Kinnate Biopharma Inc. (Nasdaq: KNTE) (Kinnate), a clinical-stage
precision oncology company, today announced the addition of two new
internally developed next generation development candidates to its
targeted oncology pipeline – a brain penetrant mitogen-activated
protein kinase (MEK) inhibitor and a highly selective
mesenchymal-epithelial transition factor gene (c-MET) inhibitor.
The company also announced that it had approximately $231
million of cash, cash equivalents and investments as of March 31,
2023, which is anticipated to fund planned operations into early
2025.
“We are proud of our growing portfolio of precision oncology
programs comprised of highly selective therapeutics with optimized
drug properties designed to address broad alteration coverage,
resistance mechanisms and now brain penetrance,” said Robert Kania,
Ph.D., senior vice president, drug discovery, Kinnate Biopharma
Inc. “The addition of Kinnate’s next generation MEK and c-MET
research programs to our development pipeline illustrates the
productivity of our capability-based discovery engine, which is
delivering on our goal of bringing forward one new IND a year.
Targeted therapies have tremendous potential to help patients, but
only about ten percent of patients with advanced or metastatic
cancer are eligible for currently approved targeted therapies. We
look forward to continued progress powered by our Kinnate Discovery
Engine and the impact we can have on the lives of those battling
cancer.”
In-House Brain-Penetrant MEK Inhibitor Designed for
Optimal Control in Potential Commercial Opportunities
KIN-7136 is designed to be a next generation brain-penetrant MEK
inhibitor for investigation in advanced adult solid tumors,
primarily non-small cell lung cancer (NSCLC), that are MAPK
pathway-driven, including those with brain metastases.
Kinnate expects to enter the clinic with KIN-7136 in the second
half of 2023, pending U.S. Food and Drug Administration (FDA)
clearance on its investigational new drug (IND) application. The
goal of the Phase 1 clinical trial will be to establish safety and
tolerability, and generate understanding of the pharmacokinetics,
pharmacodynamics and early clinical activity of KIN-7136 as a
monotherapy.
In parallel, the company intends to evaluate KIN-7136 combined
with exarafenib, Kinnate’s investigational pan-RAF inhibitor.
Kinnate plans to prioritize exploring the KIN-7136 and exarafenib
combination in BRAF Class I patients with NSCLC that have been
previously treated with a RAF inhibitor and patients with NRAS
mutant melanoma. This approach enables access to a potentially
broader patient population to be evaluated with exarafenib,
including those with brain metastases. KIN-7136 may serve as part
of the company’s long-term RAF combination strategy.
Today, the company separately provided a preliminary update on
the combination arm of the ongoing Phase 1 KN-8701 clinical trial
evaluating exarafenib with binimetinib, a first generation MEK
inhibitor with minimal brain penetrant properties, in patients
primarily with NRAS mutant melanoma.
In-House, Highly Selective c-MET Inhibitor Designed for
Broad Mutational Coverage
Research has shown that acquired resistance to approved and
in-development c-MET inhibitors limits clinical benefit. Up to 35%
of patients treated with approved c-MET inhibitors develop
on-target resistance mutations, leaving them with limited treatment
options and a poor prognosis. In patients with NSCLC, about 3-4% of
patients present with actionable MET exon 14 alterations.
KIN-8741 is designed to be a highly selective c-MET inhibitor
with broad mutational coverage, including acquired resistance
mutations, across a variety of solid tumors in which c-MET is
overexpressed, such as NSCLC.
Kinnate expects to enter the clinic with KIN-8741 in the first
half of 2024, pending FDA clearance on its IND application.
CDK12 Program Update
The company will deprioritize development for its CDK12 program
and evaluate strategic alternatives as it deepens focus on its two
clinical-stage assets and advances development of its MEK and c-MET
programs.
Virtual Investor Webcast Information
Kinnate will host a webcast today, April 17, 2023, at 5:30 p.m.
ET. Investors and the general public are invited to listen to a
live webcast of the session through the "Investors and Media"
section on Kinnate.com or by dialing the U.S. toll free number
+1-888-256-1007 and entering confirmation code: 7465233. An
archived edition of the session will be available following the
event.
About Kinnate Biopharma Inc.
Kinnate Biopharma Inc. is a clinical-stage precision oncology
company focused on expanding on the promise of targeted therapies
for those battling cancer. The company is developing medicines for
known oncogenic drivers where there are no approved targeted drugs
and to overcome the limitations of marketed cancer therapies, such
as non-responsiveness or acquired and intrinsic resistance. Kinnate
has two lead clinical programs being studied in solid tumors with
RAF, NRAS and FGFR-driven alterations, and is rapidly progressing a
pipeline of additional small molecule drug candidates as part of
the Kinnate Discovery Engine. The company is driven by the urgency
and knowledge that patients are waiting for new, effective cancer
medicines. For more information, visit Kinnate.com and follow
us on LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements that
involve substantial risks and uncertainties. These forward-looking
statements include, without limitation, statements regarding the
potential benefits of the company’s product candidates, including
KIN-7136 and KIN-8741; the timing for initiation, conduct of and
goals for clinical trials for KIN-7136 and KIN-8741; development
priorities and portfolio strategy; preliminary and unaudited
financial results and anticipated cash runway; the company’s
intention to hold a webcast; and statements by the company’s senior
vice president, drug discovery. Words such as “believes,”
“anticipates,” “plans,” “expects,” “will,” “potential” and similar
expressions are also intended to identify forward-looking
statements. We have based these forward-looking statements largely
on our current expectations and projections about future events and
trends. Such expectations and projections may never materialize or
may prove to be incorrect. These forward-looking statements are
subject to a number of risks, uncertainties, assumptions and other
factors, including recently transitioning to operating as a
clinical-stage biopharmaceutical company with a limited operating
history; the timing, progress and results of ongoing and planned
preclinical studies and clinical trials for our current product
candidates; the potential for future clinical trial results to
differ from our preclinical studies; our ability to timely enroll a
sufficient number of patients in our clinical trials; our ability
to raise additional capital to finance our operations; our ability
to discover, advance through the preclinical and clinical
development of, obtain regulatory approval for and commercialize
our product candidates; the novel approach we are taking to
discover and develop drugs; our ability to timely file and obtain
approval of investigational new drug applications for our planned
clinical trials; negative impacts of the COVID-19 pandemic on our
business, including ongoing and planned clinical trials and
preclinical studies; competition in our industry; regulatory
developments in the United States and other countries; our ability
to attract, hire and retain highly skilled executive officers and
employees; difficulties in managing our growth; our ability to
protect our intellectual property; reliance on third parties to
conduct our ongoing and planned preclinical studies and clinical
trials, and to manufacture our product candidates; general economic
and market conditions; and other risks. These and other risks,
uncertainties, assumptions and other factors are further described
under the heading “Risk Factors” in our Annual Report on Form 10-K
for the fiscal year ended December 31, 2022 that we have filed with
the Securities and Exchange Commission (“SEC”), as well as in our
subsequent filings we make with the SEC. New risk factors emerge
from time to time and it is not possible for our management to
predict all risk factors, nor can we assess the impact of all
factors on our business or the extent to which any factor, or
combination of factors, may cause actual results to differ
materially from those contained in, or implied by, any
forward-looking statements. Investors should not rely upon
forward-looking statements as predictions of future events.
Although we believe that the expectations reflected in the
forward-looking statements are reasonable, we cannot guarantee
future results, levels of activity, performance or achievements.
Our forward-looking statements speak only as of the date of this
release, and except as required by law, we undertake no obligation
to update publicly any forward-looking statements for any reason in
the future.
Investor & Media Contact:
Priyanka Shah | Priyanka.Shah@kinnate.com | +1-908-447-6134
Kinnate Biopharma (NASDAQ:KNTE)
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