LA JOLLA, CAL
LA JOLLA, CALIF–August 2, 2022–(BUSINESS
WIRE)–Calidi Biotherapeutics, Inc. (Calidi), a
clinical-stage biotechnology company that is pioneering allogeneic
cell-based platforms to revolutionize oncolytic virus therapies, is
pleased to announce that City of Hope has received U.S. Food and Drug
Administration (FDA) authorization to proceed with a phase 1
physician-sponsored clinical trial that will use Calidi’s licensed
oncolytic virotherapy platform, NSC-CRAd-S-pk7 (NeuroNova), a
cutting-edge therapeutic candidate comprising tumor-tropic neural stem
cells delivering an oncolytic adenovirus selectively to tumor sites in
patients with recurrent high-grade glioma (Calidi’s NNV-2
program).
The phase 1 physician-sponsored clinical trial will be an open-label,
non-randomized, multicenter study. Once the phase 1 trial is funded, it
will address the safety and tolerability of administering serial doses
of NeuroNova in adult patients with recurrent histologically confirmed
high-grade gliomas (WHO grade III or IV). Secondary endpoints will
evaluate treatment efficacy, including progression-free and overall
survival as well as any immune response to NeuroNova. This
physician-sponsored study will be led by principal investigator Jana
Portnow, M.D., Professor in City of Hope’s Department of Medical
Oncology & Therapeutics Research and Co-Director of the Brain Tumor
Program at City of Hope, a National Cancer Institute-designated
comprehensive cancer center and a founding member of the National
Comprehensive Cancer Network. City of Hope is one of the largest cancer
research and treatment organizations in the United States.
A previously completed phase 1 dose escalation clinical trial, in newly
diagnosed glioma patients, of a single dose of NSC-CRAd-S-pk7
(NeuroNova) given as an adjunct to radiation and temozolomide
(Calidi’s NNV-1 program) demonstrated that NeuroNova was well
tolerated in the patient population and showed promising preliminary
results of efficacy [J Fares et al, Lancet Oncology, 2021,
22(8):1103-1114].
“Worldwide, an estimated 270,000 people were diagnosed with a
primary brain tumor in 2020, with a five-year survival rate of only 5%.
Recurrent glioma patients have poor prognosis with a
median survival of less than one year. Developing our drug
candidate for this indication represents a significant milestone that
will empower us to help more individuals survive this devastating
disease,” said Calidi Biotherapeutics CEO and Chairman of the
Board Allan J. Camaisa. “As Calidi undertakes this endeavor, we
are pleased to have exclusive commercialization rights to this
technology and thrilled to collaborate with two scientific trailblazers
who have worked together on this project for over a decade: Dr. Karen
Aboody, Professor in the Department of Stem Cell Biology and
Regenerative Medicine, Scientific Leader of the Neuro-oncology Disease
Team at City of Hope, and Dr. Maciej (Matt) Lesniak, Chair of the
Department of Neurological Surgery, at Northwestern University Feinberg
School of Medicine.”
“Our team at City of Hope is excited to be a part of the
development of NeuroNova. Despite their potential, the first-generation
oncolytic virus therapies given as free virus were not very effective
— most likely due to rapid inactivation by the patient’s
immune system. Our new platform uses stem cells like a ‘Trojan
horse’ to shield the oncolytic viral particles from immune
inactivation and deliver them to the tumor sites. This results in
significantly more virus distributed at the tumor sites, inducing a
greater self-amplifying anti-tumor response. This may also result in a
secondary anti-tumor immune response,” said City of Hope’s
Dr. Karen Aboody.
“In addition to significant experience with
this technology, City of Hope has a proven track record in GMP
manufacturing of cell and gene therapy agents.”
About NeuroNova
The NeuroNova platform, NSC-CRAd-S-pk7, is an
allogeneic, “off-the-shelf” therapy comprised of an
immortalized Neural Stem Cell (NSC) line loaded with an engineered
oncolytic adenovirus. Upon surgical resection of a tumor, NSC-CRAd-S-pk7
is injected into the walls of the resection cavity, resulting in viral
infection and destruction of any remaining tumor cells. Calidi holds an
exclusive worldwide licensing agreement for patents covering the
NSC-CRAd-S-pk7 technology.
About Calidi Biotherapeutics
Calidi Biotherapeutics is a
clinical-stage immuno-oncology company with proprietary technology that
is revolutionizing the effective delivery and potentiation of oncolytic
viruses for targeted therapy against difficult-to-treat cancers. Calidi
Biotherapeutics is advancing a potent allogeneic stem cell and oncolytic
virus combination for use in multiple oncology indications.
Calidi’s off-the-shelf, universal cell-based delivery platforms
are designed to protect, amplify, and potentiate oncolytic viruses
currently in development leading to enhanced efficacy and improved
patient safety. Calidi Biotherapeutics is headquartered in La Jolla,
California. For more information, please visit www.calidibio.com.
Forward-Looking
Statement
This press release contains forward-looking statements
for purposes of the “safe harbor” provisions under the
United States Private Securities Litigation Reform Act of 1995. Terms
such as “anticipates,” “believe,”
“continue,” “could,” “estimate,”
“expect,” “intends,” “may,”
“might,” “plan,” “possible,”
“potential,” “predicts,” “project,”
“should,” “would” as well as similar terms, are
forward-looking in nature. The forward-looking statements contained in
this discussion are based on the Calidi’s current expectations and
beliefs concerning future developments and their potential effects.
There can be no assurance that future developments affecting Calidi will
be those that it has anticipated. These forward-looking statements
involve a number of risks, uncertainties (some of which are beyond
Calidi’s control) or other assumptions that may cause actual
results or performance to be materially different from those expressed
or implied by these forward-looking statements. Factors that may cause
actual results to differ materially from current expectations include,
but are not limited to: the occurrence of any event, change or other
circumstances that could give rise to the termination of negotiations
and any subsequent definitive agreements with respect to the business
combination (the “Business Combination”) with Edoc
Acquisition Corp. (“Edoc”); the outcome of any legal
proceedings that may be instituted against Edoc, Calidi, the combined
company or others following the announcement of the Business
Combination, the private placement financing proposed to be consummated
concurrently with the Business Combination (the “PIPE”), and
any definitive agreements with respect thereto; the inability to
complete the Business Combination due to the failure to obtain approval
of the shareholders of Edoc, the possibility that due diligence
completed following execution of the principal definitive transaction
documents for the Business Combination and PIPE will not be
satisfactorily concluded, the inability to complete the PIPE or other
financing needed to complete the Business Combination, or to satisfy
other conditions to closing; changes to the proposed structure of the
Business Combination that may be required or appropriate as a result of
applicable laws or regulations or as a condition to obtaining regulatory
approval of the Business Combination; the ability to meet stock exchange
listing standards following the consummation of the Business
Combination; the risk that the Business Combination disrupts current
plans and operations of Calidi as a result of the announcement and
consummation of the Business Combination; the ability to recognize the
anticipated benefits of the Business Combination or to realize estimated
pro forma results and underlying assumptions, including with respect to
estimated shareholder redemptions; costs related to the Business
Combination; changes in applicable laws or regulations; the evolution of
the markets in which Calidi competes; the inability of Calidi to defend
its intellectual property and satisfy regulatory requirements; the
ability to implement business plans, forecasts, and other expectations
after the completion of the proposed Business Combination, and identify
and realize additional opportunities; the risk of downturns and a
changing regulatory landscape in the highly competitive pharmaceutical
industry; the impact of the COVID-19 pandemic on Calidi’s
business; and other risks and uncertainties set forth in the section
entitled “Risk Factors” and “Cautionary Note Regarding
Forward-Looking Statements” in Edoc’s preliminary prospectus
dated May 25, 2022, in the Amended Registration Statement on Form S-4
filed with the Securities and Exchange Commission (“SEC”) on
May 26, 2022.
Important Information About the Business Combination Transaction and
Where to Find It
This press release relates to a proposed business
combination between Edoc Acquisition Corp. a Cayman Islands exempted
company, EDOC Merger Sub Inc., a Nevada corporation and Calidi
Biotherapeutics, Inc., a Nevada corporation. A full description of the
terms and conditions Agreement and Plan of Merger constituting the
business combination is provided in the registration statement on Form
S-4 filed with the U.S. Securities and Exchange Commission (SEC) by Edoc
Acquisition Corp., that includes a prospectus with
respect to the securities to be issued in connection with the merger,
and information with respect to an extraordinary meeting of Edoc
Acquisition Corp. shareholders to vote on the merger and related
transactions. Edoc Acquisition Corp. and Calidi Biotherapeutics, Inc.
urges its investors, shareholders and other interested persons to read
the proxy statement and prospectus as well as other documents filed with
the SEC because these documents will contain important information about
Calidi Biotherapeutics, Inc., Edoc Acquisition Corp., and the business
combination transaction. After the registration statement is declared
effective, the definitive proxy statement and prospectus to be included
in the registration statement will be distributed to shareholders of
Edoc Acquisition Corp. and Calidi Biotherapeutics, Inc., as of a record
date to be established for voting on the proposed merger and related
transactions. Shareholders may obtain a copy of the Form S-4
registration statement, including the proxy statement and prospectus,
and other documents filed with the SEC without charge, by directing a
request to: Edoc Acquisition Corp. at 7612 Main Street Fishers, Suite
200, Victor, New York 14564. The preliminary and definitive proxy
statement and prospectus included in the registration statement can also
be obtained, without charge, at the SEC’s website (www.sec.gov).
Participation in the Solicitation
Edoc Acquisition Corp., Calidi
Biotherapeutics, Inc., and their respective directors and executive
officers may be deemed to be participants in the solicitation of proxies
or consents from Edoc Acquisition Corp. and Calidi Biotherapeutics, Inc.
shareholders in connection with the proposed transaction. A list of the
names of the directors and executive officers of Edoc Acquisition Corp.
and Calidi Biotherapeutics, Inc. and information regarding
their interests in the business combination transaction is contained in
the proxy statement and prospectus. You may obtain free copies of these
documents as described in the preceding paragraph.
No Offer or Solicitation
This press release will not constitute a
solicitation of a proxy, consent or authorization with respect to any
securities or in respect of the proposed business combination. This
press release will also not constitute an offer to sell or the
solicitation of an offer to buy any securities of Calidi
Biotherapeutics, Inc., nor will there be any sale of securities in any
states or jurisdictions in which such offer, solicitation or sale would
be unlawful prior to registration or qualification under the securities
laws of any such jurisdiction. No offering of securities will be made
except by means of a prospectus meeting the requirements of section 10
of the Securities Act of 1933, as amended, or an exemption therefrom.
Contacts:
For Investors:
Stephen Jasper
stephen@gilmartinir.com
For Media:
Gwen Gordon
ggordon@cglife.com