Autolus Therapeutics to Receive $70 Million in Milestone Payments from Blackstone Life Sciences
December 08 2022 - 04:02PM
GlobeNewswire Inc.
Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage
biopharmaceutical company developing next-generation programmed T
cell therapies, today announces that Blackstone Life Sciences
(‘Blackstone’) has committed to make two pre-agreed milestone
payments of $35m each to Autolus, totaling $70m. The milestones are
expected to be recognized in Autolus’ Q4 2022 cash balance.
The first Blackstone milestone of $35m is being
paid earlier than anticipated as a result of the joint steering
committee’s review of Autolus’ interim analysis of pivotal FELIX
Phase 2 clinical trial of obecabtagene autoleucel (obe-cel) in
relapsed/refractory (r/r) adult Acute Lymphoblastic Leukemia (ALL).
The study has met its primary endpoint, the details of which have
been announced in a separate press release today.
The second Blackstone milestone of $35m is a
pre-agreed manufacturing milestone as a result of completion of
planned activities demonstrating the performance and qualification
of Autolus’ obe-cel’s manufacturing process.
“Receiving these two $35m milestone payments
highlights the continuing strength and collaborative nature of our
partnership with Blackstone,” said Dr. Christian Itin, CEO
of Autolus. “We are delighted to have demonstrated the
potential merits of obe-cel’s clinical profile and our evolving
robust manufacturing process to the Blackstone team, and look
forward to continued progress together as we focus on our goal of
submitting a Biologics License Application (BLA) to the U.S. Food
and Drug Administration (FDA) by the end of 2023.”
“We are pleased with Autolus’ progress —we
continue to believe obe-cel has the potential to become a
transformative therapy for relapsed/refractory adult ALL patients,”
said Nicholas Simon, Senior Managing Director with
Blackstone Life Sciences. “Our investments in these next
generation cell therapies with Autolus exemplifies our conviction
in the quality and promise of the life sciences sector in the
UK.”
As previously announced, Autolus and Blackstone
entered into a strategic collaboration and financing agreement in
November 2021, whereby funds managed by Blackstone agreed to
provide up to $250 million in equity and product financing to
support Autolus’ advancement of obe-cel, its CD19 CAR T cell
investigational therapy product candidate, as well as next
generation product candidates of obe-cel in B-cell
malignancies.
About Autolus Therapeutics
plcAutolus is a clinical-stage biopharmaceutical company
developing next-generation, programmed T cell therapies for the
treatment of cancer. Using a broad suite of proprietary and modular
T cell programming technologies, the Company is engineering
precisely targeted, controlled and highly active T cell therapies
that are designed to better recognize cancer cells, break down
their defense mechanisms and eliminate these cells. Autolus has a
pipeline of product candidates in development for the treatment of
hematological malignancies and solid tumors. For more information,
please visit www.autolus.com.
About Blackstone Life
SciencesBlackstone Life Sciences is an industry-leading
private investment platform with capabilities to invest across the
life cycle of companies and products within the key life science
sectors. By combining scale investments and hands-on operational
leadership, Blackstone Life Sciences helps bring to market
promising new medicines and medical technologies that improve
patients’ lives. More information is provided at
https://www.blackstone.com/our-businesses/life-sciences/.
About
obe-cel (AUTO1)Obe-cel is a CD19 CAR T cell
investigational therapy designed to overcome the limitations in
clinical activity and safety compared to current CD19 CAR T cell
therapies. Designed to have a fast target binding off-rate to
minimize excessive activation of the programmed T cells, obe-cel
may reduce toxicity and be less prone to T cell exhaustion, which
could potentially enhance persistence and improve the ability of
the programmed T cells to engage in serial killing of target cancer
cells. In collaboration with Autolus’ academic partner, University
College London (UCL), obe-cel is currently being evaluated in a
Phase 1 clinical trial for B-NHL. Autolus has progressed obe-cel to
the FELIX Phase 2 trial, a pivotal trial for r/r adult ALL.
About obe-cel
FELIX clinical trialAutolus’ Phase 1b/2 clinical
trial of obe-cel is enrolling adult patients with r/r B-precursor
ALL. The trial had a Phase 1b component prior to proceeding to the
single arm, Phase 2 clinical trial. The primary endpoint is Overall
Remission Rate, and the secondary endpoints include duration of
response, minimal residual disease (MRD) negative complete response
(CR) rate, and safety. The trial is designed to enroll
approximately 100 patients across 30 of the leading academic and
non-academic centers in the United States, United
Kingdom, and Europe. [NCT04404660]
Forward-Looking StatementsThis
press release contains forward-looking statements within the
meaning of the "safe harbor" provisions of the Private Securities
Litigation Reform Act of 1995. Forward-looking statements are
statements that are not historical facts, and in some cases can be
identified by terms such as "may," "will," "could," "expects,"
"plans," "anticipates," and "believes." These statements include,
but are not limited to, statements regarding the development of
Autolus’ product candidate pipeline and achievement of expected
near- and long-term milestones under the terms of the Blackstone
collaboration; expectations regarding the use of proceeds pursuant
to Autolus’ collaboration with Blackstone; the development of the
obe-cel program, including progress, expectations as to the
reporting of data, conduct and timing and potential future clinical
activity and milestones; and expectations and timing regarding the
regulatory approval process and status for obe-cel, including a
planned near-term Biologics License Application submission for
obe-cel in 2023. Any forward-looking statements are based on
management's current views and assumptions and involve risks and
uncertainties that could cause actual results, performance, or
events to differ materially from those expressed or implied in such
statements. These risks and uncertainties include, but are not
limited to, the risks that Autolus’ preclinical or clinical
programs do not advance or result in approved products on a timely
or cost effective basis or at all; the results of early clinical
trials are not always being predictive of future results; the cost,
timing and results of clinical trials; that many product candidates
do not become approved drugs on a timely or cost effective basis or
at all; the ability to enroll patients in clinical trials; possible
safety and efficacy concerns; and the impact of the ongoing
COVID-19 pandemic on Autolus’ business. For a discussion of other
risks and uncertainties, and other important factors, any of which
could cause Autolus’ actual results to differ from those contained
in the forward-looking statements, see the section titled "Risk
Factors" in Autolus’ Annual Report on Form 20-F filed with the
Securities and Exchange Commission on March 10, 2022, as well as
discussions of potential risks, uncertainties, and other important
factors in Autolus’ subsequent filings with the Securities and
Exchange Commission. All information in this press release is as of
the date of the release, and Autolus undertakes no obligation to
publicly update any forward-looking statement, whether as a result
of new information, future events, or otherwise, except as required
by law.
Contact:
Olivia Manser+44 (0) 7780
471568o.manser@autolus.com
Julia Wilson+44 (0) 7818
430877j.wilson@autolus.com
Susan A. NoonanS.A. Noonan
Communications+1-917-513-5303susan@sanoonan.com
Autolus Therapeutics (NASDAQ:AUTL)
Historical Stock Chart
From May 2023 to May 2023
Autolus Therapeutics (NASDAQ:AUTL)
Historical Stock Chart
From May 2022 to May 2023