
22 Fludarabine (30 mg/m2/day for 3 days) plus cyclophosphamide (500 mg/m2/day
for 3 days)
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Safety and Tolerability
As of
Adverse Event Max Grade sLD eLD
(n=6) (n=12)
CRS Grade 1 or Grade 2 3 (50%) 7 (58%)
(Cytokine release syndrome) Grade 3 or higher 0 0
ICANS Grade 1 or Grade 2 2 (33%) 3 (25%)
(Immune effector cell-associated neurotoxicity) Grade 3 or higher 0 1 (8%)
GvHD 0 0
(Graft versus host disease)
Neutropenia Grade 3 or higher 0 2 (17%)
Grade 3+ at Day 28 0 2 (17%)
Infection Grade 1 or Grade 2 0 1 (8%)
Grade 3 or higher 0 3 (25%)
Three treatment emergent deaths without disease progression occurred including
two cases of infection and one case of cardiac arrest after a choking incident.
Two of these patients were in ongoing complete responses at time of death. Only
one death, as previously reported on
Demographics for Enrolled R/R NHL Patients (PBCAR0191 with eLD)
• Over 80% of subjects had advanced and aggressive lymphomas.
• 75% had stage III/IV disease.
• Subjects had received a median of seven lines of therapy prior to study
enrollment.
• 33% of subjects had prior CD19 directed CAR therapy.
PBCAR19B Immune Evading Stealth Cell
The Company announced that initial clinical trial sites have been selected and enrollment is now open in the Phase 1 study of PBCAR19B, a next-generation, stealth cell candidate for patients with CD19-positive malignancies such as R/R NHL. PBCAR19B will be evaluated at increasing flat dose levels beginning at 2.7 x 108 cells using sLD with the ability to dose up to 8.1 x 108 cells. Of note, the first dose level is approximately equivalent to Dose Level 3 in the PBCAR0191 trial.
Forward-Looking Statements
Statements in this Current Report on Form 8-K regarding management's future
expectations, beliefs, intentions, goals, strategies, plans or prospects are
forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995, including but not limited to statements regarding
our clinical development pipeline and the clinical benefit of our product
candidates. Forward-looking statements may be identified by words such as
"anticipates," "believe," "continue," "expect," "intend," "may," "plan to,"
"potential," "projects," "will," and other similar words or expressions, or the
negative of these words or similar words or expressions. Such forward-looking
statements involve known and unknown risks, uncertainties and other important
factors, including, without limitation, the risks referred to under the section
"Risk Factors" in the Company's Quarterly Report on Form 10-Q for the quarterly
period ended
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Report on Form 8-K and, except as required by applicable law, we have no obligation to update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
Item 9.01.Financial Statements and Exhibits.
(d) Exhibits
Exhibit
No. Description
99.1 Precision BioSciences Press Release, dated June 4, 2021 .
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