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Oxford BioTherapeutics Takes Exclusive Rights to Use Amgen Xenomouse® Antibodies and ImmunoGen Technology to Develop Novel Antibody-Drug Conjugate for HER2-Negative Breast Cancer

On May 7, 2014 Oxford BioTherapeutics reported that it has obtained the exclusive global rights to certain Xenomouse antibodies generated by Amgen and to ImmunoGen’s maytansinoid ADC technology for an undisclosed target (Press release Oxford BioTherapeutics, MAY 7, 2014, View Source [SID:1234500495]). The rights were granted under the existing strategic collaboration between Oxford BioTherapeutics and Amgen. Oxford BioTherapeutics intends to use the antibodies and ADC technology to develop a novel ADC targeting a protein in HER2-negative breast cancer, initially focusing on triple negative breast cancer, and other cancers, where the target is expressed. The target was identified using the Company’s OGAP discovery technology.
This novel antibody-based cancer therapy has completed in vivo proof-of-concept in several solid and liquid tumor models and exploratory toxicology testing, and is currently undergoing preparation for an IND application.

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10-Q – Quarterly report [Sections 13 or 15(d)]

Affymax has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

Astellas and Medivation Receive Priority Review From FDA for XTANDI(R) (Enzalutamide) Capsules in Chemotherapy-Naive Advanced Prostate Cancer

On May 6, 2014 Medivation and Astellas Pharma reported that the U.S. Food and Drug Administration (FDA) has accepted for filing the supplemental New Drug Application (sNDA) to extend the indication for XTANDI (enzalutamide) capsules for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy. (Press release Medivation, MAY 6, 2014, View Source [SID:1234500736]). This sNDA application was granted Priority Review designation with a stated FDA Prescription Drug User Fee Act (PDUFA) review date of September 18, 2014. XTANDI is currently approved for the treatment of patients with mCRPC who have previously received docetaxel chemotherapy.

The sNDA application is based on the results from the Phase 3 PREVAIL trial evaluating XTANDI as compared to placebo in more than 1,700 chemotherapy-naïve mCRPC patients. A variation application to amend the European Marketing Authorization Application was submitted to the European Medicines Agency on April 2, 2014.

The FDA’s acceptance of the sNDA triggers a milestone payment to Medivation under its collaboration agreement with Astellas.

Merck Announces FDA Acceptance for Review of MK-3475 Biologics License Application for Advanced Melanoma

On May 6, 2014 Merck & Co reported that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for MK-3475, Merck’s investigational anti-PD-1 antibody, for the treatment of unresectable or metastatic melanoma in patients who have been previously treated with ipilimumab (Press release Merck & Co, MAY 6, 2014, View Source [SID:1234500607]). The FDA granted Priority Review designation with a PDUFA date of October 28, 2014, and the MK-3475 BLA will be reviewed under the FDA’s Accelerated Approval program. The FDA previously granted MK-3475 Breakthrough Therapy designation for advanced melanoma, the most dangerous type of skin cancer. If approved by the FDA, MK-3475 has the potential to be the first anti-PD-1 antibody in a new class of immune checkpoint modulators.

Merck also announced it plans to file a Marketing Authorization Application for MK-3475 in Europe for advanced melanoma by the end of 2014.

"Patients with advanced melanoma have few therapeutic options and often fail to respond to all available treatments," said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. "We are hopeful that the FDA, through their priority review of our application, will agree to make MK-3475 available to patients with advanced melanoma who have no other therapeutic options."

10-Q – Quarterly report [Sections 13 or 15(d)]

AMAG Pharmaceuticals has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing 10-Q , AMAG Pharmaceuticals, MAY 5, 2014, View Source [SID1234500484]).