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Press Release

Puma Biotechnology Announces Presentations of Investigational Data at the San Antonio Breast Cancer Symposium (SABCS)

Puma Biotechnology,Inc.
Posted on: 15 Nov 16

Puma Biotechnology, Inc. (NYSE: PBYI), a biopharmaceutical company, announced that its lead drug candidate PB272 (neratinib) will be featured in 11 poster presentations at the 2016 San Antonio Breast Cancer Symposium (SABCS), December 6 - 10, 2016, in San Antonio, Texas. Abstracts are available to the public online on the SABCS website: www.sabcs.org.

Details of the poster and poster discussion presentations are as follows:

OT1-02-05: Phase II clinical trial of neratinib in patients 60 and older with HER2 over-expressed or mutated breast cancer: Trial design considerations for older adults.
Wednesday, Dec. 7; 5:00 – 7:00 p.m. CST

P1-07-12: An exploratory correlative biomarker analysis of NSABP FB-7, a phase II randomized trial evaluating neoadjuvant therapy with weekly paclitaxel (P) plus neratinib (N) or trastuzumab (T) or neratinib and trastuzumab (N+T) followed by doxorubicin and cyclophosphamide (AC) with postoperative T in women with locally advanced HER2-positive breast cancer.
Wednesday, Dec. 7; 5:00 – 7:00 p.m. CST

PD2-05: Inhibition of mutant HER2 results in synthetic lethality when combined with ER antagonists in ER+/HER2 mutant human breast cancer cells.
Poster Discussion, Wednesday, Dec. 7; 5:00 – 7:00 p.m. CST

PD2-08: Neratinib + fulvestrant in ERBB2-mutant, HER2-non-amplified, estrogen receptor (ER)-positive, metastatic breast cancer (MBC): Preliminary analysis from the phase II SUMMIT trial.
Poster Discussion, Wednesday, Dec. 7; 5:00 – 7:00 p.m. CST

P2-03-05: Identification, clinical characteristics and treatment outcomes of somatic human epidermal growth factor receptor 2 (ERBB2) mutations in metastatic breast cancer patients.
Thursday, Dec. 8; 7:30 – 9:00 a.m. CST

P2-03-10: A fit-for-purpose NGS system that reports ERBB2 (HER2) mutations and copy number variants for clinical trials research and drug development.
Thursday, Dec. 8; 7:30 – 9:00 a.m. CST

P2-11-03: Incidence and severity of diarrhea with neratinib + intensive loperamide prophylaxis in patients (pts) with HER2+ early-stage breast cancer (EBC): Interim analysis from the multicenter, open-label, phase II CONTROL trial.
Thursday, Dec. 8; 7:30 – 9:00 a.m. CST

P3-03-03: An acquired HER2 T798I gatekeeper mutation induces resistance to neratinib in a patient with HER2 mutant-driven breast cancer.
Thursday, Dec. 8; 5:00 – 7:00 p.m. CST

P3-05-02: Quantitative ERα measurements in TNBC from the I-SPY 2 TRIAL correlate with HER2-EGFR co-activation and heterodimerization.
Thursday, Dec. 8; 5:00 – 7:00 p.m. CST

P4-12-06: Quantification of HER2-driven signaling (HER2S) inhibition of four different anti-HER2 drugs tested ex vivo in live primary HER2-negative breast cancer cell samples with abnormal HER2 signaling activity.
Friday, Dec. 9; 7:30 – 9:00 a.m. CST

P4-21-10: Characterization of neratinib-induced diarrhea in patients with early-stage HER2+ breast cancer: Analyses from the phase III ExteNET trial.
Friday, Dec. 9; 7:30 – 9:00 a.m. CST

About Puma Biotechnology

Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. The Company in-licenses the global development and commercialization rights to three drug candidates—PB272 (neratinib (oral)), PB272 (neratinib (intravenous)) and PB357. Neratinib is a potent irreversible tyrosine kinase inhibitor that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4. Currently, the Company is primarily focused on the development of the oral version of neratinib, and its most advanced drug candidates are directed at the treatment of HER2-positive breast cancer. The Company believes that neratinib has clinical application in the treatment of several other cancers as well, including non-small cell lung cancer and other tumor types that over-express or have a mutation in HER2.

Further information about Puma Biotechnology may be found at www.pumabiotechnology.com.

Forward-Looking Statements:

This press release contains forward-looking statements that involve risks and uncertainties that could cause the Company's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, which include, but are not limited to, the risk factors disclosed in the periodic reports filed by the Company with the Securities and Exchange Commission from time to time. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company assumes no obligation to update these forward-looking statements, except as required by law.

View source version on businesswire.com: http://www.businesswire.com/news/home/20161114006657/en/

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Last updated on: 15/11/2016

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