On October 2, 2018 LSK BioPharma (LSKB, Company) reported that the South Korean Ministry of Food and Drug Safety (MFDS) has approved a Phase I/IIa study protocol to investigate the combination of rivoceranib and paclitaxel, "A Phase I/IIa Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Rivoceranib in Combination with Paclitaxel in Advanced Gastric or Gastroesophageal Junction Cancer" (Press release, LSK BioPharma, OCT 2, 2018, View Source [SID1234530136]). The study will take place at Asan Medical Center in South Korea under the direction of Dr. Yoon-Koo Kang.

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"Asan Medical Center has been a key site in our pivotal Phase 3 gastric cancer trial for advanced and metastatic patients. We are excited to add this combination therapy trial at the same center with Professor Kang to investigate the use of rivoceranib in earlier stage patients," said Dr. Sung Chul Kim, LSKB President.

The study is expected to enroll its first patients in October 2018.

About Rivoceranib (Apatinib)
Rivoceranib is the first successful small-molecule angiogenesis inhibitor in gastric cancer. Rivoceranib acts by inhibiting angiogenesis, a critical process in cancer growth and proliferation. Specifically, rivoceranib selectively inhibits VEGFR-2 which mediates the primary pathway for tumor-mediated angiogenesis. It was approved in China (advanced gastric cancer, Dec 2014) where it is marketed by the Chinese-territory license-holder Jiangsu Hengrui Medicine Co., Ltd. LSK BioPharma, which holds the global rights (ex-China). The Company is currently conducting a global (12 countries including US, Japan, Korea, Italy, Germany, and Russia) Phase 3 clinical trial of rivoceranib in advanced or metastatic gastric cancer patients. Rivoceranib has been clinically tested in over 1,000 patients worldwide and has demonstrated efficacy in numerous cancers including gastric cancer, CRC, HCC, NSCLC, esophageal cancer, thyroid cancer, mesothelioma, and neuroendocrine tumors. It has also shown potential to significantly improve outcomes in combination with chemotherapeutics and immunotherapy, as well as for maintenance therapy. LSKB has received notification designating rivoceranib as an orphan medicinal product for the treatment of gastric cancer from the European Commission in the European Union, the US FDA, as well as the MFDS in South Korea.

On October 2, 2018 IMMUNOPRECISE ANTIBODIES LTD. ("ImmunoPrecise") (TSX Venture: IPA, Pink Sheets: IPATF) reported its financial results for Q1 ended July 31, 2018 (Press release, ModiQuest Therapeutics, OCT 2, 2018, View Source [SID1234530114]). The financial statements and related management’s discussion and analysis ("MD&A") can be viewed on SEDAR at www.sedar.com.

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Financial Highlights:

Revenue.During the three months ended July 31, 2018, the Company increased revenues to $2,872,785 from $591,058 in 2017. This represents a 386% increase in revenue, in part, from the acquisitions of U-Protein Express and ModiQuest Research, the Company’s ability to grow its capacity in its core business and expand its market share in Europe, as well as growth in higher revenue services.
Gross Margin. During the three months ended July 31, 2018, the Company increased its gross margin to $1,567,826 from $46,658 in 2017. In percentage terms, the Company’s gross margin increased to 55% from 8% in 2017. The lower gross margin in 2017 was mostly attributable to the fact that the Company increased its staffing levels, made salary adjustments and incurred higher lab operating costs to accommodate greater levels of activity in 2017, which drove down the gross margin.
Net Loss. The Company recorded a net loss of $1,102,362 during the three months ended July 31, 2018, compared to net loss of $857,832 for three months ended July 31, 2017. The net loss increased in 2018, primarily as a result of the acquisitions of U-Protein and ModiQuest, which required higher expenses in all facets of the business in order to manage a global landscape. The Company continues to invest in research and development as it broadens the breadth and value of its intellectual property assets.
Growth Initiatives in Fiscal 2018:

European Acquisitions. ImmunoPrecise acquired two profitable companies within the EU during the Fiscal year of 2018, U-Protein Express (August, 2017) and ModiQuest Research (April, 2018). These acquisitions will enhance ImmunoPrecise’s position as a leading, full-service antibody CRO, by strengthening its ability to partner with clients across the entire antibody discovery, manufacturing, and engineering continuum.These acquisitions also enhance ImmunoPrecise’s ability to achieve its longer-term goals by scaling to meet demand, and by expanding our global biotechnology and pharmaceutical client base.
Full-Service B-Cell Facility. During the Fiscal year of 2018, ImmunoPrecise expanded its B-cell offerings in both North America and Europe. This expansion will enable the ImmunoPrecise family of companies to increase its capacity for B-cell services supporting therapeutic antibody development, provide a client-centric focus with worldwide production centers, and help to bring leading antibody discovery services to more pharmaceutical and biotech companies around the world.
"We believe our strong revenue growth reflects our progress toward the goal of aligning our Companies’ unique continuum of services, supporting clients from target selection through pre-clinical studies, with an ever-strong and growing, global market. There has been an impressive increase in the scale of services requested by prospects and clients, further confirming the value of investing in our global presence to emerge as a leader in the full-service, antibody discovery and development sector," stated CEO and President, Dr. Jennifer Bath. "We are happy with our second-quarter performance, the integration of our new production sites, and we are optimistic about continued growth in revenue and shareholder value."

On October 2, 2018 Tocagen Inc. (Nasdaq: TOCA) reported it has received Protocol Assistance from the European Medicines Agency (EMA) under the Company’s PRIME (PRIority MEdicines) designation for Toca 511 (vocimagene amiretrorepvec) & Toca FC (flucytosine, extended-release) for the treatment of patients with recurrent high grade glioma (HGG) (Press release, Tocagen, OCT 2, 2018, View Source;p=RssLanding&cat=news&id=2369807 [SID1234529957]). In particular, the EMA indicated that the statistical analyses, seamless design, and the use of overall survival as the primary endpoint in the ongoing Phase 3 Toca 5 clinical trial are appropriate for a potential marketing authorization application for Toca 511 & Toca FC.

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"We are pleased the global Toca 5 trial has the potential to serve as the basis for a regulatory application in Europe, which we believe may expedite the advancement of Toca 511 & Toca FC as a treatment for patients with brain cancer. If the pivotal trial data are positive, our gene therapy would be the first medicine in over 20 years to show a treatment benefit in a randomized trial in patients with this disease," said Marty Duvall, chief executive officer of Tocagen. "Our interactions with the European regulators under the PRIME pathway are conducted in the spirit of collaboration and urgency to bring forward a new treatment for brain cancer as quickly as possible."

Toca 5 is an international, randomized, multi-center study evaluating the safety and efficacy of Toca 511 & Toca FC compared to standard of care in patients undergoing resection for recurrent HGG. The trial recently completed the planned enrollment of 380 patients. The primary endpoint of the trial is overall survival. Secondary endpoints of the Toca 5 trial include durable response rate, defined as complete or partial responses lasting at least 24 weeks, which is being assessed as a novel endpoint in the post-surgical setting of recurrent HGG. Tocagen plans to conduct a second interim analysis of Toca 5 in the first half of 2019 and the final planned safety and efficacy analyses by the end of 2019. More information about Toca 5 can be found on ClinicalTrials.gov using the clinical trial identifier NCT02414165.

The Committee on Orphan Medicinal Products (COMP) of the EMA has designated both Toca 511 & Toca FC as orphan medicinal products indicated for the treatment of glioma. In addition, the U.S. Food and Drug Administration granted Breakthrough Therapy Designation for Toca 511 & Toca FC in recurrent HGG.

Recurrent HGG is among the most common and aggressive primary brain cancers and often strikes in the prime of life. The two most common forms of HGGs are glioblastoma and anaplastic astrocytoma. The total number of new diagnoses of HGG expected in 2018 is about 197,000 worldwide, with approximately 38,000 in Europe. Unfortunately, HGG recurs in most patients after frontline treatment, and standard of care treatment typically offers a median survival of only seven to nine months.

About Toca 511 & Toca FC
Tocagen’s lead product candidate is a two-part cancer-selective immunotherapy comprising an investigational biologic, Toca 511, and an investigational small molecule, Toca FC. Toca 511 is a retroviral replicating vector (RRV) that selectively infects cancer cells and delivers a gene for the enzyme, cytosine deaminase (CD). Through this targeted delivery, only infected cancer cells carry the CD gene and produce CD. Toca FC is an orally administered prodrug, 5-fluorocytosine (5-FC), which is converted into an anti-cancer drug, 5-fluorouracil (5-FU), when it encounters CD. 5-FU kills cancer cells and immune-suppressive myeloid cells resulting in anti-cancer immune activation and subsequent tumor killing.

On October 2, 2018 Blue Earth Diagnostics, a leading molecular imaging diagnostics company, reported that the Transparency Committee of the French Haute Autorité de Santé (HAS) has recommended that Axumin (fluciclovine (18F)) is included on the list of medicines approved in France for hospital use, in line with its European indication (Press release, Blue Earth Diagnostics, OCT 2, 2018, View Source [SID1234529924]). Axumin is a novel molecular imaging agent approved in the European Union for use in PET imaging to detect and localize prostate cancer in men experiencing suspected recurrence based on elevated blood prostate specific antigen (PSA) levels after primary curative treatment. The positive recommendation marks a further milestone in the roll-out of Axumin across Europe, following receipt of Marketing Authorisation from the European Commission in May 22, 2017.

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Axumin is the first and only PET imaging agent approved by the European Commission for use in men with suspected recurrent prostate cancer in all European Union member states as well as in Iceland, Liechtenstein and Norway. Blue Earth Diagnostics is working to build a network of authorized and approved manufacturing locations across Europe. The company now has six European manufacturing and distribution agreements for Axumin in place, covering seventeen countries. Axumin is already commercially available in Norway, the Czech Republic, The Netherlands, United Kingdom and Austria with further European countries set to follow soon.

Jonathan Allis, Chief Executive Officer of Blue Earth Diagnostics said, "We’re delighted to announce another significant step towards our mission of making Axumin commercially available to clinicians and their patients across Europe. Detection and localization of recurrent prostate cancer is a significant unmet medical need, and Blue Earth Diagnostics is committed to maximizing access to Axumin across Europe."

On October 2, 2018 OncoSec Medical Incorporated (OncoSec) (NASDAQ:ONCS), a company developing intratumoral cancer immunotherapies, reported that Dr. Alain Algazi, Associate Professor of Medicine at UCSF, will present data from OncoSec’s OMS-100 study of TAVO (intratumoral tavokinogene telseplasmid) as a monotherapy treatment for metastatic melanoma in an oral presentation during the Melanoma Bridge Conference being held on November 29 – December 1 in Naples, Italy (Press release, OncoSec Medical, OCT 2, 2018, View Source [SID1234529888]).

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Dr. Algazi’s recently accepted presentation, entitled Intratumoral tavokinogene telseplasmid induces abscopal clinical responses in metastatic melanoma patients, will describe the OMS-100 Phase 2 multicenter, single-group study which evaluated the efficacy and safety observed after repeat dosing and different intervals between TAVO cycles. The primary endpoint was overall response rate (ORR) by modified "skin" Response Evaluation Criteria In Solid Tumors (mRECIST). Dr. Algazi, the primary investigator, is a leading expert in oncology research as well as a Clinical Strategic Advisor and a Clinical Advisory Board member for OncoSec.

The new data will demonstrate that local treatment with TAVO alone led to whole-body immune responses associated with regression of untreated lesions in half of the 50 patients treated on the study.

"We were grateful to Dr. Algazi and the Melanoma Bridge Conference for the opportunity to share this important TAVO monotherapy data demonstrating abscopal clinical responses with the clinicians, biotechnology executives, and industry opinion leaders in attendance," said Daniel J. O’Connor, OncoSec President and Chief Executive Officer. "Having Dr. Algazi present data from our OMS-100 study at the Melanoma Bridge Conference is an exciting opportunity for OncoSec as it serves to highlight our clinical work investigating TAVO as a monotherapy in the treatment of metastatic melanoma, as well as bring added visibility to our Phase 2b PISCES/KEYNOTE-695 clinical trial combining TAVO with pembrolizumab in metastatic melanoma for patients that have failed all available treatment options, including anti-PD-1 immunotherapy."

Details of the presentation are as follows:

Session Title: Mechanisms of resistance and drivers of response
Presentation Title: Intratumoral tavokinogene telseplasmid induces abscopal clinical responses in metastatic melanoma patients will address
Date and Time: Friday, November 30, 2018; 4:50 PM – 5:05 PM CEST (10:50 AM – 11:05 AM ET)
Location: Naples, Italy