Company
(location)

Product

Description

Indication

Status

Date

Agios Pharmaceuticals Inc. (Cambridge, Mass.)

AG-221

Isocitrate dehydrogenase-2-targeting candidate

Relapsed or refractory

Phase I data showed complete remissions in three of seven evaluable patients

4/8/14

Bergenbio A/S (Bergen, Norway)

BGB324

A small-molecule inhibitor of the Axl receptor tyrosine kinase

Cancer

Phase Ia data showed the drug to be safe and well tolerated in doses up to 1.5 g daily with a predictable pharmacokinetics profile and long plasma half-life, allowing for different dosing options

4/10/14

Bind Therapeutics Inc. (Cambridge, Mass.)

BIND-014

A targeted polymeric nanoparticle containing cytotoxic agent docetaxel

Prostate cancer

Phase I data demonstrated a greater dose intensity by about 50% at once weekly for three weeks dosing (Q1W), as compared to once every week dosing described in a previous study

4/9/14

Calithera Biosciences Inc. (South San Francisco)

CB-839

Selective, oral glutaminase inhibitor

Cancer

Phase I data showed that a 100-mg dose resulted in peak plasma levels of drug at or above 300 nm and generated a greater than 80% inhibition of glutaminase in platelets four hours after dosing

4/9/14

Deciphera Pharmaceuticals LLC (Lawrence, Kan.) and Eli Lilly and Co. (Indianapolis)

LY3009120

Pan-RAF inhibitor; a small-molecule kinase inhibitor

Cancer

Started a phase I trial

4/8/14

Delmar Pharmaceuticals Inc. (Vancouver, British Columbia)

VAL-083

A bifunctional alkylating agent

Refractory glioblastoma multiforme

Data from its ongoing phase I/II trial showed that the drug is well tolerated, with no drug-related serious adverse events detected in 26 patients treated to date

4/10/14

Immunogen Inc. (Waltham, Mass.)

IMGN853

A targeted antibody payload compound

Cancer

Clinical activity was seen starting at doses of 3.3 mg/kg, and its dose-limiting toxicity was the reversible ocular side effects (blurred vision and keratitis) reported with antibody-drug conjugates (ADCs)

4/10/14

Immunomedics Inc. (San Diego)

IMMU-130

Anti-CEACAM5 antibody conjugated to the irinotecan-metabolite, SN-38

Metastatic colorectal cancer

Phase I data showed it was therapeutically active in all three trials, but a more frequent dosing schedule was more active in patients

4/8/14

ISA Pharmaceuticals BV (Leiden, the Netherlands)

ISA101

Cancer vaccine

Advanced cervical carcinoma

Phase I data showed that ISA101 produced strong immune responses in almost all of the advanced cervical carcinoma patients treated

4/11/14

Lion Biotechnologies Inc. (Los Angeles)

TILs

Tumor infiltrating lymphocytes

Stage 4 metastatic melanoma

Data showed evidence of clinical efficacy from a phase II trial

4/8/14

Merck & Co. Inc. (Whitehouse Station, N.J.)

MK-3475

Anti-PD-1 immunotherapy

Advanced melanoma and advanced non-small-cell lung cancer

Responses were observed in patients with PD-L1 negative tumors; although the preliminary findings for both tumor types suggest that higher PD-L1 expression was associated with higher overall response rates

4/8/14

Merrimack Pharmaceuticals Inc. (Cambridge, Mass.)

MM-398

A nanoliposomal version of irinotecan

Cancer

Phase I data demonstrated that Feraheme was well tolerated

4/9/14

Mirna Therapeutics Inc. (Austin, Texas)

MRX34

Double-stranded microRNA mimic of naturally occurring tumor suppressor miR-34

Unresectable primary liver cancer

Interim safety data from an open-label phase I study showed that the drug has a manageable safety profile

4/9/14

Noxxon Pharma AG (Berlin)

NOX-H94

Lexaptepid pegol; a Spiegelmer designed to bind and neutralize hepcidin

Anemic cancer

Data from a pilot phase IIa study showed significant increases in hemoglobin levels (greater than 1 g/dL) in five of 12 patients (42%) in response to monotherapy

4/9/14

Oncoethix SA (Lausanne, Switzerland)

OTX015

Synthetic small-molecule inhibitor of BET bromodomain proteins 2/3/4

Hematologic malignancies

Interim results from an ongoing phase I trial showed linear pharmacokinetics and excellent tolerance

4/9/14

Pfizer Inc. (New York)

Palbociclib

CDK inhibitor

Metastatic estrogen receptor-positive breast cancer

Phase II PALOMA-1 data showed it doubled progression-free survival in an open-label phase II trial

4/8/14

Provectus Biopharmaceuticals Inc. (Knoxville, Tenn.)

PV-10

A 10% solution of Rose Bengal

Melanoma

Data showed significant decrease in melanoma cells in patients' injected tumors 7-14 days after intralesional PV-10 treatment that was accompanied by similar decrease in uninjected bystander tumors

4/8/14

Puma Biotechnology Inc. (Los Angeles)

PB272

Neratinib

Breast cancer

Phase II data showed an estimated pCR rate of 55.6% compared to the control arm, which had an estimated pCR rate of 32.6%

4/8/14

Sunesis Pharmaceuticals Inc. (South San Francisco)

Vosaroxin

Quinolone derivative

Acute myeloid leukemia and high-risk myelodysplastic syndrome

An ongoing phase Ib/II University of Texas MD Anderson Cancer Center-sponsored trial of vosaroxin in combination with decitabine in older patients showed that the combination has been found to be effective and well tolerated

4/9/14

Tolero Pharmaceuticals Inc. (Salt Lake City)

Alvocidib

A cyclin-dependent kinase

Chronic lymphocytic leukemia

In 62 patients, patient response was correlated with mitochondrial response from pre-treatment specimens to peptides known to interact with proteins that promote cell survival: Bim, Noxa, Bad, Bmf and Hrk

4/8/14

Viralytics Ltd. (Sydney)

Cavatak

Oncolytic immunotherapy

Advanced melanoma

Interim results from the ongoing phase II CALM trial showed antitumor activity in non-injected metastatic tumors in patients participating in the trial, and investigators reported partial or complete reduction of non-injected tumors in multiple patients who had been on treatment at least eight weeks

4/9/14

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.