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 Polaris Group reported results from an ongoing phase 1b study conducted at Memorial Sloan Kettering Cancer Center that tests combining ADI‑PEG 20 with folinic acid (leucovorin), fluorouracil and oxaliplatin (FOLFOX) in patients with advanced hepatocellular carcinoma (HCC) and other gastrointestinal malignancies (Press release, Polaris Pharmaceuticals, JAN 19, 2017, View Source [SID1234526288]). The results will be presented at the 2017 Gastrointestinal Cancers Symposium in San Francisco.

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Thirteen HCC patients, all with Child-Pugh A and progressed on sorafenib, were enrolled in the single-arm, open label study to assess the safety and preliminary activity of ADI+FOLFOX. The treatment was well tolerated, with no dose-limiting toxicities observed. The treatment brought rapid and sustained serum arginine depletion. Three HCC patients (23%) had a partial response, and 6 patients (46%) had stable disease for a disease control rate of 69%.

"We are excited to see that ADI+FOLFOX demonstrated encouraging anti-tumor activity in the 2nd-line or later setting for advanced HCC patients," said John Bomalaski, M.D., Executive Vice President, Medical Affairs at Polaris Pharmaceuticals, Inc. "We are planning for further clinical investigations in order to bring a safe and effective treatment to these patients."

About ADI‑PEG 20

ADI‑PEG 20 is a biologic being developed by Polaris Group to treat cancers carrying a major metabolic defect that renders them unable to internally synthesize arginine. Because arginine is essential for protein synthesis and survival of cells, these cancer cells become dependent upon the external supply of arginine to survive and grow. ADI‑PEG 20 is designed to deplete the external supply of arginine, causing arginine-dependent cancer cells to die while leaving the patient’s normal cells unharmed. Multiple cancers have been reported to have a high degree of arginine-dependency and can potentially be treated with ADI‑PEG 20.

On January 18, 2017 Oncoinvent reported that US Patent 9,539,346 entitled "Radiotherapeutic particles and suspensions" has issued (Press release, Oncoinvent, JAN 18, 2017, http://www.oncoinvent.com/pdf.cfm?dok_id=481 [SID1234517439]). The patent relates to a particle or pharmaceutical composition comprising one or more particles, or a suspension of same or different particles comprising a degradable compound and an alpha emitting radionuclide and/or a radionuclide generating alpha emitting daughter. The particles are beneficial for use in the treatment of cancer.

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Jan A. Alfheim, Oncoinvent’s CEO commented: "This is a significant milestone in the development of our lead product candidate, Radspherin. With this first patent we have gained a solid protection of Radspherin until 2035 in what we believe will be a very significant future market for the product. Our Radspherin patent applications include claims on composition of matter as well as various medical and medical device applications. The current applications and this issued patent are therefore very broad and cover a wide spectrum of Radspherin particle variants and applications."

About Radspherin

Radspherin is a novel alpha-emitting radioactive microsphere designed for treatment of metastatic cancers in body cavities. The radium based therapeutic, Radspherin has shown strong and consistent anticancer activity at doses being essentially non-toxic in preclinical studies. It is anticipated that the product can potentially treat several forms of metastatic cancer. The first clinical indication for Radspherin will be treatment of peritoneal carcinomatosis originating from ovarian cancer. Peritoneal carcinomatosis is one of the most serious complications of gastrointestinal and gynecological malignancies.

On January 18, 2017 Eli Lilly and Company and CoLucid Pharmaceuticals, Inc. reported an agreement for Lilly to acquire CoLucid for $46.50 per share or approximately $960 million (Press release, Eli Lilly, JAN 18, 2017, View Source [SID1234517451]). This all-cash transaction will enhance Lilly’s existing portfolio in pain management for migraine, while adding a potential near-term launch to its late-stage pipeline.

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CoLucid Pharmaceuticals is a public biopharmaceutical company developing an oral 5-HT1F agonist (lasmiditan) for the acute treatment of migraine. CoLucid has completed the first of two pivotal Phase 3 trials. A data read-out for the second Phase 3 trial, SPARTAN, is expected in the second half of 2017. If this trial is positive, submission of lasmiditan for U.S. regulatory approval could occur in 2018.

More than 36 million people suffer from migraine in the United States alone. Lasmiditan, if approved, would be a first-in-class therapy to treat migraine through a novel mechanism of action without vasoconstriction. This could be desirable in migraine patients who have, or are at risk for, cardiovascular disease, as well as those who are dissatisfied with their current therapies.

Lasmiditan is an important addition to Lilly’s emerging pain management pipeline, which includes galcanezumab, a potential medicine in Phase 3 clinical development for the prevention of migraine and cluster headache. In addition, tanezumab is being studied, in collaboration with Pfizer, for the treatment of multiple pain indications, including osteoarthritis, lower back and cancer pain.

"Lasmiditan is a novel, first-in-class molecule that could represent the first significant innovation for the acute treatment of migraine in more than 20 years, and CoLucid has made significant progress in advancing this potential medicine," said David A. Ricks, Lilly’s president and chief executive officer. "This innovation, along with galcanezumab, could offer important options for the millions of patients suffering from migraine."

Lasmiditan was originally discovered at Lilly and was out-licensed to CoLucid in 2005. Over the past 12 years, CoLucid has taken important steps to decrease the risk related to development and commercialization of lasmiditan as evident by the first positive Phase 3 trial. At the time lasmiditan was out-licensed, pain management was not a strategic area of focus for Lilly. Lilly has since reorganized its research and development efforts to focus on migraine as part of its emerging therapeutic area of pain.

"We are excited that lasmiditan will be back at Lilly, where it was originally discovered, for the conclusion of Phase 3 development and potential commercialization," said Thomas P. Mathers, CoLucid’s chief executive officer. "We are proud of the work that CoLucid has done to develop lasmiditan, and we believe Lilly’s expertise in pain and commitment to innovation are a natural fit to potentially bring this medicine to patients."

Under the terms of the agreement, Lilly will acquire all shares of CoLucid Pharmaceuticals for a purchase price of $46.50 per share or approximately $960 million. The transaction is expected to close by the end of the first quarter of 2017, subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions.

While the financial charge will not be finalized until after completion of the acquisition, Lilly is expecting to recognize a financial charge of approximately $850 million (no tax benefit), or approximately $0.80 per share, as an acquired in-process research and development charge to earnings in the first quarter of 2017. The company’s reported earnings per share guidance in 2017 is expected to be reduced by the amount of the charge. There will be no change to the company’s non-GAAP earnings per share guidance as a result of this transaction.

Goldman, Sachs & Co. is acting as the exclusive financial advisor, and Weil, Gotshal & Manges LLP is acting as legal advisor to Lilly in this transaction. MTS Health Partners is acting as the exclusive financial advisor, and Faegre Baker Daniels LLP is acting as legal advisor to CoLucid.

On January 18, 2017 Cancer Research UK, Cancer Research Technology and MRC Technology reported that they are joining forces to identify and validate novel drug discovery targets that could lead to new immunotherapy treatments (Press release, Cancer Research Technology, 18 18, 2017, View Source [SID1234523172]).

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The partnership brings together Cancer Research UK’s network of leading scientists with CRT’s cancer-focused target selection and validation expertise, and MRCT’s antibody screening and development capability. The collaboration will identify possible targets for the development of both antibody and small molecule therapeutics. The next stage of the collaboration will be to seek a clinical partner to accelerate the progress of promising compounds into the clinic.

New targets that increase cancer’s susceptibility to the immune system will be identified from Cancer Research UK’s funded research. MRC Technology will develop antibodies for suitable targets via its antibody screening platform, while CRT will focus on small molecule approaches.

Dr Hamish Ryder, director of discovery, Cancer Research Technology, said: "Immunotherapy is a hugely promising approach to cancer treatment and we’re delighted to extend our research in this area by partnering with MRC Technology.

"The aim of this alliance is to work together to identify highly novel immunotherapy targets and develop treatments that will complement the checkpoint inhibitors that are already having such an impact on patients.

"We want to move quickly to bring promising new drugs forward to treat cancer patients as soon as possible."

Dr Justin Bryans, director, drug discovery at MRC Technology said: "Bringing together MRC Technology’s antibody drug discovery and CRT’s cancer biology expertise and applying them to cutting-edge discoveries from the Cancer Research UK network represents a very exciting prospect and will help us identify and develop new immune-oncology therapies, which already have a significant impact on cancer patients’ lives."

CRT and MRC Technology will be joint commercialisation partners for the collaboration and any resulting immunotherapy treatments.