On August 2, 2019 Unum Therapeutics Inc. (Nasdaq: UMRX), a biopharmaceutical company focused on developing potentially curative cellular immunotherapies through its ACTR and BOXR platforms, reported that the company will host a conference call and live audio webcast on Monday, August 12, 2019 at 4:30 p.m. ET to discuss financial results for the second quarter of 2019 (Press release, Unum Therapeutics, AUG 2, 2019, View Sourcenews-releases/news-release-details/unum-therapeutics-review-second-quarter-2019-financial-results" target="_blank" title="View Sourcenews-releases/news-release-details/unum-therapeutics-review-second-quarter-2019-financial-results" rel="nofollow">View Source [SID1234538093]). Unum management will also provide an update on the Company’s recent progress and upcoming milestones.

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Participants may access the conference call by dialing 866-300-3411 (domestic) or 636-812-6658 (international) and refer to conference ID number 5658375. To join the live webcast, please visit the investor relations section of the Unum Therapeutics website at View Source at least 10 minutes before the event begins.

A webcast replay will be available at the same location on the Unum Therapeutics website beginning approximately two hours after the event and will be archived for 90 days.

On August 2, 2019 Allergan plc (NYSE: AGN) reported it will release second quarter 2019 financial results on Tuesday, August 6, 2019, prior to the open of U.S. financial markets (Press release, Allergan, AUG 2, 2019, View Source [SID1234538096]).

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For additional materials related to Allergan’s second quarter results, please visit Allergan’s Investor Relations website at View Source;.

On August 2, 2019 Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) reported that it has obtained Japanese manufacturing and marketing approval for the OncoBEAM1 RAS CRC Kit, used for blood-based circulating tumor DNA molecular testing of mutations in the RAS gene2 for colorectal cancer patients (Press release, Sysmex, AUG 2, 2019, View Source [SID1234538074]). This product is the first in vitro diagnostic reagent in Japan to be used for RAS gene mutation testing for colorectal cancer using liquid biopsy. Minimally invasive and simpler than conventional physical biopsies of tumor tissue, the new testing method provides detection results on a par with the use of tumor tissue.3 As a result, this testing method reduces the physical and mental burden on patients, expands testing opportunities, and contributes to the early-stage determination of treatment methods.

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In recent years, demand has grown for the use of liquid biopsy in the diagnosis and selection of treatment methods for cancer and other diseases. Liquid biopsy refers to using blood or other bodily fluids, which place little burden on the patient, rather than physical biopsies, which require taking samples of a cancer tumor or other tissue.4 Sysmex has defined the "resolution of medical issues through products and services" as one of the priority issues (materiality) for realizing a sustainable society and sustainable growth in corporate value for Sysmex through the creation of new technologies and markets. As one aspect of these activities, Sysmex is pursuing R&D toward the realization of personalized medicine, which involves the provision of healthcare optimized for individual patients, and the proliferation of testing to reduce the physical burden on patients.

The OncoBEAM RAS CRC Kit is used to test samples of tumor-derived DNA (circulating tumor DNA, or ctDNA) suspended in the blood of colorectal cancer patients. To help doctors determine treatment methods, this product provides auxiliary test data to determine the appropriateness for patients with colorectal cancer of the molecularly targeted drags—Cetuximab and Panitumumab (gene recombination)—, using BEAMing technology5 that detects RAS gene mutations to a high degree of sensitivity. Jointly developed between Merck KGaA, Darmstadt, Germany, and our subsidiary Sysmex Inostics, the product received CE Marking certification in March 2016, which indicates the product complies with the European IVD Directive, and is already being used for clinical applications in Europe. For the approval as an in vitro diagnostic reagent in Japan, eight medical facilities were involved in a multi-facility evaluation, including the National Cancer Center Hospital East. Gene testing using this product can be used to provide appropriate treatment opportunities for patients that would have difficulty with testing using conventional tumor tissue. Furthermore, rather than physical biopsies, this type of testing allows samples to be obtained from blood samples in a simple and minimally invasive manner. This helps reduce the physical and mental burden on the patient, shortens the time required from the start of testing, and contributes to the early-stage determination of treatment methods.

Going forward, we plan to launch the OncoBEAM RAS CRC Assay Service, an assay service for colorectal cancer using liquid biopsy to detect RAS gene mutations in the blood, at the Sysmex IMP laboratory, located in the Kobe Biomedical Innovation Cluster. To increase the opportunities for more patients to receive the testing, we plan to apply for Japan’s national insurance coverage for this product.

By providing new cancer diagnostic methods to patients at the earliest possible date, such as the OncoBEAM RAS CRC Kit, as well as the OncoGuideTM NCC Oncopanel System,5 which received insurance coverage in Japan on June 1, 2019 for use in cancer genome profiling, Sysmex aims to take the global lead in realizing personalized medicine, contributing to patient quality of life and the advancement of healthcare.

Name: OncoBEAM RAS CRC Kit
Use: To detect RAS (KRAS and NRAS) gene mutations in genomic DNA extracted from plasma
(Auxiliary use to determine the appropriateness of Cetuximab and Panitumumab (gene recombination) for patients with colorectal cancer)
Target market: Japan
Target institutions: Healthcare institutions and clinical testing centers in Japan, other
In vitro diagnostics manufacturing and marketing approval number: 30100EZX00010000 (Obtained on July 19, 2019)
Reference

・
April 6, 2016 press release entitled "New Liquid Biopsy RAS Testing for metastatic colorectal cancer patients now available for clinical practices"
View Source

Terminology

OncoBEAM:
The name of Sysmex’s technology to detect minute gene mutations circulating in the blood with a high degree of sensitivity using BEAMing technology. BEAMing technology is an acronym for "bead, emulsion, amplification and magnetics", a gene analysis method developed at Johns Hopkins University combining digital PCR and flow cytometry technologies for highly sensitive analysis of genetic mutations.

RAS gene:
As the likelihood is high that patients with RAS gene (KRAS/NRAS gene) mutations will not benefit (prolongation of life, tumor reduction) from the administration of anti-EGFR drugs, companion diagnostics may be performed to treat the gene mutation first.

According to the results of multi-facility evaluation, determination results using this method are on a par with those of conventional RAS gene mutation testing using tumor tissue. Source: British Journal of Cancer volume 120, pages 982–986 (2019)

The Guidance on Genetic Testing in the Treatment of Coloretal Cancer Vol. 4.1 (May 2019), published by the Japanese Society of Medical Oncology, indicates the necessity of using liquid biopsy for colorectal cancer and the clinical utility of ctDNA testing.

OncoGuide NCC Oncopanel System (medical device manufacturing and marketing approval No.:23000BZX00398000):
(Reference) May 31, 2019 press release entitled "The OncoGuide NCC Oncopanel System Receives Insurance Coverage for Use in Cancer Genome Profiling" View Source

On August 2, 2019 Biotechnology company Antikor Biopharma Ltd is reported that it has entered into an Investment Agreement for up to US$3,100,000 with Essex Bio-Investment, a wholly-owned subsidiary of Essex Bio-Technology Ltd ("EssexBio"), which will enable Antikor to consolidate and expand its position as a leading innovator in smaller-format conjugate therapies for solid tumours (Press release, Antikor Biopharma, AUG 2, 2019, View Source [SID1234538099]).

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Mahendra Deonarain, Antikor’s CEO and visiting Reader in Antibody Technology at Imperial College London where Antikor has its roots, commented: "We believe we have a platform that is tailored to make an impact in an area of major unmet medical need, and with EssexBio’s considerable commercial and clinical expertise, we now have the opportunity for translating the promised advantages of Antikor’s proprietary products into clinical benefit."

"We are excited to have established a strong alliance with Antikor", said Malcolm Ngiam, President of Essex Bio-Investment, "Fragment-Drug Conjugate is an innovative approach with the potential to overcome many of the challenges faced by current treatment methods. The research and commercial partnership with Antikor is an important step towards developing first-in-class treatment for cancer."

Antikor’s novel technology platform will enrich Essex’s research pipeline and is aligned with EssexBio’s long-term research and commercial strategy.

Antibody Fragment-Drug Conjugates (FDCs)

Antibody Fragment-Drug Conjugates (FDCs, also called immuno-conjugates) combine the pharmacological potency of highly cytotoxic drugs with the high specificity of an antibody against tumour-associated targets. FDCs comprise much smaller antibody fragments (single-chain scFvs) than ‘whole’ antibody drug conjugates (ADCs). FDCs are relatively easy to discover and can be bioengineered for multiple drug-molecule conjugation, leading to higher loadings than has so far been achieved with whole mAbs. FDCs demonstrate superior tumour penetration and rapid elimination from normal tissues, without running the risk of problems with product manufacturing or stability.1 As a next-generation cancer therapy that can overcome the many limitations of existing treatment options, FDCs have exciting market potential, with predicted sales of drug-conjugates of over $18 billion by 2022.2

On August 2, 2019 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, reported financial results for the second quarter ended June 30, 2019 and provided an update on clinical and corporate developments (Press release, Deciphera Pharmaceuticals, AUG 2, 2019, View Source [SID1234538080]).

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"In recent months, we’ve made substantial progress across our pipeline of novel candidates from our two Phase 3 GIST trials with ripretinib to the addition of DCC-3116, a potential first-in-class autophagy inhibitor aimed at treating mutant RAS cancers," said Steve Hoerter, President and Chief Executive Officer of Deciphera. "Later this month, we expect to announce top-line data from the INVICTUS pivotal Phase 3 clinical study, the results of which, if favorable, could serve as the basis for our first new drug application, or NDA, filing. We also recently established our first license agreement for ripretinib outside of the U.S., which we believe reflects the growing recognition that ripretinib has the potential to alter the treatment landscape for patients with GIST."

Recent Pipeline Updates

Ripretinib
Deciphera expects to report top-line data from the INVICTUS pivotal Phase 3 clinical study evaluating the safety and efficacy of ripretinib, the Company’s investigational broad-spectrum KIT and PDGFRα inhibitor, in fourth-line and fourth-line plus GIST patients in August 2019. The Company is building its commercial and medical affairs capabilities to support the planned launch of ripretinib in the United States, if approved.
In June 2019, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for ripretinib for the investigation of the treatment of patients with advanced GIST who have received prior treatment with imatinib, sunitinib and regorafenib.
Deciphera continues to activate sites and enroll patients in the INTRIGUE Phase 3 clinical study comparing ripretinib to sunitinib for the treatment of second-line GIST patients who have previously received imatinib. As of July 26, 2019, 45 sites have been activated.
Rebastinib
Deciphera previously announced the initiation of an open-label, multicenter, Phase 1b/2 combination study of rebastinib, the Company’s investigational small molecule switch control inhibitor of TIE2 kinase, with carboplatin in patients with advanced or metastatic solid tumors.
Deciphera completed enrollment of 43 patients in Part 1 of the Phase 1b/2 combination study of rebastinib with paclitaxel. Part 2 of the Phase 1b/2 study is now enrolling patients. The Company expects to report initial data from Part 1 of this study in the second half of 2019.
DCC-3014
The Company plans to present updated data from the ongoing dose escalation portion of the Phase 1 clinical study of DCC-3014, the Company’s investigational small molecule switch control inhibitor of CSF1R, in patients with advanced malignancies, in the second half of 2019.
The Company continues to enroll patients diagnosed with tenosynovial giant cell tumors (TGCT) in the Phase 1 study evaluating DCC-3014.
DCC-3116
In June 2019, Deciphera announced the addition of a new candidate to its pipeline, DCC-3116, a potential first-in-class small molecule designed to inhibit cancer autophagy, a key tumor survival mechanism, by inhibiting the ULK kinase. Subject to favorable investigational new drug (IND)-enabling studies and filing and activation of an IND, expected in mid-2020, Deciphera intends to develop DCC-3116 for the potential treatment of mutant RAS cancers in combination with inhibitors of downstream RAS effector targets including RAF, MEK, or ERK inhibitors as well as with direct inhibitors of mutant RAS.
Corporate Updates

Ripretinib License Agreement for Greater China.
In June 2019, Deciphera announced an exclusive license agreement with Zai Lab (Shanghai) Co., Ltd. (Zai) to advance the development and commercialization of ripretinib in Greater China, including mainland China, Hong Kong, Macau and Taiwan. Under the terms of the agreement, Deciphera has received an upfront cash payment of $20 million and will be eligible to receive up to $185 million in potential development and commercial milestone payments, including $5 million for an INTRIGUE study-related milestone the Company achieved. In addition, Zai will be obligated to pay Deciphera royalties ranging from low to high teens on annual net sales of ripretinib in Greater China.
New Member of the Board of Directors
In July 2019, Deciphera announced the appointment of Susan L. Kelley, M.D. to its Board of Directors. Dr. Kelley has over 25 years of experience across all stages of oncology drug research and development.
Second Quarter 2019 Financial Results

Cash Position: As of June 30, 2019, cash, cash equivalents and marketable securities were $225.4 million, compared to cash and cash equivalents of $293.8 million as of December 31, 2018. Deciphera expects its cash, cash equivalents and marketable securities as of June 30, 2019, along with the $20.0 million up-front payment from the Company’s recent license agreement with Zai received in the third quarter of 2019, will enable the Company to fund its operating expenses, capital expenditure requirements and debt service payments into the fourth quarter of 2020. This excludes any potential milestone or royalty payments, if any, under Deciphera’s license agreement with Zai.
Revenue: Revenue for the second quarter of 2019 was $25.0 million which was related to the Company’s exclusive license agreement with Zai to advance the development and commercialization of ripretinib in Greater China. Deciphera recognized license revenue of $20.0 million for an upfront fee and $5.0 million for a development milestone related to the INTRIGUE study.
R&D Expenses: Research and development expenses for the second quarter of 2019 were $34.8 million, compared to $18.0 million for the same period in 2018. The increase was primarily due to the INTRIGUE Phase 3 clinical study in second-line GIST, which the Company initiated in December 2018, and to the INVICTUS Phase 3 clinical study in fourth-line and fourth-line plus GIST, which the Company initiated in January 2018. The Company also incurred costs related to other supporting clinical trials for ripretinib. Additionally, expenses related to the rebastinib program increased primarily as a result of an increase in clinical trial costs related to the Phase 1b/2 trial of rebastinib in combination with paclitaxel, which the Company initiated in October 2018, and the second Phase 1b/2 clinical trial of rebastinib in combination with carboplatin, which the Company initiated in January 2019. Personnel-related costs increased $4.0 million primarily due to increased headcount and stock-based compensation expense in research and development functions. Personnel-related costs for the second quarters of 2019 and 2018 included non-cash stock-based compensation expense of $1.8 million and $1.0 million, respectively. Facility-related and other costs included in unallocated expenses increased $2.3 million primarily due to increased consultant fees and other costs in connection with our early-stage drug discovery programs.
G&A Expenses: General and administrative expenses for the second quarter of 2019 were $13.2 million, compared to $4.5 million for the same period in 2018. The increase was primarily due to an increase in professional, consultant and various advisory fees, including those related to commercialization preparedness. Non-cash stock-based compensation was $2.3 million and $1.2 million for the second quarters of 2019 and 2018, respectively. The increase in non-cash stock-based compensation expense was primarily related to the granting of additional employee stock option awards.
Net Loss: For the second quarter of 2019, Deciphera reported a net loss of $21.5 million, or $0.56 per share, compared with a net loss of $21.7 million, or $0.65 per share, for the same period in 2018.