On November 9, 2022 Kuraray reported that Consolidated Earnings Report for the Third Quarter of the Fiscal Year Ending
December 31, 2022 (Press release, Kuraray, NOV 9, 2022, https://pdf.irpocket.com/C3405/aG1f/Ivrn/rOhn.pdf [SID1234623644])

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1. Consolidated Financial Results for the Third Quarter of the Fiscal Year Ending December 31, 2022 (January 1, 2022 to September 30, 2022)
(1) Consolidated Operating Results (Percentage changes displayed for net sales, operating income, ordinary income and net income attributable to owners of the parent are comparisons with the corresponding period of the previous fiscal year.)
(2) Consolidated Financial Position

2. Dividends

3. Forecasts of Consolidated Financial Results for the Fiscal Year Ending December 31, 2022 (January 1, 2022 to December 31, 2022) (Percentage changes displayed for net sales, operating income, ordinary income and net income attributable to owners of the parent are comparisons with the previous fiscal year.)

1. Qualitative Information regarding Business Results
(1) Overview of Consolidated Business Results In the third quarter of fiscal 2022 (January 1, 2022–September 30, 2022), the world economy continued to gradually recover as restrictions on economic activities were eased. However, the recent trend toward economic deceleration grew stronger due in part to a rise in interest rates in various countries amid rapid inflation and the prolonged Russia-Ukraine crisis, causing the future outlook to become even murkier. Amid these circumstances, consolidated operating results for the third quarter of fiscal 2022 are as follows: net sales were ¥553,150 million (¥459,159 million in the same period of the previous fiscal year); operating income was ¥70,846 million (¥54,318 million in the same period of the previous fiscal year); ordinary income was ¥70,078 million (¥51,001 million in the same period of the previous fiscal year); and net income attributable to owners of the parent was ¥47,174 million (¥28,602 million in the same period of the previous fiscal year). Furthermore, in the third quarter, we recorded an extraordinary loss of ¥5,429 million as costs related to the suspension of operations due mainly to the suspension of some production facilities at a U.S. subsidiary.

On January 1, 2022, the Company revised its organizational structure and changed the segment classification of the aqua business from "Others" to "Functional Materials." In addition, the method of allocating eliminations of profits from some internal transactions among segments and the corporate has been changed. Figures used in comparisons and analyses of the third quarter reflect these changes.

Furthermore, from January 1, 2022, we have adopted the Accounting Standard for Revenue Recognition (ASBJ Statement No. 29; March 31, 2020). In line with the transition provisions set out in the revision to paragraph 84, the new accounting principle was not retroactively applied to the consolidated third quarter of the previous fiscal year. Net sales for the Trading segment and elimination & corporate for the third quarter of fiscal 2022 have significantly changed compared to the third quarter of fiscal 2021, mainly due to changes in accounting methods for revenues attributable to agent transactions in the Trading segment as a result of the adoption of the Accounting Standard for Revenue Recognition and other factors. Because of these changes, revenues from such transactions, which have previously been recorded on the basis of total transactional value, are now recorded on a net basis. Due to this change, net sales in the Trading segment was ¥63,010 million lower compared with the original method. To realize its long-term vision, Kuraray Vision 2026, the Group launched a medium-term management plan, "PASSION 2026," from January 1, 2022.

In line with "PASSION 2026," we set three challenges to tackle:
1) Sustainability as an opportunity,
2) Innovations starting from networking, and
3) Transformation of people and organizations. Through these initiatives, we aim to establish an upgraded business portfolio and, in fiscal 2026, the centennial of Kuraray’s founding, achieve net sales of ¥750.0 billion and operating income of ¥100.0 billion.

Results by Business Segment Vinyl Acetate Sales in this segment were ¥285,641 million (¥224,861 million in the same period of the previous fiscal year), and segment income was ¥58,987 million (¥43,775 million in the same period of the previous fiscal year).

(1) The sales volume of PVOH resin decreased due to the suspension of some production facilities at a U.S. subsidiary because of malfunctions and logistics disruptions. On the other hand, we continued revising prices amid soaring raw material and fuel prices. Shipments of optical-use poval film declined significantly in the July–September 2022 period due to the impact of LCD panel inventory adjustments. In addition, to meet needs for larger TV panel sizes, we decided to make a capital investment at the Kurashiki Plant (slated to begin operating in mid 2024), announcing this intention on May 9, 2022. As for Advanced Interlayer Solutions, the sales of PVB film for use in construction applications held steady. Sales of water-soluble PVOH film were firm for use in unit dose laundry detergent packets.

(2) As for EVAL ethylene vinyl alcohol copolymer (EVOH resin), the sales volume increased as steady performance for use in food packaging 4 applications offset a decrease for use in automotive applications. We also revised prices.

On November 9, 2022 Avstera Therapeutics Corp., a biotechnology company based in the Philadelphia area, reported the completion of its seed round to advance its lead cancer programs geared towards targeting solid tumors (Press release, Avstera Therapeutics, NOV 9, 2022, View Source [SID1234623598]). The company intends to use proceeds to enable its lead highly specific HDAC6i for IND filing targeting locally advanced and metastatic solid tumors by the end of next year.

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"Tumor associated macrophages (TAMs) account for up to 50% or more of the cell mass of solid neoplasms. Our lead programs are geared towards new understanding that macrophage differentiation is a critical piece in maintaining overall anti-tumoral responses and stabilizing the tumor microenvironment." added Karthik Musunuri, CEO & Co-Founder at Avstera Therapeutics. Avstera’s lead HDAC6i has been shown to significantly reduce tumor growth in preclinical in-vivo models, improve overall survival, and acts as an immunomodulator in polarizing macrophages to the anti-tumoral M1 phenotype within the TME while inducing other mechanisms including downregulation of PD-L1 expression. The company also aims to leverage this approach in advancing its novel autologous macrophage cell therapy program for solid tumors; where T-cell based approaches have faced significant challenges.

Avstera Therapeutics has collaborations with leading investigators from Georgetown University and the University of Pennsylvania. The company currently has three preclinical stage therapies, including a highly selective HDAC6i, an autologous ex-vivo HDAC6i activated macrophage-based cell therapy, and a mRNA TEM1 cancer vaccine. The research behind the HDAC6i technology stems from Alejandro Villagra’s lab at Georgetown; through licenses made with the George Washington University. Avstera is also excited to be engaged with the University of Pennsylvania via cancer researcher Andrea Facciabene; through a joint development collaboration on a next generation mRNA cancer vaccine.

"Current anticancer macrophage-based cell therapies have shown modest results in preclinical and clinical studies. Recent findings have shown that macrophages quickly switch their phenotype toward a protumoral phenotype after reaching tumors. Our technology aims to harness the power of HDAC6 inhibitors with the capacity to prevent the protumoral phenotype switching of macrophages and improve macrophage-based anticancer immune therapies." added Alejandro Villagra, PhD, who also serves on Avstera’s Scientific Advisory Board.

On November 9, 2022 Ginkgo Bioworks (NYSE: DNA), the leading horizontal platform for cell programming, reported that it will be presenting a poster on November 11 at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (Press release, Ginkgo Bioworks, NOV 9, 2022, View Source [SID1234623597]). The poster highlights Foundry-enabled methods for large-scale, combinatorial library design and screening of Chimeric Antigen Receptor (CAR) domains for improved persistence. The ability to screen hundreds of thousands of CAR designs in primary human T cells can enable discovery of variants with desired characteristics. This capability has the potential to discover CAR-T therapies that are effective against solid tumors.

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CAR-T cell therapies show tremendous promise for the treatment of cancer. However, their use to date has been limited to targeting blood cancers, as CAR-T has failed to show consistent efficacy in treating solid tumors, which represent approximately 90% of adult human cancers. Part of the challenge when applying CAR-T therapies to solid tumors lies in T cell exhaustion, a state of dysfunction arising from excessive antigen stimulation in the immunosuppressive environment of a solid tumor.

Signaling cascades triggered by intracellular domains (ICDs) of CARs drive T cell behaviors that correspond to different therapeutic outcomes, including CAR-T persistence. Systematic design and testing of novel ICD combinations that drive more favorable T cell phenotypes has been onerous due to technical constraints in high throughput screening. Data presented at SITC (Free SITC Whitepaper) will demonstrate that Ginkgo’s high throughput screening method enables massively parallel testing of CAR designs, and has led to discovery of new ICD combinations that outperform the canonical CD28-CD3z and 4-1BB-CD3z combinations.

Ginkgo’s platform for cell programming enables synthesis and screening of diverse libraries of genetic constructs to explore biological space. Applying these capabilities to the design of CARs enables screening of hundreds of thousands of possible combinatorial variants of different CAR ICDs. Data presented at SITC (Free SITC Whitepaper) will show how this method could be used to screen for variants with increased persistence in a serial tumor rechallenge assay. As an enabling platform company, Ginkgo can leverage its full stack of mammalian cell engineering expertise and capabilities to enable the high throughput screening of CAR-T cells to discover and optimize future next generation therapeutic candidates for its partners.

"While innovation in CAR-T cell therapies continues to grow at a dramatic pace, CAR-T is still a relatively new modality whose potential is just beginning to be fully explored," said Shawdee Eshghi, Senior Director, Mammalian Engineering, Ginkgo Bioworks. "With large scale screening and automation, Ginkgo has created a tool we believe can dramatically expand the variety and functionality of CAR domains so that our partners can build therapies targeted for particular tumor environments."

"We’ve only seen a small sliver of what revolutionary modalities like CAR-T can achieve in terms of patient outcomes. Being able to explore broader design space for this powerful technology can help unlock new potential in solid tumor treatment, inflammatory and autoimmune diseases, and beyond." said Arie Belldegrun, Executive Chairman and Co-Founder of Allogene Therapeutics and Kite Therapeutics and member of the Board of Directors for Ginkgo Bioworks. "The scale of Ginkgo’s platform helps to enable discovery and innovation in this important arena."

To view the poster, please visit Ginkgo’s blog. To learn more about SITC (Free SITC Whitepaper), to register, or to attend the poster presentation, visit www.sitcancer.org/2022.

On November 9, 2022 Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA), an oncology-focused drug development company, reported that final data from its phase II study of paxalisib in patients with newly diagnosed glioblastoma will be the subject of an oral presentation at the upcoming annual meeting of the Society for Neuro-Oncology (SNO), which will be held from 17-20 November in Tampa, FL (Press release, Kazia Therapeutics, NOV 9, 2022, View Source [SID1234623596]).

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The oral presentation will build on key findings previously presented at the ASCO (Free ASCO Whitepaper) and ESMO (Free ESMO Whitepaper) annual meetings earlier in the year.

In addition, Professor Matt Dun from the Hunter Medical Research Institute at the University of Newcastle, Australia, will present the latest data from his ongoing research with paxalisib in diffuse midline gliomas, an aggressive form of childhood brain cancer.

On November 9, 2022 Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, reported that the poster, titled "Fostrox (MIV-818) in combination with anti-PD-1 shows increased efficacy in nonclinical tumour models in vivo" will be presented at the SITC (Free SITC Whitepaper) 2022 conference, on November 10 by Fredrik Öberg, CSO at Medivir (Press release, Medivir, NOV 9, 2022, View Source [SID1234623595]).

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Fostroxacitabine bralpamide (fostrox) is an orally administered liver-targeted troxacitabine-based nucleotide prodrug currently undergoing phase 1/2a clinical trial in advanced hepatocellular carcinoma (HCC), in combination with pembrolizumab or lenvatinib (NCT03781934). Liver-selective fostrox-induced DNA-damage and tumor cell killing has the potential to enhance the efficacy of checkpoint blockade by increasing tumor antigen presentation and changing the tumor microenvironment.

The poster supports this potential as it shows that combination therapy with fostrox and anti-PD1 significantly improved anti-tumor efficacy in a pre-clinical mouse model for HCC, compared with either treatment alone. Analysis of immune-related gene expression indicated increased tumor infiltrating lymphocytes (TILs), and included upregulation of genes involved in cancer antigen presentation in the tumors. In addition, the combination of fostrox with pembrolizumab treatment, in a chorioallantoic membrane lung carcinoma model, showed enhancement of efficacy and increased tumor infiltration of CD8+ T-cells.

In conclusion the combination of fostrox with anti-PD1 showed enhanced efficacy in nonclinical tumor models, and changes in the tumor microenvironment consistent with increased immune-mediated anti-tumor activity. The results indicate a potential for combining anti-PD1 with fostrox in the treatment of HCC. The abstract and the poster will be available on Medivir’s website after the presentation.

About fostrox

Fostrox is a pro-drug designed to selectively treat liver cancers and to minimize side effects. It has the potential to become the first liver-targeted and orally administered drug for patients with HCC and other forms of liver cancer. Fostrox has completed a phase 1b monotherapy study, and a combination study in HCC currently ongoing.

About primary liver cancer

Primary liver cancer is the third leading cause of cancer-related deaths worldwide and hepatocellular carcinoma (HCC) is the most common cancer that arises in the liver. Although existing therapies for advanced HCC can extend the lives of patients, treatment benefits are insufficient and death rates remain high. There are 42,000 patients diagnosed with primary liver cancer per year in the US and current five-year survival is 11 percent. HCC is a heterogeneous disease with diverse etiologies, and lacks defining mutations observed in many other cancers. This has contributed to the lack of success of molecularly targeted agents in HCC. The limited overall benefit, taken together with the poor overall prognosis for patients with intermediate and advanced HCC, results in a large unmet medical need.