30 of a projected 39 patients have been
enrolled in the clinical trial to date, including
a monotherapy arm with KVA12123 and a combination arm
utilizing KVA12123 together with Merck's anti-PD1 therapy,
KEYTRUDA® (pembrolizumab)
Kineta anticipates the trial to be fully
enrolled by the end of 2024
TAMPA, Fla. & SAN DIEGO, August 19,
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 that Kineta,
Inc. (Nasdaq: KA) ("Kineta"), a clinical-stage biotechnology
company focused on the development of novel immunotherapies in
oncology that address cancer immune resistance, has reopened
enrollment in its ongoing VISTA-101 Phase 1/2 clinical trial. As
previously announced on July 8, 2024,
TuHURA entered into an Exclusivity and Right of First Offer
Agreement (the "Agreement") with Kineta for the potential
acquisition of Kineta's KVA12123 VISTA blocking antibody and
related rights and assets associated with and derived from the
asset. Kineta and TuHURA are cooperating on the reinitiation of
patient enrollment into this trial during TuHURA's due diligence
period with respect to the KVA12123 assets.
To date, KVA12123 has cleared the fifth of six monotherapy dose
levels and two of the four cohorts in combination with Merck's
anti-PD1 therapy, KEYTRUDA® (pembrolizumab). Initial results
demonstrating partial response and stable disease in the
combination cohorts, and durable stable disease observed in
monotherapy cohorts, were reported earlier this year at the
American Association of Cancer Research (AACR) Annual Meeting 2024.
Additionally, the initial results of KVA12123 showed a favorable
clinical safety and tolerability profile with no dose limiting
toxicities and no evidence of cytokine release syndrome
(CRS)-associated cytokines at any dose level.
Dr. James Bianco, Chief Executive
Officer of TuHURA commented, "We believe KVA12123 has the potential
to be a promising new treatment alternative for patients with
cancer. Importantly, KVA12123 has demonstrated 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. The expected completion of the
enrollment in the Phase 1 portion of the VISTA-101 trial this year
is an important milestone in the continued advancement of this
program, and we are pleased to work closely with the Kineta team to
get patient enrollment underway again as we continue to investigate
the possibility of acquiring this asset under the
Agreement."
"We have made noteworthy progress with the trial, and the data
seen to date have demonstrated KVA12123 has been well tolerated
with no dose limiting toxicities and no cytokine release syndrome.
We are very pleased to resume enrollment for VISTA-101 and are
focused on the successful execution and working towards completing
enrollment which we expect to do by the end of 2024," said Thierry
Guillaudeux, Chief Scientific Officer of Kineta.
As previously announced, under the terms of the Agreement,
Kineta received a $5 million
nonrefundable payment from TuHURA. Pursuant to the Agreement,
among other things, Kineta has granted TuHURA an exclusive right to
discuss and negotiate with Kineta the potential acquisition of
Kineta's worldwide patents, patent rights, patent applications,
product and development program assets, technical and business
information, and other rights and assets associated with and
derived from its development program related to KVA12123. This
exclusive right shall continue through the first to occur of (a)
the execution of any definitive agreement with respect to a
potential transaction by TuHURA or one or more of its affiliates
and (b) 11:59 PM Eastern Time on
October 1, 2024, subject to extension
for an additional 20 days. TuHURA is currently engaging in due
diligence under the Agreement.
About KVA12123
KVA12123 is a VISTA blocking immunotherapy in development as an
infusion dosed every two weeks being evaluated in an ongoing Phase
1/2 clinical trial 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.
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 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 definitive proxy statement and final prospectus of
Kintara (the "proxy statement/prospectus"). This Registration
Statement has was declared effective on August 13, 2024 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
DEFINITIVE 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 has been sent to Kintara's stockholders.
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 definitive 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 definitive 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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