TuHURA's lead candidate, IFx-2.0, was safe and
well tolerated at once weekly dosing for 3 weeks
Eighty percent (80%) of ICI naïve patients
with advanced MCC who failed to respond to pembrolizumab or
avelumab therapy achieved a durable Complete Response (CR),
pathologic CR or Partial Response (PR) following IFx-2.0 therapy
and rechallenge with an anti-PD(L)-1 checkpoint inhibitor
Data presented at the 2024 American Society of
Clinical Oncology (ASCO) Annual Meeting
TAMPA,
Fla. and SAN DIEGO,
June 3,
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 positive
results from the primary analysis of TuHURA's completed Phase
1b trial evaluating IFx-2.0 among
patients with advanced or metastatic MCC or cSCC who exhibited
primary resistance to immune checkpoint inhibitor (ICIs)
therapy.
The abstract titled, "Phase 1b
trial of IFx-Hu2.0, a novel in situ cancer vaccine, in checkpoint
inhibitor-resistant Merkel Cell Carcinoma (MCC) and Cutaneous
Squamous Cell Carcinoma (cSCC)," 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 session held at the 2024 ASCO Annual Meeting
in Chicago, IL.
"It is encouraging that IFx-2.0 demonstrated the ability to
overcome resistance to ICI in 63% of patients with advanced MCC,
even in patients who progressed on both anti-PD1 therapy followed
by anti-PD1/CTLA-4 combination therapy, many of whom also received
chemotherapy and several investigational agents post ICI failure
and prior to IFx-2.0 treatment," commented Dr. James Bianco, Chief Executive Officer of
TuHURA.
The group that was of most interest were the seven (7) patients
with ICI naïve, advanced MCC, who, prior to IFx-2.0 treatment,
received no subsequent systemic or investigational therapies that
may confound the ability to determine IFx-2.0's contribution to
overcoming primary resistance to ICI therapy. Five (5) of these 7
patients progressed within 3.8 months while receiving single agent
anti-PD(L)-1 therapy. IFx-2.0 was administered as the immediate
post ICI therapy. Following IFx-2.0 treatment, patients were
rechallenged with an anti-PD(L)-1 agent. Four (4) of the 5 patients
(80%) achieved a durable objective response (CR, pCR, 2 PRs)
lasting, on average, 25 months, with 2 responses ongoing at 19 and
23 months.
The remaining 2 of 7 patients, after progressing on anti-PD-1
therapy, also received and progressed on combination
anti-PD1/anti-CTLA4 therapy prior to IFx-2.0 treatment. Following
IFx-2.0, 1 patient (50%) achieved a PR, ongoing at 6 months
following rechallenge with single agent anti-PD-1 rechallenge.
The promising efficacy signal demonstrated in the Phase
1b study showing the potential for
IFx-2.0 to overcome primary resistance to anti-PD(L)-1 therapy
formed the rationale for TuHURA's planned Phase 3
registration-directed clinical trial. The Phase 3 trial will
examine IFx-2.0 as an adjunctive therapy with Keytruda®
(pembrolizumab, an anti-PD-1 agent) to improve tumor overall
response rates when compared to Keytruda® plus placebo in first
line treatment of ICI naïve patients with advanced or metastatic
MCC. This Phase 3 trial is expected to begin enrollment in 2H 2024
under the FDA's Accelerated Approval Pathway.
TuHURA's IFx-2.0 personalized cancer vaccine product involves
the injection into a patient's tumor of a small amount of pDNA that
is designed to encode for an immunogenic bacterial protein that
gets expressed on the surface of the patient's tumor so that the
surface of the tumor looks like a bacterium. By making the surface
of a tumor look like a bacterium, IFx-2.0 is designed to use each
patient's tumor itself as the source of foreign neoantigens to
prime and initiate a patient's innate immune response against the
tumor irrespective of whether the tumor escaped immune recognition
prior to IFx-2.0 administration. In doing so, IFx-2.0 is designed
to harness the power of the patient's innate immune response, which
has evolved over time to be conserved to detect foreign pathogens
like bacterial proteins.
The primary objective of the Phase 1b study was to establish safety and feasibility
of repeated administrations of IFx-2.0. The study met its primary
safety objective: ≥80% completion of planned study therapy was
predefined as a successful feasibility outcome. Given the proposed
potential for immune priming effects of IFx-2.0, researchers
performed an unplanned exploratory analysis of post-protocol
treatment efficacy to evaluate response to ICI rechallenge.
As reported at ASCO, following completion of protocol directed
therapy, 11 patients with MCC and 6 patients with cSCC who, prior
to study entry, failed anti-PD(L)1 or anti-PD-1/CTLA-4 therapy,
were re-treated with anti-PD(L)1 monotherapy or combination therapy
as the immediate IFx-2.0 post-protocol therapy: pembrolizumab (7),
nivolumab + ipilimumab (2), or avelumab (2) in MCC and cemiplimab
(6) in cSCC. The study concluded that IFx-Hu2.0 is safe and well
tolerated at weekly dosing repeated up to 3 weeks. In an
exploratory post-hoc analysis, 7 of 11 MCC patients (63%) treated
with standard of care ICI agents immediately following protocol
therapy experienced durable disease control despite prior failure
of this same drug class prior to protocol enrollment, suggesting an
"immune priming" effect of study therapy. Based on this
promising efficacy signal, a randomized study of pembrolizumab +/-
IFx-Hu2.0 is planned in the advanced MCC 1st line
setting.
For more information about TuHURA's Phase 1b IFx-2.0 study, visit clinicaltrials.gov and
reference identifier: NCT04160065.
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. In conjunction with the
execution of the definitive agreement, TuHURA entered into
subscription agreements for a $31
million financing. The combined company will focus on
advancing TuHURA's personalized cancer vaccine(s) and
first-in-class bi-functional Antibody Drug Conjugates ("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 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 news 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 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; and
(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. 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
View original content to download
multimedia:https://www.prnewswire.com/news-releases/tuhura-biosciences-and-kintara-therapeutics-announce-positive-results-from-phase-1b-trial-of-ifx-2-0--a-novel-personalized-cancer-vaccine-in-checkpoint-inhibitor-resistant-advanced-merkel-cell-carcinoma-mcc-and-cutaneous-squamo-302161301.html
SOURCE Kintara Therapeutics