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.

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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.

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]).

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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.

On January 19, 2017 Celsion Corporation reported that it will present two posters at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) – Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Clinical Immuno-Oncology Symposium being held from February 23 – 25, 2017 in Orlando, FL (Press release, Celsion, JAN 19, 2017, View Source [SID1234517449]). The symposium will focus on the latest clinical and translational research in immuno-oncology and the implications for clinical care. The first poster will report clinical results from the Phase Ib dose escalating clinical trial (the OVATION Study) combining GEN-1, the Company’s IL-12 gene-mediated immunotherapy, with the standard of care for the treatment of newly-diagnosed patients with Stage III and IV ovarian cancer who will undergo neoadjuvant chemotherapy followed by interval debulking surgery. The second poster will report translational data from the OVATION Study and previous GEN-1 clinical trials. The posters will be presented by Khursheed Anwer, Ph.D., Celsion’s executive vice president and chief science officer.

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Poster Presentation details:

Title: Phase I study and activity of formulated IL-12 plasmid administered intraperitoneally in combination with standard neoadjuvant chemotherapy in patients with newly diagnosed advanced stage ovarian cancer
Date and Time: Poster Session A – February 23, 2017 (11:30 am – 1:00 pm ET; 5:30 pm to 6:30 pm ET)
Poster Number: 155

Title: Immunological changes following intraperitoneal administration of a formulated IL-12 plasmid in combination with standard neoadjuvant chemotherapy in patients with newly diagnosed advanced stage ovarian cancer
Date and Time: Poster Session A – February 23, 2017 (11:30 am – 1:00 pm ET; 5:30 pm to 6:30 pm ET)
Poster Number: 156

"Our hypothesis is that GEN-1 plus neoadjuvant chemotherapy treatment will reprogram the tumor immune microenvironment towards a potent antitumor immune response," said Dr. Anwer. "The available data demonstrate highly relevant immunological changes in the tumor immune environment, such as tumor infiltration of cytotoxic T-cell lymphocytes and a reduction of certain immunosuppressive signals, which supports the immune activating role of GEN-1 in this patient population. Evidence of immune activation following the treatment is also supported by increases in IFN-g, a potent mediator of the anti-tumor immune response associated with IL-12 action. We are excited to present at the ASCO (Free ASCO Whitepaper)-SITC symposium, and look forward to sharing the impressive clinical and translational results with the scientific community."

The OVATION Study is designed to enroll three to six patients per dose cohort with the goal of identifying a safe, tolerable and immunologically active dose of GEN-1 by recruiting and maximizing an immune response. Enrollment in the fourth cohort is ongoing with the goal of enrolling three additional patients in this final dose cohort. Celsion expects to complete enrollment in the OVATION Study this quarter and report final data, including translational data for all patients, in the second quarter of 2017. Future studies of GEN-1 will include a Phase I/II study combining GEN-1 with Avastin and Doxil.

On January 19, 2017 Evotec reported it has entered into an integrated drug discovery collaboration on an ion channel target with Asahi Kasei Pharma Corporation, a wholly owned subsidiary of Asahi Kasei Corporation, Tokyo, Japan (Press release, Evotec, JAN 19, 2017, View Source [SID1234517452]).

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Under the terms of the agreement, Evotec will apply its integrated drug discovery platform including medicinal chemistry, computational chemistry and in vitro pharmacology to optimise hit compounds identified and selected from the Evotec compound library collection through a recent successful high-throughput screening campaign executed at Evotec.

Dr Mario Polywka, Chief Operating Officer of Evotec, stated: "We are delighted to expand our collaboration with Asahi Kasei Pharma into a fully integrated drug discovery project. Evotec operates one of the most comprehensive ion channel platforms in the industry and this collaboration represents further validation of the strength of this platform and the library screened. We look forward to working closely with our colleagues at Asahi Kasei Pharma."
No financial details were disclosed.

On January 19, 2017 NYSE-listed small cap PharmAthene and private infectious disease biotech Altimmune have signed a merger pact that will see the pair become one in an all-stock transaction (Press release, FierceBiotech, JAN 19, 2017, View Source [SID1234517453]).

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PharmAthene will merge into Altimmune, which lists Novartis Venture Fund, HealthCap, Truffle Capital and Redmont Capital as its investors, to create a new, diversified immunotherapeutics company with four clinical stage and one preclinical stage programs.

These include phase 2-ready NasoVAX, an intranasal, single-dose influenza vaccine, and HepTcell, a first-in-class immunotherapeutic for chronic hep B with "the potential to offer a functional cure," currently in phase 1.
There is also SparVax-L, billed as a next-gen lyophilized anthrax vaccine (NIAID funded), and NasoShield, an intranasal, single-dose, first-in-class anthrax vaccine that is funded by BARDA. A phase 1 trial is set to start this year, with data coming out halfway through 2018.

The preclinical program, Oncosyn, is in early testing for immuno-oncology indications.
A full financial breakdown was not given, but under the deal Altimmune will become a wholly owned subsidiary of the biotech.

The combined entity will become a public company under the name Altimmune and is slated to trade on the NYSE under the ticker symbol $ALT. The combined biotech has around $20 million in cash and cash commitments.
Bill Enright, CEO of Altimmune, and Elizabeth Czerepak, CFO and EVP of Corporate Development at Altimmune, will serve in their respective positions for the combined company, the two said in a statement.
The combined company’s headquarters will be located in Gaithersburg, Maryland.

"A merger with Altimmune is an ideal strategic match," commented John Gill, president and CEO of PharmAthene in the statement. "It fulfills our stated goal of continuing to build value for PharmAthene shareholders after we distribute the SIGA litigation proceeds on February 3. By combining forces, we will diversify our portfolio into attractive commercial product opportunities and leverage our capabilities for developing next generation anthrax vaccines."

Enright added: "The merger allows Altimmune to leverage PharmAthene’s existing U.S. public company infrastructure, providing access to the capital markets, which is essential to the continued development of immunotherapeutics clinical programs including NasoVAX, NasoShield and HepTCell that leverage Altimmune’s proprietary platform technologies."
PharmAthene currently has a market cap of $223 million and was trading at $3.40 at end of play yesterday.