Company (Location)

Product

Description

Indication

Status (Date)#


Algeta ASA (Oslo, Norway)

Alpharadin

Radium-223 chloride

Endocrine-refractory breast cancer

Phase II data showed that it met its co-primary endpoings by significantly reducing the levels of bone alkaline phosphatase and urine N-telopeptide during the 16-week treatment period (12/12)

Enzon Pharmaceuticals Inc. (Piscataway, N.J.)

PEG-SN38

EZN-2208; pegylated version of SN38

Metastatic breast cancer

Phase II data showed it demonstrated activity with an overall response of 21% in those treated with anthracycline and taxane and 11% in those treated with anthracycline, taxane and capecitabine (12/12)

Exelixis Inc. (South San Francisco)

Cabozantinib

An inhibitor of MET, RET and VEGFR2

Metastatic breast cancer

Preliminary data from 45 patients with previously treated disease showed that 14% had a partial response, 59% had stable disease and 20% had progressive disease in the Phase II trial (12/9)

Galena Biopharma Inc. (Lake Oswego, Ore.)

NeuVax

E75 plus GM-CSF

Breast cancer

Phase II trial testing NeuVax and Herceptin showed that no patients experienced recurrence, with a median follow-up of 48 months (12/12)

Genentech Inc. (South San Francisco)

Pertuzumab

An HER2-targeted medicine designed to specifrically target a different region on the HER2 receptor than Herceptin

HER2-positive metastatic breast cancer

Phase III data suggested the drug, in combination with Herceptin and docetaxel chemotherapy, provided a 38% improvement in progression-free survival compared to Herceptin and docetaxel alone (12/9)

Generex Biotechnology Corp. (Worcester, Mass.)

AE37

li-Key hybrid-based HER2/neu peptide vaccine

HER2-expressing breast cancer

Phase II data suggested that disease-free survival in low HER2 expressing patients receiving AE37 plus granulocyte-macrophage colony-stimulating factor was 88.6% compared to 71.9% in the GM-CSF alone control arm (12/9)

Genta Inc. (Berkeley Heights, N.J.)

Tesetaxel

Oral taxane

Advanced breast cancer

Phase IIb data showed that out of 24 evaluable patients, the objective response rate was 50%, including 1 complete and 11 partial responses (12/9)

MediGene AG (Martinsried, Germany)

EndoTAG-1

Monotherapy

Triple-negative breast cancer

Median overall survival data from its Phase II trial showed a time of 13 months in the EndoTAG-1/paclitaxel combination therapy arm, 11.9 months in the EndoTAG-1 monotherapy arm and 10.1 months in the paclitaxel monotherapy arm (12/12)

Novartis AG (Basel, Switzerland)

Afinitor

Everolimus tablets

Advanced breast cancer

Phase III data showed the treatment more than doubled progression-free survival to 7.4 months, compared to 3.2 months with hormonal therapy alone (12/9)

Puma Biotechnology Inc. (Los Angeles)

PB272

Neratinib

Metastatic or locally advanced breast cancer

Phase I/II data showed that PB272 when given in combination with capecitabine, was found to be tolerable, while efficacy data showed that 52% of patients not previously treated with Tykerb experienced a partial response and 8% experienced stable disease (12/12)

Syndax Pharmaceuticals Inc. (Waltham, Mass.)

Exemestane

A hormonal therapy

Locally recurrent or metastatic estrogen receptor-positive breast cancer

Phase II data of exemestane with its HDAC inhibitor entinostat in 130 patients showed median overall survival of 26.9 months compared to 19.8 months for exemestane plus placebo (12/9)

Synta Pharmaceuticals Corp. (Lexington, Mass.)

Ganetespib

Second-generation Hsp90 inhibitor

Metastatic breast cancer

Demonstrated clinical activity as monotherapy in heavily pretreated patients (12/9)


Notes:

Public biotech company stock symbols can be found in the stock report located on the last two pages of this issue.

# The date indicated refers to the BioWorld Today issue in which the news item can be found.