Morphogenesis, Inc. (“Morphogenesis”), a privately-held Phase 2/3
clinical-stage biotechnology company developing novel personalized
cancer vaccines and tumor microenvironment modulators to overcome
primary and acquired resistance to current immunotherapies, and
CohBar, Inc. (NASDAQ: CWBR) (“CohBar”), today announced positive
initial results from an exploratory analysis of anti-tumor
responses to rechallenge with an ICI following protocol directed
IFx-Hu2.0 therapy among patients with advanced MCC or cSCC who
exhibited primary resistance to ICIs.
The abstract titled, “Phase 1b trial of
IFx-Hu2.0, a novel personalized cancer vaccine, in checkpoint
inhibitor resistant Merkel cell carcinoma and cutaneous squamous
cell carcinoma,” was presented by Andrew Brohl, MD, H. Lee Moffitt
Cancer Center and Research Institute in a poster presentation as
part of the Melanoma/Skin Cancers – Advanced/Metastatic Diseases
session held at the 2023 American Society of Clinical Oncology
(ASCO) Annual Meeting, taking place June 2-6, 2023 in Chicago,
IL.
“While patients with advanced Merkel cell
carcinoma and cutaneous Squamous cell carcinoma exhibit high
response rates to immune checkpoint inhibitor therapy, the
approximately 50% of patients who fail to respond have limited
treatment options. We are particularly encouraged by the results in
patients with advanced Merkel cell who exhibited primary resistance
to ICIs, where 4 of 5 (80%) achieved long lasting, major objective
anti-tumor responses on rechallenge with an ICI within the same
checkpoint axis,” noted Dr. James Bianco, Chief Executive Officer
of Morphogenesis. “The potential for IFx-Hu2.0 adjunctive therapy
to pembrolizumab in the first line treatment of advanced MCC could
overcome primary resistance, allowing higher response rates than
pembrolizumab alone.”
IFx-Hu2.0 is Morphogenesis’ lead personalized
cancer vaccine candidate that is designed to overcome primary
resistance to checkpoint inhibitors. In a Phase 1 study in advanced
melanoma, biomarker analyses demonstrated robust immune priming
effects of IFx administration. The ongoing Phase 1b study evaluates
IFx-Hu2.0 in a two-stage study design to assess safety and to
examine the effects of repeated weekly dosing up to 3 weeks on the
magnitude of the ensuing systemic immune response to determine the
optimal dose and schedule for the company’s planned Phase 2/3
registration directed trial.
As reported at ASCO, following completion of
protocol directed therapy, 5 patients with advanced MCC and 2
patients with cSCC who, prior to study entry, failed anti-PD(L)1
therapy were re-treated with anti-PD(L)1 monotherapy: pembrolizumab
(3) or avelumab (2) in MCC and cemiplimab (2) in cSCC. Four of
5 (80%) patients with advanced MCC and 1 of 2 (50%) patients with
cSCC, or 5 of 7 total (71%), experienced objective anti-tumor
responses to ICI rechallenge in this setting, with duration of
response ongoing in 4 patients (7+, 8+, 9+, 20+ months) and one
response lasting 23 months. All 4 patients with advanced MCC with
post-protocol response to anti-PD(L1) therapy had previously
experienced progression to this same drug class prior to treatment
on protocol.
Based on the positive preliminary results seen
to-date, an additional 11 patients are planned for enrollment in
the expansion stage of the Phase 1b study using the weekly x 3
dosing schedule. Additional exploratory/biomarker analyses are
planned.
For more information about the company’s ongoing
Phase 1b IFx-Hu2.0 study, visit Clinicaltrials.gov and reference
Identifier NCT04160065.
Morphogenesis and CohBar recently announced that
they have entered into a definitive merger agreement for an
all-stock transaction to form a company combining expertise and
resources to advance a late-stage oncology pipeline. The combined
company will focus on advancing Morphogenesis’ two technologies
that seek to overcome the major obstacles that limit the
effectiveness of current immunotherapies in treating cancer. The
combined company is expected to operate under the name “TuHURA
Biosciences, Inc.” and to trade on The Nasdaq Capital Market
(“Nasdaq”). The transaction is expected to close in the third
quarter of 2023.
About Immune Fx (IFx) Personalized Cancer
Vaccines
IFx-Hu2.0 administration involves a simple
injection into the patient’s tumor of a proprietary gene that
encodes for an immunogenic bacterial protein which is expressed on
the surface of the tumor cell. Recognizing the bacterial protein as
being foreign, the patient’s immune system is activated “ingesting”
the tumor cell and educating the immune system to all of the
patient’s tumor’s neoantigens resulting in the production of tumor
specific antibodies and cytotoxic T cells. The presence of
activated T cells overcomes resistance to checkpoint inhibitors
allowing checkpoint released activated T cells to seek out and
destroy the tumor.
Additionally, Morphogenesis is advancing its
CD22 targeted, mRNA vaccine (IFx-Hu3.0), toward IND-enabling
studies in 2024 for intravenous or autologous whole cell
administration for the treatment of B cell malignancies like
diffuse large B-cell lymphoma (DLBCL).
About Morphogenesis, Inc.
Morphogenesis is a Phase 2/3 clinical-stage
biotechnology company developing novel personalized cancer vaccines
and tumor microenvironment modulators to overcome primary and
acquired resistance to immunotherapies. The company’s lead
personalized cancer vaccine candidate, IFx-Hu2.0, is designed to
overcome primary resistance to checkpoint inhibitors. Morphogenesis
is preparing to initiate a single randomized placebo-controlled
Phase 2/3 registration trial of IFx-Hu2.0 administered as an
adjunctive therapy to Keytruda® (pembrolizumab) in first line
treatment for advanced Merkel Cell Carcinoma. In addition to its
personalized cancer vaccines the company is also developing first
in class bi-functional antibody drug conjugates (ADCs) designed to
reprogram the tumor microenvironment by targeting a recently
characterized Delta receptor on Myeloid Derived Suppressor Cells
inhibiting their immunosuppressive capabilities while localizing
checkpoint inhibitor(s) in the tumor microenvironment.
For additional information, please visit
www.morphogenesis-inc.com.
About CohBar
CohBar (NASDAQ: CWBR) is a clinical-stage
biotechnology company leveraging the power of the mitochondria and
the peptides encoded in its genome to develop potential
breakthrough therapeutics targeting chronic and age-related
diseases with limited to no treatment options.
For additional company information, please visit
www.cohbar.com and engage with us on LinkedIn.
No Offer or Solicitation
This communication is not intended to and shall
not constitute an offer to buy or sell or the solicitation of an
offer to buy or sell any securities, or a solicitation of any
proxy, consent, authorization, vote or approval, nor shall there be
any sale of securities in any jurisdiction 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 shall be made, except by means of a
prospectus meeting the requirements of the U.S. Securities Act of
1933, as amended.
Additional Information About the
Proposed Transaction for Investors and Stockholders
In connection with the proposed transaction
between CohBar and Morphogenesis (the “Proposed Transaction”),
CohBar intends to file relevant materials with the U.S. Securities
and Exchange Commission (the “SEC”), including a registration
statement on Form S-4 that will contain a proxy
statement/prospectus of CohBar. This press release is not a
substitute for the registration statement or for any other document
that CohBar may file with the SEC in connection with the Proposed
Transaction. COHBAR URGES INVESTORS AND STOCKHOLDERS TO READ THE
REGISTRATION STATEMENT, PROXY STATEMENT/PROSPECTUS AND ANY OTHER
RELEVANT DOCUMENTS THAT MAY BE FILED WITH THE SEC, AS WELL AS ANY
AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN
THEIR ENTIRETY IF AND WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL
CONTAIN IMPORTANT INFORMATION ABOUT COHBAR, MORPHOGENESIS, THE
PROPOSED TRANSACTION AND RELATED MATTERS. Investors and
stockholders will be able to obtain free copies of the proxy
statement/prospectus and other documents filed by CohBar with the
SEC (when they become available) through the website maintained by
the SEC at www.sec.gov. In addition, investors and stockholders
should note that CohBar communicates with investors and the public
using its website (www.cohbar.com), including its investor
relations website (https://cohbar.com/investors), where anyone will
be able to obtain free copies of the proxy statement/prospectus and
other documents filed by CohBar with the SEC, and stockholders are
urged to read the proxy statement/prospectus and the other relevant
materials when they become available before making any voting or
investment decision with respect to the Proposed Transaction.
Participants in the
Solicitation
CohBar, Morphogenesis and their respective
directors and executive officers may be deemed to be participants
in the solicitation of proxies from CohBar’s stockholders in
connection with the Proposed Transaction. Information about
CohBar’s directors and executive officers including a description
of their interests in CohBar is included in CohBar’s most recent
Annual Report on Form 10-K (as amended), including any
information incorporated therein by reference, as filed with the
SEC. Additional information regarding these persons and their
interests in the transaction will be included in the proxy
statement/prospectus relating to the Proposed Transaction when it
is filed with the SEC. These documents can be obtained free of
charge from the sources indicated above.
Forward-Looking Statements
This news release contains forward-looking
statements that are not historical facts within the meaning of the
Private Securities Litigation Reform Act of 1995. Forward-looking
statements are based only on our current beliefs, expectations and
assumptions regarding the future of our business, future plans and
strategies, projections, anticipated events and other future
conditions. In some cases you can identify these statements by
forward-looking words such as “believe,” “may,” “will,” “estimate,”
“continue,” “anticipate,” “intend,” “could,” “should,” “would,”
“project,” “plan,” “expect,” “goal,” “seek,” “future,” “likely” or
the negative or plural of these words or similar expressions.
Examples of such forward-looking statements include but are not
limited to express or implied statements regarding CohBar’s or
Morphogenesis’ management team’s expectations, hopes, beliefs,
intentions or strategies regarding the future including, without
limitation, statements regarding: the Proposed Transaction and the
expected effects, perceived benefits or opportunities and related
timing with respect thereto, expectations regarding clinical trials
and research and development programs, in particular with respect
to Morphogenesis’ IFx-Hu2.0 product candidate, its IFx-Hu3.0
preclinical program, and its TME modulators development program,
and any developments or results in connection therewith; the
anticipated timing of the results from those studies and trials;
and the expected trading of the combined company’s stock on the
Nasdaq Capital Market. In addition, any statements that refer to
projections, forecasts or other characterizations of future events
or circumstances, including any underlying assumptions, are
forward-looking statements. You are cautioned that such
statements are not guarantees of future performance and that actual
results or developments may differ materially from those set forth
in these forward-looking statements. Factors that could cause
actual results to differ materially from these forward-looking
statements include: the risk that the conditions to the closing or
consummation of the Proposed Transaction are not satisfied,
including the failure to obtain stockholder approval for the
Proposed Transaction; the risk that the previously announced
concurrent financing in connection with the Proposed Transaction is
not completed in a timely manner or at all; uncertainties as to the
timing of the consummation of the Proposed Transaction and the
ability of each of CohBar and Morphogenesis to consummate the
transactions contemplated by the Proposed Transaction; risks
related to CohBar’s and Morphogenesis’ ability to correctly
estimate their respective operating expenses and expenses
associated with the Proposed Transaction, as applicable, as well as
uncertainties regarding the impact any delay in the closing would
have on the anticipated cash resources of the resulting combined
company upon closing and other events and unanticipated spending
and costs that could reduce the combined company’s cash resources;
the occurrence of any event, change or other circumstance or
condition that could give rise to the termination of the Proposed
Transaction by either company; the effect of the announcement or
pendency of the Proposed Transaction on CohBar’s or Morphogenesis’
business relationships, operating results and business generally;
costs related to the merger; the outcome of any legal proceedings
that may be instituted against CohBar, Morphogenesis, or any of
their respective directors or officers related to the merger
agreement or the transactions contemplated thereby; the ability of
CohBar or Morphogenesis to protect their respective intellectual
property rights; competitive responses to the Proposed Transaction;
unexpected costs, charges or expenses resulting from the Proposed
Transaction; legislative, regulatory, political and economic
developments; and additional risks described in the “Risk Factors”
section of CohBar’s Annual Report on Form 10-K for the fiscal year
ended December 31, 2022 filed with the SEC. Additional assumptions,
risks and uncertainties are described in detail in our registration
statements, reports and other filings with the Securities and
Exchange Commission and applicable Canadian authorities, which are
available on our website, and at www.sec.gov or www.sedar.com.
You are cautioned that such statements are not
guarantees of future performance and that our actual results may
differ materially from those set forth in the forward-looking
statements. The forward-looking statements and other information
contained in this news release are made as of the date hereof and
CohBar does not undertake any obligation to update publicly or
revise any forward-looking statements or information, whether as a
result of new information, future events or otherwise, unless so
required by applicable securities laws. Nothing herein shall
constitute an offer to sell or the solicitation of an offer to buy
any securities.
Investor Contacts:
Morphogenesis, Inc.Jenene Thomas JTC Team, LLC
morphogenesis@jtcir.com
CohBar, Inc.investors@cohbar.com
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