Zentalis Pharmaceuticals Announces First Patient Dosed in the Phase 1/2 Study of ZN-c3 in Combination with Gemcitabine in Patients with Osteosarcoma
September 13 2021 - 7:00AM
Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage
biopharmaceutical company focused on discovering and developing
small molecule therapeutics targeting fundamental biological
pathways of cancers, today announced that the first patient has
been dosed in the Phase 1/2 trial of ZN-c3, the Company’s oral WEE1
inhibitor product candidate, in combination with gemcitabine, a
chemotherapy used to treat certain malignant tumors,
in pediatric and adult patients with relapsed or refractory
osteosarcoma.
“We are thrilled to expand our ZN-c3 program with the initiation
of a fourth clinical trial for this candidate, underscoring ZN-c3’s
potential versatility across a broad range of solid tumors,”
commented Dr. Anthony Sun, Chairman and Chief Executive Officer of
Zentalis. “Relapsed or refractory patients with osteosarcoma, a
rare type of bone cancer, have an extremely poor prognosis,
reinforcing the need for novel treatment regimens to combat this
highly aggressive disease. With over 50% of osteosarcomas having a
mutation in TP53 – potentially resulting in chemoresistance – we
believe that inhibiting the DNA damage response protein WEE1 could
enhance the efficacy of gemcitabine in this pre-treated population.
We are eager to conduct this seminal study evaluating this
combination’s clinical safety and efficacy and look forward to
reporting initial results from this trial in the second half of
2022.”
Zentalis recently received orphan drug and rare pediatric
disease designations from the U.S. Food and Drug Administration for
pediatric osteosarcoma. If ZN-c3 were to obtain approval for the
designated indication, it could potentially be eligible for a rare
pediatric disease priority voucher upon approval.
The Phase 1/2 trial (ZN-c3-003) is a dose escalation and dose
expansion study, evaluating the clinical activity, safety,
pharmacodynamics and pharmacokinetics of ZN-c3 in combination with
gemcitabine in relapsed or refractory osteosarcoma. The primary
efficacy endpoint is event-free survival (EFS) at 18 weeks per
RECIST criteria. Secondary endpoints include EFS per RECIST, median
overall survival and overall survival at 12 months. More
information about the trial is available at www.clinicaltrials.gov:
NCT04833582.
About Osteosarcoma
Osteosarcoma, while rare, is the most common type of bone cancer
and is often associated with a high degree of malignancy, early
metastasis, rapid progression, and poor prognosis. This cancer
occurs primarily in children, teens and young adults ranging from
10 to 30 years old. The risk of diagnosis decreases in adulthood,
but rises again in older adults usually over the age of 60.
Approximately 1,000 new cases of osteosarcoma are diagnosed in the
United States each year. Treatment typically includes a combination
of surgery and chemotherapy, with chemotherapy administered before
and after surgery to help lower the risk of relapse. Even though
curative therapy is available for the primary tumor, long-term
outcomes for osteosarcoma patients continue to be impacted by
metastatic progression. In addition, over 50% of osteosarcomas have
a mutation in TP53 which portends a poorer prognosis and implies
chemoresistance. As no substantive improvements in long-term
outcomes have occurred for more than three decades, there remains
an urgent need for improved therapies to prevent or treat
metastatic disease.
About ZN-c3
ZN-c3 is a potentially first-in-class and best-in-class oral
inhibitor of WEE1 in development for the treatment of advanced
solid tumors. The inhibition of WEE1, a DNA damage response
protein, aims to generate sufficient DNA damage in cancer cells,
causing cell death, thereby preventing tumor growth and potentially
causing tumor regression. ZN-c3 has broad potential as a
monotherapy and in combination and we are currently evaluating this
candidate in several ongoing and planned studies, including two
potentially registrational monotherapy trials in USC and a
biomarker-driven setting, as well as combination studies such as
with chemotherapy in patients with advanced ovarian cancer. We also
recently received orphan drug and rare pediatric disease
designations from the FDA for pediatric osteosarcoma and have
initiated a Phase 1/2 trial in combination with chemotherapy.
About Zentalis Pharmaceuticals
Zentalis Pharmaceuticals, Inc. is a clinical-stage
biopharmaceutical company focused on discovering and developing
small molecule therapeutics targeting fundamental biological
pathways of cancers. The Company is developing a broad pipeline of
potentially best-in-class oncology candidates, all internally
discovered, which include ZN-c3, a WEE1 inhibitor for advanced
solid tumors, ZN-c5, an oral selective estrogen receptor degrader
(SERD) for ER+/HER2- breast cancer, ZN-d5, a BCL-2 inhibitor for
hematologic malignancies, and ZN-e4, an EGFR inhibitor for
non-small cell lung carcinoma (NSCLC). Zentalis has licensed ZN-c3,
ZN-c5 and ZN-d5 to its joint venture, Zentera Therapeutics, to
develop and commercialize these candidates in China. Zentalis has
operations in both New York and San Diego.
For more information, please visit www.zentalis.com. Follow
Zentalis on Twitter at @ZentalisP and on LinkedIn
at www.linkedin.com/company/zentalis-pharmaceuticals.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. All statements contained in this press release that do not
relate to matters of historical fact should be considered
forward-looking statements, including without limitation statements
regarding our expectations surrounding the development, potential,
safety, efficacy, and regulatory and clinical progress of our
product candidates, including without limitation ZN-c3, in the
Unites States and globally, potential eligibility of ZN-c3 for a
rare pediatric disease priority voucher and plans and timing for
the initiation of and the release of data from our clinical trials
and our ability to meet other key milestones. These statements are
neither promises nor guarantees, but involve known and unknown
risks, uncertainties and other important factors that may cause our
actual results, performance or achievements to be materially
different from any future results, performance or achievements
expressed or implied by the forward-looking statements, including,
but not limited to the important factors discussed under the
caption “Risk Factors” in our Quarterly Report on Form 10-Q for the
quarter ended June 30, 2021 filed with the U.S. Securities and
Exchange Commission (SEC) and our other filings with the SEC. Any
such forward-looking statements represent management’s estimates as
of the date of this press release. While we may elect to update
such forward-looking statements at some point in the future, we
disclaim any obligation to do so, even if subsequent events cause
our views to change.Investor Contact:Gitanjali
Jain OgawaSolebury Troutgogawa@soleburytrout.com
Media Contact:Julia DeutschSolebury
Troutjdeutsch@soleburytrout.com
Zentalis Pharmaceuticals (NASDAQ:ZNTL)
Historical Stock Chart
From Mar 2024 to Apr 2024
Zentalis Pharmaceuticals (NASDAQ:ZNTL)
Historical Stock Chart
From Apr 2023 to Apr 2024