Odonate Therapeutics Initiates CONTESSA TRIO

– Study Will Investigate Tesetaxel-Immuno-Oncology (IO)
Combinations in Patients with Metastatic Triple-Negative Breast Cancer
(TNBC) –

– First Randomized Clinical Study to Compare Three Approved
PD-(L)1 Inhibitors –

– Study Also Will Investigate Tesetaxel Monotherapy in Elderly
Patients with HER2 Negative Metastatic Breast Cancer (MBC) –

SAN DIEGO–(BUSINESS WIRE)–Odonate
Therapeutics, Inc. (NASDAQ: ODT), a pharmaceutical company dedicated
to the development of best-in-class therapeutics that improve and extend
the lives of patients with cancer, today announced the initiation of
CONTESSA TRIO, a multi-cohort, multicenter, Phase 2 study of tesetaxel,
Odonate’s investigational, orally administered taxane.

• In Cohort 1, approximately 90 patients (with potential expansion to up
  to 150 patients) with locally advanced or metastatic TNBC who have not
  received prior chemotherapy for advanced disease will be randomized
  1:1:1 to receive tesetaxel plus either: (1) nivolumab; (2)
  pembrolizumab; or (3) atezolizumab. Nivolumab and pembrolizumab (PD-1
  inhibitors) and atezolizumab (a PD-L1 inhibitor) are IO agents
  approved for the treatment of multiple types of cancer. One of these
  agents, atezolizumab, in combination with the intravenously delivered
  taxane, nab-paclitaxel, was recently approved by the U.S. Food and
  Drug Administration (FDA) as a first-line treatment for patients with
  metastatic TNBC. The dual primary endpoints for Cohort 1 are objective
  response rate (ORR) and progression-free survival (PFS). Secondary
  endpoints include duration of response (DoR) and overall survival
  (OS). Efficacy results for each of the three PD-(L)1 inhibitor
  combinations will be assessed for correlation with the results of each
  of the three approved PD-L1 diagnostic assays.
• In Cohort 2, approximately 40 elderly patients (with potential
  expansion to up to 60 patients) with HER2 negative MBC who have not
  received prior chemotherapy for advanced disease will receive
  tesetaxel monotherapy. The primary endpoint for Cohort 2 is ORR.
  Secondary endpoints include PFS, DoR and OS.

“Taxane-IO combinations hold great promise for patients living with
TNBC,” said Sara Tolaney, M.D., M.P.H., Associate Director, Susan F.
Smith Center for Women’s Cancers, Director, Clinical Trials, Breast
Oncology at Dana-Farber Cancer Institute and Principal Investigator of
CONTESSA TRIO. “This study will investigate the safety and antitumor
activity of tesetaxel, an orally administered taxane with a distinct
tolerability and pharmacokinetic profile, in combination with three
approved PD-(L)1 inhibitors. CONTESSA TRIO also will investigate
tesetaxel monotherapy in elderly patients with MBC, a patient population
in need of easier-to-take and better tolerated therapies.”

About Tesetaxel

Tesetaxel is an investigational, orally administered chemotherapy agent
that belongs to a class of drugs known as taxanes, which are widely used
in the treatment of cancer. Tesetaxel has several pharmacologic
properties that make it unique among taxanes, including: oral
administration with a low pill burden; a long (~8-day) terminal plasma
half-life in humans, enabling the maintenance of adequate drug levels
with relatively infrequent dosing; no history of hypersensitivity
(allergic) reactions; and significant activity against
chemotherapy-resistant tumors. In patients with metastatic breast
cancer, tesetaxel was shown to have significant, single-agent antitumor
activity in two multicenter, Phase 2 studies.

About CONTESSA TRIO

CONTESSA TRIO is a multi-cohort, multicenter, Phase 2 study of
tesetaxel, an investigational, orally administered taxane, in patients
with locally advanced or metastatic breast cancer (MBC). In Cohort 1,
approximately 90 patients (with potential expansion to up to 150
patients) with locally advanced or metastatic triple-negative breast
cancer (TNBC) who have not received prior chemotherapy for advanced
disease will be randomized 1:1:1 to receive tesetaxel dosed orally at 27
mg/m² on the first day of each 21-day cycle plus either: (1)
nivolumab at 360 mg by intravenous infusion on the first day of each
21-day cycle; (2) pembrolizumab at 200 mg by intravenous infusion on the
first day of each 21-day cycle; or (3) atezolizumab at 1,200 mg by
intravenous infusion on the first day of each 21-day cycle. Nivolumab
and pembrolizumab (PD-1 inhibitors) and atezolizumab (a PD-L1 inhibitor)
are immuno-oncology (IO) agents approved for the treatment of multiple
types of cancer. One of these agents, atezolizumab, in combination with
the intravenously delivered taxane, nab-paclitaxel, was recently
approved by the U.S. Food and Drug Administration (FDA) as a first-line
treatment for patients with metastatic TNBC. The dual primary endpoints
for Cohort 1 are objective response rate (ORR) and progression-free
survival (PFS). Secondary endpoints include duration of response (DoR)
and overall survival (OS). Efficacy results for each of the three
PD-(L)1 inhibitor combinations will be assessed for correlation with the
results of each of the three approved PD-L1 diagnostic assays. In Cohort
2, approximately 40 elderly patients (with potential expansion to up to
60 patients) with human epidermal growth factor receptor 2 (HER2)
negative MBC will receive tesetaxel monotherapy dosed orally at 27 mg/m²
on the first day of each 21-day cycle. The primary endpoint for Cohort 2
is ORR. Secondary endpoints include PFS, DoR and OS. Patients with
central nervous system metastases are eligible for both cohorts.

About Odonate Therapeutics, Inc.

Odonate Therapeutics, Inc. is a pharmaceutical company dedicated to the
development of best-in-class therapeutics that improve and extend the
lives of patients with cancer. Odonate’s initial focus is on the
development of tesetaxel, an investigational, orally administered
chemotherapy agent that belongs to a class of drugs known as taxanes,
which are widely used in the treatment of cancer. Odonate’s goal for
tesetaxel is to develop an effective chemotherapy choice for patients
that provides quality-of-life advantages over current alternatives. To
learn more, please visit www.odonate.com.

Forward-looking Statements

This press release contains “forward-looking statements” as defined by
the Private Securities Litigation Reform Act of 1995. We caution
investors that forward-looking statements are based on management’s
expectations and assumptions as of the date of this press release and
involve substantial risks and uncertainties that could cause the actual
outcomes to differ materially from what we currently expect. These risks
and uncertainties include, but are not limited to, those associated
with: the expected outcome of CONTESSA, our Phase 3 study of tesetaxel
in patients with locally advanced or metastatic breast cancer (LA/MBC);
the expected outcome of our other clinical studies, including CONTESSA 2
and CONTESSA TRIO; our ability to obtain regulatory approval of
tesetaxel; the unpredictable relationship between preclinical study
results and clinical study results; and other risks and uncertainties
identified in our filings with the U.S. Securities and Exchange
Commission. Forward-looking statements in this press release apply only
as of the date made, and we undertake no obligation to update or revise
any forward-looking statements to reflect subsequent events or
circumstances.

Contacts

Odonate Therapeutics, Inc.
John Lemkey
Chief Operating Officer
858-731-8180
[email protected]