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Tesetaxel, Administered Orally as a Single Agent, Results in 45% Confirmed Response Rate in Patients with HER2 Negative, Hormone Receptor Positive, Metastatic Breast Cancer

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- Results from Multicenter Phase 2 Study Presented at The 2018
American Society of Clinical Oncology (ASCO) Annual Meeting -

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 that results from a
multicenter Phase 2 study of tesetaxel, administered orally as a single
agent to patients with HER2 negative, hormone receptor (HR) positive,
metastatic breast cancer (MBC), were presented at the 2018 ASCO Annual
Meeting in Chicago, Illinois (Poster
Board #123; Abstract #1042)
.

In this Phase 2 study (Study TOB203), 38 patients with HER2 negative, HR
positive, MBC received tesetaxel orally as a single agent once every 3
weeks (Q3W) at a starting dose of 27 mg/m2. Eighty-seven
percent (87%) had visceral disease, 74% previously received at least one
endocrine therapy, 68% previously received neoadjuvant or adjuvant
chemotherapy and 53% previously received a taxane-containing regimen.
Objective response rate (ORR) based on Response Evaluation Criteria in
Solid Tumors (RECIST) 1.1 with confirmation no less than 4 weeks after
initial response was the primary endpoint.

In all 38 patients, the confirmed response rate was 45%. The confirmed
response rate was consistent across subgroups. Forty-four percent (44%)
of patients who did not previously receive a taxane-containing regimen
achieved a confirmed response, compared to 45% of patients who
previously received a taxane-containing regimen. Median duration of
response was 10.9 months, and median progression-free survival was 5.4
months.

Neutropenia was the most common Grade ≥3 adverse event and occurred in
25% of the 24 patients who were not dose-escalated beyond the 27 mg/m2
starting dose (the dose selected for CONTESSA, our ongoing Phase 3 study (Poster
Board #184a; Abstract #TPS1106)
; in these patients, febrile
neutropenia occurred in 1 patient (4%) and Grade ≥3 neuropathy occurred
in 1 patient (4%). There were no hypersensitivity reactions or
drug-related deaths, and the rate of Grade 2 alopecia (hair loss) was
18%.

"Despite recent advances in the treatment of advanced breast cancer,
there remains a significant need for new therapies that allow patients
to maintain a better quality of life," said Joyce O'Shaughnessy, M.D.,
Celebrating Women Chair in Breast Cancer Research, Baylor University
Medical Center, Texas Oncology and Chair, Breast Cancer Research, US
Oncology.

"Tesetaxel's significant single-agent activity, once-every-three-week
oral dosing and low rates of neuropathy and hair loss could make this
investigational agent a unique treatment option for patients, if
approved," said Andrew Seidman, M.D., Attending Physician and Associate
Chair, Academic Administration, Department of Medicine, Memorial Sloan
Kettering Cancer Center (MSKCC) and Professor of Medicine, Joan and
Sanford I. Weill Department of Medicine, Weill Cornell Medical College.
"We look forward to further characterizing tesetaxel's therapeutic
profile in CONTESSA, an ongoing Phase 3 study."

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 potential therapeutic
advantages over currently available taxanes, including: oral
administration with a low pill burden and a patient-friendly dosing
regimen; no history of hypersensitivity (allergic) reactions; and
significant activity against chemotherapy-resistant tumors. More than
500 patients have been treated with tesetaxel in clinical studies. In
patients with metastatic breast cancer, tesetaxel was shown to have
significant, single-agent antitumor activity in two, multicenter, Phase
2 studies.

About CONTESSA

CONTESSA is a multinational, multicenter, randomized, Phase 3 study of
tesetaxel, an investigational, orally administered taxane, in patients
with locally advanced or metastatic breast cancer (LA/MBC). CONTESSA is
comparing tesetaxel dosed orally at 27 mg/m2 on the first day
of a 21-day cycle plus a reduced dose of capecitabine (1,650 mg/m2/day
dosed orally on days 1-14 of a 21-day cycle) to the approved dose of
capecitabine alone (2,500 mg/m2/day dosed orally on days 1-14
of a 21-day cycle) in approximately 600 patients randomized 1:1 with
HER2 negative, hormone receptor (HR) positive LA/MBC previously treated
with a taxane in the neoadjuvant or adjuvant setting. Capecitabine is an
oral chemotherapy agent that is considered a standard-of-care treatment
in LA/MBC. Where indicated, patients must have received endocrine
therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor.
The primary endpoint is progression-free survival (PFS) assessed by an
Independent Radiologic Review Committee (IRC). CONTESSA's secondary
efficacy endpoints are overall survival, objective response rate (ORR)
assessed by IRC and disease control rate assessed by IRC. To learn more,
please visit www.contessastudy.com.

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 belonging to a class of drugs known as taxanes, which
are widely used in the treatment of cancer. Odonate recently initiated
CONTESSA, a multinational, multicenter, randomized, Phase 3 study of
tesetaxel in patients with locally advanced or metastatic breast 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 outcome of CONTESSA, our Phase 3 study of tesetaxel in
patients with locally advanced or metastatic breast cancer; our ability
to obtain regulatory approval of tesetaxel; and other risks and
uncertainties identified in our filings with the United States
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.

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