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PRIMA BIOMED COMMENCES RANDOMISED PHASE IIb CLINICAL TRIAL FOR IMP321 IN BREAST CANCER

On January 20, 2016 Prima BioMed Ltd (ASX: PRR; NASDAQ: PBMD) ("Prima" or the "Company") reported the first patient has been dosed as part of the enlarged randomised phase of its AIPAC Phase IIb clinical trial for IMP321 in metastatic breast cancer (Press release, Prima Biomed, JAN 20, 2017, View Source [SID1234517473]).

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The randomised phase of AIPAC (Active Immunotherapy PAClitaxel) will see half of the 226 patients receiving paclitaxel plus a placebo and half receiving paclitaxel in conjunction with IMP321. This follows the Dose Escalation Committee approval of the 30 mg dosage level for IMP321 and commencement of the randomised study on December 30, 2016.

Prima’s Chief Medical Officer, Dr Frédéric Triebel, said: "We are pleased to have dosed the first patient in the randomised and double-blind Phase of the AIPAC trial. Following positive interim data released in December and the 30mg dosage approval, we are now focused on screening and enrolment of the enlarged patient cohort across our European centres."

About IMP321
IMP321, a first-in-class Antigen Presenting Cell (APC) activator based on the immune checkpoint target LAG-3, represents one of the first proposed active immunotherapy drugs in which the patient’s own immune system is harnessed to respond to tumour antigenic debris created by chemotherapy. As an APC activator IMP321 boosts the network of dendritic cells in the body that can respond to tumour antigens for a better anti-tumour CD8 T cell response.

OncoMed Initiates Enrollment of Phase 1b Clinical Trial of Brontictuzumab for the Treatment of Metastatic Colorectal Cancer Patients

On January 20, 2017 OncoMed Pharmaceuticals, Inc. (NASDAQ:OMED), a clinical-stage company focused on discovering and developing novel anti-cancer stem cell and immuno-oncology therapeutics, reported dosing of the first patient in a Phase 1b clinical trial of brontictuzumab (anti-Notch1, OMP-52M51) plus chemotherapy in patients with metastatic colorectal cancer (Press release, OncoMed, JAN 20, 2017, View Source [SID1234517470]).

The Phase 1b trial is intended to determine the maximum-tolerated dose of brontictuzumab in combination with trifluridine/tipiracil (Lonsurf). The Phase 1b trial is designed to assess safety, preliminary efficacy and immunogenicity, as well as predictive and pharmacodynamics biomarkers. Metastatic colorectal cancer patients who have received at least two prior lines of therapy will be enrolled in the dose-escalation portion of the trial, and once a maximum tolerated dose is identified, additional patients whose tumors test high for the activated form of Notch1 will be enrolled in an expansion cohort.

"Brontictuzumab targets Notch1, a key receptor in the Notch pathway, and preclinical data suggest that elevated Notch1 gene expression appears to be an oncogenic driver in a number of tumor types, including colorectal cancer," said Robert Stagg, Pharm.D., OncoMed’s Senior Vice President, Clinical Research and Development. "In this Phase 1b trial, we expect to determine the safety and optimal therapeutic index of brontictuzumab in combination with chemotherapy, assess preliminary efficacy and explore the correlation of biomarker status and anti-tumor responses."

About Brontictuzumab
Brontictuzumab (anti-Notch1, OMP-52M51) blocks signaling of Notch, an important cancer stem cell pathway implicated in chemoresistance, tumor angiogenesis and stem cell self-renewal, proliferation and differentiation. Notch1 signaling is prevalent in several solid tumor types, including certain breast, esophageal, colorectal, gastric, pancreatic and small cell lung cancers, as well as adenoid cystic carcinoma and cholangiocarcinoma. Single-agent anti-tumor activity was observed in OncoMed’s Phase 1a dose escalation study of brontictuzumab in patients with certain advanced solid tumors, particularly in biomarker-defined patients whose tumors tested positive for overexpression of the activated form of Notch1. Brontictuzumab was generally well tolerated, with the most common adverse event being manageable diarrhea.1

OncoMed retains the worldwide rights to develop brontictuzumab.

Mateon Therapeutics to Present Data on Study OX4218 in Neuroendocrine Tumors at ASCO Gastrointestinal Cancers Symposium

On January 20, 2017 Mateon Therapeutics, Inc. (OTCQX:MATN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of orphan oncology indications, reported the presentation of final data from Study OX4218 in patients with neuroendocrine tumors (NETs) at a poster session at the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium being held today in San Francisco (Press release, Mateon Therapeutics, JAN 20, 2017, View Source [SID1234517469]).

Study OX4218 was a multi-center, open label, phase 2 clinical trial to investigate the safety and activity of combretastatin A4-phosphate (CA4P) in the treatment of well-differentiated, low-to-intermediate-grade unresectable, recurrent or metastatic pancreatic or gastrointestinal neuroendocrine tumors/carcinoid (PNETs or GI-NETs) with elevated biomarkers. Following patients’ completion of Study OX4218, patients were eligible to enroll in Study OX4219, a long term extension study, if they achieved a biomarker or symptom response. In OX4218 patients were treated with CA4P 60 mg/m2 on Days 1, 8, and 15 of a 21-day cycle for 3 cycles, and in OX4219 patients received CA4P maintenance on Day 1 of a 21-day cycle until disease progression or up to one year.

A total of 18 patients were enrolled in OX4218. One patient (6%) experienced significant symptomatic improvement as measured by ECOG Status and had a partial response per investigator-assessed RECIST and an additional 7 patients (39%) had stable disease. In addition, a majority of patients (53%) experienced an improvement in patient-reported quality of life. A statistically significant mean change in biomarkers from baseline, the primary endpoint of the study, was not achieved in OX4218 due to the small sample size along with a high intra- and inter-patient variability observed in the biomarkers. A total of 7 patients were enrolled in OX4219, of which 5 patients (71%) had stable disease, including one that continued for 14 months. The partial response and stable disease analyses, as well as other measures from the trial, suggest that CA4P monotherapy has activity in this indication.

"The results of OX4218 and OX4219 confirm that CA4P monotherapy has efficacy in the indications studied, as we have seen with the investigational drug in a number of other monotherapy trials," said William D. Schwieterman, M.D., President and Chief Executive Officer of Mateon. "However, we believe that the efficacy of CA4P only becomes compelling when it is used in combination with an anti-angiogenic agent, due to the complementary mechanisms of action for the two agents. Based on the evidence of efficacy observed in this trial, plus an understanding of the benefits of combination therapy, a lead investigator in this trial is sponsoring a 20 patient study in NETs using CA4P in combination with everolimus (AFINITOR, marketed by Novartis), an anti-angiogenic agent which is already approved and commonly used in this indication."

Overall CA4P monotherapy was well tolerated. Treatment related adverse events were reported in 77% of subjects. The most common Grade 3-5 AEs ( > 10%) included: anemia, abdominal pain, fatigue, hypertension, and ALT and AST increases. One Grade 5 adverse event, carcinoid syndrome, was reported and attributed to the underlying disease.

Argos Therapeutics Completes Lease Agreement for Commercial Manufacturing Space on the Centennial Campus of North Carolina State University

On January 19, 2017 Argos Therapeutics Inc. (Nasdaq:ARGS) ("Argos"), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis precision immunotherapy technology platform, reported the completion of a lease agreement with Keystone-Centennial II, LLC, for 40,000 square feet of newly constructed manufacturing space at the Center for Technology & Innovation (CTI) on the Centennial Campus of North Carolina State University in Raleigh, NC (Press release, Argos Therapeutics, JAN 19, 2017, View Source [SID1234517462]).

Argos plans to use the manufacturing space at CTI to prepare for submission of a biologics license application (BLA) to the U.S. Food & Drug Administration and to support initial commercialization of rocapuldencel-T, the company’s most advanced product candidate, which is being evaluated for the treatment of metastatic renal cell carcinoma (mRCC) in the company’s pivotal ADAPT Phase 3 clinical trial. Because the company’s Arcelis technology platform enables broad geographic coverage from a single facility, CTI is expected to support both domestic and international launches for the first few years, pending regulatory approval of rocapuldencel-T.

"Securing a lease for the CTI facility is a critical step on our path towards becoming a fully-integrated commercial-stage biotechnology company," said Jeff Abbey, president and chief executive officer of Argos. "Our two-stage manufacturing strategy positions us to employ an established and proven-effective manual manufacturing process at CTI with the capacity to support approximately 1,800 patients per year at launch, with expansion capacity to 2,400 patients per year, pending regulatory approval. This strategy optimizes capital utilization as we prepare for a BLA submission for rocapuldencel-T and also allows us to assess early commercial uptake and better project capacity requirements for our planned 125,000 square foot Centerpoint facility in Durham, NC, which can be designed to accommodate our automated manufacturing process."

"In our role of facilitating economic development, we applaud the commitment Argos is making to extend its research partnerships and North Carolina roots to Centennial Campus," said Dr. Alan Rebar, Vice Chancellor of Research, Innovation and Economic Development, at North Carolina State University. "We are excited that Argos has chosen CTI as it seeks to develop and commercialize cutting-edge immunotherapies for people with serious illnesses and look forward to a productive partnership."

About the Arcelis Technology Platform
Arcelis is a precision immunotherapy technology that captures both mutated and variant antigens that are specific to each patient’s individual disease. It is designed to overcome immunosuppression by producing a specifically targeted, durable memory T-cell response without adjuvants that may be associated with toxicity. The technology is potentially applicable to the treatment of a wide range of different cancers and infectious diseases, and is designed to overcome many of the manufacturing and commercialization challenges that have impeded other personalized immunotherapies. The Arcelis process uses only a small disease sample or biopsy as the source of disease-specific antigens, and the patient’s own dendritic cells, which are optimized from cells collected by a single leukapheresis procedure. The proprietary process uses RNA isolated from the patient’s disease sample to program dendritic cells to target disease-specific antigens. These activated, antigen-loaded dendritic cells are then formulated with the patient’s plasma, and administered via intradermal injection as an individualized immunotherapy.

Heron Therapeutics Announces Pricing of Underwritten Public Offering of Common Stock

On January 19, 2017 Heron Therapeutics reported the pricing of an underwritten public offering of $150 million of shares of its common stock, offered at a price of $12.20 per share (Press release, Heron Therapeutics, JAN 19, 2017, View Source;p=RssLanding&cat=news&id=2238307 [SID1234517457]). Heron Therapeutics, Inc. has granted the underwriters a 30-day option to purchase up to an additional $22.5 million of shares of common stock. The offering is expected to close on or about January 24, 2017, subject to customary closing conditions. BofA Merrill Lynch, Cowen and Company, LLC and Leerink Partners LLC are acting as joint book-running managers for the offering. Cantor Fitzgerald & Co. and JMP Securities LLC are acting as lead managers and Noble Capital Markets, LifeSci Capital, Aegis Capital Corp and Lake Street Capital Markets are acting as co-managers for the offering.

The gross offering size will be approximately $150 million before deducting customary underwriting discounts and commissions and offering expenses. Heron Therapeutics, Inc. intends to use the net proceeds from the underwritten offering primarily for general corporate purposes, which include, but are not limited to, the continued commercialization and marketing of SUSTOL, the commercial launch of CINVANTI, if approved by the U.S. Food and Drug Administration, funding the company’s ongoing and future clinical trials, including further Phase 2 studies and Phase 3 studies of HTX-011, preclinical development work, for general and administrative expenses, repayment of a portion of its outstanding debt, or other product development activities.