POINT Biopharma Inc. (POINT), a global radiopharmaceutical
company dedicated to successfully delivering precision radioligand
therapy to cancer patients, today announced that it has
successfully dosed multiple patients in its Phase 3 SPLASH study
evaluating the efficacy of PNT2002, the Company’s investigational
177Lu-PSMA targeted radioligand therapy for patients with PSMA
expressing metastatic castration resistant prostate cancer (mCRPC)
who are not eligible for chemotherapy.
The Phase 3 SPLASH study is a multi-center, randomized, open
label assessment of PNT2002 in patients with mCRPC who have
progressed on ARAT therapy and refuse or not eligible for
chemotherapy. The study will commence with a single-arm dosimetry
lead-in and expects to enroll a total of approximately 450 patients
across North America, Europe and the UK. Patients will be
randomized 2:1 with patients in arm A receiving PNT2002 and
patients in arm B receiving either Abiraterone or Enzalutamide. The
primary endpoint of the study is radiographic progression-free
survival (rPFS). Key secondary endpoints include overall response
rate (ORR), overall survival (OS), and pharmacokinetics (PK).
“We are pleased to announce dosing of patients in our Phase 3
SPLASH study, which represents a significant milestone for POINT. I
am very proud of the work our clinical and CMC teams have done to
bring us to this stage and believe that this study holds the
potential to demonstrate an improvement against the current
standard of care for patients with little to no current therapeutic
options,” said Joe McCann, Chief Executive Officer of POINT
Biopharma. “It is exciting to be working on PSMA targeted
radiopharmaceuticals, a technology which will likely continue to
gain interest as results from studies like the VISION trial are
published. We appreciate the collaboration and engagement from our
trial investigators as well as the guidance from global key opinion
leaders in the field.”
The first patients in the trial were dosed last month by Dr.
Luke Nordquist, Urologic Medical Oncologist, Urology Cancer Center
& GU Research Network, Omaha, Nebraska, and Dr. Ebrahim
Delpassand, Nuclear Medicine Physician, Excel Diagnostics and
Nuclear Oncology Center, Houston, Texas. “There is a
significant unmet need for therapeutic alternatives with a novel
mechanism of action for patients with PSMA expressing mCRPC,
particularly in advance of chemotherapy. The current standard of
care is not sufficient for patients with this aggressive form of
cancer,” said Dr. Nordquist. “As a nuclear medicine physician with
special interest in nuclear Oncology, I have seen an increasing
demand and appreciation for this therapeutic modality and believe
it holds much promise as the future of precision medicine,” added
Dr. Delpassand.
Additional information on the Phase 3 SPLASH study can be found
at https://www.clinicaltrials.gov/ct2/show/NCT04647526.
POINT Biopharma has entered into a definitive merger agreement
with Research Alliance Corp. I (Nasdaq: RACA). Upon closing, the
combined company is expected to be listed on Nasdaq under the
ticker symbol “PNT”. A full description of the terms of the
business combination can be found in registration statement on Form
S-4 filed with the SEC by RACA.
About POINT Biopharma
POINT Biopharma is a globally focused radiopharmaceutical
company building a platform for the clinical development and
commercialization of radioligands that fight cancer. POINT is
combining a portfolio of best-in-class radiopharmaceutical assets,
a seasoned management team, strategic partnerships in radioisotope
supply, manufacturing technology and novel direct-to-patient
targeting to revolutionize theragnostic drug development and
radioligand commercialization. Learn more at
https://www.pointbiopharma.com.
About Therapeutics Acquisition Corp, d/b/a Research Alliance
Corp. I
Research Alliance Corp. I is sponsored by RA Capital Management,
L.P., and is led by Chairman and CEO Peter Kolchinsky, PhD and CFO
Matthew Hammond, PhD. RACA is a blank check company formed for the
purpose of effecting a business combination with one or more
businesses in the healthcare industry.
About RA Capital Management
RA Capital is a multi-stage investment manager dedicated to
evidence-based investing in public and private healthcare and life
science companies that are developing drugs, medical devices, and
diagnostics. The flexibility of its strategy allows RA Capital to
provide seed funding to startups and to lead private, IPO, and
follow-on financings for its portfolio companies, allowing
management teams to drive value creation from inception through
commercialization.
Important Information About the Business Combination and
Where to Find It
A full description of the terms of the business combination is
provided in a registration statement on Form S-4 filed with the SEC
by Therapeutics Acquisition Corp. d/b/a/ Research Alliance Corp. I.
(“RACA”) which includes a prospectus with respect to the Combined
Company’s securities to be issued in connection with the business
combination and a proxy statement with respect to the shareholder
meeting of RACA to vote on the business combination. RACA urges
its investors, shareholders and other interested persons to read
the preliminary proxy statement/ prospectus as well as other
documents filed with the SEC because these documents will contain
important information about RACA, POINT and the business
combination. After the registration statement is declared
effective, the definitive proxy statement/prospectus to be included
in the registration statement will be mailed to shareholders of
RACA as of a record date to be established for voting on the
proposed business combination. Shareholders will also be able to
obtain a copy of the S-4, including the proxy statement/prospectus,
and other documents filed with the SEC without charge, by directing
a request to: Research Alliance Corp. I, Attn: Secretary, 200
Berkeley St, 18th floor, Boston, MA 02116. The preliminary and
definitive proxy statement/prospectus to be included in the
registration statement, once available, can also be obtained,
without charge, at the SEC’s website (www.sec.gov).
Participants in the Solicitation
RACA and POINT and their respective directors and executive
officers may be considered participants in the solicitation of
proxies with respect to the proposed business combination described
in this press release under the rules of the SEC. Information about
the directors and executive officers of RACA is set forth in RACA’s
final prospectus for initial public offering filed with the SEC
pursuant to Rule 424(b) of the Securities Act of 1933, as amended
(the “Securities Act”) on July 9, 2020, and is available free of
charge at the SEC’s website at www.sec.gov or by directing a
request to: Research Alliance Corp. I, Attn: Secretary, 200
Berkeley St, 18th floor, Boston, MA 02116. Information regarding
the persons who may, under the rules of the SEC, be deemed
participants in the solicitation of the RACA shareholders in
connection with the proposed business combination will be set forth
in the registration statement containing the proxy
statement/prospectus for the proposed business combination when it
is filed with the SEC. These documents can be obtained free of
charge from the sources indicated above.
Non-Solicitation
This press release is not a proxy statement or solicitation of a
proxy, consent or authorization with respect to any securities or
in respect of the proposed business combination and shall not
constitute an offer to sell or a solicitation of an offer to buy
any securities nor shall there be any sale of securities in any
state or jurisdiction in which such offer, solicitation, or sale
would be unlawful prior to registration or qualification under the
securities laws of any such state or jurisdiction. No offer of
securities shall be made except by means of a prospectus meeting
the requirements of the Securities Act.
Forward-Looking Statements
This press release contains forward-looking statements that are
based on beliefs and assumptions and on information currently
available. In some cases, you can identify forward-looking
statements by the following words: “may,” “will,” “could,” “would,”
“should,” “expect,” “intend,” “plan,” “anticipate,” “believe,”
“estimate,” “predict,” “project,” “potential,” “continue,”
“ongoing” or the negative of these terms or other comparable
terminology, although not all forward-looking statements contain
these words. These statements involve risks, uncertainties and
other factors that may cause actual results, levels of activity,
performance or achievements to be materially different from the
information expressed or implied by these forward-looking
statements. Although we believe that we have a reasonable basis for
each forward-looking statement contained in this press release, we
caution you that these statements are based on a combination of
facts and factors currently known by us and our projections of the
future, about which we cannot be certain. Forward-looking
statements in this press release include, but are not limited to,
statements regarding the proposed business combination, including
the timing and structure of the business combination, the proceeds
from the business combination, the initial market capitalization of
the Combined Company and the benefits of the business combination,
as well as statements about the potential attributes and benefits
of POINT’s product candidates and the format and timing of POINT’s
product development activities and clinical trials. We cannot
assure you that the forward-looking statements in this press
release will prove to be accurate. These forward-looking statements
are subject to a number of significant risks and uncertainties that
could cause actual results to differ materially from expected
results, including, among others, the ability to complete the
business combination due to the failure to obtain approval from
RACA’s shareholders or satisfy other closing conditions in the
business combination agreement, the occurrence of any event that
could give rise to the termination of the business combination
agreement, the outcome of any legal proceedings that may be
instituted against RACA or POINT following announcement of the
proposed business combination and related transactions, the impact
of COVID-19 on POINT’s business and/or the ability of the parties
to complete the business combination, the ability to obtain or
maintain the listing of RACA’s common stock on Nasdaq following the
proposed business combination, costs related to the proposed
business combination, changes in applicable laws or regulations,
the possibility that RACA or POINT may be adversely affected by
other economic, business, and/or competitive factors, and other
risks and uncertainties, including those to be included under the
header “Risk Factors” in the registration statement on Form S-4 to
be filed by RACA with the SEC and those included under the header
“Risk Factors” in the final prospectus of RACA related to its
initial public offering. Most of these factors are outside of
RACA’s and POINT’s control and are difficult to predict.
Furthermore, if the forward-looking statements prove to be
inaccurate, the inaccuracy may be material. In light of the
significant uncertainties in these forward-looking statements, you
should not regard these statements as a representation or warranty
by us or any other person that we will achieve our objectives and
plans in any specified time frame, or at all. The forward-looking
statements in this press release represent our views as of the date
of this press release. We anticipate that subsequent events and
developments will cause our views to change. However, while we may
elect to update these forward-looking statements at some point in
the future, we have no current intention of doing so except to the
extent required by applicable law. You should, therefore, not rely
on these forward-looking statements as representing our views as of
any date subsequent to the date of this press release.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210604005321/en/
Company: Ari Shomair VP, Corporate Affairs
media@pointbiopharma.com (647) 812-2417
Investor Relations: Alex Lobo Stern Investor Relations
investors@pointbiopharma.com
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