Unum Therapeutics Inc. (NASDAQ: UMRX), a clinical-stage
biopharmaceutical company focused on developing curative cell
therapies for cancer, today reported financial results and
corporate updates for the second quarter ended June 30, 2019, and
provided recent activities.
“During the quarter, we advanced our preclinical
and clinical pipeline programs that are designed to improve the
targeting and functionality of T cells to expand their use in
hematologic and solid tumor cancers,” said Chuck Wilson, President
and Chief Executive Officer of Unum. “Today, we reported
preliminary results from Cohort 3 of the Phase 1 trial with ACTR707
in patients with relapsed or refractory non-Hodgkin lymphoma. We
are very encouraged by the results from this trial that support our
progress towards developing a competitive program with complete
responses achieved in five of the 14 patients treated and no
reported adverse events of cytokine release syndrome or severe
neurotoxicity. Patient enrollment in Cohort 4 is now complete and
we anticipate providing results from this cohort later this year.
Our ACTR and BOXR platform initiatives in solid tumors also
continued during the quarter, with Phase 1 trial enrollment
activities progressing on our ACTR707 program in patients with
HER2+ solid tumors. Our BOXR platform is 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, and we are pleased to advance
our first candidate from this platform, BOXR1030, towards clinical
trials.”
Recent Program and Corporate Highlights
ACTR707 Hematologic Program Highlights:
- Preliminary results from Cohort 3 from the
Phase 1 trial (ATTCK-20-03) in non-Hodgkin
lymphoma: Today, Unum provided preliminary results from
patients treated in Cohort 3 in ATTCK-20-03, a Phase 1,
multicenter, open-label, single-arm, dose-escalating trial
evaluating ACTR707 in combination with rituximab in patients with
relapsed/refractory CD20+ B cell non-Hodgkin lymphoma (r/r NHL)
who, among other criteria, received adequate prior anti-lymphoma
therapy, including anti-CD20 monoclonal antibody and chemotherapy.
Among the 14 patients treated in Cohorts 1, 2 and 3, the majority
(93%) were diagnosed with diffuse large B-cell lymphoma (DLBCL) and
were heavily pre-treated with 57% having received three or more
prior lines of therapy. Previously, results from the six patients
treated in Cohort 1 (25M ACTR707+ T cells) and the three patients
treated in Cohort 2 (40M ACTR707+ T cells) were presented at the
American Society of Hematology (ASH) Annual Meeting in December
2018. As presented at ASH, complete responses were achieved in
three of six patients (50%) from Cohort 1 and a complete response
was achieved in one of three (33%) patients from Cohort 2. The
overall response rate, including complete and partial responses,
was 50% in Cohort 1 and 67% in Cohort 2.As a preliminary update
provided today, for the five patients treated in Cohort 3 (55M
ACTR707+ T cells), a complete response was achieved in one of five
patients (20%) with overall responses in four of five patients
(80%). The overall responses achieved in this cohort included
evidence of deepening responses in two patients whose stable
disease improved after the initial response assessment at day 42 to
a partial and a complete response, respectively, as of the data
cutoff in May 2019 (Table 1).
|
Table 1: ACTR707 Preliminary Phase 1 trial efficacy results in r/r
NHL (Cohorts 1-3) |
|
|
|
|
|
Clinical Response (1) |
Cohort 1 (n=6) |
Cohort 2 (n=3) |
Cohort 3 (n=5) |
Cohorts 1-3 (n=14) |
|
|
Complete Response |
3 |
1 |
1 |
36% (5/14) |
|
Partial Response |
0 |
1 |
3 |
29% (4/14) |
|
Indeterminate Response |
1 |
0 |
0 |
7% (1/14) |
|
Progressive Disease |
2 |
1 |
1 |
29% (4/14) |
|
Overall Response Rate |
50% (3/6) |
67% (2/3) |
80% (4/5) |
64% (9/14) |
|
ACTR707 + T cells administered per patient (range) |
25M (23-38M) |
40M (30-50M) |
55M (45-55M) |
|
|
(1) Data cutoff as of May 2019 |
|
|
|
|
|
|
|
Durable responses
were observed in patients achieving a complete response with the
durability of response ranging from 85-387+ days. In the first
three cohorts, ACTR707 was well-tolerated in combination with
rituximab. No dose-limiting toxicities (DLTs), no adverse events of
cytokine release syndrome (CRS), and no severe neurological adverse
events including neurotoxicity have been reported in Cohorts 1, 2
and 3 as of the May 2019 cutoff. Serious adverse events that
were assessed by the investigator as possibly related to ACTR707
include two cases of febrile neutropenia and one case of cytopenia
in Cohorts 1 and 2 (Table 2). |
|
Table 2: ACTR707 Preliminary Phase 1 trial safety results in r/r
NHL (Cohorts 1-3) |
|
|
|
|
|
|
|
|
|
Safety Event (1) |
Cohort 1 (n=6) |
Cohort 2 (n=3) |
Cohort 3 (n=5) |
|
Dose-limiting toxicities |
0 |
0 |
0 |
|
Severe neurologic events (> Grade 3) |
0 |
0 |
0 |
|
CRS (any grade) |
0 |
0 |
0 |
|
ACTR707-related SAEs |
1 |
2 |
0 |
|
febrile neutropenia |
1 |
1 |
0 |
|
cytopenia |
0 |
1 |
0 |
|
(1) Data cutoff as of May 2019 |
|
|
|
|
|
|
|
|
- Cohort 4 (80M ACTR707+ T cells) enrollment proceeding
in ATTCK-20-03: Enrollment in Cohort 4 of ATTCK-20-03 is
complete and Unum plans to report updated results from ATTCK-20-03,
including data from patients in Cohort 4, in late 2019.
ACTR707 Solid Tumor Program
Highlights:
Phase 1 trial
(ATTCK-34-01) with ACTR707 in HER2+ advanced solid tumor
cancers ongoing: Clinical trial site activation, patient
identification, screening and enrollment continues in the first
dose cohort of ATTCK-34-01, a Phase 1, multicenter, open-label,
single-arm, dose-escalation trial evaluating ACTR T cells (ACTR707)
in combination with trastuzumab for the treatment of patients with
HER2+ advanced cancers. Unum plans to report updates from the
ATTCK-34-01 trial including patient enrollment status and
preliminary safety data at the end of 2019.
Preclinical data demonstrate that, unlike
traditional trastuzumab-based CAR-T cells that target HER2,
ACTR707+ T cells administered with trastuzumab are highly selective
for HER2-overexpressing tumor cells and discriminate against cells
from normal tissues that express low levels of HER2. The
preclinical activity of ACTR707+ T cell has been shown to be
dose-dependent demonstrating control of ACTR707 activity by
modulation of trastuzumab concentration. Together, the preclinical
data suggest that ACTR cells in combination with trastuzumab may
exhibit an improved clinical therapeutic index.
BOXR Solid Tumor Program
Highlights:
- Preclinical development ongoing for BOXR1030 targeting
GPC3+ advanced cancers: Unum’s Bolt-On Chimeric Receptor
(BOXR) platform is designed to improve engineered T cell
functionality by identifying and incorporating a “bolt-on”
transgene to overcome resistance of the solid tumor
microenvironment to T cell attack. BOXR bolt-on transgenes
identified in this platform are designed to address a variety of
immunosuppressive mechanisms of solid tumors including metabolic
competition, immune suppressor cells, and exhaustion due to chronic
stimulation. These transgenes could offer the potential to add new
functionality to T cells not achievable by traditional small
molecule or antibody-based approaches. In addition, the BOXR
bolt-on transgenes may be incorporated into several different types
of therapeutic T cells, including ACTR T cells and CAR-T cells.
Using a variety of BOXR bolt-on transgenes and tumor targeting
technologies, Unum is building a pipeline of preclinical candidates
to address a diverse range of solid tumor indications.In early
2019, Unum nominated BOXR1030 as the first product candidate from
the BOXR platform. In addition to research to further characterize
its mechanism of action, preclinical studies of BOXR1030 are
underway to support the filing of an investigational new drug (IND)
application for BOXR1030. Unum plans to present preclinical data
regarding BOXR1030 in the second half of 2019.
ACTR087 Hematologic Program
Highlights:
- Dose escalation continuing in Phase 1 (ATTCK-17-01)
trial in multiple myeloma: Dose escalation continued
during the second quarter in the ATTCK-17-01 trial combining
ACTR087 with low doses of SEA-BCMA antibody. Enrollment and dosing
of patients is complete in Cohort 4 (30M ACTR087+ T cells and 2.0
mg/kg SEA-BCMA) and Cohort 5 (50M ACTR087+ T cells and 2.0 mg/kg
SEA-BCMA). Unum expects to report data from multiple dose cohorts
in the second half of 2019.
- Treatment continuing for responding patients in Phase 1
(ATTCK-20-2) trial in non-Hodgkin
lymphoma: In July 2019, Unum announced
that the U.S. Food and Drug Administration (FDA) placed a clinical
hold (since communicated by the FDA as a partial clinical hold) on
the Phase 1 trial (ATTCK-20-2) evaluating Unum’s ACTR087 in
combination with rituximab in patients with CD20+ r/r NHL. The
clinical hold was initiated following the submission of a safety
report by Unum to the FDA regarding one patient in the safety
expansion cohort of the trial who experienced serious adverse
events including neurotoxicity, cytomegalovirus infection, and
respiratory distress. As an update to this case, this patient
subsequently experienced septic shock that was fatal and reported
by the investigator as related to ACTR087. Patients who previously
received ACTR087 and have ongoing clinical responses continue to
receive rituximab infusions, with continued monitoring for adverse
events. Unum continues to work closely with the FDA to further
review these events and plans to report data from the ATTCK-20-2
trial at the end of 2019.
Corporate Highlights:
- Announced new additions to its leadership team including
Matthew Osborne as Chief Financial Officer, Mert Aktar as of Head
of Business and Corporate Development and Jessica Sachs, M.D., as
Chief Medical Officer replacing Michael Vasconcelles, M.D., who
transitioned to a clinical advisory role. Each new executive has a
proven track record of excellence and adds decades of experience to
the Unum leadership team.
- Announced the appointments of Arlene Morris and Matthew Ros to
its Board of Directors. Ms. Morris and Mr. Ros replaced Robert
Perez and Liam Ratcliffe, who transitioned from Unum’s Board of
Directors in conjunction with their new positions within the
biotechnology industry. Ms. Morris and Mr. Ross bring significant
commercial, clinical and operational experience within the oncology
field. Ms. Morris brings extensive corporate and business
development experience in the pharmaceutical and biotechnology
industries from numerous management and board roles, while Mr. Ros
adds specific commercial experience, particularly with oncology
products.
- Entered into an agreement with Harbour Antibodies BV, a
wholly-owned subsidiary of Harbour BioMed, granting Unum rights to
utilize Harbour Antibodies’ H2L2 Harbour Mice® platform. The
agreement enables Unum to discover and incorporate fully-human
antibody sequences into its novel ACTR and BOXR platforms to
further enable and accelerate Unum’s preclinical discovery and
development efforts.
Second Quarter 2019 Financial
Results
- Collaboration Revenue:
Collaboration revenue recognized during the second quarter ended
June 30, 2019 was $3.1 million, compared to $1.7 million in the
same period of 2018. The increase reflects the recognition of a
portion of the upfront payment received from Seattle
Genetics, Inc. under Unum’s collaboration agreement as well as
reimbursements of research and development costs attributed to the
collaboration agreement.
- R&D Expenses: Research and
development expenses were $10.6 million for the second quarter
ended June 30, 2019, compared to $9.1 million for the same
period of 2018. The increase primarily reflects higher
clinical trial costs for the active Phase 1 trials, as well as
increased personnel-related costs.
- G&A
Expenses: General and administrative
expenses for the second quarter ended June 30, 2019, were
$3.1 million, compared to $2.0 million for the same
period of 2018. The increase is primarily related to higher
personnel related costs due to increased headcount and increased
expenses around operating as a public company.
- Net Loss: Net loss attributable to common
stockholders was $10.5 million, or $0.34 per
share, for the second quarter ended June 30, 2019, and $9.0
million, or $0.31 per share, for the same period of
2018.
- Cash and Cash Equivalents: As of June 30,
2019, Unum had cash and cash equivalents of $55.9 million.
Unum believes that its existing cash and cash equivalents will fund
operating expenses and capital expenditure requirements into early
2021.
Investor Call and Webcast
Information
Unum will host a live conference call and
webcast today, August 12, 2019, at 4:30 p.m. ET, to discuss these
financial results and company updates. To access the call, please
dial 866-300-3411 (domestic) or 636-812-6658 (international) and
refer to conference ID number 5658375. A webcast will be available
at unumrx.com at least 10 minutes before the event begins. The
archived webcast will be available at the same location
approximately two hours after the event and will be archived for 90
days.
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 testing,
including ACTR707 used in combination with rituximab in adult
patients with r/r NHL and used in combination with trastuzumab in
adult patients with HER2+ advanced cancer, and ACTR087 used in
combination with the novel antibody SEA-BCMA in r/r multiple
myeloma. The Company is headquartered in Cambridge, MA.
Follow Unum Therapeutics on social media:
@UnumRx, and LinkedIn.
Forward looking Statements
This press release contains forward-looking
statements including, without limitation, statements regarding our
future expectations, plans and prospects, including projections
regarding future revenues and financial performance, our long-term
growth, enrollment and results for our preclinical and clinical
activities, the development of our product candidates, including
the lead ACTR product candidates and the BOXR platform and product
candidates, non-clinical or clinical options to resolve the partial
clinical hold on ATTCK-20-2, and the anticipated timing and success
of any of our preclinical studies, clinical trials and regulatory
filings, as well as other statements containing the words
"anticipate," "believe," "continue," "could," "estimate," "expect,"
"intend," "may," "might," "plan," "potential," "predict,"
"project," "should," "target," "will," or "would" and similar
expressions, constitute forward-looking statements within the
meaning of the safe harbor provisions of The Private Securities
Litigation Reform Act of 1995, as amended. We may not actually
achieve the forecasts disclosed in our forward-looking statements,
and you should not place undue reliance on our forward-looking
statements. Actual results could differ materially from the
projections disclosed in the forward-looking statements we make as
a result of a variety of risks and uncertainties, including risks
related to the accuracy of our estimates regarding expenses, future
revenues, capital requirements, and the need for additional
financing, the success, cost and timing of our product development
activities and clinical trials, our ability to obtain and maintain
regulatory approval for our product candidates, and the other risks
and uncertainties described in the "Risk Factors" sections of our
public filings with the Securities and Exchange Commission. In
addition, the forward-looking statements included in this press
release represent our views as of the date hereof. We anticipate
that subsequent events and developments may cause our views to
change. However, while we may elect to update these forward-looking
statements at some point in the future, we specifically disclaim
any obligation to do so. These forward-looking statements should
not be relied upon as representing our views as of any date
subsequent to the date hereof.
Investor Contact: Stern Investor Relations, Inc. Stephanie
Ascher, 212-362-1200 stephanie@sternir.com
Media Contact:Lissette Steele,
202-930-4762lsteele@vergescientific.com
UNUM THERAPEUTICS INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited, $ in thousands, except share and per share
amounts)
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
Collaboration revenue |
|
$ |
3,138 |
|
|
$ |
1,666 |
|
|
$ |
6,191 |
|
|
$ |
3,886 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
10,617 |
|
|
|
9,126 |
|
|
|
23,020 |
|
|
|
17,268 |
|
General and administrative |
|
|
3,062 |
|
|
|
1,979 |
|
|
|
5,553 |
|
|
|
3,043 |
|
Total operating expenses |
|
|
13,679 |
|
|
|
11,105 |
|
|
|
28,573 |
|
|
|
20,311 |
|
Loss from operations |
|
|
(10,541 |
) |
|
|
(9,439 |
) |
|
|
(22,382 |
) |
|
|
(16,425 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
25 |
|
|
|
259 |
|
|
|
175 |
|
|
|
340 |
|
Other income, net |
|
|
— |
|
|
|
157 |
|
|
|
— |
|
|
|
327 |
|
Total other income, net |
|
|
25 |
|
|
|
416 |
|
|
|
175 |
|
|
|
667 |
|
Net loss |
|
|
(10,516 |
) |
|
|
(9,023 |
) |
|
|
(22,207 |
) |
|
|
(15,758 |
) |
Accretion of redeemable
convertible preferred stock to redemption value |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(16 |
) |
Net loss attributable to
common stockholders |
|
$ |
(10,516 |
) |
|
$ |
(9,023 |
) |
|
$ |
(22,207 |
) |
|
$ |
(15,774 |
) |
Net loss per share
attributable to common stockholders, basic and diluted |
|
$ |
(0.34 |
) |
|
$ |
(0.31 |
) |
|
$ |
(0.73 |
) |
|
$ |
(0.80 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
|
30,505,773 |
|
|
|
29,155,790 |
|
|
|
30,295,557 |
|
|
|
19,732,542 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
UNUM THERAPEUTICS INC. CONSOLIDATED
SELECTED BALANCE SHEET DATA (unaudited, in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2019 |
|
|
December 31, 2018 |
Cash, cash equivalents and
marketable securities |
|
$ |
55,863 |
|
|
$ |
78,594 |
Working capital |
|
$ |
34,291 |
|
|
$ |
56,057 |
Total assets |
|
$ |
69,308 |
|
|
$ |
85,927 |
Total liabilities |
|
$ |
29,550 |
|
|
$ |
25,693 |
Total stockholders'
equity |
|
$ |
39,758 |
|
|
$ |
60,234 |
|
|
|
|
|
|
|
|
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