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	5	+= Overview =
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	7	+Argos Therapeutics (ARGS) is an immuno-oncology company focused on the development and commercialization of individualized immunotherapies for the treatment of cancer and infectious diseases based on its proprietary precision immunotherapy technology platform called Arcelis.
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9		-Argos Therapeutics is an immuno-oncology company focused on the development and commercialization of individualized immunotherapies for the treatment of cancer and infectious diseases based on its proprietary precision immunotherapy technology platform called Arcelis.
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11	11	The company's most advanced product candidate is rocapuldencel-T, which Argos Therapeutics is developing for the treatment of metastatic renal cell carcinoma, or mRCC, and other cancers. Argos Therapeutics is currently conducting a pivotal Phase 3 clinical trial of rocapuldencel-T plus sunitinib or another therapy for the treatment of newly diagnosed mRCC under a special protocol assessment, or SPA, with the Food and Drug Administration, or FDA. The company refer to this trial as the ADAPT trial. The company dosed the first patient in the ADAPT trial in May 2013 and completed enrollment of the ADAPT trial in July 2015. In February 2017, the independent data monitoring committee, or the IDMC, for the ADAPT trial recommended that the trial be discontinued for futility based on its planned interim data analysis. The IDMC concluded that the study was unlikely to demonstrate a statistically significant improvement in overall survival in the combination treatment arm, utilizing the intent-to-treat population at the pre-specified number of 290 events (deaths), the primary endpoint of the study. Notwithstanding the IDMC’s recommendation, the company determined to continue to conduct the trial while the company analyzed interim data from the trial. Following a meeting with the FDA, the company now plan to continue the ADAPT trial until at least the pre-specified number of 290 events occurs, which the company expect will occur in the first half of 2018. The company also plan to continue to analyze interim data from the trial and to submit to the FDA a protocol amendment to increase the pre-specified number of events for the primary analysis of overall survival in the trial beyond 290 events. The company believe that extending its evaluation of rocapuldencel-T beyond 290 events in the trial could enhance its ability to observe rocapuldencel-T’s expected delayed treatment effect. The FDA has agreed to review its planned protocol amendment, and the company expect to continue its discussions with the FDA regarding its development program for rocapuldencel-T. If the company agree with the FDA on an amended protocol that increases the pre-specified number of events for the primary analysis, the SPA for the ADAPT trial would no longer be in effect. In addition to the ADAPT trial, Argos Therapeutics is also currently supporting an investigator-initiated Phase 2 trial of rocapuldencel-T in patients with early stage RCC. Subject to its obtaining sufficient financing, the company plan to support an investigator-initiated Phase 2 trial of rocapuldencel-T in bladder cancer and a Phase 2 trial of rocapuldencel-T in combination with a checkpoint inhibitor in mRCC.
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13	13	Argos Therapeutics is developing AGS-004, its second Arcelis-based product candidate, for the treatment of HIV. Argos Therapeutics has completed Phase 1 and Phase 2 trials funded by government grants and a Phase 2b trial that was funded in full by the National Institutes of Health, or NIH, and the National Institute of Allergy and Infectious Diseases, or NIAID. Argos Therapeutics is currently supporting an ongoing investigator-initiated clinical trial of AGS-004 in adult HIV patients evaluating the use of AGS-004 in combination with vorinostat, a latency reversing drug, for HIV eradication, and plan to support an investigator-initiated Phase 2 clinical trial of AGS-004 evaluating AGS-004 for long-term viral control in pediatric patients provided that results from its ongoing trial in adult HIV patients are favorable and government funding is available.
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42	42	Argos Therapeutics has no external sources of funds other than its contract with the NIH and NIAID, as described under the section entitled NIH Funding below. The company do not expect to generate significant additional funds or product revenue unless and until the company successfully complete development, obtain marketing approval and commercialize its product candidates, either alone or in collaboration with third parties, which the company expect will take a number of years and is subject to significant uncertainty. Accordingly, the company will need to raise additional capital prior to the commercialization of rocapuldencel-T, AGS-004 or any of its other product candidates if the company determine to continue its business operation. Until such time, if ever, as the company can generate substantial product revenues, the company expect to seek to finance its operating activities through a combination of equity offerings, debt financings, government contracts, government and other third party grants or other third party funding, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements. However, the company may be unable to raise additional funds through these means when needed, on favorable terms or at all.
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44		-**NIH Funding**
	42	+== NIH Funding ==
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46	46	In September 2006, the company entered into a multi-year research contract with the NIH and NIAID to design, develop and clinically test an autologous HIV immunotherapy capable of eliciting therapeutic immune responses. Argos Therapeutics has used funds from this contract to develop AGS-004, including to fund in full its Phase 2b clinical trial of AGS-004. On June 29, 2016, a contract modification was agreed to that extended the NIH and NIAID’s commitment under the contract to July 31, 2018. Argos Therapeutics has agreed to a statement of work under the contract, and are obligated to furnish all the services, qualified personnel, material, equipment, and facilities not otherwise provided by the U.S. government needed to perform the statement of work.
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50	50	Argos Therapeutics has recorded revenue of $38.0 million through June 30, 2017 under the NIH and NIAID contract. This contract is the only arrangement under which Argos Therapeutics has generated substantial revenue. As of June 30, 2017, there was up to $1.8 million of potential revenue remaining to be earned under the agreement with the NIH and NIAID.
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52		-==== Development and Commercialization Agreements ====
	50	+== Development and Commercialization Agreements ==
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54	54	An important part of its business strategy is to enter into arrangements with third parties for the development and commercialization of its product candidates.
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100	100	The agreement will continue until the earlier of (i) December 31, 2017 or (ii) the effective date of a commercial supply agreement negotiated in good faith by the parties, but can be earlier terminated by either party due to a material breach or upon bankruptcy of the other party.
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102		-**Manufacturing**
	100	+= Manufacturing =
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104	104	The company currently have manufacturing suites located at its Technology Drive and Patriot Center facilities in Durham, North Carolina. The company manufacture its Arcelis-based product candidates for research and development purposes and for clinical trials at these facilities.
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114	114	The company expect that the company would establish both manual and automated manufacturing processes in its commercial manufacturing facilities if the company determine to build out such facilities. The company had decided to delay the implementation of its automated manufacturing process until after initial commercialization of rocapuldencel-T, and thus planned to seek marketing approval of rocapuldencel-T and, if approved, to initially commercially supply rocapuldencel-T using its manual manufacturing process. Prior to implementing commercial manufacturing of rocapuldencel-T, the company would be required to demonstrate that its commercial manufacturing facility is constructed and operated in accordance with current good manufacturing practice. The company would also be required to show the comparability between rocapuldencel-T that the company produce using the manual processes in its current facility and rocapuldencel-T produced using the manual process in its new facility.
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116		-==== Development Programs ====
	114	+= Development Programs =
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118	118	The following table summarizes its development programs for rocapuldencel-T and AGS-004.
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135	135	The company hold all commercial rights to rocapuldencel-T and AGS-004 in all geographies other than rights to rocapuldencel-T in Russia and the other states comprising the Commonwealth of Independent States, which the company exclusively licensed to Pharmstandard International S.A., or Pharmstandard, rights to rocapuldencel-T for the treatment of mRCC in South Korea, which the company exclusively licensed to Green Cross Corp., or Green Cross, and rights to rocapuldencel-T in China, Hong Kong, Taiwan and Macau, which the company exclusively licensed to Lummy (Hong Kong) Co. Ltd., or Lummy HK. Argos Therapeutics has granted to MEDcell Co., Ltd., a wholly-owned subsidiary of Medinet Co. Ltd., hereinafter referred to together as “Medinet,” an exclusive license to manufacture rocapuldencel-T for the treatment of mRCC in Japan.
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137		-**Rocapuldencel-T**
	135	+=== **Rocapuldencel-T** ===
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139	139	Argos Therapeutics is developing rocapuldencel-T for the treatment of mRCC and other cancers. Argos Therapeutics is conducting the ADAPT trial of rocapuldencel-T plus sunitinib / targeted therapy for the treatment of newly diagnosed mRCC under an SPA with the FDA. The company dosed the first patient in the ADAPT trial in May 2013. In July 2015 the company completed enrollment in the ADAPT trial, enrolling 462 patients with the goal of generating 290 events for the primary endpoint of overall survival. The company enrolled these patients at 107 clinical sites in North America, Europe and Israel. Under the ADAPT trial protocol, these patients were randomized between the rocapuldencel-T plus sunitinib / targeted therapy combination arm and sunitinib / targeted therapy alone control arm on a two-to-one basis. In February 2017, the IDMC for the ADAPT trial recommended that the trial be discontinued for futility based on its planned interim data analysis. The IDMC concluded that the study was unlikely to demonstrate a statistically significant improvement in overall survival in the combination treatment arm, utilizing the intent-to-treat population at the pre-specified number of 290 events (deaths), the primary endpoint of the study. Notwithstanding the IDMC’s recommendation, the company determined to continue to conduct the trial while the company analyzed interim data from the trial. Following a meeting with the FDA, the company now plan to continue the ADAPT trial until at least the pre-specified number of 290 events occurs, which the company expect will be in the first half of 2018. The company also plan to continue to analyze interim data from the trial and to submit to the FDA a protocol amendment to increase the pre-specified number of events for the primary analysis of overall survival in the trial beyond 290 events. The company believe that extending its evaluation of rocapuldencel-T beyond 290 events in the trial could enhance its ability to observe rocapuldencel-T’s expected delayed treatment effect. The FDA has agreed to review its planned protocol amendment, and the company expect to continue its discussions with the FDA regarding its development program for rocapuldencel-T. If the company agree with the FDA on an amended protocol that increases the pre-specified number of events for the primary analysis, the SPA for the ADAPT trial would no longer be in effect.
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143	143	Beyond renal cell carcinoma, the company plan to support an additional investigator-initiated Phase 2 clinical trial of rocapuldencel-T in muscle invasive bladder cancer subject to its obtaining financing for such support. The trial would have two phases: a pre-treatment phase and a treatment phase. In the pre-treatment phase, tumor tissue will be obtained via a transurethral resection of the bladder tumor, which will then be used to extract RNA for the manufacture of rocapuldencel-T. In the treatment phase, rocapuldencel-T will be given before tumor resection and combined with standard-of-care cytotoxic chemotherapy. Booster doses of rocapuldencel-T will continue after tumor resection. As with the neoadjuvant renal cancer trial, Argos Therapeutics has the unique opportunity to observe any meaningful impact of rocapuldencel-T on the immune response in the peripheral blood and immune responses infiltrating the primary tumor.
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145		-**AGS-004**
	143	+=== **AGS-004** ===
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147	147	Argos Therapeutics is developing AGS-004 for the treatment of HIV and are focusing this program on the use of AGS-004 in combination with other therapies for the eradication of HIV. The company believe that by combining AGS-004 with therapies that are being developed to expose the virus in latently infected cells to the immune system, the company can potentially eradicate the virus. The current standard of care, antiretroviral drug therapy, or ART, can reduce levels of HIV in a patient’s blood, increase the patient’s life expectancy and improve the patient’s quality of life. However, ART cannot eliminate the virus, which persists in latently infected cells, remains undetectable by the immune system and can recur. In addition, ART requires daily, life-long treatment and can have significant side effects.
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