Bellicum Pharmaceuticals, Inc. (Nasdaq: BLCM), a leader in
developing novel, controllable cellular immunotherapies for
cancers, today announced positive interim data from its ongoing
Phase 1/2 GoCAR-T clinical trials, including a confirmed partial
response (PR) in the first cohort of mCRPC patients treated in the
clinical trial for BPX-601. Bellicum has also entered into an
agreement for a $35 million private placement of equity securities
with two biotechnology specialist investment funds. Proceeds from
the financing will be used to support ongoing clinical development
of BPX-601 and BPX-603.
“We are highly encouraged by the observation of anti-tumor
activity of BPX-601 in the first mCRPC cohort, particularly in this
heavily pre-treated patient population with limited therapeutic
options,” said Rick Fair, President and Chief Executive Officer of
Bellicum. “The additional capital we raised through this private
placement will support our ongoing clinical development of BPX-601
and BPX-603 to further pursue this early efficacy signal.”
Clinical Trial Updates
BPX-601 GoCAR-T® in
Metastatic Castration-Resistant Prostate CancerCell dose
escalation and optimization of the lymphodepletion regimen was
completed in the Phase 1/2 clinical trial of BPX-601 in metastatic
pancreatic cancer patients. Earlier this year, enrollment was
initiated in previously-treated mCRPC patients at the
previously-cleared dose level.
In the first three-patient cohort of mCRPC treated at 5x106
cells/kg BPX-601 followed by single-dose rimiducid:
- No dose-limiting toxicities were observed. Adverse events were
comparable to those previously seen with BPX-601 and rimiducid in
metastatic pancreatic cancer and typical of other cell therapy
regimens.
- A confirmed partial response was observed in one patient by
RECIST v1.1 criteria on CT scan, accompanied by substantial
reduction in PSA in response to treatment with BPX-601 and
rimiducid.
Enrollment is ongoing in the second dose cohort in mCRPC of
5x106 cells/kg followed by weekly rimiducid, and results from these
patients will be submitted for presentation at a medical meeting in
2022.
BPX-603 Dual-Switch GoCAR-T in HER2+ Solid
TumorsEnrollment is ongoing in the Phase 1/2 clinical
trial for BPX-603 in patients with solid tumors that express human
epidermal growth factor 2 (HER2), including breast, endometrial,
ovarian, gastric, and colorectal cancers. BPX-603 is Bellicum’s
first dual-switch GoCAR-T product candidate incorporating
Bellicum’s iMC activation and CaspaCIDe® safety switch
technologies, which in tandem may serve to enhance cell
proliferation, persistence, and anti-tumor effect while also
enabling effective management of adverse events.
In the first patients treated in this trial at dose level 1 of
0.1x106 cells/kg BPX-603 alone or followed by weekly rimiducid:
- No dose-limiting toxicities were observed.
- Serious adverse events reported were pleural effusion and
pneumonia. Neither was determined to be related to study drug.
- Other Grade 3+ treatment-emergent adverse events reported were
neutropenia, leukopenia, and anemia.
- No CRS or ICANS events were reported.
- Limited cell engraftment and expansion were observed.
Enrollment is ongoing at dose level 2 of 1x106 cells/kg alone or
followed by weekly rimiducid, and results from these patients will
be submitted for presentation at a medical meeting in 2022.
Stated Charity Scripture, PharmD, Chief Development Officer of
Bellicum, “The early clinical activity we have observed with
BPX-601 in mCRPC and the manageable safety profiles observed across
both studies are highly encouraging. Given the very low starting
cell dose in the BPX-603 trial, the lack of clinical efficacy at
dose level 1 was in line with our expectations. I am thrilled to be
re-joining Bellicum in a full-time capacity at such an exciting
time in our programs’ development. We look forward to continued
dose escalation to more fully evaluate the safety and potential
efficacy of these product candidates.”
Private Placement Completed
Bellicum will issue, in the private placement, pre-funded
warrants to purchase up to 20,559,210 shares of common stock and
accompanying warrants to purchase up to 2,055,920 shares of common
stock. Each pre-funded warrant to purchase common stock is being
sold together with one warrant to purchase one-tenth of one share
of common stock at a combined unit price of $1.7024. The common
stock warrants will be immediately exercisable at an exercise price
of $1.69 per share of common stock and will expire seven years from
the date of issuance. Each pre-funded warrant will have an exercise
price of $0.0001 per share and will be exercisable immediately.
The aggregate offering size, before deducting placement agent
commissions and other offering expenses, is expected to be
approximately $35.0 million, excluding any proceeds that may be
received upon exercise of the common warrants. Bellicum anticipates
using the net proceeds from the offering, together with its
existing capital resources, to fund ongoing and planned BPX-601 and
BPX-603 clinical trials, and for general corporate purposes,
including research and development and to fund working capital.
In conjunction with the equity financing announced today, the
holders of the option to purchase securities associated with
Bellicum’s August 2019 Private Placement have waived their rights,
in full, to exercise their right to purchase Series 2 preferred
stock and associated warrants, and Series 3 preferred stock and
associated warrants, respectively.
Mr. Fair added, “We are pleased to have the support provided in
the financing announced today. The waiver of the rights to exercise
the Series 2 and Series 3 options is also a positive step in the
simplification of our capital structure.”
The private placement is expected to close on December 7, 2021.
A Current Report on Form 8-K containing more detailed information
regarding the financing will be filed with the Securities and
Exchange Commission.
MTS Securities, LLC, an affiliate of MTS Health Partners, L.P.,
is acting as exclusive placement agent in the financing.
The Securities issued or to be issued to the purchasers in the
Offering announced today, subject to the closing, were, or will be
issued, as applicable, pursuant to an exemption from registration
under the Securities Act of 1933 (the “Securities Act”). The
securities have not been and will not be registered under the
Securities Act or any state or other jurisdiction’s securities laws
and may not be offered or sold in the United States absent
registration or an applicable exemption from the registration
requirements of the Securities Act and applicable state or other
jurisdiction’s securities laws.
This press release shall not constitute an offer to sell or the
solicitation of an offer to buy the Securities or any other
securities, nor shall there be any offer, solicitation or sale of
the Securities or any other securities in any state or other
jurisdiction in which such an offer, solicitation or sale would be
unlawful.
About Bellicum Pharmaceuticals
Bellicum is a clinical stage biopharmaceutical company striving
to deliver cures through controllable cell therapies. The company’s
next-generation product candidates are differentiated by powerful
cell signaling technologies designed to produce more effective
CAR-T cell therapies. Bellicum’s GoCAR-T® product candidates,
BPX-601 and BPX-603, are designed to be more efficacious CAR-T cell
products capable of overriding key immune inhibitory mechanisms.
More information about Bellicum can be found at www.bellicum.com or
follow us on Twitter or LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements for
purposes of the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. Bellicum may, in some cases, use
terms such as “predicts,” “believes,” “potential,” “proposed,”
“continue,” “designed,” “estimates,” “anticipates,” “expects,”
“plans,” “intends,” “may,” “could,” “might,” “will,” “should” or
other words that convey uncertainty of future events or outcomes to
identify these forward-looking statements. Forward-looking
statements include statements regarding Bellicum’s intentions,
beliefs, projections, outlook, analyses or current expectations
concerning, among other things: the timing of interim results from
Bellicum’s clinical trials; Bellicum’s plans for further clinical
development of BPX-601 and BPX-603; the expected closing of the
private placement; and the expected use of proceeds from the
offering and Bellicum’s expected cash runway. Various factors may
cause differences between Bellicum’s expectations and actual
results as discussed in greater detail under the heading “Risk
Factors” in Bellicum’s filings with the Securities and Exchange
Commission, including without limitation Bellicum’s quarterly
report on Form 10-Q for the three months ended September 30, 2021
and Bellicum’s annual report on Form 10-K the year ended December
31, 2020. Any forward-looking statements that Bellicum makes in
this press release speak only as of the date of this press release.
Bellicum assumes no obligation to update Bellicum’s forward-looking
statements whether as a result of new information, future events or
otherwise, after the date of this press release.
Investors:Robert H. UhlManaging DirectorWestwicke
ICR858-356-5932Robert.uhl@westwicke.com
Bellicum Pharmaceuticals (NASDAQ:BLCM)
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