On October 28, 2019 PierianDx, the leading clinical genomics informatics company, reported that it has closed a $27 million Series B funding round led by ATW Partners and SJF Ventures that also includes existing investors Health Catalyst Capital, Inova Health Systems, RTI International, and ARUP Laboratories (Press release, PierianDx, OCT 28, 2019, View Source [SID1234549930]).

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PierianDx provides a SaaS platform that enables the practice of clinical genomics as a standard of care and empowers the world’s most advanced molecular diagnostic labs. Founded in 2014 out of Washington University in St. Louis, PierianDx is focused on advancing cancer diagnostics and making targeted therapeutics more accessible to healthcare systems, laboratories, and patients worldwide.

Dr. Rakesh Nagarajan, Founder and Executive Chairman of PierianDx, said, "PierianDx has grown tremendously over the past 18 months and is continuing to add the clinical expertise and resources necessary to execute on our vision. Our team is uniquely skilled and dedicated to the adoption of clinical NGS around the globe."

Michael L. Sanderson, CEO of PierianDx, said, "Our new capital infusion will accelerate the commercial expansion of PierianDx’s leading clinical genomics platform in the U.S. and global markets throughout Europe, Asia, Australia, Latin America, and North America, as we continue to work with leading sequencer, assay and pharma partners in our explosive space. PierianDx is fueled by making the most advanced clinically actionable cancer care accessible to everyone, regardless of location or ability to pay."

"We are excited about leading the Series B investment in PierianDx. We believe PierianDx will change the way cancer is treated worldwide and we are proud to be investors," said Mr. Kerry Propper, Co-Founder and Managing Partner of ATW Partners.

On October 28, 2019 Applied BioMath (www.appliedbiomath.com), the industry-leader in applying systems pharmacology and mechanistic modeling, simulation, and analysis to de-risk drug research and development, reported their participation at The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) occurring November 6th-10th in National Harbor, Maryland (Press release, Applied BioMath, OCT 28, 2019, View Source [SID1234549946]). They will present two posters at the conference Friday, November 8th.

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Katie Williams, PhD, Associate Director, Business Development, Applied BioMath will present the poster titled "A semi-mechanistic platform model to capture individual animal responses to checkpoint inhibitors in a syngeneic mouse model." In this work, we describe the generation of a model platform that captures essential aspects of the pharmacokinetics, cellular and tumor growth effects of murine surrogates of two checkpoint therapeutic antibodies, anti-PD1 and anti-CTLA4, in the CT26 syngeneic tumor model. The model describes individual animal responses regarding drug exposure, key intra-tumoral cell kinetics and tumor volume changes and provides biologically plausible explanations for the observed differences between good and poor responders to treatment with anti-PD1 or anti-CTLA4.

Jennifer Park, PhD, Director, Business Development, Applied BioMath will present the poster titled "Semi-mechanistic PK and target-occupancy modeling to support dose justification for anti-PD-L1 clinical candidate CK-301 (TG-1501) in oncology patients." In this work, a semi-mechanistic pharmacokinetic/target-occupancy (PKTO) model was developed with in vitro, preclinical and clinical data to facilitate dose selection of CK-301 (also known as TG-1501, cosibelimab), an anti-PD-L1 monoclonal antibody (mAb), for ongoing and future clinical trials in oncology patients. The model was used to compare the PK and tumor target occupancy (TO) at steady state under various dosing regimens with cosibelimab to those with three marketed anti-PD-L1 mAbs (i.e. atezolizumab, durvalumab and avelumab).

"We are excited to participate at SITC (Free SITC Whitepaper) for the first time this year!" said John Burke, PhD, Co-founder, President and CEO, Applied BioMath. "We hope to introduce the benefits of systems modeling and simulation to SITC (Free SITC Whitepaper) attendees, and how this analysis can be applied to cancer immunotherapy research and development from very early development through clinical trials."

For more information about all of Applied BioMath’s events, visit View Source

On October 28, 2019 Innovation Pharmaceuticals (OTCQB:IPIX) ("the Company"), a clinical stage biopharmaceutical company, is reported to highlight preclinical data by independent cancer researchers supporting the therapeutic potential of Kevetrin, the Company’s novel p53-modulating anti-cancer drug candidate, in treating Acute Myeloid Leukemia (AML) (Press release, Innovation Pharmaceuticals, OCT 28, 2019, View Source [SID1234549913]).

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Building on Kevetrin data in AML presented at the 2017 European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting, a group of independent cancer researchers recently presented additional data at the June 2019 EHA (Free EHA Whitepaper) Annual Meeting, and at the October 2019 Italian Society of Hematology Annual Meeting.

Results showed that Kevetrin alters cellular metabolism and several key genes, including TP53 and MYC, both of which when dysfunctional are implicated in many types of cancers, including AML.

The researchers’ conclusion as presented at the June 2019 EHA (Free EHA Whitepaper) Annual Meeting:

Our results show Kevetrin alters several key genes and cellular metabolism. Along with cellular data, this study could provide a rationale for an experimental trial in AML patients, especially those carrying TP53 mutation who actually have very few therapeutic options.

A related scientific article remains under review for publication. The paper details Kevetrin’s treatment potential in AML by targeting p53 and several key leukemia-related genes.

The continued publication flow of encouraging studies related to Kevetrin’s potential in AML is particularly promising. AML accounts for almost one-third of all leukemias worldwide and has a 5-year survival rate of only 25 percent. Pre-clinical research and academic literature also support Kevetrin’s potential in combination with cancer immunotherapies.

Kevetrin was shown to be well-tolerated in a completed Phase 1 clinical trial in Advanced Solid Tumors, with a separate Phase 2a clinical trial in late-stage Ovarian Cancer showing intra-tumor p53 modulation. P53 is the most studied gene of all time, eliciting significant private and public investment—e.g., see Aprea Therapeutics, PMV Pharma, Aileron Therapeutics—given an approved p53 drug would likely have a large impact in fighting many types of cancer. Next steps within the Innovation Pharmaceuticals cancer program is to complete the necessary remaining bridging toxicology work toward developing Kevetrin in oral formulation, both to leverage its pharmacokinetics (PK) profile and provide a more patient-friendly mode of administration.

On October 28, 2019 KSQ Therapeutics, a biotechnology company using CRISPR technology to enable the company’s powerful discovery engine to achieve higher probabilities of success in drug development, reported two upcoming presentations at leading scientific immuno-oncology congresses (Press release, KSQ Therapeutics, OCT 28, 2019, View Source [SID1234549931]). The data demonstrate the capabilities of the company’s proprietary CRISPRomics discovery engine, which allows genome-scale, in vivo validated, unbiased drug discovery.

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"There is a significant need for next-generation immuno-oncology therapies as the majority of cancer patients today experience an insufficient response to PD-1/PD-L1 therapies. The data we will be sharing demonstrate the potential of our CRISPRomics discovery platform to systematically identify and validate new cancer therapies for patients with PD-1 refractory solid tumors," said Frank Stegmeier, Ph.D., Chief Scientific Officer at KSQ Therapeutics. "KSQ was founded on the premise that CRISPR-enabled functional genomics can improve on current approaches to drug discovery and, taken together, these poster presentations describing the output of our genome-scale in vivo T-cell screens show that our platform can do this with a high degree of precision and quality, pointing the direction towards promising avenues of drug development."

Presentations include:

At the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper): Comprehensive identification of novel therapeutic targets for treatment of PD-1 resistant solid tumors via a genome-scale CRISPR/Cas9 in vivo T-cell screen – Poster # C101 – Tuesday, October 29 – 3:30-4:00 p.m. – Level 2 Hall D
At the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 34th Annual Meeting: An immune-CRISPRomics platform enabling genome-scale and pair-wise combination in vivo T-cell function screens enables comprehensive identification of novel therapeutic targets – Poster # P550 – Saturday, November 9 – 12:35–2:05 p.m. and 7:00-8:35 p.m.

On October 28, 2019 JSR reported that Consolidated Financial Results for the First Six Months of the Fiscal Year Ending March 31, 2020 (Press release, JSR, OCT 28, 2019, View Source net/doc/4185/ir_material_for_fiscal_ym3/72729/00.pdf [SID1234610438])

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1. Consolidated financial results for the first six months of the fiscal year ending March 31, 2020 (from April 1, 2019 to September 30, 2019)
(1) Consolidated operating results (Cumulative)
(2) Consolidated financial position

2. Cash dividends
3. Consolidated earnings forecasts for the fiscal year ending March 31, 2020 (from April 1, 2019 to March 31, 2020)

* Notes
(1) Changes in significant subsidiaries during the period (changes in specified subsidiaries resulting in the change in scope of consolidation): None
(2) Changes in accounting policies and changes in accounting estimates a. Changes in accounting policies required by IFRS: Yes b. Changes in accounting policies due to other reasons: None c. Changes in accounting estimates: None (3) Number of issued shares (ordinary shares) a. Total number of issued shares at the end of the period (including treasury shares)

* Quarterly financial results reports are not required to be subjected to quarterly reviews.
* Proper use of earnings forecasts, and other special matters Caution regarding forward-looking statements The forward-looking statements, including earnings forecasts, contained in these materials are based on information currently available to the Company and on certain assumptions deemed to be reasonable by the Company. These statements do not purport that the Company pledges to realize such statements. Actual business and other results may differ substantially due to various factors. How to obtain supplementary material on quarterly financial results The material on quarterly financial results is available on the Company’s website on Monday, October 28, 2019.

1. Qualitative Information on Quarterly Results
(1) Explanation of Business Results

Overview of the First Half of FY ending March 2020 (April 1, 2019 to September 30, 2019) JSR Group’s main customer industries have continued to face tough conditions since the second half of the previous fiscal year, given the U.S.-China trade conflict, the confusion surrounding the negotiations of the U.K.’s exit from the EU, and other factors, which are exacerbated by the growing economic slowdown in East Asia countries.

Under these circumstances, JSR Group has focused in the Elastomers Business on expanding global sales of products with advantages in technological competitiveness. In the Plastics Business, Techno-UMG Co., Ltd.

— in its second year since its merger — has aimed to realize synergy benefits through business consolidations and continued with integration of sales, development, and manufacturing. In the Digital Solutions Business, the Group has promoted expanded sales of semiconductor products applicable to cutting-edge technologies as well as greater sales of display materials in the Chinese market where strong growth is expected. In the Life Sciences Business, the Group has concentrated on enhancing consolidation of the structures undertaking endto-end biomedical drug discovery, production process development, and contract manufacturing obtained through active business acquisitions, in addition to enlarged sales of highly functional products, a company strength.

In the First Half of FY ending March 2020, the Company reported revenue of 240,149 million yen (down 2.3% year-on-year), operating profit of 18,999 million yen (down 15.2% year-on-year), and profit attributable to owners of parent of 13,472 million yen (down 19.4% year-on-year).

(i) Elastomers Business Segment Overall sales volume in the Elastomers Business segment decreased from the same period of the previous year and revenue was also down, despite satisfactory growth in SSBR sales volume. Operating profit dropped considerably, impacted by a contraction in price spreads due to lower sales prices caused primarily by lower raw material prices. Consequently, the Elastomers Business segment posted an operating loss of 278 million yen, down from an operating profit of 4,715 million yen in the same period of the previous year, on revenue of 91,007 million yen (down 8.4% year-on-year) in the First Half of FY ending March 2020.

(ii) Plastics Business Segment Sales volume, especially sales to overseas destinations, in the Plastics Business segment slipped from the same period of the previous year and revenue also fell. Despite better price spreads supported by lower cost prices on declining raw material prices, operating profit declined due to the significant impact of the sales volume slump. Consequently, the Plastics Business segment posted an operating profit of 3,635 million yen (down 7.9% year-on-year) on revenue of 48,962 million yen (down 6.9% year-on-year) in the First Half of FY ending March 2020.

(iii) Digital Solutions Business Segment Revenue improved in the Digital Solutions Business segment from the same period of the previous year, on the back of sales volume growth in edge computing materials and a good showing by semiconductors in spite of tough conditions in customer markets. Operating profit also rose slightly, driven by revenue growth. Consequently, the Digital Solutions Business segment posted an operating profit of 17,048 million yen (up 2.6% year-on-year) on revenue of 73,731 million yen (up 3.0% year-on-year) in the First Half of FY ending March 2020.

(iv) Life Sciences Business Segment The Life Sciences Business segment saw a sizable jump in revenue from the same period of the previous year, supported by expanded sales in biomedical drug discovery, production process development, and contract manufacturing as well as in diagnostic reagents. The segment’s operating profit increased due to a rise in profits concurrent with expanded revenue. Consequently, the Life Sciences Business segment posted an operating profit of 1,992 million yen (up 376.0% year-on-year) on revenue of 25,080 million yen (up 30.2% year-on-year) in the First Half of FY ending March 2020.

(2) Explanation of Future Forecast Information, such as Forecast of Consolidated Business Results JSR Group revised its forecast of consolidated business results for the full-year of FY ending March 2020 from those announced on July 29, 2019. While the Life Sciences Business has been going strong, sales volume declines and sluggish market conditions in the Elastomers and Plastics Businesses, and the slowdown in customer demand for display materials in the Digital Solutions Business depress the forecast and it is expected to fall below the previous forecast. For detailed numerical information, please refer to "Supplemental Data" published on October 28,2019.