On February 5, 2018 Spectrum Pharmaceuticals, Inc. (NasdaqGS:SPPI), a biotechnology Company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, reported that the first Phase 3 study of ROLONTIS, ADVANCE, has met its primary endpoint of non-inferiority in Duration of Severe Neutropenia in comparison to pegfilgrastim (Press release, Spectrum Pharmaceuticals, FEB 5, 2018, View Source [SID1234523728]). This study evaluated the safety and efficacy of ROLONTIS in the management of chemotherapy-induced neutropenia in 406 patients with early-stage breast cancer. The incidence of adverse events in this study was similar between the ROLONTIS and the pegfilgrastim arms. The Company also announced that RECOVER, the second Phase 3 study, has completed enrollment.

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"The ADVANCE study affirms the efficacy and safety of ROLONTIS that was observed in the Phase 2 study," said Lee S. Schwartzberg, M.D., FACP Professor of Medicine and Division Chief, Hematology Oncology, The University of Tennessee Health Science Center, and Executive Director, UT/West Cancer Center. "If approved, this drug would be a welcome addition to supportive care treatment options for cancer patients receiving myelosuppressive cytotoxic chemotherapy."

"The positive top line data from our Phase 3 study is an important milestone for Spectrum as we continue to move our Company forward," said Joe Turgeon, President and Chief Executive Officer of Spectrum Pharmaceuticals. "Also, the completion of enrollment of our second Phase 3, the RECOVER study, keeps us on track to file a BLA in the fourth quarter of 2018. ROLONTIS has the potential to be an important alternative for physicians and patients within this multibillion dollar market."

In accordance with the FDA Special Protocol Assessment, Phase 3 ADVANCE study was a multicenter, randomized, active-controlled trial that enrolled 406 early-stage breast cancer patients, who receive docetaxel and cyclophosphamide chemotherapy every 21 days. Patients were randomized 1:1 to treatment with ROLONTIS or pegfilgrastim. The primary study endpoint was the Duration of Severe Neutropenia (Absolute Neutrophil Counts [ANC] <0.5×109/L) in Cycle 1 of chemotherapy, based on central laboratory assessment of ANC over the 21 day cycle.

In January 2012, Spectrum entered into a licensing agreement with Hanmi Pharmaceuticals, gaining global rights for ROLONTIS (except Korea, China, and Japan).

On February 5, 2018 Argos Therapeutics Inc. (NASDAQ:ARGS), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis precision immunotherapy technology platform, reported that it has entered into an option agreement with Pharmstandard International, S.A. and Actigen Limited under which the Company has an option to license a group of fully human anti-PD1 monoclonal antibodies (PD1 checkpoint inhibitors) and related technology (Press release, Argos Therapeutics, FEB 5, 2018, View Source [SID1234523730]).

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Results of a preclinical study of a murine analogue of Rocapuldencel-T (Roca-T), the Company’s investigational dendritic cell therapy for the treatment of metastatic renal cell carcinoma (mRCC), in various combinations with a murine PD1 monoclonal antibody (anti-mPD1) and sunitinib in a mouse model of renal cell carcinoma were recently presented at the ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium. In this model, murine dendritic cell precursors were processed in a similar manner to that by which human monocytes are processed to manufacture Roca-T. Multiple combination dosing strategies were tested, all of which included treatment with sunitinib. Anti-mPD1 was tested both with administration two days following tumor inoculation (therapeutic administration) and with administration six days prior to tumor inoculation (prophylactic administration).

The dosing regimen consisting of dendritic cells followed by anti-mPD1 (therapeutic administration) and sunitinib showed a substantial synergistic effect, with median overall survival (mOS) of 67 days. This compared favorably with the regimen evaluating anti-mPD1 (therapeutic administration) and sunitinib (mOS of 39 days) and with dendritic cells followed by sunitinib (mOS of 46 days). Of note, the timing of anti-mPD1 administration was found to be important, as the regimen consisting of dendritic cells in combination with anti-mPD1 (prophylactic administration) and sunitinib showed a mOS of 48 days. Control mice had a mOS of 29 days.

Of note, histologic evaluation in these studies revealed that murine dendritic cells with similar properties to Roca-T resulted in recruitment and migration of lymphocytes into the tumor microenvironment and an increase in CD8+CD28+CD45RA- memory T cells. An increase in this same type of memory T cell after seven doses of Roca-T, as measured in blood samples, correlated with longer survival in the Company’s phase 3 ADAPT clinical trial of Roca-T in mRCC patients. These findings suggest that the mechanism of action of the murine analogue of Roca-T in this model is similar to that of Roca-T in man.

"Data from this study support the rationale for combining dendritic cell therapy with a PD1 checkpoint inhibitor in the treatment of renal cell carcinoma," noted Charles Nicolette, chief scientific officer, Argos Therapeutics. "These data also demonstrate the importance of the administration sequence for active immunotherapy with a murine analogue of Roca-T and a PD1 checkpoint inhibitor, along with sunitinib, and suggest that the cellular immune response must be initiated and established prior to administration of anti-mPD1 and sunitinib in order to achieve synergy in this murine model of mRCC."

Jeff Abbey, president and chief executive officer, Argos Therapeutics, added "We are pleased to have secured an option to license a group of fully human PD1 antibodies from Pharmstandard and Actigen. Provided sufficient funding is available, we expect to exercise this option and undertake the necessary preclinical studies in order to initiate clinical development of Roca-T in combination with a PD1 antibody."

Conference Call Logistics

The Company will host a conference call beginning at 8:30 a.m. Eastern Time on Tuesday, February 6, 2018. To participate by telephone, please dial (855) 433-0930 (Domestic) or (484) 756-4271 (International). The conference ID number is 8327219. A live and archived audio webcast can be accessed through the Investors section of the Company’s website at www.argostherapeutics.com. The archived webcast will remain available on the Company’s website for twelve (12) months following the call.

On February 4, 2018 ADC BIO reported the development of a revolutionary, ‘downstream bio-conjugation’ method that will present a new paradigm in Antibody Drug Conjugate (ADC) development and manufacturing (Press release, ADC BIO, FEB 4, 2018, View Source [SID1234526749]). In contrast to the existing approaches – which undertake bio-conjugation after both the mAb and cytotoxic have been manufactured – this new approach moves the conjugation step into the later stages of the downstream processing (DSP), with conjugation and antibody purification carried out concurrently.

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"The major benefit, and the reason this approach will prove so disruptive, is that it will save several months of manufacturing time and up to 25% of the overall costs. But it will require much of the industry, with its current ingrained manufacturing methods, to re-evaluate exactly how it structures the supply chain that often uses three CMOs," commented Charlie Johnson, CEO of ADC Bio.

Using this ‘downstream bio-conjugation’ approach, potentially means less time at the antibody manufacturer (i.e. less time in traditional downstream processing), with the remaining downstream processing and conjugation service both transferring to the bio-conjugation CMO. The result is a refined, simpler and much more efficient system – saving up to three months of development time and resources plus creating large cost savings.

Under the Company’s new process, the starting point for the conjugation will no longer be post-creation of purified antibodies and will instead begin with antibody supernatants. This persuasive approach forgoes the need for extensive chromatographic purification techniques to deliver purified antibody.

The Company’s groundbreaking production technique – yet to be formally named – would also remove the need for expensive Protein A resins, instead replacing them with capture resins that are at the heart of the Company’s core ‘Lock-Release’ technology. In ADC manufacturing, the Protein A capture step is the most costly in downstream processing, delivering semi-purified antibody. Now, starting from antibody supernatant, ADC Bio’s unique approach will see their patented ‘Lock-Release’ technology facilitate both the antibody capture step and subsequent conjugation to the ADC payload – essentially replacing the Protein A resin and assembling the ADC in an efficient manner. The subsequent viral inactivation, removal and polishing will then occur post-conjugation.

The benefits of eliminating the need for proteinaceous A & G resins extends beyond substantial cost savings. Incidental leaching of these proteins from their purification media increases the impurities in a biopharmaceutical drug product – all of which have to be removed in subsequent chromatography polishing steps before an antibody can be used for any therapeutic application. Moreover, Protein A is known to cause immunogenic responses in humans and has proven toxic in a number of clinical studies – thus its removal is mandatory.

On February 2, 2018 Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led biopharmaceutical company focused on identifying, developing and commercializing innovative and differentiated therapies to address significant unmet needs in medical and aesthetic dermatology, reported that members of its management team will present and host investor meetings at the following upcoming investor events (Press release, Aclaris Therapeutics, FEB 2, 2018, View Source [SID1234523693]):

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Dr. Neal Walker, President and Chief Executive Officer, will present at the LEERINK Partners 7th Annual Global Healthcare Conference in New York, NY on Wednesday, February 14, 2018 at 3:30 PM EST. Management will also host investor meetings on Wednesday, February 14, 2018.
Dr. Neal Walker, President and Chief Executive Officer, will present at the Cowen and Company 38th Annual Health Care Conference in Boston, MA on Tuesday, March 13, 2018 at 10:00 AM EST. Management will also host investor meetings on Tuesday, March 13, 2018.
A live webcast of the LEERINK Partners 7th Annual Global Healthcare Conference and the Cowen and Company 38th Annual Health Care Conference presentation may be accessed through the Company’s web site, www.aclaristx.com, on the ‘Events and Presentations’ section. An archived version of the presentation will be available for 30 days.

On February 2, 2018 TESARO, Inc. (NASDAQ:TSRO) reported its fourth-quarter 2017 financial results on Tuesday, February 27, 2018, after the close of the U.S. financial markets (Press release, TESARO, FEB 2, 2018, View Source [SID1234523718]). During the conference call and live audio webcast at 4:15 p.m. ET on February 27, 2018, TESARO’s senior management team will discuss the Company’s operating results in greater detail, as well as the status of its development programs and commercial products. For the month of December, ZEJULA achieved approximately 60% market share in the U.S. among PARP inhibitors utilized in patients with ovarian cancer, according to IntrinsiQ. This market-leading share position in ovarian cancer is consistent with the share ZEJULA achieved in prior months. Additional details will be discussed on the February 27, 2018 webcast.

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This quarterly earnings call will be available via phone and webcast. The conference call dial-in information is listed below. To access the webcast, please log on to the TESARO website at www.tesarobio.com at least 15 minutes prior to the start of the call to ensure adequate time for any software downloads that may be required.

******************CONFERENCE CALL & WEBCAST INFORMATION******************

TESARO will host a conference call and live audio webcast to discuss its fourth-quarter financial results.

WHEN: Tuesday, February 27, 2018 at 4:15 p.m. ET
LIVE DOMESTIC & CANADA CALL-IN: (877) 853-5334
LIVE INTERNATIONAL CALL-IN: (970) 315-0307
THIS CALL WILL ALSO BE BROADCAST LIVE, LISTEN ONLY, VIA THE WEB AT: www.tesarobio.com

A replay will be available for 30 days at www.tesarobio.com.