Affimed Enters into Collaboration with Merck to Evaluate AFM13 in Combination with KEYTRUDA(R) (pembrolizumab) for Patients with Hodgkin Lymphoma

HEIDELBERG, Germany, Jan. 25, 2016  -- Affimed N.V. (AFMD), a clinical stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies, announced today that it has entered into a clinical research collaboration in immuno-oncology with Merck (MRK), known as MSD outside the United States and Canada. Under the terms of the agreement, Affimed will fund and conduct a Phase 1b clinical trial to investigate the combination of Merck's anti-PD-1 therapy, KEYTRUDA^(R) (pembrolizumab), with Affimed's proprietary drug candidate AFM13 for the treatment of patients with Hodgkin lymphoma whose disease has relapsed or is refractory to chemotherapy, including treatment with the marketed antibody-drug-conjugate Adcetris^TM (brentuximab vedotin). Merck will supply Affimed with KEYTRUDA for the clinical trial. The purpose of the study is to establish a dosing regimen for this combination therapy and assess its safety and efficacy. Affimed is on track to initiate the study in the first half of 2016.

Agenus Announces Clearance of Investigational New Drug Applications by the FDA for anti-CTLA-4 and anti-GITR Antibodies

Clinical studies for both checkpoint modulator antibodies allowed to commence

LEXINGTON, Mass.--Agenus Inc. (AGEN), an immuno-oncology company developing checkpoint modulator antibodies and cancer vaccines, announced today that the U.S. Food and Drug Administration (FDA) cleared the company's investigational new drug (IND) application for AGEN1884, an immune checkpoint modulator (CPM) antibody that binds to cytotoxic T-lymphocyte antigen-4 (CTLA-4). Clearance was also received for a second CPM antibody partnered with Incyte (INCY) for INCAGN1876, which targets glucocorticoid-induced TNFR-related protein (GITR). Clinical trials for both candidates are expected to begin in the first half of 2016.

Zafgen's Pivotal Phase 3 Trial of Beloranib in Prader-Willi Syndrome Achieves Co-Primary Efficacy Endpoints

- bestPWS Study is the first Phase 3 pivotal trial to show significant weight-loss and improve hyperphagia-related behaviors in PWS patients-
-Statistically significant at both 2.4 mg and 1.8 mg dose levels-
-Company plans to discuss results and path forward for beloranib with the FDA-
-Conference call scheduled for 8:30 AM Eastern Time-

BOSTON, Jan. 20, 2016 -- Zafgen (ZFGN), a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity and complex metabolic disorders, announced today positive efficacy results from the bestPWS ZAF-311 study, a pivotal, double-blind, placebo-controlled Phase 3 trial evaluating the safety and efficacy of beloranib, a MetAP2 inhibitor, in patients with Prader-Willi syndrome (PWS) during a six-month randomized treatment period. The clinical trial achieved its co-primary efficacy endpoints, as beloranib demonstrated a statistically significant reduction in both body weight and hyperphagia-related behaviors, making it the first investigational drug to demonstrate a positive impact on these two hallmark challenges in PWS.

Intellipharmaceutics Announces Successful Bioequivalence Results for Abuse Deterrent Rexista™ Oxycodone XR

TORONTO, Jan. 14, 2016 -- Intellipharmaceutics International Inc. (IPCI) (TSX:I) (“Intellipharmaceutics” or the “Company”), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today announced that pivotal bioequivalence trials of the Company’s Rexista™ Oxycodone XR (abuse deterrent oxycodone hydrochloride) extended release tablets, dosed under fasted and fed conditions, had demonstrated bioequivalence to Oxycontin® (oxycodone hydrochloride) extended release tablets as manufactured and sold in the United States by Purdue Pharma LP. The study design was based on United States Food and Drug Administration (“FDA”) recommendations and compared the lowest and highest strengths of exhibit batches of the Company’s Rexista™ Oxycodone XR to the same strengths of Oxycontin®. The results show that the ratios of the pharmacokinetic metrics, C_max, AUC_0-t and AUC_0-f  for Rexista™ vs. Oxycontin®, are within the interval of 80% - 125% required by the FDA with a confidence level exceeding 90%.