Kineta, Inc. (Nasdaq: KA), a clinical-stage biotechnology company
focused on the development of novel immunotherapies in oncology
that address cancer immune resistance, announced today that
enrollment has resumed for the Company’s ongoing VISTA-101 Phase
1/2 clinical trial, effective immediately. As previously announced
on March 12, 2024, patient enrollment in the clinical trial was
suspended due to certain investors indicating that they would not
fulfill their funding obligation due in April 2024 pursuant to the
previously disclosed private placement financing.
To date, KVA12123 has cleared the fifth of six
monotherapy dose levels and two of the four cohorts in combination
with pembrolizumab. Initial results demonstrating partial response
and stable disease in the combination cohorts and durable stable
disease in the 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 CRS-associated cytokines at
any dose level.
“We are very pleased to resume enrollment for
VISTA-101. KVA12123 has been well tolerated with no dose limiting
toxicities and no cytokine release syndrome and we continue to be
encouraged by the initial data demonstrated. With enrollment now
recommenced, we are focused on 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.
On July 8, Kineta announced that it had entered
into an exclusivity and right of first offer agreement (the
“Agreement”) with TuHURA Biosciences, Inc. (“TuHURA”), a Phase 3
registration-stage immuno-oncology company developing novel
technologies to overcome resistance to cancer immunotherapy. As
part of the Agreement, Kineta received a concurrent $5 million
nonrefundable payment from TuHURA. Kineta and TuHURA are
cooperating on the reinitiation of patient enrollment into this
trial.
“KVA12123 is a novel, differentiated new
treatment alternative for patients with cancer. The completion of
the enrollment in the Phase 1 portion of the trial this year is an
important milestone for this exciting development program and we
are pleased to work closely with the Kineta team to resume
enrollment,” said James A. Bianco, Chief Executive Officer of
TuHURA.
Pursuant to the Agreement, among other things,
Kineta has granted TuHURA an exclusive right to acquire 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, Kineta’s VISTA blocking
immunotherapy. 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.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme
LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
About KinetaKineta (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 major challenges with current
cancer therapy. The company’s immuno-oncology pipeline includes
KVA12123, a novel VISTA blocking immunotherapy currently in a Phase
1/2 clinical trial in patients with advanced solid tumors, and a
preclinical monoclonal antibody targeting CD27. For more
information on Kineta, please visit www.kinetabio.com, and follow
Kineta on X (formerly Twitter) and LinkedIn.
Through the combination of unique epitope
binding and an optimized IgG1 Fc region, KVA12123 has demonstrated
strong tumor growth inhibition as both a monotherapy or in
combination with other checkpoint inhibitors in preclinical models.
KVA12123 provides a novel approach to address immune suppression in
the tumor microenvironment 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
including non-small cell lung (NSCLC), colorectal, renal cell
carcinoma, head and neck, and ovarian cancer.
In February 2024, Kineta announced a significant
corporate restructuring to substantially reduce expenses and
preserve cash. The restructuring included a significant workforce
reduction and the suspension of enrollment of new patients in its
ongoing VISTA-101 Phase 1/2 clinical trial evaluating KVA12123 in
patients with advanced solid tumors. At that time, Kineta also
announced that it was exploring strategic alternatives to maximize
stockholder value.
Cautionary Statements Regarding Forward-Looking
Statements
This press release contains “forward-looking
statements” within the meaning of the Private Securities Litigation
Reform Act of 1995. The use of words such as, but not limited to,
“believe,” “expect,” “estimate,” “project,” “intend,” “future,”
“potential,” “continue,” “may,” “might,” “plan,” “will,” “should,”
“seek,” “anticipate,” or “could” and other similar words or
expressions are intended to identify forward-looking statements.
These forward-looking statements include, without limitation,
statements relating to the anticipated benefits of the Agreement
and statements relating to Kineta’s exploration of strategic
alternatives and reinitiation of the VISTA-101 Phase 1/2 clinical
trial. Forward-looking statements are neither historical facts nor
assurances of future performance. Instead, they are based on
Kineta’s current beliefs, expectations and assumptions regarding
the future of Kineta’s business, future plans and strategies,
clinical results and other future conditions. New risks and
uncertainties may emerge from time to time, and it is not possible
to predict all risks and uncertainties. No representations or
warranties (expressed or implied) are made about the accuracy of
any such forward-looking statements.
Such forward-looking statements are subject to a
number of material risks and uncertainties including, but not
limited to: Kineta’s ability to successfully initiate and complete
clinical trials; the difficulty in predicting the time and cost of
development of Kineta’s product candidates; Kineta’s plans to
research, develop and commercialize its current and future product
candidates, including, but not limited to, Kineta’s reinitiation of
the VISTA-101 Phase 1/2 clinical trial for KVA12123; the timing and
anticipated results of Kineta’s planned pre-clinical studies and
clinical trials and the risk that the results of Kineta’s
pre-clinical studies and clinical trials may not be predictive of
future results in connection with future studies or clinical
trials; the timing of the availability of data from Kineta’s
clinical trials; the timing of any planned investigational new drug
application or new drug application; the risk of cessation or delay
of any ongoing or planned clinical trials of Kineta or its
collaborators; the clinical utility, potential benefits and market
acceptance of Kineta’s product candidates; Kineta’s
commercialization, marketing and manufacturing capabilities and
strategy; developments and projections relating to Kineta’s
competitors and its industry; the impact of government laws and
regulations; the timing and outcome of Kineta’s planned
interactions with regulatory authorities; Kineta’s ability to
protect its intellectual property position; Kineta’s ability to
prevail in litigation against investors who failed to close an
anticipated private placement; risks relating to volatility and
uncertainty in the capital markets for biotechnology companies;
availability of suitable third parties with which to conduct
contemplated strategic transactions; whether Kineta will be able to
pursue a strategic transaction, or whether any transaction, if
pursued, will be completed on attractive terms or at all; whether
Kineta’s cash resources will be sufficient to fund its foreseeable
and unforeseeable operating expenses and capital requirements; and
those risks set forth under the caption “Risk Factors” in Kineta’s
most recent Annual Report on Form 10-K filed with the SEC on March
21, 2024 and Quarterly Reports on Form 10-Q filed with the SEC on
May 15, 2024 and August 8, 2024, as well as discussions of
potential risks, uncertainties and other important factors in
Kineta’s subsequent filings with the SEC. Any forward-looking
statement speaks only as of the date on which it was made. Except
as required by law, Kineta undertakes no obligation to publicly
update or revise any forward-looking statement, whether as result
of new information, future events or otherwise.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Investor Relations:info@kineta.usSource: Kineta, Inc.
Kineta (NASDAQ:KA)
過去 株価チャート
から 8 2024 まで 9 2024
Kineta (NASDAQ:KA)
過去 株価チャート
から 9 2023 まで 9 2024