Lion TCR presents two abstracts of Phase 1 clinical trial data for lead product LioCyx-M at the 2020 Society for Immunotherapy of Cancer (SITC) Annual Meeting

On November 10, 2020 Lion TCR reported that it has presented two abstracts at the 2020 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting on November 9-14 (Press release, Lion TCR, NOV 10, 2020, View Source [SID1234570478]). Each of these abstracts highlights the good safety profile and efficacy of LioCyx-M and the promising use of HBV-specific TCR-T therapy in HBV-related HCC.

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TCR-T immunotherapy involves the bioengineering reprogramming of the human body’s natural immune defenders, T cells, to enhance their cytolytic specificity function against tumour cells. Our clinical data presented in these abstracts supports the use of Lion TCR’s lead T-cell product, LioCyx-M is a promising TCR-T immunotherapy for primary hepatocellular carcinoma (HCC) and recurrence post liver transplantation.

Each of these abstracts highlights the good safety profile and efficacy of our lead product LioCyx-M, autologous T cells modified to express Hepatitis B virus (HBV)-specific TCR, as monotherapy in either unresectable HBV-associated hepatocellular carcinoma (HCC) or recurrent HCC post liver transplantation in two independent Phase I studies. These data demonstrate the promising use of HBV-specific TCR-T therapy in HBV-related HCC.

Details of the posters are as follows:

Title Use of LioCyx-M, Autologous Hepatitis B Virus (HBV)-Specific T cell receptor (TCR) T-cells, in Advanced HBV-related Hepatocellular Carcinoma (HCC)
Abstract # 272
Co-corresponding authors Antonio Bertoletti and Fu-Sheng Wang
Presenting Author Fanping Meng
ClinicalTrials.gov number NCT03899415
Title Phase I Study of LioCyx-M, Autologous Hepatitis B Virus (HBV)-Specific T cell receptor (TCR) T-cells, in Recurrent HBV-Related Hepatocellular Carcinoma (HCC) Post-Liver Transplantation
Abstract # 273
Co-corresponding authors Antonio Bertoletti and Qi Zhang
Presenting Author Jintao Cheng
ClinicalTrials.gov number NCT02719782
The full abstracts are attached in this release and are also published online on 8 a.m. EST on Monday, Nov. 9, 2020 in Journal for ImmunoTherapy of Cancer (JITC).

Dr. Reddy’s Laboratories presents preclinical data at SITC 2020 demonstrating significant improvement in tumor growth inhibition and overall survival through a combination of E7777 (denileukin diftitox) and an immune checkpoint inhibitor

On November 10, 2020 Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries together referred to as "Dr. Reddy’s") reported a preclinical data presentation for E7777 (denileukin diftitox), its engineered IL-2-diphtheria toxin fusion protein, at the The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 35th Anniversary Annual Meeting, being held virtually (Press release, Dr Reddy’s, NOV 10, 2020, View Source [SID1234570477]).

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Dr. Anil Namboodiripad, Senior Vice President and Head of Dr. Reddy’s Proprietary Products Division stated, "We are encouraged that in addition to the clinically demonstrated safety and activity of denileukin diftitox in patients with cutaneous T cell lymphoma, these new syngeneic mouse model studies show that E7777 also shows promising activity as a potential immunotherapy agent for treatment of solid tumors. Combination of E7777 with an anti-PD-1 agent provided clear benefit both in terms of tumor growth control, and a highly significant improvement in overall survival. We look forward to conducting clinical trials to further explore this combination."

Key findings from the presentation are included below.

Title: E7777 (Denileukin Diftitox) Enhances Anti-Tumor Activity and Significantly Extends Survival Benefit of Anti-PD-1 in Syngeneic Solid Tumor Models

 E7777 administered as monotherapy inhibited tumor growth with activity comparable to anti-PD1 monotherapy in syngeneic murine tumor models
 Combination of E7777 and anti-PD-1 inhibited tumor growth substantially better than monotherapy treatments Administration of E7777 and anti-PD-1 for a limited treatment period led to highly significant improvements in long-term survival
 Combination of E7777 and anti-PD-1 was administration schedule independent

FY2020 Interim Report

On November 10, 2020 Kureha Corporation reported that (Press release, Kureha Corporation, NOV 10, 2020, View Source [SID1234570476])

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1. FY2020 Half-Year Results (Period April 1-September 30, 2020)  FY2020 1H operating profit: ¥6.2bn (down ¥4.1bn YoY)

• Limited impact of COVID on manufacturing and sales operations
• Challenging market conditions for Advanced Materials with slower automobile and shale oil production
• Primary factors attributing to operating profit:-¥2.9bn operating loss in the PGA business due to lower sales volumes (-¥1.5bn) and temporary cost of sales related to PGA manufacturing facility*(-¥1.4bn) *

There was no resin production at the US PGA plant in the 1H period, and expenses related to the plant were all temporarily recorded as cost of sales (to be incurred as inventory assets after PGA production in 3Q)

-Lower sales volumes in other businesses due to COVID-related economic slowdown, business transfer (blow bottle), effects of mandatory drug price revisions, etc. (-¥1.9bn)-Absence of a discount business purchase gain recorded in prior year (-¥1.5bn)-Lower raw materials and fuel cost (+¥0.9bn)

-Lower SG&A expenses amid COVID (+¥1.3bn) 

Shareholder returns and cash flow
• FY2020 interim dividend: ¥85 per share (same amount as FY2019) FY2020 year-end dividend: ¥85 per share (same amount as FY2019)
• The balance of cash and cash equivalents at the end of FY2020 1H amounted to ¥17.6bn (¥10.3bn up from FY2019 1H end) including cash from sale of investment securities, which will be used for further capital investment while hedging against credit risks amid COVIDRevenue down on lower sales volumes in Advanced Materials, Specialty Chemicals and Specialty Plastics’ packaging materials business, partially offset by higher Construction and environmental business volumes
• Operating profit down due largely to lower PGA volumes and temporary cost of sales related to the US PGA plant combined with the lack of prior year’s bargain business purchase gain, partially offset by margin expansion in environmental businesses
• Profit for the period decreased on lower operating profit and profit before income tax AM: Decline driven by PPS, PGA and carbon products, despite improved earnings for PVDF SC: Decline in industrial chemicals more than offsetting higher profit in agrochemicals SP: Profit even with prior year due to profit increase for fishing lines offset by a decline in packaging materials CO: Profit even with prior year despite higher sales volumes in the civil engineering business OO:

Growth driven by higher environmental engineering business volumesAdvanced plastics PPS: Profit declined on lower volumes for automobile applications and lower equity income in affiliates PVDF: Higher profit driven by volume growth for LiB binder applications, partially offset by declines in other applications PGA: Revenue down on lower frac plugs and stock shapes volumes as shale oil production slowed with falling oil prices; a sharp decline in operating profit resulting from temporary cost of sales related to the US plant (plant expenses temporarily recorded due to no production in 1H) Carbon products Profit down on lower carbon fiber sales volume for automobile and furnace insulation applications Other Profit even with prior year despite higher adhesive sales volumeAgrochemicals Higher profit driven by higher fungicides volumes Pharmaceuticals Profit improved on lower expenses, despite a decline in sales affected by the National Health Insurance drug price revisions Industrial chemicals Revenue and profit decreased due to slower demand for organic and inorganic chemicals amid COVID-related slumpHome products / Fiber products Higher profit driven by volume growth for ‘Seaguar’ fishing lines, despite flat home products sales Packaging materials Profit declined due to slower sales of heatshrink multilayer film in EU and Australia meat markets amid COVID, combined with effects of the transfer of the blow-bottle business (divested in FY2019)

Construction Revenue up on higher number of civil engineering projectsEnvironmental Engineering Profit growth driven by higher industrial waste processing and treatment volumes Logistics Revenue and profit even with prior year Hospital Operations Declines in revenue and profitFY2020 Full-year forecast: ¥14.5bn in operating profit (¥3.5bn down YoY)

• Sales expected to pick up from 3Q onward at a varying speed for each segmentAdvanced Materials exclusive of PGA to record ¥1.1bn increase in operating profit
• Expansion of environmental engineering business driven by higher industrial waste treatment volumes
• Operating profit of ¥14.5bn projected based on core operating profit at ¥15bn (¥1.0bn down YoY) and a ¥2.5bn decrease in the net effect of other income and expenses (gains from fixed asset sales and business restructuring cost recorded in FY2019)

 Capital investment PPS: 5000 ton capacity increase at Iwaki Factory; commercial operations scheduled for February 2021 PVDF: Monomer process enhancements at Iwaki Factory; commercial operations scheduled for April 2022 Revenue decline led by:-Slower PGA demand in sluggish shale market-Effects of the bottle business transfer-Slower demand for industrial chemicals partly offset by-Higher PVDF volume for LiB binder applications-Expansion of the environmental business

• Operating profit down due to lower segment operating profit led by Advanced Materials and a decrease in the net effect of other income and expenses
• Profit before income tax to decrease on lower operating profit
• Profit for the period to decrease on lower profit before income taxAM: PGA-related operating loss more than offsetting PVDF volume growth SC: Improved demand for agrochemicals after prior year’s inventory adjustments SP: Slower sales for packaging materials more than offsetting volume growth of fishing lines CO: Fewer high-margin projects and intensified market competition OO: Higher environmental engineering business volumesAdvanced plastics: Revenue down, profit down

-Negative impact of falling oil prices and slower shale oil production on PGA sales-Slower demand for PPS in auto market

-Robust volume growth of PVDF LiB binder in the EV market supported by environment and economic policies Carbon products: Revenue down, profit down-Decreased sales of carbon fiber used for automobile sliding parts Other: Revenue up, profit up-Increasing demand for high-performance materials in recovering semiconductor and 5G marketsAgrochemicals: Revenue up, profit up-Improved demand for agrochemicals after customers’ inventory adjustments Pharmaceuticals: Revenue down, profit down

-Effects of mandatory drug price revisions and distribution inventory adjustments Industrial chemicals: Revenue down, profit down-Slower demand for organic and inorganic chemicalsHome products & Fiber products: Revenue up, profit up-Continued demand for fishing lines due to increasing popularity of recreational fishing amid the pandemic-Flat sales growth for home products (NEW Krewrap, Kichinto-san series) Packaging materials: Revenue down, profit down-Slower sales of heat-shrink multilayer film in EU and Australia meat markets amid COVID-Effects of the transfer of the blow-bottle business (divested in FY2019)Construction: Revenue down, profit down-Decrease in high-margin construction projects-Intensified market competitionEnvironmental engineering: Revenue up, profit up-Higher industrial waste processing and treatment volumes related particularly to low PCB concentration wastes Logistics: Revenue down, profit down-Slower demand in and outside the Group Hospital operations: Revenue down, profit down-Fewer number of visiting patients

3. Consolidated Companies

4. Supplementary Marketing strategy for business expansion By improving the current PGA frac plugs and offering price flexibility for customers, we aim to promote PGA frac plugs for use in the entire horizontal wellbore and increase sales volume.

② Technological strategy for business expansion As a first step, we will develop a differentiated nonPGA dissolvable frac plug by leveraging our original technologies to enhance the product lineup, and begin to sell the plug in areas with low-tomiddle ground temperatures. Next we will develop a PGA frac plug targeted for the ultra-low-to-low temp areas and expand the sale of PGA frac plugs in all temperature areas.Primary customers are major South Korean and Chinese lithium-ion battery (LiB) makers

• Maintains a roughly 40% share in the automotive LiB cathode binder market

• LiB production was largely disrupted due to COVID during the first six months of FY2020, but the market is rapidly recovering on the back of tighter environmental regulations and economic stimulus policies

• Commenced production and supply of PVDF binder specialty grades at the China Changshu plant in May 2020

• Will continue to study for additional PVDF manufacturing facility, although delayed due to COVID, and will release details including its location (most likely in China) by Spring 2021. Commercial operations of the new plant is scheduled to start in FY2024 Kureha Ecology Management (KEM) leverages its waste treatment technologies for hard-to-detoxify wastes such as industrial wastes with low polychlorinated biphenyl (PCB) concentration and chlorine-and fluorine-based halogen compounds

• In FY2019, KEM acquired full ownership of Himeyuri Total Work Co. which owned a final treatment site for industrial wastesKureha’s basic policy for the distribution of earnings is to strengthen the company overall to realize longerterm growth, prepare for future business expansion, enhance retained earnings, and provide a stable and continued dividend.

◼ Share repurchase allows flexible capital management and is considered as a viable option. *Presently Kureha is closely watching for any credit risks and effects of COVID on the financial market and has no plan to repurchase its own shares. These materials are supplied to provide a deeper understanding of our company, and are not intended to as a solicitation for investment or other actions.

• These materials have been prepared by our company based on the information available at this point in time. However, actual performance may produce results that differ from the plan due to unforeseeable events and factors.

• Please utilize these materials using you own judgment and responsibility.

Phase II Bisantrene trial data published in European Journal of Haematology

On November 10, 2020 Race Oncology Limited (ASX: RAC) reported that the clinical data from the investigator initiated Phase II clinical trial of Bisantrene in relapsed and refractory Acute Myeloid Leukaemia (R/R AML), conducted at Israel’s Sheba Medical Centre has been published (Press release, Race Oncology, NOV 10, 2020, View Source [SID1234570475]).

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This open label, single agent trial, led by Professor Arnon Nagler, studied patients (n=10) with relapsed or refractory Acute Myeloid Leukaemia (R/R AML) who on average had failed three prior lines of treatment. Bisantrene was found to be well tolerated, and after only a single course of treatment, an overall clinical response rate of 40% was observed (ASX Announcement: June 16 2020).

The paper, entitled "A phase II study of Bisantrene in patients with relapsed/refractory acute myeloid leukemia" by Canaani et al. concludes:

"…bisantrene induced clinical responses in 4 of 10 patients with R/R AML with acceptable toxicity. Bisantrene is somewhat similar to Thiotepa and Treosulfan in that an old drug that is being now revisited gaining a lot of interest especially due to better understanding of its intracellular mechanism of action blocking FTO, a recently discovered key factor in leukomogenesis. Further studies are needed to make evidence-based conclusions regarding the candidate role of bisantrene in AML therapeutics. While interventions targeting FLT3, IDH1, IDH2, and hedgehog signalling provide new hope, traditional cytotoxic chemotherapy retains a critical role in AML patient management. We speculate that bisantrene-based chemotherapy may have its greatest applicability to patients with extramedullary disease given the marked activity here observed with leukemia cutis, chloromas, and CNS disease. Our data reveal a particularly encouraging response in this high-risk population and support additional bisantrene clinical trials in R/R AML patients."

SBP to Participate in the 11th Annual Craig-Hallum Alpha Select Conference

On November 10, 2020 Sun BioPharma, Inc. (Nasdaq:SNBP), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with pancreatic cancer, reported it will participate in the 11th Annual CraigHallum Alpha Select Conference to be held virtually on Tuesday, Nov 17, 2020 (Press release, Sun BioPharma, NOV 10, 2020, https://www.sunbiopharma.com/sbp-to-participate-in-the-11th-annual-craig-hallum-alpha-select-conference/?utm_source=rss&utm_medium=rss&utm_campaign=sbp-to-participate-in-the-11th-annual-craig-hallum-alpha-select-conference [SID1234570474]). Management will host one-on-one meetings with investors who are registered to attend the conference. For more information about the conference or to schedule a virtual one-on-one meeting with management, please contact your Craig-Hallum representative. Alternatively, please contact [email protected].

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About SBP-101
SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for the exocrine pancreas and pancreatic ductal adenocarcinoma. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, suggesting complementary activity with an existing FDA-approved chemotherapy regimen. In clinical studies to date, SBP-101 has not shown exacerbation of the typical chemotherapy-related adverse events of bone marrow suppression and peripheral neuropathy. The safety data and PMI profile observed in Sun BioPharma’s current clinical trial provides support for continued evaluation of the compound in a randomized clinical trial.