Unum Therapeutics Announces New Data at the American Society of Hematology (ASH) Annual Meeting
December 07 2019 - 2:45PM
Unum Therapeutics Inc. (NASDAQ: UMRX), a clinical-stage
biopharmaceutical company focused on developing curative cell
therapies for cancer, today announced Phase 1 clinical updates for
its Antibody-Coupled T cell Receptor (ACTR) engineered T-cell
therapies, ACTR707 and ACTR087, in patients with relapsed or
refractory CD20+ non-Hodgkin Lymphoma (r/r NHL) at the ASH Annual
Meeting, being held December 7-10, in Orlando, FL.
“The clinical data presented at this year’s ASH
include updates from the ongoing Phase 1 trial of ACTR707 in
combination with rituximab and the completed Phase 1 trial of
ACTR087 in combination with rituximab, both conducted in patients
with relapsed or refractory CD20+ NHL,” said Jessica Sachs, M.D.,
Chief Medical Officer of Unum. “The data with ACTR707 at this
year’s ASH continue to support further dose-escalation in this
Phase 1 trial and provide proof-of-mechanism for the ACTR platform
that we are also applying in our lead program, a Phase 1 trial with
ACTR707 in combination with trastuzumab in HER2+ solid tumor
cancers. Safety data from the Phase 1 trial with ACTR087
presented at this year’s ASH provide learnings that are being
applied to ongoing clinical trials with ACTR T cell
products.
Poster (#1587) Title: “Preliminary Clinical Results from a Phase
1 Study of ACTR707 in Combination With Rituximab in Subjects with
Relapsed or Refractory CD20+ Non-Hodgkin Lymphoma”
- ATTCK-20-03 is a Phase 1,
multicenter, open-label, single-arm, dose-escalation trial
evaluating ACTR707 in combination with rituximab in patients with
r/r CD20+ NHL who, among other criteria, received adequate prior
anti-lymphoma therapy, including anti-CD20 monoclonal antibody and
chemotherapy. In this update from the first 20 patients treated,
treatment with ACTR707 combined with rituximab generated clinical
responses with no reports of cytokine-release syndrome (CRS) or
severe neurotoxicity.
- As reported today at ASH, a
complete response was achieved in 40% (eight of 20) of patients in
Cohorts 1 through 4. Of the eight complete responders, four
remained in complete response at six months of follow-up, two
remain in complete response but have not yet reached the six-month
timepoint for evaluation, and two progressed before the six-month
timepoint (Table 1).
Table 1: ACTR707 Preliminary Phase 1 trial clinical response
results in r/r NHL (Cohorts 1-4) |
|
|
|
Clinical Response (1) |
Cohort 1 (n=6) |
Cohort 2 (n=3) |
Cohort 3 (n=5) |
Cohort 4 (n=6) |
Cohorts 1-4 (n=20) |
Complete Response |
3 |
1 |
2 |
2 |
40% (8/20) |
Partial Response |
0 |
1 |
2 |
0 |
15% (3/20) |
Stable
Disease |
0 |
0 |
0 |
1 |
5% (1/20) |
Indeterminate Response |
1 |
0 |
0 |
0 |
5% (1/20) |
Progressive
Disease |
2 |
1 |
1 |
3 |
35% (7/20) |
Overall Response Rate |
50% (3/6) |
67% (2/3) |
80% (4/5) |
33% (2/6) |
55% (11/20) |
ACTR707+T
cells administered, target per patient (range) |
25M
(23-38M) |
40M
(30-50M) |
55M
(45-55M) |
80M
(65-100M) |
|
(1) Data
cutoff as of Nov 2019 |
|
|
|
|
|
|
|
|
|
|
|
- In Cohorts 1 through 4, ACTR707 was
reported to be well-tolerated in combination with rituximab. No
dose-limiting toxicities (DLTs), no adverse events of CRS, and no
severe neurological adverse events including neurotoxicity have
been reported as of the November 2019 cutoff (Table 2).
Table 2: ACTR707 Preliminary Phase 1 trial safety results in r/r
NHL (Cohorts 1-4) |
|
|
|
Safety Event (1) |
Cohort 1 (n=6) |
Cohort 2 (n=3) |
Cohort 3 (n=5) |
Cohort 4 (n=6) |
Dose-limiting toxicities |
0 |
0 |
0 |
0 |
Severe
neurologic events (> Grade 3) |
0 |
0 |
0 |
0 |
CRS (any
grade) |
0 |
0 |
0 |
0 |
ACTR707-related SAEs |
1 |
2 |
0 |
1 |
febrile neutropenia |
1 |
1 |
0 |
1 |
cytopenia |
0 |
1 |
0 |
0 |
(1) Data
cutoff as of Nov 2019 |
|
|
|
|
|
|
|
|
|
- Given favorable tolerability
observed to date at relatively low doses, Unum announced in
November plans to continue dose escalation in two additional
cohorts (approximately four patients per cohort) in the trial,
escalating the maximum dose up to 180M ACTR707+ T cells. Patient
enrollment and planned dosing is underway, and Unum plans to report
preliminary results from this dose escalation during 2020.
Additional details about the ATTCK-20-03 Phase 1
trial can be found here.
Oral Presentation Title (#244): “A Phase 1 Study
of ACTR087 in Combination with Rituximab, in Subjects with Relapsed
or Refractory CD20-Positive B-Cell Lymphoma”
Following the decision in 2018 to prioritize
ACTR707 over ACTR087 for future development in r/r NHL and solid
tumors, Unum completed enrollment in the ATTCK-20-2 trial, a Phase
1, multicenter, open-label, single-arm, dose-escalating trial
evaluating ACTR087 in combination with rituximab in patients with
r/r CD20+ NHL.
- In this trial, ACTR087+ T cells,
when combined with rituximab, expanded and persisted long-term
(observed up to 1029 days in one patient) and generated complete
responses lasting greater than six months in 20% (four of 20) of
evaluable patients with aggressive CD20+ malignancies. In this
trial, ACTR087 was administered across three cohorts (mean dose
range of 19-67M cells).
- Severe T cell-mediated toxicities
(CRS and neurotoxicity) occurred in four of 26 patients who
received ACTR087 in combination with rituximab, with different
timing and symptomatology from those observed with currently
available CD19 CAR T cell therapies. Baseline inflammation appeared
to predispose patients to severe toxicity.
Additional details about the ATTCK-20-2 Phase 1
trial can be found here.
About Unum TherapeuticsUnum
Therapeutics is a clinical-stage biopharmaceutical company focused
on developing curative cell therapies to treat a broad range of
cancer patients. Unum’s novel proprietary technologies include
Antibody-Coupled T cell Receptor (ACTR), an autologous engineered
T-cell therapy that combines the cell-killing ability of T cells
and the tumor-targeting ability of co-administered antibodies to
exert potent antitumor immune responses, and Bolt-On Chimeric
Receptor (BOXR), designed to improve the functionality of
engineered T cells by incorporating a “bolt-on” transgene to
overcome resistance of the solid tumor microenvironment to T cell
attack. Unum has multiple programs in Phase 1 clinical and
preclinical testing, including: ACTR707 used in combination with
trastuzumab in adult patients with HER2+ advanced cancer and used
in combination with rituximab in adult patients with r/r NHL; and
BOXR1030 expressing the GOT2 transgene and targeting GPC3+ solid
tumor cancers. The Company is headquartered in Cambridge, MA.
Follow Unum Therapeutics on social media:
@UnumRx, and LinkedIn.
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Investor Contact: Stern Investor Relations, Inc. Stephanie
Ascher, 212-362-1200 stephanie@sternir.com
Media Contact:Lissette Steele,
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