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.

Inovio has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Inovio, 2017, NOV 8, 2017, View Source [SID1234521782]).

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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.

On November 8, 2017 OncoSec Medical Incorporated ("OncoSec" or "Company") (NASDAQ:ONCS), a company developing DNA-based intratumoral cancer immunotherapies, reported positive updated long-term follow-up data from its Phase 2 OMS I-102 combination study of ImmunoPulse IL-12 and pembrolizumab in patients unlikely to respond to anti-PD-1 therapy (Press release, OncoSec Medical, NOV 8, 2017, View Source [SID1234521755]). The updated data will be presented in an oral poster presentation (P524) by Dr. Alain Alagzi at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in National Harbor, MD on November 10th, 2017 at 12:45 p.m. EST.

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The updated clinical and correlative immune-focused biomarker data demonstrated a 57% progression free survival (PFS) rate at 15 months with 100% (11/11) duration of response and median PFS not yet reached. Building upon previously reported data of a best overall response rate (BORR) of 50% (41% complete response [CR] rate), the updated data further demonstrate that the combination of these therapies can prime a coordinated innate and adaptive immune response, and strongly suggests a synergistic relationship with anti-PD-1. The latest findings further demonstrate that this combination approach can reshape the tumor microenvironment, yielding a robust intratumoral and systemic anti-tumor response converting "cold" tumors to "hot," potentially improving clinical outcomes in patients predicted to not respond to anti-PD-1 therapy.

"Overall, the Phase 2 trial results, including progression free survival beyond two years in multiple patients, duration of response, best overall response rate, and tolerability of the combination, provide a strong and consistent theme across multiple endpoints, underscoring the promise of ImmunoPulse IL-12 plus pembrolizumab as a viable treatment option for patients diagnosed with metastatic melanoma," said Dr. Alain Algazi, Lead Trial Investigator, Associate Professor, Department of Medicine (Hematology/Oncology), at the University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center.

Dan O’Connor, CEO of OncoSec noted: "The robust PFS benefit and tolerability observed with ImmunoPulse IL-12 plus pembrolizumab is the first demonstrating efficacy in a predicted PD-1 non-responder population and shows that the combination represents a potentially important addition to the treatment landscape for metastatic melanoma patients who have progressed or are progressing on anti-PD-1 therapy."

The full abstract is available and can be viewed on the STIC website at www.sitcancer.org. The poster is available in the Publications section of OncoSec’s website.

Analyst Event in National Harbor, MD

OncoSec will host an analyst and investor event with clinical investigators on Friday, November 10, 2017 at 7:00 a.m. EST in National Harbor, MD during the 2017 Society of Immunotherapy for Cancer Annual Meeting. The event will include a presentation and discussion of updated clinical data for the company’s ImmunoPulse IL-12 program, highlighting the global, registration-directed PISCES/KEYNOTE-695 trial. The event will be held in-person and via live webcast.

Investors and analysts are invited to listen to a live audio webcast of the presentation. To access the audio broadcast, please dial (877) 731-1960 and enter the conference ID number 4938639. To join via webcast, please use the following link: View Source An archived version of the presentation will be available for 90 days on the "Investors" section of OncoSec’s website: View Source

For those interested in attending this event in person, please contact [email protected]. Please RSVP in advance as seating is limited.

Peer-Reviewed Publication

The findings published in Immunotherapy provide an overview of OncoSec’s preclinical and Phase 1 clinical data demonstrating that ImmunoPulse IL-12 plus electroporation is safe and well-tolerated by patients. Many patients do not respond to anti-PD-1 therapies alone, representing a significant unmet medical need. ImmunoPulse IL-12 has shown to increase intratumoral lymphocyte infiltration, pro-inflammatory cytokines and TH1 immune responses, potentially boosting the activity of PD-1 antibodies without significant systemic toxicity.

For the full-article please visit, View Source

About the SITC (Free SITC Whitepaper) Annual Meeting

The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) is a non-profit medical professional society of influential scientists, academicians, researchers, clinicians, government representatives, and industry leaders from around the world dedicated to improving cancer patient outcomes by advancing the science and application of cancer immunotherapy. Currently, SITC (Free SITC Whitepaper) has nearly 1,600 members representing 17 medical specialties and are engaged in research and treatment of at least a dozen types of cancer. The 32nd SITC (Free SITC Whitepaper) Annual Meeting & Associated Programs will take place November 8-12, 2017 at the Gaylord National Hotel & Convention Center in National Harbor, MD. For more information, please go to View Source

About PISCES/KEYNOTE-695

PISCES/KEYNOTE-695 is a global, multicenter phase 2b, open-label trial of intratumoral plasma encoded IL-12 (tavokinogene telseplasmid or "tavo") delivered by electroporation in combination with intravenous pembrolizumab in patients with stage III/IV melanoma who have progressed or are progressing on either pembrolizumab or nivolumab treatment. The Simon 2-stage study of intratumoral tavo plus electroporation in combination with pembrolizumab will enroll approximately 48 patients with histological diagnosis of melanoma with progressive locally advanced or metastatic disease defined as Stage III or Stage IV. The primary endpoint will be the Best Overall Response Rate (BORR).

Neuralstem has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Neuralstem, 2017, NOV 8, 2017, View Source [SID1234521752]).

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