KVA12123 is a rationally targeted, anti-VISTA
antibody checkpoint inhibitor to reverse VISTA immune suppression
and remodel the tumor microenvironment (TME) to overcome acquired
resistance to immunotherapies
KVA12123 is currently in a Phase 1/Phase 2
clinical study as a monotherapy and in combination with Merck's
anti-PD1 therapy, KEYTRUDA® (pembrolizumab), in patients with
advanced solid tumors
To date, KVA12123 has demonstrated a favorable
clinical safety and tolerability profile observed with no dose
limiting toxicities and no evidence of Cytokine Release Syndrome
(CRS) associated toxicities at doses examined
Concurrent $5
million investment from existing TuHURA shareholder
preserves TuHURA's strong balance sheet for advancing its IFx-2.0
Phase 3 accelerated approval trial and novel bi-functional ADCs
TAMPA,
Fla. and SAN DIEGO,
July 8,
2024 /PRNewswire/ -- TuHURA Biosciences, Inc.
("TuHURA"), a Phase 3 registration-stage immune-oncology company
developing novel technologies to overcome resistance to cancer
immunotherapy, and Kintara Therapeutics, Inc. (Nasdaq: KTRA)
("Kintara"), a biopharmaceutical company focused on the development
of new solid tumor cancer therapies, today announced TuHURA has
entered into an Exclusivity and Right of First Offer Agreement (the
"Agreement") with Kineta, Inc. (Nasdaq: KA) ("Kineta") for the
potential acquisition of Kineta's KVA12123 anti-VISTA antibody and
related rights and assets associated with and derived from the
asset.
"KVA12123 has multiple synergies with both of our IFx and Delta
receptor technologies and could be a promising addition to our
pipeline, bringing in a potential Phase 2 ready, novel checkpoint
inhibitor," commented Dr. James
Bianco, Chief Executive Officer of TuHURA. "Unlike
other checkpoint inhibitors which work on activated T-cells,
KVA12123 focuses on VISTA, which is the only known checkpoint on
quiescent T-cells preventing their activation and represents a
promising new target in cancer immunotherapy. VISTA is highly
overexpressed on tumors known not to respond to currently marketed
checkpoint inhibitors most notably gynecologic cancers like ovarian
cancer. They are also expressed on myeloid cells including tumor
associated myeloid-derived suppressor cells ("MDSCs"), which, like
VISTA, are also implicated in TME immunosuppression. Our
novel bi-functional Antibody Drug Conjugates ("ADCs") are intended
to target and block the delta receptor on MDSCs."
Under the terms of the Agreement, TuHURA will pay Kineta
$5.0 million, with $2.5 million paid at signing and, subject to
certain provisions, an additional $2.5
million to be paid by July 15,
2024. In conjunction with the Agreement, TuHURA sold
$5.0 million of shares of its common
stock in a private offering to an existing shareholder. The
exclusivity period under the Agreement lasts for 90 days (until
October 1, 2024), subject to extension for an additional 20
days.
About KVA12123
KVA12123 is a VISTA blocking immunotherapy in development as a
twice weekly monoclonal antibody infusion drug completing two
clinical trials both as a monotherapy and in combination with
Merck's anti-PD1 therapy, KEYTRUDA® (pembrolizumab), in patients
with advanced treatment refractory, solid tumors. Competitive
therapies targeting VISTA have demonstrated either poor monotherapy
anti-tumor activity in preclinical models or induction of cytokine
release syndrome (CRS) in human clinical trials. Through the
combination of unique epitope binding and an optimized IgG1 Fc
region, KVA12123 demonstrates strong monotherapy tumor growth
inhibition in preclinical models without evidence of CRS in
clinical trial participants. KVA12123 has been shown to de-risk the
VISTA target and provides a novel approach to address immune
suppression in the TME with a mechanism of action that is
differentiated and complementary with T cell focused therapies.
KVA12123 may be an effective immunotherapy for many types of cancer
and represents the introduction of a new class of checkpoint
inhibitors.
VISTA (V-domain Ig suppressor of T-cell activation) is a
negative immune checkpoint that suppresses T cell function in a
variety of solid tumors. High VISTA expression in tumor correlates
with poor survival in cancer patients and has been associated with
a lack of response to other immune checkpoint inhibitors. Blocking
VISTA induces an efficient polyfunctional immune response to
address immunosuppression and drives anti-tumor responses.
"TuHURA Biosciences is well positioned to advance KVA12123,"
said Craig W. Philips, President of
Kineta. "TuHURA has significant expertise and deep experience
in the field. We believe they will make an excellent partner for
this program and in advancing this novel drug program which could
provide an important new treatment option for cancer patients."
As previously announced, TuHURA entered into a definitive
agreement for an all-stock transaction with Kintara to form a
company combining expertise and resources to advance a risk
diversified late-stage oncology pipeline. The combined company will
focus on advancing TuHURA's personalized cancer vaccine(s) and
first-in-class bi-functional ADCs, 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 under the ticker "HURA". The
transaction is subject to customary closing conditions, including
stockholder approval of both companies, and is expected to close in
the third quarter of 2024.
About Kineta, Inc.
Kineta (Nasdaq: KA) is a clinical-stage biotechnology company
with a mission to develop next-generation immunotherapies that
transform patients' lives. Kineta has leveraged its expertise in
innate immunity and is focused on discovering and developing
potentially differentiated immunotherapies that address the
mechanisms of cancer immune resistance. For more information on
Kineta, please visit www.kinetabio.com, and follow Kineta on X
(Twitter) and LinkedIn.
About TuHURA Biosciences, Inc.
TuHURA Biosciences, Inc. is a Phase 3 registration-stage
immuno-oncology company developing novel technologies to overcome
resistance to cancer immunotherapy. TuHURA's lead personalized
cancer vaccine candidate, IFx-2.0, is designed to overcome primary
resistance to checkpoint inhibitors. TuHURA is preparing to
initiate a single randomized placebo-controlled Phase 3
registration trial of IFx-2.0 administered as an adjunctive therapy
to Keytruda® (pembrolizumab) in first line treatment for advanced
or metastatic Merkel Cell Carcinoma.
In addition to its cancer vaccine product candidates, TuHURA is
leveraging its Delta receptor technology to develop first-in-class
bi-functional ADCs, targeting Myeloid Derived Suppressor Cells to
inhibit their immune suppressing effects on the tumor
microenvironment to prevent T cell exhaustion and acquired
resistance to checkpoint inhibitors and cellular therapies.
For more information, please visit tuhurabio.com and connect
with TuHURA on Facebook, X, and LinkedIn.
About Kintara
Located in San Diego,
California, Kintara is dedicated to the development of novel
cancer therapies for patients with unmet medical needs. Kintara is
developing therapeutics for clear unmet medical needs with reduced
risk development programs. Kintara's lead program is REM-001
Therapy for cutaneous metastatic breast cancer (CMBC).
Kintara has a proprietary, late-stage photodynamic therapy
platform that holds promise as a localized cutaneous, or visceral,
tumor treatment as well as in other potential indications. REM-001
Therapy, which consists of the laser light source, the light
delivery device, and the REM-001 drug product, has been previously
studied in four Phase 2/3 clinical trials in patients with CMBC who
had previously received chemotherapy and/or failed radiation
therapy. In CMBC, REM-001 has a clinical efficacy to date of 80%
complete responses of CMBC evaluable lesions and an existing robust
safety database of approximately 1,100 patients across multiple
indications.
For more information, please visit www.kintara.com or
follow us on X
at @Kintara_Thera, Facebook and LinkedIn.
No Offer or Solicitation
This communication shall not constitute an offer to sell or the
solicitation of an offer to buy 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 Section 10 of the
U.S. Securities Act of 1933, as amended (the "Securities Act").
Additional Information About the Proposed Merger and Where to
Find It
This communication does 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 vote or approval. This communication relates to
the proposed merger of Kintara and TuHURA (the "proposed Merger").
In connection with the proposed Merger, Kintara has filed relevant
materials with the U.S. Securities and Exchange Commission (the
"SEC"), including a Registration Statement on Form S-4 that
contains a preliminary proxy statement and preliminary prospectus
of Kintara (the "proxy statement/prospectus"). This Registration
Statement has not yet been declared effective and Kintara has filed
or may file other documents regarding the proposed Merger with the
SEC. This press release is not a substitute for the Registration
Statement or for any other document that Kintara has filed or may
file with the SEC in connection with the proposed Merger. No
offering of securities shall be made, except by means of a
prospectus meeting the requirements of Section 10 of the Securities
Act. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE
REGISTRATION STATEMENT, THE PRELIMINARY PROXY STATEMENT/PROSPECTUS
AND ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SEC, AS WELL AS ANY
AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN
THEIR ENTIRETY, WHEN THEY BECOME AVAILABLE, BECAUSE THEY CONTAIN
AND THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT KINTARA, TUHURA,
THE PROPOSED MERGER AND RELATED MATTERS THAT STOCKHOLDERS SHOULD
CONSIDER BEFORE MAKING ANY DECISION REGARDING THE PROPOSED MERGER.
A definitive proxy statement/prospectus will be sent to Kintara's
stockholders once available. Investors and security holders will be
able to obtain the proxy statement/prospectus and other documents
filed by Kintara with the SEC (when available) free of charge from
the SEC's website at www.sec.gov. In addition, investors and
stockholders should note that Kintara communicates with investors
and the public using its website (www.kintara.com), the investor
relations website (https://www.kintara.com/investors) where anyone
will be able to obtain free copies of the preliminary proxy
statement/prospectus and other documents filed by Kintara with the
SEC, and stockholders are urged to read the definitive proxy
statement/prospectus and the other relevant materials when they
become available before making any voting or investment decision
with respect to the proposed Merger.
Participants in the Solicitation
Kintara, TuHURA and their respective directors and executive
officers and other members of management and employees and certain
of their respective significant stockholders may be deemed to be
participants in the solicitation of proxies from Kintara and TuHURA
stockholders in respect of the proposed Merger. Information about
Kintara's directors and executive officers is available in
Kintara's proxy statement, which was filed with the SEC on
May 17, 2024 for the 2024 Annual
Meeting of Stockholders, Kintara's Annual Report on Form 10-K for
the fiscal year ended June 30, 2023,
which was filed with the SEC on September
18, 2023. Information regarding the persons who may, under
the rules of the SEC, be deemed participants in the proxy
solicitation and a description of their direct and indirect
interests, by security holding or otherwise, has been and will be
contained in the preliminary proxy statement/prospectus and other
relevant materials to be filed with the SEC regarding the proposed
Merger when they become available. Investors should read the
definitive proxy statement/prospectus carefully when it becomes
available before making any voting or investment decisions. You may
obtain free copies of these documents from the SEC and Kintara as
indicated above.
Forward-Looking Statements
This press release contains forward-looking statements based
upon Kintara's and TuHURA's current expectations. This
communication contains "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995.
Forward-looking statements are identified by terminology 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 Kintara's or TuHURA's management
team's expectations, hopes, beliefs, intentions or strategies
regarding the future including, without limitation, statements
regarding: the anticipated benefits of the Agreement or a strategic
transaction with Kineta, the proposed Merger 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
TuHURA's IFx-Hu2.0 product candidate 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; expectations regarding the use of capital resources,
including the net proceeds from the financing that closed in
connection with the signing of the definitive agreement, and the
time period over which the combined company's capital resources
will be sufficient to fund its anticipated operations; and the
expected trading of the combined company's stock on the Nasdaq
Capital Market. These statements are only predictions.
Kintara and TuHURA have based these forward-looking statements
largely on their then-current expectations and projections about
future events, as well as the beliefs and assumptions of
management. Forward-looking statements are subject to a number of
risks and uncertainties, many of which involve factors or
circumstances that are beyond each of Kintara's and TuHURA's
control, and actual results could differ materially from those
stated or implied in forward-looking statements due to a number of
factors, including but not limited to: (i) the risk that the
conditions to the closing or consummation of the proposed Merger
are not satisfied, including the failure to obtain stockholder
approval for the proposed Merger; (ii) uncertainties as to the
timing of the consummation of the proposed Merger and the ability
of each of Kintara and TuHURA to consummate the transactions
contemplated by the proposed Merger; (iii) risks related to
Kintara's and TuHURA's ability to correctly estimate their
respective operating expenses and expenses associated with the
proposed Merger, 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; (iv) the occurrence of any
event, change or other circumstance or condition that could give
rise to the termination of the proposed Merger by either Kintara or
TuHURA; (v) the effect of the announcement or pendency of the
proposed Merger on Kintara's or TuHURA's business relationships,
operating results and business generally; (vi) costs related to the
proposed Merger; (vii) the outcome of any legal proceedings that
may be instituted against Kintara, TuHURA, or any of their
respective directors or officers related to the Merger Agreement or
the transactions contemplated thereby; (vii) the ability of Kintara
or TuHURA to protect their respective intellectual property rights;
(viii) competitive responses to the proposed Merger; (ix)
unexpected costs, charges or expenses resulting from the proposed
Merger; (x) whether the combined business of TuHURA and Kintara
will be successful; (xi) legislative, regulatory, political and
economic developments; (xii) additional risks described in the
"Risk Factors" section of Kintara's Annual Report on Form 10-K for
the fiscal year ended June 30, 2023,
and the Registration Statement on Form S-4 related to the proposed
Merger filed with the SEC; and (xiii) the risk that Kineta and
TuHURA do not enter into a definitive agreement for a strategic
transaction. Additional assumptions, risks and uncertainties are
described in detail in Kintara's registration statements, reports
and other filings with the SEC, which are available on Kintara's
website, and at www.sec.gov. Accordingly, you should not rely upon
forward-looking statements as predictions of future events. Neither
Kintara nor TuHURA can assure you that the events and circumstances
reflected in the forward-looking statements will be achieved or
occur, and actual results could differ materially from those
projected in the forward-looking statements. The forward-looking
statements made in this communication relate only to events as of
the date on which the statements are made. Except as required by
applicable law or regulation, Kintara and TuHURA undertake no
obligation to update any forward-looking statement to reflect
events or circumstances after the date on which the statement is
made or to reflect the occurrence of unanticipated events.
Investors should not assume that any lack of update to a previously
issued "forward-looking statement" constitutes a reaffirmation of
that statement.
Investor Contacts:
TuHURA Biosciences, Inc.
Jenene Thomas
JTC Team, LLC
tuhura@jtcir.com
Kintara Therapeutics, Inc.
Robert E. Hoffman
Kintara Therapeutics
rhoffman@kintara.com
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SOURCE Kintara Therapeutics