On November 8, 2017 Alkermes plc (NASDAQ: ALKS) reported the presentation of positive preclinical data on the company’s immuno-oncology drug candidate, ALKS 4230. Data presented by Dr. Brian Gastman of the Cleveland Clinic at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in National Harbor, Md. showed that treatment with ALKS 4230 significantly delayed tumor growth and led to accumulation of tumor-killing T cells in the tumor microenvironment in individualized and humanized melanoma xenograft models of tumor immunology (Press release, Alkermes, NOV 8, 2017, View Source;p=RssLanding&cat=news&id=2315292 [SID1234521736]). ALKS 4230 is an engineered fusion protein designed to preferentially bind and signal through the intermediate affinity interleukin-2 (IL-2) receptor complex, thereby selectively activating and increasing the number of immunostimulatory tumor-killing immune cells while avoiding the expansion of immunosuppressive cells that interfere with anti-tumor response.

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"These data add to the growing body of evidence supporting the unique profile of ALKS 4230, a novel immuno-oncology candidate designed to harness the IL-2 mechanism in a selective way to enhance anti-tumor activity with the potential for improved safety and tolerability," said Elliot Ehrich, M.D., Executive Vice President, Research and Development of Alkermes. "We continue to progress in the ongoing dose-escalation stage of the phase 1 study for ALKS 4230 in patients with solid tumors, and look forward to determining the optimal dose range of ALKS 4230 and initiating dose expansion in 2018."

In the preclinical data presented at SITC (Free SITC Whitepaper), treatment with ALKS 4230 significantly delayed tumor growth and led to increased numbers of CD8 T cells and non-regulatory CD4 T cells in the tumor microenvironment in individualized melanoma xenograft tumor models. Xenografts were established in immunocompromised mice using tumor cells derived from metastatic melanoma patients, and the mice subsequently received an adoptive transfer of autologous, unexpanded peripheral blood mononuclear cells (PBMC) from the same patient. These data support the rationale for ALKS 4230 as a novel immunotherapeutic for the treatment of melanoma and potentially other solid cancers as well as the strategy of screening individual, patient-specific xenograft models to assess potential treatment efficacy.

A poster on the preclinical data, titled, "A Novel, Individualized Xenograft Model of Cancer Immunotherapy and Tumor Growth Inhibition by ALKS 4230," will be presented by Dr. Brian Gastman of the Cleveland Clinic at SITC (Free SITC Whitepaper) in National Harbor, Md. on Friday, Nov. 10, 2017 (Poster #P351). For more information, please visit the conference website at View Source

About ALKS 4230
ALKS 4230 is an engineered fusion protein designed to preferentially bind and signal through the intermediate affinity interleukin-2 (IL-2) receptor complex, thereby selectively activating and increasing the number of immunostimulatory tumor-killing immune cells while avoiding the expansion of immunosuppressive cells that interfere with anti-tumor response. The selectivity of ALKS 4230 is designed to leverage the proven anti-tumor effects while overcoming limitations of existing IL-2 therapy, which activates both immunosuppressive and tumor-killing immune cells.

On November 8, 2017 Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation multifunctional biotherapeutics, reported financial results for the third quarter ended September 30, 2017 (Press release, Zymeworks, NOV 8, 2017, View Source [SID1234521823]).

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"During the third quarter, we provided an update on our ongoing Phase 1 clinical trial of ZW25 where we continued to see impressive single agent anti-tumor activity, including a partial response at each weekly dosing cohort," said Ali Tehrani, Ph.D., Zymeworks’ President & CEO. "Our strategic partners also continued advancing their therapeutic candidates developed using our Azymetric bispecific platform. Recent successes by Merck and Daiichi Sankyo further validate the value of our technology platform for developing next-generation best-in-class therapeutics."

Third Quarter Business Highlights and Recent Developments

Zymeworks received a milestone payment of one million dollars from Daiichi Sankyo based on the achievement of a research milestone for an immuno-oncology bispecific antibody candidate under their collaboration.
Merck notified Zymeworks of its plans to advance, into preclinical development, a bispecific antibody candidate developed in collaboration with Zymeworks using Zymeworks’ proprietary Azymetric and EFECT platforms.
Additional safety and anti-tumor activity data from Zymeworks’ ongoing Phase 1 study of ZW25 was presented at the European Society for Medical Oncology ("ESMO") 2017 Congress. The dose escalation portion of the Phase 1 trial is now complete and new expansion cohorts have begun enrolling.
Financial Results for the Third Quarter Ended September 30, 2017

All amounts are in U.S. dollars. Zymeworks’ unaudited condensed consolidated financial statements are prepared in accordance with generally accepted accounting principles ("GAAP") used in the United States.

Revenues for the three months ended September 30, 2017 were $0.1 million compared to $2.2 million for the same period of 2016. The decrease in collaboration revenue between the periods was due to a non-recurring $2.0 million upfront technology access fee from Daiichi Sankyo received in 2016. Collaboration revenues are expected to vary based on the timing of new partnerships and research progress within existing programs.

Research and development expenditures for the three months ended September 30, 2017 were $11.5 million, compared to $9.8 million for the same period in 2016. The $1.7 million increase in research and development expenses was primarily due to increased clinical costs for ZW25, antibody drug conjugate ("ADC") development, and antibody discovery activities, partially offset by decreased expenses associated with the development of ZW33.

General and administrative expenses for the three months ended September 30, 2017 were $5.3 million compared to $2.7 million for the same period in 2016. General and administrative expenses increased between the periods by $2.6 million primarily due to an increase in compensation costs, professional fees, and recruitment costs.

The net loss for the three months ended September 30, 2017 was $16.2 million. Zymeworks expects research and development expenditures to increase due to the ongoing development of product candidates and other clinical, preclinical, and regulatory activities.

As of September 30, 2017, Zymeworks had $49.1 million in cash and cash equivalents and short-term investments. Zymeworks expects to continue receiving revenue from its existing and future corporate collaborations, including technology access fees, research and development fees for services rendered and milestone-based payments. However, its ability to receive these payments is dependent upon either Zymeworks or its collaborators successfully completing specified research and development activities.

Provectus Biopharmaceuticals has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Provectus Biopharmaceuticals, 2017, NOV 8, 2017, View Source [SID1234521780]).

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Lipocine has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Lipocine, 2017, NOV 8, 2017, View Source [SID1234521825]).

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On November 8, 2017 Ignyta, Inc. (Nasdaq: RXDX), a biotechnology company focused on precision medicine in oncology, reported new preclinical data for RXDX-106 – a novel immunomodulatory agent that demonstrated potent anti-tumor activity, alone and in combination with checkpoint inhibitors, by modulating the tumor microenvironment (TME) through TYRO3, AXL, and MER (TAM) receptor tyrosine kinase (RTK) inhibition (Press release, Ignyta, NOV 8, 2017, View Source [SID1234521740]). In the TME, TAM RTKs contribute to cancer cell evasion of the immune system and progression by promoting anti-inflammatory and pro-tumorigenic activities. RXDX-106 is a potent and selective TAM inhibitor in late-stage preclinical development, designed to reverse TAM RTKs-mediated immunosuppression and inhibit tumor growth and progression. The data were presented in two posters (abstracts P90 and P473) at the 32nd Annual SITC (Free SITC Whitepaper) Meeting, in National Harbor, Maryland.

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"We are excited by the immunomodulatory effects of RXDX-106 observed in a variety of preclinical models, and its potential to elicit and potentiate an immune response to cancer, both as a single agent and combined with checkpoint inhibitors," said Jonathan Lim, M.D., chairman and CEO of Ignyta. "RXDX-106 represents a new class of immuno-oncologic precision medicines by targeting the TAM RTKs in the tumor microenvironment. We look forward to bringing it into clinical trials in early 2018 to continue our efforts to help patients in their fight against cancer."

Using complementary approaches, including gene and protein modulation, RXDX-106 treatment resulted in the recruitment of both innate and adaptive immune cell subtypes to the TME. Using RNA sequencing, differential expression of immunomodulatory genes were observed in RXDX-106 treated compared to vehicle treated mouse cohorts, indicative of an enrichment in pro-inflammatory/anti-tumorigenic immune cell infiltration. In addition, RXDX-106 demonstrated immune-mediated, single-agent anti-tumor activity in multiple tumor models that was further enhanced by combination therapy with immune checkpoint inhibitors. These data further demonstrate the ability of RXDX-106 to activate both innate and adaptive immunity, as observed by treatment-mediated changes in relevant cytokine levels and immune cell biomarkers, and regulating cross-talk between immune and cancer cells. These promising early findings support further development of RXDX-106 to potentially treat a wide variety of cancers.